Implementation and Feasibility of Electronic Patient-Reported Outcome (ePRO) Data Entry in the PRAEGNANT Real-Time Advanced and Metastatic Breast Cancer Registry

Wallwiener M, Heindl F, Brucker SY, Taran FA, Hartkopf A, Overkamp F, Kolberg HC, Hadji P, Tesch H, Ettl J, Lux MP, Rauh C, Blum S, Nabieva N, Brodkorb TF, Faschingbauer C, Langemann H, Schulmeyer C, Volz B, Rübner M, Lueftner D, Mueller V, Belleville E, Janni W, Fehm TN, Wallwiener D, Ganslandt T, Beckmann M, Schneeweiss A, Fasching P, Gaß P (2017)

Publication Type: Journal article

Publication year: 2017

Journal

Geburtshilfe und Frauenheilkunde Georg Thieme Verlag

Book Volume: 77

Pages Range: 870-878

Journal Issue: 8

DOI: 10.1055/s-0043-116223

Abstract

Patient-reported outcomes (PROs) have been incorporated into clinical trials for many symptoms and medical conditions. A transition from paper-based capture of PROs to electronic PROs (ePROs) has recently started. This study reports on the feasibility of ePRO assessment in a prospective registry including molecular data for patients with advanced breast cancer.As part of the PRAEGNANT network, patients were invited by clinical trial staff, physicians, and nurses to complete three standardized Internet-based questionnaires (EQ 5D 5 L, CES-D and IPAQ). Feasibility was assessed by the staff members who assigned the user accounts by the patients. The completeness of the questionnaires was also assessed.Fifteen of 17 patients who were asked agreed to participate to complete the PRO questionnaires (EQ-5D-5L and CES-D). However, the IPAQ (physical activity) questionnaire was only validly completed by 9 patients. Feasibility was ranked better by the physicians and dedicated clinical trial staff than by the nursing staff.Incorporating ePRO questionnaires into an advanced breast cancer registry is feasible, and no major hurdles were reported. Involving stakeholders from the start, the application is tailored to the capacities and abilities of both patients and clinical staff. The patients' compliance was better with some questionnaires, but others may present difficulties.

Authors with CRIS profile

Felix Heindl Medizinische Fakultät Naiba Nabieva Department of Obstetrics and Gynaecology Cornelia Faschingbauer Lehrstuhl für Geburtshilfe und Frauenheilkunde Hanna Langemann Department of Obstetrics and Gynaecology Matthias Rübner Department of Obstetrics and Gynaecology Thomas Ganslandt Lehrstuhl für Medizinische Informatik Matthias Beckmann Lehrstuhl für Geburtshilfe und Frauenheilkunde Peter Fasching Professur für Translationale Frauenheilkunde und Geburtshilfe Paul Gaß Department of Obstetrics and Gynaecology

Involved external institutions

Eberhard Karls Universität Tübingen DE Germany (DE) Krankenhaus Nordwest DE Germany (DE) Centrum für Hämatologie und Onkologie Bethanien DE Germany (DE) Technische Universität München (TUM) DE Germany (DE) Charité - Universitätsmedizin Berlin DE Germany (DE) Universitätsklinikum Hamburg-Eppendorf (UKE) DE Germany (DE) ClinSol GmbH & Co.KG DE Germany (DE) Universitätsklinikum Ulm DE Germany (DE) Heinrich-Heine-Universität Düsseldorf DE Germany (DE) Ruprecht-Karls-Universität Heidelberg DE Germany (DE) Marienhospital Bottrop DE Germany (DE)

How to cite

APA:

Wallwiener, M., Heindl, F., Brucker, S.Y., Taran, F.-A., Hartkopf, A., Overkamp, F.,... Gaß, P. (2017). Implementation and Feasibility of Electronic Patient-Reported Outcome (ePRO) Data Entry in the PRAEGNANT Real-Time Advanced and Metastatic Breast Cancer Registry. Geburtshilfe und Frauenheilkunde, 77(8), 870-878. https://doi.org/10.1055/s-0043-116223

MLA:

Wallwiener, Markus, et al. "Implementation and Feasibility of Electronic Patient-Reported Outcome (ePRO) Data Entry in the PRAEGNANT Real-Time Advanced and Metastatic Breast Cancer Registry." Geburtshilfe und Frauenheilkunde 77.8 (2017): 870-878.

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