Objective Effective decision-making is crucial for children and young people's trial participation, but specific tools to measure it are lacking. The TRECA (TRials Engagement in Children and Adolescents) Decision-Making Questionnaire (DMQ) was developed to fill this gap and has been evaluated for reliability and validity. Methods We created the TRECA Decision-Making Questionnaire, based on similar measures for adults, and recruited participants through seven Studies-Within-a-Trial (SWATs). Participants were randomly assigned to receive trial information either as a printed Participant Information Sheet or Multimedia Information, or both, and asked to complete the DMQ. We calculated item completion rates, item-remainder statistics and Cronbach’s Alpha, and conducted factor analysis. Results 549 participants (433 parents/guardians, 116 older children) completed a DMQ. It had high completion rates and internal consistency (Alpha = 0.88 for parents/guardians and 0.84 for older children) and moderate to high inter-item correlations. The DMQ had a single factor accounting for 53% of variance. Conclusions The TRECA DMQ is a useful tool for evaluating research participation decisions in older children, as well as parents and guardians. Practice implications Our study suggests that the TRECA DMQ can be used to assess the quality of decision-making about trials in parents, guardians and older children.

Background People need high-quality information to make decisions about research participation. Providing information in written format alone is conventional but may not be the most effective and acceptable approach. We developed a structure for the presentation of information using multimedia which included generic and trial-specific content. Our aim was to embed ‘Studies Within A Trial’ (SWATs) across multiple ongoing trials to test whether multimedia presentation of patient information led to better rates of recruitment. Methods Five trials included a SWAT and randomised their participants to receive a multimedia presentation alongside standard information, or standard written information alone. We collected data on trial recruitment, acceptance and retention and analysed the pooled results using random effects meta-analysis, with the primary outcome defined as the proportion of participants randomised following an invitation to take part. Results Five SWATs provided data on the primary outcome of proportion of participants randomised. Multimedia alongside written information results in little or no difference in recruitment rates (pooled odds ratio = 0.96, 95% CI: 0.79 to 1.17, p -value = 0.671, I 2 = 0%). There was no effect on any other outcomes. Conclusions Multimedia alongside written information did not improve trial recruitment rates. Trial registration ISRCTN71952900, ISRCTN 06710391, ISRCTN 17160087, ISRCTN05926847, ISRCTN62869767.

Background Randomised controlled trials are often beset by problems with poor recruitment and retention. Information to support decisions on trial participation is usually provided as printed participant information sheets (PIS), which are often long, technical, and unappealing. Multimedia information (MMI), including animations and videos, may be a valuable alternative or complement to a PIS. The Trials Engagement in Children and Adolescents (TRECA) study compared MMI to PIS to investigate the effects on participant recruitment, retention, and quality of decision-making. Methods We undertook six SWATs (Study Within A Trial) within a series of host trials recruiting children and young people. Potential participants in the host trials were randomly allocated to receive MMI-only, PIS-only, or combined MMI + PIS. We recorded the rates of recruitment and retention (varying between 6 and 26 weeks post-randomisation) in each host trial. Potential participants approached about each host trial were asked to complete a nine-item Decision-Making Questionnaire (DMQ) to indicate their evaluation of the information and their reasons for participation/non-participation. Odds ratios were calculated and combined in a meta-analysis. Results Data from 3/6 SWATs for which it was possible were combined in a meta-analysis ( n = 1758). Potential participants allocated to MMI-only were more likely to be recruited to the host trial than those allocated to PIS-only (OR 1.54; 95% CI 1.05, 2.28; p = 0.03). Those allocated to combined MMI + PIS compared to PIS-only were no more likely to be recruited to the host trial (OR = 0.89; 95% CI 0.53, 1.50; p = 0.67). Providing MMI rather than PIS did not impact on DMQ scores. Once children and young people had been recruited to host trials, their trial retention rates did not differ according to intervention allocation. Conclusions Providing MMI-only increased the trial recruitment rate compared to PIS-only but did not affect DMQ scores. Combined MMI + PIS instead of PIS had no effect on recruitment or retention. MMIs are a useful tool for trial recruitment in children and young people, and they could reduce trial recruitment periods.

