Embedding Cardiovascular Research Into Practice

Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, North Carolina2Duke Translational Medicine Institute, Duke University, Durham, North Carolina.
JAMA The Journal of the American Medical Association (Impact Factor: 30.39). 11/2013; 310(19):2037-8. DOI: 10.1001/jama.2013.282771
Source: PubMed
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    ABSTRACT: Background Mobile health (mHealth) approaches for non-communicable disease (NCD) care seem particularly applicable to sub-Saharan Africa given the penetration of mobile phones in the region. The evidence to support its implementation has not been critically reviewed. Methods We systematically searched PubMed, Embase, Web of Science, Cochrane Central Register of Clinical Trials, a number of other databases, and grey literature for studies reported between 1992 and 2012 published in English or with an English abstract available. We extracted data using a standard form in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Results Our search yielded 475 citations of which eleven were reviewed in full after applying exclusion criteria. Five of those studies met the inclusion criteria of using a mobile phone for non-communicable disease care in sub-Saharan Africa. Most studies lacked comparator arms, clinical endpoints, or were of short duration. mHealth for NCDs in sub-Saharan Africa appears feasible for follow-up and retention of patients, can support peer support networks, and uses a variety of mHealth modalities. Whether mHealth is associated with any adverse effect has not been systematically studied. Only a small number of mHealth strategies for NCDs have been studied in sub-Saharan Africa. Conclusions There is insufficient evidence to support the effectiveness of mHealth for NCD care in sub-Saharan Africa. We present a framework for cataloging evidence on mHealth strategies that incorporates health system challenges and stages of NCD care. This framework can guide approaches to fill evidence gaps in this area. Systematic review registration: PROSPERO CRD42014007527.
    Globalization and Health 06/2014; 10(1):49. DOI:10.1186/1744-8603-10-49 · 1.83 Impact Factor
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    ABSTRACT: Prior to enactment of the final investigational new drug application (IND) safety reporting rule, an attempt was made to document the effort expended at investigative sites in processing IND safety reports from sponsors and to assess the effect of these expedited reports on trial conduct. Investigators were asked to (1) prospectively document time to process IND safety reports and (2) retrospectively review safety reports from a previous 3-month period, documenting resultant actions. In this limited sample, sites spent a median of 0.25 hours per report at a median cost of US$22. Few expedited safety reports were retrospectively said to have changed study conduct or informed consent. However, a low response rate and the concentration of clinical sites in a single therapeutic area preclude generalizing these results. The authors discuss the challenges in gaining investigators' cooperation to evaluate the impact of regulatory requirements. Better methods to facilitate this type of research will enrich the scientific basis of future clinical trial regulation and guidance.
    Therapeutic Innovation and Regulatory Science 07/2014; 48(4):413-419. DOI:10.1177/2168479013520160
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    ABSTRACT: Background:For privacy and practical reasons, it is sometimes necessary to minimize sharing of individual-level information in multisite studies. However, individual-level information is often needed to perform more rigorous statistical analysis.Objectives:To compare empirically 3 analytic methods for multisite studies that only require sharing of summary-level information to perform statistical analysis that have traditionally required access to detailed individual-level data from each site.Research Design, Subjects, and Measures:We analyzed data from a 7-site study of bariatric surgery outcomes within the Scalable Partnering Network. We compared the long-term risk of rehospitalization between adjustable gastric banding and Roux-en-y gastric bypass procedures using a stratified analysis of propensity score (PS)-defined strata, a case-centered analysis of risk set data, and a meta-analysis of site-specific effect estimates. Their results were compared with the result from a pooled individual-level data analysis.Results:The study included 1327 events (18.1%) among 7342 patients. The adjusted hazard ratio was 0.71 (95% CI, 0.59, 0.84) comparing adjustable gastric banding with Roux-en-y gastric bypass in the individual-level data analysis. The corresponding effect estimate was 0.70 (0.59, 0.83) in the PS-stratified analysis, 0.71 (0.59, 0.84) in the case-centered analysis, and 0.71 (0.60, 0.84) in both the fixed-effect and random-effects meta-analysis.Conclusions:In this empirical study, PS-stratified analysis, case-centered analysis, and meta-analysis produced results that are identical or highly comparable with the result from a pooled individual-level data analysis. These methods have the potential to be viable analytic alternatives when sharing of individual-level information is not feasible or not preferred in multisite studies.
    Medical Care 07/2014; 52(7):664-8. DOI:10.1097/MLR.0000000000000147 · 2.94 Impact Factor