Observational Study
Copyright ©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Oncol. Feb 15, 2020; 12(2): 205-218
Published online Feb 15, 2020. doi: 10.4251/wjgo.v12.i2.205
Neuropathy experienced by colorectal cancer patients receiving oxaliplatin: A qualitative study to validate the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity scale
Karen Kaiser, Madison Lyleroehr, Sara Shaunfield, Leilani Lacson, Maria Corona, Sheetal Kircher, Malin Nittve, David Cella
Karen Kaiser, Madison Lyleroehr, Sara Shaunfield, Leilani Lacson, Maria Corona, David Cella, Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL 60611, United States
Sheetal Kircher, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL 60611, United States
Malin Nittve, Project and Regulatory Affairs, PledPharma AB, Stockholm 114 46, Sweden
Author contributions: Kaiser K, Shaunfield S and Cella D contributed to study conception and design; Kaiser K, Shaunfield S, Lyleroehr M, Lacson L, Kircher S and Corona M contributed to data acquisition, data analysis and data interpretation; Kaiser K contributed to writing of the article; Kaiser K, Lyleroehr M, Shaunfield S, Lacson L, Corona M, Kircher S, Nittve M and Cella D contributed to editing, reviewing, and final approval of the manuscript.
Institutional review board statement: ‎This study was reviewed and approved by the Ethics Committee of Northwestern University.
Informed consent statement: ‎ The patients provided written consent before participation in the study.
Conflict-of-interest statement: The authors declare that they have no conflict of interest.
STROBE statement: ‎ The authors have read the STROBE Statement-checklist of items, and the manuscript was prepared according to the STROBE Statement-checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Karen Kaiser, PhD, Associate Professor, Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, 625 N Michigan Ave, Suite 2700, Chicago, IL 60611, United States. k-kaiser@northwestern.edu
Received: October 7, 2019
Peer-review started: October 7, 2019
First decision: October 18, 2019
Revised: October 29, 2019
Accepted: January 6, 2020
Article in press: January 6, 2020
Published online: February 15, 2020
ARTICLE HIGHLIGHTS
Research background

A content valid assessment of neuropathy is needed for clinical research among colorectal cancer (CRC) patients receiving oxaliplatin. The authors assessed the content validity of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) scale among CRC patients who had received oxaliplatin. The measure exhibited good content validity. Moreover, patients reported that foot neuropathy was most bothersome for them. This study is significant because the authors provide evidence that the FACT/GOG-Ntx is suitable for use in clinical trials and other research studies of this population.

Research motivation

This study examines the neuropathy experiences of CRC patients and the appropriateness (i.e., content validity) of a patient reported outcome measure of neuropathy. These topics are important to examine because patient reported outcome measures are needed to assess drug side effects in clinical trial settings.

Research objectives

The main objective was to test the content validity of FACT/GOG-Ntx. This objective was realized; the measure was found to have content validity and can be used in future research and clinical practice.

Research methods

The authors used semi-structured patient interviews to assess the FACT/GOG-Ntx. Semi-structured interviews entail using a set list of questions, administered by a trained interviewer. Interviews typical contain a combination of closed-ended and open-ended questions. By using pre-planned and spontaneous probing questions, the interviewer is able to gather a detailed description of the key topics from the perspective on the interviewee.

Research results

The qualitative concept elicitation data, in combination with data from cognitive interviews and the literature, provide moderate to strong support for the content validity of 11 the 13 items of the FACT/GOG-Ntx-13. Two items - “I have trouble hearing” (NTX6) and “I get a ringing of buzzing in my ears” (NTX7), had limited support in our data. However, limited support is not surprising given that hearing impairment is a symptom of severe neuropathy, and oxaliplatin therapy may be discontinued or reduced prior to impacting hearing. The authors recommend retaining these items as indicators of severe neuropathy.

Research conclusions

The FACT/GOG-Ntx has content validity for CRC patients receiving oxaliplatin. Patients related more with the term “discomfort” than “pain” when reporting neuropathy in their hands and feet. The FACT/GOG-Ntx has content validity for CRC patients receiving oxaliplatin. This study builds upon the body of evidence supporting the use of the FACT/GOG-Ntx in future research and clinical practice.

Research perspectives

Existing patient reported outcome measures can be tested for their validity in new, specific populations. The authors anticipate continued advancement in the use of patient reported measures in clinical research and in drug development. Future work on the use of patient reported outcomes measures in clinical practice is best suited for a combination of patient-focused, qualitative research and large, quantitative surveys to assess measurement properties.