title: 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).
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  ClinicalTrials.gov:NCT01436240.
authors.affiliation: FACITtrans, LLC, 381 S. Cottage Hill Ave, Elmhurst, IL, 60126, USA.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Arnold
authors.affiliation: Division of Cancer Control and Population Sciences, Outcomes Research Branch, National Cancer Institute, 9609 Medical Center Drive, East Tower, Room 3-448, Rockville, MD, 20850, USA. mitchlls@mail.nih.gov.
authors.forename: Sandra A
authors.initials: SA
authors.lastname: Mitchell
authors.affiliation: FACITtrans, LLC, 381 S. Cottage Hill Ave, Elmhurst, IL, 60126, USA.
authors.forename: Lauren
authors.initials: L
authors.lastname: Lent
authors.affiliation: Department of Symptom Research, The University of Texas M. D. Anderson Cancer Center, 1400 Pressler Street, Unit 1450, Houston, TX, 77030, USA.
authors.forename: Tito R
authors.initials: TR
authors.lastname: Mendoza
authors.affiliation: Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, 485 Lexington Avenue, 2nd Floor, New York, NY, 10017, USA.
authors.forename: Lauren J
authors.initials: LJ
authors.lastname: Rogak
authors.affiliation: Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, 485 Lexington Avenue, 2nd Floor, New York, NY, 10017, USA.
authors.forename: Natalie M
authors.initials: NM
authors.lastname: Barragán
authors.affiliation: Division of Cancer Control and Population Sciences, Behavioral Research Program, National Cancer Institute, 9609 Medical Center Drive, Rockville, MD, 20850, USA.
authors.forename: Gordon
authors.initials: G
authors.lastname: Willis
authors.affiliation: Health Education and Digital Information Dissemination Branch, Office of Science Policy, Engagement, Education and Communications (OSPEEC), National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA.
authors.forename: Mauricio
authors.initials: M
authors.lastname: Medina
authors.affiliation: Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, 1120 NW 14 Street, C202, Miami, FL, 33136, USA.
authors.forename: Suzanne
authors.initials: S
authors.lastname: Lechner
authors.affiliation: Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, 633 N., St. Clair, USA.
authors.forename: Frank J
authors.initials: FJ
authors.lastname: Penedo
authors.affiliation: The Center for Cancer Prevention and Treatment, St. Joseph Hospital of Orange, 1010 West La Veta Avenue, Suite 470, Orange, CA, 92868, USA.
authors.forename: Jay K
authors.initials: JK
authors.lastname: Harness
authors.affiliation: Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, 485 Lexington Avenue, 2nd Floor, New York, NY, 10017, USA.|Department of Medicine, Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Campus Box 7305, Chapel Hill, NC, 27599, USA.
authors.forename: Ethan M
authors.initials: EM
authors.lastname: Basch
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D008037:Linguistics / Q000379:methods*; D008297:Male; D008875:Middle Aged; D054547:National Cancer Institute (U.S.); D009369:Neoplasms / Q000150:complications*; D000071066:Patient Reported Outcome Measures; D057566:Self Report; D011795:Surveys and Questionnaires; D014481:United States; D055815:Young Adult
keywords: Adverse events; Cancer; PRO-CTCAE; Patient-Reported outcomes; Spanish; Toxicity; Translation
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