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.
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.
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.
Objective To developapatient-reported outcomes scale of chronic obstructive pulmonary disease used for Chinese, thus offering tools for clinical efficacy assessment. Methods According to the development standard of International Patient-Reported Outcomes, the item pool was established and the preliminary scale was prepared. Then, 100 patients with chronic obstructive pulmonary disease and 50 healthy subjects were face-to-face interviewed with preliminary scale by well-trained investigators.Those copies were collected, surveys were analyzed and items were selected with 5 methods including measure of discrete tendency method, factor analysis, correlation coefficient method, Cronbach’s alpha coefficient method and item response Theory. Finally, the final scale was gained. Results The eventual scale contains 4 areas(physiological dimain, psychological dimension, social dimension, treatment), 11 dimensions(specific symptoms, general symptoms, individual, anxiety, depression, disease cognization, disease influence on social pctivity, social support, compliance, drug adverse reaction, satisfactory), and 52 items. Conclusion The ultimate scale coincides with the theoretical framework and reflects the connotation of the quality of life of patients with chronic obstructive pulmonary disease.
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.
ObjectiveTo evaluate the impact of using alanyl-glutamine dipeptide on clinical outcome for gastric cancer patients with nutritional risk after total gastrectomy. MethodsThis study was carried out in the period from March to August 2015. The nutritional risk was screened by continuous sampling method in the new hospitalized patients with gastric cancer who would undergo total gastrectomy. The patients were grouped randomly. Alanyl-glutamine was given to the experimental group patients. The clinical data of the two groups were analyzed, such as the laboratory parame-ters of nutritional status and hepatorenal function, complications of surgery, the nutrition-related hospitalization day, etc. ResultsThe preoperative data were consistent in the two groups of the included 40 cases. The results showed, in the third and seventh days after surgery, the level of plasma albumin was higher in the experimental group than in the control group〔(33.9±5.6) g/L vs. (30.8±4.0) g/L and (36.6±3.9) g/L vs. (33.9±4.2) g/L, respectively). Also, the CD4+/CD8+ cells immune index was significantly improved in the experimental group after surgery (1.7±0.7 vs. 1.2±0.3, P < 0.05). The recovery time of intestinal function〔(65.7±5.3) h vs. (71.6±7.2)h, P < 0.01)〕and nutrition-related hospitalization day〔(10.1±1.8) d vs. (11.7±1.9)d, P < 0.01)〕in alanyl-glutamine dipeptide group were shorted than that in the control group. No serious adverse drug reactions were found in the patients during the treatment period. ConclusionApplication alanyl-glutamine to the patients with nutritional risk after total gastrectomy could partly improve clinical outcome indicators.