Objective While reporting of adverse drug reactions (ADR) and adverse drug events (AE) following Chinese medicine injection (CMI) is becoming more common, the reporting quality is of concern. Methods A checklist about the reporting quality of ADR/AE was set up, and the ADR/AE reporting of Herba Houttuyniae injection was chosen as an example. Electronic databases Chinese Journal Net (CJN) (1994-2009) and Chinese Science and Technological Journal Net (VIP) (1989-2009) were searched for target literature. Results Based on our search strategy, 210 articles were included, with 175 articles reporting single or several cases of ADR/AE following Herba Houttuyniae injection (type I report). There were 7 reports from regional or national ADR monitoring centers (type II report), and 28 summary reports from a single hospital or medical center (type III report). All 210 papers mentioned ‘adverse effect,’ ‘safety’ or related meaning words in their titles, but 199 articles did not have abstract. Patient demographic characteristics were not fully reported in these articles. In type I articles, only 97 cases (43.11%) mentioned whether patients had or did not have a history of allergies, while 128 cases (56.89%) in Type II papers and Fourteen (50%) type III papers, did not mention allergic history of patients. Only three articles (3/210, 1.43%), all of them type I, mentioned the syndrome type in Chinese medicine. None of the papers gave clear indications of the type and grade of ADR/AE of patients. Most papers did not report details of the CMI procedure, such as the drug company, product serial number, or the drug’s validity period. Data about the occurrence time and management of ADR/AE was also inadequately reported. Conclusion and recommendations The current reporting format of ADR/AE in clinical CMIs is not standardized. Much fundamental information of ADR/AE following CMI is therefore missing. A standard reporting format for ADR should be developed, and should include the following: 1) a title mentioning adverse effects and safety; 2) a structured abstract including adequate information about the patient and the disease treated, the drug used, the specific ADR/AE, physician response to the ADR/AE, and result of management; 3) demographic characteristic of the patients (gender, age, etc.); 4) clinical characteristics of patients (disease, syndrome, etc); 5) allergic history of patients; 6) diagnosis and syndrome based on Chinese medicine theory; 7) detailed information about the Chinese materia medica intervention (the manufacturer of the drug, series number, valid dates, dosage, route of administration, menstruum, dripping speed, etc.); 8) concomitant drug use; 9) time and symptoms of ADR/AE; 10) type and grading of ADR/AE; 11) physiological systems affected by ADR/AE; 12) specific treatment and prognosis for ADR/AE; 13) evidence of the cause and effect of ADR/AE; 14) any other possibility of ADR/AE. Also, a ADR/AE registration system should be established.
ObjectiveTo systematically sort out acupuncture therapy research report specification issues and provide a reference for the selection of key problems in the specification of acupuncture therapy network meta-analysis reports. MethodsComputer searches of PubMed, Embase, Web of Science, Cochrane Library, CNKI, WanFang Data, and VIP databases were conducted to collect studies related to reporting norms for acupuncture therapy, with a search time from inception to November 2022. Questions were constructed according to the SPIDER model and inclusion and exclusion criteria were developed. CASP was used to evaluate the methodological quality of the included literature, and a qualitative systematic evaluation thematic synthesis method was used to analyze, summarize, and integrate the questions on reporting norms for acupuncture therapy research evidence to create a pool of question entries. ResultsA total of 66 papers covering four countries were included, including 17 papers from qualitative studies and 49 papers from quantitative studies. The CASP evaluation results showed that the overall quality of the included studies was high, and the quality of the English studies was higher than that of the Chinese studies. The thematic synthesis method resulted in 22 question entries in 7 categories. The 7 categories of questions included title, abstract, preface, methods, results, discussion and other report specification questions. The 22 entries included "Is there a need to report specific types of acupuncture therapy", "Is there a need to report based on the type of original study and its number", etc. ConclusionThere are many problems with reporting norms in existing acupuncture studies, so it is necessary to collate and summarize the key issues of reporting norms for acupuncture network meta-analysis to provide a scientific and theoretical basis for the development of reporting guidelines for acupuncture network meta-analysis.
Primary liver cancer is the sixth most common malignancy and the third leading cause of cancer-related death worldwide, and hepatocellular carcinoma (HCC) constitutes the majority of primary liver cancer cases. The Liver Imaging Reporting and Data System (LI-RADS) was introduced to standardize the lexicon, acquisition, interpretation, reporting, and data collection of imaging results in patients at increased risk for HCC. LI-RADS allows effective categorization of focal liver lesions, and has been applied in the full clinical spectrum of HCC from diagnosis, biological behavior characterization, prognosis prediction, to treatment response assessment. This review aimed to summarize the recent applications of CT/MRI LI-RADS in the diagnosis, biological behavior characterization and prognosis prediction of HCC, discuss current challenges and shed light on potential future directions.
