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Published on: September 20, 2018
Content Validity of Measurement Instruments Used to Assess Patient Quality of Life (QoL) in Women with Stress Urinary
Isabelle Legood1, Christina Pagkaki2, Subanhey Thiyagalingam3
1University Hospitals of Derby and Burton NHS Foundation Trust, Derby, UK.
Introduction And Hypothesis:
Stress urinary incontinence (SUI) significantly affects women's quality of life (QoL). Patient-reported outcome measures (PROMs) are widely used to assess QoL; however, the content validity of many instruments has not been systematically evaluated in women with SUI. This study aimed to evaluate the content validity of PROMs used to assess QoL in women with SUI.
Methods:
EMBASE, MEDLINE and PsycINFO were searched from database inception to December 2025. Additional records were identified through hand-searching Google Scholar.
Selection Criteria:
Studies describing PROM development or evaluating content validity of PROMs assessing QoL or the impact of urinary symptoms in women with SUI were included. Two reviewers independently screened studies, extracted data using a standardised form, and assessed methodological quality using the Consensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. Evidence for relevance, comprehensiveness and comprehensibility was synthesised, and quality of evidence graded using a modified GRADE approach.
Results:
Nineteen studies describing 22 PROMs were included. Methodological quality of PROM development was rated as inadequate for 21 instruments. Only one PROM had been developed specifically for women with SUI. Concept elicitation was inadequate for most instruments and patient involvement in development was limited. Evidence supporting content validity varied across PROMs.
Conclusion:
Evidence supporting the content validity of PROMs used in women with SUI is heterogeneous and often limited. Greater adherence to COSMIN guidance is needed to ensure instruments adequately capture patient-relevant outcomes.
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