Can we achieve better trial recruitment by presenting patient information through multimedia? Meta-analysis of 'studies within a trial' (SWATs).

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, I2 = 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.

Providing multimedia information to children and young people increases recruitment to trials: pre-planned meta-analysis of SWATs.

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.

Can we achieve better recruitment by providing better information? Meta-analysis of 'studies within a trial' (SWATs) of optimised participant information sheets.

BACKGROUND: 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. METHODS: 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. RESULTS: 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%). CONCLUSIONS: 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. TRIAL REGISTRATION: Healthlines Depression (ISRCTN14172341) Healthlines CVD (ISRCTN27508731) CASPER (ISRCTN02202951) ISDR (ISRCTN87561257) ECLS (NCT01925625) REFORM (ISRCTN68240461) HeLP Diabetes (ISRCTN02123133).

Barriers to Uptake of Postpartum Long-Acting Reversible Contraception: Qualitative Study of the Perspectives of Ugandan Health Workers and Potential Clients.

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.

Total/high density lipoprotein cholesterol and cardiovascular disease (re)hospitalization nadir in type 2 diabetes.

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.

Challenges in the Ethical Review of Peer Support Interventions.

PURPOSE: Ethical review processes have become increasingly complex. We have examined how 8 collaborating diabetes peer-support clinical trials were assessed by ethics committees. METHODS: The ethical reviews from the 8 peer-support studies were collated and subjected to a thematic analysis. We mapped the recommendations of local Institutional Review Boards and ethics committees onto the "4+1 ethical framework" (autonomy, beneficence, non-maleficence, and justice, along with concern for their scope of application). RESULTS: Ethics committees did not consistently focus on tasks within the 4+1 framework: many conducted reviews of scientific, organizational, and administrative activities. Of the 20 themes identified across the ethical reviews, only 4 fell within the scope of the 4+1 framework. Variation in processes and requirements for ethics committees were particularly evident between study countries. Some of the consent processes mandated by ethical review boards were disproportionate for peer support, increased participant burden, and reduced the practicality of testing an ethical intervention. Across the 8 studies, ethics committees' reviews included the required elements to ensure participant safety; however, they created a range of hurdles that in some cases delayed the research and required consent processes that could hinder the spontaneity and/or empathy of peer support. CONCLUSION: Ethics committees should avoid repeating the work of other trusted agencies and consider the ethical validity of "light touch" consent procedures for peer-support interventions. The investigators propose an ethical framework for research on peer support.

Does electronic monitoring influence adherence to medication? Randomized controlled trial of measurement reactivity.

BACKGROUND: Electronic monitoring is recommended for accurate measurement of medication adherence but a possible limitation is that it may influence adherence. PURPOSE: To test the reactive effect of electronic monitoring in a randomized controlled trial. METHODS: A total of 226 adults with type 2 diabetes and HbA1c ≥58 mmol/mol were randomized to receiving their main oral glucose lowering medication in electronic containers or standard packaging. The primary outcomes were self-reported adherence measured with the MARS (Medication Adherence Report Scale; range 5-25) and HbA1c at 8 weeks. RESULTS: Non-significantly higher adherence and lower HbA1c were observed in the electronic container group (differences in means, adjusting for baseline value: MARS, 0.4 [95 % CI -0.1 to 0.8, p = 0.11]; HbA1c (mmol/mol), -1.02 [-2.73 to 0.71, p = 0.25]). CONCLUSIONS: Electronic containers may lead to a small increase in adherence but this potential limitation is outweighed by their advantages. Our findings support electronic monitoring as the method of choice in research on medication adherence. (Trial registration Current Controlled Trials ISRCT N30522359).

Development and validation of a new tool to assess quality of decision-making by older children and parents about research participation.

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.

Testing a peer support intervention for people with type 2 diabetes: a pilot for a randomised controlled trial.

