22 minute read
What are quantitative and qualitative research methods? A brief introduction
Joanne Chalmers, Fiona Cowdell
This paper is the second in a series devoted to dermatological nursing research. In the first paper we reported the findings of a national survey conducted to scope dermatology nurses’ current roles in, understanding of, and development needs in relation to research. Our next article addresses critical appraisal skills. In this short article, we first define evidence-based practice and the need for nursing research to contribute to this agenda. We then offer a brief overview of quantitative, qualitative and mixed method approaches to research. Finally, we suggest some key reading.
Chalmers J, Cowdell F. What are quantitative and qualitative research methods? A brief introduction. Dermatological Nursing 2021. 20(2):45-48
The foundation of evidence-based practice (EBP) can be traced back to Florence Nightingale in the 1800s.1 EBP is defined as “a problem-solving approach to clinical decision making that incorporates a search for the best and latest evidence, clinical expertise and assessment, and patient preference values within a context of caring.”2 EBP is grounded in the principle that patient care should be informed by sound evidence and has much in common with evidence-based medicine (EBM). The founding definition of evidencebased medicine is “the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients”.3
EBP is not about research dictating what you should do in clinical practice. It is about taking the best research evidence available and using it in the context of the individual patient, in combination with your clinical experience and the patient’s views. Using EBP means the patient will be getting the best and most appropriate care available. However, it is important that EBP is based on the best quality evidence available, and so being able to identify the difference between good and poorquality research is crucial. An article later in this series will give you some guidance on how to do this by understanding how to critically appraise research.
Underpinning all EBP is research.4 All good research starts with a relevant and timely question. The question might come from a long-standing frustration that you do not have the information you need to advise a patient. Or perhaps a patient asks you the basis on which you are giving advice and you are aware that it is not based on any evidence.
Once the question is formed, there are two fundamentally different approaches to answering it: quantitative and qualitative research, or a careful combination of both. Quantitative research is all about numbers and includes, for example, trials and cohort studies. Qualitative research is descriptive and uses words and language in situations such as discussion groups and interviews to explore participants’ perspectives. All good research has a value, what is important is that the right method is used to answer the question. If you want to know how effective drug A is compared to drug B in a particular skin condition, then you need a quantitative study that will give you a numerical answer to how well a sample population responds to each treatment. A qualitative study, on the other hand, will give a deep understanding of people’s experiences and beliefs about, for example, their condition or healthcare. A good way to think about the two broad approaches is that quantitative research provides the “what” and qualitative research gives insight into the “why” and/or the “how”. The two different approaches can be used independently, or they can be used together in mixed methods studies to offer a holistic answer to the question.5 For example, when conducting a randomised controlled trial (quantitative) it can be valuable to to conduct interviews with selected participants to gain a nuanced understanding about
Jo Chalmers is a Senior Research Fellow, Centre of Evidence Based Dermatology, University of Nottingham. Fiona Cowdell is Professor of Nursing and Health Research, Faculty of Health, Education and Life Sciences, Birmingham City University
specific issues, such as adherence or perceived effectiveness.
In the rest of this article, we will look at what different types of quantitative and qualitative research methods are commonly used in clinical research, and some of the advantages and disadvantages of each.
What is quantitative research?
There are several different study designs that all provide numerical data. These include studies such as clinical trials, cohort studies and systematic reviews. Their objective nature means they are generally well accepted in the clinical and scientific world. However, it is important to remember that different designs provide different levels of certainty of the evidence, known as the evidence pyramid. The evidence pyramid illustrates both quality and volume of evidence available at each level. For example, there are fewer meta-analyses than randomised controlled trials, and since the former synthesises the latter, this evidence may be more useful. The evidence pyramid is problematic in that the focus is on quantitative research methods and it takes no account of evidence garnered from sources other than research.
Randomised controlled trials
The randomised controlled trial (RCT) is considered to be the gold standard research design to answer a clinical question.6 A sample of patients with the disease of interest are randomly allocated to either the intervention or the control group, so they are always interventional studies. Randomly allocating patients to their group removes much of the potential bias and therefore gives a more confident answer. The outcomes in the two groups are then compared to determine which treatment is better. Outcomes can be clinician or patient reported outcomes, but it is important that the patient perspective is considered.
