Innovation and Tribulation in the History of Randomized Controlled Trials in Surgery.

Despite persistent critiques of the rigor of surgical research, surgeons have actually pursued careful empirical studies for centuries. Their work has enriched not only surgical science but also the development of evidencebased medicine. From conducting landmark controlled trials, to using statistics, alternate patient allocation, randomization, and sham controls, surgeons have long embraced innovative trial approaches and played important roles in the development of key methods of RCTs. However, historical contexts unique to surgery have shaped the implementation of RCTs in this field. Unlike the history of pharmaceuticals, in which substantial research funding has been devoted to testing new drugs before their approval, surgical trials have followed a different trajectory. New operations have repeatedly come into wide use in the absence of RCTs. On many occasions, when established procedures have become controversial, surgeons have then marshaled the resources to conduct RCTs reassessing the operations. Such trials have triggered powerful debates in which proponents of surgical RCTs battled against ingrained practices and preferences. In such cases, RCTs often were not decisive factors in determining the fate of surgical practices but supporting tools that followed and reflected changes in surgical judgment already underway. Surgical trialists also have encountered specific, recurring challenges, especially with the methodological and ethical complexity of blinded and sham-controlled trials. The history of surgical trials thus reveals major contributions from surgeons to the advancement of evidence-based medicine, as well as ongoing challenges. Strengthened and systematic trial support could advance the future of surgical RCTs.

Evidence-Based Medicine in Plastic Surgery: From Then to Now.

SUMMARY: Evidence-based medicine, as described by Dr. Sackett, is defined as the "conscientious, explicit, and judicious use of current best evidence, combined with individual clinical expertise and patient preferences and values, in making decisions about the care of individual patients." In the late 2000s, seminal articles in Clinics in Plastic Surgery and Plastic and Reconstructive Surgery introduced evidence-based medicine's role in plastic surgery and redefined varying levels of evidence. The American Society of Plastic Surgeons sponsored the Colorado Springs Evidence-Based Medicine Summit that set forth a consensus statement and action plan regarding the increased incorporation of evidence-based medicine into the field; this key meeting ushered a new era among plastic surgeons worldwide. Over the past decade, Plastic and Reconstructive Surgery has incorporated evidence-based medicine into the Journal through an increase in articles with level I and II evidence, new sections of the Journal, and the introduction of validated tools to help authors perform prospective and randomized studies that ultimately led to best practices used today. Plastic surgery is a specialty built on problem-solving and innovation, values starkly in-line with evidence-based medicine. Evidence-based medicine is becoming more ingrained in our everyday practice and plastic surgery culture; however, we must work actively to ensure that we continue this trend. In the next decade, we will possibly see that level I and II evidence articles start to inhabit many of our journal issues.

Clinical Epidemiology in China series. Paper 1: Evidence-based medicine in China: An oral history study.

OBJECTIVE: To describe and record the evolution of EBM in China. STUDY DESIGN AND SETTING: We conducted the study following the general methodology of oral history. The interviews were done at Lanzhou University, between 18th and 22nd April 2019 using pre-defined questions. All interviews were videorecorded. Two investigators extracted and analyzed the information from the interviews independently. RESULTS: One international expert and ten Chinese experts participated in the interviews. After the introduction of EBM in China in the mid-1990s, more than 20 EBM centres have been established. According to the interviewees, Gordon Guyatt, David Sackett and Iain Chalmers are the international experts who played the most important role in the development of EBM in China. China has contributed to EBM on the international level by conducting systematic reviews, developing reporting checklists, and introducing the principles of EBM into Traditional Medicine. The Chinese Cochrane Centre and the EBM Centre of Lanzhou University were ranked the top two EBM Centres in China by the interviewees. CONCLUSION: EBM has been developing in China for nearly a quarter of a century. Many achievements have been reached, however, EBM is still facing many challenges in China, including shortages of funding support and personnel, as well as limited local high-quality evidence.

Evidence-Based Decision-Making 1: Critical Appraisal.

This chapter provides an introduction to the concept of Evidence-based Medicine (EBM) including its history, rooted in Canada and its important role in modern medicine. The chapter introduces EBM and explains the process of conducting EBM . The chapter starts with a description of the traditional hierarchy of evidence that exists in research with reference to the critical appraisal tools often used to assess the quality or credibility of individual studies. It includes a section on assessing risk of bias in randomized clinical trials and non-randomized studies and guidelines for reporting study findings now fully captured in the EQUATOR Network. In addition, a section on GRADE (Grades of Recommendation Assessment, Development and Evaluation) and the process used to determine the quality of evidence when guiding clinical decisions or developing clinical practice guidelines is included. In response to the substantial number of research syntheses being published, AMSTAR2, a tool used to critically appraise the quality and reporting of systematic reviews is described. The main focus of the chapter remains on how to critically appraise the medical literature, as one step in the EBM process. However, this process also includes an assessment of study bias and an understanding of reporting guidelines. At its basic level, critical appraisal requires an understanding of the strengths and weaknesses of study design and how these in turn impact the validity and applicability of research findings. Strong critical appraisal skills are critical to evidence-based decision-making .

