Supporting people with type 2 diabetes in effective use of their medicine through mobile health technology integrated with clinical care (SuMMiT-D pilot): results of a feasibility randomised trial.

BACKGROUND: The purpose of this 6-month intervention pilot feasibility randomised trial was to test sending brief messages using mobile phones to promote self-management through taking medication as prescribed to people with type 2 diabetes. This was to inform the design and conduct of a future large-scale United Kingdom-based clinical trial and establish the feasibility of recruitment, the technology used, follow-up, and data collection. METHODS: A multicentre individually randomised, controlled parallel group trial in primary care, recruiting adults (≥ 35 years) with type 2 diabetes in England. Consenting participants were randomly allocated to receive short message system text messages up to four times a week, or usual care, for a period of 6 months; messages contained behavioural change techniques targeting medication use. The primary outcome was the rate of recruitment to randomisation of participants to the trial with a planned rate of 22 participants randomised per month. The study also aimed to establish the feasibility of follow-up at 6 months, with an aim of retaining more than 80% of participants. Data, including patient-reported measures, were collected at baseline and the end of the 6-month follow-up period, and a notes review was completed at 24 months. RESULTS: The trial took place between 26 November 2018 and 30 September 2019. In total 209 participants were randomly allocated to intervention (n = 103) or usual care (n = 106). The maximum rate of monthly recruitment to the trial was 60-80 participants per month. In total, 12,734 messages were sent to participants. Of these messages, 47 were identified as having failed to be sent by the service provider. Participants sent 2,864 messages to the automated messaging system. Baseline data from medical records were available for > 90% of participants with the exception of cholesterol (78.9%). At 6 months, a further HbA1c measurement was reported for 67% of participants. In total medical record data were available at 6 months for 207 (99.0%) of participants and completed self-report data were available for 177 (84.7%) of participants. CONCLUSION: The feasibility of a large-scale randomised evaluation of brief message intervention for people with type 2 diabetes appears to be high using this efficient design. Failure rate of sending messages is low, rapid recruitment was achieved among people with type 2 diabetes, clinical data is available on participants from routine medical records and self-report of economic measures was acceptable. TRIAL REGISTRATION: ISCTRN ISRCTN13404264. Registered on 10 October 2018.

Experiences of online group support for engaging and supporting participants in the National Health Service Digital Diabetes Prevention Programme: A qualitative interview study.

OBJECTIVES: The National Health Service Digital Diabetes Prevention Programme is a nine-month behavioural intervention for adults in England at risk of type 2 diabetes. This qualitative study aimed to explore how service users engaged with the group support available within the programme. METHODS: The majority of participants (n = 33), all service users, were interviewed twice via telephone, at 2-4 months into the programme, and at the end of the programme at 8-10 months. Semi-structured interviews covered participants' experiences of online group support functions and how such groups served as a route of support to aid participants' behavioural changes. Data were analysed using manifest thematic analysis. RESULTS: The majority of participants valued the format of closed group chats, which provided an interactive platform to offer and receive support during their behaviour change journey. However, engagement with group chats reduced over time, and some participants did not find them useful when there was a lack of common interests within the group. Health coaches helped to promote engagement and build rapport among participants within the group chats. Participants reported mixed experiences of discussion forums. CONCLUSIONS: Programme developers should consider how to optimise online group support to help service users make behavioural changes, in terms of format, participant composition and use of health coach moderators. Further research is required to better understand who might benefit most from 'group chat' or 'discussion forum' support. Health coach moderation of online support groups is likely to facilitate engagement.

Design and Early Use of the Nationally Implemented Healthier You National Health Service Digital Diabetes Prevention Programme: Mixed Methods Study.

BACKGROUND: The Healthier You National Health Service Digital Diabetes Prevention Programme (NHS-digital-DPP) is a 9-month digital behavior change intervention delivered by 4 independent providers that is implemented nationally across England. No studies have explored the design features included by service providers of digital diabetes prevention programs to promote engagement, and little is known about how participants of nationally implemented digital diabetes prevention programs such as this one make use of them. OBJECTIVE: This study aimed to understand engagement with the NHS-digital-DPP. The specific objectives were to describe how engagement with the NHS-digital-DPP is promoted via design features and strategies and describe participants' early engagement with the NHS-digital-DPP apps. METHODS: Mixed methods were used. The qualitative study was a secondary analysis of documents detailing the NHS-digital-DPP intervention design and interviews with program developers (n=6). Data were deductively coded according to an established framework of engagement with digital health interventions. For the quantitative study, anonymous use data collected over 9 months for each provider representing participants' first 30 days of use of the apps were obtained for participants enrolled in the NHS-digital-DPP. Use data fields were categorized into 4 intervention features (Track, Learn, Coach Interactions, and Peer Support). The amount of engagement with the intervention features was calculated for the entire cohort, and the differences between providers were explored statistically. RESULTS: Data were available for 12,857 participants who enrolled in the NHS-digital-DPP during the data collection phase. Overall, 94.37% (12,133/12,857) of those enrolled engaged with the apps in the first 30 days. The median (IQR) number of days of use was 11 (2-25). Track features were engaged with the most (number of tracking events: median 46, IQR 3-22), and Peer Support features were the least engaged with, a median value of 0 (IQR 0-0). Differences in engagement with features were observed across providers. Qualitative findings offer explanations for the variations, including suggesting the importance of health coaches, reminders, and regular content updates to facilitate early engagement. CONCLUSIONS: Almost all participants in the NHS-digital-DPP started using the apps. Differences across providers identified by the mixed methods analysis provide the opportunity to identify features that are important for engagement with digital health interventions and could inform the design of other digital behavior change interventions.

