Evidence map›Paper›PMID 39067580›Full record

Trial reportThe journal of pain2024

Mean of Daily Versus Single Week Recall-Based Pain Quality Assessments in Neuropathic Pain Trials: Implications for Assay Sensitivity.

Madelaine Rangel, Soroush Besharat, Michael B Sohn, Melyssa Foust, Lori Francar, Carla Jorgensen, Karen Mustian, Gary Morrow, Eva Culakova, Mark P Jensen and 2 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in The journal of pain, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Review
  2. 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.

Madelaine RangelDepartment of Anesthesiology and Perioperative Medicine, University of Rochester Medical Center, Rochester, New York.
Soroush BesharatDepartment of Anesthesiology and Perioperative Medicine, University of Rochester Medical Center, Rochester, New York.
Michael B SohnDepartment of Biostatistics and Computational Biology, University of Rochester, Rochester, New York.
Melyssa FoustUpstate Carolina Consortium Community Oncology Research Program (UPSTATE), Gibbs Cancer Center and Research Institute, Spartanburg, South Carolina.
Lori FrancarCancer Research of Wisconsin and Northern Michigan NCORP, Green Bay, Wisconsin.
Carla JorgensenNCORP of the Carolinas-Prisma Health NCORP, Greenville, South Carolina.
Karen MustianDepartment of Surgery, Supportive Care in Cancer, University of Rochester Medical Center, Rochester, New York.
Gary MorrowDepartment of Surgery, Supportive Care in Cancer, University of Rochester Medical Center, Rochester, New York.
Eva CulakovaDepartment of Surgery, Supportive Care in Cancer, University of Rochester Medical Center, Rochester, New York.
Mark P JensenDepartment of Rehabilitation Medicine, University of Washington, Seattle, Washington.
Dale J LangfordDepartment of Anesthesiology, Critical Care & Pain Management, Pain Prevention Research Center, Hospital for Special Surgeries, New York, New York; Department of Anesthesiology, Weill Cornell Medicine, New York, New York.
Jennifer S GewandterDepartment of Anesthesiology and Perioperative Medicine, University of Rochester Medical Center, Rochester, New York. Electronic address: Jennifer_gewandter@urmc.rochester.edu.

Funding

URCC NCORP Research BaseUG1CA189961 · NCI · UNIVERSITY OF ROCHESTER · PI Michelle C Janelsins, KAREN M. MUSTIAN · 2014 to 2026
$67.7M
Wireless transcutaneous electrical stimulation (TENS) for chemotherapy-induced peripheral neuropathy: A phase II randomized clinical trialR21CA235389 · NCI · UNIVERSITY OF ROCHESTER · PI GEWANDTER, JENNIFER · 2019 to 2020
$363k
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
NCI NIH HHS R21 CA235389NCI NIH HHS UG1 CA189961NINDS NIH HHS K24 NS126861
6 · The paper itself

Abstract

Patients with neuropathic pain often present with variable pain and nonpainful sensory qualities that could serve as outcomes in randomized clinical trials (RCTs). This study aimed to investigate the within-participant variability in the severity of these sensory qualities and whether the means of 7 daily pain quality assessments provide better assay sensitivity (ie, more sensitivity to treatment effects) than single-week recall-based assessments. This secondary analysis used data from an RCT of transcutaneous electrical nerve stimulation for chemotherapy-induced peripheral neuropathy (N = 142). Participants rated the severity of painful and nonpainful sensory qualities using 0 to 10 numeric rating scales daily for 1 week (24-hour recall) and 1 time at the end of each week (week recall) at trial baseline and endpoint (after 6 weeks of treatment). For pain quality assay sensitivity analyses, the 2 types of measures were used to 1) define the study sample (ie, how many participants met minimum baseline pain quality severity) and 2) calculate the observed effect sizes (ie, between-group differences in mean pain qualities) using analysis of covariances. The projected sample sizes required to detect the observed effect sizes in future clinical trials for hot/burning pain and cramping were substantially smaller using the daily mean outcome compared with week recall (ie, hot/burning pain: 153 vs 388, cramping: 121 vs 349), and only marginally larger for sharp/shooting pain (22 participants) with the daily mean outcome. Compared with single-week recall-based assessments of pain qualities, the mean of daily assessments may improve RCT assay sensitivity when used to define entry criteria and assess outcomes. PERSPECTIVE: This study suggests that means of daily pain quality assessments may improve assay sensitivity when used to define entry criteria and assess outcomes in clinical trials. This work may inform design of future clinical trials evaluating the intensity of different pain qualities.

Indexed as

NeuralgiaPain MeasurementAdultAgedFemaleHumansMaleMental RecallMiddle AgedSensitivity and SpecificityTranscutaneous Electric Nerve Stimulationassay sensitivitychemotherapy-induced peripheral neuropathyClinical trialsdaily pain quality ratings

Identifiers

PMID39067580
PMCPMC11486568

What OpenQuestion holds

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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.