The Content Validity of a Chemotherapy-Induced Peripheral Neuropathy Patient-Reported Outcome Measure

Ellen M. Lavoie Smith, PhD, ANP-BC, AOCN®; Rylie Haupt, BSN, RN; James P. Kelly IV, BS; Deborah Lee, MSN, RN, FNP, ACNP-BC; Grace Kanzawa-Lee, BSN, RN; Robert Knoerl, PhD, RN; Celia Bridges, BA, BSN, RN; Paola Alberti, MD; Nusara Prasertsri, PhD, RN; Clare Donohoe


Purpose/Objectives: To test the content validity of a 16-item version of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire–Chemotherapy-Induced Peripheral Neuropathy (QLQ-CIPN20). 

Research Approach: Cross-sectional, prospective, qualitative design. 

Setting: Six outpatient oncology clinics within the University of Michigan Health System’s comprehensive cancer center in Ann Arbor. 

Participants: 25 adults with multiple myeloma or breast, gynecologic, gastrointestinal, or head and neck malignancies experiencing peripheral neuropathy caused by neurotoxic chemotherapy. 

Methodologic Approach: Cognitive interviewing methodology was used to evaluate the content validity of a 16-item version of the QLQ-CIPN20 instrument.

Findings: Minor changes were made to three questions to enhance readability. Twelve questions were revised to define unfamiliar terminology, clarify the location of neuropathy, and emphasize important aspects. One question was deleted because of clinical and conceptual redundancy with other items, as well as concerns regarding generalizability and social desirability. 

Interpretation: Cognitive interviewing methodology revealed inconsistencies between patients’ understanding and researchers’ intent, along with points that required clarification to avoid misunderstanding. 

Implications for Nursing: Patients’ interpretations of the instrument’s items were inconsistent with the intended meanings of the questions. One item was dropped and others were revised, resulting in greater consistency in how patients, clinicians, and researchers interpreted the items’ meanings and improving the instrument’s content validity. Following additional revision and psychometric testing, the QLQ-CIPN20 could evolve into a gold-standard CIPN patient-reported outcome measure.

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