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Practitioners and researchers must always rely on their own experience and knowledge in evaluating and using any information, methods, compounds or experiments described herein. Because of rapid advances in the medical sciences, in particular, independent verification of diagnoses and drug dosages should be made. To the fullest extent of the law, no responsibility is assumed by Elsevier, authors, editors or contributors for any injury and/or damage to persons or property as a matter of products liability, negligence or otherwise, or from any use or operation of any methods, products, instructions, or ideas contained in the material herein.
Previous editions copyrighted 2013, 2001, 1993, 1986, 1979, 1973 by Saunders, an imprint of Elsevier Inc. Library of Congress Cataloging-in-Publication Data or Control Number : 2019947133
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To all students of perinatology; our patients and their parents; Roslyn and Kristy, Mason, Cole, and Brooke Fanaroff; Peter, Jodi, Austin, and Morgan Tucker; and Amanda, Jason, Jackson, and Raya Hirsh
LIST OF CONTRIBUTORS
David H. Adamkin, MD
Professor of Pediatrics
Division of Neonatal Medicine
Department of Pediatrics
University of Louisville School of Medicine Louisville, Kentucky
Sanjay Ahuja, MD, MSc
Associate Professor
Department of Pediatrics
Case Western Reserve University School of Medicine
Director, Hemostasis and Thrombosis Center
University Hospitals Rainbow Babies & Children’s Hospital Cleveland, Ohio
Namasivayam Ambalavanan, MBBS, MD
Professor, Departments of Pediatrics, Pathology, and Cell, Developmental, and Integrative Biology
Co-Director, Division of Neonatology
University of Alabama at Birmingham Birmingham, Alabama
Felicia L. Bahadue, MD
Assistant Professor
Department of Obstetrics, Gynecology, and Reproductive Sciences
University of Miami Miami, Florida
Sheila C. Berlin, MD
Associate Professor and Vice Chair Department of Radiology
University Hospitals of Cleveland Director of Pediatric CT Department of Radiology
University Hospitals Rainbow Babies & Children’s Hospital Cleveland, Ohio
Mary Ann Blatz, DNP, RNC-NIC, IBCLC
Advanced Practice Nurse
NICU Nursing Research & Development
Neonatal Intensive Care Unit
University Hospitals Rainbow Babies & Children’s Hospital University Hospitals of Cleveland Medical Center Cleveland, Ohio
Michael Caplan, MD
Chairman
Department of Pediatrics
NorthShore University HealthSystem
Evanston, Illinois
Clinical Professor of Pediatrics
University of Chicago Pritzker School of Medicine Chicago, Illinois
Waldemar A. Carlo, MD
Edwin M. Dixon Professor of Pediatrics Co-Director, Division of Neonatology University of Alabama at Birmingham Birmingham, Alabama
Moira A. Crowley, M.D.
Associate Professor, Pediatrics
Case Western Reserve University School of Medicine Director, Neonatal ECMO Program Director, Neonatal Consultative Services
Co-Medical Director, Neonatal Intensive Care Unit
University Hospitals Rainbow Babies & Children’s Hospital Cleveland, Ohio
Clifford L. Cua, MD
Associate Professor of Clinical Pediatrics Nationwide Children’s Hospital Columbus, Ohio
Ankita P. Desai, MD
Assistant Professor
Medical Director of Antimicrobial Stewardship Fellowship Program Director Pediatric Infectious Diseases
University Hospitals Rainbow Babies & Children’s Hospital Cleveland, Ohio
Michael Dingeldein, MD
Assistant Professor of Surgery Pediatric Surgery
University Hospitals Rainbow Babies & Children’s Hospital Cleveland, Ohio
Avroy A. Fanaroff, MD, FRCP, FRCPCH Professor Emeritus
Department of Pediatrics and Neonatology in Reproductive Biology
Case Western Reserve University School of Medicine; Eliza Henry Barnes Chair in Neonatology Department of Pediatrics
University Hospitals Rainbow Babies & Children’s Hospital Cleveland, Ohio
Jonathan M. Fanaroff, MD, JD, FAAP, FCLM Professor of Pediatrics
Department of Pediatrics
Case Western Reserve University School of Medicine
Director, Rainbow Center for Pediatric Ethics
University Hospitals Rainbow Babies & Children’s Hospital
Cleveland Medical Center Cleveland, Ohio
Kimberly S. Gecsi, MD
Associate Professor
Reproductive Biology
Case Western Reserve University
Residency Program Director
Obstetrics and Gynecology
University Hospitals MacDonald Women’s Hospital Cleveland, Ohio
Amy E. Heiderich, MD
Neonatal-Perinatal Medicine Fellow
New York Presbyterian Hospital-Morgan Stanley Children’s Hospital
Columbia University Medical Center New York, New York
Terrie Eleanor Inder, MBChB, MD
Chair, Department of Pediatric Newborn Medicine
Brigham and Women’s Hospital Professor of Pediatrics
Mary Ellen Avery Professor in the field of Newborn Medicine Harvard Medical School Boston, Massachusetts
Kimberly A. Kripps, MD
University of Colorado Denver, Anschutz Medical Campus Department of Pediatrics, Section of Genetics and Metabolism Aurora, Colorado
Tina A. Leone, MD
Associate Professor of Pediatrics
Columbia University, Vagelos College of Physicians and Surgeons New York, New York
Ethan G. Leonard, MD, FAAP, FIDSA
Chief Medical Officer and Vice Chair for Clinical Operations
Associate Professor of Pediatrics
University Hospitals Rainbow Babies and Children’s Hospital
Case Western Reserve University School of Medicine Cleveland, Ohio
John Letterio, MD
Professor of Pediatrics: Chief, Pediatric Hematology Oncology University Hospitals Rainbow Babies & Children’s Hospital Cleveland, Ohio
Tom Lissauer, MB BChir, FRCPCH Honorary Consultant Pediatrician Consultant Pediatric Program Director in Global Health Imperial College London London, United Kingdom
M. Jeffrey Maisels, MB, BCh, DSc Professor
Department of Pediatrics
Oakland University William Beaumont School of Medicine Director, Academic Affairs Department of Pediatrics Beaumont Children’s Hospital Royal Oak, Michigan
Jaime Marasch, PharmD, BCPS
Clinical Pharmacist Specialist, Neonatal Intensive Care Unit University Hospitals Rainbow Babies and Children’s Hospital Cleveland, Ohio
Richard J. Martin, M.B.B.S.
Professor, Pediatrics, Reproductive Biology, and Physiology & Biophysics
Case Western Reserve University School of Medicine
Drusinsky/Fanaroff Professor in Neonatology Director, Neonatal Research Rainbow Babies & Children’s Hospital Cleveland, Ohio
Lillian G. Matthews, PhD Department of Pediatric Newborn Medicine Brigham and Women’s Hospital Harvard Medical School Boston, Massachusetts
Shawn E. McCandless, MD Professor
University of Colorado Denver, Anschutz Medical Campus Department of Pediatrics, Section of Genetics and Metabolism Aurora, Colorado
Jacquelyn D. McClary, PharmD, BCPS
Clinical Pharmacist Specialist, Neonatal Intensive Care Unit
University Hospitals Rainbow Babies & Children’s Hospital Cleveland, Ohio
Scott T. McEwen, MD, PhD Assistant Professor, Pediatrics
University of Minnesota Medical School
Division of Pediatric Nephrology University of Minnesota Masonic Children’s Hospital Minneapolis, Minnesota
Jennifer McGuirl, DO, MBE
Attending Neonatologist
Pediatrics
Brigham and Women’s Hospital
Instructor Pediatrics
Harvard Medical School Boston, Massachusetts
Mariana L. Meyers, MD
Assistant Professor Director of Fetal MRI Pediatric Radiology
University of Colorado Denver School of Medicine Children’s Hospital Colorado Colorado Fetal Care Center Aurora, Colorado
Peter D. Murray, MD, MSM Assistant Professor of Pediatrics University of Virginia School of Medicine
Department of Pediatrics, Division of Neonatology Charlottesville, Virginia
Vijayalakshmi Padmanabhan, MBBS, MD, MPH
Associate Professor
Department of Pathology Division of Cytopathology
Baylor College of Medicine Houston, Texas
Mary Elaine Patrinos, MD
Assistant Professor
Pediatrics
Case Western Reserve University School of Medicine
University Hospitals Rainbow Babies and Children’s Hospital Cleveland, Ohio
Allison H. Payne, MD, MS
Assistant Professor Pediatrics/Neonatology
University Hospitals Rainbow Babies & Children’s Hospitals/Case Western Reserve University Cleveland, Ohio
Christina M. Phelps, MD
Assistant Professor of Clinical Pediatrics
Nationwide Children’s Hospital Columbus, Ohio
Richard A. Polin, MD
Professor of Pediatrics
Director, Division of Neonatology and Perinatology
Department of Pediatrics
Columbia University
Vagelos College of Physicians and Surgeons
New York, New York
Paula G. Radmacher, MSPH, PhD
Associate Professor
Division of Neonatal Medicine
Neonatal Nutrition Research Laboratory Department of Pediatrics
University of Louisville School of Medicine Louisville, Kentucky
Sheri Ricciardi, OTR/L, CNT, NTMTC
Board Certified Neonatal Therapist
Developmental Specialist
Neonatal Intensive Care Unit
University Hospitals Rainbow Babies & Children’s Hospital
University Hospitals of Cleveland Medical Center Cleveland, Ohio
Ricardo J. Rodriguez, MD, FAAP Neonatology
Cleveland Clinic Children’s Hospital
Associate Professor Pediatrics
Cleveland Clinic Lerner College of Medicine at CWRU Cleveland, Ohio
Gautham K. Suresh, MD
Professor of Pediatrics
Section of Neonatology
Baylor College of Medicine Houston, Texas
Philip T. Thrush, MD
Assistant Professor of Pediatrics
Northwestern University Feinberg School of Medicine
Ann & Robert H. Lurie Children’s Hospital of Chicago Chicago, Illinois
Beth A. Vogt, MD
Associate Professor, Pediatrics
The Ohio State University College of Medicine Division of Nephrology
Nationwide Children’s Hospital Columbus, Ohio
Kristin C. Voos, MD
Associate Professor
Department of Pediatrics, Division of Neonatology
Case Western Reserve University School of Medicine
Director of Family Integrated Care Neonatal Intensive Care Unit
University Hospitals Rainbow Babies & Children’s Hospitals Cleveland, Ohio
Jon F. Watchko, MD
Professor of Pediatrics, Obstetrics, Gynecology, and Reproductive Sciences
University of Pittsburgh School of Medicine Pittsburgh, Pennsylvania
Deanne Wilson-Costello, MD
Professor of Pediatrics
Division of Neonatology
University Hospitals Rainbow Babies & Children’s Hospital Cleveland, Ohio
It is with a deep sense of sadness that we report the death of our mentor, original author, and source of inspiration for this book, Marshall H. Klaus, M.D. He was a pioneer in the field of neonatal perinatal medicine, an incredibly kind and caring human being, and the perfect role model for a budding neonatologist. An original thinker, he was unafraid to challenge dogma, and through his research, writing, and teaching dramatically changed delivery room and neonatal intensive care units by opening these formerly sacrosanct areas to parents and families. He and his colleague John H. Kennell developed the concepts of family-centered care long before the term had been coined. Before that, he had discovered the lipid structures in surfactant and was a superb neonatal pulmonary physiologist. He was an emeritus author in the sixth edition, and this edition carries on his plea for humane care, promoting human milk, and support of the family. He is missed, but his messages will not be forgotten, and Jon and I cherish the wonderful years we had together with Marshall and his superb mentorship, which we have attempted to pass on to subsequent generations of neonatal trainees.