Engagement with a nationally-implemented digital behaviour change intervention: Usage patterns over the 9-month duration of the National Health Service Digital Diabetes Prevention Programme.

Background: Digital behaviour change interventions may offer a scalable way to promote weight loss by increasing physical activity and improving diet. However, user engagement is necessary for such benefits to be achieved. There is a dearth of research that assesses engagement with nationally implemented digital programmes offered in routine practice. The National Health Service Digital Diabetes Prevention Programme (NHS-DDPP) is a nine-month digital behaviour change intervention delivered by independent providers for adults in England who are at high risk of developing type 2 diabetes. This study reports engagement with the NHS-DDPP for users enrolled onto the programme over the nine-month duration. Methods: Anonymous usage data was obtained for a cohort of service users (n = 1826) enrolled on the NHS-DDPP with three independent providers, between December 2020 and June 2021. Usage data were obtained for time spent in app, and frequency of use of NHS-DDPP intervention features in the apps including self-monitoring, goal setting, receiving educational content (via articles) and social support (via health coaches and group forums), to allow patterns of usage of these key features to be quantified across the nine-month intervention. Median usage was calculated within nine 30-day engagement periods to allow a longitudinal analysis of the dose of usage for each feature. Results: App usage declined from a median of 32 min (IQR 191) in month one to 0 min (IQR 14) in month nine. Users self-monitored their behaviours (e.g., physical activity and diet) a median of 117 times (IQR 451) in the apps over the nine-month programme. The open group discussion forums were utilised less regularly (accessed a median of 0 times at all time-points). There was higher engagement with some intervention features (e.g., goal setting) when support from a health coach was linked to those features. Conclusions: App usage decreased over the nine-month programme, although the rate at which the decrease occurred varied substantially between individuals and providers. Health coach support may promote engagement with specific intervention features. Future research should assess whether engagement with particular features of digital diabetes prevention programmes is associated with outcomes such as reduced bodyweight and HbA1c levels.

Description of the nationally implemented National Health Service digital diabetes prevention programme and rationale for its development: mixed methods study.

BACKGROUND: The National Health Service (NHS) Digital Diabetes Prevention Programme (DDPP) is a behaviour change programme for adults in England who are at high risk of developing type 2 diabetes. Four independent providers deliver the NHS-DDPP following a competitive tendering process. Although providers work to a single service specification, there is potential for some variation in the service across providers. This study (1) assesses fidelity of the structural features of the design of the NHS-DDPP compared to the service specification, (2) describes the structural features of delivery of the NHS-DDPP as implemented (3) reports developers' views on how the structural components of the NHS-DDPP were developed and why changes were made following implementation. METHODS: Using mixed methods, we conducted a document review of providers' NHS-DDPP design and delivery documentation, and extracted information using the Template for Intervention Description and Replication checklist, which was adapted to capture features of digital delivery. Documentation was supplemented by content analysis of interviews with 12 health coaches involved in delivering the NHS-DDPP. Semi-structured interviews were also conducted with 6 programme developers employed by the digital providers. RESULTS: Provider plans for the NHS-DDPP show relatively high fidelity to the NHS service specification. Despite this, there was wide variation in structural features of delivery of the NHS-DDPP across providers, particularly for delivery of 'support' (e.g. use, dose and scheduling of health coaching and/or group support). Interviews with developers of the programmes showed that much of this variation is likely to be attributable to the origin of each provider's programme, which was usually a pre-existing programme that was adapted to conform to the NHS-DDPP service specification. The NHS-DDPP is continually improved and developed based on user experience feedback and research conducted by the providers. CONCLUSION: Indirect evidence suggests that variation in delivery of support could affect effectiveness of the NHS-DDPP. A priority for future research is ascertaining whether the variation in delivery of the NHS-DDPP across providers is related to any differences in health outcomes. It is recommended that future rounds of commissioning the NHS-DDPP pre-specify the type of support participants should receive, including expected dose and scheduling.

What behaviour change technique content is offered to service users of the nationally implemented English NHS Digital Diabetes Prevention Programme: Analysis of multiple sources of intervention content.

