Different meta-analysis methods can change judgements about imprecision of effect estimates: a meta-epidemiological study
Conclusion
Empirical evaluation of studies of chronic medical conditions showed that conclusions about the precision of the estimates of the efficacy of a drug or device frequently changed when different pooling methods were used, particularly when the number of studies within a meta-analysis was small and statistical heterogeneity was substantial. Sensitivity analyses using more than one method may need to be considered in these two scenarios. (Source: Evidence-Based Medicine)
Source: Evidence-Based Medicine - March 23, 2023 Category: Internal Medicine Authors: Wang, Z., Alzuabi, M. A., Morgan, R. L., Mustafa, R. A., Falck-Ytter, Y., Dahm, P., Sultan, S., Murad, M. H. Tags: Original research Source Type: research
Retrieval barriers in individual participant data reviews with network meta-analysis
Conclusions
We found no clear evidence of retrieval bias (where IPD availability was linked to trial findings) in either IPD-NMA, but because retrieval bias could impact NMA findings, subsequent decision-making and guideline development, this should be considered when assessing risk of bias in IPD syntheses. (Source: Evidence-Based Medicine)
Source: Evidence-Based Medicine - March 23, 2023 Category: Internal Medicine Authors: Veroniki, A. A., Stewart, L. A., Le, S. P. C., Clarke, M., Tricco, A. C., Straus, S. E. Tags: Original research Source Type: research
Swallowing outcomes in dysphagia interventions in Parkinsons disease: a scoping review
Conclusions
The high variability of outcomes emphasises the need for an agreed standardised COS. This will inform clinical trial design in OD in PD, increase the quality of OD trials in PD and facilitate synthesising and comparing study results to reach conclusion on the safety and effectiveness of OD interventions in PD. It will not prevent or restrict researchers from examining other outcomes.
Trial registration number
The COS-DIP study, including the scoping review, was registered prospectively with the Core Outcome Measures in Effectiveness Trials Database on 24 September 2021 (www.comet-initiative.org, registration n...
Source: Evidence-Based Medicine - March 23, 2023 Category: Internal Medicine Authors: Hirschwald, J., Hofacker, J., Duncan, S., Walshe, M. Tags: Open access Original research Source Type: research
Reporting and methodological quality of studies that use Mendelian randomisation in UK Biobank: a meta-epidemiological study
Conclusions
The results identify areas in which the reporting and conducting of MR studies needs to be improved and also suggest researchers do not make use of supplementary materials to sufficiently report secondary analyses. Future research should focus on the quality of code and analyses, attempt direct replications and investigate the impact of the STROBE-MR specifically.
Study registration
https://osf.io/nwrdj (Source: Evidence-Based Medicine)
Source: Evidence-Based Medicine - March 23, 2023 Category: Internal Medicine Authors: Gibson, M. J., Spiga, F., Campbell, A., Khouja, J. N., Richmond, R. C., Munafo, M. R. Tags: Open access Original research Source Type: research
Consistency between trials presented at conferences, their subsequent publications and press releases
Conclusions
For clinical trials presented at major medical conferences, primary efficacy endpoint definitions were consistently reported and results were consistently characterised across conference abstracts, registry entries and publication abstracts; consistency rates were lower for sample sizes, follow-up periods, and effect size estimates.
Registration
This study was registered at the Open Science Framework (https://doi.org/10.17605/OSF.IO/VGXZY). (Source: Evidence-Based Medicine)
Source: Evidence-Based Medicine - March 23, 2023 Category: Internal Medicine Authors: Rowhani-Farid, A., Hong, K., Grewal, M., Reynolds, J., Zhang, A. D., Wallach, J. D., Ross, J. S. Tags: Open access Original research Source Type: research
Validity and reliability of the Spanish version of the ACE tool for assessing competencies in evidence-based medicine in medical students
Conclusion
The translated and cross-culturally adapted version of the ACE tool into Spanish had low reliability and validity in an MBE course taught and evaluated in a virtual environment.
