Background: Adapting interventions that have worked elsewhere can save resources associated with developing new interventions for each specific context. While a developing body of evidence shows benefits of adapted interventions compared with interventions transported without adaptation, there are also examples of interventions which have been extensively adapted, yet have not worked in the new context. Decisions on when, to what extent, and how to adapt interventions therefore are not straightforward, particularly when conceptualising intervention effects as contingent upon contextual interactions in complex systems. No guidance currently addresses these questions comprehensively. To inform development of an overarching guidance on adaptation of complex population health interventions, this systematic review synthesises the content of the existing guidance papers. Methods: We searched for papers published between January 2000 and October 2018 in 7 bibliographic databases. We used citation tracking and contacted authors and experts to locate further papers. We double screened all the identified records. We extracted data into the following categories: descriptive information, key concepts and definitions, rationale for adaptation, aspects of adaptation, process of adaptation, evaluating and reporting adapted interventions. Data extraction was conducted independently by two reviewers, and retrieved data were synthesised thematically within pre-specified and emergent categories. Results: We retrieved 6694 unique records. Thirty-eight papers were included in the review representing 35 sources of guidance. Most papers were developed in the USA in the context of implementing evidence-informed interventions among different population groups within the country, such as minority populations. We found much agreement on how the papers defined key concepts, aims, and procedures of adaptation, including involvement of key stakeholders, but also identified gaps in scope, conceptualisation, and operationalisation in several categories. Conclusions: Our review found limitations that should be addressed in future guidance on adaptation. Specifically, future guidance needs to be reflective of adaptations in the context of transferring interventions across countries, including macro- (e.g. national-) level interventions, better theorise the role of intervention mechanisms and contextual interactions in the replicability of effects and accordingly conceptualise key concepts, such as fidelity to intervention functions, and finally, suggest evidence-informed strategies for adaptation re-evaluation and reporting. Trial registration: PROSPERO 2018, CRD42018112714.

Evaluations of complex interventions in public health are frequently undermined by problems that can be identified before the effectiveness study stage. Exploratory studies, often termed pilot and feasibility studies, are a key step in assessing the feasibility and value of progressing to an effectiveness study. Such studies can provide vital information to support more robust evaluations, thereby reducing costs and minimising potential harms of the intervention. This systematic review forms the first phase of a wider project to address the need for stand-alone guidance for public health researchers on designing and conducting exploratory studies. The review objectives were to identify and examine existing recommendations concerning when such studies should be undertaken, questions they should answer, suitable methods, criteria for deciding whether to progress to an effectiveness study and appropriate reporting. We searched for published and unpublished guidance reported between January 2000 and November 2016 via bibliographic databases, websites, citation tracking and expert recommendations. Included papers were thematically synthesized. The search retrieved 4095 unique records. Thirty papers were included, representing 25 unique sources of guidance/recommendations. Eight themes were identified: pre-requisites for conducting an exploratory study, nomenclature, guidance for intervention assessment, guidance surrounding any future evaluation study design, flexible versus fixed design, progression criteria to a future evaluation study, stakeholder involvement and reporting of exploratory studies. Exploratory studies were described as being concerned with the intervention content, the future evaluation design or both. However, the nomenclature and endorsed methods underpinning these aims were inconsistent across papers. There was little guidance on what should precede or follow an exploratory study and decision-making surrounding this. Existing recommendations are inconsistent concerning the aims, designs and conduct of exploratory studies, and guidance is lacking on the evidence needed to inform when to proceed to an effectiveness study. PROSPERO 2016, CRD42016047843

Objectives To examine whether during a period of limited e-cigarette regulation and rapid growth in their use, smoking began to become renormalised among young people. Design Interrupted time-series analysis of repeated cross-sectional time-series data. Setting Great Britain Participants 248 324 young people aged approximately 13 and 15 years, from three national surveys during the years 1998–2015. Intervention Unregulated growth of e-cigarette use (following the year 2010, until 2015). Outcome measures Primary outcomes were prevalence of self-reported ever smoking and regular smoking. Secondary outcomes were attitudes towards smoking. Tertiary outcomes were ever use of cannabis and alcohol. Results In final models, no significant change was detected in the pre-existing trend for ever smoking (OR 1.01, CI 0.99 to 1.03). There was a marginally significant slowing in the rate of decline for regular smoking (OR 1.04, CI 1.00 to 1.08), accompanied by a larger slowing in the rate of decline of cannabis use (OR 1.21, CI 1.18 to 1.25) and alcohol use (OR 1.17, CI 1.14 to 1.19). In all models and subgroup analyses for smoking attitudes, an increased rate of decline was observed after 2010 (OR 0.88, CI 0.86 to 0.90). Models were robust to sensitivity analyses. Conclusions There was a marginal slowing in the decline in regular smoking during the period following 2010, when e-cigarettes were emerging but relatively unregulated. However, these patterns were not unique to tobacco use and the decline in the acceptability of smoking behaviour among youth accelerated during this time. These analyses provide little evidence that renormalisation of youth smoking was occurring during a period of rapid growth and limited regulation of e-cigarettes from 2011 to 2015. Trial registration number Research registry number: researchregistry4336

