Developing items for inclusion in a new pain-specific patient-reported outcome measure for pelvic floor surgery: a mixed-methods study.

Abstract

<h4>Background</h4>Women undergoing pelvic floor procedures (PFPs) to treat their pelvic floor disorder (PFD) may experience pain, affecting their health-related quality of life. Current patient-reported outcome measures (PROMs) assess pain but are not specific to PFD post-surgery. This study was part of developing a new pain-specific PROM for women following PFP, aimed to (1) refine an existing conceptual framework to better understand post- post-PFP in women, (2) draft potential items, and (3) develop a consensus set of items for the new measure to ensure content validity.<h4>Methods</h4>A mixed-methods approach was used to address the aim in three phases: (1) refining an existing conceptual framework for post-PFP pain based on feedback from semi-structured interviews with 16 women, (2) drafting potential items based on the revised framework, and (3) conducting an online two-round Delphi survey with 17 experts ranked to rank, review items, then produce a consensus set.<h4>Results</h4>The interviews conducted identified key attributes of pain that need to be addressed in the new pain instrument for PFP. From the interviews, 114 items were drafted under eight framework domains, and then presented to a panel in the Delphi survey. After two Delphi rounds, 35 items were finalised, with 11 equally merged or deleted, resulting in a final set of 35 items.<h4>Conclusion</h4>This is the first study to develop a set of items for the new pain measure based on the experiences and expertise of women and clinicians. Inclusion of the items can offer valuable insight into pain after PFP.