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1.  Self-Rated Health and Cardiovascular Disease Incidence: Results from a Longitudinal Population-Based Cohort in Norfolk, UK 
PLoS ONE  2013;8(6):e65290.
Introduction
Self-rated health (SRH) predicts chronic disease morbidity including cardiovascular disease (CVD). In a population-based cohort, we examined the association between SRH and incident CVD and whether this association was independent of socio-demographic, clinical and behavioural participant characteristics.
Methods
Population-based prospective cohort study (European Prospective Investigation of Cancer-Norfolk). 20,941 men and women aged 39–74 years without prevalent CVD attended a baseline health examination (1993–1998) and were followed for CVD events/death until March 2007 (mean 11 years). We used a Cox proportional hazards model to quantify the association between baseline SRH (reported on a four point scale – excellent, good, fair, poor) and risk of developing CVD at follow-up after adjusting for socio-demographic, clinical and behavioural risk factors.
Results
Baseline SRH was reported as excellent by 17.8% participants, good by 65.1%, fair by 16.0% and poor by 1.2%. During 225,508 person-years of follow-up, there were 55 (21.2%) CVD events in the poor SRH group and 259 (7.0%) in the excellent SRH group (HR 3.7, 95% CI 2.8–4.9). The HR remained significant after adjustment for behavioural risk factors (HR 2.6, 95% CI 1.9–3.5) and after adjustment for all socio-demographic, clinical and behavioural risk factors (HR 3.3, 95% CI 2.4–4.4). Associations were strong for both fatal and non-fatal events and remained strong over time.
Conclusions
SRH is a strong predictor of incident fatal and non-fatal CVD events in this healthy, middle-aged population. Some of the association is explained by lifestyle behaviours, but SRH remains a strong predictor after adjustment for socio-demographic, clinical and behavioural risk factors and after a decade of follow-up. This easily accessible patient-centred measure of health status may be a useful indicator of individual and population health for those working in primary care and public health.
doi:10.1371/journal.pone.0065290
PMCID: PMC3670935  PMID: 23755212
2.  Association of self-rated health with multimorbidity, chronic disease and psychosocial factors in a large middle-aged and older cohort from general practice: a cross-sectional study 
BMC Family Practice  2014;15(1):185.
Background
The prevalence of coexisting chronic conditions (multimorbidity) is rising. Disease labels, however, give little information about impact on subjective health and personal illness experience. We aim to examine the strength of association of single and multimorbid physical chronic diseases with self-rated health in a middle-aged and older population in England, and to determine whether any association is mediated by depression and other psychosocial factors.
Methods
25 268 individuals aged 39 to 79 years recruited from general practice registers in the European Prospective Investigation of Cancer (EPIC-Norfolk) study, completed a survey including self-rated health, psychosocial function and presence of common physical chronic conditions (cancer, stroke, heart attack, diabetes, asthma/bronchitis and arthritis). Logistic regression models determined odds of “moderate/poor” compared to “good/excellent” health by condition and number of conditions adjusting for psychosocial measures.
Results
One-third (8252) reported one, around 7.5% (1899) two, and around 1% (194) three or more conditions. Odds of “moderate/poor” self-rated health worsened with increasing number of conditions (one (OR = 1.3(1.2–1.4)) versus three or more (OR = 3.4(2.3–5.1)), and were highest where there was comorbidity with stroke (OR = 8.7(4.6–16.7)) or heart attack (OR = 8.5(5.3–13.6)). Psychosocial measures did not explain the association between chronic diseases and multimorbidity with self-rated health.The relationship of multimorbidity with self-rated health was particularly strong in men compared to women (three or more conditions: men (OR = 5.2(3.0–8.9)), women OR = 2.1(1.1–3.9)).
Conclusions
Self-rated health provides a simple, integrative patient-centred assessment for evaluation of illness in the context of multiple chronic disease diagnoses. Those registering in general practice in particular men with three or more diseases or those with cardiovascular comorbidities and with poorer self-rated health may warrant further assessment and intervention to improve their physical and subjective health.
doi:10.1186/s12875-014-0185-6
PMCID: PMC4245775  PMID: 25421440
General practice/family medicine; General integrated subjective health multimorbidity comorbidity
3.  Relationship of Self-Rated Health with Fatal and Non-Fatal Outcomes in Cardiovascular Disease: A Systematic Review and Meta-Analysis 
PLoS ONE  2014;9(7):e103509.
