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.
ObjectivesUsing the ARRIVE guidelines (Animal Research Reporting: In Vivo Experiments Guidelines) to carry out a retrospective study of the reporting quality of animal studies published in Chinese journals.MethodsWe searched databases including CNKI, WanFang Data, VIP and CBM to July, 2018. Four reviewers independently screened literatures and extracted data. The ARRIVE guidelines were used to assess reporting quality and the comparative analysis based on different published time.ResultsA total of 4 342 studies were included. About the cited frequency, 73.03% studies were ≤5, and merely 29.04% studies were published in journals of CSCD. The assessment results showed that the number of reported items with "low risk" in the ARRIVE guidelines, which have 20 items, that meaning 39 sub items, more than half of sub items (51.28%, 20/39) rated as "low risk" had a compliance rate of less than 50%. Among them, 65.00% (13/20) of sub items had a lower rate of compliance with "low risk" than 10%.ConclusionThe reporting quality of domestic animal studies is generally low. The coincidence rate of domestic animal studies has been improved to some extent in most of items after the ARRIVE guidelines published, however, some items of methodology, results and conclusions had problems with insufficient reporting. Therefore, we suggest that it is necessary to popularize the ARRIVE guidelines, advocate more researchers following the ARRIVE guidelines and promote endorsement of the ARRIVE Guideline by Chinese Journals to improve the design, implementation and reporting of animal experiments, and ultimately enhance the quality of animal studies.
Objective To assess the methodological quality of systematic reviews or meta-analyses of intervention published in the Chinese Journal of Evidence-Based Medicine, so as to provide evidence for improving the domestic methodological quality. Methods The systematic reviews or meta-analyses of intervention published from 2001 to 2011 were identified by searching the Chinese Journal of Evidence-Based Medicine. The methodological quality of included studies was assessed by AMSTAR scale. The Excel software was used to input data, and Mata-Analyst software was used to conduct statistical analysis. Results A total of 379 studies were included. The average score of AMSTAR was 6.15±1.35 (1.5-9.5 point). Just some items of AMSTAR scale were influenced by the following features of included studies: publication date, funded or not, number of author, author’s unit, and number of author’s unit. The total AMSTAR score of studies published after 2008 was higher than those published before 2008 (P=0.02), but the improvement of methodological quality was limited. While the total AMSTAR score of studies published by 3 or more than 3 authors were higher than those published by 2 or less than 2 authors (P=0.04). Conclusion The methodological quality of the included studies published in the Chinese Journal of Evidence-Based Pediatrics is uneven. Although the methodological quality improves somewhat after the publication of AMSTAR scale, there is no big progress, so it still needs to be further improved.
ObjectivesTo analyze the current methodological and reporting quality of both domestic and overseas clinical practice guidelines on acupuncture, and to provide reference for the development of high quality acupuncture clinical practice guidelines.MethodsGIN, NICE, AHRQ, PubMed, EMbase, AMED, CINAHL, WanFang Data, CNKI, VIP and CBM databases were electronically searched to collect domestic and overseas clinical practice guidelines on acupuncture from inception to September, 2018. Two reviewers independently screened literature, extracted data and evaluated the methodological and reporting quality by using AGREE Ⅱ and RIGHT tools.ResultsA total of 23 acupuncture clinical practice guidelines were included, in which three were developed by foreign institutions, and the remaining 20 guidelines were jointly developed by WHO Western Pacific Region and China Institute of Acupuncture and Moxibustion. Three foreign and two domestic guidelines were selected for evaluation. The AGREE Ⅱ evaluation showed that the domestic guidelines have higher scores in terms of " scope and purpose”, " stakeholder involvement”, " rigor of development”, " applicability” and " clarity of presentation”, while only " editorial independence” is lower. The overall recommendation is stronger than the foreign guidelines. The RIGHT evaluation showed that for three foreign guidelines, the " reported” items accounted for 52.38%, " unreported” items accounted for 38.09%, " partly reported” items accounted for 6.66%%; however, for domestic guidelines, the " reported” accounted for 45.71%, " unreported” items accounted for 40%, and " partly reported” items accounted for 14.28% respectively. Overall, the difference is not significant (SD<10%). Due to the specificity of acupuncture interventions, the use of AGREEⅡ and RIGHT to evaluate acupuncture clinical practice guidelines still had barriers to some extend on its applicability.ConclusionThe methodological and reporting quality of acupuncture clinical practice guidelines are relatively low. It is urgent to further improve the methodological level and reporting standards of the guidelines, and to develop evaluation tools for the acupuncture field guidelines.
To standardize and improve the reporting quality of digital health implementation research, the Geneva Digital Health Hub has developed the guidelines and checklist for reporting digital health implementations (iCHECK-DH). This paper introduces the background of iCHECK-DH and based on practical application experiences, emphasizes the importance of interdisciplinary collaboration. It focuses on economic cost-effectiveness and local policy guidance in the clinical implementation of digital health technologies. This will provide valuable insights for Chinese scholars when writing implementation reports on digital health technologies.
This paper introduces the development and changes of clinical practice guidelines based on the enlightenment of the Reporting Items for Practice Guidelines in Health Care (RIGHT), and provides policy recommendations.
ObjectiveTo provide references for scientific selection of different tools/guidelines by comprehensively collecting international and national tools/guidelines for assessing reporting quality and methodological quality of animal experiments, comparing them in development foundation, application scope, and aims. MethodsPubMed, EMbase, CNKI, VIP and WanFang Data were searched up to July 2014, to collect tools/guidelines for reporting quality and methodological quality of primary animal experiments. We extracted data from included guidelines/tools, including the number of items, development foundation, disease models, application scope, and assessment focus. Then descriptive analysis was conducted. ResultsA total of 32 studies were finally included, of which, 6 were for reporting quality and 26 for methodological quality. The item number of the included tools/guidelines ranged from 2 to 54. Seven tools/guidelines applied score system to assess methodological quality. Fifteen tools/guidelines were designed for specific disease models. Nineteen tools/guidelines were suitable for assessing preclinical drug studies, and 4 were designed to assess environmental toxicology research. ConclusionAlthough many tools for assessing methodological quality of animal experiments have been published so far, SYRCLE's risk of bias tool is the only one that is used to assess internal validity of animal experiments at present. Besides, although the ARRIVE guidelines and GSPC are not official mandatory reporting criteria at present, they are acknowledged by many researchers as efficient reference checklists and writing guidelines for writing and publishing animal experiments. We recommend the application of SYRCLE's risk of bias tool, ARRIVE guidelines and GSPC, in order to efficiently improve research design, implementation, reporting, differentiation, and evaluation of animal experiments, promote the development of animal experiments, and to promote full application and translation of scientific achievements.
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.
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.
Consensus reporting items for studies in primary care (CRISP) is a newly developed measurement tool developed abroad to standardize primary health care research, so as to improve the quality of reporting and enhance the applicability, comprehensiveness, transparency and operability of reporting. The report contains 24 Entries that follow the Introduction, Methods, Results, Discussion (IMRaD) format, and is primarily concerned with describing the research team, the patients, the study subjects, the health status, the clinical experience, the health care team, the interventions, the study interventions, and the findings in the PHC study / implementation of results, etc. This article introduces and interprets the reporting guidelines to help researchers better understand and apply this statement to improve the quality of reporting in primary health care research