OBJECTIVE:To assess the effect of a proactive, assets based, peer support infant feeding intervention in addition to usual care on breastfeeding rates, formula feeding practices, and other outcomes, compared with usual breastfeeding support alone. DESIGN:UK based, multicentre, parallel group, unblinded, randomised controlled trial. SETTING:17 localities in the UK that offered breastfeeding peer support as part of usual care between January 2022 and 30 April 2024. PARTICIPANTS:2475 nulliparous women between 20 and 35 weeks of gestation were randomised 1.43:1, to account for potential clustering by peer supporter: 1458 to the ABA-feed (Assets based feeding help Before and After birth-feed) peer support intervention and 1017 to usual care. INTERVENTIONS:The ABA-feed intervention comprised person centred proactive peer support for infant feeding underpinned by an assets based approach (focusing on the capabilities of, and resources available to, participants) and behaviour change theory delivered in person and remotely by text and telephone call. Usual care included universal care from midwives and health visitors and could also include services that provided reactive support such as peer supporters in breastfeeding groups, counselling, helplines, and social media support groups. MAIN OUTCOME MEASURES:The primary outcome was any breastfeeding at eight weeks after birth. Secondary outcomes at eight, 16, and 24 weeks after birth included breastfeeding initiation, any and exclusive breastfeeding, formula feeding practices, anxiety, social support, and healthcare utilisation. Analyses were based on the intention-to-treat principle. RESULTS:Rates of any breastfeeding at eight weeks did not differ between the intervention group (1013/1452; 69.8%) and usual care group (698/1015; 68.8%); adjusted risk difference 0.01, 95% confidence interval -0.03 to 0.04. Preplanned subgroup analyses showed no interactions between the intervention and age, prespecified feeding intentions, mother's education, index of multiple deprivation fifth, or relationship status. Breastfeeding initiation rates were high (intervention 94.2%; usual care 92.5%). At eight weeks the intervention group reported higher social support, but this was not sustained at 16 weeks. No differences were observed in other secondary outcomes. CONCLUSION:The ABA-feed peer support intervention did not improve breastfeeding rates compared with usual breastfeeding support in a UK context. TRIAL REGISTRATION:ISRCTN Registry ISRCTN17395671.

Background:In extremely preterm babies, born before 28 weeks' gestation, a large (≥ 1.5 mm in diameter) patent ductus arteriosus present beyond 3 days of age is associated with higher mortality and morbidity than infants without a patent ductus arteriosus. The cyclooxygenase inhibitor ibuprofen may be used to treat patent ductus arteriosus. Whether selective early treatment of a large patent ductus arteriosus with ibuprofen improves health and developmental outcomes is not known. Methods:We conducted a multicentre, randomised, double-blind, placebo-controlled trial evaluating early treatment (≤ 72 hours after birth) with ibuprofen for a large patent ductus arteriosus in extremely preterm infants. The primary outcome was a composite of death or moderate or severe bronchopulmonary dysplasia at 36 weeks' of post menstrual age. The short-term secondary outcomes included complications of prematurity, patent ductus arteriosus closure and side effects of treatment. The main long-term outcome was survival without moderate or severe neurodevelopmental impairment, using parent report or classified by blinded end-point review committee at 24 months of corrected age. Other secondary outcomes included survival without respiratory morbidity and duration of oxygen supplementation. A health economic evaluation was undertaken. Results:A total of 326 infants were randomised to ibuprofen and 327 to placebo. The primary outcome occurred in 220/318 infants (69.2%) in the ibuprofen group and in 202/318 infants (63.5%) in the placebo group (adjusted risk ratio 1.09, 95% confidence interval 0.98 to 1.20; p = 0.10). A total of 44 of 323 infants (13.6%) in the ibuprofen group and 33 of 321 infants (10.3%) in the placebo group died by 36 weeks of gestation (adjusted risk ratio 1.32, 95% confidence interval 0.92 to 1.90). Two unforeseeable serious adverse events occurred that were possibly related to ibuprofen. At 24 months of corrected age, outcome data were available for 263 and 274 children in the ibuprofen and placebo groups, respectively. Survival without moderate to severe neurodevelopmental impairment in the ibuprofen and placebo groups was 131/248 (53.0%) and 134/259 (51.9%), respectively; adjusted risk ratio 1.01 (95% confidence interval 0.86 to 1.18); p = 0.901. Survival without respiratory morbidity was 66/210 (31.4%) and 74/220 (33.6%), respectively; adjusted risk ratio 0.92 (95% confidence interval 0.70 to 1.20); p = 0.536. Median duration of oxygen supplementation was 76.0 and 78.0 days, respectively. Conclusion:The risk of death or moderate or severe bronchopulmonary dysplasia at 36 weeks of post menstrual age was not statistically significantly lower for extremely preterm infants randomised to early treatment with ibuprofen compared to placebo. There was no evidence of an improvement in survival without moderate to severe neurodevelopmental impairment or survival without respiratory morbidity at 24 months' corrected age, after selective early treatment of a large patent ductus arteriosus with ibuprofen in children born extremely preterm. Future work:Future work required includes a trial in babies who are clinically symptomatic and fail to close the patent ductus arteriosus beyond 7 days of age; an individual patient data meta-analysis; follow-up of babies in Baby-OSCAR at 8-10 years of age. Limitations:Open-label therapy was received by 29.8% of infants in the placebo group, potentially increasing the percentage of infants with patent ductus arteriosus closure in this group. The first dose of trial treatment was administered at a median of 61 hours after birth, later than in other trials. Funding:This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 11/92/15.

