The Behaviour Change Technique Ontology: Transforming the Behaviour Change Technique Taxonomy v1.

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.

Using machine learning to extract information and predict outcomes from reports of randomised trials of smoking cessation interventions in the Human Behaviour-Change Project.

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 3).

An ontology of mechanisms of action in behaviour change interventions.

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.

Developing and using ontologies in behavioural science: addressing issues raised.

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.

Specifying who delivers behaviour change interventions: development of an Intervention Source Ontology.

Background:  Identifying how behaviour change interventions are delivered, including by whom, is key to understanding intervention effectiveness. However, information about who delivers interventions is reported inconsistently in intervention evaluations, limiting communication and knowledge accumulation. This paper reports a method for consistent reporting: The Intervention Source Ontology. This forms one part of the Behaviour Change Intervention Ontology, which aims to cover all aspects of behaviour change interventions . Methods: The Intervention Source Ontology was developed following methods for ontology development and maintenance used in the Human Behaviour-Change Project, with seven key steps: 1) define the scope of the ontology, 2) identify key entities and develop their preliminary definitions by reviewing existing classification systems (top-down) and reviewing 100 behaviour change intervention reports (bottom-up), 3) refine the ontology by piloting the preliminary ontology on 100 reports, 4) stakeholder review by 34 behavioural science and public health experts, 5) inter-rater reliability testing of annotating intervention reports using the ontology, 6) specify ontological relationships between entities and 7) disseminate and maintain the Intervention Source Ontology. Results: The Intervention Source Ontology consists of 140 entities. Key areas of the ontology include Occupational Role of Source, Relatedness between Person Source and the Target Population, Sociodemographic attributes and Expertise. Inter-rater reliability was found to be 0.60 for those familiar with the ontology and 0.59 for those unfamiliar with it, levels of agreement considered 'acceptable'. Conclusions: Information about who delivers behaviour change interventions can be reliably specified using the Intervention Source Ontology. For human-delivered interventions, the ontology can be used to classify source characteristics in existing behaviour change reports and enable clearer specification of intervention sources in reporting.

Development of an Intervention Setting Ontology for behaviour change: Specifying where interventions take place.

Background: Contextual factors such as an intervention's setting are key to understanding how interventions to change behaviour have their effects and patterns of generalisation across contexts. The intervention's setting is not consistently reported in published reports of evaluations. Using ontologies to specify and classify intervention setting characteristics enables clear and reproducible reporting, thus aiding replication, implementation and evidence synthesis. This paper reports the development of a Setting Ontology for behaviour change interventions as part of a Behaviour Change Intervention Ontology, currently being developed in the Wellcome Trust funded Human Behaviour-Change Project. Methods: The Intervention Setting Ontology was developed following methods for ontology development used in the Human Behaviour-Change Project: 1) Defining the ontology's scope, 2) Identifying key entities by reviewing existing classification systems (top-down) and 100 published behaviour change intervention reports (bottom-up), 3) Refining the preliminary ontology by literature annotation of 100 reports, 4) Stakeholder reviewing by 23 behavioural science and public health experts to refine the ontology, 5) Assessing inter-rater reliability of using the ontology by two annotators familiar with the ontology and two annotators unfamiliar with it, 6) Specifying ontological relationships between setting entities and 7) Making the Intervention Setting Ontology machine-readable using Web Ontology Language (OWL) and publishing online. Re sults: The Intervention Setting Ontology consists of 72 entities structured hierarchically with two upper-level classes: Physical setting including Geographic location, Attribute of location (including Area social and economic condition, Population and resource density sub-levels) and Intervention site (including Facility, Transportation and Outdoor environment sub-levels), as well as Social setting. Inter-rater reliability was found to be 0.73 (good) for those familiar with the ontology and 0.61 (acceptable) for those unfamiliar with it. Conclusion: The Intervention Setting Ontology can be used to code information from diverse sources, annotate the setting characteristics of existing intervention evaluation reports and guide future reporting.

A Lay Health Worker Intervention to Increase Uptake and Completion of Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease: Assessing Fidelity of Intervention Delivery.

