D Böhringer1, D Goos2, T Ach3, N Feltgen4, M Fleckenstein5, T Kohnen6, K Lorenz7, A Pielen8, G Spital9, B Wilhelm10, S Böhringer11, T Reinhard1. 1. Klinik für Augenheilkunde, Universitätsklinikum Freiburg, Killianstr. 5, 79106, Freiburg, Deutschland. 2. Klinik für Augenheilkunde, Universitätsklinikum Freiburg, Killianstr. 5, 79106, Freiburg, Deutschland. daniela.goos@uniklinik-freiburg.de. 3. Augenklinik und Poliklinik, Universitätsklinikum Würzburg, Würzburg, Deutschland. 4. Universitäts-Augenklinik Göttingen, Göttingen, Deutschland. 5. Universitäts-Augenklinik Bonn, Bonn, Deutschland. 6. Universitäts-Augenklinik Frankfurt, Frankfurt, Deutschland. 7. Augenklinik der Universitätsmedizin Mainz, Mainz, Deutschland. 8. Universitätsklinik für Augenheilkunde, Medizinische Hochschule Hannover, Hannover, Deutschland. 9. Augenzentrum, St. Franziskus-Hospital Münster, Münster, Deutschland. 10. Department für Augenheilkunde, Universitätsklinikum Tübingen, Tübingen, Deutschland. 11. Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, Niederlande.
Abstract
BACKGROUND: Work in clinical studies is generally more elaborate and therefore more time-consuming in comparison to the clinical routine. The purpose of this study was to systematically investigate the time consumption in the German ophthalmological clinical trial centers. METHODS: The members of the working group of the German Ophthalmology Society clinical study centers (Arbeitsgemeinschaft DOG Klinische Studienzentren) were asked to fill in three questionnaires about best estimations for the time spent on study-related procedures and administration. Additionally, work sampling was performed for each employee at each study center over a period of 3 weeks. RESULTS: The questionnaires were completed by 9 of the 11 centers. Overall, 5504 working hours were recorded. On an average working day, the time spent for both documentation and administration averaged 4 h each. Operative interventions consumed a significant amount of time (2.8 h), as did ophthalmological examinations (2.5 h) and obtaining informed consent (1.5 h). The recorded time consumption for visual acuity testing, informed consent and documentation was well aligned with the best estimates of the three questionnaires. By contrast, interventions, ophthalmological examinations and biomaterial sample handling were underrated in the best estimations. DISCUSSION: A considerable amount of time in clinical studies is spent on documentation and administration. From work sampling, ophthalmological examinations and biomaterial sampling turned out to be surprisingly time consuming. This is probably due to preparation and postprocessing tasks. It is important to consider this when calculating the overall costs of a clinical study. In addition, many administrative activities cannot be attributed to specific patients and can therefore not be compensated on the basis of case payments alone. Additional remuneration is required to fully cover the costs in an ophthalmological study center.
BACKGROUND: Work in clinical studies is generally more elaborate and therefore more time-consuming in comparison to the clinical routine. The purpose of this study was to systematically investigate the time consumption in the German ophthalmological clinical trial centers. METHODS: The members of the working group of the German Ophthalmology Society clinical study centers (Arbeitsgemeinschaft DOG Klinische Studienzentren) were asked to fill in three questionnaires about best estimations for the time spent on study-related procedures and administration. Additionally, work sampling was performed for each employee at each study center over a period of 3 weeks. RESULTS: The questionnaires were completed by 9 of the 11 centers. Overall, 5504 working hours were recorded. On an average working day, the time spent for both documentation and administration averaged 4 h each. Operative interventions consumed a significant amount of time (2.8 h), as did ophthalmological examinations (2.5 h) and obtaining informed consent (1.5 h). The recorded time consumption for visual acuity testing, informed consent and documentation was well aligned with the best estimates of the three questionnaires. By contrast, interventions, ophthalmological examinations and biomaterial sample handling were underrated in the best estimations. DISCUSSION: A considerable amount of time in clinical studies is spent on documentation and administration. From work sampling, ophthalmological examinations and biomaterial sampling turned out to be surprisingly time consuming. This is probably due to preparation and postprocessing tasks. It is important to consider this when calculating the overall costs of a clinical study. In addition, many administrative activities cannot be attributed to specific patients and can therefore not be compensated on the basis of case payments alone. Additional remuneration is required to fully cover the costs in an ophthalmological study center.
Entities:
Keywords:
Clinical studies; Cost calculation; Documentation; Time survey; Work sampling
Authors: Jan Wolff; Gerd Auber; Tobias Schober; Felix Schwär; Karl Hoffmann; Marc Metzger; Andrea Heinzmann; Marcus Krüger; Claus Normann; Gerald Gitsch; Norbert Südkamp; Thomas Reinhard; Mathias Berger Journal: Dtsch Arztebl Int Date: 2017-10-20 Impact factor: 5.594