Abstract

Unwarranted variation in clinical practice contributes to inconsistent perinatal outcomes and poor quality maternity care. Value-based healthcare aims to address unwarranted variation and drive quality improvement but requires the systematic and rigorous measurement of outcomes and costs. Traditional maternity measures are insufficient to inform the value of maternity care. The ICHOM (International Consortium for Health Outcomes Measurement) Standard Set for Pregnancy and Childbirth is a core outcome set developed to measure value in maternity care, but the quality of the set has not been tested. This program of work aimed to evaluate the validity, reliability and feasibility of the ICHOM Standard Set for Pregnancy and Childbirth. The thesis follows a traditional structure with introduction, methods, results and discussion chapters. Thesis findings are presented as a series of five published papers, two submitted papers currently under review, and two unpublished papers. First, a systematic literature review evaluated the quality of maternal and neonatal core outcome set development. The review is presented in two parts: (I) prospective protocol, and (II) findings. Exponential growth in core outcome set development was identified and no core outcome set met all minimum standards for development. The ICHOM Standard Set for Pregnancy and Childbirth met 75 percent of the minimum standards for development. Although findings highlight a need for more transparency in reporting, results indicate the ICHOM Standard Set was developed using robust methods. A narrative review evaluated the quality and psychometric performance of the person-reported outcome measures (PROMs) included in the ICHOM Standard Set. Nine PROMs were evaluated against COSMIN (Consensus-Based Standards for the Selection of Health Measurement Instruments) standards for study design methodology and criteria for good measurement properties. The review identified major gaps in the literature regarding the psychometric performance of five included PROMs in relation to childbearing women. To address some of these gaps, a prospective, longitudinal cohort study was conducted with 309 childbearing women. Participants were asked to complete five online surveys at ICHOM’s prescribed time-points from booking to 26-weeks postpartum and included the ICHOM Standard Set and additional measures chosen to facilitate psychometric analysis. A series of studies then aimed to: (i) assess psychometric performance, (ii) refine PROMs to improve psychometric performance, (iii) offer recommendations, and (iv) offer an alternative if inclusion of the PROM could not be supported. The first two studies evaluated the psychometric properties of the PROMIS® (Patient-Reported Outcomes Measurement Information System) Global Short Form (health-related quality of life), the International Consultation on Incontinence Questionnaire – Urinary Incontinence Short Form (ICIQ-UI SF) and the Wexner Scale (urinary and anal incontinence). The third study developed and evaluated a framework to facilitate standardised reporting of perinatal incontinence. The fourth study compared the screening accuracy of the Patient Health Questionnaire (PHQ-2) using two case-identification methods to detect probable depression. The fifth study evaluated the construct validity of the Single Item Measure of Social Supports (SIMSS) to measure social support. The results of these studies supported the inclusion of all but one of the included PROMs in the ICHOM Standard Set for Pregnancy and Childbirth but under the caveat of some refinements and recommendations. The final study evaluated the feasibility of the ICHOM Standard Set in practice. High recruitment, response, and completion rates and high retention at 6-months post-birth supported feasibility of the ICHOM Standard Set. The revised ICHOM Standard Set for Pregnancy and Childbirth is a robust set of outcomes and measures that is acceptable to childbearing women. Universal embedding of the Standard Set into routine clinical practice has the potential to inform value-based healthcare, and drive quality improvement and is recommended. Further research is needed to inform the optimal approach for successful implementation of the Standard Set in the real-world setting.

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