Systematic reviews
Ideally there will be multiple RCTs looking at a particular question as one trial alone can provide an erroneous finding, and these trials can be brought together in a systematic review. Metaanalysis can then be used if the trials are similar enough in their design. This statistical technique allows the results of several trials to be combined to provide an overall answer, or “effect estimate”. This is the highest level of evidence on the evidence pyramid for EBP, but a systematic review is only as good as the studies that go into it. A commonly used phrase in the reviewing world is “rubbish in = rubbish out”. Good quality clinical guidelines are usually based on systematic reviews that integrate evidence and give a clear picture of quality of the evidence base and knowledge gaps. The Cochrane Collaboration reviews are amongst the best sources of evidence to inform clinical guidelines that are available.
Cohort studies
Clinical trials are notoriously expensive to deliver and tend to be relatively short in duration, with participants numbering often in the hundreds rather than tens of thousands. Consequently, they are not designed to pick up rare side effects, or side effects that take a long time to develop. Therefore, a long-term prospective cohort study of 10,000+ patients is more likely to be a suitable study design for this type of question. A prospective cohort study is one in which patients are recruited into the cohort and then data is collected on the outcomes of interest from that point onwards. A retrospective cohort is usually considered lower quality because it can be subject to significant bias. They rely on the recall of patients to remember events and what treatment they had received, or if using preexisting records, the records may not be accurate or contain all the relevant information.
Case control study
A case control study is lower on the evidence pyramid because it simply takes people that have the disease and compares them to people that do not, in order to decide whether something is a risk factor or not. There is huge potential for bias in studies of this design, so, whilst they can be good for hypothesis generating, they are less useful for reaching definitive conclusions.
Figure 1.
The Evidence Pyramid
Even lower down are case series and case reports in which initial observations on a group of patients, or even just one patient, are reported. Again, these are important in terms of generating research questions but are not good quality evidence for evidence-based decision making.
What is qualitative research?
There are many types of qualitative research, for example, grounded theory, ethnography, case study and phenomenology. Rather than being concerned about specific approaches, it is more useful to understand the underlying principles and core elements of the qualitative approach. The aim in qualitative research is to provide indepth insights and understanding of realworld issues. In contrast to quantitative research, it does not test treatments, manipulate, or quantify variables.7 A fundamental assumption in qualitative research is that reality is a phenomenon constructed by individuals.8 The subjective view of reality explored in this type of research is important and has real consequences for understanding and improving patient care.
Core elements of qualitative research are summarised in Box 1 and some are discussed in more detail below.
Interviews and focus groups
Interviews are frequently used to collect qualitative data. These are individual conversations which may be conducted face-to-face or via video or telephone, and generally last between 30-90 minutes. The structure of an interview will vary according to the research question and method. There is a continuum of the degree of structure employed but all use open-ended questions and give participants the opportunity to speak freely. One of the benefits of an interview study is the indepth nature of the data collected. It is also important that the person carrying out the interviews understands how to do them to avoid leading questions or overly influencing the participant.9
Focus groups bring people together for a group discussion, rather than talking individually to participants. Each group is usually around eight to 10 participants, lasts one to two hours and will be moderated by a researcher. Typically focus groups are held in a room face-to-face but the use of online platforms to host the groups is increasing. Focus groups require significant planning and organisation and can be expensive due to travel costs, venue hire and refreshments. There is also a danger that the more confident participants can dominate discussions, but a good facilitator can mitigate against this. A key benefit of focus groups is the production of significant insights from group dynamics and discussions.10
Both interviews and focus groups are, with permission from participant(s), audio or video recorded. Recordings are transcribed word-for-word and systematically analysed by the research team to organise the data and identify themes using an established technique congruent with the research approach being used. Commonly used techniques include thematic, content11 and framework12 analysis.
More recently, researchers have capitalised on the rich source of data on social media and methods have been developed for analysing this pre-existing data. The benefit here is that the data are readily available making it efficient and relatively low-cost to conduct, but as it was not generated for a specific purpose, there may be limitations in the conclusions that can be drawn.13
Observation
Observation is a core method of data collection in ethnographic research as it offers the opportunity to view participants’ behaviour in the context of the ‘real world’.14 Data is generally collected in the form of written field notes recorded contemporaneously or soon after periods of observation. Observation studies are good for understanding a culture because it is based on what the researcher observes rather than people’s opinion or perspective on that culture. A skilled researcher can become “part of the furniture” that participants no longer notice, with practice continuing as usual. The major advantage of observation is that it reveals day-to-day practice and avoids the potential issue of participants being told what they think you may want
The aim is to uncover a deep understanding of individual’s experiences, perceptions, behaviour and processes and the meanings attached to them. Participants are recruited because of their experience of, or knowledge about, the phenomenon. The researcher is the instrument of data collection and reflexivity is essential.