Background
People who rate their health as poor experience higher all-cause mortality. Study of disease-specific association with self-rated health might increase understanding of why this association exists.
Objectives
To estimate the strength of association between self-rated health and fatal and non-fatal cardiovascular disease.
Methods
A comprehensive search of PubMed MEDLINE, EMBASE, CINAHL, BIOSIS, PsycINFO, DARE, Cochrane Library, and Web of Science was undertaken during June 2013. Two reviewers independently searched databases and selected studies. Inclusion criteria were prospective cohort studies or cohort analyses of randomised trials with baseline measurement of self-rated health with fatal or non-fatal cardiovascular outcomes. 20 studies were pooled quantitatively in different meta-analyses. Study quality was assessed using Newcastle-Ottawa scales.
Results
‘Poor’ relative to ‘excellent’ self-rated health (defined by most extreme categories in each study, most often’ poor’ or ‘very poor’ and ‘excellent’ or ‘good’) was associated over a follow-up of 2.3–23 years with cardiovascular mortality in studies: where varying degrees of adjustments had been made for cardiovascular disease risk (HR 1.79 (95% CI 1.50 to 2.14); 15 studies, I2 = 71.24%), and in studies reporting outcomes in people with pre-existing cardiovascular disease or ischaemic heart disease symptoms (HR 2.42 (95% CI 1.32 to 4.44); 3 studies; I2 = 71.83%). ‘Poor’ relative to ‘excellent’ self rated health was also associated with the combined outcome of fatal and non-fatal cardiovascular events (HR 1.90 (95% CI 1.26 to 2.87); 5 studies; I2 = 68.61%), Self-rated health was not significantly associated with non-fatal cardiovascular disease outcomes (HR 1.66 (95% CI 0.96 to 2.87); 5 studies; I2 = 83.60%).
Conclusions
Poor self rated health is associated with cardiovascular mortality in populations with and without prior cardiovascular disease. Those with current poor self-rated health may warrant additional input from health services to identify and address reasons for their low subjective health.
doi:10.1371/journal.pone.0103509
PMCID: PMC4116199  PMID: 25076041
4.  Using the Medical Research Council Framework for the Development and Evaluation of Complex Interventions in a Theory-Based Infant Feeding Intervention to Prevent Childhood Obesity: The Baby Milk Intervention and Trial 
Journal of Obesity  2014;2014:646504.
Introduction. We describe our experience of using the Medical Research Council framework on complex interventions to guide the development and evaluation of an intervention to prevent obesity by modifying infant feeding behaviours. Methods. We reviewed the epidemiological evidence on early life risk factors for obesity and interventions to prevent obesity in this age group. The review suggested prevention of excess weight gain in bottle-fed babies and appropriate weaning as intervention targets; hence we undertook systematic reviews to further our understanding of these behaviours. We chose theory and behaviour change techniques that demonstrated evidence of effectiveness in altering dietary behaviours. We subsequently developed intervention materials and evaluation tools and conducted qualitative studies with mothers (intervention recipients) and healthcare professionals (intervention deliverers) to refine them. We developed a questionnaire to assess maternal attitudes and feeding practices to understand the mechanism of any intervention effects. Conclusions. In addition to informing development of our specific intervention and evaluation materials, use of the Medical Research Council framework has helped to build a generalisable evidence base for early life nutritional interventions. However, the process is resource intensive and prolonged, and this should be taken into account by public health research funders. This trial is registered with ISRTCN: 20814693 Baby Milk Trial.
doi:10.1155/2014/646504
PMCID: PMC4131118  PMID: 25143830
6.  Randomised controlled trial of patient centred care of diabetes in general practice: impact on current wellbeing and future disease risk 
BMJ : British Medical Journal  1998;317(7167):1202-1208.
Objective To assess the effect of additional training of practice nurses and general practitioners in patient centred care on the lifestyle and psychological and physiological status of patients with newly diagnosed type 2 diabetes.
Design Pragmatic parallel group design, with randomisation between practice teams to routine care (comparison group) or routine care plus additional training (intervention group); analysis at one year, allowing for practice effects and stratifiers; self reporting by patients on communication with practitioners, satisfaction with treatment, style of care, and lifestyle.
