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@#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.
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@#Objective To analyse the consistency of perioperative self-reported pain scores of lung cancer patients with clinical records to provide a basis for optimal pain management. Methods The patients with lung cancer who underwent surgical treatment in the Department of Thoracic Surgery, Sichuan Cancer Hospital from November 2017 to January 2020 were selected. They were divided into two groups based on the source of pain data. The self-report group used a questionnaire in which patients self-reported their pain scores, and the pain scores for the clinical record group were extracted from the electronic medical record system. Kappa test was used to compare the concordance of pain scores between the two groups preoperatively, on postoperative 1-6 days and on the day of discharge. McNemar's paired χ2 test was used to compare the differences in pain intensity levels between the two groups. Binary logistic multi-factor regression was used to analyse the factors influencing the concordance of severe pain (7-10 points) between the two groups. Results Totally 354 patients were collected, including 191 males and 163 females, with an average age of 55.64± 10.34 years. The median postoperative hospital stay was 6 days. The consistency of pain scores between the two groups was poor (Kappa=–0.035 to 0.262, P<0.05), and the distribution of pain levels at each time point was inconsistent and statistically significant (P<0.001). The percentage of inconsistent severe pain assessment ranged from 0.28% to 35.56%, with the highest percentage of inconsistent severe pain assessment on postoperative day 1 (35.56%). Single-port thoracoscopic surgical access was an influencing factor for inconsistent assessment of severe pain on postoperative day 3 (OR=2.571, P=0.005). Conclusion Self-reported perioperative pain scores of lung cancer patients are poorly aligned with clinical records. Clinical measures are needed to improve the accuracy of patient pain data reporting by choosing the correct assessment method, increasing education, and developing effective quality control measures.
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@#Objective To investigate the current status of constipation during postoperative hospitalization and the factors associated with moderate to severe constipation at discharge in lung cancer patients. Methods Lung cancer patients who underwent surgery in 6 tertiary hospitals in Sichuan Province from November 2017 to January 2020 were enrolled. The MD Anderson Symptom Scale-Lung Cancer Module was used to collect postoperative constipation scores. Unconditional logistic stepwise regression was used to analyze the related influencing factors for moderate to severe constipation on the day of discharge. Results Finally 337 patients were collected. There were 171 males and 166 females, with an average age of 55.0±10.3 years. Constipation scores of lung cancer patients increased from postoperative day 1 to day 3, and showed a decreasing trend from day 3 to day 7. Moderate to severe constipation was present in 68 (20.2%) patients at discharge. The postoperative hospital stay (OR=0.743, P<0.001) and the dose of morphine used during postoperative hospitalization (OR=1.002, P=0.015) were influencing factors for moderate to severe constipation at discharge in lung cancer patients. Conclusion Lung cancer patients have the most severe constipation on postoperative day 3. Moderate to severe constipation at discharge is associated with the postoperative hospital stay and the dose of morphine used during postoperative hospitalization.
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@#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.
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@#Objective To investigate the risk factors for postoperative complications Clavien-Dindo classification≥grade Ⅱ after lung cancer surgery. Methods The patients who underwent lung cancer surgery in a multicenter observational study from November 2017 to January 2020 were included. The Clavien-Dindo classification of postoperative complications was analyzed. Logistic regression was used to identify the risk factors for complications≥ gradeⅡ. Results A total of 388 patients were enrolled, including 203 males and 185 females with a mean age of 56.14±10.36 years. The incidence of postoperative complications was 25.52% (99/388) after lung cancer surgery and the incidence of complications≥gradeⅡ was 20.10% (78/388). The five most common postoperative complications were pneumonia (6.96%), prolonged pulmonary air leak (>7 days, 5.67%), incision dehiscence (4.64%), arrhythmia (3.87%), and postoperative pleural effusion (3.35%). Multivariate analysis showed that open surgery [reference: uniportal thoracoscopic surgery, OR=2.18, 95%CI (1.01, 4.70), P=0.047], extended resection [reference: sublobar resection, OR=2.86, 95%CI (1.11, 7.19), P=0.030; reference: lobectomy, OR=2.20, 95%CI (1.10, 4.40), P=0.026] and operative time≥3 h [OR=2.07, 95%CI (1.12, 3.85), P=0.021] were independent risk factors for postoperative complications≥gradeⅡ after lung cancer surgery. Conclusion Surgical approach, extent of resection and operative time are independent influencing factors for postoperative complications≥gradeⅡ after lung cancer surgery.
