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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.
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.
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.
It was aimed to explore the relationship between evidence-based medicine (EBM) training and medical students’ views on traditional, complementary, and alternative medicine (TCAM) and their views on conspiracies about COVID-19.
Background:
Medical students constitute the future workforce of primary health care services. The relationship between EBM training and their views on conspiracies about COVID-19 is critical to explore for providing a better primary health care. The relationship EBM training and medical students’ views on TCAM is also important in this regard.
Methods:
This is a cross-sectional study. Turkish medical students were surveyed about EBM training, TCAM, and COVID-19 conspiracies. The electronic survey form consisted of five parts: Demographic characteristics, views and self-perceived knowledge about TCAM and the methods, views on the origin of SARS-COV-2, participation in EBM training, and views on TCAM training. A total of 49 medical schools provided response. Along with descriptive statistics, Chi-square test was utilized.
Findings:
Among 2577 participants, 24.0% of them believed SARS-COV-2 was artificially designed. The students who have participated in EBM training via both lecture and small group discussions have a less positive view on TCAM than both the students who have not participated in any EBM training (p < 0.05) and the students who participated in only-lectures (p < 0.05). There was a significant association between EBM training and whether believing COVID-19 (SARS-COV-2) has been designed purposefully by some people or it has emerged naturally χ2 (1) = 17.21 p < 0.001. The odds of thinking COVID-19 emerged naturally was 1.85 times higher (95% CI: 1.38-2.47) if the students have participated in EBM training via both lectures and small group discussions than if they have not participated in any EBM training. EBM training affects medical students in terms of beliefs on COVID-19 conspiracies.
Drug benefits policy-making for seniors in British Columbia has been increasingly influenced by research since 1993. The "evidence-based medicine" paradigm, which emphasizes the primacy of direct evidence from randomized control trials, inspired key policy-makers and influenced policy concerning coverage of new and existing drugs. New drugs, if more expensive than existing similar drugs, are not covered unless published randomized control trials show superior effectiveness. Indirect evidence of effectiveness, based on surrogates, is given less weight, and non-randomized studies are rarely considered. Evidence of cost-effectiveness of new drugs is reviewed separately. For existing drugs, a new reimbursement policy, Reference Based Pricing (RBP), was introduced, based on both direct and indirect evidence of comparative effectiveness of drugs. Implementation of RBP was complex and necessarily rapid, which meant that independent systematic review of evidence relevant to implementation issues was infeasible, particularly in regard to rapid prior authorization of exemptions to RBP. Contrasts between the processes for new and existing drugs provide insights into the difficulties of applying the idea of direct evidence-based policy-making in practice.
To analyse the comparative clinical outcomes and clinicopathological significance of vocal fold leukoplakia lesions treated by appearance classification and traditional methods.
Method
A total of 1442 vocal fold leukoplakia patients were enrolled. Group A patients were treated according to appearance classification and Group B patients were treated according to traditional methods.
Results
In Group A, 24.4, 14.9 and 60.6 per cent of patients had grade I, II and III dysplasia, respectively. Grade I dysplasia (63.4 per cent) was more than twice as frequent in Group B patients than in Group A patients, while grade II dysplasia (20.4 per cent) and grade III dysplasia (16.2 per cent) were significantly less frequent in Group B patients than in Group A patients (p = 0.000). There was a significant correlation between vocal fold leukoplakia appearance and the degree of dysplasia (p = 0.000). The recurrence and malignant transformation rates (17.6 and 31 per cent, respectively) in Group B were significantly greater than those in Group A (10.8 and 25.9 per cent, respectively) (p = 0.000).
Conclusion
Vocal fold leukoplakia appearance classification is useful for guiding treatment decision-making and could help to improve therapeutic accuracy.
In the years following FDA approval of direct-to-consumer, genetic-health-risk/DTCGHR testing, millions of people in the US have sent their DNA to companies to receive personal genome health risk information without physician or other learned medical professional involvement. In Personal Genome Medicine, Michael J. Malinowski examines the ethical, legal, and social implications of this development. Drawing from the past and present of medicine in the US, Malinowski applies law, policy, public and private sector practices, and governing norms to analyze the commercial personal genome sequencing and testing sectors and to assess their impact on the future of US medicine. Written in relatable and accessible language, the book also proposes regulatory reforms for government and medical professionals that will enable technological advancements while maintaining personal and public health standards.
