Simon J. Griffin

Effect on health-related outcomes of interventions to alter the interaction between patients and practitioners: a systematic review of trials.

PURPOSE We wanted to identify published randomized trials of interventions to alter the interaction between patients and practitioners, develop taxonomies of the interventions and outcomes, and assess the evidence that such interventions improve patients’ health and well-being. METHODS Undertaking a systematic review of randomized trials, we sought trials in primary and secondary care with health-related outcomes, which we found by searching MEDLINE, HealthSTAR, and PsycINFO bibliographic databases through 1999. We also completed one round of manual citation searching. RESULTS Thirty-five trials were included. Most were set in primary care in North America. Trials were heterogeneous in populations, settings, interventions, and measures. Interventions frequently combined several poorly described elements. Explicit theoretical underpinning was rare, and only one study linked intervention through process to outcome measures. Health outcomes were rarely measured objectively (6 of 35), and only 4 trials with health outcomes met predefined quality criteria. Interventions frequently altered the process of interactions (significantly in 73%, 22 of 30 trials). Principal outcomes favored the intervention group in 74% of trials (26 of 35), reaching statistical significance in 14 (40%). Positive effects on health outcomes achieved statistical significance in 44% of trials (11 of 25); negative effects were uncommon (5 of 25, 20%). Simple approaches to increasing the participation of patients in the clinical encounter, such as providing practitioners with a note from patients about their concerns beforehand, showed promise, as did more complex programs providing specific information about disease and attention to emotion. Apparently similar interventions varied in effectiveness across studies. CONCLUSIONS Successful interactions between patients and their practitioners lie at the heart of medicine, yet there are few rigorous trials of well-specified interventions to inform best practice. Trial evidence suggests that a range of approaches can achieve changes in this interaction, and some show promise in improving patients’ health. To advance knowledge further, we need to replicate promising studies using rigorous methods. These should include explicit theoretical frameworks designed to link effects on key communication and interaction characteristics through to effects on health outcomes.

Diabetes risk score: towards earlier detection of Type 2 diabetes in general practice

Type 2 diabetes is common, costly and often goes unrecognised for many years. When patients are diagnosed, the majority exhibit associated tissue damage or established cardiovascular risk. Evidence is accumulating that earlier detection and management of diabetes and related metabolic abnormalities may be beneficial. We aimed to develop and evaluate a score based on routinely collected information to identify people at risk of having undetected diabetes.

Effect of early intensive multifactorial therapy on 5-year cardiovascular outcomes in individuals with type 2 diabetes detected by screening (ADDITION-Europe): a cluster-randomised trial

Summary Background Intensive treatment of multiple cardiovascular risk factors can halve mortality among people with established type 2 diabetes. We investigated the effect of early multifactorial treatment after diagnosis by screening. Methods In a pragmatic, cluster-randomised, parallel-group trial done in Denmark, the Netherlands, and the UK, 343 general practices were randomly assigned screening of registered patients aged 40–69 years without known diabetes followed by routine care of diabetes or screening followed by intensive treatment of multiple risk factors. The primary endpoint was first cardiovascular event, including cardiovascular mortality and morbidity, revascularisation, and non-traumatic amputation within 5 years. Patients and staff assessing outcomes were unaware of the practices study group assignment. Analysis was done by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00237549. Findings Primary endpoint data were available for 3055 (99·9%) of 3057 screen-detected patients. The mean age was 60·3 (SD 6·9) years and the mean duration of follow-up was 5·3 (SD 1·6) years. Improvements in cardiovascular risk factors (HbA1c and cholesterol concentrations and blood pressure) were slightly but significantly better in the intensive treatment group. The incidence of first cardiovascular event was 7·2% (13·5 per 1000 person-years) in the intensive treatment group and 8·5% (15·9 per 1000 person-years) in the routine care group (hazard ratio 0·83, 95% CI 0·65–1·05), and of all-cause mortality 6·2% (11·6 per 1000 person-years) and 6·7% (12·5 per 1000 person-years; 0·91, 0·69–1·21), respectively. Interpretation An intervention to promote early intensive management of patients with type 2 diabetes was associated with a small, non-significant reduction in the incidence of cardiovascular events and death. Funding National Health Service Denmark, Danish Council for Strategic Research, Danish Research Foundation for General Practice, Danish Centre for Evaluation and Health Technology Assessment, Danish National Board of Health, Danish Medical Research Council, Aarhus University Research Foundation, Wellcome Trust, UK Medical Research Council, UK NIHR Health Technology Assessment Programme, UK National Health Service R&D, UK National Institute for Health Research, Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht, Novo Nordisk, Astra, Pfizer, GlaxoSmithKline, Servier, HemoCue, Merck.

