With the implementation of “Good Clinical Practice”, the quality of clinical trials in China has increased constantly and more importance has been attached to the protection of the subject. Large scale clinical trials are primarily featured by long-term intervention, large sample size, many participant organizations, different levels of investigators, long test periods, and lots of adverse events. Consequently, the protection of subject is full of extensive complexities and difficulties and currently there is little experience to refer to. Hence, the article introduces the subject’s protection method adopted in the National Program Subject of Secondary Prevention Clinical Trial about Effect of Qi Shen Tonifying Qi on Myocardial Infarction (MISPS-TCM).
Deep learning-based automatic classification of diabetic retinopathy (DR) helps to enhance the accuracy and efficiency of auxiliary diagnosis. This paper presents an improved residual network model for classifying DR into five different severity levels. First, the convolution in the first layer of the residual network was replaced with three smaller convolutions to reduce the computational load of the network. Second, to address the issue of inaccurate classification due to minimal differences between different severity levels, a mixed attention mechanism was introduced to make the model focus more on the crucial features of the lesions. Finally, to better extract the morphological features of the lesions in DR images, cross-layer fusion convolutions were used instead of the conventional residual structure. To validate the effectiveness of the improved model, it was applied to the Kaggle Blindness Detection competition dataset APTOS2019. The experimental results demonstrated that the proposed model achieved a classification accuracy of 97.75% and a Kappa value of 0.971 7 for the five DR severity levels. Compared to some existing models, this approach shows significant advantages in classification accuracy and performance.
Telerehabilitation is a new rehabilitation technology, using internet to provide rehabilitation services for patients in remote areas or unaccessible to rehabilitation. Longshi Ability of Daily Life scale is fomulated based on Chinese living customs. The assessment content of the scale can clearly reflect the needs of the service object, and the assessment result can directly reflect the ability level of the assessment object. The scale has been put into use online on the mobile internet and amassed a certain amount of big data, which is of great significance to the adjustment of rehabilitation treatment, the continuity of nursing guidance, and the assurance of adequate social support and disability benefits for the disabled. In this paper, the application of Longshi Ability of Daily Life scale in telerehabilitation is described.
To aim directly at the individualized character and tendency about clinical assessment of Traditional Chinese Medicine (TCM), we draw off a new pathway which is evidence-based goal attainment scale(EBGAS) in the text. i.e., we will develop clinical individualized assessment method of TCM on account of GAS by the approach of evidence based medicine.
Interventional micro-axial flow blood pump is widely used as an effective treatment for patients with cardiogenic shock. Hemolysis and coagulation are vital concerns in the clinical application of interventional micro-axial flow pumps. This paper reviewed hemolysis and coagulation models for micro-axial flow blood pumps. Firstly, the structural characteristics of commercial interventional micro-axial flow blood pumps and issues related to clinical applications were introduced. Then the basic mechanisms of hemolysis and coagulation were used to study the factors affecting erythrocyte damage and platelet activation in interventional micro-axial flow blood pumps, focusing on the current models of hemolysis and coagulation on different scales (macroscopic, mesoscopic, and microscopic). Since models at different scales have different perspectives on the study of hemolysis and coagulation, a comprehensive analysis combined with multi-scale models is required to fully consider the influence of complex factors of interventional pumps on hemolysis and coagulation.
