In the process of evidence-based practice, the evaluation of evidence applicability relied on the subjective judgment of clinicians, while the systematic method of which was still in lack. The complex clinical information of traditional Chinese medicine (TCM) enhanced the uncertainty and risk of applying evidence. Based on the analysis of the process of evidence-based practice, this paper introduced the method of TCM evidence applicability evaluation and used the raw data of clinical trials to develop a clinical prediction model to enable the assessment of the evidence applicability on individual patients. The establishment of individual evidence applicability evaluation method could promote the rational application of TCM evidence in the long term.
The prominent feature and form of clinical diagnosis and treatment of traditional Chinese medicine is individualization, which has generated difficulty for clinical evaluation and has restricted the production of high-level evidence for traditional Chinese medicine for a long time. Based on the complexity and dynamics of individualized information under the characteristics of time and space, this paper references the theory of space-time of system science to analyze the individualized data of diagnosis and treatment of traditional Chinese medicine and summarizes the concept of the long time course for clinical evaluation. Based on the concept of the long time course, this paper starts with the origin of clinical evaluation, which is the construction of clinical problem elements named PICO, introduces dynamic evaluation factors, explores the construction of individualized dynamic evaluation method of traditional Chinese medicine, and provides demonstration and examples for the design and implementation of individualized clinical research in future.
Objective To evaluate the clinical effectiveness of laparoscopic cholecystectomy and laparoscopic common bile duct exploration （LC＋LCBDE） and endoscopic retrograde cholangiopancreatography/endoscopic sphincterectomy with LC（ERCP/EST＋LC） in treatment for cholecystolithiasis with choledocholithiasis. Methods From January 2008 to July 2011， 127 patients suffered from cholecystolithiasis with choledocholithiasis underwent either LC＋LCBDE（85 cases， LC＋LCBDE group） or ERCP/EST＋LC（42 cases， ERCP/EST＋LC group） were collected retrospectively. The clearance rate of calculus， hospital stay， hospitalization expenses， and the rate of postoperative complications were compared between two groups. Results Eighty-five patients were performed successfully in the LC＋LCBDE group， out of which 54 patients had primary closure of common bile duct （LC＋LCBDE primary closure group）， whereas in 28 patients common bile ducts were closed over T tube （LC＋LCBDE＋T tube group）. Forty-two patients were performed successfully in the ERCP/EST＋LC group. There were no differences in the clearance rate of calculus〔100%（82/82） versus 97.37%（37/38）， P=0.317〕 and postoperative complications rate 〔（4.71% （4/85） versus 4.76%（2/42）， P=1.000〕 between the LC＋LCBDE group and ERCP/EST＋LC group. The median （quartile） hospital stay in the LC＋LCBDE group was shorter than that in the ERCP/EST＋LC group 〔12 （6） d versus 17（9） d， P＜0.001〕. In the LC＋LCBDE primary closure group， both median （quartile）?hospital stay and median（quartile） hospitalization expenses were less than those of ERCP/EST＋LC〔hospital stay：11（5） d versus 17（9） d， P＜0.001；hospitalization expenses：27 054（8 452） yuan versus 31 595（11 743） yuan， P=0.005〕 . Conclusions In the management of patients suffered from cholecystolithiasis with choledocholithiasis， both LC＋LCBDE and ERCP/EST＋LC are safe and effective. LC＋LCBDE， especially primary closure after LCBDE， is associated with significantly less costs as compared with ERCP/EST＋LC. Moreover， patients can be cured by LC＋LCBDE through one-stage treatment with the protection of the papilla function and no limits to the amount or size of the choledocholithiasis. The LC＋LCBDE is a preferable choice for the appropriate cases of cholecystolithiasis with choledocholithiasis.
