THE USE OF A RUN-IN TO ENHANCE COMPLIANCE

被引：43

作者：

LANG, JM

机构：

[1] Department of Medicine, Brigham & Women's Hospital, Brookline, Massachusetts, 02146

来源：

STATISTICS IN MEDICINE | 1990年 / 9卷 / 1-2期

关键词：

D O I：

10.1002/sim.4780090115

中图分类号：

Q [生物科学];

学科分类号：

07 ; 0710 ; 09 ;

摘要：

With a run‐in, potential subjects are given practice with all or part of the study protocol prior to randomization. The purpose is to exclude poor compliers from the trial and randomize only proven, good compliers. The feasibility of a run‐in and the net benefit derived from that strategy depend upon the difficulty of the protocol; the availability of compliance aids during the trial; and the impact of the chosen common practices for all subjects during the run‐in on the post‐randomization event rates of the groups and the post‐randomization blinding of study subjects to their treatment assignments. Two detailed examples of the use of a run‐in are presented along with six general recommendations to guide the use of a run‐in. Copyright © 1990 John Wiley & Sons, Ltd.

引用

页码：87 / 95

页数：9

共 21 条

[1]

Hennekens C.H., Buring J.E., Epidemiology in Medicine, (1987)

[2]

Meinert C.L., Clinical Trials: Design, Conduct and Analysis, (1986)

[3]

Sackett D.L., Gent M., Controversy in counting and attributing events in clinical trials, New England Journal of Medicine, 301, pp. 1410-1412, (1979)

[4]

Haynes R.B., Dantes R., Patient compliance and the conduct and interpretation of therapeutic trials, Controlled Clinical Trials, 8, pp. 12-19, (1987)

[5]

Lang J.M., Buring J.E., Rosner B., Hutchison G.B., Hennekens C.H., (1988)

[6]

Vogt T.M., Ireland C.C., Black D., Camel G., Hughes G., Recruitment of elderly volunteers for a multicenter clinical trial: the SHEP pilot study, Controlled Clinical Trials, 1, pp. 111-113, (1986)

[7]

Lang J.M., Buring J.E., Rosner B., Hutchison G.B., Hennekens C.H., (1988)

[8]

Lang J.M., Buring J.E., Rosner B., Hutchison G.B., Hennekens C.H., (1988)

[9]

Buring J.E., Hennekens C.H., Cost and efficiency in clinical trials: the US Physicians' Health Study, Statistics in Medicine, 9, pp. 29-33, (1990)

[10]

Preliminary report: findings from the aspirin component of the ongoing Physicians' Health Study, New England Journal of Medicine, 381, pp. 262-264, (1988)

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