Electronic versus paper-pencil methods for assessing chemotherapy-induced peripheral neuropathy
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The aim of this study is to examine and compare with the validated, paper/pencil European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy Scale (QLQ-CIPN20), the psychometric properties of three electronically administered patient reported outcome (PRO) measures of chemotherapy-induced peripheral neuropathy (CIPN): (1) the two neuropathy items from the National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), (2) the QLQ-CIPN20, and (3) the 0–10 Neuropathy Screening Question (NSQ).
We employed a descriptive, cross-sectional design and recruited 25 women with breast cancer who were receiving neurotoxic chemotherapy at an academic hospital. Participants completed the paper/pencil QLQ-CIPN20 and electronic versions of the QLQ-CIPN20, PRO-CTCAE, and NSQ. Internal consistency reliability, intraclass correlation, and concurrent and discriminant validity analyses were conducted.
The alpha coefficients for the electronic QLQ-CIPN20 sensory and motor subscales were 0.76 and 0.75. Comparison of the electronic and paper/pencil QLQ-CIPN20 subscales supported mode equivalence (intraclass correlation range >0.91). Participants who reported the presence of numbness/tingling via the single-item NSQ reported higher mean QLQ-CIPN20 sensory subscale scores (p < 0.001). PRO-CTCAE neuropathy severity and interference items correlated well with the QLQ-CIPN20 electronic and paper/pencil sensory (r = 0.76; r = 0.70) and motor (r = 0.55; r = 0.62) subscales, and with the NSQ (r = 0.72; r = 0.44).
These data support the validity of the electronically administered PRO-CTCAE neuropathy items, NSQ, and QLQ-CIPN20 for neuropathy screening in clinical practice. The electronic and paper/pencil versions of the QLQ-CIPN can be used interchangeably based on evidence of mode equivalence.
KeywordsPsychometrics Chemotherapy-induced peripheral neuropathy Peripheral nervous system disease/chemically induced Patient-reported outcomes
We would like to acknowledge the Carevive Systems, Inc. for allowing us to test these instruments within their computerized care planning system. In addition, we would like to acknowledge Jill Hayden, RN, and Shraddha Pardesi, MS, BPharm for their assistance with patient accrual; James P. Kelly, IV, BS, Deborah Lee, MSN, FNP, ACNP-BC, and Grace Kanzawa, BSN, RN for their assistance with data collection; Megan Williams, PA-C, Anne Clotfelter, MS, NP-C, Tamara Ghormley, MS, NP-C, and Joan Armstrong, MS, NP-C for participating in the study as the clinical providers; Kelly Scheu, MS, NP-C, for her assistance with facilitating use of the technology within the clinical practice setting; and Celia Bridges, BA, BSN for her assistance with editing the final manuscript.
Compliance with ethical standards
Source of funding
Dr. Carrie Stricker is the CCO of Carevive® Systems Inc., which provided the Care Planning System used in this study without cost. Dr. Stricker reports grants from Genentech, Inc., personal fees from Carevive Systems, Inc., during the conduct of the study; personal fees from Carevive Systems, Inc. and other from Carevive Systems, Inc., outside the submitted work; . Mr. Evan Gray reports personal fees from Centerpoint Human Services, personal fees from Cardinal Innovations Healthcare, personal fees from Piedmont Research Strategies, Inc., outside the submitted work. Dr. Ellen Smith reports receiving a grant from Genentech Inc., during the conduct of the study; personal fees from American Society of Clinical Oncology, grants from National Institute of Health, outside the submitted work. Dr. William Dudley reports personal fees from Piedmont Research Strategies, Inc., during the conduct of the study; personal fees from Piedmont Research Strategies, Inc., outside the submitted work.
This study was conducted with oversight from the University of Michigan IRBMED: HUM00084475 Written informed consent was obtained from all enrolled participants.
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