The science of the COAG coordinated care trials

Objectives: To explicate the organisational change agenda of the COAG coordinated care trials within the Australian health system and to illuminate the role of science in this process. Methods and Results: This article briefly outlines the COAG coordinated care trial aims and the effect of the trial as a change initiative in rural South Australia. It is proposed that although the formal trial outcomes are still not clear, the trial had significant impact upon health service delivery in some sites. The trial involved standard research methods with control and intervention groups and with key hypotheses being tested to compare the costs and service utilization profile of intervention and control groups. Formal results indicate that costs were not significantly different between intervention and control groups across all sites, but that the trial, nonetheless, had a powerful impact on the attitude and behaviours of service providers in the rural trial on Eyre Peninsula in particular. Some of the key structural changes now in place are outlined. Conclusions: The COAG trial has had many and varied impacts upon those organisations and individual providers involved with it. It is argued here that since successive initiatives had been implemented before final evaluation results were published, other agendas were served by the trial apart from those of standard scientific research and hypothesis testing. That is, the main impact of the coordinated care trial in Eyre Region at least has been change by stealth, and not through scientific research and demonstration. Implications: The COAG trials have set in train a series of structural and procedural changes in the methods of delivery and management of primary health care systems; changes that are embodied in the Enhanced Primary Care packages (EPC) and other initiatives recently introduced by the Commonwealth Government. These changes have occurred and are occurring across the system without formal evidence as to their efficacy, suggesting that other financial motives are driving these new approaches apart from the goal of improving health outcomes for consumers. Also, if science is to be used in this way to drive policy and procedural change ahead of actual outcome evidence, it is important that we examine the more subtle agendas of such research projects in future if the integrity of the scientific method is to be maintained. The occurrence of such phenomena questions the very foundation of scientific endeavour and weakens the application of scientific principles in the arena of social and political science.

Efficacy and safety of thrombin-receptor antagonist (atopaxar and vorapaxar) in patients with acute coronary syndrome or coronary artery disease-a meta-analysis of randomized controlled trials

Background: Meta-analysis for the efficacy and safety data of thrombin-receptor antagonist (TRA) based on patients with acute coronary syndrome (ACS) or coronary artery disease (CAD) and indirect comparisons between TRAs were not available. Objectives: We intended to synthesize the primary end points based on different patient populations (ACS or CAD) as well as perform indirect comparison between two newly invented antiplatelet agents atopaxar and vorapaxar. Methods: A literature search was performed in MEDLINE, Embase, and Cochrane Library. Incidences of major adverse cardiovascular events (MACEs) and bleeding events according to thrombolysis in myocardial infarction were selected as primary outcomes, whereas adverse effects were considered as secondary outcomes. Corresponding results were synthesized using Revman 5.1 according to ACS or CAD cohorts. Results: Among the seven included randomized controlled trials, the efficacy end points in the TRA treatment group were favorable compared with placebo. Specifically, the odds ratio (OR) of MACEs was 0.80 (95% confidence interval [CI] 0.52-1.22) for patients with ACS and 0.74 (95% CI 0.53-1.05) for the cohort with CAD. The events of bleeding were unanimously superior in the placebo arm for both cohorts. The indirect comparison showed a superior trend in favor of atopaxar over vorapaxar in occurrences of MACEs (OR 0.93; 95% CI 0.38-1.32), myocardial infarction (OR 0.52; 95% CI 0.13-0.95), and cardiovascular death (OR 0.82; 95% CI 0.12-4.24) and caused less incidence of bleeding. Conclusions: Besides being more effective than placebo in improving the incidence of MACEs but with a higher risk of bleeding, TRAs may exert different effects in patients with ACS and CAD. Indirect comparisons also suggested that atopaxar might be better than vorapaxar in lowering the incidence of MACEs, myocardial infarction, and cardiovascular death and at the same time with lower risks of bleeding.

Adherence to a Mediterranean-style diet and effects on cognition in adults: a qualitative evaluation and systematic review of longitudinal and prospective trials

The Mediterranean-style diet (MedDiet) involves substantial intake of fruits, vegetables, and fish, and a lower consumption of dairy, red meat, and sugars. Over the past 15 years, much empirical evidence supports the suggestion that a MedDiet may be beneficial with respect to reducing the incidence of cardiovascular disease, cancer, metabolic syndrome, and dementia. A number of cross-sectional studies that have examined the impact of MedDiet on cognition have yielded largely positive results. The objective of this review is to evaluate longitudinal and prospective trials to gain an understanding of how a MedDiet may impact cognitive processes over time. The included studies were aimed at improving cognition or minimizing of cognitive decline. Studies reviewed included assessments of dietary status using either a food frequency questionnaire or a food diary assessment. Eighteen articles meeting our inclusion criteria were subjected to systematic review. These revealed that higher adherence to a MedDiet is associated with slower rates of cognitive decline, reduced conversion to Alzheimer's disease, and improvements in cognitive function. The specific cognitive domains that were found to benefit with improved Mediterranean Diet Score were memory (delayed recognition, long-term, and working memory), executive function, and visual constructs. The current review has also considered a number of methodological issues in making recommendations for future research. The utilization of a dietary pattern, such as the MedDiet, will be essential as part of the armamentarium to maintain quality of life and reduce the potential social and economic burden of dementia.

mHealth technologies to influence physical activity and sedentary behaviors: behavior change techniques, systematic review and meta-analysis of randomized controlled trials

BACKGROUND: mHealth programs offer potential for practical and cost-effective delivery of interventions capable of reaching many individuals.

