Julio F Fiore Jr, PhD, Sabrina Figueiredo, MSc, Lawrence Lee, PhD, Benedicte Nauche, MLIS, Nancy Mayo, PhD, Liane S Feldman, MD. McGill University Health Centre
Introduction: Patients and caregivers actively seek information about how long it will take to recover or “get back to normal” after an operation. Surgical techniques (e.g. laparoscopy) and perioperative care programs (e.g. enhanced recovery pathways) are widely advocated to improve recovery. In line with the principles of patient-centered care, measurement of recovery needs to include the patients’ voice through patient-reported outcomes (PROs; reports of health coming directly from the patient without interpretation by others). To draw valid conclusions regarding PRO data, instruments with robust measurement properties are required. The aim of this systematic review is to summarize and critically appraise the measurement properties of PRO instruments used in the context of postoperative recovery after abdominal surgery.
Methods: This review followed the PRISMA guidelines and was registered at PROSPERO (CRD42014014349). Eight bibliographic databases (MEDLINE, EMBASE, Biosis, PsycINFO, PubMed, CINAHL, Scopus, Web of Science) were searched. Studies were included if they (1) focused on evaluating the measurement properties of PROs used in the context of postoperative recovery (i.e. <3 months after the operation) and (2) involved adult patients (>18yo) undergoing abdominal surgery. We excluded studies involving instruments that were specific to a single domain (e.g. pain, fatigue) or disease/organ specific (i.e. reflux, bariatric surgery). The measurement properties of each instrument were appraised using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist.
Results: We identified 29 studies evaluating 19 different instruments. Fifteen instruments were recovery-specific (4 specifically focused on abdominal surgery) and 3 were generic instruments having their measurement properties assessed in the context of recovery. Only 2 instruments had content validity supported by qualitative research (Abdominal Surgery Impact Scale and Postoperative Recovery Profile). Evidence for internal consistency, reliability, structural validity, construct validity, cross-cultural validity and responsiveness was generally poor/limited. Instruments widely used in the literature such as the Quality of Recovery-40 and SF-36 had conflicting results in regards to construct validity and responsiveness. None of the instruments identified were developed according to the FDA guidelines for PROs or used modern psychometric methods to optimize item selection and scoring (e.g. Item-Response Theory).
Conclusions: There is very limited evidence supporting the measurement properties of existing PRO instruments used in the context of recovery after abdominal surgery. This should be taken into account when interpreting results from studies using these instruments. Measuring the value of innovations advocated to improve recovery requires the development of recovery-specific PRO instruments according to FDA standards.