When is it justified to use opaque artificial intelligence (AI) output in medical decision-making? Consideration of this question is of central importance for the responsible use of opaque machine learning (ML) models, which have been shown to produce accurate and reliable diagnoses, prognoses, and treatment suggestions in medicine. In this article, I discuss the merits of two answers to the question. According to the Explanation View, clinicians must have access to an explanation of why an output was produced. According to the Validation View, it is sufficient that the AI system has been validated using established standards for safety and reliability. I defend the Explanation View against two lines of criticism, and I argue that within the framework of evidence-based medicine mere validation seems insufficient for the use of AI output. I end by characterizing the epistemic responsibility of clinicians and point out how a mere AI output cannot in itself ground a practical conclusion about what to do.
This is a brief presentation of the evidence from a systematic literature review of the diagnostic accuracy in suspected traumatic shaking. The national and international reaction to this systematic literature review is also addressed, along with rebuttal of the criticism and an interpretation of the hostile reception of the review. We argue that despite the fact that a scientific controversy often includes competing theories about mechanisms, the shaken baby controversy also includes a controversy about correlation knowledge, because its function is to corroborate (or falsify) the applied theories about mechanisms. Moreover, we argue that long personal experience and groupthink within child protection teams have influenced the development of biased gold standards, resulting in turn in circular reasoning: hence most of the shaken baby literature is flawed.
Shaken baby syndrome (SBS) is a controversial medical ‘diagnosis’ that is challenged by an increasing number of reputable medical professionals, scientists, and lawyers. This chapter outlines various attacks made on those who challenge the mainstream view of the scientific and forensic reliability of these medical determinations, with the goal of delegitimising their perspective and maintaining the authority of the orthodoxy. The scientific and medical debate in the field has become toxic, described as ‘tribal warfare’. The chapter identifies and explains the fault lines at the interfaces between science, law, and medicine that have led to such an unhealthy environment, and how this has impeded the progress of science in the field.
The orthodox view of shaken baby syndrome (SBS) has been predominant amongst the medical and forensic communities for decades, over which time scores of accusations of child abuse have been made based on standard diagnostic methods, which have been scientifically verified. Convictions for murder, manslaughter and child homicide have resulted in jail sentences of up to 35 years, whilst actions taken through family courts have resulted in removal of children. We discuss how belief in SBS has been systematically incorporated into Australian medical, forensic, judicial, policing, and social service institutions. We also highlight some important challenges that have been made to the orthodox views in Australia, despite the ongoing general adoption of the orthodoxy.
A retrospective cross-sectional analysis was conducted of the US Food and Drug Administration's MAUDE (Manufacturer and User Facility Device Experience) database, to evaluate the complication profile of cochlear implantation according to manufacturer.
Methods
A review of the MAUDE database was conducted from 1 January 2010 to 31 December 2020. Complications, including infection, extrusion, facial nerve stimulation, meningitis and cerebrospinal fluid leak, were identified using key word searches. The categorised data were analysed using a chi-square test to determine a difference in global complication incidence between three major cochlear implant manufacturers: manufacturer A (Cochlear Limited), manufacturer B (Med-El) and manufacturer C (Advanced Bionics).
Results
A total of 31 857 adverse events were analysed. Implants of manufacturer C were associated with a statistically higher rate of infection (0.97 per cent), cerebrospinal fluid leak (0.07 per cent), extrusion (0.44 per cent) and facial nerve stimulation (0.11 per cent). Implants of manufacturer B were associated with a statistically higher rate of meningitis (0.07 per cent).
Conclusion
Consideration of patient risk factors along with cochlear implant manufacturers can heighten awareness of cochlear implant complications pre-operatively, intra-operatively and post-operatively.