The National Health Service Digital Diabetes Prevention Programme (NHS-DDPP) is a behavioural intervention for adults in England at risk of developing Type 2 diabetes, rolled out nationally via independent providers and their digital partners. The NHS England programme specification indicated 19 behaviour change techniques (BCTs) which should be present in the intervention, including BCTs to support self-regulation. A previous evaluation of the face-to-face service found an under-delivery of some self-regulatory BCTs. This study assessed whether those 19 BCTs were offered in the different interventions delivered by four digital providers. A cross-sectional analysis of BCT content in the NHS-DDPP was elicited from the following sources: (a) online platforms (e.g. apps), (b) educational materials, and (c) health coaching (assessed via interviews with health coaches and audio-recorded telephone consultations). All materials were coded using the Behaviour Change Technique Taxonomy v1. A total of 17, 15, 15 and 14 of the 19 specified BCTs were identified across the four digital provider programmes. A mean proportion of 43% of specified BCTs were present via providers' apps, 74% via educational materials, and 62% via health coaching. An additional 41 BCTs were included in at least one of the four providers' programmes. Fidelity of BCT content in the NHS-DDPP was better than previously identified for the face-to-face DPP service. However, BCTs were offered via multiple modalities, thus the degree to which users engage with the modalities will impact on their exposure to BCTs and likely effectiveness of the digital programme.

How the Behavior Change Content of a Nationally Implemented Digital Diabetes Prevention Program Is Understood and Used by Participants: Qualitative Study of Fidelity of Receipt and Enactment.

BACKGROUND: The National Health Service Digital Diabetes Prevention Programme (NHS-DDPP) is a program for adults in England at risk of developing type 2 diabetes mellitus (T2DM). It is based on NHS England specifications that stipulate specific behavior change techniques (BCTs), that is, active ingredients to produce behavior change to target diet and physical activity. Now rolled out nationally, the NHS-DDPP is being delivered by 4 independent providers as a 9-month intervention via apps, educational material, and remote health coaching. To optimize effectiveness, participants need to be able to understand and use behavior change content (eg, goal setting and problem solving) of an intervention delivered to them digitally. Previous research has shown that people benefit from support to aid the understanding and use of BCTs. OBJECTIVE: The objectives of this qualitative study were to evaluate how participants in the NHS-DDPP understand and use BCT content, investigate how participants describe the role of health coaches in supporting their behavior change, and examine how the understanding and use of behavior change content of the NHS-DDPP varies across providers. METHODS: In total, 45 service users were interviewed twice by telephone at 2 to 4 months into, and at the end of, the program. Topics included participants' understanding and use of key BCTs to support self-regulation (eg, goal setting) and the support they received via the program. Transcripts were analyzed thematically, informed by the framework method. RESULTS: Participants described their understanding and use of some behavior change content of the program as straightforward: use of BCTs (eg, self-monitoring of behavior) delivered digitally via provider apps. Participants valued the role of health coaches in supporting their behavior change through the emotional support they offered and their direct role in delivery and application of some BCTs (eg, problem solving) to their specific circumstances. Participants expressed frustration over the lack of monitoring or feedback regarding their T2DM risk within the program. Variations in the understanding and use of behavior change content of the NHS-DDPP were present across provider programs. CONCLUSIONS: Health coaches' support in delivery of key components of the program seems to be pivotal. To improve the understanding and use of BCTs in digital interventions, it is important to consider routes of delivery that offer additional interactive human support. Understanding of some self-regulatory BCTs may benefit from this support more than others; thus, identifying the optimal mode of delivery for behavior change content is a priority for future research. The NHS-DDPP could be improved by explicitly setting out the need for health coaches to support understanding of some self-regulatory BCT content such as problem solving in the service specification and amending the discharge process so that knowledge of any change in T2DM risk is available to participants.

Changes in a Digital Type 2 Diabetes Self-management Intervention During National Rollout: Mixed Methods Study of Fidelity.

