Danish Translation and Linguistic Validation of the U.S. National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
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Danish Translation and Linguistic Validation of the U.S. National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). / Bæksted, Christina; Nissen, Aase; Pappot, Helle; Bidstrup, Pernille Envold; Mitchell, Sandra A; Basch, Ethan; Dalton, Susanne Oksbjerg; Johansen, Christoffer.
I: Journal of Pain and Symptom Management, Bind 52, Nr. 2, 08.2016, s. 292-297.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Danish Translation and Linguistic Validation of the U.S. National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
AU - Bæksted, Christina
AU - Nissen, Aase
AU - Pappot, Helle
AU - Bidstrup, Pernille Envold
AU - Mitchell, Sandra A
AU - Basch, Ethan
AU - Dalton, Susanne Oksbjerg
AU - Johansen, Christoffer
N1 - Copyright © 2016 American Academy of Hospice and Palliative Medicine. All rights reserved.
PY - 2016/8
Y1 - 2016/8
N2 - CONTEXT: The Common Terminology Criteria for Adverse Events (CTCAE) is the basis for standardized clinician-based grading and reporting of adverse events in cancer clinical trials. The U.S. National Cancer Institute has developed the Patient-Reported Outcomes version of the CTCAE (PRO-CTCAE) to incorporate patient self-reporting of symptomatic adverse events.OBJECTIVES: The aim of the study was to translate and linguistically validate a Danish language version of PRO-CTCAE.METHODS: The U.S. English language PRO-CTCAE was translated into Danish using forward and backward procedures with reconciliation. The linguistic validity of the PRO-CTCAE Danish was examined in two successive rounds of semistructured cognitive interviews in a sample of 56 patients equally distributed by gender and cancer type (prostate, head and neck, lung, breast, gynecological, gastrointestinal, and hematological cancer), and who were currently undergoing cancer treatment.RESULTS: In the first round of linguistic validation (n = 42), the phrasing of five symptomatic toxicities was adjusted, and the refined phrasing was retested in a second round of interviews (n = 14). Agreement about phrasing that was both culturally acceptable and semantically comprehensible was achieved in the second round. Statements from participants describing the meaning of the PRO-CTCAE symptomatic toxicities support conceptual equivalence to the U.S. English language version.CONCLUSION: Availability of the NCI PRO-CTCAE in languages beyond English will support international congruence in self-reporting of side effects of cancer treatment. A rigorous methodology was used to develop the Danish language version of PRO-CTCAE. Results provide preliminary support for the use of PRO-CTCAE in cancer clinical trials that include Danish speakers.
AB - CONTEXT: The Common Terminology Criteria for Adverse Events (CTCAE) is the basis for standardized clinician-based grading and reporting of adverse events in cancer clinical trials. The U.S. National Cancer Institute has developed the Patient-Reported Outcomes version of the CTCAE (PRO-CTCAE) to incorporate patient self-reporting of symptomatic adverse events.OBJECTIVES: The aim of the study was to translate and linguistically validate a Danish language version of PRO-CTCAE.METHODS: The U.S. English language PRO-CTCAE was translated into Danish using forward and backward procedures with reconciliation. The linguistic validity of the PRO-CTCAE Danish was examined in two successive rounds of semistructured cognitive interviews in a sample of 56 patients equally distributed by gender and cancer type (prostate, head and neck, lung, breast, gynecological, gastrointestinal, and hematological cancer), and who were currently undergoing cancer treatment.RESULTS: In the first round of linguistic validation (n = 42), the phrasing of five symptomatic toxicities was adjusted, and the refined phrasing was retested in a second round of interviews (n = 14). Agreement about phrasing that was both culturally acceptable and semantically comprehensible was achieved in the second round. Statements from participants describing the meaning of the PRO-CTCAE symptomatic toxicities support conceptual equivalence to the U.S. English language version.CONCLUSION: Availability of the NCI PRO-CTCAE in languages beyond English will support international congruence in self-reporting of side effects of cancer treatment. A rigorous methodology was used to develop the Danish language version of PRO-CTCAE. Results provide preliminary support for the use of PRO-CTCAE in cancer clinical trials that include Danish speakers.
U2 - 10.1016/j.jpainsymman.2016.02.008
DO - 10.1016/j.jpainsymman.2016.02.008
M3 - Journal article
C2 - 27090851
VL - 52
SP - 292
EP - 297
JO - Journal of Pain and Symptom Management
JF - Journal of Pain and Symptom Management
SN - 0885-3924
IS - 2
ER -
ID: 180736303