We are extremely proud and deeply grateful to the many contributors who have enabled us to present the seventh edition of Klaus and Fanaroff’s Care of the High-Risk Neonate Much has changed since the first edition was published 45 years ago, and so too has the book changed. This edition has had perhaps the most radical changes, with new chapters
reflecting important advances in quality- and evidence-based medicine; a new chapter on genetics, inborn errors of metabolism and neonatal screening; a chapter on family-centered care and another on understanding the science of developmental care. We have been fortunate to add leading authorities on these important topics.
They say every baby is a miracle. Some, however, face unusually long odds, from difficult pregnancies, to harrowing births, to births at the limits of viability.
How to support the best possible outcome using evidence-based medicine, quality improvement programs, and best practices remains the abiding theme of this book. Our aim is to present all these factors in a user-friendly manner. We have stuck with the format of including editorial comments within the text and new material in the form of clinical cases with questions.
This book would not have come to fruition without the superb in-house editing of Bonnie Siner, R.N. Bonnie, you are the best, and we are eternally grateful to you for your assistance. We recognize and thank Angie Breckon from Elsevier for her guidance and assistance, and of course we thank the authors and commenters who gave of their time and expertise so that we are all better informed. Finally, we thank you the reader for all you do to support babies and families during an incredibly difficult and challenging time in their lives.
Avroy A. Fanaroff, MD, FRCP, FRCPCH Jonathan M. Fanaroff, MD, JD, FAAP, FCLM
Health care is viewed as a system, a network of interdependent components working together to accomplish a specific aim, which is to meet the needs of patients, families, and communities while constantly improving its performance. The quality of health care is defined as “the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.”1,2 A medical error is the failure of a planned action to be completed as intended, or the use of a wrong plan to achieve an aim, and an adverse event is defined as an injury resulting from a medical intervention. Unfortunately, as noted in numerous research studies and in the Institute of Medicine (IOM) reports in 2000 and 2001,2,3 the US healthcare delivery system does not consistently provide high-quality care to all patients and populations, deficiencies in the quality of health care are highly prevalent,4,5 and numerous patients suffer from preventable harm due to medical errors.
EDITORIAL COMMENT: The Institute of Medicine report concluded that up to 98,000 people die each year as a result of preventable medical errors. The report was discussed not only in medical journals but also in lay journals and news media. One especially vivid analogy came from safety researcher Dr. Lucian Leape, who stated that this was the equivalent of three jumbo jet crashes every 2 days.
Ideally, units caring for neonates should monitor the care they provide and continuously improve the quality and safety of the care provided, both to improve clinical outcomes and to avoid medical errors and preventable adverse events. Examples of errors and adverse events noted in neonatal intensive care are shown in Box 1.1. To ensure high-quality and safe care with the best possible outcomes, each neonatal unit should have a framework to assess, monitor, and improve the quality of care provided, both generally and for neonates with specific conditions. Such a framework can be developed using Donabedian’s triad and the IOM’s six domains of quality.
DONABEDIAN’S TRIAD AND THE INSTITUTE OF MEDICINE’S SIX DOMAINS OF QUALITY
In the 1960s, Donabedian proposed that the domains of quality of care are structure, process, and outcomes.6–8 Structure includes the environment in which care is provided; the
Patient Safety, Quality, and Evidence-Based Medicine
Vijayalakshmi Padmanabhan, Gautham K. Suresh
facilities, equipment, services, and manpower available for care; the qualifications, skills, and experience of the healthcare professionals; and other characteristics of the hospital or system providing care. Examples of structural measures for a neonatal unit include space per patient, the layout of the unit, the nurse–patient ratio, the availability of imaging facilities around the clock, the types of respiratory equipment used, and the level of training and skills of the health professionals working in the unit and subspecialists available for consultation.
The process consists of the activities and steps involved and the sequence of these steps when patients receive health care. It refers to the content of care, i.e., how the patient was moved into, through, and out of the healthcare system and the services that were provided during the care episode. In a neonatal unit, the process of each aspect of care received by each infant can be analyzed and improved. For example, the processes of delivery room stabilization, neonatal transport, admission to the neonatal unit, performance of an invasive procedure, clinical rounds, and discharge home can all be studied and improved. Process measures of quality can be developed and monitored, such as the percentage of personnel performing hand hygiene prior to patient contact, percentage of eligible infants stabilized on continuous positive airway pressure (CPAP) at birth, the percentage of infants in whom the examination for retinopathy of prematurity (ROP) is performed on time, the efficiency with which a neonate is transported from a referring hospital, and the time taken to administer the first dose of antibiotic to infants with suspected sepsis.
Outcomes are consequences to the health and welfare of individuals and society, or, alternatively, the measured health status of the individual or community. Outcomes of care have also been defined as “the results of care (which) can encompass biologic changes in disease, comfort, ability for self-care, physical function and mobility, emotional and intellectual performance, patient satisfaction, and self-perception of health, health knowledge and compliance with medical care, and functioning within family, job, and social role.” For Newborn Intensive Care Unit (NICU) patients and their parents, examples of outcome measures are mortality rate, the frequency of chronic lung disease (CLD), percentage of very-low-birthweight (VLBW) infants developing ROP, the number of nosocomial blood stream infections per 1000 patient days, the percentage of NICU survivors that are developmentally normal, and parental satisfaction with the care of their baby.
BOX 1.1 Errors and Adverse Events in Neonatal Care15
• Intra tracheal administration of enteral feeds
• Intravenous lipid given through orogastric/nasogastric tube
• Hundred-fold overdose of insulin
• Administration of fosphenytoin instead of hepatitis B vaccine
• Subtherapeutic dose of penicillin for Group B Streptococcal infection given for 3 days before discovery
• Infusion of total daily intravenous fluids over 1–2 hours
• Intravenous administration of lidocaine instead of saline flush
• “Stat” blood transfusion took 2.5 hours
• Antibiotic given 4 hours after ordering
• Delay of greater than an hour in obtaining intravenous dextrose to treat hypoglycemia
• Medications given to the wrong patient
• Infant fed breastmilk of wrong mother
• Medications with adverse side effects:
• Benzyl alcohol (gasping, intraventricular hemorrhage, and death)
• Chloramphenicol (gray baby syndrome)
• Tetracyclines (yellow-stained teeth)
• Intravenous vitamin E (liver failure and death)
Other Errors
• Consent for a blood transfusion obtained from wrong infant’s parent
• Infant falls from weighing scale, incubator, and swing
• Failure of supply of compressed air throughout neonatal intensive care unit
• Incubator drawn toward magnetic resonance imaging machine requiring four security guards to pull it away
Six domains of quality were described by the IOM in 2001 in the report “Crossing the Quality Chasm.”2 These domains of care include safety, timeliness, effectiveness, efficiency, equity, and patient-centeredness (these can be remembered by the acronym STEEEP). A neonatal unit should try to provide care optimally in all these domains. Safety of care provided is a high-priority domain that deserves separate emphasis and is defined as freedom from accidental injury (avoiding harm to patients from the care that is intended to help them). Timeliness is providing care within an optimal range of time, without delays and unnecessary waits, and also without undue haste for patients, their families, and health professionals. Effectiveness is the provision of healthcare interventions supported by high-quality evidence to all eligible patients. Efficiency is avoiding waste, including avoiding intervention in those in whom it is unlikely to be beneficial, and waste of equipment, supplies, ideas, and energy. Equity is provision of care that does not vary based on a patient’s personal characteristics such as gender, ethnicity, geographic location, and socioeconomic status. Patient-centered care is the provision of care that is respectful of, and responsive to, an individual neonate’s family preferences, needs, and values, and ensuring that the family’s values are incorporated into clinical decisions.