Economic inactivity rate in the UK reached 22.2

Background:Physical inactivity and suboptimal diet in pregnancy are important modifiable risk factors for gestational diabetes, a major contributor to pregnancy complications. Objectives:We aimed to assess the effects of physical activity and/or diet-based lifestyle interventions during pregnancy on gestational diabetes and if these vary by maternal (body mass index, age, parity, ethnicity, education) and intervention characteristics using individual participant data meta-analysis of randomised trials, and a cost-effectiveness analysis. Data sources:International Weight Management in Pregnancy Collaborative Network database was updated by searching major databases from February 2017 to March 2022. Review methods:The main outcomes were gestational diabetes by any criteria and by the National Institute for Health and Care Excellence. Other outcomes were gestational diabetes as per International Association of Diabetes in Pregnancy Study Group and maternal and perinatal outcomes. We performed a two-stage random-effects individual participant data meta-analysis to obtain summary estimates (odds ratio) with 95% confidence intervals. Study quality of included trials was assessed, and heterogeneity summarised using τ2. Where possible, we added the aggregate data from non-individual participant data trials to the meta-analysis. We ranked interventions by effectiveness using network meta-analysis and undertook model-based economic evaluation to assess cost-effectiveness. The cost-effectiveness analysis took an NHS cost perspective compared an overall lifestyle intervention versus usual care with a time horizon covering the beginning of pregnancy until the discharge of the mother and infant from the hospital following delivery. Results:Ninety-two trials (32,284 women) were included; 54 (23,698 women) provided individual participant data. Lifestyle interventions reduced the odds of gestational diabetes (any criteria) by 10% in individual participant data trials (odds ratio 0.90, 95% confidence interval 0.80 to 1.02, 54 studies, 23,361 women), and the findings reached statistical significance when non-individual participant data were included (odds ratio 0.81, 95% confidence interval 0.73 to 0.89, 92 studies, 31,947 women). Physical activity significantly reduced the odds of gestational diabetes by 36% (odds ratio 0.64; 95% confidence interval 0.48 to 0.84), and diet by 19% (odds ratio 0.81; 0.69 to 0.96), but not mixed interventions. Women with middle (odds ratio 0.68, 95% confidence interval 0.51 to 0.90) and high educational level (odds ratio 0.71, 95% confidence interval 0.54 to 0.93) benefited more than those with low educational status, and no differences by maternal body mass index, age, parity or ethnicity. There was no significant reduction in gestational diabetes defined by National Institute for Health and Care Excellence criteria (odds ratio 0.98, 95% confidence interval 0.84 to 1.13) in individual participant data trials. For gestational diabetes defined using International Association of Diabetes in Pregnancy Study Group criteria, interventions reduced gestational diabetes by 14% (odds ratio 0.86, 95% confidence interval 0.75 to 0.97, τ2 = 0.00, 16 studies, 6174 women) in individual participant data trials and by 17% (odds ratio 0.83, 95% confidence interval 0.72 to 0.95, τ2 = 0.01, 25 studies, 7883 women) when non-individual participant data trials were added. Overall, physical activity reduced caesarean section (odds ratio 0.83; 0.72 to 0.96), small-for-gestational age (odds ratio 0.72; 0.56 to 0.92) and large-for-gestational age babies (odds ratio 0.81; 0.71 to 0.94); diet-based interventions reduced any preterm birth (odds ratio 0.37; 0.20 to 0.68) compared to controls. No differences were observed for other outcomes. Lifestyle interventions were on average more expensive and more effective at averted gestational diabetes and major outcome averted compared to usual care. Limitations:We could not identify the specific intervention components and delivery methods associated with improved outcomes, due to variations in reporting. Conclusion:Lifestyle interventions in pregnancy prevent gestational diabetes, and the effects vary according to the definition of gestational diabetes. Physical activity-based interventions may be the most effective. Future work:Lifestyle interventions should be implemented and evaluated in routine clinical practice to prevent gestational diabetes, with additional support for women with low socioeconomic status. Study registration:This study is registered as PROSPERO CRD42020212884. www.crd.york.ac.uk/PROSPERO/view/CRD42020212884. Funding:This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: NIHR129715) and is published in full in Health Technology Assessment; Vol. 30, No. 39. See the NIHR Funding and Awards website for further award information.

Context: Between 2015 and 2020, 1,578 care homes in England closed, affecting 48,600 individuals. The financial and economic impact of such closures on various stakeholders remains largely unquantified. Objective: To develop pathways for care home closures from key stakeholders’ perspectives, quantify associated costs, and explore the economic implications to key stakeholders. Methods: A mixed-methods approach was adopted across three stages: qualitative analysis of stakeholder interviews, development of care home closure pathways, and cost analysis, including sensitivity analyses. Findings: The public sector cost for a single care home closure over 12 months was estimated at £30,550 (2021/22 prices) or £34,185 (2023/24 prices). Sensitivity analyses showed costs could range from £4,400 to £66,490 (£4,924 to £74,398 in 2023/24 prices). Qualitative findings indicated various financial implications for residents, families, and care staff, including top-up fees and increased travel costs. Limitations: The study relied on assumptions and proxy costs due to limited data availability, potentially increasing uncertainty in cost estimates. Whilst methods are transferable, findings relate specifically to England. Implications: The findings highlight the need for careful planning and resource allocation in managing care home closures. Future research should explore the association between costs and outcomes through economic evaluation to inform cost-effective strategies for addressing care home closures.

Background:The comparative rates of major complications and recovery times between laparoscopic hysterectomy and abdominal hysterectomy for benign gynaecological conditions remain uncertain. Objective(s):To assess the clinical and cost-effectiveness of laparoscopic hysterectomy compared to abdominal hysterectomy in women with benign gynaecological conditions. Design and methods:A parallel, open, non-inferiority, multicentre, randomised controlled, expertise-based surgery trial with integrated health economic evaluation and an internal pilot with an embedded qualitative process evaluation, and a post-closure survey after recruitment ended. Setting and participants:Women in secondary care requiring hysterectomy and eligible for either surgical method. Interventions:Laparoscopic hysterectomy versus abdominal hysterectomy. Main outcome measures:The primary outcome was major complications (Clavien-Dindo ≥ level III) up to 6 completed weeks post surgery, and the key secondary outcome was time from surgery to resumption of usual activities using the personalised Patient-Reported Outcomes Measurement Information System Physical Function questionnaire. The principal outcome for the economic evaluation was to be cost per quality-adjusted life-year at 12 months post surgery and was feasibility and acceptability for the qualitative process evaluation. Results:Two hundred and fifty-two patients were screened from 13 open sites over 13 months, 156 (62%) were eligible and 75 (49%) randomised. Of the 53 women not randomised, 23 (43%) preferred laparoscopic hysterectomy and 6 (11%) abdominal hysterectomy. About 32/39 (82%) and 30/36 (83%) participants randomised to laparoscopic hysterectomy and abdominal hysterectomy, respectively, had their surgery, of which 31/32 (97%) and 25/30 (83%) received their allocated route of hysterectomy. Major complications occurred in 2/32 (6%) laparoscopic hysterectomy versus 4/30 (13%) abdominal hysterectomy groups. There was no difference in time to resumption of activities [median (interquartile range, N) 7.5 weeks (3.6-8.2, 25) laparoscopic hysterectomy vs. 7.5 weeks (5.5-10.6, 26) abdominal hysterectomy groups] or quality of recovery [mean (standard deviation, N) 81.1 (13.4, 27) vs. 72.3 (17.6, 22) respectively; adjusted mean difference 7.2, 95% confidence interval -3.2 to 17.6]. The qualitative evaluation found that the trial was viewed positively by women and healthcare professionals. The reasons for failure to recruit from 21 sites open or in set-up were lack of research/clinical capacity imposed by the COVID-19 pandemic (14, 67%) and lack of clinician equipoise (11, 52%). Limitations:The main limitation was failure to recruit, resulting in a final sample of 75 patients from a target of 3250. At the time of analysis, 13 (17%) randomised patients had not had surgery, and 6 (8%) did not adhere to the allocated route of hysterectomy. The planned health economic evaluation could not be performed. Conclusions:The LAVA trial was acceptable for women and healthcare professionals but closed early due to the adverse impact of the COVID-19 pandemic and a lack of clinician equipoise. No significant differences in complications or recovery between laparoscopic hysterectomy and abdominal hysterectomy were observed. However, early trial cessation because of recruitment challenges limit inferences. Future large-scale trials are important, especially as laparoscopic hysterectomy and robotic techniques become standard. Success will depend on innovative trial designs and strategies that engage clinicians and research departments. Future work:Lessons learnt from the failed LAVA trial should be used to inform the management and designs of future studies in benign gynaecological surgery. Funding:This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number NIHR128991.