The researcher must be transparent about their own preconceived ideas and influence on the study. Data are generally collected though one or a combination of: interviews, focus groups, observation, or document/artefact review. Interview/focus group questions are generally open-ended and encourage depth and detail of response. Data collection and analysis are iterative processes that happen in parallel as the study progresses. Data are analysed inductively using specific, rigorous techniques and presented in a way that best addresses the research question. Research method must be transparent, rigorous and well reported.
BOX 1. Core elements of qualitative research
to hear – something that can occur in interviews and focus groups. Depending on the nature of the question, observations can range from weeks or months or, in exceptional circumstances, years. Key informants identified during observation are often invited to participate in interviews, which can deepen the researchers understanding of the culture.
Rigour
As with all research, qualitative studies must be rigorous. The researcher must offer a transparent account of the whole research process including: defining the research question, justifying the chosen method, reporting sampling strategy and methods of data collection, explaining the process of data analysis, demonstrating trustworthiness and offering a reflexive account.15
Mixed methods
In mixed methods studies researchers collect and analyse both quantitative and qualitative data in the same study. This approach draws on the strengths of both qualitative and quantitative methods and enables researchers to investigate different perspectives and holistically answer complex research questions. Mixed methods research requires deliberate combination of methods in data collection, data analysis, and interpretation of the evidence and most importantly, to provide the added value, there must be integration or “triangulation” of data to produce a rounded analysis.16
Conclusion
In this article, we have explored the meaning of evidence-based practice. We have examined the evidence pyramid and considered its limitations when applied to dermatology nursing. As with other healthcare practitioners, we need to base our practice on a skillful melding of available research evidence applied in the context of the individual patient and their views, in combination with your clinical experience and expertise. We have briefly introduced quantitative, qualitative and mixed-methods research and highlighted how each may contribute to generating a robust evidence base for practice. DN
References
1. Mackey A, Bassendowski S. The history of evidence-based practice in nursing education and practice. Journal of Professional Nursing 2017. 33(1):51-5 2. International Council of Nurses. Closing the gap: From evidence to action. Available at http:// www.icn.ch/publications/2012-closing-the-gapfrom-evidence-to-action/
3. Sackett DL, Rosenberg WM, Gray JM, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn’t. BMJ 1996. 312: 71-72 4. Saunders H, Gallagher‐Ford L, Kvist T, Vehviläinen‐Julkunen K. Practicing healthcare professionals’ evidence‐based practice competencies: An overview of systematic reviews. Worldviews on Evidence‐Based Nursing 2019. 16(3):176-85 5. Bressan V, Bagnasco A, Aleo G, Timmins F, Barisone M, Bianchi M et al. Mixed‐methods research in nursing–a critical review. Journal of Clinical Nursing 2017. 26(19-20):2878-90 6. Tam W, Lo K, Woo B. Reporting sample size calculations for randomized controlled trials published in nursing journals: A cross-sectional study. International Journal of Nursing Studies 2020. 102:103450
7. Miller WR. Qualitative research findings as evidence: utility in nursing practice. Clinical Nurse Specialist 2010. 24(4):191 8. Creswell J. Research Design: Qualitative & Quantitative Approaches. Thousand Oaks, CA: Sage Publications; 1994 9. Peters K, Halcomb E. Interviews in qualitative research. Nurse Researcher 2015. 22(4):6 10. Jayasekara RS. Focus groups in nursing research: methodological perspectives. Nursing Outlook 2012. 60(6):411-6 11. Vaismoradi M, Turunen H, Bondas T. Content analysis and thematic analysis: Implications for conducting a qualitative descriptive study. Nursing & Health Sciences 2013. 15(3):398-405 12. Ward DJ, Furber C, Tierney S, Swallow V. Using Framework Analysis in nursing research: a worked example. Journal of Advanced Nursing 2013. 69(11):2423-31 13. Golder S, Ahmed S, Norman G, Booth A. Attitudes toward the ethics of research using social media: a systematic review. Journal of Medical Internet Research 2017. 19(6):e195 14. Fetterman DM. Ethnography Step-By-Step. Third edition. Sage Publications, Thousand Oaks CA. 2010
15. Kalu FA, Bwalya JC. What makes qualitative research good research? An exploratory analysis of critical elements. International Journal of Social Science Research 2017. 5(2):43-56 16. Shorten, A and Smith, J. Mixed methods research: expanding the evidence base. Evidencebased Nursing 2017. 20(3):74-75. Key points Evidence-based practice is essential to enable you to provide the best possible patient care Two broad types of clinical research that can be used for EBP, qualitative and quantitative Quantitative methods provide the “what” and are numerical studies like clinical trials, whereas qualitative studies give insight into the “how” and “why” and involve methods such as interviews and focus groups.
