Incapacity in childbirth - Rare or common?

OBJECTIVE: Impaired decision making ability is common on general medical wards. Audit evidence suggests that the prevalence of incapacity may be higher than previously assumed in Obstetric Emergency Procedures (OEP) during childbirth. We investigated the prevalence of incapacity in OEP and factors associated with this. DESIGN: Capacity to consent to treatment was assessed retrospectively in 93 women undergoing OEP. All women were interviewed using a semi-structured questionnaire aided interview within 24 h of the emergency. Five assessors (3 obstetricians and 2 psychiatrists) were asked to determine capacity to consent from audio recordings of the interviews. RESULTS: All 5 assessors determined 59 % of women to have capacity to consent to treatment and 2 % of women to lack capacity. In 39 % of women there was some disagreement between assessors. Using a majority decision (3 assessors in agreement), 14 % of women lacked capacity. High pain scores, young age and no previous history of theatre deliveries were associated with more incapacity judgments, whilst parity and history of mental illness were not. Using a 7point Likert scale only marginally improved agreement between assessors, compared to their binary decision. CONCLUSION: It is often assumed that it is rare to lack capacity in an obstetric emergency procedure during childbirth, but these data suggest that incapacity may be relatively common. In particular, severe pain is a demonstrable risk factor for impaired capacity. Wide variation between assessors questions the validity of current commonly employed (informal) methods used in clinical practice to assess capacity to consent during OEP.

Standardised self-management kits for children with type 1 diabetes: pragmatic randomised trial of effectiveness and cost-effectiveness.

OBJECTIVE: To estimate the effectiveness of standardised self-management kits for children with type 1 diabetes. DESIGN: Pragmatic trial with randomisation ratio of two intervention: one control. Qualitative process evaluation. SETTING: 11 diabetes clinics in England and Wales. PARTICIPANTS: Between February 2010 and August 2011, we validly randomised 308 children aged 6-18 years; 201 received the intervention. INTERVENTION: We designed kits to empower children to achieve glycaemic control, notably by recording blood glucose and titrating insulin. The comparator was usual treatment. OUTCOME MEASURES AT 3 AND 6 MONTHS: Primary: Diabetes Pediatric Quality of Life Inventory (PedsQL). Secondary: HbA1c; General PedsQL; EQ-5D; healthcare resource use. RESULTS: Of the five Diabetes PedsQL dimensions, Worry showed adjusted scores significantly favouring self-management kits at 3 months (mean child-reported difference =+5.87; Standard error[SE]=2.19; 95% confidence interval [CI]) from +1.57 to +10.18; p=0.008); but Treatment Adherence significantly favoured controls at 6 months (mean child-reported difference=-4.68; SE=1.74; 95%CI from -8.10 to -1.25; p=0.008). Intervention children reported significantly worse changes between 3 and 6 months on four of the five Diabetes PedsQL dimensions and on the total score (mean difference=-3.20; SE=1.33; 95% CI from -5.73 to -0.67; p=0.020). There was no evidence of change in HbA1c; only 18% of participants in each group achieved recommended levels at 6 months. No serious adverse reactions attributable to the intervention or its absence were reported.Use of kits was poor. Few children or parents associated blood glucose readings with better glycaemic control. The kits, costing £185, alienated many children and parents. CONCLUSIONS: Standardised kits showed no evidence of benefit, inhibited diabetes self-management and increased worry. Future research should study relationships between children and professionals, and seek new methods of helping children and parents to manage diabetes. TRIAL REGISTRATION NUMBER: ISRCTN17551624.

Goal-oriented cognitive rehabilitation for early-stage Alzheimer's and related dementias: the GREAT RCT.

