Evidence-based Medicine Movement Research Articles

Renewed call to improve approaches for developing fetal alcohol spectrum disorder diagnostic criteria: Commentary on "Comparison of three systems for the diagnosis of fetal alcohol spectrum disorders in a community sample".

Renewed call to improve approaches for developing fetal alcohol spectrum disorder diagnostic criteria: Commentary on "Comparison of three systems for the diagnosis of fetal alcohol spectrum disorders in a community sample".

Is the evidence-based medicine movement counter-productive: are randomised controlled trials the best approach to establish evidence in complex healthcare situations?

In the modern era, evidence-based medicine (EBM) has been embraced as the best approach to practising medicine, providing clinicians with 'objective' evidence from clinical research. However, for presentations with complex pathophysiology or from complex social environments, sometimes there remains no evidence, and no amount of research will obtain it. Yet, health researchers continue to undertake randomised controlled trials (RCT) in complex environments, ignoring the risk that participants' health may be compromised throughout the trial process. This paper examines the role of research that seeks to obtain evidence to support EBM. We provide examples of RCTs on ear disease in Aboriginal populations as a case-in-point. Decades of ear research have failed to yield statistically significant findings, demonstrating that when multiple factors are at play, study designs struggle to balance the known disease process drivers, let alone unknown drivers. This paper asks the reader to consider if the pursuit of research is likely to produce evidence in complex situations; or if perhaps RCTs should not be undertaken in these situations. Instead, clinicians could apply empirical evidence, tailoring treatments to individuals while taking into account the complexities of their life circumstances.

The New Paradigm in Medicine

From the antiquity to nowadays the connection between philosophy and medicine is of substantive importance. One of the outstanding figures for medicine as Hippocrates of Kos, named “the father of medicine”, built the fundamental principals of medicine as rational endeavour. The other important figure in late antiquity – Claudius Galenus or Galen of Pergamon –made an important thesis that a good doctor is a philosopher too (work That the Best Physician is also a Philosopher). This work analyses the questions concerning contemporary relationships between philosophy and medicine today. One of the central topics is focused on contemporary criteria for medical theory, research and practice. In the beginning of the 90s, the so-called Evidence-Based Medicine (EBM) formulated specific methodological features that medicine has to aspire to. Today, every field of medicine is based on the principles formulated by EBM. This gives grounds for a number of authors to talk about a "new paradigm" in medical science and practice and to base this idea on the EBM movement. The present paper will analyse the discussion of whether EBM is a paradigm according to Kuhn’s idea of a “paradigm shift”, and will critically analyse scientific change situation in the context of modern medicine (scientific and social aspects).

Clinical recommendations: The role of mechanisms in the GRADE framework

The Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework has become one of the most influential frameworks for assessing quality of research and developing clinical recommendations. The GRADE framework has been presented as an evolution in the Evidence-Based Medicine (EBM) movement. Both GRADE and EBM emphasize effect estimates derived from population-level clinical trials and, as a consequence, devalue the role of mechanisms as the basis for clinical decisions. Although mechanisms do not hold the epistemic privilege of rigorous clinical trials in EBM reasoning, this paper will argue that mechanisms appear to be important in the use and application of GRADE, as described in the literature. The seemingly necessary role of mechanisms in the development of clinical recommendations has, so far, received little attention and is not explicitly featured in the literature describing GRADE. The analysis of the GRADE framework presented in this paper reveals an apparent tension between EBM's willingness to downplay mechanisms and what seems their inevitable use in GRADE. In this paper, we take the position that if mechanistic reasoning is inevitable in the use of GRADE, then the instructional literature on the framework would benefit from more explicit discussion of how to consider and integrate mechanisms.

Has anything changed in Evidence-Based Medicine?

The Evidence-Based Medicine (EBM) movement, undoubtably one of the most successful movements in medicine, questions dogma and “clinical authority” and combines the “best available evidence” with clinical expertise and patient values in order to provide the best care for the individual patient. Although since its inception in the 1990s its strong theoretical foundations remain unaltered, a lot has changed in its practical implementation due to the electronic explosion of information and the unprecedented COVID-19 crisis. The purpose of this article is to succinctly provide the reader with an update on the major changes in EBM, including the important most recent ones that were “fast-tracked” due to the COVID-19 challenge.

