Issuu on Google+

JOURNAL FOR

Volume 2 - Issue 3

✓ PATIENT COMPLIANCE Strategies to enhance Adherence and Health Outcomes

PEER REVIEWED

Communicating with Patients Common Sense or a “Black Art”? The Significance of Personality In Relation to Adherence Behaviour IVRS In the Service of Patient Adherence Action Duchenne Boys to Men Campaign

www.JforPC.com


Contents JOURNAL FOR

PATIENT COMPLIANCE

6

FOREWORD

Strategies to enhance Adherence and Health Outcomes

Patient Story

DIRECTORS Martin Wright

8

PUBLISHER Mark A. Barker MANAGING EDITOR Mark A. Barker EDITORIAL MANAGER Jaypreet Dhillon EDITORIAL ASSISTANTS Nick Love, Kevin Cross, Lanny McEnzie DESIGN DIRECTOR Ricky Elizabeth RESEARCH & CIRCULATION MANAGER Dorothy Brooks BUSINESS DEVELOPMENT Kristine Saunders ADMINISTRATOR Janet Morton FRONT COVER © iStockphoto PUBLISHED BY Pharma Publications Unit J413, The Biscuit Factory Tower Bridge business complex 100 clements road, London SE16 4DG Tel: +44 (0)20 7237 2036 Fax: +0014802475316 Email: info@pharmapubs.com Journal For Patient Compliance – Strategies to enhance Adherence and Health Outcomes. ISSN 2045-9823 is published quarterly by PHARMAPUBS.

The opinions and views expressed by the authors in this magazine are not necessarily those of the Editor or the Publisher. Please note that although care is taken in preparation of this publication, the Editor and the Publisher are not responsible for opinions, views and inaccuracies in the articles. Great care is taken with regards to artwork supplied, the Publisher cannot be held responsible for any loss or damage incurred. This publication is protected by copyright. 2012 PHARMA PUBLICATIONS Volume 2 issue 3

www.JforPC.com

 ommunicating with Patients – C Common Sense or a “Black Art”? The most frequently encountered reaction to communicating patient information is apathy, and there are many possible reasons for this. The most usual is that patient information is seen as ‘nothing special’, and something that ‘anyone can write’. Lisa Chamberlain James, at Trilogy Writing and Consulting Ltd, discusses why, when a medical writer is finally approached for help with the situation, explaining to clients why their leaflet has failed its readability test or their ‘Dear Doctor’ letters or sales training are not getting the desired results is met with a mixture of irritation and bemusement. Patient CORNER 12 mHealth – From Waiting Room to Living Room According to a recent report by PWC, 59% of mHealth users say it has replaced some visits to health practitioners. Patients see it as giving them easier access to care and greater control over their health, which are surely good things? Perhaps not if you’re a doctor: it is exactly this control that they object to, with 42% worrying that mHealth makes patients too independent. Caroline Criado-Perez and Rochelle Sampy from Eye for Pharma discuss how patient adherence has always been a difficult issue to understand, but a virtual patient system could help to ensure that non-adherence will be easier to tackle in the future. Regulatory & Marketplace 14 Assessment of Medication Adherence: The Next Vital Sign? Medication non-adherence is a common problem encountered in clinical practice. Prior studies have demonstrated that the prevalence of medication non-adherence among patients with hypertension, diabetes, and coronary artery disease can be as high as 50%, and is frequently not recognised by care providers. Ashley Fitzgerald at the University of Colorado and Michael Ho at the Denver VAMC provide an overview of how medication non-adherence has been associated with a broad range of adverse health outcomes across a spectrum of diseases, and results in not only increased healthcare costs, but higher rates of hospitalisations and mortality.

18 Pharma and Consumers: The Packaging Connection Now we have all opened a blister pack at some point and either dropped the pills, punctured the blister foil in our bag, or had the leaflet block the return of the blister to the box. These might seem like small aspects, mild frustrations at most, but when viewed through the eyes of both extra-need groups and medical compliance, these are much bigger issues. James Whittaker at Design Bridge provides an outlook of the growing pressure on pharma products to behave more like FMCG brands and deliver better consumer experiences, especially through the packaging. Pharma needs to appease the needs of consumers and can no longer hide behind the veil of supply chain efficiency.

Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes 1


Contents Behaviour Programmes

Therapeutics

20 The Significance of Personality in Relation to Adherence Behaviour Today adherence is a well-studied health behaviour and we know that poor adherence could be related to different factors such as social/economic status, the treatment, the patient, the condition and/or the health-care team and system. Considering adherence interventions, it has been argued that interventions that both increase adherence and improve treatment outcomes are complex, in that they incorporate an array of strategies. Malin Axelsson at Gothenburg University and University West in Sweden discusses why it has been voiced that there is no single intervention that fits everyone, which emphasises the need for tailored adherence interventions.

30 Quantification of Adherence Initiatives Results Home blood pressure monitoring is a valid way of assessing blood pressure. Although it has been marketed for some decades, quite little is known about the true opinions of the patients using this method. From a pool of 40,000 Finns, a sample of one thousand hypertensive people who had access to e-mail and performed HBPM was randomly selected. Juha Varis and Ilkka Kantola, at Turku University Hospital, discuss why Finnish hypertensive patients have vague ideas about the fundamental benefit of BP treatment, and why they did not measure their BP at home as suggested in the European guidelines.

24 Online Health Information and Patient Adherence Online information is now a key resource for health consumers, with over 80% of internet users looking online for health information. Some researchers have pointed to a complex picture in which internet use may result in an increased impact on health service use, and others have raised the possibility of information overload in which the internet increases patients’ knowledge about their health conditions but leaves them feeling overwhelmed by the information available online and unable to make an informed decision about their own healthcare. Elizabeth Sillence, Claire Hardy, Pam Briggs and Peter Harris at Northumbria University provide an overview of how little is known, however, about the effect of the internet on patient adherence. Clinical Trials 28 IVRS in the Service of Patient Adherence Many interventions targeting patient compliance have been reported in the past, and new technologies have been developed or adapted to support patient adherence. Even though many of the recent solutions—for example, apps— are developed to be as easy as possible, they still require some degree of literacy and, of course, users have to own a technological device to use them. This means that some of the potential users will be excluded from the benefits these tools can offer. Cesare Stefanelli at University of Ferrara discusses how IMS is designed for the user-friendly monitoring of patient adherence in order to maximise the response of any target group, independently of their age or technological abilities.

2 Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes

34 Make no Bones About It: Treatment Adherence is a Challenge in Osteoporosis Osteoporosis is a relatively common chronic condition affecting approximately 50% of women and 30% of men over 65 years of age. It has been estimated that over 200 million people worldwide have osteoporosis, and the prevalence is expected to increase as the population continues to age. Despite the existence of effective treatments to reduce the risk of osteoporotic fractures, patient adherence to osteoporosis treatments is poor and treatment discontinuation is common. Kate Perry at Atlantis Healthcare provides an overview on why patient reasons for treatment non-adherence and discontinuation are multiple and varied. 38 Action Duchenne – Boys to Men Campaign Duchenne Muscular Dystrophy is an incurable muscle-wasting disease affecting 1 in every 3500 male births in the UK. Duchenne is the most common and severe form of muscular dystrophy, and is the most common genetic childhood killer disease. It is caused by a genetic variation in the dystrophin gene. Nick Catlin at Action Duchenne explains the challenges faced by Duchenne patients, and how pharmaceuticals, physicians and healthcare workers may be able to help improve their treatment. 42 Cardiovascular Disease (CVD) Cardiovascular disease poses a significant public health and economic burden to the United States. By 2030, almost half (40.5%) of the US population is projected to have CVD, resulting in total healthcare costs that are estimated to exceed $1 trillion. Patient non-adherence has been described as one of the greatest challenges for success in the treatment and management of CVD. Antoinette Schoenthaler at NYU School of Medicine discusses responses to these challenges and developing new adherence measures to address several of the shortcomings outlined within this article.

Volume 2 - Issue 3


Contents Modern Technology 46 Home Telehealth User Compliance and the Technology Acceptance Model Governments and healthcare agencies around the world are increasingly exploring ways to support older people to remain living within their own homes for as long as possible. Home Telehealth, the in-home remote monitoring of a person’s health, is being trialled as a possible option to assist this to occur. However, despite numerous studies that have investigated the effectiveness of home Telehealth with older people, few have explored safety issues as they relate to this form of healthcare provision. This includes investigation of home Telehealth user compliance. Rachael Wade at Telehealth discusses home Telehealth user compliance as it relates to the Technology Acceptance Model. 50 Impacting Medication Adherence through mHealth - Why Apps are Not Enough Advances in the pharmaceutical industry have had a huge impact on patient health. Today, patients are able to live longer because of the availability of medications. But these pharmaceutical advances only work if patients adhere to their prescribed medication regimens. Medication non-adherence is an issue that payers and providers have grappled with over the years, developing interventions to help remind patients to take their medications correctly. In this article, Greg Muffler at CellepathicRx discusses the ubiquity of mobile phones and the possibilities the technology represents.

54 Therapy Services in a Digital World – The Case for Userfocussed Technology in the NHS At present, although it is clear that we increasingly live in a digital age, the use of technology in statutory services and the NHS in particular, is limited. Where it is used, it tends to focus on hardware equipment or IT infrastructure and systems, as opposed to improving the patient experience and frontline service delivery. The direction of travel suggests that eventually these changes will penetrate the way healthcare is delivered in the UK. James Seward at E-Buddy, and Adil Abrar at Sidekick Studios, discuss why more needs to be done, more quickly, to bring the digital world to NHS service delivery. Drug Delivery, Drug Packaging, Labelling & Dispensing 56 Enabling Greater Product Success through Adherence Packaging Patient non-adherence to prescribed medication is a common problem which significantly impacts patient outcomes, as well as having effects on clinicians, payers such as insurance companies, governments and the overall economy of the global healthcare system. In the US alone the estimated annual cost of poor medication adherence is almost $300 billion, with thousands of hospitalisations and deaths annually occurring as a result of non-compliance. Steve Kemp at AndersonBrecon Europe discusses a largely debated issue for a number of decades, compliance packaging is becoming increasingly recognised in the market as a way to reduce these problems by prompting compliance. 58 Emerging Trends Shaping the Future of Medication Adherence Based on recent patient and prescriber research and extensive experience in implementing comprehensive adherence solutions, the trends identified suggest that effective solutions must address the underlying barriers to adherence with integrated solutions designed to modify behaviour. In this paper, Derek Rago at McKesson Patient Relationship Solutions will review seven emerging trends that will impact the industry’s ability to address all of the challenges that prevent patients from taking their medication as prescribed. Think Tank 62 The Role of Motivational Interviewing in Adherence Programmes Changing a patient’s health beliefs is the first hurdle in medication adherence and a major challenge to overcome for anyone planning an adherence programme. With the patient-centred approach now being embraced by the healthcare industry, the patient is being put at the heart of their own decision-making process. Carole North at 90TEN Healthcare explains how the use of motivational interviewing techniques supports them to take ownership and change their health beliefs. The result is better health outcomes.

4 Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes

Volume 2 - Issue 3


Foreword Welcome to the latest issue of Journal for Patient Compliance. Changing a patient’s health beliefs is the first hurdle in medication adherence and a major challenge to overcome for anyone planning an adherence programme. With the patient-centred approach now being embraced by the healthcare industry, the patient is being put at the heart of their own decision-making process. The use of motivational interviewing techniques supports them to take ownership and change their health beliefs. The result is better health outcomes. This topic is examined more closely in JPC’s Think Tank on page 62. In JPC’s Patient Story section on page 8, Lisa Chamberlain James of Trilogy Writing and Consulting Ltd delves into Communicating with Patients and asks ‘Common Sense or a “Black Art” ‘? Rochelle Sampy on pages 12 and 13 examines the issue of how “Virtual” Patients Could Close the Gap in Patient Adherence and mHealth – From Waiting Room to Living Room. The Regulatory & Marketplace section starts on page 14 with Dr Ashley Fitzgerald and Dr Michael Ho examining issues of Assessment of Medication Adherence: The Next Vital Sign? James Whittaker of Design Bridge looks, on page 18, at the packaging connection in the pharma and consumer relationship. In the Behaviour Programmes section on page 20, Malin Axelsson, a researcher at the Krefting Research Centre at Gothenburg University, examines the Significance of Personality in Relation to Adherence Behaviour. Meanwhile, on page 24, Dr Liz Sillence, Dr Claire Hardy, Professor Pam Briggs and Professor Peter Harris investigate Online Health Information and Patient Adherence issues. The Clinical Trials section on page 28 concentrates in this issue on IVRS in the Service of Patient Adherence, in an article by Cesare Stefanelli and Erika Nerinie. The extensive Therapeutic section on page 30 opens with Quantification of Adherence Initiatives Results by Juha Varis and Ilkka Kantola of Turku University Hospital, Turku, Finland, while on page 34, Dr Kate Perry, Lead Health Psychology Specialist, Atlantis Healthcare, tackles the issue of Treatment Adherence as a Challenge in Osteoporosis. Duchenne Muscular Dystrophy (DMD) is an incurable muscle-wasting disease affecting one in every 3500 male births in the UK. Duchenne is the most common and severe form of muscular dystrophy, and is the most common genetic childhood killer disease. It is caused by a genetic variation in the dystrophin gene. In every town and every city in the UK there will be at least one boy or young man living with Duchenne; get care and research right for Duchenne and you’ve got it right for thousands of others with related conditions. Nick Catlin of Action Duchenne examines this issue by explaining the Boys to Men Campaign on page 36. Antoinette Schoenthaler of NYU School of Medicine examines Cardiovascular Disease, an important topic as, by 2030, almost half (40.5%) of the US population is projected to have cardiovascular disease. Rachael Wade examines Home Telehealth User Compliance and the Technology Acceptance Model, in JPC’s Modern Technology section on page 44, while Michael Wong of the Physician-Patient Alliance for Health & Safety looks into Three Lessons Pain Management Teaches Us About Patient Adherence, on page 48. Greg Muffler of CellepathicRx examines Impacting Medication Adherence Through mHealth, and asks Why Apps Are Not Enough. Issues relating to Therapy Services in a Digital World – The Case for User-focussed Technology in the NHS – are covered by James Seward and Adil Abrar. The Drug Delivery, Drug Packaging, Labelling & Dispensing section on page 56 starts with Enabling Greater Product Success through Adherence Packaging by Steve Kemp of Anderson Brecon. The issues relating to the Emerging Trends Shaping the Future of Medication Adherence are covered by Derek Rago of Mckesson. I hope you enjoy reading this latest edition of JPC, and we look forward to meeting you all at ICSE/CPHI Madrid, at our stand #10B01 in hall 10.

Editorial Advisory Board Andree Bates, Managing Director, Eularis Anna Dirksen, Senior Manager, PSI Behavior Change Chris Penfold, Vice Chairman - East Midlands Packaging Society, Consultant, Freelance Packaging Specialist Carole North, Managing Director, 90 TEN Healthcare Dyan Bryson, Managing Partner/VP Patient Strategy & Outcomes for Inspired Health Strategies Elisabeth Moench, President & CEO of Medici Global Helen Lawn, Managing Director, Helen Lawn & Associates a healthcare PR and communications agency Isabelle Moulon, Head of Medical Information Sector, European Medicines Agency Jay H. Bolling, President and CEO, Roska Healthcare Advertising Joseph Bedford, Director of Marketing Almac Clinical Technologies Laura Bix, Assoc. Prof. School of Packaging Michigan State University Louis A. Morris, Ph.D., is President of Louis A. Morris and Associates, Inc Mark Duman, Managing Director , MD Healthcare Consultants Michael Wong is Managing Director at hcCatalyst Peter van Iperen, Experienced Pharmaceutical Professional Phill Marley, Packaging Account Manager, Global Quality Operations AstraZeneca Ronald E. Weishaar, Executive Director, Observational Research, PharmaNet Development Group Saurabh Jain, Director of Patient Value Services and CME Solutions at Indegene. Steve Kemp, Business Development Director at Brecon Pharmaceuticals and Chairman of HCPC Europe Tassilo Korab, Co-founder of HCPC Europe (Healthcare Packaging Council) Vassilis Triantopoulos, CEO of BIOAXIS Healthcare Walter Berghahn, Executive Director, The Healthcare Compliance Packaging Council

Mark A. Barker 6 Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes

Volume 2 - Issue 3


Patient Story

Communicating with Patients – Common Sense or a “Black Art”? I am very fortunate in my role as a strategic medical writer – clients who recognise that I’ve been doing this for longer than it would be polite to admit often ask for my opinion, rather than just give me a set of instructions and tell me to churn out a document. However, what never ceases to amaze me is that whilst discussions of regulatory strategy can certainly become heated, this is nothing compared with the extremes of reaction seen in discussions about patient information. The most frequently encountered reaction to communicating patient information is apathy, and there are many possible reasons for this. The most usual is that patient information is seen as ‘nothing special’, and something that ‘anyone can write’. Therefore, anyone who has the time or vague inclination is given the task of ‘writing something to go with’ the drug or device. Therefore, when a medical writer is finally approached for help with the situation, explaining to clients why their leaflet has failed its readability test or their ‘Dear Doctor’ letters or sales training are not getting the desired results is met with a mixture of irritation and bemusement. This is all understandable, of course, and one of the skills required of a medical writer is to manage such reactions and minimise any conflict until a happy client, and hopefully a beautiful and effective document, result. However, it’s worth examining the reasons why a lot of patient information is so poorly communicated, as this has far deeper implications. Health literacy can be defined as the ability to obtain, process, and understand the basic health information and services needed to make appropriate health decisions and follow instructions for treatment 1. There is certainly no doubt that health literacy and numeracy have huge impacts on patient engagement, compliance and health outcomes. But this is not affected only by an individual’s general ability to read, write, and understand text and numbers, and certainly not just by their overall ‘intelligence’. An individual’s experience of the healthcare system, the complexity of the information being presented, how the material is being presented or explained, and cultural factors (that may influence how decisions are made) all affect the level of ‘health literacy’ or ‘numeracy’ of any individual at any given time. The quality of patient information is particularly important in the clinical trial setting, when new drugs or procedures are being investigated, and patient understanding of the potential benefits and risks of their involvement is paramount. Poor patient information can lead to both reluctance to join a trial, and poor compliance during it. Additionally, the increasing influence of patient groups should not be underestimated. The European Patients’ Forum has called for patient group involvement in healthcare policy decisions, and Patient View was formed in 2000 to gather together worldwide health non-governmental organisations (including disability groups, carers’ groups, gender-based 8 Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes

groups), work with, and study, these organisations, and is growing continually in numbers and scale of influence. Patient View conducted a survey that ranked the top 30 pharma companies on six indicators, one of which was ‘the quality of the information for patients which it provides’. Failure to take medicines properly is a growing problem, and is very common - 50% of people don’t take their medications as prescribed, and this is responsible for 10% of all hospitalisations and over 125,000 deaths annually in the cardiovascular area alone 2. Shockingly, approximately 10% of adverse drug reactions can be attributed to a communication failure between provider and patient3. Low health literacy is associated with poorer health outcomes and poorer use of healthcare services. It is significantly associated with higher all-cause mortality4, and in the US it is estimated to cost $106-236 billion per year5 . So how severe is the problem of poor health literacy? In a recent study of adults presenting to an average city emergency department in the US, 15.5% had limited health literacy, which was associated with increasing age, male sex, non-English first language, non-white ethnicity, limited education, and unstable housing 6. There is limited information on levels of health literacy in England, however the Skills for Life Survey showed that 1.1 million people in England were functionally illiterate, and approximately 16% of adults have lower literacy skills than those of an average 11-year-old 7. The figures are even worse for numeracy, with 1.7 million people being functionally innumerate, and it is known that people with a lower numeracy level make larger errors in interpreting medicines’ side-effect risk information. It is therefore very likely that for many people, low health literacy acts as a significant barrier to achieving and maintaining good health. The need for effective communication is especially important in vulnerable groups such as the elderly or paediatric populations. The elderly population is increasing (there will be around 72 million individuals aged at least 65 in the US in 2030 8, compared with 38.6 million in 2010 9 and there are increasing numbers of individuals with dementia. Poor reading skills are particularly problematic in the elderly because of their high prevalence of chronic disease and their need to understand healthcare information – often their diseases have complex treatment regimens, and require multiple consultations with different clinicians. Adherence to medicines by children and young people is even worse than that of adults, despite the oversight of parents10. Tackling the problem of poor patient information has its own challenges. We live in an increasingly information-rich environment, and patients are one of the most informationhungry sub-sections. An MHRA survey in 2005 showed that people want more medicines information, and that they value the patient information leaflet more than any other source except doctors and pharmacists. Unfortunately, they do not always understand the patient information they receive. Studies have consistently shown that patient Volume 2 - Issue 3


Patient Story education leaflets are written at an excessively high reading level. One survey showed that almost a third of patients did not understand their medicine label instructions11 and in a UK outpatients study of COPD patients, 15% were not able to use the written information they had been given12. As society becomes increasingly technologically aware, patients are turning to the internet for health information. 80% of internet users look for health information online 13 and a survey of 178 cancer listserv users showed that 35% chose the internet as their preferred source of health information. Given that well-known studies show that patients recall less than 50% of what they are told during their consultations14,15 it is perhaps understandable that patients would turn to the internet for further information or explanation. Unfortunately, not only are there myriad uncontrolled and un-reviewed sites available, but the internet does not necessarily offer more easily understandable healthcare information – even on reputable sites. As examples, information on breast cancer prevention obtained from the National Cancer Institute’s website has been assessed as being written at far too high a level16, and there is marked variation in the quality of available patient information on websites about the treatment options for Crohn’s disease and ulcerative colitis; few of which provide high quality information17. There is no doubt that patient information is important, and high quality information can make a hugely positive impact. It has been shown that patients who received specific preoperative information on the procedure and written instructions on postoperative care experienced less pain, consumed fewer analgesics, and had an earlier return to daily activities 18. So what can be done to improve the degree of health literacy in patient information? The documents need to be written for the right audience. This means taking into account what the reader wants to know, what they need to know, and what they might know already. Patients prioritise four key points of information when they are reading about medicines: the side-effects they might get from the medicine, what to do and what not to do, what the medicine does, and how they should take it. The medical writer’s job therefore is to provide this information in a format the patient can understand and access as easily as possible. Whilst this might sound very straightforward, it is often far from simple, particularly considering that English might not be the first language of the reader, or that they might be affected by mental or visual impairment, or might not be able to read at all (necessitating the careful use of visuals). It takes experience and skill to identify potential hurdles to understanding, let alone to counter them, but there are some general guidelines that can help along the way. To be effective, patient information should focus on eliciting key behaviours from the patient e.g. taking a tablet at the right time, with food — not lengthy and unnecessary detail about biochemistry and pathology. Yet many patient leaflets begin with a lengthy discussion of the disease area or physiology, instead of explaining to the patient what they need to do and why they need to do it. There are a number of tools and techniques which can www.JforPC.com

be employed to make documents more ‘patient-friendly’ such as style and formatting changes, sentence structure, and grammar and vocabulary considerations. Information should be given with short words and short sentences, and only essential information should be included, rather than information overload. Long or unfamiliar words are often difficult to understand, and they slow down reading speed. Content should be limited to one or two key objectives, and should be appropriate for the age and culture of the target audience. The average reading ability of the general public means that text should be written at or below the level of a 12year-old, and short paragraphs and the active voice should be used. Humans have a cognitive preference for picturebased information, and research has shown that using pictures, including cartoons or pictographs with verbal explanations and use of models, can greatly increase patient understanding and retention of information. In one study, mean correct recall of information was 85% with pictographs and 14% without19. Another study found that patients receiving wound care instructions with cartoons were able to answer questions correctly 46% of the time three days later, compared to only 6% of patients who received only written instructions20. However, this should be used with care, as leaflets that become too ‘cartoon-like’ can be perceived as patronising by adults, and all images should be age- and culture-sensitive. Readers will very rarely put effort into trying to decipher what a sentence or paragraph means – they just skim-read it and move on. If the message can’t be gleaned from a quick skim of the text, they will miss the point and the information leaflet is wasted. Using tools like these can lead to more effective communication with patients and thus higher rates of recruitment, retention and compliance in clinical trials, and lower incidence of side-effects, and more effective use of medicines. However, there is also a certain amount of knowledge and expertise needed to refine the documents even further, and so to maximise the effectiveness of the document for its intended audience. Once they have written the text, good medical writers will check it for ‘readability’. Although one well-known tool for this is the Flesch-Kincaid readability score, which is a useful guide for measuring how complex a piece of text is, it also has its drawbacks. The score is based primarily on word and sentence length without considering content or vocabulary. For example, the sentences ‘Cat hat is big sat on a mat. Fox stared mouse nose big hat.’ have a Flesch readability ease score of 100 (the highest possible), showing that they are very easy to read. However, they are total nonsense and impossible to understand. Therefore, it is extremely useful to have patient materials reviewed by people as close to the target audience as possible — ideally patients with limited literacy skills — to ensure that the information in the format it has been written in can be understood and interpreted correctly. The Commission on Human Medicines Expert Advisory Group on Patient Information was convened from 2006–09 to work on improvements to medicines information for patients at both a national and European level, and in 2005, the European Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes 9