This chapter explains how research is also not immune from fads and fallacies, as has been demonstrated by the replication crisis in psychology. It argues that the best antidote to fads of all kinds is more and better research. Finally, it discusses why, despite the fact that we are still at an early stage in our voyage of discovery about mental disorders, psychiatrists must as far as possible practice evidence-based medicine.
The aim of this systematic review was to collect evidence and recommendations for the applicability of the concept of evidence-based policy making (EBPM) during the coronavirus disease 2019 (COVID-19) pandemic and to discuss the implementation of this concept from a medical science perspective.
Methods:
This study was performed according to the guidelines, checklist, and flow diagram of Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020. An electronic literature search was conducted on September 20, 2022 using PubMed, Web of Science, Cochrane Library, and CINAHL databases with the following search terms: “evidence based policy making” and “infectious disease.” Study eligibility assessment was performed based on the flow diagram of PRISMA 2020, and risk of bias assessment was performed using The Critical Appraisal Skills Program.
Results:
Eleven eligible articles were included in this review and divided into three groups as follows: early, middle, and late stages of the COVID-19 pandemic. Basics of COVID-19 control were suggested in the early stage. The articles published in the middle stage discussed the importance of the collection and analysis of evidence of COVID-19 from around the world for the establishment of EBPM in the COVID-19 pandemic. The articles published in the late stage discussed the collection of large amounts of high-quality data and the development of methods to analyze them, as well as emerging issues related to the COVID-19 pandemic.
Conclusions:
This study revealed that the concept of EBPM applicable to emerging infectious disease pandemics changed between the early, middle, and late stages of the pandemic. The concept of EBPM will play an important role in medicine in the future.
The basic insight of evidence-based medicine is that randomized studies are more valid in their results than observational studies or case studies or clinical experience, in that order, because of correction for confounding bias. This concept of levels of evidence is the key to understanding EBM.
There is a case to be made for evidence-based medicine (EBM), and there is a case to be made against it. Many of the critiques of EBM are ill-founded, but some important criticisms need attention. The issues and concerns around EBM are discussed.
This chapter highlights how the evolving field of implementation research is being used to address problems of implementation of health policies, programs, practices, and technologies in low and middle-income countries (L&MICs). Implementation research offers a way to understand and address implementation challenges and contribute to building stronger health systems within the realities of specific and changing contexts. It is used to assess how and why interventions work, including the feasibility, adoption, and acceptance of interventions and their coverage, quality, equity, efficiency, scale, and sustainability. A well-designed research question is critical to successful implementation research, and provides the basis for choosing the research methods and how likely the research will influence policy and practice. In describing the theories, frameworks and tools used in implementation research, they are shown to be well suited to address inter-dependent and complex problems around improving people’s wellbeing – a critical mandate for achieving Universal Health Coverage and the Sustainable Development Goals.
The objective is to identify research priorities in prehospital care in Spain.
Method:
This was a Delphi-type study of three rounds with a panel of experts made up of members of the Red de Investigación en Emergencias Prehospitalarias (RINVEMER; Prehospital Emergency Research Network) Network and the Sociedad Española de Medicina de Urgencias y Emergencias (SEMES; Spanish Society of Emergency Medicine) Emergency Secretariat. In the first round, each participant identified up to 15 priorities. In the second round, they scored the 30 thematic areas on a Likert scale. In the third round, they ordered and scored from one to ten the first ten priorities among those that obtained a median greater than or equal to four in the second round. After adding the assigned scores, the ten priorities with the highest total score were obtained.
Results:
The ten identified research priorities were: special clinical codes and time-dependent conditions; mass-casualty incident (MCI) coordination and management; innovation in Emergency Medical Services (EMS); human factor in decision making; triage, analysis, and management of calls in the Emergency Call Center; new technologies, telemedicine, and emergencies; adverse events, clinical safety, and quality in emergencies; cardiac arrest; continuous education and training (methodology, quality, and evaluation); and big data and emergencies.
Conclusions:
The research priorities perceived by emergency professionals are related to clinical care and organizational aspects of EMS, in addition to the need to incorporate innovative aspects and new data analysis technologies.