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).

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.

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.

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.

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.

The effect of optimised patient information materials on recruitment in a lung cancer screening trial: an embedded randomised recruitment trial.

BACKGROUND: 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. METHODS: We conducted a study within a trial (SWAT) embedded in the EarlyCDT Lung Cancer Scotland (ECLS) trial that aimed to assess the effectiveness of a new test in reducing the incidence of patients with late-stage lung cancer at diagnosis compared with standard care. Potential participants approached for ECLS were randomised to receive the original participant information brochure and accompanying letter (control group) or optimised versions of these materials which had undergone user testing and a process of re-writing, re-organisation and professional graphic design (intervention group). The primary outcome was the number of patients recruited to ECLS. The secondary outcome was the proportion of patients expressing an interest in participating in ECLS. RESULTS: In total, 2262 patients were randomised, 1136 of whom were sent the intervention materials and 1126 of whom were sent the control materials. The proportion of patients enrolled and randomised into ECLS was 180 of 1136 (15.8%) in the intervention group and 176 of 1126 (15.6%) in the control group (OR = 1.016, 95% CI, 0.660 to 1.564). The proportion of patients who positively responded to the invitation was 224 of 1136 (19.7%) in the intervention group and 205 of 1126 (18.2%) in the control group (OR = 1.103, 95% CI, 0.778 to 1.565). CONCLUSIONS: Optimised patient information materials made little difference to the proportion of patients positively responding to a trial invitation or to the proportion subsequently randomised to the host trial. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01925625 . Registered on 15 August 2015. Study Within A Trial, SWAT-23. Registered on 12 April 2016.

Derivation and external validation of risk algorithms for cerebrovascular (re)hospitalisation in patients with type 2 diabetes: Two cohorts study.

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-statistics > 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.

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.

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.

Development and External Validation of Risk Scores for Cardiovascular Hospitalization and Rehospitalization in Patients With Diabetes.

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.

Can peer support be cost saving? An economic evaluation of RAPSID: a randomized controlled trial of peer support in diabetes compared to usual care alone in East of England communities.

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.

Developing and evaluating multimedia information resources to improve engagement of children, adolescents, and their parents with trials (TRECA study): Study protocol for a series of linked randomised controlled trials.

BACKGROUND: Randomised controlled trials are widely established as the best method for testing health interventions whilst minimising bias. However, recruitment and subsequent retention of children and adolescents in healthcare trials is challenging. Participant information sheets are often lengthy and difficult to read and understand. Presenting key information using multimedia may help to overcome these limitations and better support young people and their parents in deciding whether to participate in a clinical trial. METHODS: The TRECA (TRials Engagement in Children and Adolescents) study has two phases. The first phase involves a qualitative study with children and adolescents and their parents to inform the development of multimedia information resources and iterative user testing to refine the resources. The second phase will embed the use of the multimedia information resources into six host trials in the United Kingdom. Patients and parents approached to participate in the host trials will be randomly allocated to either use the multimedia information resource in conjunction with standard participant information sheets, the multimedia information resource alone, or the standard participant information sheets alone. The primary outcome will be the effect of the multimedia information resources on recruitment into trials. Other outcomes measured include the effect of multimedia information resources on retention of participants into the host trials and the impact on family members' decision-making processes, when compared to standard participant information sheets alone. DISCUSSION: This study will inform whether multimedia information resources, when developed using participatory design principles, are able to increase recruitment and retention of children and adolescents into trials. There is also the potential for patients to make better informed decisions through the use of multimedia information resources. The multimedia information resources also have the potential to assist with providing information on other healthcare decisions outside of clinical trials. TRIAL REGISTRATION: ISRCTN registry: ISRCTN73136092 (doi: 10.1186/ISRCTN73136092 ). Registered on 24 August 2016.

An optimised patient information sheet did not significantly increase recruitment or retention in a falls prevention study: an embedded randomised recruitment trial.