BACKGROUND: "Healthy Living for People with type 2 Diabetes (HeLP-Diabetes)" was a theory-based digital self-management intervention for people with type 2 diabetes mellitus that encouraged behavior change using behavior change techniques (BCTs) and promoted self-management. HeLP-Diabetes was effective in reducing HbA1c levels in a randomized controlled trial (RCT). National Health Service (NHS) England commissioned a national rollout of HeLP-Diabetes in routine care (now called "Healthy Living"). Healthy Living presents a unique opportunity to examine the fidelity of the national rollout of an intervention originally tested in an RCT. OBJECTIVE: This research aimed to describe the Healthy Living BCT and self-management content and features of intervention delivery, compare the fidelity of Healthy Living with the original HeLP-Diabetes intervention, and explain the reasons for any fidelity drift during national rollout through qualitative interviews. METHODS: Content analysis of Healthy Living was conducted using 3 coding frameworks (objective 1): the BCT Taxonomy v1, a new coding framework for assessing self-management tasks, and the Template for Intervention Description and Replication. The extent to which BCTs and self-management tasks were included in Healthy Living was compared with published descriptions of HeLP-Diabetes (objective 2). Semistructured interviews were conducted with 9 stakeholders involved in the development of HeLP-Diabetes or Healthy Living to understand the reasons for any changes during national rollout (objective 3). Qualitative data were thematically analyzed using a modified framework approach. RESULTS: The content analysis identified 43 BCTs in Healthy Living. Healthy Living included all but one of the self-regulatory BCTs ("commitment") in the original HeLP-Diabetes intervention. Healthy Living was found to address all areas of self-management (medical, emotional, and role) in line with the original HeLP-Diabetes intervention. However, 2 important changes were identified. First, facilitated access by a health care professional was not implemented; interviews revealed this was because general practices had fewer resources in comparison with the RCT. Second, Healthy Living included an additional structured web-based learning curriculum that was developed by the HeLP-Diabetes team but was not included in the original RCT; interviews revealed that this was because of changes in NHS policy that encouraged referral to structured education. Interviewees described how the service provider had to reformat the content of the original HeLP-Diabetes website to make it more usable and accessible to meet the multiple digital standards required for implementation in the NHS. CONCLUSIONS: The national rollout of Healthy Living had good fidelity to the BCT and self-management content of HeLP-Diabetes. Important changes were attributable to the challenges of scaling up a digital intervention from an RCT to a nationally implemented intervention, mainly because of fewer resources available in practice and the length of time since the RCT. This study highlights the importance of considering implementation throughout all phases of intervention development.

Assessing and ensuring fidelity of the nationally implemented English NHS diabetes prevention programme: lessons learned for the implementation of large-scale behaviour change programmes.

Background: Health services interventions are typically more effective in randomised controlled trials than in routine healthcare. One explanation for this 'voltage drop', i.e. reduction in effectiveness, is a reduction in intervention fidelity, i.e. the extent to which a programme is implemented as intended. This article discusses how to optimise intervention fidelity in nationally implemented behaviour change programmes, using as an exemplar the National Health Service Diabetes Prevention Programme (NHS-DPP); a behaviour change intervention for adults in England at increased risk of developing Type 2 diabetes, delivered by four independent provider organisations. We summarise key findings from a thorough fidelity evaluation of the NHS-DPP assessing design (whether programme plans were in accordance with the evidence base), training (of staff to deliver key intervention components), delivery (of key intervention components), receipt (participant understanding of intervention content), and highlight lessons learned for the implementation of other large-scale programmes. Results: NHS-DPP providers delivered the majority of behaviour change content specified in their programme designs. However, a drift in fidelity was apparent at multiple points: from the evidence base, during programme commissioning, and on to providers' programme designs. A lack of clear theoretical rationale for the intervention contents was apparent in design, training, and delivery. Our evaluation suggests that many fidelity issues may have been less prevalent if there was a clear underpinning theory from the outset. Conclusion: We provide recommendations to enhance fidelity of nationally implemented behaviour change programmes. The involvement of a behaviour change specialist in clarifying the theory of change would minimise drift of key intervention content. Further, as loss of fidelity appears notable at the design stage, this should be given particular attention. Based on these recommendations, we describe examples of how we have worked with commissioners of the NHS-DPP to enhance fidelity of the next roll-out of the programme.

Fidelity to Program Specification of the National Health Service Digital Diabetes Prevention Program Behavior Change Technique Content and Underpinning Theory: Document Analysis.

BACKGROUND: The National Health Service (NHS) Diabetes Prevention Program is a behavior change intervention for adults in England who are identified as being at high risk of developing type 2 diabetes. The face-to-face service was launched in 2016, followed by a digital service (NHS Digital Diabetes Prevention Program [NHS-DDPP]) in 2019. A total of 4 service providers were commissioned to deliver the NHS-DDPP and were required to deliver the digital service in line with a program specification detailing the key intervention content. The fidelity of the behavior change content in the digital service (ie, the extent to which the program is delivered as intended) is currently unknown. Digital interventions may allow higher fidelity as staff do not have to be trained to deliver all intervention content. Assessing fidelity of the intervention design is particularly important to establish the planned behavior change content in the NHS-DDPP and the extent to which this adheres to the program specification. This is the first known independent assessment of design fidelity in a large-scale digital behavior change intervention. OBJECTIVE: This study aims to assess the fidelity of the behavior change content in each of the 4 NHS-DDPP providers' intervention designs to the full program specification. METHODS: We conducted a document review of each provider's NHS-DDPP intervention design, along with interviews with program developers employed by the 4 digital providers (n=6). Providers' intervention design documents and interview transcripts were coded for behavior change techniques (BCTs; ie, the active ingredients of the intervention) using the Behavior Change Technique Taxonomy version 1 and underpinning theory using the Theory Coding Scheme framework. The BCTs identified in each digital provider's intervention design were compared with the 19 BCTs included in the program specification. RESULTS: Of the 19 BCTs specified in the program specification, the 4 providers planned to deliver 16 (84%), 17 (89%), 16 (84%), and 16 (84%) BCTs, respectively. An additional 41 unspecified BCTs were included in at least one of the 4 digital providers' intervention designs. By contrast, inconsistent use of the underpinning theory was apparent across providers, and none of the providers had produced a logic model to explain how their programs were expected to work. All providers linked some of their planned BCTs to theoretical constructs; however, justification for the inclusion of other BCTs was not described. CONCLUSIONS: The fidelity of BCT content in the NHS-DDPP was higher than that previously documented for the face-to-face service. Thus, if service users engage with the NHS-DDPP, this should increase the effectiveness of the program. However, given that a clear theoretical underpinning supports the translation of BCTs in intervention designs to intervention delivery, the absence of a logic model describing the constructs to be targeted by specific BCTs is potentially problematic.

