Journal article
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 M Institute of Nursing Science, University of Basel, Switzerland; Department of Haematology, University Hospital Basel, Switzerland.
- Mitchell SA Outcomes Research Branch, Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, United States.
- Dobbels F Health Services and Nursing Research, Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium.
- Stussi G Department of Haematology, Oncology Institute of Southern Switzerland, Bellinzona, Switzerland.
- Basch E Cancer Outcomes Research Program, Lineberger Comprehensive Cancer Center, University of North Carolina, United States.
- Halter JP Department of Haematology, University Hospital Basel, Switzerland.
- De Geest S 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.
- 2014-09-06
Published in:
- European journal of oncology nursing : the official journal of European Oncology Nursing Society. - 2015
Late effects
Mixed methods
PRO-CTCAE
Patient-reported outcomes
Stem cell transplantation
Survivorship
Symptom experience
Validity
Adult
Aged
Female
Germany
Hematopoietic Stem Cell Transplantation
Humans
Leukemia
Linguistics
Male
Middle Aged
Patient Outcome Assessment
Reproducibility of Results
Self Report
Socioeconomic Factors
Symptom Assessment
Translating
Young Adult
English
PURPOSE
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.
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.
- Language
-
- English
- Open access status
- closed
- Identifiers
-
- DOI 10.1016/j.ejon.2014.07.007
- PMID 25190633
- Persistent URL
- https://sonar.ch/global/documents/232360
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