The benefits of pulmonary rehabilitation (PR) for chronic obstructive pulmonary disease (COPD) are restricted by poor uptake and completion. Lay health workers (LHWs) have been effective in improving access to treatment and services for other health conditions. We have successfully shown the feasibility of this approach in a PR setting and its acceptability to the LHWs and COPD patients. We present here the feasibility of assessment, and the fidelity of delivery of LHW support achieved for COPD patients referred for PR. LHWs, volunteer COPD patients experienced in PR, received training in the intervention including communication skills, confidentiality and behaviour change techniques (BCTs). Interactions between LHWs and patients were recorded, transcribed and coded for delivery style and BCTs. Inter-rater agreement on the coding of delivery style and BCTs was high at >84%. LHWs built rapport and communicated attentively in over 80% of interactions. LHWs most consistently delivered BCTs concerning information provision about the consequences of PR often making those consequences salient by referring to their own positive experience of PR. Social support BCTs were also used by the majority of LHWs. The use of BCTs varied between LHWs. The assessment of intervention delivery fidelity by LHWs was feasible. LHW training in the setting of PR should add emphasis to the acquisition of BCT skills relating to goal setting and action planning.

Representation of behaviour change interventions and their evaluation: Development of the Upper Level of the Behaviour Change Intervention Ontology.

Background: Behaviour change interventions (BCI), their contexts and evaluation methods are heterogeneous, making it difficult to synthesise evidence and make recommendations for real-world policy and practice. Ontologies provide a means for addressing this. They represent knowledge formally as entities and relationships using a common language able to cross disciplinary boundaries and topic domains. This paper reports the development of the upper level of the Behaviour Change Intervention Ontology (BCIO), which provides a systematic way to characterise BCIs, their contexts and their evaluations. Methods: Development took place in four steps. (1) Entities and relationships were identified by behavioural and social science experts, based on their knowledge of evidence and theory, and their practical experience of behaviour change interventions and evaluations. (2) The outputs of the first step were critically examined by a wider group of experts, including the study ontology expert and those experienced in annotating relevant literature using the initial ontology entities. The outputs of the second step were tested by (3) feedback from three external international experts in ontologies and (4) application of the prototype upper-level BCIO to annotating published reports; this informed the final development of the upper-level BCIO. Results: The final upper-level BCIO specifies 42 entities, including the BCI scenario, elaborated across 21 entities and 7 relationship types, and the BCI evaluation study comprising 10 entities and 9 relationship types. BCI scenario entities include the behaviour change intervention (content and delivery), outcome behaviour, mechanism of action, and its context, which includes population and setting. These entities have corresponding entities relating to the planning and reporting of interventions and their evaluations. Conclusions: The upper level of the BCIO provides a comprehensive and systematic framework for representing BCIs, their contexts and their evaluations.

Ontologies relevant to behaviour change interventions: a method for their development.

Background: Behaviour and behaviour change are integral to many aspects of wellbeing and sustainability. However, reporting behaviour change interventions accurately and synthesising evidence about effective interventions is hindered by lacking a shared, scientific terminology to describe intervention characteristics. Ontologies are knowledge structures that provide controlled vocabularies to help unify and connect scientific fields. To date, there is no published guidance on the specific methods required to develop ontologies relevant to behaviour change. We report the creation and refinement of a method for developing ontologies that make up the Behaviour Change Intervention Ontology (BCIO). Aims: (1) To describe the development method of the BCIO and explain its rationale; (2) To provide guidance on implementing the activities within the development method. Method and results: The method for developing ontologies relevant to behaviour change interventions was constructed by considering principles of good practice in ontology development and identifying key activities required to follow those principles. The method's details were refined through application to developing two ontologies. The resulting ontology development method involved: (1) defining the ontology's scope; (2) identifying key entities; (3) refining the ontology through an iterative process of literature annotation, discussion and revision; (4) expert stakeholder review; (5) testing inter-rater reliability; (6) specifying relationships between entities, and; (7) disseminating and maintaining the ontology. Guidance is provided for conducting relevant activities for each step.  Conclusions: We have developed a detailed method for creating ontologies relevant to behaviour change interventions, together with practical guidance for each step, reflecting principles of good practice in ontology development. The most novel aspects of the method are the use of formal mechanisms for literature annotation and expert stakeholder review to develop and improve the ontology content. We suggest the mnemonic SELAR3, representing the method's first six steps as Scope, Entities, Literature Annotation, Review, Reliability, Relationships.

