Process evaluation of a primary care-based type 2 diabetes remission project in the North East of England.

A type 2 diabetes remission project, Remission in Diabetes (REMI.D), funded by Sport England, was developed by stakeholders based in the North East of England and begun in early 2020. This local delivery pilot sought to tackle health inequalities by working with multiple organisations to demonstrate a way of scaling up an effective type 2 diabetes remission strategy which included both physical activity and dietary components. The intended delivery of the original project was impacted by the COVID-19 pandemic and changes were made to the project delivery in 2022. The aim of this process evaluation was to learn from the reactive decisions taken by stakeholders which altered the REMI.D project in response to the COVID-19 pandemic. Twelve stakeholders (from local authorities, secondary care, universities, NHS England commissioning, Diabetes UK, Sport England, Everyone Active and Active Partnerships) involved in the design and delivery of the intervention took part in a semi-structured interview lasting up to 60 min. Interviews were recorded and transcribed verbatim. Thematic analysis used the pre-determined 'core content' themes from the Medical Research Council and National Institute for Health Research framework for developing and evaluating complex interventions. Three topics for discussion emerged as follows: (a) lack of effective collaboration, (b) perception of change and (c) scalability of the intervention. Hierarchy within the stakeholder group initially hampered collaboration. Change was reactive as a result of the COVID-19 pandemic. Project changes reduced project sustainability and scalability but offered valuable learning about the need for explicit project theory for partnership working, co-production with service users and project flexibility for long-term health behaviour change.

App-based oral health promotion interventions on modifiable risk factors associated with early childhood caries: A systematic review.

Background: Early childhood caries (ECC) is a preventable chronic disease. Parents' knowledge and attitudes toward oral healthcare have been associated with higher caries experience in their children. Mobile apps within the context of mHealth interventions are a potential tool for raising awareness and informing parents about their children's oral health. Objectives: The aim of this systematic review was to examine the effectiveness of mobile health apps, targeted at parents and caregivers, for the prevention of ECC. Data sources: A systematic search was carried out in five scientific databases; Embase, CINAHL, MEDLINE, PsycINFO and Web of Science. Study selection and data extraction: Original studies, delivering oral health interventions to parents of children <6 years via smartphones, were included. Both quantitative and qualitative findings from the included studies were extracted. Synthesis: A convergent segregated approach was used to integrate the quantitative and qualitative evidence, followed by side-by-side display and narrative synthesis. Results: Out of 5,953 retrieved articles, five met the inclusion criteria and were included in the review. Three articles reported quantitative findings, while two reported both quantitative and qualitative findings. Four studies reported that a mobile app can be an effective tool to improve the oral health knowledge of parents/caregivers, aiding them in incorporating good oral health habits into their children's daily routines. Conclusion: This review demonstrated that oral health promotion programs delivered through mobile apps to parents could be effective in improving child oral health awareness among parents. There is a need for more high-quality studies with a large number of participants to find out which features of mHealth interventions with parents could effectively be employed to reduce the prevalence of ECC. Further studies and apps should be developed based on evidence-based behaviour change techniques and incorporate features such as gamification to increase the effectiveness and engagement of the target population. Systematic Review Registration: [https://www.crd.york.ac.uk/prospero/display_record.php?], identifier [CRD42021268331].

Co-design to deliver service improvement: What does this mean and how can we do it? A qualitative study with upper gastrointestinal cancer patients and professionals.

BACKGROUND: There is strategic objective to incorporate the principles and practice of co-design into routine service development and improvement. AIM: The aim was to explore the concept and feasibility of service co-design with patients and health professionals with regards to the upper gastrointestinal (UGI) cancer care pathway. METHODS AND RESULTS: Qualitative telephone interviews and face-to-face focus groups in one region of England. Twenty patients completed interviews. Nine patients and ten professionals formed two focus groups. Patients were referred through the urgent (two week) GP referral route and were within six months of receiving their first treatment for an UGI cancer. Professionals were working as service planners and providers of the UGI cancer care pathway. Thematic analysis was undertaken. Six themes emerged: Responsibilities and expectations, Knowledge and understanding, Valuing patient input, Building relationships, Environment for co-design activities, Impact and effectiveness. Based on the themes a checklist has been created to provide practical suggestions for both professionals and patients on approaching co-design for service improvement. CONCLUSION: This study offers policy and practice partners a clearer understanding of co-design and factors to consider when approaching co-design in real life settings.

