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Warrant for singular causal claims can be ‘local’, comprising claims about features and happenings in the setting the claim concerns, or ‘from afar’, comprising claims about other settings. It may also be ‘direct’, concerning whether the claim itself is true, or indirect concerning facts that bear upon whether the claim is true. Evidence claims warranting claims of all these sorts should be understood as composed of conjunctions of factual claims and relevance claims. Such claims may be compiled into ‘evidence trees’ in which each claim is warranted (as practical and required) with further conjunctions of claims at higher ‘levels’ of evidence. This may be represented diagrammatically and serves to structure the evidence to show the roles which each piece of evidence plays, and the relation between these roles. Our primary focus is on indirect local warrant.
A ‘thick’ theory of singular causation, incorporating enough detail to allow you to know how to evidence singular causation, is required for empirical investigation of singular causal claims. The term ‘mechanism’ is often employed in describing how a cause produces its effect on any particular occasion. Here we point out that this term is ambiguous between the step-by-step process by which a cause produces an outcome, the underlying conditions that afford causal processes and the causal principles under which causes produce their effects.
This chapter reviews the principles of evidence-based medicine and evidence-based radiology as they apply to child maltreatment clinical care and research. Common pitfalls and the rise of “predatory publishing” are discussed as important challenges to rigorous medical literature appraisal and its application to clinical care and research. An approach to critical appraisal is given, to help you determine whether a study is of high quality or not. A detailed discussion of the Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU) report is included as a particular example of the misuse of evidence-based edicine principles.
The effect of Early Technology Review (ETR) through early engagement with multiple stakeholders on strategic development for technologies at prototype development and proof of concept was examined through two generic case studies of relevant outcomes. In both examples, advice to companies could have significantly changed strategic direction to become more relevant to payers and clinical experts. In one instance, the advice was followed and resulted in an expedited first-in-human study and was considered for a second ETR to inform the proof-of-concept study. In the second example, it was reported that changes in strategic direction were being considered.
These reports provide descriptive accounts of very early applications of the ETR process that now spans the entire preclinical trajectory. Had the second case study at proof of concept been able to benefit from this approach at the point of prototype development, it could have avoided the costs and research through earlier advice. This begs the question whether a sequential iterative approach to evidentiary multiple stakeholder advice across the technology life cycle may reduce risk and cost while benefitting from efficiencies of applying adaptive design.
Interest in large language models (LLMs) as a tool for meta-analyses and systematic reviews (MA/SRs). We prospectively developed 515 unique prompts by predefined screening-related categories and tested with open-access LLMs (Llama, Mistral) against four gold-standard MA/SRs from different medical fields published after the LLMs’ training cut-offs, using a Python-based pipeline. Heterogeneity between prompts was quantified, and hypothetical workload/cost reduction with top-performing prompts calculated. Across 12,360 pipeline runs, LLMs versus MA/SRs reached average recall/sensitivity = 83.6 ± 17.0%, precision = 18.5 ± 15.6%, specificity = 36.6 ± 23.7% F1-score = 27.6 ± 17.2%, and accuracy = 61.1 ± 11.0%. F1-scores were significantly higher when prompts focused on methods (0.78 ± 0.40%), explicitly mentioned MA/SR screening (0.81 ± 0.37%), included the comparison MA/SR’s title (5.64 ± 0.37%) or selection criteria (8.05 ± 0.68%), and with more LLM parameters (70b = 4.48 ± 0.31%, 123b = 7.77 ± 0.31%), but lower when screening abstracts instead of titles (−3.67 ± 0.28%). In LLM-base preselection, top-performing F1-score prompts (recall/sensitivity = 72.2%, specificity = 66.1%, precision = 28.6%) would reduce screening demands by 34.5%−37.5%, saving 8.4–8.8 weeks of work and 17,592–18,552. Recall/sensitivity increased with less MA/SR information contrasting F1-score results, which highlights a recall/sensitivity-precision/specificity trade-off. F1-score increased with detailed MA/SR information, while recall/sensitivity increased with shorter, zeroshot prompts. We provide the first prospectively assessed prompt engineering framework for early-stage LLM-based paper screening across medical fields. The publicly available Python pipeline and full prompt list used here support further development of LLM-based evidence synthesis.