The information given to people considering taking part in a trial needs to be easy to understand if those people are to become, and then remain, trial participants. However, there is a tension between providing comprehensive information and providing information that is comprehensible. User-testing is one method of developing better participant information, and there is evidence that user-tested information is better at informing participants about key issues relating to trials. However, it is not clear if user-testing also leads to changes in the rates of recruitment in trials, compared to standard trial information. As part of a programme of research, we embedded ‘studies within a trial’ (SWATs) across multiple ongoing trials to see if user-tested materials led to better rates of recruitment. Seven ‘host’ trials included a SWAT evaluation and randomised their participants to receive routine information sheets generated by the research teams, or information sheets optimised through user-testing. We collected data on trial recruitment and analysed the results across these trials using random effects meta-analysis, with the primary outcome defined as the proportion of participants randomised in a host trial following an invitation to take part. Six SWATs (n=27,805) provided data on recruitment. Optimised participant information sheets likely result in little or no difference in recruitment rates (7.2% versus 6.8%, pooled odds ratio = 1.03, 95% CI 0.90 to 1.19, p-value = 0.63, I2 = 0%). Participant information sheets developed through user testing did not improve recruitment rates. The programme of work showed that co-ordinated testing of recruitment strategies using SWATs is feasible and can provide both definitive and timely evidence on the effectiveness of recruitment strategies. Healthlines Depression (ISRCTN14172341) Healthlines CVD (ISRCTN27508731) CASPER (ISRCTN02202951) ISDR (ISRCTN87561257) ECLS (NCT01925625) REFORM (ISRCTN68240461) HeLP Diabetes (ISRCTN02123133)

Background Although health workers have been trained to provide post-partum family planning (PPFP), uptake remains low in Uganda. An important reason is that women want the agreement of their partner, who is often absent at the time of delivery. In order to address this, we aimed to understand the views of couples and explore barriers and facilitators to implementation of antenatal couples' counselling on PPFP in Uganda. Methods We conducted individual interviews with a purposive sample of 12 postpartum and 3 antenatal couples; and 34 focus groups with a total of 323 participants (68 adolescent women, 83 women aged 20-49, 79 men, 93 health workers) in four contrasting communities (urban and rural) in South-West and Central Uganda. These were recorded, transcribed, translated, and analysed thematically. Results Although most participants felt that it is important for partners to discuss family planning, half of the couples were unaware of each other's views on contraception. Most had similar views on motivation to use family planning but not on preferred contraceptive methods. Most liked the idea of antenatal couples' counselling on PPFP. The main barrier was the reluctance of men to attend antenatal clinics (ANC) in health facilities. Respondents felt that Village Health Teams (VHTs) could provide initial counselling on PPFP in couples' homes (with telephone support from health workers, if needed) and encourage men to attend ANC. Suggested facilitators for men to attend ANC included health workers being more welcoming, holding ANC clinics at weekends and "outreach" clinics (in rural villages far from health facilities). Conclusion Antenatal couples' counselling has the potential to facilitate agreement PPFP, but some men are reluctant to attend antenatal clinics. Counselling at home by VHTs as well as simple changes to the organisation of antenatal clinics, could make it possible to deliver antenatal couples' counselling on PPFP.

Objectives: People with type 2 diabetes and increased systolic blood pressure (SBP) are at high risk of cardiovascular disease (CVD). In this study, we aimed to investigate the association between CVD-related hospital payments and SBP and tested whether this association is influenced by diabetes peer support. Methods: Two cohorts comprising people with type 2 diabetes were included in the study. The first cohort comprised 4,704 patients with type 2 diabetes assessed between 2008 and 2009 from 18 general practices in Cambridgeshire and followed up to 2009-2011. The second cohort comprised 1,121 patients with type 2 diabetes from post-trial follow-up data, recruited between 2011 and 2012 and followed up to 2015. SBP was measured at baseline. Inpatient payments for CVD hospitalization within 2 years since baseline was the main outcome. The impact of 1:1, group or combined diabetes peer support and usual care were investigated in the second cohort. Adjusted mean CVD inpatient payments per person were estimated using a 2-part model after adjusting for baseline characteristics. Results: A "hockey-stick" relationship between baseline SBP and estimated CVD inpatient payment was identified in both cohorts, with a threshold at 133 to 141 mmHg, suggesting increased payments for patients with SBP below and above the threshold. The combined peer-support intervention altered the aforementioned association, with no increased payment with SBP above the threshold, and payment slightly decreased with SBP beyond the threshold. Conclusions: SBP maintained between 133 and 141 mmHg is associated with the lowest CVD disease management costs for patients with type 2 diabetes. Combined peer-support intervention could significantly decrease CVD-related hospital payments. (C) 2020 The Author(s). Published by Elsevier Inc. on behalf of Canadian Diabetes Association.

Introduction Primary care has a central role in palliative and end of life care: 45.6% of deaths in England and Wales occur under the care of primary care teams at home or in care homes. The Community Care Pathways at the End of Life (CAPE) study investigated primary care provided for patients in the final 6months of life. This paper highlights the opportunities and challenges associated with primary palliative care research in the UK, describing the methodological, ethical, logistical and gatekeeping challenges encountered in the CAPE study and how these were addressed. The study methods Using a mixed-methods approach, quantitative data were extracted from the general practitioner (GP) and district nurse (DN) records of 400 recently deceased patients in 20 GP practices in the East of England. Focus groups were conducted with some GPs and DNs, and individual interviews held with bereaved carers and other GPs and DNs. The challenges addressed Considerable difficulties were encountered with ethical permissions, with GP, DN and bereaved carer recruitment and both quantitative and qualitative data collection. These were overcome with flexibility of approach, perseverance of the research team and strong user group support. This enabled completion of the study which generated a unique primary palliative care data set.

