Foundation For Evidence-based Medicine Research Articles

Registry randomized controlled trials: the future of surgical trials?

Registry randomized controlled trials: the future of surgical trials?

Evidence-Based Medicine: History, Review, Criticisms, and Pitfalls.

Evidence-based medicine (EBM) is the use of high-quality clinical research in making decisions about the care of patients. Its formal origin dates back to the mid-nineteenth century, and since then, it has continued to evolve. The best research evidence, clinical expertise, and patient values are described as the foundations of EBM. However, several tools and skills have been developed and added over time. EBM has faced a lot of criticism, and the pitfalls are widely discussed and published in the medical literature. The biggest challenge is the changing paradigm of healthcare, cost-effectiveness, and changing evidence which has led to controversies and challenges in the rapid adaptation of the EBM. This review article discusses the history, conception, and evolution of modern-day EBM. In addition, we discuss why EBM has been criticized and highlight the pitfalls.

P32: a sex- and gender-sensitive model for evidence-based precision medicine: from knowledge generation to implementation in the field of kidney transplantation

Precision medicine emerged as a promising approach to identify suitable interventions for individual patients with a particular health concern and at various time points. Technology can enable the acquisition of increasing volumes of clinical and "omics" data at the individual and population levels and support advanced clinical decision making. However, to keep pace with evolving societal realities and developments, it is important to systematically include sex- and gender-specific considerations in the research process, from the acquisition of knowledge to implementation. Building on the foundations of evidence-based medicine and existing precision medicine frameworks, we propose a novel evidence-based precision medicine framework in the form of the P32model, which considers individual sex-related (predictive [P1], preventive [P2], and personalized [P3] medicine) and gender-related (participatory [P4], psychosocial [P5], and percipient [P6] medicine) domains and their intersection with ethnicity, geography, and other demographic and social variables, in addition to population, community, and public dimensions (population-informed [P7], partnered with community [P8], and public-engaging [P9] medicine, respectively). Through its ability to contextualize and reflect on societal realities and developments, our model is expected to promote consideration of diversity, equity, and inclusion principles and, thus, enrich science, increase reproducibility of research, and ensure its social impact.

How many US obstetrical trials reach publication? A cross-sectional analysis of ClinicalTrials.gov and PubMed from 2007 to 2019

Obstetrical clinical trials are the foundation of evidence-based medicine during pregnancy. As more obstetrical trials are conducted, understanding the publication characteristics of these trials is of utmost importance to advance obstetrical health. This study aimed to characterize the frequency of publication and trial characteristics associated with publication among obstetrical clinical trials in the United States. We additionally sought to examine time from trial completion to publication. This was a cross-sectional analysis of completed obstetrical trials with an intervention design and at least 1 site in the United States registered to ClinicalTrials.gov from 2007 to 2019. Trial characteristics were cross-referenced with PubMed to determine publication status up to 2021 using the National Clinical Trial identification number. Bivariable analyses were conducted to determine trial characteristics associated with publication. Multivariable logistic regression models controlling for prespecified covariates were generated to estimate the relationship between funding, primary purpose, and therapeutic foci with publication. Additional exploratory analyses of other trial characteristics were conducted. Time to publication was analyzed using Kaplan-Meier curves and Cox regression models. Of the 1879 obstetrical trials with registered completion, a total of 575 (30.6%) had at least 1 site in the United States, were completed before October 1, 2019, and were included in this analysis. Between October 2007 and October 2019, fewer than two-thirds (N=348, 60.5%) of trials reached publication. Annual rates of publication ranged from 46.4% in 2018 to 70.0% in 2007. No difference was observed in publication by funding, primary purpose, or therapeutic foci (all P>.05). Trials with characteristics indicating high trial quality-including randomized allocation scheme, ≥50 participants enrolled, ≥2 sites, and presence of a data safety monitoring committee-had increased odds of publication compared with those without such characteristics (all P<.05). For example, studies with randomized allocation of intervention had 2-fold greater odds of publication than nonrandomized studies (adjusted odds ratio, 2.09; 95% confidence interval, 1.30-3.37). Studies with ≥150 participants had nearly 8-fold odds of publication (adjusted odds ratio, 7.90; 95% confidence interval, 3.78-17.49) relative to studies with <50 participants. Temporal analysis demonstrated variability in time to publication among obstetrical trials, with a median time of 20.1 months after trial completion, and with most trials that reached publication having been published by 40 months. No difference was observed in time to publication by funding, primary purpose, or therapeutic foci (all P>.05). Publication of obstetrical trials remains suboptimal, with significant differences observed between trials with indicators of high quality and those without. Most trials that reach publication are published within 2 years of registered completion on ClinicalTrials.gov.

