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.
With the rapidly growing literature across the surgical disciplines, there is a corresponding need to critically appraise and summarize the currently available evidence so they can be applied appropriately to patient care. The interpretation of systematic reviews is particularly challenging in cases where few robust clinical trials have been performed to address a particular question. However, risk of bias can be minimized and potentially useful conclusions can be drawn if strict review methodology is adhered to, including an exhaustive literature search, quality appraisal of primary studies, appropriate statistical methodology, assessment of confidence in estimates and risk of bias. Therefore, the following article aims to: (Ⅰ) summarize to the important features of a thorough and rigorous systematic review or meta-analysis for the surgical literature; (Ⅱ) highlight several underused statistical approaches which may yield further interesting insights compared to conventional pair-wise data synthesis techniques; and (Ⅲ) propose a guide for thorough analysis and presentation of results.
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.
To solve the problems such as the incomplete and non-standard reporting outcomes in clinical trials, international methodologists have simultaneously launched guidelines for reporting outcomes in trial protocols and reports in 2022 on the basis of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 and the Consolidated Standards of Reporting Trials (CONSORT) statement 2010. The SPIRIT-Outcomes 2022 extension and CONSORT-Outcomes 2022 extension recommend outcome-specific reporting items should be included prospectively in trial protocols and reports, regardless of trial design or population. This paper introduces and interprets the two guidelines for reporting outcomes, and discusses their significance and enlightenment to the research in the field of traditional Chinese medicine. For example, using the outcome reporting guidelines will help clinical researchers comprehensively consider issues related to outcomes when reporting protocols or results, which may improve the quality of research design and reporting. For core outcome set, the five core elements of outcomes may help researchers extracting and analyzing outcomes, which will standardize research; the explanation of medical terminology in the outcome reporting guidelines will contribute to the improvement of methodology in the field of traditional Chinese medicine.
There are many problems in the selection of outcomes in clinical trials of traditional Chinese medicine (TCM), such as insufficient research on the applicability of outcomes, insufficient research of individualized outcomes for syndrome differentiation and treatment, incomplete selection methods for overall/comprehensive evaluation outcomes, lack of evidence in the importance of outcomes for researchers, and insufficient reflection of the humanistic value of outcomes. Although the core outcome sets (COS) may help clinical trialists to select outcomes to a certain extent, the COS has not been widely used at present, and the judgment of the importance of the outcomes in the COS is mainly based on the personal experience of the participants. The lack of methodology will also lead to multiple COS in the same disease area. The authors believe that it is necessary to improve the methodology of outcomes research, especially in the development of COS. Developing evidence and humanistic values framework may be a potential way to help researchers select core outcomes in clinical efficacy evaluation of TCM.
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 firstly introduces and interprets “core outcome sets for myocardial infarction in clinical trials of traditional Chinese medicine and Western medicine”, in order to help Chinese researchers better understand and use it. Secondly, this study surveyed the use of core outcomes in 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.