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 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 evaluate midterm and longterm clinical outcome of bilateral internal mammary artery composited Y grafts for coronary artery bypass grafting (CABG)， analyze risk factors for late death ，and to improve surgical results. Methods Between January 2000 and May 2004, One hundred and sixtyfive patients underwent bilateral internal mammary artery grafts for CABG, The clinical data, postoperative complications and survival results were retrospectively reviewed and analyzed. The preoperative and postoperative cardiac function was compared. All factors that may have affected the survival were analyzed by logistic regression, to identify significant variables associated with late death. Results Total 561 anastomosis sites of internal mammary arteries were completed with each patient received an average of 3.4 grafts. There were no perioperative deaths. There were 16 patients with postoperative complications including recurrent angina, myocardial infarction, low cardiac output syndrome, sternal infection and so on. All patients were treated conservatively without reoperation. One hundred sixty patients（97%）were followed up of 5.6±1.2 years, there were 23 late deaths including 10 patients of cardiac related death in which 3 had recurrent myocardial infarction, 4 heart failure, and 3 arrhythmia; 13 patients of nocardiac related death in which 4 upper gastrointestinal hemorrhage, 3 cancer and 6 uncertain cause. 25 patients had major cardiac related events including recurrent angina 18, myocardial infarction 4, repeated revascularization 3. Left ventricular ejection fraction [CM(159mm]was significantly improved as compared with that before operation（54%±6% vs. 43%±12%, Plt;0.05）. The 1-, 3-, 5-year actuarial survival rates and eventfree rates were 98.2%±0.3%, 96.2%±0.5%, 90.5%±1.9% and 95.5%±1.2%, 91.3%±2.1%, 86.6%±1.5%, respectively. According to statistical analysis, univariate analyses had proved that advancing age＞65 years，diabetes，ejection fraction(EF) less than 30%，the New York Heart Association (NYHA) class Ⅲ/Ⅳ, and low cardiac output syndrome required placement of the intraaortic balloon pump were predictors associated with hospital major adverse cardiac events (Plt;0.05). Those variables entered into the logistic regression model and found to be independent predictors associated with increased late cardiac death included advancing age ＞65 years(OR=11.6), diabetes (OR=21.4), EF less than 30%(OR=37.5) and NYHA class Ⅲ/Ⅳ(OR=40.2). Conclusion Patients receiving bilateral internal mammary artery composited Y grafts have better longterm survival and reduced cardiac related events. Independent risk factors for late death are NYHA function class Ⅲ/Ⅳ, EF less than 30%, diabetes and advancing age ＞65 years.
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.
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.
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.
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 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.
The use of core outcome sets reduces heterogeneity in the reporting of outcomes in clinical trials, increasing the value and significance of research. This paper first introduces and interprets “core outcome sets for myocardial infarction (COS-MI) in clinical trials of traditional Chinese medicine and Western medicine”, in order to help Chinese researchers better understand and use it. Second, this study surveyed the use of COS-MI in MI related clinical trials from January 1, 2023 to June 1, 2024, showing that 91% (10/11) of the 35 acute myocardial infarction clinical studies included reported core outcomes, and the median percentage of using core outcome sets was only 36% (4/11). As the publication time of the core outcome set is close to the literature search time, the understanding of domestic researchers about it is still unclear. Further research is needed to explore the application of core outcome sets for myocardial infarction in clinical trials of traditional Chinese medicine and Western medicine, providing a reference for its update and improvement.
