ABSTRACT
The development and influencing factors of compliance behavior of investigators in clinical trials were explored. According to literature review, a hypothetical model of development of compliance behavior of investigators in clinical trials was established, and the influencing factors of compliance behavior of investigators and their interrelationships were studied based on questionnaire survey of five hundred investigators sampled randomly from one hundred clinical trial institutions in China. Cronbach's alpha coefficient and structural equation modeling were adopted to empirically analyze the results. Six variables in the hypothetical model were included: compliance behavior of investigators, credibility of clinical trial, capability of government regulation, quality control of sponsor, quality control of clinical institution and compliance intention of investigators. Empirical analysis showed that the compliance behavior of investigators in clinical trial was directly affected by compliance intention of investigators, quality control of sponsor and quality control of clinical institution. In addition, credibility of clinical trial and capability of government regulation indirectly affected the compliance behavior of investigators in clinical trial through influencing the compliance intention of investigators, quality control of sponsor and quality control of clinical institution. Quality control of sponsor was affected by credibility of clinical trial and capability of government regulation while quality control of clinical institution was only influenced by capability of government regulation.
Subject(s)
Humans , China , Clinical Trials as Topic , Quality Control , Research Personnel , Surveys and QuestionnairesABSTRACT
The development and influencing factors of compliance behavior of investigators in clinical trials were explored. According to literature review, a hypothetical model of development of compliance behavior of investigators in clinical trials was established, and the influencing factors of compliance behavior of investigators and their interrelationships were studied based on questionnaire survey of five hundred investigators sampled randomly from one hundred clinical trial institutions in China. Cronbach's alpha coefficient and structural equation modeling were adopted to empirically analyze the results. Six variables in the hypothetical model were included: compliance behavior of investigators, credibility of clinical trial, capability of government regulation, quality control of sponsor, quality control of clinical institution and compliance intention of investigators. Empirical analysis showed that the compliance behavior of investigators in clinical trial was directly affected by compliance intention of investigators, quality control of sponsor and quality control of clinical institution. In addition, credibility of clinical trial and capability of government regulation indirectly affected the compliance behavior of investigators in clinical trial through influencing the compliance intention of investigators, quality control of sponsor and quality control of clinical institution. Quality control of sponsor was affected by credibility of clinical trial and capability of government regulation while quality control of clinical institution was only influenced by capability of government regulation.
ABSTRACT
Objective To study the incidence of complications of visceral and vascular injury in laparoscopic surgery for gynecologic diseases,and to discuss the ways to decrease the incidence. Methods The data of 2684 patients who received laparoscopic surgery from Januray 2003 to December 2005 in the Department of Obstetrics and Gynecology were reviewed retrospectively.The incidence and treatment of complications of visceral and vascular injury were observed. Results The total incidence rate of complications was 2.53%(n=68),and that of the visceral and vascular injury was 0.37%(n=10).Four cases of injury were related with trocar punctures(injury of omental blood vessel,n=2;postperitoneal vessel,n=2),three took place during the operation (severe bleeding,n=1;bladder injury,n=2),and the other three were observed in the postoperative stage(ureter injury,n=2;intestinal fistula,n=1). Conclusion The complications in laparoscopic surgery for gynecologic diseases are increased with the extension and difficulty of operation,and are closely related with the experience of the surgeons.Proper candidates for the surgery and established operative technique are the key factors in decreasing the incidence.