Objective To evaluate the methodological quality of clinical trials on traditional Chinese medicine (TCM) nursing in recent six years.Methods Such databases as CNKI, VIP, WanFang Data and CBM were searched for collecting clinical trials on TCM nursing published from January 2006 to September 2011, and domestic primary nursing journals were also searched from January 2010 and September 2011. Methodological quality of included studies was assessed using quality assessment criteria of the Cochrane systematic review guideline. Results A total of 854 clinical trials were retrieved, including 706 (82.7%) randomized controlled trials (RCTs), 108 (12.6%) quasi-randomized controlled trials and 40 (4.7%) non-randomized controlled trials. In the methodological quality analysis, the comparability of baseline was mentioned in 784 trials (91.8%), a total of 498 (58.3%) reported definite diagnosis criteria. 178 (20.8%) reported exclusive criteria. 831 studies (97.3%) applied relevant statistical methods properly. However, only 55 trials (6.4%) mentioned the method of randomization sequence. 10 studies (1.2%) described the method of randomiztion assignment. Blinding was mentioned in 22 studies (2.6%). 98 trials (11.5%) did prospective follow-up. 93 trials (10.9%) had safety description. 20 trials (2.3%) reported lost and with drawl cases, but only 2 conducted intention-to-treat analysis. It was hard to determine whether there was selective reporting bias or not because all the studies did not have protocols. Only 21 studies (2.5%) mentioned the lack of outcome indicators which could be the evidence for existing of bias. By annual analysis, there were 81 trials which conformed to at least 2 low risk criteria. 10 trials (12.3%) was published in 2009, 26 trials (32.1%) published in 2010, and 27 trials published by September 2011, indicated an uptrend. Conclusions According to the Cochrane Collaboration’s tool for assessing risk of bias, the overall quality of clinical trials on TCM nursing is low with defects in different degrees, but it rises gradually over years.
A core outcome set (COS) is an agreed minimum set of outcomes that should be reported in all clinical trials in specific areas of health care. The use of COS can reduce the heterogeneity of outcomes reporting in different trials and enhance evidence synthesis in systematic review/meta-analysis by including more studies with the same outcome. It can also enhance the value of trials and reduce cost waste to some extent. Recently, Core Outcome Measures in Effectiveness Trials (COMET) initiative has developed the COMET handbook (version 1.0). This handbook discussed the problems of COS research and made some recommendations. This paper interprets the COMET handbook (version 1.0) and analyses its insight on the construction of TCM clinical research COS, combined with the characteristics of TCM clinical research, in order to provide a reference for related researchers.
ObjectivesTo systematically review the efficacy of absorbable barbed suture versus traditional absorbable suture in total knee arthroplasty (TKA).MethodsPubMed, EMbase, The Cochrane Library, CBM, WanFang Data, CNKI and VIP databases were electronically searched to collect clinical trials of absorbable barbed suture versus traditional absorbable suture in TKA from inception to November, 2017. Two reviewers independently screened literature, extracted data and assessed risk of bias of included studies, then, meta-analysis was performed by using RevMan 5.3 software.ResultsA total of 6 randomized controlled trials (RCTs) and 5 cohort studies were included, involving 2 008 patients. Meta-analysis showed that the joint capsule suture time of the absorbable barbed suture group [MD=–4.31, 95% CI (–4.72, –3.90), P<0.000 01], the incidence of acupuncture injury during suture [OR=0.14, 95% CI (0.03, 0.61),P=0.009], and incision complication rate [OR=0.56, 95% CI (0.36, 0.88), P=0.01] were significantly lower than the traditional absorbable suture group, but the incidence of suture fracture [OR=23.03, 95% CI (3.08, 172.09),P=0.002] was higher, yet the difference was statistically significant. There were no significant differences in the incidence of superficial infection, deep infection, aseptic redness, incision dehiscence and KSS score at 3 months after operation (P>0.05).ConclusionsAvailable evidence suggests that the use of absorbable barbed sutures to close the TKA surgical incision shortens the time to suture the joint capsule, reduces the incidence of acupuncture injury as well as the overall incidence of incision complications without increasing superficial infection, deep infection, and sterility. The incidence of redness and incision splitting has no significant effects on joint function at 3 months after surgery, however the incidence of suture fracture is higher. Due to limited quality and quantity of the included studies, the above conclusions are required to be verified by more high-quality studies.
The use of placebo controls in acupuncture trials has been an international concern for many years. We discussed some common problems in placebo controls and introduced four kinds of control methods (sham acupuncture, non-points acupuncture, minimal acupuncture and non-specific sites acupuncture). For sham acupuncture, non-points acupuncture and non-specific sites acupuncture, patients who have received acupuncture are liable to doubt the intervention they are taking. Minimal acupuncture has better reliability but is limited to use in many diseases for its physiological effect. Needling on some special parts of the body, for example, head and back side of the body, can make balance among factors as reliability, physiological effect and feasibility. This paper recommends a control method needling special parts according to the tradiontional acupuncture theory, which provides references for acupuncture clinical trials.