Challenges for the practice of evidence-based medicine during COVID-19 pandemic (practice of evidence-based medicine in the new normal).

The forces which had kept the evidence-based medicine (EBM) movement alive and ongoing have altered significantly during this coronavirus disease (COVID)-19 pandemic. There has been discrepancy in the demand and availability of scientific evidence. Deaths of thousands of people including physicians and other health-care workers (while offering COVID-19 care) across the globe have shaken the confidence of the physicians towards the practice of EBM. Journals started publishing in a hurry, incomplete and at times misleading scientific articles, about COVID-19, leaving the physicians in a dilemma about the evidence. The practitioner of EBM has had to turn helplessly to non-documentary evidences to treat COVID-19 patients. Apart from the evidence becoming hyperdynamic and volatile along with a reduction in its quality, the environment got polluted by political interference. In a nutshell, the COVID-19 pandemic has affected the practice of EBM and its acceptance in multiple ways.

Orthodoxy, illusio, and playing the scientific game: a Bourdieusian analysis of infection control science in the COVID-19 pandemic.

Scientific and policy bodies' failure to acknowledge and act on the evidence base for airborne transmission of SARS-CoV-2 in a timely way is both a mystery and a scandal. In this study, we applied theories from Bourdieu to address the question, "How was a partial and partisan scientific account of SARS-CoV-2 transmission constructed and maintained, leading to widespread imposition of infection control policies which de-emphasised airborne transmission?". From one international case study (the World Health Organisation) and three national ones (UK, Canada and Japan), we selected a purposive sample of publicly available texts including scientific evidence summaries, guidelines, policy documents, public announcements, and social media postings. To analyse these, we applied Bourdieusian concepts of field, doxa, scientific capital, illusio, and game-playing. We explored in particular the links between scientific capital, vested interests, and policy influence. Three fields-political, state (policy and regulatory), and scientific-were particularly relevant to our analysis. Political and policy actors at international, national, and regional level aligned-predominantly though not invariably-with medical scientific orthodoxy which promoted the droplet theory of transmission and considered aerosol transmission unproven or of doubtful relevance. This dominant scientific sub-field centred around the clinical discipline of infectious disease control, in which leading actors were hospital clinicians aligned with the evidence-based medicine movement. Aerosol scientists-typically, chemists, and engineers-representing the heterodoxy were systematically excluded from key decision-making networks and committees. Dominant discourses defined these scientists' ideas and methodologies as weak, their empirical findings as untrustworthy or insignificant, and their contributions to debate as unhelpful. The hegemonic grip of medical infection control discourse remains strong. Exit from the pandemic depends on science and policy finding a way to renegotiate what Bourdieu called the 'rules of the scientific game'-what counts as evidence, quality, and rigour.

Miasmas, mental models and preventive public health: some philosophical reflections on science in the COVID-19 pandemic.

When the history of the COVID-19 pandemic is written, it is likely to show that the mental models held by scientists sometimes facilitated their thinking, thereby leading to lives saved, and at other times constrained their thinking, thereby leading to lives lost. This paper explores some competing mental models of how infectious diseases spread and shows how these models influenced the scientific process and the kinds of facts that were generated, legitimized and used to support policy. A central theme in the paper is the relative weight given by dominant scientific voices to probabilistic arguments based on experimental measurements versus mechanistic arguments based on theory. Two examples are explored: the cholera epidemic in nineteenth century London—in which the story of John Snow and the Broad Street pump is retold—and the unfolding of the COVID-19 pandemic in 2020 and early 2021—in which the evidence-based medicine movement and its hierarchy of evidence features prominently. In each case, it is shown that prevailing mental models—which were assumed by some to transcend theory but were actually heavily theory-laden—powerfully shaped both science and policy, with fatal consequences for some.

Orthodoxy, illusio, and playing the scientific game: a Bourdieusian analysis of infection control science in the COVID-19 pandemic.