Patient Story Commission introduced a requirement for pharmaceutical companies to undertake ‘consultations with target patient groups’ to ensure that patient information leaflets were usable and understandable for patients21. The Commission’s guidance included a recommendation for user testing of patient information leaflets, and this testing is now normal in the EU. User testing involves one-to-one interviews with potential users of a medicine, to determine whether they can find and understand key pieces of information in the patient information leaflet22. The particular needs of specific groups are also being addressed. Children and young people often feel excluded from discussions about medicines, especially regarding sideeffects, but in the UK, a patient information leaflet has been produced for children and young people by a pharmaceutical company in consultation with the University of Leeds and Luto Research Ltd. This leaflet contains an extra section entitled ‘Information for children and young people’, and all the sections are written as though the child or young person taking the medicine is reading them. Low health literacy is a recognised issue in healthcare communications. However, instead of trying to identify vulnerable groups with particularly low health literacy or numeracy, which can be a difficult and often demeaning process for the participants, wouldn’t it be more sensible to make the information understandable and accessible by all? This is not ‘dumbing down’ patient (or doctor, or medical sales training) information. Instead, it is creating written information in a form that all readers prefer. An extraordinary amount of time, effort, and money is put into creating and marketing medicines – doesn’t it make sense to have the patient information written by specialists who can maximise the chance of the medicine being used in the way it was meant to – or even used at all? I have lost track of the number of clients who have looked bemused when I asked about the experience level of the person writing their patient information, and have been told that ‘whoever had time’ had produced the information. Most people believe that writing for patients is ‘common sense’ and that, just like driving well, anyone can write well for patients. Far be it from me to criticise anyone else’s driving, but the road traffic statistics indicate that not everyone is able to drive as well as they might believe ... is it really unreasonable to suggest that not everyone can write as well for patients as they might wish? References 1. Committee on Health Literacy, Institute of Medicine, NielsenBohlman LN, Panzer AM, Kindig DA, eds. Health Literacy: A Prescription to End Confusion. Washington DC: The National Academies Press; 2004. 2. Deshmukh PR and Wasankar SW. Medical Expert System. Advances in Medical Informatics, (2012) ISSN: 2249-9466 & E-ISSN: 2249-9474, Volume 2, Issue 1, pp.-10-13. 3. Institute of Medicine. To err is human: building a safer health system (executive summary). Committee of Quality of Healthcare in America; 2000. http://www.nap.edu/catalog. php?record_id=9728 4. Peterson PN, Shetterly SM, Clarke CL, Bekelman DB, Chan PS, Allen LA, Matlock DD, Magid DJ, Masoudi FA. Health literacy 10 Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes

and outcomes among patients with heart failure. JAMA. 2011; 305(16):1695-701. 5. Ratzan SC. J Health Comm. 2011;16:227-9. 6. Olives T, Patel R, Patel S, Hottinger J, Miner JR. Health literacy of adults presenting to an urban ED. Am J Emerg Med. 2011;29(8):875-82. 7. Skills for Life Survey; 2003. 8. www.nia.nih.gov/Alzheimers 9. h t t p : / / w w w . c e n s u s . g o v / c o m p e n d i a / s ta ta b / 2 0 1 2 / tables/12s0034.pdf 10. Staples B, Bravender T. Drug compliance in adolescents: assessing and managing modifiable risk factors. Paediatric Drugs 2002;4:503–13. 11. Davis TC. Ann Intern Med 2006;145:887-94. 12. Taylor J et al., Eur Respir J. 2005;26:57. 13. PewInternet.org/reports/2011/healthtopics.aspx 14. Falvo D. J Fam Pract. 1998;26:643-7. 15. Schillinger D. Arch Intern Med. 2003;83-90. 16. Hoppe IC. Readability of patient information regarding breast cancer prevention from the Web site of the National Cancer Institute. J Cancer Educ. 2010; 25(4):490-2. 17. Langille M, Bernard A, Rodgers C, Hughes S, Leddin D, van Zanten SV. Systematic review of the quality of patient information on the internet regarding inflammatory bowel disease treatments. Clin Gastroenterol Hepatol. 2010; 8(4):322-8. 18. Makki D, Alameddine M, Al Khateeb H, Packer G. The efficacy of patient information sheets in wrist arthroscopy: a randomised controlled trial. J Orthop Surg (Hong Kong). 2011; 19(1):85-8. 19. Houts PS, Bachrach R, Witmer JT, Tringali CA, Bucher JA, Localio RA. Using pictographs to enhance recall of spoken medical instructions. Patient Educ Couns. 1998; 35:83-88. 20. Delp C, Jones J. Communicating information to patients: the use of cartoon illustrations to improve comprehension of instructions. Acad Emerg Med. 1996; 3:264-270. 21. European Commission. The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005 (SI 2005/2759). 22. Raynor DK, Knapp P, Silcock J et al. “User-testing” as a method for testing the fitness-for-purpose of written medicine information. Patient Education and Counselling 2011; 83:404–10. “This article has also run in the September issue 2012 of EPC” Lisa Chamberlain James is a Senior Partner and CEO of Trilogy Writing and Consulting Ltd., a specialised medical writing company founded in 2002. Aside from management activities, she also contributes to client projects, with extensive experience in a variety of documents. After receiving her PhD in Pathology, Lisa began her medical writing career in Cambridge in 2000. Since then she has also been involved in the European Medical Writers Association (EMWA); she is a member of the EMWA Educational Committee, a leader and assessor of EMWA workshops, has helped to produce the EMWA conference program from 2010 onwards, and holds an EMWA personal development certificate. Lisa is also a member of TOPRA and is a Fellow of the Royal Society of Medicine. Email: lisa@trilogywriting.com Volume 2 - Issue 3


Patient Story

www.JforPC.com

Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes 11


Patient Corner

mHealth – From Waiting Room to Living Room “I hate when they make you wait in the room. ‘Cause it says ‘Waiting Room’, there’s no chance of not waiting. ‘Cause they call it the waiting room, they’re gonna use it. They’ve got it. It’s all set up for you to wait. And you sit there, you know, and you’ve got your little magazine. You pretend you’re reading it, but you’re really looking at the other people. You know, you’re thinking about them. Things like, ‘I wonder what he’s got. As soon as she goes, I’m getting her magazine.’ And then, they finally call you and it’s a very exciting moment. They finally call you, and you stand up and you kinda look around at the other people in the room. ‘Well, I guess I’ve been chosen. I’ll see you all later.’” Wise words spoken from a wise Jerry Seinfeld. But might they be about to lose their universality? Will we look back on them as quaint reminders of a past where everyone was familiar with the interminable wait before you hear the magic words, “the doctor will see you now?” Well, maybe. But before we reach that brave new world, there are a number of obstacles to be overcome, not least doctors themselves. According to a recent report by PWC, 59% of mHealth users say it has replaced some visits to health practitioners. Patients see it as giving them easier access to care and greater control over their health. Which are surely good things? Perhaps not if you’re a doctor: it is exactly this control that they object to, with 42% worrying that mHealth makes patients too independent. The upshot is that only 27% of doctors encourage patients to use mHealth applications, while 13% actively discourage it. The reluctance of doctors to cede control to their patients is partly due to privacy concerns, but there are other reasons too. For example, Professor Chris Taylor claims in the report that “healthcare professionals don’t currently treat as credible any data that is being created [through lifestyle apps].” Unlike doctors, patients can’t be trusted. Even less honourably, a recent article in The Economist suggests that doctors are reluctant to embrace innovations such as mHealth because they see them as a threat to their prestige. PWC’s discovery that it is actually younger doctors who are most resistant to mHealth is therefore compelling: the implication is that younger, more vulnerable doctors are more likely to see themselves as threatened by mHealth. But for all the naysaying, when doctors can really see the benefit of mHealth, they do support it. This was recently demonstrated by the popularity of the NHS Hack Day, which proved such a success that another one has been planned for September.

12 Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes

This event rubbishes the suggestion that doctors are implacably opposed to mHealth: a commentator at The Guardian regretted that most of the apps were geared towards doctors, rather than nurses or patients. If doctors are so against apps, why create so many for themselves? And it’s not just grassroots stuff: the big players are getting involved too. Hot on the heels of the NHS clinical trials app, NICE has launched a BNF prescription drug app. In fact, despite the apparent enthusiasm of patients, they may in fact end up being the real obstacles that mHealth has to conquer: it’s not a total love-in. Give patients a free app and they might play with it for a while, but like any new relationship, the novelty soon wears off: 67% of app-patient relationships break down after six months. Ask them to pay, and they’re nearly always unresponsive, with only a quarter of those questioned paying more than US$5 a month. This is particularly noticeable in developed countries, where patients are used to freeware and the open nature of the internet. With this attitude so firmly entrenched, app developers may find it hard to achieve a decent ROI. But with demand for health services ever-increasing, the model of the physical patient in the physical waiting room seems like the camel’s back waiting for the final straw. Something’s got to give. And there might just be an app for that. Caroline Criado-Perez worked for a number of years in the digital marketing industry before leaving to gain a degree from Oxford University in English Language & Literature. Caroline was runner-up for The Times / London Library Student Writing Prize 2012. Caroline is passionate about the way digital can revolutionise our lives and her focus is on bringing her knowledge and expertise in this area to the pharmaceutical industry.

Volume 2 - Issue 3


Patient Corner

“Virtual” Patients Could Close the Gap in Patient Adherence Recently, Albert Rizzo, a research scientist at the University of South Carolina’s Institute for Creative Technologies demonstrated that a pair of new “virtual” patients can help train psychologists and psychiatrists before treating real patients. A healthcare professional can make their initial diagnosis after asking this patient, who is programmed with speech recognition software, a series of questions about their healthcare history. These virtual characters can be modified for different uses, and Rizzo plans to use them to train military clinicians as funded by the US Department of Defense. In addition to this virtual learning, healthcare trainees will benefit from group discussions with other students and supervisors, as well as receiving observed on-the-job training with real patients. As technology progresses, a comprehensive set of virtual patients with numerous diagnoses can be created. So why can we not use similar training for pharmaceutical companies and physicians in order to improve patient adherence? As AstraZeneca said previously, ‘taking medication isn’t always as simple as swallowing a pill’. In an eyeforpharma podcast about health psychology and non-adherence, John Weinman, head of the department of health psychology at the Institute of Psychiatry, Kings College London said that some patients ignore or modify treatment advice intentionally because as a human being, they think they know what is best for them. So, patient non-adherence is more than just forgetfulness, cost, ineffective communication or treatment side-effects. Similarly, an Express Scripts’ 2011 Drug Trend Report showed that although many American patients recognise the importance of adherence, their behaviours do not match their intentions, as less than half of them take their medication as prescribed. Furthermore, a UCLA study showed that physicianpatient interactions ensured adherence for only 62% of 410 medications while in-depth questions about adherence were asked for only 4.3% of the medications, demonstrating that better methods to recognise non-adherence and change behaviour should be developed. A virtual patient system can create better solutions for patient adherence by mimicking the diversity of patient preferences and characteristics. Although it will only produce results depending on the information it is given, this system can build a range of rare and common symptoms over time. The pharmaceutical industry could communicate with virtual characters through a series of questions to determine different ways to increase patient compliance, whether it is through better communication, regimen guidelines or even packaging. By minimising the occurrence of patient adherence, the pharmaceutical industry would improve their return on investment while giving patients an optimal level of care. In addition, trainee physicians should also be encouraged www.JforPC.com

to use virtual patients in order to learn about the different kinds of questions that they should be asking to determine non-adherence issues with treatment. Physicians could learn how to discuss different treatment topics with patients such as side-effects, quality of life issues or the importance of sticking to a routine. Furthermore, a virtual patient could display intentional non-adherent behaviours so that physicians can be taught how to pre-empt a real patient’s ‘I know better’ attitude. Through understanding how to better their communication and listening skills, physicians can change a patient’s behaviour towards their medication. Patient adherence has always been a difficult issue to understand, but a virtual patient system could help to ensure that non-adherence will be easier to tackle in the future. Initially, all current non-adherence data can be used to design various adherence programmes tailored for an individual patient. Over time, more data will be added to the system from interactions with various real patients, and better solutions for non-compliance can be created with ease by the pharmaceutical industry and physicians. These issues along with the other key challenges in patient adherence, communication and engagement will be taking centre stage at this year’s Patient Summit USA (taking place on 29-30 October in Philadelphia). To see the agenda and full speaker line-up visit www.eyeforpharma.com/patientusa or scan the QR code on the right. If you have any questions or wish to get involved in the event, contact Events Director Laura Barnwell at laura@eyeforpharma.com Rochelle Sampy graduated from the University of Surrey with a 2.1 in Law with International Studies. Previously Rochelle has written for Bauer Media and the South African newspaper and has contributed to the 7th edition CIPA Guide to the Patents Act by the Chartered Institute of Patent Attorneys as well as working for the European Healthcare Fraud and Corruption Network, Brussels. Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes 13


Regulatory & Market Place

Assessment of Medication Adherence: The Next Vital Sign? Medication non-adherence is a common problem encountered in clinical practice. Prior studies have demonstrated that the prevalence of medication nonadherence among patients with hypertension, diabetes, and coronary artery disease can be as high as 50% and is frequently not recognised by care providers1, 2, 3. Medication non-adherence has been associated with a broad range of adverse health outcomes across a spectrum of diseases, and results in not only increased healthcare costs, but higher rates of hospitalisations and mortality 4,5. Interventions to improve adherence to date have achieved modest success, and can be potentially implemented in routine clinical care to improve adherence. However, non-adherence is frequently unrecognized, and an important first step towards improving adherence for patients may be to identify the problem. Accordingly, the assessment of medication non-adherence should be incorporated into the routine vital signs that patients receive at the beginning of their clinic/physician visits. This assessment may highlight to the patient the importance of medication adherence, and can begin the discussion between patients and providers about ways to address non-adherence if identified. While the assessment of nonadherence in and of itself will not improve adherence, it will at least place the problem at the forefront of the clinic visit so that potential solutions can be explored and interventions implemented to address non-adherence. Hence, we propose that the assessment of medication non-adherence should be considered the next vital sign, in addition to blood pressure, heart rate and oxygenation saturation, that is routinely obtained, since recognition of non-adherence is an important first step towards addressing this common problem, especially for patients taking medications for chronic conditions. The objectives of this article are to review the most common methods of measuring and identifying nonadherence, particularly if the assessment of non-adherence is to be incorporated as a vital sign, and to discuss potential interventions that can be implemented in daily clinical practice to improve patient adherence, and future directions for addressing this challenging issue. Methods of Measuring Adherence: The literature has often defined medication adherence as the act of the patient conforming to the provider’s recommendations in regard to the timing, frequency, and dosage of medications taken. However, medication adherence should be viewed more broadly as a shared agreement between the patient and the provider about a medication regimen, to be taken by the patient, with the 14 Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes

end goal of improving patient outcomes. More specifically, adherence is thought to be synonymous with compliance and has been defined as the intensity of drug use during the duration of therapy. In contrast, persistence is defined as the duration of treatment from the time of initiation of a medication until discontinuation, and can be thought of as the overall duration of drug therapy 6,7,8,9. Measuring adherence to medications can be divided into two broad categories: direct and indirect. Direct methods include direct observed therapy, measurement of drug levels or a metabolite in the blood or urine, and measuring biological markers that have been added to the drug 10,11,12. Direct methods are thought to be more robust and accurate compared to indirect methods; however, they are more costly and not always practical for use in real-world clinical practice. Indirect methods of assessment include patient surveys, patient diaries, self-reports, pill counts, rate of prescription refills through the use of pharmacy data, assessment of the patient’s clinical response, electronic medication monitors, and measurement of physiologic markers. Of these indirect methods, the most commonly used are patient self-report, pill counts, and pharmacy refills10. Indirect methods of assessing medication adherence are more practical in everyday clinical practice. Of these, patient self-reporting is a method that can be employed easily and relies on a trusting and engaging relationship between the patient and their provider if it is to be used accurately. Prior literature has shown that self-report of medication non-adherence has high specificity, with one study showing that self-report of non-adherence was strongly associated with adverse cardiovascular events including myocardial infarction, stroke, and coronary heart disease death 13. Although prior research has shown an association between self-report of non-adherence and adverse patient outcomes, self-report can be biased by inaccurate recall or by the influence of social desirability, where patients may overestimate the level of adherence to gain approval of their providers. Pill counts represent another simple method to measure adherence, and is frequently used in randomised controlled trials. However, pill counts alone are unable to capture the timing of medication-taking, which can be a crucial component of therapy and may be time-consuming to perform when patients are on multiple medications. Both self-report and the use of pill counts represent two methods of measuring adherence that are straightforward and can be utilised in clinical practice as part of the vital signs that patients receive at the beginning of their clinic visit. One of the most commonly used methods for measuring adherence in research studies is the use of electronic pharmacy data. Currently, the two most common measures used are the proportion of days covered (PDC) and the Volume 2 - Issue 3


Regulatory & Market Place

medication possession ratio (MPR). These measures are typically defined as the ratio of the total days a medication is supplied over the total observational time period10,11,12. With pharmacy refill data, patients with medications available 80% of the time have generally been thought to be adherent. Although this definition is arbitrary, this has been a commonly used definition in both randomised controlled trials and observational studies10. One of the major advantages to using the pharmacy database as the method of measuring adherence is the ability to identify a large population of patients and their adherence to medications in a timely and efficient manner. Furthermore, prior literature has validated adherence based on pharmacy refill data with a broad range of patient outcomes 1. The disadvantages of using MPR and PDC are that these measures only capture the quantity of doses taken and not the timing of doses. Further, pharmacy refill data is dependent on a closed pharmacy system in order to ensure the accuracy of data collection, and identifies medication acquisition, but not actual medication consumption10, 11, 12. Although the PDC and MPR are commonly used in the literature as means to measure adherence longitudinally, it may not be a practical approach in routine clinical care. One potential alternative is to evaluate gaps in refills. Assessment of refill gaps can often be obtained from a quick review of the medical record in healthcare settings where the pharmacy is integrated within the same healthcare system, and may actually represent a practical point of care method for providers to screen for non-adherence. Gaps in refills can be assessed based on the dates of when a prescription is www.JforPC.com

filled and the number of days of pills supplied. For example, if a patient fills a 90-day prescription on August 1, he or she would run out of medications by October 29. If the patient filled their medications again on November 14, this would represent a gap of approximately 16 days in therapy, suggesting that the patient may have been non-adherent during that time interval (e.g., missed intermittent doses and/or missed about two weeks of therapy). The assessment of gaps in refills can also be performed by ancillary support staff as part of the vital signs taken at the beginning of a clinic visit, and if gaps are identified, this information can be given to the care provider to address during the visit. In summary there are both direct and indirect methods of measuring patient adherence, which include the methods listed below. Of these methods of measurement, the most practical and easy to utilise in clinical practice are patient self-report and the assessment of refill gaps in those healthcare systems where pharmacy refill data is available. Direct methods o direct observed therapy, o m easurement of a drug level in the blood or urine Indirect methods o Self-reporting o Pill counts o Electronic medication monitors o Patient surveys o Assessment of refill gaps o Measuring pharmacy refills using PDC and MPR Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes 15


Regulatory & Market Place Methods to Improve Adherence: While there have been multiple studies that have demonstrated an association between medication nonadherence and adverse patient health outcomes, less is known about the methods that can be implemented in clinical practice to improve patient medication taking behaviours. One study discussed four major components that should be taken into consideration when developing a plan to improve patient adherence 12. One critical component is that of education. Patient education should involve not only the patient, but family and other support members. Furthermore, this allows for the development of patient autonomy and control over their medical care. Improved dosing schedules, which includes utilising daily dosing whenever possible, pill boxes, and medication reminders are also other crucial components to consider. Third, clinical scheduling strategies with close follow-up following hospital discharge, and interventions that require the involvement of ancillary staff to focus on medication-taking, have been shown to improve adherence. Finally, better communication between healthcare workers, ancillary staff and the patient is essential to improving patient adherence. It tends to lead to a more trusting and open relationship between the patient and the provider, and helps improve the reliability of self-reporting. An important component to improving medication adherence, and hence patient outcomes, is to first understand potential reasons for non-adherence and then targeting these specific factors with appropriate interventions. Adherence is a complex behavioural process, and major factors that have been defined in the literature that lead to poor adherence include age, socioeconomic status (income, education, occupation), complexity of medication regimen, and social support and participation. Other studies have divided the reasons for medication nonadherence into broad categories: 1) the healthcare system; 2) the condition being treated; 3) patient characteristics; 4) therapy-related factors; and 5) socioeconomic factors 10. Further research is needed on how best to target the patient and system level variables that tend to impact poor adherence. Current literature has demonstrated that most interventions targeting medication adherence have a modest effect. Unimodal interventions, such as reducing the number of daily doses of medications, motivational strategies, packaging medications into special containers (pill boxes or blister packs), providing education to patients, and more frequent and convenient care, have some success. For example, Smith et al. demonstrated that informational mailings on beta-blocker therapy mailed to patients recently discharged following acute myocardial infarction resulted in an absolute increase of 4.3% of days covered monthly for beta-blocker medications compared with usual care, and a 17% relative increase in the likelihood of being adherent to this therapy 14. A prior systematic review evaluated simplifying the dosing regimen among patients with dyslipidemia and hypertension, and found that this simple medication change results in improved adherence 15. As highlighted above, there are often multiple factors that lead to non-adherence, and hence unimodal interventions 16 Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes

have been less successful because they may not target all of the reasons for non-adherence10. Multimodal interventions have shown greater success towards improving patient adherence and outcomes. Prior studies have found that combinations of these interventions, including patient reminders, pill counters, rewards for adherence, and/or support groups have improved patient adherence10. Piette et al. demonstrated improved medication adherence among diabetic patients who received direct feedback which consisted of bi-weekly health assessments and education calls. Furthermore an automated telephone system was used to assess the patients’ symptoms and satisfaction with their care 16,17. Among heart failure patients, a pharmacist-driven intervention, consisting of assistance with medication management among patients with low health literacy and limited resources also improved medication adherence18. Finally, Lee et al. demonstrated that randomising patients to an educational intervention, medication reminders, and frequent clinic visits demonstrated improved adherence along with better systolic blood pressure and LDL cholesterol control19. In general, multimodal interventions tend to be more successful than unimodal interventions because they address the multiple reasons for non-adherence. Regardless of what modality or combinations of modalities is to be utilised to improve adherence, the identification of medication non-adherence is a necessary first step. As such, incorporating the assessment of medication non-adherence as part of the vital signs taken during a clinic visit is essential. Once non-adherence is identified, the previously identified successful intervention or combinations of interventions can be implemented based on patient preferences and needs. Future Directions: Successful interventions to date have often been multimodal, however implementation of such interventions in daily clinical practice has remained challenging, given that they are often resource-intensive. Since multiple patient and system variables often play a role in medication nonadherence, a multi-faceted approach to this problem moving forward is essential. New innovative strategies are needed that are both practical and can be utilised in daily clinical practice. However, it is going to be extremely important to take what has been learned from prior research, and utilise this as a foundation. The following components are essential to consider when trying to implement strategies to improve medication adherence. • Patient education that gives the patient more autonomy and allows for them to be engaged in their own healthcare is crucial • Simplified dosing schedules with the utilisation of oncedaily dosing whenever possible • Close clinical follow-up, especially in the period following hospital discharge • Building a firm relationship with open communication between the patient and the provider Finally, more research is needed to better understand the Volume 2 - Issue 3


Regulatory & Market Place relationship between adherence and healthcare costs. Financial incentives that will help promote improved medication adherence may be an important component. A prior study demonstrated that full coverage for cardiovascular medications after an acute myocardial infarction improved medication adherence, although it did not affect the primary clinical outcomes of interest20. In conclusion, patient non-adherence is associated with a broad range of adverse outcomes. Multiple methods have been utilised in the literature to measure adherence, including patient self-report, and assess gaps in refills using pharmacy data. While there are several approaches that have demonstrated success in improving adherence, there is a continuing need for the development of new and innovative strategies. Further research is crucial to develop clinically practical and cost-effective methods to improve patient adherence, and hence health outcomes. However in order to move forward in these efforts, medication nonadherence must first be recognised and viewed as a “vital” piece of information to the clinic visit. References: 1. Ho PM, Rumsfeld JS, Masoudi FA, McClure DL, Plomondon ME, Steiner JF, Magid DJ. Effect of medication nonadherence on hospitalization and mortality among patients with diabetes mellitus. Arch Intern Med. 2006;166:1836-1841. 2. Ho PM, Spertus JA, Masoudi FA Reid KJ, Peterson ED, Magid DJ, Krumholz HM, Rumsfeld JS. Impact of medication therapy discontinuation on mortality after myocardial infarction. Arch Intern Med. 2006;166:1842-1847. 3. Cramer JA. Consequences of intermittent treatment for hypertension: the case for medication compliance and persistence. Am J Manag Care. 1998;4:1563-8. 4. Ho PM, Magid JD, Shetterly SM, Olson KL, Maddox TM, Peterson PN, Masoudi FA, Rumsfeld JS. Medication Nonadherence is associated with a broad range of adverse outcomes in patients with coronary artery disease. Am Heart J. 2008;155:772-779. 5. Fitzgerald AA, Powers JD, Ho PM, Maddox TM, Peterson PN, Allen LA, Masoudi FA, Magid DJ, Havranek EP. Impact of medication nonadherence on hospitalizations and mortality in heart failure. J Card Fail. 2011;17:664-9. 6. Delamater AM. Improving patient adherence. Clin Diabetes. 2006;24;71-77. 7. M  eichenbaum D, Turk DC. Facilitating Treatment Adherence: A Practitioner’s Guidebook. New York, NY: Plenum Press; 1987. 8. Caetano PA, Lam JM, Morgan SG. Toward a standard definition and measurement of persistence with drug therapy: examples from research on statin and antihypertensive utilization. Clin Ther. 2006;28:1411-1424. 9. Cramer JA, Roy A, Burrell A, Fairchild CJ, Fuldeore MJ, Ollendorf DA, Wong PK. Medication compliance and persistence: terminology and definitions. Value Health. 2008;11:44-47. 10. H  o PM, Byrson CL, Rumsfeld JS. Medication Adherence: Its Importance in Cardiovascular Outcomes. Circ. 2009;119:3028-3025. 11. A  ndrade SE, Kahler KH, French F, Chan KA. Methods for evaluation of medication adherence and persistence using automated databases. Pharmacoepidemiol Drug Saf. www.JforPC.com

2006;15:565-574. 12. Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005;353:487-497. 13. Gehi AK, Ali S, Na B, Whooley MA. Self-reported medication adherence and cardiovascular events in patients with stable coronary artery disease: the Heart and Soul Study. Arch Intern Med. 2007;167:1798-1803. 14. Smith DH, Kramer JM, Perrin N, Platt R, Roblin DW, Lane K, Goodman M, Nelson WW, Yang X, Soumerai SB. A randomized trial of direct-to-patient communication to enhance adherence to beta-blocker therapy following myocardial infarction. Arch Intern Med. 2008;168:477-483. 15. McDonald HP, Garg AX, Haynes RB. Interventions to enhance patient adherence to medication prescriptions: scientific review. JAMA 2002;288: 2868-79. 16. Piette JD, Kraemer FB, Weinberger M, McPhee SJ. Impact of automated calls with nurse follow-up on diabetes treatment outcomes in a Department of Veterans Affairs Health Care System. Diabetes Care. 2001;24:202-208. 17. Piette JD. Interactive voice response systems in the diagnosis and management of chronic disease. Am J Manag Care. 2000;6:817-827. 18. Murray MD, Young J, Hoke S, Tu W, Weiner M, Morrow D, Stroupe KT, Wu J, Clark D, Smith F, Gradus-Pizlo I, Weinberger M, Brater DC. Pharmacist intervention to improve medication adherence in heart failure: a randomized trial. Ann Intern Med. 2007;146:714-725. 19. Lee JK, Grace KA, Taylor AJ. Effect of a pharmacy care program on medication adherence and persistence, blood pressure, and low-density lipoprotein cholesterol: a randomized controlled trial. JAMA. 2006;296:2563-2571. 20. Choudhry NK, Avorn J, Glynn RJ, Antman EM, Schneeweiss S, Toscano M, Reisman L, Fernandes J, Spettell C, Lee JL, Levin R, Brennan T, Shrank WH; Post-Myocardial Infarction Free Rx Event and Economic Evaluation (MI FREEE) Trial. Full coverage for preventive medications after myocardial infarction. N Engl J Med. 2011 Dec 1;365(22):2088-97. Epub 2011 Nov 14.

