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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)

  • Arnold, Benjamin1
  • Mitchell, Sandra A.2
  • Lent, Lauren1
  • Mendoza, Tito R.3
  • Rogak, Lauren J.4
  • Barragán, Natalie M.4
  • Willis, Gordon5
  • Medina, Mauricio6
  • Lechner, Suzanne7
  • Penedo, Frank J.8
  • Harness, Jay K.9
  • Basch, Ethan M.4, 10
  • 1 FACITtrans, LLC, 381 S. Cottage Hill Ave, Elmhurst, IL, 60126, USA , Elmhurst (United States)
  • 2 National Cancer Institute, Division of Cancer Control and Population Sciences, Outcomes Research Branch, 9609 Medical Center Drive, East Tower, Room 3-448, Rockville, MD, 20850, USA , Rockville (United States)
  • 3 The University of Texas M. D. Anderson Cancer Center, Department of Symptom Research, 1400 Pressler Street, Unit 1450, Houston, TX, 77030, USA , Houston (United States)
  • 4 Memorial Sloan Kettering Cancer Center, Department of Epidemiology and Biostatistics, 485 Lexington Avenue, 2nd Floor, New York, NY, 10017, USA , New York (United States)
  • 5 National Cancer Institute, Division of Cancer Control and Population Sciences, Behavioral Research Program, 9609 Medical Center Drive, Rockville, MD, 20850, USA , Rockville (United States)
  • 6 National Heart, Lung, and Blood Institute, National Institutes of Health, Health Education and Digital Information Dissemination Branch, Office of Science Policy, Engagement, Education and Communications (OSPEEC), Bethesda, MD, USA , Bethesda (United States)
  • 7 University of Miami Miller School of Medicine, Sylvester Comprehensive Cancer Center, 1120 NW 14 Street, C202, Miami, FL, 33136, USA , Miami (United States)
  • 8 Northwestern University Feinberg School of Medicine, Department of Medical Social Sciences, 633 N., St. Clair, USA , St. Clair (United States)
  • 9 St. Joseph Hospital of Orange, The Center for Cancer Prevention and Treatment, 1010 West La Veta Avenue, Suite 470, Orange, CA, 92868, USA , Orange (United States)
  • 10 University of North Carolina at Chapel Hill, Department of Medicine, Lineberger Comprehensive Cancer Center, Chapel Hill, NC, 27599, USA , Chapel Hill (United States)
Published Article
Supportive Care in Cancer
Publication Date
Feb 02, 2016
DOI: 10.1007/s00520-015-3062-5
Springer Nature


PurposeThe 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.MethodsPRO-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.ResultsOne 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.ConclusionsThe 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:

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