ABSTRACT
Since the end of 2019, the spread of the corona virus disease 2019 (COVID-19) has caused serious economic shocks and social impacts. The development of clinical trials of drugs has also brought many difficulties and challenges. Based on the particularity of the population and process of the Phase I clinical trials of the drug, it caused us to think about the management of the subjects in the Phase I clinical trials under the influence of the COVID-19. It proposes various strategies from the different stages of subject recruitment, screening, and admission, to subject education, diet management, and observation of adverse events. It aims to discuss how to protect the safety and rights of subjects better under the normalization of epidemic prevention and control, strengthen the risk control of clinical trials, and ensure the successful completion of trials.
ABSTRACT
OBJECTIVE: To evaluate the completeness of diagnosis recording in problem lists in a hospital electronic health record (EHR) system during the COVID-19 pandemic. DESIGN: Retrospective chart review with manual review of free text electronic case notes. SETTING: Major teaching hospital trust in London, one year after the launch of a comprehensive EHR system (Epic), during the first peak of the COVID-19 pandemic in the UK. PARTICIPANTS: 516 patients with suspected or confirmed COVID-19. MAIN OUTCOME MEASURES: Percentage of diagnoses already included in the structured problem list. RESULTS: Prior to review, these patients had a combined total of 2841 diagnoses recorded in their EHR problem lists. 1722 additional diagnoses were identified, increasing the mean number of recorded problems per patient from 5.51 to 8.84. The overall percentage of diagnoses originally included in the problem list was 62.3% (2841 / 4563, 95% confidence interval 60.8%, 63.7%). CONCLUSIONS: Diagnoses and other clinical information stored in a structured way in electronic health records is extremely useful for supporting clinical decisions, improving patient care and enabling better research. However, recording of medical diagnoses on the structured problem list for inpatients is incomplete, with almost 40% of important diagnoses mentioned only in the free text notes.