BACKGROUND: Cognitive rehabilitation (CR) is an individualised, person-centred intervention for people with mild to moderate dementia that addresses the impact of cognitive impairment on everyday functioning. OBJECTIVES: To determine whether or not CR is a clinically effective and cost-effective intervention for people with mild to moderate Alzheimer's disease or vascular or mixed dementia, and their carers. DESIGN: This multicentre randomised controlled trial compared CR with treatment as usual (TAU). Following a baseline assessment and goal-setting to identify areas of everyday functioning that could be improved or better managed, participants were randomised (1 : 1) via secure web access to an independent randomisation centre to receive either TAU or CR and followed up at 3 and 9 months post randomisation. SETTING: Community. PARTICIPANTS: Participants had an International Classification of Diseases, Tenth Edition, diagnosis of Alzheimer's disease or vascular or mixed dementia, had mild to moderate cognitive impairment (Mini Mental State Examination score of ≥ 18 points), were stable on medication if prescribed, and had a family carer who was willing to contribute. The exclusion criteria were people with a history of brain injury or other neurological disorder and an inability to speak English. To achieve adequate power, we needed 350 people to complete the trial, with 175 people in each trial arm. INTERVENTION: Cognitive rehabilitation consisted of 10 therapy sessions over 3 months, followed by four maintenance sessions over 6 months, delivered in participants' homes. The therapists were nine occupational therapists and one nurse. OUTCOME MEASURES: The primary outcome was self-reported goal attainment at 3 months. Goal attainment was also assessed at 9 months. Carers provided independent ratings of goal attainment at both time points. The secondary outcomes were participant quality of life, mood, self-efficacy and cognition, and carer stress, health status and quality of life. The assessments at 3 and 9 months were conducted by researchers who were blind to the participants' group allocation. RESULTS: A total of 475 participants were randomised (CR arm, n = 239; TAU arm, n = 236), 427 participants (90%) completed the trial and 426 participants were analysed (CR arm, n = 208, TAU arm, n = 218). At 3 months, there were statistically significant large positive effects for participant-rated goal attainment [mean change in the CR arm: 2.57; mean change in the TAU arm: 0.86; Cohen'sd = 0.97, 95% confidence interval (CI) 0.75 to 1.19], corroborated by carer ratings (Cohen'sd = 1.11, 95% CI 0.89 to 1.34). These effects were maintained at 9 months for both the participant ratings (Cohen's d = 0.94, 95% CI 0.71 to 1.17) and the carer ratings (Cohen's d = 0.96, 95% CI 0.73 to 1.20). There were no significant differences in the secondary outcomes. In the cost-utility analyses, there was no evidence of cost-effectiveness in terms of gains in the quality-adjusted life-years (QALYs) of the person with dementia (measured using the DEMentia Quality Of Life questionnaire utility score) or the QALYs of the carer (measured using the EuroQol-5 Dimensions, three-level version) from either cost perspective. In the cost-effectiveness analyses, by reference to the primary outcome of participant-rated goal attainment, CR was cost-effective from both the health and social care perspective and the societal perspective at willingness-to-pay values of £2500 and above for improvement in the goal attainment measure. There was no evidence on the cost-effectiveness of the self-efficacy measure (the Generalized Self-Efficacy Scale) from either cost perspective. LIMITATIONS: Possible limitations arose from the non-feasibility of using observational outcome measures, the lack of a general measure of functional ability and the exclusion of people without a carer or with rarer forms of dementia. CONCLUSIONS: Cognitive rehabilitation is clinically effective in enabling people with early-stage dementia to improve their everyday functioning in relation to individual goals targeted in the therapy sessions. FUTURE WORK: Next steps will focus on the implementation of CR into NHS and social care services and on extending the approach to people with rarer forms of dementia. TRIAL REGISTRATION: Current Controlled Trials ISRCTN21027481. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 10. See the NIHR Journals Library website for further project information.

BACKGROUND: Cognitive rehabilitation (CR) is a personalised intervention to help people with early-stage dementia to manage everyday activities. This individualised therapy is conducted in people's own homes over several sessions. A therapist works with the person and the carer to identify realistic and relevant goals, plan how to tackle these and support people in achieving them. Previous small studies suggested that CR could be beneficial. METHODS: The Goal-oriented cognitive Rehabilitation in Early-stage Alzheimer's and related dementias: multicentre single-blind randomised controlled Trial (GREAT) was run in eight centres to find out whether or not CR improves everyday functioning. Participants were in the early stages of having Alzheimer's disease, vascular dementia or mixed dementia, with a family carer involved. At the first assessment, participants identified areas in which they would like to see improvements, and set goals. Participants and carers rated how well participants were currently doing in relation to these goals and completed questionnaires, for example about mood and quality of life. Participants were then randomly selected to either receive CR or continue with treatment as usual (TAU). CR consisted of 10 weekly sessions with the therapist over 3 months, followed by four sessions over the next 6 months. Participants were reassessed after 3 and 9 months. RESULTS: We included 475 participants, and 427 participants (90%) completed the trial (209 participants in the CR arm and 218 participants in the TAU arm). After 3 months, the ratings by both participants and carers in the CR group showed that participants were doing significantly better in relation to their goals, and this was maintained 6 months later. Ratings for the TAU-arm participants did not improve significantly. There were no other differences between the groups. There was a strong economic case for CR. CONCLUSIONS: Cognitive rehabilitation is effective in enabling people with early-stage dementia to improve their everyday functioning in relation to individual goals targeted in the therapy sessions. Next steps will focus on the implementation of CR into NHS and social care services.

Trial of Optimal Personalised Care After Treatment-Gynaecological Cancer (TOPCAT-G): A Randomized Feasibility Trial.

OBJECTIVE: This study aimed to evaluate the feasibility of completing a parallel-group randomized controlled trial to compare usual follow-up care for women who have completed treatment of gynecological cancer against a nurse-led telephone intervention, known as Optimal Personalised Care After Treatment-Gynaecological. METHODS: The unblinded trial aimed to recruit patients who had completed treatment of cervical, endometrial, epithelial ovarian, or vulval cancer within the previous 3 months at 3 North Wales hospitals. We randomized participants to either usual hospital-based follow-up or specialist nurse-led telephone education, empowerment, and structured needs assessment follow-up. The primary outcomes assessed the feasibility of running a larger trial including patient eligibility, recruitment and retention rates, and outcome measure completion. Secondary outcomes were generic and health-related quality of life and a patient self-report health service use (Client Service Receipt Inventory) data collected at 3 time points (baseline, 3 months, and 6 months). RESULTS: Of the 58 women screened, 44 were eligible (76%) and 24 (55%) were recruited and randomized (12:12 to control and intervention, respectively). One participant was lost to follow-up. Recruited participants had a mean (SD) age of 60 (11.2) years and were approximately 5 months from their initial diagnosis (mean [SD], 159 [58] days). Seventeen (71%) of the participants had an endometrial cancer diagnosis. All outcome measure completion rates exceeded 96%. Although not a core feasibility objective, analyses of outcome measures indicated positive changes in quality of life and well-being within the Optimal Personalised Care After Treatment-Gynaecological group; exploratory cost consequence analysis indicated that the nurse-led intervention had a mean total service use cost of £27 per patient (bootstrapped 95% confidence interval, -£290 to £240) lower than did the standard care group. CONCLUSION: Eligibility, recruitment, and retention rates as well as outcome measure completion showed that the trial is feasible.