Болезнь Фрайберга-Келера: клиника, диагностика, лечение (обзор литературы)

Introduction The paper deals with the main aspects of osteochondropathy of the heads of the II–V (small) metatarsal bones. The relevance of the problem of treating patients with Freiberg-Kohler disease can be explained by high incidence and poor results of traditional methods of its management. Objective The aim of this work was an attempt to generalize the available data and improve the understanding of approaches to the treatment of osteochondropathy of the heads of the II–V metatarsals. Materials and methods The publications obtained in various information systems (PubMed, eLibrary.ru, Google Scholar) were reviewed. Results Issues of history, etiology, pathogenesis, systematization and diagnosis of this disease were highlighted. The analysis of existing methods of treatment was carried out. Their advantages and disadvantages were assessed. Conclusion Despite more than a century of studies on Freiberg-Kohler disease, the available literature is scarce. Most works are case reports or series of cases describing small samples. This fact significantly reduces the scientific value. Thus, improving the methods of diagnosis and treatment of patients with this disease based on the foundations of evidence-based medicine is a task of current traumatology and orthopedics.

Clinical trial through the eyes of patients: benefit or unjustified risk?

Introduction. Clinical trials (CTs) are the footing foundation of evidence-based medicine. In Russia many aspects of CT implementation remain unexplored; one of them is the attitude of Russian society. Aims. This study aims to determine the knowledge and perception of CTs by potential participants. Analysis of the perception of CTs through the eyes of patients: CTs - is it a benefit or an unjustified risk? Materials. The primary method of research was a questionnaire. A total of 488 anonymous, voluntary surveys of patients from hospitals in Tomsk were studied. Results. More than half of the respondents heard about CTs, while the primary source of information was the media. The participants adequately assess the importance of conducting CTs to develop medicine and medical care for society. The primary goal of CTs is to determine the effectiveness and safety of drugs, and respondents regard their engagement as an opportunity to contribute to the development of science. The primary motivating factor in participating in CTs is receiving treatment for an incurable disease and observing conditions by a qualified doctor. The central negative aspect is the possibility of causing a risk to own health. The questionnaire demonstrated the need and importance of all points of informed consent. Several questions concerned the public attitude to researchers. According to patients, medical researchers arouse trust and confidence in altruistic motives during the CTs. Conclusion. This study revealed a low interest of Russians in participating in CTs, except for personal benefit. The behavior of the doctors, the ability to convey reliable information to the patient to adequately assess benefits and possible risks play an important role in deciding on the involvement of patients in the CTs. The results of this work will allow us to adapt the process of organizing CTs to the needs of patients in the local context.

Research Pearls: How Do We Establish the Level of Evidence?

Evidence-based medicine (EBM) guidelines were first introduced in 1986 and were defined as the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of EBM means integrating individual clinical expertise with the best available external clinical evidence from systematic research. Level of evidence (LOE) stratifies publications from Level I to Level V and provides the foundation for EBM. Three questions should be asked when an LOE is assigned to a scientific article: (1) What is the research question? (2) What is the study type? and (3) What is the hierarchy of evidence? In cases in which LOE is not appropriate or relevant (basic science and laboratory-based investigations), a clinical relevance statement should be used. Unfortunately, study quality is not assessed by the assigned hierarchy level. LOE and EBM have increased the number of investigations published with better levels of evidence. As authors, reviewers, editors, and publishers, we desire a system that is consistent, effective, and reliable. Fortunately, the system has proven to have all of those attributes with good interobserver and intra-observer values. The increase in investigations with higher LOEs allows for more frequent use of EBM.

