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1.  Adherence to and Consumption of Nicotine Replacement Therapy and the Relationship With Abstinence Within a Smoking Cessation Trial in Primary Care 
Nicotine & Tobacco Research  2013;15(9):1537-1544.
Nicotine replacement therapy (NRT) medications have been shown to be effective in increasing smoking cessation rates. There is, however, a lack of good evidence describing how individuals in primary care use these medications and which factors are likely to affect this. The study objectives are to describe adherence and consumption, examine key factors that may determine use, and examine the relationship between consumption of NRT and abstinence from smoking.
Secondary analysis of data from a randomized controlled trial conducted in smoking cessation services in primary care. Adult smokers (n = 633) starting a quit attempt within smoking cessation clinics were followed for 6 months, with NRT use closely monitored for an initial treatment period of 4 weeks. The main outcomes were 4-week adherence to prescribed NRT, mean daily consumption of NRT over the 4-week period, and abstinence from smoking at 4 weeks.
Levels of adherence to prescribed NRT were high: more than 94% in participants who completed the treatment period. After controlling for possible confounders, prescribing higher doses of patch and oral NRT was associated with higher mean daily consumption of NRT. Using an inhalator to deliver oral NRT was associated with both higher adherence and higher consumption. The amount of NRT consumed predicted future abstinence when reverse causation was accounted for.
Most individuals within a clinical trial in primary care who persisted with a quit attempt adhered closely to their prescription. Prescribing higher doses of NRT led to higher consumption and higher consumption to higher abstinence.
PMCID: PMC3741059  PMID: 23430709
2.  Altering micro-environments to change population health behaviour: towards an evidence base for choice architecture interventions 
BMC Public Health  2013;13:1218.
The idea that behaviour can be influenced at population level by altering the environments within which people make choices (choice architecture) has gained traction in policy circles. However, empirical evidence to support this idea is limited, especially its application to changing health behaviour. We propose an evidence-based definition and typology of choice architecture interventions that have been implemented within small-scale micro-environments and evaluated for their effects on four key sets of health behaviours: diet, physical activity, alcohol and tobacco use.
We argue that the limitations of the evidence base are due not simply to an absence of evidence, but also to a prior lack of definitional and conceptual clarity concerning applications of choice architecture to public health intervention. This has hampered the potential for systematic assessment of existing evidence. By seeking to address this issue, we demonstrate how our definition and typology have enabled systematic identification and preliminary mapping of a large body of available evidence for the effects of choice architecture interventions. We discuss key implications for further primary research, evidence synthesis and conceptual development to support the design and evaluation of such interventions.
This conceptual groundwork provides a foundation for future research to investigate the effectiveness of choice architecture interventions within micro-environments for changing health behaviour. The approach we used may also serve as a template for mapping other under-explored fields of enquiry.
PMCID: PMC3881502  PMID: 24359583
Choice architecture; Nudge; Nudging; Behaviour change; Health behaviour
3.  Correction: Choosing between an Apple and a Chocolate Bar: the Impact of Health and Taste Labels 
PLoS ONE  2013;8(10):10.1371/annotation/12ecd041-f8c7-4615-a898-9ee60d2d78a7.
PMCID: PMC3806870  PMID: 24194814
4.  Choosing between an Apple and a Chocolate Bar: the Impact of Health and Taste Labels 
PLoS ONE  2013;8(10):e77500.
Increasing the consumption of fruit and vegetables is a central component of improving population health. Reasons people give for choosing one food over another suggest health is of lower importance than taste. This study assesses the impact of using a simple descriptive label to highlight the taste as opposed to the health value of fruit on the likelihood of its selection. Participants (N=439) were randomly allocated to one of five groups that varied in the label added to an apple: apple; healthy apple; succulent apple; healthy and succulent apple; succulent and healthy apple. The primary outcome measure was selection of either an apple or a chocolate bar as a dessert. Measures of the perceived qualities of the apple (taste, health, value, quality, satiety) and of participant characteristics (restraint, belief that tasty foods are unhealthy, BMI) were also taken. When compared with apple selection without any descriptor (50%), the labels combining both health and taste descriptors significantly increased selection of the apple (’healthy & succulent’ 65.9% and ‘succulent & healthy’ 62.4%), while the use of a single descriptor had no impact on the rate of apple selection (‘healthy’ 50.5% and ‘succulent’ 52%). The strongest predictors of individual dessert choice were the taste score given to the apple, and the lack of belief that healthy foods are not tasty. Interventions that emphasize the taste attributes of healthier foods are likely to be more effective at achieving healthier diets than those emphasizing health alone.
PMCID: PMC3796478  PMID: 24155964
5.  Economic Instruments for Population Diet and Physical Activity Behaviour Change: A Systematic Scoping Review 
PLoS ONE  2013;8(9):e75070.
