Development of a framework for the co-production and prototyping of public health interventions.

BACKGROUND: Existing guidance for developing public health interventions does not provide information for researchers about how to work with intervention providers to co-produce and prototype the content and delivery of new interventions prior to evaluation. The ASSIST + Frank study aimed to adapt an existing effective peer-led smoking prevention intervention (ASSIST), integrating new content from the UK drug education resource Talk to Frank ( www.talktofrank.com ) to co-produce two new school-based peer-led drug prevention interventions. A three-stage framework was tested to adapt and develop intervention content and delivery methods in collaboration with key stakeholders to facilitate implementation. METHODS: The three stages of the framework were: 1) Evidence review and stakeholder consultation; 2) Co-production; 3) Prototyping. During stage 1, six focus groups, 12 consultations, five interviews, and nine observations of intervention delivery were conducted with key stakeholders (e.g. Public Health Wales [PHW] ASSIST delivery team, teachers, school students, health professionals). During stage 2, an intervention development group consisting of members of the research team and the PHW ASSIST delivery team was established to adapt existing, and co-produce new, intervention activities. In stage 3, intervention training and content were iteratively prototyped using process data on fidelity and acceptability to key stakeholders. Stages 2 and 3 took the form of an action-research process involving a series of face-to-face meetings, email exchanges, observations, and training sessions. RESULTS: Utilising the three-stage framework, we co-produced and tested intervention content and delivery methods for the two interventions over a period of 18 months involving external partners. New and adapted intervention activities, as well as refinements in content, the format of delivery, timing and sequencing of activities, and training manuals resulted from this process. The involvement of intervention delivery staff, participants and teachers shaped the content and format of the interventions, as well as supporting rapid prototyping in context at the final stage. CONCLUSIONS: This three-stage framework extends current guidance on intervention development by providing step-by-step instructions for co-producing and prototyping an intervention's content and delivery processes prior to piloting and formal evaluation. This framework enhances existing guidance and could be transferred to co-produce and prototype other public health interventions. TRIAL REGISTRATION: ISRCTN14415936 , registered retrospectively on 05 November 2014.

Multilevel population-based cross-sectional study examining school substance-misuse policy and the use of cannabis, mephedrone and novel psychoactive substances among students aged 11-16 years in schools in Wales.

OBJECTIVES: To examine whether young peoples' risk of cannabis, mephedrone and novel psychoactive substances (NPS) use is associated with school substance-misuse policy. DESIGN: A cross-sectional survey of secondary school students combined with a School Environment Questionnaire and independently coded school substance-misuse policies (2015/6). SETTING: 66 secondary schools in Wales. PARTICIPANTS: Students aged 11-16 years (n=18 939). RESULTS: The prevalence of lifetime, past 30-day and daily cannabis use was 4.8%, 2.6% and 0.7%, respectively; lifetime prevalence of mephedrone use was 1.1% and NPS use was 1.5%. Across 66 schools, 95.5% (n=63) reported having a substance-misuse policy, 93.9% (n=62) reported having a referral pathway for drug using students, such that we were insufficiently powered to undertake an analysis. We found little evidence of a beneficial association between lifetime cannabis use and involving students in policy development including student council consultation (OR=1.24, 95% CI 0.89 to 1.73), other student consultation (OR=1.42, 95% CI 0.94 to 2.14) or with the use of isolation (OR=0.98, 95% CI 0.67 to 1.43), with similar results for cannabis use in past 30 days, daily and the lifetime use of mephedrone and NPS. The School Environment Questionnaires found that 39.4% (n=26) schools reported no student involvement in policy development, 42.4% (n=28) reported student council consultation, 18.2% (n=12) used other student consultations and 9.7% (n=3) mentioned isolation. The independently coded content of policies found that no school policy recommended abstinence, one mentioned methods on harm minimisation, 16.1% (n=5) policies mentioned student involvement and 9.7% (n=3) mentioned isolation. CONCLUSIONS: Policy development involving students is widely recommended, but we found no beneficial associations between student involvement in policy development and student drug use. This paper has highlighted the need for further contextual understanding around the policy-development process and how schools manage drug misuse.

Cognitive behaviour therapy for non-cardiac pain in the chest (COPIC): a multicentre randomized controlled trial with economic evaluation.

BACKGROUND: Most patients with chest pain have nothing wrong with their cardiac function. Psychological forms of treatment for this condition are more likely to be successful than others. METHODS/DESIGN: A two-arm parallel controlled randomized trial of standard care versus a modified form of cognitive behaviour therapy for chest pain (CBT-CP) in patients who have attended emergency hospital services. Inclusion criteria include (i) emergency attendance more than once in the previous year with chest pain when no physical pathology has been found, (ii) aged between 16 and 75, (iii) signed consent to take part in the study. Exclusion criteria are (i) under current psychiatric care, (ii) those who have had new psychotropic drugs prescribed within the last two months, (iii) are receiving or about to receive a formal psychological treatment. Those satisfying these criteria will be randomized to 4-10 sessions of CBT-CP or to continue with standard care. Participants are randomized using a remote web-based system using permuted stacked blocks stratified by study centre. Assessment is carried out at baseline by researchers subsequently masked to allocation and at 6 months and 1 year after randomization. The primary outcome is the Health Anxiety Inventory score at 6 months, and secondary outcomes are generalised anxiety and depressive symptoms, the Lucock Health Anxiety Questionnaire adapted for chest pain, visual analogue scales for chest pain and discomfort (Inskip Scale), the Schedule for Evaluating Persistent Symptoms (SEPS), health related quality of life, social functioning and medical resource usage. Intention to treat analyses will be carried out with clinical and functioning data, and a cost-utility analysis will compare differences in total costs and differences in quality of life using QALYs derived from the EQ-5D. The data will also be linked to another parallel study in New Zealand where 126 patients with the same inclusion criteria have been treated in a similar trial; the form of analysis of the combined data has yet to be determined. DISCUSSION: The morbidity and costs of non-cardiac chest pain are substantial and if a simple psychological treatment given by health professionals working in medical departments is beneficial it should prove to be of great value. Combining data with a similar study in New Zealand is an additional asset. TRIAL REGISTRATION: ISRCTN14711101 (registered 05/03/2015).