Evidence-based alternative medicine?

The validity of evidence-based medicine (EBM) is the subject of ongoing controversy. The EBM movement has proposed a "hierarchy of evidence," according to which randomized controlled trials (RCTs) and meta-analyses of RCTs provide the most reliable evidence concerning the efficacy of medical interventions. The evaluation of alternative medicine therapies highlights problems with the EBM hierarchy. Alternative medical researchers-like those in mainstream medicine-wish to evaluate their therapies using methods that are rigorous and that are consistent with their philosophies of medicine and healing. These investigators have three ways to relate their work to EBM. They can accept the EBM hierarchy and carry out RCTs when possible; they can accept the EBM standards but argue that the special characteristics of alternative medicine warrant the acceptance of "lower" forms of evidence; or they can challenge the EBM approach and work to develop new research designs and new standards of evidence that reflect their approach to medical care. For several reasons, this last option is preferable. First, it will best meet the needs of alternative medicine practitioners. Moreover, because similar problems beset the evaluation of mainstream medical therapies, reevaluation of standards of evidence will benefit everyone in the medical community--including, most importantly, patients.     

Research Trends in Evidence-Based Medicine: A Joinpoint Regression Analysis of More than 50 Years of Publication Data

Background

Evidence-based medicine (EBM) has developed as the dominant paradigm of assessment of evidence that is used in clinical practice. Since its development, EBM has been applied to integrate the best available research into diagnosis and treatment with the purpose of improving patient care. In the EBM era, a hierarchy of evidence has been proposed, including various types of research methods, such as meta-analysis (MA), systematic review (SRV), randomized controlled trial (RCT), case report (CR), practice guideline (PGL), and so on. Although there are numerous studies examining the impact and importance of specific cases of EBM in clinical practice, there is a lack of research quantitatively measuring publication trends in the growth and development of EBM. Therefore, a bibliometric analysis was constructed to determine the scientific productivity of EBM research over decades.

Methods

NCBI PubMed database was used to search, retrieve and classify publications according to research method and year of publication. Joinpoint regression analysis was undertaken to analyze trends in research productivity and the prevalence of individual research methods.

Findings

Analysis indicates that MA and SRV, which are classified as the highest ranking of evidence in the EBM, accounted for a relatively small but auspicious number of publications. For most research methods, the annual percent change (APC) indicates a consistent increase in publication frequency. MA, SRV and RCT show the highest rate of publication growth in the past twenty years. Only controlled clinical trials (CCT) shows a non-significant reduction in publications over the past ten years.

Conclusions

Higher quality research methods, such as MA, SRV and RCT, are showing continuous publication growth, which suggests an acknowledgement of the value of these methods. This study provides the first quantitative assessment of research method publication trends in EBM.     

The Spatialisation of Disease: Foucualt and Evidence-based Medicine (EBM)

In this paper I draw on the French philosopher Michel Foucault for a viewpoint on aspects of EBM. This means that I develop his idea of the spaces occupied by disease. I give much of the paper to only one of these spaces, the space of perception of disease, in order to major on the medical gaze, one of Foucault’s best-known contributions to the philosophy of medicine. As I explain what I mean by each of the spaces of disease, I configure EBM into this space. The conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. Evidence-based clinical practice requires integration of individual clinical expertise and patient preferences with the best available external clinical evidence from systematic research and consideration of available resources. EBM can be considered a subcategory of evidence-based healthcare, which also includes other branches of health-care practice such as evidence-based nursing or evidence-based physiotherapy. EBM subcategories include evidence-based surgery and evidence-based cardiology (Guyatt et al. 2008, 783).     

