Evidence map›Paper›PMID 39297964›Full record

ArticleSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2024

Exploring the reliability and validity of clinically-relevant outcome measures for chemotherapy-induced peripheral neuropathy.

Robert Knoerl, Michael B Sohn, Kevin Spath, Brian Burnette, Lori Francar, Karen M Mustian, Dhaval Shah, Lynn Gauthier, Jennifer S Gewandter

Registry-linked trialAbstract readValidation Study
In one paragraph

Article in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04367490, which is not on this 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.

NCT04367490 no registry record found
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. 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.

Robert KnoerlUniversity of Michigan School of Nursing, 400 North Ingalls St, Office 2350, Ann Arbor, MI, 48109, USA. rjknoerl@med.umich.edu.ORCID http://orcid.org/0000-0002-6996-5068
Michael B SohnDepartment of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, NY, 14642, USA.
Kevin SpathDepartment of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, NY, 14642, USA.
Brian BurnetteCancer Research of Wisconsin and Northern Michigan Consortium, Green Bay, WI, 54301, USA.
Lori FrancarCancer Research of Wisconsin and Northern Michigan Consortium, Green Bay, WI, 54301, USA.
Karen M MustianDepartment of Surgery, University of Rochester Medical Center, Rochester, NY, 14642, USA.
Dhaval ShahDelaware/Christiana Care NCORP, Newark, DE, 19713, USA.
Lynn GauthierDepartment of Family and Emergency Medicine, Université Laval, Quebec, QC, G1V 0A6, Canada.
Jennifer S GewandterDepartment of Anesthesiology and Perioperative Medicine, University of Rochester Medical Center, Rochester, NY, 14642, USA.

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
National Institute for Neurologic Disorders and Stroke K24NS126861NCI NIH HHS R21 CA235389NCI NIH HHS R21CA235389NCI NIH HHS UG1 CA189961NINDS NIH HHS K24 NS126861
6 · The paper itself

Abstract

purposeTo explore the reliability and validity of clinically-relevant outcome measures for balance (i.e., The Short Physical Performance Battery [SPPB] - Balance Subscale) and sensation (i.e., monofilament threshold testing) for use in clinical trials of chemotherapy-induced peripheral neuropathy (CIPN).

methodsAdult, post-treatment cancer survivors (N = 142) who had reported ≥ 4/10 CIPN symptom severity following neurotoxic chemotherapy were recruited from six National Cancer Institute Community Oncology Research Program (NCORP) sites associated with the University of Rochester Cancer Center NCORP Research Base. Participants completed the monofilament threshold test at the screening and baseline time points (i.e., one week apart), while the Quality of Life Questionnaire-CIPN20, Treatment-Induced Neuropathy Assessment Scale, and SPPB - Balance Subscale were completed at baseline. Test-retest reliability of the monofilament threshold testing scores was assessed using the Intraclass Correlation Coefficient (ICC). The convergent validity among monofilament threshold testing, SPPB - Balance Subscale, and CIPN patient-reported outcome (PRO) scores at baseline was assessed using Spearman's correlation.

resultsCeiling effects were observed for SPPB-Balance Subscale scores as 113 (79.6%) respondents reported the highest score. Agreement between the screening and baseline monofilament threshold testing scores was moderate (ICC = 0.65). Monofilament threshold testing (r

conclusionsMonofilament threshold testing demonstrated moderate test-retest reliability, but low convergent validity with CIPN PROs, while the SPPB - Balance Subscale demonstrated low convergent validity with CIPN PROs and ceiling effects (i.e., highest possible score) among post-treatment cancer survivors with CIPN. Future research is needed to identify promising measures of balance and sensation loss for use in clinical trials that complement CIPN PROs to aid in the identification of clinically relevant treatments for CIPN.

trial registrationNCT04367490 [April 29, 2020].

Indexed as

Antineoplastic AgentsPeripheral Nervous System DiseasesAdultAgedCancer SurvivorsFemaleHumansMaleMiddle AgedNeoplasmsOutcome Assessment, Health CarePostural BalanceQuality of LifeReproducibility of ResultsSurveys and QuestionnairesAntineoplastic AgentsChemotherapy-Induced peripheral neuropathyPsychometrics, Reliability, Validity

Identifiers

PMID39297964
PMCPMC11648158

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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.