Background When care homes close, it can be detrimental to older people’s well-being. However, there is little formal evidence to guide services when undertaking such important work. Objectives This study explores what happens when homes close, how best to minimise negative outcomes for older people and families, and key lessons for councils as they manage future closures. Methods Background literature review, national survey of Director(s) of Adult Social Services and analysis of national Care Quality Commission data. Interviews with older people, families, care staff, social workers and broader managers/partners in four case study sites, together with outcomes data (EQ-5D, ICEpop CAPability measure for Older people and outcomes from the literature on what older people value about care services) at initial assessment, 28 days’ review and 1 year. Survey of care staff (Professional Quality of Life survey) before and after closures, supplemented with individual interviews; interviews with commissioners and service providers. Preliminary model-based economic evaluation comparing the costs and consequences of care home closures. Distillation of key messages into a national policy guide, an accessible guide for older people/families and a guide/free training video for care staff. Findings People assume that a care home is a home for life – but this is sadly not always the case. Care homes can close for all kinds of reasons (e.g. to do with funding, buildings, care quality, etc., but also due to broader factors beyond the control of the care sector). There can be significant differences between emergency closures (which can be especially traumatic) and more planned closures (when at least in principle there is more time to work at the pace of individual residents). Local policies vary significantly, and there may be scope for a more evidence-informed, consistent approach. Closures can be extremely difficult for everyone involved – and should perhaps only ever be a last resort. Closures are particularly traumatic for residents, who are losing their home and valued relationships. For some people, this may be similar to a bereavement. The needs of care staff – in terms of meaningful information, emotional and financial well-being and employment support – are often overlooked. This leaves people unsupported and might also reduce their ability to support others. Councils seeking to shape local care markets often lack the levers to be able to do this effectively. Care home closures can create financial pressures on the public sector, costing around £1500 per resident, while families and staff may face varying expenses, such as top-up fees and travel costs. Unplanned and emergency closures are slightly more expensive, and result in poorer outcomes for residents. We have limited long-term data, but it may sometimes be possible to manage closures in a way that minimises negative outcomes for some (especially if existing services were less than optimal and where closures are well planned). Limitations Collecting data from older people, families and staff during care home closures, and in a challenging policy context, is complex, and the amount of data it is possible to collect in such circumstances is inevitably limited in a number of ways. In reflecting on this, we nonetheless draw attention to: The novel nature of the research, filling key gaps in knowledge around such a significant topic. The diverse and multifaceted perspectives which only a programme of research could hope to include. The importance of our policy and practice materials, given the significance of the issues at stake and the lack of previous evidence on which to draw. Conclusions Care home closures can happen for many different reasons, and are always a logical possibility in a ‘care market’, which seeks to use choice and competition to keep costs down and promote quality. This study has identified a series of practical lessons and experiences shared by participants which might help others in future – made available to different audiences via a series of policy, practice and training materials. However, none of this should, in any way, minimise the distress experienced by residents, which can be very significant and may well be long lasting. Moving beyond the specific focus of this research, insights from interviews with local commissioners and providers may have broader implications for the extent to which local authorities have sufficient powers and practical tools to be able to deliver on their ‘market shaping’ responsibilities under the Care Act. Future research on care home closures could usefully focus on: The needs/experiences of people who may have additional or specific needs that might otherwise be overlooked, such as people living with dementia and people from minority ethnic communities or different faith groups. The knock-on effect that care home closures may have on partner agencies. More effective ways of managing emergency closures, and how best to support people after the closure with the trauma they may have experienced. Larger sample sizes might also generate additional insights around individual outcomes and around the implications of particular resident/staff characteristics or types of closure – but this may need to be balanced against the difficulty of conducting such research and the cost to funders of even larger studies. Study registration This study is registered as IRAS project ID: 297258. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research Programme (NIHR award ref: NIHR201585) and is published in full in Programme Grants for Applied Research; Vol. 14, No. 2. See the NIHR Funding and Awards website for further award information. Plain language summary We all want to be cared for with dignity when we are older, and we want the same for our families. Being looked after in a care home is expensive, and we have high expectations of the care that is given. But sometimes care homes close. This might be for a number of reasons, including financial problems, the state of the building or poor-quality care. This can affect the well-being of people in care homes, their families and the people who work there. Despite this, there is very little research to guide this important process. If care homes have to close, we want this to be well managed, so that older people are supported, families are reassured and care staff are helped to find new work and stay in care roles. To help with this, we: Asked Director(s) of Adult Social Services to tell us about what is happening across England and how they support older people at such potentially stressful times. Looked at some of the reasons why care homes might close from national data collected by an organisation called the Care Quality Commission. Worked in four different areas in England where homes are closing to ask older people, families, care staff and social workers about their experiences and how things could be improved. Looked at what impact closure has on older people’s health and well-being. Explored what happens to low-paid care staff after closures and the impact this has on them and the care they can give to others. Explored the cost implications for residents, family members, staff and wider society. We found that: People think that a care home is a home for life. Sadly, this is not always the case. Care homes can close for lots of different reasons. Planned closures can make it easier to support people well. Emergency closures, in particular, can be really upsetting. Local policies can be very different – perhaps there could be a more consistent national approach. Closures can be extremely difficult for everyone. They should only be a last resort. Closures are particularly traumatic for residents. For some people, this might be like a bereavement. The needs of care staff are often overlooked. It is difficult for councils to influence which homes open and close in their area. This might have broader implications for the role of councils beyond this particular topic. Closing a home costs councils money (about £1500 per resident). There can also be costs for residents and families. Even though moving to a new home can be very upsetting, some people settle and do well. We have written some guides to share what we have learnt with others. We have tried to focus on the things that people can do to make things better for residents – not on things they cannot change. There is a guide for older people and families being shared by a national charity called Age UK. Scientific summary Background We all want to be cared for with dignity when we are older, and we want the same for our families. Being looked after in a care home is expensive, and we have high expectations of the care that is given. Despite this, many care homes close every year, whether through an emergency (such as a fire/flood), councils making strategic choices to develop new service models, the cost of maintaining a dilapidated building, a private provider selling up/going bankrupt or a regulatory intervention following the discovery of poor care. In an era of austerity, care markets are increasingly fragile, and the very logic of a ‘market’ implies that the risk of failure has to be real for there to be sufficient incentives to deliver appropriate care at the right price. When care homes close, the received wisdom is that relocation can be detrimental to health and well-being. Despite this, there is little formal evidence to guide closure processes, with councils constantly ‘reinventing the wheel’. Objectives This study builds on a previous pilot in Birmingham in order to explore what happens to older people and care staff when care homes close, how best to manage closures in a way that minimises distress and negative outcomes for older people and families, and key lessons for councils as they seek to manage future closures. Our research questions are: What is the pattern of care home closures nationally? How are they undertaken in different councils, and what do councils consider to be best practice when supporting older people at such potentially stressful times? How do older people experience closures, what impact does closure have on health and quality of life, and how can any negative impacts be reduced? What impact do closures have on care staff and local care markets, and how can negative impacts be reduced? What are the costs and consequences of closures and the key data required to make this estimation? Can we develop a modelling framework to drive appropriate data collection for future home closure prediction to mitigate adverse outcomes? How can future closures be planned and conducted in a more evidence-based manner, so that outcomes for older people are improved and negative impacts reduced? Methods Work package 1 aimed to establish the pattern of care home closures nationally, how they are undertaken in different councils and what might constitute best practice when supporting older people. We carried out a cross-sectional survey targeted at social care leaders and an analysis of care home closure policy documents. All Director(s) of Adult Social Services in 152 councils in England were invited to participate. The survey explored leaders’ experiences of closures, policies, processes, perceived outcomes, challenges and any local evaluations. Participants were invited to share local care home closure policies for analysis. Descriptive statistics were analysed for quantitative survey data. Qualitative survey data and policy documents were analysed thematically. We also analysed routinely collected data from the Care Quality Commission (CQC) to understand the factors that influence care home closures. This combined individual care home characteristics from the CQC with information on council areas, taken from various sources, and data from the Social Care Collection. The CQC data provide us with information on 25,459 care homes between 2010 and 2021. These data are at the care home level and provide information on the type of care home (nursing/residential), the focus of the care home (older people, dementia, disability), size (measured by the number of beds), performance rating and indicators of whether the care home is located in an urban or rural area. The CQC data also provide us with the care home’s geographical location. This information allowed us to link data on other local characteristics (such as the proportion of the population who are over 65, deprivation, residential land prices and care home market competition). We also included variables collected as part of the Social Care Collection. This includes the proportion of self-funders, average daily rates of delayed transfers of care from hospital, total expenditure, satisfaction scores taken from the adult social care survey, proportion of individuals over 65 receiving long-term support and funds attached to carers support. The research used a multilevel logit regression model to study whether care homes close or stay open (a yes or no outcome). By using this approach, the study can account for differences between care homes within the same council, leading to more accurate results about how care home features, local factors, and social care spending affect the chances of a care home closing. Work package 2 explored the experiences of older people, families, care staff, social workers and broader stakeholders/local partners. We worked in four case study councils where homes were closing, including a mix of different locations across England, a mix of urban/rural settings and a mix in terms of socioeconomic/demographic factors. In each site, we undertook semi-structured qualitative interviews with 10–15 stakeholders/broader partners who had key roles in/perspectives on care home closures to explore the rationale for closure, key drivers, anticipated outcomes and impact on other services. We also undertook semi-structured interviews with 96 participants (older people, families, care staff and social workers) to explore the impact of closures, information/support provided, views on the process and areas for improvement. Interviews with older people took place in person with researchers based in the closing care homes (where COVID restrictions permitted). Where people were unable to consent to take part, a consultee was identified under the Mental Capacity Act. Interviews with families, care staff and assessors took place either in person or online, guided by their preference. We collected outcomes data for older people at initial review (before the closure), an early review (often 28 days after relocating) and at a longer-term review (1 year), before, during and after relocation. Twenty-two participants completed up to three paper-based questionnaires: EQ-5D, three-level version, ICEpop CAPability measure for Older people (ICECAP-O) and a 15-question, Likert scale questionnaire, based on a national review of the literature on what older people value about care services. Interviews were transcribed and analysed using the framework approach to identify key themes. Questionnaires were coded and analysed using Stata® (StataCorp LP, College Station, TX, USA). Work package 3 considered the impact of care home closures on care staff. Where access permitted, all care staff in closing homes in our four case study sites were invited to take part in interviews and to complete the Professional Quality of Life survey during and 6 months after closure. The interviews explored how care staff experienced the closure of the care home where they worked, how they prepared for closure, the impact upon themselves and current/future employment, and their insights into the closure process. All employed staff at a care home were given the opportunity to take part, including kitchen staff, cleaners and handypeople, as well as people providing direct care and those working in co-ordinating or care management capacities. In each of our four case study sites, we carried out semi-structured interviews with commissioners and providers (seeking up to eight of each per site). Participants included those in senior roles involved in decision-making or closely connected to care home functioning, as well as those who were indirectly or directly impacted by a care home closing. Interviews explored the relationship between commissioners and providers, the nature and impact of local authority strategy, the responsibilities of care homes and the local care market (including approaches to trying to shape the local market, to ensure stability and to contingency planning). Work package 4 focused on analysing the economic impacts of care home closures on residents, their families, care home staff and councils. Pathway costing employed both quantitative and qualitative methods, organised into three stages. Stage 1 involved analysing stakeholder interviews (from WP2) to identify economic themes related to care home closures. Stage 2 utilised these insights to develop closure pathways for stakeholders, including residents, families and care staff. Stage 3 conducted a full cost analysis to estimate closure costs, including using sensitivity analysis for different stakeholders. This stage involved identifying and quantifying resources needed at each pathway stage. Economic modelling focused on developing a decision tree model to analyse care home closures under three scenarios: planned, unplanned and emergency. This model was informed by interview data from WP2, specifically coded for WP4. The pathways developed in the previous pathway costing served as a foundation and were adapted to reflect the complexities of unplanned and emergency closures. Cost and resource use data were derived from the previous cost analysis, supplemented by literature and expert opinion, especially for unplanned and emergency scenarios. Probabilities within the model were informed by observations from case study sites, literature reviews, qualitative interviews and expert opinions. The analysis was conducted from a public sector perspective using a 12-month decision tree model. This model reports the cost per capability improvement by comparing unplanned and emergency scenarios to a reference case of planned closures. Outcomes were measured using ICECAP-O and EQ-5D data collected in WP2. In work package 5, we summarised findings in a national policy guide sent to all social care leaders in England, a free training video, a guide for older people/families and a guide for care staff. Results Key findings were that: People assume that a care home is a home for life – but this is sadly not always the case. Care homes can close for all kinds of reasons (e.g. to do with funding, buildings, care quality, etc., but also due to broader factors beyond the control of the care sector). There can be significant differences between emergency closures (which can be especially traumatic) and more planned closures (when at least in principle there is more time to work at the pace of individual residents). Local policies vary significantly, with scope for a more evidence-informed, consistent approach. Closures can be extremely difficult for everyone involved – and should perhaps only ever be a last resort. Closures are particularly traumatic for residents, who are losing their home and valued relationships. For some people, this may be similar to a bereavement. The needs of care staff – in terms of meaningful information, emotional and financial well-being and employment support – are often overlooked. This leaves people unsupported and might also reduce their ability to support others. Councils seeking to shape local care markets often lack the levers to be able to do this effectively. Care home closures can create financial pressures on the public sector, costing around £1500 per resident, while families and staff may face varying expenses, such as top-up fees and travel costs. Unplanned and emergency closures are slightly more expensive, and result in poorer outcomes for residents. We have limited long-term data, but it may sometimes be possible to manage closures in a way that minimises negative outcomes for some (especially if existing services were less than optimal and where closures are well planned). Conclusions Overall, we conclude that: Many people assume that moving into a care home means a home for life – but this is sadly not always the case. Homes can close for all kinds of reasons. This can be due to issues around funding, business decisions and/or the quality of care delivered – but can also be influenced by broader factors (such as changes in land values influencing people’s decisions about whether or not to exit the market). There can be very significant differences between emergency closures (which can be especially difficult and traumatic) and more planned closures (when at least in principle there is more time to plan, communicate and work at the pace of individual residents). There has previously been limited evidence to guide decision-makers and practitioners seeking to support and relocate older people. Local policies and protocols vary significantly, and there may be scope for a more evidence-informed, consistent approach (e.g. via a national or regional template). Closures can be extremely difficult and traumatic for everyone involved, from social care leaders and staff, to service providers and care staff, to older people and families – and should perhaps only ever be seen as a last resort. Closures are particularly traumatic for older people, who may be understandably angry, distressed and disorientated. People are losing their home and valued relationships with residents and staff, and the process may well be similar to that of a bereavement. The needs of care staff – in terms of meaningful information, practical details, emotional well-being and employment support – can often be overlooked. This should be a key focus in future, both to better support staff, and because care staff are so significant in terms of supporting older people. Local authorities have a duty to shape their local care markets, but often lack the levers, powers and tools to be able to do this effectively. Too often, they feel as if the ‘wrong’ homes are opening and closing in their areas. Care home closures can create financial pressures on the public sector, costing around £1500 per resident, while families and staff may face varying expenses, such as top-up fees and travel costs. Our findings indicate that unplanned and emergency closures are slightly more expensive and result in poorer outcomes for residents. Well-planned and supportive closures can potentially improve the health-related quality of life of residents over the longer-term period of a year (especially if people are unhappy with care in the original home) but are associated with a brief initial negative impact. Findings highlight the importance of careful preparation, planning and support to minimise disruption and improve overall outcomes. Recommendations for policy, practice and research Above all, there are a series of practical lessons and experiences shared by participants which might help others in future – made available to different audiences via a series of policy, practice and training materials. However, none of this should in any way minimise the distress experienced by residents, which can be very significant and may well be long lasting. We will also seek to work with regulators to learn lessons from one of our emergency closures, which happened at very short notice (hours) and was particularly traumatic for everyone involved. Moving beyond the specific focus of this research, insights from interviews with local commissioners and providers may have broader implications for the extent to which local authorities have sufficient powers and practical tools to be able to deliver on their ‘market shaping’ responsibilities under the Care Act. Future care home closures research could usefully focus on: The needs/experiences of people who may have additional or specific needs during closures that might otherwise be overlooked, such as people living with dementia and people from minority ethnic communities or different faith groups. The knock-on effect that care home closures may have on partner agencies. More effective ways of managing emergency closures and how best to support people after the closure with the trauma they may have experienced. Larger sample sizes might generate additional insights around individual outcomes and the implications of particular resident/staff characteristics or types of closure, but this may need to be balanced against the difficulty of conducting such research/the cost of even larger studies. Study registration This study is registered as IRAS project ID: 297258. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research Programme (NIHR award ref: NIHR201585) and is published in full in Programme Grants for Applied Research; Vol. 14, No. 2. See the NIHR Funding and Awards website for further award information.

