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

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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Funding

S. Doumouchtsis has previously had expenses paid by Contura (please see disclosure form). There are no funding disclosures for this review article.

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S. Doumouchtsis: conceived the idea, project development, data analysis, manuscript writing and editing; J. Loganathan: data analysis, manuscript writing and editing; J. Fahmy: data collection, data analysis and manuscript writing; G. Falconi: data analysis, manuscript editing; M. Rada: data analysis, manuscript editing; A. Elfituri: data analysis, manuscript editing; J.M. Haddad: manuscript writing and editing; V. Pergialiotis: data analysis, manuscript editing; C. Betschart: manuscript writing and editing.

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Correspondence to Jemina Loganathan.

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Doumouchtsis, S.K., Loganathan, J., Fahmy, J. et al. Patient-reported outcomes and outcome measures in childbirth perineal trauma research: a systematic review. Int Urogynecol J 32, 1695–1706 (2021). https://doi.org/10.1007/s00192-021-04820-z

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Keywords

  • Patient-reported outcomes
  • Perineal trauma
  • Core outcome sets
  • Perineal injury
  • Childbirth trauma