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.

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.

Archibald Cochrane: evidencia, efectividad y toma de decisiones en salud / Archibald Cochrane: evidence, effectiveness and decision-making in health

Resumen: Actualmente, la Medicina Basada en Evidencia tiene un papel fundamental en la toma de decisiones médicas, ya que intenta, a través de los métodos de la ciencia, justificar las diferentes alternativas que se le pueden ofrecer a un paciente. Para entender la evolución histórica de esta forma de practicar la medicina, es necesario revisar la contribución de uno de los principales participantes en este movimiento cultural: Archibald Leman Cochrane, quien ayudó a definir el marco teórico que ha permitido incorporar la ciencia a la práctica de la medicina. Su papel, al insistir en la necesidad de integrar la evidencia científica y conjuntarla con la experiencia clínica, constituyó un elemento fundamental y decisivo en el desarrollo de una nueva disciplina, la Medicina Basada en Evidencia.

Abstract: Nowadays, Evidence-Based Medicine plays a fundamental role while making medical decisions, considering that through the methods of science, it attempts to justify the variety of alternatives that may be offered to patients. In order to understand the historical evolution of this way of practicing medicine, it is necessary to review the contribution of one of the main participants in this cultural movement: Archibald Leman Cochrane, who helped to define the theoretical framework that has allowed the integration of science into the practice of medicine. Since he insisted in the need of integrating scientific evidence into clinical experience, his role became a fundamental and decisive element in the development of a new discipline: Evidence-Based Medicine.

Evidence-based pathology in its second decade: toward probabilistic cognitive computing.

Evidence-based pathology advocates using a combination of best available data ("evidence") from the literature and personal experience for the diagnosis, estimation of prognosis, and assessment of other variables that impact individual patient care. Evidence-based pathology relies on systematic reviews of the literature, evaluation of the quality of evidence as categorized by evidence levels and statistical tools such as meta-analyses, estimates of probabilities and odds, and others. However, it is well known that previously "statistically significant" information usually does not accurately forecast the future for individual patients. There is great interest in "cognitive computing" in which "data mining" is combined with "predictive analytics" designed to forecast future events and estimate the strength of those predictions. This study demonstrates the use of IBM Watson Analytics software to evaluate and predict the prognosis of 101 patients with typical and atypical pulmonary carcinoid tumors in which Ki-67 indices have been determined. The results obtained with this system are compared with those previously reported using "routine" statistical software and the help of a professional statistician. IBM Watson Analytics interactively provides statistical results that are comparable to those obtained with routine statistical tools but much more rapidly, with considerably less effort and with interactive graphics that are intuitively easy to apply. It also enables analysis of natural language variables and yields detailed survival predictions for patient subgroups selected by the user. Potential applications of this tool and basic concepts of cognitive computing are discussed.

Compreendendo a Revisão Guarda-Chuva na Pesquisa Cardiovascular / Understanding Umbrella Review of the Cardiovascular Research

A revisão guarda-chuva é uma síntese de revisões sistemáticas que permite que os resultados de avaliações pertinentes a uma pergunta de revisão possam ser comparados e contrastados. Na revisão guarda-chuva esse tipo de provas de síntese considera apenas a inclusão do maior nível de evidência, ou seja, revisões sistemáticas e meta-análise. O objetivo deste artigo é descrever a metodologia e os métodos desenvolvidos para a condução de uma revisão guarda-chuva na pesquisa cardiovascular.

Evidence-Based Plastic Surgery: Its Rise, Importance, and a Practical Guide.

There is a perfect storm developing in 21st century healthcare; rising complexity and patient expectations in the context of fiscal restraint. Evidence-based medicine (EBM) may be the best-kept secret in dealing with the "storm." Such an approach prefers management pathways that deliver better outcomes at less relative cost. In this article, the rise of EBM, its significance, a guide to practicing it, and its future in the field of plastic, reconstructive, and aesthetic surgery are presented.

"Entrenched practices and other biases": unpacking the historical, economic, professional, and social resistance to de-implementation.

BACKGROUND: In their article on "Evidence-based de-implementation for contradicted, unproven, and aspiring healthcare practices," Prasad and Ioannidis (IS 9:1, 2014) referred to extra-scientific "entrenched practices and other biases" that hinder evidence-based de-implementation. DISCUSSION: Using the case example of the de-implementation of radical mastectomy, we disaggregated "entrenched practices and other biases" and analyzed the historical, economic, professional, and social forces that presented resistance to de-implementation. We found that these extra-scientific factors operated to sustain a commitment to radical mastectomy, even after the evidence slated the procedure for de-implementation, because the factors holding radical mastectomy in place were beyond the control of individual clinicians. We propose to expand de-implementation theory through the inclusion of extra-scientific factors. If the outcome to which we aim is appropriate and timely de-implementation, social scientific analysis will illuminate the context within which the healthcare practitioner practices and, in doing so, facilitate de-implementation by pointing to avenues that lead to systems change. The implications of our analysis lead us to contend that intervening in the broader context in which clinicians work--the social, political, and economic realms--rather than focusing on healthcare professionals' behavior, may indeed be a fruitful approach to effect change.

A historical review of classic articles in surgery field.

BACKGROUND: Surgery is one of the most rapidly developing specialties in the past century. Diagnostic methods, operation technique, and knowledge of the diseases are changing continuously. In the academic history, lots of classic papers brought advances for surgery. They were accepted and cited numerously by the medical specialists all over the world. Citation analysis reflects the recognition a work has received in the scientific community by its peers. DATA SOURCES: The articles in the field of surgery have been cited at least 1,000 times since its publication to 2011 were analyzed. By categorizing the publication year, journals, authors, institutions, countries, life citation cycles, level of evidence provided, and characteristics of the topmost articles, we intended to determine what qualities make the articles important to the specialty. The methodology used in this study was based on the Science Citation Index Expanded database of Web of Science from Thomson Reuters. According to Journal Citation Reports of 2011, it indexes 8,336 journals with citation references across 176Web of Science categories in science edition. Level of evidence of these articles was graded according to the standard provided by Oxford Centre for Evidence-Based Medicine. CONCLUSION: Totally 36 articles have been cited at least 1,000 times since their publication to the year 2011. According to their citation histories, 35 articles were further evaluated. These topmost articles covered 8 subspecialties of surgery and were published in 17 journals. The publication year varied from 1940 to 1999 and the articles provided different level of evidence, most of which are retrospective studies of case series. Six articles were research articles including animal model, histology analysis, and laboratory research. The others were clinical articles. From the results of citation analysis, the classic articles are not always in top citations. In addition, some of these articles have no citations after several years post their publication. The introduction of a commonly used classification or scoring system is a major factor in propelling citation by other authors. The most cited articles in surgery present their long academic life in spite of their level of evidence and journal impact factor in which they were published.