CLINICAL MICROSYSTEMS AND HOW TO ASSESS AND MONITOR THE QUALITY OF CARE PROVIDED
A clinical microsystem can be defined as the combination of a small group of people who work together on a regular basis to provide care and the subpopulation of patients who receive that care.9 Each neonatal unit is a functioning clinical microsystem with the patient at the center and the physicians, nurses, respiratory therapists, and other professionals working with the patient and the family. It is the place where quality, safety, outcomes, satisfaction, and staff morale are created. Multiple microsystems are nested within a mesosystem (departments such as the pediatric department, or service lines such as women and children’s services), and multiple mesosystems are in turn components of a larger entity—the macrosystem or the larger organization. This macrosystem is embedded in the environment—the community, healthcare market, health policy, and the regulatory milieu. Assessment and monitoring of the quality of care provided in a neonatal unit will ultimately be shaped by the organizational culture and the environment.
Each neonatal unit should establish a set of indicators that measure the quality of neonatal care provided. The exact indicators to measure can be determined using the frameworks of the Donabedian triad and the IOM’s quality domains. Local priorities, local patterns of practice, ease of access to data, and resources required to collect, analyze, and display data, etc., will also play a role in determining the measures that are established to indicate the quality of neonatal care. The quality indicators collected can be used for (1) comparison, and (2) improvement.
Quality Indicators for Comparative Performance Measures
Comparator indicators can used to compare a unit’s clinical performance (and not process measures) against the quality indicators of other similar units, national benchmarks, or targets. To make the comparisons valid, these data should be risk adjusted using statistical methods to differentiate intrinsic heterogeneity among patients (e.g., comorbid conditions, severity of underlying disease) and institutions (e.g., available hospital personnel and resources). With risk adjustment, an outcome can be better ascribed to the quality of clinical care provided by health professionals and system, and help evaluate interinstitutional variations.
A wide variation in neonatal process measures and neonatal outcomes that persists after risk adjustment is noted in published studies of comparator quality indicators from several neonatal networks.11–14 Persistence of the variation after risk adjustment suggests that the observed differences in outcomes are the result of the quality of care provided to the patients and that the units with the poorer clinical outcomes have room to improve their quality of care. When quality indicators are monitored—although there is often a time lag between the events being measured and the analysis, display, and comparison of the data—the discrepancy between an
individual unit’s performance and the comparators can be used to motivate change and launch improvement projects around specific topics. Quality indicators may also be used by regulators and payors to rank hospitals and neonatal units (sometimes publicly) according to the quality of care they provide (their performance), withhold payments, and provide incentive payments. They may also be used by families of patients, when choice is feasible (for example, in an antenatally diagnosed fetal anomaly), to choose the neonatal unit where their infant will receive care. Many neonatal networks, such as the Vermont Oxford Network (VON), the Pediatrix neonatal database, and the Canadian Neonatal Network, collect predefined data items from member neonatal units and provide reports to these units that include quality indicators. For example, the VON provides member units each quarter and each year a report that includes, among others, their rates of ventilation, postnatal steroid use, surfactant use, inhaled nitric oxide use, pulmonary air leak, bronchopulmonary dysplasia (BPD), ROP, and mortality.
One of the most important subset of quality indicators is that of patient safety events. A variety of medical errors and adverse events related to neonatal care have been described in the literature.15–17 Each neonatal unit should monitor medical errors and adverse events. These patient safety events are most commonly identified through reporting by health professionals involved in or witnessing the event. Although reporting is convenient and requires minimal resources,18 other methods to identify patient safety events include the use of trigger tools, chart review, random safety audits, mortality and morbidity meetings, autopsies, and review of patient family complaints or medical-legal cases.18,19 However, these methods do not yield a true rate of these events and therefore cannot be used to evaluate a unit’s performance against comparators. The ideal method to identify patient safety events is prospective surveillance,20 as it yields accurate rates and can be used for comparison. However, it is not widely used, as it is laborious and requires many resources.
Quality Indicators for Improvement
These indicators are usually a combination of outcome measures and process measures and are used to monitor the progress of a specific quality improvement (QI) project. They are collected in real time and used by QI teams (see below) to monitor the progress of the project, identify unintended consequences, and draw inferences about the effects of their attempts to make change. Ideally, these data should be disaggregated as much as possible (not lumped together) and displayed over time (with time on the x-axis and the indicator on the y-axis) in the form of either run charts or statistical process control charts, as displayed in Fig. 1.1.
WHY IS QUALITY IMPROVEMENT IMPORTANT IN NEONATAL CARE?
Published literature on wide variations in neonatal process measures and neonatal morbidity that persists after risk adjustment 11–14 suggests that the observed differences in
Fig. 1.1 Example of statistical process control chart. (From Merkel L, Beers K, Lewis MM, Stauffer J, Mujsce DJ, Kresch MJ. Reducing unplanned extubations in the NICU. Pediatrics. 2014;133(5):e1367–e1372.)
outcomes are the result of the quality of care provided to the patients, that a significant proportion of neonates managed in NICUs suffer from preventable morbidity, and that the units with the poorer clinical outcomes have opportunities to improve their quality of care. A particular concern is the high incidence in VLBW infants of morbidities such as CLD, necrotizing enterocolitis, ROP, periventricular-intraventricular hemorrhage, and other conditions that often result in major long-term medical and neurodevelopmental morbidity, require chronic complex care, and are associated with high healthcare and societal costs. Despite significant advances in neonatal care over time and a decrease in frequency in some neonatal units, these conditions continue to occur in high-risk infants, and demonstrate significant variation in frequency across units despite adjustment for confounding factors (suggesting that a proportion of these conditions is preventable). Neonatal health outcomes are influenced by a variety of endogenous and exogenous factors such as birth weight, gestation, obstetric management during delivery, resuscitation practices, initial respiratory support, nutritional management, and prevention of infections. Application of systematic QI methods has the potential to reduce various forms of preventable neonatal morbidity and mortality through reliable and consistent application of existing high-level evidence, without depending on new medications, technology, or innovations to be developed. Such efforts are described below.
EDITORIAL COMMENT: A mantra of quality improvement is to “borrow shamelessly,” and indeed, healthcare quality improvement efforts have looked to other high-reliability industries such as aviation, nuclear power plants, naval aircraft carriers, and other industries that operate in complex, highrisk environments. Crew resource management, for example, which has been used in the aviation industry for years to improve communication, has been incorporated relatively recently in neonatal resuscitation as a way to improve teamwork.
IMPROVING THE QUALITY OF CARE
QI is now an established movement in health care. QI in health care has developed in the past three decades by using principles, tools, and techniques from other industries about improving product quality to meet their customers’ needs and expectations. The basic premise of QI in health care is that improvement in patient care and outcomes can be achieved by making intentional and systematic efforts using a defined set of scientific methods and by constantly reflecting on and learning from the results of attempts to improve care. QI is based on systems thinking and therefore emphasizes the organization and systems of care. Although there are multiple QI models and frameworks—IMPROVE, Model for Improvement, Lean or Lean Six Sigma (define, measure, analyze, improve, and control; DMAIC), the Toyota Production System, Rapid Cycle Improvement, four key habits (VON), Advanced Training Program of Intermountain Healthcare, and the Microsystems approach—they are all broadly similar in their approaches. The Model for Improvement (Fig. 1.2), which was formalized by Langley, Nolan, and colleagues, is a simple and effective approach that can be used to improve the quality of care.21 The use of this model and Plan-Do-StudyAct (PDSA) cycles to achieve improvement is discussed below.
Assessment of the neonatal unit as a clinical microsystem is the start of the improvement journey.9,10 Using a framework known as the “Five Ps,” various aspects of the microsystem—its purpose, the patients cared for, the professionals that provide care, the processes of care, and patterns (culture, history, and interpersonal dynamics)—can be understood and defined. Such an analysis provides a rich and deep understanding of the context of improvement that subsequently helps with change management and strategic planning.
