Systematic Bias in Clinical Decision Instrument Development: A Quantitative Meta-Analysis

Abstract Clinical decision instruments (CDIs) face an equity dilemma. On the one hand, they often reduce disparities in patient care through data-driven standardization of best practices. On the other hand, this standardization may itself inadvertently perpetuate bias and inequality within healthcare systems. Here, we quantify different measures of potential for implicit bias present in CDI development that can inform future CDI development. We find evidence for systematic bias in the development of 690 CDIs that underwent validation through various analyses: self-reported participant demographics are skewed—e.g. 73% of participants are White, 55% are male; investigator teams are geographically skewed—e.g. 52% in North America, 31% in Europe; CDIs use predictor variables that may be prone to bias—e.g. 13 CDIs explicitly use Race and Ethnicity; outcome definitions may further introduce bias—e.g. 28% of CDIs involve follow-up, which may disproportionately skew outcome representation based on socioeconomic status. As CDIs become increasingly prominent in medicine, we recommend that these factors are considered during development and clearly conveyed to clinicians using CDIs. Competing Interest Statement The authors have declared no competing interest. Funding Statement Research reported in this publication was supported by Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health under award number K23HD110716 (AK). This information or content and conclusions are those of the author and should not be construed as the official position or policy of, nor should any endorsements be inferred by HRSA, HHS or the U.S. Government. Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. 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, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Data Availability All data and code for reproducing the results in this manuscript is made publicly available through MDCalc and processed data is made available at https://github.com/csinva/clinical-rule-analysis.