Unsystematic Clinical Experience Research Articles

Neoaortic Bicuspid Valve Replacement in Patient After Arterial Switch Operation to Correct Dextro-Transposition of the Great Arteries

INTRODUCTION Transposition of the great arteries is the second most common cyanotic congenital heart defect after tetralogy of Fallot. The arterial switch procedure (А. Jatene, 1975) is the surgical treatment of choice. Neoaortic root dilatation and valve regurgitation are quite common among the patients who underwent surgery for transposition of the great arteries. However, there are a lot of conflicting data about their direct connection.CLINICAL CASE This article describes surgical repair of neoaortic bicuspid valve regurgitation, by it successful implantation, in an 18-year-old patient after arterial switch operation for transposition of the great arteries in the neonatal period.CONCLUSION Neoaortic valve insufficiency can develop primarily as well as secondary to neoaortic root dilatation, however, the questions about valve repair or aortic root replacement with or without neoaortic valve implantation remains debatable. At this stage, decision making is based only on unsystematic clinical experience, surgeon’s intuition, the basics of anatomy and pathophysiology, as well as close interaction of “pediatric” and “adult” cardiac surgeons.

Medical School: The Wrong Applicant Pool?

Evidence-based medicine has become both the mantra of clinical practice and the dominant contemporary approach to patient care. Gordon Guyatt et al. first proposed applying the concept to medical education in the early 1990s, arguing for training that "de-emphasizes intuition, unsystematic clinical experience, and pathophysiologic rationale" in favor of "examination of evidence from clinical research"; over the following twenty-five years, nearly every medical school and residency program in the United States incorporated these methods into its training. During this same period, admissions requirements and protocols have continued to rely on subjective, non-evidence-based ideals largely developed a century earlier. In light of the continued underrepresentation of certain demographic groups among matriculants, as well as the national controversy surrounding admissions standards at undergraduate institutions-most notably embodied in the lawsuit by Students for Fair Admissions against Harvard University-the moment may be ripe for a radical reexamination of those requirements.

Appendix 1: Summary of the modified GRADE system

HIV MedicineVolume 13, Issue S2 p. 151-151 British HIV Association Guidelines for the Management of HIV Infection in Pregnant Women 2012Free Access Appendix 1: Summary of the modified GRADE system First published: 26 July 2012 https://doi.org/10.1111/j.1468-1293.2012.01030_13.xAboutSectionsPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat BHIVA revised and updated the Association's guideline development manual in 2011 1. BHIVA has adopted the modified Grading of Recommendations Assessment, Development and Evaluation (GRADE) system for the assessment, evaluation and grading of evidence and the development of recommendations 2, 3. 1A Strong recommendation. High-quality evidence. Benefits clearly outweigh risk and burdens, or vice versa. Consistent evidence from well-performed, randomized, controlled trials or overwhelming evidence of some other form. Further research is unlikely to change our confidence in the estimate of benefit and risk. Strong recommendations, can apply to most patients in most circumstances without reservation. Clinicians should follow a strong recommendation unless there is a clear rationale for an alternative approach. 1B Strong recommendation. Moderate-quality evidence. Benefits clearly outweigh risk and burdens, or vice versa. Evidence from randomized, controlled trials with important limitations (inconsistent results, methods flaws, indirect or imprecise), or very strong evidence of some other research design. Further research may impact on our confidence in the estimate of benefit and risk. Strong recommendation and applies to most patients. Clinicians should follow a strong recommendation unless a clear and compelling rationale for an alternative approach is present. 1C Strong recommendation. Low-quality evidence. Benefits appear to outweigh risk and burdens, or vice versa. Evidence from observational studies, unsystematic clinical experience, or from randomized, controlled trials with serious flaws. Any estimate of effect is uncertain. Strong recommendation, and applies to most patients. Some of the evidence base supporting the recommendation is, however, of low quality. 1D Strong recommendation. Very low-quality evidence. Benefits appear to outweigh risk and burdens, or vice versa. Evidence limited to case studies. Strong recommendation based mainly on case studies and expert judgement. 2A Weak recommendation. High-quality evidence. Benefits closely balanced with risks and burdens. Consistent evidence from well-performed randomized, controlled trials or overwhelming evidence of some other form. Further research is unlikely to change our confidence in the estimate of benefit and risk. Weak recommendation, best action may differ depending on circumstances or patients or societal values. 2B Weak recommendation. Moderate-quality evidence. Benefits closely balanced with risks and burdens, some uncertainly in the estimates of benefits, risks and burdens. Evidence from randomized, controlled trials with important limitations (inconsistent results, methods flaws, indirect or imprecise). Further research may change the estimate of benefit and risk. Weak recommendation, alternative approaches likely to be better for some patients under some circumstances. 2C Weak recommendation. Low-quality evidence. Uncertainty in the estimates of benefits, risks and burdens; benefits may be closely balanced with risks and burdens. Evidence from observational studies, unsystematic clinical experience, or from randomized, controlled trials with serious flaws. Any estimate of effect is uncertain. Weak recommendation; other alternatives may be reasonable. 2D Weak recommendation. Very low-quality evidence. Uncertainty in the estimates of benefits, risks, and burdens; benefits may be closely balanced with risks and burdens. Evidence limited to case studies and expert judgment. Very weak recommendation; other alternatives may be equally reasonable. A1.1 References 1 BHIVA guideline development manual, 13th September 2011. Available at http://www.bhiva.org/guidelinedevelopmentmanual.aspx (accessed April 2012). Google Scholar 2 Guyatt GH, Oxman AD, Kunz R et al. Going from evidence to recommendations. BMJ 2008; 336: 1049– 1051. CrossrefPubMedWeb of Science®Google Scholar 3 Development and Evaluation (Short GRADE) Working Group. The grading of recommendations assessment. Available at http://www.gradeworkinggroup.org (accessed April 2012). Google Scholar Volume13, IssueS2Special Issue: British HIV Association Guidelines for the Treatment of HIV‐1‐positive Adults with Antiretroviral Therapy 2012 and Guidelines for the Management of HIV Infection in Pregnant Women 2012September 2012Pages 151-151 ReferencesRelatedInformation

