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Generalizability of the Results of Randomized Trials
Noel S. Weiss, MD, DrPH;
Thomas D. Koepsell, MD, MPH;
Bruce M. Psaty, MD, MPH
Arch Intern Med. 2008;168(2):133-135.
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The CONSORT (Consolidated Standards of Reporting Trials) guidelines,1 now endorsed by many major medical journals (including the Archives of Internal Medicine), chiefly highlight aspects of randomized trial methods that bear on a trial's internal validity—that is, whether the trial reaches the correct conclusion regarding individuals actually enrolled. Among these features are whether assignments are truly made at random, whether the health outcomes of concern are monitored accurately in all participants, and whether a large enough number of such outcomes occur in the participants to yield statistically precise results.
The results of such trials are most directly generalizable to study-eligible patients who would have enrolled and who receive the same interventions provided in the trial setting. However, as Dhruva and Redberg illustrate in this issue of the Archives,2 the demographic profile of a trial's . . . [Full Text of this Article] NATURE OF THE TREATMENT PROTOCOL
PATIENT CHARACTERISTICS
ADHERENCE
DURATION OF TREATMENT AND FOLLOW-UP
CONCLUSIONS
AUTHOR INFORMATION
RELATED ARTICLE
Variations Between Clinical Trial Participants and Medicare Beneficiaries in Evidence Used for Medicare National Coverage Decisions
Sanket S. Dhruva and Rita F. Redberg
Arch Intern Med. 2008;168(2):136-140.
ABSTRACT
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Should we use large scale healthcare interventions without clear evidence that benefits outweigh costs and harms? No
Landefeld et al.
BMJ 2008;336:1277-1277.
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