Is There Outcome Reporting Heterogeneity in Trials That Aim to Assess the Effectiveness of Surgical Treatments for Stress Urinary Incontinence in Women?

CONTEXT

Inconsistent reporting of effectiveness outcomes in surgical trials of stress urinary incontinence (SUI) has hindered direct comparisons of various surgical treatments for SUI.

OBJECTIVE

To systematically review the verbatim outcome names, outcome definitions, and tools used to measure the outcomes in surgical trials of SUI in women.

EVIDENCE ACQUISITION

Trials of women with SUI who have undergone surgical interventions were included. We conducted a systematic review (SR) on outcomes reported in randomized controlled trials of surgical management published in 2014-2019, covering the following databases: MEDLINE, EMBASE, CENTRAL, and CDSR. Verbatim outcome names extracted from the included studies were categorized and then grouped into domains using the Williamson-Clarke (W/C) outcome taxonomy. A matrix was also created to visualize and quantify the dimensions of outcome reporting heterogeneity in SUI trials.

EVIDENCE SYNTHESIS

A total of 844 verbatim outcome names were extracted, of which, 514 varied terms were reduced to 71 standardized outcome names. They were further categorized into 11 domains from the W/C taxonomy. There were 7.24 different terms on average to describe each outcome, and the four outcomes with the most heterogeneity evident in terms used to describe them were "urinary retention", "reoperation", "subjective cure rate" and "quality of life". Each of them had ≥20 different terms. Only 28% of the outcome definitions were reported and a variety of measuring tools was noted, particularly in subjective outcomes. High heterogeneity was found in the outcome names, outcome definitions, choice and number of measuring instruments of the outcomes, and choice and number of outcomes reported across studies.

CONCLUSIONS

This SR provides objective evidence of heterogeneity in outcome reporting in SUI surgical trials. Our categorization of outcomes highlights the difficulties in summarizing the current evidence base. A core outcome set, developed using the methods advocated by the Core Outcome Measures in Effectiveness Trials (COMET) and COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) initiatives, is required.

PATIENT SUMMARY

In this research, we have highlighted the diversity in outcomes reporting in stress urinary incontinence (SUI) surgical trials and have categorized the outcomes. We support the development of a core outcome set for SUI, which will promote future clinical researchers to measure the same outcome in the same way in all trials. This will, in turn, help researchers summarize the evidence more effectively and aid decision making for patients and doctors.