Education, Ethics, and History: The Peer Review Process in the US.

Despite the near-universal acceptance of the benefits of a sound peer review process (PRP), the topic of peer review remains a source of controversy among surgeons. The current PRP is plagued by heterogeneity across different hospital and institutional systems. These inconsistencies, combined with a perceived lack of fairness inherent to the PRP in some institutions, led to concerns among practicing surgeons. In this review of the relevant literature on the PRP, we attempted to provide some context and insight into the history of the PRP, its role, its shortcomings, its potential abuses, and some key requirements for its successful execution.

The methodological quality of 176,620 randomized controlled trials published between 1966 and 2018 reveals a positive trend but also an urgent need for improvement.

Many randomized controlled trials (RCTs) are biased and difficult to reproduce due to methodological flaws and poor reporting. There is increasing attention for responsible research practices and implementation of reporting guidelines, but whether these efforts have improved the methodological quality of RCTs (e.g., lower risk of bias) is unknown. We, therefore, mapped risk-of-bias trends over time in RCT publications in relation to journal and author characteristics. Meta-information of 176,620 RCTs published between 1966 and 2018 was extracted. The risk-of-bias probability (random sequence generation, allocation concealment, blinding of patients/personnel, and blinding of outcome assessment) was assessed using a risk-of-bias machine learning tool. This tool was simultaneously validated using 63,327 human risk-of-bias assessments obtained from 17,394 RCTs evaluated in the Cochrane Database of Systematic Reviews (CDSR). Moreover, RCT registration and CONSORT Statement reporting were assessed using automated searches. Publication characteristics included the number of authors, journal impact factor (JIF), and medical discipline. The annual number of published RCTs substantially increased over 4 decades, accompanied by increases in authors (5.2 to 7.8) and institutions (2.9 to 4.8). The risk of bias remained present in most RCTs but decreased over time for allocation concealment (63% to 51%), random sequence generation (57% to 36%), and blinding of outcome assessment (58% to 52%). Trial registration (37% to 47%) and the use of the CONSORT Statement (1% to 20%) also rapidly increased. In journals with a higher impact factor (>10), the risk of bias was consistently lower with higher levels of RCT registration and the use of the CONSORT Statement. Automated risk-of-bias predictions had accuracies above 70% for allocation concealment (70.7%), random sequence generation (72.1%), and blinding of patients/personnel (79.8%), but not for blinding of outcome assessment (62.7%). In conclusion, the likelihood of bias in RCTs has generally decreased over the last decades. This optimistic trend may be driven by increased knowledge augmented by mandatory trial registration and more stringent reporting guidelines and journal requirements. Nevertheless, relatively high probabilities of bias remain, particularly in journals with lower impact factors. This emphasizes that further improvement of RCT registration, conduct, and reporting is still urgently needed.

Quality improvement in pediatric urology-a historical perspective on street pumps, puerperal fever, surgical infection, and contemporary methodology.

Quality improvement and patient safety (QIPS) can trace its origin back to the court of Hammurabi (circa 1700BC). However, it did not begin its evolution into its present methodology until the mid-19th century. It was through the application of quantitative parameters around the time of World War I that the field of QIPS has matured and gained a significant presence in the practice of medicine. Herein, the authors present a historical overview of this increasingly important field and correlate the current pediatric urology literature that has arisen from it. Because QIPS research is likely to contribute to efficient, streamlined health care through rapid changes to routine clinical practices, it would behoove pediatric urologists to familiarize themselves with its history and fundamental concepts.

30 years of data: impact of the United States in vitro fertilization data registry on advancing fertility care.

OBJECTIVE: To summarize and assess the impact of key research generated through the Society of Assisted Reproductive Technology (SART)-initiated United States IVF registry and annual reporting system. DESIGN: Review. SETTING: Eligible studies included those that analyzed data generated by the National IVF data collection program (through SART or Centers for Disease Control and Prevention). PATIENT(S): Not applicable. INTERVENTION(S): Not applicable. MAIN OUTCOME MEASURE(S): Summarize and report outcomes of research using National IVF registry data. RESULT(S): The Society of Assisted Reproductive Technology was founded in 1985 and published the first annual US IVF data report 30 years ago in 1988 in Fertility and Sterility. In 1995, the Centers for Disease Control and Prevention subsequently began collecting data from IVF programs and published their first report in 1997. This annual National IVF data collection and reporting is a significant responsibility and effort for IVF programs. Using these data sources, 199 articles have been published by clinicians and researchers from across the country. This research has guided the development of evidence-based assisted reproductive technology (ART) practice guidelines during the past 30 years, which have ultimately led to improved quality and patient care. CONCLUSION(S): Since the first SART National IVF data report publication 30 years ago, SART has achieved its original goals of creating a national IVF registry that successfully assesses clinical effectiveness, quality of care, and safety.

A Look Through Time: Historical Analysis of Obstetrics and Gynecology Texts Highlights Changes in Medicine.

