Objective To systematically review the clinical effectiveness and safety of programmable valves (PV) vs. standard valves (SV) for hydrocephalus. Methods Literature search was conducted in PubMed, The Cochrane Library, EMbase, CNKI, CBM, VIP and WanFang Data to collect both randomized controlled trials (RCTs) and non-randomized concurrent controlled trials on hydrocephalus treated by PV and SV published from January 1992 to January 2012. According to the inclusion criteria, two reviewers independently screened articles, extracted data, and evaluated and cross-checked the quality of the included studies. Then meta-analysis was performed using RevMan 5.0 software. Results A total of 11 non-randomized concurrent controlled trials involving 1,485 participants were included. The results of meta-analysis showed that, compared with SV, PV was superior in overall effective rate (RR=1.14, 95%CI 1.03 to 1.27, P=0.01), 2-year survival rate (RR=1.25, 95%CI 1.04 to 1.51, P=0.02), secondary surgery rate (RR=0.53, 95%CI 0.39 to 0.73, Plt;0.001), overall complications rate (RR=0.62, 95%CI 0.51 to 0.76, Plt;0.001), and over-drainage/ under-drainage rates (RR=0.42, 95%CI 0.21 to 0.83, P=0.01). But there were no significant differences in 1-year survival rate (RR=1.04, 95%CI 0.91 to 1.19, P=0.55), postoperative infection rate (RR=1.08, 95%CI 0.73 to 1.60, P=0.71) and valve related complication rate (RR=0.80, 95%CI 0.56 to 1.21, P=0.20) between the two groups. Conclusion Current evidence suggests that PV is superior to SV in increasing the effective rate, decreasing complications, and prolonging the long-term survival rate. Because of the limitation of quantity and quality of the included studies, more high quality, multicenter and double-blind RCTs are needed to prove whether PV can be clinically recommended as a preferred drainage surgery or not.
Objective To evaluate the effect of standardized patient (SP) used in nursing fundamental. Methods Randomized controlled trials (RCTs) or quasi randomized controlled trials (q-RCTs) about comparing standardized patients with traditional teaching method in nursing fundamental were searched from the following electronic databases: PubMed, EMbase, The Cochrane Library, CNKI, CBM, VIP and so on. The methodological quality of the included RCTs was assessed according to the quality assessment scale developed by Smits PB, and the valid data were extracted and meta-analyzed with the Cochrane Collaboration’s RevMan 5.0.17 software. Results Five RCTs and one q-RCT involving 585 participants were included. The results of quality evaluation showed that the scores of five studies were more than or equaled 30. Descriptive analyses were only used because there was clinical heterogeneity between different studies. Comparing with traditional teaching method, SP teaching method in nursing fundamental improved the nursing procedure skills, the communication ability with patients and the ability of clinical judgment for nursing students. Conclusion The standardized patient teaching method is a prospective teaching mode. Because of the lack of RCTs about SP used in nursing fundamental, and the big difference of the teaching method and examine criteria in different studies, it is necessary to be verified in future by unified assessment methods and more researches with high quality.
Objective We aimed to investigate the attitude and suggestion from doctors, pharmacists and civil servants concerning brain death and organ transplantation and the legislation. Methods A questionnaire with 10 sections and 44 questions was designed and distributed. The effective questionnaire data was then recorded and checked for descriptive analysis. Results In 1 400 questionnaires distributed, 1 063 were responded and 969 of them were valid and analyzed. The respondents showed an incomplete understanding of brain death and organ transplantation laws. Seventy-four percent of the respondents recognized and accepted the standard of brain death. They agreed that legislation should be involved in the removal of organs for transplantation, the future use of the organs, and insurance and compensation for the donor for possible health risks induced by organ removal. Of the 969 respondents, 92% considered it necessary to have legislation in brain death and organ transplantation, and 61% thought that it is time to legislate. Conclusion Legislation for brain death and organ transplantation is urgent and timely in China. The laws must include the respective rights and obligations of patients, close relatives, and medical institutions. Educating the public about brain death and organ transplantation should also be encouraged in a variety of ways.
