Covariates are factors which have significant impacts on the primary analysis prior to the subjects being treated. Covariates adjustment should be considered in the design and analysis stages of the clinical trial. Through controlling in the design stage is the optimal resolution; randomization, stratified randomization and restricted covariant values could be used to balance the covariates between comparative treatments. During data analysis stage, analysis of covariance, stratified analysis, linear or generalized linear model can be conducted for covariate adjustment according to different types of outcome and covariate. For confirmatory clinical trial, covariates should be defined in advance in the protocol and statistical analysis plan with the main statistical model.
Objective To observe the changes of the multifocal electr oretinograph (mf-ERG) in commotio retinae. Methods The affected eyes (traumatic group) and the fellow eyes (control group) of 31 patients with unilateral commotio retinae were examined by RETI scan 3.15 system. The responses of 61 retinal regions were recorded, and the average amplitude densities of the N1 (the first negative) wave and P1 (the first positive) wave in different regions of retinal were analyzed. Results The average amplitude densities of 1-4 rings in N1wave and 1-5 rings in P1wave were much lower in traumatic group than those in the control. Conclusions The average amplitude densities of N1wave and P1wave of mf-ERG in retin al affected regions decreases markedly in eyes with commotio retina; mf-ERG may provide the quantificational and orientational detection for the visual ability of the eyes with commotio retinae.(Chin J Ocul Fundus Dis，2004，20：226-228)
Taking advantages of the sparsity or compressibility inherent in real world signals, compressed sensing (CS) can collect compressed data at the sampling rate much lower than that needed in Shannon’s theorem. The combination of CS and low rank modeling is used to medical imaging techniques to increase the scanning speed of cardiac magnetic resonance (CMR), alleviate the patients’ suffering and improve the images quality. The alternating direction method of multipliers (ADMM) algorithm is proposed for multiscale low rank matrix decomposition of CMR images. The algorithm performance is evaluated quantitatively by the peak signal to noise ratio (PSNR) and relative l2 norm error (RLNE), with the human visual system and the local region magnification as the qualitative comparison. Compared to L + S, kt FOCUSS, k-t SPARSE SENSE algorithms, experimental results demonstrate that the proposed algorithm can achieve the best performance indices, and maintain the most detail features and edge contours. The proposed algorithm can encourage the development of fast imaging techniques, and improve the diagnoses values of CMR in clinical applications.
ObjectiveThrough researching the "Automated Production Quality Management Specification 5th Edition" (GAMP5) promulgated by the International Society for Pharmaceutical Engineering, combined with domestic and foreign guidelines and regulatory requirements, to explore the practical methods for the verification of the central randomization system of clinical trials.MethodsThe GAMP5 verification process and specifications of the clinical trial central randomization system was established according to the GAMP5 guideline and domestic and foreign computerized system verification guidelines and regulations in combination with the characteristics of the clinical trial central randomization system, and the existing clinical trials central randomization system was used as an example to show the verification results.ResultsThe verification framework and process of the central randomization system met the requirements of the relevant regulations of clinical trials that had been constructed. For the existing system, a verification team was established, a verification plan was developed, and a computerized system verification was conducted in accordance with the V model to form a set of standardized verification documents.ConclusionsThe verification process of the central randomization system proposed by this research follows the GAMP5 specification and has high operability and reference value.
ObjectiveTo measure and analyze the tortuosity of retinal veins in neonatal and premature infants quantitatively. MethodsA retrospective clinical study. The fundus images of the left eyes were selected from 30 healthy neonates and 30 premature infants without retinopathy of prematurity underwent RetCam screening. There were 16 premature infants with a history of oxygen inspiration. The tortuosity of superior temporal veins, inferior temporal veins, superior nasal veins, inferior nasal veins was measured separately using a self-developed computer program. Pearson correlation analysis was used to analyze the relationship between tortuosity of retinal veins and birth weight, gestational age and correct gestational age. ResultsIn full-term neonatal infants, the vascular tortuosity of the nasal veins was significantly higher than the temporal veins (t=5.73, P < 0.01), while the superior veins and inferior veins showed no significant difference (t=0.39, P > 0.05). There was no correlation between vascular tortuosity of temporal (r=0.179, -0.175) or nasal veins (r=0.055, 0.345) with birth weight or gestational age (P > 0.05). In premature infants, the vascular tortuosity of the nasal veins was also significantly higher than the temporal veins (t=5.00, P < 0.01), no significant difference was found between the superior veins and inferior veins (t=0.39, P > 0.05). The vascular tortuosity of temporal veins of premature infants was negatively correlated with birth weight (r=-0.375, P < 0.05); however, no significant correlation was found with gestational age (r=-0.296, P > 0.05). The vascular tortuosity of the temporal retinal veins of premature infants with a history of oxygen inspiration was significantly higher than premature infants without a history of oxygen inspiration (t=2.517, P < 0.05), though no significant difference was found between the nasal veins (t=-0.261, P > 0.05). The vascular tortuosity of the temporal and nasal retinal veins of premature infants was both higher than neonate, but was not statistically significant (t=0.88, 1.50; P > 0.05). ConclusionsThe vascular tortuosity of the temporal veins was greater than the nasal veins in both full-term and premature infants, though no significant difference was found between superior and inferior veins. The vascular tortuosity of temporal veins of premature infants increased as birth weight decreased. The vascular tortuosity of the temporal retinal veins of premature infants with a history of oxygen inspiration was higher than premature infants without a history of oxygen inspiration.