Setting 41 practices (21 in intervention group, 20 in comparison group) in a health region in southern England.
Subjects 250/360 patients (aged 30-70 years) diagnosed with type 2 diabetes and completing follow up at one year (142 in intervention group, 108 in comparison group).
Intervention 1.5 days’ group training for the doctors and nurses—introducing evidence for and skills of patient centred care and a patient held booklet encouraging questions.
Main outcome measures Quality of life, wellbeing, haemoglobin A1c and lipid concentrations, blood pressure, body mass index (kg/m2).
Results Compared with patients in the C group, those in the intervention group reported better communication with the doctors (odds ratio 2.8; 95% confidence interval 1.8 to 4.3) and greater treatment satisfaction (1.6; 1.1 to 2.5) and wellbeing (difference in means (d) 2.8; 0.4 to 5.2). However, their body mass index was significantly higher (d=2.0; 0.3 to 3.8), as were triglyceride concentrations (d=0.4 mmol/l; 0.07 to 0.73 mmol/l), whereas knowledge scores were lower (d=−2.74; −0.23 to −5.25). Differences in lifestyle and glycaemic control were not significant.
Conclusions The findings suggest greater attention to the consultation process than to preventive care among trained practitioners; those committed to achieving the benefits of patient centred consulting should not lose the focus on disease management.
Key messagesA training programme in patient centred care for practitioners led to patients with newly diagnosed diabetes reporting better communication with doctors, greater wellbeing, and greater treatment satisfaction at one year, without loss of glycaemic controlKnowledge scores were lower and weight and other cardiovascular risk factors higher among patients attending trained practice teamsTrained practitioners may have found it difficult to integrate attention to wellbeing with management of disease riskProfessionals using patient centred consulting should not lose the focus on disease
PMCID: PMC28704  PMID: 9794859
7.  Implementation of a nurse-led behaviour change intervention to support medication taking in type 2 diabetes: beyond hypothesised active ingredients (SAMS Consultation Study) 
Background
Implementation of trial interventions is rarely assessed, despite its effects on findings. We assessed the implementation of a nurse-led intervention to facilitate medication adherence in type 2 diabetes (SAMS) in a trial against standard care in general practice. The intervention increased adherence, but not through the hypothesised psychological mechanism. This study aimed to develop a reliable coding frame for tape-recorded consultations, assessing both a priori hypothesised and potential active ingredients observed during implementation, and to describe the delivery and receipt of intervention and standard care components to understand how the intervention might have worked.
Methods
211 patients were randomised to intervention or comparison groups and 194/211 consultations were tape-recorded. Practice nurses delivered standard care to all patients and motivational and action planning (implementation intention) techniques to intervention patients only. The coding frame was developed and piloted iteratively on selected tape recordings until a priori reliability thresholds were achieved. All tape-recorded consultations were coded and a random subsample double-coded.
Results
Nurse communication, nurse-patient relationship and patient responses were identified as potential active ingredients over and above the a priori hypothesised techniques. The coding frame proved reliable. Intervention and standard care were clearly differentiated. Nurse protocol adherence was good (M (SD) = 3.95 (0.91)) and competence of intervention delivery moderate (M (SD) = 3.15 (1.01)). Nurses frequently reinforced positive beliefs about taking medication (e.g., 65% for advantages) but rarely prompted problem solving of negative beliefs (e.g., 21% for barriers). Patients’ action plans were virtually identical to current routines. Nurses showed significantly less patient-centred communication with the intervention than comparison group.
Conclusions
It is feasible to reliably assess the implementation of behaviour change interventions in clinical practice. The main study results could not be explained by poor delivery of motivational and action planning components, definition of new action plans, improved problem solving or patient-centred communication. Possible mechanisms of increased medication adherence include spending more time discussing it and mental rehearsal of successful performance of current routines, combined with action planning. Delivery of a new behaviour change intervention may lead to less patient-centred communication and possible reduction in overall trial effects.
Trial registration
ISRCTN30522359.
doi:10.1186/1748-5908-9-70
PMCID: PMC4055947  PMID: 24902481
Fidelity; Implementation; Medication adherence; Behaviour change techniques; Process evaluation
15.  Using the 7-point checklist as a diagnostic aid for pigmented skin lesions in general practice: a diagnostic validation study 
The British Journal of General Practice  2013;63(610):e345-e353.
