ObjectiveTo assess the efficacy and safety of S-amlodipine versus amlodipine, and 2.5 mg S-amlodipine versus 5.0 mg S-amlodipine in treating hypertension.MethodsMedline, Embase, CENTRAL, ClinicalTrials.gov, China National Knowledge Infrastructure, WanFang Data, and VIP databases were searched for randomized controlled trials (RCTs) about S-amlodipine for hypertension till January 2018. Two reviewers independently reviewed the literature, extracted data, and assessed the risk of bias of included RCTs. RevMan 5.3 software was used for meta-analysis.ResultsAll together 16 RCTs involving 3 946 patients were included. The results of meta-analysis showed that: (1) S-amlodipine vs. amlodipine: the levels of reduction in intima-media thickness [mean difference (MD)=–0.21 mm, 95% confidence interval (CI) (–0.35, –0.07) mm, P=0.003], pulse pressure [MD=–5.90 mm Hg (1 mm Hg=0.133 kPa), 95%CI (–8.57, –3.23) mm Hg, P<0.000 1], systolic pressure [MD=–5.08 mm Hg, 95%CI (–9.61, –0.55) mm Hg, P=0.03], and diastolic pressure [MD=–4.60 mm Hg, 95%CI (–7.82, –1.39) mm Hg, P=0.005] were all higher in the S-amlodipine group than in the amlodipine group, and the incidence of adverse event [relative risk=0.55, 95%CI (0.40, 0.77), P=0.000 4] was lower in the S-amlodipine group. But no significant differences were found in changes of left ventricular posterior wall thickness, heart rate, blood pressure variability between the two groups. (2) 2.5 mg S-amlodipine vs. 5.0 mg S-amlodipine: the levels of reduction in systolic pressure [MD=4.17 mm Hg, 95%CI (2.23, 6.11) mm Hg, P<0.000 1] and diastolic pressure [MD=1.84 mm Hg, 95%CI (1.17, 2.52) mm Hg, P<0.000 01] were higher in the 5.0 mg S-amlodipine group than in the 2.5 mg S-amlodipine group, but no significant difference was found in the incidence of adverse event between the two groups. None of the primary outcomes was analyzed because they were not reported by any one of the included studies.ConclusionsCurrent evidence shows that S-amlodipine is slightly superior to amlodipine in reducing intima-media thickness which could indirectly reflect the effect of interventions on endpoint outcome measures, blood pressure, pulse pressure, and the incidence of adverse event. 5.0 mg S-amlodipine is slightly superior to 2.5 mg S-amlodipine in reducing blood pressure, though comparable with the latter in the effect on incidence of adverse event. The effect of S-amlodipine on all the primary outcomes is unclear because none of the included studies reported on those. Due to limited quantity and quality of the included studies, more high quality studies are needed to verify the above conclusions.
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.
Objective To overview the systematic reviews of the effectiveness and safety of the charged-particle radiation therapy. Methods Databases including CNKI, WanFang Data, PubMed, and EMbase were electronically searched from January 2007 to November 2020. Two investigators independently screened literature, extracted data, and assessed the quality of the included studies by AMSTAR 2, and then reported results through a narrative synthesis of outcomes. Results A total of 6 systematic reviews were identified. One systematic review demonstrated moderate quality and the other 5 demonstrated critically low quality. The charged-particle radiation therapy had a wide range of applications. Its effectiveness was superior to traditional radiotherapy methods on various types of tumors in various regions of the body, with acceptable side effects. Specifically, the effectiveness and safety outcomes of carbon ion radiotherapy was superior to those of proton radiotherapy. Conclusions Current evidence shows that the charged-particle radiation therapy has superior effectiveness and limited toxicity, though the studies are of relatively low quality. High quality and larger sample size researches are required in the future.