Dr Ashley Fitzgerald is currently a 3rd year cardiology fellow at the University of Colorado Anschutz Medical Campus and is working on her Master’s of Clinical Sciences degree. She plans to spend the next two years of her training as an outcomes research fellow with the Denver VA with a focus on patient medication adherence and health outcomes. Email: ashley.fitzgerald@ucdenver.edu Dr Michael Ho is currently a Staff Cardiologist at the Denver VAMC, and Associate Professor of Medicine at University of Colorado Denver. His research has focused on describing the prevalence of non-adherence to prescribed cardiovascular medications and understanding reasons for non-adherence. He is currently testing several novel interventions to improve adherence to cardiovascular medications. Email: michael.ho@va.gov Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes 17


Regulatory & Market Place

Pharma and Consumers: The Packaging Connection As the pharma industry sees an increasing move from RX to OTC, there is growing pressure on pharma products to behave more like FMCG brands and deliver better consumer experiences, especially through the packaging. Pharma needs to appease the needs of consumers and can no longer hide behind the veil of supply chain efficiency. Now we have all opened a blister pack at some point and either dropped the pills, punctured the blister foil in our bag or had the leaflet block the return of the blister to the box. These might seem like small aspects, mild frustrations at most, but when viewed through the eyes of both extra-need groups and medical compliance, these are much bigger issues. Compliance, or rather non-compliance, is anything from forgetting to take the pills or ignoring the regimen, to taking the wrong dosage, but to put this into context; compliance was quoted as the biggest issue in pharma today, costing society some $30bn and 125,000 lives a year in the US alone. These are significant figures, and I use the word ‘society’ as non-compliance results in higher insurance premiums, reduction in workforce output and perhaps most importantly, family members no longer with us. Compliance is important, yet poor packaging increases non-compliance. However it is also extra-need groups like the elderly that suffer at the hands of poorly designed packaging, as anyone over 65 with arthritis will tell you. Taking childproof caps as an example, they are great for protecting the young, but this comes at the expense of the elderly as they try and close painfully arthritic fingers around a stiff, small diameter cap. This might not be as ‘costly’ as non-compliance, but as the elderly are the biggest growing segment of society, there is a need to deliver better and more considered experiences to them as well (and in part, to aid compliance). A Shift in Priority Now when viewed from a distance, the role of pharma is simple; help improve the lives of the sick and poorly through the delivery of drug-based solutions. ‘Making lives easier’ could be the headline, so how does it make sense that many of the packaging experiences increase difficulty (and in some cases cause physical pain too)? The answer lies in two areas, namely supply chain efficiency and regulation, and they co-conspire to lead us to where we are today: finance and the drive for economies-ofscale dictate that we mostly get the cheapest possible pack, and regulation ensures we are ‘protected’ against packaging and products that can maim or hurt us. Both seem like noble causes, but neither delivers a positive product/packaging experience, and this is where both the challenge and the opportunity lie. 18 Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes

If we take a quick look towards FMCG though, we can see a different balance of priorities that take the consumer much more into account, and while ‘FMCG’ can cover many products, there are a selection of products like headache pills, insecticides and drain cleaners that have more regulations than other FMCG items. A good place to look is therefore the growing crossover between pharma and FMCG to see where the future might lie, and excitingly there are good examples of consumer-centric packaging already emerging. Consumer-centred Design Many brands inhabit this crossover point, and Nurofen is a good starting example, being a linear pharma product but with the portfolio and architecture of an FMCG brand. Their innovations in packaging include the Vegas protective case, and in product format include gels, liquid capsules and regular pills. They all adhere to regulations but take steps to answer some of the challenges besetting traditional pillbased drug delivery, like puncturing the blister. This is also not dissimilar from ProPlus where the traditional card box has been replaced by a protective case. ProPlus sits somewhere between pharma and energy, so is again a good reference for where RX ‘brands’ might head in the future. These are both fairly simple containers, but MeadWestvaco’s Volume 2 - Issue 3


Regulatory & Market Place

on by getting rid of it entirely! The tablets now come in a plastic tube, doing away with the potential for blister failure, and they even comment on the shift in experience in their communication: ‘The lozenges are tightly packed in an airtight tube so there’s no fuss or fiddling with packaging’.

‘Shellpak’ takes this one step further, and with a unique opening method the blister is truly childproof, but still provides blister protection along with a calendarised blister. All of the above solutions are interesting, but more so because the material in the blister can also be light-weighted through less fear of puncturing the foil.
 Coming back to pain relief for a moment but in a different format, the ClearRX bottle from Target in the US also answers challenges in pill delivery. Misreading of information and taking the wrong pills are big and potentially lethal issues for consumers and therefore the pharma industry, but ClearRX has colour-coded rings to help you easily identify your pills, as well as much larger label areas to aid in regimen communication, both economic ways to address the miscommunication. Now while this might be an RX product, for years it has also been an icon for good consumer-centred design in pharma (and a leader in its class!). In a different product area entirely, namely powders, even a simple solution like the moulded container, powder scoop and easy-peel foil mean that Nutricia’s Nutrilon baby milk formula packaging can be opened, used and closed with one hand while balancing ‘junior’ in the other. Again a class-leading example. Finally, Strepsils also lies in this crossover space, and their ‘Handy Tube’ has tackled the challenges with a blister head www.JforPC.com

Naturally Human So we can see in the above that many pharma brands are already listening more intently to the consumer’s needs, and the result is invariably higher sales, stronger consumer connection and of course a better consumer experience. Good signs for the consumer, and the rest of pharma should sit up and take note, but interestingly this innovation also has a few market side-effects which are worth noting: Firstly the market is getting tougher for newcomers; the competition in branded pharma is getting ever hotter, which means new entrants have a bigger task to stand out and be credible. Secondly the consumer’s demands are being well met in branded pharma and it will not be long before they place the same demands on core pharma products, meaning a bigger need for packaging innovation. Finally, the products and packaging that were once overtly clinical are increasingly humanising and trading in emotional values familiar to consumers. They look more like brands and talk in a language that consumers can connect to, and this enables better connection and ultimately might also aid compliance. As pharma moves from RX to OTC and ultimately into the branded space, it has no choice really but to answer the consumer’s questions, and class leaders like the above are showing the way. However this is no bad thing as, after all, the end goal of pharma is not the supply chain, but about you and me, consumers and humans. James Whittaker is the Head of 3D Branding and Innovation at Design Bridge in Amsterdam and has been creating compelling branded 3D experiences across numerous industries for 20 years. He has worked on product and packaging for top 100 global brands and he has won international design awards including the Red Dot and IF awards twice. James is originally from England where he completed his Masters degree in ‘Design, Strategy and Innovation’ at Brunel University. Email: james.whittaker@designbridge.com

Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes 19


Behaviour Programmes

The Significance of Personality in Relation to Adherence Behaviour

Adherence Behaviour That people are not adherent to prescribed treatment is not a modern phenomenon, but one with historic wings. A long time ago, in ancient Greece, Hippocrates noted that his patients did not always follow treatment recommendations. However, the most famous incident of so called non-adherence is probably when Eve, in the Judeo-Christian tradition, ate the apple from the tree of knowledge in the Garden of Eden, despite having been advised not to. 1 Today adherence is a well-studied health behaviour, and we know that poor adherence could be related to different factors such as social/economic status, the treatment, the patient, the condition and/or the healthcare team and system. 2 The dilemma with poor adherence is that it could have negative consequences for the existing health condition. Simultaneously, inadequate adherence could prevent an accurate evaluation of the prescribed treatment. 3 From an economic perspective, poor adherence could lead to both increased costs due to more frequent utilisation of healthcare 4,5 and a reduction in productivity 3 due to impaired functioning and disability. 6 The World Health Organization has emphasised that striving for improving adherence to long-term treatments is equal to working with patient safety, because increased adherence most likely would minimise the risk for poor disease control. 2 Despite the large body of adherence research, the dilemma with poor adherence seems to persist. 3,7 An estimation of adherence to prescribed long-term treatments is 50%, and even lower in developing countries. 2 Adherence should be regarded as a multifaceted behaviour, which requires sufficient resources in terms of time and ability to allow for healthcare staff to promote this health behaviour. 8 It is also of great importance that healthcare professionals have sufficient knowledge of adherence behaviour as well as of effective methods to improve adherence. 2 Considering adherence interventions, it has been argued that interventions that both increase adherence and improve treatment outcomes are complex in that they incorporate an array of strategies. Still they do not seem to result in large improvements. 9 It has been stated that there is no single intervention that fits everyone, 3 which emphasises the need for tailored adherence interventions. To enable such interventions, knowledge of potential personal needs regarding adherence support is warranted. In this respect, personality could serve as a useful guide. 20 Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes

Personality Perhaps it is reasonable to say that adding personality as an influential factor on adherence to medication treatment has been inspired by what Hippocrates once noted: “It is more important to know what sort of person has a disease than to know what sort of disease a person has.” Hippocrates, 460 BC - ca. 370 BC This quote from Hippocrates could be interpreted by stating that people are different, and that these individual differences may influence their disease management. At the initiation of the research project that I am involved in, it was regarded as a rather novel entrance to the field of adherence research when personality was added as a potential determinant of adherence behaviour. Although some studies describing associations between personality and adherence already existed, it was argued that these did not provide enough evidence to draw any conclusions. 10 Personality has great influence on our thoughts, feelings and behaviour, and could be defined as “psychological qualities that contribute to an individual’s enduring and distinctive patterns of feeling, thinking and behaving” (p.8). 11 There exist several personality theories, but one that has gained ground in recent decades is the five-factor model of normal personality. According to this theory personality could be described in terms of five broad and bipolar personality traits: neuroticism, extraversion, openness to experience, agreeableness and conscientiousness. These five personality traits represent the highest hierarchical level, and each of them consists of facets containing more specific personality traits. 12 People are characterised by the degree to which they show these five personality traits in their thoughts, feelings and behaviour. It is to be noted that the personality traits remain rather stable in adulthood and that they appear and function quite similarly across cultures, and in both men and women. 13 Personality and Adherence Neuroticism measures degrees of emotional stability. 11 People with high scores on this trait are more likely to be worried and anxious, with difficulties handling stress and controlling their desires. People scoring low on neuroticism could be described as emotionally stable, which means that they are more likely to be even-tempered and able to face stressful situations calmly. 12 In order to determine the significance of personality in relation to adherence to Volume 2 - Issue 3


Behaviour Programmes

medication treatment, we conducted a population-based study including participants with various chronic diseases, such as, for instance, hypertension, asthma, diabetes and depression. We could show that participants with high scores on neuroticism were less prone to be adherent to long-term medication treatment. 14 Similar associations between neuroticism and adherence have also been found in other studies based on reports from people living with multiple sclerosis 15 and asthma. 16 Agreeableness includes the quality of interpersonal interaction, 11 meaning that people with high scores on this trait are likely to be altruistic, sympathetic and helpful to others. Moreover, they are more inclined to cooperate. People with low scores on this trait are more likely to be egocentric and sceptical about other people’s intentions. They are also more inclined to be competitive instead of being cooperative. 12 With reference to adherence behaviour, we could show that agreeableness had a positive impact on adherence to medication treatment in people with chronic disease. 14 Similar associations have also been found in candidates for liver transplantation. 17 In a study among young adults with asthma, we could show that men with high scores on antagonism reported poorer adherence to asthma medication treatment. 18 Antagonism is a health-relevant facet of agreeableness, and a person with higher scores on antagonism could be described as being reluctant and sceptical in disposition. 19 Conscientiousness measures the degree of motivation in goal-directed behaviour. 11 People with high scores on this trait could be described as being reliable, scrupulous www.JforPC.com

and well-organised. In comparison, people with low scores on conscientiousness are more likely to be relaxed when it comes to achieving goals, and tend to be somewhat disorganised. 12 Conscientiousness is the trait that most frequently has been associated with adherence behaviour. In the population-based study that we conducted, we could show that the participants with high scores on this trait were more inclined to be adherent to prescribed medication treatment. 14 This finding is consistent with reports from other studies describing how high scores on conscientiousness in patients undergoing renal dialysis, 20 patients with HIV21 and patients who have been prescribed cholesterol-lowering medications 22 were associated with better adherence. It should be mentioned that there exists at least one study that failed to show any clear associations between medication adherence and conscientiousness. 23 However, based on reports from young adults with asthma, we could show that participants with an impulsive personality were less adherent to prescribed asthma medication treatment. 18 Impulsivity is a healthrelevant facet of conscientiousness, and a person with high scores on impulsivity is less inclined to plan ahead, but rather to act on the spur of the moment. 19 Conclusion Based on the current presentation, it could be reasonable to argue that personality is of significance in relation to adherence behaviour. The advantage of combining personality with adherence behaviour is that it could help to identify people in need of adherence support. Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes 21


Behaviour Programmes At the same time it may become evident that no single intervention can fit everyone. The “worrying kind of person” scoring high on neuroticism may need adherence support including strategies to tackle emotional expressions. Another personality characteristic that should be identified in relation to adherence behaviour is low levels of agreeableness. People scoring low on this trait could be described as being antagonistic and sceptical about other people’s intentions and less inclined to cooperate. 12 It could be speculated that these behavioural tendencies may have a negative influence on adherence behaviour. This may indicate that the first priority should be to build mutual trust between the patient and the healthcare professional for a successful adherence outcome. Another personality characteristic that it is essential to recognise is people with low scores on conscientiousness, because they seem predisposed to poor adherence behaviour. People at the lower end of this personality trait tend to be somewhat unstructured and aimless in disposition, 12 which may explain their adherence behaviour. It could be assumed that these persons need adherence support in terms of integration of routines or reminders for their medication intake. Using personality could guide us to identify people who need adherence support, and contribute to an increased awareness that people need support of various kinds. References 1. H aynes RB. Compliance in health care. Baltimore: Johns Hopkins U.P., 1979. 2. S abate E, editor. Adherence to long-term therapies: evidence for action. Genova: World Health Organization, 2003 http://www.emro.who.int/ncd/Publications/ adherence_report.pdf. Accessed: 2012-09-04. 3. L evensky ER, O’Donohue, William T. Patient adherence and nonadherence to treatments. In: O’donohue WT, Levensky, Eric R., editor. Promoting treatment adherence: A practical handbook for health care providers. Thousand Oaks, CA: Sage Publications, inc, 2006:3-14. 4. B ender BG, Rand C. Medication non-adherence and asthma treatment cost. Curr Opin Allergy Clin Immunol 2004;4(3):191-5. 5. S okol MC, McGuigan KA, Verbrugge RR, Epstein RS. Impact of medication adherence on hospitalization risk and healthcare cost. Med Care 2005;43(6):521-30. 6. Cook PF. Adherence to medications. In: O’donohue WT, Levensky, Eric R., editor. Promoting treatment adherence: A practical handbook for health care providers. Thousand Oaks, CA: Sage Publications, inc, 2006:183-202. 7. D unbar-Jacob J, Mortimer-Stephens MK. Treatment adherence in chronic disease. J Clin Epidemiol 2001;54 Suppl 1:S57-60. 8. K ing NM. Ethical issues in lifestyle change and adherence. In: Shumaker SAO, JK Riekert, KA, editor. The handbook of health behavior change. New york, NY: Springer Publishing Company, LLC, 2009:757-70. 9. H aynes RB, Ackloo E, Sahota N, McDonald HP, Yao X. Interventions for enhancing medication adherence. Cochrane Database of Systematic Reviews 2008(2):CD000011. 22 Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes

10. D  unbar-Jacob J GL, Schlenk EA. Predictors of patient adherence: Patient characteristics. In: Shumaker SA OJ, Riekert KA, , editor. The handbook of health behavior change. . 3 ed. New York: Springer Pub, 2008:397-410. 11. Pervin LA, John OP, Cervone D. Personality: theory and research. 10. ed. Hoboken, NJ: Wiley, 2008. 12. Costa PT, Jr., McCrae, R.R. Revised NEO Personality Inventory (NEO-PI-R) and NEO Five-Factor Inventory (NEO-FFI) professional manual: Odessa. Fl: Psychological Assessment Resources., 1992. 13. M cCrae RR, Costa PT, Jr. Personality in adulthood: a fivefactor theory perspective. 2. ed. New York: Guilford Press, 2002. 14. A xelsson M, Brink E, Lundgren J, Lötvall J. The influence of personality traits on reported adherence to medication in individuals with chronic disease: an epidemiological study in west Sweden. PloS One 2011;6(3):e18241. 15. B ruce JM, Hancock LM, Arnett P, Lynch S. Treatment adherence in multiple sclerosis: association with emotional status, personality, and cognition. J Behav Med 2010;33(3):219-27. 16. E milsson M, Berndtsson I, Lötvall J, Millqvist E, Lundgren J, Johansson A, et al. The influence of personality traits and beliefs about medicines on adherence to asthma treatment. Prim Care Respir J 2010;20(2):141-47. 17. Telles-Correia D, Barbosa A, Mega I, Monteiro E. Adherence correlates in liver transplant candidates. Transplant Proc 2009;41(5):1731-4. 18. A xelsson M, Emilsson M, Brink E, Lundgren J, Torén K, Lötvall J. Personality, adherence, asthma control and health-related quality of life in young adult asthmatics. Respir Med 2009;103(7):1033-40. 19. G ustavsson JP, Jönsson EG, Linder J, Weinryb RM. The HP5 inventory: Definition and assessment of five healthrelevant personality traits from a five-factor model perspective. Pers Individ Dif 2003;35(1):69-89. 20. C hristensen AJ, Smith TW. Personality and patient adherence: correlates of the five-factor model in renal dialysis. J Behav Med 1995;18(3):305-13. 21. O ’Cleirigh C, Ironson G, Weiss A, Costa PT, Jr. Conscientiousness predicts disease progression (CD4 number and viral load) in people living with HIV. Health Psychol 2007;26(4):473-80. 22. S tilley CS, Sereika S, Muldoon MF, Ryan CM, DunbarJacob J. Psychological and cognitive function: predictors of adherence with cholesterol lowering treatment. Ann Behav Med 2004;27(2):117-24. 23. Penedo FJ, Gonzalez JS, Dahn JR, Antoni M, Malow R, Costa PJ, et al. Personality, quality of life and HAART adherence among men and women living with HIV/ AIDS. J Psychosom Res 2003;54(3):271-8.