Effects of Using a Text Message Intervention on Psychological Constructs and the Association Between Changes to Psychological Constructs and Medication Adherence in People With Type 2 Diabetes: Results From a Randomized Controlled Feasibility Study.

BACKGROUND: Poor adherence to oral medications is common in people with type 2 diabetes and can lead to an increased chance of health complications. Text messages may provide an effective delivery method for an intervention; however, thus far, the majority of these interventions do not specify either a theoretical basis or propose specific mechanisms of action. This makes it hard to determine how and whether an intervention is having an effect. The text messages included in the current intervention have been developed to deliver specific behavior change techniques. These techniques are the "active ingredients" of the intervention and were selected to target psychological constructs identified as predictors of medication adherence. OBJECTIVE: There are 2 aims of this study: (1) to assess whether a text message intervention with specified behavior change techniques can change the constructs that predict medication adherence behaviors in people with type 2 diabetes and (2) to assess whether changes to psychological constructs are associated with changes in self-reported medication adherence. METHODS: We conducted a randomized controlled, 6-month feasibility trial. Adults prescribed oral medication for type 2 diabetes (N=209) were recruited from general practice and randomized to either receive a text message-based intervention or care as usual. Data were analyzed with repeated measures analysis of covariance and Spearman rho correlation coefficients. RESULTS: For 8 of the 14 constructs that were measured, a significant time-by-condition interaction was found: necessity beliefs, intention, maintenance self-efficacy, recovery self-efficacy, action control, prompts and cues, social support, and satisfaction with experienced consequences all increased in the intervention group compared to the control group. Changes in action self-efficacy, intention, automaticity, maintenance self-efficacy, and satisfaction with experienced consequences were positively associated with changes in self-reported medication adherence. CONCLUSIONS: A relatively low-cost, scalable, text message-only intervention targeting medication adherence using behavior change techniques can influence psychological constructs that predict adherence. Not only do these constructs predict self-reported medication adherence, but changes in these constructs are correlated with changes in self-reported medication adherence. These findings support the promise of text message-based interventions for medication adherence in this population and suggest likely mechanisms of action. TRIAL REGISTRATION: ISRCTN Registry ISRCTN13404264; https://www.isrctn.com/ISRCTN13404264.

Development of an observer-reported outcome measure to capture the signs and impact of fever distress symptoms in infants and young children.

PURPOSE: This qualitative study aimed to construct an observer-reported outcome measure (ObsRO) to evaluate fever distress in young children. METHODS: A literature review was conducted to identify fever-related concepts. Clinical experts were interviewed for feedback on these concepts. Parents of young children were interviewed to identify behaviours the child exhibited during a recent fever episode. Fever sign and behaviour concepts endorsed by ≥ 20% parents were used to create items for the draft ObsRO. Parents of young children who recently had fever completed the ObsRO and gave feedback during two successive rounds of cognitive interviews. RESULTS: Twenty-five parents participated in the concept elicitation. Mean child age was 2.7 years (range: 0.6-5.8 years). Fever sign and behaviour concepts endorsed by ≥ 20% participants were high temperature (80%), skin hot to touch (32%), skin redness/flushing (32%), reduced appetite/drink (96%), needy/clingy/irritable (48-92%), less active/interactive (68-84%) and lethargic (64-88%). Eighteen items, four in the Fever Signs Module and 14 in the Fever Behaviours Module, were developed for the draft ObsRO. Chosen recall period was 24 h. Thirty participants (Round 1: n = 17; Round 2: n = 13), participated in cognitive interviews. Mean child age was 2.4 years (range 0.3-5.8). Round 1 feedback resulted in two Fever Signs items being combined. Three Fever Behaviour items were deleted, six revised and four unchanged. No changes were made following Round 2 feedback. Most participants understood all aspects of the ObsRO and found it user-friendly. CONCLUSION: The ObsRO will undergo further development in validation studies testing measurement properties of each item.

