Balancing benefits and potential risks of vaccination: the precautionary principle and the law of unintended consequences
Vaccination is a life-saving endeavour, yet risk and uncertainty are unavoidable in science and medicine. Vaccination remains contentious in the public mind, and vaccine hesitancy is a serious public health issue. This has recently been reignited in the discussion over potential side effects of COVID-19 vaccines, and the decision by several countries to suspend measures such as the AstraZeneca vaccine. In these instances, the precautionary principle has often been invoked as a rationale, yet such heuristics do not adequately weigh potential harms against real benefits. How we analyse, communicate and react to potential har...
Source: Evidence-Based Medicine - November 22, 2022 Category: Internal Medicine Authors: Grimes, D. R. Tags: COVID-19 EBM analysis Source Type: research

COP27 climate change conference: urgent action needed for Africa and the world
Wealthy nations must step up support for Africa and vulnerable countries in addressing past, present and future impacts of climate change The 2022 report of the Intergovernmental Panel on Climate Change paints a dark picture of the future of life on earth, characterised by ecosystem collapse, species extinction and climate hazards such as heatwaves and floods.1 These are all linked to physical and mental health problems, with direct and indirect consequences of increased morbidity and mortality. To avoid these catastrophic health effects across all regions of the globe, there is broad agreement—as 231 health journals...
Source: Evidence-Based Medicine - November 22, 2022 Category: Internal Medicine Authors: Zielinski, C., On behalf of the authorship group listed below Tags: Open access Editorials Source Type: research

Bayesian interpretation of p values in clinical trials
Commonly accepted statistical advice dictates that large-sample size and highly powered clinical trials generate more reliable evidence than trials with smaller sample sizes. This advice is generally sound: treatment effect estimates from larger trials tend to be more accurate, as witnessed by tighter confidence intervals in addition to reduced publication biases. Consider then two clinical trials testing the same treatment which result in the same p values, the trials being identical apart from differences in sample size. Assuming statistical significance, one might at first suspect that the larger trial offers stronger e...
Source: Evidence-Based Medicine - September 22, 2022 Category: Internal Medicine Authors: Ferguson, J. Tags: Open access Research methods and reporting Source Type: research

Correlation between chest CT and RT-PCR testing in Indias second COVID-19 wave: a retrospective cohort study
Conclusion In our experience, chest CT has a good sensitivity and provides a reliable diagnostic tool for moderate-to-severe COVID-19 cases in resource limited settings. (Source: Evidence-Based Medicine)
Source: Evidence-Based Medicine - September 22, 2022 Category: Internal Medicine Authors: Mehta, V., Jyoti, D., Guria, R. T., Sharma, C. B. Tags: COVID-19 Original research Source Type: research

Preventable deaths from SARS-CoV-2 in England and Wales: a systematic case series of coroners reports during the COVID-19 pandemic
Conclusions PFDs contain a rich source of information on preventable deaths that has previously been difficult to examine systematically. Our openly available tool (https://preventabledeathstracker.net/) streamlines this process and has identified many concerns raised by coroners that should be addressed during the government’s inquiry into the handling of the COVID-19 pandemic, so that mistakes made are less likely to be repeated. Study protocol preregistration https://osf.io/bfypc/. (Source: Evidence-Based Medicine)
Source: Evidence-Based Medicine - September 22, 2022 Category: Internal Medicine Authors: Swift, B., Heneghan, C., Aronson, J., Howard, D., Richards, G. C. Tags: COVID-19 Original research Source Type: research

Kidney trajectory charts to assist general practitioners in the assessment of patients with reduced kidney function: a randomised vignette study
Conclusions Use of the chart changed GPs interpretation of eGFR, with increased recognition of the younger male patient’s clinically relevant kidney problem, and increased numbers classifying the older female patient’s kidney function as normal for her age. This study has shown the potential of an age-based kidney function chart to reduce both overdiagnosis and underdiagnosis. (Source: Evidence-Based Medicine)
Source: Evidence-Based Medicine - September 22, 2022 Category: Internal Medicine Authors: Guppy, M., Glasziou, P., Beller, E., Flavel, R., Shaw, J. E., Barr, E., Doust, J. Tags: Open access Original research Source Type: research

Diagnostic accuracy of rapid point-of-care tests for diagnosis of current SARS-CoV-2 infections in children: a systematic review and meta-analysis
Conclusions The performance of current antigen tests in paediatric populations under real-life conditions varies broadly. Relevant data were only identified for very few antigen tests on the market, and the risk of bias was mostly unclear due to poor reporting. Additionally, the most common uses of these tests in children (eg, self-testing in schools or parents testing their toddlers before kindergarten) have not been addressed in clinical performance studies yet. The observed low diagnostic sensitivity may impact the planned purpose of the broad implementation of testing programmes. PROSPERO registration number CRD420212...
Source: Evidence-Based Medicine - September 22, 2022 Category: Internal Medicine Authors: Fujita-Rohwerder, N., Beckmann, L., Zens, Y., Verma, A. Tags: Open access, Press releases, COVID-19 Evidence synthesis Source Type: research

Risks of infection, hospital and ICU admission, and death from COVID-19 in people with asthma: systematic review and meta-analyses
Conclusions Though absence of evidence of a clear association between asthma and worse outcomes from COVID-19 should not be interpreted as evidence of absence, the data reviewed indicate that risks from COVID-19 in people with asthma, as a whole, may be less than originally anticipated. (Source: Evidence-Based Medicine)
Source: Evidence-Based Medicine - September 22, 2022 Category: Internal Medicine Authors: Otunla, A., Rees, K., Dennison, P., Hobbs, R., Suklan, J., Schofield, E., Gunnell, J., Mighiu, A., Hartmann-Boyce, J. Tags: COVID-19 Evidence synthesis Source Type: research