OBJECTIVES:To assess the effects of lifestyle interventions on gestational diabetes, determine whether the effects vary by maternal body mass index, age, parity, ethnicity, education level, or intervention, and rank interventions by effectiveness. DESIGN:Individual participant data (IPD) and network meta-analysis. DATA SOURCES:Major electronic databases (January 1990 to April 2025). METHODS:This meta-analysis included randomised trials on the effects of lifestyle interventions (physical activity based, diet based, or mixed) in pregnancy on gestational diabetes. Main outcomes were gestational diabetes defined by any criteria and by UK NICE (National Institute for Health and Care Excellence) criteria; other outcomes included IADPSG (International Association of Diabetes in Pregnancy Study Group) and modified IADPSG defined gestational diabetes. A two stage IPD meta-analysis estimated summary odds ratios and 95% confidence intervals and interactions (subgroup effects), along with absolute risk reduction estimates. Aggregate data from non-IPD trials were added to the meta-analysis when possible. Intervention effects were ranked using network meta-analysis. RESULTS:104 randomised trials (35 993 women) were included, with IPD for 68% of participants (24 391 women; 54 studies). Lifestyle interventions reduced gestational diabetes defined by any criteria by 10% in IPD trials (odds ratio 0.90, 95% confidence interval (CI) 0.80 to 1.02; absolute risk reduction 1.3%, 95% CI -0.3% to 2.6%), and by 20% when combining IPD and non-IPD trials (odds ratio 0.80, 95% CI 0.73 to 0.88; absolute risk reduction 2.6%, 95% CI 1.6% to 3.6%), and no reduction was observed using NICE criteria (odds ratio 0.98, 95% CI 0.84to 1.13). Lifestyle interventions reduced gestational diabetes defined using IADPSG criteria by 14% in IPD trials (odds ratio 0.86, 95% CI 0.75 to 0.97; absolute risk reduction 2.7%, 95% CI 0.6% to 5.0%) and by 18% when combining IPD and non-IPD trials (odds ratio 0.82, 95% CI 0.72 to 0.93; absolute risk reduction 3.5%, 95% CI 1.3% to 5.7%). Effects did not vary by maternal characteristics, except for education. Although women of all educational levels benefited from the intervention, the benefit was less in those with low education (low v middle interaction: odds ratio 0.68, 95% CI 0.51 to 0.90; low v high interaction: odds ratio 0.71, 95% CI 0.54 to 0.93). Benefits did not vary by intervention characteristics, except for greater effectiveness with group format (odds ratio 0.81, 95% CI 0.68 to 0.97; absolute risk reduction 2.5%, 95% CI 0.4% to 4.3%) and newly trained facilitators (odds ratio 0.82, 95% CI 0.69 to 0.96; absolute risk reduction 2.4%, 95% CI 0.5% to 4.2%). Physical activity based interventions ranked highest (mean rank 1.1, 95% CI 1 to 2) in preventing gestational diabetes. CONCLUSIONS:Lifestyle interventions in pregnancy are likely to prevent gestational diabetes, with effects varying according to diagnostic criteria. Implementation strategies should address inequalities by maternal education, and consider group formats, provider training, and physical activity based interventions to prevent gestational diabetes. STUDY REGISTRATION:PROSPERO CRD42020212884.