The lay health worker-patient relationship in promoting pulmonary rehabilitation (PR) in COPD: What makes it work?

Lay health workers (LHWs) can improve access to services and adherence to treatment, as well as promoting self-care and prevention. Their effect in promoting uptake and adherence in pulmonary rehabilitation (PR) for chronic obstructive pulmonary disease (COPD) has not been tested. PR is the most effective treatment for the symptoms and disability of COPD, but this effectiveness is undermined by poor rates of completion. Trained LHWs with COPD, who also have first-hand experience of PR, are well placed to help overcome the documented barriers to its completion. The relationship between LHWs and patients may be one of the keys to their effectiveness but it has been little explored. Semi-structured qualitative interviews were used with the aim of examining the LHW-patient partnership in a feasibility study of trained PR-experienced LHWs used to support COPD patients referred to PR. Twelve volunteers with COPD who completed LHW training supported 66 patients referred for PR. All 12 of these LHWs gave end-of-study interviews, 21 COPD patients supported by LHWs were also interviewed. Patients reported that the LHWs were keen to share their experiences of PR, and that this had a positive impact. The enthusiasm of the LHWs for PR was striking. The common bond between LHWs and patients of having COPD together with the LHWs positive, first-hand experience of PR were dominant and recurring themes in their relationship.

Arthritis prevention in the pre-clinical phase of RA with abatacept (the APIPPRA study): a multi-centre, randomised, double-blind, parallel-group, placebo-controlled clinical trial protocol.

TRIAL DESIGN: We present a study protocol for a multi-centre, randomised, double-blind, parallel-group, placebo-controlled trial that seeks to test the feasibility, acceptability and effectiveness of a 52-week period of treatment with the first-in-class co-stimulatory blocker abatacept for preventing or delaying the onset of inflammatory arthritis. METHODS: The study aimed to recruit 206 male or female subjects from the secondary care hospital setting across the UK and the Netherlands. Participants who were at least 18 years old, who reported inflammatory sounding joint pain (clinically suspicious arthralgia) and who were found to be positive for serum autoantibodies associated with rheumatoid arthritis (RA) were eligible for enrolment. All study subjects were randomly assigned to receive weekly injections of investigational medicinal product, either abatacept or placebo treatment over the course of a 52-week period. Participants were followed up for a further 52 weeks. The primary endpoint was defined as the time to development of at least three swollen joints or to the fulfilment of the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for RA using swollen but not tender joints, whichever endpoint was met first. In either case, swollen joints were confirmed by ultrasonography. Participants, care givers, and those assessing the outcomes were all blinded to group assignment. Clinical assessors and ultrasonographers were also blinded to each other's assessments for the duration of the study. CONCLUSIONS: There is limited experience of the design and implementation of trials for the prevention of inflammatory joint diseases. We discuss the rationale behind choice and duration of treatment and the challenges associated with defining the "at risk" state and offer pragmatic solutions in the protocol to enrolling subjects at risk of RA. TRIAL REGISTRATION: Current Controlled Trials, ID: ISRCTN46017566 . Registered on 4 July 2014.

Improving uptake and completion of pulmonary rehabilitation in COPD with lay health workers: feasibility of a clinical trial.

PURPOSE: This study was designed to evaluate the feasibility of a cluster randomized controlled trial to test the efficacy of lay health workers (LHWs) in improving the uptake and completion of pulmonary rehabilitation (PR) in the treatment of COPD. MATERIALS AND METHODS: LHWs, trained in confidentiality, role boundaries, and behavior change techniques, supported patients newly referred for PR. Interactions between LHWs and participants were recorded with smartphones. Outcomes were recruitment and retention rates of LHWs, questionnaire and interview-evaluated acceptability and analysis of intervention fidelity. RESULTS: Forty (36%) of 110 PR-experienced COPD patients applied to become LHWs. Twenty (18%) were selected for training. Twelve (11%) supported patients. Sixty-six COPD patients referred for PR received the intervention (5.5 participants per LHW). Ten LHWs were retained to the end of the study. Seventy-three percent of supported patients were satisfied or very satisfied with the intervention. LHWs delivered the intervention with appropriate style and variable fidelity. LHWs would welcome more intensive training. Based on this proof of concept, a cluster randomized controlled trial of an LHW intervention to improve uptake and completion of PR is feasible. CONCLUSION: PR-experienced COPD patients can be recruited, trained, and retained as LHWs to support participation in PR, and can deliver the intervention. Participant COPD patients found the intervention acceptable. A cluster randomized controlled clinical trial is feasible.

