Objective To set up and to evaluate an acute closed brain injury model in rats. Methods The acute closed brain injury was produced in rats by using an impactor consisting of a stand, a guide tube, a weight and a footplate. Ninetysix SD rats were divided into a control group(n＝32, no impact), a mild injury group(n＝32, impact once at force level of 400 g·cm) and a severe injury group(n＝32, impact once at force level of 800 g·cm) to elucidate the physiological responses, the pathophysiological changes and brain edema after brain injury at different injury levels. Results In the mild injury group and the severe injury group, a sudden rise or reduction of blood pressure, deep and fast breath apnea, and pain reflects inhibition were observed. The responses were more obvious in the severe injury group than in the mild injury group. The water content of the brain increased after 6 hours of injury. The pathological contusion and edema of brain were noted or above the impact force level of 800 g·cm. When the impact force rose to or over 1200g·cm, the animals died of persistent apnea mostly. Conclusion Although the established closed brain injury model with different biomechanical mechanisms as the clinical brain injury, it is in conformity with pathological changes and pathophysiological characteristics of acute clinical brain injury, it can be utilized extensively because of its convenient and practice.
ObjectivesTo provide a reference for the evaluation procedures of genetic testing technology applicable to China by combining the existing evaluation frameworks and procedures for genetic testing techniques globally, and also put forward design suggestions for the construction of evaluation procedures in China.MethodsThe literature research method was primarily used to summarize different evaluation progress, as well as put forward design suggestions.ResultsAt present, numerous developed countries have organized genetic testing technology evaluation projects. The various evaluation frameworks developed were based on the ACCE or HTA framework. The evaluation and decision-making procedures were similar in general, including topic selection, evaluation implementation, results reporting and making recommendations. However, there still remained difficulties such as limited evidence and uncertainty in decision-making.ConclusionsTo establish the procedures of genetic testing technology applicable in China, the following specific procedures are recommended: selecting target genetic testing technology topics; analyzing necessity and feasibility of target testing technology evaluation; evaluating and reviewing the evidence; applying results and decision-making transformation; developing regular review and revision mechanisms.
Active medical device is a kind of medical device which is widely used. In order to realize the goal of high-quality development, product with high reliability is a necessary requirement for the domestic active medical device industry. By means of literature research, data collection, field research, materials comprehensive combing and analysis, this paper systematically analyzes and studies the current situations and the existing problems of reliability and evaluation from the dimensions of Chinese active medical device industry policy, enterprise situation and evaluation method. In addition, by considering the technical characteristics of reliability work, concrete suggestions for solving the problems are given from the directions of standard and guiding principle, so as to provide reference for active medical device industry to develop scientific and objective reliability technical standard system and guiding principle, which are in accord with the current characteristics of Chinese active medical device industry and supervision.
The background and status of the quality assessment instruments of clinical trials, and several frequently used instruments both domesticly and abroad were introduced, and the problems in this field were discussed.
ObjectiveTo evaluate the usefulness of estimation of physiologic ability and surgical stress (E-PASS) for predicting postoperative complications in patients undergoing elective colorectal cancer surgery. MethodsPatients underwent colorectal cancer surgery between August 2009 and October 2010 were analyzed retrospectively. E-PASS equations were applied to those patients for estimation of operative risk. The preoperative risk score (PRS), surgical stress score (SSS), and comprehensive risk score (CRS) of the E-PASS were compared with actual postoperative complications. The relationship between E-PASS variables and morbidity after colorectal cancer surgery was identified. ResultsOf the 313 patients, 22 (7.0%) had postoperative complications. Of all the E-PASS variables between complicative group and noncomplicative group, the morbidity was significantly correlated to age (P=0.003), weight (P=0.019), tumor histologic types (P=0.033), Dukes stage (P=0.001), severe heart disease (P=0.019), severe pulmonary disease (P=0.000), performance status (P=0.000), loss of blood volume/body weight (P=0.007), loss of blood volume (P=0.001) and operation time (P=0.001). Differentiation degree of tumor (P=0.503), diabetes (P=0.745), ASA grade (P=0.085), and size of surgical incision (P=0.726) were not significantly associated with postoperative complications. The PRS and CRS were higher in complicative group than those in noncomplicative group (Plt;0.001). But the difference of SSS between the two groups was not statistically significant (P=0.059). ConclusionThe E-PASS scoring system is a relatively simple, fast, and operable tool that can be used to predict short-term postoperative morbidity accurately for clinical decision-making in colorectal cancer surgery.
