This paper summaries the Risk of Bias in Non-randomized Studies-of Environmental Exposure (ROBINS-E), a tool for evaluating risk of bias about non-randomized studies of exposures (NRSE), and introduces the application of ROBINS-E in a published NRSE. According to the characteristics of NRSE, evaluation fields and signaling questions were designed in ROBINS-E to provide essential information about risk of bias for NRSE included in systematic reviews and GRADE. ROBINS-E is the tool in assessment of risk of bias in observational studies and quasi-randomized studies. Although the tool has been used in practice to some extent, but it still needs further improvement. Attention should be paid to its update and progress.
Bias ; Environmental Exposure ; Humans ; Systematic Reviews as Topic

This paper introduces the Risk of Bias in Systematic Review (ROBIS), including: 1) the development of ROBIS, 2) three phases of ROBIS tool judging the overall risk of bias that related to systematic reviews, and 3) illustration on the application of ROBIS in a published systematic review. ROBIS is the first rigorously developed tool which is specifically designed to assess the risk of bias in systematic reviews. ROBIS will help improve the process of risk assessment on bias which appeared in overviews and guidelines.
Humans ; Bias ; Risk Assessment/methods* ; Systematic Reviews as Topic

BACKGROUND: Functional constipation (FC) is one of the most prevalent functional gastrointestinal disorders. Dissatisfaction with medications prescribed to treat FC may lead patients to seek alternative treatments. Numerous systematic reviews (SRs) examining the use of acupuncture to treat FC have reported inconsistent results, and the quality of these studies has not been fully evaluated. OBJECTIVE: In this overview, we evaluated and summarized clinical evidence on the effectiveness and safety of acupuncture for treating FC and evaluated the quality and bias of the SRs we reviewed. SEARCH STRATEGY: The search strategy was structured by medical subject headings and search terms such as "acupuncture therapy" and "functional constipation." Electronic searches were conducted in eight databases from their inception to September 2020. INCLUSION CRITERIA: SRs that investigated the effectiveness and safety of acupuncture for managing FC were included. DATA EXTRACTION AND ANALYSIS: Two authors independently extracted information and appraised the methodology, reporting accuracy, quality of evidence, and risk of bias using the following critical appraisal tools: (1) A Measurement Tool to Assess Systematic Reviews 2 (AMSTAR 2); (2) Risk of Bias in Systematic Reviews (ROBIS); (3) Preferred Reporting Items for Systematic Reviews and Meta-analyses for Acupuncture (PRISMA-A); and (4) the Grading of Recommendations, Assessment, Development and Evaluations (GRADE). A κ index was used to score the level of agreement between the 2 reviewers. RESULTS: Thirteen SRs that examined the clinical utility of acupuncture for treating FC were identified. Using the AMSTAR 2 tool, we rated 92.3% (12/13) of the SRs as "critically low" confidence and one study as "low" confidence. Using the ROBIS criteria, 38.5% (5/13) of the SRs were considered to have "low risk" of bias. Based on PRISMA-A, 76.9% (10/13) of the SRs had over 70% compliance with reporting standards. The inter-rater agreement was good for AMSTAR 2, ROBIS, and PRISMA-A. Using the GRADE tool, we classified 22.5% (9/40) of the measured outcomes as "moderate" quality, 57.5% (23/40) as "low" quality, and 20.0% (8/40) as "very low" quality. The inter-rater agreement was moderate when using GRADE. Descriptive analyses indicated that acupuncture was more efficacious than sham acupuncture for improving weekly complete spontaneous bowel movements (CSBMs) and for raising the Bristol Stool Form Scale (BSFS) score. Acupuncture appeared to be superior to anti-constipation drugs for improving weekly spontaneous bowel movements, the total effective rate, and the Patient Assessment of Constipation Quality of Life score. Although ten SRs mentioned the occurrence of adverse events, serious adverse events were not associated with acupuncture treatment. CONCLUSION: Acupuncture may be more efficacious than sham acupuncture for improving CSBMs and BSFS scores and may be superior to anti-constipation drugs for improving bowel movement frequency, as well as quality of life. Limitations to current studies and inconsistent evidence suggest a need for more rigorous and methodologically sound SRs to draw definitive conclusions. SYSTEMATIC REVIEW REGISTRATION PROSPERO CRD42020189173.
Acupuncture Therapy ; Constipation/therapy* ; Humans ; Quality of Life ; Systematic Reviews as Topic

