STRAWB2 (Stress and Wellbeing After Childbirth): a randomised controlled trial of targeted self-help materials to prevent post-traumatic stress disorder following childbirth.

OBJECTIVES: To test whether providing psychological self-help materials would significantly lower the incidence of post-traumatic stress disorder (PTSD) at 6-12 weeks postnatally. DESIGN: Open-label randomised controlled trial, with blinded outcome assessment. SETTING: Community midwifery services in two National Health Service (NHS) trusts in the North West. SAMPLE: A cohort of 2419 women receiving normal NHS postnatal care. METHODS: Midwives screened women for traumatic birth experience; 678 women who screened positively (28.1%) were randomly allocated to self-help with usual care (n = 336) or to usual care alone (n = 342). The self-help materials were a leaflet and online film designed to prevent the development of PTSD after trauma exposure through explaining how to manage early psychological responses. MAIN OUTCOME MEASURE: The primary outcome was a composite of diagnostic and subdiagnostic PTSD at 6-12 weeks postnatally using the gold-standard Clinician-Administered PTSD Scale (CAPS-5) interview. RESULTS: Of the 678 women correctly randomised plus the nine women randomised in error, 478 (70.5%) were followed up. Diagnostic or subdiagnostic PTSD rates at follow-up did not differ between groups who received self-help (26.7%, 65/243) or usual care alone (26.2%, 64/244) (intention-to-treat analysis: RR 1.02, 95% CI 0.68-1.53). Findings remained consistent in the per-protocol analysis (RR 1.04, 95% CI 0.85-1.27). Women viewed the materials very positively. There were no adverse effects. Health economic micro-costing indicated implementation would be very low cost. CONCLUSIONS: Many women experience a traumatic birth and risk developing PTSD, but self-help strategies without professional support are insufficient and should not be routinely introduced. TWEETABLE ABSTRACT: Self-help information alone does not reduce the number of women developing PTSD after a traumatic childbirth.

Dental RECUR Randomized Trial to Prevent Caries Recurrence in Children.

The purpose of this study was to determine the efficacy of a dental nurse-delivered intervention-the Dental RECUR Brief Negotiated Interview for Oral Health (DR-BNI)-in reducing the recurrence of dental caries in children who have a primary tooth extracted. It was based on a 2-arm multicenter randomized controlled trial with blinded outcome assessment. Participants were 5- to 7-y-old children (n = 241) scheduled to have primary teeth extracted in 12 UK centers. Test intervention parents (n = 119) received DR-BNI led by trained dental nurses. DR-BNI is a 30-min structured conversation informed by motivational interviewing with a forward focus to prevent future caries. Preventive goals are agreed, and a review appointment is made with child's general dental practitioner, who is advised to treat the child as being at high caries risk. The control intervention (n = 122) was a parent-nurse conversation about child's future tooth eruption, with advice given to visit a general dental practitioner as usual. At baseline, the DR-BNI group's mean dmft was 6.8, and the control group's was 6.3. A median of 5 teeth were extracted, mainly under general anesthesia. Final dental assessments were conducted by a single examiner visiting 189 schools 2 y after intervention; 193 (80%) of 241 children were examined. In the control group, 62% developed new caries in teeth that were caries-free or unerupted at baseline, as compared with 44% in the test group, a significant reduction (P = 0.021). The odds of new caries experience occurring were reduced by 51% in the DR-BNI group as compared with control. There was a 29% decrease in the relative risk of new caries experience in the DR-BNI group as compared with control. This single low-cost, low-intensity intervention was successful in significantly reducing the risk of recurrence of dental caries in children. This trial has implications for changing pediatric dental practice internationally. Training in and implementation of a motivational interviewing-informed brief intervention provides opportunities for dental nurses to facilitate behavior change improving the oral health of children at high caries risk (ISRCTN 24958829).

Elevation and spatial structure explain most surface-water isotopic variation across five Pacific Coast basins.

