The number of investigator initiated research (IIR) is increasing. But the recognition and management of IIR in China is still in its infancy, and there is a lack of specific and operable guidance for the implementation process. Based on our practical experiences, previous literature reports, and current policy regulations, the authors took prospective IIR as an example to summarize the implementation process of IIR into 14 steps, which are as the following: study initiation, ethical review, study registration, study filing, case report form design, database establishment, standard operating procedure making, investigator training, informed consent, data collection, data entry, data verification, data locking and data archiving.

Telephone follow-up is one of the important ways to follow up patients. High-quality follow-up can benefit both doctors and patients. However, clinical research-related follow-up is often faced with problems such as time-consuming, laborious and poor patient compliance. The authors belong to a team that has been committed to the study of patient-reported outcomes for a long time. The team has carried out long-term follow-up of symptoms, daily function and postoperative complications of more than 1 000 patients after lung cancer surgery, and accumulated certain experience. In this paper, the experience of telephone follow-up was summarized and discussed with relevant literatures from the aspects of clarifying the purpose of clinical research follow-up, understanding the needs of patients in follow-up, and using follow-up skills.

Objective:To investigate the effects of preoperative nutritional status on postoperative functional prognosis in elderly patients with proximal humerus fracture.Methods:From January 2020 to December 2020, 103 elderly patients (≥65 years old) were treated for proximal humerus fractures by open reduction and internal fixation at Department of Traumatology, Honghui Hospital Affiliated to Xi'an Jiaotong University. Upon admission, according to the Geriatric Nutrition Risk Index (GNRI), they were assigned into a normal nutrition group (55 cases, with GNRI≥92) and a malnutrition group (48 cases, with GNRI<92). The baseline data, preoperative hemoglobin level, time from injury to operation, intraoperative blood transfusion, postoperative complications, 1-year mortality, and Neer shoulder functional scores at 3 months, 6 months and the last follow-up were compared between the 2 groups.Results:The 2 groups were comparable because there were no significant differences in gender, injury side, Neer fracture classification, injury cause, or American Society of Anesthesiologists (ASA) grading ( P>0.05). The age of the malnutrition group was significant older than that of the normal nutrition group ( P<0.05). All patients were followed up for 9 to 16 months (mean, 13.6 months) after surgery. In the normal nutrition group and the malnutrition group, respectively, the preoperative hemoglobin level was (10.24±0.68) g/dL and (8.94±0.89) g/dL, the time from injury to operation (3.9±1.3) d and (5.8±1.2) d, the rate of intraoperative blood transfusion 14.5%(8/55) and 60.4%(29/48), the rate of postoperative complications 20.0%(11/55) and 39.6%(19/48), the 1-year mortality 1.8%(1/55)、4.2%(2/48), and the Neer shoulder function score (46.7±8.8) points and (43.2±5.6) points at 3 months after operation, (67.6±6.2) points and (76.3±5.5) points at 6 months after operation, and (80.4±5.0) points and (76.3±5.5) points at the last follow-up. Comparisons of all the above items showed significant differences between the 2 groups (all P<0.05). Conclusions:Preoperative malnutrition in elderly patients with proximal humerus fracture has adverse effects on preoperative waiting time, intraoperative blood transfusion, complications and postoperative shoulder function. Therefore, perioperatively, attention should be paid to the nutritional status of elderly patients to reduce their stress responses to fracture, surgery and anesthesia, and to improve their postoperative function and quality of life.

As varus posteromedial rotatory instability (VPMRI) is not common, its injury mechanisms are complex and presents no obvious dislocation on X-ray, it may be considered as a simple coronoid fracture, likely leading to a missed diagnosis or misdiagnosis. Moreover, the treatment of VPMRI is also controversial. Conservative treatment or improper treatment can cause serious complications. Therefore, this review expounds on the injury mechanisms, anatomical structure, O'Driscoll classification, imaging examination, treatment and postoperative rehabilitation of this complicated elbow injury which is rare and difficult to treat clinically.

