scholarly journals Scale for efficacy and safety evidence based on design and methodological quality of treatments and preventive technologies trials

2018 ◽  
Vol 15 (3) ◽  
pp. 25-29
Author(s):  
O Yu Rebrova
Keyword(s):  
Methodological Quality ◽  
Traditional Approach ◽  
Relative Effectiveness ◽  
Assessment Procedure ◽  
Efficacy And Safety ◽  
Modern Approach ◽  
Evidence Quality ◽  
Meta Analyses ◽  
Indirect Comparisons

The quality of the evidence on the efficacy and safety of therapeutic and preventive interventions is analyzed in health technology assessment procedure (including the development of reimbursement lists such as the List of Vital and Essential Drugs in Russian Federation) and during development of clinical guidelines. The traditional approach to assess the evidence quality is based on the well-known pyramid of research designs (from meta-analyses to case descriptions), and now it is obsolete. The modern approach is to take into account also the methodological quality of studies. The methodological quality depends on risks of biases and the risk of incorrect data analysis. The article proposes a scale based on combinations of designs and three levels of methodological quality (high, medium, poor) for each of them. The scale differentiates meta-analyses based on randomized controlled trials and comparative studies of other designs. In the scale, the new design of indirect comparisons is envisaged, its’ evidence is lower than for RCT that are used for indirect comparisons. The scale can be used for assessing the absolute and relative effectiveness and safety of medical and preventive medical technologies. At present, the scale is included in the guidelines for the complex assessment of pharmaceuticals.

scholarly journals A Critical Overview of Systematic Reviews and Meta-Analyses on Acupuncture for Poststroke Insomnia

2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Jinke Huang ◽  
Manli Wu ◽  
Simin Liang ◽  
Xiaohui Qin ◽  
Min Shen ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Systematic Reviews ◽  
Methodological Quality ◽  
Acupuncture Treatment ◽  
Descriptive Analysis ◽  
Control Group ◽  
Evidence Quality ◽  
Meta Analyses ◽  
Quality Evidence

Objectives. Acupuncture has increasingly been used for insomnia relief after stroke. We aimed to evaluate the methodological quality and summarize the evidence regarding the effectiveness of acupuncture for poststroke insomnia (PSI) from systematic reviews/meta-analyses (SRs/MAs). Methods. Eight databases were searched from inception through August 23, 2020. SRs/MAs on acupuncture treatment for PSI were included. Methodological quality assessment was performed using Assessing the Methodological Quality of Systematic Reviews 2 (AMSTAR-2), and evidence quality assessment was performed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE). Results. Six SRs/MAs on acupuncture treatment for PSI were included. The AMSTAR-2 showed that the methodological quality of all included SRs/MAs was rated as critically low. According to the evaluation results of GRADE, 38.9% (7/18) of outcomes were rated as very low-quality evidence, 22.2% (4/18) were low-quality evidence, and 8.9% (7/18) were moderate-quality evidence. Descriptive analysis results showed that acupuncture was an effective treatment modality for PSI. Conclusions. All included reviews indicated that acupuncture was more effective than the control group for the treatment of PSI, but the credibility of the results is limited owing to the generally low methodological and evidence quality of the included SRs/MAs. More high-quality evidence is needed to determine whether acupuncture is more effective than other treatments.

scholarly journals The Associations between Inflammatory Bowel Disease and a Range of Other Diseases：Umbrella Review of Systematic Reviews and Meta-analyses

2021 ◽  
Author(s):  
Liqun Li ◽  
Qianli Cen ◽  
Lijian Liu ◽  
Jinxiu Wei ◽  
Jinjing Tan ◽  
...  
Keyword(s):  
Methodological Quality ◽  
Gallstone Disease ◽  
Cochrane Library ◽  
Increased Risk ◽  
Evidence Quality ◽  
Bowel Diseases ◽  
Thyroid Cancer Risk ◽  
Inflammatory Bowel ◽  
Meta Analyses