The stable isotope ratios of stream water can be used to trace water sources within river basins; however, drivers of variation in water isotopic spatial patterns across basins must be understood before ecologically relevant and isotopically distinct water sources can be identified and this tool efficiently applied. We measured the isotope ratios of surface-water samples collected during summer low-flow across five basins in Washington and southeast Alaska (Snoqualmie, Green, Skagit, and Wenatchee Rivers, and Cowee Creek) and compared models (isoscapes) describing the spatial variation in surface-water isotope ratios across a range of hydraulic and climatic conditions. We found strong correlations between mean watershed (MWE) elevation and surface-water isotopic ratios on the windward west side of the Cascades and in Alaska, explaining 48-90% of variation in δ18O values. Conversely, in the Wenatchee basin, located leeward of the Cascade Range, MWE alone had no predicative power. The elevation relationship and predictive isoscapes varied between basins, even those adjacent to each other. Applying spatial stream network models (SSNMs) to the Snoqualmie and Wenatchee Rivers, we found incorporating Euclidean and flow-connected spatial autocovariance improved explanatory power. SSNMs improved the accuracy of river water isoscapes in all cases; however, their utility was greater for the Wenatchee basin, where covariates explained only a small proportion of total variation. Our study provides insights into why basinscale surface-water isoscapes may vary even in adjacent basins and the importance of incorporating spatial autocorrelation in isoscapes. For determining source water contributions to downstream waters, our results indicate that surface water isoscapes should be developed for each basin of interest.

The WASh Trial: water-assisted sigmoidoscopy in the English Bowel Scope Screening Programme: study protocol for a randomized multicenter trial.

Background and study aims The English National Bowel Scope Screening Programme (BSSP) invites 55-year-olds for a one-off, unsedated flexible sigmoidoscopy (FSIG). Data from BSSP participant-reported experience studies shows 1 in 3 participants report moderate or severe discomfort. Water-assisted colonoscopy (WAS) may improve participants' comfort. The primary objective of this study is to ascertain if post-procedural participant-assessed pain is reduced in WAS compared with carbon dioxide (CO 2 ) insufflation, in invitees undergoing FSIG in BSSP. Patients and methods This is a multicenter, prospective, randomized, two-arm, single-blinded trial designed to evaluate the performance of WAS versus CO 2 insufflation in BSSP. Participants will be randomized to either CO 2 or WAS and will be asked to rate pain post-procedure. Key procedure-related data will be analyzed, including adenoma detection rates (ADR) and degree of sigmoid looping. A cost-effectiveness analysis of WAS versus CO 2 and a discrete choice experiment exploring preferences of participants for attributes of sigmoidoscopy will also be performed. Discussion This is the first trial in the United Kingdom (UK) to investigate the effects of WAS in a screening setting. If the trial shows WAS either reduces pain or increases ADR, this may result in a practice change to implement WAS in screening and non-screening endoscopic practice directly impacting on 256,000 people a year who will undergo BSSP FSIG by 2020. Trial funding came from National Institute for Health Research (NIHR) Research for Patient Benefit (RfPB) supported by the NIHR Clinical Research Network. The trial is actively recruiting. ID: 35866 ISRCTN: 81466870.

A randomised controlled trial and cost-consequence analysis of traditional and digital foot orthoses supply chains in a National Health Service setting: application to feet at risk of diabetic plantar ulceration.

BACKGROUND: Diabetic foot ulceration is a considerable cost to the NHS and foot orthotic provision is a core strategy for the management of the people with diabetes and a moderate to high risk of foot ulceration. The traditional process to produce a custom-made foot orthotic device is to use manual casting of foot shape and physical moulding of orthoses materials. Parts of this process can be undertaken using digital tools rather than manual processes with potential advantages. The aim of this trial was to provide the first comparison of a traditional orthoses supply chain to a digital supply chain over a 6 month period. The trial used plantar pressure, health status, and health service time and cost data to compare the two supply chains. METHODS: Fifty-seven participants with diabetes were randomly allocated to each supply chain. Plantar pressure data and health status (EQ5D, ICECAP) was assessed at point of supply and at six-months. The costs for orthoses and clinical services accessed by participants were assessed over the 6 months of the trial. Primary outcomes were: reduction in peak plantar pressure at the site of highest pressure, assessed for non-inferiority to current care. Secondary outcomes were: reduction in plantar pressure at foot regions identified as at risk (> 200 kPa), cost-consequence analysis (supply chain, clinician time, service use) and health status. RESULTS: At point of supply pressure reduction for the digital supply chain was non-inferior to a predefined margin and superior (p < 0.1) to the traditional supply chain, but both supply chains were inferior to the margin after 6 months. Custom-made orthoses significantly reduced pressure for at risk regions compared to a flat control (traditional - 13.85%, digital - 20.52%). The digital supply chain was more expensive (+£13.17) and required more clinician time (+ 35 min). There were no significant differences in health status or service use between supply chains. CONCLUSIONS: Custom made foot orthoses reduce pressure as expected. Given some assumptions about the cost models we used, the supply chain process adopted to produce the orthoses seems to have marginal impact on overall costs and health status. TRIAL REGISTRATION: Retrospectively registered on ISRCTN registry (ISRCTN10978940, 04/11/2015).