Implementing multiple health behaviour change interventions for cardiovascular risk reduction in primary care: a qualitative study.

BACKGROUND: The implementation of multiple health behaviour change interventions for cardiovascular risk reduction in primary care is suboptimal. This study aimed to identify barriers and facilitators to implementing multiple health behaviour change interventions for cardiovascular disease (CVD) risk reduction in primary care. METHODS: Qualitative study using semi-structured interviews informed by the Theoretical Domains Framework. Interviews were conducted with a purposive sample of healthcare professionals working in the implementation of the NHS Health Check programme in London. Data were analysed using the Framework method. RESULTS: Thirty participants were recruited including ten general practitioners, ten practice nurses, seven healthcare assistants and three practice managers from 23 practices. Qualitative analysis identified three main themes: healthcare professionals' conceptualising health behaviour change; delivering multiple health behaviour change interventions in primary care; and delivering the health check programme. Healthcare professionals generally recognised the importance of health behaviour change for CVD risk reduction but were more sceptical about the potential for successful intervention through primary care. Participants identified the difficulty of sustained behaviour change for patients, the lack of evidence for effective interventions and limited access to appropriate resources in primary care as barriers. Discussing changing multiple health behaviours was perceived to be overwhelming for patients and difficult to implement for healthcare professionals with current primary care resources. The health check programme consists of several components that are difficult to fully complete in limited time. CONCLUSIONS: Advancing the prevention agenda will require strategies to support the delivery of behaviour change interventions in primary care. Greater emphasis needs to be given to promoting behaviour change through supportive environmental context. Further research is needed to evaluate current external lifestyle services to improve the intervention outcomes.

Improving medication adherence in stroke survivors: the intervention development process.

BACKGROUND: Medications targeting stroke risk factors have shown good efficacy, yet adherence is suboptimal. A lack of underlying theory may contribute to the ineffectiveness of eliciting or sustaining behaviour change in many existing interventions targeting medication adherence in stroke. Intervention effectiveness and implementation could be enhanced by consideration of evidence base and theory to drive development. The purpose of this study is to identify appropriate components for a theory-driven and evidence-based medication adherence intervention for stroke survivors. METHODS: The Behaviour Change Wheel (BCW), a guide to intervention development, informed our systematic process of intervention development. Our earlier systematic review had identified important determinants of medication adherence that were mapped into the Theoretical Domains Framework (TDF), with Knowledge, Beliefs about consequences and Emotions found to be more influential. Utilising the BCW facilitated selection of intervention options and behaviour change techniques (BCTs); the active ingredients within an intervention. To further refine BCT selection, APEASE criteria were employed, allowing evaluation of potential BCTs within context: The National Health Service (NHS), United Kingdom (UK). RESULTS: Five intervention functions (Education, Persuasion, Training, Environmental Restructuring and Enablement) and five policy categories (Communication/marketing, Guidelines, Regulation, Environmental/social planning and Service provision) were identified as potential intervention options, underpinned by our systematic review findings. Application of APEASE criteria led to an initial pool of 21 BCTs being reduced to 11 (e.g. Habit Formation, Information about Health Consequences and Action Planning) identified as potential intervention components that would both be feasible and directly target the underlying determinants of stroke survivors' medication adherence. CONCLUSIONS: Careful consideration of underlying evidence and theory to drive intervention design, facilitated by the BCW, enabled identification of appropriate intervention components. BCTs including Habit Formation, Information about Health Consequences and Self-monitoring of Behaviour were considered potentially effective and appropriate to deliver within the NHS. Having reduced the pool of potential intervention components to a manageable number, it will now be possible to explore the perceived acceptability of selected BCTs in interviews with stroke survivors and healthcare professionals. This approach to intervention development should be generalisable to other chronic conditions and areas of behaviour change (e.g. exercise adherence).

Automated recruitment and randomisation for an efficient randomised controlled trial in primary care.

