Master protocol with adaptive design is a new complex innovative trial design that combines an adaptive treatment strategy and master protocol. It is more flexible and adjustable. In the complex clinical trial environment, the dynamics emphasized in this design are consistent with the idea of traditional Chinese medicine (TCM) syndrome differentiation and treatment. In this study, we summarized its concept, characteristics and advantages, and we also discussed its application in TCM clinical research. We hope this paper can provide more thinking and suggestions for TCM clinical trials.
Heart sound signal is a kind of physiological signal with nonlinear and nonstationary features. In order to improve the accuracy and efficiency of the phonocardiogram (PCG) classification, a new method was proposed by means of support vector machine (SVM) in which the complete ensemble empirical modal decomposition with adaptive noise (CEEMDAN) permutation entropy was as the eigenvector of heart sound signal. Firstly, the PCG was decomposed by CEEMDAN into a number of intrinsic mode functions (IMFs) from high to low frequency. Secondly, the IMFs were sifted according to the correlation coefficient, energy factor and signal-to-noise ratio. Then the instantaneous frequency was extracted by Hilbert transform, and its permutation entropy was constituted into eigenvector. Finally, the accuracy of the method was verified by using a hundred PCG samples selected from the 2016 PhysioNet/CinC Challenge. The results showed that the accuracy rate of the proposed method could reach up to 87%. In comparison with the traditional EMD and EEMD permutation entropy methods, the accuracy rate was increased by 18%–24%, which demonstrates the efficiency of the proposed method.
Ensemble empirical mode decomposition (EEMD) is an effective method for non-stationary signal analysis, such as electrocardiogram (ECG) signals. However, the precision and correctness of EEMD are affected by the two parameters, ratio of the added noise and ensemble number. The values of two parameters are set relying on experience and lacking of adaptability for uncertain signals. In order to solve these problems, we proposed a method based on white noise decomposed by EEMD in the present study shown in this paper. Empirical mode decomposition (EMD) was applied to decompose the signal to different intrinsic mode functions (IMFs) in the de-noising process. The white noise IMFs were selected to constitute high frequency part based on the character that the product of the energy density of white noise and its average period tended to be a constant. Then the two parameters of EEMD were adaptively obtained according to the criterion which was used to avoid modal aliasing. Experimental results showed that the method was an effective one for ECG signal de-noising.
Image-guided radiation therapy using magnetic resonance imaging (MRI) is a new technology that has been widely studied and developed in recent years. The technology combines the advantages of MRI imaging, and can offer online real-time tracking of tumor and adjacent organs at risk, as well as real-time optimization of radiotherapy plan. In order to provide a comprehensive understanding of this technology, and to grasp the international development and trends in this field, this paper reviews and summarizes related researches, so as to make the researchers and clinical personnel in this field to understand recent status of this technology, and carry out corresponding researches. This paper summarizes the advantages of MRI and the research progress of MRI linear accelerator (MR-Linac), online guidance, adaptive optimization, and dosimetry-related research. Possible development direction of these technologies in the future is also discussed. It is expected that this review can provide a certain reference value for clinician and related researchers to understand the research progress in the field.
Recently, deep learning has achieved impressive results in medical image tasks. However, this method usually requires large-scale annotated data, and medical images are expensive to annotate, so it is a challenge to learn efficiently from the limited annotated data. Currently, the two commonly used methods are transfer learning and self-supervised learning. However, these two methods have been little studied in multimodal medical images, so this study proposes a contrastive learning method for multimodal medical images. The method takes images of different modalities of the same patient as positive samples, which effectively increases the number of positive samples in the training process and helps the model to fully learn the similarities and differences of lesions on images of different modalities, thus improving the model's understanding of medical images and diagnostic accuracy. The commonly used data augmentation methods are not suitable for multimodal images, so this paper proposes a domain adaptive denormalization method to transform the source domain images with the help of statistical information of the target domain. In this study, the method is validated with two different multimodal medical image classification tasks: in the microvascular infiltration recognition task, the method achieves an accuracy of (74.79 ± 0.74)% and an F1 score of (78.37 ± 1.94)%, which are improved as compared with other conventional learning methods; for the brain tumor pathology grading task, the method also achieves significant improvements. The results show that the method achieves good results on multimodal medical images and can provide a reference solution for pre-training multimodal medical images.