Evidence-Based Medicine,Clinical Practice Guidelines,and Common Sense in the Management of Osteoporosis

ObjectiveTo evaluate the benefits and limitations of randomized controlled trials (RCTs), clinical practice guidelines (CPGs), and clinical judgment in the management of osteoporosis.MethodsA review was conducted of the English-language literature on the origins and applications of RCTs, CPGs, evidence-based medicine, and clinical judgment in the management of osteoporosis.ResultsEvidence-based medicine is use of the currently available best evidence in making clinical decisions for individual patients. CPGs are recommendations for making clinical decisions based on research evidence, sometimes with consideration of expert opinion, health care policy, and costs of care. The highest levels of medical evidence are usually thought to be RCTs and meta-analyses of high-quality RCTs. Although it is desirable and appropriate for clinicians to consider research evidence from RCTs and recommendations presented in CPGs in making clinical decisions, other factors—such as patient preference, comorbidities, affordability, and availability of care—are important for the actual implementation of evidence-based medicine.ConclusionDecisions about who to treat, which drug to use, how best to monitor, and how long to treat require clinical skills in addition to knowledge of medical research. The necessity of integrating common sense and clinical judgment is highlighted by the fact that many patients treated for osteoporosis in clinical practice would not qualify for participation in the pivotal clinical trials that demonstrated efficacy and safety of the drugs used to treat them. (Endocr Pract. 2009;15:573-579)     

Mechanistic reasoning and informed consent

Evidence‐based medicine (EBM) proponents have argued that mechanistic evidence concerning medical treatments should be considered secondary to evidence derived from randomized controlled trials (RCTs). One common criticism of RCTs is that they often do not yield results that are generalizable to clinical practice, and that for clinical practice application, mechanistic evidence is needed. However, proponents of EBM have argued that mechanistic reasoning is often unreliable and thus not very useful. Here we suggest an important role of mechanistic explanation that has been left out of this discussion entirely, namely, its importance in a patient’s decision of whether or not to take certain drugs. We argue that in certain cases, knowing how a treatment works is just as important for the patient as knowing whether it does. In this paper, we explore how and why giving patients mechanistic information can be an important factor in obtaining informed consent for medical treatment, focusing on the example case of hormonal contraceptives.     

Gezamenlijke besluitvorming zorgt voor een betere toepassing van evidence-based medicine in de geriatrische patiënt

Evidence based medicine (EBM) is the integration of the best research evidence, clinical expertise and patient values in the decision making process for patient care. However, elderly people are often excluded from participating in scientific studies and they often have multiple morbidities, which complicates the application of EBM. Shared decision making (SDM), a process where clinicians and patients share the best available evidence when faced with the task of making decisions, and where patients are supported to consider options, to achieve appropriate treatment can help to shape EBM for this group of patients.In this article, we provide tools for finding relevant literature for the geriatric patient population and for shaping the SDM process to achieve personalized care.     

Dissemination of evidence-based standards of care

Standards of care pertain to crafting and implementing patient-centered treatment interventions. Standards of care must take into consideration the patient's gender, ethnicity, medical and dental history, insurance coverage (or socioeconomic level, if a private patient), and the timeliness of the targeted scientific evidence. This resolves into a process by which clinical decision-making about the optimal patient-centered treatment relies on the best available research evidence, and all other necessary inputs and factors to provide the best possible treatment. Standards of care must be evidence-based, and not merely based on the evidence - the dichotomy being critical in contemporary health services research and practice. Evidence-based standards of care must rest on the best available evidence that emerges from a concerted hypothesis-driven process of research synthesis and meta-analysis. Health information technology needs to become an every-day reality in health services research and practice to ensure evidence-based standards of care. Current trends indicate that user-friendly methodologies, for the dissemination of evidence-based standards of care, must be developed, tested and distributed. They should include approaches for the quantification and analysis of the textual content of systematic reviews and of their summaries in the form of critical reviews and lay-language summaries.     