Malin Axelsson is a researcher at the Krefting Research Centre, at Gothenburg University and a senior lecturer in health care science at University West in Sweden. The research is mainly focusing personality and adherence to medication treatment. E-mail: malin.axelsson@gu.se Volume 2 - Issue 3


Regulatory & Market Place

www.JforPC.com

Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes 23


Behaviour Programmes

Online Health Information and Patient Adherence Online information is now a key resource for health consumers, with over 80% of internet users looking online for health information 1. Young people in particular are turning to the internet rather than to a family doctor or a parent to get health information and advice, and the appeal of the internet is particularly strong for those with chronic conditions 1 or who wish to obtain advice on important but sensitive matters 2. Reviews suggest a number of ways in which online health information might impact upon users in terms of improved knowledge and/or behavioural outcomes 3. Certain types of online health resources may also assist in decision-making and provide support, and exposure to other people’s accounts of positive experiences of coping with disease may help people stay more positive in terms of their condition, improve their adjustment to the disease, and help them realise that they are not alone in their “patient journey” 4. The effect of the internet on health outcomes may however not be so straightforward. Some researchers have pointed to a complex picture in which internet use may result in an increased impact on health service use 5, and others have raised the possibility of “information overload” in which the internet increases patients’ knowledge about their health conditions but leaves them feeling overwhelmed by the information available online and unable to make an informed decision about their own healthcare 6. Little is known, however, about the effect of the internet on patient adherence. Adherence, “the extent to which a person’s behaviour (e.g. taking medication or following a specific diet) follows the recommendations of their healthcare provider” (p.3,7) is recognised as a critical issue in health maintenance 8. In this paper we review the literature highlighting internet developments that may have the potential to improve patient adherence, as well as any potential obstacles to its success. Traditionally, health information (both online and from healthcare professionals) has been based on the scientific facts and figures concerning the illness or condition. However, people may desire more than facts. They may want to know about how others have experienced what they are going through or wish to share their own experiences with others 9. The “patient as expert” provides information and advice not directly available from any other source. There is increasing evidence that the sharing of patient experiences forms an important part of health-related internet use. We know that hearing or reading about other peoples’ experiences can help patients to recognise that there are decisions to be made and can assist them in clarifying their options 10, and that personal narratives are often more powerful in affecting decision-making than straightforward health facts and figures 11. Data from The 2011 Pew Internet Survey show that 34% of internet users 24 Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes

have read someone else’s commentary or experience about health or medical issues on an online news group, website, or blog, with chronic health sufferers in particular using the internet to find other people with similar health concerns 1. In our own work, focusing on how patient groups search for, trust and use online health information 12,13,14 we have noted a number of examples of information integration, in which people use the information online to cross-check, question, or reinforce the advice and guidance they have received from healthcare professionals. We present three examples below to illustrate how the internet has been effective in ultimately promoting adherence. Kath: HRT and the menopause Kath had been on hormone replacement therapy (HRT) for approximately five years when she took part in the study. Over the four weekly sessions she looked at several different websites, and having reviewed the options decided that she would try to come off HRT to find out how her body was coping with the menopause. The scare stories she had come across had played on her mind to some extent, but really she just wanted to find out if she could cope without the medication. The follow-up interviews and the diaries indicated that Kath had been off HRT for about five months before the menopausal symptoms, in particular the night sweats, had proved unbearable. She had started taking HRT once again and was very happy with her decision. Stan: Changing his hypertension medication Stan was in his early forties when he came to take part in the discussion groups. At that time he had been taking medication for his high blood pressure for about two years, but was unhappy with what he saw as the debilitating sideeffects. Earlier discussions had left him frustrated since his doctor had advised him that side-effects were very unusual for this medication. Stan was convinced his symptoms were not normal. During the internet café-style search sessions he came across one website in particular which detailed other people’s experiences of side-effects whilst taking this particular medication. He shared his findings with the rest of the participants in the group and made it clear that he intended to show these results to his doctor. Along with the other people in the study Stan kept a six-month follow-up diary. This diary indicated that he returned to the website several times before visiting his doctor. Stan reported that in consultation with his doctor he had agreed a change in his medication. Bill: Seeing the asthma specialist nurse Bill was a young man in his early twenties who described his asthma as relatively mild. He had had the condition since childhood and for most of the time he did not give too much Volume 2 - Issue 3


Behaviour Programmes

thought to his asthma. During his website searches he came across a number of pages that described the experiences of people with moderate to severe asthma. Whilst Bill did not think that these accounts were directly applicable to him, he was shocked to be reminded of the potential severity of the condition. At follow-up two weeks later Bill reported that he had made an appointment to see the asthma nurse for his annual review, something that he had previously forgotten to do, or simply dismissed. These examples point to ways in which information and advice derived from the internet have ultimately promoted patient adherence. In most cases, the knowledge gained from other patients online has either complemented professional knowledge or promoted useful dialogue between patient and clinician. In some areas, however, there are concerns that health consumers are using the internet to support non-adherence by seeking treatment strategies that are inconsistent with those recommended by their clinicians 15. It is certainly the case that for most health topics online there are a wide variety of potentially conflicting and contradictory experiences and advice sets on offer. We know that people typically prefer to read information that supports their preexisting beliefs 16 and sometimes this means disregarding information that suggests other potentially valid treatment options. Conflicting reports about side-effects, outcomes, and risk can act as a powerful tool for justifiably dismissing information that is not welcome. People may respond differently to information and advice they find unwelcome or threatening compared to sites containing information they find congenial and comforting 17, and this again can pose problems for adherence. www.JforPC.com

Promoting Adherence through the Internet Designing trustworthy websites is one way to help manage the process of information dismissal. People find it more difficult to reject a lifestyle health message, even one they would rather not hear, when it is presented via a well-designed and trustworthy website as opposed to a website containing, for example, adverts 18. Given that we know that narratives are important in health decisionmaking it is important to think about how best to include these within online health resources. Our current work as part of a National Institute for Health Research (NIHR) Programme Grant (Examining the role of patients’ experiences as a resource for choice and decision-making in health care – iPEX) is examining those very issues. Information integration is important, and people use a variety of sources including friends, family, clinicians and the internet to make their decisions and to support their current health behaviours. The information from a clinician can be successfully supported by online information and by other people’s health experiences. Healthcare providers need to be aware that people often want to gain more information and check their experiences against those of people with similar health issues. As such, they might want to consider directing their patients to sites that have already been developed with clinical guidance, such as, in the UK, NHS Choices and Healthtalkonline.org. However, research exploring patient adherence through the internet is in its infancy and has the potential to become a key asset to any patient adherence programme or intervention within healthcare. Acknowledgement: The iPEX study presents independent research commissioned by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research programme (RP-PG-0608-10147). Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes 25


Behaviour Programmes References 1. Fox, S. Peer-to-peer healthcare. Washington, DC: Pew Internet & American Life Project, Retrieved from http:// www.pewinternet.org/~/media//Files/Reports/2011/ Pew_P2PHealthcare_2011.pdf (2011). 2. K lein, J. D. & Wilson, K. M. Delivering quality care: Adolescents’ discussion of health risks with their providers. J Adolesc Health, Mar 30(3), 190-195 (2002). 3. Wantland, D., Portillo, J., Holzemer, W., Slaughter, R. & McGhee, E. The effectiveness of web-based vs. nonweb based interventions: A meta-analysis of behavioral change outcomes. J Med Internet Res, 6(4), e40 (2004). 4. C unnington, M. S., Plummer, C. J., McDiarmid, A. K. & McComb, J. M. The patient journey from symptom onset to pacemaker implantation. QJM: An International Journal of Medicine, 101(12), 955-960 (2008). 5. Z iebland, S. & Wyke, S. Health and illness in a connected world: How might sharing experiences on the Internet affect people’s health? Millbank Quarterly, Jun 90(2), 219-49 doi: 10.1111/j.1468-0009.2012.00662.x. (2012). 6. H art, A., Henwood, F. & Wyatt, S. The role of the Internet in patient practitioner relationships: Findings from a qualitative research study. J Med Internet Res 6(3),e36 (2004). 7. S abate, E. Adherence to long-term therapies: Evidence for action. World Health Organization. Retrieved from http://www.who.int/chp/knowledge/publications/ adherence_full_report.pdf (2003). 8. B auman, M. E., Massicotte, M. P., Ray, L. & NewburnCook, C. Developing educational materials to facilitate adherence: Pediatric thrombosis as a case Illustration. Journal of Pediatric Health Care, 21(3), 198-206 (2007). 9. Z iebland, S. & Herxheimer, A. How patients’ experiences contribute to decision making: Illustrations from DIPEx (personal experiences of health and illness). Journal of Nursing Management, 6, 433-439 (2008). 10. E ntwistle, V. A., France, E. F., Wyke, S., Jepson, R., Hunt, K., Ziebland, S. & Thompson, A. G. H. How information about other people’s personal experiences can help with healthcare decision-making: A qualitative study. Patient Education and Counseling, Dec 85(3), e291-8, doi: 10.1016/j.pec.2011.05.014 (2011). 11. W interbottom, A., Bekker, H. L, Conner, M. & Mooney, A. Does narrative information bias individual’s decision making? A systematic review. Social Science & Medicine, 67(12), 2079-2088 (2008). 12. S illence, E., Briggs, P., Harris, P. & Fishwick, L. How do patients evaluate and make use of online health information? Social Science & Medicine, 64 (9), 18531862 (2007). 13. H  arris, P. R., Sillence, E., Briggs, E. Perceived threat and corroboration: Key factors that improve a predictive model of trust in Internet-based health information and advice. J Med Internet Res, 13(3), e51, doi:10.2196/ jmir.1821 (2011). 14. S illence, E., Hardy, C., Briggs, P. & Harris, P. How do 26 Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes

15.

16.

17.

18.

people engage with patient experiences on health websites? (in prep). Weaver, J. B., Thompson, N. J., Sargent-Weaver, S. & Hopkins, G. L. Healthcare non-adherence decisions and internet health information. Computers and Human Behavior November 25(6), 1373–1380 (2009). S illence, E. Seeking out very like-minded others: Exploring trust and advice issues in an online health support group. International Journal of Web Based Communities, October 6(4), 376-394 (2010). H arris, P. & Epton, T. The impact of self-affirmation on health-related cognition and health behaviour: Issues and prospects. Social and Personality Psychology Compass, 4, 439-454 (2010). H  arris, P. R. Sillence, E. & Briggs, P. The effect of trustrelated design cues on responses to a Web-based message about the breast cancer risks from alcohol. J Med Internet Res. http://dx.doi:10.2196/jmir.1097 (2009).

Dr Liz Sillence is a Senior Lecturer in Psychology at Northumbria University UK. She has published extensively on the area of trust and online interactions particularly within an e-health context. Email:elizabeth.sillence@northumbria.ac.uk

Dr Claire Hardy is a Senior Research Associate in the Psychology and Communication Technology (PaCT) Laboratory at Northumbria University, and is currently working with the other authors on a large e-health research project funded by the National Institute for Health Research (NIHR). Email: claire2.hardy@northumbria.ac.uk Professor Pam Briggs is Dean of the School of Life Sciences at Northumbria University, and also holds a Chair in Applied Psychology. In the last five years, Pam has published over forty articles on human perceptions of trust, privacy and security in computermediated communication. Email: p.briggs@northumbria.ac.uk Professor Peter Harris is Chair of Heath Psychology at Sheffield University, UK. He has extensively published in both national and international journal in psychology and related fields, and has a long standing successful partnership with Northumbria University researching e-health from a psychological perspective. Email: p.harris@sheffield.ac.uk

Volume 2 - Issue 3


Clinical Trials

IVRS in the Service of Patient Adherence Medication compliance estimation has become of the utmost importance in clinical practice. In particular, the evaluation of adherence to treatment for chronic conditions has called attention to the high costs that non-adherent behaviour may have on health-related consequences. Many can benefit from methods designed to improve patient adherence: from the patients themselves, to physicians, pharmaceutical companies, and healthcare systems. Many interventions targeting patient compliance have been reported in the past, and new technologies have been developed or adapted to support patient adherence (such as the Medication Event Monitoring System [MEMS], reminders, apps on smartphones and tablets, and the recent smart pill)1. Even though many of the recent solutions — for example, apps — are developed to be as easy as possible, they still require some degree of literacy and, of course, users have to own a technological device to use them. This means that some of the potential users will be excluded from the benefits these tools can offer. On the contrary, different solutions requiring simple and widespread technologies can ensure a high level of usability and be beneficial to improving adherence to medication. Interactive Voice Response System (IVRS) is one of these solutions: a totally automated system that operates via phone calls. Some clinical trials have already evaluated the use of such a system in different care settings and data showed that IVRS can be a valuable tool in helping patients adopt a more positive perception of their medication, which then in turn leads to improved treatment adherence2-4. Of course, a multiple approach including patient education and support is necessary to achieve a long-lasting effect on patient adherence. Many of the technologies for patient adherence are not equipped to investigate the reasons for non-compliant behaviour, thus it is more difficult to intervene when patients do not comply. Indeed, most of the practiced interventions for improving treatment adherence with automated methods aim to remind patients to take their medication, or to encourage them to take it, but rarely give feedback about the major barriers leading to poor medication adherence. Here, we would like to describe the Interactive Monitoring Service (IMS), an IVRS-based system developed by the University of Ferrara (CenTec) in collaboration with FBCommunication. IMS is designed for the user-friendly monitoring of patient adherence in order to maximise the response of any target group, independently of their age or technological abilities. IMS can be exploited not only to remind patients to take the drug, monitoring their behaviour, but it may also help investigate and understand the causes of that behaviour.

monitoring durations. IMS is a completely automatic system that calls patients on landline or mobile telephones at different programmed time intervals according to the medical prescription – every day if required either at a specific time or with a different frequency. A registered voice will ask the user simple questions that will be answered by using the telephone keypad. Real-time data coming from patients’ answers are stored in the IMS databases. Physicians retrieve information regarding the project and can monitor adherence to medication at any moment by using a web interface to access aggregated or per-patient statistics. IMS integrates an IVRS, the most user-friendly technology now available for monitoring patient adherence. There are several advantages in adopting IMS: •A  utomation: there is no need for a great amount of manpower, eg, people working in a call centre • Simplicity: allowing patients, even though not technologically savvy, to benefit from a user-friendly tool • Opportunity: reminding patients to take their medication, as well as the ability to obtain a great deal of patient information quickly • High scalability: the chance to use the system for hundreds (or even thousands) of people at the same time • Cost-effectiveness •A  vailability: offering real-time statistics For these reasons, and supported by the results of a recent study showing that phone calls help make patients more compliant with their therapy5, we think that IMS is a valuable solution in the growing field of patient adherence monitoring systems, and can aid patients who are struggling to maintain adherence to their medication plan. IMS Design The IMS infrastructure is designed for the user-friendly monitoring of a large patient population in an automatic way, via the telephone. To reach these goals, IMS integrates several components: the software private branch exchange (PBX), automatic call distribution (ACD), and IVRS (Figure 1).

IMS for Monitoring Adherence to Medication FBCommunication’s IMS can target patient populations of any age, with various diseases, attitudes toward new technologies, or social conditions, and with different 28 Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes

Volume 2 - Issue 3


Clinical Trials

The PBX interconnects IMS to the public switched telephone network (PSTN) in order to call users. We adopted Asterisk, an open-source software PBX, which is highly efficient, scalable, and affords easy configuration and personalisation. The Asterisk component realises a really scalable solution in terms of cost: traditional PBX proprietary solutions in fact have licensing fees proportional to the number of concurrently called users, thus spoiling cost-efficiency. The ACD component interconnects with Asterisk in order to support hundreds of calls at the same time. The maximum number of concurrent calls is limited only by the number of available telephone lines. IMS supports the creation and organisation of multilevel (and multilanguage) IVRS, with different degrees of complexity and a multiple submenu, which can provide varied responses. The entire IMS software infrastructure is written in Python and coordinates the interactions between all components — in particular, the Asterisk PBX and the MySQL RDBMS. IMS is highly scalable and collects a huge amount of information without human operators and in a short amount of time. IMS is also highly fault-tolerant: it not only minimises every single point of failure, but also promptly warns an operator about any fault detected. It is also specifically designed to run in a cluster of servers, even spread over different geographical locations, with full support for load-sharing and automatic failover between all of them. Pilot Study for Hepatitis C Treatment Adherence The value of the IMS project to improve patient adherence to medication will be tested in the gastroenterology clinic of the University of Palermo. Patients infected with hepatitis C virus who are prescribed triple therapy with a protease inhibitor added to the standard of care — that is, pegylated interferon and ribavirin — may be enrolled in the study. Adherence to hepatitis C treatment is crucial to successfully eradicate the virus, especially using triple therapy. The treatment regimen requires the administration of many pills a day, as often as three times a day, for a maximum of 48 weeks. Drugs are administered either orally or subcutaneously. This complicated therapeutic scheme implies that patients may have reluctance or problems with adequately adhering to treatment. The consequences of non-adherent behaviour can lead to therapy failure, with the virus remaining at detectable levels in plasma, or can lead to resistance issues that can cause even failure with future and different therapies. Patients who do not achieve a cure for the hepatitis C infection may develop serious complications (eg, cirrhosis or hepatocellular carcinoma, which ultimately can lead to transplantation). It is clear, thus, that a system that can monitor the rate of adherence and understand the barriers to it is a valuable tool. The Palermo pilot will involve about 30 patients infected with hepatitis C who are prescribed triple therapy. They will be followed through the IMS for the duration of the treatment, and they will be called by the automatic IMS three times a day, when the administration of the pills is scheduled. In www.JforPC.com

answer to questions, patients could state their intention to take the medications if not already done, or decline for reasons that will be further investigated. We expect IMS to help patients manage their scheduled therapy, with adherence and treatment success. Monitoring adherence is a delicate matter that requires the highest operative standards possible. IMS, as designed by FBCommunication and the University of Ferrara, is a userfriendly system that acts as a reminder for people who are under pharmacological therapies, and, more importantly, can also ascertain possible reasons for non-adherent behaviour. References 1. Capgemini Consulting. Patient adherence: the next frontier in patient care. Vision & Reality, 9th Ed. Paris: Capgemini Consulting (2011). 2. Bender, B. G., Apter, A., Bogen, D. K., et al. Test of an interactive voice response intervention to improve adherence to controller medications in adults with asthma. J Am Board Fam Med. 23(2), 159-165 (2010). 3. Stacy, J. N., Schwartz, S. M., Ershoff, D., Shreve, M. S. Incorporating tailored interactive patient solutions using interactive voice response technology to improve statin adherence: results of a randomized clinical trial in a managed care setting. Popul Health Manag. 12(5), 241-245 (2009). 4. Magid, D. J., Ho, P. M., Olson, K. L., et al. A multimodal blood pressure control intervention in 3 healthcare systems. Am J Manag Care. 17(4), e96-103 (2011). 5. Rinfret, S., et al. Telephone contacts to improve adherence to dual anti-platelet therapy following drug-eluting stent implantation; a randomized controlled-trial. SCAI 2012; Poster A-017. Cesare Stefanelli holds a Laurea degree in electronic engineering and a PhD in computer science engineering from the University of Bologna, Italy. As professor of computer science engineering at the University of Ferrara, his research interests include distributed and mobile computing, adaptive and distributed multimedia systems, network and systems management, and network security. Email: cesare.stefanelli@unife.it Erika Nerinie holds a degree in pharmaceutical chemistry and technologies from the University of Pisa, Italy, and a doctorate in science and technologies for health products. At EML Research Laboratory, Heidelberg, she worked as a guest researcher and contributed to several publications. Erika is a scientific advisor at FBCommunication and a contributor to product development through scientific and market research. Email: erika.nerini@fbcommunication.org Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes 29


Therapeutic

Quantification of Adherence Initiatives Results

Abstract Home blood pressure monitoring (HBPM) is a valid way of assessing blood pressure. Although it has been marketed for some decades, relatively little is known about the true opinions of the patients using this method. From a pool of 40,000 Finns, a sample of 1000 hypertensive people who had access to e-mail and performed HBPM was randomly selected. Their attitude towards HBPM was analysed using an electronic questionnaire in February 2008. Altogether 640 people answered the questionnaire. The majority of the patients (73%) measured their blood pressure (BP) at least once a month. Weekly measurements were done by 106 (36%) and daily by 13 (4%) of the patients. Practically no-one measured BP as suggested in the guidelines. The most important argument for HBPM was monitoring of antihypertensive treatment (63% of the patients). The most important benefit seen by the patients was freedom to measure BP as often as desired (73%). Thirty per cent of the patients valued the possibility to adjust antihypertensive treatment. Also the possibility to lower the burden on the healthcare system was seen as important (43%). Only a few (18%) saw the prevention of subsequent organ complications as an important argument for HBPM. The BP treatment compliance seems inadequate, and patients must be instructed properly about the consequences of BP and its treatment by their treating physicians. According to this study it appears also that Finnish hypertensive patients have vague ideas about the fundamental benefit of BP treatment, and they did not measure their BP at home as suggested in the European guidelines. Keywords Blood pressure Blood pressure monitoring Home blood pressure measurement Patients’ opinion

medication changes in the presence of uncontrolled BP values was noticed. HBPM is a time-consuming procedure, and good patient compliance is essential. Although HBPM has been used for at least a decade, little is known about patients’ opinion of it. This study clarified why and when HBPM is used by patients. Methods TNS Gallup Forum, a private Finnish population survey company, performed a blood pressure-oriented Gallup study in 2008. From their pool of 40,000 Finns who significantly represent the total active-aged Finnish population, a random sample of 1000 individuals who declared themselves suffering from high blood pressure and used HBPM, was selected. Their attitude towards HBPM was analysed using a straightforward e-mailed electronic questionnaire, sent and completed through the internet in February 2008. It had five simple questions and free space for people to write in their answers. The selected individuals were asked the frequency of HBPM, information about other diseases besides elevated BP, possible HBPM instructions received from healthcare professionals, arguments for BP measurement and opinion about the importance and benefits of HBPM. Although not all the selected individuals can be regarded as patients, this nomination was used for practical reasons. Students’ T-test, ANOVA and Wilcoxon methods were used in statistical analysis. Results are given as mean and standard deviation (SD). Results Out of the 1000 selected subjects with hypertension and HBPM, a completed questionnaire was received from 640 individuals (295 men and 345 women), who are called the study patients. The mean age of the patients was 55.6 (18, 9) years. The age distribution of the study patients is shown in detail in Figure 1. About half of the subjects suffered only from elevated blood

Introduction Home blood pressure measurement (HBPM) has been accepted as a valid way to assess blood pressure1. In Finland more than 60% of hypertensive patients used HBPM in 2006 2. Agarwal et al.3 found in their meta-analysis that treatment-induced BP reductions were slightly but significantly higher (systolic 2.7 mm Hg and diastolic 1.7 mm Hg) as also were the percentage of patients achieving BP control in patients using HBPM. Also, more frequent 30 Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes

Volume 2 - Issue 3


Therapeutic pressure. Besides hypertension other diseases were reported by 45.3% of the patients (see Table 1).

The majority of the study patients (73%) measured their blood pressure at least once a month. Weekly measurements were done by 106 (36%) and daily by 13 (4%) of the patients (Table 2). Men performed weekly measurements

more often (Table 2). Practically none of the study patients performed the one-week, double morning and evening measurement suggested by the guidelines1. Healthcare professionals have recommended the use of the home BP method quite randomly as only 13% (men 12%, women 13%) of the study patients announced having discussed regularly the use of home BP during regular office visits. Nearly 30% of the patients have not been instructed to do home BP at all, or it was touched on so briefly that they did not remember it.

The most important reason to measure home BP was to monitor the effect of antihypertensive treatment (Table 3). Only a minority (18%) appreciated the prevention of organ complications as an important argument for HBPM. Five per cent of the patients saw it as not important at all to measure BP at home. The most important benefit seen in HBPM was freedom to measure BP as often as liked (Table 3). One-third of the patients adjusted their antihypertensive treatment according to HBPM. Also the possibility to lower the measurement burden on the healthcare system was www.JforPC.com

seen as important. Only four per cent of the patients did not see any benefit in HBPM. Discussion Main Findings According to our e-mail interview performed through internet questionnaires, practically no patient performed HBPM as suggested by the guidelines 1. Only one-third measured their blood pressure weekly. The patient compliance was far from adequate. The most important argument for HBPM was monitoring of the antihypertensive treatment, and the most important benefit seen by the patients was the freedom to measure BP individually. Although health personnel was not interviewed it seems that they neither inform the patients properly about blood pressure and its consequences, nor instruct quality BP measurement at home. Strengths and Limitations The patient material in the present study was collected using a population pool of a private Gallup survey company. The method used enabled us to communicate with the patients directly, without healthcare interference. On the other hand this method is susceptible to various biases, like the age factor, ability to use a computer, and perhaps also economic status. We also lack precise information about the BP medication arguments and details, the patient’s morbidity, and the BP values achieved. Nevertheless, we believe that we have received real thoughts and opinions of the individuals with elevated BP. We also believe that to assess opinions about BP monitoring, this approach is better compared to the situation where healthcare professionals interview patients and fill in papers. An electronic questionnaire is also quite straightforward and easy to complete and send back. The ease probably explains quite well why our response percentage (64%) was considerable, compared for example to the 34% seen in the study of Tyson et al. which used a mailed questionnaire4. It is, of course, possible that data derived from a private survey company’s hypertensive pool, although chosen randomly from all parts in Finland, is not applicable to the whole Finnish hypertensive population. Because in this survey BP data was not collected we cannot judge our material in relation to the severity of the hypertension. On the other hand, patients’ cardiovascular risk factor profiles in our material were quite similar when compared with national cross-sectional BP studies 2,5,6. Age distribution in our study was comparable with the home BP study by Niiranen et al. 7 but when compared with the population in a larger cross-sectional BP study by Varis et al. 2, the present material was somewhat younger. Interpretation of the Study Results In the European Society of Hypertension guidelines1 it has been recommended to monitor home BP using a seven-day schedule before each visit to the physician. According to our results patients do not measure their blood pressure regularly, but on the contrary quite randomly, as only onethird of the Finnish patients measured their BP at least weekly. Men’s tendency for more regular weekly HBPM may reflect their concern for a poorer life expectancy assumption, Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes 31


Therapeutic or just for more severe BP. It appears also that the study patients were not advised to perform HBPM according to the guidelines, because in general Finnish patients follow medical instructions well8. Better patient information would very likely promote more frequent measurements, and hence a greater possibility of following the BP level and adjusting the antihypertensive therapy. Implications for Clinical Practice Standardised procedures concerning patient assessment and education are essential to successful home BP monitoring 1,9. It is obvious that more patient information and media-campaigning work needs to be done to popularise the guidelines along with the use of home BP monitoring. By extending home BP measurements long enough to determine day-to-day, week-to-week, or monthto-month BP, a new tool for risk reduction estimation might be achieved. Because electronic communication is likely to lower the patient-to-doctor reporting threshold, the use of telemonitoring connected to HBPM should be researched more in the future10. Conclusion This interview survey revealed that the most important argument to measure BP at home was to monitor antihypertensive treatment and health, and the most important benefit seen in BP home measurement was the freedom to measure BP individually. It also appeared that the patients did not measure their BP at home as suggested by the guidelines, but quite randomly, which usually does not give enough useful information. Although the health personnel were not interviewed it seems likely that the patients were not instructed to perform home measurement according to the guidelines. The BP treatment compliance seems inadequate, and patients must be instructed properly about the consequences of BP and its treatment by their treating physicians. More work should be done to popularise the correct use of home BP measurement. References 1. Parati G, Stergiou GS, Asmar R, Bilo G, de Leeuw P, Imai Y, et al. ESH Working Group on Blood Pressure Monitoring. European Society of Hypertension guidelines for blood pressure monitoring at home: a summary report of the Second International Consensus Conference on Home Blood Pressure Monitoring. J Hypertens 2008;26:1505– 1526. 2. Varis J, Savola H, Vesalainen R, Kantola I. Treatment of hypertension in Finnish general practice seems unsatisfactory despite evidence-based guidelines. Blood Press 2009;18:62-7. 3. A garwal R, Bills JE, Hecht TJW, Light RP. Role of home blood pressure monitoring in overcoming therapeutic inertia and improving hypertension control: a systematic review and meta-analysis. Hypertension 2011;57:29–38.

