Objective To systematically review the effectiveness of Yindan Xinnaotong capsule for cardiovascular and cerebrovascular diseases. Methods We electronically searched databases including PubMed, MEDLINE, CBM, CNKI, VIP, WanFang Data for published articles of randomized controlled trials (RCTs) of Yindan Xinnaotong capsule plus conventional drugs versus conventional drugs for cardiovascular and cerebrovascular diseases from inception to April, 2016. According to the inclusion and exclusion criteria, two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then, meta-analysis was performed using RevMan 5.3 software. Results A total of 62 RCTs involving 6 306 patients with cardiovascular and cerebrovascular diseases were included. The results of meta-analysis showed that the improvement of symptoms, such as the total clinical effective rate of cerebrovascular disease indications (stroke) (RR=1.25, 95% CI 1.19 to 1.31,P<0.000 01), and the total clinical effective rate of cerebrovascular disease (ischemic headache) indications (RR=1.27, 95% CI 1.17 to 1.38,P<0.000 01), and the total clinical effective rate of coronary heart disease and angina pectoris (RR=1.21, 95% CI 1.17 to 1.25,P<0.000 01), were superior in the combination arm to the conventional drugs alone arm. Conclusion The current evidence shows that the combination of Yindan Xinnaotong capsule and conventional drugs may significantly improve the effectiveness. Due to the limited quality and quantity of the included studies, the above conclusions need more high quality studies to verify.
Objective To compare the effectiveness of anatomical single-bundle (ASB) and over-the-top singlebundle (OSB) reconstruction of the anterior cruciate l igament (ACL). Methods Between January 2008 and June 2008, 64 patients with ACL injury underwent arthroscopic ACL reconstruction. ASB ACL reconstruction was performed in 28 cases (ASB group) and OSB ACL reconstruction in 36 cases (OSB group). There was no significant difference in gender, age, diseaseduration, International Knee Documentation Committee (IKDC) score, Lysholm score, and side-to-side difference between 2 groups (P gt; 0.05). Results All incisions healed by first intention; no infection or other compl ications occurred. All cases were followed up 20-24 months (mean, 21.5 months). There were significant differences in the IKDC score, Lysholm score, and the side-to-side difference between last follow-up and preoperation in 2 groups (P lt; 0.05), but there was no significant difference between 2 groups at last follow-up (P gt; 0.05). Significant differences were found in negative rate of the pivot shift test between last follow-up and preoperation in ASB group and between 2 groups at last follow-up (P lt; 0.05), but there was no significant difference between last follow-up and preoperation in OSB group (P gt; 0.05). Conclusion The effectiveness of arthroscopic ASB ACL reconstruction is better than that of arthroscopic OSB ACL reconstruction, especially in controll ing rotational stabil ity.
To analyze the effectiveness of anterior cruciate l igament (ACL) reconstruction with preserving the remnant ACL by allograft l igament. Methods Between January and July in 2008, 97 patients underwent ACL reconstruction with the allograft l igament. On the basis of the ACL’s condition, patients were divided into 2 groups. In the trial group (patients having remnant ACL, n=38), there were 27 males and 11 females with an average age of 24.3 years (range, 16-43 years); of them, 8 cases compl icated by menicus injury and 13 cases by Outbridge I degree cartilage injury; the time from injuryto operation was 3-20 weeks (mean, 8.6 weeks). In the control group (patients having no remnant ACL, n=59), there were 35 males and 24 females with an average age of 27.8 years (range, 18-48 years); of them, 16 cases compl icated by menicus injury and 23 cases by Outbridge I degree cartilage injury; the time from injury to operation was 4-44 weeks (mean, 12.7 weeks). All injuries were caused by sports in 2 groups. All patients had positive anterior drawer test and positive Lackman test. Before operation and 3, 8, 9, 15 months after operation, the function of the knee joint was evaluated by the International Knee Documentation Committee (IKDC) scale and Lysholm score. KT-2000 arthrometer was used to evaluate knee laxity. Results All incisions healed primarily, and no intraarticular infection occurred. Thirty-seven cases and 57 cases were followed up 15 months in the trial group and the control group, respectively. Knee instabil ity disappeared; the patients showed negative anterior drawer test and negative Lackman test. By the evaluation of KT-2000, the joint sl ippage of 2 groups were less than 2 mm at 3 and 6 months after operation, but it was more than 2 mm in 2 cases of the trial group and in 3 cases of the control group at 9 months after operation; and it was no change in the trial group and 2.5-4.0 mm (mean, 3.4 mm) in the control group at 15 months after operation. Both the IKDC scale and Lysholm score were higher in the trial group than in the control group 3 months after operation, but the differences were not significant (P gt; 0.05). Both the IKDC scale and Lysholm score were
