Clinical trials : journal of the Society for Clinical Trials
-
Randomized Controlled Trial
Design of a randomized trial of diabetes genetic risk testing to motivate behavior change: the Genetic Counseling/lifestyle Change (GC/LC) Study for Diabetes Prevention.
The efficacy of diabetes genetic risk testing to motivate behavior change for diabetes prevention is currently unknown. ⋯ We designed a randomized clinical trial designed to explore the motivational impact of disclosing both higher than average and lower than average genetic risk for type 2 diabetes. This design allowed exploration of both increased risk and false reassurance, and has implications for future studies in translational genomics.
-
Randomized Controlled Trial Comparative Study
A point-of-care clinical trial comparing insulin administered using a sliding scale versus a weight-based regimen.
Clinical trials are widely considered the gold standard in comparative effectiveness research (CER) but the high cost and complexity of traditional trials and concerns about generalizability to broad patient populations and general clinical practice limit their appeal. Unsuccessful implementation of CER results limits the value of even the highest quality trials. Planning for a trial comparing two standard strategies of insulin administration for hospitalized patients led us to develop a new method for a clinical trial designed to be embedded directly into the clinical care setting thereby lowering the cost, increasing the pragmatic nature of the overall trial, strengthening implementation, and creating an integrated environment of research-based care. ⋯ The methods proposed will demonstrate outcome-based evaluation of control of hyperglycemia in hospitalized veterans. By institutionalizing a process of statistically sound and efficient learning, and by integrating that learning with automatic implementation of best practice, the participating VA Healthcare Systems will accelerate improvements in the effectiveness of care.
-
Randomized Controlled Trial Multicenter Study
Impact and costs of targeted recruitment of minorities to the National Lung Screening Trial.
To promote results in the National Lung Screening Trial (NLST) that are generalizable across the entire US population, a subset of NLST sites developed dedicated strategies for minority recruitment. ⋯ Strategic efforts were associated with significant increases in minority enrollment. The greatest successes require that a priori goals be established based on eligible racial/ethnic proportions; the historical performance of sites in minority accrual should factor into the selection of sites; recruitment planning must begin well in advance of trial launch; and there must be endorsement by prominent representatives of the racial groups of interest.
-
Randomized Controlled Trial
Motivating the unmotivated for health behavior change: a randomized trial of cessation induction for smokers.
Many smokers remain unwilling or unable to make a quit attempt. For these smokers, novel strategies to induce quit attempts are necessary to achieve further reductions in smoking prevalence. ⋯ The study has translational potential to guide both clinical and policy recommendations for cessation induction. Further, while the focus is on smoking, this trial may serve as an example to researchers and clinicians who focus on other health behaviors, and who themselves are challenged with motivating people who are unmotivated for change.
-
Randomized Controlled Trial Comparative Study
Design, conduct, and analyses of Breast International Group (BIG) 1-98: a randomized, double-blind, phase-III study comparing letrozole and tamoxifen as adjuvant endocrine therapy for postmenopausal women with receptor-positive, early breast cancer.
Aromatase inhibitors provide superior disease control when compared with tamoxifen as adjuvant therapy for postmenopausal women with endocrine-responsive early breast cancer. ⋯ BIG 1-98 is an example of an enriched design, involving complementary analyses addressing different questions several years apart, and subject to evolving analytic plans influenced by new data that emerge over time.