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 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 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 responsiveness of Chinese version of Neck Outcome Score (NOOS-C) and provide a reliable measure to assess intervention effect for patients with neck pain.MethodsCross-cultural adaptation of NOOS was performed according to the Beaton’s guidelines for cross-cultural adaptation of self-report measures. Eighty patients with neck pain were recruited between September 2016 and May 2017. Those patients were assessed using NOOS-C and Chinese version of Neck Disability Index (NDI) before and after intervention. And 71 patients completed those questionnaires. The statistic differences of the score of each subscale and the total scale before and after intervention were evaluated by paired-samples t test. Internal responsiveness was determined by effect size (ES) and standardized response mean (SRM) based on the calculated difference before and after intervention. External responsiveness was analyzed by Spearman correlation coefficient.ResultsThe differences in symptom subscale, sleep disturbance subscale, participating in everyday life subscale, every day activity and pain subscale, and the scale between before and after intervention were significant (P<0.05) except for mobility subscale (P>0.05). The difference of NDI-C before and after intervention was –12.11%±17.45%, ES was 0.77, and SRM was 0.69. The difference of NOOS-C before and after intervention was 13.74±17.22, ES was 0.83, and SRM was 0.80. Spearman correlation analysis revealed that the relativity about NOOS-C and NDI-C before and after intervention were both negative (r=–0.914, P=0.000; r=–0.872, P=0.000).ConclusionNOOS-C’s responsiveness is good.
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.
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.
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 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 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.