Evidence map›Paper›PMID 29804057›Full record

SynthesisBMJ open2018

Evaluation of person-level heterogeneity of treatment effects in published multiperson N-of-1 studies: systematic review and reanalysis.

Gowri Raman, Ethan M Balk, Lana Lai, Jennifer Shi, Jeffrey Chan, Jennifer S Lutz, Robert W Dubois, Richard L Kravitz, David M Kent

Abstract readSystematic Review
In one paragraph

Synthesis in BMJ open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
–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

12 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Review
  7. Article
  8. Review
  9. Article
  10. Article
  11. What is Evidence-Based Functional Medicine in the 21st Century?Integrative medicine (Encinitas, Calif.) · 2019
    Article
  12. Review
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

9 authors.

Gowri RamanCenter for Clinical Evidence Synthesis, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center/Tufts University School of Medicine, Boston, MA, USA.
Ethan M BalkCenter for Evidence Synthesis in Health, School of Public Health, Brown University, Providence, Rhode Island, USA.
Lana LaiPredictive Analytics and Comparative Effectiveness (PACE) Center, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center/Tufts University School of Medicine, Boston, Massachusetts, USA.
Jennifer ShiCenter for the Evaluation of Value and Risk in Health, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center/Tufts University School of Medicine, Boston, MA, USA.
Jeffrey ChanVA Boston Healthcare System, Center for Healthcare Organization and Implementation Research (CHOIR), Boston, Massachusetts, USA.
Jennifer S LutzPredictive Analytics and Comparative Effectiveness (PACE) Center, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center/Tufts University School of Medicine, Boston, Massachusetts, USA.
Robert W DuboisNational Pharmaceutical Council, Washington, District of Columbia, USA.
Richard L KravitzDepartment of Internal Medicine, University of California, Davis, San Francisco, California, USA.
David M KentPredictive Analytics and Comparative Effectiveness (PACE) Center, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center/Tufts University School of Medicine, Boston, Massachusetts, USA.

Funding

Institute for Clinical and Translational ResearchUL1TR001079 · NCATS · JOHNS HOPKINS UNIVERSITY · PI FORD, DANIEL ERNEST · 2013 to 2017
$60.1M
NCATS NIH HHS UL1 TR001079
6 · The paper itself

Abstract

objectiveIndividual patients with the same condition may respond differently to similar treatments. Our aim is to summarise the reporting of person-level heterogeneity of treatment effects (HTE) in multiperson N-of-1 studies and to examine the evidence for person-level HTE through reanalysis. STUDY

designSystematic review and reanalysis of multiperson N-of-1 studies. DATA SOURCES: Medline, Cochrane Controlled Trials, EMBASE, Web of Science and review of references through August 2017 for N-of-1 studies published in English. STUDY SELECTION: N-of-1 studies of pharmacological interventions with at least two subjects. DATA SYNTHESIS: Citation screening and data extractions were performed in duplicate. We performed statistical reanalysis testing for person-level HTE on all studies presenting person-level data.

resultsWe identified 62 multiperson N-of-1 studies with at least two subjects. Statistical tests examining HTE were described in only 13 (21%), of which only two (3%) tested person-level HTE. Only 25 studies (40%) provided person-level data sufficient to reanalyse person-level HTE. Reanalysis using a fixed effect linear model identified statistically significant person-level HTE in 8 of the 13 studies (62%) reporting person-level treatment effects and in 8 of the 14 studies (57%) reporting person-level outcomes.

conclusionsOur analysis suggests that person-level HTE is common and often substantial. Reviewed studies had incomplete information on person-level treatment effects and their variation. Improved assessment and reporting of person-level treatment effects in multiperson N-of-1 studies are needed.

Indexed as

Clinical Trials as TopicCross-Over StudiesEvidence-Based MedicineHumansModels, StatisticalTherapeuticsTreatment Outcomeheterogeneity of treatment effectN-of-1 studiesperseonalized medicinesystematic review

Identifiers

PMID29804057
PMCPMC5988083

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.