OBJECTIVE: Our objective was to analyze systematically the preface and foreword of each edition of Williams Obstetrics and Te Linde's Operative Gynecology to gain insight into historical changes in medicine. METHODS: The preface and foreword from 24 editions of Williams Obstetrics and 11 editions of Te Linde's Operative Gynecology were obtained. Documents were assessed for the inclusion of predefined key words or topics, including sex-specific pronoun usage, insurance, fertility regulation, government regulation/laws, documentation burden, malpractice, race, medicine as "art" or medicine as "science," and others. Data were extracted and analyzed using Microsoft Excel. RESULTS: Changing pronoun usage was evident across both texts. From 1941 through 1950, physicians were referred to as male 19 times and as female once. The ratio of male-to-female pronoun usage equalized in the 1990s. Medicine increasingly was referred to as a science rather than as an art within the last 2 decades. From the 1970s onward, emerging physician concerns, including malpractice, documentation burden, regulation, and insurance, were mentioned increasingly. The first mention of governmental regulation and evidence-based medicine occurred in the 21st century. Since 1903, race was never mentioned and "change" and "improvement" were cited almost universally. CONCLUSIONS: The increase in female pronoun usage reflects the expanding role of women in medicine. Another trend noted relates to increasing external influence on and regulation of our profession. Previously less important concerns such as documentation burden have emerged in the last 2 decades.

Fifteen-Year Journey to High Reliability in Pathology and Laboratory Medicine.

Many high-reliability organizations in industries outside of health care have sustained high levels of excellence and prevention of harm while managing complex systems and risk. To date, no health care organizations has organized its efforts to achieve highly reliable results despite several decades of improvement science. Laboratorians were early adopters of quality initiatives and process improvements. In the late 1990s, the Division of Pathology and Laboratory Medicine at The University of Texas MD Anderson Cancer Center embarked on a major effort to improve quality and patient safety and to reduce waste. This article describes the institution's journey toward approaching high reliability with the intent to share not only the tools and best practices, but also the ongoing reassessment of the problems detected on the journey. The authors hope that their experience will help the reader develop interventions to adapt in their own environment to facilitate more optimal patient care.

The key incident monitoring and management system - history and role in quality improvement.

BACKGROUND: The determination of reliable, practical Quality Indicators (QIs) from presentation of the patient with a pathology request form through to the clinician receiving the report (the Total Testing Process or TTP) is a key step in identifying areas where improvement is necessary in laboratories. METHODS: The Australasian QIs programme Key Incident Monitoring and Management System (KIMMS) began in 2008. It records incidents (process defects) and episodes (occasions at which incidents may occur) to calculate incident rates. KIMMS also uses the Failure Mode Effects Analysis (FMEA) to assign quantified risk to each incident type. The system defines risk as incident frequency multiplied by both a harm rating (on a 1-10 scale) and detection difficulty score (also a 1-10 scale). RESULTS: Between 2008 and 2016, laboratories participating rose from 22 to 69. Episodes rose from 13.2 to 43.4 million; incidents rose from 114,082 to 756,432. We attribute the rise in incident rate from 0.86% to 1.75% to increased monitoring. Haemolysis shows the highest incidence (22.6% of total incidents) and the highest risk (26.68% of total risk). "Sample is suspected to be from the wrong patient" has the second lowest frequency, but receives the highest harm rating (10/10) and detection difficulty score (10/10), so it is calculated to be the 8th highest risk (2.92%). Similarly, retracted (incorrect) reports QI has the 10th highest frequency (3.9%) but the harm/difficulty calculation confers the second highest risk (11.17%). CONCLUSIONS: TTP incident rates are generally low (less than 2% of observed episodes), however, incident risks, their frequencies multiplied by both ratings of harm and discovery difficulty scores, concentrate improvement attention and resources on the monitored incident types most important to manage.

"Don't Mind the Gap!" Reflections on Improvement Science as a Paradigm.

Responding to this issue's invitation to bring new disciplinary insights to the field of improvement science, this article takes as its starting point one of the field's guiding metaphors: the imperative to "mind the gap". Drawing on insights from anthropology, history, and philosophy, the article reflects on the origins and implications of this metaphoric imperative, and suggests some ways in which it might be in tension with the means and ends of improvement. If the industrial origins of improvement science in the twentieth century inform a metaphor of gaps, chasms, and spaces of misalignment as invariably imperfect and potentially dangerous, and therefore requiring bridging or closure, other currents that feed the discipline of improvement science suggest the potential value and uses of spaces of openness and ambiguity. These currents include the science of complex adaptive systems, and certain precepts of philosophical pragmatism acknowledged to inform improvement science. Going a step further, I reflect on whether or not these two contrasting approaches within improvement science should be treated as incommensurable paradigms, and what each approach tells us about the very possibility of accommodating seemingly irreconcilable or incommensurable approaches within improvement science.

Electronic multidimensional health assessment questionnaire (eMDHAQ): past, present and future of a proposed single data management system for clinical care, research, quality improvement, and monitoring of long-term outcomes.

