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Abstract This is a process evaluation of a large UK-based randomised controlled trial (RCT) (n = 5602) evaluating the effectiveness of recommending an alcohol reduction app, Drink Less, compared with usual digital care in reducing alcohol consumption in increasing and higher risk drinkers. The aim was to understand whether participants’ engagement (‘self-reported adherence’) and behavioural characteristics were mechanisms of action underpinning the effectiveness of Drink Less. Self-reported adherence with both digital tools was over 70% (Drink Less: 78.0%, 95% CI = 77.6–78.4; usual digital care: 71.5%, 95% CI = 71.0–71.9). Self-reported adherence to the intervention (average causal mediation effect [ACME] = −0.250, 95% CI = −0.42, −0.11) and self-monitoring behaviour (ACME = −0.235, 95% CI = −0.44, −0.03) both partially mediated the effect of the intervention (versus comparator) on alcohol reduction. Following the recommendation (self-reported adherence) and the tracking (self-monitoring behaviour) feature of the Drink Less app appear to be important mechanisms of action for alcohol reduction among increasing and higher risk drinkers.

Abstract Background Promoting the uptake of vaccination for infectious diseases such as COVID-19 remains a global challenge, necessitating collaborative efforts between public health units (PHUs) and communities. Applied behavioural science can play a crucial role in supporting PHUs’ response by providing insights into human behaviour and informing tailored strategies to enhance vaccination uptake. Community engagement can help broaden the reach of behavioural science research by involving a more diverse range of populations and ensuring that strategies better represent the needs of specific communities. We developed and applied an approach to conducting community-based behavioural science research with ethnically and socioeconomically diverse populations to guide PHUs in tailoring their strategies to promote COVID-19 vaccination. This paper presents the community engagement methodology and the lessons learned in applying the methodology. Methods The community engagement methodology was developed based on integrated knowledge translation (iKT) and community-based participatory research (CBPR) principles. The study involved collaboration with PHUs and local communities in Ontario, Canada to identify priority groups for COVID-19 vaccination, understand factors influencing vaccine uptake and co-design strategies tailored to each community to promote vaccination. Community engagement was conducted across three large urban regions with individuals from Eastern European communities, African, Black, and Caribbean communities and low socioeconomic neighbourhoods. Results We developed and applied a seven-step methodology for conducting community-based behavioural science research: (1) aligning goals with system-level partners; (2) engaging with PHUs to understand priorities; (3) understanding community strengths and dynamics; (4) building relationships with each community; (5) establishing partnerships (community advisory groups); (6) involving community members in the research process; and (7) feeding back and interpreting research findings. Research partnerships were successfully established with members of prioritized communities, enabling recruitment of participants for theory-informed behavioural science interviews, interpretation of findings, and co-design of targeted recommendations for each PHU to improve COVID-19 vaccination uptake. Lessons learned include the importance of cultural sensitivity and awareness of sociopolitical context in tailoring community engagement, being agile to address the diverse and evolving priorities of PHUs, and building trust to achieve effective community engagement. Conclusion Effective community engagement in behavioural science research can lead to more inclusive and representative research. The community engagement approach developed and applied in this study acknowledges the diversity of communities, recognizes the central role of PHUs, and can help in addressing complex public health challenges.

Objectives: The importance of SARS-CoV-2 transmission via the eyes is unknown, with previous studies mainly focusing on protective eyewear in healthcare settings. This study aimed to test the hypothesis that wearing eyeglasses is associated with a lower risk of COVID-19. Methods: Participants from the Virus Watch prospective community cohort study responded to a questionnaire on the use of eyeglasses and contact lenses. Infection was confirmed through data linkage, self-reported positive results, and, for a subgroup, monthly capillary antibody testing. Multivariable logistic regression models, controlling for age, sex, income, and occupation, were used to identify the odds of infection depending on frequency and purpose of eyeglasses or contact lenses use. Results: A total of 19,166 participants responded to the questionnaire, with 13,681 (71.3%, CI 70.7-72.0) reporting they wore eyeglasses. Multivariable logistic regression model showed a 15% lower odds of infection for those who reported using eyeglasses always for general use (odds ratio [OR] 0.85, 95% 0.77-0.95, P = 0.002) compared to those who never wore eyeglasses. The protective effect was reduced for those who said wearing eyeglasses interfered with mask-wearing and was absent for contact lens wearers. Conclusions: People who wear eyeglasses have a moderate reduction in risk of COVID-19 infection, highlighting that eye protection may make a valuable contribution to the reduction of transmission in community and healthcare settings.

BackgroundThe extent to which interventions are perceived as acceptable to users impacts engagement and efficacy. ObjectiveIn this study, we evaluated the acceptability of (1) the smartphone app Drink Less (intervention) and (2) the National Health Service (NHS) alcohol advice web page (usual digital care and comparator) among adult drinkers in the United Kingdom participating in a randomized controlled trial evaluating the effectiveness of the Drink Less app. MethodsA subsample of 26 increasing- and higher-risk drinkers (Alcohol Use Disorders Identification Test score≥8) assigned to the intervention group (Drink Less; n=14, 54%; female: n=10, 71%; age: 22-72 years; White: n=9, 64%) or usual digital care group (NHS alcohol advice web page; n=12, 46%; female: n=5, 42%; age: 23-68 years: White: n=9, 75%) took part in semistructured interviews. The interview questions were mapped on to the 7 facets of acceptability according to the Theoretical Framework of Acceptability: affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs, and self-efficacy. Alongside these constructs, we also included a question on perceived personal relevance, which previous research has linked to acceptability and engagement. Framework and thematic analysis of data was undertaken. ResultsThe Drink Less app was perceived as being ethical, easy, user-friendly, and effective for the period the app was used. Participants reported particularly liking the tracking and feedback sections of the app, which they reported increased personal relevance and which resulted in positive affect when achieving their goals. They reported no opportunity cost. Factors such as negative affect when not meeting goals and boredom led to disengagement in the longer term for some participants. The NHS alcohol advice web page was rated as being easy and user-friendly with no opportunity costs. However, the information presented was not perceived as being personally relevant or effective in changing drinking behavior. Most participants reported neutral or negative affect, most participants thought the alcohol advice web page was accessible, and some participants reported ethical concerns around the availability of suggested resources. Some participants reported that it had acted as a starting point or a signpost to other resources. Participants in both groups discussed motivation to change and contextual factors such as COVID-19 lockdowns, which influenced their perceived self-efficacy regardless of their assigned intervention. ConclusionsDrink Less appears to be an acceptable digital intervention among the recruited sample. The NHS alcohol advice web page was generally considered unacceptable as a stand-alone intervention among the recruited sample, although it may signpost and help people access other resources and interventions.

IntroductionThis study evaluated a series of disposal instruction labels for their effectiveness in enabling the desired disposal of compostable plastic packaging.MethodsMixed methods were employed: an online experiment and a survey. UK citizens (n = 1,008) completed a task, sorting packaging labelled with various disposal instructions into one of three bins (general waste, food waste, and recycling). They also selected a preferred compostable disposal instruction logo and provided reasons for their preference.ResultsItems lacking disposal instructions followed intuitive disposal practices: items with a common practice of being compostable were most frequently disposed of into food waste; items with a common practice of being recycled were most frequently disposed of into recycling; and items with a common practice of being disposed of with general waste were most frequently disposed of with general waste. “Do not recycle” was effective at diverting compostable plastic packaging to general waste. The label “compost with food waste” had the highest rate of correct disposal in the food waste bin when compared to the control group and to the “compost” disposal instruction. “Compost with food waste”, however, was not statistically different from “put with food waste” or “recycle with food waste”; all three led to statistically similar disposal rates in the food waste bin. Qualitative findings showed that participants preferred clarity and directness in the disposal instructions logo denoting compostability.DiscussionFindings suggest that citizens struggle to identify compostable plastic packaging from appearance alone. Clear direct disposal instruction wording can help enable the appropriate disposal behaviours. Qualitative findings showed that participants preferred clarity and directness in the disposal instructions logo denoting compostability. The depiction of simple yet unambiguous and instructive symbols was valued and likely to be the better instigators of behaviour change compared with associative symbols. Implications for labelling policy are discussed.

Background Behaviour change interventions influence behaviour through causal processes called “mechanisms of action” (MoAs). Reports of such interventions and their evaluations often use inconsistent or ambiguous terminology, creating problems for searching, evidence synthesis and theory development. This inconsistency includes the reporting of MoAs. An ontology can help address these challenges by serving as a classification system that labels and defines MoAs and their relationships. The aim of this study was to develop an ontology of MoAs of behaviour change interventions. Methods To develop the MoA Ontology, we (1) defined the ontology’s scope; (2) identified, labelled and defined the ontology’s entities; (3) refined the ontology by annotating (i.e., coding) MoAs in intervention reports; (4) refined the ontology via stakeholder review of the ontology’s comprehensiveness and clarity; (5) tested whether researchers could reliably apply the ontology to annotate MoAs in intervention evaluation reports; (6) refined the relationships between entities; (7) reviewed the alignment of the MoA Ontology with other relevant ontologies, (8) reviewed the ontology’s alignment with the Theories and Techniques Tool; and (9) published a machine-readable version of the ontology. Results An MoA was defined as “a process that is causally active in the relationship between a behaviour change intervention scenario and its outcome behaviour”. We created an initial MoA Ontology with 261 entities through Steps 2-5. Inter-rater reliability for annotating study reports using these entities was α=0.68 (“acceptable”) for researchers familiar with the ontology and α=0.47 for researchers unfamiliar with it. As a result of additional revisions (Steps 6-8), 23 further entities were added to the ontology resulting in 284 entities organised in seven hierarchical levels. Conclusions The MoA Ontology extensively captures MoAs of behaviour change interventions. The ontology can serve as a controlled vocabulary for MoAs to consistently describe and synthesise evidence about MoAs across diverse sources.