How is the Behavior Change Technique Content of the NHS Diabetes Prevention Program Understood by Participants? A Qualitative Study of Fidelity, With a Focus on Receipt.

BACKGROUND: The National Health Service (NHS) Diabetes Prevention Program (DPP) is a nationally implemented behavioral intervention for adults at high risk of developing Type 2 diabetes in England, based on a program specification that stipulates inclusion of 19 specific behavior change techniques (BCTs). Previous work has identified drift in fidelity from these NHS England specifications through providers' program manuals, training, and delivery, especially in relation to BCTs targeting self-regulatory processes. PURPOSE: This qualitative study investigates intervention receipt, i.e., how the self-regulatory BCT content of the NHS-DPP is understood by participants. METHODS: Twenty participants from eight NHS-DPP locations were interviewed; topics included participants' understanding of self-monitoring of behavior, goal setting, feedback, problem solving, and action planning. Transcripts were analyzed thematically using the framework method. RESULTS: There was a wide variation in understanding among participants for some BCTs, as well as between BCTs. Participants described their understanding of "self-monitoring of behaviors" with ease and valued BCTs focused on outcomes (weight loss). Some participants learned how to set appropriate behavioral goals. Participants struggled to recall "action planning" or "problem solving" or found these techniques challenging to understand, unless additional support was provided (e.g., through group discussion). CONCLUSIONS: Participants' lack of understanding of some self-regulatory BCTs is consistent with the drift across fidelity domains previously identified from NHS design specifications. Behavioral interventions should build-in necessary support for participants to help them understand some BCTs such as action planning and problem solving. Alternatively, these self-regulatory BCTs may be intrinsically difficult to use for this population.

Narrative review of the prevalence and distribution of acute pain in children in the self-care setting.

Acute pain among children is common, yet it may be underestimated and undertreated if the pain is not recognized. Assessing and managing pediatric pain can be complicated, and as such, measuring the prevalence of acute pain in children can be challenging. We sought to provide a consolidated review of the available data on the prevalence of commonly occurring acute pain in children in the self-care setting. An extensive literature search was performed to determine the prevalence of acute pain at multiple bodily locations in children aged between 3 months and 18 years. We considered the influence of age, sex, and sociodemographic factors on prevalence estimates. We also sought to identify some of the challenges involved in assessing and managing pediatric pain, thus shedding light on areas where there may be clinical and medical unmet needs. In general, a high prevalence of acute pain in children was detected, particularly headache, menstruation-related pain, and dental and back pain. Older age, female sex, and lower socioeconomic status were associated with increased pain prevalence. Risk factors were identified for all pain types and included psychological issues, stress, and unhealthy lifestyle habits. Owing to the heterogeneity in study populations, the prevalence estimates varied widely; there was also heterogeneity in the pain assessment tools utilized. The paucity of information regarding pain prevalence appears to be out of proportion with the burden of acute pain in children. This could indicate that clinicians may not be equipped with an optimal pain management strategy to guide their practice, especially regarding the use of developmentally appropriate pain assessment tools, without which prevalence data may not be captured. If acute pain is not accurately identified, it cannot be optimally treated. Further investigation is required to determine how the information from prevalence studies translates to the real-world setting.

Reducing bias in trials from reactions to measurement: the MERIT study including developmental work and expert workshop.

