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.
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.
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 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.
With the development of science and technology, a large number of advanced technologies are applied to medical equipment, which play an increasingly important role in clinical engineering. Therefore, new requirements are put forward for clinical engineering and clinical engineers in hospitals. This study comprehensively analyzed the training objectives and certification assessment of clinical engineering in many countries around the world. Combined with the current situation in China, it is of reference significance for the discipline construction and certification assessment of clinical engineering at the present stage in China, so as to promote the development of clinical engineering in China and speed up the development and certification of international clinical engineering.
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 investigate the association between cardiometabolic indicators and the risk of incident renal insufficiency using a longitudinal physical examination cohort. MethodsBased on a large-scale, multi-center, repeated-measurement physical examination cohort in China, this study evaluated the impact of baseline cardiovascular metabolic indicators on incident renal insufficiency using logistic regression, Cox proportional hazards models, Poisson regression, and generalized linear mixed-effects models. Furthermore, latent class mixed models (LCMM) were employed to identify the longitudinal trajectories of these indicators, and the associations between distinct trajectory patterns and the risk of renal insufficiency were analyzed using Cox and logistic regression models. ResultsDerived from a massive longitudinal cohort of 680 000 individuals across a multi-center healthcare network, a total of 264 379 participants were ultimately included, among whom 82 849 developed renal insufficiency during the follow-up period. Baseline analyses revealed that elevated levels of triglycerides (TG) and fasting glucose (FG) consistently increased the risk of renal insufficiency across multiple statistical models (all PFDR<0.001). Trajectory analyses demonstrated that high-level longitudinal trajectories of FG (HR=1.274, 95%CI 1.230 to 1.320) and diastolic blood pressure (DBP) (HR=1.042, 95%CI 1.023 to 1.061) were significant independent risk factors for the disease. Notably, the evolutionary trajectory of systolic blood pressure (SBP) exhibited opposite association directions between the Cox and logistic models, whereas the TG trajectory lost its statistical significance after fully adjusting for smoking and alcohol consumption. ConclusionBoth baseline characteristics and longitudinal variations of cardiovascular metabolic indicators are significantly associated with the incidence of renal insufficiency. Abnormal levels and high-level evolutionary trajectories of fasting glucose and triglycerides serve as robust risk factors for the disease. Regular monitoring and longitudinal tracking of these metabolic profiles are of profound clinical value for the prevention and early identification of renal insufficiency.
The guideline for reporting meta-epidemiological research, based on PRISMA, aims to increase the reporting quality and transparency of meta-epidemiological studies. This paper introduced and interpreted the 24 reporting items in the guidelines for reporting meta-epidemiological research to provide a reference for standardizing the reporting of meta-epidemiological studies.
ObjectiveTo investigate the association between kidney function indicators in routine health examinations and the incidence of urinary stone disease using longitudinal repeated-measurement data. MethodsThis study was based on the large-scale longitudinal data in the WHALE study. Cox proportional hazards models were first applied to examine the associations between baseline kidney function indicators and incident urolithiasis. Subsequently, Poisson regression and mixed-effects models were used to analyze repeated-measurement data to further explore the relationships between kidney function indicators and urolithiasis. Latent class trajectory modeling was then employed to characterize longitudinal patterns of kidney function indicators. Based on the optimal trajectory models, logistic regression analyses and Cox regression analyses were performed to assess the associations between trajectory classes and the risk of urolithiasis. ResultsAmong 313 280 health examination participants included in the study, 8 864 incident cases of urolithiasis were identified during follow-up. In the baseline Cox analyses, cystatin C showed the strongest association with urolithiasis (HR=1.230, 95%CI 1.083 to 1.396, FDR=0.001). In analyses incorporating repeated measurements, serum uric acid demonstrated a strong association in both Poisson regression and mixed-effects models (RR=1.123, 95%CI 1.094 to 1.152, FDR<0.001; RR=1.106, 95%CI 1.075 to 1.137, FDR<0.001). In trajectory analyses, U-shaped trajectories of blood urea (HR=0.548, 95%CI 0.438 to 0.685, FDR<0.001) and uric acid (HR=0.910, 95%CI 0.857 to 0.685, FDR=0.005) were associated with a lower risk of urolithiasis. ConclusionBoth baseline levels and longitudinal changes in kidney function indicators measured during routine health examinations are significantly associated with the incidence of urolithiasis. Regular assessment and longitudinal monitoring of kidney function may contribute to the prevention and early identification of urolithiasis development and progression.