Abstract Background Multiple meta-analyses have reported inflammatory bowel diseases (IBD) are associated with an increased risk of diverse diseases, but the evidence quality remains unclear. Objectives We aimed to summarize and evaluate this existing evidence on the associations between IBD and a range of diseases a-crossed from meta-analyses. Methods PubMed, the Cochrane Library Database, Embase, Web of Science, CNKI Databases, Wanfang Databases and VIP Database were searched to obtain eligible literatures from inception to November 1, 2019. We appraised the methodological quality of the included meta-analyses using AMSTAR 2 tool, and evaluated the quality of evidence for each outcome using the GRADE approach. Results Nineteen articles covering associations between IBD and 28 types of health outcomes were included. The methodological quality of meta-analyses was rated moderate for 5.26%, low for 21.05%, and critically low for 73.68%. Overall, summary effect estimates were significant in 26 meta-analyses. The evidence quality was rated high for 3.57%, moderate for 21.43%, low for 28.57%, and very low for 46.43%. Evidence quality was high for association between IBD and an increased periodontitis risk (OR = 4.55; 95% CI, 3.00-6.19). Evidence quality was moderate for associations between IBD and an increased thyroid cancer risk (OR = 1.75; 95% CI, 1.48–2.07), myocardial infarction incidence (RR = 1.12; 95% CI, 1.05–1.21), preterm birth incidence (OR = 1.85; 95% CI, 1.67–2.05), stillbirth incidence (OR = 1.57; 95% CI, 1.03–2.38), gallstone disease prevalence (OR = 1.72; 95% CI, 1.40–2.12), and vitamin D deficiency prevalence (OR = 1.64; 95% CI, 1.30–2.08). Conclusions Though, associations between IBD and diverse diseases have been extensively studied, few of the reported associations have robust support. Further well-designed studies are essential to determine whether IBD increases the risk of other diseases.

scholarly journals Quality of the Evidence Supporting the Role of Acupuncture for Stable Angina Pectoris: An Umbrella Review of Systematic Reviews

2021 ◽  
Vol 8 ◽  
Author(s):  
Min Shen ◽  
Jinke Huang ◽  
Tao Qiu
Keyword(s):  
Angina Pectoris ◽  
Systematic Reviews ◽  
Stable Angina ◽  
Methodological Quality ◽  
Reporting Quality ◽  
Stable Angina Pectoris ◽  
Quality Reporting ◽  
Evidence Quality ◽  
Meta Analyses

Background: To systematically appraise and synthesize evidence, we conducted an overview of systematic reviews/meta-analyses (SRs/MAs) on acupuncture for stable angina pectoris (SAP).Methods: Eight databases were searched for SRs/MAs of acupuncture on SAP. The methodological quality, reporting quality, and evidence quality were evaluated by Assessing the Methodological Quality of Systematic Reviews 2 (AMSTAR-2), the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist, and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system, respectively.Results: A total of seven published SRs/MAs met the inclusion criteria. According to the evaluation results of AMSTAR-2, two studies were considered as of moderate quality; the remaining five were considered as of very low quality. According to the evaluation results of the PRISMA checklist, only one study reported the checklist in its entirety, while others had reporting deficiencies. According to GRADE, a total of 18 outcome indicators extracted from the included studies were evaluated. The evidence quality was very low in three, low in three, moderate in eight, and high in four.Conclusion: Acupuncture may be beneficial for SAP from the currently published evidence. However, this conclusion must be interpreted cautiously due to the generally low methodological quality, reporting quality, and evidence quality of the included studies. More rigorous, more standardized and comprehensive SRs/MAs are needed to provide strong evidence for convincing conclusions.

scholarly journals The Effects of Tai Chi Exercise Among Adults With Chronic Heart Failure: An Overview of Systematic Review and Meta-Analysis

2021 ◽  
Vol 8 ◽  
Author(s):  
Jinke Huang ◽  
Xiaohui Qin ◽  
Min Shen ◽  
Yanjuan Xu ◽  
Yong Huang
Keyword(s):  
Systematic Reviews ◽  
Methodological Quality ◽  
Tai Chi ◽  
Meta Analysis ◽  
Reporting Quality ◽  
Risk Of Bias ◽  
Quality Reporting ◽  
Evidence Quality ◽  
Meta Analyses

