Developing a patient-reported outcome measure (PROM) for postpartum care in Ireland

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Date
2024
Authors
O'Byrne, Laura
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University College Cork
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Abstract
Background and Aims: Patient-reported outcome measures (PROMs) are validated tools completed by patients to assess the impact of an intervention or therapy on them. In recent years, PROMs have gained attention for their patient-centred focus. However, there is no gold standard for assessing maternity care quality through PROM. The aim of this thesis was to examine the construction, feasibility, and validity of a comprehensive postnatal PROM, created as a combination of existing validated PROMs. This was achieved by systematically reviewing existing literature and conducting a range of analyses using recruited patient data from a postnatal population. Methods: This thesis includes an introductory chapter and a comprehensive methods section detailing the study designs, methodological choices, and statistical analyses. Chapters Three and Four present the systematic review and meta-analysis of existing postnatal PROMs. Chapter Five explores the feasibility of using a combination PROM based on the recommended findings from the systematic review. Chapters Six and Seven assess the content validity and construct validity of this approach. Chapter Eight discusses the overall findings, evaluates the strengths and limitations of the thesis, and offers recommendations for future studies. Results: The systematic review identified 10,324 records and 41 eligible studies evaluating 29 individual tools. Their psychometric properties were assessed according to the COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN). Twenty-one postnatal PROMs were recommended with 17 covering mental health, 4 addressing health-related quality of life, 4 focusing on breastfeeding and 3 on role transition. Gaps were found in postpartum urinary incontinence and pain with sexual intercourse coverage. The feasibility study assessed combining the identified psychometric tools with two bespoke sexual health inquiries to create a comprehensive postpartum PROM. Using the International Consortium for Health Outcomes Measurement (ICHOM) domains as a framework, the study tested the Postpartum Quality of Life (PQoL) and International Consultation on Incontinence Questionnaire–Urinary Incontinence Short Form (ICIQ-UI SF) questionnaires with additional sexual health questions on 86 women within the first week postpartum (T1), at 6 weeks after delivery (T2) and at 12 weeks post-partum (T3). High participation and favourable response rates were achieved: 69% (n=59) at T1, 67% (n=57) at T2, and 48% (n=41) at T3. There was high concordance between self-reported and clinician-reported delivery complications, providing a foundation for further validity studies. The content validity section examined the ability of the combination PROM in addressing ICHOM’s framework for postpartum care. 534 women agreed to participate, with observed response rates of 63% (n=334) at T1, 53% (n=283) at T2, and 45% (n=240) at T3. This analysis highlighted gaps in the coverage of mental health, early postpartum trauma related to childbirth, feeding challenges beyond breastfeeding, and evolving comprehensive physical health concerns throughout the postpartum period. The construct validity assessed how well the comprehensive PROM aligned with theoretical hypotheses regarding postpartum health. There were longitudinal changes in scores over time, with significant changes observed in PQoL and ICIQ-UI SF scores but not in pelvic pain scores. PQoL T1: 128 [±9.67], T2: 125 [±8.47], and T3: 126 [±8.51] p= 0.002. The ICIQ-UI SF had a median score and interquartile ranges of T1: 7.7 (IQR=6), T2: 9 (IQR=7), and T3: 9 (IQR=7), p = <0.001. No significant differences in scores were found between women with and without maternal morbidity, or across different morbidity types, neonatal unit admissions, or delivery types. Conclusion: This thesis evaluated the use of a comprehensive postpartum PROM, created as a combination of the best available instruments. The data suggests that current tools, including our comprehensive PROM, despite good psychometric properties, do not adequately cover postpartum health and wellbeing or discern between clinically distinct groups and outcomes.
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Keywords
Postpartum , Patient outcome reported measures , Maternity service improvements , Maternal morbidity , Quality obstetric care
Citation
O'Byrne, L. 2024. Developing a patient-reported outcome measure (PROM) for postpartum care in Ireland. PhD Thesis, University College Cork.
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