Intervention Now to Eliminate Repeat Unintended Pregnancy in Teenagers (INTERUPT): a systematic review of intervention effectiveness and cost-effectiveness, and qualitative and realist synthesis of implementation factors and user engagement.

BACKGROUND: Unintended repeat conceptions can result in emotional, psychological and educational harm to young women, often with enduring implications for their life chances. This study aimed to identify which young women are at the greatest risk of repeat unintended pregnancies; which interventions are effective and cost-effective; and what are the barriers to and facilitators for the uptake of these interventions. METHODS: We conducted a mixed-methods systematic review which included meta-analysis, framework synthesis and application of realist principles, with stakeholder input and service user feedback to address this. We searched 20 electronic databases, including MEDLINE, Excerpta Medica database, Applied Social Sciences Index and Abstracts and Research Papers in Economics, to cover a broad range of health, social science, health economics and grey literature sources. Searches were conducted between May 2013 and June 2014 and updated in August 2015. RESULTS: Twelve randomised controlled trials (RCTs), two quasi-RCTs, 10 qualitative studies and 53 other quantitative studies were identified. The RCTs evaluated psychosocial interventions and an emergency contraception programme. The primary outcome was repeat conception rate: the event rate was 132 of 308 (43%) in the intervention group versus 140 of 289 (48%) for the control group, with a non-significant risk ratio (RR) of 0.92 [95% confidence interval (CI) 0.78-1.08]. Four studies reported subsequent birth rates: 29 of 237 (12%) events for the intervention arm versus 46 out of 224 (21%) for the control arm, with an RR of 0.60 (95% CI 0.39-0.93). Many repeat conceptions occurred in the context of poverty, low expectations and aspirations and negligible opportunities. Qualitative and realist evidence highlighted the importance of context, motivation, future planning and giving young women a central and active role in the development of new interventions. CONCLUSIONS: Little or no evidence for the effectiveness or cost-effectiveness of any of the interventions to reduce repeat pregnancy in young women was found. Qualitative and realist evidence helped to explain gaps in intervention design that should be addressed. More theory-based, rigorously evaluated programmes need to be developed to reduce unintended repeat pregnancy in young women. TRIAL REGISTRATION: PROSPERO, CRD42012003168 . Cochrane registration number: i = fertility/0068.

Epidemiology of Pain in People With Dementia Living in Care Homes: Longitudinal Course, Prevalence, and Treatment Implications.

INTRODUCTION: Knowledge regarding the longitudinal course, impact, or treatment implications of pain in people with dementia living in care homes is very limited. METHODS: We investigated the people with dementia living in 67 care homes in London and Buckinghamshire, United Kingdom. Pain, dementia severity, neuropsychiatric symptoms, depression, agitation, and quality-of-life were measured using appropriate instruments at baseline (N = 967) and after 9 months (n = 629). RESULTS: Baseline prevalence of pain was 35.3% (95% CI 32.3-38.3). Pain severity was significantly correlated with dementia severity, neuropsychiatric symptoms, depression, agitation, and quality of life at both time points. Regular treatment with analgesics significantly reduced pain severity. Pain was significantly associated with more antipsychotic prescriptions. Pain was significantly associated (OR 1.48; 95% CI 1.18-1.85) with all-cause mortality during follow-up. CONCLUSIONS: Pain is an important determinant of neuropsychiatric symptoms, mortality, quality-of-life, and antipsychotic prescriptions. Improved identification, monitoring, and treatment of pain are urgent priorities to improve the health and quality-of-life for people with dementia.

Impact of antipsychotic review and non-pharmacological intervention on health-related quality of life in people with dementia living in care homes: WHELD-a factorial cluster randomised controlled trial.

BACKGROUND: Very few interventional studies have directly examined the impact of treatment approaches on health-related quality of life (HRQL) in people with dementia. This is of particular importance in therapies to address behavioural symptoms, where HRQL is often severely affected. METHODS: Analysis within the WHELD cluster randomised factorial study in 16 UK care homes examining the impact of person-centred care in combination with antipsychotic review, social interaction and exercise interventions. This study analysed impact on HRQL through the DEMQOL-Proxy. RESULTS: Data on HRQL were available for 187 participants. People receiving antipsychotic review showed a significant worsening in two DEMQOL-Proxy domains (negative emotion: p = 0.02; appearance: p = 0.04). A best-case scenario analysis showed significant worsening for total DEMQOL-Proxy score. Social interaction intervention resulted in a significant benefit to HRQL (p = 0.04). There was no deterioration in HRQL in groups receiving both antipsychotic review and social interaction (p = 0.62). CONCLUSIONS: This demonstrates an important detrimental impact of discontinuation of antipsychotics in dementia on HRQL, highlighting the need for careful review of best practice guidelines regarding antipsychotic use and emphasising the importance of providing evidence-based non-pharmacological interventions in conjunction with antipsychotic review. Copyright © 2016 John Wiley & Sons, Ltd.

