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.

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.

Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial.

BACKGROUND: Type 2 diabetes is a chronic disorder that requires lifelong treatment. We aimed to assess whether intensive weight management within routine primary care would achieve remission of type 2 diabetes. METHODS: We did this open-label, cluster-randomised trial (DiRECT) at 49 primary care practices in Scotland and the Tyneside region of England. Practices were randomly assigned (1:1), via a computer-generated list, to provide either a weight management programme (intervention) or best-practice care by guidelines (control), with stratification for study site (Tyneside or Scotland) and practice list size (>5700 or ≤5700). Participants, carers, and research assistants who collected outcome data were aware of group allocation; however, allocation was concealed from the study statistician. We recruited individuals aged 20-65 years who had been diagnosed with type 2 diabetes within the past 6 years, had a body-mass index of 27-45 kg/m2, and were not receiving insulin. The intervention comprised withdrawal of antidiabetic and antihypertensive drugs, total diet replacement (825-853 kcal/day formula diet for 3-5 months), stepped food reintroduction (2-8 weeks), and structured support for long-term weight loss maintenance. Co-primary outcomes were weight loss of 15 kg or more, and remission of diabetes, defined as glycated haemoglobin (HbA1c) of less than 6·5% (<48 mmol/mol) after at least 2 months off all antidiabetic medications, from baseline to 12 months. These outcomes were analysed hierarchically. This trial is registered with the ISRCTN registry, number 03267836. FINDINGS: Between July 25, 2014, and Aug 5, 2017, we recruited 306 individuals from 49 intervention (n=23) and control (n=26) general practices; 149 participants per group comprised the intention-to-treat population. At 12 months, we recorded weight loss of 15 kg or more in 36 (24%) participants in the intervention group and no participants in the control group (p<0·0001). Diabetes remission was achieved in 68 (46%) participants in the intervention group and six (4%) participants in the control group (odds ratio 19·7, 95% CI 7·8-49·8; p<0·0001). Remission varied with weight loss in the whole study population, with achievement in none of 76 participants who gained weight, six (7%) of 89 participants who maintained 0-5 kg weight loss, 19 (34%) of 56 participants with 5-10 kg loss, 16 (57%) of 28 participants with 10-15 kg loss, and 31 (86%) of 36 participants who lost 15 kg or more. Mean bodyweight fell by 10·0 kg (SD 8·0) in the intervention group and 1·0 kg (3·7) in the control group (adjusted difference -8·8 kg, 95% CI -10·3 to -7·3; p<0·0001). Quality of life, as measured by the EuroQol 5 Dimensions visual analogue scale, improved by 7·2 points (SD 21·3) in the intervention group, and decreased by 2·9 points (15·5) in the control group (adjusted difference 6·4 points, 95% CI 2·5-10·3; p=0·0012). Nine serious adverse events were reported by seven (4%) of 157 participants in the intervention group and two were reported by two (1%) participants in the control group. Two serious adverse events (biliary colic and abdominal pain), occurring in the same participant, were deemed potentially related to the intervention. No serious adverse events led to withdrawal from the study. INTERPRETATION: Our findings show that, at 12 months, almost half of participants achieved remission to a non-diabetic state and off antidiabetic drugs. Remission of type 2 diabetes is a practical target for primary care. FUNDING: Diabetes UK.

Clinical and metabolic features of the randomised controlled Diabetes Remission Clinical Trial (DiRECT) cohort.

AIMS/HYPOTHESIS: Substantial weight loss in type 2 diabetes can achieve a return to non-diabetic biochemical status, without the need for medication. The Diabetes Remission Clinical Trial (DiRECT), a cluster-randomised controlled trial, is testing a structured intervention designed to achieve and sustain this over 2 years in a primary care setting to determine practicability for routine clinical practice. This paper reports the characteristics of the baseline cohort. METHODS: People with type 2 diabetes for <6 years with a BMI of 27-45 kg/m2 were recruited in 49 UK primary care practices, randomised to either best-practice diabetes care alone or with an additional evidence-based weight management programme (Counterweight-Plus). The co-primary outcomes, at 12 months, are weight loss ≥15 kg and diabetes remission (HbA1c <48 mmol/mol [6.5%]) without glucose-lowering therapy for at least 2 months. Outcome assessors are blinded to group assignment. RESULTS: Of 1510 people invited, 423 (28%) accepted; of whom, 306 (72%) were eligible at screening and gave informed consent. Seven participants were later found to have been randomised in error and one withdrew consent, leaving 298 (176 men, 122 women) who will form the intention to treat (ITT) population for analysis. Mean (SD) age was 54.4 (7.6) years, duration of diabetes 3.0 (1.7) years, BMI 34.6 (4.4) kg/m2 for all participants (34.2 (4.2) kg/m2 in men and 35.3 (4.6) kg/m2 in women) and baseline HbA1c (on treatment) 59.3 (12.7) mmol/mol (7.6% [1.2%]). The recruitment rate in the intervention and control groups, and comparisons between the subgroups recruited in Scotland and England, showed few differences. CONCLUSIONS/INTERPRETATION: DiRECT has recruited a cohort of people with type 2 diabetes with characteristics similar to those seen in routine practice, indicating potential widespread applicability. Over 25% of the eligible population wished to participate in the study, including a high proportion of men, in line with the prevalence distribution of type 2 diabetes. TRIAL REGISTRATION: www.controlled-trials.com/ISRCTN03267836 ; date of registration 20 December 2013.