Background
GPs need to recognise significant pigmented skin lesions, given rising UK incidence rates for malignant melanoma. The 7-point checklist (7PCL) has been recommended by NICE (2005) for routine use in UK general practice to identify clinically significant lesions which require urgent referral.
Aim
To validate the Original and Weighted versions of the 7PCL in the primary care setting.
Design and setting
Diagnostic validation study, using data from a SIAscopic diagnostic aid randomised controlled trial in eastern England.
Method
Adults presenting in general practice with a pigmented skin lesion that could not be immediately diagnosed as benign were recruited into the trial. Reference standard diagnoses were histology or dermatology expert opinion; 7PCL scores were calculated blinded to the reference diagnosis. A case was defined as a clinically significant lesion for primary care referral to secondary care (total 1436 lesions: 225 cases, 1211 controls); or melanoma (36).
Results
For diagnosing clinically significant lesions there was a difference between the performance of the Original and Weighted 7PCLs (respectively, area under curve: 0.66, 0.69, difference = 0.03, P<0.001). For the identification of melanoma, similar differences were found. Increasing the Weighted 7PCL’s cut-off score from recommended 3 to 4 improved detection of clinically significant lesions in primary care: sensitivity 73.3%, specificity 57.1%, positive predictive value 24.1%, negative predictive value 92.0%, while maintaining high sensitivity of 91.7% and moderate specificity of 53.4% for melanoma.
Conclusion
The Original and Weighted 7PCLs both performed well in a primary care setting to identify clinically significant lesions as well as melanoma. The Weighted 7PCL, with a revised cut-off score of 4 from 3, performs slightly better and could be applied in general practice to support the recognition of clinically significant lesions and therefore the early identification of melanoma.
doi:10.3399/bjgp13X667213
PMCID: PMC3635581  PMID: 23643233
diagnostic techniques and procedures; general practice; melanoma; pigmented skin lesions
16.  Multiple behaviour change intervention and outcomes in recently diagnosed type 2 diabetes: the ADDITION-Plus randomised controlled trial 
Diabetologia  2014;57(7):1308-1319.
Aims/hypothesis
The aim of this study was to assess whether or not a theory-based behaviour change intervention delivered by trained and quality-assured lifestyle facilitators can achieve and maintain improvements in physical activity, dietary change, medication adherence and smoking cessation in people with recently diagnosed type 2 diabetes.
Methods
An explanatory randomised controlled trial was conducted in 34 general practices in Eastern England (Anglo–Danish–Dutch Study of Intensive Treatment in People with Screen Detected Diabetes in Primary Care-Plus [ADDITION-Plus]). In all, 478 patients meeting eligibility criteria (age 40 to 69 years with recently diagnosed screen or clinically detected diabetes) were individually randomised to receive either intensive treatment (n = 239) or intensive treatment plus a theory-based behaviour change intervention led by a facilitator external to the general practice team (n = 239). Randomisation was central and independent using a partial minimisation procedure to balance stratifiers between treatment arms. Facilitators taught patients skills to facilitate change in and maintenance of key health behaviours, including goal setting, self-monitoring and building habits. Primary outcomes included physical activity energy expenditure (individually calibrated heart rate monitoring and movement sensing), change in objectively measured fruit and vegetable intake (plasma vitamin C), medication adherence (plasma drug levels) and smoking status (plasma cotinine levels) at 1 year. Measurements, data entry and laboratory analysis were conducted with staff unaware of participants’ study group allocation.
Results
Of 475 participants still alive, 444 (93%; intervention group 95%, comparison group 92%) attended 1-year follow-up. There were no significant differences between groups in physical activity (difference: +1.50 kJ kg−1 day−1; 95% CI −1.74, 4.74), plasma vitamin C (difference: −3.84 μmol/l; 95% CI −8.07, 0.38), smoking (OR 1.37; 95% CI 0.77, 2.43) and plasma drug levels (difference in metformin levels: −119.5 μmol/l; 95% CI −335.0, 95.9). Cardiovascular risk factors and self-reported behaviour improved in both groups with no significant differences between groups.
Conclusions/interpretation
For patients with recently diagnosed type 2 diabetes receiving intensive treatment in UK primary care, a facilitator-led individually tailored behaviour change intervention did not improve objectively measured health behaviours or cardiovascular risk factors over 1 year.