Effectiveness-implementation hybrid designs can test the effectiveness of interventions and the outcomes of implementation strategies concurrently and accelerate the transformation of research results into routine practice. This paper introduced three types of effectiveness-implementation hybrid designs and corresponding reporting guidelines, including standards for reporting implementation studies, cluster randomized design and CONSORT 2010, stepped-wedge cluster randomized design and extended version CONSORT 2018, qualitative research and COREQ reporting guideline, and provide references for domestic researchers to produce research reports on effectiveness-implementation hybrid design.
ObjectiveTo analyze the characteristics and reporting quality of the registered health Qigong-related clinical trials, and to analyze the progress and shortcomings of health Qigong-related clinical trials.MethodsChinese Clinical Trial Registry (ChiCTR) and ClinicalTrials.gov were electronically searched to collect the health Qigong-related clinical trials from inception to October 15st, 2020. Characteristics of trials were analyzed in the aspects of basic information, funding source, study content and more. The quality of registration was evaluated by WHO Trial Registration Data Set (TRDS).ResultsA total of 121 registered clinical trials were included. The annual registration quantity has been increasing with a peak (33.06%) reached in 2020. Among the registered trials, Baduanjin exercise- related studies accounted for the highest proportion (65.29%). The quantity of studies registered in Shanghai accounted for the most (29.75%). The largest contribution of registered trials was from Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine (5.79%). 50.83% funds in trials were originated from universities and hospitals. Type 2 diabetes, and chronic obstructive pulmonary disease were the most studied diseases in the registered trials. 90.08% trials were designed as randomised parallel control studies, and the sample sizes of trials were concentrated between 30 and 100 (71.07%), and the age of the subjects was distributed over 40 years old (46.15%). The average quality of registration completion of the two registries was 87.44%.ConclusionsAt present, the general trend of health Qigong clinical research is positive. However, these trials contain unbalanced attributes such as the research type of health Qigong, distribution of registration area and organization, allocation of funds, and age composition of subjects. The design of clinical trials and registration details are needed to be improved.
In order to standardize the reporting of sham acupuncture and improve the quality of reporting of sham acupuncture, Beijing University of Chinese Medicine has developed a specific reporting guideline for sham acupuncture: SHam Acupuncture REporting (SHARE) which contains ten categories with nineteen items. This paper introduces the development methods and main contents of the guidelines to provide a reference for researchers to correctly understand and reasonably apply the guidelines.
ObjectiveTo explore low-seniority nurses' attitudes regarding adverse events reporting.
MethodA total of 200 low-seniority nurses were investigated with the Chinese version of Reporting of Clinical Adverse Events Scale from October to December 2013. Epidata software was used to collect and manage data and SPSS 17.0 software was applied to analyze the collected data.
ResultsThe nurses who once witnessed or experienced adverse events accounted for 76%, of whom 74.3% reported adverse events. The mean score of reporting of clinical adverse events among low-seniority nurses was 48.5±7.2. Age was positively associated with the global scores of reporting of clinical adverse events, when compared with other variables (r=0.20, P=0.01).
ConclusionsOverall, low-seniority nurses' attitudes toward reporting adverse events are negative. Age is positively associated with attitudes toward reporting adverse events. Therefore, a non-punitive culture should be established and an efficient reporting system is good to enhance the quality of care.
ObjectivesTo assess the methodological and reporting quality of surgical meta-analyses published in English in 2014.MethodsAll meta-analyses investigating surgical procedures published in 2014 were selected from PubMed and EMbase. The characteristics of these meta-analyses were collected, and their reporting and methodological quality were assessed by the PRISMA and AMSTAR, respectively. Independent predictive factors associated with these two qualities were evaluated by univariate and multivariate analyses.ResultsA total of 197 meta-analyses covering 10 surgical subspecialties were included. The mean PRISMA and AMSTAR score (by items) were 22.2±2.4 and 7.8±1.2, respectively, and a positive linear correlation was found between them with a R2 of 0.754. Those meta-analyses conducted by the first authors who had previously published meta-analysis was significantly higher in reporting and methodological quality than those who had not (P<0.001). Meanwhile, there were also significant differences in these reporting (P<0.001) and methodological (P<0.001) quality between studies published in Q1 ranked journals and (Q2+Q3) ranked jounals. On multivariate analyses, region of origin (non-Asiavs. Asia), publishing experience of first authors (ever vs. never), rank of publishing journals (Q1 vs. Q2+Q3), and preregistration (presence vs. absence) were associated with better reporting and methodologic quality, independently.ConclusionThe reporting and methodological quality of current surgical meta-analyses remained suboptimal, and first authors' experience and ranking of publishing journals were independently associated with both qualities. Preregistration may be an effective measure to improve the quality of meta-analysis, which deserves more attention from future meta-analysis reviewers.
To improve the comprehensive and accurate of overviews of reviews, BMJ published the guideline for overviews of reviews of healthcare interventions: the PRIOR statement. This paper explained the background and core contents of PRIOR statement and interpreted each item with examples to provide references for domestic scholars to write overviews of reviews.