Stepped wedge cluster randomized trials (SW-CRT) is a kind of cluster randomized controlled trial mainly applied in the field of public health policy that has emerged in recent years, which has gradually attracted the attention of workers in the field of health and wellness. At present, this trial method is not widely used at home and abroad, and there are various ways of sample size calculation and statistical analysis. This paper describes the principles, categories, and differences between SW-CRT and traditional randomized controlled trials, and outlines sample size calculation and statistical analysis methods. In general, SW-CRT is characterized by clustering, cross-design, and measurement of results at multiple time points. In terms of sample size calculation, it is necessary to distinguish between clusters with the same and different sizes, and commonly used sample size calculation procedures can be implemented in Stata, R, and SAS software, as well as in fixed online websites, including the "Steppedwedge" program, the "swCRTdesign" program, the "Swdpwr" program, the "CRTpowerdist" program, and the "Shiny CRT Calculator" tool and so on. Based on the design characteristics of SW-CRT, the researcher should also consider the confounding factors of time effects and repeated measurements of result. Therefore, the statistical analysis methods are often based on generalized linear mixed model (GLMM) and generalized estimating equations (GEE). However, most of the above models have been proposed based on cross-sectional studies, there is a lack of statistical methods for queue design and SW-CRT with transitional period now, and more comprehensive methodological exploration is still needed in the future.
ObjectiveTo evaluate the reporting quality of clinical randomized controlled trials (RCTs) published in five Chinese psychiatric journals from 2016 to 2020 and to compare the reporting quality with that from 2004 to 2008. MethodsRCTs in five Chinese psychiatric journals were collected through a computerized search of the CNKI, WanFang Data, and CBM databases and manual searches of paper journals, all with a search timeframe from 2016 to 2020. The CONSORT 2010 statement and two extensions (CONSORT extension for abstracts and CONSORT harms extension) were used to evaluate the RCTs. The criteria for reporting quality were the evaluation score, reporting proportion, and compliance proportion. The reporting quality of RCTs in the past 5 years was compared by year group. In addition, the RCT reporting quality from 2004 to 2008 was compared with that from 2016 to 2020. ResultsIn total, 226 RCTs were included. There was no statistically significant difference in the total evaluation score or abstract score from 2016 to 2020 (F=0.54, P=0.71; H=1.49, P=0.83). However, there were statistically significant differences in the harm scores from 2016 to 2020 (H=10.78, P=0.03). Further analysis of the items revealed statistically significant differences in the reporting proportion of items 16 and 19 (Fisher’s=8.61, P=0.04; χ2=11.63, P=0.02) and no significant differences in the other items (P>0.05). The reporting proportion of defined primary and secondary outcome indicators, allocation concealment, randomization implementation, outcomes and estimation, generalization, trial registration, and flow chart was <10% in each year. There was a statistically significant difference in the compliance proportion of RCT reporting quality from 2016 to 2020 versus 2004 to 2008 (39.54%±8.92% vs. 34.76%±9.16%, t=6.60, P<0.001). ConclusionThe reporting quality of RCTs in five Chinese psychiatric journals from 2016 to 2020 is better than that from 2004 to 2008. However, the reporting quality of RCTs within the latter 5 years still have reporting deficiencies in important items, and many aspects still are needed to be improved and enhanced.
Under the background of the global COVID-19 pandemic, electronic informed consent (eConsent) utilizes technology to provide a new method and idea for clinical trials. It has the advantages of convenience and efficiency, which greatly improves the efficiency of clinical trials. At present, this concept has not been put forward in China while it has been clarified clearly abroad, and some countries have launched a variety of trials and formulated various regulations to further standardize the eConsent. Based on the current situation of eConsent in China, this study analyzed the design and implementation of eConsent, summarized relevant domestic and foreign laws and regulations, and proposed opportunities and challenges for electronic informed consent as well as the relevant preparations for the implementation of this technology in China.