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

Volumn 52, Issue 2, 2016, Pages 292-297

  Bæksted, Christina ^a,b   Nissen, Aase ^a   Pappot, Helle ^b   Bidstrup, Pernille Envold ^a   Mitchell, Sandra A ^c   Basch, Ethan ^d   Dalton, Susanne Oksbjerg ^a   Johansen, Christoffer ^a,b  

^a DANISH CANCER SOCIETY RESEARCH CENTER   (Denmark)

^b FINSEN LABORATORY   (Denmark)

^c NATIONAL CANCER INSTITUTE   (United States)

^d UNIVERSITY OF NORTH CAROLINA   (United States)

Author keywords

cancer clinical trials; linguistic validation; Patient reported outcomes; PRO CTCAE; symptomatic toxicity; treatment adverse events

Indexed keywords

ADULT; ADVERSE OUTCOME; AGED; ARTICLE; BREAST AUGMENTATION; BREAST CANCER; BREAST TENDERNESS; CANCER THERAPY; CANCER TRANSPLANTATION; CLINICAL ASSESSMENT TOOL; DIGESTIVE SYSTEM CANCER; ENERGY; FATIGUE; FEMALE; GYNECOLOGIC CARE; HEAD AND NECK CANCER; HEART PALPITATION; HEMATOLOGIC MALIGNANCY; HUMAN; LINGUISTICS; LUNG CANCER; MAJOR CLINICAL STUDY; MALE; NATIONAL HEALTH ORGANIZATION; PATIENT REPORTED OUTCOMES VERSION OF THE COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENT; PATIENT-REPORTED OUTCOME; PROSTATE CANCER; SYMPTOM ASSESSMENT; UNITED STATES; VALIDITY; VITREOUS FLOATERS; CLINICAL TRIAL (TOPIC); INTERVIEW; MIDDLE AGED; NEOPLASM; SOCIOECONOMICS; TRANSLATING (LANGUAGE); VALIDATION STUDY;

ANTINEOPLASTIC AGENT;

ADULT; AGED; ANTINEOPLASTIC AGENTS; CLINICAL TRIALS AS TOPIC; FEMALE; HUMANS; INTERVIEWS AS TOPIC; MALE; MIDDLE AGED; NATIONAL CANCER INSTITUTE (U.S.); NEOPLASMS; PATIENT REPORTED OUTCOME MEASURES; SOCIOECONOMIC FACTORS; TRANSLATING; UNITED STATES;

EID: 84965058017     PISSN: 08853924     EISSN: 18736513     Source Type: Journal    
DOI: 10.1016/j.jpainsymman.2016.02.008     Document Type: Article

References (15)

1. 1 Basch, E., Reeve, B.B., Mitchell, S.A., et al. Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). J Natl Cancer Inst, 106, 2014 dju244.
2. 2 Basch, E.M., Reeve, B.B., Mitchell, S.A., et al. Electronic toxicity monitoring and patient-reported outcomes. Cancer J 17 (2011), 231–234.
3. 3 Trotti, A., Colevas, A.D., Setser, A., Basch, E., Patient-reported outcomes and the evolution of adverse event reporting in oncology. J Clin Oncol 25 (2007), 5121–5127.
4. 4 Di Maio, M., Gallo, C., Leighl, N.B., et al. Symptomatic toxicities experienced during anticancer treatment: agreement between patient and physician reporting in three randomized trials. J Clin Oncol 33 (2015), 910–915.
5. 5 Xiao, C., Polomano, R., Bruner, D.W., Comparison between patient-reported and clinician-observed symptoms in oncology. Cancer Nurs 36 (2013), E1–E16.
6. 6 Quinten, C., Maringwa, J., Gotay, C.C., et al. Patient self-reports of symptoms and clinician ratings as predictors of overall cancer survival. J Natl Cancer Inst 103 (2011), 1851–1858.
7. 7 Fromme, E.K., Eilers, K.M., Mori, M., Hsieh, Y.C., Beer, T.M., How accurate is clinician reporting of chemotherapy adverse effects? A comparison with patient-reported symptoms from the Quality-of-Life Questionnaire C30. J Clin Oncol 22 (2004), 3485–3490.
8. 8 Basch, E., Iasonos, A., McDonough, T., et al. Patient versus clinician symptom reporting using the national Cancer Institute common terminology criteria for adverse events: results of a questionnaire-based study. Lancet Oncol 7 (2006), 903–909.
9. 9 U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research; U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research; U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health Qual Life Outcomes, 4, 2006, 79.
10. 10 Hay, J.L., Atkinson, T.M., Reeve, B.B., et al. Cognitive interviewing of the U.S. National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). Qual Life Res 23 (2014), 257–269.
11. 11 Dueck, A.C., Mendoza, T.R., Mitchell, S.A., et al. Validity and reliability of the U.S. National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). JAMA Oncol 1 (2015), 1051–1059.
12. 12 Arnold, B., Mitchell, S.A., Lent, L., et al., on behalf of the National Cancer Institute Spanish Translation and Linguistic Validation Study Group. Linguistic validation of the Spanish translation of the U.S. National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). Support Care Cancer, 2016 [Epub ahead of print].
13. 13 Kirsch, M., Mitchell, S.A., Dobbels, F., et al. Linguistic and content validation of a German-language PRO-CTCAE-based patient-reported outcomes instrument to evaluate the late effect symptom experience after allogenic hematopoietic stem cell transplantation. Eur J Oncol Nurs 19 (2014), 66–74.
14. 14 Wild, D., Grove, A., Martin, M., et al. Principles of good practice for the translation and cultural adaptation process for patient-reported outcomes (PRO) measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health 8 (2005), 94–104.
15. 15 Willis, G., Analysis of the cognitive interview in questionnaire design. Understanding qualitative research. 2015, Oxford University Press, New York.