Health workers have received training on delivering postpartum long-acting reversible contraceptives (LARCs) through several projects in Uganda, yet uptake still remains poor. To understand the reasons, and to gather suggestions for improving uptake, we conducted individual semi-structured interviews with a total of 80 postpartum parents, antenatal parents, health workers, and village health teams in rural south-west Uganda. Interviews were recorded, transcribed, translated, and analyzed using qualitative thematic analysis. Specific barriers to uptake of immediate postpartum contraception for women included: the need to discuss this option with their husband, the belief that time is needed to recover before insertion of a LARC, and fear that the baby might not survive. Furthermore, social consequences of side-effects are more serious in low-income settings. Suggestions for improving uptake of postpartum contraception included health education by "expert users," couples counseling during antenatal care, and improved management of side-effects.

Context Cardiovascular disease (CVD) is a common and costly reason for hospitalization and rehospitalization among patients with type 2 diabetes. Objective This study aimed to develop and externally validate two risk-prediction models for cardiovascular hospitalization and cardiovascular rehospitalization. Design Two independent prospective cohorts. Setting The derivation cohort includes 4704 patients with type 2 diabetes from 18 general practices in Cambridgeshire. The validation cohort comprises 1121 patients with type 2 diabetes from post-trial follow-up data. Main Outcome Measure Cardiovascular hospitalization over 2 years and cardiovascular rehospitalization after 90 days of the prior CVD hospitalization. Results The absolute rate of cardiovascular hospitalization and rehospitalization was 12.5% and 6.7% in the derivation cohort and 16.3% and 7.0% in the validation cohort. Discrimination of the models was similar in both cohorts, with C statistics above 0.70 and excellent calibration of observed and predicted risks. Conclusion Two prediction models that quantify risks of cardiovascular hospitalization and rehospitalization have been developed and externally validated. They are based on a small number of clinical measurements that are available for patients with type 2 diabetes in many developed countries in primary care settings and could serve as the tools to screen the population at high risk of cardiovascular hospitalization and rehospitalization.

Aims: Cerebrovascular disease is one of more typical reasons for hospitalisation and re-hospitalisation in people with type 2 diabetes. We aimed to derive and externally validate two risk prediction algorithms for cerebrovascular hospitalisation and re-hospitalisation. Methods: Two independent cohorts were used to derive and externally validate the two risk scores. The development cohort comprises 4704 patients with type 2 diabetes registered in 18 general practices across Cambridgeshire. The validation cohort includes 1121 type 2 patients from a post-trial cohort data. Outcomes were cerebrovascular hospitalisation within two years and cerebrovascular re-hospitalisation within ninety days of the previous cerebrovascular hospitalisation. Logistic regression was applied to derive the two risk scores for cerebrovascular hospitalisation and re-hospitalisation from development cohort, which were externally validated in the validation cohort. Results: The incidence of cerebrovascular hospitalisation and re-hospitalisation was 3.76% and 1.46% in the development cohort, and 4.99% and 1.87% in the external validation cohort. Age, gender, body mass index, blood pressures, and lipid profiles were included in the final model. Model discrimination was similar in both cohorts, with all C-statis tics >0.70, and very good calibration of observed and predicted individual risks. Conclusion: Two new risk scores that quantify individual risks of cerebrovascular hospitalisation and re-hospitalisation have been well derived and externally validated. Both scores are on the basis of a few of clinical measurements that are commonly available for patients with type 2 diabetes in primary care settings and could work as tools to identify individuals at high risk of cerebrovascular hospitalisation and re-hospitalisation. (C) 2018 Elsevier B.V. All rights reserved.

Total cholesterol to HDL cholesterol ratio (TC/HDL) is an important prognostic factor for CVD. This study used restricted cubic spline modeling to investigate the dose-response associations between TC/HDL and both CVD hospitalization and CVD rehospitalization in two independent prospective cohorts. The East Cambridgeshire and Fenland cohort includes 4,704 patients with T2D from 18 general practices in Cambridgeshire. The Randomized controlled trial of Peer Support In type 2 Diabetes cohort comprises 1,121 patients with T2D with posttrial follow-up data. TC/HDL and other demographic and clinical measurements were measured at baseline. Outcomes were CVD hospitalization over 2 years and CVD rehospitalization after 90 days of the prior CVD hospitalization. Modeling showed nonlinear relationships between TC/HDL and risks of CVD hospitalization and rehospitalization consistently in both cohorts (all P < 0.001 for linear tests). The lowest risks of CVD hospitalization and rehospitalization were consistently found for TC/HDL at 2.8 (95% CI: 2.6-3.0) in both cohorts and both overall and by gender. This is lower than the current lipid control target, 4.0 of TC/HDL. Reducing the TC/HDL target to 2.8 would include a further 33-44% patients with TC/HDL in the 2.8-4.0 range. Studies are required to assess the effectiveness and cost-effectiveness of the earlier introduction of, and more intensive, lipid-lowering treatment needed to achieve this new lower TC/HDL target.