BACKGROUND:Maternal infection and sepsis are major causes of maternal death and severe illness worldwide, particularly in low- and middle-income countries. Inconsistent implementation of evidence-based recommendations for infection prevention and management and delays in detection and treatment of maternal sepsis contribute to the number of preventable deaths. METHODS:We conducted a cluster-randomized trial to assess a multicomponent intervention, the Active Prevention and Treatment of Maternal Sepsis (APT-Sepsis) program. This program was designed to support health care providers in achieving three goals: adherence to World Health Organization (WHO) hand-hygiene standards; adoption of evidence-based practices for maternal infection prevention and management; and early detection of sepsis and use of the FAST-M (fluids, antibiotics, source control, transfer if required, and monitoring) treatment bundle. Usual care was provided in the control group, along with dissemination of guidelines. The primary outcome was a composite of infection-related maternal death, infection-related near-miss event (events in which women survived a life-threatening complication), or severe infection-related illness (deep surgical-site, deep perineal, or body-cavity infection) among women who were pregnant or had recently been pregnant. RESULTS:We randomly assigned 59 health facilities (where 431,394 women gave birth during the trial) in Malawi and Uganda to the intervention group (30 clusters) or the usual-care group (29 clusters). A primary-outcome event occurred in 1.4% of the patients in the intervention group and in 1.9% of those in the usual-care group (risk ratio, 0.68; 95% confidence interval, 0.55 to 0.83; P<0.001). This effect was generally consistent between countries and among facilities of difference sizes and was sustained over time. CONCLUSIONS:Implementation of the APT-Sepsis program led to a significantly lower risk of a composite of infection-related maternal death, infection-related near-miss event, or severe infection-related illness than usual care. (Funded by the Joint Global Health Trials scheme and others; APT-Sepsis ISRCTN number, ISRCTN42347014.).

