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.

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.

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.

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.

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.

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.

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.

Incredible Years parent training support for foster carers in Wales: a multi-centre feasibility study.

BACKGROUND: the incidence of conduct disorder in young children is 10% in the general population and 37% among fostered children. Up to 40% of untreated children diagnosed with conduct disorder develop problems later in life including drug misuse, criminal and violent behaviour. There are more than 80,000 looked after children in the UK, with 5000 in Wales. Challenging child behaviour is the main reason for placement breakdown and has huge cost implications as challenging children cost up to 10 times more in service use than children without conduct disorder. The Incredible Years (IY) evidence-based parenting programme is an effective, low cost solution in improving child behaviour and social competence in 'conventional' families and thus has the potential to support foster carers in managing difficult behaviours. Our main aims were to establish: • The feasibility of delivery and the effectiveness of the IY parenting programme in supporting carers in managing difficult behaviour in looked after children. • Service use costs for foster carers and looked after child. METHODS: This was a 12-month trial platform study with 46 foster carers in three authorities in Wales. Carers were allocated 2:1 intervention to waiting-list control. Validated measures were used to assess 'parenting' competency, carers' depression levels, child behaviour and service use. Measures were administered at baseline and 6-month follow-up. Intervention carers received the programme between baseline and follow-up. RESULTS: Analyses showed a significant reduction in child problem behaviour and improvement in carers' depression levels for intervention families at follow-up, compared with control. Unexpectedly, there was a significant improvement in control carers' self-reported 'parenting' strategies. Special education was the greatest service cost for looked after children. CONCLUSIONS: Initial foster carer training could incorporate the IY programme to support carers in establishing positive relationships and managing difficult child behaviour. Programme participation may lead to reduced service use and improved placement stability.

Diabetic retinopathy screening: a systematic review of the economic evidence.

This paper systematically reviews the published literature on the economic evidence of diabetic retinopathy screening. Twenty-nine electronic databases were searched for studies published between 1998 and 2008. Internet searches were carried out and reference lists of key studies were hand searched for relevant articles. The key search terms used were 'diabetic retinopathy', 'screening', 'economic' and 'cost'. The search identified 416 papers of which 21 fulfilled the inclusion criteria, comprising nine cost-effectiveness studies, one cost analysis, one cost-minimization analysis, four cost-utility analyses and six reviews. Eleven of the included studies used economic modelling techniques and/or computer simulation to assess screening strategies. To date, the economic evaluation literature on diabetic retinopathy screening has focused on four key questions: the overall cost-effectiveness of ophthalmic care; the cost-effectiveness of systematic vs. opportunistic screening; how screening should be organized and delivered; and how often people should be screened. Systematic screening for diabetic retinopathy is cost-effective in terms of sight years preserved compared with no screening. Digital photography with telemedicine links has the potential to deliver cost-effective, accessible screening to rural, remote and hard-to-reach populations. Variation in compliance rates, age of onset of diabetes, glycaemic control and screening sensitivities influence the cost-effectiveness of screening programmes and are important sources of uncertainty in relation to the issue of optimal screening intervals. There is controversy in relation to the economic evidence on optimal screening intervals. Further research is needed to address the issue of optimal screening interval, the opportunities for targeted screening to reflect relative risk and the effect of different screening intervals on attendance or compliance by patients.

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).

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).

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.

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.

Additional therapy for young children with spastic cerebral palsy: a randomised controlled trial.

OBJECTIVES: To investigate whether, in the short and medium term, additional support by (a) a physiotherapy assistant improved physical function in young children with spastic cerebral palsy and (b) a family support worker improved family functioning. DESIGN: This was a multi-centre randomised controlled trial (RCT) with blinded assessments and a cost-effectiveness analysis. The children studied had spastic cerebral palsy that was the consequence of perinatal adversity. All were less than 4 years old on entry to the study. SETTING: In the child development centre and in the home. PARTICIPANTS: Seventy-six families completed the intervention period. Forty-three families were reassessed 6 months after the end of the intervention and 34 of these after a further 6-month period. INTERVENTIONS: Randomisation was to: (a) a group who received extra physiotherapy from a physiotherapy assistant; (b) a group who received standard physiotherapy; and (c) a group where the child received standard physiotherapy and the family was also visited by a family support worker. Children in all groups continued to receive standard physiotherapy in addition to the study interventions. MAIN OUTCOME MEASURES: The child outcome measures were motor functioning, developmental status and adaptive functioning. The family outcome measures were self-reported maternal stress, level of family needs and parental satisfaction. RESULTS: There was no evidence that additional physical therapy for 1 hour per week for 6 months by a physiotherapy assistant improved any child outcome measure in the short or medium term. Intervention by a family support worker did not have a clinically significant effect on parental stress or family needs. Over the 6-month period the total cost of services for each child ranged from 250 pounds to 6750 pounds, with higher costs associated with children with more severe impairments. No significant relationship was found between measures of intensity of services received by the children and families and the main outcome measures. Low-functioning children, in terms of both motor and cognitive function, were more likely to receive more services in terms of range and frequency. Parents generally reported high satisfaction ratings after all interventions and some stated that the interventions had benefited the child and/or the family. There was therefore a discrepancy between the perceptions of these parents and the objective, quantitative measurements. The family support workers identified a small number of families who were experiencing considerable family problems, but who had not been referred for appropriate support by any other agency. CONCLUSIONS: The findings of this study provide support for the current literature that there was no evidence that additional intervention (in this case by a physiotherapy assistant or family support worker) helped the motor or general development of young children with spastic cerebral palsy. Nor was there any quantitative evidence that providing extra family support helped levels of parental stress and family needs. The implication was that the provision of extra physical therapy does not necessarily improve the motor function of a young child with cerebral palsy and additional family support should not automatically be assumed to be beneficial. In addition, no significant association was found between the intensity of the local services provided and any outcome measure, other than a slight association with lowered family needs. The provision of local services was related to the severity of the child's impairments and not to family difficulties. A small group of families with complex family problems needed more service input. There was a wide range in the costs of services. Research is needed to examine what 'sufficient' levels of provision or therapy might be for which children and which families. A time series of different levels of input and outcomes would provide valuable information for practitioners. It is also recommended that future assessments of therapies of this type adopt a similar multifaceted approach, which is likely to be more suitable than a simple RCT for the evaluation of clinical interventions where the effects are complex. The most appropriate measures of outcome should be used, including assessment of provision of information and emotional support for families.