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.

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.

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.

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.

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).

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.

Psychological Determinants of Medication Adherence in Stroke Survivors: a Systematic Review of Observational Studies.

BACKGROUND: Medications targeting stroke risk factors have shown good efficacy, yet adherence is suboptimal. To improve adherence, its determinants must be understood. To date, no systematic review has mapped identified determinants into the Theoretical Domains Framework (TDF) in order to establish a more complete understanding of medication adherence. PURPOSE: The aim of this study was to identify psychological determinants that most influence stroke survivors' medication adherence. METHODS: In line with the prospectively registered protocol (PROSPERO CRD42015016222), five electronic databases were searched (1953-2015). Hand searches of included full text references were undertaken. Two reviewers conducted screening, data extraction and quality assessment. Determinants were mapped into the TDF. RESULTS: Of 32,825 articles, 12 fulfilled selection criteria (N = 43,984 stroke survivors). Tested determinants mapped into 8/14 TDF domains. Studies were too heterogeneous for meta-analysis. Three TDF domains appeared most influential. Negative emotions ('Emotions' domain) such as anxiety and concerns about medications ('Beliefs about Consequences' domain) were associated with reduced adherence. Increased adherence was associated with better knowledge of medications ('Knowledge' domain) and stronger beliefs about medication necessity ('Beliefs about Consequences' domain). Study quality varied, often lacking information on sample size calculations. CONCLUSIONS: This review provides foundations for evidence-based intervention design by establishing psychological determinants most influential in stroke survivors' medication adherence. Six TDF domains do not appear to have been tested, possibly representing gaps in research design. Future research should standardise and clearly report determinant and medication adherence measurement to facilitate meta-analysis. The range of determinants explored should be broadened to enable more complete understanding of stroke survivors' medication adherence.

Factors influencing participation in colorectal cancer screening-a qualitative study in an ethnic and socio-economically diverse inner city population.

BACKGROUND: Ethnic and socio-economic inequalities have been reported in the uptake of colorectal cancer (CRC) screening. This study aimed to explore the factors affecting CRC screening participation in an ethnically and socio-economically diverse inner city population. METHODS: Semi-structured interviews were undertaken with 50 people aged 55-74 years, recruited from GP practices in south-east London. Participants were from Black African (n=13), Black Caribbean (n=15), White British (n=17), Black other (n=2) and White other (n=3) backgrounds. Participants' socio-economic status (SES) was assessed using a combined measure of educational attainment, housing tenure and car ownership. Participants' SES varied although there were more participants from less deprived backgrounds than those from more deprived backgrounds. The interview topic guide was informed by the Theoretical Domains Framework. Interviews were recorded, transcribed and analysed using framework analysis. FINDINGS: Lack of awareness of CRC screening was a barrier for all participants. There were also some notable group differences by ethnicity and SES. Cancer fear was a barrier for White British participants of varying SES. Misunderstanding instructions for completing the guaiac faecal occult blood test (gFOBt) was a barrier for people of low SES regardless of ethnicity. For Black African and Black Caribbean participants, of any SES, religious faith and a perceived civic duty to participate in screening encouraged participation. DISCUSSION AND CONCLUSIONS: This is the first study to provide detailed information on the separate views of Black African and Black Caribbean participants about screening. Consideration of ethnicity and SES together also allowed us to identify pertinent barriers for particular groups that can be targeted to improve access to screening for those who wish to take part.

Changes in cardiovascular disease risk and behavioural risk factors before the introduction of a health check programme in England.

A population-based programme of health checks was introduced for adults in England in 2011 for the primary prevention of cardiovascular diseases (CVD) and risk factors management. The aim was to evaluate changes in cardiovascular risk and behavioural risk factors in a health check eligible population in England from 1994 to 2013, by using repeated cross-sectional design using seven surveys of the Health Survey for England. Measures included traditional CVD risk factors and behavioural risk factors. Linear trends were estimated allowing for sampling design. The surveys comprised 49,805 adults aged 45 to 74years; 30,639 were free from cardiovascular comorbidity; 16,041 (52%) had complete data for quantitative risk factors. Between 1994 and 2013, systolic blood pressure decreased by 3.1 (95% confidence interval 2.5 to 3.6) mmHg per decade in men and 5.0 (4.5 to 5.5) in women. Total cholesterol decreased by 0.20 (0.16 to 0.24) mmol/l per decade in men; 0.23 (0.19 to 0.26) in women. Smoking declined by 6% (5% to 8%) per decade in men; 7% (6% - 8%) in women. The proportion with CVD-risk ≥20% declined by 6.8% per decade in men; 2.4% in women. Multiple behavioural risk factors were strongly associated with estimated CVD-risk, but improving trends in traditional CVD risk factors were inconsistent with increasing indicators of adiposity. Long-term declines in traditional risk factors contributed to reductions in estimated CVD-risk prior to the introduction of a health check programme. Behaviour change interventions for multiple risk factor exposures remain a key area for future research.

