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

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Implementation and Feasibility of Electronic Patient-Reported Outcome (ePRO) Data Entry in the PRAEGNANT Real-Time Advanced and Metastatic Breast Cancer Registry. / Wallwiener, Markus; Heindl, Felix; Brucker, Sara Y; Taran, Florin-Andrei; Hartkopf, Andreas; Overkamp, Friedrich; Kolberg, Hans-Christian; Hadji, Peyman; Tesch, Hans; Ettl, Johannes; Lux, Michael P; Rauh, Claudia; Blum, Simon; Nabieva, Naiba; Brodkorb, Tobias F; Faschingbauer, Cornelia; Langemann, Hanna; Schulmeyer, Carla; Volz, Bernhard; Rübner, Matthias; Lüftner, Diana; Müller, Volkmar; Belleville, Erik; Janni, Wolfgang; Fehm, Tanja N; Wallwiener, Diethelm; Ganslandt, Thomas; Beckmann, Matthias W; Schneeweiss, Andreas; Fasching, Peter A; Gass, Paul.

In: GEBURTSH FRAUENHEILK, Vol. 77, No. 8, 08.2017, p. 870-878.

Research output: SCORING: Contribution to journalSCORING: Journal articleResearchpeer-review

Harvard

Wallwiener, M, Heindl, F, Brucker, SY, Taran, F-A, Hartkopf, A, Overkamp, F, Kolberg, H-C, 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, Lüftner, D, Müller, V, Belleville, E, Janni, W, Fehm, TN, Wallwiener, D, Ganslandt, T, Beckmann, MW, Schneeweiss, A, Fasching, PA & 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', GEBURTSH FRAUENHEILK, vol. 77, no. 8, pp. 870-878. https://doi.org/10.1055/s-0043-116223

APA

Wallwiener, M., Heindl, F., Brucker, S. Y., Taran, F-A., Hartkopf, A., Overkamp, F., Kolberg, H-C., Hadji, P., Tesch, H., Ettl, J., Lux, M. P., Rauh, C., Blum, S., Nabieva, N., Brodkorb, T. F., Faschingbauer, C., Langemann, H., Schulmeyer, C., Volz, B., ... 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. GEBURTSH FRAUENHEILK, 77(8), 870-878. https://doi.org/10.1055/s-0043-116223

Vancouver

Bibtex

@article{b54c5339ed9443a1b1bd12c01ae7b396,
title = "Implementation and Feasibility of Electronic Patient-Reported Outcome (ePRO) Data Entry in the PRAEGNANT Real-Time Advanced and Metastatic Breast Cancer Registry",
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 patients' compliance was better with some questionnaires, but others may present difficulties.",
keywords = "Journal Article",
author = "Markus Wallwiener and Felix Heindl and Brucker, {Sara Y} and Florin-Andrei Taran and Andreas Hartkopf and Friedrich Overkamp and Hans-Christian Kolberg and Peyman Hadji and Hans Tesch and Johannes Ettl and Lux, {Michael P} and Claudia Rauh and Simon Blum and Naiba Nabieva and Brodkorb, {Tobias F} and Cornelia Faschingbauer and Hanna Langemann and Carla Schulmeyer and Bernhard Volz and Matthias R{\"u}bner and Diana L{\"u}ftner and Volkmar M{\"u}ller and Erik Belleville and Wolfgang Janni and Fehm, {Tanja N} and Diethelm Wallwiener and Thomas Ganslandt and Beckmann, {Matthias W} and Andreas Schneeweiss and Fasching, {Peter A} and Paul Gass",
year = "2017",
month = aug,
doi = "10.1055/s-0043-116223",
language = "English",
volume = "77",
pages = "870--878",
journal = "GEBURTSH FRAUENHEILK",
issn = "0016-5751",
publisher = "Georg Thieme Verlag KG",
number = "8",

}

RIS

TY - JOUR

T1 - Implementation and Feasibility of Electronic Patient-Reported Outcome (ePRO) Data Entry in the PRAEGNANT Real-Time Advanced and Metastatic Breast Cancer Registry

AU - Wallwiener, Markus

AU - Heindl, Felix

AU - Brucker, Sara Y

AU - Taran, Florin-Andrei

AU - Hartkopf, Andreas

AU - Overkamp, Friedrich

AU - Kolberg, Hans-Christian

AU - Hadji, Peyman

AU - Tesch, Hans

AU - Ettl, Johannes

AU - Lux, Michael P

AU - Rauh, Claudia

AU - Blum, Simon

AU - Nabieva, Naiba

AU - Brodkorb, Tobias F

AU - Faschingbauer, Cornelia

AU - Langemann, Hanna

AU - Schulmeyer, Carla

AU - Volz, Bernhard

AU - Rübner, Matthias

AU - Lüftner, Diana

AU - Müller, Volkmar

AU - Belleville, Erik

AU - Janni, Wolfgang

AU - Fehm, Tanja N

AU - Wallwiener, Diethelm

AU - Ganslandt, Thomas

AU - Beckmann, Matthias W

AU - Schneeweiss, Andreas

AU - Fasching, Peter A

AU - Gass, Paul

PY - 2017/8

Y1 - 2017/8

N2 - 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.

AB - 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.

KW - Journal Article

U2 - 10.1055/s-0043-116223

DO - 10.1055/s-0043-116223

M3 - SCORING: Journal article

C2 - 28845051

VL - 77

SP - 870

EP - 878

JO - GEBURTSH FRAUENHEILK

JF - GEBURTSH FRAUENHEILK

SN - 0016-5751

IS - 8

ER -