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.
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.
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.
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.
Outcome-based education (OBE) emphasizes student learning outcomes as the core, utilizing a backward design approach to construct the curriculum. In teaching practice based on OBE, teachers need to develop a blueprint in advance that is closely aligned with the content of the teaching, aiming to promote deep learning and ensure that students can fully demonstrate their learning outcomes. Electroencephalogram (EEG) is a widely used technology in the field of neuroscience, and the special EEG changes convey a variety of information, which is crucial to the study of diseases. However, due to its specialization and learning difficulty, EEG teaching has been facing many challenges. Under the guidance of OBE concept, traditional knowledge lecture and problem-based learning (PBL) are organically integrated, combined with case analysis and flipped classroom teaching mode, which are applied in EEG teaching practice, in order to obtain more ideal teaching effect.
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 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 Core Outcome Measures in Effectiveness Trials (COMET) Working Group has published a series of research and reporting guidelines related to core outcome sets since it was established. This article introduces and interprets the Core Outcome Set-STAndardised Protocol Items: the COS-STAP Statement which is developed by the COMET and published in February 2019. It will then be compared with Core Outcome Set-STAndards for Reporting (COS-STAR) and Core Outcome Set-STAndards for Development (COS-STAD), which have been introduced to China. The significance of these guidelines for the development of core outcomes in the field of traditional Chinese medicine is discussed, so as tp draw researchers' attention to this area.
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.