Joseph F Collins Sc.D. , Debra Egan M.Sc., M.P.H. , Salim Yusuf M.B.B.S., F.R.C.P. , Rekha Garg M.D., M.S. , William O Williford Ph.D. , Nancy Geller Ph.D. , on behalf of the DIG Investigators
{"title":"Overview of the DIG trial","authors":"Joseph F Collins Sc.D. , Debra Egan M.Sc., M.P.H. , Salim Yusuf M.B.B.S., F.R.C.P. , Rekha Garg M.D., M.S. , William O Williford Ph.D. , Nancy Geller Ph.D. , on behalf of the DIG Investigators","doi":"10.1016/S0197-2456(03)00104-1","DOIUrl":null,"url":null,"abstract":"<div><p>Congestive heart failure is a major public health problem in the United States, Canada, and other Western countries. The Digitalis Investigation Group (DIG) trial was a randomized, double-blind placebo-controlled trial that evaluated the effects of digoxin on all-cause mortality and on hospitalization for heart failure in patients with heart failure and left ventricular ejection fraction ≤0.45 with normal sinus rhythm. It was designed as a large simple trial. There were 6800 patients entered into the main study over a 31.5-month recruitment period at 302 participating centers in the United States and Canada. All patients were followed for a minimum of 28 months. In order for this study to succeed, many groups had to work together successfully. In this supplement, we present practical aspects of organizing and conducting a large simple trial such as DIG.</p></div>","PeriodicalId":72706,"journal":{"name":"Controlled clinical trials","volume":"24 6","pages":"Pages S269-S276"},"PeriodicalIF":0.0000,"publicationDate":"2003-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S0197-2456(03)00104-1","citationCount":"6","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Controlled clinical trials","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0197245603001041","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 6
Abstract
Congestive heart failure is a major public health problem in the United States, Canada, and other Western countries. The Digitalis Investigation Group (DIG) trial was a randomized, double-blind placebo-controlled trial that evaluated the effects of digoxin on all-cause mortality and on hospitalization for heart failure in patients with heart failure and left ventricular ejection fraction ≤0.45 with normal sinus rhythm. It was designed as a large simple trial. There were 6800 patients entered into the main study over a 31.5-month recruitment period at 302 participating centers in the United States and Canada. All patients were followed for a minimum of 28 months. In order for this study to succeed, many groups had to work together successfully. In this supplement, we present practical aspects of organizing and conducting a large simple trial such as DIG.
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