Family involvement in weight control, weight maintenance and weight-loss interventions: a systematic review of randomised trials

OBJECTIVE: To conduct a descriptive systematic review into the nature and effectiveness of family involvement in weight control, weight maintenance and weight-loss interventions.METHOD: We searched Medline and Psyclit for English language papers describing randomised trials with at least 1-y follow-up that evaluated interventions incorporating a family-based component. Studies involving people with eating disorders, learning disabilities and undernutrition or malnutrition were excluded. Data were extracted on characteristics of the participants, study design, target behaviours, nature of the intervention and study outcomes. A taxonomy was developed and used to classify family involvement in behaviour change interventions. Interventions were also classified according to an existing taxonomy that characterised the behaviour change techniques employed.RESULTS: A total of 21 papers describing 16 intervention studies were identified. Studies were small (mean sample size: 52), heterogeneous, poorly described but with few losses to follow-up (median 15%). The majority were North American and aimed at weight loss. Few studies described a theoretical underpinning to the behaviour change techniques employed. There was a suggestion that spouse involvement increased effectiveness but that adolescents achieved greater weight loss when treated alone. In studies including children, beneficial effects were seen when greater numbers of behaviour change techniques were taught to both parents and children.CONCLUSION: Relatively few intervention studies exist in this important area, particularly studies targeting adolescents, and they highlight continued uncertainty about how best to involve family members. The studies provide limited support for the involvement of spouses. They suggest that parental involvement is associated with weight loss in children, and that use of a greater range of behaviour change techniques improves weight outcomes for both parents and children. The development of future interventions and assessment of factors influencing effectiveness may be improved by paying careful attention to which family members are targeted and how they are involved in the intervention in terms of setting goals for behaviour change, providing support and training in behaviour change techniques.

Interventions to prevent weight gain: a systematic review of psychological models and behaviour change methods.

OBJECTIVE: To identify and review published interventions aimed at the prevention of weight gain.DESIGN: A systematic review of published interventions aimed at the prevention of weight gain.METHODS: Search strategies—we searched eight databases, manually checked reference lists and contacted authors. Inclusion and exclusion criteria—studies of any design, in which participants were selected regardless of weight or age, were included. Interventions targeting a specific subgroup, multifactorial interventions, interventions aimed at weight loss, and those with an ambiguous aim were excluded. Data extraction—data were extracted on behaviours targeted for change, psychological model, behaviour change methods and modes of delivery, methodological quality, characteristics of participants, and outcomes related to body weight and self-reported diet and physical activity. Classification and validation—a taxonomy of behaviour change programmes was developed and used for classification of underlying model, behaviour change methods, and modes of delivery. The data extraction and subsequent classification were independently validated.RESULTS: Eleven publications were included, describing five distinct interventions in schools and four in the wider community. Where diet and physical activity were described, positive effects were usually obtained, but all were measured by self-report. Effects on weight were mixed but follow-up was generally short. Smaller effects on weight gain were found among low-income participants, students and smokers. Many participants in the community-based studies were overweight or obese. Study dropout was higher among thinner and lower-income subjects.CONCLUSION: Interventions to prevent weight gain exhibited various degrees of effectiveness. Definite statements about the elements of the interventions that were associated with increased effect size cannot be made as only one of the five studies that involved an RCT design reported a significant effect on weight. This intervention involved a correspondence programme and a mix of behaviour change methods including goal setting, self-monitoring and contingencies. Future interventions might be more effective if they were explicitly based on methods of behaviour change that have been shown to work in other contexts. Effective interventions would be more easily replicated if they were explicitly described. Effectiveness might be more precisely demonstrated if more objective measures of physical activity and diet were used, and if the follow-up was over a longer period.

