‘One mission accomplished,more important ones remain’: commentary on Every‐Palmer,S., Howick,J. (2014) How evidence‐based medicine is failing due to biased trials and selective publication. Journal of Evaluation in Clinical Practice, 20 (6), 908–914

Every‐Palmer and Howick suggest that evidence‐based medicine (EBM) is failing in its mission because of contamination of research by manufacturer and researcher‐motivated bias and self‐interest. They fail to define that mission and to distinguish between the EBM movement and the research enterprise it was developed to critique. An educational movement, EBM accomplished its mission to simplify and package clinical epidemiological concepts in a form accessible to clinical learners. Its wide adoption within educational circles fostered critical literacy among several generations of practitioners. Illumination of bias, subterfuge and incomplete reporting of research has been a strength of EBM. Increased uptake and use of clinical research within the health care system properly defines the failing mission that eludes Every‐Palmer and Howick. Responsibility for failure to make progress towards its achievement is shared by virtually all relevant streams within the system, including policy, clinical guideline development, educational movements and the development of approaches to evidence synthesis. Discordance between the epistemological premises pervading today's research and health care community and the complex social processes that ultimately determine research use constitutes an important factor that must be addressed as part of a remedy. Enhanced emphasis on and demonstration of alternative approaches to research such as realism and realist synthesis and the momentum towards development of a learning health care system hold promise as guideposts for the rapidly evolving health care environment.     

Evidence-based medicine: arguments for and against

In this article I will discuss the various definitions of evidence-based medicine (EBM), and summarize the application, criticisms and limitations of EBM. The spectrum of evidence, from pathophysiological inference to randomized controlled trials, will be presented as a mechanism for filtering bias with more rigorous evidence being required when bias is more likely. Although randomized controlled trials and meta-analyses are at the top of the evidence hierarchy, they are not always necessary, might not be the most appropriate forms of evidence for some clinical questions, and have their own limitation that need to be understood. Best available evidence, applied to individual patients, is the corner stone of EBM. Although there are valid criticisms and limitations of EBM, if these are understood then the practice of EBM can provide guidance to the clinician and enhance patient care.     

Evidence-based medicine: revisiting the pyramid of priorities

Evidence-based medicine (EBM) is beset with numerous problems. In addition to the fact that varied audiences have each customarily sought differing types of evidence, EBM traditionally incorporated a hierarchy of clinical research designs, placing systematic reviews and meta-analyses at the pinnacle. Yet the canonical pyramid of EBM excludes numerous sources of research information, such as basic research, epidemiology, and health services research. Models of EBM commonly used by third party payers have ignored clinical judgment and patient values and expectations, which together form a tripartite and more realistic guideline to effective clinical care. Added to this is the problem in which enhanced placebo treatments in experimentation may obscure verum effects seen commonly in practice. Compounding the issue is that poor systematic reviews which comprise a significant portion of EBM are prone to subjective bias in their inclusion criteria and methodological scoring, shown to skew outcomes. Finally, the blinding concept of randomized controlled trials is particularly problematic in applications of physical medicine. Examples from the research literature in physical medicine highlight conclusions which are open to debate. More progressive components of EBM are recommended, together with greater recognition of the varying audiences employing EBM.     

Mechanistic understanding in clinical practice: complementing evidence‐based medicine with personalized medicine

In the last century, medicine has undergone an unprecedented wave of radical changes. From the implementation of surgery up to the development of single gene‐targeted therapies, clinical decision making has become increasingly complex to handle. Today, this complexity needs to be rethought in the light of two emerging paradigms: evidence‐based medicine (EBM) and personalized medicine (P‐Med). The new availability of diverse sources of scientific evidence raises significant issues concerning how clinicians will compare, evaluate and orient their decisions in front of a rapidly growing plethora of therapies, procedures, medical technologies and drugs. In this paper, we compare the background visions behind these two paradigms, evaluating their respective relevance for present and future clinical decision making. In particular, we argue that EBM and P‐Med are driven by two diverse modes of reasoning about ‘evidence making’ in medicine. EBM is grounded on statistical notions and epidemiological data, generally gathered through systematic meta‐reviews of randomized controlled trials; P‐Med, instead, is grounded on mechanistic explanations of molecular interactions, metabolic pathways and biomarkers. While both paradigms are epistemically sound, we argue that they cannot, and should not, be hybridized into a unique model. Rather, they ought to represent two compatible, but alternative ways of informing the clinical practice. Hence, we conclude that clinicians may expect to see their responsibility increasing as they will deal with diverse, but equally compelling, ways of reasoning and deciding about which intervention will qualify as the ‘best one’ in each individual case.     