Trial registration
ISRCTN99175498
Funding
The trial is supported by the Medical Research Council, the Wellcome Trust, National Health Service R&D support funding (including the Primary Care Research and Diabetes Research Networks) and National Institute of Health Research under its Programme Grants for Applied Research scheme. The Primary Care Unit is supported by NIHR Research funds. Bio-Rad provided equipment for HbA1c testing during the screening phase.
Electronic supplementary material
The online version of this article (doi:10.1007/s00125-014-3236-6) contains peer-reviewed but unedited supplementary material, which is available to authorised users.
doi:10.1007/s00125-014-3236-6
PMCID: PMC4052009  PMID: 24759957
ADDITION-Plus; Diabetes; General practice; Health behaviour; Randomised trial
17.  Does Electronic Monitoring Influence Adherence to Medication? Randomized Controlled Trial of Measurement Reactivity 
Annals of Behavioral Medicine  2014;48(3):293-299.
Background
Electronic monitoring is recommended for accurate measurement of medication adherence but a possible limitation is that it may influence adherence.
Purpose
To test the reactive effect of electronic monitoring in a randomized controlled trial.
Methods
A total of 226 adults with type 2 diabetes and HbA1c ≥58 mmol/mol were randomized to receiving their main oral glucose lowering medication in electronic containers or standard packaging. The primary outcomes were self-reported adherence measured with the MARS (Medication Adherence Report Scale; range 5–25) and HbA1c at 8 weeks.
Results
Non-significantly higher adherence and lower HbA1c were observed in the electronic container group (differences in means, adjusting for baseline value: MARS, 0.4 [95 % CI −0.1 to 0.8, p = 0.11]; HbA1c (mmol/mol), −1.02 [−2.73 to 0.71, p = 0.25]).
Conclusions
Electronic containers may lead to a small increase in adherence but this potential limitation is outweighed by their advantages. Our findings support electronic monitoring as the method of choice in research on medication adherence. (Trial registration Current Controlled Trials ISRCT N30522359)
doi:10.1007/s12160-014-9595-x
PMCID: PMC4223537  PMID: 24573909
Measurement reactivity; Medication adherence; Electronic monitoring; Diabetes
18.  Predictors of change in objectively measured and self-reported health behaviours among individuals with recently diagnosed type 2 diabetes: longitudinal results from the ADDITION-Plus trial cohort 
Background
There is limited evidence about predictors of health behaviour change in people with type 2 diabetes. The aim of this study was to assess change in health behaviours over one year and to identify predictors of behaviour change among adults with screen-detected and recently clinically diagnosed diabetes.
Methods
ADDITION-Plus was a randomised controlled trial of a behaviour change intervention among 478 patients (40–69 years). Physical activity and diet were measured objectively (physical activity at 1 year) and by self-report at baseline and one year. Associations between baseline predictors and behaviour change were quantified using multivariable linear regression.
Results
Participants increased their plasma vitamin C and fruit intake, reduced energy and fat intake from baseline to follow-up. Younger age, male sex, a smaller waist circumference, and a lower systolic blood pressure at baseline were associated with higher levels of objectively measured physical activity at one year. Greater increases in plasma vitamin C were observed in women (beta-coefficient [95% CI]: beta = −5.52 [−9.81, -1.22]) and in those with screen-detected diabetes (beta = 6.09 [1.74, 10.43]). Younger age predicted a greater reduction in fat (beta = −0.43 [−0.72, -0.13]) and energy intake (beta = −6.62 [−13.2, -0.05]). Patients with screen-detected diabetes (beta = 74.2 [27.92, 120.41]) reported a greater increase in fruit intake. There were no significant predictors of change in self-reported physical activity. Beliefs about behaviour change and diabetes did not predict behaviour change.
Conclusions
Older patients, men and those with a longer duration of diabetes may need more intensive support for dietary change. We recommend that future studies use objective measurement of health behaviours and that researchers add predictors beyond the individual level. Our results support a focus on establishing healthy lifestyle changes early in the diabetes disease trajectory.
doi:10.1186/1479-5868-10-118
PMCID: PMC3874745  PMID: 24152757
Health behaviour; Behaviour change; Predictors; Type 2 diabetes; Newly diagnosed
19.  Trials to Improve Blood Pressure Through Adherence to Antihypertensives in Stroke/TIA: Systematic Review and Meta‐Analysis 
Background
The purpose of this study was to determine whether interventions including components to improve adherence to antihypertensive medications in patients after stroke/transient ischemic attack (TIA) improve adherence and blood pressure control.