Trial registration
Not applicable. (Source: Evidence-Based Medicine)
Source: Evidence-Based Medicine - March 23, 2023 Category: Internal Medicine Authors: Sgarbossa, N., Marino, S., Aletta, L., Vazquez Pena, F. R., Franco, J. V. A. Tags: Primary care Original research Source Type: research
Perspectives from China, India and Sri Lanka on the drivers and potential solutions to overuse and overdiagnosis
Overuse is defined as provision of healthcare which is more likely to result in harm than good, and it is fast becoming a threat to human health and the sustainability of health systems worldwide.1 Overuse may, but not always, increase the risk of overdiagnosis, which occurs when someone is diagnosed with a disease that would have never caused them harm if not recognised and is a well-known adverse outcome of screening.2 3 Overuse and overdiagnosis have a different signification when it occurs in LMICs, where wise utilisation of the already limited healthcare resources is paramount, especially in the COVID-19 pandemic era....
Source: Evidence-Based Medicine - March 23, 2023 Category: Internal Medicine Authors: Pathirana, T., Wang, Y., Martiny, F., Copp, T., Kumar, R., Mendis, K., Tang, J. Tags: EBM opinion and debate Source Type: research
Improving FDA postmarket adverse event reporting for medical devices
Postmarket surveillance represents a critical component of the US Food and Drug Administration’s (FDA) lifecycle assessment of medical devices, as many devices—including high-risk implanted devices—are often approved on the basis of limited premarket clinical efficacy and safety data.1 The FDA collects information on real-world adverse events through passive surveillance and shares it with the public using the agency’s Manufacturer and User Facility Device Experience (MAUDE) database, a national database of device-associated deaths, injuries and malfunctions. Reporting to the FDA is mandatory for ce...
Source: Evidence-Based Medicine - March 23, 2023 Category: Internal Medicine Authors: Wunnava, S., Miller, T. A., Bourgeois, F. T. Tags: EBM opinion and debate Source Type: research
FDAs dilemma with the aducanumab approval: public pressure and hope, surrogate markers and efficacy, and possible next steps
Accelerating Food and Drug Administration (FDA) product approval to market based on surrogate markers in the absence of proven efficacy creates a risk of adverse outcomes for affected patients, even in response to a life-threatening condition, such as in this case, Alzheimer’s disease. FDA’s recent unexpected approval of aducanumab, despite the unified opposition of its own highly respected advisory committee after the early termination of two efficacy trials, creates the potential risk of adverse effects and lack of clinical efficacy at very high costs. In view of these concerns, a thorough review of the issue...
Source: Evidence-Based Medicine - March 23, 2023 Category: Internal Medicine Authors: Rizk, J. G., Lewin, J. C. Tags: EBM analysis Source Type: research
Methylphenidate denied access to the WHO List of Essential Medicines for the second time
Introduction Attention deficit hyperactivity disorder (ADHD) is a common psychiatric disorder with estimated prevalence between 3% and 5% in children and about 2.5% in adults.1 The prevalence varies across countries and even regions within the same country.2 The psychostimulant methylphenidate is used as the first-line treatment for ADHD in children, adolescents and adults in many countries.3 Essential medicines are those that satisfy the priority healthcare needs of the majority of the population and, as such, should be available in a functioning healthcare system at all times. This concerns the availability of appropriat...
Source: Evidence-Based Medicine - March 23, 2023 Category: Internal Medicine Authors: Pereira Ribeiro, J., Lunde, C., Gluud, C., Simonsen, E., Storebo, O. J. Tags: Mental Health EBM analysis Source Type: research
Revisiting the value of Archie Cochranes contributions
The thoughts of Cochrane (1909–1988), more known as Archie Cochrane, deserve to be treasured also by the next generations. His name has become famous worldwide thanks to the Cochrane Collaboration and before it, thanks to the publication of his book Effectiveness and efficiency. Random reflections on health services1—of which we remember its 50th anniversary this year and was properly commemorated 25 years ago.2 Archie Cochrane’s thoughts cannot be fully understood apart from his life, so marked by the Spanish Civil War and the World War II,3–5 which shaped his antiauthoritarian spirit that he trans...
