Objective To translate the Water Orientation Test of Alyn 1 (WOTA1) into Chinese and investigate the test-retest reliability, inter-rater reliability and validity of this Chinese Version. Methods The Water Orientation Test of Alyn 1 was translated from English into Chinese. 25 children with cerebral palsy were tested with Chinese Version of WOTA1 by 2 raters. One of the raters accessed the same children again after 2 days. While the children were assessed with Brief Assessment of Motor Function (BAMF). The scores from both raters, twice of one rater, and of WOTA1 and of BAMF were analyzed with Pearson correlation coefficient. Results The correlation coefficient of test-retest of WOTA1 total score is 0.992 (95% CI: 0.982-0.996), and it was 0.887 to 1.000 of the scores of items. The correlation coefficient of inter-rater of total score is 0.992 (95% CI: 0.980-0.998), and it was 0.748 to 1.000 of the scores of items. The correlation coefficient between scores of WOTA1 and BAMF was 0.926 (P<0.01). Conclusion The Chinese Version of WOTA1 is good reliable and valid to assess the motor function in hydrotherapy pool.

Objective To observe the effects of Traditional Chinese Medicine bubble bath on the children with spastic diplegia cerebral palsy. Methods 13 children with spastic diplegia cerebral palsy received routine rehabilitation and bubble bath (control group), while 14 children received routine rehabilitation and Traditional Chinese Medicine bubble bath (experimental group). All the children were assessed with Gross Motor Function Measure (GMFM-66) and Modified Ashworth Scale (MAS) of triceps surae muscle before and 10 weeks after treatment.Results The total score of GMFM-66 increased (P<0.001) and the MAS score decreased in both groups (P<0.01) after treatment. The dimensions B, D, and E of GMFM-66 only increased in the experimental group (P<0.05). The MAS score decreased more in the experimental group than in the control group after treatment (P<0.05). Conclusion Traditional Chinese Medicine bubble bath can improve gross motor function and reduce triceps surae muscle tension of the children with spastic diplegia cerebral palsy.

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.

Humans ; Nephrectomy ; Hemostatics/therapeutic use* ; Laparoscopy ; Kidney Neoplasms/surgery* ; Minimally Invasive Surgical Procedures

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<0.000 01) 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.