From hierarchy to network: a richer view of evidence for evidence-based medicine

Evidence-based medicine (EBM) advocates the improvement of patient care through the use of current best research evidence in medical decision making. In practice, "best evidence" generally refers to where a study fits on a hierarchy of evidence, which places randomized controlled trials (RCTs) and other population-level research above laboratory research. Because population research is concerned primarily with average results obtained from large groups of people, ranking evidence on the basis of its place in the hierarchy is shortsighted and ultimately limits the ability of research results to inform the care of individual patients. The history and methodology of epidemiology reveals a close relationship between population-level and laboratory research; both types of research are necessary if we are to understand the causes of a disease. What EBM does not take into account in its hierarchy of evidence is that the same thing is true for research on the safety and efficacy of medical interventions. To maximize the information that clinical research can provide for clinical care, RCTs should be designed to elucidate within-group variability. This can only be done if the hierarchy of evidence is replaced by a network that takes into account the relationship between epidemiological and laboratory research.     

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.     

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.     

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.     

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)     

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).     

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.     

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.     

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.     

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.     

Media Coverage,Journal Press Releases and Editorials Associated with Randomized and Observational Studies in High-Impact Medical Journals: A Cohort Study

Background

Publication of clinical research findings in prominent journals influences health beliefs and medical practice, in part by engendering news coverage. Randomized controlled trials (RCTs) should be most influential in guiding clinical practice. We determined whether study design of clinical research published in high-impact journals influences media coverage.

Methods and Findings

We compared the incidence and amount of media coverage of RCTs with that of observational studies published in the top 7 medical journals between 1 January 2013 and 31 March 2013. We specifically assessed media coverage of the most rigorous RCTs, those with >1000 participants that reported ‘hard’ outcomes. There was no difference between RCTs and observational studies in coverage by major newspapers or news agencies, or in total number of news stories generated (all P>0.63). Large RCTs reporting ‘hard’ outcomes did not generate more news coverage than small RCTs that reported surrogate outcomes and observational studies (all P>0.32). RCTs were more likely than observational studies to attract a journal editorial (70% vs 46%, P = 0.003), but less likely to be the subject of a journal press release (17% vs 50%, P<0.001). Large RCTs that reported ‘hard’ outcomes did not attract an editorial more frequently than other studies (61% vs 58%, P>0.99), nor were they more likely to be the subject of a journal press release (14% vs 38%, P = 0.14).

Conclusions

The design of clinical studies whose results are published in high-impact medical journals is not associated with the likelihood or amount of ensuing news coverage.     

Looking for rules in a world of exceptions: reflections on evidence-based practice

After more than a decade, evidence-based medicine (EBM) is well established as an important influence in health care. EBM has engendered a wide range of responses from near-evangelical fervor to angered rejection, with supporters convinced of its scientific superiority and detractors of its needless reductionism. EBM is not a philosophical doctrine, and its originators and proponents have, for the most part, ignored critics and foresworn theorizing. However, EBM claims to be a normative guide to being a better physician. The theoretical, practical, and philosophical dimensions of EBM are intimately intertwined. This essay is a sustained reflection on the issues raised by EBM as experienced by a clinician/teacher who has tried to apply the tenets of EBM in clinical care and teaching over the past decade, and who has sought to expand the borders of EBM from a philosophical point of view.     

Reflections on humanizing biomedicine

Although biomedicine is responsible for the "miracles" of modern medicine, paradoxically it has also led to a quality-of-care crisis in which many patients feel disenfranchised from the health-care industry. To address this crisis, several medical commentators make an appeal for humanizing biomedicine, which has led to shifts in the philosophical boundaries of medical knowledge and practice. In this paper, the metaphysical, epistemological, and ethical boundaries of biomedicine and its humanized versions are investigated and compared to one another. Biomedicine is founded on a metaphysical position of mechanistic monism, an epistemology of objective knowing, and an ethic of emotionally detached concern. In humanizing modern medicine, these boundaries are often shifted to a metaphysical position of dualism/holism, an epistemology of subject knowing, and an ethic of empathic care. In a concluding section, the question is discussed whether these shifts in the philosophical boundaries are adequate to resolve the quality-of-care crisis.     

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。     

Medical students' application of published evidence: randomised trial

ObjectivesTo determine how medical students apply research evidence that varies in validity of methods and importance of results to a clinical decision.DesignStudents examined a standardised patient with a whiplash injury, decided whether to order a cervical spine radiograph, and rated their confidence in their decision. They then read one of four randomly assigned variants of a structured abstract from a study of a decision rule that argued against such a procedure in this patient. Variants factorially combined two levels of validity of methods (prospective cohort or chart review) with two levels of importance of results (high sensitivity or high specificity rule). After reading the abstract, students repeated their choice and rated their confidence.SettingAcademic medical centre in the United States.Participants164 graduating medical students.ResultsWhen abstracts were of low importance students were more likely to shift their beliefs in favour of radiography, which was not supported by the evidence (odds ratio 3.42, 95% confidence interval 1.10 to 10.66). Neither methodological validity nor the interaction between validity and importance influenced decision shift. Few students acquired all necessary clinical data from the patient.ConclusionsAlthough the students could apply concepts of diagnostic testing, greater focus is needed on appraisal of validity and application of evidence to a particular patient.

