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.
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.
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.
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 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 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.
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 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.
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.
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.