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Objective:To retrospectively analyze the pregnancy outcomes of patients with adenomyosis requiring fertility in a single center under real world condition.Methods:From June 2015 to May 2020, 231 cases of pregnancy complicated with adenomyosis diagnosed by ultrasound with fertility requirements were treated in the Women′s and Children′s Hospital Affiliated to Qingdao University with complete clinical data. And they were divided into three groups according to the treatment of adenomyosis before pregnancy: expectation group, drug group and operation group. The relevant data before pregnancy of the three groups were analyzed, and the pregnancy outcomes of the patients were summarized. According to whether the early pregnancy was treated with medication, the patients who were naturally conceived without symptoms of threatened abortion were divided into observation group and fetus protection group, and the pregnancy outcomes of the two groups were compared.Results:(1) Compared with the expectation group, the ages of patients in the drug group and the operation group were larger [(31.5±1.8) vs (34.1±3.7) vs (36.9±3.6) years old], and the difference was statistically significant ( P<0.05). Only 9 patients (11.5%, 9/78) had clinical symptoms in the expectation group, while the patients in the drug group and the operation group had a higher proportion of dysmenorrhea and increased menstrual volume. The uterine volume of the drug group and the operation group were larger than that of the expectation group [(151±46) vs (166±27) vs (97±18) cm 3], the difference was statistically significant ( P<0.05). 78.6% (33/42) of the operation group were focal adenomyosis. The proportion of natural pregnancy in the expectation group was 97.4% (76/78), and in vitro fertilization and embryo transfer was mainly used in the drug group and the operation group. (2) The abortion rates of the three groups were 48.7% (26/111), 4/17, 67.5% (27/78) respectively. Compared with the drug group and the operation group, the preterm birth rate was lower [55.9% (33/111) vs 11/17 vs 12.5% (5/78)] and the natural delivery rate was higher [44.1% (26/111) vs 4/17 vs 67.5% (27/78)] in the expectation group. (3) There were 89 cases of spontaneous pregnancy without threatened abortion symptoms, including 31 cases in the observation group and 58 cases in the fetus protection group. Compared with the observation group, the abortion rate of patients in the fetus protection group was lower [41.9% (13/31) vs 34.5% (20/58)], and the difference was statistically significant ( P<0.05). Conclusions:Patients with adenomyosis who have fertility requirements should be comprehensively evaluated and individualized treatment plans should be given. Pregnancy patients with adenomyosis have a high rate of miscarriage, and they should be included in the management of high-risk pregnant women. Active fetal protection treatment during early pregnancy might improve pregnancy outcomes.
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Objective:To investigate the clinical effect of focused ultrasound ablation surgery (FUAS) combined with suction curettage for mass-type cesarean scar pregnancy (CSP) and to analyze the influencing factors of vaginal bleeding and readmission.Methods:From January 2014 to December 2020, 88 patients with mass-type CSP were treated by FUAS combined with suction curettage in the Third Xiangya Hospital of Central South University. The clinical results and the influencing factors of bleeding and readmission for mass-type CSP were analyzed.Results:All the patients underwent one time FUAS treatment successfully. Immediately after FUAS treatment, color Doppler ultrasound showed obvious necrosis and no perfusion area in all lesions, and the blood flow in the mass-type CSP tissue significantly decreased. The median volume of blood loss in the procedure was 20 ml (range: 5-950 ml). Thirteen patients (15%, 13/88) had vaginal bleeding≥200 ml, and 15 patients (17%, 15/88) were hospitalized again. The average time for menstruation recovery was (28±8) days (range: 18-66 days). The average time needed for serum human chorionic gonadotropin-beta subunit to return to normal levels was (22±6) days (range: 7-59 days). The risk of large vaginal bleeding of patients were related to the blood supply of the mass ( OR=5.280, 95% CI: 1.335-20.858, P=0.018) and the largest diameter of the mass ( OR=1.060, 95% CI: 1.010-1.120, P=0.030). The risk of readmission were related to the largest diameter of the mass ( OR=1.055, 95% CI: 1.005-1.108, P=0.030) and the depth of the uterus cavity ( OR=1.583, 95% CI: 1.015-2.471, P=0.043). No serious complications such as intestinal and nerve injury occurred during and after FUAS treatment. Conclusions:FUAS combined with suction curettage is safe and effective in treating patients with mass-type CSP through this preliminary study. The volume of vaginal bleeding are associated with the blood supply of the mass and the largest diameter of the mass, the risk of readmission are related to the largest diameter of the mass and the depth of the uterus cavity.
