Objective To investigate the predictive factors of clinical progression and short-term prognosis of cerebral infarction caused by large artery atherosclerosis (LAA). MethodsPatients with acute LAA cerebral infarction who were hospitalized in the Department of Neurology, Lianyungang Hospital of Traditional Chinese Medicine between January 2016 and May 2019 were included. On admission, the patients’ medical history was collected. The degree of neurological deficit was assessed, blood pressure, blood glucose, blood lipids, plasma homocysteine, lipoprotein-associated phospholipase A2 (Lp-PLA2) were measured, and intracranial and extracranial blood vessels related test results were collected. Within 72 hours of onset, the Scandinavian Stroke Scale (SSS) was used to determine whether the patients’ condition progressed. The modified Rankin scale was used to evaluate the short-term prognosis at 30 days of onset. The related factors of clinical progression and short-term prognosis of LAA cerebral infarction were analyzed. Results Finally, 100 patients were included. According to the SSS assessment results within 72 hours of onset, 27 cases were divided into the progression group and 73 cases in the non-progression group. There was no significant difference in gender and age between the two groups (P>0.05). According to the evaluation results of the modified Rankin scale at 30 days of onset, they were divided into 31 cases in the poor prognosis group and 69 cases in the good prognosis group. There was no significant difference in gender and age between the two groups (P>0.05). Logistic regression analysis showed that plasma Lp-PLA2 [odds ratio (OR)=1.013, 95% confidence interval (CI) (1.007, 1.018), P<0.001], SSS score [OR=0.910, 95%CI (0.842, 0.985), P=0.019], and history of hypertension [OR=5.527, 95%CI (1.241, 24.613), P=0.025] were the predictors of disease progression within 72 hours. SSS score [OR=0.849, 95%CI (0.744, 0.930), P<0.001], carotid artery stenosis [OR=9.536, 95%CI (1.395, 65.169), P=0.021] and progressive stroke [OR=8.873, 95%CI (1.937, 40.640), P=0.005] were the predictors of short-term prognosis of LAA cerebral infarction. Conclusions History of hypertension and high levels of plasma Lp-PLA2 are predictors of early progression of cerebral infarction. Carotid artery stenosis and progressive stroke are predictors of adverse outcomes in the acute phase of cerebral infarction. Neurological scores on admission was a predictor for short-term adverse outcomes in the early and acute phases.
In order to better incorporate patient input in clinical trials, the US Food and Drug Administration has included "patient-focused drug development" in the selection and development of clinical outcome assessments, and formulated a series of guidelines. Based on the third guiding principle, "Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments", this article summarizes the clinical outcome assessments from five aspects: concept, development process, scoring mechanism, interference factors and sensitivity, and introduces four different types of clinical outcome assessments, providing new ideas for "patient-focused drug development" efficacy evaluation in clinical trials.
With the transformation of modern medical models, patient-reported outcomes, clinician-reported outcomes, observer-reported outcomes, and performance outcomes have become internationally recognized clinical outcome assessment indicators, and scales have also become important evaluation tools, among which translation and cross-cultural adaptation are one of the important sources of scales. However, at present, there are fewer guidelines for scale translation in China. At present, domestic scale translation has not yet been unified and standardized in clinical reporting. Most translation reports provide readers with incomplete information, which affects the development of scale translation, and the methodology related to the translation of clinical outcome assessment scales still focuses on patient-reported outcome scales, which creates a gap in terms of the recommendations for the rest of the types of translations, a gap which leads to inconsistencies in the translation methodology and process. In this paper, we will develop specific translation methods and processes for each of the four current types of clinical outcome assessments by combining scale translation guidelines to support a standardized approach to translation, cross-cultural adaptation, and linguistic validation for use in standardizing the process of recommending translations of patient-reported outcome scales, clinical-reported outcome scales, observer-reported outcome scales, and behavioral outcome scales.
ObjectiveTo analyze dynamic characteristics of peripheral blood cells in patients with different types of coronavirus disease 2019 (COVID-19), so as to investigate the predictive value of peripheral blood cells and their dynamic changes for clinical outcome of patients with COVID-19.MethodsForty-eight patients with COVID-19 were collected and analyzed from East Hospital of Renmin Hospital of Wuhan University from February 2 to March 15, 2020. These patients were divided into general group (group A, 17 cases), severe survival group (group B, 21 cases), and severe death group (group C, 10 cases). Blood routine examination was done and analyzed before and after admission and among the three groups. The changes of neutrophils and lymphocytes were compared. The predictive power of neutrophils, lymphocytes, neutrophil-to-lymphocyte ratio (NLR), and platelet-to-lymphocyte ratio (PLR) for clinical outcomes was analyzed through the receiver operating characteristic (ROC) curve.ResultsIn group B, the lymphocyte count at discharge was significantly higher than at admission (P=0.002), and the neutrophil count, NLR and PLR were significantly lower than at admission (P values were 0.012, 0.001 and 0.007, respectively). The lymphocyte counts in the A, B, and C groups were ranked from high to low upon admission, and the differences among the three groups were statistically significant (P values were 0.020, <0.001 and 0.006 for the contrasts between groups A and B, groups A and C, groups B and C, respectively), the NLR were ranked from low to high, and the differences among the three groups were statistically significant (P values were 0.001, <0.001 and 0.026 for the contrasts between groups A and B, groups A and C, groups B and C, respectively). Before discharge or death, there was no significant difference in lymphocyte counts and NLR between A and B groups (P>0.05), and there were statistically significant differences between group C and groups A and B (all P values were<0.001). The proportions of “Neutrophils Lymphocytes Convergence” in groups A and B were 64.7% and 76.2%, respectively, which were significantly higher than that in group C (10.0%). The proportions of “Neutrophils Lymphocytes Separation” in group C was 70.0%, which was significantly higher than those in groups A (0) and B (4.8%). The area under the curve of NLR predicting patients with severe disease (excluding death) was 0.843, with the sensitivity and specificity of ≥3.55 be 0.810 and 0.882; The area under the curve of lymphocyte count predicting death in severe patients was 0.845, with the sensitivity and specificity be 0.700 and 0.905, respectively.ConclusionsDynamic changes in the composition of peripheral blood cells are one of the clinical features of COVID-19, “Neutrophils Lymphocytes Convergence” and “Neutrophils Lymphocytes Separation” predict better and worse clinical outcomes, respectively. NLR and lymphocyte counts are effective indicators for predicting the severity and death of COVID-19.