An MDHAQ/RAPID3 (multidimensional health assessment questionnaire/routine assessment of patient index data) was developed from the HAQ over 25 years, based on observations made from completion by every patient (with all diagnoses) at every routine rheumatology visit since 1980. Modification of the HAQ was viewed as similar to improving a laboratory test, with a primary focus on clinical value for diagnosis, prognosis, and/or management, as well as feasibility for minimal effect on clinical workflow. Rigorous attention, was also directed to validity, reliability, other methodologic and technological considerations, but after clinical value and feasibility were established. A longer "intake" MDHAQ was introduced for new patients to record a complete past medical history - illnesses, hospitalisations, surgeries, allergies, family history, social history and medications. MDHAQ scales not found on the HAQ record complex activities, sleep quality, anxiety, depression, self-report joint count, fatigue, symptom checklist, morning stiffness, exercise status, recent medical history, social history and demographic data within 2 pages on one sheet of paper. An electronic eMDHAQ/RAPID3 provides a similar platform to pool data from multiple sites. A patient may be offered a patient-administered, password-protected, secure, web site, to store the medical history completed on the eMDHAQ. This eMDHAQ would allow a patient to complete a single general medical history questionnaire rather than different intake questionnaires in different medical settings. The eMDHAQ would be available for updates and correction by the patient for future visits, regardless of electronic medical record (EMR). The eMDHAQ is designed to interface with an EMR using HL7 (health level seven) and SMART (Substitutable Medical Apps, Reusable Technology) on FHIR (Fast Healthcare Interoperability Resources), although implementation requires collaboration with the EMR vendor. Advanced features include reports for the physician formatted as a medical record note of past medical history for entry into any EMR without typing or dictation, and a periodic "tickler" function to monitor long-term outcomes with minimal effort of the physician and staff. Nonetheless, clinical use of an eMDHAQ should be guided primarily not by the latest technology, but by value and feasibility in clinical care, the same principles that guided development of the pencil-and-paper MDHAQ/RAPID3.

Excellence in Ophthalmology: Continuous Certification.

Over the course of a century, American medical specialty boards including the American Board of Ophthalmology (ABO) have developed significant expertise in assessing physician competence on completion of postgraduate training and, more recently, in defining appropriate criteria for continuous learning and quality improvement in practicing physicians. This article explores why maintaining career-long excellence is an evolving challenge, but one that is at the heart of the ABO's mission to protect the public by improving patient care.

Measurement, Certification, and Quality: Meeting Enduring Challenges with Modern Tools.

The author, a former chair of the ABIM, describes the challenges that the board certification enterprise is experiencing as medicine shifts from being a paper-based to a digital industry. While there are clearly threats to board certification, he argues that boards can remain highly relevant if they focus on areas in which they can make unique contributions, such as the measurement of cognitive skills, diagnostic accuracy, "keeping up," and procedural skills.

Improving care delivery at the community level: an examination of the AF4Q legacy.

OBJECTIVE: Aligning Forces for Quality (AF4Q) was the Robert Wood Johnson Foundation's nearly 10-year, multicomponent initiative to create meaningful and sustainable change in 16 communities. Our purpose was to describe the likely legacy of the care delivery component of AF4Q among participating communities and the factors that influenced the legacy. METHODS: We used a multiple-case study approach. Our analysis relied on 3 key documents for each community, based on key informant interviews conducted between 2006 and 2015: (1) a summary of the community's care delivery activities under AF4Q, (2) a summary of the community's experience in the AF4Q program, and (3) a summary of the characteristics of each community and the multi-stakeholder alliance that led local efforts under AF4Q. We used a team-based consensual approach to analysis. RESULTS: We identified 3 types of legacies: (1) in 3 communities, there appear to be sustained infrastructures or wide-reaching activities attributable to AF4Q; (2) in 5 communities, AF4Q participation was used to advance preexisting activities; and (3) in 8 communities, the care delivery legacy is likely to be limited, because the local alliance focused on performance measurement instead of care delivery or the care delivery activities had limited reach and sustainability. Community contextual factors (eg, availability of other grant support) and alliance characteristics (eg, areas of expertise) greatly influenced the AF4Q care delivery legacy. CONCLUSION: AF4Q appears to have created meaningful and sustained change in care delivery in half of the participating communities. Among the other communities, the considerable financial support and technical assistance provided by RWJF was not enough to overcome some of the contextual barriers that often hamper quality-improvement efforts.

Quality improvement 101 for surgeons: Navigating the alphabet soup.

It is a fundamental value of the surgical profession to improve care for its patients. In the last 100 years, the principles of prospective quality improvement have started to work their way into the traditional method of retrospective case review in morbidity and mortality conference. This article summarizes the history of "improvement science" and its intersection with the field of surgery. It attempts to clarify the principles and jargon that may be new or confusing to surgeons with a different vocabulary and experience. This is done to bring the significant power and resources of improvement science to the traditional efforts to improve surgical care.