Trial of Optimal Personalised Care After Treatment for Gynaecological cancer (TOPCAT-G): a study protocol for a randomised feasibility trial.

BACKGROUND: Gynaecological cancers are diagnosed in over 1000 women in Wales every year. We estimate that this is costing the National Health Service (NHS) in excess of £1 million per annum for routine follow-up appointments alone. Follow-up care is not evidence-based, and there are no definitive guidelines from The National Institute for Health and Care Excellence (NICE) for the type of follow-up that should be delivered. Standard care is to provide a regular medical review of the patient in a hospital-based outpatient clinic for a minimum of 5 years. This study is to evaluate the feasibility of a proposed alternative where the patients are delivered a specialist nurse-led telephone intervention known as Optimal Personalised Care After Treatment for Gynaecological cancer (OPCAT-G), which comprised of a protocol-based patient education, patient empowerment and structured needs assessment. METHODS: The study will recruit female patients who have completed treatment for cervical, endometrial, epithelial ovarian or vulval cancer within the previous 3 months in Betsi Cadwaladr University Health Board (BCUHB) in North Wales. Following recruitment, participants will be randomised to one of two arms in the trial (standard care or OPCAT-G intervention). The primary outcomes for the trial are patient recruitment and attrition rates, and the secondary outcomes are quality of life, health status and capability, using the EORTC QLQ-C30, EQ-5D-3L and ICECAP-A measures. Additionally, a client service receipt inventory (CSRI) will be collected in order to pilot an economic evaluation. DISCUSSION: The results from this feasibility study will be used to inform a fully powered randomised controlled trial to evaluate the difference between standard care and the OPCAT-G intervention. TRIAL REGISTRATION: ISRCTN45565436.

Systematic review of physical activity and exercise interventions to improve health, fitness and well-being of children and young people who use wheelchairs.

AIM: To perform a systematic review establishing the current evidence base for physical activity and exercise interventions that promote health, fitness and well-being, rather than specific functional improvements, for children who use wheelchairs. DESIGN: A systematic review using a mixed methods design. DATA SOURCES: A wide range of databases, including Web of Science, PubMed, BMJ Best Practice, NHS EED, CINAHL, AMED, NICAN, PsychINFO, were searched for quantitative, qualitative and health economics evidence. ELIGIBILITY: participants: children/young people aged >25 years who use a wheelchair, or parents and therapists/carers. Intervention: home-based or community-based physical activity to improve health, fitness and well-being. RESULTS: Thirty quantitative studies that measured indicators of health, fitness and well-being and one qualitative study were included. Studies were very heterogeneous preventing a meta-analysis, and the risk of bias was generally high. Most studies focused on children with cerebral palsy and used an outcome measure of walking or standing, indicating that they were generally designed for children with already good motor function and mobility. Improvements in health, fitness and well-being were found across the range of outcome types. There were no reports of negative changes. No economics evidence was found. CONCLUSIONS: It was found that children who use wheelchairs can participate in physical activity interventions safely. The paucity of robust studies evaluating interventions to improve health and fitness is concerning. This hinders adequate policymaking and guidance for practitioners, and requires urgent attention. However, the evidence that does exist suggests that children who use wheelchairs are able to experience the positive benefits associated with appropriately designed exercise. TRIAL REGISTRATION NUMBER: CRD42013003939.

Reducing repeat pregnancies in adolescence: applying realist principles as part of a mixed-methods systematic review to explore what works, for whom, how and under what circumstances.

BACKGROUND: Previous research has demonstrated emotional, psychological and educational harm to young mothers following unintended conceptions. The UK has one of the highest rates of pregnancies in adolescence in Western Europe with a high proportion of these being repeat pregnancies, making it a topic of interest for public health policy makers, and health and social care practitioners. As part of a wider mixed-methods systematic review, realist principles were applied to synthesise evidence about interventions aiming to reduce repeat pregnancies in adolescence. METHODS: A multi-streamed, mixed-methods systematic review was conducted searching 11 major electronic databases and 9 additional databases from 1995 onwards, using key terms such as pregnancy, teen or adolescent. The principles of realist synthesis were applied to all included literature to uncover theories about what works, for whom, how and in what context. Initial theory areas were developed through evidence scoping, group discussion by the authors and stakeholder engagement to uncover context + mechanism = outcome (CMO) configurations and related narratives. RESULTS: The searches identified 8,664 documents initially, and 403 in repeat searches, filtering to 81 included studies, including qualitative studies, randomised controlled trials, quantitative studies and grey literature. Three CMO configurations were developed. The individual experiences of young mothers' triggered self-efficacy, notions of perceived risks, susceptibility and benefits of pregnancy, resulting in the adolescent taking control of their fertility and sexual encounters. The choice between motherhood and other goals triggered notions of motivations, resulting in the adolescent managing their expectations of motherhood and controlling their fertility and sexual encounters. Barriers and facilitators to accessing services triggered notions of connectedness and self-determination; resulting in interventions that are tailored so they are relevant to young persons, and improve access to services and engagement with the issue of pregnancy in adolescence. CONCLUSIONS: Pregnancy in adolescence is a complex issue with many factors to consider. The conceptual platform described here could help guide policy makers and professionals towards a number of areas that need to be attended to in order to increase the likelihood of an intervention working to prevent rapid repeat pregnancy in adolescence. TRIAL REGISTRATION: PROSPERO CRD42012003168.

