Evidence map›Paper›PMID 25881274›Full record

Trial reportTrials2015

The PREEMPT study - evaluating smartphone-assisted n-of-1 trials in patients with chronic pain: study protocol for a randomized controlled trial.

Colin Barr, Maria Marois, Ida Sim, Christopher H Schmid, Barth Wilsey, Deborah Ward, Naihua Duan, Ron D Hays, Joshua Selsky, Joseph Servadio and 9 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02116621 (N-of-1 Trials Using mHealth in Chronic Pain Aka PREEMPT), which is not on this map. Cited by 27 papers.

0numbers the graph read from it
0cells of the map it votes in
27citing 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.

NCT02116621 nacompletednot on this map

N-of-1 Trials Using mHealth in Chronic Pain Aka PREEMPT (Personalized Research for Monitoring Pain Treatment)

TypeinterventionalSponsorUniversity of California, DavisRan2014 to 2017Enrolled215ConditionsMusculoskeletal Pain, Chronic PainArmsTrialist Intervention, smartphone
3 · Its place in the literature

Who cites it

27 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Review
  4. The N-of-1 Trials and where to use them in Rheumatology.Mediterranean journal of rheumatology · 2025
    Review
  5. Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. Bayesian Models for N-of-1 Trials.Harvard data science review · 2022
    Article
  11. Article
  12. Review
  13. Observational
  14. Article
  15. Article
  16. Examining Opportunities for Goal-Directed Self-Tracking to Support Chronic Condition Management.Proceedings of the ACM on interactive, mobile, wearable and ubiquitous technologies · 2019
    Article
  17. Article
  18. Article
  19. Article
  20. Article
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

19 authors.

Colin BarrCenter for Health Care Policy and Research, University of California Davis, 2103 Stockton Blvd, Suite 2224, Sacramento, CA, 95817, USA. colin.barr@ucdmc.ucdavis.edu.
Maria MaroisCenter for Health Care Policy and Research, University of California Davis, 2103 Stockton Blvd, Suite 2224, Sacramento, CA, 95817, USA. mtstoecklin@ucdavis.edu.
Ida SimDepartment of General Internal Medicine, University of California San Francisco, 1545 Divisadero St, Suite 308, San Francisco, CA, 94118, USA. sim@medicine.ucsf.edu.
Christopher H SchmidDepartment of Biostatistics and Center for Evidence Based Medicine, Brown University School of Public Health, 121 South Main Street, Providence, RI, 02912, USA. Christopher_Schmid@brown.edu.
Barth WilseyDepartment of Physical Medicine & Rehabilitation, 4150 V Street, Suite 1200, Sacramento, CA, 95817, USA. barth.wilsey@ucdmc.ucdavis.edu.
Deborah WardBetty Irene Moore School of Nursing, University of California Davis, 4610 X Street, Sacramento, CA, 95817, USA. deborah.ward@ucdmc.ucdavis.edu.
Naihua DuanDepartment of Psychiatry, Columbia University, 1051 Riverside Drive, Unit 48, New York, NY, 10032, USA. Naihua.Duan@Columbia.edu.
Ron D HaysDivision of General Internal Medicine & Health Services Research, Department of Medicine, University of California Los Angeles, 911 Broxton Avenue, Los Angeles, CA, 90024, USA. drhays@ucla.edu.
Joshua SelskyOpen mHealth, 412 Broadway, Floor 2, New York, NY, 10013, USA. joshua.selsky@gmail.com.
Joseph ServadioDepartment of Biostatistics and Center for Evidence Based Medicine, Brown University School of Public Health, 121 South Main Street, Providence, RI, 02912, USA. joseph_servadio@brown.edu.
Marc Schwartz2Know, Inc, 257 Gold Street #1408, Brooklyn, NY, 11201, USA. marc@2know.com.
Clyde DsouzaCenter for Health Care Policy and Research, University of California Davis, 2103 Stockton Blvd, Suite 2224, Sacramento, CA, 95817, USA. cvdsouza@ucdavis.edu.
Navjot DhammiCenter for Health Care Policy and Research, University of California Davis, 2103 Stockton Blvd, Suite 2224, Sacramento, CA, 95817, USA. nkdhammi@ucdavis.edu.
Zachary HoltDepartment of Internal Medicine, University of California Davis, 4150 V Street, Suite 3100, Sacramento, CA, 95817, USA. zachary.holt@ucdmc.ucdavis.edu.
Victor BaqueroUniversity of California Davis Medical Group - Folsom, 1370 Prairie City Road, Folsom, CA, 95630, USA. victor.baquero@ucdmc.ucdavis.edu.
Scott MacDonaldUniversity of California Davis Medical Group - Sacramento, 2825 J Street, Suite 300, Sacramento, CA, 95816, USA. scott.macdonald@ucdmc.ucdavis.edu.
Anthony JerantDepartment of Family and Community Medicine, University of California Davis, 4860 Y Street, Suite 2300, Sacramento, CA, 95817, USA. anthony.jerant@ucdmc.ucdavis.edu.
Ron SprinkleUniversity of California Davis Medical Group - Davis, 2660 West Covell Boulevard, Suites A, B and C, Davis, CA, 95616, USA. ron.sprinkle@ucdmc.ucdavis.edu.
Richard L KravitzCenter for Health Care Policy and Research, University of California Davis, 2103 Stockton Blvd, Suite 2224, Sacramento, CA, 95817, USA. rlkravitz@ucdavis.edu.