Objective: To evaluate the methodology of the published systematic reviews and Meta-analyses (SR/MA) on efficacy and safety of coronavirus disease 2019 (COVID-19) vaccines. Methods: We conducted a retrieval for literatures published as of December 10, 2021 in English databases (Medline, Embase, Cochrane Library, Web of science) and Chinese databases (CNKI, Wanfang data, VIP, Sinomed). Two reviewers independently screened literatures and extracted data. The methodology of included SR/MA papers was assessed by A MeaSurement Tool to Assess systematic Review-2 (AMSTAR-2) tool in 16 items. Results: A total 22 SR/MA papers were included, in which 3 (13.6%) had low quality and 19 (86.4%) had very low quality. The main problems of these SR/MA included having no definite PICO (Participants, intervention, control and outcome), providing no preliminary research protocol, no list of excluded studies and justify the exclusions, making no evaluation and explanation or discussion of the risk of bias of original studies, no adequate evaluation of publication bias and discuss its likely impact on the results, etc. Conclusion: SR/MA for the efficacy and safety of COVID-19 vaccines had varied methodological deficiencies, further improvements are needed.
COVID-19/prevention & control* ; COVID-19 Vaccines/adverse effects* ; Humans ; Meta-Analysis as Topic ; Systematic Reviews as Topic

Anemia/epidemiology* ; Causality ; Dissent and Disputes ; Humans ; Meta-Analysis as Topic ; Risk Factors ; Systematic Reviews as Topic ; Tuberculosis/epidemiology*

To investigate the feasibility of applying the evidence-based rapid review in studying the nephrotoxicity of Tripterygium wilfordii preparation. We used four methods in relevant studies on the nephrotoxicity of T. wilfordii preparation. The first method had no limitation on any search terms， which was a traditional approach to retrieve systematic reviews. The second method limited the relevant search terms of T. wilfordii preparation to "all of CHMs containing T. wilfordii preparation approved by CFDA". The third method was to limit the relevant retrieval terms of nephrotoxicity as the "most frequently reported terms related to nephrotoxicity found in the study literature screening process in the early stage of systematic review". The fourth method was to limit the search terms relating to both T. wilfordii preparation and nephrotoxicity. Finally， the results of the last three search methods were compared with those of the first search method， and the feasibility of the rapid review method in the study for the nephrotoxicity of CHM was discussed. For the total number of literatures searched， the fourth method had the smallest number of literatures. For the number of articles in line with the inclusion criteria， the second method had the largest number of eligible literatures. For the type of literatures included， the forth method had a higher coincidence degree. The forth method was the best one， because it was not only consistent with the results， but also could minimize the workload. Rapid review is feasible in the study of nephrotoxicity of T. wilfordii.
Drugs, Chinese Herbal ; toxicity ; Humans ; Kidney ; drug effects ; Research Design ; Systematic Reviews as Topic ; Tripterygium ; toxicity

At present, there have been many clinical trials and systematic reviews/Meta-analysis proving the good clinical efficacy of Shufeng Jiedu Capsules in the treatment of respiratory diseases, while comprehensive discussion is still required. This article overviews and analyzes the systematic reviews/Meta-analysis of Shufeng Jiedu Capsules to provide evidence support for clinical practice. The systematic reviews/Meta-analysis of Shufeng Jiedu Capsules were searched from CBM, Wanfang, CNKI, VIP, PubMed, EMbase and Cochrane Library. The AMSTAR 2 scale and GRADE system were respectively employed for the evaluation of methodological quality and the grading of evidence quality. Finally, 8 systematic reviews/Meta-analysis published during 2018-2021 were included for analysis. The diseases involved include acute exacerbation of chronic obstructive pulmonary disease, community-acquired pneumonia, acute tonsillitis, acute exacerbation of chronic bronchitis and acute upper respiratory tract infection. The number of included RCTs studies ranged from 8 to 25. The results showed that Shufeng Jiedu Capsules combined with western medicine routine had better therapeutic effect than the latter alone in the treatment of the above five diseases. The reported adverse reactions caused by Shufeng Jiedu Capsules were mainly gastrointestinal discomforts such as mild nausea, diarrhoea and vomiting, with low incidence and mild symptoms, which can be relieved by drug withdrawal. The methodological quality of the included studies was extremely low, and the outcome indicators were mainly of low and very low grades. The efficacy and safety of Shufeng Jiedu Capsules in the clinical treatment of diseases still need to be verified based on more high-quality studies. The relevant clinical research and systematic review/Meta-analysis should pay more attention to methodological quality and reporting standards and strengthen the scientificity of research.
Capsules ; Drugs, Chinese Herbal/therapeutic use* ; Systematic Reviews as Topic ; Treatment Outcome