Background The Behaviour Change Technique Taxonomy v1 (BCTTv1) specifies the potentially active content of behaviour change interventions. Evaluation of BCTTv1 showed the need to extend it into a formal ontology, improve its labels and definitions, add BCTs and subdivide existing BCTs. We aimed to develop a Behaviour Change Technique Ontology (BCTO) that would meet these needs. Methods The BCTO was developed by: (1) collating and synthesising feedback from multiple sources; (2) extracting information from published studies and classification systems; (3) multiple iterations of reviewing and refining entities, and their labels, definitions and relationships; (4) refining the ontology via expert stakeholder review of its comprehensiveness and clarity; (5) testing whether researchers could reliably apply the ontology to identify BCTs in intervention reports; and (6) making it available online and creating a computer-readable version. Results Initially there were 282 proposed changes to BCTTv1. Following first-round review, 19 BCTs were split into two or more BCTs, 27 new BCTs were added and 26 BCTs were moved into a different group, giving 161 BCTs hierarchically organised into 12 logically defined higher-level groups in up to five hierarchical levels. Following expert stakeholder review, the refined ontology had 247 BCTs hierarchically organised into 20 higher-level groups. Independent annotations of intervention evaluation reports by researchers familiar and unfamiliar with the ontology resulted in good levels of inter-rater reliability (0.82 and 0.79, respectively). Following revision informed by this exercise, 34 BCTs were added, resulting in the first published version of the BCTO containing 281 BCTs organised into 20 higher-level groups over five hierarchical levels. Discussion The BCTO provides a standard terminology and comprehensive classification system for the content of behaviour change interventions that can be reliably used to describe interventions. The development and maintenance of an ontology is an iterative and ongoing process; no ontology is ever ‘finished’. The BCTO will continue to evolve and grow (e.g. new BCTs or improved definitions) as a result of user feedback and new available evidence.

Background Trace amine-associated receptor 1 (TAAR1) agonism shows promise for treating psychosis, prompting us to synthesise data from human and non-human studies. Methods We co-produced a living systematic review of controlled studies examining TAAR1 agonists in individuals (with or without psychosis/schizophrenia) and relevant animal models. Two independent reviewers identified studies in multiple electronic databases (until 17.11.2023), extracted data, and assessed risk of bias. Primary outcomes were standardised mean differences (SMD) for overall symptoms in human studies and hyperlocomotion in animal models. We also examined adverse events and neurotransmitter signalling. We synthesised data with random-effects meta-analyses. Results Nine randomised trials provided data for two TAAR1 agonists (ulotaront and ralmitaront), and 15 animal studies for 10 TAAR1 agonists. Ulotaront and ralmitaront demonstrated few differences compared to placebo in improving overall symptoms in adults with acute schizophrenia (N=4 studies, n=1291 participants; SMD=0.15, 95%CI: -0.05, 0.34), and ralmitaront was less efficacious than risperidone (N=1, n=156, SMD=-0.53, 95%CI: -0.86, -0.20). Large placebo response was observed in ulotaront phase-III trials. Limited evidence suggested a relatively benign side-effect profile for TAAR1 agonists, although nausea and sedation were common after a single dose of ulotaront. In animal studies, TAAR1 agonists improved hyperlocomotion compared to control (N=13 studies, k=41 experiments, SMD=1.01, 95%CI: 0.74, 1.27), but seemed less efficacious compared to dopamine D2 receptor antagonists (N=4, k=7, SMD=-0.62, 95%CI: -1.32, 0.08). Limited human and animal data indicated that TAAR1 agonists may regulate presynaptic dopaminergic signalling. Conclusions TAAR1 agonists may be less efficacious than dopamine D2 receptor antagonists already licensed for schizophrenia. The results are preliminary due to the limited number of drugs examined, lack of longer-term data, publication bias, and assay sensitivity concerns in trials associated with large placebo response. Considering their unique mechanism of action, relatively benign side-effect profile and ongoing drug development, further research is warranted. Registration PROSPERO-ID:CRD42023451628.

Background The Behaviour Change Intervention Ontology (BCIO) aims to improve the clarity, completeness and consistency of reporting within intervention descriptions and evidence synthesis. However, a recommended method for transparently annotating intervention evaluation reports using the BCIO does not currently exist. This study aimed to develop a data extraction template for annotating using the BCIO. Methods The BCIO data extraction template was developed in four stages: i) scoping review of papers citing component ontologies within the BCIO, ii) development of a draft template, iii) piloting and revising the template, and iv) dissemination and maintenance of the template. Results A prototype data extraction template using Microsoft Excel was developed based on BCIO annotations from 14 papers. The ‘BCIO data extraction template v1’ was produced following piloting and revision, incorporating a facility for user feedback. Discussion This data extraction template provides a single, accessible resource to extract all necessary characteristics of behaviour change intervention scenarios. It can be used to annotate the presence of BCIO entities for evidence synthesis, including systematic reviews. In the future, we will update this template based on feedback from the community, additions of newly published ontologies within the BCIO, and revisions to existing ontologies.

BackgroundRandomized controlled trials (RCTs) with no in-person contact (ie, remote) between researchers and participants offer savings in terms of cost and time but present unique challenges. ObjectiveThe goal of this study is to examine the differences between different forms of remote recruitment (eg, National Health Service [NHS] website, social media, and radio advertising) in the proportion of participants recruited, demographic diversity, follow-up rates, and cost. We also examine the cost per participant of sequential methods of follow-up (emails, phone calls, postal surveys, and postcards). Finally, our experience with broader issues around study advertising and participant deception is discussed. MethodsWe conducted a descriptive analysis of 5602 increasing-and-higher-risk drinkers (Alcohol Use Disorders Identification Test score ≥8), taking part in a 2-arm, parallel group, remote RCT with a 1:1 allocation, comparing the intervention (Drink Less app) with usual digital care (NHS alcohol advice web page). Participants were recruited between July 2020 and March 2022 and compensated with gift vouchers of up to £36 (a currency exchange rate of £1=US $1.26988 is applicable) for completing follow-up surveys, with 4 stages of follow-up: email reminders, phone calls, postal survey, and postcard. ResultsThe three main recruitment methods were advertisements on (1) social media (2483/5602, 44.32%), (2) the NHS website (1961/5602, 35.01%), and (3) radio and newspapers (745/5602, 13.3%), with the remaining methods of recruitment accounting 7.37% (413/5602) of the sample. The overall recruitment cost per participant varied from £0 to £11.01. Costs were greater when recruiting participants who were men (£0-£28.85), from an ethnic minority group (£0-£303.81), and more disadvantaged (£0-£49.12). Targeted approaches were useful for recruiting more men but less useful in achieving diversity in ethnicity and socioeconomic status. Follow-up at 6 months was 79.58% (4458/5602). Of those who responded, 92.4% (4119/4458) responded by email. Each additional stage of follow-up resulted in an additional 2-3 percentage points of the overall sample being followed up, although phone calls, postal surveys, and postcards were more resource intensive than email reminders. ConclusionsFor remote RCTs, researchers could benefit from using a range of recruitment methods and cost-targeted approaches to achieve demographic diversity. Automated emails with substantial financial incentives for prompt completion can achieve good follow-up rates, and sequential, offline follow-up options, such as phone calls and postal surveys, can further increase follow-up rates but are comparatively expensive. We also make broader recommendations focused on striking the right balance when designing remote RCTs. Careful planning, ongoing maintenance, and dynamic decision-making are required throughout a trial to balance the competing demands of participation among those eligible, deceptive participation among those who are not eligible, and ensuring no postrandomization bias is introduced by data-checking protocols.

BackgroundHospital infection control policies protect patients and healthcare workers (HCWs) and limit the spread of pathogens, but adherence to COVID-19 guidance varies. We examined hospital HCWs' enactment of social distancing and use of personal protective equipment (PPE) during the COVID-19 pandemic, factors influencing these behaviours, and acceptability and feasibility of strategies to increase social distancing.MethodsAn online, cross-sectional survey (n = 86) and semi-structured interviews (n = 22) with HCWs in two English hospitals during the first wave of the COVID-19 pandemic (May-December 2020). The Capability, Opportunity, Motivation (COM-B) model of behaviour change underpinned survey and topic guide questions. Spearman Rho correlations examined associations between COM-B domains and behaviours. Interviews were analysed using inductive and deductive thematic analysis. Potential strategies to improve social distancing were selected using the Behaviour Change Wheel and discussed in a stakeholder workshop (n = 8 participants).ResultsSocial distancing enactment was low, with 85% of participants reporting very frequently or always being in close contact with others in communal areas. PPE use was high (88% very frequently or always using PPE in typical working day). Social distancing was associated with Physical Opportunity (e.g., size of physical space), Psychological Capability (e.g., clarity of guidance), and Social Opportunity (e.g., support from managers). Use of PPE was associated with Psychological Capability (e.g., training), Physical Opportunity (e.g., availability), Social Opportunity (e.g., impact on interactions with patients), and Reflective Motivation (e.g., beliefs that PPE is effective). Local champions and team competition were viewed as feasible strategies to improve social distancing.ConclusionsIt is valuable to understand and compare the drivers of individual protective behaviours; when faced with the same level of perceived threat, PPE use was high whereas social distancing was rarely enacted. Identified influences represent targets for intervention strategies in response to future infectious disease outbreaks.

Background: Investigating and enhancing the effectiveness of behaviour change interventions requires detailed and consistent specification of all aspects of interventions. We need to understand not only their content, that is the specific techniques, but also the source, mode, schedule, and style in which this content is delivered. Delivery style refers to the manner by which content is communicated to intervention participants. This paper reports the development of an ontology for specifying the style of delivery of interventions that depend on communication. This forms part of the Behaviour Change Intervention Ontology, which aims to cover all aspects of behaviour change intervention scenarios. Methods: The Style of Delivery Ontology was developed following methods for ontology development used in the Human Behaviour-Change Project, with seven key steps: 1) defining the scope of the ontology, 2) identifying key entities and developing their preliminary definitions by reviewing 100 behaviour change intervention evaluation reports and existing classification systems, 3) refining the ontology by piloting the ontology through annotations of 100 reports, 4) stakeholder review by eight behavioural science and public health experts, 5) inter-rater reliability testing through annotating 100 reports using the ontology, 6) specifying ontological relationships between entities, and 7) disseminating and maintaining the ontology. Results: The resulting ontology is a five-level hierarchical structure comprising 145 unique entities relevant to style of delivery. Key areas include communication processes, communication styles, and attributes of objects used in communication processes. Inter-rater reliability for annotating intervention evaluation reports was α=0.77 (good) for those familiar with the ontology and α=0.62 (acceptable) for those unfamiliar with it. Conclusions: The Style of Delivery Ontology can be used for both annotating and describing behaviour change interventions in a consistent and coherent manner, thereby improving evidence comparison, synthesis, replication, and implementation of effective interventions.