Funding

N-of-1 Trials Using mHealth in Chronic PainR01NR013938 · NINR · UNIVERSITY OF CALIFORNIA AT DAVIS · PI KRAVITZ, RICHARD L · 2012 to 2016
$2.9M
NINR NIH HHS 5R01NR013938NINR NIH HHS R01 NR013938
6 · The paper itself

Abstract

backgroundChronic pain is prevalent, costly, and clinically vexatious. Clinicians typically use a trial-and-error approach to treatment selection. Repeated crossover trials in a single patient (n-of-1 trials) may provide greater therapeutic precision. N-of-1 trials are the most direct way to estimate individual treatment effects and are useful in comparing the effectiveness and toxicity of different analgesic regimens. The goal of the PREEMPT study is to test the 'Trialist' mobile health smartphone app, which has been developed to make n-of-1 trials easier to accomplish, and to provide patients and clinicians with tools for individualizing treatments for chronic pain. METHODS/

designA randomized controlled trial is being conducted to test the feasibility and effectiveness of the Trialist app. A total of 244 participants will be randomized to either the Trialist app intervention group (122 patients) or a usual care control group (122 patients). Patients assigned to the Trialist app will work with their clinicians to set up an n-of-1 trial comparing two pain regimens, selected from a menu of flexible options. The Trialist app provides treatment reminders and collects data entered daily by the patient on pain levels and treatment side effects. Upon completion of the n-of-1 trial, patients review results with their clinicians and develop a long-term treatment plan. The primary study outcome (comparing Trialist to usual care patients) is pain-related interference with daily functioning at 26 weeks. DISCUSSION: Trialist will allow patients and clinicians to conduct personalized n-of-1 trials. In prior studies, n-of-1 trials have been shown to encourage greater patient involvement with care, which has in turn been associated with better health outcomes. mHealth technology implemented using smartphones may offer an efficient means of facilitating n-of-1 trials so that more patients can benefit from this approach.

trial registrationClinicalTrials.gov: NCT02116621 , first registered 15 April 2014.

Indexed as

Clinical ProtocolsPrecision MedicineSmartphoneChronic PainCross-Over StudiesHumansQuality of LifeSample Size

Identifiers

PMID25881274
PMCPMC4367894

What OpenQuestion holds

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Registered trials

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.