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 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.

Key words

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

Schlüsselwörter

Brustkrebs - Patient-reported Outcomes - Electronic Data Capture - Compliance - Lebensqualität

^* Shared first authorship

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