BACKGROUND: 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. METHODS: A three-arm, embedded randomised methodology trial was conducted within the National Institute for Health Research-funded REducing Falls with ORthoses and a Multifaceted podiatry intervention (REFORM) cohort randomised controlled trial. Routine National Health Service podiatry patients over the age of 65 were randomised to receive either the control patient information sheet (PIS) for the host trial or one of two optimised versions, a bespoke user-tested PIS or a template-developed PIS. The primary outcome was the proportion of patients in each group who went on to be randomised to the host trial. RESULTS: Six thousand and nine hundred patients were randomised 1:1:1 into the embedded trial. A total of 193 (2.8%) went on to be randomised into the main REFORM trial (control n = 62, template-developed n = 68; bespoke user-tested n = 63). Information sheet allocation did not improve recruitment to the trial (odds ratios for the three pairwise comparisons: template vs control 1.10 (95% CI 0.77-1.56, p = 0.60); user-tested vs control 1.01 (95% CI 0.71-1.45, p = 0.94); and user-tested vs template 0.92 (95% CI 0.65-1.31, p = 0.65)). CONCLUSIONS: This embedded methodology trial has demonstrated limited evidence as to the benefit of using optimised information materials on recruitment and retention rates in the REFORM study. TRIAL REGISTRATION: International Standard Randomised Controlled Trials Number registry, ISRCTN68240461 . Registered on 01 July 2011.

Training in positivity for stroke? A qualitative study of acceptability of use of Positive Mental Training (PosMT) as a tool to assist stroke survivors with post-stroke psychological problems and in coping with rehabilitation.

BACKGROUND: Post-stroke psychological problems predict poor recovery, while positive affect enables patients to focus on rehabilitation and may improve functional outcomes. Positive Mental Training (PosMT), a guided self-help audio shows promise as a tool in promoting positivity, optimism and resilience. OBJECTIVE: To assess acceptability of training in positivity with PosMT for prevention and management of post-stroke psychological problems and to help with coping with rehabilitation. METHODS: A modified PosMT tool consisted of 12 audio tracks each lasting 18 minutes, one listened to every day for a week. Survivors and carers were asked to listen for 4 weeks, but could volunteer to listen for more. Interviews took place about experiences of the tool after 4 and 12 weeks. SUBJECTS: 10 stroke survivors and 5 carers from Stroke Support Groups in the UK. RESULTS: Three stroke survivors did not engage with the tool. The remainder reported positive physical and psychological benefits including improved relaxation, better sleep and reduced anxiety after four weeks. Survivors who completed the programme gained a positive outlook on the future, increased motivation, confidence and ability to cope with rehabilitation. No adverse effects were reported. CONCLUSIONS: The PosMT shows potential as a tool for coping with rehabilitation and overcoming post-stroke psychological problems including anxiety and depression.

Barriers to medication adherence for the secondary prevention of stroke: a qualitative interview study in primary care.

BACKGROUND: Medications are highly effective at reducing risk of recurrent stroke, but success is influenced by adherence to treatment. Among survivors of stroke and transient ischaemic attack (TIA), adherence to medication is known to be suboptimal. AIM: To identify and report barriers to medication adherence for the secondary prevention of stroke/TIA. DESIGN AND SETTING: A qualitative interview study was conducted within general practice surgeries in the East of England, UK. METHOD: Patients were approached by letter and invited to take part in a qualitative research study. Semi-structured interviews were undertaken with survivors of stroke, caregivers, and GPs to explore their perspectives and views around secondary prevention and perceived barriers to medication adherence. Key themes were identified using a grounded theory approach. Verbatim quotes describing the themes are presented here. RESULTS: In total, 28 survivors of stroke, including 14 accompanying caregivers and five GPs, were interviewed. Two key themes were identified. Patient level barriers included ability to self-care, the importance people attach to a stroke event, and knowledge of stroke and medication. Medication level barriers included beliefs about medication and beliefs about how pills work, medication routines, changing medications, and regimen complexity and burden of treatment. CONCLUSION: Patients who have had a stroke are faced with multiple barriers to taking secondary prevention medications in UK general practice. This research suggests that a collaborative approach between caregivers, survivors, and healthcare professionals is needed to address these barriers and facilitate medication-taking behaviour.