BACKGROUND:Sickle cell disease (SCD) is an inherited condition that impairs red blood cell function, posing a substantial health burden on patients. As the prevalence of SCD in Australia rises due to migration, discussions surrounding treatment and management strategies are becoming more prominent. AIMS:Australia lacks a dedicated study on the prevalence and economic implications of SCD. In this study, we estimate the economic burden of SCD in Australia from the perspective of the Australian healthcare system. METHODS:We performed a cost-of-illness study by using a bottom-up approach to estimate resource use per patient from a national registry with unit costs from national sources, and a top-down estimate of the prevalence of SCD in Australia using stratification by ancestry. RESULTS:We estimated the prevalence of SCD in Australia in 2021 to be 8485 patients, the cost per patient per year to be AU$13 975 and the total cost to the Australian healthcare system to be approximately AU$119 million per year. Factors influencing costs were age, interventions and frequency of hospital visits for vaso-occlusive crises. Prevalence had the greatest influence on results in the sensitivity analysis. CONCLUSIONS:While the estimated prevalence of SCD in Australia resulted in a relatively small total cost, the per patient annual cost of SCD remains high. This cost of SCD is anticipated to increase alongside migration and improved treatment. There are policies that could enhance patients' quality of life, thereby mitigating both economic and health burdens.

[This corrects the article DOI: 10.1016/j.eclinm.2025.103424.].