Beyond evidence-based medicine: bridge-building a medicine of meaning

Contesting that a debate on evidence-based health care has taken place, this article charts three paths to the future: continuing avoidance of debate by proponents of evidence-based medicine (EBM); conflict, which the EBM movement courts and critics have espoused, and dialogue. The last portal allows for integration, which would end the disagreement between EBM and its critics and make a debate unnecessary. In search of integration, I sketch a bridge whose construction requires not compromise but a win- win approach. The bridge is a medicine of meaning (MOM). Consolidating multiple pillars of evidence to unify questions that are not necessarily the same for protagonists and critics of EBM, a MOM contends that the purpose or meaning of medicine is always healing and helping, and each party finds meaning in medicine by contributing to this common purpose in its own distinctive way.     

The judgements that evidence‐based medicine adopts

In “The evidence that evidence‐based medicine omits”, Brendan Clarke and colleagues argue that when establishing causal facts in medicine, evidence of mechanisms ought to be included alongside evidence of correlations. One of the reasons they provide is that correlations can be spurious and generated by unknown confounding variables. A causal mechanism can provide a plausible explanation for the correlation, and the absence of such an explanation is an indication that the correlation is not causal. Evidence‐based medicine (EBM) proponents remain sceptical about this argument, one problem being that the formulation of a mechanism requires judgements that are external to the evaluation of data and experimental designs—for instance judgements of plausibility against, or derivability from, background knowledge. Because background knowledge is always incomplete and therefore unreliable, EBM proponents maintain that the plausibility of a hypothesis should be evaluated mainly by the quality of population data that yielded it. Here, I use the example of oestrogen replacement therapy's effect on coronary heart disease, an example that is often quoted in defence of the epistemic advantage of randomized controlled trials, to show that the evaluation of the most reliable study design necessarily implies the adoption of judgements that are external to the specific evidence of correlation. The exclusion of evidence of mechanism, therefore, is not effective in bypassing paradigm‐dependent judgements, which are external to specific evidence. Because such judgements cannot be excluded by evidence evaluation, they can only be kept under scrutiny, or adopted uncritically. I propose that the latter option can hinder the maintenance of an active critical inquiry, as well as the analysis of experts' disagreement.     

Challenging the epistemological foundations of EBM: what kind of knowledge does clinical practice require?

This paper raises questions about the epistemological foundations of evidence‐based medicine (EBM). We argue that EBM is based upon reliabilist epistemological assumptions, and that this is appropriate – we should focus on identifying the most reliable processes for generating and collecting medical knowledge. However, we note that this should not be reduced to narrow questions about which research methodologies are the best for gathering evidence. Reliable processes for generating medical evidence might lie outside of formal research methods. We also question the notion of the knower that is assumed by EBM. We argue that EBM assumes an enlightenment conception of knowers as autonomous, substitutable individuals. This conception is troubled by the way that clinicians learn the role of anecdote in health care and the role of patient choice, all of which bring into play features of clinicians and patients as situated individuals with particular backgrounds and experiences. EBM's enlightenment conception of the knower is also troubled by aspects of the way evidence is produced. Given these limitations, we argue that EBM should retain its reliabilist bent, but should look beyond formal research methodologies in identifying processes that yield reliable evidence for clinical practice. We suggest looking to feminist epistemology, with its focus on the standpoints of individual situated knowers, and the role of social context in determining what counts as knowledge.     