Webinar Please join us at 7.00pm on Wednesday 14th July for a onehour webinar to further explore how different research methods are used to answer different types of research question. To help make the session relevant to dermatology nursing (and hopefully more fun!) it would be fantastic if some of you could pre-submit research ideas/ questions for discussion during the session, so we have real-world examples from the dermatology nursing community to think about and explore. Please send these (no more than a couple of sentences) to ukdctn@nottingham.ac.uk no later than Mon 12th July. This online session will be facilitated by UK DCTN Network Manager Carron Layfield with research expertise provided by Prof Fiona Cowdell and Prof Kim Thomas and is a relaxed and informal environment. To register please contact https://bdng.org.uk/research-2
Further reading Harvey M, Land L (2016) Research
Methods for Nurses and Midwives:
Theory and Practice: Theory and
Practice. London, Sage. Holloway I, Galvin K (2016)
Qualitative Research in Nursing and Healthcare. Oxford. Wiley
Blackwell. Saks M, Allsop J (2019)
Researching Health: Qualitative,
Quantitative and Mixed Methods.
London, Sage.
Learn more at DERMAWorld
Active flare management and maintenance treatment of adult plaque psoriasis1
Enstilar® is indicated for the topical treatment of psoriasis vulgaris in adults.1
treatment during the active flare…1-4 maintenance treatment for long-term control1,5
Prescribing Information for Enstilar® (calcipotriol/betamethasone) 50 micrograms/g + 0.5 mg/g cutaneous foam
Please refer to the full Summary of Product Characteristics (SmPC) (www.medicines.org.uk/emc or www.medicines.ie) before prescribing. Indication: Topical treatment of psoriasis vulgaris in adults. Active ingredients: 50 µg/g calcipotriol (as monohydrate) and 0.5 mg/g betamethasone (as dipropionate). Dosage and administration: Flare treatment: Apply by spraying onto affected area once daily. Recommended treatment period is 4 weeks. If it is necessary to continue or restart treatment after this period, treatment should be continued after medical review and under regular supervision. Longterm maintenance treatment: Patients who have responded at 4 weeks’ treatment using Enstilar once daily are suitable for long-term maintenance treatment. Enstilar should be applied twice weekly on two non-consecutive days to areas previously affected by psoriasis vulgaris. Between applications there should be 2-3 days without Enstilar treatment. If signs of a relapse occur, flare treatment, as described above, should be re-initiated. Maximum dose: The daily maximum dose of Enstilar should not exceed 15 g, i.e. one 60 g can should last for at least 4 days of treatment. 15 g corresponds to the amount administered from the can if the actuator is fully depressed for approximately one minute. A two-second application delivers approximately 0.5 g. As a guide, 0.5 g of foam should cover an area of skin roughly corresponding to the surface area of an adult hand. If using other calcipotriol-containing medical products in addition to Enstilar, the total dose of all calcipotriol-containing products should not exceed 15 g per day. Total body surface area treated should not exceed 30%. Safety and efficacy in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated. Safety and efficacy in children below 18 years have not been established. Shake the can for a few seconds before use. Apply by spraying, holding the can at least 3 cm from the skin, in any orientation except horizontally. Spray directly onto each affected skin area and rub in gently. If used on the scalp, spray into the palm of the hand then apply to affected scalp areas with the fingertips. See hair washing instructions in the package leaflet. Wash hands after use (unless Enstilar is used to treat the hands) to avoid accidentally spreading to other parts of the body as well as unintended drug absorption on the hands. Avoid application under occlusive dressings since systemic absorption of corticosteroids increases. It is recommended not to take a shower or bath immediately after application. Let the foam remain on the scalp and/or skin during the night or during the day. Contraindications: Hypersensitivity to the active substances or any of the excipients. Erythrodermic and pustular psoriasis. Patients with known disorders of calcium metabolism. Viral (e.g. herpes or varicella) skin lesions, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis, perioral dermatitis, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers and wounds. Precautions and warnings: Adverse reactions found in connection with systemic corticosteroid treatment, e.g. adrenocortical suppression or impaired glycaemic control of diabetes mellitus, may occur also during topical corticosteroid treatment due to systemic absorption. Application under occlusive dressings should be avoided since it increases the systemic absorption of corticosteroids. Application on large areas of damaged skin, or on mucous membranes or in skin folds should be avoided since it increases the systemic absorption of corticosteroids. Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for a referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids. Due to the content of calcipotriol, hypercalcaemia may occur. Serum calcium is normalised when treatment is discontinued. The risk of hypercalcaemia is minimal when the maximum daily dose of Enstilar (15 g) is not exceeded. Enstilar contains a potent group III-steroid and concurrent treatment with other steroids on the same treatment area must be avoided. The skin on the face and genitals is very sensitive to corticosteroids. Enstilar should not be used in these areas. Instruct the patient in the correct use of the product to avoid application and accidental transfer to the face, mouth and eyes. Wash hands after each application to avoid accidental transfer to these areas as well as unintended drug absorption on the hands. If lesions become secondarily infected, they should be treated with antimicrobiological therapy. However, if infection worsens, treatment with corticosteroids should be discontinued. When treating psoriasis with topical corticosteroids, there may be a risk of rebound effects when discontinuing treatment. Medical supervision should therefore continue in the post-treatment period. Long-term use of corticosteroids may increase the risk of local and systemic adverse reactions. Treatment should be discontinued in case of adverse reactions related to longterm use of corticosteroid. There is no experience with the use of Enstilar in guttate psoriasis. Enstilar contains butylhydroxytoluene (E321), which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes. Pregnancy and lactation: There are no adequate data from the use of Enstilar in pregnant women. Enstilar should only be used during pregnancy when the potential benefit justifies the potential risk. Caution should be exercised when prescribing Enstilar to women who breast-feed. The patient should be instructed not to use Enstilar on the breast when breastfeeding. Side effects: There are no common adverse reactions based on the clinical studies. The most frequently reported adverse reactions are application site reactions. Uncommon (≥1/1,000 to <1/100): Folliculitis, hypersensitivity, hypercalcaemia, skin hypopigmentation, rebound effect, application site pruritus, application site irritation, application site pain (including application site burning). Not known (cannot be estimated from available data): Blurred vision, hair colour changes. Calcipotriol: Adverse reactions include application site reactions, pruritus, skin irritation, burning and stinging sensation, dry skin, erythema, rash, dermatitis, psoriasis aggravated, photosensitivity and hypersensitivity reactions, including very rare cases of angioedema and facial oedema. Systemic effects after topical use may appear very rarely causing hypercalcaemia or hypercalciuria. Betamethasone: Local reactions can occur after topical use, especially during prolonged application, including skin atrophy, telangiectasia, striae, folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, depigmentation and colloid milia. When treating psoriasis with topical corticosteroids, there may be a risk of generalised pustular psoriasis. Systemic reactions due to topical use of corticosteroids are rare in adults; however, they can be severe. Adrenocortical suppression, cataract, infections, impaired glycaemic control of diabetes mellitus, and increase of intra-ocular pressure can occur, especially after longterm treatment. Systemic reactions occur more frequently when applied under occlusion (plastic, skin folds), when applied onto large skin areas, and during long-term treatment. Precautions for storage: Do not store above 30°C. Extremely flammable aerosol. Pressurised container. May burst if heated. Protect from sunlight. Do not expose to temperatures exceeding 50°C. Do not pierce or burn, even after use. Do not spray on an open flame or other ignition source. Keep away from sparks/open flames. No smoking. Legal category: POM. Marketing authorisation number and holder: PL 05293/0008 (UK), PA 1025/5/1 (Ireland). LEO Pharma A/S, Ballerup, Denmark. Basic NHS price (UK): £39.68/60 g, £79.36/2 x 60 g. Last revised: March 2021.
Reporting of Suspected Adverse Reactions
Adverse events should be reported. For the United Kingdom, reporting forms and information can be found at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Drug Safety at LEO Pharma by calling +44 (0)1844 347333 or e-mail: medical-info.uk@leo-pharma.com For the Republic of Ireland, reporting forms and information can be obtained from: HPRA Pharmacovigilance, Earlsfort Terrace, Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie, e-mail: medsafety@hpra.ie. Adverse events should also be reported to Drug Safety at LEO Pharma by calling +353 1 4908924 or e-mail: medical-info.ie@leo-pharma.com
References:
1. Enstilar® SPC, UK www.medicines.org.uk / IE www.medicines.ie. Last accessed: April 2021. 2. Leonardi C et al. J Drugs Dermatol 2015;14(12):1468–1477. 3. Koo J et al. J Dermatolog Treat 2016;27(2):120–127. 4. King C and Lowson D. Poster 237 presented at the 5th Psoriasis International Network Annual Meeting, Paris, France, 5–7 July 2016. 5. Lebwohl M et al. J Am Acad Dermatol 2020;doi: https://doi.org/10.1016/j.jaad.2020.09.037.