The purpose of this paper is to discuss the evaluation standard of rationality of medical examination from different perspectives, so as to provide theoretical evidence for medical department to establish the evaluation standard of the rationality of medical examination. By researching the relevant literature in the field of rational medical examination and combing the existing research results, this paper discusses the evaluation criteria of the rationality of medical examination from four dimensions: technology, ethics, law, and health economy. The following four suggestions are proposed for the current status of medical examination: construct clinical pathway management to avoid excessive medical examination; establish the internal supervision and evaluation mechanism to improve the professional quality of medical staff; improve medical examination-related policies, laws, and regulations, carry out specialized legislation; apply diagnosis-related group payment method, control the cost of medical examination.
Objective To systematically review the methodological quality of guidelines concerning infertility, so as to provide references for clinical practice. Methods Guidelines concerning infertility were electronically retrieved (from inception to Feb. 2013) in PubMed, EMbase, CBM, WanFang Data, CNKI, GIN guideline database guideline development websites (including NGC, NICE, SIGN, NZGG, SOGC, etc.), and medical associtation websites (including IFFS, FIGO, ESHRE, NFOG, RCOG, ASRM, ACOG, etc.). We also searched Chinese guideline websites including the website of the National Health and Family Planning Commission of People’s Republic of China, CGC (China Guideline Clearinghouse), and CPGN (Clinical Practice Guideline Net). Two reviews independently screened literature according to the inclusion and exclusion criteria, and assessed the quality of guideline development and reporting using the Appraisal of Guidelines for Research and Evaluation (AGREE II). Results a) A total of 16 guidelines concerning infertility were included, with development time ranging from 1998 to 2012. Among 16 guidelines, 10 guidelines were made by the USA, 3 by Britan, 1 by the Europe, and 1 by America and Europe. b) The scores of guidelines according to the domains of AGREE II decreased from “Clarity of presentations, scope and purpose”, “Participants”, “Applicability”, “Rigour of development”, and “Editorial independence”. 16 guidelines were generally low in quality. The levels of recommendations were Level A (5 guidelines), Level B (8 guidelines), and Level C (3 guidelines). c) Four evidence-based guidelines scored the top three in the domain of “Rigour of development”. d) The recommendations of different guidelines were fairly the same. e) No guidelines on infertility have been developed in China. Conclusion a) The guidelines on infertility should be improved in “Rigour of development” and “Applicability” in future. Conficts of interest should be addressed. b) Guidelines are recommended to be developed on the basis of the methods of evidence-based medicine, and best evidence is recommended. c) National organizations such as ASRM should be established in China, so as to develop biomedicine and TCM guidelines based on evidence and regulate the treatment. d) For the general assessment of guidelines, AGREE II should offer threshold criteria of suggestion.
Objective To explore the evaluation index and appointment mechanism of healthy professional titles. Methods We collected the data of people evaluated and appointed as advanced professional titles, and the evaluation and appointment documents in West China Hospital. We analyzed the evaluation index and appointment mechanism. Results A total of 400 people gained senior title promotion. The evaluation indexes focused on academic degrees, papers, research projects, patents, as well as awards and honors. The research achievements reduced of 80% people who had gained senior titles. Conclusion Current evaluation indexes prefer to inflexible index and ignore flexible index. The appointment mechanism lacks outcome evaluation, and the professional title will not be eliminated once appointed. In the future, we should improve the evaluation index and appointment mechanism focusing on the specific characteristics of healthy professional titles.
Objective To introduce the evidence-based evaluation on off-label uses at home and abroad, so as to investigate a systematic method of evidence-based evaluation on off-label uses. Methods In combination with the domestic and international research literature, a systematic method of evidence-based evaluation on off-label uses was discussed from the following three aspects: sources of evidence, levels of evidence, and recommendation strength. Results Sources of evidence included Clinical Pharmacology, DRUGDEX? System, NCCN Drugs amp; Biologics Compendium and handsearched literature. Levels of evidence and recommendation strength could refer to the 2009 grade system of Oxford Centre for Evidence-Based Medicine, and the strength of recommendations and scientific support of DRUGDEX? System. Conclusion A systematic method of evidence-based evaluation on off-label uses is initially established.
With the flourishing career of scientific research, the number of medical literature is in the explosion of growth. According to the statistics revealed by the Royal Society in March 2011, it showed that the proportion of published literature in China increased from 4.4% at the beginning of this century to 12.2%, and leaped into the second rank of the world. But the citations lagged behind the growth in number. In addition, the quality of medical literature relates to the reliability of results. Therefore, how to evaluate and improve the quality of medical literature is important. This paper will present some evaluation methods of credible medical literatures.