Cardiotocograph interpretation based on pattern recognition has a poor positive predictive value for intrapartum hypoxia and a high false-positive rate. Only about 40–60% of fetuses with a CTG classified as abnormal by NICE guidelines have confirmed metabolic acidaemia on cord gases after birth. The rates of perinatal deaths, hypoxic encephalopathy and cerebral palsy have remained stable, whereas the rate of operative deliveries among fetuses monitored using CTG has been continuously increasing. There were over 25 different clinical guidelines, each employing different classification systems and indications for continuous electronic fetal heart rate (FHR) monitoring until the mid-1980s. Therefore, the older clinical trials did not use standardized criteria for continuous electronic FHR monitoring. A more individualized care by prelabour risk assesment and a physiological approach may be beneficial in terms of maternal and fetal outcome
The European Union’s Health Technology Assessment Regulation (HTAR) and its implementing acts foresee various forms of clinician involvement, such as joint clinical assessment or Joint Scientific Consultation. However, considering the varying preparedness levels for HTAR, as well as the understanding of the health technology assessment (HTA) principles and processes, this study aimed to evaluate the levels of HTA-related skills among medical and dental doctors in Croatia.
Methods
A cross-sectional survey study was conducted among medical and dental medicine doctors in Croatia. The survey recorded respondents’ relevant experience with HTA processes along with skill levels across the entire HTA process, mainly for acting as individual clinical experts or on behalf of their professional organizations, as well as potential HTA doers. Skill levels were evaluated using a 5-point scale (1 – no knowledge to 5 – full expertise).
Results
Among the 376 respondents included, only 6.1 percent had previous involvement in HTA, and 2.2 percent were familiar with HTAR. Related to the HTA process, the highest scores were observed in the understanding of key concepts and results of searching for studies, critical appraisal, study synthesis preparation, and ethics. The lowest scores were recorded in health economics, evidence grading, qualitative synthesis, and public/patient involvement. Respondents with prior research experience and those who reported frequent research use had significantly higher HTA skill scores.
Conclusions
A significant gap in HTA-related skills highlights the need for targeted professional development programs and long-term educational reforms to build the capacity for various modes of involvement in HTA processes and their implementation.
This chapter describes the excitement surrounding scientific progress as a driver of medical progress in the Cold War and subsequent theoretical and practical challenges. Medicine, for skeptical theories, was a powerful example that there is no such thing as knowledge that continually approaches the truth, that even the body is historical, and that knowledge is always a tool of the powerful. From the medical side, some respondents were adamant that scientific knowledge about the body is “real” and that medicine is uniquely immune to uncertainties inherent in relativistic accounts of knowledge. The chapter concludes by analyzing two recent examples, evidence-based medicine and health artificial intelligence, which have been praised as objective examples of a particular kind of medical knowledge progress. Throughout, I show the implications for medical progress of larger debates about the progress of knowledge, as well as how an excessive focus on biomedical knowledge gains neglects other, important dimensions of progress.
The aim of this study is to assess outcomes in managing post-operative chyle leaks, following neck dissection using a volume-based risk stratification algorithm.
Methods
A retrospective series (2010–2024) at a tertiary head and neck centre included all patients with chyle leaks after neck dissection for malignancy. Chyle leaks were stratified as low, medium or high volume and managed either medically or with planned intervention, video-assisted thoracoscopic surgery, thoracic duct ligation or thoracic duct embolisation.
Results
Thirty-five patients were identified. Sixty-five point seven per cent (n = 23) with low-volume leaks resolved with conservative management, 31.4 per cent (n = 11) with moderate-/high-volume leaks underwent video-assisted thoracic duct ligation, with 10/11 resolving within one day post-operatively, 5.7 per cent (n = 2) underwent thoracic duct embolisation. All cases with ongoing chyle leaks resolved without neck re-exploration surgery.
Conclusion
Volume-based risk stratification, paired with early video-assisted thoracoscopic surgery ligation or embolisation, provides a highly effective, low-morbidity strategy for managing post-operative chyle leaks.
Health technology assessment (HTA) has been characterized as a complex adaptive system that centrally features stakeholder interactions. This article provides an overview of current practices in HTA stakeholder engagement concerning medicines.
Methods
We conducted a scoping review of English-language sources published between 2018 and 2023, including 66 peer-reviewed articles and 264 gray literature sources describing stakeholder involvement in HTA processes relating to medicines.
Results
Industry is commonly permitted to provide a submission for funding, though the modes and time points of industry engagement are many. Clinician and patient engagement are regarded as especially important with increased intervention complexity and innovation. Stakeholder engagement is perhaps mostly conducted to enhance the collation and interpretation of evidence, not necessarily to increase the legitimacy of the HTA process or give stakeholders influence over a decision that affects them. Patients are mostly engaged through broader public consultation. Sometimes they work directly with other stakeholders. Problems with patient engagement include challenges with recruitment, time, and resource constraints. Stakeholder groups can also differ in how they view and prioritize public and patient engagement. Public engagement is often limited to a matter of transparency and public accountability, but the reasons to undertake public engagement are numerous and varied. They include gaining input on affordability or prioritization issues.