The Improvement Team
At the start of a QI project, it is important to obtain support and resources from the department’s leaders. This will allow for time, personnel, and resource allocation for improvement. An early step in a QI project is the creation of a QI team that consists of personnel from multiple disciplines. QI teams usually are comprised of physicians, nurses, respiratory therapists,
What are we trying to accomplish? How will we know that a change is an improvement?
and other stakeholders who are directly or indirectly involved in aspects of the topic that is targeted for improvement. The more disciplines represented, the better the QI efforts will be. However, time and resources are limited and have to be used efficiently and effectively. The members of the QI team have to become skilled in several techniques, such as how to have productive meetings, how to work together as a team, how to bring about change in a unit, how to deal with barriers to improvement, and how to collect, analyze, and display data. A key responsibility for the QI team is to increase buy-in among the staff of the neonatal unit and heighten awareness of the problem being addressed, thereby creating a Hawthorne effect, which facilitates improvement.
Cooperation and Collaboration
Improvement in patient care is impossible without cooperation—working together to produce mutual benefit or attain a common purpose. Collaboration and cooperation have to occur within each unit. Collaboration is a powerful force in motivating people toward improvement and in sustaining the momentum for change in each unit. Often, individual team members will need to be excused from their clinical duties when they participate in a QI project, with these clinical duties assigned to other unit personnel. The improvement team has to ensure “buy-in” from other members in their unit and get them to participate in the improvement effort. Such buy-in of all the professionals will decrease resistance to change as improvement interventions are implemented. Collaboration and cooperation among different units that can work together, share ideas, and help each other can also help improve care. Clemmer and colleagues22 suggest five methods to foster cooperation: (1) develop a shared purpose; (2) create an open, safe environment; (3) include all those who share the common purpose and encourage diverse viewpoints; (4) learn how to negotiate agreement; and (5) insist on fairness and equity in applying rules.
Aim: What Are We Trying to Accomplish?
Any improvement project should start with a clear aim of what needs to be accomplished, or the global aim. This should next be narrowed down to a specific aim statement (Fig. 1.3). This can be done in three stages. First, a list of problems faced by the unit or opportunities for change is made in two to three sentences followed by why the current system or process needs improvement. This should include baseline data and relevant benchmarks from the published literature or other sources. The existence of quality indicators as described above will assist the compilation of such a list. Second, the problems or opportunities for change that are listed are then prioritized using criteria such as the resources available, the probability of achieving change, emotional appeal, the importance to stakeholders (including patients and their families), and practicality. Third, one item is finally selected from this list as the aim for improvement. The aim statement defines a goal, a population, and a time period. For those unfamiliar with QI, it is best to choose for the initial project a small and well-focused topic on which data are easy to obtain and that will generate interest among clinicians and nurses. VLBW
neonates have been the obvious target for QI in many QI initiatives. VLBW neonates contribute significantly to the mortality and morbidity burden in the neonatal units, consume the largest proportion of resources, are easily identified, and develop potentially preventable outcomes like nosocomial infections, intraventricular hemorrhage, BPD, and ROP. When an aim is selected, it should be specified as a SMART aim, i.e., it should be specific, measurable, achievable, realistic, and time-bound. Fig. 1.3 provides a template for a SMART aim.
Measurement: How Will We Know That a Change Is an Improvement?
Measurement is key to knowing whether a change is an improvement or not. Without objective measurement, clinicians will be left guessing or relying on subjective impressions. Objective measurement of structures, processes, and outcomes provides strong motivation for a unit to embark on an improvement project. Measurement serves three purposes: (1) it indicates the current status of the unit or practice. This is called assessing “current reality”; (2) it informs QI teams whether or not they are actually making an improvement, without having to rely on subjective impressions or opinions (which can be misleading); and (3) measuring quality helps teams learn from attempts to make improvements and learn from successes as well as failures.
What Changes Can We Make That Will Result in an Improvement?
Prior to understanding what changes one can make, it is important to understand the “forces that are holding the unchanged present in place before selecting changes.” For every problem, the QI team needs to understand the potential causes, the facilitators, and the barriers to change. There are many steps one can take to understand the current situation and the changes one can make that will result in an improvement. These include:
1. A detailed analysis and mapping of the process by which care is provided (process mapping). An overview of the process can be obtained using a flowchart. A flowchart
SPECIFIC AIM TEMPLATE
We aim to
(increase/decrease/improve, etc.)
The_______________________________
(number, %, scores, time taken, etc.)
Of__________________________________
(name the exact thing you want to improve)
By/from
(exact amount of improvement, e.g., from 50% to 90%)
By (enter month/year)
Fig. 1.3 Template for Aim Statement
helps understand the systematic flow of information in the system. The basic element of a flowchart is a simple action. It is a map of what follows what, with arrows between sequential action boxes and symbols for start and end steps in the sequence. Other symbols are used in flowcharts to represent different kinds of steps, e.g., process, decision, start, delay, cloud;
2. A review of published literature and using the principles of evidence-based medicine;
3. Benchmarking, i.e., learning from superior performers in the area chosen for improvement;
4. Advice from experts or others who have attempted improvement in similar topics;
5. Brainstorming, critical thinking, and hunches about the current system of care, especially involving individuals who are at the front line for delivering the care and intimately involved in a process. An Ishikawa/Fishbone diagram offers a useful outline for brainstorming and to identify potential factors causing an overall effect. Each cause is a source of variation. Causes are usually grouped into major categories to identify and classify these sources of variation;
6. Use of “change concepts,” a set of principles of redesign of process or work flow (such as “change the sequence of steps” or “eliminate unnecessary steps”)21; and
7. In analyzing medical errors and adverse events, a detailed systems analysis23 is recommended. Such an analysis (the most extensive form of which is a root cause analysis [RCA]24) attempts to identify workplace-related, human-re lated, and organizational factors25 that contributed to the occurrence and propagation of the event. An RCA reveals key relationships among various variables, and the possible causes provide additional insight into process behavior. Box 1.2 details the steps involved in the RCA process. The leader of the RCA should be well versed in RCA methodology and also be focused on identifying system-related challenges rather than assignment of individual blame. The well-known Swiss cheese model26 (Fig. 1.4) depicts how an error reaches a patient in spite of a series of existing safety mechanisms because the “holes in the Swiss cheese line up” (multiple safety
1.2 Steps of a Root Cause Analysis
Step 1: Identify a sentinel event.
Step 2: Assemble a multidisciplinary team including executive and operational leadership, QI coaches, and providers who come in contact with the system.
Step 3: Verify facts surrounding the event and collect associated data.
Step 4: Chart causal factors using process maps, brainstorming, pareto charts, fishbone diagrams, etc.
Step 5: Identify root causes by asking “why” five times for each issue to get to the bottom of the cause.
Step 6: Develop strategies and make recommendations for process change.
Step 7: Present results to all stakeholders.
Step 8: Perform “tests of change.”
BOX
mechanisms fail concurrently or serially and allow propagation of the error). A key principle of improving patient safety and reducing medical errors is to focus not on individual healthcare providers as the cause of errors (the “person approach”), but more broadly on the system of care (in which the provider is embedded) as the desired locus of prevention (the “system approach”). Ensuring patient safety involves the establishment of operational systems and processes that minimize the likelihood of errors and maximize the likelihood of intercepting them when they occur.5 Optimal design of equipment, tasks, and the work environment can enhance error-free human performance, and the use of principles of human factors engineering as well as principles of cognitive psychology can successfully guide such optimal design.
Using one or a combination of these approaches, one or more interventions are identified that, if implemented, have the potential to result in improvements in patient care and outcomes. These interventions are variously known as “change concepts,” “potentially better practices,”27 “key clinical activities,”28 or, for patient safety events, “safety practices.” They are sometimes grouped into a set of synergistic or complementary interventions that are known as “bundles.”
After the changes or potentially better practices or safety practices are selected, it is not sufficient to implement them and assume that patient outcomes will improve. The next step in the improvement process is to carry out a series of PDSA cycles.
Plan-Do-Study-Act Cycles
In 1924, Walter Shewhart showed that the constant evaluation of management policy and procedures leads to continuous improvement. The Shewhart cycle, or Shewhart learning and improvement cycle, combines management thinking with statistical analysis. This cycle has also been called the Deming cycle, the Plan-Do-Check-Act cycle, or the PDSA cycle. The QI team, using the aforementioned steps, will have to decide what change concept to test. No matter what the sources of ideas for improvement are, there is no guarantee that these changes, if tried, will make things better. The results of the
implementation of these changes have to be studied, using the measures that have previously been set up when answering the question, “How will we know that a change is an improvement?” In other words, the change has to be tested. This process also allows process-related obstacles to be identified and resolved. This process of testing a change is called a PDSA cycle. This is a critical step in the process of QI, since it allows troubleshooting prior to widespread implementation. Each PDSA cycle includes planning an intervention (e.g., steps to enhance adherence to hand hygiene), carrying out the intervention, studying its effect (e.g., hand hygiene compliance rate, hospital-acquired infection rate), and finally, implementing the intervention in day-to-day practice. Common questions the QI team should ask itself are: Why did we succeed? Why did we fail? What further changes do we now need to make in order to succeed? By doing a series of PDSA cycles and thus learning from each effort at improvement, the team can achieve lasting improvements in the way they provide patient care and in patient outcomes. The apparent simplicity of the PDSA cycle is deceptive. The cycle is a sophisticated, demanding way to achieve learning and change in complex systems.29
Ensuring Success of Quality Improvement Projects
QI projects often are not completed as intended, unsuccessful in achieving the desired results, or unable to achieve sustained results. The following ten tips can contribute to successful completion and sustained results:
1. Gain a deep understanding of the problem first using systems thinking30 (“formulate the mess”) before trying to implement solutions and resist quick “off-the-shelf” solutions.
