‘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.     

Corroborating evidence‐based medicine

Proponents of evidence‐based medicine (EBM) have argued convincingly for applying this scientific method to medicine. However, the current methodological framework of the EBM movement has recently been called into question, especially in epidemiology and the philosophy of science. The debate has focused on whether the methodology of randomized controlled trials provides the best evidence available. This paper attempts to shift the focus of the debate by arguing that clinical reasoning involves a patchwork of evidential approaches and that the emphasis on evidence hierarchies of methodology fails to lend credence to the common practice of corroboration in medicine. I argue that the strength of evidence lies in the evidence itself, and not the methodology used to obtain that evidence. Ultimately, when it comes to evaluating the effectiveness of medical interventions, it is the evidence obtained from the methodology rather than the methodology that should establish the strength of the evidence.     

Reconciling evidence‐based medicine and patient‐centred care: defining evidence‐based inputs to patient‐centred decisions

Evidence‐based and patient‐centred health care movements have each enhanced the discussion of how health care might best be delivered, yet the two have evolved separately and, in some views, remain at odds with each other. No clear model has emerged to enable practitioners to capitalize on the advantages of each so actual practice often becomes, to varying degrees, an undefined mishmash of each. When faced with clinical uncertainty, it becomes easy for practitioners to rely on formulas for care developed explicitly by expert panels, or on the tacit ones developed from experience or habit. Either way, these tendencies towards ‘cookbook’ medicine undermine the view of patients as unique particulars, and diminish what might be considered patient‐centred care. The sequence in which evidence is applied in the care process, however, is critical for developing a model of care that is both evidence based and patient centred. This notion derives from a paradigm for knowledge delivery and patient care developed over decades by Dr. Lawrence Weed. Weed's vision enables us to view evidence‐based and person‐centred medicine as wholly complementary, using computer tools to more fully and reliably exploit the vast body of collective knowledge available to define patients’ uniqueness and identify the options to guide patients. The transparency of the approach to knowledge delivery facilitates meaningful practitioner–patient dialogue in determining the appropriate course of action. Such a model for knowledge delivery and care is essential for integrating evidence‐based and patient‐centred approaches.     

Underdetermination in evidence‐based medicine

This article explores the philosophical implications of evidence‐based medicine's (EBM's) epistemology in terms of the problem of underdetermination of theory by evidence as expounded by the Duhem–Quine thesis. EBM hierarchies of evidence privilege clinical research over basic science, exacerbating the problem of underdetermination. Because of severe underdetermination, EBM is unable to meaningfully test core medical beliefs that form the basis of our understanding of disease and therapeutics. As a result, EBM adopts an epistemic attitude that is sceptical of explanations from the basic biological sciences, and is relegated to a view of disease at a population level. EBM's epistemic attitude provides a limited research heuristic by preventing the development of a theoretical framework required for understanding disease mechanism and integrating knowledge to develop new therapies. Medical epistemology should remain pluralistic and include complementary approaches of basic science and clinical research, thus avoiding the limited epistemic attitude entailed by EBM hierarchies.     

An epistemological shift: from evidence‐based medicine to epistemological responsibility

In decision making concerning the diagnosis and treatment of patients, doctors have a responsibility to do this to the best of their abilities. Yet we argue that the current paradigm for best medical practice – evidence‐based medicine (EBM) – does not always support this responsibility. EBM was developed to promote a more scientific approach to the practice of medicine. This includes the use of randomized controlled trials in the testing of new treatments and prophylactics and rule‐based reasoning in clinical decision making. But critics of EBM claim that such a scientific approach does not always work in the clinic. In this article, we build on this critique and argue that rule‐based reasoning and the use of general guidelines as promoted by EBM does not accommodate the complex reasoning of doctors in clinical decision making. Instead, we propose that a new medical epistemology is needed that accounts for complex reasoning styles in medical practice and at the same time maintains the quality usually associated with ‘scientific’. The medical epistemology we propose conforms to the epistemological responsibility of doctors, which involves a specific professional attitude and epistemological skills. Instead of deferring part of the professional responsibility to strict clinical guidelines, as EBM allows for, our alternative epistemology holds doctors accountable for epistemic considerations in clinical decision making towards the diagnosis and treatment plan of individual patients. One of the key intellectual challenges of doctors is the ability to bring together heterogeneous pieces of information to construct a coherent ‘picture’ of a specific patient. In the proposed epistemology, we consider this ‘picture’ as an epistemological tool that may then be employed in the diagnosis and treatment of a specific patient.     