Objective:To study the association between preoperative hemoglobin amount and incidence of lower limb deep vein thrombosis (DVT) in patients with lower limb fracture.Methods:A retrospective study was performed of the 2, 482 patients with lower limb fracture who had been treated at Department of Orthopaedics Trauma, Honghui Hospital Affiliated to Xi'an Jiaotong University from July 2014 to August 2019. They were 1, 174 males and 1, 308 females with an age of (60.6±19.3) years. Recorded were the patients' age, gender, injury time, hemoglobin amount, D-dimer measurement, combined medical conditions, time and results of ultrasound vein examination on both lower extremities. According to the ultrasound results, the patients were divided into a thrombosis group and a thrombosis-free group. The 2 groups were compared in hemoglobin amount. Logistic regression was used to analyze the relationship between preoperative hemoglobin amount and incidence of lower limb DVT. The patients were divided into 5 groups according to the quintile of hemoglobin amount; the incidences of thrombosis were compared between the 5 groups.Results:The total incidence of DVT in this cohort was 29.53%(733/2, 482). The hemoglobin amount in the thrombosis group was (116.57±19.24) g/L, significantly lower than that in the thrombosis-free group (124.76±19.79) g/L ( P<0.05). The preoperative hemoglobin amount was a risk factor for incidence of DVT after a lower limb fracture ( OR=0.985, 95% CI: 0.980 to 0.990, P<0.001). As the quintile level of hemoglobin increased, the incidence of DVT showed a downward trend. In comparison of the group with the highest DVT incidence (40.58%) and the group with the lowest DVT incidence (17.27%), the risk increased by 2.386 times (95% CI: 1.718 to 3.315). Conclusions:The preoperative hemoglobin amount can affect the DVT incidence after a lower limb fracture, and a low hemoglobin amount may more likely lead to lower limb DVT.

Objective:To investigate the differences in incidence of deep vein thrombosis (DVT) after closed fracture of lower extremity between patients with different blood types ABO.Methods:A retrospective study was conducted in the 1, 951 patients who had been admitted to Department of Orthopaedics Trauma, Honghui Hospital Affiliated to Xi'an Jiaotong University for lower extremity fractures from August 2014 to June 2018. They were 924 males and 1,027 females with a mean age of 63 (46, 78) years (range, from 16 to 102 years). Of them, 572 were type O, 564 type A, 609 type B and 206 type AB. Venous ultrasonography was performed on both lower extremities within 12 hours after admission. The incidences of DVT after fracture were compared between different blood types in all the patients, patients with proximal fracture of the knee, peri-knee fracture and distal fracture of the knee, and patients<60 years old and ≥60 years old.Results:The incidences of DVT were, respectively, 26.75% (153/572), 28.72% (162/564), 34.32% (209/609) and 29.61% (61/206) for patients with blood type O, type A, type B and type AB. The DVT incidence for type B was significantly higher than that for type O ( P< 0.008). The incidences of DVT were, respectively, 28.74% (98/341), 28.99% (100/345), 39.45% (144/365) and 30.97% (35/113) for blood type O, type A, type B and type AB in the patients with proximal fracture of the knee. The DVT incidence for blood type B was significantly higher than those for blood type O and blood type A ( P< 0.008). There were no significant differences in the DVT incidence between different blood types ABO in the patients with peri-knee fracture, distal fracture of the knee,<60 years old or ≥60 years old( P>0.05). The incidences of DVT were, respectively, 30.99% (97/313), 33.33% (108/324), 45.22% (156/345), 34.74% (33/95) for blood type O, type A, type B and type AB in the patients ≥60 years old. The DVT incidence for blood type B was significantly higher than those for blood type O and blood type A ( P< 0.008). Conclusions:The incidence of DVT varied with different blood types ABO after lower extremity fracture. The highest DVT incidence was found in patients with blood type B. The impact of blood type on the DVT incidence after lower extremity fracture was mainly observed in the patients with proximal fracture of the knee or an age of ≥ 60 years old.