2. Avoid solely using a research mentality, especially with measurement. Successful QI requires a combination of rigorous scientific thinking and pragmatism. Particularly with measurement, seek usefulness, not perfection.31
3. Focus on sustainability from the beginning, and not just on short-term wins.
4. Develop a consensus-based approach to decision-making when the evidence for interventions is sparse, incomplete, or flawed.
5. Manage change carefully using published expert recommendations.32,33
6. Learn from “failure” through multiple PDSA cycles. Understanding the reasons for failure can guide future refinements of the changes implemented, with eventual success.
7. Use the principles and methods of project management,34 including good meeting skills.
8. Go beyond just using jargon such as “silo,” “low-hanging” fruit, and “checklist.”
9. Use a QI coach if possible. Coaching can enhance the success of QI teams.35
10. Do not feel compelled to adhere rigidly to any one model or framework for QI.
James Reason 2000 Patient
Fig. 1.4 Swiss-Cheese Model. (From Reason J. Human error: models and management. BMJ. 2000;320(7237):768–770.)
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Which when as all the lookers on beheld, xxxv They weened sure the warre was at an end, And Iudges rose, and Marshals of the field Broke vp the listes, their armes away to rend; And Canaceegan wayle her dearest frend.
All suddenly they both vpstarted light, The one out of the swownd, which him did blend, The other breathing now another spright, And fiercely each assayling, gan afresh to fight.
Long while they then continued in that wize, xxxvi
As if but then the battell had begonne:
Strokes, wounds, wards, weapons, all they did despise, Ne either car’d to ward, or perill shonne, Desirous both to haue the battell donne; Ne either cared life to saue or spill, Ne which of them did winne, ne which were wonne. So wearie both of fighting had their fill, That life it selfe seemd loathsome, and long safetie ill.
Whilst thus the case in doubtfull ballance hong, xxxvii
Vnsure to whether side it would incline,
And all mens eyes and hearts, which there among Stood gazing, filled were with rufull tine, And secret feare, to see their fatall fine, All suddenly they heard a troublous noyes, That seemd some perilous tumult to desine, Confusd with womens cries, and shouts of boyes, Such as the troubled Theaters oftimes annoyes.
Thereat the Champions both stood still a space, xxxviii
To weeten what that sudden clamour ment; Lo where they spyde with speedie whirling pace, One in a charet of straunge furniment, Towards them driuing like a storme out sent. The charet decked was in wondrous wize,
With gold and many a gorgeous ornament, After the Persian Monarks antique guize, Such as the maker selfe could best by art deuize.
And drawne it was (that wonder is to tell) xxxix
Of two grim lyons, taken from the wood, In which their powre all others did excell; Now made forget their former cruell mood, T’obey their riders hest, as seemed good. And therein sate a Ladie passing faire And bright, that seemed borne of Angels brood, And with her beautie bountie did compare, Whether of them in her should haue the greater share.
Thereto she learned was in Magicke leare, xl
And all the artes, that subtill wits discouer, Hauing therein bene trained many a yeare, And well instructed by the Fay her mother, That in the same she farre exceld all other. Who vnderstanding by her mightie art,
Of th’euill plight, in which her dearest brother
Now stood, came forth in hast[62] to take his part, And pacifie the strife, which causd so deadly smart.
And as she passed through th’vnruly preace xli
Of people, thronging thicke her to behold, Her angrie teame breaking their bonds of peace, Great heapes of them, like sheepe in narrow fold, For hast did ouer-runne, in dust enrould, That thorough rude confusion of the rout, Some fearing shriekt, some being harmed hould, Some laught for sport, some did for wonder shout, And some that would seeme wise, their wonder turnd to dout.
In her right hand a rod of peace shee bore, xlii
About the which two Serpents weren wound,
Entrayled mutually in louely lore, And by the tailes together firmely bound, And both were with one oliue garland crownd, Like to the rod which Maiassonne doth wield, Wherewith the hellish fiends he doth confound. And in her other hand a cup she hild, The which was with Nepenthe to the brim vpfild.
Nepenthe is a drinck of souerayne grace, xliii
Deuized by the Gods, for to asswage Harts grief, and bitter gall away to chace, Which stirs vp anguish and contentious rage:
In stead thereof sweet peace and quiet age[63] It doth establish in the troubled mynd. Few men, but such as sober are and sage, Are by the Gods to drinck thereof assynd; But such as drinck, eternall happinesse do fynd.
Such famous men, such worthies of the earth, xliv As Iouewill haue aduaunced to the skie, And there made gods, though borne of mortall berth, For their high merits and great dignitie, Are wont, before they may to heauen flie, To drincke hereof, whereby all cares forepast Are washt away quite from their memorie. So did those olde Heroes hereof taste, Before that they in blisse amongst the Gods were plaste.
Much more of price and of more gratious powre xlv Is this, then that same water of Ardenne, The which Rinaldodrunck in happie howre, Described by that famous Tuscane penne: For that had might to change the hearts of men Fro loue to hate, a change of euill choise: But this doth hatred make in loue to brenne, And heauy heart with comfort doth reioyce.
Who would not to this vertue rather yeeld his voice?
At last arriuing by the listes side, xlvi
Shee with her rod did softly smite the raile, Which straight flew ope, and gaue her way to ride. Eftsoones out of her Coch she gan auaile, And pacing fairely forth, did bid all haile, First to her brother, whom she loued deare, That so to see him made her heart to quaile: And next to Cambell, whose sad ruefull cheare Made her to change her hew, and hidden loue t’appeare.
They lightly her requit (for small delight xlvii They had as then her long to entertaine,) And eft them turned both againe to fight, Which when she saw, downe on the bloudy plaine Her selfe she threw, and teares gan shed amaine; Amongst her teares immixing prayers meeke, And with her prayers reasons to restraine[64] From blouddy strife, and blessed peace to seeke, By all that vnto them was deare, did them beseeke.
But when as all might nought with them preuaile, xlviii Shee smote them lightly with her powrefull wand. Then suddenly as if their hearts did faile, Their wrathfull blades downe fell out of their hand, And they like men astonisht still did stand. Thus whilest their minds were doubtfully distraught, And mighty spirites bound with mightier band, Her golden cup to them for drinke she raught, Whereof full glad for thirst, ech drunk an harty draught.
Of which so soone as they once tasted had, xlix Wonder it is that sudden change to see: Instead of strokes, each other kissed glad, And louely haulst from feare of treason free,
And plighted hands for euer friends to be. When all men saw this sudden change of things, So mortall foes so friendly to agree, For passing ioy, which so great maruaile brings, They all gan shout aloud, that all the heauen rings.
All which, when gentle Canaceebeheld, l In hast she from her lofty chaire descended, To[65] weet what sudden tidings was befeld: Where when she saw that cruell war so ended, And deadly foes so faithfully affrended, In louely wise she gan that Lady greet, Which had so great dismay so well amended, And entertaining her with curt’sies meet, Profest to her true friendship and affection sweet.
Thus when they all accorded goodly were, li The trumpets sounded, and they all arose, Thence to depart with glee and gladsome chere. Those warlike champions both together chose, Homeward to march, themselues there to repose, And wise Cambinataking by her side
Faire Canacee, as fresh as morning rose, Vnto her Coch remounting, home did ride, Admir’d of all the people, and much glorifide.
Where making ioyous feast[66] theire daies they spent lii
In perfect loue, deuoide of hatefull strife, Allide with bands of mutuall couplement; For Triamondhad Canaceeto wife, With whom he ledd a long and happie life; And Cambeltooke Cambinato his fere, The which as life were each to other liefe. So all alike did loue, and loued were, That since their days such louers were not found elswhere[67] .
It often fals, (as here it earst befell) i That mortall foes doe turne to faithfull frends, And friends profest are chaungd to foemen fell: The cause of both, of both their minds depends,[68] And th’end of both likewise of both their ends. For enmitie, that of no ill proceeds, But of occasion, with th’occasion ends; And friendship, which a faint affection breeds Without regard of good, dyes like ill grounded seeds.
That well (me seemes) appeares, by that of late ii Twixt Cambelland Sir Triamondbefell, As als[69] by this, that now a new debate Stird vp twixt Scudamour[70] and Paridell, The which by course befals me here to tell: Who hauing those two other Knights espide
Marching afore, as ye remember well, Sent forth their Squire to haue them both descride, And eke those masked Ladies riding them beside.
Who backe returning, told as he had seene, iii
That they were doughtie knights of dreaded name; And those two Ladies, their two loues vnseene; And therefore wisht them without blot or blame, To let them passe at will, for dread of shame. But Blandamourfull of vainglorious spright, And rather stird by his discordfull Dame, Vpon them gladly would haue prov’d his might, But that he yet was sore of his late lucklesse fight.