How do young women approaching screening age interpret the NHS cervical screening leaflet? A mixed methods study of identifying interpretation difficulties, barriers, facilitators, and leaflet interpretation, engagement and future screening behaviour.

BACKGROUND: Cervical cancer is a common cancer among young women aged 25-29 in England, and the NHS cervical screening leaflet is the first point of contact for those being invited for their first screening. This study aimed to explore how young women (18-24) understand and engage with the leaflet, as well as the barriers and facilitators associated with its interpretation, engagement, and screening intentions. METHODS: The study used a mixed-methods approach, including a survey (n = 120) to identify interpretation difficulties and how they were affected by different characteristics, and a follow-up interview (n = 10) to assess the utility of the leaflet, identify issues with its practicality, and determine the factors that influence screening intentions. RESULTS: The survey results showed that interpretation difficulties were common, particularly regarding HPV assessment, screening results, additional tests/treatment, and screening risks. Lower interpretation accuracy was associated with lower numeracy scores and non-white ethnicity. Despite these difficulties, participants had high confidence and motivation to engage with the leaflet. The interviews revealed knowledge gaps, issues with the leaflet's practicality, and a preference for digital information. Factors that were identified as barriers and facilitators of leaflet interpretation, engagement, and screening intentions included knowledge, social influence, beliefs about consequences, environmental context and resources, social role and identity, emotions and intentions. CONCLUSION: The current leaflet does not provide enough information for young women to make an informed decision about screening attendance. Implementing a digital invitation featuring simplified gist representation, targeted behaviour change techniques (BCTs), videos, and interactive tools can enhance education and promote screening behaviour. Future research should consider using digital tools and strategies to address existing barriers related to interpretation and engagement.

Life after meningitis: a qualitative study exploring survivors' experience of living with sequelae.

BACKGROUND: Around twenty percent of meningitis survivors experience after-effects. However, very little research on their psychological impact has been conducted. This report details a small explorative investigation into these psychological impacts. OBJECTIVE: To explore the impact sequelae have on the meningitis survivors affected. METHODS AND MEASURES: Thematic analysis of one-hundred individual user's blog posts, self-reporting one or more sequelae after a diagnosis of meningitis. RESULTS: Blog posters' experiences varied greatly. Common trends in experience were mapped onto three themes. 'Struggling to Adjust to the New Normal' captures blog posters' struggles in returning to their lives post-hospitalization. 'Navigating Possibilities for Positivity' explores how blog posters either reported positive change due to their illness experience or felt a pressure, or inability, to do so. 'The Impact of Knowledge and Support' overarching two sub-themes; 'Lack of Awareness Causing Further Suffering' and 'Validation Leads to Narrative Shift'. These sub-themes contrast differences in experience blog posters reported, with and without knowledge, of the cause of their symptoms and support in dealing with the resulting difficulties. CONCLUSIONS: Consistent and structured after-care would benefit patients experiencing sequelae. Suggestions of a possible format this could take are put forward. In addition, self-regulatory models of illness perception help explain some variations in blog posters experiences, with possible intervention plans based on these models also suggested. However, limitations, including the comparatively small and highly selected sample, mean that further research is necessary to validate the findings and assess their validity, widespread applicability, and financial feasibility.

Enhancing making every contact count (MECC) training and delivery for the third and social economy (TSE) sector: a strategic behavioural analysis.