The Evidence Based Medicine approach to diagnostic testing: practicalities and limitations

Evidence-Based Medicine (EBM) has become a popular approach to medical decision making and is increasingly part of undergraduate and postgraduate medical education. EBM follows four steps: 1. formulate a clear clinical question from a patient's problem; 2. search the literature for relevant clinical articles; 3. evaluate (critically appraise) the evidence for its validity and usefulness; 4. implement useful findings into clinical practice. This review describes the concepts, terminology and skills taught to attendees at EBM courses, focusing specifically on the approach taken to diagnostic questions. It covers how to ask an answerable clinical question, search for evidence, construct diagnostic critically appraised topics (CATs), and use sensitivity, specificity, likelihood ratios, kappa and phi statistics. It familiarises readers with the lexicon and techniques of EBM and allows better understanding of the needs of EBM practitioners.     

Community-equipoise and the ethics of randomized clinical trials

This paper critically examines a particular strategy for resolving the central ethical dilemma associated with randomized clincial trials (RCTs) -- the "community equipoise" strategy (CE). The dilemma is that RCTs appear to violate a physician's duty to choose that therapy which there is most reason to believe is in the patient's best interest, randomizing patients even once evidence begins to favor one treatment. The community equipose strategy involves the suggestion that our judgment that neither treatment is to be preferred (that there obtains a state of "equipoise") is to be assessed according to a community rather than an individual standard. Thus, though a physician may personally believe that there is some reason to prefer one treatment, patients can legitimately be randomized if there remains disagreement in the community of medical professionals. Rationales in favor of this conception include the following: (i) medical knowledge is best understood as residing in the community, (ii) the judgments of others count as evidence, and so should change one's own opinion, (iii) subjects would not be better off outside the trial, and (iv) the point of any trial is the resolution of dispute in the medical community. I critically examine these rationales and argue that they are insufficient. Amongst the problems are tensions between various of these underlying rationales, and important ambiguities in just what the CE criterion is to amount to. Finally, I argue that even if use of CE was justified, it would not justify carrying out RCTs anywhere near long enough to discharge our duty to gain reliable knowledge on which to base safe and effective medical practice. Hence, we need some different justification for carrying out RCTs.     

Norwegian Physicians' Knowledge of and Opinions about Evidence-Based Medicine: Cross-Sectional Study

Objective

To answer five research questions: Do Norwegian physicians know about the three important aspects of EBM? Do they use EBM methods in their clinical practice? What are their attitudes towards EBM? Has EBM in their opinion changed medical practice during the last 10 years? Do they use EBM based information sources?

Design

Cross sectional survey in 2006.

Setting

Norway.

Participants

966 doctors who responded to a questionnaire (70% response rate).

Results

In total 87% of the physicians mentioned the use of randomised clinical trials as a key aspect of EBM, while 53% of them mentioned use of clinical expertise and only 19% patients'' values. 40% of the respondents reported that their practice had always been evidence-based. Many respondents experienced difficulties in using EBM principles in their clinical practice because of lack of time and difficulties in searching EBM based literature. 80% agreed that EBM helps physicians towards better practice and 52% that it improves patients'' health. As reasons for changes in medical practice 86% of respondents mentioned medical progress, but only 39% EBM.

Conclusions

The results of the study indicate that Norwegian physicians have a limited knowledge of the key aspects of EBM but a positive attitude towards the concept. They had limited experience in the practice of EBM and were rather indifferent to the impact of EBM on medical practice. For solving a patient problem, physicians would rather consult a colleague than searching evidence based resources such as the Cochrane Library.     

循证医学在慢性充血性心力衰竭药物治疗中的应用

循证医学(evidence-based medicine,EBM)是近年来国际临床医学领域迅速发展起来的新学科,强调"为每位病人作出医疗决定时,应明确而仔细地使用现有的最好证据"。本文利用循证医学的方法,参照若干著名的大规模多中心的随机对照试验(ran- domized controlled trial,RCT)来评估目前几类临床常用药物在治疗慢性充血性心力衰竭中的作用,试图找出针对不同NYHA等级患者的最佳治疗建议。     

