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http://conacyt.repositorioinstitucional.mx/jspui/handle/1000/265| Bias Attributable to Composite Outcome | |
| Fredi Alexander Diaz-Quijano | |
| Novel Coronavirus | |
| Acceso Abierto | |
| Atribución-NoComercial | |
| 10.1101/2020.02.13.20020966 | |
| Background: Little guidance is available on how composite outcomes should be interpreted, especially in situations of varied direction in the association across the event subtypes. I proposed an index to evaluate the bias attributable to composite outcomes (BACO) and applied it in recently published clinical trials. Methods: I defined the BACO index as the ratio between logarithms of the association measures of both a composite outcome and its most relevant component (e.g., any-cause mortality). By using the non-linear combination of parameters, based on the delta method, I calculated the confidence intervals and performed Wald-type tests for the null hypotheses (BACO index = 1). I applied this method in systematically selected clinical trials, and in two other preselected trials which I considered "positive controls". These last trials have been recognized as examples of primary composite outcomes that were disregarded because of inconsistency with the treatment effect on mortality. Results: BACO index values different from one were classified according to whether the use of composite outcomes overestimated (BACO index >1), underestimated (BACO index between zero and <1), or inverted (BACO index <0) the association between exposure and prognosis. In three of 23 clinical trials and the two positive controls, the BACO indices were significantly lower than one (using p <0.005 as a preset cutoff). Conclusion: Based on the BACO index testing, researchers could predefined rules to make impartial decisions about maintaining a composite outcome as the primary endpoint or to state cautions regarding its interpretation. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This work had no specific funding. However, the author is beneficiary of a fellowship for research productivity from the National Council for Scientific and Technological Development CNPq. ### Author Declarations All relevant ethical guidelines have been followed; any necessary IRB and/or ethics committee approvals have been obtained and details of the IRB/oversight body are included in the manuscript. Yes All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All data necessary to verify the results were included in the manuscript or are available in the papers cited in the references. | |
| Cold Spring Harbor Laboratory Press | |
| 2020 | |
| Preimpreso | |
| https://www.medrxiv.org/content/10.1101/2020.02.13.20020966v1 | |
| Inglés | |
| VIRUS RESPIRATORIOS | |
| Aparece en las colecciones: | Artículos científicos |
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| bias attributable.pdf | 1.25 MB | Adobe PDF | Visualizar/Abrir |