Introduction Mammographic screening identifies many women with small breast cancers with favourable biological features, which have an excellent prognosis. Some of these may never have become clinically apparent without screening and are commonly described as ‘overdiagnosed’ cancers. Despite this, all patients with screen-detected cancers are currently treated with surgical excision and sentinel lymph node biopsy, although this may represent overtreatment. There is, therefore, a need for less invasive approaches to reduce treatment burden for patients while maintaining current excellent oncological outcomes. Vacuum-assisted excision (VAE) may represent such an alternative treatment approach, and the SMALL (Open Surgery versus Minimally invasive-vacuum Assisted excision for smaLL screen-detected breast cancer) trial aims to investigate the use of VAE for the safe de-escalation of surgical treatment for such excellent prognosis invasive breast cancers.Methods SMALL is a prospective, multicentre, randomised phase III trial of VAE versus surgery in patients with small, biologically favourable screen-detected invasive breast cancer. SMALL has an innovative hybrid design with coprimary endpoints. These include a randomised non-inferiority comparison of surgical re-excision rates following initial treatment, and a single-arm analysis of local recurrence at 5 years following VAE. Secondary outcomes include complication rates, overall survival, quality of life and a health economic analysis. The trial includes a QuinteT Recruitment Intervention to support recruitment.Ethics and dissemination Ethical approval was obtained from the Office for Research Ethics (Northern Ireland) for all UK sites. Results will be submitted for publication in a peer-reviewed journal, presented, shared with patient partners and with relevant professional organisations to inform future guideline development for the management of screen-detected breast cancer.Trial registration number ISRCTN12240119.

Background Increased use of emergency and secondary care by children and young people, especially in deprived populations, drives increased costs in health and social care systems in rich country settings, without necessarily delivering quality care. This study aims to assess the potential cost-effectiveness of the Sparkbrook Children’s Zone (SCZ), a pilot clinic for children and young people which integrates health and early years support in a highly deprived area of Birmingham, the UK’s second city, compared with standard primary care.Methods A decision-analytic model taking a healthcare and partial social care perspective was developed using the best available, though limited, evidence from aggregated data of an ongoing pilot, published literature, expert opinions and assumptions. Effectiveness was measured as a proportion of patients attending the emergency department (ED). Deterministic and probabilistic sensitivity analyses were performed to assess the impact of parameter uncertainties.Results The integrated SCZ clinic may potentially be cost-effective based on this preliminary model-based analysis. The SCZ had a lower proportion of patients attending ED, 0.017 compared with 0.029 for standard primary care, reducing the proportion of ED visits by 0.012. The average cost of SCZ was £66.22 compared with £110.36 for standard primary care, leading to a cost saving of £44.08 per patient. This potential reduction in total costs resulted from fewer referrals to children’s social care and secondary medical services, including the ED. Extensive sensitivity analysis supported the indications that the intervention was likely to be cost-effective.Conclusion The SCZ shows the potential that integrating health and social care that is place-based is potentially cost-effective, with its early years support likely enhancing the cost-effectiveness of the intervention compared with standard primary care. Further robust data and trial evaluation are essential to confirm these findings, ensuring the scalability and sustainability of such programmes.

BACKGROUND:Epileptic seizures during pregnancy may increase the risk of adverse pregnancy outcomes. Socioeconomic disparities in epilepsy incidence may extend to seizure control. We conducted a systematic review and meta-analysis to assess the association between epileptic seizures during pregnancy and adverse pregnancy outcomes. We also evaluated the association between socioeconomic and individual-level factors and seizure occurrence. METHODS AND FINDINGS:We searched MEDLINE, Embase, CINAHL, and PsycINFO databases from inception to May 2025 for observational studies on pregnant women with epileptic seizures. We compared maternal and foetal outcomes in pregnant women with and without seizures and assessed the association between seizure occurrence and socioeconomic or individual-level factors. We used the Newcastle-Ottawa Scale to assess the risk of bias of included studies. Meta-analyses using random effects model were performed to estimate pooled odds ratios (ORs) with 95% confidence intervals (CIs). From 13,381 identified publications, 25 studies (24,596 pregnancies) are included in this analysis. In pregnant women with epilepsy, women with seizures compared to those without had increased odds of caesarean birth (OR 1.62, 95% CI 1.14 to 2.30, p = 0.007), peripartum depression (OR 2.20, 95% CI 1.04 to 4.65, p = 0.04), and small for gestational age baby (OR 1.32, 95% CI 1.03 to 1.69, p = 0.03). The odds of preterm birth (OR 1.66, 95% CI 1.29 to 2.15, p < 0.001), low birthweight (OR 1.47, 95% CI 1.12 to 1.93, p = 0.006), and small for gestational age baby (OR 1.44, 95% CI 1.19 to 1.74, p < 0.001) were higher in women with seizures compared to women without epilepsy. The risk of seizures was greater in pregnant women with epilepsy with low income compared to those with higher income (OR 1.57, 95% CI 1.22 to 2.02, p < 0.001), and in women with focal epilepsy compared to those with generalised epilepsy (OR 1.84, 95% CI 1.54 to 2.20, p < 0.001). The number of studies for some outcomes was small, limiting subgroup analyses and detection of heterogeneity. CONCLUSION:Epileptic seizures are associated with increased risks of adverse maternal and foetal outcomes. Risk assessment to identify women with epilepsy at highest risk of seizures is needed to optimise care.

TPS625 Background: Mammographic screening programmes reduce breast cancer mortality but detect many small tumours with favourable biology which may not progress. These are treated with surgery and adjuvant therapies, but associated morbidities mean there is a need to reduce overtreatment. Minimally invasive treatments such as vacuum-assisted excision (VAE) have been described but there is no prospective randomised evidence to support their routine use. SMALL (ISRCTN 12240119) is designed to establish the feasibility of using VAE to treat small tumours detected within the UK NHS Breast Screening Programme (BSP). Methods: Phase III multicentre randomised trial comparing surgery with VAE for screen-detected good prognosis cancers. Eligibility criteria are age ≥47 years, unifocal grade 1 tumours (maximum diameter 15mm), strongly ER/PR+ve and HER2-ve, with negative axillary staging. Patients are randomised 2:1 to VAE or surgery, with no axillary surgery in the VAE arm. Excision is assessed radiologically, and if incomplete, patients undergo surgery. Adjuvant radiotherapy and endocrine therapy are mandated in the VAE arm. Co-primary end-points are 1) Non-inferiority comparison of the requirement for a second procedure. 2) Single arm analysis of local recurrence (LR) at 5 years after VAE. Recruitment of 800 patients will permit demonstration of 10% non-inferiority of VAE for requirement of a second procedure, ensuring sufficient patients for single arm analysis of LR rates, where expected LR free survival is 99% at 5 years, with an undesirable survival probability after VAE of 97%. Secondary outcome measures include time to ipsilateral recurrence, overall survival, complications, quality of life and health economic analysis. A QuinteT Recruitment Intervention (QRI) is integrated throughout SMALL to optimise recruitment and informed consent. Recruitment challenges are identified by analysing recruiter/patient interviews, audio-recordings of trial discussions, and by review of screening, eligibility and recruitment data and study documentation. Solutions are developed collaboratively, including recruiter feedback and recruitment tips documents. Results: At 10 th February 2023, 231 patients had been recruited from 32 centres, (~45% of eligible patients), with per site recruitment of 0.4-0.5 patients/month. Based on preliminary QRI findings, a recruitment tips document has been circulated (on discussing SMALL, providing balanced information on treatment options and explaining randomisation), with individual recruiter feedback underway and wider feedback planned shortly. Conclusion: SMALL has excellent recruitment to date, confirming feasibility and acceptability, and is expected to have a global impact on treatment of screen-detected breast cancer. Clinical trial information: ISRCTN12240119 .

