PMID- 23868457
OWN - NLM
STAT- MEDLINE
DCOM- 20140912
LR  - 20240413
IS  - 1573-2649 (Electronic)
IS  - 0962-9343 (Print)
IS  - 0962-9343 (Linking)
VI  - 23
IP  - 1
DP  - 2014 Feb
TI  - Cognitive interviewing of the US National Cancer Institute's Patient-Reported 
      Outcomes version of the Common Terminology Criteria for Adverse Events 
      (PRO-CTCAE).
PG  - 257-69
LID - 10.1007/s11136-013-0470-1 [doi]
AB  - PURPOSE: 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.
FAU - Hay, Jennifer L
AU  - Hay JL
AD  - Department of Psychiatry and Behavioral Sciences, Memorial Sloan-Kettering Cancer 
      Center, 641 Lexington Ave., 7th Floor, New York, NY, 10022, USA, hayj@mskcc.org.
FAU - Atkinson, Thomas M
AU  - Atkinson TM
FAU - Reeve, Bryce B
AU  - Reeve BB
FAU - Mitchell, Sandra A
AU  - Mitchell SA
FAU - Mendoza, Tito R
AU  - Mendoza TR
FAU - Willis, Gordon
AU  - Willis G
FAU - Minasian, Lori M
AU  - Minasian LM
FAU - Clauser, Steven B
AU  - Clauser SB
FAU - Denicoff, Andrea
AU  - Denicoff A
FAU - O'Mara, Ann
AU  - O'Mara A
FAU - Chen, Alice
AU  - Chen A
FAU - Bennett, Antonia V
AU  - Bennett AV
FAU - Paul, Diane B
AU  - Paul DB
FAU - Gagne, Joshua
AU  - Gagne J
FAU - Rogak, Lauren
AU  - Rogak L
FAU - Sit, Laura
AU  - Sit L
FAU - Viswanath, Vish
AU  - Viswanath V
FAU - Schrag, Deborah
AU  - Schrag D
FAU - Basch, Ethan
AU  - Basch E
CN  - NCI PRO-CTCAE Study Group
LA  - eng
GR  - HHSN261201000043C/CA/NCI NIH HHS/United States
GR  - HHSN261201000063C/CA/NCI NIH HHS/United States
GR  - P30 CA008748/CA/NCI NIH HHS/United States
GR  - P30 CA016672/CA/NCI NIH HHS/United States
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, N.I.H., Extramural
PT  - Validation Study
DEP - 20130720
PL  - Netherlands
TA  - Qual Life Res
JT  - Quality of life research : an international journal of quality of life aspects of 
      treatment, care and rehabilitation
JID - 9210257
RN  - 0 (Antineoplastic Agents)
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems/standards
MH  - Antineoplastic Agents/adverse effects/toxicity
MH  - Cognition Disorders/complications/etiology/*psychology
MH  - Drug Labeling/standards
MH  - Drug-Related Side Effects and Adverse Reactions/*classification
MH  - Female
MH  - Humans
MH  - Interview, Psychological/*methods/*standards
MH  - Male
MH  - *National Cancer Institute (U.S.)
MH  - Neoplasms/diagnosis/drug therapy/radiotherapy
MH  - Outcome and Process Assessment, Health Care/methods
MH  - Psychometrics
MH  - Reproducibility of Results
MH  - *Self Report
MH  - Terminology as Topic
MH  - United States
PMC - PMC3896507
MID - NIHMS517337
FIR - Geoghegan, Cindy
IR  - Geoghegan C
FIR - Sloan, Jeff A
IR  - Sloan JA
FIR - Cleeland, Charles S
IR  - Cleeland CS
FIR - Abernethy, Amy P
IR  - Abernethy AP
FIR - Bruner, Deborah W
IR  - Bruner DW
FIR - Barz, Allison
IR  - Barz A
FIR - Dueck, Amylou C
IR  - Dueck AC
FIR - Li, Yuelin
IR  - Li Y
EDAT- 2013/07/23 06:00
MHDA- 2014/09/13 06:00
PMCR- 2014/02/01
CRDT- 2013/07/23 06:00
PHST- 2013/07/01 00:00 [accepted]
PHST- 2013/07/23 06:00 [entrez]
PHST- 2013/07/23 06:00 [pubmed]
PHST- 2014/09/13 06:00 [medline]
PHST- 2014/02/01 00:00 [pmc-release]
AID - 10.1007/s11136-013-0470-1 [doi]
PST - ppublish
SO  - Qual Life Res. 2014 Feb;23(1):257-69. doi: 10.1007/s11136-013-0470-1. Epub 2013 
      Jul 20.