This paper summarizes the Risk of Bias of Individual Studies in Systematic Reviews of Health Care Interventions revised by the Agency for Healthcare Research and Quality (AHRQ) and introduces how to use Revman software make risk of bias graph or risk of bias summary. AHRQ tool can be used to evaluate following study designs: RCTs, cohort study, case-control study (including nested case-control), case series study and cross-sectional study. The tool evaluates the risk of bias of individual studies from selection bias, performance bias, attrition bias, detection bias and reporting bias. Each of the bias domains contains different items, and each item is available for the assessment of one or more study designs. It is worth noting that the appropriate items should be selected for evaluation different study designs instead of using all items to directly assess the risk of bias. AHRQ tool can be used to evaluate risk of bias individual studies when systematic reviews of health care interventions is including different study designs. Moreover, the tool items are relatively easy to understand and the assessment process is not complicated. AHRQ recommends the use of high, medium and low risk classification methods to assess the overall risk of bias of individual studies. However, AHRQ gives no recommendations on how to determine the overall bias grade. It is expected that future research will give corresponding recommendations.
Bias ; Evidence-Based Medicine/standards* ; Health Services Research ; Systematic Reviews as Topic

To evaluate the efficacy and safety of Kuntai Capsules in the treatment of perimenopausal syndrome. Systematic reviews on Kuntai Capsules in the treatment of perimenopausal syndrome were retrieved from Chinese and English databases from database establishment to August 31, 2020. AMSTER-2 scale, GRADE scale and ROBIS tools were used respectively to evaluate the methodological quality, evidence quality level and bias risk of the finally included systematic reviews. A total of 6 systematic reviews with 28 outcome indicators were included. The results of AMSTER-2 methodological quality assessment showed that one of the six systematic reviews was of low quality, and the other five were of extremely low quality. GRADE scale showed that 28 clinical outcome indicators were evaluated, three of which were intermediate-level ones, and the rest were low-level or very low-level ones. Two evidences of the three intermediate evidences were total efficiency, and the other intermediate evidence was Kupperman score. ROBIS bias risk assessment showed all the included studies were of high risk. The results showed that, Kuntai Capsules were effective in the treatment of perimenopausal symptoms, such as hot flashes and sweating. The improvement of E_2 level was not as good as that in the menopause hormone therapy group, but the incidence of adverse reactions was lower than that in the menopause hormone therapy group. However, the quality of evidence needs to be improved due to the low quality of methodology and high risk of bias. It is suggested that systematic review and reasonable design should be carried out in the future, and attention should be paid to the registration of research schemes. In addition, the research reports shall be prepared according to PRISMA statement.
Drugs, Chinese Herbal ; Female ; Hormone Replacement Therapy ; Humans ; Perimenopause ; Syndrome ; Systematic Reviews as Topic

BACKGROUND: Influenza places a heavy public health burden in numerous countries every year. In addition to vaccines, there are some interventions that are effective in preventing influenza. OBJECTIVE: This overview of systematic reviews (SRs) aimed to evaluate the efficacy and safety of interventions for influenza prevention. SEARCH STRATEGY: We searched the Cochrane Database of Systematic Reviews, 2020, Issue 1 for relevant Cochrane SRs using the keywords "common cold," "influenza," and "flu." INCLUSION CRITERIA: Cochrane SRs that investigated the prevention of influenza were included. Participants included the general population without influenza or influenza-like symptoms, who were treated with preventative interventions and compared to individuals receiving no treatment or placebo. DATA EXTRACTION AND ANALYSIS: Two reviewers independently screened citations against pre-defined inclusion criteria and extracted data. The methodological quality of these SRs was evaluated using the Assessing the Methodological Quality of Systematic Reviews-II (AMSTAR-II) guidelines. The primary outcome of our analysis was the incidence of influenza, and the secondary outcomes were the incidence of influenza-like illness and hospitalization. In addition to the narrative summary of SR findings, we also pooled data from homogeneous trials among these SRs and produced evidence mapping. We conducted a network meta-analysis to compare the effect across interventions and used the Cochrane approach to grading of recommendations, assessment, development, and evaluation (GRADE) to assess the quality of evidence. RESULTS: Eleven Cochrane SRs were included, covering five medications, eleven vaccinations and four complementary therapies. Among these SRs, 73% scored "high" quality on AMSTAR-II rating. We found that eight interventions, including amantadine, garlic, and six different vaccines, were beneficial for reducing the incidence of influenza compared to placebo, while oseltamivir, zanamivir, Ganmao capsule, Echinacea, and another three types of vaccine were probably beneficial. Ganmao capsule ranked highest for influenza prevention in the network meta-analysis, followed by amantadine, garlic, and vaccines of all types. Monovalent inactivated parenteral vaccine was found to be beneficial in reducing the incidence of influenza-like illness. None of the interventions reduced the hospitalization rate. CONCLUSION High-quality evidence showed that garlic or vaccine had advantages in preventing influenza, and that vitamin C is not effective. The effect of other interventions needs to be further verified with high-quality evidence.
Bayes Theorem ; Humans ; Influenza, Human/prevention & control* ; Network Meta-Analysis ; Systematic Reviews as Topic ; Vitamins