ObjectiveTo review the registration and technical data for sodium hyaluronate facial derma fillers. MethodsRecent literature concerning registration for sodium hyaluronate facial derma fillers was reviewed and analyzed. ResultsThe aspects on registration for sodium hyaluronate facial derma fillers include nominating the product, dividing registration unit, filling in a registration application form, preparing the technical data, developing the standard, and developing a registration specification. ConclusionThe main difficulty in registration is how to prepare the research data of that product, so the manufacturers need to enhance their basic research ability and work out a scientific technique routing which could ensure the safety and effectiveness of the product, also help to set up the supportive documents to medical device registration.
ObjectiveTo review the registration and technical data for breast implants. MethodsRecent literature concerning registration for breast implants was reviewed and analyzed. ResultsThe aspects on registration for breast implants are complicated. The major aspects include providing technical data, establishing develop standard, progress type test, and developing the registration specification. ConclusionThe manufacturers need to be well aware of the risk of this kind of product and have the full ability to conduct the researching and developing. Only the strict risk controlling can ensure the safety and effectiveness of the product.
Objective To compare the cl inical results between high-flexion and standard cruciate-stabling prostheses in total knee arthroplasty (TKA) by using the 36-item short form health survey (SF-36). Methods Between August 2007 and January 2009, 98 patients (106 knees) underwent TKA with standard cruciate-stabl ing prostheses (standard group), and 46 patients (50 knees) underwent TKA with high-flexion prostheses (high-flexion group). In standard group, there were30 males (32 knees) and 68 females (74 knees) with an age of (70.0 ± 3.5) years, including 78 cases (82 knees) of osteoarthritis (OA) and 20 cases (24 knees) of rheumatoid arthritis (RA) with a disease duration of (14.5 ± 3.3) years; the Hospital for Special Surgery Scoring System (HSS) and the range of motion (ROM) were 56.1 ± 21.6 and (89.0 ± 16.1)°, respectively. In high-flexion group, there were 8 males (10 knees) and 38 females (40 knees) with an age of (68.6 ± 8.9) years, including 44 cases (47 knees) of OA and 2 cases (3 knees) of RA with a disease duration of (13.9 ± 4.1) years; the HSS and ROM were 58.9 ± 25.3 and (91.0 ± 19.3)°, respectively. There was no significant difference in the general data (P gt; 0.05) between 2 groups, so the cl inical data of 2 groups had comparabil ity. Results In standard group, poor wound heal ing and persistent headache caused by cerebrospinal fluid leakage occurred in 1 case, respectively. In high-flexion group, transient common peroneal nerve palsy occurred in 1 case. There was significant difference (P lt; 0.05) in the hospital ization expense between standard group [ (39 000 ± 6 000)] and highflexion goup [ (52 000 ± 8 000)]. The follow-up time was 12-26 months (18 months on average) in standard group (91 cases, 98 knees) and 11-19 months (13 months on average) in high-flexion group (44 cases, 47 knees). The SF-36 showed significant difference in role-physical score (P lt; 0.05), but no significant difference in other 7 indices scores (P gt; 0.05). At the final follow-up, the ROM was (129.1 ± 19.2)° in high-flexion group and (123.6 ± 16.7)° in standard group; showing significant difference (P lt; 0.05). The HSS was 91.2 ± 17.6 in high-flexion group and 92.5 ± 14.5 in standard group; showing no significant difference (P gt; 0.05). Conclusion After TKA, the ROM in high-flexion group is superior to that in standard group, but there is no obvious advantages in terms of the HSS and SF- 36 outcomes.
Objective Tissue engineering advance in supplying the reparative and reconstructive medicine with promising tissue engineered medical products(TEMPs) and the new therapy alternative. The related supervision and administration of TEMPs is being developed and the standard research of TEMPs is also in progress. The Food and Drug Administration(FDA) of the United States has treated TEMPs as combined products and supervised them according to the level of risk to patients. Lately, FDA has determined that the Center for Devices and Radiological Health (CDRH) should take charge of examination and approval of TEMPs, with the cooperation of the Center for Biological Evaluations and Research(CBER). The regulatory controls have been established respectively in European Union and Japan. In China, TEMPs are identified as medical devices combined with cells. The Department of Medical Device of the State Food and Drug Administration (SFDA) is responsible for the examination and approval of TEMPs, and National Institute for the Control of Pharmaceutical amp; Biological Products(NICPBP) is responsible for evaluation tests. The standards of TEMPs are formulated mainly by the American Society of Testing Materials(ASTM) and International Standardization Organization(ISO).