Background Using reports of randomised trials of smoking cessation interventions as a test case, this study aimed to develop and evaluate machine learning (ML) algorithms for extracting information from study reports and predicting outcomes as part of the Human Behaviour-Change Project. It is the first of two linked papers, with the second paper reporting on further development of a prediction system. Methods Researchers manually annotated 70 items of information (‘entities’) in 512 reports of randomised trials of smoking cessation interventions covering intervention content and delivery, population, setting, outcome and study methodology using the Behaviour Change Intervention Ontology. These entities were used to train ML algorithms to extract the information automatically. The information extraction ML algorithm involved a named-entity recognition system using the ‘FLAIR’ framework. The manually annotated intervention, population, setting and study entities were used to develop a deep-learning algorithm using multiple layers of long-short-term-memory (LSTM) components to predict smoking cessation outcomes. Results The F1 evaluation score, derived from the false positive and false negative rates (range 0-1), for the information extraction algorithm averaged 0.42 across different types of entity (SD=0.22, range 0.05-0.88) compared with an average human annotator’s score of 0.75 (SD=0.15, range 0.38-1.00). The algorithm for assigning entities to study arms (e.g., intervention or control) was not successful. This initial ML outcome prediction algorithm did not outperform prediction based just on the mean outcome value or a linear regression model. Conclusions While some success was achieved in using ML to extract information from reports of randomised trials of smoking cessation interventions, we identified major challenges that could be addressed by greater standardisation in the way that studies are reported. Outcome prediction from smoking cessation studies may benefit from development of novel algorithms, e.g., using ontological information to inform ML (as reported in the linked paper (1)).

In anxiety, depression and psychosis, there has been frustratingly slow progress in developing novel therapies that make a substantial difference in practice, as well as in predicting which treatments will work for whom and in what contexts. To intervene early in the process and deliver optimal care to patients, we need to understand the underlying mechanisms of mental health conditions, develop safe and effective interventions that target these mechanisms, and improve our capabilities in timely diagnosis and reliable prediction of symptom trajectories. Better synthesis of existing evidence is one way to reduce waste and improve efficiency in research towards these ends. Living systematic reviews produce rigorous, up-to-date and informative evidence summaries that are particularly important where research is emerging rapidly, current evidence is uncertain and new findings might change policy or practice. Global Alliance for Living Evidence on aNxiety, depressiOn and pSychosis (GALENOS) aims to tackle the challenges of mental health science research by cataloguing and evaluating the full spectrum of relevant scientific research including both human and preclinical studies. GALENOS will also allow the mental health community—including patients, carers, clinicians, researchers and funders—to better identify the research questions that most urgently need to be answered. By creating open-access datasets and outputs in a state-of-the-art online resource, GALENOS will help identify promising signals early in the research process. This will accelerate translation from discovery science into effective new interventions for anxiety, depression and psychosis, ready to be translated in clinical practice across the world.

BackgroundEvaluating digital interventions using remote methods enables the recruitment of large numbers of participants relatively conveniently and cheaply compared with in-person methods. However, conducting research remotely based on participant self-report with little verification is open to automated “bots” and participant deception. ObjectiveThis paper uses a case study of a remotely conducted trial of an alcohol reduction app to highlight and discuss (1) the issues with participant deception affecting remote research trials with financial compensation; and (2) the importance of rigorous data management to detect and address these issues. MethodsWe recruited participants on the internet from July 2020 to March 2022 for a randomized controlled trial (n=5602) evaluating the effectiveness of an alcohol reduction app, Drink Less. Follow-up occurred at 3 time points, with financial compensation offered (up to £36 [US $39.23]). Address authentication and telephone verification were used to detect 2 kinds of deception: “bots,” that is, automated responses generated in clusters; and manual participant deception, that is, participants providing false information. ResultsOf the 1142 participants who enrolled in the first 2 months of recruitment, 75.6% (n=863) of them were identified as bots during data screening. As a result, a CAPTCHA (Completely Automated Public Turing Test to Tell Computers and Humans Apart) was added, and after this, no more bots were identified. Manual participant deception occurred throughout the study. Of the 5956 participants (excluding bots) who enrolled in the study, 298 (5%) were identified as false participants. The extent of this decreased from 110 in November 2020, to a negligible level by February 2022 including a number of months with 0. The decline occurred after we added further screening questions such as attention checks, removed the prominence of financial compensation from social media advertising, and added an additional requirement to provide a mobile phone number for identity verification. ConclusionsData management protocols are necessary to detect automated bots and manual participant deception in remotely conducted trials. Bots and manual deception can be minimized by adding a CAPTCHA, attention checks, a requirement to provide a phone number for identity verification, and not prominently advertising financial compensation on social media. Trial RegistrationISRCTN Number ISRCTN64052601; https://doi.org/10.1186/ISRCTN64052601

Background: Behaviour change interventions influence behaviour through causal processes called “mechanisms of action” (MoAs). Reports of such interventions and their evaluations often use inconsistent or ambiguous terminology, creating problems for searching, evidence synthesis and theory development. This inconsistency includes the reporting of MoAs. An ontology can help address these challenges by serving as a classification system that labels and defines MoAs and their relationships. The aim of this study was to develop an ontology of MoAs of behaviour change interventions. Methods: To develop the MoA Ontology, we (1) defined the ontology’s scope; (2) identified, labelled and defined the ontology’s entities; (3) refined the ontology by annotating (i.e., coding) MoAs in intervention reports; (4) refined the ontology via stakeholder review of the ontology’s comprehensiveness and clarity; (5) tested whether researchers could reliably apply the ontology to annotate MoAs in intervention evaluation reports; (6) refined the relationships between entities; (7) reviewed the alignment of the MoA Ontology with other relevant ontologies, (8) reviewed the ontology’s alignment with the Theories and Techniques Tool; and (9) published a machine-readable version of the ontology. Results: An MoA was defined as “a process that is causally active in the relationship between a behaviour change intervention scenario and its outcome behaviour”. We created an initial MoA Ontology with 261 entities through Steps 2-5. Inter-rater reliability for annotating study reports using these entities was α=0.68 (“acceptable”) for researchers familiar with the ontology and α=0.47 for researchers unfamiliar with it. As a result of additional revisions (Steps 6-8), 21 further entities were added to the ontology resulting in 282 entities organised in seven hierarchical levels. Conclusions: The MoA Ontology extensively captures MoAs of behaviour change interventions. The ontology can serve as a controlled vocabulary for MoAs to consistently describe and synthesise evidence about MoAs across diverse sources.

Abstract The COVID-19 pandemic has brought the combined disciplines of public health, infectious disease and policy modelling squarely into the spotlight. Never before have decisions regarding public health measures and their impacts been such a topic of international deliberation, from the level of individuals and communities through to global leaders. Nor have models—developed at rapid pace and often in the absence of complete information—ever been so central to the decision-making process. However, after nearly 3 years of experience with modelling, policy-makers need to be more confident about which models will be most helpful to support them when taking public health decisions, and modellers need to better understand the factors that will lead to successful model adoption and utilization. We present a three-stage framework for achieving these ends.

Objectives: Seroprevalence studies can provide a measure of SARS-CoV-2 cumulative incidence, but a better understanding of spike and nucleocapsid (anti-N) antibody dynamics following infection is needed to assess the longevity of detectability. Methods: Adults aged ≥18 years, from households enrolled in the Virus Watch prospective community cohort study in England and Wales, provided monthly capillary blood samples, which were tested for spike antibody and anti-N. Participants self-reported vaccination dates and past medical history. Previous polymerase chain reaction (PCR) swabs were obtained through Second Generation Surveillance System linkage data. The primary outcome variables were seropositivity and total anti-N and spike antibody levels after PCR-confirmed infection. Results: A total of 13,802 eligible individuals provided 58,770 capillary blood samples. A total of 537 of these had a previous positive PCR-confirmed SARS-CoV-2 infection within 0-269 days of antibody sample date, among them 432 (80.45%) having a positive anti-N result. Median anti-N levels peaked between days 90 and 119 after PCR results and then began to decline. There is evidence of anti-N waning from 120 days onwards, with earlier waning for females and younger age categories. Conclusion: Our findings suggest that anti-N has around 80% sensitivity for identifying previous COVID-19 infection, and the duration of detectability is affected by sex and age.

Background Context is recognized as important to successful knowledge translation (KT) in health settings. What is meant by context, however, is poorly understood. The purpose of the current study was to elicit tacit knowledge about what is perceived to constitute context by conducting interviews with a variety of health system stakeholders internationally so as to compile a comprehensive list of contextual attributes and their features relevant to KT in healthcare. Methods A descriptive qualitative study design was used. Semi-structured interviews were conducted with health system stakeholders (change agents/KT specialists and KT researchers) in four countries: Australia, Canada, the United Kingdom, and the United States. Interview transcripts were analyzed using inductive thematic content analysis in four steps: (1) selection of utterances describing context, (2) coding of features of context, (3) categorizing of features into attributes of context, (4) comparison of attributes and features by: country, KT experience, and role. Results A total of 39 interviews were conducted. We identified 66 unique features of context, categorized into 16 attributes. One attribute, Facility Characteristics, was not represented in previously published KT frameworks. We found instances of all 16 attributes in the interviews irrespective of country, level of experience with KT, and primary role (change agent/KT specialist vs. KT researcher), revealing robustness and transferability of the attributes identified. We also identified 30 new context features (across 13 of the 16 attributes). Conclusion The findings from this study represent an important advancement in the KT field; we provide much needed conceptual clarity in context, which is essential to the development of common assessment tools to measure context to determine which context attributes and features are more or less important in different contexts for improving KT success.

Ontologies are ways of representing aspects of the world in terms of uniquely defined classes of ‘entities’ and relationships between them. They are widely used in biological science, data science and commerce because they provide clarity, consistency, and the ability to link information and data from different sources. Ontologies offer great promise as representational systems in behavioural science and could revolutionise descriptions of studies and findings, and the expression of models and theories. This paper discusses issues that have been raised about using ontologies in behavioural science and how these can be addressed. The issues arise partly from the way that ontologies represent information, which can be perceived as reductionist or simplistic, and partly from issues to do with their implementation. However, despite the simplicity of their structure, ontologies can represent complex entities that change over time, as well as their inter-relationships and highly nuanced information about them. Nevertheless, ontologies are only one of many ways of representing information and it is important to recognise when other forms are more efficient. With regard to implementation, it is important to build ontologies with involvement from the communities who will be using them. Far from constraining intellectual creativity, ontologies that are broadly-based can facilitate expression of nuance, comparison of findings and integration of different approaches and theories. Maintaining and updating ontologies remain significant challenges but can be achieved through establishing and coordinating communities of practice.