ObjectiveTo explore the abilities of thesis writing of postgraduate medical freshpeople and their factors, and provide a basis for postgraduate education and course design of thesis writing.MethodsA designed questionnaire was administered to postgraduate medical freshpeople enrolled in West China Medical School of Sichuan University in 2020. The general characteristics, current status of skills or experiences related to thesis writing, and abilities including literature retrieval and reading, statistical analysis, diagramming, research paper writing, and journal selection and submission of the postgraduates were collected in September 2020. Logical regression was conducted to analyze the factors affecting the abilities of thesis writing.ResultsA total of 503 valid questionnaires were collected. Over one half of the graduate students (58.3%) were satisfied with the ability of literature retrieval and reading, with the highest score among the five abilities [median (lower quartile, upper quartile) was 3 (2, 3)]. Less than 20% of the students were satisfied with the remaining four abilities, with the lowest scores in the abilities of diagramming, research paper writing, and journal selection and submission [each median (lower quartile, upper quartile) was 1 (1, 2)]. Research experience and acknowledge of reporting guidelines were independent factors for all abilities related to thesis writing (P<0.05). Proficiency in statistical software was an independent factor for the abilities of data statistical analysis, diagramming, research paper writing, and journal selection and submission (P<0.05). Having published scientific paper was an independent factor for ability of journal selection and submission [odds ratio=4.695, 95% confidence interval (2.166, 10.180), P<0.001].ConclusionsThe postgraduate medical freshpeople of West China Medical School are not satisfied with the ability of statistical analysis, diagramming, paper writing, or journal selection and submission. Attention should be paid to research practice and learning of reporting guidelines, while statistical courses and diagramming courses should be set up expressly.
Objective To systematically review the endometrial receptivity evaluated by transvaginal ultrasound and predict the clinical pregnancy outcome of in vitro fertilization-embryo transfer (IVF-ET). Methods PubMed, The Cochrane Library, EMbase, Web of Science, CNKI, WanFang Data and VIP databases were electronically searched to collect studies on transvaginal ultrasound evaluation of endometrial receptivity to predict the clinical pregnancy outcome of IVF-ET from inception to December 1st, 2021. Two researchers independently screened literature, extracted data and evaluated the risk of bias of the included studies. RevMan 5.4 software and Stata 16.0 software were used to perform meta-analysis. Results A total of 24 cohort studies and 1 case-control study were included. The total sample size was 6 632 cases, including 3 340 in non-pregnancy group and 3 292 in pregnancy group. The results of meta-analysis showed that there was no difference in endometrial volume (MD=−0.11, 95%CI −0.33 to 0.11, P=0.34) or uterine artery S/D (MD= −0.04, 95%CI −0.17 to 0.09, P=0.55) between the two groups. The endometrial thickness measured on human chorionic gonadotrophin (HCG) day in the non-pregnant group (MD=−0.48, 95%CI −0.77 to −0.18, P=0.001) was thinner than that in the pregnant group. On embryo transfer (ET) day, uterine artery pulsatility index (PI) (MD=0.08, 95%CI 0.02 to 0.15, P=0.01) and resistance index (RI) (MD=0.01, 95%CI 0.01 to 0.01, P<0.000 01) were higher than those in the pregnancy group. Conclusion Endometrial volume and uterine artery S/D measured during IVF-ET were not correlated with clinical pregnancy outcome, while endometrial thickness measured on HCG day and uterine artery PI and RI measured on ET day were correlated with clinical pregnancy outcome. Transvaginal ultrasound evaluation of endometrial receptivity has a certain predictive value for clinical pregnancy outcome of IVF-ET. Due to the limited quality and quantity of included studies, more high-quality studies are needed to verify the above conclusion.
The pre-market approval and clinical application of innovative medical devices should be based on high-quality evidence, proving their reliability, safety and effectiveness. In 2016, the IDEAL (Idea, Development, Exploration, Assessment and Long-term follow-up) collaboration modified the original IDEAL framework and recommendation to the IDEAL-D methodological framework for the entire life cycle evaluation of innovative medical devices. The framework included five stages, namely the preclinical development stage, idea stage, exploration stage, assessment stage and long-term follow-up stage. This paper aims to interpret the study purpose, content and design at each step of the IDEAL-D framework based on IDEAL framework and recommendation (2019) to provide practical methodological guidance for the design and conduct of clinical research on innovative medical devices.