BACKGROUND/AIMS: Use of electronic health records and information technology to deliver more efficient clinical trials is attracting the attention of research funders and researchers. We report on methodological issues and data quality for a comparison of 'automated' and manual (or 'in-practice') methods for recruitment and randomisation in a large randomised controlled trial, with individual patient allocation in primary care. METHODS: We conducted a three-arm randomised controlled trial in primary care to evaluate interventions to improve the uptake of invited NHS health checks for cardiovascular risk assessment. Eligible participants were identified using a borough-wide health check management information system. An in-practice recruitment and randomisation method used at 12 general practices required the research team to complete monthly visits to each general practice. For the fully automated method, employed for six general practices, randomisation of eligible participants was performed automatically and remotely using a bespoke algorithm embedded in the health check management information system. RESULTS: There were 8588 and 4093 participants recruited for the manual and automated methods, respectively. The in-practice method was ready for implementation 3 months sooner than the automated method and the in-practice method allowed for full control and documentation of the randomisation procedure. However the in-practice approach was labour intensive and the requirement for participant records to be stored locally resulted in the loss of data for 10 practice months. No records for participants allocated using the automated method were lost. A fixed-effects meta-analysis showed that effect estimates for the primary outcome were consistent for the two allocation methods. CONCLUSIONS: This trial demonstrated the feasibility of automated recruitment and randomisation methods into a randomised controlled trial performed in primary care. Future research should explore the application of these techniques in other clinical contexts and health care settings. TRIAL REGISTRATION: Current Controlled Trials, ID: ISRCTN42856343 . Registered on 21 March 2013.

Enhanced Invitations Using the Question-Behavior Effect and Financial Incentives to Promote Health Check Uptake in Primary Care.

Background: Uptake of health checks for cardiovascular risk assessment in primary care in England is lower than anticipated. The question-behavior effect (QBE) may offer a simple, scalable intervention to increase health check uptake. Purpose: The present study aimed to evaluate the effectiveness of enhanced invitation methods employing the QBE, with or without a financial incentive to return the questionnaire, at increasing uptake of health checks. Methods: We conducted a three-arm randomized trial including all patients at 18 general practices in two London boroughs, who were invited for health checks from July 2013 to December 2014. Participants were randomized to three trial arms: (i) Standard health check invitation letter only; (ii) QBE questionnaire followed by standard invitation letter; or (iii) QBE questionnaire with offer of a financial incentive to return the questionnaire, followed by standard invitation letter. In intention to treat analysis, the primary outcome of completion of health check within 6 months of invitation, was evaluated using a p value of .0167 for significance. Results: 12,459 participants were randomized. Health check uptake was evaluated for 12,052 (97%) with outcome data collected. Health check uptake within 6 months of invitation was: standard invitation, 590 / 4,095 (14.41%); QBE questionnaire, 630 / 3,988 (15.80%); QBE questionnaire and financial incentive, 629 / 3,969 (15.85%). Difference following QBE questionnaire, 1.43% (95% confidence interval -0.12 to 2.97%, p = .070); following QBE questionnaire and financial incentive, 1.52% (-0.03 to 3.07%, p = .054). Conclusions: Uptake of health checks following a standard invitation was low and not significantly increased through enhanced invitation methods using the QBE.

Unsupervised Information Extraction from Behaviour Change Literature.

This paper describes our approach to construct a scalable system for unsupervised information extraction from the behaviour change intervention literature. Due to the many different types of attribute to be extracted, we adopt a passage retrieval based framework that provides the most likely value for an attribute. Our proposed method is capable of addressing variable length passage sizes and different validation criteria for the extracted values corresponding to each attribute to be found. We evaluate our approach by constructing a manually annotated ground-truth from a set of 50 research papers with reported studies on smoking cessation.

Factors influencing the impact of pharmacogenomic prescribing on adherence to nicotine replacement therapy: A qualitative study of participants from a randomized controlled trial.

