Objective To evaluate the effect of urgent psychological crisis intervention for 148 patients who were transferred to other provinces to receive treatment after the Wenchuan earthquake. Methods We randomly selected 148 patients from the disaster area who received treatment in The Third Hospital of Mianyang City and then transferred to other provinces. A self-designed questionnaire, SAS, and SDS scales were administered to all patients 7 days and 1 day before their transfer. After the initial assessment, all patients received urgent psychological interventions including catharsis, leading, explanation, and cognition reconstruction. Results After psychological intervention, both the full score and the standardized score of SAS and SDS declined significantly (Plt;0.01). Conclusion Earthquake sufferers who were transferred to other provinces to receive treatment had psychological problems. Crisis psychological intervention may have improved their psychological status effectively.
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.
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.
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.
ObjectiveTo evaluate the reporting quality of systematic reviews (SRs)/meta-analyses on acupuncture focusing on literature screening results and explore the influencing factors of the complete reporting.MethodsPubMed, EMbase, CNKI, WanFang Data, and VIP databases were searched to collect SRs/meta-analyses on acupuncture from inception to December 31st, 2019. Two reviewers independently screened literature, extracted data and evaluated the reporting quality of literature screening results of SRs/meta-analyses on acupuncture based on PRISMA statement. Logistic regression model analysis was applied to explore the influencing factors of the complete reporting rate of literature screening results. Statistical analysis was performed by using Excel 2016 and SPSS 16.0 software.ResultsA total of 1 227 SRs/meta-analyses were included. Only 62.3% SRs fully reported the four parts of literature screening results. The parts with a low reporting rate included the number of studies assessed for eligibility (73.2%) and the reasons for exclusions at each stage (67.0%). And the reporting rate of the literature screening flowchart was also low (63.6%). The reporting rate of literature screening results in Chinese SRs was lower than that in English SRs, and there was significantly statistical difference (P<0.001). Multivariate logistic regression analysis showed that the type of published journal, publication year, pages of article and the number of searched databases were correlated with the complete reporting rate of literature screening results (P<0.001).ConclusionsThe complete reporting rate of the literature screening results of SRs on acupuncture is low, especially in Chinese SRs. The complete reporting rate of literature screening results is significantly higher for SRs published after PRISMA statement, in SCI journals, with longer length and more searched databases.
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.
Objective To systematically evaluate the safety, efficacy, and economics of intracardiac echocardiography (ICE) versus transesophageal echocardiography (TEE) in left atrial appendage occlusion (LAAO). Methods PubMed, EMbase, The Cochrane Library, CBM, CNKI, VIP and WanFang Database were systematically searched to collect relevant studies on comparing ICE and TEE-guided LAAO from inception to June 15th, 2022. Two reviewers independently screened the literatures, extracted the data, and assessed the risk of bias of the included studies. Meta-analyses were performed using RevMan 5.3 and R 4.0.3. Retrospective cohort studies were excluded for sensitivity analysis. Subgroup analyses were performed based on the types of occluder and ICE catheter. Results A total of 14 studies with 6 599 patients were included. Meta-analyses showed no statistical differences in technical success rate, overall complications, device embolization, peri-device leakage, device-related thrombus, stroke, vascular complications, bleeding, operation time, fluoroscopy time, or contrast agent volume between the ICE and TEE-guided LAAO. The total in-room time (MD=–33.47 min, 95%CI –41.20 to –25.73, P<0.00001) and radiation dosage (MD=–170.20 mGy, 95%CI –309.79 to –30.62, P=0.02) were lower in the ICE group than those in the TEE group, whereas the incidence of pericardial effusion/tamponade was higher than the TEE group (RR=1.57, 95%CI 1.01 to 2.45, P=0.048). Except for pericardial effusion/tamponade, subgroup analyses and sensitivity analysis showed similar results. The analysis based on the cost data from the United States showed comparable or even lower total costs for ICE versus TEE, but comparative domestic cost studies were lacking. Conclusion Current evidence suggests that ICE-guided LAAO can reduce radiation dosage and total in-room time, and there is no statistical difference in the overall complication rate between the two groups. Owing to the limitations of sample size and quality of the included studies, the conclusion still needs to be verified by large sample size and high-quality randomized controlled trials.
ObjectiveTo construct a structural equation model of the mechanism of the role of medical humanities literacy in job competency and to conduct empirical analysis to verify the supporting role of medical humanities literacy in cultivating job competency. MethodsLiterature research was conducted to select the initial indicator system for medical humanities literacy and job competency, and then a conceptual model was constructed. Questionnaire data from four hospitals in Chengdu were collected. Through exploratory factor analysis, an indicator system for medical humanities literacy and job competency more suitable for the research population was obtained and the conceptual model was adjusted. Finally, the positive mechanism of medical humanities literacy on job competency was verified using confirmatory factor analysis (structural equation model). ResultsThe Cronbach's alpha coefficient of the overall questionnaire involved in the exploratory and confirmatory factor analyses was greater than 0.9, and the KMO values of the questionnaire were greater than 0.8, with a Bartlett's sphericity test P value less than 0.01, indicating good reliability and validity of the questionnaire. The model fit of the structural equation model met the requirements, with a chi-square degree of freedom ratio (CMIN/df) of 2.768, root mean square error of approximation (RMSEA) of 0.077, comparative fit index (CFI) of 0.891, normalized fit index (NFI) of 0.840, and incremental fit index (IFI) of 0.891. ConclusionThe improvement of individual characteristics in job competency is mainly influenced by medical humanities knowledge and spirit. The improvement of cognitive characteristics in job competency is mainly influenced by medical humanities knowledge and ability. The improvement of achievement characteristics in job competency is mainly influenced by medical humanities ability and spirit. The improvement of management characteristics in job competency is mainly influenced by medical humanities spirit.
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.