1.Reflection of quality management of conducting international cooperative academic clinical research in China
Meirong WANG ; Haibo WANG ; Ping JI ; Yangfeng WU
Chinese Journal of Medical Science Research Management 2017;30(3):164-168
Objective Through summarizing quality management practices of international cooperative academic clinical studies funded by Peking University Health Science Center,analyzing its present major challenges of implementation in China,this paper proposed related measurements and suggestions to improve the quality of clinical research.Methods To sort the project management archive data,as well as descriptive analysis of the common monitoring/auditing findings.Results From the year 2011 to 2016,there were 14 such studies funded by Peking University health science center,common findings during monitoring and or auditing were classified as following categories,study files problem (100.0%),ethics problem (71.4%),protocol noncompliance (64.3%),data quality issues (71.4%),communication problem in study teams (14.3%),export problems of bio-specimens (14.3 %),recruiting delay (14.3 %) and cooperation termination in advance (7.1 %).Conclusions In order to obtain credible and reliable data,peer recognized research conclusion and accurate answered scientific questions,it is essential for investigators to comply with laws and regulations and being strongly supported.Furthermore,researchers also need to establish and strictly follow study protocols,standard operating procedures (SOPs),research quality management system and relevant national laws and regulations that are comply with actual requirements in China.
2.Effectiveness of home service in rehabilitation of post-stroke patients on recovering period
Weiping XU ; Yulan QIU ; Yuchang LIU ; Haihua JIN ; Meirong JI
Chinese Journal of General Practitioners 2017;16(3):224-226
One hundred and fifty eight post-stroke patients in the recovering period were divided into intervention group (78 cases) and control group (80 cases).Patients in intervention group received home rehabilitation service provided by general practitioners (GP) for 6 months,while patients in control group received routine rehabilitation.After 6-months,the scores of self-rated health measurement scale (SRHMS) in intervention group were significantly higher than those of control group (P <0.01);the visiting time and frequency,medical costs and time of caregiving were decreased (P < 0.01);and the satisfaction score of the patients in intervention group was 97%.The results show that home rehabilitation service can improve effectiveness of rehabilitation for post-stroke patient in recovering period.
3.Analysis of characteristics of dysplasia in 345 patients with myelodysplastic syndrome
Meirong JI ; Bobin CHEN ; Xiaoping XU ; Guowei LIN
Journal of Leukemia & Lymphoma 2009;18(7):402-406
Objective To investigate the characteristics of dysplasia in myeledysplastic syndrome (MDS). Methods 716 samples of adult patients with abnormal blood routine and unelear cause were collected between July 04, 2003 and March 14, 2007. Based on the gold diagnostic standard of WHO MDS classification, all eases were detected on cytomorphology, cytochemical stain, bone marrow pathological assay,cytogenetics, flow eytometry et al. The cytological study of bone marrow on some abnormal hematopaietie cells has a diagnostic value to determine clonal or non-clonal diseases and assess sensitivity and specificity. Results in the complicated various dysplasia of hematopeiefic ceils, the following characteristics can be the main basis of cytomorphological diagnosis: one of granular Auer bodies, micronuclens (MN), or nuclear budding, erythroid nuclear budding, megakaryocytes presented in peripheral blood, myeloblast or prorubricyte exhibited in peripheral blood, ringed sideroblasts>1%. The subordinate basis of cytomorphological diagnosis development of nuclei, ring-shaped nuclei, and aggregation of nuclear chromafin, erythroid multi-nuclei, odd nucleus, mother-daughter nucleus, nuclear fragmentation, vacuole, anisoeytosis and mieromegakaryocytes.Conclusion Cytomorphologic assay is the base for the diagnosis of MDS, however, it presents certain limit,especially when eytomnrphoiogical change does not possess specificity for early MDS. Hereby, it requires to combine other deteetion methods.
4.Serological screening and analysis of clinical characteristics for celiac disease in susceptible population in Southern China
Xiuying LIU ; Wanyan ZHOU ; Wei WU ; Meirong HE ; Dekai ZHENG ; Guiyuan JI ; Wenjun MA ; Ye CHEN
Chinese Journal of Internal Medicine 2021;60(6):539-543
Objective:To determine the seroprevalence of celiac disease in susceptible population, and to analyze the relationship between demographic characteristics, dietary habits, lifestyle and serological positivity so as to provide guidance for the prevention and treatment of celiac disease in Southern China.Methods:A total of 1 273 individuals who participated in Guangdong Province Health Screening Program in 2015, were selected as serologically positive subjects of celiac disease, including people with irritable bowel syndrome, colitis, diarrhea, anemia, low BMI, short stature, type 1 diabetes mellitus (T1DM), rheumatoid arthritis (RA), ankylosing spondylitis, psoriasis and bristol grade=6 or 7. All subjects were tested for serum IgA anti-tissue transglutaminase antibodies (TTGA), IgA antibodies against deamidated gliadin peptides(DGPA) and IgG against deamidated gliadin peptides (DGPG). Dietary habits, lifestyle and demographic characteristics were compared in subgroups.Results:The seroprevalence of celiac disease in susceptible population was 0.94% (95% CI 0.54%-1.64%) including 0.08% (1/1 273) for TTGA, 0.47% (6/1 273) for DGPA, and 0.39% (5/1 273) for DGPG. The seropositive rate was 3.6% (1/28) in patients with psoriasis, 2.1% (2/95) in the low BMI group, 1.9% (1/53) in T1DM group, 1.8% (3/169) in diarrhea group and 1.1% (5/463) in RA group. No significant difference was found in age, gender, high carbohydrate diet or lifestyle between the negative and the positive subjects. Conclusions:In Southern China, the seropositive rate of celiac disease is 0.94% in susceptible population, which prompts an urgent need of serological screening for early diagnosis.