32 Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes

4. T  yson MJ, McElduff P. Self blood pressure monitoring – a questionnaire study: response, requirement, training, support-group popularity and recommendations. J Human Hypertens 2003;17:51-61 5. K astarinen MJ, Antikainen RL, Laatikainen TK, Salomaa VV, Tuomilehto JO, Nissinen AM, et al. Trends in hypertension care in eastern and south-western Finland during 19822002. J Hypertens. 2006; 24: 829-36. 6. A  ntikainen RL, Moltchanov VA, Chukwuma C Sr, Kuulasmaa KA, Marques-Vidal PM, Sans S, et al. WHO MONICA Project. Trends in the prevalence, awareness, treatment and control of hypertension: the WHO MONICA Project. Eur J Cardiovasc Prev Rehabil. 2006; 13: 13-29. 7. N iiranen TJ, Jula AM, Kantola IM, Reunanen A. Comparison of agreement between clinic and home-measured blood pressure in the Finnish population: the Finn-HOME Study. J Hypertens 2006;24:1549-55. 8. K  yngäs H, Lahdenperä T. Compliance of patients with hypertension and associated factors. J Adv Nurs. 1999; 29: 832-9. 9. S tergiou GS, Baibas NM, Gantzarou AP, Skeva II, Kalkana CB, Roussias LG, et al. Reproducibility of home, ambulatory, and clinic blood pressure: implications for the design of trials for the assessment of antihypertensive drug efficacy. Am J Hypertens. 2002;15:101–104. 10. O  mboni S, Guardia A. Impact of home blood pressure telemonitoring and blood pressure control: a metaanalysis of randomized controlled studies. Am J Hypertens 2011; 24: 989-998. MD.PhD Juha Varis Senior Lecturer in the Department of Medicine, Turku University Hospital, Turku, Finland. Medical degree, specialist in internal medicine and doctoral degree. About 25 articles both in international peer-reviewed journals, in domestic peer-reviewed journals and public journals regarding high blood pressure, kidney diseases and health economics Email: juha.varis@tyks.fi MD.PhD Ilkka Kantola Chief administrative physician. Department of Medicine, Turku University Hospital, Turku, Finland. Adjunct professor. European Hypertension specialist. 150 articles in international peer-reviewed journals, in domestic peer-reviewed journals and domestic textbooks regarding high blood pressure, Fabry disease, sleep apnea and hypokalemic periodic paralysis Email: ilkka.kantola@tyks.fi

Volume 2 - Issue 3


Therapeutic

Make No Bones About It: Treatment Adherence is a Challenge in Osteoporosis Osteoporosis is a relatively common chronic condition affecting approximately 50% of women and 30% of men over 65 years of age (Wolf et al., 2000). It has been estimated that over 200 million people worldwide have osteoporosis (Cooper, 1999) and the prevalence is expected to increase as the population continues to age. Osteoporosis is a significant clinical and public health concern. Indeed, fractures are one of the most common causes of patient disability and a major contributor to medical costs worldwide (Cummings & Melton, 2002). Despite the existence of effective treatments to reduce the risk of osteoporotic fractures, patient adherence to osteoporosis treatments is poor and treatment discontinuation is common (e.g., Cramer et al., 2007). As with other chronic diseases, patient reasons for treatment nonadherence and discontinuation are multiple and varied. But I Don’t Feel Sick? The asymptomatic nature of osteoporosis poses particular problems for treatment adherence and continuation, as patients are neither feeling ill nor experiencing symptoms. It is widely understood that feeling ill and experiencing symptoms function as internal cues for patients to take treatment. When these cues are absent, however, the likelihood of treatment non-adherence or discontinuation is greater as patients are neither reminded to take their treatment, nor do they see the need for treatment. The asymptomatic nature of osteoporosis also means that patients do not receive any tangible ‘evidence’ that the treatment is working. That is to say, the benefits of taking treatment are not evident to the patient as they do not experience an observable reduction in symptoms. But Osteoporosis is Not Really a Serious Illness? In addition to the issues arising as a result of the asymptomatic nature of osteoporosis, research demonstrates that many patients also fail to appreciate the risk and potential consequences of osteoporosis. For example, a number of studies have demonstrated that where personal risk and consequences are perceived by the patient to be low, treatment non-adherence is likely to result (e.g., Cline & Worley, 2003; McHorney et al., 2007). Moreover, it is likely that the asymptomatic nature of osteoporosis precludes patients from accurately assessing their personal risk and the potential consequences of not adhering to the treatment regimen.

34 Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes

But I’m Worried About Treatment Side-effects? Troublesome side-effects pose one of the biggest challenges to patient adherence across chronic diseases (e.g., Horne et al., 2005). In osteoporosis, the side effects of oral bisphosphonates are multiple and can significantly interfere with a patient’s day-to-day life. It is perhaps unsurprising, therefore, that side-effects are frequently cited as the main reason for treatment non-adherence and discontinuation in osteoporosis (e.g., Lau et al., 2008; McHorney et al., 2007). For example, McHorney and colleagues (2007) reported that 67% of patients categorised as ‘non-adherers’ rated the presence of side-effects as an ‘extremely important’ or ‘very important’ reason for non-adherence. Interventions to Improve Treatment Adherence and Continuation In a health economics analysis, Hiligsmann and colleagues (in press) estimate that poor adherence with osteoporosis treatments results in approximately a 50% reduction in the potential benefits observed in clinical trials and a doubling of the cost per quality-adjusted life-year (QALY) gained from these treatments. On the back of this data, the authors suggest that programmes to increase adherence have the potential to be an efficient use of healthcare resources. For example, the authors state that an intervention to improve adherence by 25% would result in an incremental costeffectiveness ratio of €11,511 per QALY and €54,182 per QALY, compared with real-world adherence, if the intervention cost an additional €50 and €100 per year, respectively. To date, few interventions have been conducted to promote treatment adherence and continuation in patients with osteoporosis. Indeed, a recent systematic review of existing literature identified only seven adherence intervention studies in osteoporosis (Gleeson et al., 2009). Even though the literature in this area is in its infancy, there is some evidence to suggest that interventions designed to change patient’s beliefs about their osteoporosis and treatment result in increased treatment adherence and continuation. For example, a recent intervention study (see Solomon et al., 2012) involving motivational interviewing techniques with osteoporosis patients demonstrated some success in improving treatment adherence and continuation. Although the study did not report a statistically significant result, the increase observed [8% difference in median medication possession ratio (MPR) between the intervention and control arms] can be perceived as clinically significant Volume 2 - Issue 3


Therapeutic

References 1. Cline, R. R. & Worley, M. M. (2003). Osteoporosis health beliefs and self-care behaviours: An exploratory investigation. Journal of the American Pharmacy Association, 46(3), 356363. 2. C  ooper, C. (1999). Epidemiology of osteoporosis. Osteoporosis International, 9(Suppl 2): S2–8. 3. C  ramer, J. A., Gold, D. T., Silverman, S. L. & Lewiecki, E. M. (2007). A systematic review of persistence and compliance with bisphosphonates for osteoporosis. Osteoporosis International, 18, 1023-1031. 4. Cummings, S. R. & Melton, L. J. (2002). Epidemiology and outcomes of osteoporotic fractures. Lancet, 359; 17611767. 5. G  leeson, T., Iversen, M. D., Avorn, J., Brookhart, A. M., Katz, J. N., Losina, E., May, F., Patrick, A. R., Shrank W. H. & Solomon, D. H. (2009). Interventions to improve adherence and persistence with osteoporosis medications: A systematic literature review. Osteoporosis International, 20, 2127– 2134. 6. H  aynes R., Ackllo, E., Sahota, N., McDonald, H. P. & Yao, X. (2008). Interventions for enhancing medication adherence. Cochrane Database Systematic Review (2):CD000011 6. Hiligsmann, M., McGowan, B., Bennett, K., Barry, M. & Reginster, J. (in press). The clinical and economic burden of poor adherence and persistence with osteoporosis medications in Ireland. Value in Health, published online 13 April 2012. 7. H  orne, R., Weinman, J., Barber, N., Elliott, R. & Morgan, M. (2005). Concordance, adherence and compliance in medicine taking. Report for the National Co-Ordinating Centre for NHS Service Delivery and Organisation. London: R & D (NCCSDO). 8. Lau, E., Papaioannou, A., Dolovich, L., Adachi, J., Sawka, A. M., www.JforPC.com

Burns, S., Nair, K. & Pathak, A. (2008). Patients’ adherence to osteoporosis therapy: Exploring the perceptions of postmenopausal women. Canadian Family Physician, 54(3), 394-402. 9. McHorney, C. A., Schousboe, J. T., Cline, R. R. & Weiss, T. W. (2007). The impact of osteoporosis medication beliefs and side effects experiences on on-adherence to oral bisphosphonates. Current Medical Research and Opinions, 23(12), 3137-3152. 10. Solomon, D. H., Iversen, M. D., Avorn, J., Gleeson, T., Brookhart, M. A., Patrick, A. R., Rededal, L., 12. Shrank, W. H., Lii, J., Losina, E. & Katz, J. N. (2012). Osteoporosis telephonic intervention to improve medication regimen adherence: A large, pragmatic, randomized controlled trial. Archives of Internal Medicine, 172(6), 477-483. 13. Wolf, R. L., Stone, K. L. & Cauley, J. A. (2000). Update on the epidemiology of osteoporosis. Medicine Current Rheumatology Reports, 2(1), 74-86.

Dr Kate Perry, Lead Health Psychology Specialist, Atlantis Healthcare. Kate is a registered psychologist with over 10 years of experience working within the healthcare sector. Kate obtained her MSc in Health Psychology from the University of Auckland and completed her doctoral qualification in Clinical Psychology at the University of Surrey. Prior to her work with Atlantis, Kate worked in New Zealand and the United Kingdom as a clinical psychologist specialising in neuropsychology assessment and intervention. Kate is particularly interested in the application of psychological strategies to help patients manage specific difficulties including pain, fatigue and stress. Email: kate.perry@atlantishealthcare.com Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes 35


38 Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes

Volume 1 - Issue 2


www.JforPC.com

Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes 39


Therapeutic

Action Duchenne – Boys to Men Campaign Duchenne Muscular Dystrophy (DMD) is an incurable musclewasting disease affecting 1 in every 3500 male births in the UK. Duchenne is the most common and severe form of muscular dystrophy, and is the most common genetic childhood killer disease. It is caused by a genetic variation in the dystrophin gene. In every town and every city in the UK there will be at least one boy or young man living with Duchenne; get care and research right for Duchenne and you’ve got it right for thousands of others with related conditions. Tyran Hawthorn, aged 25, who is living with Duchenne, recently featured in an ITV Meridian news piece: “Out of the sixteen boys at Treloars College who were there at the same time as me only one other friend is still alive. Unfortunately, he is in intensive care where he has been since January. We keep hearing how young men with Duchenne should live into their 30s and 40s, but at the moment that simply isn’t happening. We need these gene therapies urgently.” In one chilling statement Tyran sums up the hopes and highlights the current failures of the UK’s medical care of young men living with Duchenne Muscular Dystrophy. Recently in Northern Ireland we have seen the publication of the Muscular Dystrophy Campaigns 4th report into neuromuscular services in the UK. The McCollum Report (NI 2012) follows the Walton Report (England 2009), Mackie Report (Scotland 2010) and the Thomas Report (Wales 2010). Abbott and Carpenter (2010) also published a report on the paucity of transition to adult services for Duchenne in the UK. These excellent reports all document and support Tyran’s personal experience in often distressing detail. Despite a lack of evidence for survival rates for the UK, or indeed exactly how many young people are living today with DMD, it must be clear that Tyran’s experience of seeing all but one of his Duchenne friends die in late teens and early twenties is the rule and not the exception. So why do we keep hearing how advances in medical care mean that boys with Duchenne today could be living into their thirties and beyond, whereas a generation ago they would not have lived beyond adolescence? Why do we see some statistics from Newcastle and Denmark supporting this, when the overriding trend is for our children to continue to die too young? Something is not working. Action Duchenne conducted a widespread audit of muscle centre provision in 2011 (www.dmdcentres.org). At that time we reported 20 paediatric muscle centres, and seven centres providing adult provision after the age of 18. Centres reported patient numbers from 30 – 200. This does show a significant investment in Duchenne care across the UK and does not include many smaller clinical support services. The survey showed a good general awareness of the need for multidisciplinary care, however there are 38 Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes

significant gaps especially with psychosocial provision. From our audit it is clear that adult services are woefully inadequate and this must be having an impact on the need to provide assessment and ongoing respiratory and cardiac care, the two biggest killers in Duchenne. However, I would suggest another factor - the fragmented “networks” of muscle provision - are also playing a part. It will not be possible to build the type of multidisciplinary care services outlined in the Standards of Care documents at small centres. Where we have success at Centres of Excellence like GOSH or Newcastle the model is of the development of expert clinical assessment built over a number of years aligned with research and programmes of clinical trials. This is not to deny the excellent work of many clinicians across the UK, but simply the weight of knowledge and experience of managing a complex condition with expertise from a host of other disciplines requires a critical mass of Duchenne patients and health professionals alike. Meetings, seminars, exchanges of best practice, clinically trialling new medicines and approaches can only take place within one well-funded institution. This is why networks of small outcrops of provision will not work. Muscle networks have been established in Wales and Scotland in the past and have not improved survival rates. Earlier this year we announced our latest campaign, ‘Boys to Men’, through a series of lobbies to Westminster and each of the devolved parliaments in the UK. The campaign is in recognition that existing or proposed “networks” and asking for extra neuromuscular care nurses is not going to be the answer. It’s not even beginning to solve the problems. One of Action Duchenne’s key campaign promises is to ensure that every Duchenne patient receives good quality medical care so that our children are able to grow into adults and live more fulfilled lives where they are able to contribute to society. Action Duchenne is actively campaigning for best practice in care for Duchenne patients based on the publication of an international consensus document in Lancet Neurology in Jan/Feb 2010. The published article was the product of an extensive review by 84 international experts in Duchenne Muscular Dystrophy diagnosis and care, and was supported by the Centers for Disease Control (CDC) in the US. It provides an expert guide to recommendations on the multidisciplinary care that should be available to all individuals with Duchenne. Several Duchenne patient organisations including Action Duchenne and the TREAT-NMD network have helped to produce a ‘Guide for Families’, based on the original academic article, which is written in language accessible to all without a medical background. Boys to Men highlights the need for appropriate services to be coordinated across the whole of the UK to support these young men into adult life. Volume 2 - Issue 3


Therapeutic

The Boys to Men Campaign With their condition properly managed and access to new drugs, boys with Duchenne should live long into adulthood. As these boys become men, they need extra support due to the worsening nature of the condition. Along with this, they also need support with social inclusion to become contributing members of society. They need help with getting access to education, to live independently if they want to, to work and to navigate relationships. The Boys to Men campaign calls on decision-makers at all UK parliaments and national assemblies to sign up to a new 4-point plan to support this transition and also to support research into the first genetic treatment. Boys to Men - 4-Point Plan Centres of Excellence We need nine Centres of Excellence for Duchenne that will deliver the full range of services needed to properly manage the condition, as set out in the internationally agreed Standards of Care for Duchenne (published in the Lancet Dec 2009/Jan 2010). This includes at least one Centre of Excellence in Scotland, one in Wales and one in Northern Ireland, building on our DMD Centres work launched by Action Duchenne in 2011, which was highly commended by Minister of State for Care Services Paul Burstow MP. NICE must now adopt the Standards of Care for Duchenne. We know that best practice medical care can help children with Duchenne live at least 10-15 years longer. In addition, proactive medical care has been shown to reduce emergency admissions which are extremely costly – something that is beneficial to the patient, family and the NHS. Funding for Further Research Action Duchenne is looking to raise £5 million in five years of matched funding, to help the ‘skipDuchenne’ project and other research programmes to ensure the development of the first-ever genetic treatments that could benefit every case of Duchenne. Thanks to the work of academics in leading UK and international universities, there is a real hope of a breakthrough treatment for this genetic condition. However, for this to become a reality, we have identified the need to raise funds to support pioneering research such as that currently being undertaken at the School of Biological Sciences, Royal Holloway, University of London. Specialist Educational Assessments Access to specialist educational assessments and interventions, careers advice and support for independent living, for all young men living with Duchenne, through person-centred planning and personal budgets. Young people with Duchenne are at higher risk of learning and behavioural www.JforPC.com

problems such as dyslexia, ADHD and autism, and need early and specialist interventions at school to get them started on the right track. Teenagers and young men with Duchenne want to be empowered through person-centred planning and personal budgets to fulfil their aspirations to lead a full adult life including choices about college/university, forging relationships and engaging in employment. Simplified Clinical Trials for Genetic Medicines A simplified means of clinical trials for genetic medicines that will bring treatments that use the same or similar chemistry to market much more quickly. As genetic medicines by their very nature are designed to meet the genetic requirements of individuals, if every variation of a drug has to go through the full Phase I, II and III clinical trials, the treatments will be too expensive and may never reach their intended patients. By sanctioning the approval of so called N=1 trials for variations of drugs that have already completed full clinical trials, the government will significantly speed up the delivery of potential treatments to our children. Centres of Excellence for the Treatment of Neurological Conditions Living with Duchenne, you need to see a huge range of clinical, medical, educational, psychological and social care specialists, and this care needs to be linked up to ensure that all elements of this complex condition are taken into account. This needs to happen at one specialist centre that leads and links with community provision. In addition, these specialist centres are ideally placed to support translational research and long-term appraisal of new genetic therapies by extended N=1 clinical trials where new personalised drugs are approved for trials for individual patients. As the condition progresses, travel becomes more difficult, and repeated visits are much harder to plan for than visiting a ‘one-stop shop’. That’s why Action Duchenne has long campaigned for Centres of Excellence to ensure all young men and their families receive the best care possible. As Daniel Baker, 36 and living with Duchenne, commented, “Having access to a centre of excellence would have saved me over a year of suffering and misdiagnosis.” Meeting Internationally Agreed Standards of Care The International Standards of Care for Duchenne Muscular Dystrophy were published in the Lancet in Dec 2009/Jan 2010, and have since been adopted by NICE as accredited evidence. This model has been agreed by international experts in Duchenne and endorsed by NICE to meet the complex medical needs of young people with this severe muscle-wasting condition. However, in practice, not all young people are receiving the levels of care stipulated. Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes 39


Therapeutic Action Duchenne would highlight examples of best practice at Great Ormond Street Hospital, London and Newcastle. The multidisciplinary care at these centres is closest to the model advised in the published Lancet paper of Dec 2009/Jan 2010. They also integrate research and clinical trial programmes with ongoing care of patients. However, these centres are heavily used because families from across the UK do not have the confidence to rely on their local clinical services. Adult services remain seriously underdeveloped at a time in the life of Duchenne patients where expert care is most needed. This is a major factor in the poor life expectancy statistics for Duchenne in the UK in relation to countries like Denmark, where men with Duchenne are regularly living into their 40s and beyond.

This evidence is backed up by reports from Newcastle (Eagle et al., 2002) and Denmark (Rahbek 2003). In other words if we can start by supporting breathing we will improve life expectancy. Add improved multidisciplinary management with physiotherapy, early use of heart drugs, corticosteroids, then there should be every hope for significant improvement in survival rates. This is well described in the publication for Standards of Care for Duchenne (Lancet 2010). A wholesale reform of existing provision for Duchenne Muscular Dystrophy is required. We need to create Centres of Excellence with critical mass that can draw together the best of our clinical and research teams to work in a smaller number of bigger specialist Centres. It is now not an option to continue advocating for piecemeal reforms – we owe it to the next generation of young men to get this right. About Action Duchenne. Established in 2001, Action Duchenne aims to support and promote innovative research into a cure and effective medicines for Duchenne/Becker Muscular Dystrophy. The charity, which is led by Duchenne families, aims to promote awareness of the condition, improve care services, and provide access to a range of educational and support/ development programmes for people living with Duchenne at every stage of the condition. This is achieved by working in partnership with government agencies, NHS and care organisations, other charities, academic, scientific and research groups, and biotech/ pharmaceutical/drug discovery companies worldwide.

Action Duchenne would like to see a national strategic approach to planning for services covering the whole of the UK, as existing provision has grown up over a number of years. Only at National Centres of Excellence can we start what Professor Anita Simonds calls the Quiet Revolution. “The combination of NIV (Non Invasive Ventilation) with cough-assist techniques decreases pulmonary morbidity and hospital admissions. Trials have confirmed that NIV works in part by enhancing chemosensitivity, and in patients with many different neuromuscular conditions the most effective time to introduce NIV is when symptomatic sleep-disordered breathing develops.” (Simonds 2006). 40 Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes

References 1. w w w . e v i d e n c e . n h s . u k / accreditation/current-andcompleted-submissions/scontent-quality-accreditationsubmissions-dmd-accreditationreports-final-final-accreditationreport-dmd.pdf Nick Catlin is founder and Head of Research of charity Action Duchenne. The charity was set up by Nick and his partner Janet Hoskin and other Duchenne families in 2001 to support and promote innovative research into a cure and effective medicines for Duchenne Muscular Dystrophy. Nick and Janet have a son Saul, aged 11 who has Duchenne. Email: nick@actionduchenne.org Volume 2 - Issue 3


Therapeutic

Cardiovascular Disease (CVD) Cardiovascular disease (CVD) poses a significant public health and economic burden to the United States. 1 By 2030, almost half (40.5%) of the US population is projected to have CVD, resulting in total healthcare costs that are estimated to exceed $1 trillion. 1,2 Patient non-adherence has been described as one of the greatest challenges for success in the treatment and management of CVD. 3 While much work has been done to understand the barriers to medication adherence in patients with CVD, an equally problematic area that warrants further study is the impact that the measure selected to assess medication adherence has on the intended outcomes. The importance of accurate measurement of medication adherence has received substantial attention in the literature in recent years. 4,13 Research scientists and healthcare providers require valid measures of adherence to determine whether the magnitude of change in patient outcomes is due to their medication-taking behaviours. Results of clinical trials targeting medication adherence as well as the effectiveness of a treatment regimen on patient outcomes in clinical practice are partially dependent on the quality and appropriateness of the adherence measure chosen. For the provider, an accurate understanding of patient adherence behaviours is a critical component of effective disease management. Several studies have demonstrated that healthcare providers inaccurately estimate patient adherence behaviours. 14-17 Thus, having precise yet practical measures available is essential in order to assist providers in determining whether inadequate responses to treatment are due to patient non-adherence or the need to intensify treatment. In clinical trials, the selection of accurate measures is a crucial element of study design. Ultimately, the effectiveness of an intervention on the study outcomes is determined in part by the quality of the measures chosen. If the measures selected are not considered reliable or valid for that particular study question or patient population, it may compromise the researchers’ ability to detect statistically and clinically significant improvements in the outcomes of interest as a result of the intervention. 18 Perhaps the greatest challenge to the field is that there is no “gold standard” for all types of adherence research or clinic settings. 11,19 That is, despite the significant advancements made in adherence measurement with the introduction of electronic monitoring devices (EMD), there is no measure available that provides a reliable and direct assessment of adherence that is also unobtrusive, costeffective and simple to use. 11 As a result, measures are often chosen based upon feasibility of implementation, the degree of accuracy as it relates to the treatment or research goals, usefulness, and the resources available. 11 42 Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes

This tradeoff between the accuracy of the measure vs. practicality is an inherent problem of the adherence field. Imprecise adherence measures such as self-report questionnaires are often utilised because they offer a practical solution to a complex problem. Akin to the challenges associated with selecting an adherence measure, the variability in how non-adherence is defined across trials has also received much scrutiny. In the CVD literature, the widely-used adherence threshold of 80% is considered the cut-point that distinguishes adherent behaviours from non-adherent. However, the empirical evidence to support this threshold as clinically relevant has not been well established 20 and has been shown to vary according to the cardiovascular condition, patient population, and primary outcome being studied (e.g., 80% in patients with HTN vs. 88% in heart failure patients vs. 89% in patients with diabetes). 21-23 More importantly, using a dichotomous cut-point (above or below 80%) to define adherence does not account for the possible nonlinear dose–response relationship that can characterise the adherence-outcome association. 3 The shortcomings of adherence measures are further complicated by the variation in the methods used to calculate the degree of non-adherence across studies. Definitions of adherence are partly dependent on the measure used and can range from the per cent of prescribed doses taken correctly (“taking adherence”), to the proportion of doses taken within a prescribed time interval (“timing adherence”), to a summary score based on the averaged responses to a self-report measure. The inconsistency in definitions across trials makes comparisons difficult. Moreover, the various, arbitrary cut-points employed across cardiovascular diseases can directly impact the accuracy of the measure by altering the level of sensitivity and specificity. 11 For example, methods that utilise a higher adherence threshold (e.g., 90%) will be more likely to correctly identify adherent patients (higher sensitivity) than non-adherent patients (lower specificity). Alternatively, lower adherence thresholds (e.g. 80%) will identify non-adherent patients with greater precision than adherent patients. 11 Finally, reducing adherence data to a point estimate creates the assumption of constant adherence over time, which often does not hold. Rather, adherence behaviours are multi-dimensional and should not be reduced to a simplified summary measure without taking into consideration the patient’s dosing histories or adherence patterns over time (e.g., execution of and persistence with the regimen), which are more reflective of patients’ true adherence behaviours. 24,25 In an attempt to identify a ‘gold standard’ measure, several studies have compared the level of agreement between the various measures of medication adherence Volume 2 - Issue 3