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.     

Appreciating the ‘person’ in long‐term care

Background. Internationally, approaches to the long‐term care of older people are changing. New models are being developed that aim to de‐institutionalise care settings, maximise opportunities for older people to participate in decision‐making and move from a predominant medical model of care to one that is community orientated. Aims. The aim of this study is to highlight similarities and differences between the different models that exist and explore the implications of these for the role of the registered nurse in long‐term care. Methods. We chose three models for review as these represent a range of views of person centredness, each having distinct roots and focus. The models chosen were as follows: (i) culture change, (ii) person‐centred practice and (iii) relationship‐centred care. Results. The review highlights two key issues – (i) the distinctiveness of different models and frameworks and (ii) different interpretations of ‘person’. Firstly, we identify a disconnection between espoused differences between models and frameworks and the reality of these differences. The evidence also identifies how some models and frameworks adopt a more inclusive conceptualisation of person and personhood and do not define personhood in relation to role (resident, nurse and family member). Conclusions. There is merit in the development of models and frameworks that try to make explicit the different dimensions of person centredness in long‐term care. However, the focus on the development of these, without sufficient attention being paid to evidence of best practices grounded in the concept of personhood, person‐centred care is in danger of losing its original humanistic emphasis. Further, models and frameworks need to take account of the personhood of all persons. Implications for practice. Registered nurses need to have an understanding of the concept of personhood to make sense of the various person‐centred practice frameworks that exist. Without this understanding, there is a danger that the essence of personhood may be lost in the zeal to implement particular models and frameworks.     

Beyond ‘person‐centred’ care: a new vision for gerontological nursing

Currently considerable emphasis is placed on the promotion of person‐centred care, which has become a watchword for good practice. This paper takes a constructively critical look at some of the assumptions underpinning person‐centredness, and suggests that a relationship‐centred approach to care might be more appropriate. A framework describing the potential dimensions of relationship‐centred care is provided, and implications for further development are considered.     

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.     

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.     

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.     

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.     

‘There's more to a person than what's in front of you’: Nursing students’ experiences of consumer taught mental health education

Holistic and person‐centred nursing care is commonly regarded as fundamental to nursing practice. These approaches are complementary to recovery which is rapidly becoming the preferred mode of practice within mental health. The willingness and ability of nurses to adopt recovery‐oriented practice is essential to services realizing recovery goals. Involving consumers (referred herein as Experts by Experience) in mental health nursing education has demonstrated positive impact on the skills and attitudes of nursing students. A qualitative exploratory research project was undertaken to examine the perspectives of undergraduate nursing students to Expert by Experience‐led teaching as part of a co‐produced learning module developed through an international study. Focus groups were held with students at each site. Data were analysed thematically. Understanding the person behind the diagnosis was a major theme, including subthemes: person‐centred care/seeing the whole person; getting to know the person, understanding, listening; and challenging the medical model, embracing recovery. Participants described recognizing consumers as far more than their psychiatric diagnoses, and the importance of person‐centred care and recovery‐oriented practice. Understanding the individuality of consumers, their needs and goals, is crucial in mental health and all areas of nursing practice. These findings suggest that recovery, taught by Experts by Experience, is effective and impactful on students’ approach to practice. Further research addressing the impact of Experts by Experience is crucial to enhance our understanding of ways to facilitate the development of recovery‐oriented practice in mental health and holistic and person‐centred practice in all areas of health care.     