Evidence-based medicine: a brief historical analysis of conceptual landmarks and practical goals for care. / Medicina baseada em evidências: breve aporte histórico sobre marcos conceituais e objetivos práticos do cuidado.

Evidence-based medicine (EBM) is intended to improve the efficiency and quality of health services provided to the population and reduce the operational costs of prevention, treatment, and rehabilitation; the objective of EBM is to identify relevant issues and promote the social applicability of conclusions. This article underscores the importance of EBM in modern clinical teaching and social practices from the contributions of Archibald Cochrane and David Sackett to the development and dissemination of this paradigm in care and education during the twentieth century. EBM has helped broaden discussions on the relationships between teaching and medical practice, and has taken on an important role in curriculum reforms and training models and practices in health care.

A medicina baseada em evidências (MBE) pretende aumentar a eficiência e qualidade dos serviços de saúde prestados à população e diminuir os custos operacionais dos processos de prevenção, tratamento e reabilitação. Busca identificar problemas relevantes do paciente e promover a aplicabilidade social das conclusões. O artigo ressalta a importância da MBE para o ensino e para as práticas clínicas sociais da atualidade a partir da contribuição de Archibald Cochrane e David Sackett no desenvolvimento e na difusão desse paradigma assistencial e pedagógico durante o século XX. A MBE tem contribuído para ampliar a discussão sobre as relações entre ensino e prática da medicina, assumindo papel de destaque em reformas curriculares e modelos de formação no cuidado e práticas em saúde.

Medicina baseada em evidências: breve aporte histórico sobre marcos conceituais e objetivos práticos do cuidado / Evidence-based medicine: a brief historical analysis of conceptual landmarks and practical goals for care

Resumo A medicina baseada em evidências (MBE) pretende aumentar a eficiência e qualidade dos serviços de saúde prestados à população e diminuir os custos operacionais dos processos de prevenção, tratamento e reabilitação. Busca identificar problemas relevantes do paciente e promover a aplicabilidade social das conclusões. O artigo ressalta a importância da MBE para o ensino e para as práticas clínicas sociais da atualidade a partir da contribuição de Archibald Cochrane e David Sackett no desenvolvimento e na difusão desse paradigma assistencial e pedagógico durante o século XX. A MBE tem contribuído para ampliar a discussão sobre as relações entre ensino e prática da medicina, assumindo papel de destaque em reformas curriculares e modelos de formação no cuidado e práticas em saúde.

Abstract Evidence-based medicine (EBM) is intended to improve the efficiency and quality of health services provided to the population and reduce the operational costs of prevention, treatment, and rehabilitation; the objective of EBM is to identify relevant issues and promote the social applicability of conclusions. This article underscores the importance of EBM in modern clinical teaching and social practices from the contributions of Archibald Cochrane and David Sackett to the development and dissemination of this paradigm in care and education during the twentieth century. EBM has helped broaden discussions on the relationships between teaching and medical practice, and has taken on an important role in curriculum reforms and training models and practices in health care.

Machine Learning: The Next Paradigm Shift in Medical Education.

Machine learning (ML) algorithms are powerful prediction tools with immense potential in the clinical setting. There are a number of existing clinical tools that use ML, and many more are in development. Physicians are important stakeholders in the health care system, but most are not equipped to make informed decisions regarding deployment and application of ML technologies in patient care. It is of paramount importance that ML concepts are integrated into medical curricula to position physicians to become informed consumers of the emerging tools employing ML. This paradigm shift is similar to the evidence-based medicine (EBM) movement of the 1990s. At that time, EBM was a novel concept; now, EBM is considered an essential component of medical curricula and critical to the provision of high-quality patient care. ML has the potential to have a similar, if not greater, impact on the practice of medicine. As this technology continues its inexorable march forward, educators must continue to evaluate medical curricula to ensure that physicians are trained to be informed stakeholders in the health care of tomorrow.

Visualizing the evolution of evidence: Cumulative network meta-analyses of new generation antidepressants in the last 40 years.