Methods and Results
We searched MEDLINE, EMBASE, CINAHL, BNI, PsycINFO, and article reference lists to October 2012. Search terms included stroke/TIA, adherence/prevention, hypertension, and randomized controlled trial (RCT). Inclusion criteria were participants with stroke/TIA; interventions including a component to improve adherence to antihypertensive medications; and outcomes including blood pressure, antihypertensive adherence, or both. Two reviewers independently assessed studies to determine eligibility, validity, and quality. Seven RCTs were eligible (n=1591). Methodological quality varied. All trials tested multifactorial interventions. None targeted medication adherence alone. Six trials measured blood pressure and 3 adherence. Meta‐analysis of 6 trials showed that multifactorial programs were associated with improved blood pressure control. The difference between intervention versus control in mean improvement in systolic blood pressure was −5.3 mm Hg (95% CI, −10.2 to −0.4 mm Hg, P=0.035; I2=67% [21% to 86%]) and in diastolic blood pressure was −2.5 mm Hg (−5.0 to −0.1 mm Hg, P=0.046; I2=47% [0% to 79%]). There was no effect on medication adherence where measured.
Conclusions
Multifactorial interventions including a component to improve medication adherence can lower blood pressure after stroke/TIA. However, it is not possible to say whether or not this is achieved through better medication adherence. Trials are needed of well‐characterized interventions to improve medication adherence and clinical outcomes with measurement along the hypothesized causal pathway.
doi:10.1161/JAHA.113.000251
PMCID: PMC3828799  PMID: 23963756
blood pressure; hypertension; prevention; stroke
20.  Cardiovascular risk reduction following diagnosis of diabetes by screening: 1-year results from the ADDITION-Cambridge trial cohort 
The British Journal of General Practice  2012;62(599):e396-e402.
Background
Uncertainties persist concerning the effects of early intensive management of type 2 diabetes and which patients benefit most from such an approach.
Aim
To describe change in modelled cardiovascular risk in the 14 months following diagnosis, and to examine which baseline patient characteristics and treatment components are associated with risk reduction.
Design and setting
A cohort of individuals from a pragmatic, single-blind, cluster-randomised controlled trial of 236 females and 361 males with screen-detected type 2 diabetes and without prior cardiovascular disease (CVD), from 49 GP surgeries in eastern England, examined at baseline (2002–2006) and after 14-months’ follow-up.
Method
Multiple linear regression was used to quantify the association between baseline patient characteristics, treatment components, and change in modelled 10-year cardiovascular risk (UK Prospective Diabetes Study [UKPDS] [version 3] risk engine).
Results
There was a downward shift in the distribution of modelled CVD risk over 14 months mean 31% (standard deviation [SD] = 14%) to 26% [SD = 13%]). Older individuals, males, and those with a larger waist circumference at baseline exhibited smaller risk reductions. Individuals prescribed higher numbers of drugs over the follow-up period, and those who decreased their energy intake or reduced their weight, demonstrated larger reductions in modelled risk.
Conclusion
It is possible to achieve significant reductions in modelled CVD risk over 14 months following diagnosis of diabetes by screening. Risk reduction appeared to be driven mainly by prescription of higher numbers of drugs, decreased energy intake, and weight reduction. There was room for further risk reduction, as many patients were not prescribed recommended treatments.
doi:10.3399/bjgp12X649070
PMCID: PMC3361118  PMID: 22687231
cardiovascular diseases, prevention and control; diabetes mellitus; equity; mass screening; primary care; risk factors; socioeconomic factors
21.  Screening for type 2 diabetes and population mortality over 10 years (ADDITION-Cambridge): a cluster-randomised controlled trial 
Lancet  2012;380(9855):1741-1748.
Summary
Background
The increasing prevalence of type 2 diabetes poses a major public health challenge. Population-based screening and early treatment for type 2 diabetes could reduce this growing burden. However, uncertainty persists around the benefits of screening for type 2 diabetes. We assessed the effect of a population-based stepwise screening programme on mortality.