BACKGROUND: Measurement can affect the people being measured; for example, asking people to complete a questionnaire can result in changes in behaviour (the 'question-behaviour effect'). The usual methods of conduct and analysis of randomised controlled trials implicitly assume that the taking of measurements has no effect on research participants. Changes in measured behaviour and other outcomes due to measurement reactivity may therefore introduce bias in otherwise well-conducted randomised controlled trials, yielding incorrect estimates of intervention effects, including underestimates. OBJECTIVES: The main objectives were (1) to promote awareness of how and where taking measurements can lead to bias and (2) to provide recommendations on how best to avoid or minimise bias due to measurement reactivity in randomised controlled trials of interventions to improve health. METHODS: We conducted (1) a series of systematic and rapid reviews, (2) a Delphi study and (3) an expert workshop. A protocol paper was published [Miles LM, Elbourne D, Farmer A, Gulliford M, Locock L, McCambridge J, et al. Bias due to MEasurement Reactions In Trials to improve health (MERIT): protocol for research to develop MRC guidance. Trials 2018;19:653]. An updated systematic review examined whether or not measuring participants had an effect on participants' health-related behaviours relative to no-measurement controls. Three new rapid systematic reviews were conducted to identify (1) existing guidance on measurement reactivity, (2) existing systematic reviews of studies that have quantified the effects of measurement on outcomes relating to behaviour and affective outcomes and (3) experimental studies that have investigated the effects of exposure to objective measurements of behaviour on health-related behaviour. The views of 40 experts defined the scope of the recommendations in two waves of data collection during the Delphi procedure. A workshop aimed to produce a set of recommendations that were formed in discussion in groups. RESULTS: Systematic reviews - we identified a total of 43 studies that compared interview or questionnaire measurement with no measurement and these had an overall small effect (standardised mean difference 0.06, 95% confidence interval 0.02 to 0.09; n = 104,096, I2 = 54%). The three rapid systematic reviews identified no existing guidance on measurement reactivity, but we did identify five systematic reviews that quantified the effects of measurement on outcomes (all focused on the question-behaviour effect, with all standardised mean differences in the range of 0.09-0.28) and 16 studies that examined reactive effects of objective measurement of behaviour, with most evidence of reactivity of small effect and short duration. Delphi procedure - substantial agreement was reached on the scope of the present recommendations. Workshop - 14 recommendations and three main aims were produced. The aims were to identify whether or not bias is likely to be a problem for a trial, to decide whether or not to collect further quantitative or qualitative data to inform decisions about if bias is likely to be a problem, and to identify how to design trials to minimise the likelihood of this bias. LIMITATION: The main limitation was the shortage of high-quality evidence regarding the extent of measurement reactivity, with some notable exceptions, and the circumstances that are likely to bring it about. CONCLUSION: We hope that these recommendations will be used to develop new trials that are less likely to be at risk of bias. FUTURE WORK: The greatest need is to increase the number of high-quality primary studies regarding the extent of measurement reactivity. STUDY REGISTRATION: The first systematic review in this study is registered as PROSPERO CRD42018102511. FUNDING: Funded by the Medical Research Council UK and the National Institute for Health Research as part of the Medical Research Council-National Institute for Health Research Methodology Research Programme.

When people are asked to complete measures such as questionnaires in research studies this can produce changes in the behaviour or emotions of those people. For example, people who are asked to complete questionnaires about drinking alcohol have been found to drink slightly less, on average, than people who are not asked to complete questionnaires. Current established methods of research usually ignore these reactions to measurement. The present research aimed to produce recommendations for how best to deal with reactions to measurement. The scope of these recommendations was limited to 'trials' used to test whether or not a treatment improves health. To do this, we identified relevant research studies that have investigated various different aspects of whether or not measurement affects the people being measured. We then consulted 40 experts about what the current recommendations should consider and what was not within the scope of the current recommendations. We then gathered 23 experts together for 2 days to produce a set of recommendations. We found 43 research studies that have looked at whether or not being asked to complete questionnaires or being interviewed affects the behaviour of those people invited. In general, there were some effects of completing questionnaires, but the effects were not very consistent across research studies. There were few studies that have looked at the effects of using measures of behaviour other than questionnaires (e.g. blood pressure cuffs). We could find no existing recommendations for how best to deal with reactions to measurement in research studies that examine whether or not treatments improve health. We have produced 14 recommendations for researchers to better take account of the issue of measuring affecting the people being measured. We hope that this will help future research produce more accurate answers. We also identified that there is a need for more studies of the effects of measures other than questionnaires.

Reducing bias in trials due to reactions to measurement: experts produced recommendations informed by evidence.

OBJECTIVE: This study (MEasurement Reactions In Trials) aimed to produce recommendations on how best to minimize bias from measurement reactivity (MR) in randomized controlled trials of interventions to improve health. STUDY DESIGN AND SETTING: The MERIT study consisted of: (1) an updated systematic review that examined whether measuring participants had effects on participants' health-related behaviors, relative to no-measurement controls, and three rapid reviews to identify: (i) existing guidance on MR; (ii) existing systematic reviews of studies that have quantified the effects of measurement on behavioral or affective outcomes; and (iii) studies that have investigated the effects of objective measurements of behavior on health-related behavior; (2) a Delphi study to identify the scope of the recommendations; and (3) an expert workshop in October 2018 to discuss potential recommendations in groups. RESULTS: Fourteen recommendations were produced by the expert group to: (1) identify whether bias is likely to be a problem for a trial; (2) decide whether to collect data about whether bias is likely to be a problem; (3) design trials to minimize the likelihood of this bias. CONCLUSION: These recommendations raise awareness of how and where taking measurements can produce bias in trials, and are thus helpful for trial design.

Understanding acceptability in the context of text messages to encourage medication adherence in people with type 2 diabetes.