Bringing New Technologies to Market: Hurdles and Solutions

Bringing New Technologies to Market: Hurdles and Solutions

Evidence and Narrative in Contemporary Psychiatry

In 1992, the Evidence-Based Medicine Working Group issued a clarion call to physicians to focus away from intuition, unsystematic clinical experience, and pathophysiological rationale as grounds for clinical decisions. They recommended, instead, that we base patient care on evidence from clinical research, that is, on our review of published literature (EBM Working Group, 1992). It ranked clinical evidence in a hierarchy based on the design of the study, from single case reports up through double blind randomized clinical trials (RCT), without regard to the quality of the research. An early training film showed a medicine resident telling a patient the results of some laboratory tests, then leaving the examining room to do a computer search, then returning to give the patient a prescription. In this scenario, the patient seems to make no contribution to the discussion, either as participant or as a person. Criticism came rapidly from various sectors of medicine. Dynamic psychiatrists wondered whether this was a new paradigm or a new cognitive disorder. Others noted that this sort of medicine relies on imperfect methodology and a science base that is currently incomplete (Phelps, 1993); it addresses single aspects of a complex patient; it devalues clinical intelligence (Tanenbaum, 1993); and it views the patient as an inconvenient container of a biomedical process. It serves policies that aim to control costs for populations by sacrificing efficient care over the lifetime of the individual (Gray, 2000; Kassirer, 1993).

Evidence-Based Medicine Must Be ...

Proponents of evidence-based medicine (EBM) provide the "hierarchy of evidence" as a criterion for judging the reliability of therapeutic decisions. EBM's hierarchy places randomized interventional studies (and systematic reviews of such studies) higher in the hierarchy than observational studies, unsystematic clinical experience, and basic science. Recent philosophical work has questioned whether EBM's special emphasis on evidence from randomized interventional studies can be justified. Following the critical literature, and in particular the work of John Worrall, I agree that many of the arguments put forward by advocates of EBM do not justify the ambitious claims that are often made on behalf of randomization. However, in contrast to the recent philosophical work, I argue that a justification for EBM's hierarchy of evidence can be provided. The hierarchy should be viewed as a hierarchy of comparative internal validity. Although this justification is defensible, the claims that EBM's hierarchy substantiates when viewed in this way are considerably more circumscribed than some claims found in the EBM literature.