Background: The Behaviour Change Technique Taxonomy v1 (BCTTv1) specifies the potentially active content of behaviour change interventions. Evaluation of BCTTv1 showed the need to extend it into a formal ontology, improve its labels and definitions, add BCTs and subdivide existing BCTs. We aimed to develop a Behaviour Change Technique Ontology (BCTO) that would meet these needs. Methods: The BCTO was developed by: (1) collating and synthesising feedback from multiple sources; (2) extracting information from published studies and classification systems; (3) multiple iterations of reviewing and refining entities, and their labels, definitions and relationships; (4) refining the ontology via expert stakeholder review of its comprehensiveness and clarity; (5) testing whether researchers could reliably apply the ontology to identify BCTs in intervention reports; and (6) making it available online and creating a machine-readable version. Results: Initially there were 282 proposed changes to BCTTv1. Following first-round review, 19 BCTs were split into two or more BCTs, 27 new BCTs were added and 26 BCTs were moved into a different group, giving 161 BCTs hierarchically organised into 12 logically defined higher-level groups in up to five hierarchical levels. Following expert stakeholder review, the refined ontology had 247 BCTs hierarchically organised into 20 higher-level groups. Independent annotations of intervention evaluation reports by researchers familiar and unfamiliar with the ontology resulted in good levels of inter-rater reliability (0.82 and 0.79, respectively). Following revision informed by this exercise, 34 BCTs were added, resulting in a final version of the BCTO containing 281 BCTs organised into 20 higher-level groups over five hierarchical levels. Discussion: The BCT Ontology provides a standard terminology and comprehensive classification system for the content of behaviour change interventions that can be reliably used to describe interventions.

Abstract Social mixing contributes to the transmission of SARS-CoV-2. We developed a composite measure for risky social mixing, investigating changes during the pandemic and factors associated with risky mixing. Forty-five waves of online cross-sectional surveys were used (n = 78,917 responses; 14 September 2020 to 13 April 2022). We investigated socio-demographic, contextual and psychological factors associated with engaging in highest risk social mixing in England at seven timepoints. Patterns of social mixing varied over time, broadly in line with changes in restrictions. Engaging in highest risk social mixing was associated with being younger, less worried about COVID-19, perceiving a lower risk of COVID-19, perceiving COVID-19 to be a less severe illness, thinking the risks of COVID-19 were being exaggerated, not agreeing that one’s personal behaviour had an impact on how COVID-19 spreads, and not agreeing that information from the UK Government about COVID-19 can be trusted. Our composite measure for risky social mixing varied in line with restrictions in place at the time of data collection, providing some validation of the measure. While messages targeting psychological factors may reduce higher risk social mixing, achieving a large change in risky social mixing in a short space of time may necessitate a reimposition of restrictions.

Abstract Background Behaviour is key to suppressing the COVID-19 pandemic. Maintaining behaviour change can be difficult. We investigated engagement with hand cleaning, reducing the number of outings, and wearing a face covering over the course of the pandemic. Methods We used a series of 64 cross-sectional surveys between 10 February 2020 and 20 January 2022 (n ≈ 2000 per wave). Surveys investigated uptake of hand cleaning behaviours, out of home activity (England only, n ≈ 1700 per wave) and wearing a face covering (England only, restricted to those who reported going out shopping in the last week, n ≈ 1400 per wave). Results Reported hand cleaning has been high throughout the pandemic period (85 to 90% of participants consistently reporting washing their hands thoroughly and regularly with soap and water frequently or very frequently). Out of home activity has mirrored the easing and re-introduction of restrictive measures. Total number of outings were higher in the second national lockdown than in the first and third lockdowns. Wearing a face covering increased steadily between April to August 2020, plateauing until the end of measurement in May 2021, with approximately 80% of those who had been out shopping in the previous week reporting wearing a face covering frequently or very frequently. Conclusions Engagement with protective behaviours increased at the start of the pandemic and has remained high since. The greatest variations in behaviour reflected changes to Government rules. Despite the duration of restrictions, people have continued to adopt personal protective behaviours that were intended to prevent the spread of COVID-19.

Abstract Background Acute low back pain is a common condition, has high burden, and there are evidence-to-practice gaps in the chiropractic and physiotherapy setting for imaging and giving advice to stay active. The aim of this cluster randomised trial was to estimate the effects of a theory- and evidence-based implementation intervention to increase chiropractors’ and physiotherapists’ adherence to a guideline for acute low back pain compared with the comparator (passive dissemination of the guideline). In particular, the primary aim of the intervention was to reduce inappropriate imaging referral and improve patient low back pain outcomes, and to determine whether this intervention was cost-effective. Methods Physiotherapy and chiropractic practices in the state of Victoria, Australia, comprising at least one practising clinician who provided care to patients with acute low back pain, were invited to participate. Patients attending these practices were included if they had acute non-specific low back pain (duration less than 3 months), were 18 years of age or older, and were able to understand and read English. Practices were randomly assigned either to a tailored, multi-faceted intervention based on the guideline (interactive educational symposium plus academic detailing) or passive dissemination of the guideline (comparator). A statistician independent of the study team undertook stratified randomisation using computer-generated random numbers; four strata were defined by professional group and the rural or metropolitan location of the practice. Investigators not involved in intervention delivery were blinded to allocation. Primary outcomes were X-ray referral self-reported by clinicians using a checklist and patient low back pain-specific disability (at 3 months). Results A total of 104 practices (43 chiropractors, 85 physiotherapists; 755 patients) were assigned to the intervention and 106 practices (45 chiropractors, 97 physiotherapists; 603 patients) to the comparator; 449 patients were available for the patient-level primary outcome. There was no important difference in the odds of patients being referred for X-ray (adjusted (Adj) OR: 1.40; 95% CI 0.51, 3.87; Adj risk difference (RD): 0.01; 95% CI − 0.02, 0.04) or patient low back pain-specific disability (Adj mean difference: 0.37; 95% CI − 0.48, 1.21, scale 0–24). The intervention did lead to improvement for some key secondary outcomes, including giving advice to stay active (Adj OR: 1.96; 95% CI 1.20, 3.22; Adj RD: 0.10; 95% CI 0.01, 0.19) and intending to adhere to the guideline recommendations (e.g. intention to refer for X-ray: Adj OR: 0.27; 95% CI 0.17, 0.44; intention to give advice to stay active: Adj OR: 2.37; 95% CI 1.51, 3.74). Conclusions Intervention group clinicians were more likely to give advice to stay active and to intend to adhere to the guideline recommendations about X-ray referral. The intervention did not change the primary study outcomes, with no important differences in X-ray referral and patient disability between groups, implying that hypothesised reductions in health service utilisation and/or productivity gains are unlikely to offset the direct costs of the intervention. We report these results with the caveat that we enrolled less patients into the trial than our determined sample size. We cannot recommend this intervention as a cost-effective use of resources. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12609001022257 . Retrospectively registered on 25 November 2009

Background: To build cumulative evidence about what works in behaviour change interventions, efforts have been made to develop classification systems for specifying the content of interventions. The Behaviour Change Techniques (BCT) Taxonomy v1 (BCTTv1) is one of the most widely used classifications of behaviour change techniques across a variety of behaviours. The BCTTv1 was intentionally named version 1 to allow for further revisions to the taxonomy. This study aimed to gather data to improve the BCTTv1 and provide recommendations for developing it into a more elaborated knowledge structure, an ontology. Methods: Feedback from users of BCTTv1 about limitations and proposed improvements was collected through the BCT website, user survey, researchers and experts involved in the Human Behaviour-Change Project, and a consultation. In addition, relevant published research reports and other classification systems of BCTs were analysed. These data were synthesised to produce recommendations to inform the development of an ontology of BCTs. Results: A total of 282 comments from six sources were reviewed and synthesised into four categories of suggestions: additional BCTs, amendments to labels and definitions of specific BCTs, amendments to the groupings, and general improvements. Feedback suggested some lack of clarity regarding understanding and identifying techniques from labels, definitions, and examples; distinctions and relations between BCTs; and knowing what they would look like in practice. Three recommendations to improve the BCTTv1 resulted from this analysis: to review the label and definition of each BCT, the 16 groupings of BCTs, and the examples illustrating BCTs. Conclusions : This review of feedback about BCTTv1 identified the need to improve the precision and knowledge structure of the current taxonomy. A BCT ontology would enable the specification of relationships between BCTs, more precise definitions, and allow better interoperability with other ontologies. This ontology will be developed as part of the Human Behaviour-Change Project.

Background: The prevalence of genital chlamydia and gonorrhoea is higher in the 16–24 years age group than those in other age group. With users, we developed the theory-based safetxt intervention to reduce sexually transmitted infections. Objectives: To establish the effect of the safetxt intervention on the incidence of chlamydia/gonorrhoea infection at 1 year. Design: A parallel-group, individual-level, randomised superiority trial in which care providers and outcome assessors were blinded to allocation. Setting: Recruitment was from 92 UK sexual health clinics. Participants: Inclusion criteria were a positive chlamydia or gonorrhoea test result, diagnosis of non-specific urethritis or treatment started for chlamydia/gonorrhoea/non-specific urethritis in the last 2 weeks; owning a personal mobile phone; and being aged 16–24 years. Allocation: Remote computer-based randomisation with an automated link to the messaging system delivering intervention or control group messages. Intervention: The safetxt intervention was designed to reduce sexually transmitted infection by increasing partner notification, condom use and sexually transmitted infection testing before sex with new partners. It employed educational, enabling and incentivising content delivered by 42–79 text messages over 1 year, tailored according to type of infection, gender and sexuality. Comparator: A monthly message regarding trial participation. Main outcomes: The primary outcome was the incidence of chlamydia and gonorrhoea infection at 12 months, assessed using nucleic acid amplification tests. Secondary outcomes at 1 and 12 months included self-reported partner notification, condom use and sexually transmitted infection testing prior to sex with new partner(s). Results: Between 1 April 2016 and 23 November 2018, we assessed 20,476 people for eligibility and consented and randomised 6248 participants, allocating 3123 to the safetxt intervention and 3125 to the control. Primary outcome data were available for 4675 (74.8%) participants. The incidence of chlamydia/gonorrhoea infection was 22.2% (693/3123) in the intervention group and 20.3% (633/3125) in the control group (odds ratio 1.13, 95% confidence interval 0.98 to 1.31). There was no evidence of heterogeneity in any of the prespecified subgroups. Partner notification was 85.6% in the intervention group and 84.0% in the control group (odds ratio 1.14, 95% confidence interval 0.99 to 1.33). At 12 months, condom use at last sex was 33.8% in the intervention group and 31.2% in the control group (odds ratio 1.14, 95% confidence interval 1.01 to 1.28) and condom use at first sex with most recent new partner was 54.4% in the intervention group and 48.7% in the control group (odds ratio 1.27, 95% confidence interval 1.11 to 1.45). Testing before sex with a new partner was 39.5% in the intervention group and 40.9% in the control group (odds ratio 0.95, 95% confidence interval 0.82 to 1.10). Having two or more partners since joining the trial was 56.9% in the intervention group and 54.8% in the control group (odds ratio 1.11, 95% confidence interval 1.00 to 1.24) and having sex with someone new since joining the trial was 69.7% in the intervention group and 67.4% in the control group (odds ratio 1.13, 95% confidence interval 1.00 to 1.28). There were no differences in safety outcomes. Additional sensitivity and per-protocol analyses showed similar results. Limitations: Our understanding of the mechanism of action for the unanticipated effects is limited. Conclusions: The safetxt intervention did not reduce chlamydia and gonorrhoea infections, with slightly more infections in the intervention group. The intervention increased condom use but also increased the number of partners and new partners. Randomised controlled trials are essential for evaluating health communication interventions, which can have unanticipated effects. Future work: Randomised controlled trials evaluating novel interventions in this complex area are needed. Trial registration: This trial is registered as ISRCTN64390461. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 11, No. 1. See the NIHR Journals Library website for further project information.