Randomised feasibility study to compare the use of Therabite® with wooden spatulas to relieve and prevent trismus in patients with cancer of the head and neck.

Our aim was to compare the efficacy of the Therabite® jaw motion rehabilitation system (Atos Medical) with that of wooden spatulas to relieve and prevent trismus in patients who have had radiotherapy for stage three and four oral and oropharyngeal cancer. Secondary aims were to assess the feasibility and the impact of exercise on health-related quality of life (QoL), and the use of health services after treatment. We designed a randomised, open-label, controlled, three-centre feasibility study to compare the effectiveness and cost of the Therabite® and wooden spatulas. We studied compliance with exercises and health-related QoL, assessed cost using three health economics measures, and conducted semistructured interviews with patients. Patients were randomised into two groups: the Therabite® group (n=37) and the wooden spatula group (n=34). All patients had some sense of jaw tightening before the study started. Mean mouth opening after six months increased in both groups, but the difference between the groups was not significant (p=0.39). Completion rates for the three economic measures were good. There was no significant difference between the two groups in frequency of contact with care services or in QoL. Exercises during and after radiotherapy can ameliorate trismus in patients with stage three and four oral and oropharygeal cancers, but differences between groups in efficacy, compliance, QoL, or use of hospital or community health services, were not significant.

Impact of place of residence on place of death in Wales: an observational study.

BACKGROUND: Previous research in England showed that deprivation level of a person's place of residence affects the place of death and quality of care received at the end of life. People dying in their preferred place of death has also been shown to act as an indication for high quality of end of life care services and social equality. This study expands on current research to explore the effects of deprivation and place of residence on health related choices and place of death in Wales. METHODS: We used ten years combined mortality statistics from 2005 to 2014 and Welsh Index of Multiple Deprivation rankings for each lower super output area. After accounting for the population's age, the number of deaths in Hospital, Hospice, Home, Care Home, Psychiatric Units, and Elsewhere were compared across deprivation quintiles. RESULTS: Distribution of place of death was found to be concentrated in three places - hospital (60%), home (21%) and care home (13%). Results from this study shows a high number of hospital deaths, especially for more deprived areas, despite being the least preferred place of death. CONCLUSION: This is the first Welsh study investigating place of death in relation to deprivation, which could be of major importance to academics, end of life care providers and policy makers interested in to reduce health care inequality in Wales.

Cost-effectiveness of yoga for managing musculoskeletal conditions in the workplace.

Background: Back pain and musculoskeletal conditions negatively affect the health-related quality of life (HRQL) of employees and generate substantial costs to employers. Aims: To assess the cost-effectiveness of yoga for managing musculoskeletal conditions. Methods: A randomized controlled trial evaluated an 8-week yoga programme, with a 6-month follow-up, for National Health Service (NHS) employees. Effectiveness in managing musculoskeletal conditions was assessed using repeated-measures generalized linear modelling for the Roland-Morris Disability Questionnaire (RDQ) and the Keele STarT Back Screening Tool. Cost-effectiveness was determined using area-under-the-curve linear regression for assessing HRQL from healthcare and societal perspectives. The incremental cost per quality-adjusted life year (QALY) was also calculated. Sickness absence was measured using electronic staff records at 6 months. Results: There were 151 participants. At 6 months, mean differences between groups favouring yoga were observed for RDQ [-0.63 (95% CI, -1.78, 0.48)], Keele STarT [-0.28 (95% CI, -0.97, 0.07)] and HRQL (0.016 QALY gain). From a healthcare perspective, yoga yielded an incremental cost-effectiveness ratio of £2103 per QALY. Given a willingness to pay for an additional QALY of £20 000, the probability of yoga being cost-effective was 95%. From a societal perspective, yoga was the dominant treatment compared with usual care. At 6 months, electronic staff records showed that yoga participants missed a total of 2 working days due to musculoskeletal conditions compared with 43 days for usual care participants. Conclusions: Yoga for NHS employees may enhance HRQL, reduce disability associated with back pain, lower sickness absence due to musculoskeletal conditions and is likely to be cost-effective.