Unhealthy diet and low levels of physical activity are common behavioural factors in the aetiology of many non-communicable diseases. Recent years have witnessed an upsurge of policy and research interest in the use of taxes and other economic instruments to improve population health.
To assemble, configure and analyse empirical research studies available to inform the public health case for using economic instruments to promote dietary and physical activity behaviour change.
We conducted a systematic scoping review of evidence for the effects of specific interventions to change, or general exposure to variations in, prices or income on dietary and physical activity behaviours and corollary outcomes. Systematic electronic searches and parallel snowball searches retrieved >1 million study records. Text mining technologies were used to prioritise title-abstract records for screening. Eligible studies were selected, classified and analysed in terms of key characteristics and principal findings, using a narrative, configuring synthesis focused on implications for policy and further research.
We identified 880 eligible studies, including 192 intervention studies and 768 studies that incorporated evidence for prices or income as correlates or determinants of target outcomes. Current evidence for the effects of economic instruments and exposures on diet and physical activity is limited in quality and equivocal in terms of its policy implications. Direct evidence for the effects of economic instruments is heavily skewed towards impacts on diet, with a relative lack of evidence for impacts on physical activity.
The evidence-based case for using economic instruments to promote dietary and physical activity behaviour change may be less compelling than some proponents have claimed. Future research should include measurement of people’s actual behavioural responses using study designs capable of generating reliable causal inferences regarding intervention effects. Policy implementation needs to be carefully aligned with evaluation planning and design.
PMCID: PMC3782495  PMID: 24086440
6.  Underestimating Calorie Content When Healthy Foods Are Present: An Averaging Effect or a Reference-Dependent Anchoring Effect? 
PLoS ONE  2013;8(8):e71475.
Previous studies have shown that estimations of the calorie content of an unhealthy main meal food tend to be lower when the food is shown alongside a healthy item (e.g. fruit or vegetables) than when shown alone. This effect has been called the negative calorie illusion and has been attributed to averaging the unhealthy (vice) and healthy (virtue) foods leading to increased perceived healthiness and reduced calorie estimates. The current study aimed to replicate and extend these findings to test the hypothesized mediating effect of ratings of healthiness of foods on calorie estimates.
In three online studies, participants were invited to make calorie estimates of combinations of foods. Healthiness ratings of the food were also assessed.
The first two studies failed to replicate the negative calorie illusion. In a final study, the use of a reference food, closely following a procedure from a previously published study, did elicit a negative calorie illusion. No evidence was found for a mediating role of healthiness estimates.
The negative calorie illusion appears to be a function of the contrast between a food being judged and a reference, supporting the hypothesis that the negative calorie illusion arises from the use of a reference-dependent anchoring and adjustment heuristic and not from an ‘averaging’ effect, as initially proposed. This finding is consistent with existing data on sequential calorie estimates, and highlights a significant impact of the order in which foods are viewed on how foods are evaluated.
PMCID: PMC3743811  PMID: 23967216
7.  Patient accounts of diagnostic testing for familial hypercholesterolaemia: comparing responses to genetic and non-genetic testing methods 
BMC Medical Genetics  2012;13:87.
Continuing developments in genetic testing technology together with research revealing gene-disease associations have brought closer the potential for genetic screening of populations. A major concern, as with any screening programme, is the response of the patient to the findings of screening, whether the outcome is positive or negative. Such concern is heightened for genetic testing, which it is feared may elicit stronger reactions than non-genetic testing.
This paper draws on thematic analysis of 113 semi-structured interviews with 39 patients being tested for familial hypercholesterolaemia (FH), an inherited predisposition to early-onset heart disease. It examines the impact of disease risk assessments based on both genetic and non-genetic information, or solely non-genetic information.
The impact of diagnostic testing did not seem to vary according to whether or not genetic information was used. More generally, being given a positive or negative diagnosis of FH had minimal discernible impact on people's lives as they maintained the continuity of their beliefs and behaviour.
The results suggest that concerns about the use of genetic testing in this context are unfounded, a conclusion that echoes findings from studies in this and other health contexts.
PMCID: PMC3495051  PMID: 22994377
Behaviour change; Genetics; Genetic testing; Health behaviour; Risk; Qualitative
8.  Effect on Adherence to Nicotine Replacement Therapy of Informing Smokers Their Dose Is Determined by Their Genotype: A Randomised Controlled Trial 
PLoS ONE  2012;7(4):e35249.
The behavioural impact of pharmacogenomics is untested. We tested two hypotheses concerning the behavioural impact of informing smokers their oral dose of NRT is tailored to analysis of DNA.
