Evidence map›Paper›PMID 23849149›Full record

ReviewJournal of clinical epidemiology2013

Single-patient (n-of-1) trials: a pragmatic clinical decision methodology for patient-centered comparative effectiveness research.

Naihua Duan, Richard L Kravitz, Christopher H Schmid

Abstract readReview
In one paragraph

Review in Journal of clinical epidemiology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 118 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
118citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

118 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. N-of-1 Randomized Intervention Trials in Health Psychology: A Systematic Review and Methodology Critique.Annals of behavioral medicine : a publication of the Society of Behavioral Medicine · 2018
    Pooled it
  2. Application of n-of-1 treatment trials in schizophrenia: systematic review.The British journal of psychiatry : the journal of mental science · 2018
    Pooled it
  3. Pooled it
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  5. Effects of a cannabidiol/terpene formulation on sleep in individuals with insomnia: a double-blind, placebo-controlled, randomized, crossover study.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2025
    Trial
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  7. A Randomized Placebo-ControlledCanadian journal of gastroenterology & hepatology · 2019
    Trial
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58 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Naihua DuanDivision of Biostatistics, Department of Psychiatry, Columbia University, 1051 Riverside Drive, Unit 48, New York, NY 10032, USA. Naihua.Duan@Columbia.Edu
Richard L Kravitz
Christopher H Schmid

Funding

UC Davis Clinical and Translational Science CenterUL1TR000002 · NCATS · UNIVERSITY OF CALIFORNIA AT DAVIS · PI BERGLUND, LARS F · 2012 to 2015
$12.2M
Research Methods CoreP30MH090322 · NIMH · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI HOAGWOOD, KIMBERLY E. · 2011 to 2015
$8.1M
Targeted and Tailored Messages to Enhance Depression CareR01MH079387 · NIMH · UNIVERSITY OF CALIFORNIA AT DAVIS · PI KRAVITZ, RICHARD L · 2007 to 2011
$3.4M
N-of-1 Trials Using mHealth in Chronic PainR01NR013938 · NINR · UNIVERSITY OF CALIFORNIA AT DAVIS · PI KRAVITZ, RICHARD L · 2012 to 2016
$2.9M
RCT of Patient, Caregiver and Physician Communication Coaching in Advanced CancerR01CA140419 · NCI · UNIVERSITY OF ROCHESTER · PI EPSTEIN, RONALD M., KRAVITZ, RICHARD L · 2011 to 2015
$2.7M
NCATS NIH HHS UL1 TR000002NCATS NIH HHS UL1TR000002NCI NIH HHS 5 R01 CA140419NCI NIH HHS R01 CA140419NIMH NIH HHS 5 R01 MH079387NIMH NIH HHS 7 P30 MH090322NIMH NIH HHS P30 MH090322NIMH NIH HHS R01 MH079387NINR NIH HHS 1 R01 NR013938NINR NIH HHS R01 NR013938
6 · The paper itself

Abstract

objectiveTo raise awareness among clinicians and epidemiologists that single-patient (n-of-1) trials are potentially useful for informing personalized treatment decisions for patients with chronic conditions. STUDY DESIGN AND

settingWe reviewed the clinical and statistical literature on methods and applications of single-patient trials and then critically evaluated the needs for further methodological developments.

resultsExisting literature reports application of 2,154 single-patient trials in 108 studies for diverse clinical conditions; various recent commentaries advocate for wider application of such trials in clinical decision making. Preliminary evidence from several recent pilot acceptability studies suggests that single-patient trials have the potential for widespread acceptance by patients and clinicians as an effective modality for increasing the therapeutic precision. Bayesian and adaptive statistical methods hold promise for increasing the informational yield of single-patient trials while reducing participant burden, but are not widely used. Personalized applications of single-patient trials can be enhanced through further development and application of methodologies on adaptive trial design, stopping rules, network meta-analysis, washout methods, and methods for communicating trial findings to patients and clinicians.

conclusionsSingle-patient trials may be poised to emerge as an important part of the methodological armamentarium for comparative effectiveness research and patient-centered outcomes research. By permitting direct estimation of individual treatment effects, they can facilitate finely graded individualized care, enhance therapeutic precision, improve patient outcomes, and reduce costs.

Indexed as

Bayes TheoremDecision Support TechniquesEvidence-Based MedicineChronic DiseaseComparative Effectiveness ResearchCross-Over StudiesHumansOutcome Assessment, Health CarePatient ParticipationPatient SelectionPilot ProjectsRandomized Controlled Trials as TopicAdaptive trialBayesian methodBorrow from strengthCarryover effectCrossover trialSequential trialWashout

Identifiers

PMID23849149
PMCPMC3972259

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.