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 evaluate clinical outcomes of complete video-assisted thoracoscopic surgery （VATS） lobectomy for patients with peripheral lung cancer.?Methods?We retrospectively analyzed clinical data of 90 consecutive patients with peripheral lung cancer who underwent complete VATS lobectomy from July 2009 to December 2011 in Provincial Hospital Affiliated to Anhui Medical University. There were 55 male patients and 35 female patients with their age of 33-79 （62.5 ±11.5） years. Lymph node dissection group and number, operation time, intraoperative blood loss, length of postoperative chest drainage, length of postoperative hospitalization, postoperative morbidity and pain score were analyzed.?Results?There was no hospital death in this group. Operation time was 135.0±32.5 min, intraoperative blood loss was 230.0±80.4 ml, length of postoperative chest drainage was 4.8±2.1 days, and pain score on the third postoperative day was 5.3±1.2. A total of 520 groups and 1 568 lymph nodes were dissected during the operation, with 5.8 groups and 17.4 lymph nodes dissected in each patient. There were 71 groups with lymph node metastasis, a positive rate of 13.7% （71/520）. Postoperatively, 2 patients had hoarseness and 3 patients had chylothorax, who were all cured after proper treatment. Ninety patients were followed up for 1-24 months. During follow-up, 4 patients died of tumor metastasis, and other patients were all alive with good quality of life.?Conclusion?Complete VATS lobectomy is a minimally invasive technique for patients with peripheral lung cancer with better postoperative recovery and reduced pain level. The safety and degree of radical resection of complete VATS lobectomy is similar to those of routine thoracotomy lobectomy. Complete VATS lobectomy can be recommended as a surgical treatment for patients with peripheral lung cancer.
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 investigate surgical indications and techniques of video-assisted thoracoscopic surgery (VATS) for mediastinal lymph node tuberculosis. MethodsClinical data of 27 patients who underwent VATS for mediastinal lymph node tuberculosis between January 2010 and March 2013 in Wuhan Medical Treatment Center were retrospectively analyzed. There were 16 male and 11 female patients with their age of 18-67 (30.23±10.72) years. ResultsThere was no in-hospital death. Postoperative complications included recurrent laryngeal nerve injury in 1 patient, delayed wound healing in 1 patient and pneumothorax in 1 patient. Postoperatively, all the patients received intensified anti-tubercular treatment, and were engaged in normal physical activities during follow-up of 6 months. ConclusionVATS is safe and reliable for the treatment of mediastinal lymph node tuberculosis, and anti-tubercular treatment is needed before and after the operation.
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.
ObjectiveTo investigate clinical outcomes and risk factors of patients with valvular heart disease (VHD) and giant left ventricle undergoing heart valve replacement (HVR). MethodsClinical data of 144 VHD patients with giant left ventricle who underwent HVR in Union Hospital of Tongji Medical College, Huazhong University of Science and Technology from January 2009 to December 2012 were retrospectively analyzed. There were 116 male and 28 female patients with their age of 15-69 (44.9±11.9) years and disease duration of 57.8±98.3 months (range, 1 month to 40 years). There were 92 patients with rheumatic VHD, 28 patients with degenerative VHD, 15 patients with congenital VHD, and 9 patients with infective endocarditis. A total of 137 patients who were discharged alive were followed up. Risk factors of postoperative mortality, morbidity and late death of VHD patients with giant left ventricle undergoing HVR were analyzed with t-test, chi-square test or Fisher's exact test, and logistic regression analysis. The life-table method was used to calculate long-term survival rate and draw the survival curve. ResultsMajor postoperative complications included low cardiac output syndrome (LCOS) in 19 patients (13.2%), ventricular arrhythmias in 56 patients (38.9%), prosthetic paravalvular leaks in 7 patients (4.9%), pleural effusion in 33 patients (22.9%), pericardial effusion in 8 patients (5.6%), liver failure in 23 patients (16.0%), and renal failure in 5 patients (3.5%). Seven patients (4.9%) died postoperatively. Logistic univariate analysis showed that advanced-age ( > 50 years), rheumatic VHD, higher preoperative NYHA class (Ⅲ or Ⅳ), long disease duration, poor