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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

Kirsch, Monika and Mitchell, Sandra A. and Dobbels, Fabienne and Stussi, Georg and Basch, Ethan and Halter, Jorg P. and De Geest, Sabina. (2015) 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. European Journal of Oncology Nursing : The Official Journal of European Oncology Nursing Society, 19 (1). pp. 66-74.

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Official URL: https://edoc.unibas.ch/63389/

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Abstract

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.; 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.; 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.; 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.
Faculties and Departments:03 Faculty of Medicine > Departement Public Health > Institut für Pflegewissenschaft
UniBasel Contributors:De Geest, Sabina M.
Item Type:Article, refereed
Article Subtype:Research Article
ISSN:1532-2122
Note:Publication type according to Uni Basel Research Database: Journal article
Identification Number:
Last Modified:08 Dec 2018 11:43
Deposited On:08 Dec 2018 11:43

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