Objective To review the surgical management for Chinese children urethral injury (CUI). Methods According to the evidence-based medicine principal and the approach of systematic review, we searched Chinese Biomedicine Database and PubMed, all literature retrievals were updated until September 8th, 2008. At least two reviewers independently screened the studies for eligibility, evaluated the quality with the Joanna Briggs Institute critical appraisal checklist for descriptive/cases series studies and extracted the data with excel 2003 from the eligible literatures, with confirmation of cross-check. Different views were consulted by the third party. The characteristics of literature, research quality, study content, cases characteristics, diagnosis and treatment, outcome appraisal and follow-up were analyzed. Results A total of 22 studies involving 1019 patients were included, most patients were male children. All 22 studies were descriptive researches and the study quality was low. The etiologies were mainly pelvic fracture and straddle injury as results of misadventure. The diagnosis was based on the relatively objective diagnostic tests such as urethrography, operations research and the exploration of urethral bougie etc in 16 studies. The most categories of CUI were obsolete urethral injuries such as stricture and atresia, the injury sites mainly lied in posterior urethra. The management of CUI were divided into the primary treatment included the first-stage operation and delayed-stage repair, and the second-stage management. Moreover, the individual operation was according to the injury sites and patterns. A total of 14 studies reported the outcomes of operation at various success rates (52%-100%). Except 4 studies, the others reported incomplete follow-up time, from 3 months to 16 years, but few adopted objective methods such as urethrography and urodynamic test. The main complications were urethral stricture, urinary fistula and sexual dysfunction etc. Conclusion The quality of CUI studies was low for lack of prospective randomized controlled trials. The major patients were male children with posterior urethra injuries. Because of the heterogeneitiy of the individual case, different surgeon’s managements and the variety of treatment options, we cannot make identical conclusion. We need more researches with high methodological quality. Moreover, we recommend that, following the clinical practice guideline of CUI made by Chinese Urological Association for the Chinese urologist, and then performing individual surgical management.
Clinical research reports are the main form of clinical evidence. Based on the requirements of clinical research reports and the characteristics of clinical research on traditional Chinese medicine, it is an important basic systematic project to construct a standardized system of clinical curative effects study report on Chinese medicine. This article elaborates existing problems, focus of attention and construction process in order to help promote the improvement of clinical curative effects research report on Chinese medicine, provide more high-quality evidences for clinical decision-making and promote the development of Chinese medicine.
ObjectiveUsing Quality in prognosis studies (QUIPS) analysis, this paper systematically reviewed the factors influencing the poor outcome of children with convulsive status epilepticus (CSE).MethodsTo longitudinal cohort studies on the prognostic evaluation of CSE mortality and mobidity in children.The retrieval time was from January 2008 to November 2019, and three system reviewers PUBMED, EMBASE, COCHRANE and other databases were used to search for literatures related carried out literature extraction and quality evaluation. According to the QUIPS analysis method, the included literatures were scored, the quality grade was divided, and the analysis variables of medium/high quality literatures with statistical significance were selected to draw a conclusion.ResultsQUIPS analysis was used to assess the literature quality, 17 medium/high quality literatures were included, and the factors with statistical significance (P<0.05) mentioned at least twice or more in≥2 medium/high quality literatures were selected, which were considered as important risk factors affecting prognosis.These factors include: etiology, age, duration of convulsion, refractory CSE, neuroimaging abnormalities.ConclusionFive risk factors indicating poor outcome of CSE in children were summarized. Due to the heterogeneity of various literature studies, Meta-analysis has not been completed, so it has certain limitations.
At the end of 2022, the National Medical Products Administration (NMPA), in conjunction with the National Cancer Center, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College raised for the first time the important issue of clinical research globally: whether the source of the death time of clinical trials based on the simple follow-up records is credible, and proposed a consensus document on the source of the death time of clinical trials. The results were published in The Lancet Regional Health-Western Pacific, which attracted wide attention and recognition from the international industry. This is the first time that the China consensus on quality standards for clinical research has been ahead of the U.S. Food and Drug Administration and other international colleagues. The NMPA has been leading China in promoting the scientific development of clinical research, so as to constantly establish and improve the scientific regulatory system and ecological system, and promote China's full integration into the global pharmaceutical research and development system. China clinical research institutions and the whole industry are also gradually from standardized development to scientific development, high-quality development process. In this study, we summarized the scientific and subject-oriented development of China clinical research industry in recent years, and continuously strengthened the international competitiveness of China pharmaceutical industry. It is suggested that scientific thinking model should be used to deal with the normative problems in clinical research and promote the development of medical model to scientific model.