PURPOSE: To (1) compare the effectiveness of mHealth interventions to promote physical activity (PA) and reduce sedentary behavior (SB) in free-living young people and adults with a comparator exposed to usual care/minimal intervention; (2) determine whether, and to what extent, such interventions affect PA and SB levels and (3) use the taxonomy of behavior change techniques (BCTs) to describe intervention characteristics.

METHODS: A systematic review and meta-analysis following PRISMA guidelines was undertaken to identify randomized controlled trials (RCTs) comparing mHealth interventions with usual or minimal care among individuals free from conditions that could limit PA. Total PA, moderate-to-vigorous intensity physical activity (MVPA), walking and SB outcomes were extracted. Intervention content was independently coded following the 93-item taxonomy of BCTs.

RESULTS: Twenty-one RCTs (1701 participants-700 with objectively measured PA) met eligibility criteria. SB decreased more following mHealth interventions than after usual care (standardised mean difference (SMD) -0.26, 95 % confidence interval (CI) -0.53 to -0.00). Summary effects across studies were small to moderate and non-significant for total PA (SMD 0.14, 95 % CI -0.12 to 0.41); MVPA (SMD 0.37, 95 % CI -0.03 to 0.77); and walking (SMD 0.14, 95 % CI -0.01 to 0.29). BCTs were employed more frequently in intervention (mean = 6.9, range 2 to 12) than in comparator conditions (mean = 3.1, range 0 to 10). Of all BCTs, only 31 were employed in intervention conditions.

CONCLUSIONS: Current mHealth interventions have small effects on PA/SB. Technological advancements will enable more comprehensive, interactive and responsive intervention delivery. Future mHealth PA studies should ensure that all the active ingredients of the intervention are reported in sufficient detail.

Interventions to reduce sedentary behaviour in 0-5-year-olds: A systematic review and meta-analysis of randomised controlled trials

Aim or objective To evaluate the effectiveness of behavioural interventions that report sedentary behaviour outcomes during early childhood. Design Systematic review and meta-analysis. Data sources Academic Search Complete, CINAHL Complete, Global Health, MEDLINE Complete, PsycINFO, SPORTDiscus with Full Text and EMBASE electronic databases were searched in March 2016. Eligibility criteria for selecting studies Inclusion criteria were: (1) published in a peer-reviewed English language journal; (2) sedentary behaviour outcomes reported; (3) randomised controlled trial (RCT) study design; and (4) participants were children with a mean age of =5.9 years and not yet attending primary/ elementary school at postintervention. Results 31 studies were included in the systematic review and 17 studies in the meta-analysis. The overall mean difference in screen time outcomes between groups was -17.12 (95% CI -28.82 to -5.42) min/day with a significant overall intervention effect (Z=2.87, p=0.004). The overall mean difference in sedentary time between groups was -18.91 (95% CI -33.31 to -4.51) min/day with a significant overall intervention effect (Z=2.57, p=0.01). Subgroup analyses suggest that for screen time, interventions of =6 months duration and those conducted in a community-based setting are most effective. For sedentary time, interventions targeting physical activity (and reporting changes in sedentary time) are more effective than those directly targeting sedentary time. Summary/conclusions Despite heterogeneity in study methods and results, overall interventions to reduce sedentary behaviour in early childhood show significant reductions, suggesting that this may be an opportune time to intervene.

FTO genotype and weight loss: systematic review and meta-analysis of 9563 individual participant data from eight randomised controlled trials

OBJECTIVE:  To assess the effect of the FTO genotype on weight loss after dietary, physical activity, or drug based interventions in randomised controlled trials.

DESIGN:  Systematic review and random effects meta-analysis of individual participant data from randomised controlled trials.

DATA SOURCES:  Ovid Medline, Scopus, Embase, and Cochrane from inception to November 2015.

ELIGIBILITY CRITERIA FOR STUDY SELECTION:  Randomised controlled trials in overweight or obese adults reporting reduction in body mass index, body weight, or waist circumference by FTO genotype (rs9939609 or a proxy) after dietary, physical activity, or drug based interventions. Gene by treatment interaction models were fitted to individual participant data from all studies included in this review, using allele dose coding for genetic effects and a common set of covariates. Study level interactions were combined using random effect models. Metaregression and subgroup analysis were used to assess sources of study heterogeneity.

RESULTS:  We identified eight eligible randomised controlled trials for the systematic review and meta-analysis (n=9563). Overall, differential changes in body mass index, body weight, and waist circumference in response to weight loss intervention were not significantly different between FTO genotypes. Sensitivity analyses indicated that differential changes in body mass index, body weight, and waist circumference by FTO genotype did not differ by intervention type, intervention length, ethnicity, sample size, sex, and baseline body mass index and age category.

CONCLUSIONS:  We have observed that carriage of the FTO minor allele was not associated with differential change in adiposity after weight loss interventions. These findings show that individuals carrying the minor allele respond equally well to dietary, physical activity, or drug based weight loss interventions and thus genetic predisposition to obesity associated with the FTO minor allele can be at least partly counteracted through such interventions.