Suchergebnisse

IntroductionCreation of registries using linked population-based databases could potentially be used to conduct large registry-based clinical trials. As part of the CANHEART-Strategy for Patient-Oriented Research (SPOR) innovative clinical trials initiative, we explored the practicality of using the linked CANHEART registry to conduct a cluster-randomized trial aimed at improving lipid management.
Objectives and ApproachThe CANHEART registry (www.canheart.ca) was created through the linkage of 19 population-based health databases in Ontario, Canada, providing individual-level socio-demographic, geographic, hospitalization, disease testing/screening, mortality, prescription medication, and behavior/lifestyle information. Using CANHEART defined eligibility criterion, small and medium-sized, high cardiovascular-risk health regions (defined as having acute myocardial infarction, stroke or cardiovascular death rates greater than the Ontario average) are being randomly allocated to receive either the intervention (availability of a lipid management 'toolbox') or standard care. Cohort linkages to additional years of data will occur regularly over the 3-year trial to ascertain the primary outcome of appropriate statin prescribing rates.

\section*{Results}
Record linkage enabled us to determine baseline characteristics of 835,345 patients aged 40-75 as of January 2016, being treated in the 28 study-eligible regions by 2,012 family physicians. Preceding the study, the baseline statin use rate was 35.7\% (in 66-75 year olds) across these regions and the cardiovascular event rate ranged from 3.78-5.64 events/1000 person-years. A randomization procedure yielded 14 regions in both the intervention and control arms which did not differ significantly in socio-demographic characteristics, traditional cardiovascular risk factors, disease history, prevalence of statin use, or access to healthcare indicators. Working groups have been established to operationalize the lipid management tools that will be made available in the intervention regions. Analysis of newly linked participant data will permit outcome ascertainment at trial completion.

\section*{Conclusion/Implications}
Our work demonstrates the feasibility of using the CANHEART 'big data' registry to conduct a large, cluster-randomized clinical trial aimed at improving lipid management, without requiring any primary data collection. Broader use of this methodology has the potential to change the existing paradigm for conducting pragmatic clinical trial research.

The incidence of cardiovascular (CV) risk factors is increasing globally, with a disproportionate burden in the low and low-middle income countries (L/LMICs). Peer support, as a low-cost lifestyle intervention, has succeeded in managing chronic illness. For global CV risk reduction, limited data exists in LMICs. Aim: The GHP-CHANGE was designed as a community-based randomized trial to test the effectiveness of peer support strategy for CV risk reduction in the island of Grenada, a LMIC. Methods: We recruited 402 adults from the Grenada Heart Project (GHP) Cohort Study of 2827 subjects with at least two CV risk factors. Subjects were randomized in a 1:1 fashion to a peer-group based intervention group (n = 206) or a self-management control group (n = 196) for 12 months. The primary outcome was the change from baseline in a composite score related to Blood pressure, Exercise, Weight, Alimentation and Tobacco (FBS, Fuster-BEWAT Score), ranging from 0 to 15 (ideal health = 15). Linear mixed-effects models were used to test for intervention effects. Results: Participants mean age was 51.4 years (SD 14.5) years, two-thirds were female, and baseline mean FBS was 8.9 (SD 2.6) and 8.5 (SD 2.6) in the intervention and control group, respectively (P = .152). At post intervention, the mean FBS was higher in the intervention group compared to the control group [9.1 (SD 2.7) vs 8.5 (SD 2.6), P = .028]. When balancing baseline health profile, the between-group difference (intervention vs. control) in the change of FBS was 0.31 points (95% CI: −0.12 to 0.75; P = .154). Conclusions: The GHP-CHANGE trial showed that a peer-support lifestyle intervention program was feasible; however, it did not demonstrate a significant improvement in the FBS as compared to the control group. Further studies should assess the effects of low-cost lifestyle interventions in LMICs ; This study was funded by the Louis B Mayer Foundation. VF is a recipient of funding from the American Heart Association under grant No 14SFRN20490315. R.F-J is a recipient of funding from the European Union Horizon 2020 research and innovation programme under the Marie Skłodowska-Curie grant agreement No 707642. The CNIC is supported by the Instituto de Salud Carlos III (ISCIII), the Ministerio de Ciencia, Innovación y Universidades (MCNU) and the Pro CNIC Foundation, and is a Severo Ochoa Center of Excellence (SEV-2015-0505)