What historiography can tell us about evidence-based medicine and policy: A response to Pawson’s ‘The Realist Foundations of Evidence-based Medicine’

In the battle between experimental study designs and realist approaches, Ray Pawson has fired the next shot. This time evidence based medicine is in his aim. He argues that evidence based medicine is becoming more appreciative of specific circumstances of interventions and hence medical research may be approximating realist evaluation’s approach. He illustrates his argument with the history of cancer where the disease increasingly looks like it is playing ‘cat and mouse’ with researchers. In the paper I try to disentangle the epistemological and methodological dimensions of Pawson’s claim. I argue that, what may look similar on a narrative level, may not be consequential for the different types of epistemologies that sustain medical and policy impact research.

Determining If Sex Bias Exists in Human Surgical Clinical Research

Sex is a variable that is poorly controlled for in clinical research. To determine if sex bias exists in human surgical clinical research, to determine if data are reported and analyzed using sex as an independent variable, and to identify specialties in which the greatest and least sex biases exist. For this bibliometric analysis, data were abstracted from 1303 original peer-reviewed articles published from January 1, 2011, through December 31, 2012, in 5 surgery journals. Study type, location, number and sex of participants, degree of sex matching of included participants, and inclusion of sex-based reporting, statistical analysis, and discussion of data. Of 2347 articles reviewed, 1668 (71.1%) included human participants. After excluding 365 articles, 1303 remained: 17 (1.3%) included males only, 41 (3.1%) included females only, 1020 (78.3%) included males and females, and 225 (17.3%) did not document the sex of the participants. Although female participants represent more than 50% (n = 57 688 606) of the total number (115 377 213) included, considerable variability existed with the number of male (46 111 818), female (58 805 665), and unspecified (10 459 730) participants included among the journals, between US domestic and international studies, and between single vs multicenter studies. For articles included in the study, 38.1% (497 of 1303) reported these data by sex, 33.2% (432 of 1303) analyzed these data by sex, and 22.9% (299 of 1303) included a discussion of sex-based results. Sex matching of the included participants in the research overall was poor, with 45.2% (589 of 1303) of the studies matching the inclusion of both sexes by 50%. During analysis of the different surgical specialties, a wide variation in sex-based inclusion, matching, and data reporting existed, with colorectal surgery having the best matching of male and female participants and cardiac surgery having the worst. Sex bias exists in human surgical clinical research. Few studies included men and women equally, less than one-third performed data analysis by sex, and there was wide variation in inclusion and matching of the sexes among the specialties and the journals reviewed. Because clinical research is the foundation for evidence-based medicine, it is imperative that this disparity be addressed so that therapies benefit both sexes.

Foreword: Getting research into practice

Randomized controlled trials (RCTs) are rightly considered the foundation of evidence-based medicine, providing the opportunity—through rigorous methodology and meticulous assessment in selected populations—to carefully assess the efficacy and safety of proposed therapeutic interventions. Translating the findings of such important research studies into routine clinical practice is at times challenging, especially under circumstances where the population evaluated in an RCT may have been restricted through the application of extensive, but frequently necessary, inclusion and …

Knowledge and Attitudes of Oman Medical Specialty Board Residents towards Evidence-Based Medicine.

