NDLI: 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.

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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.

Content Provider	Semantic Scholar
Author	Holch, Patricia Warrington, Lorraine Potrata, Barbara Ziegler, L. Euller Hector, Ceri Keding, Ada Harley, Clare Absolom, Kate Morris, Carolyn Thomas Bamforth, Leon C. A. Velikova, Galina
Copyright Year	2016
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. MATERIAL AND METHOD 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). CONCLUSION 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.
Starting Page	1220
Ending Page	1226
Page Count	7
File Format	PDF HTM / HTML
DOI	10.1080/0284186X.2016.1213878
PubMed reference number	27551774
Journal	Medline
Volume Number	55
Issue Number	9-10
Alternate Webpage(s)	http://eprints.whiterose.ac.uk/103430/7/9-23-2016_Asking%20the.pdf
Alternate Webpage(s)	http://eprints.leedsbeckett.ac.uk/2918/20/Asking%20the%20right%20questions%20to%20get%20the%20right%20answers%20using%20cognitive%20interviews%20to%20review%20the%20acceptability%20comprehension%20and%20clinical%20meaningfulness.pdf
Journal	Acta oncologica
Language	English
Access Restriction	Open
Content Type	Text
Resource Type	Article

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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.

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