Evidence-based medicine has already adapted and is very much alive
Greenhalgh et al1 argue that the COVID-19 pandemic has uncovered a need for a shift in the evidence-based medicine (EBM) paradigm in which mechanistic evidence is also used as a complementary source for decision-making. Their justification is based on limitations of evidence hierarchies, which prioritise meta-analyses and randomised controlled trials (RCTs)1; and the urgency, threat and complexity of a pandemic. However, in defence of EBM, we present a counter argument. First, mechanistic evidence may be misleading. Textbooks of clinical epidemiology and EBM manuals include numerous examples of mechanistic evidence support...
Source: Evidence-Based Medicine - September 22, 2022 Category: Internal Medicine Authors: Murad, M. H., Saadi, S. Tags: EBM opinion and debate Source Type: research

Adapt or die: how the pandemic made the shift from EBM to EBM+ more urgent
Evidence-based medicine (EBM’s) traditional methods, especially randomised controlled trials (RCTs) and meta-analyses, along with risk-of-bias tools and checklists, have contributed significantly to the science of COVID-19. But these methods and tools were designed primarily to answer simple, focused questions in a stable context where yesterday’s research can be mapped more or less unproblematically onto today’s clinical and policy questions. They have significant limitations when extended to complex questions about a novel pathogen causing chaos across multiple sectors in a fast-changing global context....
Source: Evidence-Based Medicine - September 22, 2022 Category: Internal Medicine Authors: Greenhalgh, T., Fisman, D., Cane, D. J., Oliver, M., Macintyre, C. R. Tags: Open access EBM analysis Source Type: research

Correction: Developing future leaders in evidence-based medicine: the inaugural David Sackett Fellowship
Gill PJ, O’Neil B, Richards GC. Developing future leaders in evidence-based medicine: the inaugural David Sackett Fellowship. BMJ Evidence-Based Medicine 2022;27:131–132. doi:10.1136/bmjebm-2022-111996. Author name Braden O’Neil should be listed as Braden O’Neill. (Source: Evidence-Based Medicine)
Source: Evidence-Based Medicine - July 28, 2022 Category: Internal Medicine Tags: Miscellaneous Source Type: research

Later is not necessarily better: limitations of survival analysis in studies of long-term drug treatment of psychiatric conditions
Survival analysis is routinely used to assess differences between groups in relapse prevention and treatment discontinuation studies involving people with long-term psychiatric conditions. The actual outcome in survival analysis is ‘time to event’, yet, in the mental health field, there has been little consideration of whether a temporary delay to relapse is clinically relevant in a condition that can last for decades. Moreover, in psychiatric drug trials, a pattern of elevated early relapses following randomisation to placebo or no treatment is common. This may be the result of the withdrawal of previous treat...
Source: Evidence-Based Medicine - July 28, 2022 Category: Internal Medicine Authors: Moncrieff, J., Jakobsen, J. C., Bachmann, M. Tags: Open access Research methods and reporting Source Type: research

Interventions for Menieres disease: an umbrella systematic review
Conclusions A definite effective and well-tolerated therapy for MD has yet to be discovered and information on the natural course of disease is one of the biggest flaws in current research. PROSPERO registration number CRD4201502424. (Source: Evidence-Based Medicine)
Source: Evidence-Based Medicine - July 28, 2022 Category: Internal Medicine Authors: van Esch, B. F., van der Zaag-Loonen, H., Bruintjes, T., Kuijpers, T., van Benthem, P. P. G. Tags: Evidence synthesis Source Type: research

Ivabradine added to usual care in patients with heart failure: a systematic review with meta-analysis and trial sequential analysis
Conclusion and relevance High certainty evidence shows that ivabradine does not seem to affect the risks of all-cause mortality and cardiovascular mortality. The effects on quality of life were small and possibly without relevance to patients on the KCCQ and were very uncertain for the MLWHFQ. The effects on serious adverse events, myocardial infarction and hospitalisation are uncertain. Ivabradine seems to increase the risk of atrial fibrillation, bradycardia and non-serious adverse events. PROSPERO registration number: CRD42018112082. (Source: Evidence-Based Medicine)
Source: Evidence-Based Medicine - July 28, 2022 Category: Internal Medicine Authors: Maagaard, M., Nielsen, E. E., Sethi, N. J., Liang, N., Yang, S.-H., Gluud, C., Jakobsen, J. C. Tags: Open access Evidence synthesis Source Type: research

Economic evaluation of direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs) for stroke prevention in patients with atrial fibrillation: a systematic review and meta-analysis
Conclusions Our meta-analysis provides comprehensive economic evidence that allows policy makers to generalise cost-effectiveness data to their local context. All DOACs may be cost-effective compared with VKA in HICs with TPP perspective. The pooling results produced moderate to high heterogeneity particularly in UMICs. Further studies are required to inform UMICs with SP. PROSPERO registeration number CRD 42019146610. (Source: Evidence-Based Medicine)
Source: Evidence-Based Medicine - July 28, 2022 Category: Internal Medicine Authors: Noviyani, R., Youngkong, S., Nathisuwan, S., Bagepally, B. S., Chaikledkaew, U., Chaiyakunapruk, N., McKay, G., Sritara, P., Attia, J., Thakkinstian, A. Tags: Open access Evidence synthesis Source Type: research