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 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.
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.
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.
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.
Inconsistency, impracticability and non-standardization of the selection, measurement and reporting of outcomes are three primary existing issues in clinical trials. These problems pose a threat to huge research waste when the results of similar studies are not able to be combined or compared. The key for resolution will be to standardize outcomes in traditional Chinese medicine (TCM) clinical trials and to establish a core outcome set (COS), which is a set of outcomes to be reported as a minimum in all TCM clinical trials of similar healthcare system and syndromes. The first step in the development of COS is to collect all existing outcomes, that is, to build a pool of outcomes for clinical trials of TCM. A pool of outcome is the basis of developing COS, which is important to follow strict and scientific methodology. This paper aims to construct an outcome pool from published literature, clinical trial registration protocols, and clinicians, and patients questionnaires were used to form a list of outcomes. In addition, the influencing factors of constructing an outcome pool and considerations for each problem are summarized in order to provide guidance and reference for the development of COS in clinical trials for TCM.