Embedding clinical interventions into observational studies

详细信息    查看全文

• 作者：Anne B. Newman^a ; ^{newmana@edc.pitt.edu" class="auth_mail" title="E-mail the corresponding author} ; M. Larissa Avilé ; s-Santa^b ; ^{avilessantal@nhlbi.nih.gov" class="auth_mail" title="E-mail the corresponding author} ; Garnet Anderson^c ; ^{garnet@whi.org" class="auth_mail" title="E-mail the corresponding author} ; Gerardo Heiss^d ; ^{gerardo_heiss@unc.edu" class="auth_mail" title="E-mail the corresponding author} ; Wm. James Howard^e ; ^{wm.james.howard@medstar.net" class="auth_mail" title="E-mail the corresponding author} ; Mitchell Krucoff^f ; ^{mitchell.krucoff@duke.edu" class="auth_mail" title="E-mail the corresponding author} ; Lewis H. Kuller^g ; ^{kullerl@edc.pitt.edu" class="auth_mail" title="E-mail the corresponding author} ; Cora E. Lewis^h ; ^{bethlew@uab.edu" class="auth_mail" title="E-mail the corresponding author} ; Jennifer G. Robinsonⁱ ; ^{jennifer-g-robinson@uiowa.edu" class="auth_mail" title="E-mail the corresponding author} ; Herman Taylor^j ; ^{htaylor@umc.edu" class="auth_mail" title="E-mail the corresponding author} ; ^{htaylor@msm.edu" class="auth_mail" title="E-mail the corresponding author} ; Roberto P. Treviñ ; o^k ; ^{rtrevino@sahrc.org" class="auth_mail" title="E-mail the corresponding author} ; William Weintraub^l ; ^{wweintraub@christianacare.org" class="auth_mail" title="E-mail the corresponding author}
• 关键词：SANDS ; Stop Atherosclerosis in Native Diabetics Study in the Strong Heart Study ; GEM ; The Ginkgo Evaluation of Memory Study ; CHS ; Cardiovascular Health Study ; CVD ; cardiovascular disease ; JHS ; Jackson Heart Study ; IBT ; intensive behavioral therapy ; CMS ; Centers for Medicare and Medicaid Services ; HCPCS ; Healthcare Common Procedure Coding System ; ICD-10 ; 10th revision of the International Statistical Classification of Diseases and Related Health Problems ; BMI ; body mass index ; WHI ; Women's Health
• 刊名：Contemporary Clinical Trials
• 出版年：2016
• 出版时间：January 2016
• 年：2016
• 卷：46
• 期：Complete
• 页码：100-105
• 全文大小：260 K

文摘

Novel approaches to observational studies and clinical trials could improve the cost-effectiveness and speed of translation of research. Hybrid designs that combine elements of clinical trials with observational registries or cohort studies should be considered as part of a long-term strategy to transform clinical trials and epidemiology, adapting to the opportunities of big data and the challenges of constrained budgets. Important considerations include study aims, timing, breadth and depth of the existing infrastructure that can be leveraged, participant burden, likely participation rate and available sample size in the cohort, required sample size for the trial, and investigator expertise. Community engagement and stakeholder (including study participants) support are essential for these efforts to succeed.