Abstract
Purpose
The U.S. NCI’s PRO-CTCAE is a library of self-report items for assessing symptomatic adverse events in cancer clinical trials from the patient perspective. The aim of this study was to translate and linguistically validate a Spanish version.
Methods
PRO-CTCAE’s 124 items were translated from English into Spanish using multiple forward and back translations. Native Spanish speakers undergoing cancer treatment were enrolled at six cancer treatment sites. Participants each completed approximately 50 items and were then interviewed using cognitive probes. The interviews were analyzed at the item level by linguistic themes, and responses were examined for evidence of equivalence to English. Items for which ≥20 % of participants experienced difficulties were reviewed, and phrasing was revised and then retested in subsequent interviews. Items where <20 % of respondents experienced difficulties were also reviewed and were considered for rephrasing and retesting.
Results
One hundred nine participants from diverse Spanish-speaking countries were enrolled (77 in Round 1 and 32 in Round 2). A majority of items were well comprehended in Round 1. Two items presented difficulties in ≥20 % of participants and were revised/retested without further difficulties. Two items presented difficulties in <20 %, and when retested exhibited no further difficulties. Two items presented difficulties in <20 %, but were not revised due to lack of alternatives. Sixteen items presented difficulties in ≤12 % and were not revised because difficulties were minor.
Conclusions
The Spanish PRO-CTCAE has been developed and refined for use in Spanish-speaking populations, with high levels of comprehension and equivalence to the English PRO-CTCAE.
Trial registration: ClinicalTrials.gov:NCT01436240
Similar content being viewed by others
References
National Cancer Institute, National Institutes of Health, U.S. Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. NIH publication # 09-7473. Published May 29, 2009; Revised Version 4.02 September 15, 2009. Available at http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.02_2009-09-15_QuickReference_5x7.pdf (last accessed 7/25/15)
National Cancer Institute, National Institutes of Health, U.S. Department of Health and Human Services. caBIG Knowledge Center, CTCAE FAQ. Available at https://cabig-kc.nci.nih.gov/Vocab/KC/index.php/CTCAE_FAQ (last accessed 7/25/15)
Basch EM, Reeve BB, Mitchell SA, Clauser SB, Minasian L, Sit L, Chilukuri R, Baumgartner P, Rogak L, Blauel E, Abernethy AP, Bruner D (2011) Electronic toxicity monitoring and patient-reported outcomes. Cancer J 17(4):231–234
Basch E, Reeve BB, Mitchell SA, Clauser SB, Minasian LM, Dueck AC, Mendoza TR, Hay J, Atkinson TM, Abernethy AP, Bruner DW, Cleeland CS, Sloan JA, Chilukuri R, Baumgartner P, Denicoff A, St Germain D, O’Mara AM, Chen A, Kelaghan J, Bennett AV, Sit L, Rogak L, Barz A, Paul DB, Schrag D (2014) 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(9):dju244
Hay JL, Atkinson TM, Reeve BB, Mitchell SA, Mendoza TR, Willis G, Minasian LM, Clauser SB, Denicoff A, O’Mara A, Chen A, Bennett AV, Paul DB, Gagne J, Rogak L, Sit L, Viswanath V, Schrag D, Basch E (2014) NCI PRO-CTCAE Study Group. 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(1):257–269
Dueck AC, Mendoza TR, Mitchell SA, Reeve BB, Castro KM, Rogak LJ, Atkinson TM, Bennett AV, Denicoff AM, O’Mara AM, Li Y, Clauser SB, Bryant DM, Bearden JD, Gillis TA, Harness JK, Siegel RD, Paul DB, Cleeland CS, Schrag D, Sloan JA, Abernethy AP, Bruner DW, Minasian LM, Basch E (2015) 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. doi:10.1001/jamaoncol.2015.2639. Published online August 13, 2015
Eremenco SL, Cella D, Arnold BJ (2005) A comprehensive method for the translation and cross-cultural validation of health status questionnaires. Eval Health Prof 28(2):212–232
Wild D, Grove A, Martin M, Eremenco S, Ford S, Verjee-Lorenz A et al (2005) 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(2):94–104
Mullin V, Cella D, Chang CH, Eremenco S, Mertz M, Lent L, Falkson C, Falkson G (2000) Development of three African language translations of the FACT-G. Qual Life Res 9(2):139–149
Bonomi AE, Cella DF, Hahn EA, Bjordal K, Sperner-Unterweger B, Gangeri L, Bergman B, Willems-Groot J, Hanquet P, Zittoun R (1996) Multilingual translation of the functional assessment of cancer therapy (FACT) quality of life measurement system. Qual Life Res 5(3):309–320
Flaherty JA, Gaviria FM, Pathak D, Mitchell T, Wintrob R, Richman JA, Birz S (1988) Developing instruments for cross-cultural psychiatric research. J Nerv Ment Dis 176(5):257–263
Willis GB (2015) Analysis of the cognitive interview in questionnaire design. Oxford, New York
