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Geburtshilfe Frauenheilkd. 2017 Aug;77(8):870-878. doi: 10.1055/s-0043-116223. Epub 2017 Aug 24.

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

Author information

1
Department of Obstetrics and Gynecology, University of Heidelberg, Heidelberg, Germany.
2
Department of Gynecology and Obstetrics, Erlangen University Hospital, Comprehensive Cancer Center Erlangen-EMN, Friedrich-Alexander University of Erlangen-Nuremberg, Germany.
3
Department of Obstetrics and Gynecology, University of Tübingen, Tübingen, Germany.
4
Outpatient Department of Hematology and Oncology, Recklinghausen, Germany.
5
Marienhospital Bottrop, Bottrop, Germany.
6
Nordwest Hospital, Frankfurt, Germany.
7
Onkologie Bethanien, Frankfurt, Germany.
8
Department of Obstetrics and Gynecology, Technical University of Munich, Munich, Germany.
9
Institut für Frauengesundheit (IFG), Erlangen, Germany.
10
Department of Hematology, Oncology and Tumor Immunology, Charité University Hospital, Berlin, Campus Benjamin Franklin, Berlin, Germany.
11
Department of Gynecology, Hamburg-Eppendorf University Medical Center, Hamburg, Germany.
12
Clin-Sol Ltd., Würzburg, Germany.
13
Department of Gynecology and Obstetrics, Ulm University Hospital, Ulm, Germany.
14
Department of Gynecology and Obstetrics, Heinrich Heine University of Düsseldorf, Düsseldorf, Germany.
15
Chair of Medical Informatics, Friedrich-Alexander-University Erlangen-Nuremberg, Erlangen, Germany.
16
National Center for Tumor Diseases and Department of Gynecology and Obstetrics, Heidelberg University Hospital, Heidelberg, Germany.

Abstract

in English, German

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 patients' compliance was better with some questionnaires, but others may present difficulties.

KEYWORDS:

breast cancer; compliance; electronic data capture; patient-reported outcomes; quality of life

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