Pharmacogenomics may improve health outcomes in two ways: by more precise and therefore more effective prescribing, tailored to genotype, and by increasing perceived effectiveness of treatments and so motivation for adherence. Little is known about patients' experiences of, and reactions to, receiving pharmacogenomically tailored treatments. The aim of this study was to explore the impact of pharmacogenomic prescribing of nicotine replacement therapy (NRT) on smokers' initial expectations of quit success, adherence, and perceived important differences from previous quit attempts. Semi-structured interviews were conducted with 40 smokers, purposively sampled from the Personalized Extra Treatment (PET) trial (ISRCTN 14352545). Together with NRT patches, participants were prescribed doses of oral NRT based on either mu-opioid receptor (OPRM1) genotype or nicotine dependence questionnaire score (phenotype). Data were analyzed using framework analysis, comparing views of participants in the two trial arms. Although most participants understood the basis for their prescribed NRT dose, it little influenced their views. The salient features of this quit attempt were the individualized behavioral support and combined NRT, not pharmacogenomic tailoring. Participants' initial expectations of success were mostly based on prior experiences of quitting. They attributed taking medication to nurse advice to do so, and attributed reducing or stopping it to side effects, forgetfulness, or practical difficulties. Intentional nonadherence appeared very rare. Pharmacogenomic NRT prescribing was not especially remarkable to participants and did not seem to influence adherence. Where services already tailor prescriptions to phenotype and provide individualized behavioral support for treatment adherence, pharmacogenomic prescribing may have limited additional benefit.

Cardiovascular risk at health checks performed opportunistically or following an invitation letter. Cohort study.

Background: A population-based programme of health checks has been established in England. Participants receive postal invitations through a population-based call-recall system but health check providers may also offer health checks opportunistically. We compared cardiovascular risk scores for 'invited' and 'opportunistic' health checks. Methods: Cohort study of all health checks completed at 18 general practices from July 2013 to June 2015. For each general practice, cardiovascular (CVD) risk scores were compared by source of check and pooled using meta-analysis. Effect estimates were compared by gender, age-group, ethnicity and fifths of deprivation. Results: There were 6184 health checks recorded (2280 invited and 3904 opportunistic) with CVD risk scores recorded for 5359 (87%) participants. There were 17.0% of invited checks and 22.2% of opportunistic health checks with CVD risk score ≥10%; a relative increment of 28% (95% confidence interval: 14-44%, P < 0.001). In the most deprived quintile, 15.3% of invited checks and 22.4% of opportunistic checks were associated with elevated CVD risk (adjusted odds ratio: 1.94, 1.37-2.74, P  < 0.001). Conclusions: Respondents at health checks performed opportunistically are at higher risk of cardiovascular disease than those participating in response to a standard invitation letter, potentially reducing the effect of uptake inequalities.

Multiple health behaviour change interventions for primary prevention of cardiovascular disease in primary care: systematic review and meta-analysis.

BACKGROUND: It is uncertain whether multiple health behaviour change (MHBC) interventions are effective for the primary prevention of cardiovascular disease (CVD) in primary care. A systematic review and a meta-analysis were performed to evaluate the effectiveness of MHBC interventions on CVD risk and CVD risk factors; the study also evaluated associations of theoretical frameworks and intervention components with intervention effectiveness. METHODS: The search included randomised controlled trials of MHBC interventions aimed at reducing CVD risk in primary prevention population up to 2017. Theoretical frameworks and intervention components were evaluated using standardised methods. Meta-analysis with stratification and meta-regression were used to evaluate intervention effects. RESULTS: We identified 31 trials (36 484 participants) with a minimum duration of 12 months follow-up. Pooled net change in systolic blood pressure (16 trials) was -1.86 (95% CI -3.17 to -0.55; p=0.01) mm Hg; diastolic blood pressure (15 trials), -1.53 (-2.43 to -0.62; p=0.001) mm Hg; body mass index (14 trials), -0.13 (-0.26 to -0.01; p=0.04) kg/m2; serum total cholesterol (14 trials), -0.13 (-0.19 to -0.07; p<0.001) mmol/L. There was no significant association between interventions with a reported theoretical basis and improved intervention outcomes. No association was observed between intervention intensity (number of sessions and intervention duration) and intervention outcomes. There was significant heterogeneity for some risk factor analyses, leading to uncertain validity of some pooled net changes. CONCLUSIONS: MHBC interventions delivered to CVD-free participants in primary care did not appear to have quantitatively important effects on CVD risk factors. Better reporting of interventions' rationale, content and delivery is essential to understanding their effectiveness.