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.
ObjectiveTo systematically review the outcomes reported in clinical trials of post-stroke dysarthria.MethodsPubMed, The Cochrane Library, EMbase, CNKI, Sinomed, WanFang Data and VIP databases were electronically searched to collect randomized controlled trials (RCTs) of post-stroke dysarthria from inception to December 6th, 2019. Two reviewers independently screened literature, extracted data and analyzed outcomes using qualitative method.ResultA total of 112 RCTs involving 39 outcomes (therapeutic effect assessment outcomes and safety outcomes) were included. The top 4 outcomes were the Frenchay dysarthria assessment scale, the dysarthria examination method developed by the Chinese rehabilitation center, the evaluation of the speech therapists or clinicians and GRBAS.ConclusionsCurrent evidence shows that there is no acceptable outcomes for post-stroke dysarthria. It is recommended to improve the suitable assessment scale for Chinese to improve quality of studies on post-strohe dysarthria.
Core Outcome Set (COS) is an important approach to address problems in which the outcomes are inconsistent, non-essential and reporting biased in clinical researches. In order to ensure the standardization of the COS development process, the Core Outcome Measures in Effectiveness Trials (COMET) has initiatively developed the Core Outcome Set-STAndards for Development (COS-STAD). The recommendation includes 11 minimum standards, involving 3 common key domains: the scope, the stakeholders, and the consensus process. The COS-STAD is used by COS developers for standardizing research design, determining the quality of the methodology to develop a COS. Based on the background and conditions of clinical practice and clinical trials in China, especially the characteristics of the development of Core Outcome Set of Traditional Chinese Medicine (TCM-COS), this paper interprets the recommendations of COS-STAD, providing a reference for the potential users of COS in China.
The use of core outcome sets reduces heterogeneity in the reporting of outcomes in clinical trials, increasing the value and significance of research. This paper first introduces and interprets “core outcome sets for myocardial infarction (COS-MI) in clinical trials of traditional Chinese medicine and Western medicine”, in order to help Chinese researchers better understand and use it. Second, this study surveyed the use of COS-MI in MI related clinical trials from January 1, 2023 to June 1, 2024, showing that 91% (10/11) of the 35 acute myocardial infarction clinical studies included reported core outcomes, and the median percentage of using core outcome sets was only 36% (4/11). As the publication time of the core outcome set is close to the literature search time, the understanding of domestic researchers about it is still unclear. Further research is needed to explore the application of core outcome sets for myocardial infarction in clinical trials of traditional Chinese medicine and Western medicine, providing a reference for its update and improvement.
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.
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 investigate the role of amygdala volume index(AVI) in surgcial evaluation in patients with mesial temporal lobe epilepsy (mTLE), including clinical features, etiologies and surgical outcome. MethodsThirty six patients were diagnosed as mTLE after surgical evaluation including clinical manifestations, video-electroencephalogram (VEEG) and magnetic resonance imaging (MRI) at the Second Affiliated Hospital of Zhejiang University between March 2013 and March 2016. Bilateral amygdala AVI was then calculated from amygdala volumes on MRI, which were measured with region of interest (ROI) analysis. All patients were treated surgically. Etiologies of mTLE were further confirmed by the histopathology of the resected tissue. ResultsAmong the 35 patients, there is a strong correlation between AVI on the lesion side and age of onset (R =-0.389, P = 0.019) as well as age of surgery (R =-0.357, P = 0.032). No obvious relation can be seen between AVI and gender, history of febrile convulsion, duration of epilepsy, secondary generalized seizure, side of lesion, presurgical seizure frequency and electrode implantation. There is no significant difference in AVI among the five etiologies. At follow-up, thirty patients (80.5%) reached seizure-free, AVI on the lesion side is nota predictor of surgical failure (P > 0.05). ConclusionAVI plays a role in etiology evaluation in patients with mesial temporal lobe epilepsy. Moreover, a larger AVI on the lesion side is correlated with an earlier age of onset. There is limited value of amygdala volume insurgical outcome prediction of patients with mTLE.
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.
Implementation science is a relatively emergent and growing research area. Implementation research can assist to transform what is possible in theory to reality in practice and address the challenge of implementing proven interventions in the real world. Implementation research has a wide range of usages and complex research problems, so appropriate research methods, designs, and outcomes variables are required to address different research objectives. To better conduct implementation research, this paper systematically introduces the research designs, outcome variables, and reporting guideline of the implementation research in health care, based on the purposes and research questions of implementation research.