Ethical issues

Key concepts which should be recognized to understand today's medical ethics required for information management regarding clinical research are privacy protection, use limitation, individual participation, and accountability. Special attention should be paid to concepts other than privacy protection, because they are fairly new to medical professionals. Furthermore, in laboratory medicine, we have real problems, for example, how to protect privacy concerning specimens gathered from patients. Therefore, there have been many kinds of rules or guidelines established recently. Although we tend to strictly follow these guidelines, it is not always clear which guidelines should be applied to certain cases, or they do not always exactly correspond to a specific case. The full understanding of the principles of medical ethics represented by these guidelines is essential. In this paper, a clinical research document reviewed by an ethical review board is shown as an example.     

Teaching evidence-based medicine: caveats and challenges.

Evidence-based medicine (EBM) is an important new paradigm of the medical profession. While the quantitative approach of EBM has its place, clinical medicine must take into account many subtleties that EBM fails to consider. In this article, the authors describe three caveats to this quantitative approach: (1) the detection of "maybe disease" (physiologic, anatomic, or histologic abnormalities that may not ever be overtly expressed in the patient's lifetime) inflates apparent diagnostic test performance; (2) probability revision is valuable primarily as an exercise to gain qualitative insights; and (3) patients are likely to be interested more than just central tendencies in making treatment decisions. They then consider some challenging questions facing clinician-educators: how do they prepare students for situations where there is an absence of rigorous evidence? Should they teach students that the burden of proof lies in demonstrating efficacy or in demonstrating ineffectiveness? And what should they tell students about when to seek evidence to aid diagnostic and treatment decisions?     

Evidence based medicine in inborn errors of metabolism: is there any and how to find it

Evidence based medicine (EBM) represents an attempt to assist healthcare providers in basing clinical decisions on the best available evidence. That evidence in the treatment realm usually takes the form of clinical trials (CTs), with the randomized controlled clinical trial (CCT or RCT) being the gold standard. Many specialties such as internal medicine have embraced EBM. Medical geneticists who care for patients with inborn errors of metabolism (IEM) have by and large not benefited from the EBM movement. IEM are rare genetic conditions, many of which are treatable. Therefore, the principles of EBM should be applicable to IEM. Notably, Archibald Cochrane, one of the founders of EBM, suffered from porphyria, an IEM. The principles of EBM as applied to IEM are explored herein. The author hypothesized that EBM has not infiltrated the specialty of medical genetics, that few controlled trials for IEM have been published, and that where CTs have been carried out in IEM they can be difficult to find with electronic bibliographic database searches. To test the hypothesis, MEDLINE searches for CTs were carried out for a few representative IEM. The search results support the hypothesis. In this article, the principles of EBM are introduced and its history reviewed as background information to lay the groundwork for further discussion. Next, the dearth of evidence base in IEM, impediments to the application of EBM to IEM, steps to be taken to improve the evidence base for IEM, and finally strategies to make it easier to find CTs for IEM in database searches are all discussed.     

Dilemmas of contemporary epilepsy pharmacotherapy

The last decade was characterized by an enormous progress in all fields of epilepsy. The availability of a relatively great number of drugs that can be categorized into standard and new antiepileptic drugs (AEDs) has made individualization of therapy possible, but has challenged the clinician to answer many questions in everyday clinical routine that are not even theoretically satisfactorily solved. Among other questions, it refers to the choice of the most appropriate AED for specific therapeutic situations. Certainly, clinical trials that are harmonized with the principles of evidence-based medicine (EBM) constitute the basis for the evaluation of AEDs. In the forming of value judgments concerning new AEDs, the most influential were clinical trials with these drugs tested as add-on therapy in pharmacoresistant epilepsy. However, many relevant clinical questions have remained unanswered by these studies, primarily because the design of these trials was more appropriate for the licensing of new drugs than for clinical practice. As far as such a complex clinical condition as epilepsy is concerned, it is difficult to define the design for clinical drug trials that might be considered generally acceptable. Nevertheless, randomized controlled studies in newly diagnosed epilepsy, where the main outcome variable is the seizure absence, constitute the main methodological standard. The disproportion between the enormous quantity of easily accessible information about epilepsy therapy and the individual capability to meaningfully process that information is certainly one of the main challenges faced by a clinician. One of the solutions offered lately by some respectable professional organizations might be the implementation of treatment guidelines made on the basis of available studies that satisfy the standards of EBM. It can be assumed that the existing guidelines, and the guidelines that are yet expected, will be very influential. However, there is a prevailing consensus that therapy should be definitely individualized. Based on the contemporary level of knowledge, it means that it should be the result of dynamic interaction between the seizure type and epileptic syndrome, specific features of AEDs, and individual characteristics of the patient.     