Influences on individuals' decisions to take up the offer of a health check: a qualitative study.

BACKGROUND: Health checks are promoted to evaluate individuals' risk of developing disease and to initiate health promotion and disease prevention interventions. The NHS Health Check is a cardiovascular risk assessment programme introduced in the UK aimed at preventing cardiovascular disease (CVD). Uptake of health checks is lower than anticipated. This study aimed to explore influences on people's decisions to take up the offer of a health check. METHODS: Semi-structured interviews were conducted with people registered at four general practices in South London. The interview schedule was informed by the Theoretical Domains Framework. Data were analysed qualitatively using the Framework method using NVivo for data management. RESULTS: Twenty-seven participants invited for a health check were included in the study. Seventeen received the health check while 10 either did not attend or failed to complete the check. Five themes emerging from the data included a lack of awareness of the health check programme, beliefs about susceptibility to CVD, beliefs about civic responsibility, issues concerning access to appointments, and beliefs about the consequences of having a check. CONCLUSIONS: Health check programmes need to raise public awareness to ensure that people are informed about the objectives and nature of the programme in order to reach an informed decision about taking up the invitation. Emphasizing the benefits of prevention and early detection might encourage attendance in those who are reluctant to burden the public health-care systems. Extending outreach initiatives and increasing 'out of hours' provision at local community sites could facilitate access.

Effectiveness of behavioural weight loss interventions delivered in a primary care setting: a systematic review and meta-analysis.

BACKGROUND: Overweight and obesity have negative health effects. Primary care clinicians are best placed to intervene in weight management. Previous reviews of weight loss interventions have included studies from specialist settings. The aim of this review was to estimate the effect of behavioural interventions delivered in primary care on body weight in overweight and obese adults. METHODS: The review included randomized controlled trials (RCTs) of behavioural interventions in obese or overweight adult participants in a primary care setting, with weight loss as the primary outcome, and a minimum of 12 months of follow-up. A systematic search strategy was implemented in Medline, Embase, Web of Science and the Cochrane Central Registry of Controlled Trials. Risk of bias was assessed using the Cochrane Risk of Bias tool and behavioural science components of interventions were evaluated. Data relating to weight loss in kilograms were extracted, and the results combined using meta-analysis. RESULTS: Fifteen RCTs, with 4539 participants randomized, were selected for inclusion. The studies were heterogeneous with respect to inclusion criteria and type of intervention. Few studies reported interventions informed by behavioural science theory. Pooled results from meta-analysis indicated a mean weight loss of -1.36 kg (-2.10 to -0.63, P < 0.0001) at 12 months, and -1.23 kg (-2.28 to -0.18, P = 0.002) at 24 months. CONCLUSION: Behavioural weight loss interventions in primary care yield very small reductions in body weight, which are unlikely to be clinically significant. More effective management strategies are needed for the treatment of overweight and obesity.

Self-affirmation promotes physical activity.

The present study tests whether a self-affirmation intervention (i.e., requiring an individual to focus on a valued aspect of their self-concept, such as honesty) can increase physical activity and change theory of planned behavior (TPB) variables linked to physical activity. Eighty young people completed a longitudinal intervention study. Baseline physical activity was assessed using the Godin Leisure-Time Physical Activity Questionnaire (LTPAQ). Next, participants were randomly allocated to either a self-affirmation or a nonaffirmation condition. Participants then read information about physical activity and health, and completed measures of TPB variables. One week later, participants again completed LTPAQ and TPB items. At follow up, self-affirmed participants reported significantly more physical activity, more positive attitudes toward physical activity, and higher intentions to be physically active compared with nonaffirmed participants. Neither attitudes nor intentions mediated the effects of self-affirmation on physical activity. Self-affirmation can increase levels of physical activity and TPB variables. Self-affirmation interventions have the potential to become relatively simple methods for increasing physical activity levels.

Effectiveness of interventions to promote healthy diet in primary care: systematic review and meta-analysis of randomised controlled trials.

