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International Urogynecology Journal
Published in: International Urogynecology Journal 7/2021

01-07-2021 | Review Article

Patient-reported outcomes and outcome measures in childbirth perineal trauma research: a systematic review

Authors: Stergios K. Doumouchtsis, Jemina Loganathan, John Fahmy, Gabriele Falconi, Maria Rada, Abdullatif Elfituri, Jorge Milhem Haddad, Vasilios Pergialiotis, Cornelia Betschart, CHORUS: An International Collaboration for Harmonising Outcomes, Research and Standards in Urogynaecology and Women’s Health

Published in: International Urogynecology Journal | Issue 7/2021

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Abstract

Introduction and hypothesis

In evaluating the effectiveness of interventions in perineal trauma research, outcomes reported by patients should have a prominent focus. There is no international consensus regarding the use of either patient-reported outcomes (PROs) or tools used to determine these outcomes (patient-reported outcome measures, PROMs). The objective was to evaluate the selection, reporting and geographical variations of PROs and PROMs in randomised controlled trials (RCTs) on perineal trauma.

Methods

We performed a systematic review of RCTs in perineal trauma research evaluating outcome and outcome measure reporting. We identified PROs and PROMs and grouped PROs into domains and themes, a classification system based on a medical outcome taxonomy.

Results

Of 48 included RCTs, 47 reported PROs. In total, we identified 51 PROs. Outcome reporting consistency was low, with 27 PROs reported only once. Nine PROs were reported more than five times, the most frequent being perineal pain, with no geographical variation in reporting. Four themes encompassing 12 domains were identified. The most frequently reported theme was “Clinical”, with 25 PROs grouped within four domains. “Resource use” and “Adverse events” themes were rarely reported, with only five PROs. PROMs also exhibited variation. Most common were visual analogue scale (VAS; 100 mm), Cleveland Clinic Continence Score, The Faecal Incontinence Quality of Life scale, VAS (0–10) and the McGill Pain Questionnaire.

Conclusions

Significant heterogeneity in PROs and PROMs was observed among RCTs. Despite inconsistency, PROs are the most prevalent outcome in perineal trauma research. Patient-reported adverse events are underreported. Their use in determining the effectiveness and safety of interventions makes their integration important in perineal trauma core outcome sets. Identification and grouping of outcomes will assist future core outcome consensus studies.
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Metadata
Title
Patient-reported outcomes and outcome measures in childbirth perineal trauma research: a systematic review
Authors
Stergios K. Doumouchtsis
Jemina Loganathan
John Fahmy
Gabriele Falconi
Maria Rada
Abdullatif Elfituri
Jorge Milhem Haddad
Vasilios Pergialiotis
Cornelia Betschart
CHORUS: An International Collaboration for Harmonising Outcomes, Research and Standards in Urogynaecology and Women’s Health
Publication date
01-07-2021
Publisher
Springer International Publishing
Published in
International Urogynecology Journal / Issue 7/2021
Print ISSN: 0937-3462
Electronic ISSN: 1433-3023
DOI
https://doi.org/10.1007/s00192-021-04820-z

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