Objective To observe the fundus characteristics and associated factors of retinal hemorrhage (RH) in newborns. Methods A total of 293 healthy newborns (586 eyes) were enrolled in this study. A digital wide-angle retinal imaging device (RetCam Ⅲ) was used to examine the subjects at about 2 days after birth (2.7plusmn;0.9) days. The images of posterior pole, temporal quadrant, superior quadrant, nasal quadrant and inferior quadrant of the fundus of each eye were taken sequentially. Every newborn completed the examination and the mean duration of the procedure was (2.62plusmn;0.55) minutes. Newborns with RH were reexamined after one month. RH was classified according to the location and size of the hemorrhages based on guidelines in the literature. The location and degree of RH was determined in each newborn. The incidence of RH by gender, parity, birth weight, maternal age and delivery method was compared and analyzed. Results RH was present in 87 eyes (14.8%) of 58 newborns (19.8%) and of the 58 newborns with RH, half (29 eyes) had hemorrhages in both eyes, and half (29 eyes) had hemorrhages in only one eye. The site of the hemorrhage was all on the superficial retina. Of the 87 eyes with RH, 72 eyes (82.8%) had hemorrhage in zone Ⅰ, 86 eyes (98.9%) had hemorrhage in zone Ⅱ, and 36 eyes (41.4%) had hemorrhage in zone Ⅲ. Thirty-eight eyes (43.7%) had hemorrhage in zone Ⅰand Ⅱ. Three eyes (3.4%) had hemorrhage in zone Ⅱ and Ⅲ. Thirtythree eyes (37.9%) had hemorrhage in zone Ⅰ, Ⅱ and Ⅲ. One eye (0.4%) had hemorrhage in zoneⅠonly. Twelve eyes (13.8%) had hemorrhage in zone Ⅱ only. None had hemorrhage in zone Ⅲ only. The severity of RH was grade Ⅰ in 13 of 87 eyes (14.9%), grade Ⅱ in 33 of 87eyes (37.9%), and grade Ⅲ in 41 of 87 eyes (47.1%). Fourteen of 58 newborns with RH (24.1%) were lost to follow-up. Forty-four of 58 newborns with RH (75.9%) were reexamined one month after birth and all the RH disappeared entirely. There were no statistically significant differences among the incidences of RH of the different gender (chi;2=0.018,P=0.893), parity（chi;2=0.772,P=0.380）, birth weight（chi;2=1.611,P=0.447）and maternal age (chi;2=0.915,P=0.339). The incidence of RH was higher for vaginal delivery than that for cesarean section delivery (chi;2=3.073,P＜0.05). Conclusions The RH in newborn is located in the superficial retina, mostly located in zone Ⅰor zone Ⅱ, and resolves itself within one month after birth. The RH in newborns is related to the mode of delivery, but not related to gender, parity, birth weight or maternal age.
Objective To investigate the effectiveness of endoscopic low-temperature plasma radiofrequency ablation with acellular dermal matrix patch for chronic abdominal wall sinus by comparing with the traditional surgical method. Methods Retrospective analysis was made on the clinical data of 53 cases of chronic abdominal wall sinus between January 2006 and May 2012. Of 53 patients, 18 underwent endoscopic low-temperature plasma radiofrequency ablation with acellular dermal matrix patch (trial group), and 35 underwent traditional surgical treatment (control group). No significant difference was found in gender, age, etiology, disease duration, and location between 2 groups (P gt; 0.05). Results The blood loss during sinus clearance, postoperative hospitalization days, and sinus union time of the trial group were significantly better than those of the control group (P lt; 0.05), but no significant difference was found in the operative time for sinus clearance (t=0.28, P=0.78). No postoperative sinus bleeding or infection occurred in the trial group, but bleeding and infection in 5 and 3 cases of the control group respectively, showing significant differences between 2 groups (P lt; 0.05). The follow-up time was 4-18 months (mean, 12.4 months) in the trial group, and was 6-48 months (mean, 38.5 months) in the control group. No sinus recurrence was observed during follow-up. Conclusion Endoscopic low-temperature plasma radiofrequency ablation with acellular dermal matrix patch has the following advantages in treating chronic abdominal wall sinus: clear view, thorough cleaning of granulation necrosis tissues, less bleeding, faster sinus union, and shorter hospitalization days; however, further observations on the long-term effectiveness and the safety are required .