Cited by 55Cancer survivorship and careHealth Systems, Economic Evaluations, Quality of LifeHealth Education and Validation

Reliability of an e-PRO Tool of EORTC QLQ-C30 for Measurement of Health-Related Quality of Life in Patients With Breast Cancer: Prospective Randomized Trial

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Wallwiener, Markus, Matthies, Lina, Simoes, Elisabeth, Keilmann, Lucia, Hartkopf, Andreas D, Sokolov, Alexander N, Walter, Christina B, Sickenberger, Nina +11 more·2017·Journal of Medical Internet Research

Abstract

BACKGROUND: Breast cancer represents the most common malignant disease in women worldwide. As currently systematic palliative treatment only has a limited effect on survival rates, the concept of health-related quality of life (HRQoL) is gaining more and more importance in the therapy setting of metastatic breast cancer. One of the major patient-reported outcomes (PROs) for measuring HRQoL in patients with breast cancer is provided by the European Organization for Research and Treatment of Cancer (EORTC). Currently, paper-based surveys still predominate, as only a few reliable and validated electronic-based questionnaires are available. Facing the possibilities associated with evolving digitalization in medicine, validation of electronic versions of well-established PRO is essential in order to contribute to comprehensive and holistic oncological care and to ensure high quality in cancer research. OBJECTIVE: The aim of this study was to analyze the reliability of a tablet-based measuring application for EORTC QLQ-C30 in German language in patients with adjuvant and (curative) metastatic breast cancer. METHODS: Paper- and tablet-based questionnaires were completed by a total of 106 female patients with adjuvant and metastatic breast cancer recruited as part of the e-PROCOM study. All patients were required to complete the electronic- (e-PRO) and paper-based versions of the HRQoL EORTC QLQ-C30 questionnaire. A frequency analysis was performed to determine descriptive sociodemographic characteristics. Both dimensions of reliability (parallel forms reliability [Wilcoxon test] and test of internal consistency [Spearman rho and agreement rates for single items, Pearson correlation and Kendall tau for each scale]) were analyzed. RESULTS: High correlations were shown for both dimensions of reliability (parallel forms reliability and internal consistency) in the patient's response behavior between paper- and electronic-based questionnaires. Regarding the test of parallel forms reliability, no significant differences were found in 27 of 30 single items and in 14 of 15 scales, whereas a statistically significant correlation in the test of consistency was found in all 30 single items and all 15 scales. CONCLUSIONS: The evaluated e-PRO version of the EORTC QLQ-C30 is reliable for patients with both adjuvant and metastatic breast cancer, showing a high correlation in almost all questions (and in many scales). Thus, we conclude that the validated paper-based PRO assessment and the e-PRO tool are equally valid. However, the reliability should also be analyzed in other prospective trials to ensure that usability is reliable in all patient groups. TRIAL REGISTRATION: ClinicalTrials.gov NCT03132506; https://clinicaltrials.gov/ct2/show/NCT03132506 (Archived by WebCite at http://www.webcitation.org/6tRcgQuou).

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Authors
Wallwiener, M., Matthies, L., Simoes, E., Keilmann, L., Hartkopf, A. D., Sokolov, A. N., Walter, C. B., Sickenberger, N., Wallwiener, S., Feisst, M., Gass, P., Fasching, P. A., Lux, M. P., Wallwiener, D., Taran, F.-A., Rom, J., Schneeweiss, A., Graf, J., & Brucker, S. Y.
Affiliations
  • Heidelberg University (DE)
  • Universitätsklinikum Tübingen (DE)
  • Universitäts Frauenklinik (DE)
  • University Hospital Heidelberg (DE)
  • Universitätsklinikum Erlangen (DE)
Corresponding author
Wallwiener, Markus
Venue
Journal of Medical Internet Research
Published
2017-09-14
Volume
19
Issue
9
Pages
e322
ISSN
1438-8871 (ISSN-L)
OpenAlex
W2754949924
Cited by
55
References
49
Citations by year
2026: 3 · 2025: 2 · 2024: 2 · 2023: 6 · 2022: 7 · 2021: 9 · 2020: 8 · 2019: 7 · 2018: 10 · 2017: 1
FWCI
3.14
Type
journal article
Language
en
Open access
Licence
cc-by
Locations
  • Journal of Medical Internet Research (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Oncology › Cancer survivorship and care
  • Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Health Systems, Economic Evaluations, Quality of Life
  • Social Sciences › Education › Health Education and Validation
Keywords
electronic patient-reported outcomes, EORTC QLQ-C30, health-related quality of life, breast cancer, metastatic breast cancer, adjuvant breast cancer, parallel forms reliability, internal consistency, questionnaire validation
MeSH terms
Adult, Aged, Aged, 80 and over, Breast Neoplasms, Female, Humans, Middle Aged, Prospective Studies, Quality of Life, Surveys and Questionnaires, Reproducibility of Results

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