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

G H Guyatt ¹, J L Keller , R Jaeschke

⁰McMaster University, Hamilton, Ontario.

Annals of Internal Medicine +

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February 15, 1990

View abstract on PubMed

Summary

N-of-1 randomized controlled trials (n-of-1 trials) are feasible and useful in clinical practice. These trials help physicians confidently manage patient care, with many leading to changes in treatment plans.

Area Of Science

Clinical Trials
Evidence-Based Medicine
Personalized Medicine

Background

N-of-1 randomized controlled trials (n-of-1 trials) offer a method for evaluating treatment effectiveness in individual patients.
Assessing the feasibility and clinical utility of n-of-1 trials is crucial for their integration into routine practice.

Observation

A referral service managed n-of-1 trials requested by physicians.
Seventy-three n-of-1 trials were planned, with 57 completed and 50 yielding definitive clinical or statistical answers.
Physician management plans were altered in 39% of completed trials, often leading to the discontinuation of planned long-term drug therapy.

Findings

N-of-1 trials demonstrated feasibility, with a high completion rate and a significant proportion providing clear outcomes.
The results of n-of-1 trials directly influenced physician decision-making, leading to changes in patient management strategies.
Increased physician confidence in management plans was observed post-trial, supporting the utility of this methodology.

Implications

N-of-1 trials can be effectively implemented in clinical settings to guide individualized patient care.
The methodology supports evidence-based decision-making by providing personalized treatment efficacy data.
Widespread adoption of n-of-1 trials could enhance the precision and effectiveness of medical treatments.

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