title: Cognitive interviewing of the US National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
abstract: OBJECTIVE
  The National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is a library of question items that enables patient reporting of adverse events (AEs) in clinical trials. This study contributes content validity evidence of the PRO-CTCAE by incorporating cancer patient input of the relevance and comprehensiveness of the item library.
  
  
  METHODS
  Cognitive interviews were conducted among patients undergoing chemotherapy or radiation therapy at multiple sites to evaluate comprehension, memory retrieval, judgment, and response mapping related to AE terms (e.g., nausea), attribute terms (regarding frequency, severity, or interference), response options, and recall period. Three interview rounds were conducted with ≥20 patients completing each item per round. Items were modified and retested if ≥3 patients exhibited cognitive difficulties or if experienced by ≤25% patients.
  
  
  RESULTS
  One hundred and twenty-seven patients participated (35% ≤high school, 28% non-white, and 59% female). Most AE terms (63/80) generated no cognitive difficulties. The remaining 17 were modified without further difficulties by Round 3. Terms were comprehended regardless of education level. Attribute terms and response options required no modifications. Patient adherence to recall period (7 days) was improved when the reference period was incorporated.
  
  
  CONCLUSIONS
  This study provides evidence confirming comprehension of the US English language versions of items in the PRO-CTCAE library for measuring symptomatic AEs from the patient perspective within the context of cancer treatment. Several minor changes were made to the items to improve item clarity, comprehension, and ease of response judgment. This study helps to establish the content validity of PRO-CTCAE items for patient reporting of AEs during cancer treatment.
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, 641 Lexington Ave., 7th Floor, New York, NY, 10022, USA, hayj@mskcc.org.
authors.forename: Jennifer L
authors.initials: JL
authors.lastname: Hay
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Atkinson
authors.forename: Bryce B
authors.initials: BB
authors.lastname: Reeve
authors.forename: Sandra A
authors.initials: SA
authors.lastname: Mitchell
authors.forename: Tito R
authors.initials: TR
authors.lastname: Mendoza
authors.forename: Gordon
authors.initials: G
authors.lastname: Willis
authors.forename: Lori M
authors.initials: LM
authors.lastname: Minasian
authors.forename: Steven B
authors.initials: SB
authors.lastname: Clauser
authors.forename: Andrea
authors.initials: A
authors.lastname: Denicoff
authors.forename: Ann
authors.initials: A
authors.lastname: O'Mara
authors.forename: Alice
authors.initials: A
authors.lastname: Chen
authors.forename: Antonia V
authors.initials: AV
authors.lastname: Bennett
authors.forename: Diane B
authors.initials: DB
authors.lastname: Paul
authors.forename: Joshua
authors.initials: J
authors.lastname: Gagne
authors.forename: Lauren
authors.initials: L
authors.lastname: Rogak
authors.forename: Laura
authors.initials: L
authors.lastname: Sit
authors.forename: Vish
authors.initials: V
authors.lastname: Viswanath
authors.forename: Deborah
authors.initials: D
authors.lastname: Schrag
authors.forename: Ethan
authors.initials: E
authors.lastname: Basch
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000633:toxicity; D003072:Cognition Disorders / Q000150:complications / Q000209:etiology / Q000523:psychology*; D004348:Drug Labeling / Q000592:standards; D064420:Drug-Related Side Effects and Adverse Reactions / Q000145:classification*; D005260:Female; D006801:Humans; D007406:Interview, Psychological / Q000379:methods* / Q000592:standards*; D008297:Male; D054547:National Cancer Institute (U.S.); D009369:Neoplasms / Q000175:diagnosis / Q000188:drug therapy / Q000532:radiotherapy; D010043:Outcome and Process Assessment, Health Care / Q000379:methods; D011594:Psychometrics; D015203:Reproducibility of Results; D057566:Self Report; D009626:Terminology as Topic; D014481:United States
chemical_list: D000970:Antineoplastic Agents