preoperative left ventricular function[left ventricular ejection fraction (LVEF) < 40%], double valve replace-ment (DVR), other concomitant intracardiac procedures, prolonged cardiopulmonary bypass (CPB) time and aortic cross-clamping time, postoperative LCOS and ventricular arrhythmias were risk factors of early mortality of VHD patients with giant left ventricle undergoing HVR (P < 0.05). Logistic multivariate analysis showed that advanced age ( > 50 years), long disease duration, higher preoperative NYHA class (Ⅳ), poor preoperative left ventricular function (LVEF < 40%), DVR, prolonged CPB time were independent predictors of early mortality (P < 0.05). Logistic multivariate analysis showed that higher preoperative NYHA class (Ⅲ or Ⅳ), other concomitant intracardiac procedures, poor preoperative left ventricular function (LVEF < 50%) were independent predictors of postoperative LCOS (P < 0.05). Higher preoperative NYHA class (Ⅲ or Ⅳ) and preoperative non-sinus rhythm were independent predictors of postoperative ventricular arrhy-thmias (P < 0.05). Within 2 weeks after the operation, left ventricular end-diastolic dimension (LVEDD), left atrial diameter (LAD), LVEF and left ventricular fractional shortening (LVFS) were all significantly reduced compared with preoperative parameters (P < 0.05). Five patients died during follow-up. One-year, 2-year, 3-year and 4-year survival rates were 97.1%, 95.0%, 92.7% and 92.7% respectively. Preoperative LVEF, LVEDD and NYHA were significantly different between patients who died or survived during follow-up. ConclusionsHVR can produce low postoperative mortality, high long-term survival rates and satisfactory clinical outcomes for VHD patients with giant left ventricle. Advanced age ( > 50 years), long disease duration, higher preoperative NYHA class (Ⅳ), preoperative non-sinus rhythm, poor preoperative left ventricular function (LVEF < 40%), DVR and prolonged operation time may be risk factors of postoperative mortality and morbidity. Poor preoperative left ventricular function and significantly enlarged left ventricle may be risk factors of late death after HVR.
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 compare extra-articular and intra-articular olecranon osteotomy in treating intercondylar fractures of the distal humerus managed with open reduction and internal fixation regarding the functional outcomes and complications. MethodsBetween September 2008 and December 2010, 36 patients with intercondylar fractures of the distal humerus were treated by open reduction and internal fixation using the trans-olecranon approach. Among the, 21 underwent extra-articular olecranon osteotomy and 15 accepted intra-articular olecranon osteotomy. The mean follow-up time was three years. We compared the elbow function, the rate of no non-union or delayed union and the rate of postoperative complications between the two groups. ResultsThe elbow function and Mayo elbow performance scores were good at the latest follow-up. There was no non-union in all osteotomies. We found significant difference in delayed union (P=0.01) and traumatic arthritis rate (P=0.02) between the two groups. ConclusionExtra-articular olecranon osteotomy is better for bone union and the decrease of traumatic arthritis rate.
ObjectiveTo analyze the outcome and prognostic factors of using locking plate for treating proximal humerus fracture. MethodsBetween January 2005 and January 2012, 45 aged patients with a displaced 3-part or 4-part fracture of the proximal humerus were treated by locking plate. Range of motion and Constant-Mudey score were observed during the follow-up. ResultsForty-three patients were followed up from 12 to 48 months with an average of 18 months. The mean final Constant-Mudey score was 72.3±9.5 and 6 of them needed a second surgery. In addition to fracture type, other prognostic factors included redisplacement (4 cases, 9.3%), nonunion (3 cases, 7.0%), crashing (3 cases, 7.0%), necrosis of the humeral head (6 cases, 14.0%) and screw cut-out (5 cases, 11.6%). Among the patients with disrupted medial calcar, 4 needed a second surgery at the final follow-up, 3 had redisplacement, 2 had nonunion, and 2 had screw cut-out. ConclusionLocked screw-plates provide more secure fixation of fracture in aged patients, but the complication rate remains high. We suggest anatomic reduction, and plate and screws position, length of the screws, the medial cortical contact and stability may be the chief prognostic factors affecting the shoulder function following a proximal humeral fracture.
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.