BACKGROUND: Acceptability is recognised as a key concept in the development of health interventions, but there has been a lack of consensus about how acceptability should be conceptualised. The theoretical framework of acceptability (TFA) provides a potential tool for understanding acceptability. It has been proposed that acceptability measured before use of an intervention (anticipated acceptability) may differ from measures taken during and after use (experienced acceptability), but thus far this distinction has not been tested for a specific intervention. This paper 1) directly compares ratings of anticipated and experienced acceptability of a text message-based intervention, 2) explores the applicability of the TFA in a technology-based intervention, and 3) uses these findings to inform suggestions for measuring acceptability over the lifespan of technology-based health interventions. METHODS: Data were obtained from a quantitative online survey assessing anticipated acceptability of the proposed text messages (n = 59) and a 12-week proof-of-concept mixed methods study assessing experienced acceptability while receiving the text messages (n = 48). Both quantitative ratings by return text message, and qualitative data from participant interviews were collected during the proof-of-concept study. RESULTS: The quantitative analysis showed anticipated and experienced acceptability were significantly positively correlated (rs > .4). The qualitative analysis identified four of the seven constructs of the TFA as themes (burden, intervention coherence, affective attitude and perceived effectiveness). An additional two themes were identified as having an important impact on the TFA constructs (perceptions of appropriateness and participants' role). Three suggestions are given related to the importance of appropriateness, what may affect ratings of acceptability and what to consider when measuring acceptability. CONCLUSIONS: The high correlation between anticipated and experienced acceptability was a surprising finding and could indicate that, in some cases, acceptability of an intervention can be gauged adequately from an anticipated acceptability study, prior to an expensive pilot or feasibility study. Directly exploring perceptions of appropriateness and understanding whether the acceptability described by participants is related to the intervention or the research - and is for themselves or others - is important in interpreting the results and using them to further develop interventions and predict future use.

The theoretical basis of a nationally implemented type 2 diabetes prevention programme: how is the programme expected to produce changes in behaviour?

BACKGROUND: It is considered best practice to provide clear theoretical descriptions of how behaviour change interventions should produce changes in behaviour. Commissioners of the National Health Service Diabetes Prevention Programme (NHS-DPP) specified that the four independent provider organisations must explicitly describe the behaviour change theory underpinning their interventions. The nationally implemented programme, launched in 2016, aims to prevent progression to Type 2 diabetes in high-risk adults through changing diet and physical activity behaviours. This study aimed to: (a) develop a logic model describing how the NHS-DPP is expected to work, and (b) document the behaviour change theories underpinning providers' NHS-DPP interventions. METHODS: A logic model detailing how the programme should work in changing diet and activity behaviours was extracted from information in three specification documents underpinning the NHS-DPP. To establish how each of the four providers expected their interventions to produce behavioural changes, information was extracted from their programme plans, staff training materials, and audio-recorded observations of mandatory staff training courses attended in 2018. All materials were coded using Michie and Prestwich's Theory Coding Scheme. RESULTS: The NHS-DPP logic model included information provision to lead to behaviour change intentions, followed by a self-regulatory cycle including action planning and monitoring behaviour. None of the providers described an explicit logic model of how their programme will produce behavioural changes. Two providers stated their programmes were informed by the COM-B (Capability Opportunity Motivation - Behaviour) framework, the other two described targeting factors from multiple theories such as Self-Regulation Theory and Self-Determination Theory. All providers cited examples of proposed links between some theoretical constructs and behaviour change techniques (BCTs), but none linked all BCTs to specified constructs. Some discrepancies were noted between the theory described in providers' programme plans and theory described in staff training. CONCLUSIONS: A variety of behaviour change theories were used by each provider. This may explain the variation between providers in BCTs selected in intervention design, and the mismatch between theory described in providers' programme plans and staff training. Without a logic model describing how they expect their interventions to work, justification for intervention contents in providers' programmes is not clear.

The Fidelity of Training in Behaviour Change Techniques to Intervention Design in a National Diabetes Prevention Programme.

BACKGROUND: The National Health Service Diabetes Prevention Programme (NHS-DPP) is a behavioural intervention for people identified as high risk for developing type 2 diabetes that has been rolled out across England. The present study evaluates whether the four commercial providers of the NHS-DPP train staff to deliver behaviour change technique (BCT) content with fidelity to intervention plans. METHOD: One set of mandatory training courses across the four NHS-DPP providers (seven courses across 13 days) was audio-recorded, and all additional training materials used were collected. Recordings and training materials were coded for BCT content using the BCT Taxonomy v1. BCTs and depth of training (e.g. instruction, demonstration, practice) of BCT content was checked against providers' intervention plans. RESULTS: Ten trainers and 78 trainees were observed, and 12 documents examined. The number of unique BCTs in audio recordings and associated training materials ranged from 19 to 44 across providers, and staff were trained in 53 unique BCTs across the whole NHS-DPP. Staff were trained in 66% of BCTs that were in intervention plans, though two providers trained staff in approximately half of BCTs to be delivered. The most common way that staff were trained in BCT delivery was through instruction. Training delivery style (e.g. experiential versus educational) varied between providers. CONCLUSION: Observed training evidences dilution from providers' intervention plans. NHS-DPP providers should review their training to ensure staff are trained in all key intervention components, ensuring thorough training of BCTs (e.g. demonstrating and practicing how to deliver) to enhance BCT delivery.

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.