ObjectiveTo develop a transparent evaluation tool for the transparency of clinical practice guidelines.MethodsLiterature, books and policy documents related to the transparency of guidelines were retrieved from PubMed, EMbase, Web of Science, WanFang Data and CNKI databases to form a pool of items. After two rounds of Delphi expert consultation, the items were modified and scored to determine whether to be included in the final evaluation system. Expert consensus would determine the organization and evaluation method of the final tool.ResultsA total of 77 references were included, and 399 items related to transparency of guidelines were extracted. The items pool containing 53 items was formed after normalization and de-duplication. After two rounds of Delphi consultation, the evaluation tool for transparency of clinical practice guidelines covering 32 items in 6 areas was formed. The established tool consisted of planning (5 items), personnel selection (6 items), conflict of interest management (6 items), recommendation formation process (8 items), external review process (3 items), and guide reporting process (4 items).ConclusionsThe developed evaluation tool for transparency of clinical practice guidelines can provide a standard for the formulation, evaluation and utilization of guidelines from the perspective of transparency.
A surrogate endpoint is intended to substitute for a clinical endpoint and is expected to predict the effect of the intervention on clinical endpoints based on epidemiologic, diagnostic, and pathophysiologic evidence. A validated surrogate endpoint can reduce sample size and follow-up duration of clinical trials; hence, the evaluation and validation methods of surrogate endpoints have been discussed for more than 30 years around the world. This paper comprehensively introduced the definition evolution, evaluation, and validation methods of surrogate endpoints, and provided references for future research.
ObjectiveTo develop a transparency evaluation tool 2.0 of clinical practice guidelines (CPGs) oriented by public trust. MethodsThe Delphi method was employed to score and select the importance and operability of evaluation indicators. The analytic hierarchy process was used to determine the weights of the indicators. And the final evaluation indicator system was determined through expert consensus meeting. ResultsIt constructed two first-level indicators including conflict of interest and formulation process, and six second-level indicators, including guideline developers, reviewers, protocol and registration, evidence production, recommendation formation, and external review. Based on the second-level indicators, a total of 21 third-level indicators were constructed from the perspectives of disclosure and management. The logical structure of the tool is rigorous and harmonious. ConclusionThe CPGs transparency assessment tool 2.0 developed in this study provides measurement standards and an evaluation framework for assessing transparency in CPGs.
ObjectiveTo systematically review efficacy application of fibrin glue (FG) after thyroidectomy.MethodsPubMed, EMbase, The Cochrane Library, ClinicalTrials.gov, CBM, CNKI, WanFang Data and VIP databases were searched to collect randomized controlled trials (RCTs) regarding the use of FG after thyroidectomy from inception to October 29th, 2019. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of included studies. Then, meta-analysis was performed by using RevMan 5.3 software.ResultsA total of 15 RCTs involving 2 406 patients were included. The results of meta-analysis showed that compared with non-FG group, the use of FG could reduce postoperative drainage amount at the initial 24 hours (MD=−17.98, 95%CI −28.35 to −7.60, P=0.000 7), total amount of wound drainage (MD=−40.92, 95%CI −46.25 to −35.59, P<0.000 01), and postoperative discomfort (RR=0.48, 95%CI 0.35 to 0.66, P<0.000 01), as well as shorten drainage time (MD=−9.99, 95%CI −15.74 to −4.23, P=0.000 7) and stitches removal time (MD=−1.49, 95%CI −2.1 to −0.87, P<0.000 01). However, there was no statistically significant difference concerning postoperative short-term complications such as swelling (RR=0.78, 95%CI 0.48 to 1.28, P=0.32), recurrent laryngeal nerve injury (RR=0.83, 95%CI 0.21 to 3.29, P=0.79) and wound infection (RR=0.28, 95%CI 0.07 to 1.21, P=0.09) between two groups.ConclusionsThe current evidence shows that FG can reduce postoperative drainage amount and shorten postoperative recovery time in thyroidectomy. Due to the limited quality and quantity of included studies, more high quality studies are required to verify above conclusions.