循证医学实践与干部医疗保健工作

循证医学实践在临床工作中已取得一定经验，采用循证医学的原理和方法指导干部和老年人群的医疗保健工作是一项全新的课题。不仅对临床医生认识疾病诊治和判断疗效及预后，建立客观合理的健康保健计划具有指导意义。对保健对象获取科学先进的预防保健知识，认知疾病治疗目标和预后，避免不合理和不必要的医疗负荷具有重要意义。同时对卫生行政部门的医疗保健决策也有一定的参考意义。     

Mechanisms: what are they evidence for in evidence‐based medicine?

Even though the evidence‐based medicine (EBM) movement labels mechanisms a low quality form of evidence, consideration of the mechanisms on which medicine relies, and the distinct roles that mechanisms might play in clinical practice, offers a number of insights into EBM itself. In this paper, I examine the connections between EBM and mechanisms from several angles. I diagnose what went wrong in two examples where mechanistic reasoning failed to generate accurate predictions for how a dysfunctional mechanism would respond to intervention. I then use these examples to explain why we should expect this kind of mechanistic reasoning to fail in systematic ways, by situating these failures in terms of evolved complexity of the causal system(s) in question. I argue that there is still a different role in which mechanisms continue to figure as evidence in EBM: namely, in guiding the application of population‐level recommendations to individual patients. Thus, even though the evidence‐based movement rejects one role in which mechanistic reasoning serves as evidence, there are other evidentiary roles for mechanistic reasoning. This renders plausible the claims of some critics of EBM who point to the ineliminable role of clinical experience. Clearly specifying the ways in which mechanisms and mechanistic reasoning can be involved in clinical practice frames the discussion about EBM and clinical experience in more fruitful terms.     

How evidence‐based medicine is failing due to biased trials and selective publication

Evidence‐based medicine (EBM) was announced in the early 1990s as a ‘new paradigm’ for improving patient care. Yet there is currently little evidence that EBM has achieved its aim. Since its introduction, health care costs have increased while there remains a lack of high‐quality evidence suggesting EBM has resulted in substantial population‐level health gains. In this paper we suggest that EBM's potential for improving patients' health care has been thwarted by bias in the choice of hypotheses tested, manipulation of study design and selective publication. Evidence for these flaws is clearest in industry‐funded studies. We argue EBM's indiscriminate acceptance of industry‐generated ‘evidence’ is akin to letting politicians count their own votes. Given that most intervention studies are industry funded, this is a serious problem for the overall evidence base. Clinical decisions based on such evidence are likely to be misinformed, with patients given less effective, harmful or more expensive treatments. More investment in independent research is urgently required. Independent bodies, informed democratically, need to set research priorities. We also propose that evidence rating schemes are formally modified so research with conflict of interest bias is explicitly downgraded in value.     

Evidence databases application: comparison of university faculties versus clinical residents in a developing country

Rationale, aims and objectives One of the main barriers against the implementation of evidence‐based medicine (EBM) is the lack of search skills, an element that affects the finding of the best available evidence. Faculty staff should be capable of using the best evidence in practice and of teaching students to implement EBM elements. They should be familiar with search strategies and evidence databases. The aim of this study is to compare the application of evidence databases by faculties and by residents with no training in this field. Methods Two hundred fifty‐seven faculties and first‐year residents of the Tabriz University of Medical Sciences filled out a valid self‐administered questionnaire on information‐seeking behaviour from August 2008 to June 2010. A chi‐square test was used to compare the variables. Results There were 52.1% of the respondents who were faculty members and 47.9% were residents. Only 8.7% used the Internet for their practice mostly. While Google was the most used resource, TRIP and Cochrane were less used. Significantly, the faculties used these resources more than the residents in both cases. Furthermore, two‐thirds of the participants were unfamiliar with medical subject headings (MeSH), and only 14.5% consulted a clinical librarian for help. Conclusion Significantly, clinicians used evidence databases and online resources minimally for their practice. Additionally, as the faculties used EBM resources more than the residents, this programme should be considered for inclusion in the curricula of medical schools.     