The societal cost of Huntington's disease: are we underestimating the burden?

BACKGROUND AND PURPOSE: Approximately 9000 people in the UK are affected by Huntington's disease (HD). People with HD require ongoing health and social care support. There is a knowledge gap about costs of health and social care use associated with HD in the UK. This paper estimates the economic cost in the UK. METHODS: Data on UK patients for the year 2013 were extracted from the European Huntington's Disease Network REGISTRY study, a full clinical dataset, including the full medical history and medication history for patients with HD. National unit costs for the price year 2013 were applied to health and social care services. RESULTS: Data were available for 131 people. The mean annual cost per person with HD was £21 605. The largest proportion of this cost (65%) was due to informal care (£14 085). CONCLUSIONS: Informal care was the largest driver of costs across all stages of HD; thus there is a need to also consider the needs of carers when planning services for people with HD.

Use of programme budgeting and marginal analysis as a framework for resource reallocation in respiratory care in North Wales, UK.

BACKGROUND: Since the global financial crisis, UK NHS spending has reduced considerably. Respiratory care is a large cost driver for Betsi Cadwaladr University Health Board, the largest health board in Wales. Under the remit of 'prudent healthcare' championed by the Welsh Health Minister, a Programme Budgeting Marginal Analysis (PBMA) of the North Wales respiratory care pathway was conducted. METHODS: A PBMA panel of directors of medicines management, therapies finance, planning, public health and healthcare professionals used electronic voting to establish criteria for decision-making and vote on candidate interventions in which to disinvest and invest. RESULTS: A sum of £86.9 million was spent on respiratory care in 2012-13. Following extensive discussion of 13 proposed candidate interventions facilitated by a chairperson, 4 candidates received recommendations to disinvest, 7 to invest and 2 to maintain current activity. Marginal analysis prioritized mucolytics and high antibiotic prescribing as areas for disinvestment, and medicines waste management and pulmonary rehabilitation for investment. CONCLUSIONS: This exercise demonstrates the potential for health boards to use evidence-based approaches to reach potentially controversial disinvestment and investment decisions. Initial progress has begun with communication from the Medical Director in relation to the disinvestment in mucolytics prescribing and possible redirection of funding options being explored.

A cluster randomised controlled trial to investigate the effectiveness and cost effectiveness of the 'Girls Active' intervention: a study protocol.

BACKGROUND: Despite the health benefits of physical activity, data from the UK suggest that a large proportion of adolescents do not meet the recommended levels of moderate-to-vigorous physical activity (MVPA). This is particularly evident in girls, who are less active than boys across all ages and may display a faster rate of decline in physical activity throughout adolescence. The 'Girls Active' intervention has been designed by the Youth Sport Trust to target the lower participation rates observed in adolescent girls. 'Girls Active' uses peer leadership and marketing to empower girls to influence decision making in their school, develop as role models and promote physical activity to other girls. Schools are provided with training and resources to review their physical activity, sport and PE provision, culture and practices to ensure they are relevant and attractive to adolescent girls. METHODS/DESIGN: This study is a two-arm cluster randomised controlled trial (RCT) aiming to recruit 20 secondary schools. Clusters will be randomised at the school level (stratified by school size and proportion of Black and Minority Ethnic (BME) pupils) to receive either the 'Girls Active' intervention or carry on with usual practice (1:1). The 20 secondary schools will be recruited from state secondary schools within the Midlands area. We aim to recruit 80 girls aged 11-14 years in each school. Data will be collected at three time points; baseline and seven and 14 months after baseline. Our primary aim is to investigate whether 'Girls Active' leads to higher objectively measured (GENEActiv) moderate-to-vigorous physical activity in adolescent girls at 14 months after baseline assessment compared to the control group. Secondary outcomes include other objectively measured physical activity variables, adiposity, physical activity-related psychological factors and the cost-effectiveness of the 'Girls Active' intervention. A thorough process evaluation will be conducted during the course of the intervention delivery. DISCUSSION: The findings of this study will provide valuable information on whether this type of school-based approach to increasing physical activity in adolescent girls is both effective and cost-effective in the UK. TRIAL REGISTRATION: ISRCTN10688342. Registered 12 January 2015.