Background: Digital interventions offer a potentially cost-effective means to support patient self-management in primary care, but evidence for the feasibility, acceptability and cost-effectiveness of digital interventions remains mixed. This programme focused on the potential for self-management digital interventions to improve outcomes in two common, contrasting conditions (i.e. hypertension and asthma) for which care is currently suboptimal, leading to excess deaths, illness, disability and costs for the NHS. Objectives: The overall purpose was to address the question of how digital interventions can best provide cost-effective support for patient self-management in primary care. Our aims were to develop and trial digital interventions to support patient self-management of hypertension and asthma. Through the process of planning, developing and evaluating these interventions, we also aimed to generate a better understanding of what features and methods for implementing digital interventions could make digital interventions acceptable, feasible, effective and cost-effective to integrate into primary care. Design: For the hypertension strand, we carried out systematic reviews of quantitative and qualitative evidence, intervention planning, development and optimisation, and an unmasked randomised controlled trial comparing digital intervention with usual care, with a health economic analysis and nested process evaluation. For the asthma strand, we carried out a systematic review of quantitative evidence, intervention planning, development and optimisation, and a feasibility randomised controlled trial comparing digital intervention with usual care, with nested process evaluation. Setting: General practices (hypertension, n = 76; asthma, n = 7) across Wessex and Thames Valley regions in Southern England. Participants: For the hypertension strand, people with uncontrolled hypertension taking one, two or three antihypertensive medications. For the asthma strand, adults with asthma and impaired asthma-related quality of life. Interventions: Our hypertension intervention (i.e. HOME BP) was a digital intervention that included motivational training for patients to self-monitor blood pressure, as well as health-care professionals to support self-management; a digital interface to send monthly readings to the health-care professional and to prompt planned medication changes when patients’ readings exceeded recommended targets for 2 consecutive months; and support for optional patient healthy behaviour change (e.g. healthy diet/weight loss, increased physical activity and reduced alcohol and salt consumption). The control group were provided with a Blood Pressure UK (London, UK) leaflet for hypertension and received routine hypertension care. Our asthma intervention (i.e. My Breathing Matters) was a digital intervention to improve the functional quality of life of primary care patients with asthma by supporting illness self-management. Motivational content intended to facilitate use of pharmacological self-management strategies (e.g. medication adherence and appropriate health-care service use) and non-pharmacological self-management strategies (e.g. breathing retraining, stress reduction and healthy behaviour change). The control group were given an Asthma UK (London, UK) information booklet on asthma self-management and received routine asthma care. Main outcome measures: The primary outcome for the hypertension randomised controlled trial was difference between intervention and usual-care groups in mean systolic blood pressure (mmHg) at 12 months, adjusted for baseline blood pressure, blood pressure target (i.e. standard, diabetic or aged > 80 years), age and general practice. The primary outcome for the asthma feasibility study was the feasibility of the trial design, including recruitment, adherence, intervention engagement and retention at follow-up. Health-care utilisation data were collected via notes review. Review methods: The quantitative reviews included a meta-analysis. The qualitative review comprised a meta-ethnography. Results: A total of 622 hypertensive patients were recruited to the randomised controlled trial, and 552 (89%) were followed up at 12 months. Systolic blood pressure was significantly lower in the intervention group at 12 months, with a difference of –3.4 mmHg (95% confidence interval –6.1 to –0.8 mmHg), and this gave an incremental cost per unit of systolic blood pressure reduction of £11 (95% confidence interval £5 to £29). Owing to a cost difference of £402 and a quality-adjusted life-year (QALY) difference of 0.044, long-term modelling puts the incremental cost per QALY at just over £9000. The probability of being cost-effective was 66% at willingness to pay £20,000 per quality-adjusted life-year, and this was higher at higher thresholds. A total of 88 patients were recruited to the asthma feasibility trial (target n = 80; n = 44 in each arm). At 3-month follow-up, two patients withdrew and six patients did not complete outcome measures. At 12 months, two patients withdrew and four patients did not complete outcome measures. A total of 36 out of 44 patients in the intervention group engaged with My Breathing Matters [with a median of four (range 0–25) logins]. Limitations: Although the interventions were designed to be as accessible as was feasible, most trial participants were white and participants of lower socioeconomic status were less likely to take part and complete follow-up measures. Challenges remain in terms of integrating digital interventions with clinical records. Conclusions: A digital intervention using self-monitored blood pressure to inform medication titration led to significantly lower blood pressure in participants than usual care. The observed reduction in blood pressure would be expected to lead to a reduction of 10–15% in patients suffering a stroke. The feasibility trial of My Breathing Matters suggests that a fully powered randomised controlled trial of the intervention is warranted. The theory-, evidence- and person-based approaches to intervention development refined through this programme enabled us to identify and address important contextual barriers to and facilitators of engagement with the interventions. Future work: This research justifies consideration of further implementation of the hypertension intervention, a fully powered randomised controlled trial of the asthma intervention and wide dissemination of our methods for intervention development. Our interventions can also be adapted for a range of other health conditions. Trial and study registration: The trials are registered as ISRCTN13790648 (hypertension) and ISRCTN15698435 (asthma). The studies are registered as PROSPERO CRD42013004773 (hypertension review) and PROSPERO CRD42014013455 (asthma review). Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 10, No. 11. See the NIHR Journals Library website for further information.

Compostable and biodegradable plastics are growing in popularity but their environmental credentials need to be more fully assessed to determine how they can be a part of the solution to the plastic waste crisis. We present results and analysis on home compostable packaging. This type of packaging requires the citizen to be able to correctly identify the packaging as “home compostable,” to have composting facilities at home, and to successfully compost the plastic. Using a citizen science approach, we engaged with 9,701 UK citizens geographically spread across the UK to examine their capability, opportunity, and motivation to do this. Of this cohort 1,648 citizens performed home compost experiments to test the environmental performance of compostable plastics. We report on the type of plastics they tested and their disintegration under real home composting conditions. The results show that the public are confused about the meaning of the labels of compostable and biodegradable plastics. 14% of sampled plastic packaging items tested were certified “industrial compostable” only and 46% had no compostable certification. Of the biodegradable and compostable plastics tested under different home composting conditions, the majority did not fully disintegrate, including 60% of those that were certified “home compostable.” We conclude that for both of these reasons, home composting is not an effective or environmentally beneficial waste processing method for biodegradable or compostable packaging in the UK.

BackgroundConversational agents (CAs) are increasingly used in health care to deliver behavior change interventions. Their evaluation often includes categorizing the behavior change techniques (BCTs) using a classification system of which the BCT Taxonomy v1 (BCTTv1) is one of the most common. Previous studies have presented descriptive summaries of behavior change interventions delivered by CAs, but no in-depth study reporting the use of BCTs in these interventions has been published to date. ObjectiveThis review aims to describe behavior change interventions delivered by CAs and to identify the BCTs and theories guiding their design. MethodsWe searched PubMed, Embase, Cochrane’s Central Register of Controlled Trials, and the first 10 pages of Google and Google Scholar in April 2021. We included primary, experimental studies evaluating a behavior change intervention delivered by a CA. BCTs coding followed the BCTTv1. Two independent reviewers selected the studies and extracted the data. Descriptive analysis and frequent itemset mining to identify BCT clusters were performed. ResultsWe included 47 studies reporting on mental health (n=19, 40%), chronic disorders (n=14, 30%), and lifestyle change (n=14, 30%) interventions. There were 20/47 embodied CAs (43%) and 27/47 CAs (57%) represented a female character. Most CAs were rule based (34/47, 72%). Experimental interventions included 63 BCTs, (mean 9 BCTs; range 2-21 BCTs), while comparisons included 32 BCTs (mean 2 BCTs; range 2-17 BCTs). Most interventions included BCTs 4.1 “Instruction on how to perform a behavior” (34/47, 72%), 3.3 “Social support” (emotional; 27/47, 57%), and 1.2 “Problem solving” (24/47, 51%). A total of 12/47 studies (26%) were informed by a behavior change theory, mainly the Transtheoretical Model and the Social Cognitive Theory. Studies using the same behavior change theory included different BCTs. ConclusionsThere is a need for the more explicit use of behavior change theories and improved reporting of BCTs in CA interventions to enhance the analysis of intervention effectiveness and improve the reproducibility of research.