Evidence-Based Medicine, Systematic Reviews, and Guidelines in Interventional Pain Management: Part 4: Observational Studies

Evidence-based medicine (EBM) stresses the examination of evidence from clinical research and describes it as a shift in medical paradigms, in contrast to intuition, unsystematic clinical experience, and pathophysiologic rationale. While the importance of randomized trials has been created by the concept of the hierarchy of evidence in guiding therapy, much of the medical research is observational. There is competition, contrast, and a feeling of inferiority and uselessness for observational studies, created by a lack of understanding of medical research. However, observational studies and randomized clinical trials (RCTs) can be viewed as the steps of observation and experimentation that form the basis of the scientific methodology. Further, rational healthcare practices require knowledge about the etiology and pathogenesis, diagnosis, prognosis, and treatment of disorders. The reporting of observational research is often not detailed and clear enough with insufficient quality and poor reporting, which hampers the assessment of strengths and weaknesses of the study and the generalizability of the mixed results. Thus, design, implementation, and reporting of observational studies is crucial. The biased interpretation of results from observational studies, either in favor of or opposed to a treatment, and lack of proper understanding of observational studies, leads to a poor appraisal of the quality. Similar to the Consolidated Standards of Reporting Trials (CONSORT) statement for the reporting of randomized trials, the Strengthening of the Reporting of Observational Studies in Epidemiology (STROBE) statement was developed with recommendations to improve the quality of reporting observational studies. The STROBE statement consists of a checklist of 22 items, which relate to the title, abstract, introduction, methods, results, and discussion sections of articles. Multiple types of observational studies are conducted; however, 3 types have been highlighted in the STROBE document and also in the present review, which include cohort studies, case-controlled studies, and cross-sectional studies. This comprehensive review provides an introduction and rationale, types, design, and reporting of observational studies; outcomes assessment and data presentation and analysis; statistical analysis, results, and a discussion of observational studies.

Troublesome times demand more effective practices

The intensifying financial pressures bearing down on the American government and taxpayers due to egregious corporate mismanagement will focus increasing and unprecedented scrutiny on the business world. The risk management community believes a paradigm shift is at hand. Organizations of every kind will feel pressure to do more than they have in the past to understand the risks they face, expose and challenge every assumption they make, and take steps to quantify and appropriately mitigate the exposures they identify. This will not be an easy transition. Just as the healthcare community has struggled over the past 25 years with the paradigm shift from the unsystematic clinical experience to a more analytical, evidence-based approach, the corporate world will have to move from a traditional silo-centric risk management system to a more formalized, analytical, enterprise-wide risk management competency.

Evidence-Based Medicine, Systematic Reviews, and Guidelines in Interventional Pain Management: Part 2: Randomized Controlled Trials

Evidence-based medicine (EBM) is a shift in medical paradigms and about solving clinical problems, acknowledging that intuition, unsystematic clinical experience, and pathophysiologic rationale are insufficient grounds for clinical decision-making. The importance of randomized trials has been created by the concept of the hierarchy of evidence in guiding therapy. Even though the concept of hierarchy of evidence is not absolute, in modern medicine, most researchers synthesizing the evidence may or may not follow the principles of EBM, which requires that a formal set of rules must complement medical training and common sense for clinicians to interpret the results of clinical research. N of 1 randomized controlled trials (RCTs) has been positioned as the top of the hierarchy followed by systematic reviews of randomized trials, single randomized trial, systematic review of observational studies, single observational study, physiologic studies, and unsystematic clinical observations. However, some have criticized that the hierarchy of evidence has done nothing more than glorify the results of imperfect experimental designs on unrepresentative populations in controlled research environments above all other sources of evidence that may be equally valid or far more applicable in given clinical circumstances. Design, implementation, and reporting of randomized trials is crucial. The biased interpretation of results from randomized trials, either in favor of or opposed to a treatment, and lack of proper understanding of randomized trials, leads to a poor appraisal of the quality. Multiple types of controlled trials include placebo-controlled and pragmatic trials. Placebo-controlled RCTs have multiple shortcomings such as cost and length, which limit the availability for studying certain outcomes, and may suffer from problems of faulty implementation or poor generalizability, despite the study design which ultimately may not be the prime consideration when weighing evidence for treatment alternatives. However, in practical clinical trials, interventions compared in the trial are clinically relevant alternatives, participants reflect the underlying affected population with the disease, participants come from a heterogeneous group of practice settings and geographic locations, and endpoints of the trial reflect a broad range of meaningful clinical outcomes. Key words: Randomized controlled trial (RCT), placebo-controlled trial, pragmatic controlled trial, randomization, allocation concealment, sample size, blinding, consolidated standards of reporting trials (CONSORT) statement, minimal clinically important change (MCIC), minimal clinical important difference (MCID)

