Objective:To analyze the current management status of real-world studies (RWS) in the medical institutions in China and suggest improvement focus for the management optimization.Methods:Surveys were conducted in 81 medical institutions nationwide. Convenience sampling was used to recruit survey subjects, and data were collected through self-administered questionnaires, followed by statistical analysis using descriptive methods.Results:The survey results indicated that 92.6% (75/81) of the medical institutions surveyed had undertaken RWS projects, with electronic medical records being the primary data source (89.3%, 67/75). Retrospective and prospective observational studies were the main types of study designs. Additionally, 96.3% (78/81) of the research subjects indicated that their medical institution expressed willingness to participate in or undertake RWS projects in the future. In terms of management, all types of RWS projects were managed by clinical trial center (24.0, 18/75), but differences existed in the management practices among medical institutions. Moreover, the challenges in data quality and standardization, study design and staff training, data and privacy protection and information technology support appeared in the management of RWS projects.Conclusions:It suggests to optimize the management processes of RWS projects in medical institutions and improve relevant laws and regulations to promote the development of RWS in China.

Objective:To analyze the current management status of real-world studies (RWS) in the medical institutions in China and suggest improvement focus for the management optimization.Methods:Surveys were conducted in 81 medical institutions nationwide. Convenience sampling was used to recruit survey subjects, and data were collected through self-administered questionnaires, followed by statistical analysis using descriptive methods.Results:The survey results indicated that 92.6% (75/81) of the medical institutions surveyed had undertaken RWS projects, with electronic medical records being the primary data source (89.3%, 67/75). Retrospective and prospective observational studies were the main types of study designs. Additionally, 96.3% (78/81) of the research subjects indicated that their medical institution expressed willingness to participate in or undertake RWS projects in the future. In terms of management, all types of RWS projects were managed by clinical trial center (24.0, 18/75), but differences existed in the management practices among medical institutions. Moreover, the challenges in data quality and standardization, study design and staff training, data and privacy protection and information technology support appeared in the management of RWS projects.Conclusions:It suggests to optimize the management processes of RWS projects in medical institutions and improve relevant laws and regulations to promote the development of RWS in China.

Malaria is suspected in pregnant women with fever of unknown origin who come from areas with high transmission of the disease. Pregnant women are at greater risk of infection due to a weakened immune response and higher parasite burden because of placental sequestration. A 26-year-old Sudanese primigravid 23 6/7 weeks of gestation presented at our institution with mixed infection of malaria, with severe features (hypotension and anemia). Malaria was highly suspected due to her country of origin, which was highly endemic and has high transmission of the disease. Fetal surveillance to monitor fetal well-being was done since malaria is known to cause perinatal adverse outcomes. Intrauterine growth restriction, preterm labor and stillbirth are the most common perinatal morbidity from malaria. These are not present in the patient due to the prompt initiation of artemisinin-based combination therapy, which significantly decreased the parasite load, leading to successful outcome.

Human ; Female ; Adult (a Person 19-44 Years Of Age) ; Pregnancy ; Artemisinine ; Artemisinins ; Parasites ; Coinfection ; Malaria ; Prenatal Care ; Parasite Load ; Gravidity ; Obstetric Labor, Premature ; Anemia ; Hypotension