Yet nigh approching, he them fowle bespake, iv Disgracing them, him selfe thereby to grace, As was his wont, so weening way to make To Ladies loue, where so he came in place, And with lewd termes their louers to deface. Whose sharpe prouokement them incenst so sore, That both were bent t’auenge his vsage base, And gan their shields addresse them selues afore: For euill deedes may better then bad words be bore.
But faire Cambinawith perswasions myld, v
Did mitigate the fiercenesse of their mode, That for the present they were reconcyld, And gan to treate of deeds of armes abrode, And strange aduentures, all the way they rode: Amongst the which they told, as then befell, Of that great turney, which was blazed brode, For that rich girdle of faire Florimell, The prize of her, which did in beautie most excell.
To which folke-mote they all with one consent, vi Sith each of them his Ladie had him by,
Whose beautie each of them thought excellent, Agreed to trauell, and their fortunes try.
So as they passed forth, they did espy
One in bright armes, with ready speare in rest, That toward them his course seem’d to apply, Gainst whom Sir Paridellhimselfe addrest, Him weening, ere he nigh approcht to haue represt.
Which th’other seeing, gan his course relent, vii And vaunted speare eftsoones to disaduaunce,
As if he naught but peace and pleasure ment, Now falne into their fellowship by chance,
Whereat they shewed curteous countenaunce.
So as he rode with them accompanide, His rouing eie did on the Lady glaunce, Which Blandamourhad riding by his side: Whom sure he weend, that he some wher tofore had eide.
It was to weete that snowy Florimell, viii
Which Ferrau[71] late from Braggadochiowonne, Whom he now seeing, her remembred well, How hauing reft her from the witches sonne, He soone her lost: wherefore he now begunne
To challenge her anew, as his owne prize, Whom formerly he had in battell wonne, And proffer made by force her to reprize, Which scornefull offer, Blandamourgan soone despize.
And said, Sir Knight, sith ye this Lady clame, ix Whom he that hath, were loth to lose so light, (For so to lose a Lady, were great shame)
Yee shall her winne, as I haue done in fight: And lo shee shall be placed here in sight,[72]
Together with this Hag beside her set,
That who so winnes her, may her haue by right: But he shall haue the Hag that is ybet,
And with her alwaies ride, till he another get.
That offer pleased all the company, x
So Florimellwith Ateforth was brought, At which they all gan laugh full merrily:
But Braggadochiosaid, he neuer thought
For such an Hag, that seemed worse[73] then nought, His person to emperill so in fight. But if to match that Lady they had sought Another like, that were like faire and bright, His life he then would spend to iustifie his right.
At which his vaine excuse they all gan smile, xi
As scorning his vnmanly cowardize: And Florimellhim fowly gan reuile, That for her sake refus’d to enterprize The battell, offred in so knightly wize. And Ateeke prouokt him priuily, With loue of her, and shame of such mesprize. But naught he car’d for friend or enemy, For in base mind nor friendship dwels nor enmity.
But Cambellthus did shut vp all in iest, xii
Braue Knights and Ladies, certes ye doe wrong
To stirre vp strife, when most vs needeth rest, That we may vs reserue both fresh and strong, Against the Turneiment which is not long. When who so list to fight, may fight his fill, Till then your challenges ye may prolong; And then it shall be tried, if ye will, Whether shall haue the Hag, or hold the Lady still.
They all agreed, so turning all to game, xiii
And pleasaunt bord, they past forth on their way, And all that while, where so they rode or came, That masked Mock-knight was their sport and play.
Till that at length vpon th’appointed day, Vnto the place of turneyment they came; Where they before them found in fresh aray Manie a braue knight, and manie a daintie dame Assembled, for to get the honour of that game.
There this faire crewe arriuing, did diuide xiv Them selues asunder: Blandamourwith those Of his, on th’one; the rest on th’other side. But boastfull Braggadocchiorather chose, For glorie vaine their fellowship to lose, That men on him the more might gaze alone. The rest them selues in troupes did else dispose, Like as it seemed best to euery one; The knights in couples marcht, with ladies linckt attone.
Then first of all forth came Sir Satyrane, xv
Bearing that precious relicke in an arke
Of gold, that bad eyes might it not prophane: Which drawing softly forth out of the darke, He open shewd, that all men it mote marke. A gorgeous girdle, curiously embost
With pearle and precious stone, worth many a marke; Yet did the workmanship farre passe the cost: It was the same, which lately Florimelhad lost.
That same aloft he hong in open vew, xvi
To be the prize of beautie and of might; The which eftsoones discouered, to it drew
The eyes of all, allur’d with close delight, And hearts quite robbed with so glorious sight, That all men threw out vowes and wishes vaine. Thrise happie Ladie, and thrise happie knight, Them seemd that could so goodly riches gaine, So worthie of the perill, worthy of the paine.
Then tooke the bold Sir Satyranein hand xvii
An huge great speare, such as he wont to wield, And vauncing forth from all the other band
Of knights, addrest his maiden-headed[74] shield,
Shewing him selfe all ready for the field.
Gainst whom there singled from the other side
A Painim knight, that well in armes was skild, And had in many a battell oft bene tride,
Hight Bruncheualthe bold, who fiersly forth did ride.
So furiously they both together met, xviii
That neither could the others force sustaine;
As two fierce Buls, that striue the rule to get
Of all the heard, meete with so hideous maine,
That both rebutted, tumble on the plaine:
So these two champions to the ground were feld, Where in a maze they both did long remaine, And in their hands their idle troncheons held, Which neither able were to wag, or once to weld.
Which when the noble Ferramontespide, xix
He pricked forth in ayd of Satyran; And him against Sir Blandamourdid ride
With all the strength and stifnesse that he can.
But the more strong and stiffely that he ran, So much more sorely to the ground he fell,
That on an[75] heape were tumbled horse and man.
Vnto whose rescue forth rode Paridell; But him likewise with that same speare he eke did quell.
Which Braggadocchioseeing, had no will xx
To hasten greatly to his parties ayd, Albee his turne were next; but stood there still, As one that seemed doubtfull or dismayd.
But Triamondhalfe wroth to see him staid, Sternly stept forth, and raught away his speare,
With which so sore he Ferramontassaid, That horse and man to ground he quite did beare, That neither could in hast themselues againe vpreare.
Which to auenge, Sir Deuonhim did dight, xxi
But with no better fortune then the rest: For him likewise he quickly downe did smight, And after him Sir Douglashim addrest, And after him Sir Paliumord[76] forth prest, But none of them against his strokes could stand, But all the more, the more his praise increst. For either they were left vppon the land, Or went away sore wounded of his haplesse hand.
And now by this, Sir Satyraneabraid, xxii
Out of the swowne, in which too long he lay; And looking round about, like one dismaid, When as he saw the mercilesse affray, Which doughty Triamondhad wrought that day, Vnto the noble Knights of Maidenhead, His mighty heart did almost rend in tway, For very gall, that rather wholly dead Himselfe he wisht haue beene, then in so bad a stead.
Eftsoones he gan to gather vp around xxiii
His weapons, which lay scattered all abrode, And as it fell, his steed he ready found. On whom remounting, fiercely forth he rode, Like sparke of fire that from the anduile glode,[77] There where he saw the valiant Triamond Chasing, and laying on them heauy lode. That none his force were able to withstond, So dreadfull were his strokes, so deadly was his hond.
With that at him his beamlike[78] speare he aimed, xxiv And thereto all his power and might applide:
The wicked steele for mischiefe first ordained, And hauing now misfortune got for guide,[79] Staid not, till it arriued in his side, And therein made a very griesly wound, That streames of bloud his armour all bedide. Much was he daunted with that direfull stound, That scarse he him vpheld from falling in a sound.
Yet as he might, himselfe he soft withdrew xxv Out of the field, that none perceiu’d it plaine, Then gan the part of Chalengers anew To range the field, and victorlike to raine, That none against them battell durst maintaine. By that the gloomy euening on them fell, That forced them from fighting to refraine, And trumpets sound to cease did them compell, So Satyranethat day was iudg’d to beare the bell.
The morrow next the Turney gan anew, xxvi And with the first the hardy Satyrane Appear’d in place, with all his noble crew, On th’other side, full many a warlike swaine, Assembled were, that glorious prize to gaine. But mongst them all, was not Sir Triamond, Vnable he new battell to darraine, Through grieuaunce of his late receiued wound, That doubly did him grieue, when so himselfe he found.
Which Cambellseeing, though he could not salue, xxvii Ne done vndoe, yet for to salue his name, And purchase honour in his friends behalue,[80] This goodly counterfesaunce he did frame. The shield and armes well knowne to be the same, Which Triamondhad worne, vnwares to wight, And to his friend vnwist, for doubt of blame,
If he misdid,[81] he on himselfe did dight, That none could him discerne, and so went forth to fight.
There SatyraneLord of the field he found, xxviii
Triumphing in great ioy and iolity;
Gainst whom none able was to stand on ground; That much he gan his glorie to enuy, And cast t’auenge his friends indignity. A mightie speare eftsoones at him he bent; Who seeing him come on so furiously, Met him mid-way with equall hardiment, That forcibly to ground they both together went.