BACKGROUND: People with Type 2 diabetes face various psycho-social, self-management and clinical care issues and evidence is mixed whether support from others with diabetes, 'peer support', can help. We now describe a 2 month pilot study of different peer support interventions. METHODS: The intervention was informed by formative evaluation using semi-structured interviews with health professionals, community support groups and observation of diabetes education and support groups. Invitations to participate were mailed from 4 general practices and included a survey of barriers to care. Participants were randomized by practice to receive individual, group, combined (both individual and group) or no peer support. Evaluation included ethnographic observation, semi-structured interviews and questionnaires at baseline and post-intervention. RESULTS: Of 1,101 invited, 15% expressed an interest in participating in the pilot. Sufficient numbers volunteered to become peer supporters, although 50% of these (8/16) withdrew. Those in the pilot were similar to other patients, but were less likely to feel they knew enough about diabetes (60.8% vs 44.6% p = 0.035) and less likely to be happy with the diabetes education/care to date (75.4% vs 55.4% p = 0.013). Key issues identified were the need to recruit peer supporters directly rather than through clinicians, to address participant diabetes educational needs early and the potential for group sessions to have lower participation rates than 1:1 sessions. CONCLUSIONS: Recruitment to a full trial of peer support within the existing study design is feasible with some amendments. Attendance emerged as a key issue needing close monitoring and additional intervention during the trial.

Young people's perspectives on the adoption of preventive measures for HIV/AIDS, malaria and family planning in South-West Uganda: focus group study.

BACKGROUND: Despite the possibility of preventing many cases of HIV, malaria and unplanned pregnancy, protective measures are often not taken by those at risk in Uganda. The study aim was to explore young people's perspectives on the reasons why this is so. METHODS: Focus groups were conducted with 100 secondary school and college students in Kanungu, Uganda in 2011. Three parallel groups considered HIV, malaria and family planning, and common messages were then explored jointly in a workshop based on the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation and Maintenance). RESULTS: Participants identified various reasons why preventive action was not always taken. They worried about the effectiveness and side effects of several key interventions: condoms, antiretroviral treatment, various contraceptives and impregnated mosquito nets. Cost, rural isolation and the quality and availability of health services also limited the extent to which people were able to follow health advice. Although there was respect for policy supporting abstinence and fidelity, it was seen as hard to follow and offering inadequate protection when gender imbalance put pressure on women to have sex. CONCLUSIONS: There is an opportunity to improve the uptake of preventive measures by tackling the misconceptions and fears that participants reported with clear, evidence-based messages. This should be done in a way that encourages more open communication about reproductive health between men and women, that reaches out to isolated communities, that draws on both voluntary and government services and enlists young people so that they can shape their future.

An explanatory randomised controlled trial of a nurse-led, consultation-based intervention to support patients with adherence to taking glucose lowering medication for type 2 diabetes.

BACKGROUND: Failure to take medication reduces the effectiveness of treatment leading to increased morbidity and mortality. We evaluated the efficacy of a consultation-based intervention to support objectively-assessed adherence to oral glucose lowering medication (OGLM) compared to usual care among people with type 2 diabetes. METHODS: This was a parallel group randomised trial in adult patients with type 2 diabetes and HbA1c ≥ 7.5% (58 mmol/mol), prescribed at least one OGLM. Participants were allocated to a clinic nurse delivered, innovative consultation-based intervention to strengthen patient motivation to take OGLM regularly and support medicine taking through action-plans, or to usual care. The primary outcome was the percentage of days on which the prescribed dose of medication was taken, measured objectively over 12 weeks with an electronic medication-monitoring device (TrackCap, Aardex, Switzerland). The primary analysis was intention-to-treat. RESULTS: 211 patients were randomised between July 1, 2006 and November 30, 2008 in 13 British general practices (primary care clinics). Primary outcome data were available for 194 participants (91.9%). Mean (sd) percentage of adherent days was 77.4% (26.3) in the intervention group and 69.0% (30.8) in standard care (mean difference between groups 8.4%, 95% confidence interval 0.2% to 16.7%, p = 0.044). There was no significant adverse impact on functional status or treatment satisfaction. CONCLUSIONS: This well-specified, theory based intervention delivered in a single session of 30 min in primary care increased objectively measured medication adherence, with no adverse effect on treatment satisfaction. These findings justify a definitive trial of this approach to improving medication adherence over a longer period of time, with clinical and cost-effectiveness outcomes to inform clinical practice.

Learning from the experience of peer support facilitators and study nurses in diabetes peer support: A qualitative study.

