title: Linguistic and content validation of a German-language PRO-CTCAE-based patient-reported outcomes instrument to evaluate the late effect symptom experience after allogeneic hematopoietic stem cell transplantation.
abstract: OBJECTIVE
  The aim of this sequential mixed methods study was to develop a PRO-CTCAE (Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events)-based measure of the symptom experience of late effects in German speaking long-term survivors of allogeneic stem cell transplantation (SCT), and to examine its content validity.
  
  
  METHODS
  The US National Cancer Institute's PRO-CTAE item library was translated into German and linguistically validated. PRO-CTCAE symptoms prevalent in ≥50% of survivors (n = 15) and recognized in its importance by SCT experts (n = 9) were identified. Additional concepts relevant to the symptom experience and its consequences were elicited. Content validity of the PROVIVO (Patient-Reported Outcomes of long-term survivors after allogeneic SCT) instrument was assessed through an additional round of cognitive debriefing in 15 patients, and item and scale content validity indices by 9 experts.
  
  
  RESULTS
  PROVIVO is comprised of a total of 49 items capturing the experience of physical, emotional and cognitive symptoms. To improve the instrument's utility for clinical decision-making, questions soliciting limitations in activities of daily living, frequent infections, and overall well-being were added. Cognitive debriefings demonstrated that items were well understood and relevant to the SCT survivor experience. Scale Content Validity Index (CVI) (0.94) and item CVI (median = 1; range 0.75-1) were very high.
  
  
  CONCLUSIONS
  Qualitative and quantitative data provide preliminary evidence supporting the content validity of PROVIVO and identify a PRO-CTCAE item bundle for use in SCT survivors. A study to evaluate the measurement properties of PROVIVO and to examine its capacity to improve survivorship care planning is underway.
authors.affiliation: Institute of Nursing Science, University of Basel, Switzerland; Department of Haematology, University Hospital Basel, Switzerland.
authors.forename: Monika
authors.initials: M
authors.lastname: Kirsch
authors.affiliation: Outcomes Research Branch, Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, United States.
authors.forename: Sandra A
authors.initials: SA
authors.lastname: Mitchell
authors.affiliation: Health Services and Nursing Research, Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium.
authors.forename: Fabienne
authors.initials: F
authors.lastname: Dobbels
authors.affiliation: Department of Haematology, Oncology Institute of Southern Switzerland, Bellinzona, Switzerland.
authors.forename: Georg
authors.initials: G
authors.lastname: Stussi
authors.affiliation: Cancer Outcomes Research Program, Lineberger Comprehensive Cancer Center, University of North Carolina, United States.
authors.forename: Ethan
authors.initials: E
authors.lastname: Basch
authors.affiliation: Department of Haematology, University Hospital Basel, Switzerland.
authors.forename: Jorg P
authors.initials: JP
authors.lastname: Halter
authors.affiliation: Institute of Nursing Science, University of Basel, Switzerland; Health Services and Nursing Research, Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium. Electronic address: sabina.degeest@unibas.ch.
authors.forename: Sabina
authors.initials: S
authors.lastname: De Geest
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D005858:Germany; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D007938:Leukemia / Q000150:complications* / Q000175:diagnosis / Q000628:therapy; D008037:Linguistics; D008297:Male; D008875:Middle Aged; D063868:Patient Outcome Assessment; D015203:Reproducibility of Results; D057566:Self Report; D012959:Socioeconomic Factors; D063189:Symptom Assessment; D014175:Translating; D055815:Young Adult
keywords: Late effects; Mixed methods; PRO-CTCAE; Patient-reported outcomes; Stem cell transplantation; Survivorship; Symptom experience; Validity