Conclusions
HTA decision-making committees should commit to publicly communicating how they considered and made use of various stakeholder inputs. This could build trust and confidence in the committees and guide the public and patients on the information that committees find helpful.
Recent changes in artificial intelligence (AI) applications have made the technology accessible for practitioners in prehospital and disaster medicine in a way that was nearly unthinkable a few years ago. Initial anecdotal use of this technology has been met with enthusiasm and excitement. However, evidence-based research in the field is often lacking. The PDM Special Collection on Evidence-Based Artificial Intelligence in Prehospital and Disaster Medicine introduces a new forum for dissemination of innovative, high-impact research.
Edited by
Richard Pinder, Imperial College of Science, Technology and Medicine, London,Christopher-James Harvey, Imperial College of Science, Technology and Medicine, London,Ellen Fallows, British Society of Lifestyle Medicine
Brief interventions are quick, targeted interventions to support individuals to change their health behaviour and reduce future disease risk. Brief interventions are delivered opportunistically in a consultation often initiated for other reasons, and can be as short as 30 seconds. Brief interventions differ from longer and more complex interventions such as health coaching, motivational interviewing, or cognitive behavioural therapies. Brief interventions are effective and cost-effective for smoking cessation, reducing hazardous drinking, weight loss in obesity, and increasing physical activity. Brief interventions typically involve asking about the behaviour, advising on the best way to change it, and assisting by providing or referring to support. Brief interventions can be enhanced by using conversational strategies that avoid stigmatising, create hope and self-efficacy, and facilitate referral or treatment. Brief interventions can be used across a range of health behaviours, such as harmful substance use, using screening tools, and referral to more intensive treatment where necessary. Making Every Contact Count (MECC) is a UK health campaign that aims to use every interaction in healthcare settings to support behaviour change, drawing on motivational interviewing techniques.
Edited by
Richard Pinder, Imperial College of Science, Technology and Medicine, London,Christopher-James Harvey, Imperial College of Science, Technology and Medicine, London,Ellen Fallows, British Society of Lifestyle Medicine
Lifestyle Medicine is an evidence-based medical discipline that emphasises behaviour change to improve overall health, focusing on mental wellbeing, social connections, healthy eating, physical activity, sleep, and minimising harmful behaviours. The approach bridges clinical practice with public health interventions, targeting both individual and population health. It is effective in preventing, treating, and sometimes reversing chronic diseases through lifestyle modification. Clinicians practising Lifestyle Medicine support actions beyond clinical consultations, advocating for healthy environments and policies. The discipline also addresses the challenges of non-communicable diseases and enhances resilience against infectious diseases. It offers an alternative to over-medicalisation, promoting self-care and lifestyle changes alongside traditional medical treatments. The new medical paradigm recognises the modifiability of gene expression and the importance of lifestyle factors in health outcomes. Lifestyle Medicine is increasingly integrated into medical education and healthcare delivery systems. It aligns with the shift towards person-centred care that focuses on patients’ values and goals, contributing to a more holistic approach to health and wellbeing.
This article discusses changes to the Prehospital and Disaster Medicine (PDM) mission statement which will take effect as of January 1, 2025. The new mission statement focuses on innovative, high-impact, evidence-based research.
The aim of this study is to identify risk factors for residual dizziness in benign paroxysmal positional vertigo patients after repositioning manoeuvres and explore the mediation role of lipid indicators.
Methodology
In all, 110 benign paroxysmal positional vertigo patients treated from January 2019 to February 2022 were studied. Data on demographics, diseases, behaviours, and lipids were collected. Multivariate logistic regression assessed risk factors, and mediation analyses explored effects via lipid indicators. Odds ratios and 95 per cent confidence intervals are reported.
Results
Differences between groups with and without residual dizziness included limb weakness, hypertension, nausea, arteriosclerosis, medication, dizziness handicap inventory scores, hospital anxiety and depression scale scores, and lipid distributions (p < 0.05). Significant risk factors were sleep disorders, medication, hypertension, triglycerides, and total cholesterol (p < 0.05). Total cholesterol mediated 9.1 per cent of the effect of sleep disorders on residual dizziness.
Conclusion
Managing lipid levels and sleep disorders is crucial in treating residual dizziness in benign paroxysmal positional vertigo patients after repositioning.
