title: Asking the right questions to get the right answers: using cognitive interviews to review the acceptability, comprehension and clinical meaningfulness of patient self-report adverse event items in oncology patients.
abstract: BACKGROUND
  Standardized reporting of treatment-related adverse events (AE) is essential in clinical trials, usually achieved by using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) reported by clinicians. Patient-reported adverse events (PRAE) may add value to clinician assessments, providing patient perspective on subjective toxicity. We developed an online patient symptom report and self-management system for real-time reporting and managing AE during cancer treatment integrated with electronic patient records (eRAPID). As part of this program we developed a patient version of the CTCAE (version 4.0), rephrasing terminology into a self-report format. We explored patient understanding of these items via cognitive interviews.
  
  
  METHODS
  Sixty patients (33 female, 27 male) undergoing treatment were purposively sampled by age, gender and tumor group (median age 61.5, range 35-84, 12 breast, 12 gynecological, 13 colorectal, 12 lung and 11 renal). Twenty-one PRAE items were completed on a touch-screen computer. Subsequent audio-recorded cognitive interviews and thematic analysis explored patients' comprehension of items via verbal probing techniques during three interview rounds (n = 20 patients/round).
  
  
  RESULTS
  In total 33 item amendments were made; 29% related to question comprehension, 68% response option and 3% order effects. These amendments to phrasing and language improved patient understanding but maintained CTCAE grading and key medical information. Changes were endorsed by members of a patient advisory group (N = 11).
  
  
  CONCLUSIONS
  Item adaptations resulted in a bank of consistently interpreted self-report AE items for use in future research program. In-depth analysis of items through cognitive interviews is an important step towards developing an internationally valid system for PRAE, thus improving patient safety and experiences during cancer treatment.
authors.affiliation: a Patient Reported Outcomes Group , University of Leeds , Leeds , UK.
authors.forename: Patricia
authors.initials: P
authors.lastname: Holch
authors.affiliation: a Patient Reported Outcomes Group , University of Leeds , Leeds , UK.
authors.forename: Lorraine
authors.initials: L
authors.lastname: Warrington
authors.affiliation: b Institute of Health Sciences, University of Leeds , Leeds , UK.
authors.forename: Barbara
authors.initials: B
authors.lastname: Potrata
authors.affiliation: b Institute of Health Sciences, University of Leeds , Leeds , UK.
authors.forename: Lucy
authors.initials: L
authors.lastname: Ziegler
authors.affiliation: a Patient Reported Outcomes Group , University of Leeds , Leeds , UK.
authors.forename: Ceri
authors.initials: C
authors.lastname: Hector
authors.affiliation: c Department of Health Sciences , University of York , York , UK.
authors.forename: Ada
authors.initials: A
authors.lastname: Keding
authors.affiliation: d School of Healthcare, University of Leeds , Leeds , UK.
authors.forename: Clare
authors.initials: C
authors.lastname: Harley
authors.affiliation: a Patient Reported Outcomes Group , University of Leeds , Leeds , UK.
authors.forename: Kate
authors.initials: K
authors.lastname: Absolom
authors.affiliation: e Patient Representative eRAPID Project Management Group , UK.
authors.forename: Carolyn
authors.initials: C
authors.lastname: Morris
authors.affiliation: a Patient Reported Outcomes Group , University of Leeds , Leeds , UK.
authors.forename: Leon
authors.initials: L
authors.lastname: Bamforth
authors.affiliation: a Patient Reported Outcomes Group , University of Leeds , Leeds , UK.
authors.forename: Galina
authors.initials: G
authors.lastname: Velikova
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D032882:Comprehension; D064420:Drug-Related Side Effects and Adverse Reactions; D057286:Electronic Health Records; D005260:Female; D006801:Humans; D008297:Male; D062527:Meaningful Use; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy* / Q000523:psychology; D009862:Online Systems; D000073222:Patient Health Questionnaire; D057566:Self Report; D000073278:Self-Management; D009626:Terminology as Topic
chemical_list: D000970:Antineoplastic Agents