OBJECTIVE: To enhance Making Every Contact Count (MECC, an opportunistic approach to health promotion), training in the Third and Social Economy (TSE, all groups and organisations primarily working towards social justice, outside of the government or household) by examining the degree to which the behavioural content of MECC training tackled significant factors influencing MECC delivery. METHODS AND MEASURES: A strategic behavioural analysis design. Semi-structured interviews with service providers (n = 15) and users (n = 5) were coded for barriers and facilitators of MECC delivery using the Theoretical Domains Framework (TDF). Existing MECC training was coded for behaviour change techniques (BCTs) and intervention functions (IFs). The degree to which BCTs and IFs addressed the key TDF domains of influences on MECC delivery in the TSE were examined using prespecified tools. RESULTS: Seven key TDF domains of influences in MECC delivery were identified. Overall, only 9/31 linked BCTs were utilised within MECC training, with percentage utilisation of relevant BCTs for each domain ranging from 0% to 66.7%. Training adequately addressed 2/7 key domains. CONCLUSION: The TSE and healthcare share many common key TDF domains, although there are differences in how each are relevant. Limitations and recommendations for MECC training are discussed.

Mapping regional implementation of 'Making Every Contact Count': mixed-methods evaluation of implementation stage, strategies, barriers and facilitators of implementation.

BACKGROUND: The Making Every Contact Count (MECC) programme provides training and materials to support public-facing workers to encourage health-promoting behaviour change by using the day-to-day interactions between organisations and individuals. This project aimed to analyse MECC implementation through a comparative analysis of implementation stage, strategies used for implementation and enablers/barriers of the implementation process within a region in England-the North East and North Cumbria (NENC). METHODS: A mixed-methods process evaluation was conducted applying normalisation process theory and theoretical domains framework. MECC programme documents were reviewed and mapped against specific criteria (eg, implementation strategies). An online mapping survey was conducted to establish current implementation/delivery of MECC within NENC settings (eg, local government, healthcare and voluntary community sector). Qualitative research, using individual interviews and group discussions, was conducted to establish further understanding of MECC implementation. RESULTS: Our findings were informed by reviewing documents (n=5), surveying participants (n=34), interviews (n=18) and group discussions (n=48). Overall, the implementation of MECC within the region was at an early stage, with training mostly delivered between, rather than within, organisations. Qualitative findings highlighted factors that influence stakeholders to implement MECC (eg, organisational goals that were facilitated by MECC implementation, including the prevention agenda), supported resources that facilitate the implementation of MECC (eg, logic models) and enabling factors that promote MECC sustainability across the region (eg, buy-in from leadership and management). CONCLUSIONS: The NENC MECC programme is built around regional leadership that supports the implementation process. This process evaluation identified key influences of MECC implementation across the region. We discuss evidence-based recommendation for policy and practice that can be taken forward to develop targeted strategies to support future MECC implementation. For example, a co-ordinated infrastructure and strategy is needed to combat delivery and implementation issues identified.

Understanding the implementation of 'Making Every Contact Count' (MECC) delivered by healthcare professionals in a mental health hospital: protocol for a pragmatic formative process evaluation.

Background: 'Making Every Contact Count' (MECC) is a public health strategy supporting public-facing workers to use opportunities during routine contacts to enable health behaviour change. A mental health hospital in the North East of England is currently implementing a programme to embed MECC across the hospital supporting weight management ('A Weight Off Your Mind'). Bespoke MECC training has been developed to improve staff confidence in discussing physical activity, healthy eating, and related behaviour change with service users. This article describes the protocol for a pragmatic formative process evaluation to inform the implementation plan for MECC and facilitate successful implementation of the bespoke MECC training at scale. Methods/Design: An 18-month, mixed method pragmatic formative process evaluation, including qualitative research, surveys, document review and stakeholder engagement. This project is conducted within a mental health inpatient setting in the North East of England. Programme documents will be reviewed, mapped against MECC national guidelines, Behaviour Change Techniques (BCTs) and intervention functions within the Behaviour Change Wheel. A cross-sectional survey (n = 365) and qualitative semi-structured interviews (n = 30) will be conducted with healthcare practitioners delivering MECC to assess capability, opportunity and motivation. Data collection and fidelity procedures will be examined, including design, training and delivery dimensions of fidelity. Interviews with service users (n = 20) will also be conducted. Discussion: Anticipated outcomes include developing recommendations to overcome barriers to delivery of and access to MECC, including whether to either support the use of the existing MECC protocol or tailor the MECC training programme. The findings are anticipated to improve fidelity of MECC training within mental health inpatient settings as well as provide evidence for MECC training at a national level. We also expect findings to influence strategic plans, policy, and practice specific to MECC and inform best practice in implementing wider brief intervention programmes.

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.

Asking questions changes health-related behavior: an updated systematic review and meta-analysis.

