Validation of PREM-PS, a patient-reported experience instrument, in a randomized controlled trial of pregnant women undergoing prenatal screening

Patient-reported experience measures are valuable instruments for assessing care quality in alignment with the Triple Aim framework. We sought to validate the PREM-PS questionnaire (Patient Reported Experience Measure – Prenatal Screening) by evaluating its psychometric properties (structural validity, internal consistency, and cross-cultural validity) for Canadian French-and English-speaking populations. This secondary analysis used data from a prospective, open-label, multicenter randomized trial in Quebec and British Columbia (2019–2023). Pregnant women aged 19+ were randomized 2:1 to receive either first-tier cell-free DNA (cfDNA) or traditional biochemical screening for chromosomal anomalies (T21, T18, T13). Participants completed the PREM-PS, a 10-item questionnaire on a 5-point Likert scale, at 22 weeks of pregnancy. Exploratory factor analysis, conducted separately for French and English questionnaires, used half the data to identify underlying factors. Confirmatory factor analysis of the remaining data evaluated structural validity. Internal consistency was assessed using Cronbach’s alpha, and cross-cultural validity through measurement invariance analyses. Mean scores were compared across arms using linear mixed models. Of 7815 enrolled pregnant women, 3398 completed the French questionnaire and 2875 the English version (80.3% response rate, 96.4% completion rate). Mean age was 32.11 years (SD = 4.01), with 65.1% identifying as White. Factor analyses retained seven items grouped into two latent factors interpreted as Communication and Professionalism. Standardized loadings from exploratory factor analysis ranged from 0.66–0.93 (French) and 0.69–0.96 (English), while standardized parameter estimates from the confirmatory factor analysis ranged from 0.67–0.98 (French) and 0.62–0.98 (English). Cronbach’s alpha exceeded 0.85 for both factors in French and 0.88 in English. No significant differences were observed between the two study arms for either Professionalism or Communication scores, indicating comparable patient-reported experiences regardless of screening method. The PREM-PS demonstrates adequate validity for assessing patient-reported experiences of pregnant women undergoing prenatal screening in both Canadian French and English, with potential to guide improvements in prenatal care. ClinicalTrials.gov, NCT03831256. Registered February 5th, 2019, https://clinicaltrials.gov/study/NCT03831256?term=NCT03831256&rank=1 We developed and validated the first French and English questionnaires specifically designed to measure pregnant women’s experiences during prenatal screening. The questionnaire measures two core physician skills from Canada’s CanMEDS framework: Communication (how well providers listen and enable patient-centered dialogue) and Professionalism (clinical competence). Our study found that women receiving newer genetic screening methods (cfDNA) and traditional biochemical screening reported similar experiences, suggesting that the type of screening does not significantly impact how patients perceive their quality of care.