CC BY-NC-ND 4.0 · Geburtshilfe Frauenheilkd 2017; 77(08): 870-878
DOI: 10.1055/s-0043-116223
GebFra Science
Original Article
Georg Thieme Verlag KG Stuttgart · New York

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

Evaluation einer elektronischen Erhebung von Patient-reported-Outcomes (PROs) im PRAEGNANT-Register
Markus Wallwiener*
1  Department of Obstetrics and Gynecology, University of Heidelberg, Heidelberg, Germany
,
Felix Heindl*
2  Department of Gynecology and Obstetrics, Erlangen University Hospital, Comprehensive Cancer Center Erlangen-EMN, Friedrich-Alexander University of Erlangen-Nuremberg, Germany
,
Sara Y. Brucker
3  Department of Obstetrics and Gynecology, University of Tübingen, Tübingen, Germany
,
Florin-Andrei Taran
3  Department of Obstetrics and Gynecology, University of Tübingen, Tübingen, Germany
,
Andreas Hartkopf
3  Department of Obstetrics and Gynecology, University of Tübingen, Tübingen, Germany
,
Friedrich Overkamp
4  Outpatient Department of Hematology and Oncology, Recklinghausen, Germany
,
Hans-Christian Kolberg
5  Marienhospital Bottrop, Bottrop, Germany
,
Peyman Hadji
6  Nordwest Hospital, Frankfurt, Germany
,
Hans Tesch
7  Onkologie Bethanien, Frankfurt, Germany
,
Johannes Ettl
8  Department of Obstetrics and Gynecology, Technical University of Munich, Munich, Germany
,
Michael P. Lux
2  Department of Gynecology and Obstetrics, Erlangen University Hospital, Comprehensive Cancer Center Erlangen-EMN, Friedrich-Alexander University of Erlangen-Nuremberg, Germany
,
Claudia Rauh
2  Department of Gynecology and Obstetrics, Erlangen University Hospital, Comprehensive Cancer Center Erlangen-EMN, Friedrich-Alexander University of Erlangen-Nuremberg, Germany
,
Simon Blum
2  Department of Gynecology and Obstetrics, Erlangen University Hospital, Comprehensive Cancer Center Erlangen-EMN, Friedrich-Alexander University of Erlangen-Nuremberg, Germany
,
Naiba Nabieva
2  Department of Gynecology and Obstetrics, Erlangen University Hospital, Comprehensive Cancer Center Erlangen-EMN, Friedrich-Alexander University of Erlangen-Nuremberg, Germany
,
Tobias F. Brodkorb
2  Department of Gynecology and Obstetrics, Erlangen University Hospital, Comprehensive Cancer Center Erlangen-EMN, Friedrich-Alexander University of Erlangen-Nuremberg, Germany
,
Cornelia Faschingbauer
2  Department of Gynecology and Obstetrics, Erlangen University Hospital, Comprehensive Cancer Center Erlangen-EMN, Friedrich-Alexander University of Erlangen-Nuremberg, Germany
,
Hanna Langemann
2  Department of Gynecology and Obstetrics, Erlangen University Hospital, Comprehensive Cancer Center Erlangen-EMN, Friedrich-Alexander University of Erlangen-Nuremberg, Germany
,
Carla Schulmeyer
2  Department of Gynecology and Obstetrics, Erlangen University Hospital, Comprehensive Cancer Center Erlangen-EMN, Friedrich-Alexander University of Erlangen-Nuremberg, Germany
,
Bernhard Volz
2  Department of Gynecology and Obstetrics, Erlangen University Hospital, Comprehensive Cancer Center Erlangen-EMN, Friedrich-Alexander University of Erlangen-Nuremberg, Germany
,
Matthias Rübner
2  Department of Gynecology and Obstetrics, Erlangen University Hospital, Comprehensive Cancer Center Erlangen-EMN, Friedrich-Alexander University of Erlangen-Nuremberg, Germany
9  Institut für Frauengesundheit (IFG), Erlangen, Germany
,
Diana Lüftner
10  Department of Hematology, Oncology and Tumor Immunology, Charité University Hospital, Berlin, Campus Benjamin Franklin, Berlin, Germany
,
Volkmar Müller
11  Department of Gynecology, Hamburg-Eppendorf University Medical Center, Hamburg, Germany
,
Erik Belleville
12  Clin-Sol Ltd., Würzburg, Germany
,
Wolfgang Janni
13  Department of Gynecology and Obstetrics, Ulm University Hospital, Ulm, Germany
,
Tanja N. Fehm
14  Department of Gynecology and Obstetrics, Heinrich Heine University of Düsseldorf, Düsseldorf, Germany
,
Diethelm Wallwiener
3  Department of Obstetrics and Gynecology, University of Tübingen, Tübingen, Germany
,
Thomas Ganslandt
15  Chair of Medical Informatics, Friedrich-Alexander-University Erlangen-Nuremberg, Erlangen, Germany
,
Matthias W. Beckmann
2  Department of Gynecology and Obstetrics, Erlangen University Hospital, Comprehensive Cancer Center Erlangen-EMN, Friedrich-Alexander University of Erlangen-Nuremberg, Germany
,
Andreas Schneeweiss
1  Department of Obstetrics and Gynecology, University of Heidelberg, Heidelberg, Germany
16  National Center for Tumor Diseases and Department of Gynecology and Obstetrics, Heidelberg University Hospital, Heidelberg, Germany
,
Peter A. Fasching
2  Department of Gynecology and Obstetrics, Erlangen University Hospital, Comprehensive Cancer Center Erlangen-EMN, Friedrich-Alexander University of Erlangen-Nuremberg, Germany
,
Paul Gass
2  Department of Gynecology and Obstetrics, Erlangen University Hospital, Comprehensive Cancer Center Erlangen-EMN, Friedrich-Alexander University of Erlangen-Nuremberg, Germany
› Author Affiliations
Further Information

