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 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.
In recent years, clinical trial research on stroke intervention measures has been developing rapidly. In order to provide reliable conclusions, the outcome assessment of clinical trials is crucial. Tools for functional status evaluation have been widely adopted as outcome assessment, and have become mandatory for qualified clinical trials of stroke treatment. In this paper, the classification of functional assessment scales in stroke is reviewed, and the applications of functional assessment scales in clinical trials of stroke treatment are presented. National Institute of Health Stroke Scale, Barthel Index, and modified Rankin Scale are the top three frequently applied assessment scales in stroke trials. Also, their validity, reliability, responsiveness, and feasibility are described. Furthermore, analytical methods used to assess those functional assessments are highly heterogenous, while dichotomy of scale score is the most widely used. Although there is no consensus on designation of the functional assessment time, three-month is the most popular, reliable, and feasible choice in stroke trails.
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.
ObjectiveTo overview of systematic reviews of the efficacy and safety of antimicrobials in the prevention of postpartum infection after vaginal delivery, and to provide evidence for the rational use of antimicrobials. MethodsThe CNKI, WanFang Data, VIP, PubMed, Embase, and Cochrane Library databases were searched to collect systematic reviews/meta-analyses on antibiotic prophylaxis for transvaginal delivery from inception to June 25, 2023. The data of the included systematic reviews were extracted by 2 investigators independently, and the methodological quality, risk of bias, and report quality were evaluated by AMSTAR 2.0 scale, ROBIS tool, and PRISMA, respectively. And a pool of outcomes for assessing the effectiveness of antimicrobials in prevention of postpartum infection after transvaginal delivery was developed. ResultsA total of 7 systematic reviews were included. And the AMSTAR 2.0 indicated that most studies (5/7) were from very low quality to low quality. The ROBIS tool showed 3 studies with low risk of bias, 3 with high risk of bias, and 1 with unclear risk of bias. The results of the PRISMA statement showed that the included system evaluation reports were relatively complete. The present evidence showed that prophylactic use of antimicrobials may be beneficial and recommended in women with Ⅲ-Ⅳ perineal fissures, with no significant benefit in women with manual placenta removal, but prophylactic use of antimicrobials was recommended considering their invasive nature, but it was controversial whether antimicrobials should be used in the categories of vaginal assisted delivery, perineal lateralization, and spontaneous delivery (without complications). ConclusionAntimicrobial prophylaxis may not be recommended for all the pregnant women undergoing vaginal delivery to prevent the postpartum infection, but considering the low methodological quality of the included systematic review and the inconsistent outcomes in this field, the conclusion should be further verified by future research with high-quality.
To solve the problems such as the incomplete and non-standard reporting outcomes in clinical trials, international methodologists have simultaneously launched guidelines for reporting outcomes in trial protocols and reports in 2022 on the basis of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 and the Consolidated Standards of Reporting Trials (CONSORT) statement 2010. The SPIRIT-Outcomes 2022 extension and CONSORT-Outcomes 2022 extension recommend outcome-specific reporting items should be included prospectively in trial protocols and reports, regardless of trial design or population. This paper introduces and interprets the two guidelines for reporting outcomes, and discusses their significance and enlightenment to the research in the field of traditional Chinese medicine. For example, using the outcome reporting guidelines will help clinical researchers comprehensively consider issues related to outcomes when reporting protocols or results, which may improve the quality of research design and reporting. For core outcome set, the five core elements of outcomes may help researchers extracting and analyzing outcomes, which will standardize research; the explanation of medical terminology in the outcome reporting guidelines will contribute to the improvement of methodology in the field of traditional Chinese medicine.
The Core Outcome Set-STAndards for Reporting (COS-STAR) is a latest guide tool made by Core Outcome Measures in Effectiveness Trials (COMET) group. It can enhance the transparency and completeness of Core Outcome Set (COS) report. This paper introduces the generation process, report items and application of COS-STAR to provide reference for domestic similar researches.