To investigate the impact of a low‐cost diabetes peer‐support intervention, aimed at reducing inpatient and outpatient care utilization and healthcare payments, by conducting a cohort study that followed up a randomized controlled trial.

Written participant information materials are important for ensuring that potential trial participants receive necessary information so that they can provide informed consent. However, such materials are frequently long and complex, which may negatively impact patient understanding and willingness to participate. Improving readability, ease of comprehension and presentation may assist with improved participant recruitment. The Systematic Techniques for Assisting Recruitment to Trials (MRC START) study aimed to develop and evaluate interventions to improve trial recruitment. This study aimed to assess the effectiveness of an optimised participant information brochure and cover letter developed by MRC START regarding response and participant recruitment rates.

People with newly-diagnosed type 2 diabetes are offered structured education, but there are few programmes for those with established diabetes. The empowerment-based education approach from the United States has been advocated as one approach that supports self-management, but is not used in England. The aim of this study was to assess the acceptability of empowerment-based diabetes education for patients with established type 2 diabetes.One 3.5-hour workshop was offered to participants joining a trial of peer support in rural Cambridgeshire, UK. Four main aspects of self-care (carbohydrates and portion size; truths and myths about diabetes; know your numbers and medications; keeping active and foot care) were addressed, followed by a question and answer session. Change in diabetes knowledge and participant perspectives were evaluated using questionnaires. Qualitative evaluation was by ethnographic observation of sessions.Patient expectations were met in 93.5% of participants. Aspects thought to be particularly useful related to diet and carbohydrates and also medications. Ethnography revealed five main themes: diet, group process, health service experience, within session peer support, and educator clinical grounding. Sixty percent of those participating increased their ability to answer diabetes knowledge-based questions.Adopting the empowerment approach' is a valid method of diabetes education for those with established type 2 diabetes in England. Delivery by experienced educators is important to address queries that arise during the sessions. Copyright (C) 2017 John Wiley & Sons.

BACKGROUND:Diabetes peer support, where one person with diabetes helps others, may improve diabetes management. The objective of this study was to perform a cost analysis of peer support strategies used in RAndomized controlled trial of Peer Support in type 2 Diabetes. METHODS:We performed a 2×2 factorial randomized cluster controlled trial in England. People with type 2 diabetes were invited to participate as either 'peer' or 'peer support facilitator' (PSF) through postal invitation predominantly from general practice. Clusters, based on local communities, were each randomly assigned to one arm of group, 1:1, both group and 1:1 or control interventions. The intervention was delivered over 8-12 months by trained PSFs, supported by monthly meetings with a diabetes nurse. Out-of-pocket expenses/service utilization were self-reported at baseline, midpoint and on trial completion. Intervention costs were collated. Non-hospital costs used National Health Service (NHS) reference costs. Hospital payments were obtained from one local commissioning group and mean payments calculated. The analysis employed a societal perspective. Costs were evaluated at the conclusion of the trial. RESULTS:Participants (n=1299) were recruited across 130 clusters. The four arms were well balanced and matched (60% male, mean diabetes duration 9.5 years, mean glycated haemoglobin (HbA1c) 7.4+/-1.3%, 17% insulin treated). Implementation costs at 2013 rates were £13.84/participant/annum, participant out-of-pocket expenses for any intervention were £11.41/participant/annum and the NHS-incurred costs were reduced by £138.38/participant/annum. Savings for the 1:1, group and any intervention were £233.65, £90.52 and £113.13/participant/annum, respectively. CONCLUSIONS:We conclude that both 1:1 and group diabetes peer support over 8-12 months are cost saving in this setting, although much of the benefit is largely derived by differences in self-reported healthcare utilization. Long-term benefits should be investigated. TRIAL REGISTRATION NUMBER:ISRCTN66963621.

Randomised controlled trials are generally regarded as the ‘gold standard’ experimental design to determine the effectiveness of an intervention. Unfortunately, many trials either fail to recruit sufficient numbers of participants, or recruitment takes longer than anticipated. The current embedded trial evaluates the effectiveness of optimised patient information sheets on recruitment of participants in a falls prevention trial.