15599
document
Determination of vital status at the end of the DIG trial . The Digitalis Investigation Group ( DIG ) trial was a randomized , double-blind placebo-controlled trial whose primary objective was to determine whether digoxin had beneficial , harmful , or no effect on total mortality in patients with heart failure who were in sinus rhythm and whose ejection fraction was < /=0.45 . The study was designed as a large simple trial with a large number of centers ( 302 ) in the United States and Canada , many of which were inexperienced in research . To ensure that the results of the trial would be reported accurately without possible bias due to missing data , the study leadership decided that no outcome results would be reported until the vital status at the end of the study was known for at least 97 % of the study participants . Planning for closeout of the study began a year prior to the common end date of December 31 , 1995 and included plans for obtaining vital status on December 31 , 1995 . Participants were given postcards at their final study visit to be completed and mailed on or after January 1 , 1996 . Of 5602 postcards distributed , 5070 ( 90.5 % ) were completed and returned . A contract search agency was hired to locate the remaining participants . Of the total 7788 participants entered into the DIG trial , only 97 participants ( 1.2 % ) could not have their vital status as of December 31 , 1995 determined . It is recommended that investigators having an outcome measure with a common end date include plans in their protocols for obtaining their measures and activate those plans as early as possible during the course of the study .
15600
Intervention_Control
placebo-controlled
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Intervention_Pharmacological
digoxin
15602
Intervention_Educational
given postcards at their final study visit to be completed and mailed on or after January 1 , 1996
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Outcome_Physical
vital status
15604
Participant_Condition
patients with heart failure who were in sinus rhythm and whose ejection fraction was < /=0.45 .
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Participant_Condition
a large number of centers ( 302 ) in the United States and Canada , many of which were inexperienced in research .