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
Open accessAbstract
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
- ORCID
- Wallwiener, Markus
- Matthies, Lina
- Simoes, Elisabeth
- Keilmann, Lucia
- Hartkopf, Andreas D
- Sokolov, Alexander N
- Walter, Christina B
- Sickenberger, Nina
- Wallwiener, Stephanie
- Feisst, Manuel
- Gass, Paul
- Fasching, Peter A
- Lux, Michael P
- Wallwiener, Diethelm
- Taran, Florin-Andrei
- Rom, Joachim
- Schneeweiss, Andreas
- Graf, Joachim
- Brucker, Sara Y
- Venue
- Journal of Medical Internet Research
- Publisher
- JMIR Publications Inc.
- Published
- 2017-09-14
- Volume
- 19
- Issue
- 9
- Pages
- e322
- ISSN
- 1438-8871 (ISSN-L)
- PMC
- PMC5620457
- 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
- gold
- doi.org
- 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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