This study aims to evaluate the knowledge and attitudes of Oman Medical Specialty Board (OMSB) residents towards Evidence-Based Medicine (EBM). This cross sectional study was conducted on all OMSB residents through a self-administered online questionnaire between October 2012 and March 2013. An electronic survey was designed to identify and determine residents' knowledge and attitudes toward the use of EBM. The survey was completed by 93 (21%) OMSB residents, 76 (82%) of whom took part in continuing education courses and 50 (54%) belonged to professional practice-oriented organizations. On average, the residents were reportedly involved in patient care for approximately 70% (Standard Deviation [SD] 17%) of their time, while 14% (SD 12%) participated in research activities. The results showed that 53 respondents (57%) were competent users of medical search engines compared to 23 residents (25%) who rated their skills as neutral. Sixteen percent of the respondents strongly agreed and 46% only agreed that the facility supports the use of current research in practice. Fourteen percent strongly agreed and fifty-three percent only agreed that the foundation of EBM is part of OMSB academic preparation. On the other hand, 17% of the respondents thought that insufficient time is always a barrier against EBM, while another 27% perceived insufficient time as a usual barrier. The lack of information resources was reported to always be a barrier in 11% of the respondents while 32% thought that it usually acts as a barrier. Time constraints and skills in EBM were found to be the two major obstacles. This study was, however, limited by the low response rate of the survey; thus larger studies with a previously validated questionnaire should be conducted in the future.

Moving Forward From rhBMP-2

A few years ago, a storm of controversy not only called into question the safety of recombinant bone morphogenetic protein-2 (rhBMP-2) [1], but also introduced an approach that addressed a fundamental weakness in the foundations of evidence-based medicine. Nearly half of all clinical trials are never published [2–4]; those that are often exclude important data and may face long delays to publication [5–6], and individual patient level data has rarely been available for re-analysis [7–8]. Moreover, financial conflicts of interest have been associated with actions that have had the potential to bias the conduct and dissemination of clinical research. All of these foundational weaknesses were at issue when a series of publications in the Spine Journal [1] suggested that the investigators behind the key publications supporting rhBMP-2 had significant financial conflicts of interest and that the published reports of these industry-sponsored studies may have incompletely reported important adverse events. In response to these concerns, Medtronic (Minneapolis, Minnesota) provided the Yale University Open Data Access (YODA) Project with the opportunity to apply its model [9–10] of data transparency and data stewardship to clarify the effectiveness and safety of rhBMP-2. This model entailed the oversight of two independent systematic reviews based on individual patient level data from all clinical trials conducted by Medtronic and the subsequent availability to scientists of the individual patient-level data from the trials. As part of this initiative, Medtronic fully granted jurisdiction over the data to the YODA Project and funded the effort. This project was conceived as a new type of industry-academic partnership to address the problem of unpublished and selectively published clinical evidence, with the hope of advancing open science, developing norms for good stewardship of clinical trial data, and serving patients and society, all while respecting legitimate industry concerns about the use of previously proprietary clinical trial data.

