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

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

Effectiveness of physical activity promotion based in primary care: systematic review and meta-analysis of randomised controlled trials

Objectives To determine whether trials of physical activity promotion based in primary care show sustained effects on physical activity or fitness in sedentary adults, and whether exercise referral interventions are more effective than other interventions

Patients' experiences of screening for type 2 diabetes:prospective qualitative study embedded in the ADDITION (Cambridge) randomised controlled trial

Objectives To provide insight into factors that contribute to the anxiety reported in a quantitative study of the psychological effect of screening for type 2 diabetes. To explore expectations of and reactions to the screening experience of patients with positive, negative, and intermediate results. Design Prospective qualitative interview study of patients attending a screening programme for type 2 diabetes. Setting Seven general practices in the ADDITION (Cambridge) trial in the east of England. Participants 23 participants (aged 50-69) attending different stages in the screening process. Results Participants' perceptions changed as they progressed through the screening programme; the stepwise process seemed to help them adjust psychologically. The first screening test was typically considered unimportant and was attended with no thought about its implications. By the final diagnostic test, type 2 diabetes was considered a strong possibility, albeit a “mild” form. After diagnosis, people with screen detected type 2 diabetes tended to downplay its importance and talked confidently about their plans to control it. Participants with intermediate results seemed uncertain about their diagnosis, and those who screened negative were largely unaware of their remaining high risk. Conclusions This study helps in understanding the limited psychological impact of screening for type 2 diabetes quantified previously, in particular by the quantitative substudy of ADDITION (Cambridge). The findings have implications for implementing such a screening programme in terms of timing and content

Relationship of self-rated health with fatal and non-fatal outcomes in cardiovascular disease: a systematic review and meta-analysis.

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.This is the final published version. It is accessible from the PLOS One website at: http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0103509

The brain, self and society: a social-neuroscience model of predictive processing.

This paper presents a hypothesis about how social interactions shape and influence predictive processing in the brain. The paper integrates concepts from neuroscience and sociology where a gulf presently exists between the ways that each describe the same phenomenon - how the social world is engaged with by thinking humans. We combine the concepts of predictive processing models (also called predictive coding models in the neuroscience literature) with ideal types, typifications and social practice - concepts from the sociological literature. This generates a unified hypothetical framework integrating the social world and hypothesised brain processes. The hypothesis combines aspects of neuroscience and psychology with social theory to show how social behaviors may be "mapped" onto brain processes. It outlines a conceptual framework that connects the two disciplines and that may enable creative dialogue and potential future research.St John's College Cambridge Annual Fun

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’

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 these. 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 work was supported by the Centre for Diet and Activity Research (CEDAR), a UKCRC Public Health Research Centre of Excellence. Funding from the British Heart Foundation, Economic and Social Research Council, Medical Research Council, the National Institute for Health Research, and the Wellcome Trust, under the auspices of the UK Clinical Research Collaboration, is gratefully acknowledged. The Baby Milk Trial is funded by the National Prevention Research Initiative (http://www.npri.org.uk Grant number MR/J000361/1). The Funding Partners relevant to this award are (in alphabetical order): Alzheimer's Research Trust; Alzheimer's Society; Biotechnology and Biological Sciences Research Council; British Heart Foundation; Cancer Research UK; Chief Scientist Office, Scottish Government Health Directorate; Department of Health; Diabetes UK; Economic and Social Research Council; Health and Social Care Research and Development Division of the Public Health Agency (HSC R&D Division); Medical Research Council; The Stroke Association; Wellcome Trust; Welsh Assembly Government; and World Cancer Research Fund. RL was funded by a MRC Population Health Fellowship (Grant number G070165).This is the final published version. It is also available from Hindawi at http://www.hindawi.com/journals/jobe/2014/646504/

The DiGEM trial protocol--a randomised controlled trial to determine the effect on glycaemic control of different strategies of blood glucose self-monitoring in people with type 2 diabetes [ISRCTN47464659].