The precise recognition of feature points of impedance cardiogram (ICG) is the precondition of calculating hemodynamic parameters based on thoracic bioimpedance. To improve the accuracy of detecting feature points of ICG signals, a new method was proposed to de-noise ICG signal based on the adaptive ensemble empirical mode decomposition and wavelet threshold firstly, and then on the basis of adaptive ensemble empirical mode decomposition, we combined difference and adaptive segmentation to detect the feature points, A, B, C and X, in ICG signal. We selected randomly 30 ICG signals in different forms from diverse cardiac patients to examine the accuracy of the proposed approach and the accuracy rate of the proposed algorithm is 99.72%. The improved accuracy rate of feature detection can help to get more accurate cardiac hemodynamic parameters on the basis of thoracic bioimpedance.
Surface electromyogram (sEMG) may have low signal to noise ratios. An adaptive wavelet thresholding technique was developed in this study to remove noise contamination from sEMG signals. Compared with conventional wavelet thresholding methods, the adaptive approach can adjust thresholds based on different signal to noise ratios of the processed signal, thus effectively removing noise contamination and reducing distortion of the EMG signal. The advantage of the developed adaptive thresholding method was demonstrated using simulated and experimental sEMG recordings.
The use of echocardiography ventricle segmentation can obtain ventricular volume parameters, and it is helpful to evaluate cardiac function. However, the ultrasound images have the characteristics of high noise and difficulty in segmentation, bringing huge workload to segment the object region manually. Meanwhile, the automatic segmentation technology cannot guarantee the segmentation accuracy. In order to solve this problem, a novel algorithm framework is proposed to segment the ventricle. Firstly, faster region-based convolutional neural network is used to locate the object to get the region of interest. Secondly, K-means is used to pre-segment the image; then a mean shift with adaptive bandwidth of kernel function is proposed to segment the region of interest. Finally, the region growing algorithm is used to get the object region. By this framework, ventricle is obtained automatically without manual localization. Experiments prove that this framework can segment the object accurately, and the algorithm of adaptive mean shift is more stable and accurate than the mean shift with fixed bandwidth on quantitative evaluation. These results show that the method in this paper is helpful for automatic segmentation of left ventricle in echocardiography.
Objective To investigate the predictive value of mechanical power (MP) in the weaning outcome of adaptive mechanical ventilation plus intelligent trigger (AMV+IntelliCycle, simply called AMV) mode for acute respiratory distress syndrome (ARDS) patients. Methods From November 2019 to March 2021, patients with mild to moderate ARDS who were treated with invasive mechanical ventilation in the intensive care unit of the First Affiliated Hospital of Jinzhou Medical University were divided into successful weaning group and failed weaning group according to the outcome of weaning. All patients were treated with AMV mode during the trial. The MP, oral closure pressure (P0.1), respiratory rate (RR) and tidal volume (VT) of the two groups were compared 30 min and 2 h after spontaneous breathing trial (SBT). The correlation between 30 min and 2 h MP and shallow rapid respiratory index (RSBI) was analyzed by Pearson correlation. Receiver operating characteristic (ROC) curve was used to analyze the predictive value of 30 min MP in ARDS patients with AMV mode weaning failure. Results Sixty-eight patients were included in the study, 49 of them were successfully removed and 19 of them failed. There was no statistical significance in age, gender, body mass index, oxygenation index, acute physiology and chronic health evaluation Ⅱ score, reasons for mechanical ventilation (respiratory failure, sepsis, intracranial lesions, and others) between the two groups (all P>0.05). The MP, P0.1 and RR at SBT 30 min and 2 h of the successful weaning group was lower than those of the failed weaning group (all P<0.05), but the VT of the successful weaning group was higher than the failed weaning group (all P<0.05). There was a significant relation between the MP at SBT 30 min and 2 h and RSBI (r value was 0.640 and 0.702 respectively, both P<0.05). The area under ROC curve of MP was 0.674, 95% confidence interval was 0.531 - 0.817, P value was 0.027, sensitivity was 71.73%, specificity was 91.49%, positive predictive value was 0.789, negative predictive value was 0.878, optimal cutoff value was 16.500. The results showed that 30 min MP had a good predictive value for the failure of weaning in AMV mode in ARDS patients. Conclusion MP can be used as an accurate index to predict the outcome of weaning in ARDS patients with AMV mode.
The covariate-adjusted response-adaptive randomisation (CARA) design combines the advantages of response-adaptive randomisation and covariate-adaptive randomisation, and improves the efficiency and reliability of clinical trials by combining analytical results and covariates and dynamically adjusting the allocation of subsequent patients. This paper describes in detail several methods of CARA design and their example applications of various methods, including the dominant confidence method, the urn model, the generalized linear model, and the Atkinson model, and provides the corresponding R codes in anticipation of a wider application of the provided R codes in clinical trials.