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.
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 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.
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.
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 summarize and compare the functional characteristics and technical parameters of the comprehensive global clinical practice guideline (CPG) databases, so as to provide references for the construction of CPG database of China. Methods CPG databases were collected worldwide by discussing with experts in the guideline and database fields. Studies on guideline databases were searched in PubMed and CNKI to additionally collect CPG databases mentioned in these studies. Representative comprehensive CPG databases were finally selected by consulting relevant guideline experts. The basic information, functional characteristics (including column settings, service contents, and related file types) and technical parameter data were extracted and summarized. A descriptive analysis was conducted to compare different CPG databases. Results Nine guideline databases which are distributed in eight countries of the Americas, Europe, Oceania and Asia were included. The number of included guidelines of the nine databases ranged from 31 to 15 410. The earliest database was established in 1993. Except that the MINDS database didn’t provide search function, eight databases provided basic search function, and six provided further advanced search function. PDF and HTML formats of guidelines were available in most databases, but the XML format was only available in National Guideline Clearinghouse (NGC). Responsive Web design was an important feature for most websites of databases and four databases developed mobile applications. Local mainstream social media sharing function was provided by six databases. All databases’ construction was professional in technical parameters including network transmission, Web server, programming language and the selection of server room. Conclusion This study compares the functional features and technical parameters of the comprehensive global CPG databases, which provides important information that should be considered in establishing a guideline database, to strengthen the top-level design or to help optimize the functionality of a guideline database. It also helps guideline databases users to find more proper resources.
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.
ObjectivesTo summarize and compare the operative mechanisms of the most representative comprehensive clinical practice guideline (CPG) databases worldwide, so as to provide references for establishing and managing Chinese CPG database.MethodsCPG databases were collected worldwide by discussing with experts in the guideline and database fields. Studies on guideline databases were searched in PubMed and CNKI to further collect CPG databases mentioned in these studies. Representative comprehensive guideline databases were finally selected by consulting relevant guideline experts. The institutions’ names of establishing and managing CPG databases, funding sources, human resources, aims, quality control measures (including CPG inclusion and updating criteria) were extracted and summarized. Databases were divided into government-led, society-led, and enterprise-led models. A descriptive analysis was conducted.ResultsThere were four government-led databases, four society-led databases and merely one enterprise-led database. The institutions of establishing CPG databases were same as the institutions of managing databases in the seven databases. All CPG databases had set up offices, seven of which were located in the capital. Most databases’ funds came from the government. Four databases implemented board management. According to the division of functions, members involved in establishing and managing CPG databases mainly included leaders, expert teams, managerial personnel, secretaries, web developers, and patient representatives. Criteria for inclusion of CPG were relevant to the purpose of establishing databases. Most databases required guidelines that had be updated within three to five years.ConclusionsThis study provides comprehensive information on operative mechanism of different CPG databases which can assist guideline database builders to optimize their operative mechanism.
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.