Publication History

received 31 May 2017
revised 09 July 2017

accepted 09 July 2017

Publication Date:
24 August 2017 (online)

Abstract

Purpose 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.

Methods 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.

Results 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.

Conclusions 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 patientsʼ compliance was better with some questionnaires, but others may present difficulties.

Zusammenfassung

Hintergrund Das PRAEGNANT-Netzwerk ist ein prospektives translationales Forschungskonzept zur Optimierung der gesundheitlichen Versorgung von Patientinnen mit lokal fortgeschrittenem oder metastastiertem Brustkrebs. Patient-reported outcomes (PROs) wurden in vielen klinischen Studien aufgenommen. Zunehmend geht es von der analogen Erhebung auf Papier (pPRO) in die elektronische Erhebung (ePRO) über. Dieses Subprotokoll der PRAEGNANT soll die Implementierung und Machbarkeit dieses neuen Vorgehens evaluieren.

Methoden Die Patientinnen wurden von dem Personal der Studienzentrale, dem ärztlichen oder dem pflegerischen Personal am Brustzentrum Franken des Universitätsklinikums Erlangen, gebeten, 3 standardisierte Fragebögen zum PROs (EQ-5D-5L, CES-D und IPAQ) elektronisch auszufüllen. Anschließend wurde die Bedienbarkeit und Zufriedenheit der Patientinnen und die Benutzerfreundlichkeit zur Vergabe der Zugangsdaten von den 3 Personalgruppen abgefragt.

Ergebnisse Fünfzehn von 17 eingeschlossenen Patientinnen füllten abschließend die 2 ePRO-Fragebögen (EQ-5D-5L und CES-D) aus. Der elektronische Fragebogen zur körperlichen Aktivität (IPAQ) konnte von 9 der 15 Patientinnen erhoben werden. Machbarkeit zur Benutzerdatenvergabe wurde absteigend von den Ärzten gegenüber dem Studienzentralenpersonal und Pflegepersonal als besser bewertet.

Schlussfolgerung Die Benutzung der ePRO-Fragebögen ist in der PRAEGNANT Registry grundsätzlich durchführbar. Die Machbarkeit hängt maßgeblich von den Fähigkeiten und Kapazitäten der beteiligten Patientinnen und Personalgruppen ab. Die Compliance und Vollständigkeit war nicht bei allen ePRO-Fragebögen gleich gut und ergab teilweise Schwierigkeiten.

* Shared first authorship