ABSTRACT
BACKGROUND: Increasingly, genetic specimens are collected to expand the value of clinical trials through study of genetic effects on disease incidence, progression or response to interventions. PURPOSE: and methods We describe the experience obtaining IRB-approved DNA consent forms across the 19 institutions in the Action for Health in Diabetes (Look AHEAD), a clinical trial examining the effect of a lifestyle intervention for weight loss on the risk of serious cardiovascular events among individuals with type 2 diabetes. We document the rates participants provided consent for DNA research, identify participant characteristics associated with consent, and discuss implications for genetics research. RESULTS: IRB approval to participate was obtained from 17 of 19 institutions. The overall rate of consent was 89.6% among the 15 institutions that had completed consenting at the time of our analysis, which was higher than reported for other types of cohort studies. Consent rates were associated with factors expected to be associated with weight loss and cardiovascular disease and to affect the distribution of candidate genes. Non-consent occurred more frequently among participants grouped as African-American, Hispanic, female, more highly educated or not dyslipidemic. LIMITATIONS: The generalizabilty of results is limited by the inclusion/exclusion criteria of the trial. CONCLUSIONS: Barriers to obtaining consent to participate in genetic studies may differ from other recruitment settings. Because of the potentially complex associations between personal characteristics related to adherence, outcomes and gene distributions, differential rates of consent may introduce biases in estimates of genetic relationships.
Subject(s)
Clinical Trials as Topic , Genetic Research , Informed Consent , Aged , Diabetes Mellitus, Type 2/genetics , Ethics Committees, Research , Ethics, Research , Female , Genetic Research/ethics , Humans , Male , Middle Aged , Multicenter Studies as Topic , Patient Education as Topic , Research Design , Risk Reduction BehaviorABSTRACT
The councilor model of shared governance was implemented at the Central Arkansas Veterans Healthcare System in January 1995. The goal was to reduce, eliminate, and consolidate nursing committees, enhance communication, and increase the decision-making abilities and opportunities of staff members. A study was conducted to determine the perceptions of the nursing staff relative to the culture of the organization after implementation of the model. The authors describe the process and outcomes of the resulting performance improvement processes, organizational redesign, and outcomes of this initiative.
Subject(s)
Decision Making, Organizational , Models, Nursing , Nursing Service, Hospital/organization & administration , Arkansas , Communication , Hospitals, Veterans/organization & administration , Humans , Nursing Staff, Hospital/organization & administration , Nursing Staff, Hospital/psychology , Organizational Culture , Organizational Innovation , Professional Autonomy , Professional Staff CommitteesABSTRACT
Human milk triacylglycerols were separated by high-performance liquid chromatography. A 5-mu Supelcosil LC-18 column (Supelco, Inc., Bellefonte, PA) was used with acetone/acetonitrile (64:36, vol/vol) as mobile phase. Triacylglycerols were tentatively identified based on theoretical carbon number and relative retention time. Despite changes resulting from dietary fat variation, the major component triacylglycerols were those composed of palmitic, oleic and linoleic acids. Triacylglycerols with palmitic, stearic and oleic acids were present as minor components. Fatty acids were quantified by gas chromatography relative to an internal standard. Ratios of n-6/n-3 fatty acids were found to be higher than previously reported.