Objective To investigate clinical features and surgical outcome in children with frontal lobe epilepsy by evaluating the correlation between the predictive factors and seizure freedom. Methods 18 children who underwent frontal lobe epileptogenic resection in the Epilepsy Center of the Children's Hospital of Fudan University between January 2017 and December 2019 with a minimum follow up of 2 year were analyzed retrospectively. Each patient was evaluated with detailed data to predict postsurgical seizure freedom by analysis of variance. Results Of the 18 patients, there were 11 males and 7 females, the age at surgery ranged from 21 months to 11 years old (6.8±2.73) and the duration of seizures was from 1 month to 9 years. 17 patients had focal seizures, while 1 had generalized epileptic spasm. In scalp EEG, interictal and initial ictal discharges were frontal in 11 and 9 cases, respectively. MRI was indicative of FCD in 10 cases, tumor in 2, tuberous sclerosis and gliosis lesion in 1 case each. 4 patients were MRI negative. 11 patients underwent epileptogenic lesion resections directly and 7 cases received depth electrodes implantation and underwent stereo-electroencephalography to localize epileptogenic zone. At follow-up of 2 years, 14 (77.8%) patients remained seizure-free (Engel Ⅰ), 1 (5.6%) had marked seizure reduction (Engel Ⅱ), 2 (11.0%) showed minor improvement (Engel Ⅲ), and only 1 (5.6%) showed no response (Engel Ⅳ). About predictors of seizure recurrence, there were no significant differences in gender, age at surgery, age of seizure onset, duration of epilepsy, lateralization of epileptogenic zone, positive MRI findings, interictal and ictal discharge, etiology, intellectual development and stereo-electroencephalography implantation, while significantly higher rates of seizure freedom correlated with complete the resection of the epileptogenic zone. Conclusions Focal cortical dysplasia is the most common cause in childhood with frontal lobe epilepsy and complete resection of the epileptogenic zone can lead to good seizure control outcome.
ObjectiveTo analyze responsiveness of Chinese version of Neck Outcome Score (NOOS-C) and provide a reliable measure to assess intervention effect for patients with neck pain.MethodsCross-cultural adaptation of NOOS was performed according to the Beaton’s guidelines for cross-cultural adaptation of self-report measures. Eighty patients with neck pain were recruited between September 2016 and May 2017. Those patients were assessed using NOOS-C and Chinese version of Neck Disability Index (NDI) before and after intervention. And 71 patients completed those questionnaires. The statistic differences of the score of each subscale and the total scale before and after intervention were evaluated by paired-samples t test. Internal responsiveness was determined by effect size (ES) and standardized response mean (SRM) based on the calculated difference before and after intervention. External responsiveness was analyzed by Spearman correlation coefficient.ResultsThe differences in symptom subscale, sleep disturbance subscale, participating in everyday life subscale, every day activity and pain subscale, and the scale between before and after intervention were significant (P<0.05) except for mobility subscale (P>0.05). The difference of NDI-C before and after intervention was –12.11%±17.45%, ES was 0.77, and SRM was 0.69. The difference of NOOS-C before and after intervention was 13.74±17.22, ES was 0.83, and SRM was 0.80. Spearman correlation analysis revealed that the relativity about NOOS-C and NDI-C before and after intervention were both negative (r=–0.914, P=0.000; r=–0.872, P=0.000).ConclusionNOOS-C’s responsiveness is good.
ObjectiveTo evaluate the current status and trend of methodological quality of multi-center randomized controlled trials (RCTs) of stroke treatments in Chinese Mainland.MethodsMulti-center RCTs of stroke treatments conducted in Chinese Mainland published in Chinese or English language from January 2000 to December 2019 were retrieved from seven databases including PubMed, Cochrane Central Registry of Controlled Trials, Embase, China Biology Medicine, China National Knowledge Infrastructure, Chinese Science and Technique Journals Database, and Wanfang Database. The basic information was collected. Methodological items were referred to the Cochrane Collaboration’s tool for assessing risk of bias. The definitions of Wade were used to assess the outcome measure.ResultsA total of 90 multi-center RCTs were included, of which 39 were published from 2000 to 2009, and 51 were published from 2010 to 2019. The total number of trials published from 2010 to 2019 was 1.31 times of that published from 2000 to 2009. The research subjects were ischemic stroke patients in 58.9% (53/90) of the RCTs, intracerebral hemorrhage patients in 14.4% (13/90) of the RCTs, and ischemic stroke patients as well as hemorrhagic stroke patients in 26.7% (24/90) of the RCTs. There were 55.6% (50/90) drug trials, and 44.4% (40/90) non-drug trials. There were statistically significant differences in the loss of visit report (P=0.005), primary and secondary outcome indicators report (P=0.027), and adverse reaction report (P=0.007) between the two periods; there was no statistically significant difference in reported adequate randomized methods (P=0.341), allocation concealment (P=0.611), blindness (P=0.551), used intentionality analysis (P=0.573), or follow-up time (P=0.061) between the two periods.ConclusionIn the past 20 years in Chinese Mainland, the quality of stroke treatment RCTs improves slowly, and more attention should be paid to develop the RCTs of true randomization, blinding, and better patient outcome measures.
