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(Circulation. 2004;110:107-108.)
© 2004 American Heart Association, Inc.

Editorial

Randomized Clinical Trials

How Long Should They Last?

Hein J. Wellens, MD

From the Cardiovascular Research Institute Maastricht, Maastricht, The Netherlands.

Correspondence to Hein J. Wellens, MD, Cardiovascular Research Institute Maastricht, 21, Henric van Veldekeplein, Maastricht 6211 TG, The Netherlands. E-mail hwellens@xs4all.nl

Key Words: Editorials • arrhythmia • defibrillation • trials

An extract of the first 250 words of the full text is provided, because this article has no abstract.

Well-conducted randomized clinical trials (RCT) are essential for the objective assessment of the value of new diagnostic or therapeutic medical interventions. They also will give us information about the effect of the intervention on cost and quality of life. Although the RCT was introduced >50 years ago, the requirements to ensure the best possible quality are continuously scrutinized.^1–4 That holds for several aspects of the RCT, such as the proper selection of patients, fulfilling strict criteria to make groups comparable, correct calculation of the required number of patients, well-defined end points, adequate information and follow-up care of the patients, and clarity about medicolegal aspects. An important issue in the RCT is the required length of the study to come to a meaningful outcome.

See p 112

In the present issue, data are reported⁵ on a subset of a 120 patients who participated in the Canadian Implantable Defibrillator Study (CIDS)⁶ and continued with the treatment assigned to them after CIDS was formally ended.

CIDS was a RCT comparing the effect of implantation of a defibrillator with the administration of amiodarone in patients needing secondary prevention of sudden cardiac death after having survived an episode of ventricular fibrillation or poorly tolerated ventricular tachycardia. At the end of CIDS, no statistically significant difference in risk reduction in overall mortality was found between the implantable cardioverter defibrillator (ICD) and the amiodarone arm, and the CIDS steering committee made no formal recommendation regarding ongoing management of the patients receiving amiodarone.

Although a meta-analysis of CIDS . . . [Full Text of this Article]