The ADDITION study : proposed trial of the cost-effectiveness of an intensive multifactorial intervention on morbidity and mortality among people with Type 2 diabetes detected by screening

OBJECTIVE: The overall aims of the ADDITION study are to evaluate whether screening for prevalent undiagnosed Type 2 diabetes is feasible, and whether subsequent optimised intensive treatment of diabetes, and associated risk factors, is feasible and beneficial.DESIGN: Population-based screening in three European countries followed by an open, randomised controlled trial.SUBJECTS AND METHODS: People aged 40–69 y in the community, without known diabetes, will be offered a random capillary blood glucose screening test by their primary care physicians, followed, if equal to or greater than 5.5 mmol/l, by fasting and 2-h post-glucose-challenge blood glucose measurements. Three thousand newly diagnosed patients will subsequently receive conventional treatment (according to current national guidelines) or intensive multifactorial treatment (lifestyle advice, prescription of aspirin and ACE-inhibitors, in addition to protocol-driven tight control of blood glucose, blood pressure and cholesterol). Patients allocated to intensive treatment will be further randomised to centre-specific interventions to motivate adherence to lifestyle changes and medication. Duration of follow-up is planned for 5 y. Endpoints will include mortality, macrovascular and microvascular complications, patient health status and satisfaction, process-of-care indicators and costs.

Targeting sedentary time or moderate- and vigorous-intensity activity: independent relations with adiposity in a population-based sample of 10-y-old British children

BACKGROUND It is unclear whether subcomponents of physical activity (PA) are associated with adiposity independent of time spent while sedentary. OBJECTIVE The objective was to examine associations between objectively measured PA and its subcomponents [ie, time spent at light-intensity PA, moderate-intensity PA (MPA), vigorous-intensity PA (VPA), and moderate-plus-vigorous-intensity PA (MVPA)], independent of sedentary time, and self-reported leisure screen time (television and electronic game use) with indexes of adiposity in a population-based sample of British children. DESIGN A cross-sectional study was conducted in 1862 UK children aged 9-10 y. PA and sedentary activity were measured by accelerometry, and indicators of adiposity were waist circumference, body mass index (BMI), and fat mass index calculated from bioimpedance measurements. Screen time was assessed by self-report. We examined the associations between PA subcomponents and adiposity by multilevel linear models adjusted for birth weight, maternal BMI, energy intake, and sleep duration. RESULTS Objectively measured sedentary time was positively associated with waist circumference (P = 0.04) and fat mass index (P = 0.05), independent of age and sex. However, this association was attenuated after adjustment for MVPA and other covariates. VPA (all P < 0.0001), combined MVPA (all P < 0.01), and total activity (counts/min) (all P < 0.001) were all inversely associated with each of the adiposity indexes, independent of sedentary time and other important covariates. Associations were weaker for MPA: P = 0.05, 0.87, and 0.1 for waist circumference, BMI, and fat mass index, respectively. CONCLUSIONS Time spent in VPA appears to be more strongly associated with adiposity than sedentary time. Interventions may therefore need to incorporate higher intensity-based activities to curb the growing obesity epidemic.

