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.
【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.
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.
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.
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.
Objective To investigate the effects of component blood transfusion combined with heparin therapy on coagulation function and clinical outcomes in pregnant women with acute disseminated intravascular coagulation (DIC). Methods A retrospective analysis was conducted on the clinical data of 65 pregnant women with acute DIC who were treated in Obstetrics Department of Luzhou People’ s Hospital between March 2020 and March 2022. Pregnant women treated with component blood transfusion were included in the control group, while those treated with component blood transfusion combined with heparin were included in the observation group. Before and after treatment, the DIC scoring system was used for score evaluation. Coagulation function indicators and routine blood indicators were compared between the two groups of pregnant women. Adverse clinical outcomes and adverse reactions were observed in both groups of pregnant women. Results The study enrolled 65 pregnant women, comprising 30 in the observation group and 35 in the control group. Before treatment, there was no statistical difference in DIC score, coagulation function indicators, or routine blood indicators between the two groups (P>0.05). After treatment, the DIC score, prothrombin time, activated partial thromboplastin time, thrombin time, and D-dimer significantly decreased in both groups (P<0.05), and the above indicators in the observation group [3.39±0.48, (13.28±2.28) s, (24.68±2.06) s, (14.27±1.82) s, and (2.23±0.88) mg/L, respectively] were lower than those in the control group [4.11±1.56, (15.02±2.45) s, (26.79±3.18) s, (15.61±1.91) s, and (2.87±0.74) mg/L, respectively] (P<0.05). The levels of fibrinogen, platelet count, hemoglobin, and hematocrit significantly increased in both groups (P<0.05), and the levels in the observation group [(4.29±1.05) g/L, (175.36±20.46)×109/L, (84.09±7.27) g/L, and (25.49±3.13)%, respectively] were higher than those in the control group [(3.44±1.27) g/L, (145.77±21.12)×109/L, (76.58±7.13) g/L, and (23.03±3.05)%, respectively] (P<0.05). The observation group had a lower incidence rate of adverse clinical outcomes compared to the control group (33.3% vs. 74.3%, P<0.05). The incidence rates of adverse reactions were not statistically different between the two groups (P>0.05). Conclusions Component blood transfusion combined with heparin therapy for pregnant women with acute DIC can effectively improve their coagulation function, reduce the risk of bleeding, and further improve adverse clinical outcomes such as postpartum hemorrhage and hysterectomy. Additionally, this treatment approach demonstrates a high safety profile.
Objective To investigate the scientificity of patient-reported outcomes instrument for asthma ( Asthma-PRO) , which maybe used to evaluate the efficacy of anti-asthma drugs in clinical trials and clinical practice.Methods 366 asthma patients and 100 healthy subjects were face-to-face interviewed by well-trained investigators, and the data of Asthma-PRO instrument were collected. The psychometric performance such as reliability, validity, responsiveness and clinical feasibility in the Asthma-PRO instrument was evaluated. Results The split-half reliabilities of the Asthma-PRO instrument and each dimension were greater than 0.8. In the analysis of internal consistency of each dimension, the cronbach’s alpha coefficient was greater than 0.7. Factor analysis showed that the instrument has good construct validity. The scores of each of the facets and total scores between the asthma 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 20 minutes, indicating that the scale had a high clinical feasibility. Conclusion The Asthma-PRO instrument has good reliability, validity, responsiveness and clinical feasibility.
Objective To explore the clinical characteristics, in-hospital outcomes, and short-term survival of patients with acute kidney injury (AKI) in a large non-surgical cardiac intensive care unit (ICCU) in China. Methods Patients who had been admitted to the ICCU of the Department of Cardiology, West China Hospital of Sichuan University between June 2016 and May 2017 were retrospectively included. The diagnosis and staging of AKI were based on the Kidney Disease: Improving Global Outcomes criteria. The in-hospital outcomes were the composite of all-cause death or discharge against medical advice under extremely critical conditions. Patients without in-hospital composite outcomes were followed up to determine whether all-cause death occurred during the study period. The association of AKI with in-hospital composite outcomes or short-term survival was analyzed. Normally distributed quantitative data were expressed as mean±standard deviation, and non-normally distributed quantitative data were expressed as median (lower quartile, upper quartile). Results This study included 2083 patients, with an average age of (65.5±14.6) years old, and 681 (32.7%) were women. The prevalence rate of AKI was 15.0% (312/2083) (stage 1: 6.9%; stage 2: 4.9%; stage 3: 3.2%; respectively). Compared with patients without AKI, patients with AKI were older [(68.9±14.3) vs. (64.9±14.6) years old, P<0.001], had a higher Charles Comorbidity Index [4.0 (3.0, 6.0) vs. 2.0 (1.0, 3.0), P<0.001] and a greater Oxford Acute Illness Severity Score [32.0 (24.0, 41.2) vs. 21.0 (16.0, 26.0), P<0.001]. The incidence of in-hospital composite endpoint events was 8.4% (174/2083). Multiple logistic regression analysis showed that as the AKI stage increased, the risk of in-hospital composite endpoint events was higher [AKI stage 1 vs. no AKI: odds ratio (OR)=1.13, 95% confidence interval (CI) (0.57, 2.24); AKI stage 2 vs. no AKI: OR=2.21, 95%CI (1.08, 4.51); AKI stage 3 vs. no AKI: OR=10.88, 95%CI (4.50, 26.34); P for trend<0.001]. The patients without in-hospital composite endpoint events were followed up for a median time of 13.5 (10.7, 16.6) months, and the all-cause mortality rate was 5.5% (105/1909). Multiple Cox regression analysis showed that AKI was independently associated with all-cause death [hazard ratio=2.27, 95%CI (1.40, 3.69), P<0.001]. Conclusions AKI is common in the large ICCU in China and is more likely to occur in older patients who have more significant chronic illness complexity and acute illness severity. Moreover, AKI is independently associated with the in-hospital composite endpoint events and short-term survival.
ObjectiveTo investigate the prevalence of the nutritional risks, the relationship between application of nutritional support and the clinical outcome of patients with gastrointestinal major surgery in the Frist People's Hospital of Shuangliu. MethodsGastrointestinal major surgery patients in Department of General Surgery in the Frist People's Hospital of Shuangliu from March 2010 to March 2014 were consecutively enrolled. Patients who provided informed consent were screened by NRS 2002, tracking nutrition support status and analysis the relationship between nutrition support and clinical outcome. In this study, the clinical outcome index included postoperative complications and hospitalization time. ResultsThere were totally 130 cases enrolled, 112 cases completed assessment by NRS 2002. The prevalence of nutritional risk was 75.9%(85/112), there were totally 57 patients(50.9%) received nutrition support, and all for parenteral nutrition. The prevalence of postoperative complication was 46.4%(52/112). The prevalence of postoperative complication in patients who had nutritional risk and received nutritional support was 41.7%(15/36), whereas, in patients who had nutritional risk but not received nutritional support was 73.5%(36/49), there was statistically significant difference between the 2 groups(P=0.002). In patients who not had nutritional risk, the postoperative complication rate was only 3.7%(1/27). ConclusionsBecause of noninvasive and easy to operate, NRS 2002 are adpted to hospitalized patients with gastrointestinal major surgery. Because of the specific of disease metabolism, the higher nutritional risk occurres in patients with gastrointestinal major surgery, appropriate nutritional support for this kinds of patients can reduce the incidence of postoperative complication, and improve the prognosis.