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 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.
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 systematically review the non-inferiority trials in the cardiovascular domain that utilize medical devices as interventions, and investigate its characteristics and threshold settings. MethodsThe PubMed, Embase, and CENTRAL databases were electronically searched to collect non-inferiority trials in the cardiovascular field involving medical devices from inception to July 26, 2023. Two reviewers independently screened literature and extracted data. The reported information included basic characteristics, features of non-inferiority trials, and threshold-setting features of the included studies. Data analysis was performed using Excel 2020 and R 4.2.1 software. ResultsA total of 214 studies were included, with 167 studies (78.0%) focusing on interventions related to coronary artery stents. The trials predominantly utilized a two-arm design (92.9%), with a prevalent use of non-inferiority absolute thresholds (96.7%) as the criteria for non-inferiority determination. In 150 studies (70.1%), non-inferiority thresholds were established based on estimated control group effect values, while 33 studies (15.4%) did not report the source of these values. The non-inferiority trial endpoint outcomes exhibited diversity, and there were substantial differences in threshold settings. The three most studied qualitative indicators were target lesion failure rates (2.1%-8.6%), target vessel failure rates (2.5%-19.6%), and major adverse cardiovascular events rates (2.1%-10.0%). Late lumen loss (0.1-0.4 mm) emerged as the most frequently studied quantitative indicator. After converting absolute non-inferiority thresholds for all indicators into relative thresholds, the range was 1.20-3.67. ConclusionSignificant variations in non-inferiority threshold settings are observed for identical endpoint outcomes across included studies, highlighting a lack of reporting on the rationale behind threshold settings.