The coronavirus disease 2019 (COVID-19) has been evaluated as a pandemic by the World Health Organization (WHO). Although several vaccines with an efficacy of more than 50% have been developed, in terms of treatment, remdesivir remains the antiviral drug approved by the U.S. Food and Drug Administration (FDA) for the treatment of COVID-19, while none of the other treatments has been recommended by FDA due to insufficient clinical data. A number of clinical trials have been registered to study therapeutic drugs or vaccines for COVID-19. To promote the collection, tabulation, analysis of COVID-19 clinical research data, improve the efficiency of clinical research, and facilitate the integration, sharing and secondary analysis of multiple similar research data, CDISC has developed a therapeutic area user guide for COVID-19 and resources for public health researchers. The resources included two documents, one is a SDTM annotated CRF based on ISARIC and WHO core COVID-19 case report form, and the other is SDTM and CDASH mapping spreadsheet. Moreover, CDISC has developed the guidance for ongoing studies disrupted by COVID-19 pandemic and interim ADaM guidance for ongoing studies disrupted by COVID-19 pandemic to help disrupted clinical trials to collect, store, and analyze relevant data. This paper introduced the structure and content of the guide and its related standards, with a view to promoting its application in COVID-19 clinical trials and in ongoing studies disrupted by COVID-19 pandemic.
Although the evidence from randomized controlled trials (RCTs) is regarded as a golden standard, it often fails to be applied in clinical practice for lack of generalizability. Evidence from either RCTs or non-RCTs is mutually complementary and referred. Different designs are suitable for different stages and can resolve different issues. During evaluation of an intervention, the proper research design should be selected in accordance with the objective, feasibility, and merits and limitations of different design modes.
The background and status of the quality assessment instruments of clinical trials, and several frequently used instruments both domesticly and abroad were introduced, and the problems in this field were discussed.
ObjectiveThis study aimed to revise the perioperative recovery scale for integrative medicine (PRSIM) based on item response theory (IRT). MethodsUnder the guidance of IRT, a total of 349 patient data collected during the development of the original version of PRSIM at Guangdong Provincial Hospital of Chinese Medicine were used. Principal component analysis was performed using SPSS 18.0 software to test the unidimensionality. The R language was utilized for parameter estimation, including discrimination coefficient, difficulty parameters and information content, as well as drawing item characteristic curves to assess item quality and estimate item functioning differences. A comprehensive screening process was carried out by combining expert consultations, patient evaluations, and discussions within a core group. ResultsThe degree of discrimination of all items ranged from −0.535 to 2.195. The difficulty coefficient ranged from −10.343 to 5.461, and the average information content of all items ranged from 0.043 to 1.075. Based on the criteria for parameter selection, nine items were retained. The results of expert consultations indicated the removal of 5 items and the modification of 7 items. After discussion within the core group, a final decision was made to remove 5 items. ConclusionBased on a synthesis of IRT and expert consultation feedback, and following discussions within the core group, a revised version comprising 15 items is retained and modified from the original 20 items.
Objective The basic terms of the technical specifications for case-control studies in the field of traditional Chinese medicine (TCM) are formed by expert consensus methods, in order to develop detailed texts of the technical specifications. Methods According to the process of international guidelines, a total of 44 experts participated in the Delphi survey. Results The three rounds of questionnaire response rates were 73.3%, 86.4%, and 86.8%, respectively. The experts' authority coefficients were 0.82, 0.85, and 0.86, respectively; and the expert opinion coordination coefficients were 0.356, 0.349, and 0.422, respectively. Expert enthusiasm, authority, opinion centralization, and degree of coordination were relatively high. There were many opinions raised in the expert consensuses on how to measure TCM syndrome, TCM constitution, the time point of measurement and the selection of new cases. Conclusion The case-control studies in TCM field should pay more attention to the characteristics of TCM. The draft of technical specification involves the study design and reporting, which can improve the methodological and reporting quality of case-control studies.
The estimation of the minimal important difference (MID) in patient-reported outcomes (PRO) relies on various selection principles and statistical methodologies, resulting in varying degrees of credibility among studies. When applying these findings, it is crucial to consider their evaluation outcomes. In the context of widely accepted MID studies based on the anchoring method, the credibility of the MID of PRO is influenced by the selection of anchors and the statistical methods employed for estimation. Variations in the anchors utilized, differences in clinical trial designs, disparities in the characteristics of measurement subjects and environment, as well as the control of biases in studies, can all contribute to inconsistencies in the MID of PRO. In response to this, McMaster University in Canada has developed a credibility evaluation tool specifically for MID studies in PRO. The tool comprises five core items and four additional items. The five core items encompass an evaluation framework that assesses: (1) Is the patient or necessary proxy responding directly to both the PRO and the anchor? (2) Is the anchor easily understandable and relevant for patients or necessary proxy? (3)Has the anchor shown good correlation with the PRO? (4) Is the MID precise? (5) Does the threshold or difference between groups on the anchor used to estimate the MID reflect a small but important difference? The four additional items concerning transition-rated anchors assess: (1) Is the amount of elapsed time between baseline and follow-up measurement for MID estimation optimal? (2) Does the transition item have a satisfactory correlation with the PRO score at follow-up? (3) Does the transition item correlate with the PRO score at baseline? (4) Is the correlation of the transition item with the PRO change score appreciably greater than the correlation of the transition item with the PRO score at follow-up? Given the relative weights of each item in the tool are uncertain and environment-dependent, items are not scored; instead, an overall judgment is made using a qualitative rating approach. This article introduces the specific items of this tool and illustrates the evaluation process through a case study to improve its use in optimizing PRO results presentation and interpretation in clinical trials, reviews, assessments, and guidelines.
