The complete, transparent, and standardized reporting of the outcome of a clinical trial is a key factor in ensuring the practicality, reproducibility, and transparency of the trial, and reducing bias in selective reporting. The consolidated standards of reporting trials (CONSORT) 2010 statement provides normative guidelines for reporting clinical trials. In December 2022, JAMA released the guidelines for reporting outcomes in trial reports (CONSORT-Outcomes) 2022 extension, aiming to explain the entries related to trial outcomes, sample size, statistical methods, and auxiliary analysis in the CONSORT 2010 statement, to further improve the standards for outcome reporting in clinical trial reports. This article combines research examples to interpret the CONSORT-Outcomes 2022 extension, in order to provide normative references for domestic scholars to report clinical research results.
Objective To assess the appropriateness of Barthel Index (BI) and Modified Rankin Scales (MRS) used as long-term outcome measures in a stroke data register and to investigate the correlation between cutoff points of the two scales in different stroke patients with and without disability. Methods Nine hundred and twelve patients were registered prospectively. BI and MRS were evaluated at the end of 1, 3, 6 and 12 months after stroke onset. The distribution, ceiling effects and floor effects of the two scales were evaluated. A logistic regression model was established to investigate correlation of cutoff points of BI and MRS. Results There were a total of 2 829 evaluation points of BI and MRS. The percentages of patients reaching the maximum scores of BI at the end of 3, 6 and 12 months (54.8％, 62.2％ and 68.3％, respectively) were higher than those of MRS. There was significant correlation between the two scales (Spearman’s correlation coefficient 0.887, P＜0.05), when MRS scores of ≤1 and ≤2 were taken as cutoff points, the corresponding cutoff points of BI score were ≥90 and ≥85, respectively. Conclusions BI has significant ceiling effects when used as long-term outcome measurement in a stroke data register. There was significant correlation between BI and MRS scores. In future clinical studies, an MRS score ≤2 or BI score ≥85 could be used as cutoff points in predicting stroke patients with and without disability.
Objective To investigate the risk factors，clinical features and outcome of invasive aspergillosis（IA） in nonneutropenic patients.Methods Fifty-four patients with IA at the First Affiliated Hospital of Zhengzhou University from Jan 2001 to Dec 2006 were analyzed retrospectively.According to the definitions of EORTC/MSG，proven diagnosis was made in 9 cases，probable diagnosis in 30 cases and possible diagnosis in 15 cases.Results In the neutropenic group（n=24），hematological malignancies were the major underlying conditions（n=20）.In nonneutropenic group（n=30），the main underlying condition was steroid-treated COPD（n=11）.Fever，dyspnea，cough，chest pain and haemoptysis were commonly symptoms.Thoracic computed tomography showed that segmental consolidation occurred more frequently in neutropenic patients，whereas diffuse nodules more frequently in nonneutropenic patients.Nodules or consolidation with evidence of cavity lesion had a higher sensitivity than the halo sign or air crescent sign in both groups.The total mortality of IA was 72.2%.The mortality of nonneutropenic group was higher than that of neutropenic group（83.3% vs 58.3%，P=0.042）.Multivariate analysis showed that secondary central nerves system IA and delayed diagnosis were associated with poor outcome of IA.Conclusion There were high incidence and mortality of IA among nonneutropenic patients，especially those with COPD treated with long-term corticosteroids.
Objective To evaluate midterm and longterm clinical outcome of bilateral internal mammary artery composited Y grafts for coronary artery bypass grafting (CABG)， analyze risk factors for late death ，and to improve surgical results. Methods Between January 2000 and May 2004, One hundred and sixtyfive patients underwent bilateral internal mammary artery grafts for CABG, The clinical data, postoperative complications and survival results were retrospectively reviewed and analyzed. The preoperative and postoperative cardiac function was compared. All factors that may have affected the survival were analyzed by logistic regression, to identify significant variables associated with late death. Results Total 561 anastomosis sites of internal mammary arteries were completed with each patient received an average of 3.4 grafts. There were no perioperative deaths. There were 16 patients with postoperative complications including recurrent angina, myocardial infarction, low cardiac output syndrome, sternal infection and so on. All patients were treated conservatively without reoperation. One hundred sixty patients（97%）were followed up of 5.6±1.2 years, there were 23 late deaths including 10 patients of cardiac related death in which 3 had recurrent myocardial infarction, 4 heart failure, and 3 arrhythmia; 13 patients of nocardiac related death in which 4 upper gastrointestinal hemorrhage, 3 cancer and 6 uncertain cause. 25 patients had major cardiac related events including recurrent angina 18, myocardial infarction 4, repeated revascularization 3. Left ventricular ejection fraction [CM(159mm]was significantly improved as compared with that before operation（54%±6% vs. 43%±12%, Plt;0.05）. The 1-, 3-, 5-year actuarial survival rates and eventfree rates were 98.2%±0.3%, 96.2%±0.5%, 90.5%±1.9% and 95.5%±1.2%, 91.3%±2.1%, 86.6%±1.5%, respectively. According to statistical analysis, univariate analyses had proved that advancing age＞65 years，diabetes，ejection fraction(EF) less than 30%，the New York Heart Association (NYHA) class Ⅲ/Ⅳ, and low cardiac output syndrome required placement of the intraaortic balloon pump were predictors associated with hospital major adverse cardiac events (Plt;0.05). Those variables entered into the logistic regression model and found to be independent predictors associated with increased late cardiac death included advancing age ＞65 years(OR=11.6), diabetes (OR=21.4), EF less than 30%(OR=37.5) and NYHA class Ⅲ/Ⅳ(OR=40.2). Conclusion Patients receiving bilateral internal mammary artery composited Y grafts have better longterm survival and reduced cardiac related events. Independent risk factors for late death are NYHA function class Ⅲ/Ⅳ, EF less than 30%, diabetes and advancing age ＞65 years.
