Patient-reported outcome measures for pain in women with pelvic floor disorders: a systematic review

Abstract

Introduction and hypothesis Patient-reported outcome measures (PROMs) are helpful instruments when measuring and reporting changes in patient health status (Al Sayah et al. J Patient Rep Outcomes 5 (Suppl 2):99, 2021) such as the health-related quality of life (HrQoL) of women with pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The Australasian Pelvic Floor Procedure Registry (APFPR) aims to increase capacity for women to report surgical outcomes through the collection of HrQoL data (Ruseckaite et al. Qual Life Res. 2021) but currently lacks a pain-specific PROM for women with pelvic floor disorders (PFDs), particularly POP and SUI. This review aims to systematically review the existing literature and identify instruments that measure pain in women with POP and SUI for inclusion within the APFPR, which reports on complications from these conditions. Methods We conducted a literature search on OVID MEDLINE, Embase, CINAHL, PsycINFO and EMCARE databases in addition to Google Scholar and grey literature to identify studies from inception to April 2021. Full-text studies were included if they used PROMs to measure pain in women with POP and SUI. Two authors independently screened articles, extracted data and assessed methodological quality. Results From 2001 studies, 23 publications describing 19 different PROMs were included for analysis. Eight of these instruments were specific to the pelvic floor; four were only specific to pain and used across multiple disorders; three were generic quality of life instruments and four were other non-validated instruments such as focus group interviews. These instruments were not specific to pain in women with POP or SUI, as they did not identify all relevant domains such as the sensation, region and duration of pain, or incidents where onset of pain occurs. Conclusions The findings of this review suggest there are no current PROMs that are suitable pain-specific instruments for women with POP or SUI. This knowledge may inform and assist in the development of a new PROM to be implemented into the APFPR.

Development of a conceptual framework for a new patient-reported outcome measure for pain in women following mesh surgery for pelvic floor disorders: a qualitative study

“…Based on the findings of our systematic review [10] and themes arising from analysis of the interview transcripts, a conceptual framework for an ideal pain instrument for the APFPR was developed. The findings were summarised into a comprehensive diagram and domains from the analysed themes were synthesised, where elements of pain important to women following mesh surgery for POP and SUI and their clinicians were described [16].…”

“…This reinforces the need for the female voice to inform researchers on what is important. Our previous research has identified that the instruments included in pelvic floor registries are not particularly helpful for women following surgery for POP and SUI [9,10]. It remains a complex situation as pain may exist because of a woman's original PFD; typical post-operative pain; or pain following mesh surgery due to complications.…”

“…Researchers developed a semi-structured interview guide based on a previously conducted systematic review [10] and acceptability study [9] to understand views and perceptions on pain following mesh surgery from women with POP and SUI and their clinicians. The interview guide has been included as Electronic Supplementary Material.…”

“…The APFPR is currently implementing PROMs including instruments that are incontinence specific, as well as those that measure sexual function and patient global impression of improvement [9], but does not have an accurate condition-specific instrument that measures pain. This implementation may identify post-operative complications associated with pelvic mesh [10]. A few PROMs that measure pain exist; however, they are not suitable for women with POP and SUI because they lack specificity and fail to recognise the full impact of significant pain arising from these procedures [10].…”

“…This implementation may identify post-operative complications associated with pelvic mesh [10]. A few PROMs that measure pain exist; however, they are not suitable for women with POP and SUI because they lack specificity and fail to recognise the full impact of significant pain arising from these procedures [10]. The addition of a specific instrument to measure pain in the APFPR may add to information regarding the safety of mesh procedures [9] by ensuring that the experiences that are important to women are captured [11].…”