Question: Does self-monitoring of blood pressure by pregnant individuals at higher risk of preeclampsia lead to earlier detection of pregnancy hypertension compared to usual antenatal care? Findings: In this randomized clinical trial that included 2441 pregnant individuals at increased risk for pre-eclampsia, use of self-monitoring of BP with telemonitoring compared with usual care resulted in a mean time to clinic-based detection of hypertension of 104 vs 106 days, a difference that was not statistically significant.Meaning: Among pregnant individuals at higher risk of pre-eclampsia, blood pressure selfmonitoring with telemonitoring did not lead to earlier clinic-based detection of hypertension.

Aim:To determine health practitioners' experience of using the culturally adapted Ages and Stages Questionnaire -Talking about Raising Aboriginal Kids (ASQ-TRAK) and the Ages and Stages Questionnaire-3 (ASQ-3) with Australian Aboriginal families and their perception about parents' acceptability and understanding of the instruments. Methods: We surveyed a convenience sample of practitioners who had used both the ASQ-TRAK and the ASQ-3 developmental screening tools with Aboriginal children in the Northern Territory and South Australia. We compared their experience and perception about parents' acceptability and understanding of both instruments. Results: All 38 respondents used the ASQ-3 and 35 the ASQ-TRAK; 100% rated the ASQ-TRAK as more acceptable and easier to understand for parents compared with 68% (P < 0.001) and 52.6% (P < 0.001), respectively, for the ASQ-3. A greater proportion of respondents were satisfied using the ASQ-TRAK (100%) than the ASQ-3 (65.7%) (P = 0.003). A higher proportion indicated that the ASQ-TRAK was respectful (85.3% compared with ASQ-3 27.8%, P < 0.001), culturally relevant (70.6% compared to 16.2%, P < 0.001) and engaging (76.5% compared to 16.2%, P < 0.001). Qualitative exploration of respondents' comments supported the quantitative findings. The ASQ-TRAK was considered more culturally appropriate, engaging and useful. Conclusions: Our findings demonstrate that the culturally adapted ASQ-TRAK is preferred to the ASQ-3 by health practitioners in the Australian Aboriginal context. Failing to address cultural and linguistic factors and applying measurement tools developed for one population to another, is problematic in any setting. While further research is required to explore parents' experience directly, these data provide support for the ASQ-TRAK to be used in this context.

Background As a pragmatic randomised timing-of-birth trial, WILL adapted its trial procedures in response to the COVID-19 pandemic. These are reviewed here to inform post-pandemic trial methodology. Methods The trial (internal pilot) paused in March 2020, re-opened in July 2020, and is currently recruiting in 37 UK NHS consultant-led maternity units. We evaluated pandemic adaptations made to WILL processes and surveyed sites for their views of these changes (20 sites, videoconference). Results Despite 88% of sites favouring an electronic investigator site file (ISF), information technology requirements and clinical trial unit (CTU) operating procedures mandated the ongoing use of paper ISFs; site start-up delays resulted from restricted access to the CTU. Site initiation visits (SIVs) were conducted remotely; 50% of sites preferred remote SIVs and 44% felt that it was trial-dependent, while few preferred SIVs in-person as standard procedure. The Central team felt remote SIVs provided scheduling and attendance flexibility (for sites and trial staff), the option of recording discussions for missing or future staff, improved efficiency by having multiple sites attend, and time and cost savings; the negative impact on rapport-building and interaction was partially mitigated over time with more familiarity with technology and new ways-of-working. Two methods of remote consent were developed and used by 30/37 sites and for 54/156 recruits. Most (86%) sites using remote consenting felt it improved recruitment. For remote data monitoring (5 sites), advantages were primarily for the monitor (e.g. flexibility, no time constraints, reduced cost), and disadvantages primarily for the sites (e.g. document and access preparation, attendance at a follow-up meeting), but 81% of sites desired having the option of remote monitoring post-pandemic. Conclusions COVID adaptations to WILL trial processes improved the flexibility of trial delivery, for Central and site staff, and participants. Flexibility to use these strategies should be retained post-pandemic. Trial registration ISRCTN77258279. Registered on 05 December 2018.

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