Objective To compare the balance of simple randomization, stratified blocked randomization and minimization. Methods Monte Carlo technique was employed to simulate the treatment allocation of simple randomization, stratified blocked randomization and minimization respectively, then the balance of treatment allocation in each group and the balance for every prognostic factor were compared. Results The simulation demonstrated that minimization provides the best performance to ensure balance in the number of patients between groups and prognostic factors. Balance in prognostic factors achieved with stratified blocked randomization was similar to that achieved with simple randomization. Conclusion Minimization offers the best balance in the number of patients and prognostic factors between groups.
To evaluate the clinical efficacy and safety of piperacillin/ tazobactam in the treatment of hospital acquired pneumonia( HAP) . Methods A multicenter, open-labeled, non-comparative clinical trial was conducted. Patients with HAP were administered intravenously with piperacillin /tazobactam( 4. 5 g) every 8 h for 7-14 days. Results A total of 250 patients were enrolled in this study and 246 subjects were clinical valuable. At the end point, the clinical efficacy rate was 81. 7% ( 201 /246) and the bacterial eradication rate was 74. 1% ( 83 /112) . The rate of drug related adverse events was 2. 8% ( 7 /250) , in which 4 cases had clinical significance ( rash, dyspnea, injection site pain and diarrhea, respectively) and 3 cases had abnormal laboratory findings ( hepatic dysfuction , eosinophilia and so on ) . All events were mild and transient . Conclusions Piperacillin/ tazobactamis effective and safe in the treatment of HAP, therefore, it is recommended as one of the first-line antibiotics to treat the patients with HAP.
Objective To evaluate the efficacy and safety of safflower yellow pigment lyophilized power amp; dripping solution in the treatment of patients with angina, by using parenteral solution of Dan-shen root extraction as control, we designed the nonferiority clinical trial phase Ⅲ. Method 784 patients with stable angina pectoris Ⅰ, Ⅱ, Ⅲ degree and occurred more than twice per week were selected. They were randomly, stratified and blindly assigned into 5 parallel groups including one control. They were treated by using safflower yellow pigment lyophilized power (SYPLP) 80 mg + 0.9% NS 250ml, intravenously guttae, daily (trial group 1); SYPLP 160 mg + 0.9% NS 250 ml, intravenously guttae, daily (trial group 2); safflower yellow pigment lyophilized dripping solution (SYPLDS) 200 ml (160 mg), intravenously guttae, daily (trial group 3); SYPLDS 100 ml (80 mg), intravenously guttae, daily (trial group 4) and parenteral solution of Dan-shen root extraction 20 ml + 0.9% NS 250 ml, intravenously guttae, daily (control group) respectively. Efficacy and safety were evaluated after 14 days of continuous treatment. Results The angina efficacy (per-protocol population, PP): The notable effective rates of trial groups 1 to 4 and control group were 53.27%，69.44%，70.09%，55.09% and 26.00% respectively, and the effective rates were 88.79%，92.59%，93.46%，89.81% and 73.00% respectively。There was significant differences between trial group 1 and 2, trial group 3 and 4. All trial groups showed significant different effect when compared with control (P＜0.05). The effect of trial group 2 was better than those of trial group 1, and trial group 3 better than trial group 4, the four trial groups better than control group. The intention-to-treat (ITT) analysis result was almost the same to PP analysis, but trial group 3 showed no significant difference to trial group 4. In trial group 2, 3 and 4, each occurred one adverse effect, while the number was 10 in control group.Conclusion SYPLP amp; SYPLDS have certain effect on angina. They are more effective than parenteral solution of Dan-shen root extraction. No toxic side effect has been found in clinic tests.
Controversy exists regarding the ethics of using placebo control groups in clinical trials when effective treatments exist. The debate was fueled by the announcement of the 5th revision of the Declaration of Helsinki (2000). This study reviews the history and scientific background surrounding the controversy and investigates the prevailing attitudes of Hong Kong researchers regarding this issue. The controversy has centered on a few issues. The first involves the methodological superiority of placebo-controlled trials in discerning treatment effects. Secondly, it is unclear if the treatment effects encompass absolute treatment effects (including placebo effects) or are confined to treatment-specific effects (excluding placebo effects). Thirdly, there are worries that subjects in the placebo group could be exposed to higher risk for developing serious adverse events. Fourthly, it is debated whether the standard of best available treatment should be a local one, or an international one. Preliminary research findings suggest that the opinions of the Hong Kong researchers seemed to be divided on the use of placebo control groups in clinical trials when effective treatment exists. Further researcher on the topic is therefore warranted, training and consensus meeting may be necessary to minimize the confusion related to this issue.
Compared with traditional medical devices, artificial intelligence medical devices face greater challenges in the process of clinical trials due to their related characteristics of artificial intelligence technology. This paper focused on the challenges and risks in each stage of clinical trials on artificial intelligence medical devices for assisted diagnosis, and put forward corresponding coping strategies, with the aim to provide references for the performance of high-quality clinical trials on artificial intelligence medical devices and shorten the research period in China.