Scientific and policy bodies' failure to acknowledge and act on the evidence base for airborne transmission of SARS-CoV-2 in a timely way is both a mystery and a scandal. In this study, we applied theories from Bourdieu to address the question, "How was a partial and partisan scientific account of SARS-CoV-2 transmission constructed and maintained, leading to widespread imposition of infection control policies which de-emphasised airborne transmission?". From one international case study (the World Health Organisation) and four national ones (UK, Canada, USA and Japan), we selected a purposive sample of publicly available texts including scientific evidence summaries, guidelines, policy documents, public announcements, and social media postings. To analyse these, we applied Bourdieusian concepts of field, doxa, scientific capital, illusio, and game-playing. We explored in particular the links between scientific capital, vested interests, and policy influence. Three fields-political, state (policy and regulatory), and scientific-were particularly relevant to our analysis. Political and policy actors at international, national, and regional level aligned-predominantly though not invariably-with medical scientific orthodoxy which promoted the droplet theory of transmission and considered aerosol transmission unproven or of doubtful relevance. This dominant scientific sub-field centred around the clinical discipline of infectious disease control, in which leading actors were hospital clinicians aligned with the evidence-based medicine movement. Aerosol scientists-typically, chemists, and engineers-representing the heterodoxy were systematically excluded from key decision-making networks and committees. Dominant discourses defined these scientists' ideas and methodologies as weak, their empirical findings as untrustworthy or insignificant, and their contributions to debate as unhelpful. The hegemonic grip of medical infection control discourse remains strong. Exit from the pandemic depends on science and policy finding a way to renegotiate what Bourdieu called the 'rules of the scientific game'-what counts as evidence, quality, and rigour.

Orthodoxy, illusio, and playing the scientific game: a Bourdieusian analysis of infection control science in the COVID-19 pandemic

Background: Scientific and policy bodies’ failure to acknowledge and act on the evidence base for airborne transmission of SARS-CoV-2 in a timely way is both a mystery and a scandal. In this study, we applied theories from Bourdieu to address the question, “How was a partial and partisan scientific account of SARS-CoV-2 transmission constructed and maintained, leading to widespread imposition of infection control policies which de-emphasised airborne transmission?”. Methods: From one international case study (the World Health Organisation) and three national ones (UK, Canada and Japan), we selected a purposive sample of publicly available texts including scientific evidence summaries, guidelines, policy documents, public announcements, and social media postings. To analyse these, we applied Bourdieusian concepts of field, doxa, scientific capital, illusio, and game-playing. We explored in particular the links between scientific capital, vested interests, and policy influence. Results: Three fields—political, state (policy and regulatory), and scientific—were particularly relevant to our analysis. Political and policy actors at international, national, and regional level aligned—predominantly though not invariably—with medical scientific orthodoxy which promoted the droplet theory of transmission and considered aerosol transmission unproven or of doubtful relevance. This dominant scientific sub-field centred around the clinical discipline of infectious disease control, in which leading actors were hospital clinicians aligned with the evidence-based medicine movement. Aerosol scientists—typically, chemists, and engineers—representing the heterodoxy were systematically excluded from key decision-making networks and committees. Dominant discourses defined these scientists’ ideas and methodologies as weak, their empirical findings as untrustworthy or insignificant, and their contributions to debate as unhelpful. Conclusion: The hegemonic grip of medical infection control discourse remains strong. Exit from the pandemic depends on science and policy finding a way to renegotiate what Bourdieu called the ‘rules of the scientific game’—what counts as evidence, quality, and rigour.

Orthodoxy, illusio, and playing the scientific game: a Bourdieusian analysis of infection control science in the COVID-19 pandemic