Objective To study the factors that affect the prognosis of status epilepticus (SE) and to improve the understanding of clinicians. Methods A retrospective analysis of 57 patients with SE witch from the General Hospital of Ningxia Medical University and Cardio-cerebrovascular Disease Hospital were carried out to collect their clinical data. The data were analyzed by SPSS 17.0 software. The prognosis of the patients was assessed by the Status epilepticus severity score (STESS) scale. Results A total of 57 patients were included, 53 cases improved, 4 cases were automatically discharged. Telephone follow-up showed that 4 cases of automatic discharge were dead. The mortality rate of SE was 7.02%. The most common cause of SE was acute cerebrovascular disease (17.54%), followed by intracranial infection (10.53%); The most common incidence were the occasional medication, self-medication, withdrawal (15.79%). Age, state of consciousness and concurrent infection were associated with prognosis (improvement/death) (P<0.05). STESS score of 0 to 2 points were 45 patients, all improved; score of 3 to 5 points were 12 patients, 8 patients improved, 4 patients died. There were significant differences in the prognosis between the two groups (P<0.05). Conclusions Age, state of consciousness, concurrent infection were related to prognosis, more than 65 years, the state of consciousness for the sleeping or coma had the poor prognosis. STESS scale can predict the prognosis of patients effectively.
ObjectiveTo compare and analyze the postoperative quality of life in patients after minimally invasive coronary artery bypass grafting (MICABG) and conventional median thoracotomy off-pump coronary artery bypass grafting surgery (OPCABG). MethodsFrom November 2015 to January 2018, 94 patients who underwent MICABG in the Peking University Third Hospital were included in the MICABG group. During the same period 441 patients who received OPCABG were included in the OPCABG group. The patients were matched by using propensity score matching method with a ratio of 1∶1. The quality of life was compared between two groups at 1 month, 6 months and 12 months after the surgery using SF-36 scale. ResultsA total of 82 patients were matched for each group. In the MICABG group, there were 66 males and 16 females with a mean age of 62.6±8.2 years. In the OPCABG group, there were 67 males and 15 females with a mean age of 63.2±13.2 years. One month after the operation, the physical health assessment (PCS) and mental health assessment (MCS) of the MICABG group were higher than those of the OPCABG group (50.3±10.6 points vs. 46.1±10.3 points, P=0.011; 59.5±9.3 points vs. 54.2±11.0 points, P=0.002). Scores of these following five dimensions: general health, physical functioning (PF), role-physical, social functioning (SF), role-emotion in the MICABG group were higher than those in the OPCABG group, while the score of body pain was inferior to that in the OPCABG group, and the differences were statistically significant (P<0.05). Six months after the surgery, the PCS and MCS of the two groups were not statistically different (80.0±13.1 points vs. 77.8±12.4 points, P=0.271; 81.6±13.5 points vs. 80.4±11.2 points, P=0.537). However, the scores of PF and SF in the MICABG group were still higher than those in the OPCABG group (P<0.05). Twelve months after the surgery, there was no statistical difference in the score of each dimension between the two groups (P>0.05). ConclusionThe improvement of quality of life within 6 months after MICABG is better than that of OPCABG, and it is similar between the two groups at 12 months after the surgery, indicating that MICABG has a certain effect of improving the short-term quality of life after the surgery, and the long-term quality of life is comparable to conventional surgery.
ObjectiveTo systemically review the efficacy and safety of Schwann cells (SCs) or activated Schwann cells (ASCs) transplantation in the treatment of traumatic spinal-cord injury (TSCI) in rats models. MethodsRandomized controlled trials (RCTs) about the effects of SCs and ASCs transplantation for TSCI in rats were searched in PubMed, EMbase, The Cochrane Library (Issue 12, 2014), CBM, CNKI, WanFang Data and VIP from inception to December 2014. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, and assessed the risk of bias of included studies. Then meta-analysis was performed using RevMan 5.3 software. ResultsA total of 14 RCTs involving 510 rats were included. The results of meta-analysis showed that:compared with the control group, the Basso, Beattie and Bresnahan (BBB) scores in the SCs or ASCs transplantation group were superior in 4 weeks (SMD=2.31, 95%CI 1.48 to 3.13, P<0.000 01), 8 weeks (SMD=3.93, 95%CI 3.06 to 4.81, P<0.000 01) and 12 weeks (SMD=6.15, 95%CI 4.30 to 8.00, P<0.000 01) after surgery. The BBB scores in the SCs or ASCs transplantation combined with other therapies group were also better in 4 weeks (SMD=1.06, 95%CI 0.44 to 1.68, P=0.000 8), 8 weeks (SMD=2.26, 95%CI 1.57 to 2.96, P<0.000 01) and 12 weeks (SMD=1.49, 95%CI 0.72 to 2.25, P<0.000 01) after surgery. Compared with the SCs group, the BBB score in the ASCs transplantation group were superior in 4 weeks (SMD=4.31, 95%CI 3.50 to 5.13, P<0.000 01) and 12 weeks (SMD=5.44, 95%CI 3.99 to 6.89, P<0.000 01) after surgery. No significant difference was found in mortality between the transplantation group and the control group. ConclusionCurrent evidence indicates that SCs and ASCs can promote the recovery of motor function in the rats with TSCI. More functional recoveries can be obtained in ASCs transplantation compared with SCs transplantation. Due to limited quality of the included studies, the above conclusion should be verified by conducting more large-scale, high quality RCTs.
