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 journal › SCORING: Journal article › Research › peer-review
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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 -