Objective To summarize the surgical experience of supracardiac total anomalous pulmonary venous connection(S-TAPVC) and study the surgical technique and outcomes for S -TAPVC. Methods Eightysix patients with S-TAPVC underwent the surgical repair from May 1985 to December 2007. There were 49 males and 37 females. The patients aged from 7 months to 35 years (mean 9.6 years) and weighed from 4.9 kg to 68.0 kg (mean 23.8 kg). The patients were divided into three groups by the approach for the anastomosis. There were 20 patients in groupⅠthrough the right atrium incision, 49 patients in group Ⅱ through the right and left atrium incisions and 17 patients in group Ⅲ through the top of the left atrium incision. The interrupt continuous anastomosis between the common pulmonary venous and the left atrium was used in all patients. The enlarged atrial septal defect(ASD) was repaired with autopericardium. The vertical vein was ligated if the postoperative left atrial pressure was less than 15 mm Hg. But the vertical vein was opened or just partialy ligated if the postoperative left atrial pressure was more than 15 mm Hg. Results There was no early operative death. The postoperative left atrial pressure in three groups were 9.3±3.2 mm Hg, 9.9±2.9 mm Hg and 11.6±3.8 mm Hg, respectively. The cases with open or just partly ligated vertical vein in three groups were 0 case （0%）, 7 cases (14.3%) and 2 cases (11.8%), respectively. The cases of arrhythmia in three groups were 5 cases （25.0％）, 15 cases （30.6%）and 1 case （5.9%）. The severely low cardiac output syndrome occurred in 2 patients and reoperation for bleeding in 2 patients. The morbidity of arrhythmia in group Ⅲ was less than in group Ⅱ（P=0.042）. Conclusion The outcome of surgical repair for S -TAPVC is satisfactory. The anastomosis through the top of the left atrium incision has low occurrence of arrhythmia. The anastomosis through the right and left atrium incision is easy to expose and to perform surgery, especial for old children and adult patients.
To observe the histology change of the insertion using different diamertrical bone tunnel in anterior cruciate l igament (ACL) reconstruction. Methods Ninety Japanese rabbits were selected, wihout female and male l imit, weighing 2.5-3.0 kg, and were randomly divided into 3 groups, 30 in each group. The ratio of transplantation l igament diameter and bone tunnel diameter was 1/1 (group A), the ratio was 1/1.5 (group B), and the ratio was 1/2 (group C). Bone tunnel observation and histology observation were carried out in the 4th, 8th and 16th weeks postoperat ively. Results Wound healed well in 3 groups. The mean time of walking functional recovery was 1.5, 2.0 and 3.5 days in groups A, B and C respectively. After 4 weeks of operation, more soft tissues at tunnel entry were observed in group A and group B than in group C; after 8 weeks of operation, there was no crevice at bone-tunnel entry of the groups A and B, there was no improvement in group C; after 16 weeks of operation, groups A and B showed the normal insertion, group C had no normal insertion. Histology observation: in groups A, B and C, bone-tunnel was filled with loose connective tissue after 4 weeks of operation; group A and group B emerged the discontinuation ACL insertion tidal l ine after 8 weeks of operation, group C had no insertion; groups A and B emerged the similarity normal ACL insertion tidal l ine structure after 16 weeks of operation, but group C had no this structure. The results of ultimate tensile strength in groups A, B and C were (75.44 ± 7.06), (91.37 ± 6.14) and (126.91 ± 4.61) N respectively at 4 weeks; the results were (74.31 ± 4.81), (88.30 ± 7.46) and (124.34±8.44) N respectively at 8 weeks; and the results were (62.20 ± 5.32), (71.53 ± 5.99) and (83.62 ± 5.69) N respectively at 16 weeks. There was no significant difference between group A and group B (P gt; 0.05), and there were significant differences between groups A, B and group C (P lt; 0.05). Conclusion In the ACL reconstruction, the ratioof transplantation l igament diameter and bone tunnel diameter being 1/1.5 will not affect the insertion outcome, but if theratio less than the l imit it will affect the insertion outcome.