Objective:To investigate the risk factors of deep venous thrombosis in patients before hip arthroplasty, and to explore the possible causes of postoperative thrombosis.Methods:The clinical data of 361 patients with hip arthroplasty treated in the Department of Orthopaedic Trauma of Xi′an Honghui Hospital from September 2015 to December 2019 were studied retrospectively, including 102 males and 259 females, aged 65 to 94 years, and the average age was 72.25 years old. All fracture patients were given subcutaneous injection of low molecular weight heparin calcium to prevent lower extremity thrombosis. The deep veins of both lower extremities were examined before and after operation. The general data of the two groups of patients were collected and recorded, including age, sex, whether complicated with medical diseases (essential hypertension, type 2 diabetes, coronary heart disease), serological indexes, time from injury to admission, and time from admission to operation. The software of SPSS 19.0 was used for statistical analysis.Results:The incidence of lower limb DVT, before operation was 29.92%, including 26 males (24.07%) and 82 females (75.93%). The results of multivariate logistic regression analysis showed that diabetes mellitus ( OR=2.127, 95% CI: 1.134-3.989, P=0.019), coronary heart disease ( OR=1.692, 95% CI: 1.056-2.713, P=0.029) and the time from injury to admission ( OR=1.677, 95% CI: 1.037-2.712, P=0.035) were independent risk factors for DVT in elderly patients undergoing hip arthroplasty. The incidence of lower limb DVT, after operation was 46.54%. After operation, proximal thrombus were occurred in 2 cases (1.19%), distal thrombus in 143 cases (85.12%), and mixed thrombus in 23 cases (13.69%). Postoperative thrombus was ipsilateral to the fracture limb in 84 cases (50.00%), thrombus was located in the healthy side of the fracture in 19 cases (11.31%), and DVT occurred in 65 cases (38.69%) in both lower limbs. Conclusions:Delayed admission longed than 48 hours, coronary heart disease and diabetes mellitus are the risk factors for the formation of DVT. The thrombus that existed before operation and did not disappear after operation accounted for 48.81% of the total incidence of postoperative thrombosis, and the new thrombus accounted for 51.19% of the total incidence of postoperative thrombosis. For the elderly patients with femoral neck fracture undergoing hip arthroplasty, ultrasonic examination of both lower limbs should be performed before and after operation to find the changes of thrombus in time and do a good job of prevention and treatment.

The coronavirus disease 2019 (COVID-19) was confirmed by nucleic acid test in 15 juvenile patients aged 4-17 years in Hangzhou Xixi Hospital from January 24 to February 10, 2020. The clinical data and the initial chest high resolution CT (HRCT) findings were retrospectively analyzed.Among 15 cases, 8 patients with a mean age of (6.5±2.3) years (4-11 year) had normal HRCT manifestations (mild disease), while 7 patients with a mean age of (11.9±3.0) years (7-17 years) showed abnormal manifestations (moderate disease). In the 7 moderate cases the CT findings included local thickening of bronchial wall in 2 cases, single lesion in 1 case, bilateral pulmonary lesions in 4 cases. There were total 11 lesions, 6 of which were ground glass and slightly high-density nodules, 5 of which were speckled ground glass and 2 with a little consolidation. There were 10 subpleural lesions, including 7 in the lower lobe of the two lungs, and 1 non-subpleural lesion; the thickened local bronchioles were observed in 3 cases. None of them had hilum and mediastinal lymph node enlargement or pleural effusion.