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: Exercise referral schemes are recommended for patients with health conditions or risk factors. There is evidence for the initial effectiveness and cost-effectiveness of such schemes for increasing physical activity, but effects often diminish over time. Techniques such as goal setting, self-monitoring and personalised feedback may support motivation for physical activity and maintenance of effects. Use of wearable technologies could provide an opportunity to integrate motivational techniques into exercise schemes. However, little is known about acceptability to exercise referral populations, or implementation feasibility within exercise referral services. Objective: This study aimed to determine the feasibility and acceptability of implementing an activity monitoring device within the Welsh National Exercise Referral Scheme, to inform a decision on whether and how to proceed to an effectiveness trial. Methods: Pilot randomized controlled trial with embedded mixed-methods process evaluation and exploratory economic analysis. Adults (N=156) were randomized to intervention (plus usual practice) (n=88) or usual practice only (n=68). Usual practice was a 16-week structured exercise programme. The intervention group additionally received an accelerometry-based activity monitor (MyWellnessKey) and associated web platform (MyWellnessCloud). Primary outcomes were predefined progression criteria assessing acceptability and feasibility of the intervention and proposed evaluation. Postal questionnaires were completed at baseline (time 0: T0), 16 weeks after T0 (T1), and 12 months after T0 (T2). Routine data were accessed at the same time-points. A subsample of intervention participants and scheme staff were interviewed following initiation of intervention delivery and at the end of the study. Results: Participants were on average 56.6 (SD 16.3) years old and mostly female (101/156) and white (150/156). Only two of five progression criteria were met; recruitment and randomisation methods were acceptable to participants and contamination was low. However, recruitment and retention rates (11.3% and 67.3% respectively) fell substantially short of target criteria (20% and 80%), and disproportionally recruited those from the least deprived quintile. Only 57.4% of intervention participants reported receipt of the intervention (below the 80% progression threshold). Less than half reported the intervention to be acceptable in the T2 questionnaire. Participant and staff interviews revealed barriers to intervention delivery and engagement related to the device design which impacted uptake and context-specific technological challenges which made it difficult to integrate the technology into the service. Routinely collected health economic measures had substantial missing data, suggesting other methods for collecting these should be used in future. Conclusions: To our knowledge, this is the first study to evaluate short- and long-term feasibility and acceptability of integrating wearable technologies into community-based exercise referral schemes. The findings highlight some device- and context-specific barriers to doing this in routine practice, with typical exercise referral populations. Key criteria for progression to a full scale evaluation were not met. Clinical Trial: The trial is registered with the International Standard Randomised Control Trial Number Register (ISRCTN85785652).

Transition between primary and secondary school represents an important milestone in young people’s development. While most young people look forward to this transition, it is a source of anxiety for many. Drawing on a nationally representative survey of 2218 children in 73 schools in Wales, this study aimed to understand the extent to which 10–11 year old children worried about and/or looked forward to their imminent transition to secondary school, the things they worried about and/or looked forward to, and how feelings about transition differed by socioeconomic status, as well as by emotional and behavioural difficulties. About a third of children reported being quite or very worried about transition to secondary school, while approximately two-thirds reported looking forward to it quite a bit or very much. These items were only moderately correlated, with many children both looking forward to and worrying about transition, or neither. Major sources of worry about transition centred around bullying and impact on existing friendships, while forming new friendships or joining existing friends in their new school were key things children looked forward to. Children from poorer backgrounds, attending poorer schools and reporting more emotional difficulties were significantly more likely to report worries about transition. Children from poorer families, and children reporting more emotional difficulties and behavioural difficulties, were less likely to look forward to transition. Interventions to support children in transition to secondary school need to be sensitive to the needs of children from poorer backgrounds and children with mental health difficulties.

Addressing complex public health problems, such as smoking, obesity and mental health, requires complex, often multilevel, interventions. Given the costs associated with delivering such interventions and the possibility of unanticipated harm, they need to be evaluated using the most robust methods available. It is important, where possible, that public health interventions and their proposed evaluation designs are optimised prior to being subject to an expensive evaluation of their effectiveness, through rigorous assessment of their feasibility.1 Consequently, a growing number of exploratory studies (ie, studies intended to generate the evidence needed to decide whether and how to proceed with a full-scale evaluation, also (inconsistently) referred to as ‘pilot’ or ‘feasibility’ studies) are being conducted. These generally have one, or both, of the following objectives: to optimise or assess the (1) feasibility of the intervention or (2) design of the full-scale effectiveness evaluation. However, conflicting guidance exists regarding what exploratory studies should be called, what they should achieve, what they should entail, whether and how they should determine progression to future studies and how they should be reported.2 3 This presents a challenge for researchers in designing and conducting exploratory studies, and for peer reviewers and funders in judging the merits of research proposals and outputs. This paper briefly discusses these issues, before describing current work funded by the Medical Research Council (MRC)/National Institute of Health Research (NIHR) Methodology Research Programme to develop GUidance for Exploratory STudies of complex public health interventions (henceforth referred to as the GUEST study). There is increasing recognition that pressure to identify effective interventions has led to premature commissioning of large-scale evaluation trials of poorly developed interventions, wasting finite resource.1 4 In the development of pharmaceuticals, over 80% fail to reach ‘Phase III’ effectiveness trials, even after considerable investment.5 Yet, with public health …