Understanding the implementation strategy of a secondary care tobacco addiction treatment pathway (the CURE project) in England: a strategic behavioural analysis.

OBJECTIVES: The Conversation, Understand, Replace, Experts and evidence-based treatment (CURE) project implemented an evidence-based intervention that offers a combination of pharmacotherapy and behavioural support to tobacco-dependent inpatients. Understanding key characteristics of CURE's implementation strategy, and identifying areas for improvement, is important to support the roll-out of nationwide tobacco dependence services. This study aimed to (1) specify key characteristics of CURE's exiting implementation strategy and (2) develop theoretical-informed and stakeholder-informed recommendations to optimise wider roll-out. DESIGN AND METHODS: Data were collected via document review and secondary analysis of interviews with 10 healthcare professionals of a UK hospital. Intervention content was specified through behaviour change techniques (BCTs) and intervention functions within the Behaviour Change Wheel. A logic model was developed to specify CURE's implementation strategy and its mechanisms of impact. We explored the extent to which BCTs and intervention functions addressed the key theoretical domains influencing implementation using prespecified matrices. The development of recommendations was conducted over a two-round Delphi exercise. RESULTS: We identified six key theoretical domains of influences: 'environmental context and resources', 'goals', 'social professional role and identity', 'social influences', 'reinforcement' and 'skills'. The behavioural analysis identified 26 BCTs, 4 intervention functions and 4 policy categories present within the implementation strategy. The implementation strategy included half the relevant intervention functions and BCTs to target theoretical domains influencing CURE implementation, with many BCTs focusing on shaping knowledge. Recommendations to optimise content were developed following stakeholder engagement. CONCLUSIONS: CURE offers a strong foundation from which a tobacco dependence treatment model can be developed in England. The exiting strategy could be strengthened via the inclusion of more theoretically congruent BCTs, particularly relating to 'environmental context and resources'. The recommendations provide routes to optimisation that are both theoretically grounded and stakeholder informed. Future research should assess the feasibility/acceptability of these recommendations in the wider secondary-care context.

The effectiveness of e-health interventions for the treatment of overweight or obesity in children and adolescents: A systematic review and meta-analysis.

The aim of this systematic review and meta-analysis was to examine the effectiveness of e-health interventions for the treatment of children and adolescents with overweight or obesity. Databases were searched up to November 2020. Studies were randomized controlled trials where interventions were delivered via e-health (e.g., computers, tablets, and smartphones, but not phone calls). Studies should target the treatment of overweight or obesity in children or their agent of changes and report body mass index (BMI) or BMI z-score. A meta-analysis using a random-effects model was conducted. Nineteen studies met the inclusion criteria, and 60% were of high quality. The narrative review revealed variation in behavior change strategies and modes of delivery. The pooled mean reduction in BMI or BMI z-score showed evidence for a nonzero effect (standardized mean difference = -0.31, 95% confidence interval -0.49 to -0.13), with moderately high heterogeneity between studies (I2 = 74%, p < 0.001). Subgroup analysis revealed high heterogeneity in studies with a high or unclear risk of bias. E-health interventions can be effective in treating children and adolescents with overweight and obesity and should be considered by practitioners and policymakers. However, an understanding of the most effective and acceptable intervention components, long-term benefits, and sustainability should be further studied.

Barriers and facilitators to implementing the CURE stop smoking project: a qualitative study.