Does an early home-based progressive resistance training program improve function following total hip replacement? Results of a randomized controlled study.

BACKGROUND: In-hospital progressive resistance training (PRT) has been shown to be an effective method of rehabilitation following hip surgery. The aim of this study was to assess whether a home-based PRT program would be beneficial in improving patients' muscle strength and physical function compared to standard rehabilitation. METHODS: Subjects (n = 49) either received home-based PRT rehabilitation (n = 25) or standard rehabilitation (n = 24) in a prospective single blinded randomized trial carried out over a two-year period. The primary outcome measure was the maximal voluntary contraction of the operated leg quadriceps (MVCOLQ) with secondary measures of outcome being the sit to stand score (ST), timed up and go (TUG), stair climb performance (SCP), the 6 min walk test (6MWT), and lean mass of the operated leg (LM). RESULTS: Twenty-six patients completed follow up at 1 year (n = 13 per group) for the final comparative analysis. All the outcome measures showed marked progressive improvements from the baseline measures at 9-12 months post op (Estimated effect (std error); p value)- MVCOLQ 26.50 (8.71) N p = 0.001; ST 1.37 (0.33) p = 0.0001; TUG -1.44 (0.45) s p =0.0001; SCP -3.41(0.80)s p = 0.0001; 6MWT 45.61 (6.10)m p = 0.0001; LM 20 (204)g p = 0.326) following surgery for both groups. Overall, there was no significant effect for participation in the exercise regime compared with standard care for all outcomes assessed. CONCLUSIONS: Overall, this study demonstrated that there is no significant difference between the two groups for participation in the home-based PRT exercise programme when compared to standard care for all outcomes. TRIAL REGISTRATION: ISRCTN 1309951. Registered February 2011.

Intervention Now to Eliminate Repeat Unintended Pregnancy in Teenagers (INTERUPT): a systematic review of intervention effectiveness and cost-effectiveness, and qualitative and realist synthesis of implementation factors and user engagement.

BACKGROUND: The UK has one of the highest rates of teenage pregnancies in Western Europe. One-fifth of these are repeat pregnancies. Unintended conceptions can cause substantial emotional, psychological and educational harm to teenagers, often with enduring implications for life chances. Babies of teenage mothers have increased mortality and are at a significantly increased risk of poverty, educational underachievement and unemployment later in life, with associated costs to society. It is important to identify effective, cost-effective and acceptable interventions. OBJECTIVES: To identify who is at the greatest risk of repeat unintended pregnancies; which interventions are effective and cost-effective; and what the barriers to and facilitators of the uptake of these interventions are. DATA SOURCES: We conducted a multistreamed, mixed-methods systematic review informed by service user and provider consultation to examine worldwide peer-reviewed evidence and UK-generated grey literature to find and evaluate interventions to reduce repeat unintended teenage pregnancies. We searched the following electronic databases: MEDLINE and MEDLINE In-Process & Other Non-Indexed Citations, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, The Cochrane Library (Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects and the Health Technology Assessment Database), EMBASE (Excerpta Medica database), British Nursing Index, Educational Resources Information Center, Sociological Abstracts, Applied Social Sciences Index and Abstracts, BiblioMap (the Evidence for Policy and Practice Information and Co-ordinating Centre register of health promotion and public health research), Social Sciences Citation Index (supported by Web of Knowledge), Research Papers in Economics, EconLit (American Economic Association's electronic bibliography), OpenGrey, Scopus, Scirus, Social Care Online, National Research Register, National Institute for Health Research Clinical Research Network Portfolio and Index to THESES. Searches were conducted in May 2013 and updated in June 2014. In addition, we conducted a systematic search of Google (Google Inc., Mountain View, CA, USA) in January 2014. Database searches were guided by an advisory group of stakeholders. REVIEW METHODS: To address the topic's complexities, we used a structured, innovative and iterative approach combining methods tailored to each evidence stream. Quantitative data (effectiveness, cost-effectiveness, risk factors and effect modifiers) were synthesised with reference to Cochrane guidelines for evaluating evidence on public health interventions. Qualitative evidence addressing facilitators of and barriers to the uptake of interventions, experience and acceptability of interventions was synthesised thematically. We applied the principles of realist synthesis to uncover theories and mechanisms underpinning interventions (what works, for whom and in what context). Finally, we conducted an overarching narrative of synthesis of evidence and gathered service user feedback. RESULTS: We identified 8664 documents initially, and 816 in repeat searches. We filtered these to 12 randomised controlled trials (RCTs), four quasi-RCTs, 10 qualitative studies and 53 other quantitative studies published between 1996 and 2012. None of the RCTs was based in the UK. The RCTs evaluated an emergency contraception programme and psychosocial interventions. We found no evidence for effectiveness with regard to condom use, contraceptive use or rates of unprotected sex or use of birth control. Our primary outcome was repeat conception rate: the event rate was 132 of 308 (43%) in the intervention group versus 140 of 289 (48%) for the control goup, with a non-significant risk ratio (RR) of 0.92 [95% confidence interval (CI) 0.78 to 1.08]. Four studies reported subsequent birth rates: 29 of 237 (12%) events for the intervention arm versus 46 out of 224 (21%) for the control arm, with a RR of 0.60 (95% CI 0.39 to 0.93). Many repeat conceptions occurred in the context of poverty, low expectations and aspirations, and negligible opportunities. Service user feedback suggested that there were specific motivations for many repeat conceptions, for example to replace loss or to please a partner. Realist synthesis highlighted that context, motivation, planning for the future and letting young women take control with connectedness and tailoring provide a conceptual framework for future research. LIMITATIONS: Included studies rarely characterised adolescent pregnancy as intended or unintended, that is interventions to reduce repeat conceptions rarely addressed whether or not pregnancies were intended. Furthermore, interventions were often not clearly defined, had multiple aims and did not indicate which elements were intended to address which aims. Nearly all of the studies were conducted in the USA and focused largely on African American or Hispanic and Latina American populations. CONCLUSIONS: We found no evidence to indicate that existing interventions to reduce repeat teenage pregnancy were effective; however, subsequent births were reduced by home-based interventions. Qualitative and realist evidence helped to explain gaps in intervention design that should be addressed. More theory-based, rigorously evaluated programmes need to be developed to reduce repeat teenage pregnancy in the UK. STUDY REGISTRATION: This study is registered as PROSPERO CRD42012003168. Cochrane registration number: i=fertility/0068. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Development of a composite outcome score for a complex intervention - measuring the impact of Community Health Workers.

