Pregnancy-related outcomes among women with physical disabilities: A systematic review.

BACKGROUND: Disability among women of reproductive age is common; many of these women desire children and do not have impaired fertility. OBJECTIVES: To examine the epidemiological literature on perinatal health outcomes among women with physical disabilities. DATA SOURCES: We searched Medline and CINAHL for articles published January 2009-April 2020 following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. STUDY SELECTION AND DATA EXTRACTION: Eligible studies were observational, quantitative, and reported on physical disabilities in association with prenatal, perinatal, postpartum, and/or infant health outcomes. We included studies that grouped physical and non-physical disabilities, such as surveys that queried only about general daily life limitations. We excluded case reports, descriptive studies without comparison groups, and studies conducted in low- or middle-income countries. Data extraction was done using predefined data fields. SYNTHESIS: All authors were involved in screening activities, data extraction, and/or quality assessment (rating and areas for bias). RESULTS: A total of 2650 articles were evaluated, of which sixteen met inclusion criteria (8 cross-sectional studies and 8 retrospective cohort studies). Assessments of disability status and perinatal outcomes widely varied across studies. Studies were rated as poor (n = 8) or fair quality (n = 8). Findings suggested that women with physical disabilities were at risk of several adverse outcomes, including caesarean delivery, infections, preterm complications, and maternal post-delivery hospitalisations, while their infants may be at risk of low birthweight and small-for-gestational age. Women classified as having complex/severe disabilities were often observed to be at higher risk of adverse outcomes compared to women with less severe disabilities. CONCLUSIONS: Research assessing how physical, functional, and medical restrictions influence health outcomes among women with physical disabilities, from preconception through postpartum, is limited. Longitudinal studies with comprehensive data collection that accurately identify women with physical disabilities are critical to understanding their reproductive health risks and outcomes.

An aligned framework of actively collected and passively monitored clinical outcome assessments (COAs) for measure selection.

Regulators increasingly require clinical outcome assessment (COA) data for approval. COAs can be collected via questionnaires or digital health technologies (DHTs), yet no single resource provides a side-by-side comparison of tools that collect complementary or related COA measures. We propose how to align ontologies for actively collected and passively monitored COAs into a single framework to allow for rapid, evidence-based, and fit-for-purpose measure selection.

Does clinical research account for diversity in deploying digital health technologies?

Digital health technologies (DHTs) should expand access to clinical research to represent the social determinants of health (SDoH) across the population. The frequency of reporting participant SDoH data in clinical publications is low and is not known for studies that utilize DHTs. We evaluated representation of 11 SDoH domains in 126 DHT-enabled clinical research publications and proposed a framework under which these domains could be captured and subsequently reported in future studies. Sex, Race, and Education were most frequently reported (in 94.4%, 27.8%, and 20.6% of publications, respectively). The remaining 8 domains were reported in fewer than 10% of publications. Medical codes were identified that map to each of the proposed SDoH domains and the resulting resource is suggested to highlight that existing infrastructure could be used to capture SDoH data. An opportunity exists to increase reporting on the representation of SDoH among participants to encourage equitable and inclusive research progress through DHT-enabled clinical studies.

Type 1 Diabetes Accelerates Progression of Coronary Artery Calcium Over the Menopausal Transition: The CACTI Study.

OBJECTIVE: Type 1 diabetes is associated with a higher risk of cardiovascular disease (CVD) in women. Although menopause increases risk of CVD, it is uncertain how menopause affects risk of CVD in women with type 1 diabetes. We examined whether risk of CVD changes differentially in women with and those without type 1 diabetes over the transition through menopause. RESEARCH DESIGN AND METHODS: Premenopausal women with type 1 diabetes (n = 311) and premenopausal women without diabetes (n = 325) enrolled in the Coronary Artery Calcification in Type 1 Diabetes (CACTI) study and attended up to four study visits over 18 years. Coronary artery calcium (CAC) volume was measured from computed tomography scans obtained at each visit. Longitudinal repeated-measures modeling estimated the effect of diabetes on CAC volume over time and the effect of menopause on the diabetes-CAC relationship. RESULTS: CAC volume was higher at baseline and increased more over time in women with type 1 diabetes than in women without diabetes. A significant diabetes-by-menopause interaction was found (P < 0.0001): postmenopausal women with type 1 diabetes had significantly higher CAC volumes than premenopausal women (5.14 ± 0.30 vs. 2.91 ± 0.18 mm3), while there was no difference in women without diabetes (1.78 ± 0.26 vs. 1.78 ± 0.17 mm3). This interaction remained significant after adjusting for CVD risk factors. CONCLUSIONS: Type 1 diabetes was associated with higher CAC volume and accelerated progression of CAC over time. Menopause increased CAC progression more in women with diabetes than in women without diabetes independent of age and other CVD risk factors known to worsen with menopause.