Patient-Reported Outcome Measures for Use in Women With Pelvic Organ Prolapse: A Systematic Review

To describe the psychometric properties of existing patient-reported outcome measures for women with prolapse using the COSMIN (Consensus-Based Standards for the Selection of Health Measurement Instruments) framework. Additional objectives were to describe the patient-reported outcome scoring method or interpretation, methods of administration, and to compile a list of the non-English languages in which the patient-reported outcomes are reportedly validated.

PubMed and EMBASE was searched through September 2021. Study characteristics, patient-reported outcome details, and psychometric testing data were extracted. Methodologic quality was assessed with COSMIN guidelines.

Studies reporting the validation of a patient-reported outcome in women with prolapse (or women with pelvic floor disorders that included a prolapse assessment) and reporting psychometric testing data on English-language patient-reported outcome for at least one measurement property per COSMIN and the U.S. Department of Health and Human Services definitions were included, as well as studies reporting the translation of an existing patient-reported outcome into another language, a new method of patient-reported outcome administration, or a scoring interpretation. Studies reporting only pretreatment and posttreatment scores, only content or face validity, or only findings for nonprolapse domains of the patient-reported outcome were excluded.

Fifty-four studies covering 32 patient-reported outcomes were included; 106 studies assessing translation into a non-English language were excluded from the formal review. The number of validation studies per patient-reported outcome (one version of one questionnaire) ranged from 1 to 11. Reliability was the most reported measurement property, and most measurement properties received an average rating of sufficient. The condition-specific patient-reported outcomes had on average more studies and reported data across more measurement properties compared with adapted and generic patient-reported outcomes.

Although measurement property data vary on patient-reported outcomes for women with prolapse, most data were of good quality. Overall, condition-specific patient-reported outcomes had more studies and reported data across more measurement properties.

PROSPERO, CRD42021278796.