G. Furze et al. A cost for each trial participant was calculated as the product of resources used by their relevant costs over the period of 6 months. Two components were considered in the estimation of cost per participant – the cost of treatment and the cost of angina and heart related healthcare utilization. Apart from the resource use mentioned below, other resource uses were assumed to be equal across both treatment arms and thus not included in the following economics analyses. Validity and reliability The NACR minimum dataset aims to give a standardized audit tool covering clinical, behavioural and health-related aspects of rehabilitation for UK cardiac rehabilitation programmes. The measures included in the dataset (including the HADS) were adopted following screening of over 200 measures for previous evidence of validity and reliability in UK cardiac populations, and assessment for acceptability among staff and patients in UK cardiac rehabilitation programmes (Lewin et al. 2004). The Seattle Angina Questionnaire scales and the angina diary were found to be reliable in the original Angina Plan study (Lewin et al. 2002). The YABQ was developed among angina popula- tions in the UK and reported good internal consistency (Cron- bach’s alpha 0Æ79–0Æ82) and stability (test–retest Pearson’s r = 0Æ79) (Furze et al. 2003). Recruitment procedure and data collection Participants were recruited between May 2006 – September 2008, with follow-up complete in April 2009. The partici- pants completed a 1-week angina diary after which the research nurse phoned the remote randomization service and arranged for a follow-up appointment with either the Angina Nurse Specialist (control arm) in outpatients’ clinic, or with a lay facilitator (intervention arm) to visit the participant at home, appropriately. All data were collected at baseline and 6-month follow-up, questionnaire measures were also collected at 3 months. The 3-month follow-up was by postal questionnaires, and 6-month follow-up of all outcomes was undertaken by postal questionnaire and by a home visit from the research nurse to collect other outcome data. Ethical considerations Ethical approval was granted prior to study commencement by an NHS Local Research Ethics Committee (05/Q1406/ 66). Approval for the study was also granted by the site Research Governance team. 2272 Data analysis Analysis was conducted using the both Statistical Package for the Social Sciences (SPSS) version 16 and STATA version 10 (StataCorp 2007, College Station, TX, USA). All analyses were by intention to treat. As the primary outcome total number of angina episodes at month 6 was count data and there was over-dispersion in the data, a negative binomial regression model was used to compare the two treatment groups. Intervention group was included in the model and the analysis was also adjusted for the number of angina episodes at baseline. The results are presented as incidence rate ratios. The secondary outcome measures include; blood pressure, cholesterol, BMI, waist/hip ratio, SAQ and HADs. These were analysed by linear regression, the dependent variable being the outcome at month 3 or month 6. All analyses were adjusted for the baseline score of the dependent variable, including a term for the intervention group and controlling for the appropriate baseline value. Other secondary outcomes include smoking status at month 6 and whether or not the participant was undertaking the recommended level of exercise (5 · 30 minutes per week). These were both binary variables and so were analysed using a logistic regression model with the dependent data variable being the outcome at month 3 or month 6, the analyses were also adjusted for the baseline category, also included was a term for treatment group. Model checking was performed to ensure that the models were an adequate ﬁt for the data. Cost-effectiveness analysis A cost-utility analysis was conducted using STATA 10. The health beneﬁt of treatment was measured in units of quality adjusted life year (QALY). Utility was measured by the EQ-5D questionnaire at baseline and each follow-up of 3 and 6 months. The utility is derived from EQ-5D index score to which a pre-deﬁned weight was assigned accordingly. The pre-deﬁned weight represents the social preference of the general population in England and Wales towards EQ-5D health states. These utilities scores were then used to calculate QALYs. The incremental costs were compared with incre- mental QALY on an intention-to-treat basis. The adopted perspective was that of the UK NHS and Personal Social Service. The year of pricing was 2008. The cost-effectiveness analysis used a net beneﬁt regres- sion approach with imputation of missing values, control- ling for a number of covariates (age, gender, marital status, Canadian angina class, Charlson comorbidity score, smoker 2012 Blackwell Publishing Ltd