Objectives: This systematic review assesses the reporting quality and risk of bias in studies evaluating the diagnostic test accuracy (DTA) of clinical decision support systems (CDSS).
Study design and setting: The Cochrane Library, PubMed/MEDLINE, Scopus, and Web of Science were searched for studies, published between January 1, 2016 and May 31, 2021, evaluating the DTA of CDSS for human patients. Articles using a patient's self-diagnosis, assessing disease severity, focusing on treatment/follow-up, or comparing pre-post CDSS implementation periods were excluded. All eligible studies were assessed for reporting quality using STARD 2015 and for risk of bias using QUADAS-2. Item ratings were presented using heat maps. This study was reported as per PRISMA-DTA.
Results: In total, 158 of 2,820 screened articles were included in the analysis. The studies were heterogeneous in terms of study characteristics, reporting quality, risk of biases, and applicability concerns with few highly rated studies. Mostly the overall quality was deficient for items addressing the domains 'methodology,' 'results,' and 'other information'.
Conclusion: Our analysis revealed shortcomings in critical domains of reporting quality and risk of bias, indicating the need for additional guidance and training in an interdisciplinary scientific field with mixed biostatistical expertise.
Keywords: Clinical decision support system; Diagnostic study; Diagnostic test accuracy; Reporting quality; Risk of bias; Systematic review.
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