They vp againe them selues can lightly reare, xxix And to their tryed swords them selues betake; With which they wrought such wondrous maruels there, That all the rest it did amazed make, Ne any dar’d their perill to partake; Now cuffling close, now chacing to and fro, Now hurtling round aduantage for to take: As two wild Boares together grapling go, Chaufing and foming choler each against his fo.
So as they courst, and turneyd here and theare, xxx
It chaunst Sir Satyranehis steed at last, Whether through foundring or through sodein feare To stumble, that his rider nigh he cast; Which vauntage Cambelldid pursue so fast, That ere him selfe he had recouered well, So sore he sowst him on the compast creast, That forced him to leaue his loftie sell, And rudely tumbling downe vnder his horse feete fell.
Lightly Cambelloleapt downe from his steed, xxxi
For to haue rent his shield and armes away, That whylome wont to be the victors meed;
When all vnwares he felt an hideous sway
Of many swords, that lode on him did lay. An hundred knights had him enclosed round, To rescue Satyraneout of his pray; All which at once huge strokes on him did pound, In hope to take him prisoner, where he stood on ground.
He with their multitude was nought dismayd, xxxii
But with stout courage turnd vpon them all, And with his brondiron round about him layd; Of which he dealt large almes, as did befall: Like as a Lion that by chaunce doth fall
Into the hunters toile, doth rage and rore, In royall heart disdaining to be thrall. But all in vaine: for what might one do more? They haue him taken captiue, though it grieue him sore.
Whereof when newes to Triamondwas brought, xxxiii
There as he lay, his wound he soone forgot, And starting vp, streight for his armour sought: In vaine he sought; for there he found it not; Cambelloit away before had got: Cambelloesarmes therefore he on him threw, And lightly issewd forth to take his lot. There he in troupe found all that warlike crew, Leading his friend away, full sorie to his vew.
Into the thickest of that knightly preasse xxxiv
He thrust, and smote downe all that was betweene, Caried with feruent zeale, ne did he ceasse, Till that he came, where he had Cambellseene, Like captive thral two other Knights atweene, There he amongst them cruell hauocke makes, That they which lead him, soone enforced beene To let him loose, to saue their proper stakes, Who being freed, from one a weapon fiercely takes.
With that he driues at them with dreadfull might, xxxv
Both in remembrance of his friends late harme, And in reuengement of his owne despight, So both together giue a new allarme,
As if but now the battell wexed[82] warme.
As when two greedy Wolues doe breake by force Into an heard, farre from the husband farme, They spoile and rauine without all remorse, So did these two through all the field their foes enforce.
Fiercely they followd on their bolde emprize, xxxvi
Till trumpets sound did warne them all to rest; Then all with one consent did yeeld the prize
To Triamondand Cambellas the best.
But Triamondto Cambellit relest. And Cambellit to Triamondtransferd; Each labouring t’aduance the others gest, And make his praise before his owne preferd: So that the doome was to another day differd.
The last day came, when all those knightes againe xxxvii
Assembled were their deedes of armes to shew.
Full many deedes that day were shewed plaine:
But Satyraneboue all the other crew, His wondrous worth declared in all mens view.
For from the first he to the last endured, And though some while Fortune from him withdrew, Yet euermore his honour he recured, And with vnwearied powre his party still assured.
Ne was there Knight that euer thought of armes, xxxviii
But that his vtmost prowesse there made knowen, That by their many wounds, and carelesse harmes, By shiuered speares, and swords all vnder strowen, By scattered shields was easie to be showen. There might ye see loose steeds at randon ronne,
Whose luckelesse riders late were ouerthrowen; And squiers make hast to helpe their Lords fordonne, But still the Knights of Maidenhead the better wonne.
Till that there entred on the other side, xxxix
A straunger knight, from whence no man could reed, In quyent disguise, full hard to be descride. For all his armour was like saluage weed, With woody mosse bedight, and all his steed With oaken leaues attrapt, that seemed fit For saluage wight, and thereto well agreed His word, which on his ragged shield was writ, Saluagessesansfinesse, shewing secret wit.
He at his first incomming, charg’d his spere xl
At him, that first appeared in his sight: That was to weet, the stout Sir Sangliere, Who well was knowen to be a valiant Knight, Approued oft in many a perlous fight.
Him at the first encounter downe he smote, And ouerbore beyond his crouper quight, And after him another Knight, that hote Sir Brianor, so sore, that none him life behote.
Then ere his hand he reard, he ouerthrew xli
Seuen Knights one after other as they came: And when his speare was brust, his sword he drew, The instrument of wrath, and with the same Far’d like a lyon in his bloodie game, Hewing, and slashing shields, and helmets bright, And beating downe, what euer nigh him came, That euery one gan shun his dreadfull sight, No lesse then death it selfe, in daungerous affright.
Much wondred all men, what, or whence he came, xlii That did amongst the troupes so tyrannize;
And each of other gan inquire his name. But when they could not learne it by no wize, Most answerable to his wyld disguize It seemed, him to terme the saluage knight. But certes his right name was otherwize, Though knowne to few, that Arthegallhe hight, The doughtiest knight that liv’d that day, and most of might.
Thus was Sir Satyranewith all his band xliii
By his sole manhood and atchieuement stout Dismayd, that none of them in field durst stand, But beaten were, and chased all about.
So he continued all that day throughout, Till euening, that the Sunne gan downward bend. Then rushed forth out of the thickest rout
A stranger knight, that did his glorie shend: So nought may be esteemed happie till the end.
He at his entrance charg’d his powrefull speare xliv At Artegall, in middest of his pryde, And therewith smote him on his Vmbriere So sore, that tombling backe, he downe did slyde Ouer his horses taile aboue a stryde; Whence litle lust he had to rise againe. Which Cambellseeing, much the same enuyde, And ran at him with all his might and maine; But shortly was likewise seene lying on the plaine.
Whereat full inly wroth was Triamondxlv
And cast t’auenge[83] the shame doen to his freend:
But by his friend himselfe eke soone he fond, In no lesse neede of helpe, then him he weend. All which when Blandamourfrom end to end Beheld, he woxe therewith displeased sore, And thought in mind it shortly to amend: His speare he feutred, and at him it bore;
But with no better fortune, then the rest afore.
Full many others at him likewise ran: xlvi But all of them likewise dismounted were, Ne certes wonder; for no powre of man Could bide the force of that enchaunted speare, The which this famous Britomartdid beare; With which she wondrous deeds of arms atchieued, And ouerthrew, what euer came her neare, That all those stranger knights full sore agrieued, And that late weaker band of chalengers relieued.
Like as in sommers day when raging heat xlvii Doth burne the earth, and boyled riuers drie, That all brute beasts forst to refraine fro meat, Doe hunt for shade, where shrowded they may lie, And missing it, faine from themselues to flie; All trauellers tormented are with paine: A watry cloud doth ouercast the skie, And poureth forth a sudden shoure of raine, That all the wretched world recomforteth againe.
So did the warlike Britomartrestore xlviii
The prize, to knights of Maydenhead that day, Which else was like to haue bene lost, and bore The prayse of prowesse from them all away. Then shrilling trompets loudly gan to bray, And bad them leaue their labours and long toyle, To ioyous feast and other gentle play, Where beauties prize shold win that pretious spoyle: Where I with sound of trompe will also rest a whyle.
It hath bene through all ages euer seene, i That with the praise of armes and cheualrie, The prize of beautie still hath ioyned beene; And that for reasons speciall priuitie: For either doth on other much relie.
For he me seemes most fit the faire to serue, That can her best defend from villenie; And she most fit his seruice doth deserue, That fairest is and from her faith will neuer swerue.
So fitly now here commeth next in place, ii
After the proofe of prowesse ended well, The controuerse of beauties soueraine grace; In which to her that doth the most excell, Shall fall the girdle of faire Florimell: That many wish to win for glorie vaine, And not for vertuous vse, which some doe tell
That glorious belt did in it selfe containe, Which Ladies ought to loue, and seeke for to obtaine.
That girdle gaue the vertue of chast loue, iii And wiuehood true, to all that did it beare; But whosoeuer contrarie doth proue, Might not the same about her middle weare, But it would loose, or else a sunder teare. Whilome it was (as Faeries wont report) Dame Venusgirdle, by her steemed deare, What time she vsd to liue in wiuely sort; But layd aside, when so she vsd her looser sport.
Her husband Vulcanwhylome for her sake, iv When first he loued her with heart entire, This pretious ornament they say did make, And wrought in Lemnowith vnquenched fire: And afterwards did for her loues first hire, Giue it to her, for euer to remaine, Therewith to bind lasciuious desire, And loose affections streightly to restraine; Which vertue it for euer after did retaine.
The same one day, when she her selfe disposd v To visite her beloued Paramoure, The God of warre, she from her middle loosd, And left behind her in her secret bowre,
On Acidalian[84] mount, where many an howre She with the pleasant Graceswont to play. There Florimellin her first ages flowre Was fostered by those Graces, (as they say) And brought with her from thence that goodly belt away.
