The development of a quality appraisal tool for studies of diagnostic reliability (QAREL)

Background and Objective: In systematic reviews of the reliability of diagnostic tests, no quality assessment tool has been used consistently. The aim of this study was to develop a specific quality appraisal tool for studies of diagnostic reliability. Methods: Key principles for the quality of studies of diagnostic reliability were identified with reference to epidemiologic principles, existing quality appraisal checklists, and the Standards for Reporting of Diagnostic Accuracy (STARD) and Quality Assessment of Diagnostic Accuracy Studies (QUADAS) resources. Specific items that encompassed each of the principles were developed. Experts in diagnostic research provided feedback on the items that were to form the appraisal tool. This process was iterative and continued until consensus among experts was reached. Results: The Quality Appraisal of Reliability Studies (QAREL) checklist includes 11 items that explore seven principles. Items cover the spectrum of subjects, spectrum of examiners, examiner blinding, order effects of examination, suitability of the time interval among repeated measurements, appropriate test application and interpretation, and appropriate statistical analysis. Conclusions: QAREL has been developed as a specific quality appraisal tool for studies of diagnostic reliability. The reliability of this tool in different contexts needs to be evaluated.