Patient and Clinician Feedback to Inform the Development of a New Pain-Specific Patient-Reported Outcome Measure for Pelvic Floor Surgery.

Abstract

Introduction: Pelvic floor procedures may result in pain, negatively affecting women's health-related quality of life. Existing patient-reported outcome measures (PROMs) inadequately capture specific pain attributes and their relationship to pelvic floor disorders (PFDs). This study aimed to pretest items for a new pain-specific PROM post-pelvic floor surgery through focus groups/interviews.

Methods: This qualitative study utilised six focus groups/interviews with 15 adult Australian and New Zealand women with PFDs experiencing post-surgical pain and mesh complications. Consolidation with the Australasian Pelvic Floor Procedure Registry Steering Committee, consisting of 11 clinicians, also occurred. Women and clinicians provided feedback regarding 35 potential items for the new pain-specific PROM. Data from the discussions were transcribed and then thematically analysed using NVivo.

Results: Women and clinicians agreed the new PROM could effectively address PFDs and pelvic floor surgical pain. Their feedback guided decision-making to modify items and design the pain instrument. Women recommended removing 14 of the 35 items, and clinicians from the registry steering committee suggested removing a further five items. The preliminary PROM with 16 items has been developed under seven key pain-related domains: sensation, region, intensity and continuity, triggers, interference, comorbidities and complications, and pain relief and management.

Conclusions: This qualitative study obtained direct input from women with PFDs and clinicians in formulating items for the new measure. A preliminary version of the PROM was produced from the feedback. Once fully developed and validated, the PROM could assist shared patient-clinician decision-making and track pain-related health outcomes important to women following pelvic floor surgery.