OBJECTIVES: The question-behavior effect (QBE) refers to whether asking people questions can result in changes in behavior. Such changes in behavior can lead to bias in trials. This study aims to update a systematic review of randomized controlled trials investigating the QBE, in light of several large preregistered studies being published. STUDY DESIGN AND SETTING: A systematic search for newly published trials covered 2012 to July 2018. Eligible trials randomly allocated participants to measurement vs. non-measurement control conditions or to different forms of measurement. Studies that reported health-related behavior as outcomes were included. RESULTS: Forty-three studies (33 studies from the original systematic review and 10 new studies) compared measurement vs. no measurement. An overall small effect was found using a random effect model: standardized mean difference = 0.06 (95% CI: 0.02-0.09), n = 104,388. Statistical heterogeneity was substantial (I2 = 54%). In an analysis restricted to studies with a low risk of bias, the QBE remained small but significant. There was positive evidence of publication bias. CONCLUSION: This update shows a small but significant QBE in trials with health-related outcomes but with considerable unexplained heterogeneity. Future trials with lower risk of bias are needed, with preregistered protocols and greater attention to blinding.

Durability of a primary care-led weight-management intervention for remission of type 2 diabetes: 2-year results of the DiRECT open-label, cluster-randomised trial.

BACKGROUND: The DiRECT trial assessed remission of type 2 diabetes during a primary care-led weight-management programme. At 1 year, 68 (46%) of 149 intervention participants were in remission and 36 (24%) had achieved at least 15 kg weight loss. The aim of this 2-year analysis is to assess the durability of the intervention effect. METHODS: DiRECT is an open-label, cluster-randomised, controlled trial done at primary care practices in the UK. Practices were randomly assigned (1:1) via a computer-generated list to provide an integrated structured weight-management programme (intervention) or best-practice care in accordance with guidelines (control), with stratification for study site (Tyneside or Scotland) and practice list size (>5700 or ≤5700 people). Allocation was concealed from the study statisticians; participants, carers, and study research assistants were aware of allocation. We recruited individuals aged 20-65 years, with less than 6 years' duration of type 2 diabetes, BMI 27-45 kg/m2, and not receiving insulin between July 25, 2014, and Aug 5, 2016. The intervention consisted of withdrawal of antidiabetes and antihypertensive drugs, total diet replacement (825-853 kcal per day formula diet for 12-20 weeks), stepped food reintroduction (2-8 weeks), and then structured support for weight-loss maintenance. The coprimary outcomes, analysed hierarchically in the intention-to-treat population at 24 months, were weight loss of at least 15 kg, and remission of diabetes, defined as HbA1c less than 6·5% (48 mmol/mol) after withdrawal of antidiabetes drugs at baseline (remission was determined independently at 12 and 24 months). The trial is registered with the ISRCTN registry, number 03267836, and follow-up is ongoing. FINDINGS: The intention-to-treat population consisted of 149 participants per group. At 24 months, 17 (11%) intervention participants and three (2%) control participants had weight loss of at least 15 kg (adjusted odds ratio [aOR] 7·49, 95% CI 2·05 to 27·32; p=0·0023) and 53 (36%) intervention participants and five (3%) control participants had remission of diabetes (aOR 25·82, 8·25 to 80·84; p<0·0001). The adjusted mean difference between the control and intervention groups in change in bodyweight was -5·4 kg (95% CI -6·9 to -4·0; p<0·0001) and in HbA1c was -4·8 mmol/mol (-8·3 to -1·4 [-0·44% (-0·76 to -0·13)]; p=0·0063), despite only 51 (40%) of 129 patients in the intervention group using anti-diabetes medication compared with 120 (84%) of 143 in the control group. In a post-hoc analysis of the whole study population, of those participants who maintained at least 10 kg weight loss (45 of 272 with data), 29 (64%) achieved remission; 36 (24%) of 149 participants in the intervention group maintained at least 10 kg weight loss. Serious adverse events were similar to those reported at 12 months, but were fewer in the intervention group than in the control group in the second year of the study (nine vs 22). INTERPRETATION: The DiRECT programme sustained remissions at 24 months for more than a third of people with type 2 diabetes. Sustained remission was linked to the extent of sustained weight loss. FUNDING: Diabetes UK.

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.

Aware, motivated and striving for a 'safe tan': an exploratory mixed-method study of sun-protection during holidays.

