Patient-reported outcome measures (PROMs) are widely used to assess quality of life (QoL) following childbirth-related perineal trauma. However, their content validity in this population remains unclear. This study aimed to evaluate the content validity of PROMs used to assess QoL in women with childbirth-related perineal trauma using the COSMIN methodology.

A systematic review was conducted in accordance with COSMIN methodology and reported following PRISMA principles. Electronic databases (EMBASE, MEDLINE, PsycINFO) were searched from inception to December 2025.

Studies were eligible if they described PROM development or evaluated content validity in women with childbirth-related perineal trauma. Additional searches of Google Scholar and reference lists were performed.

Content validity was assessed using COSMIN criteria, including relevance, comprehensiveness, and comprehensibility. Methodological quality of PROM development was evaluated using COSMIN standards, and overall quality of evidence was graded using a modified GRADE approach.

A total of 10,827 records were identified. After screening, no studies evaluating content validity in the target population were found. Three PROM development studies were included: the Cleveland Incontinence Score, the McGill Pain Questionnaire, and the Fecal Incontinence Quality of Life Scale.

None of the PROMs were developed using concept elicitation involving women with childbirth-related perineal trauma, and no cognitive interview studies were identified. Target populations were poorly defined and not specific to childbirth-related perineal trauma.

Consequently, evidence for relevance and comprehensiveness was indeterminate for all PROMs, although comprehensibility was generally acceptable. Overall, the quality of evidence for content validity was rated as very low across all instruments.

There is a critical lack of evidence supporting the content validity of PROMs used to assess QoL following childbirth-related perineal trauma. The absence of patient involvement in PROM development and lack of validation in the target population limit confidence in current outcome measurement and may contribute to research waste.

No PROM can currently be recommended as having adequate content validity for assessing QoL in women with childbirth-related perineal trauma. Future research should prioritise COSMIN-guided, patient-centred PROM development incorporating concept elicitation and cognitive interviewing to ensure clinically meaningful outcome measurement.

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Continence 19S (2026) 102527
DOI: 10.1016/j.cont.2026.102527