Who applies and who gets admitted to UK graduate entry medicine? - an analysis of UK admission statistics

Background

Two of the key steps in evidence based medicine (EBM) are being able to construct a clinical question and effectively search the literature to source relevant information. No evidence currently exists that informs whether such skills should be taught to medical students during their pre-clinical years, or delivered to include both the pre-clinical and clinical years of study. This is an important component of curriculum design as the level of clinical maturity of students can affect their perception of the importance and uptake of EBM principles in practice.

Methods/Design

A randomised controlled trial will be conducted to identify the effectiveness of delivering a formal workshop in EBM literature searching skills to third year medical students entering their clinical years of study. The primary outcome of EBM competency in literature searching skills will be evaluated using the Fresno tool.

Discussion

This trial will provide novel information on the effectiveness of delivering a formal education workshop in evidence based medicine literature searching skills during the clinical years of study. The result of this study will also identify the impact of teaching EBM literature searching skills to medical students during the clinical years of study.     

Using television shows to teach communication skills in internal medicine residency

Background

Evidence based medicine (EBM) is considered an integral part of medical training, but integration of teaching various EBM steps in everyday clinical practice is uncommon. Currently EBM is predominantly taught through theoretical courses, workshops and e-learning. However, clinical teachers lack confidence in teaching EBM in workplace and are often unsure of the existing opportunities for teaching EBM in the clinical setting. There is a need for continuing professional development (CPD) courses that train clinical trainers to teach EBM through on-the-job training by demonstration of applied EBM real time in clinical practice. We developed such a course to encourage clinically relevant teaching of EBM in post-graduate education in various clinical environments.

Methods

We devised an e-learning course targeting trainers with EBM knowledge to impart educational methods needed to teach application of EBM teaching in commonly used clinical settings. The curriculum development group comprised experienced EBM teachers, clinical epidemiologists, clinicians and educationalists from institutions in seven European countries. The e-learning sessions were designed to allow participants (teachers) to undertake the course in the workplace during short breaks within clinical activities. An independent European steering committee provided input into the process.

Results

The curriculum defined specific learning objectives for teaching EBM by exploiting educational opportunities in six different clinical settings. The e-modules incorporated video clips that demonstrate practical and effective methods of EBM teaching in everyday clinical practice. The course encouraged focussed teaching activities embedded within a trainer's personal learning plan and documentation in a CPD portfolio for reflection.

Conclusion

This curriculum will help senior clinicians to identify and make the best use of available opportunities in everyday practice in clinical situations to teach various steps of EBM and demonstrate their applicability to clinical practice. Once fully implemented, the ultimate outcome of this pilot project will be a European qualification in teaching EBM, which will be used by doctors, hospitals, professional bodies responsible for postgraduate qualifications and continuing medical education.     

A review of current concepts in evidence-based radiology

It has been noted that "Good doctors use both individual clinical expertise and the best available external evidence, and neither alone is enough. " Evidence-based medicine (EBM) is defined as the process of systematically finding, critically appraising, and using contemporary research published in the medical literature as a basis to make decisions regarding individual patient care and health care policy. In radiology, including its diagnostic and interventional aspects, the principles and practice of EBM have not been thoroughly studied. In this brief review article, we describe key aspects of evidence-based radiology (EBR), concepts and steps followed in EBM and meta-analysis. The skills required to practice EBR are identified, and the roles of EBR in radiologic practice, education, and research are discussed. The application of EBM principles to diagnostic imaging facilitates the interpretation of imaging studies and produces a sound and comprehensive radiologic evaluation. This review could be useful for radiologists and clinicians at any stage of their training or career. It encourages the practice of EBM and EBR especially in developing countries.     

Overview and recent trends of systematic reviews and meta-analyses in hepatology

A systematic review (SR) is a research methodology that involves a comprehensive search for and analysis of relevant studies on a specific topic. A strict and objective research process is conducted that comprises a systematic and comprehensive literature search in accordance with predetermined inclusion/exclusion criteria, and an assessment of the risk of bias of the selected literature. SRs require a multidisciplinary approach that necessitates cooperation with clinical experts, methodologists, other experts, and statisticians. A meta-analysis (MA) is a statistical method of quantitatively synthesizing data, where possible, from the primary literature selected for the SR. Review articles differ from SRs in that they lack a systematic methodology such as a literature search, selection of studies according to strict criteria, assessment of risk bias, and synthesis of the study results. The importance of evidence-based medicine (EBM) in the decision-making for public policy has recently been increasing thanks to the realization that it should be based on scientific research data. SRs and MAs are essential for EBM strategy and evidence-based clinical practice guidelines. This review addresses the current trends in SRs and MAs in the field of hepatology via a search of recently published articles in the Cochrane Library and Ovid-MEDLINE.