ObjectiveTo investigate the current situation of domestic registry studies, and to provide basis for future research.MethodsWorld Health Organization (WHO) registration platform, ClinicalTrials.gov registration platform and other registration platforms were searched to collect the registered registration studies in Mainland China from inception to July 31st, 2018. Two researchers collected and collated data, analyzed by descriptive statistical methods, and then python-igraph package in Python 3.5 was used to draw the network diagram.ResultsA total of 247 studies were retrieved, mainly for disease registry and pharmaceutical product registry. Cohort and case-series were the principally study design. The research focused on chronic diseases such as cardiovascular and cerebrovascular diseases, and research sites were based on the economically developed area, for example, Beijing, Shanghai and Guangdong. The network diagram of study design and disease system shows that cohort research design is widely used in the nervous system and circulatory system; the network diagram of the research sites and disease system found that Beijing mainly studied circulatory and nervous system diseases, Shanghai mainly studied circulatory system diseases, and Guangdong relatively studied more on nervous system and urinary system diseases.ConclusionThe increasing number of registry studies in China reflects the importance of long-term outcome assessment of diseases.
在缺乏数据进行 Meta 分析的系统评价中，通常使用替代合成方法，但这些方法却很少被报道，而模糊的方法阐述可能会导致人们质疑系统评价结果的真实性。无 Meta 分析数据合成（SWiM）报告规范是用于指导采用了替代合成方法评估干预措施效应的系统评价进行清晰报告的规范。本文介绍了 SWiM 规范的研制过程及 9 个 SWiM 报告条目及其相应的解释与示例。
ObjectiveTo systematically analyze the distribution of research evidence on diabetes in current clinical practice guidelines of Chinese medicine (CM). MethodsThe PubMed, Embase, Cochrane Library, CBM, WanFang Data, CNKI, VIP databases and related guideline websites were electronically searched to collect clinical practice guidelines for CM in diabetes published before December 2023. We systematically reviewed the distribution of evidence in these guidelines. ResultsThe 27 CM guidelines on diabetes mainly covered syndrome differentiation and treatment, specific disease-specific drugs, diet, external therapies, and traditional exercises. The included guidelines used three different levels of evidence grading, with most of the evidence falling into the low-to-moderate level (67.3%). However, guidelines on diabetes-related osteoporosis, diabetic cardiomyopathy, prediabetes, and diabetic peripheral neuropathy had a relatively low proportion of high-level evidence, accounting for only 7.2%, 7.6%, 13.2%, and 13.3% respectively. Only guidelines on diabetic nephropathy provided evidence on the toxicity of Chinese herbal medicine, while other guidelines did not cover this aspect. Acupuncture, Tai Chi, Baduanjin, and other characteristics therapies had varying levels of evidence for different types of complications. Low-level evidence mainly focused on syndrome differentiation and treatment, symptom-based treatment, sign-based treatment, indicator-based treatment, Chinese patent medicine, specific disease-specific formulas, etc., for diabetes and related complications. ConclusionCurrently, topics supported by low/no evidence, new themes, inconsistent content between guidelines, evidence sources for overlapping targets, classical formulas, toxicity of Chinese herbal medicine, and characteristic CM therapies can provide directions for future research on CM in diabetes. We advocate addressing important issues related to diabetes specifically, to improve research value, eliminate unnecessary duplication of studies and resource waste, and promote the healthy development of CM research in the field of diabetes.
ObjectiveTo develop a standardized dataset for adverse drug reactions (ADR) of Chinese herbal formula granules (CHFG) to regulate the collection content of ADR, promote the standardization and normalization of ADR data collection for CHFG, and facilitate the sharing, integration, and analysis of adverse reaction data. MethodsWe used a combination of literature research, Delphi survey and consensus meeting. ResultsA Delphi survey questionnaire was constructed based on the results of literature research, including 6 domains and 76 items. After the Delphi survey and consensus meeting, a final CHFG adverse reaction dataset was developed, including 6 domains and 75 items. The six domains were patient details, suspected drugs, other treatments/concomitant medications, detailed information on the suspected adverse reaction, possible influencing factors (causes of the suspected adverse reaction), and details of the person reporting the suspected adverse reaction. Compared with the data collected by the National Adverse Drug Reaction Monitoring Center, this dataset introduced a new domain called "Possible influencing factors", which included several items such as irrational use of CHFG, toxic varieties of Chinese herbal medicine, storage and usage conditions, physical characteristics, processing methods, and patient diet. It also contained the information on Chinese medicine syndromes and other herbs in the prescription, and modified multiple items based on the particularities of formula granules. ConclusionThe development and application of this standardized dataset of ADR for CHFG can facilitate data collection, integration, and analysis, furthermore improve doctors' awareness of prescribing safely and enhance patient medication safety.