Since its inception, Health Technology Assessment (HTA) has typically determined the value of a technology by collecting information derived from randomized clinical trials (RCTs), in line with the principles of evidence-based medicine (EBM). However, data from RCTs did not constitute the sole source of information, as other types of evidence (such as primary qualitative research) have often been utilized. Recent advances in both generating and collecting other types of evidence are broadening the landscape of evidence, adding complexity to the discussion of “robustness of evidence.” What are the consequences of these recent developments for the methodology and conduct of HTA, the HTA community, and its ethical commitments? The aim of this article is to explore some ethical challenges that are emerging in the current evolving evidence landscape, particularly changes in evidence generation and collection (e.g., diversification of data sources), and shifting standards of evidence in the field of HTA (e.g., increasing acceptability of evidence that is thought of as lower quality). Our conclusion is that deciding how to best maintain trustworthiness is common to all these issues.
To appraise clinical practice guidelines for anaplastic thyroid carcinoma treatment and management using the Appraisal of Guidelines for Research and Evaluation II tool.
Methods
A literature search was performed using MEDLINE/PubMed, Embase, Scopus, Cochrane, and Google Scholar. Four reviewers evaluated clinical practice guidelines utilising Appraisal of Guidelines for Research and Evaluation II, with domain scores requiring a threshold of greater than 60 per cent. Inter-reviewer agreement was evaluated using intraclass correlation coefficients.
Results
Twelve clinical practice guidelines were evaluated after application of inclusion and exclusion criteria. There were two “high-”, four “average-”, and six “low-” quality clinical practice guidelines. The domains with the highest scores were “clarity of presentation” (69.44 ± 16.75) and “scope and purpose” (68.87 ± 20.88), while “applicability” (7.12 ± 6.17) and “rigor of development” (50.26 ± 20.77) had the lowest scores. Intraclass correlation coefficients showed a high level of inter-reviewer agreement (0.689–0.924; good–excellent).
Conclusion
These results showcased wide variability in quality amongst guidelines for the treatment and management of anaplastic thyroid carcinoma. These findings necessitate greater standardisation among clinical practice guidelines and greater focus on the applicability of recommended practices.
Forensic psychiatry, of all the specialties in medicine, needs its own strong academic core. Academic forensic psychiatry is founded in scientific research, with its systematic approach to making and recording observations, formulating hypotheses from them, testing those hypotheses with new observations and accumulating the most comprehensive picture possible in a way that is transparent and replicable. An academic approach supports application of scientific principles as strongly in the individual case as in developing relevant collective knowledge, is able to make links between them and can communicate all this effectively within and outside the specialty. This requires highly developed and defined specialist training. Academic forensic psychiatry in this sense is the business of all forensic psychiatrists. In order for forensic psychiatry to thrive, however, it is vital that some forensic psychiatrists further specialise in academic work in terms of additional training, time and immersion in skills that support accurate scientific questioning and testing and, ultimately, the capacity to innovate and keep this cycle active.
Vestibular migraine is a newly recognised and debilitating condition. This article aims to provide an overview of what is known of vestibular migraine, delineating its diagnostic criteria and presenting some initial management strategies to aid ENT professionals in delivering optimal care when patients first present to the otolaryngology clinic.
Method
Although traditionally underdiagnosed, there are now clearly defined diagnostic criteria to aid accurate diagnosis of vestibular migraine.
Results
A detailed history and clinical examination are the cornerstone of the diagnostic process, but supportive evidence is required from appropriate audio-vestibular tests and imaging.
Conclusion
This is a unique condition that commonly initially presents to ENT. This article provides a summary of diagnostic and management strategies to facilitate early diagnosis and first-line treatment that can be employed in general ENT settings, which may be particularly useful given the limited availability of specialist audio-vestibular medicine and neuro-otology services.
Evidence development for medical devices is often focused on satisfying regulatory requirements with the result that health professional and payer expectations may not be met, despite considerable investment in clinical trials. Early engagement with payers and health professionals could allow companies to understand these expectations and reflect them in clinical study design, increasing chances of positive coverage determination and adoption into clinical practice.
Methods
An example of early engagement through the EXCITE International model using an early technology review (ETR) is described which includes engagement with payers and health professionals to better inform companies to develop data that meet their expectations. ETR is based on an early evidence review, a framework of expectations that guides the process and identified gaps in evidence. The first fourteen ETRs were reviewed for examples of advice to companies that provided additional information from payers and health professionals that was thought likely to impact on downstream outcomes or strategic direction. Given that limitations were imposed by confidentiality, examples were genericized.
Results
Advice through early engagement can inform evidence development that coincides with expectations of payers and health professionals through a structured, objective, evidence-based approach. This could reduce the risk of business-related adverse outcomes such as failure to secure a positive coverage determination and/or acceptance by expert health professionals.
Conclusions
Early engagement with key stakeholders exemplified by the ETR approach offers an alternative to the current approach of focusing on regulatory expectations. This could reduce the time to reimbursement and clinical adoption and benefit patient outcomes and/or health system efficiencies.