Methods and Findings
We conducted an RCT with smokers in smoking cessation clinics (N = 633). In combination with NRT patch, participants were informed that their doses of oral NRT were based either on their mu-opioid receptor (OPRM1) genotype, or their nicotine dependence questionnaire score (phenotype). The proportion of prescribed NRT consumed in the first 28 days following quitting was not significantly different between groups: (68.5% of prescribed NRT consumed in genotype vs 63.6%, phenotype group, difference  =  5.0%, 95% CI −0.9,10.8, p  =  0.098). Motivation to make another quit attempt among those (n  =  331) not abstinent at six months was not significantly different between groups (p  =  0.23). Abstinence at 28 days was not different between groups (p = 0.67); at six months was greater in genotype than phenotype group (13.7% vs 7.9%, difference  =  5.8%, 95% CI 1.0,10.7, p  =  0.018).
Informing smokers their oral dose of NRT was tailored to genotype not phenotype had a small, statistically non-significant effect on 28-day adherence to NRT. Among those still smoking at six months, there was no evidence that saying NRT was tailored to genotype adversely affected motivation to make another quit attempt. Higher abstinence rate at six months in the genotype arm requires investigation.
Trial registration ISRCTN14352545.
PMCID: PMC3324463  PMID: 22509402
9.  Trial Protocol: Communicating DNA-based risk assessments for Crohn's disease: a randomised controlled trial assessing impact upon stopping smoking 
BMC Public Health  2011;11:44.
Estimates of the risk of developing Crohn's disease (CD) can be made using DNA testing for mutations in the NOD2 (CARD15) gene, family history, and smoking status. Smoking doubles the risk of CD, a risk that is reduced by stopping. CD therefore serves as a timely and novel paradigm within which to assess the utility of predictive genetic testing to motivate behaviour change to reduce the risk of disease. The aim of the study is to describe the impact upon stopping smoking of communicating a risk of developing CD that incorporates DNA analysis. We will test the following main hypothesis:
Smokers who are first degree relatives (FDRs) of CD probands are more likely to make smoking cessation attempts following communication of risk estimates of developing CD that incorporate DNA analysis, compared with an equivalent communication that does not incorporate DNA analysis.
A parallel groups randomised controlled trial in which smokers who are FDRs of probands with CD are randomly allocated in families to undergo one of two types of assessment of risk for developing CD based on either:
i. DNA analysis, family history of CD and smoking status, or
ii. Family history of CD and smoking status
The primary outcome is stopping smoking for 24 hours or longer in the six months following provision of risk information. The secondary outcomes are seven-day smoking abstinence at one week and six month follow-ups. Randomisation of 470 smoking FDRs of CD probands, with 400 followed up (85%), provides 80% power to detect a difference in the primary outcome of 14% between randomised arms, at the 5% significance level.
This trial provides one of the strongest tests to date of the impact of communicating DNA-based risk assessment on risk-reducing behaviour change. Specific issues regarding the choice of trial design are discussed.
Trial Registration
PMCID: PMC3036624  PMID: 21247480
10.  Trial Protocol: Using genotype to tailor prescribing of nicotine replacement therapy: a randomised controlled trial assessing impact of communication upon adherence 
BMC Public Health  2010;10:680.
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.
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), or
ii. 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).
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
PMCID: PMC2996370  PMID: 21062464
11.  Effect of communicating DNA based risk assessments for Crohn’s disease on smoking cessation: randomised controlled trial 
Objective To test the hypothesis that communicating risk of developing Crohn’s disease based on genotype and that stopping smoking can reduce this risk, motivates behaviour change among smokers at familial risk.
Design Parallel group, cluster randomised controlled trial.
Setting Families with Crohn’s disease in the United Kingdom.
Participants 497 smokers (mean age 42.6 (SD 14.4) years) who were first degree relatives of probands with Crohn’s disease, with outcomes assessed on 209/251 (based on DNA analysis) and 217/246 (standard risk assessment).
Intervention Communication of risk assessment for Crohn’s disease by postal booklet based on family history of the disease and smoking status alone, or with additional DNA analysis for the NOD2 genotype. Participants were then telephoned by a National Health Service Stop Smoking counsellor to review the booklet and deliver brief standard smoking cessation intervention. Calls were tape recorded and a random subsample selected to assess fidelity to the clinical protocol.
Main outcome measure The primary outcome was smoking cessation for 24 hours or longer, assessed at six months.
Results The proportion of participants stopping smoking for 24 hours or longer did not differ between arms: 35% (73/209) in the DNA arm versus 36% (78/217) in the non-DNA arm (difference −1%, 95% confidence interval −10% to 8%, P=0.83). The proportion making a quit attempt within the DNA arm did not differ between those who were told they had mutations putting them at increased risk (36%), those told they had none (35%), and those in the non-DNA arm (36%).
Conclusion Among relatives of patients with Crohn’s disease, feedback of DNA based risk assessments does not motivate behaviour change to reduce risk any more or less than standard risk assessment. These findings accord with those across a range of populations and behaviours. They do not support the promulgation of commercial DNA based tests nor the search for gene variants that confer increased risk of common complex diseases on the basis that they effectively motivate health related behaviour change.
Trial registration Current Controlled Trials ISRCTN21633644.
PMCID: PMC3401124  PMID: 22822007

Results 1-11 (11)