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 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.
ObjectiveTo analyze the status quo of outcome indicators in the randomized controlled trials (RCTs) of premature ovarian failure (POF)/primary ovarian insufficiency (POI) published at home and abroad, and provide a sufficient basis for the selection of outcome indicators in related studies in the future.MethodsChina National Knowledge Infrastructure, Chongqing VIP Data, Wanfang Data, SinoMed, PubMed, the Cochrane Library, and Embase were searched for RCT articles of POF/POI published between the establishment of the databases and June 2021. Two researchers independently screened and extracted the literature, and finally summarized the outcome indicators of the included studies.ResultsA total of 186 articles meeting the inclusion criteria were selected, including 180 articles in Chinese and 6 articles in English. The choice of outcome indicators was diverse. Of the 186 articles, 2 Chinese articles and 1 English article used primary and secondary outcome indicators; 19 Chinese articles and 4 English articles used independent indicators, 4 Chinese articles used composite indicators, and 157 Chinese articles and 2 English articles used both independent indicators and composite indicators.ConclusionsThe selection and use of outcome indicators in clinical RCTs of POF/POI are not standardized, and there are problems such as neglect of primary and secondary outcome indicators, and lack of standards for the selection of clinical research outcome indicators. As a result, the credibility of the curative effect is reduced, and the results of similar studies cannot be combined and compared.
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.
ObjectiveTo evaluate the outcomes used in randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) in the treatment of unstable angina pectoris, so as to provide references for the study of the core outcome set of TCM on the treatment of unstable angina pectoris.MethodsWe searched RCTs of TCM on the treatment of unstable angina pectoris in the databases of PubMed, EMbase, The Cochrane Library, CBM, CNKI, WanFang Data and VIP from January 2009 to August 2019. Two reviewers independently screened all records, extracted data and evaluated risk of bias of included trials. A qualitative analysis was conducted to analysis the outcomes.ResultsA total of 43 RCTs were included and their outcomes were categorized into 7 categories: clinical symptoms and signs, quality of life evaluation, blood biochemical outcomes, ECG, cardiac function outcomes, safety outcomes (including adverse reactions and events), and other related outcomes. Blood biochemical outcomes were the most frequently reported outcomes, followed by the clinical symptoms and signs. Of the 43 RCTs, 35 RCTs applied TCM syndromes efficacy as outcomes. Our analysis identified a series of problems in the application of outcomes: no distinction between primary and secondary outcomes, and most of the primary outcomes were intermediate alternative outcomes; the efficacy evaluation standards for TCM syndromes were different; the blinding method was ignored when the subjective outcomes were measured; less attention was paid on adverse outcomes than efficacy outcomes; the names of the same outcome were not standardized; the statistical expression of outcomes required improvement; the quantity of outcomes selected in different studies varied significantly; in TCM related efficacy outcomes, the effective rates were frequently used, however, the evaluation criteria were different.ConclusionsThere are numerous problems for the outcomes’ selecting for RCTs of TCM treatment of unstable angina pectoris. We should use the international standardized method of creating the core outcome sets to establish a core outcome set in line with the characteristics and laws of diagnosis and treatment of traditional Chinese medicine.
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.
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 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.