Reeve BB, Mitchell SA, Dueck AC, Basch E, Cella D, Reilly CM, Minasian LM, Denicoff AM, O’Mara AM, Fisch MJ, Chauhan C, Aaronson NK, Coens C, Bruner DW (2014) Recommended patient-reported core set of symptoms to measure in adult cancer treatment trials. J Natl Cancer Inst 8:106(7)
Wallen GR, Feldman RH, Anliker J (2002) Measuring acculturation among Central American women with the use of a brief language scale. J Immigr Health 4(2):95–102
Willis GB (2005) Cognitive interviewing: a tool for improving questionnaire design. SAGE Publications, Inc., Thousand Oaks, CA
Patrick DL, Burke LB, Gwaltney CJ, Leidy NK, Martin ML, Molsen E, Ring L (2011) Content validity—establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 2—assessing respondent understanding. Value Health 14(8):978–988
Ennis SR, Rios-Vargas M, Albert NG. The Hispanic Population: 2010, 2011; http://www.census.gov/prod/cen2010/briefs/c2010br-04.pdf (last accessed 7/25/15)
Bennett AV, Dueck AC, Mitchell SA, Mendoza TR, Reeve BB, Atkinson TM, Castro KM, Denicoff A, Rogak LJ, Harness JK, Bearden JD, Bryant D, Siegel RD, Schrag D, Basch E. Mode equivalence and acceptability of web-, interactive voice response system-, and paper-based administration of U.S. National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Presented at International Society for Quality of Life Research (ISOQOL): October 12, 2013; Miami, FL, USA
Wilson MK, Collyar D, Chingos DT, Friedlander M, Ho TW, Karakasis K, Kaye S, Parmar MK, Sydes MR, Tannock IF, Oza AM (2015) Outcomes and endpoints in cancer trials: bridging the divide. Lancet Oncol 16(1):e43–e52
Basch E, Abernethy AP, Mullins CD, Reeve BB, Smith ML, Coons SJ, Sloan J, Wenzel K, Chauhan C, Eppard W, Frank ES, Lipscomb J, Raymond SA, Spencer M, Tunis S (2012) Recommendations for incorporating patient-reported outcomes into clinical comparative effectiveness research in adult oncology. J Clin Oncol 30(34):4249–4255
Acknowledgments
The authors wish to thank the patients who participated in this research and staff members at participating institutions who supported this work. The authors are particularly grateful for the work of Gitana Davila who enrolled patients at St. Joseph Hospital of Orange, Orange, CA and to Stella Rodriguez and Dr. Javier Valenzuela who conducted interviews at University of Texas, M.D. Anderson Cancer Center, Houston, TX. We also acknowledge the work of the staff of the Non-Therapeutic Research Support Core Services of the Sylvester Comprehensive Cancer Center at the University of Miami, Miller School of Medicine.
Authors’ contributions
BA, SAM, LL, TRM, LJR, NB, GW, MM, and EB have all made a substantial contribution to the conception and design of this study; BA, SAM, LL, TRM, LJR, NB, SL, FJP, JH, and EB have all made substantial contributions to the acquisition of data for this study; and BA, SAM, LL, TRM, LJR, NB, GW, MM, SL, FJP, JH, and EB have all made substantial impact into the analysis and interpretation of data used in this study and manuscript. All authors (BA, SAM, LL, TRM, LJR, NB, GW, MM, SL, FJP, JH, and EB) have been involved in the drafting and/or critically revising this manuscript for important intellectual content. All authors (BA, SAM, LL, TRM, LJR, NB, GW, MM, SL, FJP, JH, and EB) have given final approval of the version to be published. All authors (BA, SAM, LL, TRM, LJR, NB, GW, MM, SL, FJP, JH, and EB) agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Author information
Authors and Affiliations
Consortia
Corresponding author
Ethics declarations
Competing interests
All of the co-authors of this manuscript declare no financial competing interests nor any non-financial competing interests. We declare no relevant conflicts of interest associated with this work.
Funding support
This work was supported by the U.S. National Cancer Institute contract HHSN261201000063C.
Additional information
PRO-CTCAE Spanish Translation and Linguistic Validation Study Group additional members
Narre Heon, Mary Shaw, Sean Ryan, Melissa Barragán-Cruz, Jana Eisenstein, Laura Sit, Araceli Garcia-Gonzalez, Pauline Le, Angela Acevedo, Michael Mejia, Madeline Hernandez Krause, Andrea Vinard, Maria Corona, Veronica Valenzuela, Bárbara Pérez, Venus Ginés, Wen-ying Sylvia Chou, Michael Sanchez, Sherri Sheinfeld Gorin, Scott Debb, Robert Guillen.
Electronic supplementary material
Below is the link to the electronic supplementary material.
ESM 1
(DOC 128 kb)
Rights and permissions
About this article
Cite this article
Arnold, B., Mitchell, S.A., Lent, L. et al. Linguistic validation of the Spanish version of the National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Support Care Cancer 24, 2843–2851 (2016). https://doi.org/10.1007/s00520-015-3062-5
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00520-015-3062-5