BACKGROUND: The incidence of cardiovascular (CV) risk factors is increasing globally, with a disproportionate burden in the low and low-middle income countries (L/LMICs). Peer support, as a low-cost lifestyle intervention, has succeeded in managing chronic illness. For global CV risk reduction, limited data exists in LMICs. AIM: The GHP-CHANGE was designed as a community-based randomized trial to test the effectiveness of peer support strategy for CV risk reduction in the island of Grenada, a LMIC. METHODS: We recruited 402 adults from the Grenada Heart Project (GHP) Cohort Study of 2827 subjects with at least two CV risk factors. Subjects were randomized in a 1:1 fashion to a peer-group based intervention group (n = 206) or a self-management control group (n = 196) for 12 months. The primary outcome was the change from baseline in a composite score related to Blood pressure, Exercise, Weight, Alimentation and Tobacco (FBS, Fuster-BEWAT Score), ranging from 0 to 15 (ideal health = 15). Linear mixed-effects models were used to test for intervention effects. RESULTS: Participants mean age was 51.4 years (SD 14.5) years, two-thirds were female, and baseline mean FBS was 8.9 (SD 2.6) and 8.5 (SD 2.6) in the intervention and control group, respectively (P = .152). At post intervention, the mean FBS was higher in the intervention group compared to the control group [9.1 (SD 2.7) vs 8.5 (SD 2.6), P = .028]. When balancing baseline health profile, the between-group difference (intervention vs. control) in the change of FBS was 0.31 points (95% CI: -0.12 to 0.75; P = .154). CONCLUSIONS: The GHP-CHANGE trial showed that a peer-support lifestyle intervention program was feasible; however, it did not demonstrate a significant improvement in the FBS as compared to the control group. Further studies should assess the effects of low-cost lifestyle interventions in LMICs. ; This study was funded by the Louis B Mayer Foundation. VF is a recipient offunding from the American Heart Association under grant No 14SFRN20490315. R.F-J isa recipient of funding from the European Union Horizon 2020 research and innovationprogramme under the Marie Skłodowska-Curie grant agreement No 707642. The CNIC is supported by the Instituto de Salud Carlos III (ISCIII), the Ministerio de Ciencia, Innovación yUniversidades (MCNU) and the Pro CNIC Foundation, and is a Severo Ochoa Center ofExcellence (SEV-2015-0505). ; Sí

BACKGROUND: Prior studies suggest that persistence with and adherence to statin therapy is low. Interventions to improve statin persistence and adherence have been developed over the past decade. METHODS AND RESULTS: This was a retrospective cohort study of adults aged ≥21 y with commercial or government health insurance in the MarketScan (Truven Health Analytics) and Medicare databases who initiated statins in 2007–2014 and (1) started treatment after a myocardial infarction (n=201 573), (2) had diabetes mellitus but without coronary heart disease (CHD; n=610 049), or (3) did not have CHD or diabetes mellitus (n=2 244 868). Persistence with (ie, not discontinuing treatment) and high adherence to statin therapy were assessed using pharmacy fills in the year following treatment initiation. In 2007 and 2014, the proportions of patients persistent with statin therapy were 78.1% and 79.1%, respectively, among those initiating treatment following myocardial infarction; 66.5% and 67.3%, respectively, for those with diabetes mellitus but without CHD; and 64.3% and 63.9%, respectively, for those without CHD or diabetes mellitus. Between 2007 and 2014, high adherence to statin therapy increased from 57.9% to 63.8% among patients initiating treatment following myocardial infarction and from 34.9% to 37.6% among those with diabetes mellitus but without CHD (each P (trend)<0.001). Among patients without CHD or diabetes mellitus, high adherence did not improve between 2007 (35.7%) and 2014 (36.8%; P (trend)=0.14). In 2014, statin adherence was lower among younger, black, and Hispanic patients versus white patients and those initiating a high‐intensity statin dosage. Statin adherence was higher among men and patients with cardiologist care following treatment initiation. CONCLUSIONS: Persistence with and adherence to statin therapy remain low, particularly among those without CHD.