Validation of the PROMIS-29 Questionnaire as a Measure of Recovery after Pancreatic Surgery

Abstract

Objective: To contribute evidence for the reliability, construct validity and responsiveness of the PROMIS-29 profile questionnaire as a measure of recovery after pancreatic surgery. Summary Background Data: PROMIS questionnaires have been recommended to evaluate post-discharge recovery after surgery. Evidence supporting their measurement properties in pancreatic surgery is missing. Methods: An observational validation study designed according to the COSMIN checklist was conducted including data from a prospective clinical trial. Patients undergoing pancreatectomy completed PROMIS-29 preoperatively and on postoperative days (PODs) 15, 30, 90, 180. Reliability was assessed by internal consistency using Cronbach’s alpha. Construct validity was assessed by known-groups comparison. Responsiveness was evaluated hypothesizing that scores would be higher (1) preoperatively versus POD15, (2) on POD30 versus POD15, (3) on POD90 versus POD30, and (4) on POD180 versus POD90. Results: Overall, 510 patients were included in the study. Reliability was good to excellent (alpha values ranged from 0.82 to 0.97). Data supported 4 of 5 hypotheses tested for construct validity for five domains (physical function, anxiety, depression, fatigue and ability to participate in social roles) at most time points. Responsiveness hypotheses 1, 2, 3 were supported by the data for physical function, fatigue, sleep disturbance, pain interference and ability to participate in social roles domains. Conclusion: PROMIS had excellent reliability, discriminated between most groups expected to have different recovery trajectories and was responsive to the expected trajectory of recovery up to 90 days after surgery. Our findings support the use of PROMIS-29 profile as a patient reported outcome measure of post-discharge recovery after pancreatectomy.