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Neoadjuvant therapy has become the first choice for locally advanced esophageal carcinoma. Patients with post-neoadjuvant positive lymph node staging (ypN+) have poor prognosis, and there is no effective adjuvant therapy. Programmed death protein-1 (PD-1) antibody can obtain better clinical efficacy in the treatment of advanced esophageal cancer. The authors designed a multicenter, prospective, randomized controlled clinical trial of Toripalimab (PD-1 antibody) adjuvant therapy on esophageal squamous cell carcinoma patients with ypN+ after the treatment of neoadjuvant chemotherapy combined with surgical resection, in order to provide clinical practices for the adjuvant treatment of ypN+ patients.
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@#The postoperative symptom burden in patients with lung cancer is severe and adversely impairs their quality of life. Symptom management is the cornerstone of medical care. Patient-reported outcome (PRO)-based symptom management is being increasingly recognized as the best "patient-centered care" model in clinical practice. However, the precise implementation of this model in patients undergoing lung cancer surgery is hindered by the lack of a lung cancer surgery-specific scale, implementation standards, clinical application parameters and high-quality researches. The use of a precise and simple PRO scale and an electronic PRO platform may greatly improve the feasibility of implementing this model. Currently, the application of PRO-based symptom management in lung cancer surgery is still being explored and needs to be improved in clinical research and practice.
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Objective To determine whether color doppler ultrasonography (CDU),thyroid function or thyroid autoimmune antibodies could identify Graves' disease in pregnancy(GDP) in pregnant patients with newly diagnosed thyrotoxicosis.Methods It is an observational study.Sixty-eight pregnant patients with newly diagnosed thyrotoxicosis including gestational hyperthyroidism (GHT) subjects (GHT group,n =33) and GDP subjects (GDP group,n =35),and 62 age-and sex-matched healthy subjects (C1 group:pregnant,n =32,C2 group:non-pregnant,n =30) were recruited.Thyroid function,human chorionic gonadotropin(HCG),thyroid autoimmune antibodies were detected.Peak systolic velocity of the superior thyroid artery (STA-PSV) and diastole inner diameter(STA-D) of the superior thyroid artery were measured by CDU.A ROC curve was used to evaluate STA-PSV,STA-D,thyroid function and thyroid autoimmune antibodies for identification of GDP.Results The area under the ROC curve of STA-PSV,STA-D and thyroid stimulating hormone (TSH),free T4 (FT4) for GDP were 0.905,0.887,0.803 and 0.786,respectively.The optimal cut-off points of STA-PSV,STA-D,TSH and FT4 for GDP were 40 cm/s,2.0mm,0.03 mIU/L and 30 pmol/L with the sensitivity of 82.9％,72.1％,81.8％,76.2％ and specificity of 81.8％,87.9％,75.2％,80.3％,respectively.Conclusions Detection of STA-PSV and STA-D by CDU,as well as thyroid function,is useful in screening GDP in pregnant patients with thyrotoxicosis.
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<p><b>OBJECTIVE</b>To prospective examine the relationship between smoking, quitting and mortality in older Chinese men by in Xi'an, China.</p><p><b>METHODS</b>The design was a cohort analytic study. One thousand two hundred and sixty-eight retired male military veterans aged 60 or older were examined in 1987. At baseline, there were 388 never-smokers, 461 former smokers and 419 current smokers. Main outcome measure was all-cause and tobacco-associated mortality.</p><p><b>RESULTS</b>Through 1999, 299 had died, 943 were alive and 26 lost. The mean follow-up time was 11 years and total person-year of follow-up was 14 163. After adjusting for age, blood pressure, body mass index, total cholesterol, triglycerides, alcohol intake, exercise and existing diseases, using Cox proportional hazard regression model, the relative risks (95% confidence intervals) for ever-smoking, deaths resulting from all causes, chronic obstructive pulmonary disease (COPD), lung cancer and coronary heart disease (CHD) were 1.34 (1.02 - 1.76), 3.23 (0.95 - 10.91), 2.31 (0.95 - 5.61) and 1.60 (0.81 - 3.19) respectively. The risks increased significantly with increasing amount and duration of smoking. Compared with current smokers, former smokers had lower risks of total mortality (excess risk reduction of 56%) and from CHD death (93%), but had higher risks for COPD death (excess risk increased 174%).</p><p><b>CONCLUSIONS</b>Smoking is a major cause of death in older Chinese men and quitting can save lives. These results showing that higher risks of COPD death in former smokers with or without existing diagnosed COPD at baseline than those in current smokers could be explained by either the "healthy smoker effect" or the "ill quitter effect" or both. Early recognition of the significance of COPD symptoms followed by prompt quitting should be emphasized as strategies in the control of the growing tobacco epidemic.</p>