Evidence-based management: a literature review

This paper presents a review of evidence-based management (EBM), exploring whether management activities within healthcare have been, or can be, subject to the same scientific framework as clinical practice. The evidence-based approach was initially examined, noting the hierarchy of evidence ranging from randomized control trials to clinical anecdote. The literature varied in its degree of criticism of this approach; the most common concern referring to the assumed superiority of positivism. However, evidence-based practice was generally accepted as the best way forward. Stewart (1998) offered the only detailed exposition of EBM, outlining a necessary 'attitude of mind' both for EBM and for the creation of a research culture. However, the term 'clinical effectiveness' emerged as a possible replacement buzz-word for EBM (McClarey 1998). The term appears to encompass the sentiments of the evidence-based approach, but with a concomitant concern for economic factors. In this paper the author has examined the divide between those who viewed EBM as an activity for managers to make their own practice accountable and those who believed it to be a facilitative practice to help clinicians with evidence-based practice. Most papers acknowledged the limited research base for management activities within the health service and offered some explanation such as government policy constraints and lack of time. Nevertheless, the overall emphasis is that ideally there should be a management culture firmly based in evidence.     

Technology‐induced bias in the theory of evidence‐based medicine

Designing trials and studies to minimize confounding and bias is central to evidence‐based medicine (EBM). The widespread use of recent technologies such as machine learning, smartphones, and the World Wide Web to collect, analyse, and disseminate information can improve the efficiency, reliability, and availability of medical research. However, it also has the potential to introduce new sources of significant, technology‐induced evidential bias. This paper assesses the extent of the impact by reviewing some of the methods by and principles according to which evidence is collected, analysed, and disseminated in EBM, supported by specific examples. It considers the effect of personal health tracking via smartphones, the current proliferation of research data and the influence of search engine “filter bubbles”, the possibility of machine learning‐driven study design, and the implications of using machine learning to seek patterns in large quantities of data, for example from observational studies and medical record databases. It concludes that new technology may introduce profound new sources of bias that current EBM frameworks do not accommodate. It also proposes new approaches that could be incorporated in to EBM theory to mitigate the most obvious risks, and suggests where further assessment of the practical implications is needed.     

The need for a rationalist turn in evidence‐based medicine

When evidence‐based medicine (EBM) became established, its dominant rhetoric was empiricist, in spite of rationalist elements in its practice. Exploring some of the key statements about EBM down the years, the paper examines the tensions between empiricism and rationalism and argues for a rationalist turn in EBM to help to develop the next generation of scholarship in the field.     

Evidence‐based medicine meets person‐centred care: a collaborative perspective on the relationship

In a recent list‐serve, the way forward for evidence‐based medicine was discussed. The purpose of this paper was to share the reflections and multiple perspectives discussed in this peer‐to‐peer encounter and to invite the reader to think with a mind for positive change in the practice of health care. Let us begin with a simple question. What if we dared to look at evidence‐based medicine (EBM) and informed shared decision making like two wheels on a bike? They both need to be full of substance, well connected, lubricated and working in balance, propelled and guided by a competent driver, with good vision to get the bike where we want it to go. We need all the tools in the toolkit for the bike to stay operational and to meet the needs of the driver. By the same rationale, evidence alone is necessary but not sufficient for decision making; values are necessary and if neglected, may default to feelings based on social pressures and peer influence. Medical decisions, even shared ones, lack focus without evidence and application. Just as a bike may need a tune up from time to time to maintain optimal performance, EBM may benefit from a tune up where we challenge ourselves to move away from general assumptions and traditions and instead think clearly about the issues we face and how to ask well‐formed, specific questions to get the answers to meet the needs we face in health care.     

Evidence‐based medicine: A cornerstone for clinical care but not for quality improvement

Quality improvement (QI) as a clinical improvement science has been criticized for failing to deliver broad patient outcome improvement and for being a top‐down regulatory and compliance construct. These critics have argued that the focus of QI should be on increasing adherence to clinical practice guidelines (CPGs) and, as a result, should be consolidated into research structures with the science of evidence‐based medicine (EBM) at the helm. We argue that EBM often overestimates the role of knowledge as the root cause of quality problems and focuses almost exclusively on the effectiveness of care while often neglecting the domains of safety, efficiency, patient‐centredness, and equity. Successfully addressing quality problems requires a much broader, systems‐based view of health‐care delivery. Although essential to clinical decision‐making and practice, EBM cannot act as the cornerstone of health system improvement.