BACKGROUND: The Conversation, Understand, Replace, Experts and evidence-based treatment (CURE) project aims to provide a comprehensive offer of both pharmacotherapy and specialist support for tobacco dependence to all smokers admitted to hospital and after discharge. CURE was recently piloted within a single trust in Greater Manchester, with preliminary evidence suggesting this intervention may be successful in improving patient outcomes. Plans are currently underway to pilot a model based upon CURE in other sites across England. To inform implementation, we conducted a qualitative study, which aimed to identify factors influencing healthcare professionals' implementation behaviour within the pilot site. METHODS: Individual, semi-structured telephone interviews were conducted with 10 purposively sampled health professionals involved in the delivery and implementation of the CURE project pilot. Topic guides were informed by the Theoretical Domains Framework (TDF). Transcripts were analysed in line with the framework method, with data coded to TDF domains to highlight important areas of influence and then mapped to the COM-B to support future intervention development. RESULTS: Eight TDF domains were identified as important areas influencing CURE implementation; 'environmental context and resources' (physical opportunity), 'social influence' (social opportunity), 'goals', 'professional role and identity' and 'beliefs about consequences' (reflective motivation), 'reinforcement' (automatic motivation), 'skills' and 'knowledge' (psychological capability). Most domains had the potential to both hinder and/or facilitate implementation, with the exception of 'beliefs about consequences' and 'knowledge', which were highlighted as facilitators of CURE. Participants suggested that 'environmental context and resources' was the most important factor influencing implementation; with barriers most often related to challenges integrating into the wider healthcare context. CONCLUSIONS: This qualitative study identified multi-level barriers and facilitators to CURE implementation. The use of theoretical frameworks allowed for the identification of domains known to influence behaviour change, and thus can be taken forward to develop targeted interventions to support future service implementation. Future work should focus on discussing these findings with a broad range of stakeholders, to ensure resultant intervention strategies are feasible and practicable within a healthcare context. These findings complement wider evaluative work to support nationwide roll out of NHS funded tobacco dependence treatment services in acute care trusts.

Clinicians' perceived barriers and enablers to the dietary management of adults with type 2 diabetes in primary care: A systematic review.

BACKGROUND: Dietary management of type 2 diabetes is considered as a key remission and management strategy. This review explored clinicians' perceived barriers and enablers to the dietary management of adults with type 2 diabetes in primary care. METHODS: MEDLINE, EMBASE, CINAHL, PsycINFO and ASSIA were searched from 1980 to 16 June 2020. RESULTS: Of 2021 records, 14 studies met the inclusion criteria, describing the 14 domains of the refined Theoretical Domains Framework. The data synthesised to the domains of environmental context and resources, intentions and beliefs about capabilities were considered most trustworthy, closely followed by knowledge, behavioural regulation and beliefs about consequences. Two-thirds of studies cited time for staff training or patient education as major constraints to type 2 diabetes management. Clinicians also identified lack of patient engagement and poor dietary adherence as issues. Despite this, clinician confidence about giving dietary advice to patients was high. With further exploration, knowledge gaps were apparent and feelings of despondency as a result of poor outcomes were visible. CONCLUSIONS: This review revealed four clinician behaviours: (2) the perception of the dietitian; (2) the definition of a clinician qualified to give dietary advice; (3) clinician belief in dietary management as a treatment; and (4) clinician belief in a patient's capability to change dietary behaviour. These behaviours, if challenged and changed, have the potential to improve dietary management and outcomes for people with type 2 diabetes in primary care.

Identifying and exploring the self-management strategies used by childhood cancer survivors.

PURPOSE: Childhood cancer survivors (CCSs) are at increased risk of chronic health problems. Effective self-management could help CCSs cope with the challenges that accompany survivorship and reduce their risk of developing further health problems. There is little evidence about the extent to which CCSs engage with self-management and the specific strategies they use. This study aimed to identify and explore the strategies that CCSs use to manage the consequences of cancer. METHODS: Twenty-four CCSs were recruited via follow-up clinics. Participants completed a semi-structured interview which was audio-recorded and transcribed. Directed content analysis was used to identify self-reported self-management strategies and categorise them into main self-management types. RESULTS: CCSs reported 118 specific self-management strategies which fell under 20 main self-management strategy types. All CCSs reported using several main self-management strategy types and specific self-management strategies. Main strategy types used by all CCSs were "adopting a healthy lifestyle", "self-motivating", "using support", "reasoned decision-making" and "creating a healthy environment". The most common specific self-management strategies were "receiving family support" (n = 20) and "attending follow-up and screening appointments" (n = 20). CONCLUSIONS: This is the first study which has enabled CCSs to self-report the numerous strategies they employ to look after their health and well-being, contributing to a more comprehensive picture of self-management in CCSs. IMPLICATIONS FOR CANCER SURVIVORS: These findings may increase healthcare professionals' awareness of the many ways in which CCSs manage their health and is a valuable first step in the development of a supported self-management intervention for CCSs in follow-up care.

Patient experiences of the urgent cancer referral pathway-Can the NHS do better? Semi-structured interviews with patients with upper gastrointestinal cancer.