Source: Evidence-Based Medicine - March 23, 2023 Category: Internal Medicine Authors: Bonfill, X. Tags: Editorials Source Type: research
Registration of health and medical research
is an effective way of improving the transparency and credibility of evidence. Registration involves pre-specifying the research objectives, design, methods and analytic plan on a publicly accessible repository before conducting the study. Registration can reduce bias and improve the transparency and credibility of research findings. Registration is mandated for clinical trials, but it is also relevant to systematic reviews, observational and preclinical experimental research. This paper describes how researchers can register their research and outlines possible barriers and challenges in doing so. Widespread adoption of ...
Source: Evidence-Based Medicine - January 19, 2023 Category: Internal Medicine Authors: Cashin, A. G., Richards, G. C., DeVito, N. J., Mellor, D. T., Lee, H. Tags: Research methods and reporting Source Type: research
Knowledge user survey and Delphi process to inform development of a new risk of bias tool to assess systematic reviews with network meta-analysis (RoB NMA tool)
Conclusions
This Delphi process and knowledge user survey informs the development of the RoB NMA tool. (Source: Evidence-Based Medicine)
Source: Evidence-Based Medicine - January 19, 2023 Category: Internal Medicine Authors: Lunny, C., Veroniki, A. A., Hutton, B., White, I., Higgins, J., Wright, J. M., Kim, J. Y., Thirugnanasampanthar, S. S., Siddiqui, S., Watt, J., Moja, L., Taske, N., Lorenz, R. C., Gerrish, S., Straus, S., Minogue, V., Hu, F., Lin, K., Kapani, A., Nagi, S. Tags: Open access, General Medicine Original research Source Type: research
Perspectives on the production, and use, of rapid evidence in decision making during the COVID-19 pandemic: a qualitative study
Conclusions
Rapid evidence products were considered invaluable to decision making. The credibility of EPs, a close relationship with SUs and having a highly skilled and adaptable team to meet the workload demands were identified as key strengths that optimised the utilisation of rapid evidence.
Ethics approval
Ethical approval was obtained from the National Research Ethics Committee for COVID-19-related Research, Ireland. (Source: Evidence-Based Medicine)
Source: Evidence-Based Medicine - January 19, 2023 Category: Internal Medicine Authors: Clyne, B., Hynes, L., Kirwan, C., McGeehan, M., Byrne, P., Killilea, M., Smith, S. M., Ryan, M., Collins, C., ONeill, M., Wallace, E., Murphy, A. W., Kelly, M. E. Tags: Open access, General Medicine Original research Source Type: research
Proportion attributable to contextual effects in general medicine: a meta-epidemiological study based on Cochrane reviews
Conclusions
The results suggest that much of the observed benefit is not just due to the specific effect of the interventions. The specific effects of interventions may be larger for subjective outcomes than for objective or semiobjective outcomes. However, PCEs were exceptionally variable. When we evaluate the magnitude of PCEs, we should consider each PCE individually, for each condition, intervention and outcome in its context, to assess the importance of an intervention for each specific clinical setting. (Source: Evidence-Based Medicine)
Source: Evidence-Based Medicine - January 19, 2023 Category: Internal Medicine Authors: Tsutsumi, Y., Tsujimoto, Y., Tajika, A., Omae, K., Fujii, T., Onishi, A., Kataoka, Y., Katsura, M., Noma, H., Sahker, E., Ostinelli, E. G., Furukawa, T. A. Tags: Open access, General Medicine Original research Source Type: research