Background: Scientific and policy bodies’ failure to acknowledge and act on the evidence base for airborne transmission of SARS-CoV-2 in a timely way is both a mystery and a scandal. In this study, we applied theories from Bourdieu to address the question, “How was a partial and partisan scientific account of SARS-CoV-2 transmission constructed and maintained, leading to widespread imposition of infection control policies which de-emphasised airborne transmission?”. Methods: From one international case study (the World Health Organisation) and four national ones (UK, Canada, USA and Japan), we selected a purposive sample of publicly available texts including scientific evidence summaries, guidelines, policy documents, public announcements, and social media postings. To analyse these, we applied Bourdieusian concepts of field, doxa, scientific capital, illusio, and game-playing. We explored in particular the links between scientific capital, vested interests, and policy influence. Results: Three fields—political, state (policy and regulatory), and scientific—were particularly relevant to our analysis. Political and policy actors at international, national, and regional level aligned—predominantly though not invariably—with medical scientific orthodoxy which promoted the droplet theory of transmission and considered aerosol transmission unproven or of doubtful relevance. This dominant scientific sub-field centred around the clinical discipline of infectious disease control, in which leading actors were hospital clinicians aligned with the evidence-based medicine movement. Aerosol scientists—typically, chemists, and engineers—representing the heterodoxy were systematically excluded from key decision-making networks and committees. Dominant discourses defined these scientists’ ideas and methodologies as weak, their empirical findings as untrustworthy or insignificant, and their contributions to debate as unhelpful. Conclusion: The hegemonic grip of medical infection control discourse remains strong. Exit from the pandemic depends on science and policy finding a way to renegotiate what Bourdieu called the ‘rules of the scientific game’—what counts as evidence, quality, and rigour.

Machine Learning: The Next Paradigm Shift in Medical Education.

Machine learning (ML) algorithms are powerful prediction tools with immense potential in the clinical setting. There are a number of existing clinical tools that use ML, and many more are in development. Physicians are important stakeholders in the health care system, but most are not equipped to make informed decisions regarding deployment and application of ML technologies in patient care. It is of paramount importance that ML concepts are integrated into medical curricula to position physicians to become informed consumers of the emerging tools employing ML. This paradigm shift is similar to the evidence-based medicine (EBM) movement of the 1990s. At that time, EBM was a novel concept; now, EBM is considered an essential component of medical curricula and critical to the provision of high-quality patient care. ML has the potential to have a similar, if not greater, impact on the practice of medicine. As this technology continues its inexorable march forward, educators must continue to evaluate medical curricula to ensure that physicians are trained to be informed stakeholders in the health care of tomorrow.

Assessing the quality of evidence from epidemiological agent-based models for the COVID-19 pandemic.

Agent-based models (ABMs) are one of the main sources of evidence for decisions regarding mitigation and suppression measures against the spread of SARS-CoV-2. These models have not been previously included in the hierarchy of evidence put forth by the evidence-based medicine movement, which prioritizes those research methods that deliver results less susceptible to the risk of confounding. We point out the need to assess the quality of evidence delivered by ABMs and ask the question of what is the risk that assumptions entertained in ABMs do not include all the key factors and make model predictions susceptible to the problem of confounding.

Teaching Medical Epistemology within an Evidence-Based Medicine Curriculum

Issue: Epistemology, the branch of philosophy that deals with the nature, value, and use of knowledge, receives little or no formal attention in medical education. Yet the understanding of medical epistemology - focused on what kinds of medical knowledge are relevant to clinical decisions, the strengths and limitations of those different kinds of knowledge, and how they relate to one another and to clinical expertise - represents a critical aspect of medical practice. Evidence: Understanding the meaning of the term “evidence” is one of the fundamental tasks of medical epistemology. Other foundations of the evidence-based medicine movement, such as the “hierarchy of evidence” and the concept of “best” evidence, rest upon epistemological assertions, claims regarding the appropriate kinds and relative value of knowledge in medicine. Here we rely upon the work of philosophers of medicine who have been engaged in debates regarding the epistemic tenets of the evidence-based medicine movement. We argue that medical students and physicians-in-training should learn basic terminology and methods of epistemology as they are being introduced to the concepts and techniques of evidence-based medicine. Implications: The skepticism and critical analysis encouraged by EBM can and should be applied to the underlying assumptions and primary tenets of EBM itself. It is not enough for philosophers to partake in this endeavor; students, trainees, and clinicians need to carefully and constantly examine the reasons and reasoning that coalesce into clinical acumen. Our role as medical educators is to give them the tools, including a basic understanding of epistemology, to do that over a lifetime.

Relevance, validity, and evidential reasoning in clinical practice

Relevance, validity, and evidential reasoning in clinical practice

Evidence-poor medicine: just how evidence-based are Australian clinical practice guidelines?