Background:Children born extremely preterm are at increased risk of developmental problems and respiratory morbidity due to patent ductus arteriosus (PDA). The objective of this study was to evaluate whether early treatment of a PDA ≥1.5 mm with ibuprofen improved neurodevelopmental and respiratory outcomes at 24 months of age, corrected for prematurity. Methods:Baby-OSCAR was a UK multi-center placebo-controlled masked randomized clinical trial in infants born 23+0-28+6 weeks' gestation. The main long-term outcome was survival without moderate or severe neurodevelopmental impairment at 24 months' corrected age, assessed using parent report primarily or classified by blinded end-point review committee where parent-reported data were not available. Other secondary outcomes included survival without respiratory morbidity and duration of oxygen supplementation. (ISRCTN Registry number ISRCTN84264977). Findings:From July 2015 through December 2020, 653 infants underwent randomization. At 24 months' corrected age, outcome data were available for 537 children: 263 in the ibuprofen group and 274 in the placebo group. Survival without moderate to severe neurodevelopmental impairment in the ibuprofen and placebo groups was 131/248 (53.0%) and 134/259 (51.9%) respectively; adjusted risk ratio 1.01 (95% confidence interval [CI] 0.86-1.18); p = 0.901. Survival without respiratory morbidity was 66/220 (30%) and 74/225 (32.9%) respectively; adjusted risk ratio 0.89 (95% CI 0.68-1.18). Median duration of oxygen supplementation from randomization was 76.0 and 78.0 days, respectively; adjusted median difference -1.5 (-13.8 to 10.9). Interpretation:We found no evidence of an improvement in neurodevelopmental and respiratory outcomes at 24 months' corrected age, after selective early treatment of a PDA ≥1.5 mm with ibuprofen in children born extremely preterm. Funding:This study was funded by the National Institute for Health Research (NIHR) Health Technology Assessment Programme (11/92/15).

Objective: Incremental healthcare costs attributed to back pain, and characterisation by patient and clinical factors have rarely been documented. This study aimed to assess annual healthcare resource utilisation and costs associated with back pain in primary care. Methods: Using the IQVIA Medical Research Data (IMRD), patients with back pain were identified (study period: 01 January 2006 to 31 December 2015) using diagnostic records and analgesics prescriptions (n = 133,341), and propensity score matched 1:1 to patients without back pain. The annual incremental costs of back pain associated with consultations and prescriptions were estimated and extrapolated to a national level. Sensitivity analysis was conducted by restricting the study population to the most recent diagnosis of back pain. Variations in cost were assessed stratified by gender, age-groups, deprivation, and comorbidity categories. Results: The mean age was 57 years, and 62% were females in both the case and control groups. The total incremental healthcare costs associated with back pain was 32.5 pound million in 2015 (35.9 pound million in 2020), with per-patient cost of 244 pound (265 pound in 2020) per year. On a national level, this translated to an estimated 3.2 pound billion (3.5 pound billion in 2020). Eighty percent of the costs were attributed to consultations; and female gender, older age, higher deprivation, and higher comorbidity were all associated with increased mean healthcare costs of patients with back pain. Conclusion: Our findings confirm the substantial healthcare costs attributed to back pain, even with primacy care costs only. The data also revealed significant cost variations across socio-demographic and clinical factors.

ObjectivesTo evaluate the cost-effectiveness of long-acting progestogens (LAP), including levonorgestrel-releasing intrauterine system (LNG-IUS) and depot-medroxyprogesterone acetate (DMPA), compared with the combined oral contraceptives pill (COCP) in preventing recurrence of endometriosis-related pain postsurgery.DesignWithin-trial economic evaluation alongside a multicentre, pragmatic, parallel-group, open-label, randomised controlled trial (Preventing Recurrence of Endometriosis by means of Long-Acting Progestogen Therapy trial).SettingThirty-four UK hospitals recruiting participants from November 2015 to March 2019.PatientsFour hundred and five women aged 16–45 years undergoing conservative endometriosis surgery.InterventionsThe ratio of 1:1 randomisation to receive LAPs (LNG-IUS or DMPA) or COCP.Main outcome measuresThe primary evaluation was a cost-utility analysis based on cost per quality-adjusted life-year (QALY) gained at 3 years. We adopted a UK National Health Service perspective. Secondary analyses in the form of cost-effectiveness analysis based on a range of outcomes were also undertaken.ResultsFor the primary analysis, the COCP group incurred an additional cost of £533 (95% CI £52 to £983) per woman compared with LAPs. Treatment with COCP generated additional QALYs of 0.031 (95% CI −0.079 to 0.139) compared with the LAP group over 36-month follow-up. The incremental cost-effectiveness ratio for COCP compared with LAPs is therefore approximately £17 193 per QALY. The probabilistic sensitivity analysis suggested that there was a 54.7% probability that COCP would be cost-effective at the £20 000/QALY threshold. The secondary analyses revealed results more in favour of LAPs.ConclusionAlthough the COCP has a slightly higher probability of being cost-effective at £20 000/QALY threshold, there remains considerable uncertainty, with only marginal differences in outcomes between the two treatments. The lower rates of further surgery and second-line medical treatment for women allocated to LAPs may make this option preferable for some women.Trial registration numberISRCTN 97865475.