Background
Conveying the complex trade-offs of continuous-flow left ventricular assist devices (CF LVAD) is challenging, and made more difficult by absence of an evidence summary for the full range of possible outcomes. We aimed to summarize the current evidence on outcomes of CF LVAD.
Methods and Results
PubMed and Cochrane Library were searched from January 2007–December 2013, supplemented with manual review. Three reviewers independently assessed each study for saliency regarding patient-centered outcomes. Data were summarized in tabular form. Overall study characteristics encouraged inclusion of all indications (destination therapy and bridge to transplant) and prevented meta-analysis. The electronic search identified 465 abstracts, of which 50 met inclusion criteria; manual review added 2 articles in press. The articles included 10 industry-funded trials and registries, 10 multi-center reports, and the remainder single-center observational experiences. Estimated actuarial survival after CF LVAD ranged from 56–87% at 1-year, 43–84% at 2-years, and 47% at 4-years. Improvements in functional class and quality of life were reported, but missing data complicated interpretation. Adverse events were experienced by the majority of patients, but estimates for bleeding, stroke, infection, right heart failure, arrhythmias, and rehospitalizations varied greatly.
Conclusions
The totality of data for CF LVADs show consistent improvements in survival and quality of life counterbalanced by a range of common complications. While this summary should provide a practical resource for health care provider-led discussions with patients, it highlights the critical need for high-quality patient-centered data collected with standard definitions.
Background
Early childhood is a crucial time to foster healthy eating and physical activity (PA) habits, which are critical for optimal child health, growth and development. Child care facilities are important settings to promote healthy eating and PA and prevent childhood obesity; however, almost all prior intervention studies have focused on child care centers and not family child care homes (FCCH), which care for over 1.6 million U.S. children.
Methods
This paper describes Healthy Start/Comienzos Sanos, a cluster-randomized trial evaluating the efficacy of a multicomponent intervention to improve nutrition and PA environments in English and Spanish-speaking FCCH. Eligible child care providers complete baseline surveys and receive a two-day FCCH observation of the home environment and provider practices. Parent-consented 2–5 year-old children are measured (height, weight, waist circumference), wear accelerometers and have their dietary intake observed during child care using validated protocols. FCCH providers are then randomly assigned to receive an 8-month intervention including written materials tailored to the FCCH providers’ need and interest, videos, peer support coaching using brief motivational interviewing, and periodic group meetings focused on either nutrition and PA (Intervention) or reading readiness (Comparison). Intervention materials focus on evidence-based nutrition and physical activity best practices. The initial measures (surveys, two-day observation of the FCCH and provider practices, child diet observation, physical measures, and accelerometer) are assessed again 8 and 12 months after the intervention starts. Primary outcomes are children’s diet quality (Healthy Eating Index), time in moderate and vigorous PA and sedentary PA during child care. Secondary outcomes include FCCH provider practices and foods served, and PA environments and practices. Possible mediators (provider attitudes, self-efficacy, barriers and facilitators) are also being explored. Process evaluation measures to assess reach, fidelity and dose, and their relationship with dietary and PA outcomes are included.
Discussion
Healthy Start/Comienzos Sanos fills an important gap in the field of childhood obesity prevention by rigorously evaluating an innovative multicomponent intervention to improve the nutrition and physical activity environments of FCCH.
Trial registration
(#
NCT02452645
) ClinicalTrials.gov Trial registered on May 22, 2015.
Electronic supplementary material
The online version of this article (10.1186/s12889-019-6704-6) contains supplementary material, which is available to authorized users.
Large-scale, teacher-implemented CPR education sessions in the middle school setting are a successful approach to increase middle school student's knowledge and comfort in performing HOCPR and to increase overall bystander CPR rates.
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