Objective To investigate the occurrence of deep venous thrombosis (DVT) in the perioperative period of patients with fracture distal to the knee,so that clinicians have a better understanding of the occurrence of DVT in the perioperative period of the fracture distal to the knee.Methods A retrospective analysis of the clinical data of 365 patients with distal knee fractures who underwent surgery in the Department of Orthopaedics Trauma,Xi'an Jiaotong University Medical College Red Cross Hospital from June 2014 to March 2018 was conducted.There were 213 males and 152 females,aged (45.05 ± 15.24) years,with an age range of 17-83 years.Classification of fracture sites:177 cases of tibiofibular shaft fracture,130 cases of ankle fracture,and 58 cases of foot fracture.According to whether thrombosis occurred or not,the patients were divided into thrombotic group and non-thrombotic group before and after operation.There were 66 patients with thrombosis before operation,299 patients without thrombosis before operation,88 patients with thrombosis after operation,and 277 patients without thrombosis after operation.The incidence of thrombosis and the location of the thrombus were recorded.The sex,age,fracture site,ASA score,operation time,the time from injury to admission,the time from injury to surgery,intraoperative tourniquet time,intraoperative blood transfusion volume,intraoperative blood loss,intraoperative transfusion volume,hemoglobin volume at admission and 1 day after operation,D-dimer level at admission and 1 day after operation,multiple injuries,chronic hepatitis and medical diseases were analyzed.The measuremernt data of normal distribution and homogeneity of variance were expressed as mean ± standard deviation (Mean ± SD),the t test was used for comparison between two groups.The comparison of count data was performed by x2 test or Fisher exact probability method,and multivariate logistic regression analysis was performed on the risk factors affecting the occurrence of DVT in both lower extremities.Results The preoperative DVT rate was 18.1％ (66/365).In patients with thrombosis,distal thrombosis accounted for 93.94％ (62/66),and mixed thrombosis accounted for 6.06％ (4/66).The incidence of postoperative DVT was 24.1％ (88/365).In patients with thrombosis,distal thrombosis accounted for 94.32％ (83/88),proximal thrombosis accounted for 1.14％ (1/88),and mixed thrombus accounted for 4.55％ (4/88).Fracture site,ASA score,operation time,intraoperative tourniquet time,intraoperative blood transfusion volume,intraoperative blood loss,intraoperative transfusion volume were not statistically significant(P ＞0.05).Age ≥ 40 years (OR =2.691,95％ CI:1.422-5.093,P =0.002),the time from injury to admission ＞ 3 days (OR =1.927,95 ％ CI:1.072-3.463,P =0.028)were independent risk factors for DVT formation in fracture distal to the knee before operation.Age ≥ 40 years (OR =3.925,95 ％ CI:2.161-7.129,P =0.000),the time from injury to surgery ＞ 5 days (OR =1.835,95 ％ CI:1.080-3.119,P =0.025),D-dimer level at 1 day after operation (OR =1.191,95％ CI:1.096-1.293,P =0.000),combined with multiple injuries (OR =1.981,95％ CI:1.006-3.902,P =0.048),combined with coronary atherosclerotic heart disease (OR =2.692,95％ CI:1.112-6.517,P =0.028) were independent risk factor for DVT formation after operation for fracture distal to the knee.Conclusions The occurrence of DVT before and after the fracture of the knee is mainly caused by distal thrombosis,and proximal thrombosis also occurs.Those patients aged≥40 years,combined with multiple injuries and coronary heart disease,should focus on preventing the occurrence of DVT.After the injury,the patient is immediately admitted to the hospital for DVT screening,and when the general condition allowed,shortening the preoperative waiting time can reduce the occurrence of DVT.

PURPOSE: Hrd1 has recently emerged as a critical regulator of B-cells in autoimmune diseases. However, its role in the pathogenesis of chronic rhinosinusitis with nasal polyps (CRSwNP) remains largely unexplored. This study aimed to examine Hrd1 expression and B-cell accumulation and their possible roles in CRSwNP. METHODS: Quantitative real-time polymerase chain reaction, immunohistochemistry, enzyme-linked immunosorbent assay and Western blotting were used to assess gene and protein expression in nasal tissue extracts. Cells isolated from nasal tissues and peripheral blood mononuclear cells were characterized by flow cytometry. Local antibody production was measured in tissue extracts with a Bio-Plex assay. Additionally, changes in Hrd1 expression in response to specific inflammatory stimuli were measured in cultured dispersed polyp cells. RESULTS: Nasal polyps (NPs) from patients with eosinophilic CRSwNP (ECRS) had increased levels of Hrd1, B-cells and plasma cells compared with NPs from patients with non-eosinophilic CRSwNP (non-ECRS) or other control subjects (P < 0.05). The average Hrd1 levels in B-cells in NPs from ECRS patients were significantly higher than those from non-ECRS patients and control subjects (P < 0.05). NPs also contained significantly increased levels of several antibody isotypes compared with normal controls (P < 0.05). Interestingly, Hrd1 expression in cultured polyp cells from ECRS patients, but not non-ECRS patients, was significantly increased by interleukin-1β, lipopolysaccharide and Poly(I:C) stimulation, and inhibited by dexamethasone treatment (P < 0.05). CONCLUSIONS: Differential Hrd1 expression and B-cell accumulation between the ECRS and non-ECRS subsets suggests that they can exhibit distinct pathogenic mechanisms and play important roles in NP.
Antibody Formation ; Autoimmune Diseases ; B-Lymphocytes* ; Blotting, Western ; Dexamethasone ; Enzyme-Linked Immunosorbent Assay ; Eosinophils* ; Flow Cytometry ; Humans ; Immunity, Innate ; Immunohistochemistry ; Nasal Polyps* ; Plasma Cells ; Polyps ; Real-Time Polymerase Chain Reaction ; Tissue Extracts