What is already known on this topic

Evidence based medicine is increasingly emphasised and taught in medical schoolsFew studies have assessed the ability of physicians to apply literature findings to clinical decisions

What this paper adds

In making decisions about ordering investigations during a standardised patient exam students were sensitive to the importance of resultsThis effect was not moderated by validity of the study that produced the results or whether the students had collected enough information to apply the results     

Osteoarthritis and nutrition. From nutraceuticals to functional foods: a systematic review of the scientific evidence

The scientific and medical community remains skeptical regarding the efficacy of nutrition for osteoarthritis despite their broad acceptation by patients. In this context, this paper systematically reviews human clinical trials evaluating the effects of nutritional compounds on osteoarthritis. We searched the Medline, Embase, and Biosis databases from their inception to September 2005 using the terms random, double-blind method, trial, study, placebo, and osteoarthritis. We selected all peer-reviewed articles reporting the results of randomised human clinical trials (RCTs) in osteoarthritis that investigated the effects of oral interventions based on natural molecules. Studies on glucosamine and chondroitin sulfate were excluded. The quality of the RCTs was assessed with an osteoarthritic-specific standardised set of 12 criteria and a validated instrument. A best-evidence synthesis was used to categorise the scientific evidence behind each nutritional compound as good, moderate, or limited. A summary of the most relevant in vitro and animal studies is used to shed light on the potential mechanisms of action. Inclusion criteria were met by 53 RCTs out of the 2,026 identified studies. Good evidence was found for avocado soybean unsaponifiables. Moderate evidence was found for methylsulfonylmethane and SKI306X, a cocktail of plant extracts. Limited evidence was found for the Chinese plant extract Duhuo Jisheng Wan, cetyl myristoleate, lipids from green-lipped mussels, and plant extracts from Harpagophytum procumbens. Overall, scientific evidence exists for some specific nutritional interventions to provide symptom relief to osteoarthritic patients. It remains to be investigated whether nutritional compounds can have structure-modifying effects.     

WHAT DOES RESPECT FOR THE PATIENT'S AUTONOMY REQUIRE?

Personal autonomy presupposes the notion of rationality. What is not so clear is whether, and how, a compromise of rationality to various degrees will diminish a person's autonomy. In bioethical literature, three major types of threat to the rationality of a patient's medical decision are identified: insufficient information, irrational beliefs/desires, and influence of different framing effects. To overcome the first problem, it is suggested that patients be provided with information about their diseases and treatment choices according to the objective standard. I shall explain how this should be finessed. Regarding the negative impact of irrational beliefs/desires, some philosophers have argued that holding irrational beliefs can still be an expression of autonomy. I reject this argument because the degree of autonomy of a decision depends on the degree of rationality of the beliefs or desires on which the decision is based. Hence, to promote patient autonomy, we need to eliminate irrational beliefs by the provision of evidence and good arguments. Finally, I argue that the way to smooth out the framing effects is to present the same information in different perspectives: it is too often assumed that medical information can always be given in a complete and unadorned manner. This article concludes with a cautionary note that the protection of patient autonomy requires much more time and effort than the current practice usually allows.     

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.     

A Clinically Integrated Post-Graduate Training Programme in Evidence-Based Medicine versus ‘No Intervention’ for Improving Disability Evaluations: A Cluster Randomised Clinical Trial

Background

Although several studies have shown that teaching EBM is effective in improving knowledge, at present, there is no convincing evidence that teaching EBM also changes professional behaviour in practice. Therefore, the primary aim of this study was to evaluate the effectiveness of a clinically integrated post-graduate training programme in EBM on evidence-based disability evaluation.

Methods and Findings

In a cluster randomised controlled trial, fifty-four case-based learning groups consisting of 132 physicians and 1680 patients were randomly assigned to the intervention or control groups. A clinically integrated, post-graduate, 5-day training programme in evidence-based medicine, consisting of (home) assignments, peer teaching, interactive training in searching databases, lectures and brainstorming sessions was provided to the intervention group. The control group received no training. The primary outcome was evidence-based disability evaluation, as indicated by the frequency in use of evidence of sufficient quality in disability evaluation reports. There are no general EBM behaviour outcome measures available. Therefore, we followed general guidelines for constructing performance indicators and defined an a priori cut-off for determination of sufficient quality as recommended for evaluating EB training. Physicians trained in EBM performed more evidence-based disability evaluations compared to physicians in the control group (difference in absolute proportion 9.7%, 95% CI 3.5 to 15.9). The primary outcome differences between groups remained significant after both cluster-adjusted analysis and additional sensitivity analyses accounting for subjects lost to follow-up.

Conclusions

A EBM programme successfully improved the use of evidence in a non-hospital based medical specialty. Our findings support the general recommendations to use multiple educational methods to change physician behaviour. In addition, it appeared important that the professional context of the intervention was very supportive in the sense that searches in databases, using and applying guidelines and other forms of evidence are considered standard practice and are encouraged by colleagues and management.