That goodly belt was Cestus[85] hight by name, vi And as her life by her esteemed deare. No wonder then, if that to winne the same
So many Ladies sought, as shall appeare; For pearelesse she was thought, that did it beare. And now by this their feast all being ended, The iudges which thereto selected were, Into the Martian field adowne descended, To deeme this doutfull case, for which they all contended.
But first was question made, which of those Knights vii That lately turneyd, had the wager wonne: There was it iudged by those worthie wights, That Satyranethe first day best had donne: For he last ended, hauing first begonne. The second was to Triamondbehight, For that he sau’d the victour from fordonne: For Cambellvictour was in all mens sight, Till by mishap he in his foemens hand did light.
The third dayes prize vnto that[86] straunger Knight, viii Whom all men term’d Knight of the Hebene speare, To Britomartwas giuen by good right; For that with puissant stroke she downe did beare The SaluageKnight, that victour was whileare, And all the rest, which had the best afore, And to the last vnconquer’d did appeare; For last is deemed best. To her therefore The fayrest Ladie was adiudgd for Paramore.
But thereat greatly grudged Arthegall, ix And much repynd, that both of victors meede, And eke of honour she did him forestall. Yet mote he not withstand, what was decreede; But inly thought of that despightfull deede Fit time t’awaite auenged for to bee. This being ended thus, and all agreed, Then[87] next ensew’d the Paragon to see Of beauties praise, and yeeld the fayrest her due fee.
Then first Cambellobrought vnto their view x His faire Cambina, couered with a veale; Which being once withdrawne, most perfect hew And passing beautie did eftsoones reueale, That able was weake harts away to steale.
Next did Sir Triamondvnto their sight
The face of his deare Canaceevnheale; Whose beauties beame eftsoones did shine so bright, That daz’d the eyes of all, as with exceeding light.
And after her did Paridellproduce xi
His false Duessa, that she might be seene, Who with her forged beautie did seduce
The hearts of some, that fairest her did weene; As diuerse wits affected diuers beene.
Then did Sir Ferramontvnto them shew
His Lucidathat was full faire and sheene, And after these an hundred Ladies moe
Appear’d in place, the which each other did outgoe.
All which who so dare thinke for to enchace, xii
Him needeth sure a golden pen I weene,
To tell the feature of each goodly face.
For since the day that they created beene, So many heauenly faces were not seene
Assembled in one place: ne he that thought
For Chianfolke to pourtraict beauties Queene,
By view of all the fairest to him brought, So many faire did see, as here he might haue sought.
At last the most redoubted Britonesse, xiii
Her louely Amoretdid open shew; Whose face discouered, plainely did expresse
The heauenly pourtraict of bright Angels hew. Well weened all, which her that time did vew, That she should surely beare the bell away,
Till Blandamour, who thought he had the trew And very Florimell, did her display: The sight of whom once seene did all the rest dismay.
For all afore that seemed fayre and bright, xiv Now base and contemptible did appeare, Compar’d to her, that shone as Phebes light, Amongst the lesser starres in euening cleare. All that her saw with wonder rauisht weare, And weend no mortall creature she should bee, But some celestiall shape, that flesh did beare: Yet all were glad there Florimellto see; Yet thought that Florimellwas not so faire as shee.
As guilefull Goldsmith that by secret skill, xv With golden foyle doth finely ouer spred Some baser metall, which commend he will Vnto the vulgar for good gold insted, He much more goodly glosse thereon doth shed, To hide his falshood, then if it were trew: So hard, this Idole was to be ared, That Florimellher selfe in all mens vew She seem’d to passe: so forged things do fairest shew.
Then was that[88] golden belt by doome of all xvi Graunted to her, as to the fayrest Dame. Which being brought, about her middle small They thought to gird, as best it her became; But by no meanes they could it thereto frame. For euer as they fastned it, it loos’d And fell away, as feeling secret blame. Full oft about her wast she it enclos’d; And it as oft was from about her wast disclos’d.
That all men wondred at the vncouth sight, xvii And each one thought, as to their fancies came.
But she her selfe did thinke it doen for spight, And touched was with secret wrath and shame Therewith, as thing deuiz’d her to defame. Then many other Ladies likewise tride, About their tender loynes to knit the same; But it would not on none of them abide, But when they thought it fast, eftsoones it was vntide.
Which when that scornefull SquireofDamesdid vew, xviii
He lowdly gan to laugh, and thus to iest; Alas for pittie that so faire a crew, As like can not be seene from East to West, Cannot find one this girdle to inuest. Fie on the man, that did it first inuent, To shame vs all with this, Vngirtvnblest. Let neuer Ladie to his loue assent, That hath this day so many so vnmanly shent.
Thereat all Knights gan laugh, and Ladies lowre: xix
Till that at last the gentle Amoret
Likewise assayd, to proue that girdles powre; And hauing it about her middle set, Did find it fit, withouten breach or let.
Whereat the rest gan greatly to enuie: But Florimellexceedingly did fret, And snatching from her hand halfe angrily The belt againe, about her bodie gan it tie.
Yet nathemore would it her bodie fit; xx Yet nathelesse to her, as her dew right, It yeelded was by them, that iudged it: And she her selfe adiudged to the Knight, That bore the Hebene speare, as wonne in fight. But Britomartwould not thereto assent, Ne her owne Amoretforgoe so light
For that strange Dame, whose beauties wonderment
She lesse esteem’d, then th’others vertuous gouernment.
Whom when the rest did see her to refuse, xxi
They were full glad, in hope themselues to get her: Yet at her choice they all did greatly muse. But after that the Iudges did arret her Vnto the second best, that lou’d her better; That was the SaluageKnight: but he was gone In great displeasure, that he could not get her. Then was she iudged Triamondhis one; But Triamondlou’d Canacee, and other none.
Tho vnto Satyranshe was adiudged, xxii
Who was right glad to gaine so goodly meed: But Blandamourthereat full greatly grudged, And litle prays’d his labours euill speed, That for to winne the saddle, lost the steed. Ne lesse thereat did Paridellcomplaine, And thought t’appeale from that, which was decreed, To single combat with Sir Satyrane.
Thereto him Atestird, new discord to maintaine.
And eke with these, full many other Knights xxiii She through her wicked working did incense, Her to demaund, and chalenge as their rights, Deserued for their perils recompense. Amongst the rest with boastfull vaine pretense Stept Braggadochioforth, and as his thrall
Her claym’d, by him in battell wonne long sens[89]: Whereto her selfe he did to witnesse call; Who being askt, accordingly confessed all.
Thereat exceeding wroth was Satyran; xxiv And wroth with Satyranwas Blandamour; And wroth with Blandamourwas Eriuan; And at them both Sir Paridelldid loure.
So all together stird vp strifull[90] stoure, And readie were new battell to darraine. Each one profest to be her paramoure, And vow’d with speare and shield it to maintaine; Ne Iudges powre, ne reasons rule mote them restrains.
Which troublous stirre when Satyraneauiz’d, xxv
He gan to cast how to appease the same, And to accord them all, this meanes deuiz’d: First in the midst to set that fayrest Dame,
To whom each one[91] his chalenge should disclame, And he himselfe his right would eke releasse: Then looke to whom she voluntarie came, He should without disturbance her possesse: Sweete is the loue that comes alone with willingnesse.
They all agreed, and then that snowy Mayd xxvi
Was in the middest plast[92] among them all; All on her gazing wisht, and vowd, and prayd, And to the Queene of beautie close did call, That she vnto their portion might befall. Then when she long had lookt vpon each one, As though she wished to haue pleasd them all, At last to Braggadochioselfe alone She came of her accord, in spight of all his fone.
Which when they all beheld they chaft[93] and rag’d, xxvii
And woxe nigh mad for very harts despight, That from reuenge their willes they scarse asswag’d: Some thought from him her to haue reft by might; Some proffer made with him for her to fight. But he nought car’d for all that they could say: For he their words as wind esteemed light. Yet not fit place he thought it there to stay, But secretly from thence that night her bore away.
They which remaynd, so soone as they perceiu’d, xxviii
That she was gone, departed thence with speed, And follow’d them, in mind her to haue reau’d From wight vnworthie of so noble meed.
In which poursuit[94] how each one did succeede, Shall else be told in order, as it fell.
But now of Britomartit here doth neede, The hard aduentures and strange haps to tell; Since with the rest she went not after Florimell.
For soone as she them saw to discord set, xxix
Her list no longer in that place abide; But taking with her louely Amoret, Vpon her first aduenture forth did ride, To seeke her lou’d, making blind loue her guide.
Vnluckie Mayd to seeke her enemie, Vnluckie Mayd to seeke him farre and wide, Whom, when he was vnto her selfe most nie, She through his late disguizement could him not descrie.
So much the more her griefe, the more her toyle: xxx
Yet neither toyle nor griefe she once did spare, In seeking him, that should her paine assoyle; Whereto great comfort in her sad misfare
Was Amoret, companion of her care: Who likewise sought her louer long miswent, The gentle Scudamour, whose hart whileare
That stryfull[95] hag with gealous discontent Had fild, that he to fell reueng was fully bent.
Bent to reuenge on blamelesse Britomartxxxi
The crime, which cursed Atekindled earst,
The which like thornes did pricke his[96] gealous hart, And through his soule like poysned arrow perst, That by no reason it might be reuerst,
