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 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.
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.
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 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.
ObjectiveThrough the analysis on outcome measurements in domestic and overseas randomized controlled trials (RCTs) of smoking cessation, this study aimed to provide references for clinical trial design in the future. MethodsWe searched CNKI, WanFang Data, VIP, PubMed, EMbase, ScienceDirect and SpringLink databases to collect RCTs regarding smoking cessation from January 1998 to December 2013. Two reviewers screened literature according to the inclusive and exclusive criteria, extracted the data, and analyzed the outcome measurements of included RCTs. ResultsA total of 68 RCTs regarding smoking cessation were included. As for the baseline measurements, the frequency from high to low were age, sex, daily cigarette, smoking duration, Fagerstrom Test For Nicotine Dependence (FTND), race and education, etc.; there were significant differences of race, education level, smoking duration, smoking, starting age of smoking, attempts of trying to stop smoking, the presence of other basic disease, FTND and quit date between English and Chinese RCTs (all P<0.05). As for efficacy measurements, the continuous abstinence rate (77.8%) was mainly adopted in Chinese RCTs, while point abstinence rate (95.1%) and continuous abstinence rate (82.9%) was selected in English RCTs. As for the follow-up measurements, 22.1% of the included RCTs did not report it, 70.6% of the RCTs reported abstinence rate, and the follow-up time in Chinese RCTs was shorter than that in the English RCTs (P<0.05). ConclusionThe selection of outcome measurements is significantly different among RCTs regarding smoking cessation, the Chinese RCTs are inferior to English RCTs, and these are needed to be improved in the future clinical trials.
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.
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.
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.