Implementation of electronic checklists for muscle biopsies, tilt table experiments and spiro-ergometry in order to increase medical safety and scientific quality during biomedical studies at the DLR

Kurzfassung

Background Checklists are a powerful safety tool in aviation. Their use in cockpits has proven to be effective for many years to decrease the number of mistakes made by pilots in the environment of the complex system airplane. Safety checklists are more and more being introduced in medicine and clinical operations but not in human biomedical research so far. Thus the goal of this thesis is to implement medical safety checklists in the context of complex human biomedical studies and evaluate whether or not they can improve medical safety and scientific data quality. Methods Between January and April 2016, the second campaign of a longterm bed rest study was hosted at the :envihab facility of the German Aerospace Center (DLR) in Cologne. Three complex experiments were chosen which were performed at least twice for each subject: 1. Muscle biopsy, 2. Tilt table tests, 3. Bicycle Spiro-ergometry. Before developing and implementing checklists for the above-mentioned experiments, data was collected to evaluate the performance regarding subject safety and scientifc data quality. During the baseline data collection phase in January, 36 experiments on 12 subjects were analyzed. The actual bed rest phase, which lasted for 60 days, was used to generate a Visual Basic based website, which allows electronic checklists to be conducted on tablet computers. The application enables users to open and conduct predefined checklists and save comments and photos for documentation purposes. Furthermore, checklist templates can be edited and thus adapted to changing requirements of upcoming studies. During the recovery phase at the end of the campaign, each of the three experiments was repeated for every subject. The electronic checklists were introduced to and tested by DLR personnel conducting the experiments. The performance was analyzed again using the same indicators to evaluate the effect checklists have on medical safety and data quality. Results The overall performance combining all three types of experiments was 67% before the checklists were introduced and rose to 97% afterward. Subject safety performance was 39% at baseline and 90% after the introduction of checklists. Considering the quality of scientific data, the performance was increased from 64% to 99% with the help of electronic checklists. Conclusions Implementation of electronic checklists in human biomedical studies was associated with concomitant increase in medical safety and scientifc data quality among subjects participating in complex experiments during a long-term bed rest study at the German Aerospace Center in Cologne.