BACKGROUND: Timeliness is viewed as a key feature of health-care quality. Internationally, this is challenging. In England, cancer waiting time targets are currently not being met. For example, between 2015 and 2018 only 71% of patients with upper gastrointestinal (UGI) cancer started treatment within the recommended 62 days of referral. OBJECTIVE: We explored patients' experiences to identify areas for service improvement. DESIGN: Semi-structured interviews were conducted. SETTING AND PARTICIPANTS: Twenty patients who were referred through the urgent (two-week) GP referral route and were within six months of receiving first treatment were recruited. DATA ANALYSIS: Data from the interviews were analysed thematically. RESULTS: Four themes were developed: organization of care; diagnosis; support; and views and expectations of the NHS. Patients described cross-cutting issues such as complex and varied pathways and uncertainty about what would happen next. They felt daunted by the intensity and speed of investigations. They were presented with a recommended course of action rather than options and had little involvement in decision making. They were grateful for care, reluctant to complain and resigned to the status quo. DISCUSSION AND CONCLUSIONS: In order to meet patient needs, the NHS needs to improve communication and streamline pathways. Future cancer pathways also need to be designed to support shared decision making, be truly person-centred and informed by patient experience.

Stakeholders' perceptions and experiences of the National Health Service diabetes prevention programme in England: qualitative study with service users, intervention providers and deliverers, commissioners and referrers.

BACKGROUND: The National Health Service diabetes prevention programme in England, (NHS DPP) aims to identify people at high risk of type 2 diabetes (T2D) and offer them a face-to-face, group-based, behaviour change intervention for at least 9 months. The NHS DPP was rolled out in phases. We aimed to elicit stakeholders' perceptions and experiences of the factors influencing implementation of, and participation in, the programme during the development phase. METHODS: Individual, semi-structured telephone interviews were conducted with 50 purposively sampled stakeholders: service users (n = 20); programme commissioners (n = 7); referrers (n = 8); and intervention deliverers (n = 15). Topic guides were structured using a pragmatic, theory-informed approach. Analysis employed the framework method. RESULTS: We identified factors that influenced participation: Risk communication at referral - stakeholders identified point of referral as a window of opportunity to offer brief advice, to provide an understanding of T2D risk and information about the programme; Perceived impact of the NHS DPP - service users highlighted the positive perceived impact on their behaviour change, the peer support provided by participating in the programme, the option to involve a relative, and the 'knock on' effect on others. Service users also voiced disappointment when blood test results still identified them at high risk after the programme; and Behavioural maintenance - participants highlighted the challenges linked to behavioural maintenance (e.g. discontinuation of active support). Factors influencing implementations were also identified: Case finding - stakeholders suggested that using community involvement to identify service users could increase reach and ensure that the workload was not solely on GP practices; Adaptability: intervention deliverers acknowledged the need to tailor advice to service users' preferences and needs; Accountability - the need to acknowledge who was responsible for what at different stages of the NHS DPP pathway; and Fidelity - stakeholders described procedures involved in monitoring service users' satisfaction, outcome data collection and quality assurance assessments. CONCLUSIONS: The NHS DPP offers an evidence-informed behavioural intervention for T2D prevention. Better risk communication specification could ensure consistency at the referral stage and improve participation in the NHS DPP intervention. Cultural adaptations and outreach strategies could ensure the NHS DPP contributes to reducing health inequalities.

Management information systems for community based interventions to improve health: qualitative study of stakeholder perspectives.

BACKGROUND: Community based providers are well place to deliver behavioural interventions to improve health. Good project management and reliable outcome data are needed to efficiently deliver and evaluate such interventions, and Management information systems (MIS) can facilitate these processes. We explored stakeholders perspectives on the use of MIS in community based behavioural interventions. METHODS: Stakeholders, purposively selected to provide a range of MIS experience in the delivery of community based behavioural interventions to improve health (public health commissioners, intervention service managers, project officers, health researchers and MIS designers), were invited to participate in individual semi-structured interviews. We used a topic guide and encouraged stakeholders to reflect on their experiences.: Interviews were recorded, transcribed and analysed using five steps of Framework analysis. We applied an agreed coding framework and completed the interviews when no new themes emerged. RESULTS: We interviewed 15 stakeholders. Key themes identified were: (i) MIS access; (ii) data and its function; (iii) MIS development and updating. Within these themes the different experiences, needs, use, training and expertise of stakeholders and the variation and potential of MIS were evidenced. Interviews advised the need to involve stakeholders in MIS design and development, build-in flexibility to accommodate MIS refinement and build on effective MIS. CONCLUSIONS: Findings advised involving stakeholders, early in the design process. Designs should build on existing MIS of proven utility and ensure flexibility in the design, to incorporate adaptations and ongoing system development in response to early MIS use and evolving stakeholder needs.

