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

Abstract

BackgroundBreast 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.ObjectiveThe 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.MethodsPaper- 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.ResultsHigh 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.ConclusionsThe 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 RegistrationClinicalTrials.gov NCT03132506; https://clinicaltrials.gov/ct2/show/NCT03132506 (Archived by WebCite at http://www.webcitation.org/6tRcgQuou).

An Electronic Patient-Reported Outcome Tool for the FACT-B (Functional Assessment of Cancer Therapy-Breast) Questionnaire for Measuring the Health-Related Quality of Life in Patients With Breast Cancer: Reliability Study (Preprint)

“…In order to achieve these aims, patients were asked to complete both the paper-and tablet-based version of the FACT-B questionnaire. [40] and FACT-B (reported in the current paper). The PEPPER study intends to evaluate the impact of web-based and paper-4 based PRO for health care services by patients from the PRAEGNANT study.…”

“…The patients completed the second part of the assessment both on paper and using a tablet, while they answered the questions in the other parts only in paper-based form. In the present study, we report the results of the second part of the assessment (reliability analysis of the ePRO tool of FACT-B) [40].…”

“…Nevertheless, knowledge regarding patient acceptance, feasibility, and barriers remains limited [35], especially since hurdles might exist in relation to health status, technical skills, and socioeconomic aspects, which could influence both patients´ willingness to use ePRO and their response behavior [10,36,37]. Although studies have already demonstrated a potential equivalence between some paper-based PRO and ePRO, reliability of ePRO questionnaires should be verified so as not to endanger the validity of ePRO surveys [10,[36][37][38][39][40]. Indeed, ePRO tools of the FACT-B questionnaire with proven reliability are missing so far.…”

“…The PEPPER study intends to evaluate the impact of web-based and paper-4 based PRO for health care services by patients from the PRAEGNANT study. The methods are described in detail in the EORTC paper [40]. Inclusion criteria of ePROCOM and PEPPER studies were female gender, full legal age, the proven diagnosis of breast cancer in adjuvant or metastatic setting, sufficient language skills in German, and signed declaration of consent.…”

“…The study was approved by the Ethics Committee at the University of Tübingen (project number 089/2015B02) [40].…”