Objective To learn if appropriate methods and clinically relevant outcomes were used by analyzing methods of outcome assessment in Chinese acute stroke trials. Method Randomised and quasi-randomised controlled trials on acute stroke published before March 2003 in 6 Chinese neurological journals were included. Types of outcome measures, blinding of outcome assessment, duration of follow up, statistical methods used for data analysis and the significance of the results were evaluated. Types of outcomes were classified as death and four levels: ① Pathology. ② Impairment. ③ Disability. ④ Handicap/quality of life. Results Two hundreds and ten trials were included in this analysis. 57% of the trials used outcomes in pathology level, 77% in impairment level, 12% in disability level and none in the quality of life level. No dichotomous data was analyzed for disability measures. Only 16% of the trials reported number of death but few of them designed death as an outcome measure. Duration of follow up ranged from 3h to 3 years (median 17 d, interquartile range 14-30 d). Most trials did not assess outcomes blindly. Results in 95% of the trials were favorable to the tested interventions. Conclusions In Chinese acute stroke trials, outcome measures used were mainly in pathology and impairment levels and very few trials used functional outcome or death. Blinding of outcome assessment was not commonly used. The average duration of follow up was short.
ObjectiveTo explore the related factors for the influences and outcomes of mothers and infants, and further provide a basic reference for reducing maternal and prenatal mortality caused by central placenta previa, through the analysis of its clinical characteristics. MethodsWe retrospectively analyzed the clinical data of 89 patients with central placenta previa treated from January to August 2012. ResultsThere were 89 patients with central placenta previa, and the average age of these patients was (29.6±11.4) years, and the average number of pregnancy among the patients was 3.17. Nine patients had scar uterus; 8 had pernicious placenta previa (9%); 34 had prenatal anemia symptoms; 44 had prenatal vaginal bleeding with the bleeding volume ranged from 2 to 500 mL; 40 were treated before delivery. The average gestational age was 36 weeks ±4.2 days, and 28 of them were readmitted. The intraoperative bleeding in such patients as had placenta located in the anterior wall, placenta adhesion or implantation, history of uterine cavity operation or multipara was more than other patients. The postpartum hemorrhage of patients with the gestational age of 36 weeks or more was more than that of patients with the gestational age shorter than 36 weeks. The incidence of fetal distress in patients with the gestational age of 36 weeks or more is lower and the neonatal 1-minute Apgar score was higher than that in patients with the gestational age shorter than 36 weeks (P<0.05). ConclusionThe treatment of central type of placenta previa should be more active to prolong the gestational week. Patients with placenta adhesion or implantation, caesarean, multipara and placenta in the anterior wall are susceptible to intraoperative bleeding during the termination of pregnancy. Termination of pregnancy in these patients with central placenta previa should be carried out by cesarean section when gestation is more than 36 weeks to reduce postpartum hemorrhage and complications.
ObjectiveTo learn the outcomes of hepatitis B virus (HBV)-related acute-on-chronic liver failure (ACLF) cases after artificial liver support system (ALSS) treatment and the relevant factors correlated with the clinical outcomes. MethodsIn the period from January 2011 to June 2014, 321 patients with HBV-ACLF were admitted to West China Hospital. The clinical data at baseline, before and after treatment were analyzed by univariate and multivariate logistic regressions to identify the independent risk factors correlated with 30-day outcomes. ResultsOf all the 321 patients, 233 survived and 88 died by the end of a 30-day observation. The univariate analysis identified that the incidences of cirrhosis, hepatorenal syndrome and peritonitis in the death group were significantly higher (P<0.05). The model for end-stage liver disease values, white blood cells (WBC), blood ammonia, creatinine and total bilirubin (TBIL) at different stages in the death group were significantly higher than those in the survival group (P<0.05). In the death group, the HBV-DNA, TBIL decrease after triple ALSS treatments, baseline prothrombin time activity (PTA) and PTA level after triple ALSS treatments were significantly lower (P<0.05). The multivariate logistic regression indicated that WBC (OR=2.337, P<0.001) and TBIL level after triple ALSS treatments (OR=4.935, P<0.001) were independent predicting factors for death within 30 days after ALSS treatment; HBV-DNA (OR=0.403, P<0.001), the decrease of TBIL after triple ALSS treatments (OR=0.447, P<0.001) and PTA level after triple ALSS treatments (OR=0.332, P<0.001) were protecting factors for the 30-day prognosis. ConclusionThese five factors including WBC, HBV-DNA, PTA, TBIL and TBIL decrease after triple ALSS treatments influence the short-term prognosis for HBV-ACLF patients, which are valuable for decision making in clinical practices.