Determinants of Change in Physical Activity in Children and Adolescents: A Systematic Review

Context Data are available on correlates of physical activity in children and adolescents, less is known about the determinants of change. This review aims to systematically review the published evidence regarding determinants of change in physical activity in children and adolescents. Evidence acquisition Prospective quantitative studies investigating change in physical activity in children and adolescents aged 4–18 years were identified from seven databases (to November 2010): PubMed, SCOPUS, PsycINFO, Ovid MEDLINE, SPORTDdiscus, Embase, and Web of Knowledge. Study inclusion, quality assessment, and data extraction were independently validated by two researchers. Semi-quantitative results were stratified by age (4–9 years, 10–13 years, and 14–18 years). Evidence synthesis Of the 46 studies that were included, 31 used self-reported physical activity; average methodologic quality was 3.2 (SD=1.2), scored 0–5. Of 62 potential determinants identified, 30 were studied more than three times and 14 reported consistent findings (66% of the reported associations were in the same direction). For children aged 4–9 years, girls reported larger declines than boys. Among those aged 10–13 years, higher levels of previous physical activity and self-efficacy resulted in smaller declines. Among adolescents (aged 14–18 years), higher perceived behavioral control, support for physical activity, and self-efficacy were associated with smaller declines in physical activity. Conclusions Few of the variables studied were consistently associated with changes in physical activity, although some were similar to those identified in cross-sectional studies. The heterogeneity in study samples, exposure and outcome variables, and the reliance on self-reported physical activity limit conclusions and highlight the need for further research to inform development and targeting of interventions.

Diabetes care in general practice: meta-analysis of randomised control trials

Abstract Objective : To assess the effectiveness of care in general practice for people with diabetes. Design : Meta-analysis of randomised trials comparing general practice and shared care with follow up in hospital outpatient clinic. Identification : Trials were identified from searches of eight bibliographic and research databases. Results : Five trials identified included 1058 people with diabetes, overall mean age 58.4 years, receiving hospital outpatient follow up for their diabetes. Results were heterogeneous between trials. In shared care schemes featuring more intensive support through a computerised prompting system for general practitioners and patients, there was no difference in mortality between care in hospital and care in general practice (odds ratio 1.06, 95% confidence interval 0.53 to 2.11); glycated haemoglobin tended to be lower in primary care (weighted difference in means of 0.28%, 0.59% to 0.03%); and losses to follow up were significantly lower in primary care (odds ratio 0.37, 0.22 to 0.61). However, schemes with less well developed support for family doctors were associated with adverse outcomes for patients. Conclusions : Unstructured care in the community is associated with poorer follow up, worse glycaemic control, and greater mortality than in hospital care. Computerised central recall, with prompting for patients and their family doctors, can achieve standards of care as good as or better than hospital outpatient care, at least in the short term. The evidence supports provision of regular prompted recall and review of selected people with diabetes by willing general practitioners. This can be achieved if suitable organisation is in place.

Risk Assessment Tools for Identifying Individuals at Risk of Developing Type 2 Diabetes

Trials have demonstrated the preventability of type 2 diabetes through lifestyle modifications or drugs in people with impaired glucose tolerance. However, alternative ways of identifying people at risk of developing diabetes are required. Multivariate risk scores have been developed for this purpose. This article examines the evidence for performance of diabetes risk scores in adults by 1) systematically reviewing the literature on available scores and 2) their validation in external populations; and 3) exploring methodological issues surrounding the development, validation, and comparison of risk scores. Risk scores show overall good discriminatory ability in populations for whom they were developed. However, discriminatory performance is more heterogeneous and generally weaker in external populations, which suggests that risk scores may need to be validated within the population in which they are intended to be used. Whether risk scores enable accurate estimation of absolute risk remains unknown; thus, care is needed when using scores to communicate absolute diabetes risk to individuals. Several risk scores predict diabetes risk based on routine noninvasive measures or on data from questionnaires. Biochemical measures, in particular fasting plasma glucose, can improve prediction of such models. On the other hand, usefulness of genetic profiling currently appears limited.