Background: This article presents an exploratory study, aiming to explore the correspondence between knowledge, motivation and sun-protection practices during holidays. Methods: Seventeen participants aged 21-62 years old, recruited from community settings took part in individual face-to-face semi-structured interviews, completed sun sensitivity questions and an objective assessment of sunscreen use. Holidaymakers' knowledge about sun-safe messages, intentions and perceptions of barriers and facilitators for sun-protection were assessed. Qualitative data were analysed using thematic analysis and integrated with quantitative data, using a pragmatic theory-informed approach to synthesise the findings. Results: Participants were well informed about sun-safe messages, highly motivated to protect themselves from solar UV radiation (UVR) and they perceived themselves as well protected. However, they did not seem to use effective protective practices. Sunscreen was the preferred method of sun-protection, but most participants used considerably less than the recommended amount and significantly overestimated the amount of time they could be safely exposed. Seeking shade was the least used method of sun-protection and covering-up strategies were mostly implemented as a partial protection (i.e. hats or sunglasses). The desire to reach an optimal balance between getting a tan and using sun-protection to avoid sunburns was preeminent. Several additional barriers and facilitators for sun-protection were identified. Conclusions: Holidaymakers might have a false sense of security when it comes to sun-exposure. They are aware of the need to protect from solar UVR, but the motive for a safe tan, the overreliance on sunscreen, the overestimation of the safe sun-exposure time for their skin type and the insufficient application of sunscreen leaves holidaymakers motivated to protect their skin at significant risk of overexposure, sunburn and skin cancer. Public health messages need to address how to implement effective sun-safe strategies.

Systematic and Iterative Development of a Smartphone App to Promote Sun-Protection Among Holidaymakers: Design of a Prototype and Results of Usability and Acceptability Testing.

BACKGROUND: Sunburn and intermittent exposure to ultraviolet rays are risk factors for melanoma. Sunburn is a common experience during holidays, making tourism settings of particular interest for skin cancer prevention. Holidaymakers are a volatile populations found at different locations, which may make them difficult to reach. Given the widespread use of smartphones, evidence suggests that this might be a novel, convenient, scalable, and feasible way of reaching the target population. OBJECTIVE: The main objective of this study was to describe and appraise the process of systematically developing a smartphone intervention (mISkin app) to promote sun-protection during holidays. METHODS: The iterative development process of the mISkin app was conducted over four sequential stages: (1) identify evidence on the most effective behavior change techniques (BCTs) used (active ingredients) as well as theoretical predictors and theories, (2) evidence-based intervention design, (3) co-design with users of the mISkin app prototype, and (4) refinement of the app. Each stage provided key findings that were subsequently used to inform the design of the mISkin app. RESULTS: The sequential approach to development integrates different strands of evidence to inform the design of an evidence-based intervention. A systematic review on previously tested interventions to promote sun-protection provided cues and constraints for the design of this intervention. The development and design of the mISkin app also incorporated other sources of information, such as other literature reviews and experts' consultations. The developed prototype of the mISkin app was evaluated by engaging potential holidaymakers in the refinement and further development of the mISkin app through usability (ease-of-use) and acceptability testing of the intervention prototype. All 17 participants were satisfied with the mISkin prototype and expressed willingness to use it. Feedback on the app was integrated in the optimization process of the mISkin app. CONCLUSIONS: The mISkin app was designed to promote sun-protection among holidaymakers and was based on current evidence, experts' knowledge and experience, and user involvement. Based on user feedback, the app has been refined and a fully functional version is ready for formal testing in a feasibility pilot study.

The question-behavior effect: genuine effect or spurious phenomenon? A systematic review of randomized controlled trials with meta-analyses.

OBJECTIVE: Simply answering questions about a specific behavior may change that behavior. This is known as the mere-measurement or question-behavior effect (QBE). Our objective was to synthesize the evidence for the QBE on health-related behaviors. METHOD: Included studies were randomized controlled trials that tested the effect of questionnaires or interviews about health-related behaviors and/or related cognitions compared with a no-measurement control condition or another form of measurement. Subgroup analyses were conducted to identify potential moderators. RESULTS: 41 studies were included assessing a range of health behaviors. Meta-analyses showed a small overall QBE effect (SMD = 0.09; 95% CI [0.04, 0.13]; k = 33). Studies showed moderate heterogeneity, variable risk of bias, and evidence of publication bias. No dose-response relationships were found from studies comparing more with less intensive measurement conditions. There were no significant differences in QBE by behavior, but QBEs for dental flossing, physical activity, and screening attendance were significantly different from 0. Findings were not altered by whether behavior or cognitions were measured, attitudes were or were not measured, studies used questionnaires or interviews, or outcomes were objective or self-reported. CONCLUSIONS: There is some evidence for the QBE on health-related behavior. However, risk of bias within studies and evidence of publication bias indicate that the observed small effect size may be overestimated, especially given that some studies included intervention techniques in addition to providing questionnaires. Preregistered high-quality trials with clear specification of intervention content are needed to confirm if and when measurement leads to behavior change.