Team-Based Learning of Evidence-Based Medicine: Screening

OPEN ACCESSJune 20, 2013Team-Based Learning of Evidence-Based Medicine: Screening Joan M. Bedinghaus, MD, David Nelson, PhD, MA Joan M. Bedinghaus, MD Medical College of Wisconsin Google Scholar More articles by this author , David Nelson, PhD, MA Medical College of Wisconsin Google Scholar More articles by this author https://doi.org/10.15766/mep_2374-8265.9450 SectionsAboutAbstract ToolsDownload Citations ShareFacebookTwitterEmail AbstractAbstract Introduction: This team-based learning session is one of a series of five developed for a course called “Foundations of Evidence-Based Medicine” for first-year medical students. Of these five, four are published on MedEdPORTAL and cover the topics of randomized controlled trials, case-control and cohort studies, diagnostic testing, and screening. Methods: The resource includes a list of objectives, preparation assignments, slides for a brief in-class presentation, a quiz, and application exercises. An instructor's manual is also included. Students arrive at the session having already reviewed a series of preparatory readings. They are first administered an individual readiness assurance test before being grouped into teams of 5–7 students and retake the same test (group readiness assurance test) as a unit. This is followed by a review of the answers and an informational PowerPoint presentation. Finally, the students complete a series of application exercises while remaining in their groups. Results: The course was given twice (Fall 2011 and Spring 2012), each time with a group of 100–104 students. Discussion: Previously, we had taught evidence-based medicine using 10–12 hours of lecture, three 1.5 hour small group sessions, and two online self-study modules. The course was poorly rated by students and the performance on USMLE in biostats was consistently below national averages. The sessions published here were developed in hopes of improving understanding and retention of evidence-based medicine concepts. Educational Objectives By the end of this session, learners will be able to: Define and identify examples of primary, secondary, and tertiary prevention.List and define the characteristics of an effective screening program.Identify bias and error in the evaluation of screening programs.Identify and evaluate the features of a high-quality systematic review. Sign up for the latest publications from MedEdPORTAL Add your email below FILES INCLUDEDReferencesRelatedDetails FILES INCLUDED Included in this publication: Instructor's Manual.pdf Session 5 EBM - APPLICATIONS - Answer Key.doc Session 5 EBM - FAQs.pptx Session 5 EBM - IRAT GRAT.pptx Session 5 EBM-APPLICATIONS.pptx Session 5 EBM-OBJ and PREP-RAT Answer Key.docx To view all publication components, extract (i.e., unzip) them from the downloaded .zip file. Download editor’s noteThis publication may contain technology or a display format that is no longer in use. Related Team-Based Learning of EBM: Case-Control and Cohort Studies Team-Based Learning of Evidence-Based Medicine: Screening Team-Based Learning of EBM: Randomized Controlled Trials Team-Based Learning of EBM: Diagnostic Testing Copyright & Permissions© 2013 Bedinghaus and Nelson. This is an open-access publication distributed under the terms of the Creative Commons Attribution-NonCommercial-Share Alike license.KeywordsScreeningLead Time BiasEvidence-Based MedicineTeam-Based LearningLength BiasReviewTBLSystematic Review Disclosures None to report. Funding/Support None to report. Loading ...

The failure of evidence-based medicine?

Evidence-based medicine (EBM) claims to provide gold-standard methods based on group and population statistics. However, the main issues in clinical medicine concern classification and prediction. During diagnosis, a patient’s illness is classified; then it is predicted that a specific treatment will be successful with that particular patient. Most scientific disciplines concerned with classification and prediction have rejected group and population statistics as being misleading, inadequate and inaccurate for such applications. This paper lists some of the critical findings from the decision sciences that bring the utility, application and validity of EBM into question. One of the foundations of EBM is that large clinical trials provide the best evidence. However, EBM misapplies the law of large numbers and best evidence really means selected data. EBM is inconsistent with modern science, theoretically unsound, impractical and erroneous in its application.

Clinical Manual for Treatment of Schizophreniaedited by LaurielloJohn, M.D., and PallantiStefano, M.D. Washington, DC, American Psychiatric Publishing, 2012, 523 pp., $79.00 (paper).

Clinical Manual for Treatment of Schizophreniaedited by LaurielloJohn, M.D., and PallantiStefano, M.D. Washington, DC, American Psychiatric Publishing, 2012, 523 pp., $79.00 (paper).

History of evidence-based medicine.

This essay reviews the historical circumstances surrounding the introduction and evolution of evidence-based medicine. Criticisms of the approach are also considered. Weaknesses of existing standards of clinical practice and efforts to bring more certainty to clinical decision making were the foundation for evidence-based medicine, which integrates epidemiology and medical research. Because of its utility in designing randomized clinical trials, assessing the quality of the literature, and applying medical research at the bedside, evidence-based medicine will continue to have a strong influence on everyday clinical practice.