OBJECTIVES: We report on the experiences of peer support facilitators and study nurses who participated in a large trial of peer support for type 2 diabetes. The support was led by volunteer peer support facilitators, who were trained in overcoming barriers to diabetes care, motivational interviewing, listening skills and setting up and running group support sessions. There is currently a distinct lack of qualitative evidence on what works in peer support. METHODS: The peer support facilitators and study nurses completed open-answer questionnaire items on what worked well and less well, problems encountered and how they were resolved, group dynamics and suggestions for improvement. We also collected data from end-of-study meetings. Inductive thematic analysis was used to allow the emergent themes to be strongly based in the data.Findings: We find that process factors, peer support facilitator and peer characteristics, their relationships with each other and group dynamics are all fundamental for effective peer support. Sustaining and ending support also emerged as a key theme. DISCUSSION: Given the increasing interest in peer support, these findings will be useful to those interested in running groups in the future. Training programmes should help peer support facilitators develop confidence whilst emphasising that peer support ideally entails an equal, democratic dynamic. More attention is needed on to how to end groups appropriately.

Association Between Systolic Blood Pressure and Cardiovascular Inpatient Cost Moderated by Peer-Support Intervention Among Adult Patients With Type 2 Diabetes: A 2-Cohort Study.

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.

Couples' decision-making on post-partum family planning and antenatal counselling in Uganda: A qualitative study.

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.

Trials within trials? Researcher, funder and ethical perspectives on the practicality and acceptability of nesting trials of recruitment methods in existing primary care trials.

BACKGROUND: Trials frequently encounter difficulties in recruitment, but evidence on effective recruitment methods in primary care is sparse. A robust test of recruitment methods involves comparing alternative methods using a randomized trial, 'nested' in an ongoing 'host' trial. There are potential scientific, logistical and ethical obstacles to such studies. METHODS: Telephone interviews were undertaken with four groups of stakeholders (funders, principal investigators, trial managers and ethics committee chairs) to explore their views on the practicality and acceptability of undertaking nested trials of recruitment methods. These semi-structured interviews were transcribed and analysed thematically. RESULTS: Twenty people were interviewed. Respondents were familiar with recruitment difficulties in primary care and recognised the case for 'nested' studies to build an evidence base on effective recruitment strategies. However, enthusiasm for this global aim was tempered by the challenges of implementation. Challenges for host studies included increasing complexity and management burden; compatibility between the host and nested study; and the impact of the nested study on trial design and relationships with collaborators. For nested recruitment studies, there were concerns that host study investigators might have strong preferences, limiting the nested study investigators' control over their research, and also concerns about sample size which might limit statistical power. Nested studies needed to be compatible with the main trial and should be planned from the outset. Good communication and adequate resources were seen as important. CONCLUSIONS: Although research on recruitment was welcomed in principle, the issue of which study had control of key decisions emerged as critical. To address this concern, it appeared important to align the interests of both host and nested studies and to reduce the burden of hosting a recruitment trial. These findings should prove useful in devising a programme of research involving nested studies of recruitment interventions.

More than measurement: practice team experiences of screening for type 2 diabetes.

BACKGROUND: The feasibility, cost-effectiveness and best means to implement population screening for type 2 diabetes remain to be established. OBJECTIVE: To learn from the experiences of practice staff undertaking a diabetes screening programme in order to inform future screening initiatives. METHODS: Qualitative analysis of interviews with staff in six general practices in the 'ADDITION-Cambridge' trial; three randomly allocated to intensively manage screen-detected patients and three providing usual care. We conducted semi-structured interviews with seven nurses, four doctors, three health care assistants and four managers. Four researchers analysed the transcripts practice by practice, preparing vignettes and comparing interpretations. Participants commented on a summary report. RESULTS: Each practice team implemented the screening and intervention programme differently, depending on numbers at risk and decisions about staff contributions. Several emphasized the importance of administrative support. As they screened, they extended the reach of the programme, testing patients outside the target group if requested, checking other risk factors, providing health information and following up people with impaired glucose tolerance. Staff felt that patients accepted the screening and subsequent management as any other clinical activity. CONCLUSIONS: Although those developing screening programmes attempt to standardize them, primary care teams need to adapt the work to fit local circumstances. Staff need a sense of ownership, training, well-designed information technology systems and protected time. Furthermore, screening is more than measurement; at the individual level, it is a complete health care interaction, requiring individual explanations, advice on health-related behaviour and appropriate follow-up. The UK 'NHS Health Checks' programme should embrace these findings.

