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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: 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).

SUBMITTER: Wallwiener M

PROVIDER: S-EPMC5620457 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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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.

Wallwiener Markus M Matthies Lina L Simoes Elisabeth E Keilmann Lucia L Hartkopf Andreas D AD Sokolov Alexander N AN Walter Christina B CB Sickenberger Nina N Wallwiener Stephanie S Feisst Manuel M Gass Paul P Fasching Peter A PA Lux Michael P MP Wallwiener Diethelm D Taran Florin-Andrei FA Rom Joachim J Schneeweiss Andreas A Graf Joachim J Brucker Sara Y SY

Journal of medical Internet research 20170914 9

<h4>Background</h4>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 o ...[more]

PMID: 28912116

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Project description:BackgroundMobile apps are evolving in the medical field. However, ongoing discussions have questioned whether such apps are really valuable and whether patients will accept their use in day-to-day clinical life. Therefore, we initiated a usability study in our department.ObjectiveWe present our results of the first app prototype and patient testing of health-related quality of life (HRQoL) assessment in oncological patients.MethodsWe developed an app prototype for the iOS operating system within eight months in three phases: conception, initial development, and pilot testing. For the HRQoL assessment, we chose to implement only the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30; German version 3). Usability testing was conducted for three months. Participation was voluntary and pseudonymized. After completion of the QLQ-C30 questionnaire using iPads provided by our department, we performed a short survey with 10 questions. This survey inquired about patients' opinions regarding general aspects, including technical advances in medicine, mobile and app assistance during cancer treatment, and the app-specific functions (eg, interface and navigation).ResultsAfter logging into the app, the user can choose between starting a questionnaire, reviewing answers (administrators only), and logging out. The questionnaire is displayed with the same information, questions, and answers as on the original QLQ-C30 sheet. No alterations in wording were made. Usability was tested with 81 patients; median age was 55 years. The median time for completing the HRQoL questionnaire on the iPad was 4.0 minutes. Of all participants, 84% (68/81) owned a mobile device. Similarly, 84% (68/81) of participants would prefer a mobile version of the HRQoL questionnaire instead of a paper-based version. Using the app in daily life during and after cancer treatment would be supported by 83% (67/81) of participants. In the prototype version of the app, data were stored on the device; in the future, 79% (64/81) of the patients would agree to transfer data via the Internet.ConclusionsOur usability test showed good results regarding attractiveness, operability, and understandability. Moreover, our results demonstrate a high overall acceptance of mobile apps and telemedicine in oncology. The HRQoL assessment via the app was accepted thoroughly by patients, and individuals are keen to use it in clinical routines, while data privacy and security must be ensured.

Project description:In oncology, health-related quality of life (HRQoL) data are often collected using disease-specific patient questionnaires while generic, patient-level utility data required for health economic modeling are often not collected.We developed a mapping algorithm for multiple myeloma that relates HRQoL scores from the European Organization for Research and Treatment of Cancer (EORTC) questionnaires QLQ-C30 and QLQ-MY20 to a utility value from the European QoL-5 Dimensions (EQ-5D) questionnaire. Data were obtained from 154 multiple myeloma patients who had participated in a multicenter cohort study in the UK or Germany. All three questionnaires were administered at a single time point. Scores from all 19 domains of the QLQ-C30 and QLQ-MY20 instruments were univariately tested against EQ-5D values and retained in a multivariate regression model if statistically significant. A 10-fold cross-validation model selection method was also used as an alternative testing means. Two models were developed: one based on QLQ-C30 plus QLQ-MY20 scores and one based on QLQ-C30 scores alone. Adjusted R-squared, correlation coefficients, and plots of observed versus predicted EQ-5D values were presented for both models.Mapping revealed that Global Health Status/QoL, Physical Functioning, Pain, and Insomnia were significant predictors of EQ-5D utility values. Similar results were observed when QLQ-MY20 scores were excluded from the model, except that Emotional Functioning and became a significant predictor and Insomnia was no longer a significant predictor. Adjusted R-squared values were of similar magnitude with or without inclusion of QLQ-MY20 scores (0.70 and 0.69, respectively), suggesting that the EORTC QLQ-MY20 adds little in terms of predicting utility values in multiple myeloma.This algorithm successfully mapped EORTC HRQoL data onto EQ-5D utility in patients with multiple myeloma. Current mapping will aid in the analysis of cost-effectiveness of novel therapies for this indication.

Project description:BACKGROUND:The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 is a widely used cancer-specific questionnaire assessing 15 domains of health-related quality of life (HRQoL). Our aim was to facilitate the interpretation of scores on this questionnaire by providing Austrian normative data based on a general population sample. METHODS:The calculation of normative data was based on the EORTC QLQ-C30 data collected from an Austrian general population sample that was part of an international online panel study on the development of European normative data. Data reported herein were stratified and weighted by age and sex. Normative data were calculated for all 15 HRQoL domains of the EORTC QLQ-C30. For precise predictions of EORTC QLQ-C30 scores, a regression model based on sex, age and the presence of health conditions was built. RESULTS:The Austrian sample comprised 1002 Austrian participants (50.1% female, 51.4% when weighted by age and sex based on United Nation statistics). The mean age was 53.7?years (weighted: 47.7?years) and 53.6% (weighted: 47.4%) reported at least one health condition. Men reported better physical (Cohen's d?=?0.17) and emotional (Cohen's d?=?0.17) functioning as well as less fatigue (Cohen's d?=?0.18) and insomnia (Cohen's d?=?0.25) compared with women. Younger individuals (<?40?years) reported less dyspnea (Cohen's d?=?0.61) and pain (Cohen's d?=?0.51), whereas older individuals (?60?years) reported better emotional functioning (Cohen's d?=?0.55). CONCLUSIONS:We present Austrian normative data for the EORTC QLQ-C30. Differences by age and sex are mostly in line with the findings of other European normative studies. The Austrian population sample shows higher HRQoL and lower morbidity compared with other European countries. The normative data in this study will facilitate the interpretation of EORTC QLQ-C30 scores in oncological practice and research at a national and international level (including cross-cultural comparisons).

Dataset Information

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.

Publications

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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