Recherche de données factuelles

The foundation of evidence-based medicine is critical analysis and synthesis of the best data available concerning a given health problem. These factual data are accessible because of the availability on the Internet of web tools specialized in research for scientific publications. A bibliographic database is a collection of bibliographic references describing the documents indexed. Such a reference includes at least the title, summary (or abstract), a set of keywords, and the type of publication. To conduct a strategically effective search, it is necessary to formulate the question - clinical, diagnostic, prognostic, or related to treatment or prevention - in a form understandable by the research engine. Moreover, it is necessary to choose the specific database or databases, which may have particular specificity, and to analyze the results rapidly to refine the strategy. The search for information is facilitated by the knowledge of the standardized terms commonly used to describe the desired information. These come from a specific thesaurus devoted to document indexing. The most frequently used is MeSH (Medical Subject Heading). The principal bibliographic database whose references include a set of describers from the MeSH thesaurus is Medical Literature Analysis and Retrieval System Online (Medline), which has in turn become a subpart of a still more vast bibliography called PubMed, which indexes an additional 1.4 million references. Numerous other databases are maintained by national or international entities. These include the Cochrane Library, Embase, and the PASCAL and FRANCIS databases.

Data Supporting the Use of Prescription Medications for Off-Label Indications

he American Society ofHealth-System Pharmacists(ASHP) issued a press releasein September 2008 stating that theywere launching a collaborative ini-tiative with the Foundation for Evidence-Based Medicine (FEBM)to evaluate and publish evidencerelated to “off-label” uses of med-ications. This information will beincorporated into the drug mono-graphs published as supplements toASHP’s drug compendium,

The biomarker revolution: a step toward personalized medicine.

Any drug-based treatment, be it prophylactic or therapeutic, is bound to suffer from two limitations. The fi rst one is that the drug will never be active in 100% of individuals. In fact, even in classes of drugs such as prophylactic vaccines, which exhibit very high levels of effi cacy, a full effi cacy rate is very rarely obtained. In the case of small chemical drugs, the range of effi cacy is approximately 50‐70% and overall, 30% of patients do not benefi t from current medicines. The second limitation of any drug is its safety profi le. An ‘active’ drug is likely to induce side effects that will vary in severity from one individual to another. It is noteworthy in this context that the number of reported serious adverse

Enhancing the research experience through peer-reviewed literature

Dear Editors, Your article “Clinical research 101: Why should you care?” [1] was very interesting and I applaud the journal, which in its infancy is addressing issues such as importance of clinical research. As you correctly mention, the emergency department (ED) is a clinical laboratory, and clinical research apart from answering some of the most pertinent questions has the additional value of being immediately relevant to patient care. As a research director of a very busy pediatric ED with an active fellowship in pediatric emergency medicine, I am constantly struggling to convey the message that research is not an entity which gets conducted solely in laboratories or demands extensive knowledge of statistics to my colleagues. Research is a very important step in improving patient care by applying what is known to the patient immediately in front of you. Research provides the foundation for evidence-based medicine and the tools for evidence-based practice. I would also add that research can vary in its quality and comprehensiveness. Practitioners of emergency medicine must be discerning enough to critically appraise research as there are many instances of “published” studies that either lack the appropriate methodology, adequate sample size, or rigorous analysis. Additionally, research is constantly evolving and what is considered as gospel may be eventually refuted with a well-conducted study. Use of steroids in bronchiolitis is an example. A well-conducted double-blinded randomized controlled trial (n = 70) performed at one ED comparing a single dose of oral dexamethasone with a placebo in children with moderate to severe bronchiolitis showed a substantial reduction in hospitalization along with clinical improvement. This study was powered to detect a difference in a clinical score not rates of hospitalization [2]. Yet, using these efficacy data, many practitioners changed their practice and started using oral dexamethasone in the management of bronchiolitis. A subsequent larger, multicenter study (effectiveness study) showed no effect of a single dose of oral dexamethasone when the study was powered to detect a 12% difference in admission rates (n = 600). This second study clearly showed that there was no difference in hospitalization rates [3]. The challenge now is to disseminate these findings—translating research into practice (TRIP). In conclusion, I think it is important for journals such as yours to enhance the research experience by (a) publishing articles on research methodology, (b) being more discerning as to which articles get accepted, and (c) broadening the scope of emergency research by publishing articles on research ethics in varied settings, i.e., international emergency medicine.