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 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.
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.
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.
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.
The Core Outcome Measures in Effectiveness Trials (COMET) Working Group has published a series of research and reporting guidelines related to core outcome sets since it was established. This article introduces and interprets the Core Outcome Set-STAndardised Protocol Items: the COS-STAP Statement which is developed by the COMET and published in February 2019. It will then be compared with Core Outcome Set-STAndards for Reporting (COS-STAR) and Core Outcome Set-STAndards for Development (COS-STAD), which have been introduced to China. The significance of these guidelines for the development of core outcomes in the field of traditional Chinese medicine is discussed, so as tp draw researchers' attention to this area.
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.
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.
ObjectiveTo explore the association between prediabetes and poor outcome in patients with acute ischemic stroke (AIS).MethodsThe patients with first-ever AIS who were hospitalized in the Department of Neurology, the First Affiliated Hospital of Henan University of Science and Technology from September to December 2018 were retrospectively enrolled. According to the different levels of hemoglobin A1c, the patients were divided into prediabetes group, diabetes mellitus (DM) group and non-DM group. The outcome of the patients 3 months after the discharge was assessed by the modified Rankin Scale and dichotomized as good and poor outcomes. ResultsA total of 188 patients were included, and 160 were eventually included. Among them, 66 cases were in the non-DM group, 39 were in the prediabetes group, and 55 were in the DM group; 68 patients were in the poor prognosis group and 92 were in the good prognosis group. There was no statistically significant difference among the non-DM group, prediabetes group, and DM group (P>0.05) except for hyperlipidemia (χ2=7.781, P=0.020), triglyceride (TG) (F=8.220, P<0.001) and admission blood glucose (F=44.356, P<0.001). There was no statistically significant difference between the good prognosis group and the poor prognosis group (P>0.05) except for hyperlipidemia (χ2=4.847, P=0.028), admission blood glucose (t=−2.940, P=0.004), TG (t=−2.766, P=0.006), and NIHSS (Z=−6.038, P<0.001). Prediabetic [odds ratio (OR)=4.053, 95% confidence interval (CI) (1.491, 11.019)] and diabetic [OR=5.986, 95%CI (2.330, 15.379)] patients had a worse prognosis 3 months after the discharge.ConclusionIn adults with first-ever AIS, prediabetes and diabetes were associated with poor prognosis in patients with AIS after 3 months.