Progress in Evidence-Based Medicine

A new paradigm for medical practice is emerging. Evidence-based medicine de-emphasizes intuition, unsystematic clinical experience, and pathophysiologic rationale as sufficient grounds for clinical decision making and stresses the examination of evidence from clinical research. Evidence- based medicine requires new skills of the physician, including efficient literature searching and the application of formal rules of evidence evaluating the clinical literature.See PDF for full text of the original JAMA article.

Evidence-Based Medicine, Systematic Reviews, and Guidelines in Interventional Pain Management: Part 6. Systematic Reviews and Meta-Analyses of Observational Studies

Observational studies provide an important source of information when randomized controlled trials (RCTs) cannot or should not be undertaken, provided that the data are analyzed and interpreted with special attention to bias. Evidence-based medicine (EBM) stresses the examination of evidence from clinical research and describes it as a shift in medical paradigm, in contrast to intuition, unsystematic clinical experience, and pathophysiologic rationale. While the importance of randomized trials has been created by the concept of the hierarchy of evidence in guiding therapy, much of the medical research is observational. The reporting of observational research is often not detailed and clear enough with insufficient quality and poor reporting, which hampers the assessment of strengths and weaknesses of the study and the generalizability of the mixed results. Thus, in recent years, progress and innovations in health care are measured by systematic reviews and meta-analyses. A systematic review is defined as, "the application of scientific strategies that limit bias by the systematic assembly, clinical appraisal, and synthesis of all relevant studies on a specific topic." Meta-analysis usually is the final step in a systematic review. Systematic reviews and meta-analyses are labor intensive, requiring expertise in both the subject matter and review methodology, and also must follow the rules of EBM which suggests that a formal set of rules must complement medical training and common sense for clinicians to integrate the results of clinical research effectively. While expertise in the review methods is important, the expertise in the subject matter and technical components is also crucial. Even though, systematic reviews and meta-analyses, specifically of RCTs, have exploded, the quality of the systematic reviews is highly variable and consequently, the opinions reached of the same studies are quite divergent. Numerous deficiencies have been described in methodologic assessment of the quality of the individual articles. Consequently, observational studies can provide an important complementary source of information, provided that the data are analyzed and interpreted in the context of confounding bias to which they are prone. Appropriate systematic reviews of observational studies, in conjunction with RCTs, may provide the basis for elimination of a dangerous discrepancy between the experts and the evidence. Steps in conducting systematic reviews of observational studies include planning, conducting, reporting, and disseminating the results. MOOSE, or Meta-analysis of Observational Studies in Epidemiology, a proposal for reporting contains specifications including background, search strategy, methods, results, discussion, and conclusion. Use of the MOOSE checklist should improve the usefulness of meta-analysis for authors, reviewers, editors, readers, and decision-makers. This manuscript describes systematic reviews and meta-analyses of observational studies. Authors frequently utilize RCTs and observational studies in one systematic review; thus, they should also follow the reporting standards of the Quality of Reporting of Meta-analysis (QUOROM) statement, which also provides a checklist. A combined approach of QUOROM and MOOSE will improve reporting of systematic reviews and lead to progress and innovations in health care.

