The n-of-1 randomized controlled trial: clinical usefulness. Our three-year experience

Title

The n-of-1 randomized controlled trial: clinical usefulness. Our three-year experience

Creator

Guyatt GH; Keller JL; Jaeschke R; Rosenbloom D; Adachi JD; Newhouse MT

Publisher

Annals Of Internal Medicine

Date

1990

Subject

Female; Humans; Adult; Physician's Role; Research Design; Double-Blind Method; Patient Compliance; Clodronate; Randomized Controlled Trials/methods; Amitriptyline/therapeutic use; Propranolol/therapeutic use; Syncope/drug therapy

Description

OBJECTIVE: To review the feasibility and effectiveness of n-of-1 randomized controlled trials (n-of-1 trials) in clinical practice. DESIGN: Individual trials were double-blind, randomized, multiple crossover trials. The impact of n-of-1 trials was determined by eliciting physicians' plans of management and confidence in those plans before and after each trial. SETTING: Referral service doing n-of-1 trials at the requests of community and academic physicians. OBJECT of ANALYSIS: All trials were planned, started, and completed by the n-of-1 service. MEASURES of OUTCOME: The proportion of planned n-of-1 trials that were completed and the proportion that provided a definite clinical or statistical answer. A definite clinical answer was achieved if an n-of-1 trial resulted in a high level of physician's confidence in the management plan. Specific criteria were developed for classifying an n-of-1 trial as providing a definite statistical answer. MAIN RESULTS: Seventy-three n-of-1 trials were planned in various clinical situations. Of 70 n-of-1 trials begun, 57 were completed. The reasons for not completing n-of-1 trials were patients' or physicians' noncompliance or patients' concurrent illness. Of 57 n-of-1 trials completed, 50 provided a definite clinical or statistical answer. In 15 trials (39% of trials in which appropriate data were available), the results prompted physicians to change their "prior to the trial" plan of management (in 11 trials, the physicians stopped the drug therapy that they had planned to continue indefinitely). CONCLUSION: We interpret the results as supporting the feasibility and usefulness of n-of-1 trials in clinical practice.
1990

Rights

Article information provided for research and reference use only. PedPalASCNET does not hold any rights over the resource listed here. All rights are retained by the journal listed under publisher and/or the creator(s).

Type

Journal Article

Citation List Month

Backlog

Pages

293-299

Issue

4

Volume

112

Citation

Guyatt GH; Keller JL; Jaeschke R; Rosenbloom D; Adachi JD; Newhouse MT, “The n-of-1 randomized controlled trial: clinical usefulness. Our three-year experience,” Pediatric Palliative Care Library, accessed September 20, 2021, https://pedpalascnetlibrary.omeka.net/items/show/12406.

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