Background: Many male prison leavers have significant mental health problems. Prison leavers often have a history of trauma, ongoing substance misuse and housing insecurity. Only a minority of prison leavers receive mental health care on release from prison. Objectives: The aim of the Engager research programme was to develop and evaluate a theory- and evidence-informed complex intervention designed to support individuals with common mental health problems (e.g. anxiety, depression) and other complex needs, including mental health comorbidity, before and after release from prison. Methods: In phase 1, the intervention was developed through a set of realist-informed substudies, including a realist review of psychosocial care for individuals with complex needs, case studies within services demonstrating promising intervention features, focus groups with individuals from under-represented groups, a rapid realist review of the intervention implementation literature and a formative process evaluation of the prototype intervention. In a parallel randomised trial, methodological development included selecting outcome measures through reviewing literature, piloting measures and a consensus process, developing ways to quantify intervention receipt, piloting trial procedures and modelling economic outcomes. In phase 2, we conducted an individually randomised superiority trial of the Engager intervention, cost-effectiveness and cost–consequence analyses and an in-depth mixed-methods process evaluation. Patient and public involvement influenced the programme throughout, primarily through a Peer Researcher Group. Results: In phase 1, the Engager intervention included multiple components. A practitioner offered participants practical support, emotional help (including mentalisation-based approaches) and liaison with other services in prison on the day of the participant’s release and for 3–5 months post release. An intervention delivery platform (i.e. training, manual, supervision) supported implementation. Outcome measures were selected through testing and stakeholder consensus to represent a broad range of domains, with a general mental health outcome as the primary measure for the trial. Procedures for recruitment and follow-up were tested and included flexible approaches to engagement and retention. In phase 2, the trial was conducted in three prison settings, with 280 participants randomised in a 1 : 1 ratio to receive either Engager plus usual care (n = 140) or usual care only (n = 140). We achieved a follow-up rate of 65% at 6 months post release from prison. We found no difference between the two groups for the Clinical Outcomes in Routine Evaluation – Outcome Measure at 6 months. No differences in secondary measures and sensitivity analyses were found beyond those expected by chance. The cost-effectiveness analysis showed that Engager cost significantly more at £2133 (95% of iterations between £997 and £3374) with no difference in quality-adjusted life-years (–0.017, 95% of iterations between –0.042 and 0.007). The mixed-methods process evaluation demonstrated implementation barriers. These barriers included problems with retention of the intervention team, and the adverse health and criminal justice system context. Seventy-seven per cent (108/140) of individuals had at least one community contact. Significant proportions of participants engaging received day release work and practical support. In contrast, there was evidence that the psychological components, mentalisation and developing a shared understanding were used less consistently. When engagement was positive, these components were associated with positive achievement of goals for individuals. We were also able to identify how to improve the intervention programme theory, including how to support individuals who were unrealistic in their perception of their ability to cope with challenges post release. Strengths and limitations: Our development work provides a worked example of the development of a complex intervention, particularly given little prior evidence or theory specific to male offenders to build on. Our trial methodological development enabled the completion of, to the best of our knowledge, the first fully powered trial of a mental health intervention for prison leavers with common mental health problems. There were potential weaknesses in the trial methodology in terms of follow-up rates and outcome measures, with the latter potentially being insufficiently sensitive to important but highly individual changes in participants who responded to the intervention. Conclusions: Delivering a randomised controlled trial for prison leavers with acceptable levels of follow-up is possible, despite adverse conditions. Full intervention implementation was challenging, but this is to be expected. Some individuals did respond well to the intervention when both practical and psychological support were flexibly deployed as intended, with evidence that most components were experienced as helpful for some individuals. It is recommended that several key components be developed further and tested, along with improved training and supervision, to support delivery of the Engager intervention within existing teams working with prison leavers. Trial registration: This trial is registered as ISRCTN11707331. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 10, No. 8. See the NIHR Journals Library website for further project information.

ObjectiveSince the outbreak of COVID-19, public health and social measures to contain its transmission (e.g., social distancing and lockdowns) have dramatically changed people's lives in rural and urban areas globally. To facilitate future management of the pandemic, it is important to understand how different socio-demographic groups adhere to such demands. This study aims to evaluate the influences of restriction policies on human mobility variations associated with socio-demographic groups in England, UK.MethodsUsing mobile phone global positioning system (GPS) trajectory data, we measured variations in human mobility across socio-demographic groups during different restriction periods from Oct 14, 2020 to Sep 15, 2021. The six restriction periods which varied in degree of mobility restriction policies, denoted as “Three-tier Restriction,” “Second National Lockdown,” “Four-tier Restriction,” “Third National Lockdown,” “Steps out of Lockdown,” and “Post-restriction,” respectively. Individual human mobility was measured with respect to the time period people stayed at home, visited places outside the home, and traveled long distances. We compared these indicators across the six restriction periods and across socio-demographic groups.ResultsAll human mobility indicators significantly differed across the six restriction periods, and the influences of restriction policies on individual mobility behaviors are correlated with socio-demographic groups. In particular, influences relating to mobility behaviors are stronger in younger and low-income groups in the second and third national lockdowns.ConclusionsThis study enhances our understanding of the influences of COVID-19 pandemic restriction policies on human mobility behaviors within different social groups in England. The findings can be usefully extended to support policy-making by investigating human mobility and differences in policy effects across not only age and income groups, but also across geographical regions.

Compostable plastics have great potential environmental benefits, however, the damage caused by incorrect waste management offsets them. This study aims to develop a behavior change intervention aimed at improving compostable plastic disposal. We illustrate application of the Behaviour Change Wheel framework to design an intervention in this context. First, the target behavior was understood by specifying it and identifying potential behavioral influences. Second, behavioral influences were systematically linked to potential intervention strategies and refined by evaluating the likely affordability, practicability, effectiveness, acceptability, equity and potential for side-effects (APEASE criteria) in a UK implementation context. Finally, intervention content and implementation options were selected by systematically selecting specific Behavior Change Techniques and refining them by evaluating them against APEASE criteria. The target behavior was identified as UK citizens disposing of compostable plastic waste in the food waste bin meant for collection by local authorities. Influences on compostable plastic disposal were identified as “psychological capability” (i.e., attention and knowledge), “reflective motivation” (i.e., beliefs around environmental impact of compostable plastics) and “physical opportunity” (i.e., access to appropriate waste management). “Education” and “environmental restructuring” were the intervention types selected. “Communications/marketing”, “guidelines” and “restructuring the physical and social environment” were the policy options selected. Selected behavior change techniques were: instruction on how to perform the behavior, prompts/cues, adding objects to the environment and restructuring the physical environment. The resulting intervention is a disposal instruction label for compostable packaging, comprising of instructions and a logo. The next step is user testing the developed disposal instruction labels in terms of their effect on promoting the desired disposal behavior. The novelty of this study includes the development of an intervention to reduce compostable plastic waste and the explicit, step-by-step documentation of the intervention development process. The scientific significance is therefore both applied and theoretical. When evaluated, our intervention has the potential to yield insights relating to what improves compostable plastic disposal amongst citizens. This, in turn, has key policy implications for product and package labeling. By openly documenting our method, we demonstrate a systematic and transparent approach to intervention design, providing an adaptable template and model for others.

Objectives To investigate changes in beliefs and behaviours following news of the Omicron variant and changes to guidance understanding of Omicron-related guidance, and factors associated with engaging with protective behaviours.Design Series of cross-sectional surveys (1 November to 16 December 2021, five waves of data collection).Setting Online.Participants People living in England, aged 16 years or over (n=1622–1902 per wave).Primary and secondary outcome measures Levels of worry and perceived risk, and engagement with key behaviours (out-of-home activities, risky social mixing, wearing a face covering and testing uptake).Results Degree of worry and perceived risk of COVID-19 (to oneself and people in the UK) fluctuated over time, increasing slightly around the time of the announcement about Omicron (p

Abstract Background Incorporating the feedback of expert stakeholders in ontology development is important to ensure content is appropriate, comprehensive, meets community needs and is interoperable with other ontologies and classification systems. However, domain experts are often not formally engaged in ontology development, and there is little available guidance on how this involvement should best be conducted and managed. Social and behavioural science studies often involve expert feedback in the development of tools and classification systems but have had little engagement with ontology development. This paper aims to (i) demonstrate how expert feedback can enhance ontology development, and (ii) provide practical recommendations on how to conduct expert feedback in ontology development using methodologies from the social and behavioural sciences. Main body Considerations for selecting methods for engaging stakeholders are presented. Mailing lists and issue trackers as existing methods used frequently in ontology development are discussed. Advisory boards and working groups, feedback tasks, consensus exercises, discussions and workshops are presented as potential methods from social and behavioural sciences to incorporate in ontology development. Conclusions A variety of methods from the social and behavioural sciences exist to enable feedback from expert stakeholders in ontology development. Engaging domain experts in ontology development enables depth and clarity in ontology development, whilst also establishing advocates for an ontology upon its completion.

Abstract Background Smartphone apps are increasingly used for health-related behaviour change and people discover apps through different sources. However, it is unclear whether users differ by mode of app discovery. Drink Less is an alcohol reduction app that received national media coverage in the UK caused by celebrity influence (a male TV and radio national broadcaster, aged 51). Our aim was to compare users who discovered the app before and after this coverage. Methods A natural experiment assessing the impact of media coverage of Drink Less on users’ socio-demographic and drinking characteristics, app engagement levels, and extent of alcohol reduction. The study period was from 17th May 2017 to 23rd January 2019, with media coverage starting on 21st August 2018. Users were 18 years or over, based in the UK and interested in drinking less. Interrupted time series analyses using Generalised Additive Mixed Models were conducted for each outcome variable aggregated at the weekly level. Results In 66 weeks prior to the media coverage, 8617 users downloaded the app and 18,959 in 23 weeks afterwards. There was a significant step-level increase in users’ mean age (B = 8.17, p

Abstract Background Audit and feedback (A&F) interventions are one of the most common approaches for implementing evidence-based practices. A key barrier to more effective A&F interventions is the lack of a theory-guided approach to the accumulation of evidence. Recent interviews with theory experts identified 313 theory-informed hypotheses, spread across 30 themes, about how to create more effective A&F interventions. In the current survey, we sought to elicit from stakeholders which hypotheses were most likely to advance the field if studied further. Methods From the list of 313, three members of the research team identified 216 that were clear and distinguishable enough for prioritization. A web-based survey was then sent to 211 A&F intervention stakeholders asking them to choose up to 50 ‘priority’ hypotheses following the header “A&F interventions will be more effective if…”. Analyses included frequencies of endorsement of the individual hypotheses and themes into which they were grouped. Results 68 of the 211 invited participants responded to the survey. Seven hypotheses were chosen by > 50% of respondents, including A&F interventions will be more effective… “if feedback is provided by a trusted source”; “if recipients are involved in the design/development of the feedback intervention”; “if recommendations related to the feedback are based on good quality evidence”; “if the behaviour is under the control of the recipient”; “if it addresses barriers and facilitators (drivers) to behaviour change”; “if it suggests clear action plans”; and “if target/goal/optimal rates are clear and explicit”. The most endorsed theme was Recipient Priorities (four hypotheses were chosen 92 times as a ‘priority’ hypotheses). Conclusions This work determined a set of hypotheses thought by respondents to be to be most likely to advance the field through future A&F intervention research. This work can inform a coordinated research agenda that may more efficiently lead to more effective A&F interventions.

Abstract Background Better information on the typical course and management of acute common infections in the community could inform antibiotic stewardship campaigns. We aimed to investigate the incidence, management, and natural history of a range of infection syndromes (respiratory, gastrointestinal, mouth/dental, skin/soft tissue, urinary tract, and eye). Methods Bug Watch was an online prospective community cohort study of the general population in England (2018–2019) with weekly symptom reporting for 6 months. We combined symptom reports into infection syndromes, calculated incidence rates, described the proportion leading to healthcare-seeking behaviours and antibiotic use, and estimated duration and severity. Results The cohort comprised 873 individuals with 23,111 person-weeks follow-up. The mean age was 54 years and 528 (60%) were female. We identified 1422 infection syndromes, comprising 40,590 symptom reports. The incidence of respiratory tract infection syndromes was two per person year; for all other categories it was less than one. 194/1422 (14%) syndromes led to GP (or dentist) consultation and 136/1422 (10%) to antibiotic use. Symptoms usually resolved within a week and the third day was the most severe. Conclusions Most people reported managing their symptoms without medical consultation. Interventions encouraging safe self-management across a range of acute infection syndromes could decrease pressure on primary healthcare services and support targets for reducing antibiotic prescribing.