BACKGROUND: In health services research, composite scores to measure changes in health-seeking behaviour and uptake of services do not exist. We describe the rationale and analytical considerations for a composite primary outcome for primary care research. We simulate its use in a large hypothetical population and use it to calculate sample sizes. We apply it within the context of a proposed cluster randomised controlled trial (RCT) of a Community Health Worker (CHW) intervention. METHODS: We define the outcome as the proportion of the services (immunizations, screening tests, stop-smoking clinics) received by household members, of those that they were eligible to receive. First, we simulated a population household structure (by age and sex), based on household composition data from the 2011 England and Wales census. The ratio of eligible to received services was calculated for each simulated household based on published eligibility criteria and service uptake rates, and was used to calculate sample size scenarios for a cluster RCT of a CHW intervention. We assume varying intervention percentage effects and varying levels of clustering. RESULTS: Assuming no disease risk factor clustering at the household level, 11.7% of households in the hypothetical population of 20,000 households were eligible for no services, 26.4% for 1, 20.7% for 2, 15.3% for 3 and 25.8% for 4 or more. To demonstrate a small CHW intervention percentage effect (10% improvement in uptake of services out of those who would not otherwise have taken them up, and additionally assuming intra-class correlation of 0.01 between households served by different CHWs), around 4,000 households would be needed in each of the intervention and control arms. This equates to 40 CHWs (each servicing 100 households) needed in the intervention arm. If the CHWs were more effective (20%), then only 170 households would be needed in each of the intervention and control arms. CONCLUSIONS: This is a useful first step towards a process-centred composite score of practical value in complex community-based interventions. Firstly, it is likely to result in increased statistical power compared with multiple outcomes. Second, it avoids over-emphasis of any single outcome from a complex intervention.

Well-being, health and fitness of children who use wheelchairs: feasibility study protocol to develop child-centred 'keep-fit' exercise interventions.

AIM: To undertake the pre-clinical and modelling phases of the Medical Research Council complex intervention framework to underpin development of child-centred 'keep-fit', exercise and physical activity interventions for children and young people who use wheelchairs. BACKGROUND: Children who use wheelchairs face many barriers to participation in physical activity, which compromises fitness, obesity, well-being and health. 'Keep-fit' programmes that are child-centred and engaging are urgently required to enhance participation of disabled children and their families as part of a healthy lifestyle. Nurses will likely be important in promoting and monitoring 'keep-fit' intervention(s) when implemented in the community. DESIGN: Mixed-method (including economic analysis) feasibility study to capture child and family preferences and keep-fit needs and to determine outcome measures for a 'keep-fit' intervention. METHODS: The study comprises three stages. Stage 1 includes a mixed-method systematic review of effectiveness, cost effectiveness and key stakeholder views and experiences of keep-fit interventions, followed by qualitative interviews with children, young people and their parents to explore preferences and motivations for physical activity. Stage 2 will identify standardized outcome measures and test their application with children who use wheelchairs to obtain baseline fitness data. Options for an exercise-based keep-fit intervention will then be designed based on Stage 1 and 2 findings. In stage 3, we will present intervention options for feedback and further refinement to children and parents/carers in focus groups. (Project funded October 2012). DISCUSSION: At completion, this study will lead to the design of the intervention and a protocol to test its efficacy.

A stepped wedge cluster randomized control trial of dried blood spot testing to improve the uptake of hepatitis C antibody testing within UK prisons.