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

BACKGROUND: The UK has the highest rate of teenage pregnancies in Western Europe, a fifth are repeat pregnancies. Unintended conceptions can result in emotional, psychological and educational harm to teenage girls, often with enduring implications for their life chances. Babies of teenage mothers have increased mortality in their first year and increased risk of poverty, educational underachievement and unemployment later in life, with associated societal costs. METHODS AND ANALYSIS: We will conduct a streamed, mixed-methods systematic review to find and evaluate interventions designed to reduce repeat unintended teen pregnancies. OUR AIMS ARE TO IDENTIFY:  Who is at greater risk of repeat unintended pregnancies? Which interventions are effective, cost-effective, how they work, in what setting and for whom? What are the barriers and facilitators to intervention uptake? Traditional electronic database searches will be augmented by targeted searches for evidence 'clusters' and guided by an advisory group of experts and stakeholders. To address the topic's inherent complexities, we will use a highly structured, innovative and iterative approach combining methodological techniques tailored to each stream of evidence. Quantitative data will be synthesised with reference to Cochrane guidelines for public health interventions. Qualitative evidence addressing facilitators and barriers to the uptake of interventions, experience and acceptability of interventions will be synthesised thematically. We will apply the principles of realist synthesis to uncover theories and mechanisms underpinning interventions. We will conduct an integration and overarching narrative of findings authenticated by client group feedback. ETHICS AND DISSEMINATION: We will publish the complete review in 'Health Technology Assessment' and sections in specialist peer-reviewed journals. We will present at national and international conferences in the fields of public health, reproductive medicine and review methodology. Findings will be fed back to service users and practitioners via workshops run by the partner collaborators. TRAIL REGISTRATION NUMBER: PROSPERO CRD42012003168. COCHRANE REGISTRATION NUMBER: i=fertility/0068.

Cancer of Oesophagus or Gastricus - New Assessment of Technology of Endosonography (COGNATE): report of pragmatic randomised trial.

BACKGROUND: Endoscopic ultrasonography is recommended for staging gastro-oesophageal cancers, but has never been evaluated. OBJECTIVE: COGNATE (Cancer of Oesophagus or Gastricus - New Assessment of Technology of Endosonography) therefore aimed to evaluate whether adding 'endoscopic ultrasound' (EUS) to the usual staging algorithm changes treatment, improves (quality-adjusted) survival, and uses resources cost-effectively. DESIGN: Pragmatic parallel-group trial. Patients with gastro-oesophageal cancer received standard staging algorithms. Multidisciplinary teams chose provisional management plans from endoscopic mucosal resection, immediate surgery, surgery after chemotherapy, or chemotherapy and radiotherapy. We used dynamic randomisation to allocate consenting patients remotely by telephone in equal proportions between EUS and not. Thereafter we recorded changes in management plan, use of health-care resources, and three aspects of participant-reported quality of life: generic [measured by European Quality of Life - 5 Dimensions (EQ-5D)], cancer related [Functional Assessment of Cancer Therapy - General scale (FACT-G)] and condition-specific [FACT - Additional Concerns scale (FACT-AC)]. We followed participants regularly until death or the end of the trial - for between 1 and 4.5 years. We devised a quality assurance programme to maintain standards of endosonographic reporting. SETTING: Eight British hospitals, of which two - one Scottish teaching hospital and one English district general hospital - contributed 80% of participants; we combined the other six for analysis. PARTICIPANTS: Patients were eligible if they had a diagnosis of gastro-oesophageal cancer, had not started treatment, were free of metastatic disease, were fit for surgery (even if not planned) and had American Society of Anesthesiologists and World Health Organization grades of less than 3. INTERVENTIONS: Intervention group: standard staging algorithm plus EUS; control group: standard staging algorithm. MAIN OUTCOME MEASURES: Primary: quality-adjusted survival. Secondary: survival; health-related quality of life (EQ-5D, FACT-G and FACT-AC scales); changes in management plan; and complete resection rate. Although blinding participants was neither possible nor desirable, those responsible for analysis remained blind until the Trial Steering Committee had reviewed the definitive analysis. RESULTS: We randomised 223 patients, of whom 213 yielded enough data for primary analysis. EUS improved survival adjusted for generic quality of life with a hazard ratio of 0.705 [95% confidence interval (CI) 0.499 to 0.995], and crude survival with a hazard ratio of 0.706 (95% CI 0.501 to 0.996). The benefits of EUS were significantly greater for those with poor initial quality of life, but did not differ between centres. EUS reduced net use of health-care resources by £2860 (95% 'bootstrapped' CI from -£2200 to £8000). Combining benefits and savings shows that EUS is likely to be cost-effective, with 96% probability of achieving the National Institute for Health and Care Excellence criterion of costing of < £20,000 to gain a QALY. There were no serious adverse reactions attributable to EUS. EUS enhanced the management plan for many participants, increased the proportion of tumours completely resected from 80% (44 out of 55) to 91% (48 out of 53), and improved the survival of those who changed plan; although underpinning the significant differences in outcome, none of these process differences was itself significant. CONCLUSION: Endoscopic ultrasound significantly improves (quality-adjusted) survival, has the potential to reduce health-care resource use (not statistically significant) and is probably cost-effective (with 96% probability). We recommend research into the best time to evaluate new technologies. TRIAL REGISTRATION: ISRCTN1444215. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 17, No. 39. See the HTA programme website for further project information.