Objective To evaluate proton MR spectroscopy (1H-MRS) for detection of the motor cortex and adjacent brain in amyotrophic lateralsclerosis (ALS) patients with apparent upper motor neuron involvement after olfactory ensheathing cells(OECs) transplantation. Methods From December 2004 to February 2005, 7 patients with clinically definite ALS who could safely undergo MRS were admitted into the perspective study. The neurological status, ALS functional rating scale (ALSFRS), EMG, and 1H-MRS taken before and 2 weeks after operationswere carefully analyzed. The NAA/Cr and Cho/Cr ratios were measured in the cerebral peduncle,genu and posterior limb of the internal capsule, corona radiata and precentral gyrus. Results The ALSFRS in 2 cases mproved obviously whose ALSFRS increased from 30 to 33 and from 29 to 34 respectively. And 5 cases remained stable 2 weeks after OECs transplantation. Statistical analyses for all seven cases showed both theNAA/Cr and Cho/Cr ratios decreased, but in the two cases with ALSFRS improvement the NAA/Cr increased in the certain anatomic position which confirmed the neurological and EMG findings. Conclusion The proton MR spectroscopy is a suitablenoninvasive measure for ALS evaluation. The preliminary study suggests that twoof the seven ALS cases improved apparently shortterm after OECs transplantation. More patients are required for the clinical study and longer followup duration is needed for future research.
ObjectiveTo understand the application of the Braden pressure ulcer risk-factor assessment scale in the nursing staff, in order to provide reference for clinical nurses to standardize the use of Braden assessment scale and facilitate the hospital to develop training programs on pressure ulcer related knowledge. MethodsStratified cluster sampling method was applied in February 2015. Using the self-designed questionnaire of “Application of Braden pressure ulcer risk-factor assessment scale in the nursing staff ”, we conducted a survey on 198 clinical nurses, and the survey results were scrutinized. The difficulty level of using Braden assessment scale in the nurses was analyzed based on their different demographic characteristics. We also analyzed the items which were most difficult to judge for the nurses and nurses’ learning needs for knowledge on Braden assessment scale. ResultsA total of 168 (84.85%) nurses found it difficult in using Braden scale for the evaluation of pressure ulcer. The most difficult items to judge for the nurses were friction force, shear force and feeling. Nurses in departments with pressure ulcer as a common symptom of the patients could better use the Braden pressure ulcer risk-factor scale, compared with those in departments where pressure ulcer was uncommon (P＜ 0.05) . A total of 189 (95.46%) nurses thought it necessary to carry out a unified quantitative standard analysis of six risk factors in the Braden scale. Conclusions The poor mastery of the assessment standards for Braden scale in the nurses causes various degrees of difficulty in applying the scale, which can influence the accuracy of assessment. It is important to train the nurses on pressure ulcer risk factor assessment in order to raise the clinical assessment accuracy.