Nurse middle managers contributions to patient‐centred care: A ‘managerial work’ analysis

Nurse middle managers are in an ideal position to facilitate patient‐centred care. However, their contribution is underexposed in literature due to difficulties to articulate this in practice. This paper explores how nurse middle managers contribute to patient‐centred care in hospitals. A combination of time‐use analysis and ethnographic work was used to disclose their contribution to patient‐centred care at a micro level. Sixteen nurse managers were shadowed for over 560 hours in four hospitals. Some nurse middle managers seldom contribute to patient‐centred care. Others are involved in direct patient care, but this does not result in patient‐centred practices. At one hospital, the nurse middle managers did contribute to patient‐centred care. Here balancing between “organizing work” and “caring work” is seen as a precondition for their patient‐centeredness. Other important themes are feedback mechanisms; place matters; with whom to talk and how to frame the issues at stake; and behavioral style. Both “hands‐on” and “heads‐on” caring work of nurse middle managers enhances their patient‐centeredness. This study is the first of its kind to obtain insight in the often difficult to articulate “doings” of nurse middle managers with regard to patient‐centred care through combining time‐use analysis with ethnographic work.     

Health,utilisation of health services, ‘core’ information,and reasons for non‐participation: a triangulation study amongst non‐respondents

Aim. To explore health, use of health services, ‘core’ information and reasons for non‐participation amongst males. Background. Gender may provide an explanation for non‐participation in the healthcare system. A growing body of research suggests that males are less likely than females to seek help from health professionals for their problems. The current research had its beginnings with the low response rate in a prior voluntary survey and health examination for Finnish males born in 1961. Design. Data triangulation among 28 non‐respondent middle‐aged males in Helsinki was used. Methods. The methods involved structured and in‐depth interviews and health measurements to explore the views of these males concerning their health‐related behaviours and use of health services. Results. Non‐respondent males seldom used healthcare services. Despite clinical risk factors (e.g. obesity and blood pressure) and various symptoms, males perceived their health status as good. Work was widely experienced as excessively demanding, causing insomnia and other stress symptoms. Males expressed sensitive messages when a session was ending and when the participant was close to the door and leaving the room. This ‘core’ information included major causes of concern, anxiety, fears and loneliness. Conclusions. This triangulation study showed that by using an in‐depth interview as one research strategy, more sensitive ‘feminist’ expressions in health and ill‐health were got by men. The results emphasise a male’s self‐perception of his masculinity that may have relevance to the health experience of the male population. Relevance to clinical practice. Nurses and physicians need to pay special attention to the requirements of gender‐specific healthcare to be most effective in the delivery of healthcare to males.     

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.     

‘I know what I need to recover’: Patients’ experiences and perceptions of forensic psychiatric inpatient care

Patients find forensic psychiatric care inadequate in that they are not treated as individuals and not involved in their own care. The purpose of this study was to describe patients’ experiences and perceptions of forensic psychiatric inpatient care. Semi‐structured interviews were conducted with 11 inpatients. A qualitative content analysis resulted in a recurring theme, ‘I know what I need to recover’, and three main categories: ‘A need for meaning in a meagre existence’, ‘A need to be a person in an impersonal context’, and ‘A need for empowerment in a restricted life’. Participants experienced and perceived forensic care as predominantly monotonous, predetermined, and not adapted to them as individuals, forcing them to fight and adapt to get through it and not lose themselves. Perceived needs were largely ignored or opposed by staff due to the content and structure of care. Findings suggest a need for reflective practices and patient involvement in order to develop and maintain a person‐centred and recovery‐oriented nursing practice. The study adds to previous research showing the importance of patients in forensic psychiatric inpatient care being listened to and involved in their care. The study is reported in accordance with the COREQ guidelines.     

User participation in district psychiatry. The social construction of ‘users’ in handovers and meetings

An ideal in mental health care is user participation. This implies inclusion and facilitation by clinicians to enable users to participate in decisions about themselves and in the design of suitable treatment. However, much of the work of clinicians consists of handovers and other meetings where patients are not present. It is therefore interesting to study how the patient perspective is handled in such meetings and whether it forms a basis for user participation. We conducted fieldwork in three different inpatient wards in Norwegian District Psychiatric Centres. We used an interactional perspective in our analysis, where speech acts, framing and footing were key concepts. The findings show that the talk in the handovers and meetings contained five main themes and that there was a clear correlation between what was said and how it was said, and whether clinicians related to the content in a decisive, person‐centred or indecisive manner. We discuss potential participation statuses for patients and their limited opportunity to influence the talk and possible decisions about themselves. Our conclusion is that handover meetings primarily function as an aid in organising clinicians' work and could ultimately be seen as counteracting user participation.