BACKGROUND: We do not yet know how to use blood glucose self-monitoring (BGSM) most effectively in the self-management of type 2 diabetes treated with oral medication. Training in monitoring may be most effective in improving glycaemic control and well being when results are linked to behavioural change. METHODS/DESIGN: DiGEM is a three arm randomised parallel group trial set in UK general practices. A total of 450 patients with type 2 diabetes managed with lifestyle or oral glucose lowering medication are included. The trial compares effectiveness of three strategies for monitoring glycaemic control over 12 months (1) a control group with three monthly HbA1c measurements; interpreted with nurse-practitioner; (2) A self-testing of blood glucose group; interpreted with nurse- practitioner to inform adjustment of medication in addition to 1; (3) A self-monitoring of blood glucose group with personal use of results to interpret results in relation to lifestyle changes in addition to 1 and 2. The trial has an 80% power at a 5% level of significance to detect a difference in change in the primary outcome, HbA1c of 0.5% between groups, allowing for an attrition rate of 10%. Secondary outcome measures include health service costs, well-being, and the intervention effect in sub-groups defined by duration of diabetes, current management, health status at baseline and co-morbidity. A mediation analysis will explore the extent to which changes in beliefs about self-management of diabetes between experimental groups leads to changes in outcomes in accordance with the Common Sense Model of illness. The study is open and has recruited more than half the target sample. The trial is expected to report in 2007. DISCUSSION: The DiGEM intervention and trial design address weaknesses of previous research by use of a sample size with power to detect a clinically significant change in HbA1c, recruitment from a well-characterised primary care population, definition of feasible monitoring and behaviour change strategies based on psychological theory and evidence, and measures along the hypothesised causal path from cognitions to behaviours and disease and well being related outcomes. The trial will provide evidence to support, focus or discourage use of specific BGSM strategies.RIGHTS : This article is licensed under the BioMed Central licence at http://www.biomedcentral.com/about/license which is similar to the 'Creative Commons Attribution Licence'. In brief you may : copy, distribute, and display the work; make derivative works; or make commercial use of the work - under the following conditions: the original author must be given credit; for any reuse or distribution, it must be made clear to others what the license terms of this work are

Patient-centred care, health behaviours and cardiovascular risk factor levels in people with recently diagnosed type 2 diabetes: 5-year follow-up of the ADDITION-Plus trial cohort.

OBJECTIVE: To examine the association between the experience of patient-centred care (PCC), health behaviours and cardiovascular disease (CVD) risk factor levels among people with type 2 diabetes. DESIGN: Population-based prospective cohort study. SETTING: 34 general practices in East Anglia, UK, delivering organised diabetes care. PARTICIPANTS: 478 patients recently diagnosed with type 2 diabetes aged between 40 and 69 years enrolled in the ADDITION-Plus trial. MAIN OUTCOME MEASURES: Self-reported and objectively measured health behaviours (diet, physical activity, smoking status), CVD risk factor levels (blood pressure, lipid levels, glycated haemoglobin, body mass index, waist circumference) and modelled 10-year CVD risk. RESULTS: Better experiences of PCC early in the course of living with diabetes were not associated with meaningful differences in self-reported physical activity levels including total activity energy expenditure (β-coefficient: 0.080 MET h/day (95% CI 0.017 to 0.143; p=0.01)), moderate-to-vigorous physical activity (β-coefficient: 5.328 min/day (95% CI 0.796 to 9.859; p=0.01)) and reduced sedentary time (β-coefficient: -1.633 min/day (95% CI -2.897 to -0.368; p=0.01)). PCC was not associated with clinically meaningful differences in levels of high-density lipoprotein cholesterol (β-coefficient: 0.002 mmol/L (95% CI 0.001 to 0.004; p=0.03)), systolic blood pressure (β-coefficient: -0.561 mm Hg (95% CI -0.653 to -0.468; p=0.01)) or diastolic blood pressure (β-coefficient: -0.565 mm Hg (95% CI -0.654 to -0.476; p=0.01)). Over an extended follow-up of 5 years, we observed no clear evidence that PCC was associated with self-reported, clinical or biochemical outcomes, except for waist circumference (β-coefficient: 0.085 cm (95% CI 0.015 to 0.155; p=0.02)). CONCLUSIONS: We found little evidence that experience of PCC early in the course of diabetes was associated with clinically important changes in health-related behaviours or CVD risk factors. TRIAL REGISTRATION NUMBER: ISRCTN99175498; Post-results.The trial is supported by the Medical Research Council (grant reference no: G0001164 ), the Wellcome Trust (grant reference no: G061895 ),Diabetes UK and National Health Service R&D support funding . SJG is a member of the National Institute for Health Research (NIHR) School for Primary Care Research. The General Practice and Primary Care Research Unit was supported by NIHR Research funds. ATP is supported by the NIHR Biomedical Research Centre at Guy’s and St Thomas’ NHS Foundation Trust and King’s College London. The views expressed in this publication are those of the authors and not necessarily those of the Department of Health.This is the final version of the article. It was first available from BMJ via http://dx.doi.org/10.1136/bmjopen-2015-00893

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.

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.EPIC-Norfolk is supported by programme grants from Medical Research Council UK (G9502233, G0300128) and Cancer Research UK (C865/A2883), with additional support from the European Union, Stroke Association, Research into Ageing, British Heart Foundation, Department of Health and Wellcome Trust.This is the final version. It was first published by BioMed Central at http://www.biomedcentral.com/1471-2296/15/18

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

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