Clinical practice guidelines aim to assist medical practitioners in making efficient evidence-based decisions in daily practice. However, international studies have shown that the majority of recommendations in American and European guidelines are not based on strong evidence. To review Australian clinical practice guidelines across a broad range of high-impact conditions and determine how evidence-based they are. Australian guidelines published from January 2010 to May 2018 relating to the top 10 causes of death in Australia were identified from the National Health and Medical Research Council (NHMRC) clinical practice guideline database and other relevant sources. The graded recommendations in these guidelines were extracted for analysis and the systems used for grading the recommendations were recorded. Ten relevant Australian guidelines were identified, containing a total of 748 graded recommendations. All 10 guidelines used either the Grading of Recommendations Assessment, Development and Evaluation (GRADE) or NHMRC systems to assess recommendations. However, only 18% (n = 136) of these recommendations were based on Level I (or equivalent) evidence; 25% (n = 185) were based on Level II evidence, 29% (n = 218) on Level III, and 9% (n = 66) on Level IV. Consensus-based recommendations accounted for 19% (n = 143) of all recommendations. Despite the enthusiasm of the evidence-based medicine movement and its documented successes, contemporary medicine appears to remain largely evidence-poor, not evidence-based. Future research should aim to provide reliable descriptions of what constitutes valid clinical reasoning in evidence-poor situations.

Emergence and Evidence: A Close Look at Bunge’s Philosophy of Medicine

In his book “Medical Philosophy: Conceptual issues in Medicine”, Mario Bunge provides a unique account of medical philosophy that is deeply rooted in a realist ontology he calls “systemism”. According to systemism, the world consists of systems and their parts, and systems possess emergent properties that their parts lack. Events within systems may form causes and effects that are constantly conjoined via particular mechanisms. Bunge supports the views of the evidence-based medicine movement that randomized controlled trials (RCTs) provide the best evidence to establish the truth of causal hypothesis; in fact, he argues that only RCTs have this ability. Here, we argue that Bunge neglects the important feature of patients being open systems which are in steady interaction with their environment. We show that accepting this feature leads to counter-intuitive consequences for his account of medical hypothesis testing. In particular, we point out that (i) the confirmation of hypotheses is inherently stochastic and affords a probabilistic account of both confirmation and evidence which we provide here; (ii) RCTs are neither necessary nor sufficient to establish the truth of a causal claim; (iii) testing of causal hypotheses requires taking into account background knowledge and the context within which an intervention is applied. We conclude that there is no “best” research methodology in medicine, but that different methodologies should coexist in a complementary fashion.

DSM-5: the definitive inclusion of psychiatry in medicine?

DSM-5 is a significant factor in promoting the "remedicalization" of psychiatry as the focus of psychiatric knowledge, developed by the evidence-based medicine movement, shifted from the clinically-based biopsychosocial model to a research-based medical model. DSM-5 purposes are 1]clinical: diagnosis, prevention, early identification, management, outcome, assessment of improvement; 2] clinical research: etiology, course, effective treatments, cost-effective treatments, reliability and validity and utility of diagnosis; 3] a worldwide common language of diagnostic criteria used by mental health professionals; and 4] to improve communication with users of services, caregivers, and society in general. In the absence of a "gold standard" there are two basic questions still without answers 1] what kind of entities are psychiatric disorders?; and 2] How to integrate the multiple explanatory perspectives of psychiatric illness?.

The Dismal Disease: Temozolomide and the Interaction of Evidence

Evidence interacts. However, the dominant model of evidence in medicine from the Evidence-Based Medicine (EBM) movement, drawing on hierarchies of evidence, provides little room for interpreting and understanding the relationships between different sources and pieces of evidence. This paper uses the case-study of temozolomide, a chemotherapy drug for glioblastoma, to explore the ways in which evidence interacts and the limitations of existing models of evidence, arguing that it is the combination of subgroup analysis, mechanistic evidence and secondary trial results, not the result of a large randomized controlled trial, that underpins our understanding of the effects of the drug. Despite this, much of oncological practice for glioblastoma remains based solely on the trial result, an unnecessarily blunt instrument for clinical decision-making.

Complex health interventions in complex systems: improving the process and methods for evidence-informed health decisions

The 2030 Agenda for Sustainable Development calls for real transformation, recognising that health goes beyond survival to include human rights, equity and the empowerment of vulnerable populations, including women and...