Methods
In a pragmatic parallel group, cluster-randomised trial, 33 general practices in eastern England were randomly assigned by the method of minimisation in an unbalanced design to: screening followed by intensive multifactorial treatment for people diagnosed with diabetes (n=15); screening plus routine care of diabetes according to national guidelines (n=13); and a no-screening control group (n=5). The study population consisted of 20 184 individuals aged 40–69 years (mean 58 years), at high risk of prevalent undiagnosed diabetes, on the basis of a previously validated risk score. In screening practices, individuals were invited to a stepwise programme including random capillary blood glucose and glycated haemoglobin (HbA1c) tests, a fasting capillary blood glucose test, and a confirmatory oral glucose tolerance test. The primary outcome was all-cause mortality. All participants were flagged for mortality surveillance by the England and Wales Office of National Statistics. Analysis was by intention-to-screen and compared all-cause mortality rates between screening and control groups. This study is registered, number ISRCTN86769081.
Findings
Of 16 047 high-risk individuals in screening practices, 15 089 (94%) were invited for screening during 2001–06, 11 737 (73%) attended, and 466 (3%) were diagnosed with diabetes. 4137 control individuals were followed up. During 184 057 person-years of follow up (median duration 9·6 years [IQR 8·9–9·9]), there were 1532 deaths in the screening practices and 377 in control practices (mortality hazard ratio [HR] 1·06, 95% CI 0·90–1·25). We noted no significant reduction in cardiovascular (HR 1·02, 95% CI 0·75–1·38), cancer (1·08, 0·90–1·30), or diabetes-related mortality (1·26, 0·75–2·10) associated with invitation to screening.
Interpretation
In this large UK sample, screening for type 2 diabetes in patients at increased risk was not associated with a reduction in all-cause, cardiovascular, or diabetes-related mortality within 10 years. The benefits of screening might be smaller than expected and restricted to individuals with detectable disease.
Funding
Wellcome Trust; UK Medical Research Council; National Health Service research and development support; UK National Institute for Health Research; University of Aarhus, Denmark; Bio-Rad.
doi:10.1016/S0140-6736(12)61422-6
PMCID: PMC3607818  PMID: 23040422
22.  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.
Background
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).
Conclusions
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
Controlled-Trials.com ISRCTN14352545.
doi:10.1371/journal.pone.0035249
PMCID: PMC3324463  PMID: 22509402
23.  An explanatory randomised controlled trial of a nurse-led, consultation-based intervention to support patients with adherence to taking glucose lowering medication for type 2 diabetes 
BMC Family Practice  2012;13:30.
Background
Failure to take medication reduces the effectiveness of treatment leading to increased morbidity and mortality. We evaluated the efficacy of a consultation-based intervention to support objectively-assessed adherence to oral glucose lowering medication (OGLM) compared to usual care among people with type 2 diabetes.
Methods
This was a parallel group randomised trial in adult patients with type 2 diabetes and HbA1c≥7.5% (58 mmol/mol), prescribed at least one OGLM. Participants were allocated to a clinic nurse delivered, innovative consultation-based intervention to strengthen patient motivation to take OGLM regularly and support medicine taking through action-plans, or to usual care. The primary outcome was the percentage of days on which the prescribed dose of medication was taken, measured objectively over 12 weeks with an electronic medication-monitoring device (TrackCap, Aardex, Switzerland). The primary analysis was intention-to-treat.
Results
211 patients were randomised between July 1, 2006 and November 30, 2008 in 13 British general practices (primary care clinics). Primary outcome data were available for 194 participants (91.9%). Mean (sd) percentage of adherent days was 77.4% (26.3) in the intervention group and 69.0% (30.8) in standard care (mean difference between groups 8.4%, 95% confidence interval 0.2% to 16.7%, p = 0.044). There was no significant adverse impact on functional status or treatment satisfaction.
Conclusions
This well-specified, theory based intervention delivered in a single session of 30 min in primary care increased objectively measured medication adherence, with no adverse effect on treatment satisfaction. These findings justify a definitive trial of this approach to improving medication adherence over a longer period of time, with clinical and cost-effectiveness outcomes to inform clinical practice.