Objective To investigate the awareness of rational use of drug (RUD) on medical workers in hospitals of different ranks, the establishment and execution of relevant strategies in hospitals of different ranks, and the main factors affecting RUD on medical workers, so as to provide references for the generalization of RUD. Methods A certain number of different ranks of hospitals in Chengdu and Zigong were randomly selected by the convenience sample method. Medical workers in each hospital were selected through face-to-face interviews with a self-designed questionnaire. Monte Carlo Chi-square analysis was applied on the hospital ranks and formulation of RUD guidelines, and logistic regression analysis was performed on the awareness of RUD knowledge of the respondents. Results Among 700 questionnaires distributed, 672 were retrieved (response rate 96.0%). The numbers of respondents who were familiar with the Pharmaceutical Affairs Councils (PACs) as well as the Pharmacy and Therapeutics Committees (PTCs) were 217 (32.29%) and 83 (12.35%), respectively. The number of respondents who understood the concept of essential medicine was 502 (74.71%). A total of 441 (61.16%) medical workers had been trained on RUD, 199 (29.61%) medical workers denied there were PTCs in their hospitals, and 60.71% of the medical workers mentioned that the use of drug was monitored and controlled with the feedback in their hospitals. The result of logistic regression analysis indicated that the professional title (P=0.038), awareness of essential medicine (Plt;0.001) and participation of RUD training (P=0.008) were the factors influencing the awareness of RUD. Conclusion Both management and education should be executed at the same time to elevate the level of rational use of drug. In order to increase the level of RUD we should complete monitoring institution and improving RUD awareness of workers. Additionally enhancing the rationality of medication should be performed by establishing guidelines of treatment or medication. Improving personal knowledge, scientific information and medication custom should be performed by standardizing regulations, strengthening management, emphasizing education and promoting communication between doctors and patients.
Objective To establish standards, methods and processes for evidence-based evaluation and selection of essential medicine that meet the needs of the 8 pilot township health centers in China. Methods A descriptive analysis was conducted to compare the similarities/differences and the advantages/disadvantages of the standards, methods and processes between the World Health Organization (WHO) essential medicines evaluation and selection, and the GRADE evidence quality and recommend intensity. In combination with the former outcomes of this series of study, the standards, methods and processes of evidence-based evaluation and selection of essential medicines in the domestic pilot township health centers were optimized, restructured and improved. Softwares such as GRADEprofiler were used to assess the quality of evidence. Results a) Localized standards, methods and processes for evidence-based evaluation and selection of essential medicine were established, and the evaluation tool was ascertained; and b) Disease and drug names, guidelines and searching processes for evaluation and selection of essential medicine were developed with standardized, systematic and transparent approaches. Conclusion a) Standards, methods and processes for searching, evaluating and recommending the best evidence are preliminarily established, through comparative analysis on the effectiveness, safety, cost-effectiveness and applicability of the candidate medicines for diagnosing, treating and preventing diseases in township health centers in China; b) Following the principle of “utilizing the best existing evidences and developing the urgently-needed but lacking evidence”, a good exploration was done for the localization, standardization and transparency of the standards, methods and processes of evidence-based evaluation and selection of essential medicine for pilot township health centers.
Since the medical research has becomes one of the basic responsibilities of medical staff, the education of medical research ethics plays a key role in standard transformation in the study of research ethics and publishing ethics. Based on the teaching of medical ethics for medial undergraduates, this paper discusses the feasibility of research ethics as the breakthrough point of medical ethics course to cultivate the scientific thought and ethic awareness of medical students, analyzes the shortages existing in the traditional teaching of medical ethics, and finally puts forward suggestions of the construction of medical humanism coping with the rapid improvement of medical science.