Therapeutic in the CVD literature. However, a majority of these studies have failed to show a consistent association between selfreport (e.g., questionnaires and interviews) and objective (e.g., EMD, pharmacy refill records, and pill count) measures that would allow for selection of such a measure to be made. These challenges, which range from variations in study methodology and the target population 26 to the length of the monitoring period, 27 the definition of adherence utilised (taking vs. timing adherence) 28 and frequency of the prescribed dosing regimen (once-daily vs. twice-daily dosing) 29 greatly impact the interpretation of one’s findings. However, it can also be argued that the measures should not be expected to exhibit high levels of agreement because they do not measure the same aspects of adherence. Factors that impact adherence estimates assessed by one method (e.g., ability to use a pill bottle for EMD) may not be relevant to another method (e.g., ability to travel to and use the same pharmacy for electronic refill records). Pharmacy refills only give quantitative information on whether the patient has the medication in their possession. Alternatively, self-report measures give information on the patient’s perception of how often they take their medications, or why they do not take them. Pill count gives quantitative information on whether the patient is taking the correct number of pills per day, while EMDs give information on dose, dose timing, and dose intervals as well as display patterns of non-adherence. Pill counts could be a useful tool in conjunction with EMDs 30 since they often correlate with this data 31,32 and could serve as a check that adherence reported by the EMD corresponds to pills being removed from the bottle. Self-report measures and patient interviews can also complement EMD data by assisting to identify reasons why patients do not adhere. 33 The accumulation of evidence presented thus far returns to one central point: there is no single, “gold standard” measure of adherence. As a result, researchers and providers alike are faced with the task of weighing the strengths and weaknesses of the available methods to select measures, or more often than not, create a new measure that is suitable for their treatment or study goals. However, measurement selection should extend beyond the feasibility of implementation and even sophistication of the data to also include careful consideration on how the measure will perform in the particular population in which it is being administered. This notion is particularly salient when selecting self-report adherence measures. In many cases, the self-report measure selected to assess medication adherence is either not appropriate for the specific patient population it is being administered to, or has not undergone adequate psychometric testing with them. Conclusion Medication adherence is at the cornerstone of effective treatment and management of CVD. Despite the availability of numerous efficacious medications to manage CVD, adherence to prescribed medications remains suboptimal. Poor adherence has been estimated to cause 33-69% of all medication-related hospitalisations, and repeat doctors’ visits, 23% of nursing home admissions, 125,000 deaths, www.JforPC.com

and $300 billion annually in direct healthcare costs. 4,34,35 Annual indirect costs exceed $1.5 billion in lost patient earnings and $50 billion in lost productivity. 36 Fortunately, patients’ adherence behaviours are modifiable and can lead to improvements in clinical and economic outcomes, if intervened upon. 37-39 However, the gains produced by efforts to increase adherence will not be realised until the fundamental methodological challenges are addressed. In response to these challenges, researchers are developing new adherence measures to address several of the shortcomings outlined here. Health information technology (health IT) is emerging as a promising and cost-effective way to measure adherence. 40 Smartphone applications and electronic diaries in particular have the potential to overcome the inherent limitations of existing adherence measures. 40,41 With the capability for asynchronous “anytime, anywhere” assessments of patient’s medicationtaking behaviours, as well as their reasons for nonadherence, all on one platform, data can be wirelessly transmitted to multiple stakeholders (patient, family, provider, nurse case manager) eliminating the need for in-person appointments or multiple measures. Until a ‘gold standard’ measure is created, the adherence field must continue to develop innovative analytic methods to capitalise on the data produced by existing measures. Noteworthy examples of efforts already underway include the use of adaptive statistical modelling, group-based trajectory modelling, and time series analysis to model trajectories of adherence patterns over time; 42-44 the development of adherence metrics that are more sensitive to fluctuations in medication-taking; 28,45 and composite adherence scores that take into account the strengths and weaknesses of the measures being utilised. 46 For providers, accurate assessment of medication adherence begins with the quality of communication in the patient-provider relationship. Studies have consistently shown that patient-provider communication that is perceived to include shared decision-making 47,48 and patient-centredness, 49,50 and address patients’ general and disease-specific concerns 51-53 is associated with better self-reported medication adherence among patients with chronic diseases. In fact, one study has shown that the odds of patient non-persistence can be reduced by as much as 23% if the provider possesses good communication and clinical decision-making skills. 54 In light of these findings, healthcare practices would benefit from integrating evidence-based teaching models into the culture of the organisation that offer healthcare providers multiple avenues to learn, as well as practice, tangible, and effective communication skills. 55 References 1. Roger VL, Go AS, Lloyd-Jones DM, et al. Heart disease and stroke statistics--2011 update: a report from the American Heart Association. Circulation. Feb 1 2011;123(4):e18e209. 2. H eidenreich PA, Trogdon JG, Khavjou OA, et al. Forecasting the future of cardiovascular disease in the United States: a policy statement from the American Heart Association. Circulation. Mar 1 2011;123(8):933-944. Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes 43


Therapeutic 3. World Health Organization. Adherence to long-term therapies : evidence for action. [Geneva]: World Health Organization; 2003. 4. O sterberg L, Blaschke T. Adherence to medication. N Engl J Med. Aug 4 2005;353(5):487-497. 5. D iMatteo MR. Variations in patients’ adherence to medical recommendations: a quantitative review of 50 years of research. Medical care. Mar 2004;42(3):200209. 6. J erant A, DiMatteo R, Arnsten J, Moore-Hill M, Franks P. Self-report adherence measures in chronic illness: retest reliability and predictive validity. Med Care. Nov 2008;46(11):1134-1139. 7. Rolley JX, Davidson PM, Dennison CR, Ong A, Everett B, Salamonson Y. Medication adherence self-report instruments: implications for practice and research. J Cardiovasc Nurs. Nov-Dec 2008;23(6):497-505. 8. H o PM, Bryson CL, Rumsfeld JS. Medication adherence: its importance in cardiovascular outcomes. Circulation. Jun 16 2009;119(23):3028-3035. 9. L ee JK, Grace KA, Foster TG, et al. How should we measure medication adherence in clinical trials and practice? Ther Clin Risk Manag. Aug 2007;3(4):685-690. 10. D iMatteo MR. Enhancing patient adherence to medical recommendations. JAMA. Jan 5 1994;271(1):79, 83. 11. Farmer KC. Methods for measuring and monitoring medication regimen adherence in clinical trials and clinical practice. Clin Ther. Jun 1999;21(6):1074-1090; discussion 1073. 12. Voils CI, Hoyle RH, Thorpe CT, Maciejewski ML, Yancy WS, Jr. Improving the measurement of self-reported medication nonadherence. Journal of clinical epidemiology. Mar 2011;64(3):250-254. 13. B urnier M. Medication adherence and persistence as the cornerstone of effective antihypertensive therapy. Am J Hypertens. Nov 2006;19(11):1190-1196. 14. Zeller A, Taegtmeyer A, Martina B, Battegay E, Tschudi P. Physicians’ ability to predict patients’ adherence to antihypertensive medication in primary care. Hypertens Res. Sep 2008;31(9):1765-1771. 15. G ross R, Bilker WB, Friedman HM, Coyne JC, Strom BL. Provider inaccuracy in assessing adherence and outcomes with newly initiated antiretroviral therapy. AIDS. Sep 6 2002;16(13):1835-1837. 16. B angsberg DR, Hecht FM, Clague H, et al. Provider assessment of adherence to HIV antiretroviral therapy. Journal of acquired immune deficiency syndromes. Apr 15 2001;26(5):435-442. 17. N orell SE. Accuracy of patient interviews and estimates by clinical staff in determining medication compliance. Social science & medicine. Part E, Medical psychology. Feb 1981;15(1):57-61. 18. Rossi PH, Lipsey WM, Freeman HE. Evaluation: A systematic approach. 7th ed. Thousand Oaks, CA: Sage; 2004. 19. Wetzels GE, Nelemans PJ, Schouten JS, van Wijk BL, Prins MH. All that glisters is not gold: a comparison of electronic monitoring versus filled prescriptions--an observational study. BMC Health Serv Res. 2006;6:8. 20. S chroeder K, Fahey T, Ebrahim S, Peters TJ. Adherence to long-term therapies: recent WHO report provides some 44 Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes

answers but poses even more questions. J Clin Epidemiol. Jan 2004;57(1):2-3. 21. K arve S, Cleves MA, Helm M, Hudson TJ, West DS, Martin BC. Good and poor adherence: optimal cut-point for adherence measures using administrative claims data. Curr Med Res Opin. Sep 2009;25(9):2303-2310. 22. Wu JR, Moser DK, Chung ML, Lennie TA. Objectively measured, but not self-reported, medication adherence independently predicts event-free survival in patients with heart failure. J Card Fail. Apr 2008;14(3):203-210. 23. Steiner JF, Prochazka AV. The assessment of refill compliance using pharmacy records: methods, validity, and applications. J Clin Epidemiol. Jan 1997;50(1):105-116. 24. V rijens B, Vincze G, Kristanto P, Urquhart J, Burnier M. Adherence to prescribed antihypertensive drug treatments: longitudinal study of electronically compiled dosing histories. BMJ. May 17 2008;336(7653):11141117. 25. B ova CA, Fennie KP, Knafl GJ, Dieckhaus KD, Watrous E, Williams AB. Use of electronic monitoring devices to measure antiretroviral adherence: practical considerations. AIDS and behavior. Mar 2005;9(1):103-110. 26. H ansen RA, Kim MM, Song L, Tu W, Wu J, Murray MD. Comparison of methods to assess medication adherence and classify nonadherence. Ann Pharmacother. Mar 2009;43(3):413-422. 27. Wetzels GE, Nelemans P, Schouten JS, Prins MH. Facts and fiction of poor compliance as a cause of inadequate blood pressure control: a systematic review. Journal of hypertension. Oct 2004;22(10):1849-1855. 28. C hoo PW, Rand CS, Inui TS, Lee MT, Canning C, Platt R. Derivation of adherence metrics from electronic dosing records. J Clin Epidemiol. Jun 2001;54(6):619-626. 29. L ee JY, Kusek JW, Greene PG, et al. Assessing medication adherence by pill count and electronic monitoring in the African American Study of Kidney Disease and Hypertension (AASK) Pilot Study. American journal of hypertension. Aug 1996;9(8):719-725. 30. van Onzenoort HA, Verberk WJ, Kessels AG, et al. Assessing medication adherence simultaneously by electronic monitoring and pill count in patients with mild-to-moderate hypertension. Am J Hypertens. Feb 2010;23(2):149-154. 31. C hoo PW, Rand CS, Inui TS, et al. Validation of patient reports, automated pharmacy records, and pill counts with electronic monitoring of adherence to antihypertensive therapy. Med Care. Sep 1999;37(9):846-857. 32. H amilton GA. Measuring adherence in a hypertension clinical trial. Eur J Cardiovasc Nurs. Sep 2003;2(3):219228. 33. S choenthaler A, Ogedegbe G. Patients’ perceptions of electronic monitoring devices affect medication adherence in hypertensive African Americans. Ann Pharmacother. May 2008;42(5):647-652. 34. Peterson AM, Takiya L, Finley R. Meta-analysis of trials of interventions to improve medication adherence. Am J Health Syst Pharm. Apr 1 2003;60(7):657-665. 35. D iMatteo MR, Giordani PJ, Lepper HS, Croghan TW. Patient adherence and medical treatment outcomes: a meta-analysis. Med Care. Sep 2002;40(9):794-811. Volume 2 - Issue 3


Therapeutic 36. N oncompliance with medication regimens. An economic tragedy. Emerging issues in pharmaceutical cost containing. Washington, DC: National Pharmaceutical Council; 1992:1-16. 37. S okol MC, McGuigan KA, Verbrugge RR, Epstein RS. Impact of medication adherence on hospitalization risk and healthcare cost. Med Care. Jun 2005;43(6):521-530. 38. S chroeder K, Fahey T, Ebrahim S. How can we improve adherence to blood pressure-lowering medication in ambulatory care? Systematic review of randomized controlled trials. Arch Intern Med. Apr 12 2004;164(7):722732. 39. S chedlbauer A, Schroeder K, Peters TJ, Fahey T. Interventions to improve adherence to lipid lowering medication. Cochrane Database Syst Rev. 2004(4):CD004371. 40. H orowitz B. Health Care IT: Mobile Apps Show Promise for Medication Adherence. February 15; http://www.eweek. com/c/a/Health-Care-IT/Mobile-Apps-Show-Promise-forMedication-Adherence-828895/. Accessed September 22, 2011. 41. S tone AA, Shiffman S, Schwartz JE, Broderick JE, Hufford MR. Patient compliance with paper and electronic diaries. Controlled clinical trials. Apr 2003;24(2):182-199. 42. A loia MS, Goodwin MS, Velicer WF, et al. Time series analysis of treatment adherence patterns in individuals with obstructive sleep apnea. Annals of behavioral medicine : a publication of the Society of Behavioral Medicine. Aug 2008;36(1):44-53. 43. K nafl GJ, Bova CA, Fennie KP, O’Malley JP, Dieckhaus KD, Williams AB. An analysis of electronically monitored adherence to antiretroviral medications. AIDS and behavior. Aug 2010;14(4):755-768. 44. M odi AC, Rausch JR, Glauser TA. Patterns of nonadherence to antiepileptic drug therapy in children with newly diagnosed epilepsy. JAMA : the journal of the American Medical Association. Apr 27 2011;305(16):1669-1676. 45. B ryson CL, Au DH, Young B, McDonell MB, Fihn SD. A refill adherence algorithm for multiple short intervals to estimate refill compliance (ReComp). Med Care. Jun 2007;45(6):497-504. 46. L iu H, Golin CE, Miller LG, et al. A comparison study of multiple measures of adherence to HIV protease inhibitors. Annals of internal medicine. May 15 2001;134(10):968977. 47. B each MC, Duggan PS, Moore RD. Is patients’ preferred involvement in health decisions related to outcomes for patients with HIV? J Gen Intern Med. Aug 2007;22(8):1119-1124. 48. B ultman DC, Svarstad BL. Effects of physician communication style on client medication beliefs and adherence with antidepressant treatment. Patient Educ Couns. May 2000;40(2):173-185. 49. B each MC, Keruly J, Moore RD. Is the quality of the patientprovider relationship associated with better adherence and health outcomes for patients with HIV? J Gen Intern Med. Jun 2006;21(6):661-665. 50. Fuertes JN, Mislowack A, Bennett J, et al. The physicianpatient working alliance. Patient Educ Couns. Apr 2007;66(1):29-36. 51. H eisler M, Bouknight RR, Hayward RA, Smith DM, Kerr www.JforPC.com

EA. The relative importance of physician communication, participatory decision making, and patient understanding in diabetes self-management. J Gen Intern Med. Apr 2002;17(4):243-252. 52. P iette JD, Schillinger D, Potter MB, Heisler M. Dimensions of patient-provider communication and diabetes selfcare in an ethnically diverse population. J Gen Intern Med. Aug 2003;18(8):624-633. 53. S chneider J, Kaplan SH, Greenfield S, Li W, Wilson IB. Better physician-patient relationships are associated with higher reported adherence to antiretroviral therapy in patients with HIV infection. J Gen Intern Med. Nov 2004;19(11):1096-1103. 54. Tamblyn R, Abrahamowicz M, Dauphinee D, et al. Influence of physicians’ management and communication ability on patients’ persistence with antihypertensive medication. Archives of internal medicine. Jun 28 2010;170(12):10641072. 55. S tein T, Frankel RM, Krupat E. Enhancing clinician communication skills in a large healthcare organization: a longitudinal case study. Patient education and counseling. Jul 2005;58(1):4-12. Antoinette Schoenthaler, EdD is an Assistant Professor of Medicine in the Department of Population Health at NYU School of Medicine and faculty in the newly formed Center for Healthful Behavior Change. Dr. Schoenthaler is a behavioral scientist with an interest in understanding the mechanisms underlying racial disparities in cardiovascular health. Her research focuses on examining the reasons for patients’ decision to adhere to prescribed anti-hypertensive medications and lifestyle behaviors, with emphasis on psychosocial factors such as depression, self-efficacy, and intrinsic motivation. Recently, she has extended this work to the patient-physician relationship. Dr. Schoenthaler has worked in diverse settings from faithbased organisations and senior centers to community-based primary care practices. She has also been involved in various programs targeted at cardiovascular risk reduction while she was at the NYC Department of Health and Mental Hygiene. She has delivered over 450 motivational interviewing sessions within a study that aimed to improve medication adherence in African American patients with high blood pressure. Currently, Dr. Schoenthaler leads motivational interviewing trainings and coaching sessions for community health workers and staff members as well as implements the treatment fidelity protocol to assess how well motivational interviewing is being delivered. In recognition of this work she was accepted as a motivational interviewing trainer by the Motivational Interviewing Network of Trainers (MINT), Inc Group. Email: antoinette.schoenthaler@nyumc.org

Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes 45


Modern Technology

Home Telehealth User Compliance and the Technology Acceptance Model

Governments and healthcare agencies around the world are increasingly exploring ways to support older people to remain living within their own homes for as long as possible. Home Telehealth, the in-home remote monitoring of a person’s health,1 is being trialled as a possible option to assist this to occur. However, despite numerous studies that have investigated the effectiveness of home Telehealth with older people, few have explored safety issues as they relate to this form of healthcare provision.2 This includes investigation of home Telehealth user compliance.3,4 This paper will discuss home Telehealth user compliance as it relates to the Technology Acceptance Model (TAM). Technology Acceptance Model The Technology Acceptance Model (TAM) is a theoretical framework that aims to predict future technology acceptance and usage. Developed by Davis (1989) the original TAM suggests that the degree to which an individual accepts and subsequently uses technology is significantly related to their beliefs of how useful they perceive the technology will be (perceived usefulness), and also how easy they perceive it will be to operate (perceived ease of use).5 In essence, TAM suggests that when a person positively believes that a piece of technology will be useful and easy to use, they will be more accepting of that technology, and if required likely to use it (see Figure 1).

Figure 1. Original TAM Model To measure an individual’s beliefs of perceived usefulness and ease of use Davis developed two separate multiple-item scales. These scales were aptly named perceived usefulness and perceived ease of use.5 Since TAM’s development, variations of the original model and measurement scales have been utilised (see Figure 2). For example Venkatesh and Davis (2000) extended the original model and scales by adding technology acceptance predictive variables such as social influence e.g. social norm, the belief that those who are important to the person would approve of them using the equipment.6 46 Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes

Figure 2. Example of an Extended TAM Model

A major strength of the TAM model is that it allows for future behaviour towards technology to be predicted. Furthermore within the model researchers are able to use either the intention to use the technology, or actual usage rates, as the measure for usage behaviour. This gives the model flexibility when actual behavioural measures are not able to be obtained. It should be noted that the use of intention as the measure of behaviour has met with some criticism.14 This is given that an intention to perform behaviour does not in all instances lead to behaviour. 15 The application and versatility of TAM has been quite widespread with the model used to predict technology acceptance and usage behaviour in an array of different areas. These include, among others, the acceptance and usage of office technology,5 the internet,7 Telehealth8,9 and home Telehealth.4 Studies have also investigated TAM’s application with different groups. For example TAM research exploring Telehealth technology has included examination of its acceptance and usage with patients,3 informal carers,4 organisational staff,4 physicians,12,13 and frail older people.4 Home Telehealth Safety and User Compliance Research A recent Australian study examined the acceptance and usage of home Telehealth by frail older people who were discharged from hospital to their home and were at risk of either returning to hospital, or of being moved into a residential aged care facility. In this Australian study participants were required to use home Telehealth equipment on a once daily basis (Monday to Friday) to monitor their vital signs, e.g. heart rate and blood pressure. Those vital sign readings were electronically transmitted to a Data Monitoring Officer, and if necessary the participants’ treating physician.10 A small body of work published from this study included examination of safety issues as they relate to home Volume 2 - Issue 3


Modern Technology

Telehealth usage and home Telehealth usage compliance.4,11 The researchers reported an overall 13% Telehealth reading failure rate for all participants who had commenced the study,11 and a 12% reading failure rate for those who had completed the study.4 In both instances user non-compliance was found to be a significant contributor of those failed readings, in addition to equipment failure, staff not following up missed or incomplete readings, and user error.4,11 To examine possible factors related to this user noncompliance the researchers utilised the Technology Acceptance Model as a theoretical framework to investigate the relationship between participants’ self-reported acceptance of home Telehealth and their future usage compliance. Wade, Cartwright and Shaw (2012) reported that participants’ pre-conceived perceptions of how easy they believed the equipment would be to use, as selfreported prior to receiving training in and using the home Telehealth equipment, was significantly related to their future usage compliance. In this, the easier a participant had pre-conceived the home Telehealth equipment would be to use, the higher their usage compliance rates were during the study. Conversely, the more negatively a participant had pre-conceived the ease of use to be, the lower their usage compliance was during the study. Pre-conceived beliefs about how useful the equipment would be were not related to future compliance rates.4 What is of interest about this result is that after participants had reported their pre-conceived beliefs of how easy and useful they perceived the equipment would be to use, they all received equipment training. Participants had to be competent in using the study equipment prior to being monitored by it. As such, the impact of negative preconceived beliefs about how easy the Telehealth equipment would be to use endured beyond a person being trained and becoming competent in using the equipment. This is due to those pre-conceived beliefs having a statistically significant relationship with future usage behaviour. This finding warrants further investigation to allow a greater understanding of the relationship between frail older people’s pre-conceived beliefs about home Telehealth ease of use and their future compliance with using the equipment. Research in this area may also benefit by exploring the factors that influence older people’s pre-conceived beliefs about home Telehealth ease of use.4 The finding of a significant relationship between preconceived beliefs about ease of use and home Telehealth usage compliance has potential practical application for the development of targeted interventions to increase usage compliance of home Telehealth among frail older people. www.JforPC.com

This result may indicate that the provision of training in using the equipment is not the only form that an intervention to improve compliance should take; rather, that before commencing a home Telehealth programme, patients should not only be trained and competent in using the equipment, but time should also be spent assessing, and if necessary addressing, any negative pre-conceived beliefs about how easy the equipment will be to use. Telehealth Compliance Process The paper by Wade et al. (2012) focuses on the application of TAM with frail older people’s compliance with home Telehealth use.4 However, an individual who is being remotely monitored in their own home with Telehealth is not the only person responsible for the successful implementation of, and compliance with, a home Telehealth programme. The very nature of home Telehealth means that a number of different groups are involved in the compliance process. Organisational staff members need to remotely monitor the equipment readings, and physicians need to remotely interpret the health data. As such, organisational staff and physicians are as much part of the compliance process as the person who is taking their own in-home readings. Furthermore, informal carers may also be involved if the person receives in-home assistance from family members and/or friends. At any time compliance with the requirements of each role may not be met and result in reading failure. The research findings reported by Wade et al. (2012) support this, given that missed or incomplete readings by informal carers who were assisting the older person,11 and periodic non-compliance by organisational staff in following up missed or incomplete readings,4,11 were found to be a contributing factor in home Telehealth reading failure rates. In regard to physicians, a small number of studies have utilised TAM to investigate the intention of physicians to use Telehealth. Mixed results have been reported. For example, research by Orruno, Gagnon, Asua and Abdeljelil (2011) used the TAM model to investigate factors affecting the intention of physicians to use Telehealth equipment (teledermatology). It was reported that physicians’ perceptions of both how useful and how easy they believed the equipment would be to use were significantly related to their intention to use the equipment.13 Chismar and Wiley-Patton (2003) utilised TAM to investigate physicians’ intention to adopt internet health applications.12 In contrast to Orruno et al. (2011)13 it was reported that whilst physicians’ perceptions of the technologies’ usefulness were significantly related to the intention of future use, ease of use was not. Given this Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes 47


Modern Technology reported significance of perceived usefulness, Chismar and Wiley-Patton (2003) made a number of suggestions about possible interventions to encourage physician usage of Telehealth. These included that when new health technology is being implemented for physician usage, organisational management should place emphasis on the usefulness and utility of the equipment for the performance of daily tasks.12 In Telehealth TAM studies, what is of particular interest is that differences in TAM results have been reported between the groups who are part of the compliance process. For example, Wade et al. (2012) reported that for frail older people a significant relationship with future home Telehealth usage compliance was found only with pre-conceived beliefs about ease of use, and not for pre-conceived usefulness.4, In contrast, Chismar and Wiley-Patton (2003) reported that for physicians only perceived usefulness was significantly related to future usage intention of the health technology, and not ease of use.12 These mixed findings warrant further investigation. Whilst they may possibly result from differences in the methodologies utilised across studies, they may also be due to actual differences in the factors affecting Telehealth acceptance for each user group. If differences between groups exist (i.e. between the patient, informal carers, organisational staff, and physicians), and usage compliance becomes an issue in a home Telehealth programme, all groups who are part of the usage compliance process should be considered separately when interventions to encourage usage and compliance with Telehealth are being developed and implemented. Concluding Remarks The importance of medical compliance is well documented. In regard to home Telehealth, compliance with using the equipment is an important factor in the safe and successful implementation of an in-home health monitoring programme. As has been discussed in this paper, the compliance process in home Telehealth rests not only with the patient using the equipment but also with any informal carers who provide inhome assistance, and the physician and organisational staff who remotely monitor the person. Further safety research in home Telehealth is needed for a greater understanding of the determinants of home Telehealth usage compliance; and also for how these determinants may differ between those involved in the compliance process. This information may assist in the development of targeted interventions to improve compliance rates for home Telehealth programmes that are recording lower reading rates. This is vitally important given the frailty of certain groups with whom home Telehealth is currently being trialled. TAM is a theoretical framework that could contribute to this body of research. References 1. Bunn, F. (2005). The effects of telephone consultation on triage and healthcare use and patient satisfaction: A systematic review. J Gen Pract, 55, 956-961. 2. Schlachta-Fairchild, L., Elffrink, V., Deickman, A. (2008). Patient safety, telenursing and telehealth. In: Hughes RG editor. Patient Safety and Quality: an Evidence Based Handbook for Nurses. Rockville, MD: Agency for Healthcare Research and Quality (US). 48 Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes

