Journal of clinical epidemiology
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Prior epidemics of high-mortality human coronaviruses, such as the acute respiratory syndrome coronavirus (SARS-CoV or SARS-1) in 2003, have driven the characterization of compounds that could be possibly active against the currently emerging novel coronavirus SARS-CoV-2 (COVID-19). Presently, no approved treatment or prophylaxis is available for COVID-19. We comment on the existing COVID-19 research methodologies in general and the published reporting. Given the media attention and claims of effectiveness, we chose chloroquine and hydroxychloroquine, in combination with azithromycin, as an area of COVID-19 research to examine. ⋯ We found that the COVID-19 research methodology is very poor in the area of chloroquine/hydroxychloroquine research. In screening the literature, we observed the same across COVID-19 research in relation to potential treatments. The reporting is very poor and sparse, and patient-important outcomes needed to discern decision-making priorities are not reported. We do understand the barriers to perform rigorous research in health care settings overwhelmed by a novel deadly disease. However, this emergency pandemic situation does not transform flawed methods and data into credible results. The adequately powered, comparative, and robust clinical research that is needed for optimal evidence-informed decision-making remains absent in COVID-19.
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The Grading of Recommendations Assessment, Development, and Evaluations (GRADE) working group has recognized some scenarios in which strong recommendations may be supported by low-quality evidence, the so-called paradigmatic situations. The adherence to these paradigmatic situations by the American Thyroid Association (ATA) guidelines, however, remains unknown. ⋯ ATA clinical guidelines are discordant with GRADE guidance. Future guidelines should carefully evaluate the quality of evidence and recognize its limitations when developing recommendations.
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We assessed the reporting of replicability items with the BayesWatch guidelines and crucial items of Bayesian analyses with the Reporting Of Bayes Used in clinical STudies (ROBUST) guidelines in reports of phase III trials. ⋯ CRD42017054929.