BACKGROUND: The prevalence of hepatitis C (HCV) is elevated within prison populations, yet diagnosis in prisons remains low. Dried blood spot testing (DBST) is a simple procedure for the detection of HCV antibodies; its impact on testing in the prison context is unknown. METHODS: We carried out a stepped-wedge cluster-randomized control trial of DBST for HCV among prisoners within five male prisons and one female prison. Each prison was a separate cluster. The order in which the intervention (training in use of DBST for HCV testing and logistic support) was introduced was randomized across clusters. The outcome measure was the HCV testing rate by prison. Imputation analysis was carried out to account for missing data. Planned and actual intervention times differed in some prisons; data were thus analysed by intention to treat (ITT) and by observed step times. RESULTS: There was insufficient evidence of an effect of the intervention on testing rate using either the ITT intervention time (OR: 0.84; 95% CI: 0.68-1.03; P = 0.088) or using the actual intervention time (OR: 0.86; 95% CI: 0.71-1.06; P = 0.153). This was confirmed by the pooled results of five imputed data sets. CONCLUSIONS: DBST as a stand-alone intervention was insufficient to increase HCV diagnosis within the UK prison setting. Factors such as staff training and allocation of staff time for regular clinics are key to improving service delivery. We demonstrate that prisons can conduct rigorous studies of new interventions, but data collection can be problematic. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number Register (ISRCTN number ISRCTN05628482).

Care staff and family member perspectives on quality of life in people with very severe dementia in long-term care: a cross-sectional study.

BACKGROUND: Little is known about the quality of life of people with very severe dementia in long-term care settings, and more information is needed about the properties of quality of life measures aimed at this group. In this study we explored the profiles of quality of life generated through proxy ratings by care staff and family members using the Quality of Life in Late-stage Dementia (QUALID) scale, examined factors associated with these ratings, and further investigated the psychometric properties of the QUALID. METHODS: Proxy ratings of quality of life using the QUALID were obtained for 105 residents with very severe dementia, categorised as meeting criteria for Functional Assessment Staging (FAST) stages 6 or 7, from members of care staff (n = 105) and family members (n = 73). A range of resident and staff factors were also assessed. RESULTS: Care staff and family member ratings were similar but were associated with different factors. Care staff ratings were significantly predicted by resident mood and awareness/responsiveness. Family member ratings were significantly predicted by use of antipsychotic medication. Factor analysis of QUALID scores suggested a two-factor solution for both care staff ratings and family member ratings. CONCLUSIONS: The findings offer novel evidence about predictors of care staff proxy ratings of quality of life and demonstrate that commonly-assessed resident variables explain little of the variability in family members' proxy ratings. The findings provide further information about the psychometric properties of the QUALID, and support the applicability of the QUALID as a means of examining quality of life in very severe dementia.

Folate Augmentation of Treatment--Evaluation for Depression (FolATED): randomised trial and economic evaluation.

BACKGROUND: Folate deficiency is associated with depression. Despite the biological plausibility of a causal link, the evidence that adding folate enhances antidepressant treatment is weak. OBJECTIVES: (1) Estimate the clinical effectiveness and cost-effectiveness of folic acid as adjunct to antidepressant medication (ADM). (2) Explore whether baseline folate and homocysteine predict response to treatment. (3) Investigate whether response to treatment depends on genetic polymorphisms related to folate metabolism. DESIGN: FolATED (Folate Augmentation of Treatment - Evaluation for Depression) was a double-blind and placebo-controlled, but otherwise pragmatic, randomised trial including cost-utility analysis. To yield 80% power of detecting standardised difference on the Beck Depression Inventory version 2 (BDI-II) of 0.3 between groups (a 'small' effect), FolATED trialists sought to analyse 358 participants. To allow for an estimated loss of 21% of participants over three time points, we planned to randomise 453. SETTINGS: Clinical - Three centres in Wales - North East Wales, North West Wales and Swansea. Trial management - North Wales Organisation for Randomised Trials in Health in Bangor University. Biochemical analysis - University Hospital of Wales, Cardiff. Genetic analysis - University of Liverpool. PARTICIPANTS: Four hundred and seventy-five adult patients presenting to primary or secondary care with confirmed moderate to severe depression for which they were taking or about to start ADM, and able to consent and complete assessments, but not (1) folate deficient, vitamin B12 deficient, or taking folic acid or anticonvulsants; (2) misusing drugs or alcohol, or suffering from psychosis, bipolar disorder, malignancy or other unstable or terminal illness; (3) (planning to become) pregnant; or (4) participating in other clinical research. INTERVENTIONS: Once a day for 12 weeks experimental participants added 5 mg of folic acid to their ADM, and control participants added an indistinguishable placebo. All participants followed pragmatic management plans initiated by a trial psychiatrist and maintained by their general medical practitioners. MAIN OUTCOME MEASURES: Assessed at baseline, and 4, 12 and 25 weeks thereafter, and analysed by 'area under curve' (main); by analysis of covariance at each time point (secondary); and by multi-level repeated measures (sensitivity analysis): Mental health - BDI-II (primary), Clinical Global Impression (CGI), Montgomery-Åsberg Depression Rating Scale (MADRS), UKU side effects scale, and Mini International Neuropsychiatric Interview (MINI) suicidality subscale; General health - UK 12-item Short Form Health Survey (SF-12), European Quality of Life scale - 5 Dimensions (EQ-5D); Biochemistry - serum folate, B12, homocysteine; Adherence - Morisky Questionnaire; Economics - resource use. RESULTS: Folic acid did not significantly improve any of these measures. For example it gained a mean of just 2.9 quality-adjusted life-days [95% confidence interval (CI) from -12.7 to 7.0 days] and saved a mean of just £48 (95% CI from -£292 to £389). In contrast it significantly reduced mental health scores on the SF-12 by 3.0% (95% CI from -5.2% to -0.8%). CONCLUSIONS: The FolATED trial generated no evidence that folic acid was clinically effective or cost-effective in augmenting ADM. This negative finding is consistent with improving understanding of the one-carbon folate pathway suggesting that methylfolate is a better candidate for augmenting ADM. Hence the findings of FolATED undermine treatment guidelines that advocate folic acid for treating depression, and suggest future trials of methylfolate to augment ADM. TRIAL REGISTRATION: Current Controlled Trials ISRCTN37558856. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 48. See the HTA programme website for further project information.