The role of basic science in evidence-based medicine

Proponents of Evidence-based medicine (EBM) do not provide a clear role for basic science in therapeutic decision making. Of what they do say about basic science, most of it is negative. Basic science resides on the lower tiers of EBM’s hierarchy of evidence. Therapeutic decisions, according to proponents of EBM, should be informed by evidence from randomised studies (and systematic reviews of randomised studies) rather than basic science. A framework of models explicates the links between the mechanisms of basic science, experimental inquiry, and observed data. Relying on the framework of models I show that basic science often plays a role not only in specifying experiments, but also analysing and interpreting the data that is provided. Further, and contradicting what is implied in EBM’s hierarchy of evidence, appeals to basic science are often required to apply clinical research to therapeutic questions.     

From Evidence to Best Practice in Laboratory Medicine

Laboratory tests offer value if they provide benefit to patients at acceptable costs. Laboratory testing is one of the most widely used diagnostic interventions supporting medical decisions, yet evidence demonstrating its value and impact on health outcomes is limited. This contributes to wide variations in test utilisation including underdiagnosis, overdiagnosis and misdiagnosis, which may impact the quality and the clinical- and cost-effectiveness of care and patient safety. Therefore implementing evidence into the care of patients is a moral and social imperative to laboratory professionals and all health care staff.This review investigates the reasons research does not get into practice, or only does with a very long delay. Apart from reviewing the common barriers to implementation, it also discusses the drivers of inappropriate test utilisation. By reviewing the theoretical and practical aspects of implementation science, recommendations are made for approaches that are thought to be most effective and that can be adopted to close the gap between evidence and practice, and to facilitate evidence-based laboratory medicine. Passive dissemination of the evidence and educational interventions are insufficient and do not offer sustainable solutions. A multifaceted and individualised implementation strategy, including individually tailored academic detailing, reminder systems, clinical decision support systems, feedback on performance, and participation of doctors and laboratory professionals in quality improvement activities addressing test selection and interpretation and in clinical audits, has greater potential for success. Examples of these initiatives at the laboratory and clinical interface are provided with links to valuable resources.

‘Knowing is not enough; we must apply.Willing is not enough; we must do.’JW von Goethe

     

Ethics and evidence-based medicine: is there a conflict?

This article addresses the advantages, disadvantages, and traps to which evidence-based medicine (EBM) may lead and suggests that, to be ethically valid, EBM must be aimed at the patient's best interests and not at the financial interests of others. While financial considerations are by no means trivial, it is hypocritical - if not dangerous - to hide them behind words like "evidence" or "quality."     

Beyond EBM: new directions for evidence-based public health

Public health researchers, policy makers, and practitioners agree that health is the outcome of interactions between biological, behavioral, and social determinants. Nonetheless, institutional patterns of research funding and practice remain obstacles to generating research at and between each of these levels. These practices are embedded in historic assumptions about the nature of reality and how it can best be understood. Current debates over the criteria for evaluating public health research have centered on the applicability of the clinical evidence-based medicine (EBM) model to the field of public health. The EBM hierarchy, which is based on traditional scientific assumptions about causality, is insufficient and potentially harmful as the basis for evaluating research on the determinants of health. Yet those who have put forward a critique of EBM have failed to develop a plausible alternative. Critical realism, based on the philosophy of Roy Bhaskar, may provide a way out of the current stalemate, enabling public health researchers from various disciplines and research paradigms to work together, bringing the full weight of scientific knowledge to bear on increasingly complex and global public health problems.     

