ArticleBMC medicine2023
Assessment of redundant randomized clinical trials among patients with ST segment elevation myocardial infarction.
Article in BMC medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
6 authors at 6 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRedundant clinical trials waste resources and unnecessarily put patients at risk for harm. The objectives of the study were to assess redundant randomized clinical trials (RCTs) conducted in mainland China or the USA among patients with ST segment elevation myocardial infarction (STEMI) and estimate the harm to patients enrolled in redundant RCTs.
methodsWe searched bibliographic databases for eligible RCTs comparing a routine therapy with a placebo or no treatment among patients with STEMI in mainland China or the United States. The routine therapy for STEMI included reperfusion (percutaneous coronary intervention or fibrinolytic therapy), P2Y
resultsNine hundred eighty-three eligible RCTs conducted in mainland China were identified, of which 775 (78.8%) were redundant. None of the five eligible RCTs conducted in the United States were redundant. All redundant RCTs have reiterated the benefits of routine therapies for patients with STEMI, while none were cited by the 2019 clinical practice guideline for the management of STEMI. The 18,819 patients in the control groups of redundant RCTs experienced 3305 (95% CI: 3169-3441) extra MACEs, including 1091 (1014-1165) deaths, 576 (519-633) recurrent myocardial infarctions, 31 (19-42) revascularizations, 39 (23-54) strokes, 744 (679-810) heart failures, and 823 (754-893) patients with recurrent or exacerbated angina pectoris. Cumulative meta-analyses confirmed the efficacy of the routine therapies among patients in mainland China and supported using practice guidelines to define redundant RCTs.
conclusionsRedundant RCTs conducted in mainland China have resulted in unnecessary MACEs among patients with STEMI. While the reasons behind redundant RCTs need to be further investigated, these results suggest potential research waste and violation of research ethics.
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