The Other War on Drugs: The Pharmaceutical Industry, Evidence-Based Medicine, and Clinical Practice

Over the past decade, evidence-based medicine (EBM) has become the standard for medical practice.1 Evidence-based practices have been established in general medicine and specialized fields; new evidence-based journals have been launched.2 Although its roots can be found in mid-nineteenth-century medical philosophy, contemporary EBM was largely developed by the clinical epidemiology program at McMaster University in 1992.3 According to the McMaster manifesto published inJAMA, EBM “deemphasizes intuition, unsystematic clinical experience, and pathophysiologic rationale as sufficient grounds for clinical decision-making, and stresses the examination of evidence from clinical research.”4 The most frequently cited definition of EBM is reliance on the “conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients,” based on an integration of “individual clinical expertise with the best available external clinical evidence from systematic research.”5 However, as Stefan Timmermans and Aaron Mauck recently observed, EBM “is loosely used and can refer to anything from conducting a statistical meta-analysis of accumulated research to promoting randomized clinical trials, to supporting uniform reporting styles for research, to a personal orientation toward critical self-evaluation.”6

Evidence-based medicine: medical practice in the third millennium.

Evidence-based medicine (EBM) is a growing international movement in health care that aims to bring the best evidence from medical research to the bedside, clinic and community. Evidence-based medicine de-emphasizes intuition, unsystematic clinical experience and pathophysiologic rationale as sufficient grounds for clinical decision-making and stresses the examination of evidence from clinical research. The aim of this paper is to familiarize the readers with the basic concept, methodology, resources of evidence-based medicine and its applicability in Pakistan.

La place des nouvelles méthodes basées sur l'apport de " preuves " dans la prise en charge des patients

Are we going to change the way we practice medicine? There are two kinds of medical knowledge: one is impersonal and results from research based on scientific methodology and scientific reasoning; the other is personal and results from learning and apprenticeship with seniors and from individual experience. Evidence-based medicine (EBM) is a new approach to teaching the practice of medicine. Instead of using personal knowledge, intuition, unsystematic clinical experience, and pathophysiological reasoning, it stresses evidence from clinical research. With this new paradigm in mind, clinicians should regularly consult the original literature, critically appraise the methods and the results, and then apply to the patient the optimal knowledge they have at their disposal. This new approach to medicine is gaining worldwide adoption, even if it more or less strictly interpreted. In France, even the translation of the English word "evidence " is controversial. There are two different translations for EBM. The most common is "Médecine fondée sur les preuves", and the other is "Médecine factuelle". The French word "Preuves" is the literal translation of "evidence" Some people argue against this term because its meaning is ambiguous for two reasons: --it does not express the full meaning of the English word "evidence", --there is a fear that the epistemological significance of "preuves" could be misinterpreted, giving birth to legal quibbles. Some people prefer the term "meilleures données acquises de la science". Other problems are linguistic and organizational. How can a busy French-speaking practitioner locate, retrieve and critically appraisal original articles, most of which are in English, unless he/she has a library containing the combined international medical literature? French meta-analyses, systematic reviews and books dedicated to evidence-based subjects are alternative options. Even when these practical problems can be solved, the proper place of research-based evidence must be clarified. When evidence is lacking, practitioners have to rely on other forms of medical reasoning for their decisions. Moreover, decision-making is not automatic: in addition to taking scientific knowledge into consideration, each medical decision is the result of a series of judgments based on human and environmental factors.

Editorial—Evidence‐based practice: new opportunities for librarians

A new paradigm for medical practice is emerging. Evidence‐based medicine de‐emphasizes intuition, unsystematic clinical experience, and pathophysiological rationale as sufficient grounds for clinical decision making and stresses the examination of evidence from clinical research. Evidence‐based medicine requires new skills of the physician, including efficient literature searching and the application of formal rules of evidence evaluating the clinical literature.1

Evidence-based medicine. A new approach to teaching the practice of medicine.

A NEW paradigm for medical practice is emerging. Evidence-based medicine de-emphasizes intuition, unsystematic clinical experience, and pathophysiologic rationale as sufficient grounds for clinical decision making and stresses the examination of evidence from clinical research. Evidence-based medicine requires new skills of the physician, including efficient literature searching and the application of formal rules of evidence evaluating the clinical literature. An important goal of our medical residency program is to educate physicians in the practice of evidence-based medicine. Strategies include a weekly, formal academic half-day for residents, devoted to learning the necessary skills; recruitment into teaching roles of physicians who practice evidence-based medicine; sharing among faculty of approaches to teaching evidence-based medicine; and providing faculty with feedback on their performance as role models and teachers of evidence-based medicine. The influence of evidencebased medicine on clinical practice and medical education is increasing. <h3>CLINICAL SCENARIO</h3> A junior medical resident working in a teaching hospital