Concept domain validation and item generation for the Treatment-Induced Neuropathy Assessment Scale (TNAS)
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Treatment-induced peripheral neuropathy (TIPN) is a difficult problem experienced by patients with cancer that can interfere with their ability to receive optimal therapy. The Treatment-Induced Peripheral Neuropathy Scale (TNAS) is a patient-reported outcome (PRO) measure developed to assess TIPN symptom burden. However, PRO validation is an ongoing process. The aim of this qualitative study was to define the conceptual model, establish content domain validity, and refine items for the TNAS based on patient input.
Patients who received bortezomib, oxaliplatin, or platinum–taxane combination therapy reported their experience of TIPN in single qualitative audiotaped interviews. Themes of the TIPN experience were identified by descriptive analysis of the transcribed interviews.
Three groups of 10 patients each who had received bortezomib, oxaliplatin, or platinum–taxane combination therapy, for a total of 30 patients, reported their experiences. Two themes reported by patients were TIPN sensations and functional interference. Five sensations (numbness, tingling, pain, heat or burning, and coldness) and five functional impacts (using hands, walking, maintaining balance or falling, wearing shoes, and sleeping) were reported by at least 20% of patients and were selected for inclusion in the TNAS v3.0 for additional psychometric testing.
The assessment of TIPN must be convenient, reliable, and practical for patients, who are the most reliable source of information about symptoms. The TNAS, developed with direct patient input, provides an easily administered and conceptually valid method of patient report of TIPN burden for use in research and practice.
KeywordsChemotherapy-induced peripheral neuropathy Treatment-induced peripheral neuropathy Patient-reported outcomes Qualitative research Symptom burden
The authors acknowledge Jeanie F. Woodruff, BS, ELS, for editorial support. The sponsors played no role in study design; in the collection, analysis and interpretation of data; in the writing of the report; or in the decision to submit the article for publication. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute, the National Institutes of Health, the US Cancer Pain Relief Committee, or Genentech.
This research was sponsored by funding from Genentech and the US Cancer Pain Relief Committee. All research at The University of Texas MD Anderson Cancer Center is supported in part by the institution’s Cancer Center Support Grant, NCI P30 CA016672.
Compliance with ethical standards
Conflict of interest
Drs. Mendoza and Cleeland report a grant from Genentech during the conduct of the study. Dr. Williams reports grants from US Cancer Pain Relief Committee and from Genentech during the conduct of the study; and personal fees from Pled Pharma and Immune Design Corp, grants from AstraZeneca, Merck, Bayer Pharmaceuticals, and Bristol-Myers Squibb, and non-financial support from Amgen outside the submitted work.
Research involving human participants and/or animals
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Informed consent was obtained from all individual participants included in the study.
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