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Background Patient and Public Involvement and Engagement (PPIE) is an essential element of any clinical trial, to ensure that the research design and resources are acceptable and the trial produces findings that are relevant to research participants and service-users. The WILL (When to Induce Labour to Limit risk in pregnancy hypertension) Trial Management Team involved a group of patient and public members to develop an infographic, for service-users and -providers, to communicate the risks of chronic and gestational hypertension at term gestational age. Methods Based on national resources in the UK for PPIE, including those from the National Institute for Health and Care Research (NIHR) and Health Research Authority, active trial sites (all in the UK) were approached to invite women with pregnancy hypertension to the PPIE group, and advertisements were placed on the Action on Pre-Eclampsia Charity (APEC) and NIHR People in Research websites. PPIE resources were established by the Trial Management Team and virtual meetings with the PPIE members held to co-design and develop the infographic from existing trial materials, using Microsoft Publisher. Results Seven diverse PPIE members were involved, six from NIHR People in Research and one from APEC. No members were engaged from active sites. From initial set-up to REC approval of the infographic took 9 months, and a considerable time commitment from the Trial Manager and Senior Research Midwives, to navigate practicalities (e.g. team consensus-building). Four meetings were held and 15 iterations of the infographic were developed with the group. The infographic incorporated requests from PPIE members for a design that was inclusive of all races, cultures, abilities and genders. Discussions with PPIE group members improved our understanding of the acceptability of the trial intervention to some cultures. The Research Ethics Committee (REC) requested revisions to PPIE-approved wording about the risk of stillbirth, from ‘1 in 1000’ to ‘small increased risk’ prior to issuing approval for use. Conclusions More practical support would be useful for researchers seeking to establish PPIE groups, and RECs reviewing resources that are co-produced. Our case study provides a practical, step-by-step account of establishing a PPIE group without a funded co-lead, highlighting strengths such as the diversity of members, the incorporation of cultural perspectives, and the development of inclusive patient-facing materials. These findings add to PPIE practice by offering operational guidance, lessons learned and a summary checklist as an additional resource that can complement existing high-level frameworks. Trial registration ISRCTN77258279, registered on 05 December 2018.

Patient and Public Involvement and Engagement (PPIE) is an essential element of any clinical trial, to ensure that the research design and resources are acceptable and the trial produces findings that are relevant to research participants and service-users. The WILL (When to Induce Labour to Limit risk in pregnancy hypertension) Trial Management Team involved a group of patient and public members to develop an infographic, for service-users and -providers, to communicate the risks of chronic and gestational hypertension at term gestational age. Based on national resources in the UK for PPIE, including those from the National Institute for Health and Care Research (NIHR) and Health Research Authority, active trial sites (all in the UK) were approached to invite women with pregnancy hypertension to the PPIE group, and advertisements were placed on the Action on Pre-Eclampsia Charity (APEC) and NIHR People in Research websites. PPIE resources were established by the Trial Management Team and virtual meetings with the PPIE members held to co-design and develop the infographic from existing trial materials, using Microsoft Publisher. Seven diverse PPIE members were involved, six from NIHR People in Research and one from APEC. No members were engaged from active sites. From initial set-up to REC approval of the infographic took 9 months, and a considerable time commitment from the Trial Manager and Senior Research Midwives, to navigate practicalities (e.g. team consensus-building). Four meetings were held and 15 iterations of the infographic were developed with the group. The infographic incorporated requests from PPIE members for a design that was inclusive of all races, cultures, abilities and genders. Discussions with PPIE group members improved our understanding of the acceptability of the trial intervention to some cultures. The Research Ethics Committee (REC) requested revisions to PPIE-approved wording about the risk of stillbirth, from '1 in 1000' to 'small increased risk' prior to issuing approval for use. More practical support would be useful for researchers seeking to establish PPIE groups, and RECs reviewing resources that are co-produced. Our case study provides a practical, step-by-step account of establishing a PPIE group without a funded co-lead, highlighting strengths such as the diversity of members, the incorporation of cultural perspectives, and the development of inclusive patient-facing materials. These findings add to PPIE practice by offering operational guidance, lessons learned and a summary checklist as an additional resource that can complement existing high-level frameworks.

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.

CAUSES OF EXCESS RISK The increased risk is multifactorial; combining increased maternal medical morbidity, poor maternal health (especially nutritional status), reduced ability to monitor mother and child due to high BMI and maternal habitus directly affecting the use of delivery interventions such as epidurals and general anaesthetic. None Box 1 Key issues for the primary care team to discuss with women of childbearing age with a BMI > 30 kg/m2 * It is important to explain the higher risks conferred by obesity and that most are reversible or reduced with weight loss * Weight loss measures should be encouraged prior to conception * The woman needs to be made aware that her pregnancy will be managed more medically with a higher risk of having to take medication and needing doctors to help her deliver * It will be more difficult for the obstetric team to monitor her and her baby during pregnancy because of her high BMI Box 2 Increased risks of pregnancy related problems in obese women Gestational diabetes mellitus (GDM) Studies have reported a three-fold increased risk of developing GDM in women with obesity compared with those who are not obese. Aspirin 150 mg daily from 12 weeks' gestation should be offered to women with more than one moderate risk factor (BMI > 35 kg/m2, primiparity, maternal age > 40 years, family history of pre-eclampsia and multiple pregnancy) to reduce this risk. Box 3 Obstetric management for obese women * Consultant led obstetric care required if BMI > 35 kg/m2 * Elective induction to reduce risk of emergency caesarean section * 1:1 midwife care during labour * Post-delivery thromboprophylaxis if they have one or more additional risk factors * Post-caesarean prophylactic antibiotics * 150 mg aspirin from week 12/40 if their BMI is >35 kg/m2 and they have an additional moderate risk factor * Folic acid 5 mg from conception * Early screening for mental health problems key points SELECTED BY Dr Phillip Bland Former GP Dalton-in-Furness, UK For obese women the risks of adverse outcomes during pregnancy, for both the mother and her child, are significantly higher than the general population.