Micro-costing in public health economics: steps towards a standardized framework, using the incredible years toddler parenting program as a worked example.

Complex interventions, such as parenting programs, are rarely evaluated from a public sector, multi-agency perspective. An exception is the Incredible Years (IY) Basic Parenting Program; which has a growing clinical and cost-effectiveness evidence base for preventing or reducing children's conduct problems. The aim of this paper was to provide a micro-costing framework for use by future researchers, by micro-costing the 12-session IY Toddler Parenting Program from a public sector, multi-agency perspective. This micro-costing was undertaken as part of a community-based randomized controlled trial of the program in disadvantaged Flying Start areas in Wales, U.K. Program delivery costs were collected by group leader cost diaries. Training and supervision costs were recorded. Sensitivity analysis assessed the effects of a London cost weighting and group size. Costs were reported in 2008/2009 pounds sterling. Direct program initial set-up costs were £3305.73; recurrent delivery costs for the program based on eight parents attending a group were £752.63 per child, falling to £633.61 based on 10 parents. Under research contexts (with weekly supervision) delivery costs were £1509.28 per child based on eight parents, falling to £1238.94 per child based on 10 parents. When applying a London weighting, overall program costs increased in all contexts. Costs at a micro-level must be accurately calculated to conduct meaningful cost-effectiveness/cost-benefit analysis. A standardized framework for assessing costs is needed; this paper outlines a suggested framework. In prevention science it is important for decision makers to be aware of intervention costs in order to allocate scarce resources effectively.

REMCARE: reminiscence groups for people with dementia and their family caregivers - effectiveness and cost-effectiveness pragmatic multicentre randomised trial.