3. Rahimpour, M., Lovell, N., Celler, B., McCormick, J. (2008). Patient’s perceptions of a home telehealth system. Int J Med Inform, 77, 486-498. 4. Wade, R., Cartwright, C., Shaw, K. (2012). Factors relating to home Telehealth acceptance and usage compliance. Risk Management and Healthcare Policy, 5, 25-33. 5. Davis, F. (1989). Perceived usefulness, perceived ease of use, and user acceptance of information technology. MIS Quarterly, 13, 319-339. 6. Venkatesh, V., Smith, R.H. (1999). Creation of favourable user perceptions: Exploring the role of intrinsic motivation. MIS Quarterly, 23, 239-259. 7. Kripanont, N. (2006). Using a Technology Acceptance Model to investigate academic acceptance of the internet. Journal of Business Systems, Governance and Ethics, 1,13-23. 8. Huis, R., Kosterink, S.M., Barbe, T., Lindegard, A., Marecek, T., Vollenbroek-Hutten. (2010). Relation between patient satisfaction, compliance and the clinical benefit of a teletreatment application for chronic pain. Journal of Telemedicine and Telecare, 16, 322-328. 9. Jude, E., Leila, H. (2007). Telemedicine usage in France and the U.S: An exploratory investigation using the technology acceptance model. International Journal Business Research, 7. 10. Cartwright, C., Wade, R., Shaw, K. (2011). The impact of Telehealth and Telecare on clients of the Transition Care Program Report. ASLaRC, Southern Cross University. 11. Wade, R., Shaw, K., Cartwright, C. (2012). Factors affecting provision of successful monitoring in home Telehealth. Gerontology, 58, 371-377. 12. Chismar, G., Wiley-Patton, S. (2003). Does the extended Technology Acceptance Model apply to physicians? Proceedings of the 36th Hawaii International Conference on System Sciences. 13. Orruno, E., Gagnon, M., Asua, J., Abdeljelil, A. (2011). Evaluation of teledermatology adoption by health-care professionals using a modified Technology Acceptance Model. Journal of Telemedicine and Telecare, 17, 303-307. 14. Turner, M., Kitchenham, B., Brereton, P., Charters, S., Budgen, D. (2010). Does the technology acceptance model predict actual use? A systematic literature review. Information and Software Technology, 52, 463-479. 15. Armitage, C., Conner, M. (2001). Efficacy of the Theory of Planned Behaviour: A meta-analytic review. British Journal of Social Psychology, 40, 471-499. Rachael Wade has extensive experience in the not-for-profit supported accommodation sector. She recently completed work as part of an Australian research team investigating the acceptance and usage of home Telehealth with frail older adults. Rachael has a particular interest in the safe provision of home Telehealth and has authored several peer reviewed journal articles on this topic. Email: waderachael@hotmail.com

Volume 2 - Issue 3


www.JforPC.com

Journal For Patient Compliance Strategies to enhance Health Outcomes 37


Modern Technology

Impacting Medication Adherence Through mHealth – Why Apps Are Not Enough Advances in the pharmaceutical industry have had a huge impact on patient health. Today, patients are able to live longer because of the availability of medications. But these pharmaceutical advances only work if patients adhere to their prescribed medication regimens. Medication non-adherence is an issue that payers and providers have grappled with over the years, developing interventions to help remind patients to take the medications correctly. With the ubiquity of mobile phones and the possibilities the technology represents, there is a great opportunity to harness the power of mobile health (mhealth) to influence patient behaviour. In order to be effective, however, the mhealth tools need to be intuitive, easy-touse and offer dialogue between patients, providers and pharmacies. Medication Non-adherence: The Billion-Dollar Problem What is Medication Non-adherence? Medication nonadherence means delaying or failing to fill or refill prescriptions, taking a smaller amount of the prescribed dosage, and skipping doses. Medication non-adherence is a billion-dollar problem in the United States, causing increased costs in hospitalisation, increased need for further prescription drugs and increased doctor’s office visits as a result of unmanaged illness and chronic disease. The statistics around medication adherence are grim:1 – Patients frequently do not adhere to essential medications, with substantial consequences to public health. – Medication non-adherence is an enormous burden to the world’s healthcare system. – Half of the 3.2 billion annual prescriptions dispensed in the United States are not taken as prescribed. –N  umerous studies have shown that patients with chronic conditions adhere only to 50-60 per cent of medications as prescribed, despite evidence that medication therapy improves life expectancy and quality of life. – Approximately 125,000 deaths per year in the United States are linked to medication non-adherence. – Between 33 and 69 per cent of medication-related hospital admissions in the US are due to poor adherence, with total cost estimates for non-adherence ranging from $100-300 billion each year including costs for additional doctor visits, emergency room visits, hospital admissions, and additional medicines. Worldwide, poor medication adherence in the treatment of chronic disease is a significant problem as well. In developing countries, medication rates are even lower than those in the United States; and the impact of poor adherence grows as the burden of chronic disease grows, according to the World Health Organization (WHO).2 For example, WHO states that non-communicable diseases and mental disorders, human immunodeficiency virus/ 50 Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes

acquired immunodeficiency syndrome and tuberculosis, together represented 54% of the burden of all diseases worldwide in 2001, and will exceed 65% worldwide in 2020. The poor are disproportionately affected. Pharmacological therapy is an important component to treat chronic disease and illnesses effectively. But patients must take the prescribed medications appropriately in order to reap the most health benefit. Improving adherence also improves patient safety.3 Interventions that influence patient behaviour and increase likelihood of patient adherence can have a tremendous impact, not only in cost-savings, but in quality of life for healthier patients. It is estimated that for every additional dollar spent on adhering to a prescribed medication, medical costs would be reduced by:4 $7.00 for people with diabetes; $5.10 for people with high cholesterol; and $3.98 for people with high blood pressure.

For medication adherence interventions to be effective, they must be consistent, multichannel, in a format the patient prefers, match the doctors’ orders, are tied to overall patients’ medical records systems, and are able to be viewed and reinforced by the prescriber. mHealth and How it Can Impact Medication Adherence What is mHealth? Quite simply, mobile health or “mHealth” is the use of mobile and wireless devices to improve health outcomes, healthcare services and health research.5 mHealth is touted as an effective way to communicate with patients and impact their behaviour because of the availability of mobile technologies in all parts of the world. The mobile phone is the first information and communications technologies (ICT) tool that has reached even remote areas in low- and middle-income countries (LMICs). The coverage of mobile networks is increasing rapidly all over the world, and the number of subscribers has by far exceeded the number of fixed-line connections in many LMICs in recent years.6 This growing coverage provides health systems with new possibilities to address problems in accessibility, quality, effectiveness, efficiency and costs of healthcare. Clients of health services make and receive phone calls or text/voice messages related to health education, treatment adherence, contacting health workers, or organising transport to health services. Healthcare workers receive diagnostic support, consult with colleagues, communicate with clients, enhance their skills and gather and analyse data using mobile devices.7 Volume 2 - Issue 3


Modern Technology Why is mHealth important? Because it meets patients where they are. According to Pew Internet Research, three-quarters of US adults go online. A majority of US households have broadband internet access. Eight in 10 adults have a cellphone. Six in 10 adults go online wirelessly with a laptop or mobile device. Half of adult cellphone owners have apps on their phone.8 Pew Internet Research also shows that people are using these technologies to connect with up-to-date health information and, more powerfully, with each other. Ubiquity of Apps Mobile apps are everywhere and available for nearly every subject. Smartly, a major smartphone manufacturer based a branding campaign on the phrase, “There’s an app for that.” Even the children’s show Sesame Street® parodied the concept in a song of the same title. There are tens of thousands of apps on the market, with new ones being introduced each day to feed the frenzy. There are now more than 250,000 apps available for the iPhone, more than 30,000 such apps for smartphones running Android, and several thousand for those who have Blackberry devices.9 The share of adult cellphone owners who have downloaded an app to their phone nearly doubled in the past two years — rising from 22% in September 2009 to 38% in August 2011 — according to a new survey by the Pew Research Center’s Internet & American Life Project. The share of US adults who purchased a phone already equipped with apps also increased five percentage points in the past year, from 38% in May 2010 to 43% in August 2011, according to the survey.10

There are many health and wellness apps available — from apps that offer fitness tips to apps that keep personal health records — and with good reason. According to a Pew survey, 15% of adults have used their cellphones to look for health information.11 But the quality of apps available, particularly those related to health and wellness management, varies widely. The good: Apps like Lose It! are designed with user benefit and user intention in mind. They’re easy to use and provide easy-to-understand information immediately, which is why people keep using them. The bad: Health apps that don’t take into account the patient or the patient’s lifestyle. For example, there are many apps for people with diabetes, but the apps aren’t designed by diabetics or people who understand the disease. The apps don’t take into consideration what diabetics go through each morning to use their bolus pump, do their glucose testing and take their insulin. Many health apps also require patients to enter their own medication history and health history. If patients already www.JforPC.com

struggle to take their medication correctly, why would we believe that they will take the time to enter very detailed and specific information into an app, and actually use it? As a result, many apps and health reminder services have had low adoption rates. In fact, of smartphone owners, 68% open only five or fewer apps at least once a week, finds a survey by the Pew Research Center’s Internet & American Life Project.12 According to the blog Flurry, health, medical and fitness apps have a similar rate of “stickiness”: medical apps have a 72% retention rate after 30 days, but that falls to 43% after 90 days; health and fitness apps have a 65% retention rate after 30 days, but that falls to 30% after 90 days.13

mHealth is a slow train on a fast track. The ability of technology to impact patient adherence to medication or chronic disease management instructions has outpaced user adoption of these tools. Developers are working feverishly to get things out into the market, without first validating that their solutions meet patient and provider need. It has caused fragmentation and confusion for the patient; as a result, the market is cluttered. But the industry needs to find a way to meet patients where they are. As smartphones become less and less expensive — a smartphone that cost $500 just a few years ago is available today for just $99 — there is a greater opportunity to reach people through their mobile phones. That’s where the mHealth platform is valuable. Why Apps Aren’t Enough With a few exceptions, mHealth apps tend to be stand-alone, or disconnected from a larger network of payer/provider health information. They also tend to have a very specific use that is not expandable among a larger collection of tools to helps patients and their doctors communicate. An mHealth platform, however, allows for flexible, intuitive patient use and enhances communications with physicians, health plans and pharmacists. What is an mHealth platform? In the case of medication adherence, an mHealth platform has an API or ability to easily interface with healthcare systems, such as Electronic Medical Record, a pharmacy management system, a payer or insurance system, or other legacy systems. More importantly, a platform allows pre-population of patient information (e.g. drug history, claims history, etc.) to take advantage of data sources. Through a platform, vendors can aggregate that information in a secure, HIPAA-compliant fashion and message patients according to the right protocol. A business rules engine allows pharmacies and healthcare companies to be able to message and communicate with patients in the way the prescriber intended. Furthermore, in a platform, patients have to opt in. They can choose how they want to be contacted. Technologies such as SMS text, QR codes, mobile web and apps for all major Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes 51


Modern Technology smartphone and feature phone platforms, including e-mail, and interactive voice response (IVR) technology, all help deliver meaningful and timely communication to patients in a way they want, on a device they have with them at all times. mHealth platforms have other advantages as well. For one, they can be “private-labelled,” which means the platform can be branded in the pharmacy or payer’s name. Doing so elicits a high level of trust with patients, who already have some loyalty to the brand, which allows for faster patient adoption. Internally, it speeds up the go-to-market time because the customised platform has functionality already built in. Typically, such platforms only require a 20 to 30% customisation of the platform for the business rules and for the user experience. Secondly, mHealth platforms can be modified to reach audiences who have low health literacy or find English difficult to understand. Through strategic partnerships, mHealth companies can use the platform to deliver mobile medication adherence instructions written to a fifth- or sixth-grade reading level in more than a dozen languages, ranging from English and Spanish to simplified and traditional Chinese characters, Korean and Bengali. Large fonts are also available for people with impaired vision, as well as videos to demonstrate medications that may be difficult to use. (For example, http://mhealthwatch. com/polyglot-partners-with-cellepathicrx-for-medicationadherence-18856/.) Additionally, mHealth platforms can deliver patient analytics in a way that no app can do. The platform gathers “transactional exhaust” — which is a by-product of the patient interaction and their behaviours — and delivers it in an easyto-understand dashboard report for providers. Depending on the intended audience, payers, providers or pharmacies can log in and get appropriate levels of information and insights into patient adherence, in a HIPAA-compliant environment. Most importantly, a robust mHealth platform can influence patient outcomes. It allows the doctor to become more educated about their patients and gain insights into their behaviour. The patient is more educated and tuned in to adherence. The payer gets a lower healthcare cost and can potentially offer lower healthcare premiums. In short, better outcomes equal lower premiums and lower healthcare costs. We already know there is significant evidence that traditional adherence methods like IVRs, letters, and automated patient communication improve adherence, increase pull-through at pharmacies, and improve top-line revenue for pharmaceutical manufacturers. The promise of mhealth is to leverage the ubiquity of new technology with motivated patients and a motivated value chain (payers, providers, pharmacies and pharmaceutical manufacturers) to establish a much more intimate and direct two-way patient dialogue than what’s possible with traditional patient communication alone. 1 (Hayden B. Bosworth) 2 (World Health Organization, 2003) 3 (World Health Organization, 2003) 4 (Hayden B. Bosworth) 5 (U.S. Department of Health and Human Services, 2010) 6 (Royal Tropical Institute) 52 Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes

7 (Royal Tropical Institute) 8 (Fox, 2012) 9 (Fox, Mobile Health 2010, 2010) 10 (Purcell, 2011) 11 (Fox, The Social Life of Health Information, 2011, 2011) 12 (Fox, Peer-to-Peer Healthcare and the C3N Project, 2012) 13 (Farago, 2009) Bibliography Farago, P. (2009, September 25). Mobile Apps: Models, Money and Loyalty. Retrieved Februrary 16, 2012, from Flurry: http:// blog.flurry.com/bid/26376/Mobile-Apps-Models-Money-andLoyalty Fox, S. (2010, October). Mobile Health 2010. Retrieved February 16, 2012, from Pew Internet & American Life Project: http:// www.pewinternet.org/Reports/2010/Mobile-Health-2010/ Report/Mobile-health-apps.aspx Fox, S. (2011, May 12). The Social Life of Health Information, 2011. Retrieved February 16, 2012, from Pew Internet & American Life Project: http://pewinternet.org/~/media/files/ reports/2011/ pip_social_life_of_health_info.pdf Fox, S. (2012). Peer-to-Peer Healthcare and the C3N Project. Cincinnati, OH: Pew Internet Research. Hayden B. Bosworth, P. D. (n.d.). Medication Adherence: Making the Case for Increased Awareness. Purcell, K. (2011, November 2). Half of adult cellphone owners have apps on their phones. Retrieved February 16, 2012, from Pew Internet & American Life Project: http://pewinternet.org/ Reports/2011/Apps-update.aspx Royal Tropical Institute. (n.d.). What is mHealth? Retrieved January 31, 2012, from mHealth in Low-Resource Settings: http://www.mhealthinfo.org/what-mhealth U.S. Department of Health and Human Services. (2010, November). What is mHealth? Retrieved January 31, 2012, from Health Resources and Services Administration: http:// www.hrsa. gov/healthit/mhealth.html World Health Organization. (2003). Adherence to Long-Term Therapies, Evidence for Action. Greg Muffler, Co-Founder and CEO,has been in senior leadership roles with several start-up organisations throughout his career in IT. Before co-founding AMI, Mr. Muffler cofounded and held the position of CEO of Exential LLC, a Cleveland-based IT consulting firm. Prior to that, Mr. Muffler held the position of General Manager for TITAN Technology Partners, a technology consulting firm headquartered in Charlotte, North Carolina. Before that, he established the services division of Foresight Technology Group, one of the larger IBM resellers in the country, where he was responsible for the vision, direction, sales and project delivery. Mr. Muffler also served as Branch Partner with PRIMA Consulting, a 200 person IT consulting firm. Mr. Muffler holds a B.A. degree in Business from Baldwin-Wallace College and MBA studies from Cleveland State University. Email: gmuffler@cellepathicrx.com

Volume 2 - Issue 3


Modern Technology

Therapy Services in a Digital World – The Case for User-focussed Technology in the NHS At present, although it is clear that we increasingly live in a digital age, the use of technology in statutory services and the NHS in particular, is limited. Where it is used, it tends to focus on hardware equipment or IT infrastructure and systems, as opposed to improving the patient experience and frontline service delivery. So, for example, the NHS can truly be said to embrace cutting edge technology in relation to surgical procedures, such as keyhole surgery or pharmacological treatment, for cancer, for example. But it has also spent huge sums of public money over the last ten years on information technology, as the infamous, and ultimately doomed, National Programme for Information Technology (NPfIT) demonstrates. But in neither of these areas of technological advance – treatment or managing patient data – has there been a real focus, effort or spend on harnessing digital and web technologies to better communicate and empower service users by placing the patient experience at the centre of the innovation. As a result, we currently have an NHS system which demonstrates a tragic mismatch between what service users are accustomed to in the wider consumer culture, and what the NHS is offering. These changes in user experience have been embraced in other service industries and are changing the very fabric of society. The public is buying – in ever increasing numbers – iPads, smartphones and apps; and they are using them to manage their finances, arrange holidays, listen to music, and read books and newspapers. Yet the ‘user interface’ within the NHS is, with a few notable exceptions, steadfastly analogue and as such is increasingly an anachronism in modern society. The direction of travel suggests that eventually these changes will penetrate the way healthcare is delivered in the UK. However, more needs to be done quicker, to bring the digital world to NHS service delivery. We shall use design and technology to tackle social problems. Using best digital practice, we should try and bring these approaches into the NHS and marry them to the wealth of knowledge and expertise that already exists, bringing together the formal professional-led care that dominates today, with the informal digitally-powered tools of tomorrow. Businesses in the sector are starting a quiet revolution by working collaboratively with service users, clinical teams and digital designers to bring together new digital possibilities to solving some of the knotty problems that traditionally beset mental health services. Here are some of the headline issues, which we are challenging: • How can we reach the people in our local community who can benefit from our services, and when we find them how can we inspire them to stay engaged? • How can we empower users to begin to actively manage their own journey to recovery? • H ow can we get a better insight into how people feel and behave in their everyday lives? 54 Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes

• H ow can we prompt users to turn up for sessions or at least make it easy to change appointments? • H ow can we prompt, nudge and encourage users to make small step-by-step improvements to support their move to recovery? • H ow can we be confident that they have got support so that we can discharge them from our care, but have a way of staying in touch? • A nd how can we do all of this more cost-effectively to manage to deliver the best service possible within limited resources? Engaging Clients Using simple digital technologies, like SMS and websites, it is possible to overcome much of the stigma associated with using traditional health services by providing a personal and discreet way of engaging with services. Receiving and sending text messages (which most people do every day in every social situation and does not require an expensive smartphone) is far less stigmatising way of engaging with, for example, mental health support than physically going to a mental health institution. SMS works well because it is persistent – it will prompt the user regularly, and it is consistent – it will stay with the user throughout the time that they are with the service as part of their package of care. Empowering Clients Using technology, it is possible to enable users to create their own session plan by using a web platform to reflect on their weekly entries and to think about what they would like to talk to their clinician about from the beginning of their care pathway. By looking back over their daily entries over the period since they last spoke to their clinician, users are encouraged to flag up (literally to mark with a ‘star’) particular days or issues that they want to discuss and to spot patterns in the relationship between their daily mood and the things that they were doing on those days. From this, they are encouraged to write a session plan about the things that they would like to put on the agenda for discussion with their clinician at their next session. Providing a Rich Insight into Clients’ Lives Digital tools can add a great deal of value to the therapeutic relationship between user and clinician. It is the clinician that offers clients the option to use technology with the goal of improving the therapy provided by basing it on the user’s daily life and his/her goals. This helps to overcome the range of problems with traditional paper-based mood diaries, where users often don’t complete them or do them retrospectively (often just before sessions). By providing a contemporaneous record of the individual’s daily mood, we can paint a better picture of the user’s daily life, unaffected Volume 2 - Issue 3


Modern Technology goals and behaviour change. This means that clinicians are able to move people through their care pathway to recovery more efficiently. Also, the reminder systems mean that did not attend (DNA) rates can be brought down – by around 10%; and, of course, people are more likely to attend sessions if they have helped to plan them. User-focussed, Simple Technology The big NHS IT projects (eg electronic records) are a good example of the barrier that digital tech can be to patient care. Proprietary technology is cumbersome and focussed on the demands of the system, not the service user. By using the consumer tools – like mobile phones – that most people are used to, it’s possible to build small things quickly and cheaply and get on with evolving them iteratively... We believe that in the near future, the patient will have their own tools, their own data and their own solutions that they will share with their professional, rather than being prescribed generic packages of care that present a challenge to compliance.

by their mood on the day that the session takes place (which can distort any verbal account of their experience offered during the session). The application of this sort of technology extends far beyond mental health services: any service that requires regular contacts with and participation from service users can benefit from increased patient engagement. Better Client Understanding of their Own Condition By offering users analysis tools to help them to better understand how the things that they do influence their care, technology enables users to more easily reflect on their behaviour and make appropriate changes. Earl Howe with Buddy MD James Seward Improved Client Compliance Improved Behavioural Activation Towards Recovery Using tools to support behavioural activation – where users and their professionals are able to collaborate during sessions to agree, set and then subsequently for the service user to receive, text messages – can reinforce the goals promoting recovery. Because these goals are personal, in that the exact wording is agreed with the user to suit their personal preferences, compliance rates can be dramatically improved. Supporting Clients Move Back into the Community Sidekick is exploring ways that users who wish to can continue to use the tool to provide services with a supported discharge arrangement. Clinicians can stay in touch with the user in the period immediately after they have been discharged from their service. In this way, we can provide the basis for planned follow-up, giving clinicians and provider organisations a valuable way of demonstrating sustained recovery and/or improved mental health and wellbeing. Cost-effectiveness By empowering and prompting the service user to set the agenda for their care, we can provide more time to focus on www.JforPC.com

James Seward, MD Buddy Enterprises. James is an experienced mental health strategist and change maker, with 20 years NHS experience, he is best known for delivering successful Government projects in mental health, particularly the Improving Access to Psychological Therapies (IAPT) programme. As MD for Buddy App he remains committed to improving mental health and well-being through harnessing digital tools and design approaches to improving service users’ experience and adding values to clinical teams and provider organisations in an environment where the sector is challenged by structural change, the need for quality improvement and fiscal constraints. Adil Abrar, Buddy Founder. In 2010. Adil set up of Sidekick Studios, an innovation consultancy, that helps large organisations act like startups. He is the Founder of Buddy the co-founder of The Amazings, a marketplace for retired adults to sell their skills and experiences to their local community. His passion is using the startup process to solve problems that really matter. Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes 55