八年制医学生妇产科临床实习教学法探讨

八年制医学生临床实习是理论应用于临床实践的过程,是八年制医学生教学的重点。传统”填鸭式”的教学方法限制了八年制医学生的进一步发展,不能满足高素质教育的要求。PBL教学法是以问题为基础的教学方法。大多研究表明,PBL影响知识的应用而不影响知识的获得,而EBM一循证医学的思维恰好是医学生获取知识的最佳指导思想。本文将PBL教学法和EBM思维结合到八年制医学生妇产科实际临床教学中发现,虽然在理论考试成绩上无明显差异,但在临床病例分析能力、临床证据采集能力、教学方式满意程度等方面均优于仅用PBL或者是仅用EBM的教学组。PBL教学法联合EBM思维更能提高八年制医学生分析问题、解决问题的能力,值得进一步推广应用。     

On-the-Job Evidence-Based Medicine Training for Clinician-Scientists of the Next Generation

Clinical scientists are at the unique interface between laboratory science and frontline clinical practice for supporting clinical partnerships for evidence-based practice. In an era of molecular diagnostics and personalised medicine, evidence-based laboratory practice (EBLP) is also crucial in aiding clinical scientists to keep up-to-date with this expanding knowledge base. However, there are recognised barriers to the implementation of EBLP and its training. The aim of this review is to provide a practical summary of potential strategies for training clinician-scientists of the next generation.Current evidence suggests that clinically integrated evidence-based medicine (EBM) training is effective. Tailored e-learning EBM packages and evidence-based journal clubs have been shown to improve knowledge and skills of EBM. Moreover, e-learning is no longer restricted to computer-assisted learning packages. For example, social media platforms such as Twitter have been used to complement existing journal clubs and provide additional post-publication appraisal information for journals.In addition, the delivery of an EBLP curriculum has influence on its success. Although e-learning of EBM skills is effective, having EBM trained teachers available locally promotes the implementation of EBM training. Training courses, such as Training the Trainers, are now available to help trainers identify and make use of EBM training opportunities in clinical practice. On the other hand, peer-assisted learning and trainee-led support networks can strengthen self-directed learning of EBM and research participation among clinical scientists in training. Finally, we emphasise the need to evaluate any EBLP training programme using validated assessment tools to help identify the most crucial ingredients of effective EBLP training.In summary, we recommend on-the-job training of EBM with additional focus on overcoming barriers to its implementation. In addition, future studies evaluating the effectiveness of EBM training should use validated outcome tools, endeavour to achieve adequate power and consider the effects of EBM training on learning environment and patient outcomes.     

Medicine, methodology, and values: trade-offs in clinical science and practice

The current guidelines of evidence-based medicine (EBM) presuppose that clinical research and clinical practice should advance from rigorous scientific tests as they generate reliable, value-free knowledge. Under this presupposition, hypotheses postulated by doctors and patients in the process of their decision making are preferably tested in randomized clinical trials (RCTs), and in systematic reviews and meta-analyses summarizing outcomes from multiple RCTs. Since testing under this scheme is predominantly focused on the criteria of generality and precision achieved through methodological rigor, at the cost of the criterion of realism, translating test results to clinical practice is often problematic. Choices concerning which methodological criteria should have priority are inevitable, however, as clinical trials, and scientific research in general, cannot meet all relevant criteria at the same time. Since these choices may be informed by considerations external to science, we must acknowledge that science cannot be value-free in a strict sense, and this invites a more prominent role for value-laden considerations in evaluating clinical research. The urgency for this becomes even more apparent when we consider the important yet implicit role of scientific theories in EBM, which may also be subjected to methodological evaluation and for which selectiveness in methodological focus is likewise inevitable.     

The randomized controlled trial: gold standard, or merely standard?

The randomized controlled trial (RCT) is not a gold standard: it is a good experimental design in some circumstances, but that's all. Potential shortcomings in the design and implementation of RCTs are often mentioned in passing, yet most researchers consider that RCTs are always superior to all other types of evidence. This paper examines the limitations of RCTs and shows that some types of evidence commonly supposed to be inferior to all RCTs are actually superior to many. This has important consequences for research methodology, for quality of care in clinical medicine, and--especially--for research funding policy. Because every study design may have problems in particular applications, studies should be evaluated by appropriate criteria, and not primarily according to the simplistic RCT/non-RCT dichotomy promoted by some prominent advocates of the evidence-based medicine movement and by the research evaluation guidelines based on its principles.