OBJECTIVES: The aim of the REMiniscence groups for people with dementia and their family CAREgivers (REMCARE) study was to assess the effectiveness and cost-effectiveness of joint reminiscence groups for people with dementia and their family caregivers as compared with usual care. DESIGN: A multicentre, pragmatic randomised controlled trial with two parallel arms - an intervention group and a usual-care control group - was carried out. A restricted dynamic method of randomisation was used with an overall allocation ratio of 1 : 1, restricted to ensure intervention groups of a viable size. Assessments, blind to treatment allocation, were carried out at baseline, 3 months and 10 months (primary end point). SETTING: Most participants were recruited through NHS Memory Clinics and Community Mental Health Teams for older people. Assessments were usually carried out in the person's home, and treatment groups were held in a variety of community settings. PARTICIPANTS: A total of 488 individuals (mean age 77.5 years) with mild to moderate dementia (meeting Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition criteria), who were initially living in the community, and who had a relative or other caregiver maintaining regular contact, who could act as an informant and was willing and able to participate in the intervention, were recruited to the study. Most carers were spouses (71%). A total of 350 dyads completed the study. INTERVENTIONS: The intervention consisted of joint reminiscence groups held weekly for 12 consecutive weeks, followed by monthly maintenance sessions for a further 7 months. The sessions followed a treatment manual, and were led by two trained facilitators in each centre, supported by a number of volunteers. Up to 12 dyads were invited to attend each group. MAIN OUTCOME MEASURES: The primary outcome measures were self-reported quality of life for the person with dementia and psychological distress for the carer [General Health Questionnaire-28 item version (GHQ-28)]. Secondary outcome measures included autobiographical memory and activities of daily living for the person with dementia, carer stress for the carer and mood, relationship quality and service use and costs for both parties. RESULTS: The intention-to-treat analysis identified no differences in outcome between the intervention and control conditions on primary or secondary outcomes [self-reported quality of life in Alzheimer's disease: mean difference 0.07, standard error (SE) 0.65; F = 0.48; p = 0.53]. Carers of people with dementia allocated to the reminiscence intervention reported a significant increase in anxiety on a subscale of the GHQ-28 at the 10-month end point (mean difference 1.25, SE 0.5; F = 8.28; p = 0.04). Compliance analyses suggested some benefits for people with dementia who attended more reminiscence sessions; however, carers attending more groups showed increased caregiving stress. Use of health- and social-care services was modest, with no significant difference in service use between conditions. Owing to negligible difference in quality-adjusted life-year gains (derived from European Quality of Life-5 Dimensions) between the conditions the planned full economic analysis was curtailed. CONCLUSIONS: This trial does not provide support for the effectiveness or cost-effectiveness of joint reminiscence groups for people with dementia and their carers. Although there may be some beneficial effects for people with dementia who attend sessions as planned, this must be viewed in the context of raised anxiety and stress in their carers. The reasons for these discrepant outcomes need to be explored further, and may necessitate reappraisal of the movement towards joint interventions. TRIAL REGISTRATION: Current Controlled Trials ISRCTN42430123. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 16, No. 48. See the HTA programme website for further project information.

Yoga for reducing perceived stress and back pain at work.

BACKGROUND: Stress and back pain are two key factors leading to sickness absence at work. Recent research indicates that yoga can be effective for reducing perceived stress, alleviating back pain, and improving psychological well-being. AIMS: To determine the effectiveness of a yoga-based intervention for reducing perceived stress and back pain at work. METHODS: Participants were recruited from a British local government authority and randomized into a yoga group who received one 50 min Dru Yoga session each week for 8 weeks and a 20 min DVD for home practice and a control group who received no intervention. Baseline and end-programme measurements of self-reported stress, back pain and psychological well-being were assessed with the Perceived Stress Scale, Roland Morris Disability Questionnaire and the Positive and Negative Affect Scale. RESULTS: There were 37 participants in each group. Analysis of variance and multiple linear regression showed that in comparison to the control group, the yoga group reported significant reductions in perceived stress and back pain, and a substantial improvement in psychological well-being. When compared with the control group at the end of the programme, the yoga group scores were significantly lower for perceived stress, back pain, sadness and hostility, and substantially higher for feeling self-assured, attentive and serene. CONCLUSIONS: The results indicate that a workplace yoga intervention can reduce perceived stress and back pain and improve psychological well-being. Larger randomized controlled trials are needed to determine the broader efficacy of yoga for improving workplace productivity and reducing sickness absence.

Preferences of people with diabetes for diabetic retinopathy screening: a discrete choice experiment.

AIMS: The ever-increasing prevalence of diabetes places pressure on the provision of diabetic retinopathy screening services. As the first study of its kind, we aimed to determine preferences for diabetic retinopathy screening in people with diabetes and to examine the trade-offs between frequency of screening and other service attributes. METHODS: A questionnaire including a discrete choice experiment was administered to people (n = 198) attending diabetic retinopathy screening at eight clinics across Wales, United Kingdom. The discrete choice experiment contained eight pairwise choices in which screening provision was described by five attributes: frequency of screening; travel time; results time; ability of screening to detect other changes; and explanation of results. Data were analysed using logistic regression techniques. RESULTS: We gained a response rate of 86.4% from the 198 questionnaires administered at clinics; 160 complete responses were analysed. Respondents valued four out of the five attributes [ability of screening to detect other changes (P = 0.000), explanation of results (P = 0.024), frequency of screening (P = 0.000) and travel time (P = 0.007)]. Results time was insignificant (P = 0.122). Respondents were willing to wait an additional 12, 2 and 1 month between screening tests to have a test that was able to detect additional changes, to have their results explained in person rather than by letter and to have a 15-min reduction in travel time, respectively. CONCLUSIONS: Respondents were willing to accept a longer screening interval, as long as preferences for other attributes of service provision (ability of screening to detect other changes, explanation of results and travel time) were made available.