Drug Delivery, Drug Packaging, Labelling & Dispensing

Enabling Greater Product Success through Adherence Packaging

Executive Summary Patient non-adherence to prescribed medication is a common problem which significantly impacts patient outcomes, as well as having an effect on clinicians, payers such as insurance companies, governments, and the overall economy of the global healthcare system. As a result of this, pharmaceutical companies are increasingly looking for ways to improve medicine adherence. In the US alone the estimated annual cost of poor medication adherence is almost $300 billion,1 with thousands of hospitalisations and deaths annually occurring as a result of non-compliance. As a result of the rocketing costs associated with the issue and patient fatalities as a result of this, this is becoming a truly global pandemic. Patient Compliance – A Growing Issue Patient compliance to a selected medication regime is an issue of global importance and can be severely affected by a number of factors. In 2003 the World Health Organization (WHO) quoted that patient-related factors were just one determinant of adherence, alongside: condition-related factors, social/economic factors, therapy-related factors and health system/HCT-factors.2 Here, it is important to realise that contrary to the prior assumptions held by many, patients are not solely responsible for lack of adherence. The medication compliance rate for chronic conditions, prescribed long-term medication, is cited by the WHO as being as little as 50% with the number falling even lower in developing countries. These countries are often caught up in a vicious cycle of economic poverty and as a result, bad healthcare. As chronic diseases continue to grow in underprivileged countries, the same problems continue to occur. Low - or no - income, combined with the lack of clean water/adequate food supplies and deficiency of medical care, means that it is essential that patients remain compliant in order to not further progress this problem by wasting already limited resources. With rates of compliance this low, it is essential that patients who do choose to adhere to their therapy are greeted with complementary, adherenceprompting packaging. The Current Landscape of Compliance Packaging Looking to relieve the industry of these burdens are companies providing compliance packaging. A recent paper from the Healthcare Compliance Packaging Council (HCPC) discusses its support of modern packaging solutions including patient prompting, also know as compliance packaging, as a successful option for improving patient adherence.3 In this report the HCPC aims to have compliance-prompting packaging recognised as a key tool to improving patient adherence and outcomes. Benefitting a range of stakeholders 56 Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes

from pharmaceutical manufacturers through to payers, clinicians, patients and governments, the implementation of innovative packaging solutions would provide significant economic and public health benefits. With reports stating that corporate health insurance premiums are showing annual double-digit growth rates as a direct result of nonadherence,4 payers such as insurance companies are one of the biggest influencers on pharmaceutical companies when it comes to implementing adherence packaging. Although greater patient compliance is often cited as one of the potential key ways to cut healthcare costs, burdens and fatalities, there is still a surprising lack of companies choosing to conform to the process. While there are a number of drugs such as contraceptive drugs, steroids and hormone replacements currently benefitting from patientcompliance packaging, the technique is still to be properly adopted industry-wide, regardless of the numerous industry data highlighting its success. Particularly with chronic conditions, compliance packaging would prove hugely beneficial due to the ever-increasing rise of patients with chronic conditions and the very low adherence rates associated with treatment regimes. Drug packaging designed specifically to prompt and remind patients to take their medication, such as calendarised packaging, can support a patient in routine with their therapy regime. It is unclear why, regardless of a number of success stories over the past decade, companies are still reluctant to embrace compliance packaging. The cost association of implementing compliance packaging is a stumbling-block for many, however, while the cost of this approach can potentially add costs, the industry also needs to consider how low compliance as a result of non-patient-prompting packaging can significantly add to costs. In addition, as the industry recognises the ultimate benefits of compliance packaging, packaging companies are now able to provide cost-effective compliance packaging for their customers. Through the use of cutting-edge technologies, compliance packaging is now an affordable solution in addressing patient needs and achieving better health outcomes. When the disease state and needs of the patient are taken into account, a comprehensive, bespoke adherence packaging programme can be developed to boost patient compliance and generate better patient outcomes. Key Factors in Successful Compliance Packaging A successful compliance package integrates a range of factors such as innovative packaging design supported by a comprehensive manufacturing process. As the first point of contact for those taking prescriptions, aesthetically pleasing packaging can reap a range of benefits. However, Volume 2 - Issue 3


Drug Delivery, Drug Packaging, Labelling & Dispensing

it is essential that compliance packaging also conforms to regulatory constraints concerning child safety, while also remaining ‘senior-friendly’. By incorporating smart designs such as concise graphics which guide the patient to their dosing regime, and other graphics highlighting opening instructions for novel, child-resistant packaging techniques, pharmaceutical companies can ensure compliance packaging. Other innovative packaging solutions such as the introduction of RFID-enabled computer chips technologies a few years back has offered the ability to monitor if a patient has taken their medication, and when exactly it was taken. Advances in technology over recent years have meant that these novelties can be produced with standard machinery, saving on costs, and to appear the same to customers as standard packaging. Ultimately, compliance packaging must be thought about carefully and adapted for each individual medication in order to meet with the requirements of a variety of different patients. One of the keys to success is having a complimentary team, combining design expertise with packaging and manufacturing knowledge. This need for combined proficiencies often results in collaborations of companies striving to share expert knowledge to provide industry-leading adherence solutions. Compliance through Education Many would agree that in order to encourage compliance packaging industry-wide, educational programmes are in order. When developed properly, compliance packaging can be used as a significant patient-education tool when combined with personalised patient counselling and wellwritten medication instructions by health professionals. Poor health decisions often occur due to a lack of education, therefore graphics on compliance packaging should not be exclusively about reminding but should also be educational. With patients often not feeling the full benefits of medication due to not fully adhering to their regime, this needs to be highlighted in education programmes. Compliance packaging solutions often now encompass a number of education tools integrated directly into the package, including: regulatory and marketing literature, coupons, cash and co-pay cards and reimbursement tools, tip guides and instructions for lifestyle changes, patient education tools, enrolment devices, electronic tools including DVDs and USB devices, patient reminders and removable chart stickers. All of these factors aid in educating patients about the importance of complying to their therapy regime, and facilitate improved engagement.

www.JforPC.com

Conclusion As financial pressures continue to grow, pharmaceutical companies are under constant pressure to generate the best patient outcomes possible under even tighter budgets. With non-adherence sapping healthcare budgets, as well as claiming fatalities and increasing the number of hospital admissions drastically, the industry is actively looking for ways to address these issues. A much-debated issue for a number of decades, compliance packaging is becoming increasingly recognised in the market as a way to reduce these problems by prompting compliance. Through an innovative mix of smart packaging and adherence-prompting materials, pharmaceutical companies are able to benefit from increased patient compliance, and in turn, significant cost savings. References 1. www.thecollaborativeforum.com/91/ thevaluequadrantofhealthcarereform/medicationadherencea-value-quadrant-opportunity-part-ii/ 2. World Health Organization, 2003, Adherence to long-term therapies – Evidence for action 3. w ww.hcpconline.org/member-news-document/hcpc-whitepaper-on-adherence-packaging-research.pdf 4. 10th Annual Survey of Large Employers: Watson Wyatt Worldwide and National Business Group on Health, March 2005 Following a 15 year career in operations and works management in the engineering and automotive sector, Steve moved to the pharmaceutical industry in 1995 holding directorial and executive board positions in major companies including Cardinal Health (now Catalent) and Anderson Brecon. As Business Development Director at AndersonBrecon, formally Brecon Pharmaceuticals, Steve has been instrumental in the company’s growth from a £2.4m business in 2001, to a £21m business today. Steve has also been integral to the company’s recent rebrand which saw Brecon Pharmaceuticals merge with its sister company, Anderson Packaging, to form AndersonBrecon within AmerisourceBergen Consulting Services. In 2011, Steve was appointed Chairman of the Board of Healthcare Compliance Packaging Council (HCPCEurope), a commitment that recognises his personal conviction that patient compliance is one of the key issues facing the pharmaceutical sector. He has also been influential in building industry recognition of the value of pack design and the crucial role it plays in prompting patients’ adherence to medication. Email: steve.kemp@andersonbrecon.com

Journal For Patient Compliance Strategies to enhance Health Outcomes 57


Drug Delivery, Drug Packaging, Labelling & Dispensing

Emerging Trends Shaping the Future of Medication Adherence Medication adherence is a complex and often misunderstood problem. While the healthcare industry has made significant progress over the past few years, it is clear that there is no onesize-fits-all solution. This paper will review seven emerging trends that will impact the industry’s ability to address all of the challenges that prevent patients from taking their medication as prescribed. Based on recent patient and prescriber research and our extensive experience in implementing comprehensive adherence solutions, the trends we’ve identified suggest that effective solutions must address the underlying barriers to adherence with integrated solutions designed to modify behaviour. This requires a shift towards a more patient-centric approach with a strong emphasis on collaboration across adherence stakeholders, which not only includes physicians, but also pharmacists, payers, PBMs, employers, policy-makers and medical device and pharmaceutical manufacturers. Behavioural-based interactions with personal, one-to-one conversations designed to deliver the right message at the right time are the cornerstone of patient-centric programmes. Comprehensive solutions integrate technology to enable personalised conversations that result in more meaningful patient interactions, increased engagement and higher adherence. The Healthcare Consumer is Changing As America’s 50 and older population reaches 100 million, two-thirds of American adults and one-third of children are considered clinically obese. With these staggering numbers, an aging and overweight population has shifted the industry focus from acute care to chronic disease management. In fact, many patients have more than one chronic disease. Our research showed that 88% of patients have at least two therapeutic conditions of interest, with 55% of patients having more than four conditions. This continues to emphasise the need for stakeholders to work together, as patients are likely seeing multiple doctors and are often on multiple drugs and treatment regimens. Through lack of adherence, conditions are worsening. Patients are experiencing premature disability, lower quality of life, and sometimes even death. The bottom line is pharmaceutical manufacturers, providers and all healthcare participants who have a stake in improving adherence have to leverage, or acknowledge, other patient resources. Twitter and Healthline are offering personal perspectives and experiences; YouTube is enabling users to share videos on health topics. Online resources are becoming more credible with 65% of consumers viewing ‘patients living with the condition’ as a credible source. For instance, PatientsLikeMe, a health data-sharing platform where patients can share and learn from real-world, outcome-based health data, has nearly 135,000 members interacting across 1000+ conditions. McKesson’s research has shown that 55% of patients 58 Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes

rely entirely on their physician to make treatment decisions, indicating that almost half are looking elsewhere. The top three sources patients cited for acquiring condition-related information were doctors (72%), pharmacists (44%), and the internet (54%). Online information can be useful for patients before AND after their physician visit. In a study conducted by Edelman, it was found that 91% of patients approach their physicians to validate information they found online, while 68% turn to other sources to validate information received from their doctor. This shift highlights the need for healthcare stakeholders to engage in conversations with patients online to provide credible support messaging around the importance of adherence. Beyond disease states, the patient population is also changing culturally. This is challenging what we know – or think we knew – about health behaviours and attitudes. Hispanics suffer disproportionately from chronic conditions including diabetes, HIV/AIDS, Alzheimer’s disease, asthma, and obesity. A recent study by Global Advertising Strategies found that 20% of Hispanics and African Americans – who top the charts in chronic diseases like diabetes and heart disease – don’t comply with their drug regimens. The study also notes that less than 5% of consumer advertising budgets are devoted to what amounts to 40% of the population. It is important that manufacturers and adherence stakeholders look to understand and engage effectively with these populations going forward. Pharmacists Deliver More Adherence Support than Ever The pharmacist is coming out from behind the counter and becoming a strong clinical resource in driving medication adherence. Serving as trusted and accessible resources for the community, pharmacists have a unique opportunity to help patients adhere to their medication regimens. As their role shifts to more direct patient engagement, the industry is shifting as well. The growth of personal care in independent pharmacies has prompted larger chain pharmacies to develop their own patient-centred care programmes. In September 2011, CVS Caremark partnered with Dovetail Health, a provider of transitional care services, to help prevent hospital readmissions, stating that helping patients better manage and understand their medication regimens after they are discharged from a hospital can play a large part in reducing the likelihood of readmissions. To that end, Dovetail is providing plan members with in-home medication counselling focused on medication adherence and drug safety. In an October 2011 New York Times article, it was estimated that insurance questions and other administrative tasks occupy 25% of pharmacists’ time. Technology is providing opportunities for the pharmacist to become a more important member of the care team. Routine pharmacy functions are now automated, allowing the pharmacist to Volume 2 - Issue 3


Drug Delivery, Drug Packaging, Labelling & Dispensing

play a larger role in patient counselling. Targeted behaviouralbased patient conversations delivered in the pharmacy can help patients to better understand their disease or illness, how medication adherence impacts it, and the importance of taking an active role in managing their health outcome. McKesson’s Pharmacy Intervention Program, which has been operating since 2008, has found that patients who received face-to-face behavioural coaching from their pharmacists showed significant adherence benefits. For example, in a 2011 COPD programme, patients who received coaching showed an average of 1.6 incremental fills over 12 months, and patients coached in multiple diabetes programmes showed an average of 4 incremental refills over 12 months when compared to patients who did not receive behavioural coaching. CVS/Caremark’s six-month pharmacist counselling pilot echoed the sentiment of increased patient adherence and went so far as to assert payers could save an estimated $600 per member per year by using the programme. Training resources and adherence networks will continue to raise pharmacists’ comfort and skill levels, making the role of pharmacies and their staff a more prominent part of medication adherence. Physicians Central to Adherence, but Need Help A physician’s role in adherence is critical. According to SDI/ IMS, physicians’ choice of language can influence adherence. Patients who were told by a physician how often to take their medication had a 21% greater Rx utilisation. Better, more informed conversations between physicians and their patients also increase their likelihood to adhere. An SDI study reported that patients purchased one-third more Rx’s in their first 150 days of therapy when physicians discussed ‘why this medication was right for me.’ While non-adherence is physicians’ biggest complaint about their patients, many physicians acknowledge they do not have sufficient time for adequate adherence counselling. Recent McKesson research has shown 71% of physicians want more information about support programmes offered by manufacturers; therefore, there is an opportunity to provide physician communications and training programmes to enhance skills. Additionally, physician assistants and nurse practitioners are becoming more visible in direct patient care. Both in-store pharmacists and hospital-based nurses talking with patients as they are discharged have been proven more effective than doctors at encouraging patients to stay on their medications. Furthermore, through the use of new communication technologies, physician face-time is decreasing and more patient care is being done remotely through virtual visits and email. Email messaging research shows that communication can be patient-centred and give patients an even stronger voice than in-person visits.

www.JforPC.com

Advances in Technology Support Adherence Emerging technologies, such as ePrescribing and electronic health records (EHRs) are improving access to data and providing critical linkages and data sharing across healthcare stakeholders. Combined with digital health media and patient-focused technologies, this creates new opportunities to influence adherence and increase patient engagement. For example, MyPHR allows patients to create, share, and manage their personal health record, while wikis are informing patients by providing articles on health, diseases, and treatment. In the field, electronic prescribing is steadily growing. The number of prescriptions routed electronically grew 75% from 2010 to 2011, representing more than one-third of all prescriptions dispensed. The benefit of this real-time identification of non-adhering patients was illustrated in Surescripts research which indicated a 10% improvement in new prescriptions filled using electronic prescribing. In light of the Health Information Technology for Economic and Clinical Health (HITECH) Act providing more than $35 billion in incentives to healthcare organisations, more than 30% of clinical settings now utilise EHRs. It is estimated that HITECH incentives will boost EHR adoption rates to 90% by 2019. The widespread adoption of EHRs has also been successful in driving medication adherence. A recent study by Kaiser Permanente has shown an improved number of patients following physician recommendations on medications for chronic illnesses. Only 7% (hypertension), 11% (diabetes), and 13% (cholesterol) of those Kaiser patients receiving medical care in this ‘integrated’ manner failed to pick up their medication. Previous studies have shown up to 22% of patients in non-‘integrated’ health systems neglect to fill new prescriptions. Pharmaceutical companies will need to determine the value of incorporating EHR and, specifically, ePrescribing into their strategic marketing plans. For example, can ePrescribing be used as a means to increase adherence and brand loyalty through an ePrescribing coupon? Also, what impact will ePrescribing have on how brands engage with patients? The ever improving technology, meaningful use and financial incentives, and the need for operational efficiencies will continue to drive the adoption and improvement of ePrescribing and EHR systems. Going forward, EHRs will provide an opportunity for pharma to partner with Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes 59


Drug Delivery, Drug Packaging, Labelling & Dispensing institutions by encouraging them to use EHR data to monitor where patients are in their treatment, identify barriers to taking medications as prescribed and help determine what could be done to help them increase adherence. One-size-fits-all Adherence Approach is Not Effective Patients are also receiving financial incentives to adhere to healthy behaviours. One of the more familiar financial incentives for patients is prescription co-pay coupons. They have shown to be one important element of many adherence solutions as patients value co-pay cards and believe that they are easy to use. For example, our research shows that 74% of card users said they are a “tremendous help” financially. However, financial assistance is an adherence strategy that has become highly debated recently as its usage increased. The number of co-pay coupon programmes has steadily increased over the past several years. This has led the FDA to investigate whether rebates and other DTC offers influence patient perceptions of the drug’s value and performance. In “Letting the Facts Get in the Way: An empirical defense of coupons and co-pay offset programs,” Mason Tenaglia, managing director of the Amundsen Group and a member of PharmaExec’s editorial board, states that co-pay card programme usage is not correlated with any lower generic utilisation in any of the major therapeutic classes. Also, coupons today are most frequently used by patients taking the least expensive drugs for employers and insurers, and the return on investment comes from higher adherence to therapies that have already been chosen by the physician and patient. With a heightened focus on improving patient care and cutting healthcare costs, there is widespread testing of other medication adherence solutions taking place. Numerous stakeholders, including payers, PBMs, employers and manufacturers, are considering investment in and implementation of a multitude of adherence tactics. Individual tactics, such as predictive modelling, reminders, behavioural coaching, value-based rewards, social media, pharmacy programmes and financial incentives do have the ability to impact adherence in certain situations. However, implementing comprehensive adherence programmes to raise awareness and promote healthier outcomes is the only way to address the myriad barriers preventing medication adherence. Payment Incentives Influence Health Outcomes From 2015 to 2017, as the Affordable Care Act is phased in, payment incentives tying physician payments to performance metrics will encourage a focus on chronic care management and health outcomes. Shifting from a fee-for-service model to payment systems that reward for health outcomes gives incentives to providers to work towards driving adherence. Providers will be seeking resources to help achieve these healthier outcomes. Additionally, some health plans are providing financial incentives which pay patients to comply with their treatment regimens. For example, Aetna, Inc. in Philadelphia entered patients taking warfarin into a daily lottery offering financial incentives for remaining adherent. The lottery was designed to take advantage of behavioural research indicating that 60 Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes

even small rewards and punishments can be great motivators for patients. Payment incentives and accountability can continue to be influential in driving more effective patient/provider engagement. Manufacturers can help physicians navigate this new terrain by providing them resources to maximise patient adherence. Changes in Regulatory Policy The current regulatory environment creates opportunity and risks. Regulatory changes are having a widespread impact on how the healthcare industry communicates and shares data. From the Patient Protection and Affordable Care Act to the Sunshine Act, a number of regulations may expand medical coverage for millions, further increasing the need for management of chronic conditions. There is a substantial emphasis on transparency and expanded coverage, particularly as it relates to wellness and prevention. Agencies from CMS to the FDA to the DEA are expected to continue to issue rules on a wide range of topics, including ePrescribing for controlled substances, meaningful use of health IT, HIPAA, and Rx electronic tracking. Advancing Comprehensive Adherence Solutions Adherence is a costly problem with both human and economic costs. Because healthcare reform will continue to be a key driver in advancing adherence solutions through incentives, accountability, and the adoption of new technologies, it will be incumbent on industry to work with partners that understand the regulatory climate and provide solutions that are compliant. The trends outlined in this paper confirm the need for comprehensive solutions that include technology and personalised interactions to help adherence stakeholders better address barriers to medication adherence. Only through this integrated approach can we truly help patients become more adherent and achieve better health outcomes. Derek S. Rago is Vice President of Marketing and Strategy for McKesson Patient Relationship Solutions, a division of McKesson Corporation dedicated to improving health outcomes by increasing patient adherence to prescribed medication regimens. He has over 15 years’ experience in pharmaceutical sales and marketing, and manages the company’s core solutions that include alternative sampling programs, fully integrated patient loyalty programs, patient outreach services and in-pharmacy patient counseling programs. Derek is also responsible for creating and defining the organizations strategic and long-term goals. Derek can be reached at Email: derek.rago@mckesson.com

Volume 2 - Issue 3


Think Tank

The Role of Motivational Interviewing in Adherence Programmes Changing a patient’s health beliefs is the first hurdle in medication adherence and a major challenge to overcome for anyone planning an adherence programme. With the patient-centred approach now being embraced by the healthcare industry, the patient is being put at the heart of their own decision-making process. The use of motivational interviewing (MI) techniques supports them to take ownership and change their health beliefs. The result is better health outcomes. How is it Applied in the Healthcare Setting? We’ve all heard it before: My name is Dave and I’m an alcoholic. The first step towards behaviour change is being able to recognise your problem. However, getting to that point of self-confession can be a long and difficult path. Motivational interviewing is a collaborative, personcentred way of guiding the patient to elicit and strengthen motivation to change. The ultimate goal is to increase a patient’s intrinsic motivation rather than to impose it externally. It is not a set of tools, but rather a method of communication with that patient – a flexible blend of informing, asking and listening – which evokes the patient’s own values, goals, insights, motivation and resources for change. The most important part of motivational interviewing is being able to express empathy – to put oneself in the shoes of the patient. Physicians and nurses can use this method to build trust and a companionship with patients, which they are more likely to respond to. In a trial comparing primary care physicians (PCPs) who were randomised to MI training to those who were not, the PCPs trained in MI evaluated it to be more effective and no more time consuming than ‘traditional advice giving’. Making the Best Use of MI Techniques Motivational interviewing is not just a technique that is restricted to healthcare professionals. It can be incorporated into every aspect of an adherence programme, from helping to identify those that may be at risk of non-compliance early, to supporting them throughout their treatment journey. This is where the use of information in the right tone of voice becomes fundamentally important. Every adherence programme that contains a clear value proposition has an increased likelihood of resonating with healthcare professionals (HCPs). For example, training nurses to incorporate motivational interviewing techniques into their patient communications not only supports their relationship with their patients, but it means you can tailor a patient’s adherence programme from the start, making it much more effective in the long run. There are many forms that this training could take, such as a simple tool of interview prompts to facilitate the HCP/ patient discussion, or local market MI training through promotional or educational meetings. 62 Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes

Knowing When and Where Motivational interviewing techniques include using the right tone of voice with patients to build their trust, support them in a positive way throughout their treatment journey and ultimately keep them concordant. Knowing when and where to incorporate motivational messages, or when to be asking questions, is crucially important whether you are developing patient support material, preparing training material for call-centre staff, or developing HCP tools. Giving the right amount of information at the right time is of equal importance. Patients are more likely to respond to small pieces of information that they receive more often, than lengthy essays. Asking questions draws out a patient’s thoughts, feelings and beliefs at crucial touch-points throughout their treatment journey. Tailored messaging, according to how that patient is feeling at that time, makes your programme more likely to succeed in its objectives. In summary, for behaviour change to occur, a person has to want to change, believe that they can change, and feel it is the right time to prioritise this action. By using motivational interviewing techniques, we are able to identify patients who are at risk of non-adherence early in the treatment pathway, tailor their information accordingly and support the patient in the right way throughout their treatment journey, leading to better health outcomes in the long run. Sources Miller WR, Rollnick S. Ten things that motivational interviewing is not. Behav Cogn Psychother 2009;37:129-40 Rollnick S, Miller WR, Butler CC. Motivational interviewing in health care: Helping patients change behaviour. New York: Guildford Press, 2008 Rubak S, Sandbaek A, Lauritzen T, Borch-Johnsen K, Chistensen B. An education and training course in motivational interviewing influence: GPs’ professional behaviour – ADDITION Denmark. Br J Gen Pract 2006;56:429-36 Carole North is co-founder and Joint Managing Director of 90TEN Healthcare. She has over 11 years’ experience delivering programmes that increase adherence to treatment by empowering patients to change their health beliefs and behaviours, supporting HCPs to manage those patients, and developing initiatives that help reduce acute hospital admissions. 90TEN Healthcare consistently wins awards for its adherence, concordance, experiential and social marketing campaigns, and is currently delivering patient adherence programmes in 23 countries. Email: carole.north@90ten.co.uk

Volume 2 - Issue 3


Drug Delivery, Drug Packaging, Labelling & Dispensing

JOURNAL FOR

✓ PATIENT COMPLIANCE Strategies to enhance Adherence and Health Outcomes

Advertisers Index IFC Page 61 Page 3 OBC IBC Page 7 Page 23 Page 36 & 37 Page 53 Page 63 Page 49 Page 41 Page 27 Page 11 Page 33 Page 5

AndersonBrecon - AmerisourceBergen Consulting Services 9th Annual Patient Summit USA 2012 90 Ten Healthcare Atlantis Healthcare BOBST SA Cegedim Relationship Management (Opus Healthcare) Chesapeake Limited CRF Health Health Window ICSE Expo – 2012 (UBM Plc) ICSE India – 2012 (UBM Plc) Information Mediary Corporation (IMC) MediciGlobal Mobile PRM Pharma Publications Pharmexx

Subscription offer Guarantee you receive your copy of JPC: 4 issues per year. Pharma Publications is delighted to be able to offer it’s readers a great one year’s subscription offer.

Card number

Subscribe now to receive your 20% discount

Valid from

Post: Complete form below, detach and post to: Pharma Publications, Unit J413, The Biscuit Factory Tower Bridge business complex 100 clements road, London SE16 4DG

Security code

Expiry date

Name: Job title:

Tel:

+44 (0)20 7237 2036

Fax:

Complete and fax this form to +44 0014802475316

Company: Address:

Email: Your details to info@pharmapubs.com Please tick the relevant boxes below:

UK & N. Ireland £120 inc p&p Europe €130 inc p&p USA $200 inc p&p I enclose a cheque made payable to Pharmapubs I wish to pay by credit card (Mastercard or Visa)

Postcode

Tel: Fax: Email: Signature

64 Journal For Patient Compliance Strategies to enhance Adherence and Health Outcomes

Volume 2 - Issue 3



Journal for Patient Compliance