BACKGROUND: A diet rich in fruit, vegetables and dietary fibre and low in fat is associated with reduced risk of chronic disease. This review aimed to estimate the effectiveness of interventions to promote healthy diet for primary prevention among participants attending primary care. METHODS: A systematic review of trials using individual or cluster randomisation of interventions delivered in primary care to promote dietary change over 12 months in healthy participants free from chronic disease or defined high risk states. Outcomes were change in fruit and vegetable intake, consumption of total fat and fibre and changes in serum cholesterol concentration. RESULTS: Ten studies were included with 12,414 participants. The design and delivery of interventions were diverse with respect to grounding in behavioural theory and intervention intensity. A meta-analysis of three studies showed an increase in fruit consumption of 0.25 (0.01 to 0.49) servings per day, with an increase in vegetable consumption of 0.25 (0.06 to 0.44) serving per day. A further three studies that reported on fruit and vegetable consumption together showed a pooled increment of 0.50 (0.13 to 0.87) servings per day. The pooled effect on consumption of dietary fibre, from four studies, was estimated to be 1.97 (0.43 to 3.52) gm fibre per day. Data from five studies showed a mean decrease in total fat intake of 5.2% of total energy (1.5 to 8.8%). Data from three studies showed a mean decrease in serum cholesterol of 0.10 (-0.19 to 0.00) mmol/L. CONCLUSION: Presently-reported interventions to promote healthy diet for primary prevention in primary care, which illustrate a diverse range of intervention methods, may yield small beneficial changes in consumption of fruit, vegetables, fibre and fat over 12 months. The present results do not exclude the possibility that more effective intervention strategies might be developed.

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.

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.

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).

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.

Impact of communicating personalized genetic risk information on perceived control over the risk: a systematic review.

PURPOSE: Much concern has been expressed that feedback of personalized genetic risk information may lead to fatalism, i.e., a lack of perceived control over the risk. This review aimed to assess the strength of evidence for such a view. METHOD: Electronic databases were searched to find eligible studies, which comprised randomized, controlled trials and analog studies, in which participants in one arm received either real or imagined personalized genetic risk information and assessed perceived control in relation to the treatability or preventability of the health problem. RESULTS: Inspection of 1340 abstracts resulted in 5 studies meeting the inclusion criteria, involving the prediction of obesity, heart disease, depression, and diabetes. Meta-analyses of the clinical studies revealed no impact of personalized genetic risk information on perceived control in either the short term (pooled standardized mean difference 0.09, 95% confidence interval, -0.51 to 0.70) or longer term (pooled standardized mean difference 0.00, confidence interval, -0.20 to 0.21). Similarly, no impact on perceived control was evident in the three analog studies (pooled standardized mean difference 0.02, confidence interval, -0.17 to 0.20). CONCLUSION: Few studies have assessed empirically the impact of personalized genetic risk information on fatalism, assessed using perceptions of control over the risk. Limited evidence suggests feedback of genetic risk information may have little impact on such beliefs.

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.

Trial Protocol: Using genotype to tailor prescribing of nicotine replacement therapy: a randomised controlled trial assessing impact of communication upon adherence.

BACKGROUND: The behavioural impact of pharmacogenomics is untested; informing smokers of genetic test results for responsiveness to smoking cessation medication may increase adherence to this medication. The objective of this trial is to estimate the impact upon adherence to nicotine replacement therapy (NRT) of informing smokers that their oral dose of NRT has been tailored to a DNA analysis. Hypotheses to be tested are as follows: I Adherence to NRT is greater among smokers informed that their oral dose of NRT is tailored to an analysis of DNA (genotype), compared to one tailored to nicotine dependence questionnaire score (phenotype). II Amongst smokers who fail to quit at six months, motivation to make another quit attempt is lower when informed that their oral dose of NRT was tailored to genotype rather than phenotype. METHODS/DESIGN: An open label, parallel groups randomised trial in which 630 adult smokers (smoking 10 or more cigarettes daily) using National Health Service (NHS) stop smoking services in primary care are randomly allocated to one of two groups:i. NRT oral dose tailored by DNA analysis (OPRM1 gene) (genotype), orii. NRT oral dose tailored by nicotine dependence questionnaire score (phenotype)The primary outcome is proportion of prescribed NRT consumed in the first 28 days following an initial quit attempt, with the secondary outcome being motivation to make another quit attempt, amongst smokers not abstinent at six months. Other outcomes include adherence to NRT in the first seven days and biochemically validated smoking abstinence at six months. The primary outcome will be collected on 630 smokers allowing sufficient power to detect a 7.5% difference in mean proportion of NRT consumed using a two-tailed test at the 5% level of significance between groups. The proportion of all NRT consumed in the first four weeks of quitting will be compared between arms using an independent samples t-test and by estimating the 95% confidence interval for observed between-arm difference in mean NRT consumption (Hypothesis I). Motivation to make another quit attempt will be compared between arms in those failing to quit by six months (Hypothesis II). DISCUSSION: This is the first clinical trial evaluating the behavioural impact on adherence of prescribing medication using genetic rather than phenotypic information. Specific issues regarding the choice of design for trials of interventions of this kind are discussed. TRIAL DETAILS: Funder: Medical Research Council (MRC)Grant number: G0500274. ISRCTN: 14352545. Date trial stated: June 2007. Expected end date: December 2009. Expected reporting date: December 2010.