Barriers to and Facilitators of Implementing Programs for Return to Work (RTW) of Cancer Survivors in Four European Countries: A Qualitative Study.

Purpose Implementation of return to work (RTW) programs for cancer survivors has proved to be challenging. The purpose of our study was to gather experiences about barriers to and facilitators of implementing RTW programs for cancer survivors in four European countries. Methods Separate multidisciplinary focus groups were held in Belgium (n = 8), the Netherlands (n = 8), Ireland (n = 6), and UK (n = 4) in 2017 and included among others a physician, and a representative of an employer, a cancer society, and the government. Primary focus of thematic analysis was what could be done to improve the implementation of RTW programs for cancer survivors. Analysis used the 'Arena in work disability prevention model' as the conceptual framework. Results Many barriers to and facilitators of implementing RTW programs for cancer survivors were described including the personal, workplace, healthcare and legislative system as well as the overall societal and political context. That is, for example cooperation between stakeholders, time, money and ability issues at the workplace, and insufficient/inadequate legislation. Insufficient knowledge of cancer and its implications for work was identified as an overarching theme in all countries leading to stigma, misconceptions and lack of communication. This was mentioned in relation to the workplace, personal and healthcare system, and in the overall societal context. Conclusions Results indicate that a prerequisite for implementing RTW programs is raising sufficient knowledge regarding cancer and its implications for work. Greater knowledge could be a first step to better implement RTW programs which may result in better supporting cancer survivors with their RTW .

Using evidence-based guidelines to inform service provision: a structured mapping exercise within the National Health Service Diabetes Prevention Programme in England.

OBJECTIVE: The National Health Service (NHS) in England planned a national diabetes prevention programme (NHS DPP) with phased implementation. Evidence-based guidelines and service specifications support efficient and effective translation of research into practice. We aimed to evaluate the use of a structured mapping exercise to appraise how evidence, service specification and early phase practice could inform recommendations to guide subsequent implementation of the NHS DPP. RESULTS: The mapping exercise facilitated comparison and appraisal of key components from different documentary sources (evidence-based NICE guidelines, service specification, and provider documents). Key components were categorised into (A) pathways into programmes, (B) intervention content (C) inequalities and (D) quality assurance and staff training. We identified where key components were the same (accordance), where they varied (discrepancies) and where they were lacking (discontinuities), across the documentary sources. For example there was discrepancy in intervention duration and discontinuity in intervention enrolment procedures. This mapping exercise was useful to compare the fidelity in translation of evidence-based guidance into service specification and programme documents, thus identifying where future service implementation might be improved. This method may be applicable for use with other health conditions where research evidence requires translation into real world population programmes.

Problems recruiting and retaining postnatal women to a pilot randomised controlled trial of a web-delivered weight loss intervention.

OBJECTIVE: This paper highlights recruitment and retention problems identified during a pilot randomised controlled trial and process evaluation. The pilot trial aimed to evaluate the feasibility and acceptability of a web-delivered weight loss intervention for postnatal women and associated trial protocol. RESULTS: General practice database searches revealed low rates of eligible postnatal women per practice. 16 (10%) of the 168 identified women were recruited and randomised, seven to the intervention and nine to the control. 57% (4/7) of the intervention women completed 3 month follow-up measurements in comparison to 56% (5/9) in the control group. By 12 months, retention in the intervention group was 43% (3/7), with 2/7 women active on the website, in comparison to 44% (4/9) of the control group. Interview findings revealed the web as an acceptable method for delivery of the intervention, with the suggestion of an addition of a mobile application. Alternative recruitment strategies, using health visitor appointments, midwifery departments or mother and baby/toddler groups, should be explored. Greater involvement of potential users should enable better recruitment methods to be developed. Trial registration ISRCTN: ISRCTN48086713, Registered 26 October 2012.

NHS Diabetes Prevention Programme in England: formative evaluation of the programme in early phase implementation.