Stroke survivors', caregivers' and GPs' attitudes towards a polypill for the secondary prevention of stroke: a qualitative interview study.

OBJECTIVES: To understand the perspectives of stroke survivors, caregivers and general practitioners (GPs) on a polypill approach, consisting of blood pressure and cholesterol-lowering therapies, with or without aspirin, for the secondary prevention of stroke. METHODS: A qualitative interview study was undertaken in 5 GP surgeries in the East of England. 28 survivors of stroke/transient ischaemic attack (TIA) were interviewed, 14 of them with a caregiver present, along with a convenience sample of 5 GPs, to assess attitudes towards a polypill and future use. Topic guides explored participants attitudes, potential uptake and long-term use, management of polypill medication and factors influencing the decision to prescribe. Data were analysed using a grounded theory approach. Key themes are presented and illustrated with verbatim quotes. RESULTS: The analysis identified 3 key themes: polypill benefits, polypill concerns and polypill lessons for implementation. Stroke/TIA survivors were positive about the polypill concept and considered it acceptable in the secondary prevention of stroke. Perceived benefits of a polypill included convenience resulting in improved adherence and reduced burden of treatment. Caregivers felt that a polypill would improve medication-taking practices, and GPs were open to prescribing it to those at increased cardiovascular risk. However, concerns raised included whether a polypill provided equivalent therapeutic benefit, side effects through combining medications, consequences of non-adherence, lack of flexibility in regulating dosage, disruption to current treatment and suitability to the wider stroke population. CONCLUSIONS: Participants acknowledged potential advantages in a polypill approach for secondary prevention of stroke; however, significant concerns remain. Further research on the efficacy of a polypill is needed to reassure practitioners whose concerns around inflexibility and treatment suitability are likely to influence the decision to prescribe a polypill for secondary prevention of stroke. Acceptability among survivors, caregivers and GPs is likely to determine the uptake and subsequent use of a polypill in the future.

Creating a whole institution approach to in-service training in sexual and reproductive health in Uganda.

BACKGROUND: Uganda has one of the world's highest fertility rates, and high unmet need for family planning, even when clients have contact with health facilities. Misconceptions about contraceptive side effects and inadequate training for healthcare workers contribute to this. AIM: To develop and evaluate in-service training for family planning, across a whole institution. DESIGN: Course evaluation. Impact on services. METHODS: Following a needs assessment, two courses were developed, adapting WHO's Training Resource Package for Family Planning. All staff were offered level 1 training (five 1 h sessions). The 30 h level 2 course aimed to train clinical staff to certificate level; assessed by written exam, consultation skills and presentations. Quantitative evaluation assessed changes in pre-course and post-course knowledge and confidence scores. Participant feedback was analysed thematically. RESULTS: Of the hospital's 76 clinical staff, 44 attended some training. Of these, 21 attended and 19 completed level 2. Mean knowledge scores increased from 15.9 (SD 4.5) to 20.8 (SD 3.1)/26 (95% CI 4.9 (2.5-7.2)). Confidence rose from 8.1 (SD 1.5) to 9.5 (SD 0.5) (95% CI 1.4 (0.7-2.2)). Nine were accredited to fit intrauterine devices and implants, and three just implants. Screening for unmet need is being introduced and outreach work aims to overcome barriers to adoption of family planning. CONCLUSIONS: Brief in-service training improves health workers' knowledge and skills, corrects misconceptions and increases the priority given to family planning. When aligned to local need and the culture of the institution, training can prompt moves to address unmet need for family planning.