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 tidsskriftTidsskriftartikelForskningfagfællebedømt

Harvard

Bæksted, C, Nissen, A, Pappot, H, Bidstrup, PE, Mitchell, SA, Basch, E, Dalton, SO & Johansen, C 2016, '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)', Journal of Pain and Symptom Management, bind 52, nr. 2, s. 292-297. https://doi.org/10.1016/j.jpainsymman.2016.02.008

APA

Bæksted, C., Nissen, A., Pappot, H., Bidstrup, P. E., Mitchell, S. A., Basch, E., Dalton, S. O., & Johansen, C. (2016). 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). Journal of Pain and Symptom Management, 52(2), 292-297. https://doi.org/10.1016/j.jpainsymman.2016.02.008

Vancouver

Bæksted C, Nissen A, Pappot H, Bidstrup PE, Mitchell SA, Basch E o.a. 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). Journal of Pain and Symptom Management. 2016 aug.;52(2):292-297. https://doi.org/10.1016/j.jpainsymman.2016.02.008

Author

Bæksted, Christina ; Nissen, Aase ; Pappot, Helle ; Bidstrup, Pernille Envold ; Mitchell, Sandra A ; Basch, Ethan ; Dalton, Susanne Oksbjerg ; Johansen, Christoffer. / 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). I: Journal of Pain and Symptom Management. 2016 ; Bind 52, Nr. 2. s. 292-297.

Bibtex

@article{ba940102508a4c95813f4e72bf7f1a5f,
title = "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)",
abstract = "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.",
author = "Christina B{\ae}ksted and Aase Nissen and Helle Pappot and Bidstrup, {Pernille Envold} and Mitchell, {Sandra A} and Ethan Basch and Dalton, {Susanne Oksbjerg} and Christoffer Johansen",
note = "Copyright {\textcopyright} 2016 American Academy of Hospice and Palliative Medicine. All rights reserved.",
year = "2016",
month = aug,
doi = "10.1016/j.jpainsymman.2016.02.008",
language = "English",
volume = "52",
pages = "292--297",
journal = "Journal of Pain and Symptom Management",
issn = "0885-3924",
publisher = "Elsevier",
number = "2",

}

RIS

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