ABSTRACT
Clinical data is one of the key sources of real-world data, while the reliability of such data is often hindered by unscientific and irregular data management. Based on various problems found in the application of clinical data to scientific research, this study formulated a standard operation procedure(SOP) for real-world data management, and organized the data in terms of content and logic consistency, completeness and standardization. The clinical data of syphilis at a tertiary hospital were used as an example for verification. The clinical data of syphilis patients in the dermatology department from January 1, 2008 to January 1, 2018 were derived from the basic information database, diagnosis database, laboratory information database, and treatment information database of its hospital information system, and a total of 71 705 pieces of relevant information were extracted. SOP analysis showed that 6 816 articles were completely repeated. There were content or logical inconsistencies in name, medical identification number, resident ID number, age and gender, being 152, 360, 88, 107 and 457 respectively. There were many missing entries for marital status, ethnicity, gender, birthday, and ID number, being 1 711, 1 077, 457, 496 and 355 respectively. The standardization situation was generally good, and the number of irregularities in filling out occupational items was 1 884. The standardized and collated data could effectively count the proportion of patients in different stages of syphilis and the cost of diagnosis and treatment, indicating that the real-world data management and analysis SOP proposed in this study could be used to build a clinical-research oriented dual-functional database based on medical practice data.
ABSTRACT
Objective:To investigate distribution characteristics of Treponema pallidum (Tp) in secondary syphilis lesions, and to analyze its correlation with histopathological findings. Methods:Totally, 41 patients were collected from Department of Dermatology and Venereology, Peking Union Medical College Hospital from January 2008 to December 2018, who were confirmedly diagnosed with secondary syphilis according to clinical manifestations and serological examinations, and had undergone histopathological examinations. Immunohistochemical results of skin tissue sections were analyzed, and differences in clinical and histopathological characteristics were analyzed between immunohistochemically Tp-positive and Tp-negative sections. Continuous data were compared by using t test or Kruskal-Wallis test, and categorical data were compared by using Chi-square test or Fisher′s exact test. Results:Immunohistochemical examination showed that Tp was detected in 68.3% of the 42 secondary syphilis tissue sections, and Tp was mainly distributed in the lower epidermis and superficial and middle dermis. The positive rate of Tp was significantly higher in secondary syphilis lesions mainly manifesting as maculae (80% [16/20]) than in those mainly manifesting as papules (50% [11/22], P < 0.05) . Among 10 pathological characteristics, extended rete ridges, basal cell liquefaction degeneration, neutrophil infiltration in the stratum corneum, lichenoid pattern of infiltration and punctate keratinocyte necrosis were observed more frequently in immunohistochemically Tp-positive sections than in Tp-negative sections (all P < 0.05) . Immunohistochemical study revealed that tissue sections with a larger number of Tp showed more pathological features ( H = 17.914, P < 0.001) . Immunohistochemical staining showed that there were 8, 7 and 6 syphilis-specific histopathological characteristics on average in 8 tissue sections with a larger number of Tp, 14 with a medium number of Tp and 5 with a small number of Tp, respectively; while only 4 syphilis-specific histopathological characteristics were observed on average in 15 immunohistochemically Tp-negative tissue sections. Conclusion:Immunohistochemical staining could show the distribution of Tp in secondary syphilis lesions, and it seems that tissue sections with a larger number of Tp present with more syphilis-specific histopathological characteristics.