ObjectiveTo evaluate the reliability,validity and feasibility of a patient-reported outcomes (PRO) scale in the subjects with respiratory failure. Methods364 patients with chronic respiratory failure and 97 healthy subjects were face-to-face interviewed by well-trained investigators,and the data of respiratory failure -PRO instrument were collected. The psychometric performance such as reliability,validity,responsiveness and clinical feasibility in the respiratory failure -PRO instrument was evaluated. ResultsThe Cronbach's alpha coefficient of the respiratory failure -PRO instrument and each dimension were greater than 0.7. Factor analysis showed that the instrument had good construct validity. The scores of each of the facets and total scores between the patients and the healthy subjects were different. The recovery rate and the efficient rate of the questionnaire were more than 95%,and the time required to complete a questionnaire was within 15 minutes,indicating that the scale had a high clinical feasibility. ConclusionThe respiratory failure -PRO instrument has good reliability,validity,responsiveness and clinical feasibility.
To ensure the scientific and recognized evaluation of patient-centered clinical research outcomes, the drug development tool qualification certification website of the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research have disclosed the information of clinical outcome assessment (COA) submitted for certification, and encouraged the use of certified COA. This paper searched all COA and approval decisions on the website, analyzed the submitted information and certification status of COA, and interpreted the certification technology and process of COA, so as to provide references and suggestions for the development of patient-centered clinical research outcome evaluation.
Objective To summarize the application of enteral nutrition support in hospitalized patients. Methods The related literatures about enteral nutrition support in recent years were reviewed. Results The rates of malnutrition and nutritional risk were still high in patients. Enteral nutrition support could improve the condition and result of these cases in better clinical outcome, such as shorten hospitalization time and reduced the cost of hospital expenditure. Enteral nutritional support included both oral supplementation and tube-feeding techniques. Artificial nutrition may be provided by nasal tube (nasogastric or nasojejunal tube) or surgically placed tube (gastrostomy, jejunostomy, percutaneous endoscopic gastrostomy or percutaneous endoscopic gastrostomy-jejunostomy). More attention should be paid to the issues relating to feeding intolerance, including abdominal distension, diarrhea, reflux, and aspiration, especially for postoperative patients with early enteral nutrition support. Conclusion Enteral nutrition support requires highly individually and specialized tailored management.
【摘要】 目的 观察提前去除卵丘细胞对胚胎质量的影响，进一步探讨其临床应用价值。 方法 将2009年7-9月行体外受精-胚胎移植治疗的患者随机分为两组，试验组共137个周期，于授精后5 h去除卵丘细胞；对照组共146个周期，于授精后16～18 h去除卵丘细胞。两组均于授精后16～18 h观察受精情况，72 h对胚胎进行评分，选择1～3枚优质胚胎进行胚胎移植。分别比较两组的年龄、不育年限、获卵数、受精率、卵裂率、优质胚胎率、胚胎种植率和临床妊娠率。 结果 两组的优质胚胎率差异有统计学意义（Plt;0.01）；但年龄、不育年限、获卵数、受精率、卵裂率、胚胎种植率和临床妊娠率比较，差异均无统计学意义（Pgt;0.05）。 结论 体外受精中提前去除卵丘细胞优质胚胎增加，有助于提高临床累积妊娠率。【Abstract】 Objective To evaluate the effect of denuding the oocyte granulose cells soon after fertilization in vitro (IVF). Methods A total of 283 IVF cycles in patients from July to September 2009 were divided into a trial group and a control group randomly. The trial group contained 137 cycles, being denuded the oocyte granulose cells only 5 hours after IVF. The controlled group contained 146 cycles, being denuded the oocyte granulose cell and observed the pronuclear 18 hours after IVF. The outcomes of female age, infertile duration, the number of oocyte, fertilization rate,abnormal fertilization rate, good quality embryo rate, and clinical pregnancy rate were measured. Results There was no difference in any of the outcomes between the two groups except for the high quality embryo rate (Plt;0.01). The clinical pregnancy rate was higher in the trial group without significant differences (Pgt;0.05). Conclusions Denuding the oocyte granulose cells soon after IVF helps to improve the embryo quality and the clinical accumulated pregnancy rate.
The patient, as the person who experiences the disease first-hand, has the most direct and accurate experience of the pain of the disease and the most accurate need for health products. Although there is a vast array of technological means to combat disease and maintain health, the human burden of disease has not been reduced and the health needs of patients have not been fully met. Therefore, "patient-focused drug development" is imperative. Gathering comprehensive information from patients through multiple channels and incorporating this information into the entire drug development process can help ensure that patients’ experiences, perspectives, needs and priorities are taken into account and valued. This article will introduce the concept, development process and the specific problems it faces in patient-focused drug development.