Evidence map›Paper›PMID 29480026›Full record

ArticleCancer control : journal of the Moffitt Cancer Center

In Search of a Gold Standard Patient-Reported Outcome Measure for Use in Chemotherapy- Induced Peripheral Neuropathy Clinical Trials.

Ellen M Lavoie Smith, Robert Knoerl, James J Yang, Grace Kanzawa-Lee, Deborah Lee, Celia M Bridges

Open access · goldAbstract read
In one paragraph

Article in Cancer control : journal of the Moffitt Cancer Center. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 2 pooled it
2.8field-weighted citation impact, top 7% of its field
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

28 citing papers in PubMed, 2 syntheses or guidelines pooled it, 44 citations in OpenAlex.

  1. Pooled it
  2. Assessing chemotherapy-induced peripheral neuropathy with patient reported outcome measures: a systematic review of measurement properties and considerations for future use.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2022
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  17. Chemotherapy-induced peripheral neuropathy in newly diagnosed breast cancer survivors treated with taxane: a prospective longitudinal study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2021
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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

6 authors at 2 institutions in 1 country.

Ellen M Lavoie Smith1 University of Michigan School of Nursing, Ann Arbor, MI, USA.
Robert Knoerl2 Phylllis F. Cantor Center for Research in Nursing and Patient Care Services, Dana Farber Cancer Institute, Boston, MA, USA.ORCID http://orcid.org/0000-0002-6996-5068
James J Yang1 University of Michigan School of Nursing, Ann Arbor, MI, USA.
Grace Kanzawa-Lee1 University of Michigan School of Nursing, Ann Arbor, MI, USA.
Deborah Lee1 University of Michigan School of Nursing, Ann Arbor, MI, USA.
Celia M Bridges1 University of Michigan School of Nursing, Ann Arbor, MI, USA.
University of Michigan · USDana-Farber Cancer Institute · US

Funding

Chemotherapy-Induced Peripheral Neuropathy (CIPN) Measurement ValidationR03CA186183 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI SMITH, ELLEN MARY LAVOIE · 2015 to 2016
$155k
NCI NIH HHS R03 CA186183
6 · The paper itself

Abstract

purposeTo test a reduced version-CIPN15-of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy scale (QLQ-CIPN20) to establish a possible gold-standard patient-reported outcome measure for chemotherapy-induced peripheral neuropathy (CIPN).

methodsUsing a prospective, longitudinal, case-control design, patients (n = 121) receiving neurotoxic chemotherapy completed the CIPN15 at baseline and 12 weeks and underwent objective neurological assessment using the 5-item Total Neuropathy Score-Clinical (TNSc). Healthy controls (n = 30) completed the CIPN15 once. Structural validity was evaluated using factor analysis. Because a stable factor structure was not found, a sum score was used to evaluate measures of the CIPN15's psychometric properties-reliability, validity, sensitivity, and responsiveness-as follows: internal consistency via Cronbach's α and item-item correlations; test-retest reliability via correlation between 2 CIPN15 scores from each patient; concurrent validity via correlation between CIPN15 and 5-item TNSc scores; contrasting group validity via comparison of CIPN15 scores from patients and healthy controls; sensitivity via descriptive statistics (means, standard deviation, ranges); and responsiveness via Cohen's d effect size.

resultsMost patients received single agent oxaliplatin (33.7%), paclitaxel (21.2%), or more than 1 neurotoxic drug concurrently (29.8%). Factor analysis revealed no stable factor structure. Cronbach's α for the CIPN15 sum score was 0.91 (confidence interval [CI] = 0.89-0.93). Test-retest reliability was demonstrated based on strong correlations between the 2 scores obtained at the 12-week time point ( r = 0.86; CI = 0.80-0.90). The CIPN15 and 5-item TNSc items reflecting symptoms (not signs) were moderately correlated ( r range 0.57-0.72): concurrent validity. Statistically significant differences were found between patient and healthy control CIPN15 mean scores ( P < .0001): contrasting group validity. All items encompassed the full score range but the CIPN15 linearly converted sum score did not: sensitivity. The CIPN15 was responsive based on a Cohen's d of 0.52 (CI = 0.25-0.79).

conclusionThe sum-scored CIPN15 is reliable, valid, sensitive, and responsive when used to assess taxane- and platinum-induced CIPN.

Indexed as

Patient Reported Outcome MeasuresAdultAgedAged, 80 and overCase-Control StudiesClinical Trials as TopicFemaleHumansLongitudinal StudiesMaleMiddle AgedPeripheral Nervous System DiseasesProspective StudiesReproducibility of Resultschemotherapy-induced peripheral neuropathy (CIPN)QLQ-CIPN20reliabilityresponsivenesssensitivityvalidity

Identifiers

PMID29480026
PMCPMC5925747
OpenAlexW2790675286

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.