Trial registration
Current Controlled Trials ISRCTN30522359
doi:10.1186/1471-2296-13-30
PMCID: PMC3499458  PMID: 22480341
Adherence; Brief intervention; Diabetes
24.  More than measurement: practice team experiences of screening for type 2 diabetes 
Family Practice  2010;27(4):386-394.
Background. The feasibility, cost-effectiveness and best means to implement population screening for type 2 diabetes remain to be established.
Objective. To learn from the experiences of practice staff undertaking a diabetes screening programme in order to inform future screening initiatives.
Methods. Qualitative analysis of interviews with staff in six general practices in the ‘ADDITION-Cambridge’ trial; three randomly allocated to intensively manage screen-detected patients and three providing usual care. We conducted semi-structured interviews with seven nurses, four doctors, three health care assistants and four managers. Four researchers analysed the transcripts practice by practice, preparing vignettes and comparing interpretations. Participants commented on a summary report.
Results. Each practice team implemented the screening and intervention programme differently, depending on numbers at risk and decisions about staff contributions. Several emphasized the importance of administrative support. As they screened, they extended the reach of the programme, testing patients outside the target group if requested, checking other risk factors, providing health information and following up people with impaired glucose tolerance. Staff felt that patients accepted the screening and subsequent management as any other clinical activity.
Conclusions. Although those developing screening programmes attempt to standardize them, primary care teams need to adapt the work to fit local circumstances. Staff need a sense of ownership, training, well-designed information technology systems and protected time. Furthermore, screening is more than measurement; at the individual level, it is a complete health care interaction, requiring individual explanations, advice on health-related behaviour and appropriate follow-up. The UK ‘NHS Health Checks’ programme should embrace these findings.
doi:10.1093/fampra/cmq022
PMCID: PMC2908159  PMID: 20403926
Attitude of health personnel; delivery of health care; implementation; mass screening; primary health care; (MeSH terms): type 2 diabetes mellitus
25.  Protocol for the ADDITION-Plus study: a randomised controlled trial of an individually-tailored behaviour change intervention among people with recently diagnosed type 2 diabetes under intensive UK general practice care 
BMC Public Health  2011;11:211.
Background
The increasing prevalence of type 2 diabetes poses both clinical and public health challenges. Cost-effective approaches to prevent progression of the disease in primary care are needed. Evidence suggests that intensive multifactorial interventions including medication and behaviour change can significantly reduce cardiovascular morbidity and mortality among patients with established type 2 diabetes, and that patient education in self-management can improve short-term outcomes. However, existing studies cannot isolate the effects of behavioural interventions promoting self-care from other aspects of intensive primary care management. The ADDITION-Plus trial was designed to address these issues among recently diagnosed patients in primary care over one year.
Methods/Design
ADDITION-Plus is an explanatory randomised controlled trial of a facilitator-led, theory-based behaviour change intervention tailored to individuals with recently diagnosed type 2 diabetes. 34 practices in the East Anglia region participated. 478 patients with diabetes were individually randomised to receive (i) intensive treatment alone (n = 239), or (ii) intensive treatment plus the facilitator-led individual behaviour change intervention (n = 239). Facilitators taught patients key skills to facilitate change and maintenance of key behaviours (physical activity, dietary change, medication adherence and smoking), including goal setting, action planning, self-monitoring and building habits. The intervention was delivered over one year at the participant's surgery and included a one-hour introductory meeting followed by six 30-minute meetings and four brief telephone calls. Primary endpoints are physical activity energy expenditure (assessed by individually calibrated heart rate monitoring and movement sensing), change in objectively measured dietary intake (plasma vitamin C), medication adherence (plasma drug levels), and smoking status (plasma cotinine levels) at one year. We will undertake an intention-to-treat analysis of the effect of the intervention on these measures, an assessment of cost-effectiveness, and analyse predictors of behaviour change in the cohort.
Discussion
The ADDITION-Plus trial will establish the medium-term effectiveness and cost-effectiveness of adding an externally facilitated intervention tailored to support change in multiple behaviours among intensively-treated individuals with recently diagnosed type 2 diabetes in primary care. Results will inform policy recommendations concerning the management of patients early in the course of diabetes. Findings will also improve understanding of the factors influencing change in multiple behaviours, and their association with health outcomes.
Trial registration
ISRCTN: ISRCTN99175498
doi:10.1186/1471-2458-11-211
PMCID: PMC3076276  PMID: 21463520

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