Evidence map›Paper›PMID 37327942›Full record

ReviewThe journal of pain2023

Covariate Adjustment in Chronic Pain Trials: An Oft-Missed Opportunity.

Dale J Langford, Sonia Sharma, Michael P McDermott, Avinash Beeram, Soroush Besherat, Fallon O France, Remington Mark, Meghan Park, Mahd Nishtar, Dennis C Turk and 2 more

Abstract readReview
In one paragraph

Review in The journal of pain, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 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

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. 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

12 authors.

Dale J LangfordDepartment of Anesthesiology, Critical Care & Pain Management, Hospital for Special Surgery, New York, New York; Department of Anesthesiology & Perioperative Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York; Department of Anesthesiology & Pain Medicine, University of Washington, Seattle, Washington.
Sonia SharmaNeuro Pain Management Center, Department of Neurosurgery, University of Rochester Medical Center, Rochester, New York.
Michael P McDermottDepartment of Biostatistics and Computational Biology, University of Rochester School of Medicine and Dentistry, Rochester, New York.
Avinash BeeramDepartment of Anesthesiology & Perioperative Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York.
Soroush BesheratDepartment of Anesthesiology & Perioperative Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York.
Fallon O FranceDepartment of Anesthesiology & Perioperative Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York.
Remington MarkDepartment of Anesthesiology & Perioperative Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York.
Meghan ParkDepartment of Anesthesiology & Perioperative Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York.
Mahd NishtarDepartment of Anesthesiology & Perioperative Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York.
Dennis C TurkDepartment of Anesthesiology & Pain Medicine, University of Washington, Seattle, Washington.
Robert H DworkinDepartment of Anesthesiology & Perioperative Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York.
Jennifer S GewandterDepartment of Anesthesiology & Perioperative Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York.

Funding

Promoting high-quality pain treatment trials through mentorship of junior investigators: A focus on study conduct and method developmentK24NS126861 · NINDS · UNIVERSITY OF ROCHESTER · PI GEWANDTER, JENNIFER · 2021 to 2021
$306k
FDA HHS U01 FD007702NINDS NIH HHS K24 NS126861
6 · The paper itself

Abstract

Self-reported pain intensity, frequently used as an outcome in randomized clinical trials (RCTs) of chronic pain, is often highly variable and could be associated with multiple baseline factors. Thus, the assay sensitivity of pain trials (ie, the ability of the trial to detect a true treatment effect) could be improved by including prespecified baseline factors in the primary statistical model. The objective of this focus article was to characterize the baseline factors included in statistical analyses of chronic pain RCTs. Seventy-three RCTs published between 2016 and 2021 that investigated interventions for chronic pain were included. The majority of trials identified a single primary analysis (72.6%; n = 53). Of these, 60.4% (n = 32) included one or more covariates in the primary statistical model, most commonly baseline value of the primary outcome, study site, sex, and age. Only one of the trials reported information regarding associations between covariates and outcomes (ie, information that could inform prioritization of covariates for prespecification in future analyses). These findings demonstrate inconsistent use of covariates in the statistical models in chronic pain clinical trials. Prespecified adjustments for baseline covariates that could increase precision and assay sensitivity should be considered in future clinical trials of chronic pain treatments. PERSPECTIVE: This review demonstrates inconsistent inclusion and potential underutilization of covariate adjustment in analyses of chronic pain RCTs. This article highlights areas for possible improvement in design and reporting related to covariate adjustment to improve efficiency in future RCTs.

Indexed as

Chronic PainHumansModels, StatisticalPain MeasurementResearch DesignCovariate adjustmentPainRandomized clinical trials

Identifiers

PMID37327942
PMCPMC11261744

What OpenQuestion holds

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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.