Background: Blood transfusion is a common but costly treatment. Repeated national audits in the UK suggest that up to one-fifth of transfusions are unnecessary when judged against recommendations for good clinical practice. Audit and feedback seeks to improve patient care and outcomes by comparing clinical care against explicit standards. It is widely used internationally in quality improvement. Audit and feedback generally has modest but variable effects on patient care. A considerable scope exists to improve the impact that audit and feedback has, particularly through head-to-head trials comparing different ways of delivering feedback. Objectives: The AFFINITIE (Development & Evaluation of Audit and Feedback INterventions to Increase evidence-based Transfusion practIcE) programme aimed to design and evaluate enhanced feedback interventions, within a national blood transfusion audit programme, to promote evidence-based guidance and reduce the unnecessary use of blood components. We developed, piloted and refined two feedback interventions, ‘enhanced content’ and ‘enhanced follow-on’ (workstream 1), evaluated the effectiveness and cost-effectiveness of the two feedback interventions compared with standard feedback practice (workstream 2), examined intervention fidelity and contextual influences (workstream 3) and developed general implementation recommendations and tools for other audit and feedback programmes (workstream 4). Design: Interviews, observations and documentary analysis in four purposively sampled hospitals explored contemporary practice and opportunities for strengthening feedback. We developed two interventions: ‘enhanced content’, to improve the clarity and utility of feedback reports, and ‘enhanced follow-on’, to help hospital staff with action-planning (workstream 1). We conducted two linked 2 × 2 factorial cross-sectional cluster-randomised trials within transfusion audits for major surgery and haematological oncology, respectively (workstream 2). We randomised hospital clusters (the organisational level at which hospital transfusion teams operate) to enhanced or standard content or enhanced or standard follow-on. Outcome assessment was masked to assignment. Decision-analytic modelling evaluated the costs, benefits and cost-effectiveness of the feedback interventions in both trials from the perspective of the NHS. A parallel process evaluation used semistructured interviews, documentary analyses and web analytics to assess the fidelity of delivery, receipt and enactment and to identify contextual influences (workstream 3). We explored ways of improving the impact of national audits with their representatives (workstream 4). Setting and participants: All NHS hospital trusts and health boards participating in the National Comparative Audit of Blood Transfusions were invited to take part. Among 189 hospital trusts and health boards screened, 152 hospital clusters participated in the surgical audit. Among 187 hospital trusts and health boards screened, 141 hospital clusters participated in the haematology audit. Interventions: ‘Enhanced content’ aimed to ensure that the content and format of feedback reports were consistent with behaviour change theory and evidence. ‘Enhanced follow-on’ comprised a web-based toolkit and telephone support to facilitate local dissemination, planning and response to feedback. Main outcome measures: Proportions of acceptable transfusions, based on existing evidence and guidance and algorithmically derived from national audit data. Data sources: Trial primary outcomes were derived from manually collected, patient-level audit data. Secondary outcomes included routinely collected data for blood transfusion. Results: With regard to the transfusions in the major surgery audit, 135 (89%) hospital clusters participated from 152 invited. We randomised 69 and 66 clusters to enhanced and standard content, respectively, and 68 and 67 clusters to enhanced and standard follow-on, respectively. We analysed a total of 2222 patient outcomes at 12 months in 54 and 58 (enhanced and standard content, respectively) and 54 and 58 (enhanced and standard follow-on, respectively) hospital clusters. With regard to the haematology audit, 134 hospital clusters (95%) participated from 141 invited. We randomised 66 and 68 clusters to enhanced and standard content, respectively, and 67 clusters to both enhanced and standard follow-on. We analysed a total of 3859 patient outcomes at 12 months in 61 and 61 (enhanced and standard content, respectively) and 63 and 59 (enhanced and standard follow-on) hospital clusters. We found no effect of either of the enhanced feedback interventions in either trial across all outcomes. Incremental enhanced intervention costs ranged from £18 to £248 per site. The enhanced feedback interventions were dominated by the standard intervention in cost-effectiveness analyses. The interventions were delivered as designed and intended, but subsequent local engagement was low. Although the enhancements were generally acceptable, doubts about the credibility of the blood transfusion audits undermined the case for change. Limitations: Limitations included the number of participating clusters; loss to follow-up of trial clusters, reducing statistical power and validity; incomplete audit and cost data contributing to outcome measures; participant self-selection; reporting; missing data related to additional staff activity generated in response to receiving feedback; and recall biases in the process evaluation interviews. Conclusions: The enhanced feedback interventions were acceptable to recipients but were more costly and no more effective than standard feedback in reducing unnecessary use of blood components, and, therefore, should not be recommended on economic grounds. Future work: We have demonstrated the feasibility of embedding ambitious large-scale rigorous research within national audit programmes. Further head-to-head comparisons of different feedback interventions are needed in these programmes to identify cost-effective ways of increasing the impact of the interventions. Trial registration: This trial is registered as ISRCTN15490813. Funding: This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 10, No. 2. See the NIHR Journals Library website for further project information.

We aimed to describe worry and uptake of behaviours that prevent the spread of infection (respiratory and hand hygiene, distancing) in the UK at the start of the COVID-19 outbreak (January and February 2020) and to investigate factors associated with worry and adopting protective behaviours. Three cross-sectional online surveys of UK adults (28 to 30 January, n = 2016; 3 to 6 February, n = 2002; 10 to 13 February 2020, n = 2006) were conducted. We used logistic regressions to investigate associations between outcome measures (worry, respiratory and hand hygiene behaviour, distancing behaviour) and explanatory variables. 19.8% of participants (95% CI 18.8% to 20.8%) were very or extremely worried about COVID-19. People from minoritized ethnic groups were particularly likely to feel worried. 39.9% of participants (95% CI 37.7% to 42.0%) had completed one or more hand or respiratory hygiene behaviour more than usual in the last seven days. Uptake was associated with greater worry, perceived effectiveness of individual behaviours, self-efficacy for engaging in them, and having heard more information about COVID-19. 13.7% (95% CI 12.2% to 15.2%) had reduced the number of people they had met. This was associated with greater worry, perceived effectiveness, and self-efficacy. At the start of novel infectious disease outbreaks, communications should emphasise perceived effectiveness of behaviours and the ease with which they can be carried out.

Abstract Background National Health Service Health Checks were introduced in 2009 to reduce cardiovascular disease (CVD) risks and events. Since then, national evaluations have highlighted the need to maximise the programme’s impact by improving coverage and outputs. To address these challenges it is important to understand the extent to which positive behaviours are influenced across the NHS Health Check pathway and encourage the promotion or minimisation of behavioural facilitators and barriers respectively. This study applied behavioural science frameworks to: i) identify behaviours and actors relevant to uptake, delivery and follow up of NHS Health Checks and influences on these behaviours and; ii) signpost to example intervention content. Methods A systematic review of studies reporting behaviours related to NHS Health Check-related behaviours of patients, health care professionals (HCPs) and commissioners. Influences on behaviours were coded using theory-based models: COM-B and Theoretical Domains Framework (TDF). Potential intervention types and behaviour change techniques (BCTs) were suggested to target key influences. Results We identified 37 studies reporting nine behaviours and influences for eight of these. The most frequently identified influences were physical opportunity including HCPs having space and time to deliver NHS Health Checks and patients having money to adhere to recommendations to change diet and physical activity. Other key influences were motivational, such as beliefs about consequences about the value of NHS Health Checks and behaviour change, and social, such as influences of others on behaviour change. The following techniques are suggested for websites or smartphone apps: Adding objects to the environment, e.g. provide HCPs with electronic schedules to guide timely delivery of Health Checks to target physical opportunity, Social support (unspecified), e.g. include text suggesting patients to ask a colleague to agree in advance to join them in taking the ‘healthy option’ lunch at work; Information about health consequences, e.g. quotes and/or videos from patients talking about the health benefits of changes they have made. Conclusions Through the application of behavioural science we identified key behaviours and their influences which informed recommendations for intervention content. To ascertain the extent to which this reflects existing interventions we recommend a review of relevant evidence.

Abstract Background Reducing the need for antibiotics is crucial in addressing the global threat of antimicrobial resistance. Catheter-associated urinary tract infection (CAUTI) is one of the most frequent device-related infections that may be amenable to prevention. Interventions implemented nationally in England target behaviours related to catheter insertion, maintenance and removal, but the extent to which they target barriers to and facilitators of these behaviours is unclear. This strategic behavioural analysis applied behavioural science frameworks to (i) identify barriers to and facilitators of behaviours that lead to CAUTI (CAUTI-related behaviours) in primary, community and secondary care and nursing homes; (ii) describe the content of nationally adopted interventions; and (iii) assess the extent to which intervention content is theoretically congruent with barriers and facilitators. Methods A mixed-methods, three-phased study: (1) systematic review of 25 studies to identify (i) behaviours relevant to CAUTI and (ii) barriers to and facilitators of CAUTI-related behaviours, classified using the COM-B model and Theoretical Domains Framework (TDF); (2) content analysis of nationally adopted CAUTI interventions in England identified through stakeholder consultation, classified using the Behaviour Change Wheel (BCW) and Behaviour Change Techniques Taxonomy (BCTTv1); and (3) findings from 1 and 2 were linked using matrices linking COM-B and TDF to BCW/BCTTv1 in order to signpost to intervention design and refinement. Results The most frequently reported barriers to and facilitators of CAUTI-related behaviours related to ‘environmental context and resources’; ‘knowledge’; ‘beliefs about consequences’; ‘social influences’; ‘memory, attention and decision processes’; and ‘social professional role and identity.’ Eleven interventions aiming to reduce CAUTI were identifed. Interventions were primarily guidelines and included on average 2.3 intervention functions (1–5) and six BCTs (2–11), most frequently ‘education’, ‘training’ and ‘enablement.’ The most frequently used BCT was ‘information about health consequences’ which was used in almost all interventions. Social professional role and identity and environmental context and resources were targeted least frequently with potentially relevant BCTs. Conclusions Interventions incorporated half the potentially relevant content to target identifed barriers to and facilitators of CAUTI-related behaviours. There were missed opportunities for intervention as most focus on shaping knowledge rather than addressing motivational, social and environmental influences. This study suggests that targeting motivational, social and environmental influences may lead to more effective intervention design and refinement.