Improving Well-being and Health for People with Dementia (WHELD): study protocol for a randomised controlled trial.

BACKGROUND: People with dementia living in care homes often have complex mental health problems, disabilities and social needs. Providing more comprehensive training for staff working in care home environments is a high national priority. It is important that this training is evidence based and delivers improvement for people with dementia residing in these environments. Well-being and Health for People with Dementia (WHELD) combines the most effective elements of existing approaches to develop a comprehensive but practical staff training intervention. This optimised intervention is based on a factorial study and qualitative evaluation, to combine: training on person-centred care, promoting person-centred activities and interactions, and providing care home staff and general practitioners with updated knowledge regarding the optimal use of psychotropic medications for persons with dementia in care homes. DESIGN: The trial will be a randomised controlled two-arm cluster single blind trial that will take place for nine months across 80 care homes in the United Kingdom. DISCUSSION: The overarching goal of this trial is to determine whether this optimised WHELD intervention is more effective in improving the quality of life and mental health than the usual care provided to people with dementia living in nursing homes. This study will be the largest and best powered randomised controlled trial (RCT) evaluating the benefits of an augmented person-centred care training intervention in care homes worldwide. TRIAL REGISTRATION: Current controlled trials ISRCTN62237498 Date registered: 5 September 2013.

'Keep fit' exercise interventions to improve health, fitness and well-being of children and young people who use wheelchairs: mixed-method systematic review protocol.

AIM: This mixed-method systematic review aims to establish the current evidence base for 'keep fit', exercise or physical activity interventions for children and young people who use wheelchairs. BACKGROUND: Nurses have a vital health promotion, motivational and monitoring role in optimizing the health and well-being of disabled children. Children with mobility impairments are prone to have low participation levels in physical activity, which reduces fitness and well-being. Effective physical activity interventions that are fun and engaging for children are required to promote habitual participation as part of a healthy lifestyle. Previous intervention programmes have been trialled, but little is known about the most effective types of exercise to improve the fitness of young wheelchair users. DESIGN: Mixed-method design using Cochrane systematic processes. Evidence regarding physiological and psychological effectiveness, health economics, user perspectives and service evaluations will be included and analysed under distinct streams. METHODS: The project was funded from October 2012. Multiple databases will be searched using search strings combining relevant medical subheadings and intervention-specific terms. Articles will also be identified from ancestral references and by approaching authors to identify unpublished work. Only studies or reports evaluating the effectiveness, participation experiences or cost of a physical activity programme will be included. Separate analyses will be performed for each data stream, including a meta-analysis if sufficient homogeneity exists and thematic analyses. Findings across streams will be synthesized in an overarching narrative summary. DISCUSSION: Evidence from the first systematic review of this type will inform development of effective child-centred physical activity interventions and their evaluation.

Self-management in early-stage dementia: a pilot randomised controlled trial of the efficacy and cost-effectiveness of a self-management group intervention (the SMART study).

BACKGROUND: The possibility of living well with a long-term condition has been identified as centrally relevant to the needs of people living with dementia. Growing numbers of people with early-stage dementia are contributing accounts that emphasise the benefits of actively engaging in managing the condition. Self-management interventions share the common objectives of educating about the condition, optimising well-being, enhancing control over the situation and enabling people to take more responsibility for managing the condition. Benefits of such an approach can include improved knowledge, self-efficacy, health status, and better performance of self-management behaviours. However, there is only preliminary evidence that people with early-stage dementia can benefit from such interventions. METHODS: This feasibility study involves the development of a self-management group intervention for people with early-stage Alzheimer's disease, vascular dementia or mixed Alzheimer's and vascular dementia. This study is a single-site pilot randomised-controlled trial. Forty-two people with early stage dementia, each with a caregiver (family member/friend), will be randomised to either the self-management group intervention or to treatment as usual.The self-management group intervention will involve eight weekly sessions, each lasting 90 minutes, held at a memory clinic in North Wales. All participants will be re-assessed three and six months post-randomisation. This study is intended to supply an early evaluation of the self-management intervention so that a full scale trial may be powered from the best available evidence. It will assess the feasibility of the intervention, the study design and the recruitment strategies. It will estimate the parameters and confidence intervals for the research questions of interest. The primary outcome of interest is the self-efficacy score of the person with dementia at three months post-randomisation. Secondary outcomes for the person with dementia are self-efficacy at six months post-randomisation and cognitive ability, mood and well-being at three and six months post-randomisation. Secondary outcomes for caregivers are their distress and stress at three and six months post-randomisation. The cost-effectiveness of the intervention will also be examined. DISCUSSION: This study will provide preliminary information about the feasibility, efficacy and cost-effectiveness of a self-management group intervention for people in the early stages of dementia. TRIAL REGISTRATION: Current Controlled Trials, ISRCTN02023181.