Reliability of patient‐reported outcome measures: Hemorrhage, anticoagulant, antiplatelet medication use

• Main Authors: Nicholyn Selvanayagam, Fabrice Mowbray, Natasha Clayton, Asfia Soomro, Catherine Varner, Shelley McLeod, Kerstin deWit
• Format: Article
• Language: English
• Published: Wiley 2021-05-01
• Series: Research and Practice in Thrombosis and Haemostasis
• Subjects: anticoagulants; hemorrhage; patient‐reported outcome measures; platelet aggregation inhibitors; reproducibility of results
• Online Access: https://doi.org/10.1002/rth2.12501

Abstract Background Most antithrombotic medication users are older adults. Patient‐reported outcome measures are commonly used in clinical research on antithrombotic medication, such as the diagnosis of intracranial hemorrhage. Objectives To determine the reliability of patient‐reported intracranial hemorrhage, anticoagulant and platelet aggregation inhibitor use in the older adult population. Patients/Methods We conducted a secondary analysis of a prospective, observational cohort study of older adults who presented to the emergency department with a fall. The primary outcome was diagnosis of intracranial bleeding. We compared patient‐reported intracranial bleeding to structured chart review with adjudication. We also compared patient‐reported use of antiplatelet and anticoagulant medication to physician‐reported medication use supplemented with structured chart review. We calculated the diagnostic accuracy of the patient‐reported outcomes using our comparators as the reference standard. Results Exact agreement for patient‐reported intracranial bleeds was 95%, with a Cohen’s kappa of 0.30 (95% confidence interval [CI], 0.15‐0.45). The sensitivity was 36.7% (95% CI, 20.6%‐56.1%) and specificity 97.2% (95% CI, 95.8%‐98.1%). For anticoagulant medication use, exact agreement was 87%, Cohen’s kappa 0.66 (95% CI, 0.63‐0.72), sensitivity 84.0% (95% CI, 79.3%‐83.8%), and specificity 87.6% (95% CI, 85.1%‐89.7%). For antiplatelet medication use, exact agreement was 77%, Cohen’s kappa 0.50 (95% CI, 0.44‐0.55), sensitivity 68.7% (95% CI, 64.0%‐73.1%), and specificity 81.2% (95% CI, 78.0‐83.8%). Conclusions Patient‐reported outcome and exposure data were unreliable in this study. Our findings have a bearing on future research study design.