Diabetic retinopathy screening: perspectives of people with diabetes, screening intervals and costs of attending screening.

AIMS: To obtain the views of people with diabetes about the provision of diabetic retinopathy screening services; and the interval of screening. METHODS: Between October 2009 and January 2010, people with diabetes attending diabetic retinopathy screening clinics across Wales were asked to complete a questionnaire comprising of two parts: the first asking about their health, diabetes history, demographic characteristics and views about the diabetic retinopathy screening service, and the second asking about the costs of attending the screening. RESULTS: The response rate was 40% (n = 621) from 1550 questionnaires distributed at diabetic retinopathy clinics, with 600 complete responses analysed. Respondents had a mean known duration of diabetes of 8.5 years (sd 7.8) and had attended for screening on average 3.2 times (sd 1.6) in the last 5 years. Sixty-eight per cent (n = 408) of respondents reported having their eyes screened approximately once a year. Eighty-five per cent (n = 507) felt that they should have their eyes screened every year. However, 65% (n = 390) of respondents would accept screening at 2- or 3-year intervals if medical evidence showed that it was safe. The reported personal costs incurred by respondents attending diabetic retinopathy screening were low. CONCLUSION: Our study suggests that people with diabetes undergoing diabetic retinopathy screening would accept a greater screening interval, provided that adequate clinical evidence and medical reassurance were given.

EQ-5D for the assessment of health-related quality of life and resource allocation in children: a systematic methodological review.

OBJECTIVES: EQ-5D is widely used in studies with adults as a source of generic health-related quality of life information and utility weights to inform resource allocation decisions. This methodological systematic review describes the extent to which EQ-5D has been used in the evaluation of children's health care, assesses psychometric properties, and makes recommendations for future good practice. METHODS: Systematic searches of databases and the Internet to identify studies published during 2000-2010 that either used EQ-5D with children younger than age 19 years as an outcome measure or reported psychometric data. Study characteristics, including measures and psychometric data, were extracted into tables for analysis. RESULTS: We identified 29 studies that used four versions of the EQ-5D: adult EQ-5D, EQ-5D-Y, Dutch EQ-5D child, and extended with cognitive dimension, EQ-5D+C. Twelve of 29 studies did not specify the EQ-5D version used. Existing literature lacks detail on the specific use of EQ-5D and its potential effects on findings. Version use and psychometric properties were inadequately reported. There are large gaps in current knowledge of psychometric properties across all versions when used with children. CONCLUSIONS: For reasons of comparability with resource use across adult and children's services, there are arguments for continued use of EQ-5D in studies with children. We recommend use of EQ-5D alongside children-specific quality of life measures and disease-specific measures. Researchers are encouraged to undertake methodological and philosophical analyses to better understand and improve evidence as to how adults who make decisions about resource allocation can best take account of children in decision making.

Parenting interventions: a systematic review of the economic evidence.

Conduct disorder (CD) places huge costs on the individual, family and society. Parenting programmes can reduce CD symptomatology, but economic evaluations of their cost-effectiveness are rarely undertaken. The objective of this paper was to conduct the first specific systematic review of the published economic evidence of parenting programmes as a means to support families with children with or at risk of developing CD. A systematic search of 12 electronic databases was conducted. We identified 93 papers, of which six fulfilled the inclusion criteria. The search found one review article, mainly focusing upon clinical evidence with secondary focus on cost-effectiveness, one cost-effectiveness study, two partial economic evaluations and two cost studies. The costs of group parenting programme delivery ranged from £629.00 to £3839.00. Cost-effectiveness was influenced by intervention type and delivery method, i.e. individual versus group programme. The review highlights a need for a more standardized approach towards the comparison of the cost-effectiveness of parent programmes. In future studies it may be helpful to adopt a 'complex intervention approach', exploring in detail the attribution of cause and effect, the role of socio-economic setting and ripple effects, e.g. benefits to other family members.