UK research staff perspectives on improving recruitment and retention to primary care research; nominal group exercise.

BACKGROUND: Primary care studies often encounter recruitment difficulties, but there is little evidence to inform solutions. As part of a National Institute for Health Research School for Primary Care Research and UK Clinical Research Network programme, we elicited research staff perspectives on factors facilitating or obstructing recruitment. OBJECTIVE: To identify factors that experienced research staff consider important in successful recruitment and retention and their confidence in achieving them. METHODS: An iterative series of three workshops was held. The third used a modified nominal group technique to categorize whether factors related to the 'context' in which the research took place, the 'content' of the study or the recruitment 'process' and to prioritize them by their importance to success. RESULTS: Eighteen research staff participated in the prioritization workshop. They prioritized positive attitudes of primary care staff towards research and trust of researchers by potential participants as major contextual factors affecting recruitment. Studies needed to be considered safe and relevant by staff and fit with practice systems. They proposed that researchers strengthen relationships with staff and participants and minimize workload for primary care teams. Although confident in many recruitment processes, respondents remained uncertain how to achieve cultural change so that research became part of normal practice activity and how best to motivate patients to participate. CONCLUSIONS: Research workers taking part identified factors which might be important in recruitment, several of which they expressed little confidence in addressing. Understanding how to improve recruitment is crucial if current efforts to strengthen primary care research are to bear fruit.

Improving recruitment to health research in primary care.

BACKGROUND: Recruitment to health research is known to be problematic. However, evidence concerning ways of improving recruitment is sparse. OBJECTIVE: To outline the process of recruitment, factors impacting on recruitment success and key areas for further research and development. METHODS: Narrative literature review. RESULTS: This paper argues that three ways of improving recruitment should form the focus of future work: developing a repository of evidence-based techniques and methods which can be introduced by research teams; developing the infrastructure to support recruitment, especially new technologies around the electronic patient record; and increasing public engagement with research, to improve participation by both clinicians and patients. CONCLUSION: Recruitment to health research in primary care remains a major hurdle, and key research and development priorities must be addressed.

Primary palliative care research: opportunities and challenges.

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 6 months 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.

Associations between barriers to self-care and diabetes complications among patients with type 2 diabetes.

AIMS: To determine which barriers to care are associated with type 2 diabetes complications in an area in rural East England. METHODS: 3649 individuals with type 2 diabetes from 62 general practices were contacted via postal invitation which included a 33 item Barriers-to-Diabetes-Care Survey. Barriers were grouped into five priori major categories: educational, physical, psychological, psychosocial, and systems. The associations of reported barriers, both individually and as a group, with self-reported complications were assessed using logistic regression. RESULTS: 39.5% of participants had self-reported diabetes complications. Physical health barriers (OR = 3.3; 95%CI: 2.7, 4.0), systems barriers (OR = 1.6; 95%CI: 1.3, 2.0) and psychological barriers (OR = 1.3 (95%CI: 1.1, 1.5) were associated with diabetes complications. In subcategories, presence of comorbidities (OR = 4.8; 95%CI: 3.9, 5.9), financial difficulties (OR = 1.7; 95%CI: 1.3, 2.1), absence of services (OR = 2.0; 95%CI: 1.4, 3.0), feeling others should bear more financial responsibility for their care (OR = 1.6 (95%CI: 1.1, 2.1), no access to diabetes service (OR = 1.3; 95%CI: 1.1, 1.5), feeling worried about their diabetes (OR = 1.5; 95%CI: 1.2, 2.0) and lack of readiness to exercise (OR = 1.4; 95%CI: 1.2, 1.7) were associated with diabetes complications. CONCLUSIONS: Barriers to self-care are significantly more common among those with, than those without, diabetes complications. Systematic identification and management of different barriers to self-care could help personalise care for those with diabetes related complications.