OBJECTIVES: Evaluation of the demonstrator phase and first wave roll-out of the National Health Service (NHS) Diabetes Prevention Programme (DPP) in England. To examine: (1) intervention design, provision and fidelity assessment procedures; (2) risk assessment and recruitment pathways and (3) data collection for monitoring and evaluation. To provide recommendations informing decision makers on programme quality, improvements and future evaluation. DESIGN: We reviewed programme documents, mapping against the NHS DPP specification and National Institute for Health and Care Excellence (NICE) public health guideline: Type 2 diabetes (T2D) prevention in people at high risk (PH38), conducted qualitative research using individual interviews and focus group discussions with stakeholders and examined recruitment, fidelity and data collection procedures. SETTING: Seven NHS DPP demonstrator sites and, subsequently, 27 first wave areas across England. INTERVENTIONS: Intensive behavioural intervention with weight loss, diet and physical activity goals. The national programme specifies at least 13 sessions over 9 months, delivered face to face to groups of 15-20 adults with non-diabetic hyperglycaemia, mainly recruited from primary care and NHS Health Checks. PARTICIPANTS: Participants for qualitative research were purposively sampled to provide a spread of stakeholder experience. Documents for review were provided via the NHS DPP Management Group. FINDINGS: The NHS DPP specification reflected current evidence with a clear framework for service provision. Providers, with national capacity to deliver, supplied intervention plans compliant with this framework. Stakeholders highlighted limitations in fidelity assessment and recruitment and retention challenges, especially in reach and equity, that could adversely impact on implementation. Risk assessment for first wave eligibility differed from NICE guidance. CONCLUSIONS: The NHS DPP provides an evidence-based behavioural intervention for prevention of T2D in adults at high risk, with capacity to deliver nationally. Framework specification allows for balance between consistency and contextual variation in intervention delivery, with session details devolved to providers. Limitations in fidelity assurance, data collection procedures and recruitment issues could adversely impact on intervention effectiveness and restrict evaluation.

Web-Based Weight Loss Intervention for Men With Type 2 Diabetes: Pilot Randomized Controlled Trial.

BACKGROUND: Rising obesity levels remain a major public health concern due to the clear link with several comorbidities such as diabetes. Diabetes now affects 6% of the UK population. Modest weight loss of 5% to 10% has been shown to be associated with significant reductions in blood sugar, lipid, and blood pressure levels. Men have been shown to be attracted to programs that do not require extensive face-to-face time commitments, illustrating the potential audience available for health behavior change via the Web. OBJECTIVE: The objective of our study was to evaluate the feasibility and acceptability of a Web-based weight loss intervention in men with type 2 diabetes. METHODS: We conducted a pilot, parallel 2-arm, individually randomized controlled trial with embedded process evaluation. Participants were randomly assigned in a one-to-one ratio to the usual care group or the 12-month Web-based weight loss intervention, including dietitian and exercise expert feedback. Face-to-face recruitment and assessment were performed by the researcher unblinded. Data collected included weight, height, body mass index (BMI), and waist circumference, together with an audit trail of eligibility, recruitment, retention, and adherence rates. A process evaluation (website use data and qualitative interviews) monitored adherence, acceptability, and feasibility of the intervention. RESULTS: General practice database searches achieved the recruitment target (n=61) for the population of men with type 2 diabetes, of whom 66% (40/61) completed 3-month follow-up measurements. By 12 months, the retention rate was 52% (32/61), with 12 of the 33 men allocated to the intervention group still active on the website. The intervention was seen as acceptable by the majority of participants. We gained insights about acceptability and use of the website from the parallel process evaluation. CONCLUSIONS: Recruitment to the Web-based weight loss intervention was successful. Results are descriptive, but there were positive indications of increased weight loss (in kilograms and as a percentage), and reduced waist circumference and BMI for the intervention group from 3 to 12 months, in comparison with control. This research adds to the evidence base in relation to incorporating a Web-based weight loss intervention within the UK National Health Service (NHS). NHS weight loss services are struggling to provide sufficient referrals. Therefore, alternative modes of delivery, with the potential to reduce health professional input and time per patient while still enabling individual and tailored care, need to be investigated to identify whether they can be effective and thus benefit the NHS. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN): 48086713; http://www.isrctn.com/ISRCTN48086713 (Archived by WebCite at http://www.webcitation.org/6rO4xSlhI).