Abstract Background Overuse of antibiotics has contributed to antimicrobial resistance; a growing public health threat. In long-term care facilities, levels of inappropriate prescribing are as high as 75%. Numerous interventions targeting long-term care facilities’ antimicrobial stewardship have been reported with varying, and largely unexplained, effects. Therefore, this review aimed to apply behavioural science frameworks to specify the component behaviour change techniques of stewardship interventions in long-term care facilities and identify those components associated with improved outcomes. Method A systematic review (CRD42018103803) was conducted through electronic database searches. Two behavioural science frameworks, the Behaviour Change Wheel and Behaviour Change Technique Taxonomy were used to classify intervention descriptions into intervention types and component behaviour change techniques used. Study design and outcome heterogeneity prevented meta-analysis and meta-regression. Interventions were categorised as ‘very promising’ (all outcomes statistically significant), ‘quite promising’ (some outcomes statistically significant), or ‘not promising’ (no outcomes statistically significant). ‘Promise ratios’ (PR) were calculated for identified intervention types and behaviour change techniques by dividing the number of (very or quite) promising interventions featuring the intervention type or behaviour change technique by the number of interventions featuring the intervention type or behaviour change technique that were not promising. Promising intervention types and behaviour change techniques were defined as those with a PR ≥ 2. Results Twenty studies (of19 interventions) were included. Seven interventions (37%) were ‘very promising’, eight ‘quite promising’ (42%) and four ‘not promising’ (21%). Most promising intervention types were ‘persuasion’ (n = 12; promise ratio (PR) = 5.0), ‘enablement’ (n = 16; PR = 4.33) and ‘education’ (n = 19; PR = 3.75). Most promising behaviour change techniques were ‘feedback on behaviour’ (n = 9; PR = 8.0) and ‘restructuring the social environment’ (e.g. staff role changes; n = 8; PR = 7.0). Conclusion Systematic identification of the active ingredients of antimicrobial stewardship in long-term care facilities was facilitated through the application of behavioural science frameworks. Incorporating environmental restructuring and performance feedback may be promising intervention strategies for antimicrobial stewardship interventions within long-term care facilities.

Abstract Background It is important to evaluate fidelity of delivery and engagement during feasibility trials. However, there is little guidance on how to systematically develop strategies to improve implementation if problems arise. We aimed to: 1) Assess fidelity of delivery and engagement, 2) Identify factors influencing fidelity of delivery and engagement, and 3) Develop strategies to improve fidelity of delivery of, and engagement with, a complex intervention to improve independence in dementia, within a feasibility trial. Methods A mixed methods evaluation of an intervention that aimed to improve independence in dementia. To assess fidelity of delivery and engagement, observation and self-report methods were used: 60% of audio-recorded intervention sessions were transcribed and reliably rated for fidelity. Providers (n = 12) and people with dementia/supporters (n = 34) were asked to complete checklists after each session. Descriptive statistics were used to analyse the data. To identify factors influencing fidelity and engagement, one-to-one semi-structured interviews were conducted with providers (n = 8), people with dementia (n = 7) and supporters (n = 7). Thematic analysis and content analysis were used to analyse data. To develop strategies, we followed four steps proposed by the authors of the Behaviour Change Wheel (1. Understanding the behaviour, 2. Identifying intervention functions, 3. Specifying intervention content, 4. Identifying mode of delivery). Results Researcher ratings indicated moderate fidelity and provider/participant ratings indicated high fidelity of delivery. Knowledge, providers’ attributes, ease of adaptation of the intervention in relation to participants’ needs and logistical considerations influenced fidelity. We developed four strategies to improve fidelity of delivery of PRIDE: 1) showing a video, 2) giving an instruction sheet, 3) giving time to practice and 4) providing continued support. Participants reported high levels of engagement. Participants’ attributes, capability and opportunity influenced engagement. We developed four strategies to improve engagement with PRIDE: 1) a session summary document, 2) clear instructions, 3) time to practice activity and 4) providing regular compulsory telephone support. Conclusion Fidelity of delivery and engagement are complex behaviours. This manuscript provides an example of how the Behaviour Change Wheel can be used during a feasibility trial to systematically develop strategies to improve implementation of complex interventions.

Abstract Background Older people living in care homes are particularly susceptible to infections and antibiotics are therefore used frequently for this population. However, there is limited information on antibiotic prescribing in this setting. This study aimed to investigate the frequency, patterns and risk factors for antibiotic prescribing in a large chain of UK care homes. Methods Retrospective cohort study of administrative data from a large chain of UK care homes (resident and care home-level) linked to individual-level pharmacy data. Residents aged 65 years or older between 1 January 2016 and 31 December 2017 were included. Antibiotics were classified by type and as new or repeated prescriptions. Rates of antibiotic prescribing were calculated and modelled using multilevel negative binomial regression. Results 13,487 residents of 135 homes were included. The median age was 85; 63% residents were female. 28,689 antibiotic prescriptions were dispensed, the majority were penicillins (11,327, 39%), sulfonamides and trimethoprim (5818, 20%), or other antibacterials (4665, 16%). 8433 (30%) were repeat prescriptions. The crude rate of antibiotic prescriptions was 2.68 per resident year (95% confidence interval (CI) 2.64–2.71). Increased antibiotic prescribing was associated with residents requiring more medical assistance (adjusted incidence rate ratio for nursing opposed to residential care 1.21, 95% CI 1.13–1.30). Prescribing rates varied widely by care home but there were no significant associations with the care home-level characteristics available in routine data. Conclusions Rates of antibiotic prescribing in care homes are high and there is substantial variation between homes. Further research is needed to understand the drivers of this variation to enable development of effective stewardship approaches that target the influences of prescribing.

Abstract Background To reduce inappropriate antibiotic use, public health campaigns often provide fear-based information about antimicrobial resistance (AMR). Meta-analyses have found that fear-based campaigns in other contexts are likely to be ineffective unless respondents feel confident they can carry out the recommended behaviour (‘self-efficacy’). This study aimed to test the likely impact of fear-based messages, with and without empowering self-efficacy elements, on patient consultations/antibiotic requests for influenza-like illnesses, using a randomised design. Methods We hypothesised that fear-based messages containing empowering information about self-management without antibiotics would be more effective than fear alone, particularly in a pre-specified subgroup with low AMR awareness. Four thousand respondents from an online panel, representative of UK adults, were randomised to receive three different messages about antibiotic use and AMR, designed to induce fear about AMR to varying degrees. Two messages (one ‘strong-fear’, one ‘mild-fear’) also contained empowering information regarding influenza-like symptoms being easily self-managed without antibiotics. The main outcome measures were self-reported effect of information on likelihood of visiting a doctor and requesting antibiotics, for influenza-like illness, analysed separately according to whether or not the AMR information was ‘very/somewhat new’ to respondents, pre-specified based on a previous (non-randomised) survey. Results The ‘fear-only’ message was ‘very/somewhat new’ to 285/1000 (28.5%) respondents, ‘mild-fear-plus-empowerment’ to 336/1500 (22.4%), and ‘strong-fear-plus-empowerment’ to 388/1500 (25.9%) (p = 0.002). Of those for whom the respective information was ‘very/somewhat new’, only those given the ‘strong-fear-plus-empowerment’ message said they would be less likely to request antibiotics if they visited a doctor for an influenza-like illness (p

Background'Engager' is an innovative 'through-the-gate' complex care intervention for male prison-leavers with common mental health problems. In parallel to the randomised-controlled trial of Engager (Trial registration number: ISRCTN11707331), a set of process evaluation analyses were undertaken. This paper reports on the depth multiple case study analysis part of the process evaluation, exploring how a sub-sample of prison-leavers engaged and responded to the intervention offer of one-to-one support during their re-integration into the community.MethodsTo understand intervention delivery and what response it elicited in individuals, we used a realist-informed qualitative multiple 'case' studies approach. We scrutinised how intervention component delivery lead to outcomes by examining underlying causal pathways or 'mechanisms' that promoted or hindered progress towards personal outcomes. 'Cases' (n = 24) were prison-leavers from the intervention arm of the trial. We collected practitioner activity logs and conducted semi-structured interviews with prison-leavers and Engager/other service practitioners. We mapped data for each case against the intervention logic model and then used Bhaskar's (2016) 'DREIC' analytic process to categorise cases according to extent of intervention delivery, outcomes evidenced, and contributing factors behind engagement or disengagement and progress achieved.ResultsThere were variations in the dose and session focus of the intervention delivery, and how different participants responded. Participants sustaining long-term engagement and sustained change reached a state of 'crises but coping'. We found evidence that several components of the intervention were key to achieving this: trusting relationships, therapeutic work delivered well and over time; and an in-depth shared understanding of needs, concerns, and goals between the practitioner and participants. Those who disengaged were in one of the following states: 'Crises and chaos', 'Resigned acceptance', 'Honeymoon' or 'Wilful withdrawal'.ConclusionsWe demonstrate that the 'implementability' of an intervention can be explained by examining the delivery of core intervention components in relation to the responses elicited in the participants. Core delivery mechanisms often had to be 'triggered' numerous times to produce sustained change. The improvements achieved, sustained, and valued by participants were not always reflected in the quantitative measures recorded in the RCT. The compatibility between the practitioner, participant and setting were continually at risk of being undermined by implementation failure as well as changing external circumstances and participants' own weaknesses.Trial registration numberISRCTN11707331, Wales Research Ethics Committee, Registered 02-04-2016-Retrospectively registered https://doi.org/10.1186/ISRCTN11707331.

Abstract Background Interpreting data about intervention effectiveness requires an understanding of which intervention components were delivered and whether they were delivered as planned (fidelity of delivery). These studies aimed to develop a reliable measure for assessing fidelity of delivery of the Community Occupational Therapy in Dementia-UK intervention (COTiD-UK) (Study 1) and measure fidelity of delivery of COTiD-UK across sessions, sites and occupational therapists (Study 2). Methods The studies used a longitudinal observational design nested within a multi-site randomised controlled trial. Where practicable, all intervention sessions were audio-recorded. Fidelity checklists and coding guidelines were developed, piloted and refined until good agreement was achieved between two coders. Ten percent of sessions were purposively sampled from 12 sites and 31 occupational therapists. Transcripts were coded using checklists developed in Study 1; 10% of sets of intervention session transcripts were double coded to ensure that agreement was maintained. Percentages of components that were delivered were calculated for each session, site and occupational therapist. Results A reliable measure of fidelity of delivery for COTiD-UK was developed after several rounds of piloting and amendments. COTiD-UK was delivered with moderate fidelity across all six sessions (range: 52.4–75.5%). The mean range of fidelity varied across sites (26.7–91.2%) and occupational therapists (26.7–94.1%). Conclusions A reliable, systematic method for measuring fidelity of delivery of COTiD-UK was developed and applied, and can be adapted for use in similar interventions. As COTiD-UK was delivered with moderate fidelity, there is a reasonable degree of confidence that intervention effects were attributable to COTiD-UK.