It is often challenging to present the available evidence in a timely and comprehensible manner. We aimed to visualize the evolution of evidence about antidepressants for depression by conducting cumulative network meta-analyses (NMAs) and to examine whether it could have helped the selection of optimal drugs. We built a Shiny web application that performs and presents cumulative NMAs based on R netmeta. We used a comprehensive dataset of double-blind randomized controlled trials of 21 antidepressants in the acute treatment of major depression. The primary outcomes were efficacy (treatment response) and acceptability (all-cause discontinuation), and treatment effects were summarized via odds ratios. We evaluated the confidence in evidence using the CINeMA (Confidence in Network Meta-Analysis) framework for a series of consecutive NMAs. Users can change several conditions for the analysis, such as the period of synthesis, among the others. We present the league tables and two-dimensional plots that combine efficacy, acceptability and level of confidence in the evidence together, for NMAs conducted in 1990, 1995, 2000, 2005, 2010, and 2016. They reveal that through the past four decades, newly approved drugs often showed initially exaggerated results, which tended to diminish and stabilize after approximately a decade. Over the years, the drugs with relative superiority changed dramatically; but as the evidence network grew larger and better connected, the overall confidence improved. The Shiny app visualizes how evidence evolved over years, emphasizing the need for a careful interpretation of relative effects between drugs, especially for the potentially amplified performance of newly approved drugs. HIGHLIGHTS: Network meta-analysis is considered to be a proper way of demonstrating the available evidence, since it allows comparisons between multiple interventions, and has been proved to be statistically powerful. It is challenging to present the voluminous results of NMA in an efficient and comprehendible manner. Evidence evolution based on the relatively new method NMA has not been investigated yet. The results of NMA should not only include the effects but also the confidence in the evidence, which can help interpret the findings appropriately. Effective use of rapidly developing statistical analysis and presentation tools such as Shiny package in R, may facilitate and simplify the visualization of NMA output. We should stay conservative towards new drugs, as their performance was often shown to be exaggerated initially, and it took time to become stable.

Exploring Current Evidence on the Past, the Present, and the Future of the Heart Team: A Narrative Review.

INTRODUCTION: Including healthcare professionals dealing with cardiovascular diseases, Heart Team is a concept/structure designed for selecting diagnostic strategies, facilitating therapeutic decisions, and improving cardiovascular outcomes in patients with complex heart pathologies, requiring input from different subspecialties and the necessity of a multidisciplinary approach. The aim of this narrative review is to search for and to summarize current evidence regarding Heart Team and to underline the future directions for the development of this concept. METHODS: We searched the electronic database of PubMed, SCOPUS, and Cochrane CENTRAL for studies including Heart Team. Forty-eight studies were included, if reference was made to Heart Team structure and functionality. RESULTS: We depicted the structure and the timeline of Heart Team, along with actual evidence-based recommendations from European Guidelines. We underlined the importance of quality of knowledge-sharing and decision-making inside the Team, analyzing bad decisions which did not reflect members' true beliefs due to "uniformity pressure, closed mindedness, and illusion of invulnerability." The observation that Guidelines' indications regarding Heart Team carry a level C indication underlines the very future of this Team: randomized controlled trials proving solid benefits in an evidence-based world. CONCLUSIONS: Envisioned as a tool for optimizing the management of various complex cardiovascular pathologies, Heart Team should simplify and facilitate the activity in the cardiovascular ward. Finally, these facts should be translated into better cardiovascular outcomes and a lower psychological distress among Team participants. Despite all future changes, there must always be a constant part: the patient should remain at the very center of the Team.

Evidence-Based Medicine in the Domain of Nuclear Medicine, the Fifty-Year View.

The discipline of evidence-based medicine (EBM), though yet unnamed, was in its infancy when Seminars in Nuclear Medicine was inaugurated in 1971; commemorating the golden anniversary of this prestigious journal and the contemporaneous reign of its editors by publishing a 50-year historical consideration of EBM seems most apropos. EBM should be understood as a system of methods to eliminate partiality and improve the quality of evidence in the performance and review of data; much of EBM revolves around ensuring that conclusions are derived from rigorous research studies that protect against bias and are widely generalizable to other groups of patients. Subdomains within EBM that we will survey in this review include methods of performing and evaluating primary studies, standards of reporting of medical studies, methods of combining and aggregating data, and finally, methods of creating clinical practice guidelines. While many practitioners of nuclear medicine may not presently be familiar with the innovations of EBM, having been introduced after their formal education was completed, with the eventual arrival of more-recently trained staff, firm recommendations from our primary research journals, and with efforts to educate practicing physicians, this shortcoming is being addressed.