Background: Tai chi (TC) is a popular form of exercise among adults with chronic heart failure (CHF), yet services are greatly underutilized. The aim of the current study was to identify and summarize the existing evidence and to systematically determine the clinical effectiveness of Tai Chi in the management of CHF using a systematic overview.Methods: Both English and Chinese databases were searched for systematic reviews (SRs)/meta-analyses (MAs) on TC for CHF from their inception to June 2020. The methodological quality, reporting quality, and risk of bias of SRs/MAs were assessed using Assessing the Methodological Quality of Systematic Reviews 2 (AMSTAR-2), the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist, and Risk of Bias in Systematic reviews (ROBIS), respectively. The evidence quality of outcome measures was assessed by the Grades of Recommendations, Assessment, Development and Evaluation (GRADE).Results: Six SRs/MAs using a quantitative synthesis to assess various outcomes of TC in CHF were included in this overview. The methodological quality, reporting quality and risk of bias of the SRs/MAs and the evidence quality of the outcome measures are generally unsatisfactory. The limitations of the past SRs/MAs included the lack of either the protocol or registration, the list of excluded studies, and the computational details of meta-analysis were inadequately reported. The critical problems were that qualitative data synthesis relied on trials with small sample sizes and critical low quality.Conclusions: TC may be a promising complementary treatment for CHF. However, further rigorous and comprehensive SRs/MAs and RCTs are required to provide robust evidence for definitive conclusions.

scholarly journals A Critical Overview of Systematic Reviews of Shenfu Injection for Heart Failure

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Jinke Huang ◽  
Yanlu Wang ◽  
Suihe Huang ◽  
Xiaohui Qin ◽  
Fang Yan ◽  
...  
Keyword(s):  
Heart Failure ◽  
Outcome Measures ◽  
Systematic Reviews ◽  
Methodological Quality ◽  
Descriptive Analysis ◽  
Research Area ◽  
Shenfu Injection ◽  
Evidence Quality ◽  
Meta Analyses

Objectives. Shenfu Injection (SFI) was widely used in the treatment of heart failure (HF) in China. A plethora of systematic reviews/meta-analyses (SRs/MAs) has been conducted in this research area, although with scattered results. The purpose of this overview was to conduct a comprehensive review to summarize and critically evaluate the existing evidence. Methods. Digital databases were searched for SRs/MAs up to January 28, 2021. Two authors independently screened the reviews and assessed the methodological quality of included SRs/MAs using Assessing the Methodological Quality of Systematic Reviews 2 (AMSTAR-2). Quality of evidence for outcomes evaluated within the reviews was appraised with the Grading of Recommendation, Assessment, Development, and Evaluation (GRADE). Results. Thirteen SRs/MAs met the inclusion criteria. Based on AMSTAR-2, the quality of all SRs/MAs was critically low, because all of them have more than one critical domains that were unmet. Based on GRADE, the evidence quality of 24 outcome measures was low or very low, 27 outcome measures was moderate, and none outcome measure was high. Descriptive analysis showed that SFI was an effective and safe method for HF. Conclusions. The use of SFI for the treatment of HF may be clinically effective and safe. However, this conclusion must be interpreted cautiously due to the generally low methodological quality and low evidence quality of the included SRs/MAs. More rigorously designed SRs/MAs and RCTs with high methodological quality are necessary for further proof.

scholarly journals Quality of Evidence Supporting the Role of Acupuncture for the Treatment of Irritable Bowel Syndrome

2021 ◽  
Vol 2021 ◽  
pp. 1-10
Author(s):  
Jinke Huang ◽  
Mengxiong Lu ◽  
Yijun Zheng ◽  
Jinxin Ma ◽  
Xiangxue Ma ◽  
...  
Keyword(s):  
Irritable Bowel Syndrome ◽  
Systematic Reviews ◽  
Methodological Quality ◽  
Reporting Quality ◽  
Current Evidence ◽  
Assessment Development ◽  
Evidence Quality ◽  
Irritable Bowel ◽  
Meta Analyses

Objectives. To systematically collate, appraise, and synthesize the current evidence on acupuncture for irritable bowel syndrome (IBS). Methods. Systematic reviews (SRs)/meta-analyses (MAs) of acupuncture for IBS were searched in eight databases. For quality evaluation of the enrolled studies, Assessment of Multiple Systematic Reviews 2 (AMSTAR-2) was used for methodological quality, Preferred Reporting Item for Systematic Reviews and Meta-Analyses (PRISMA) for reporting quality, and Grading of Recommendations Assessment, Development, and Evaluation (GRADE) for evidence quality. Results. Ten studies were included in our review. According to AMSTAR-2, only one study met all the criteria and was rated as high methodological quality, and the rest were rated as low or very low methodological quality. According to the PRISMA checklist, most of the items were fully reported, with the exception of Q5 (protocol and registration), Q8 (search), and Q27 (funding). With the GRADE system, no outcome measure was rated as high quality. Conclusions. Acupuncture may be a promising therapy for IBS. However, this conclusion must be treated with caution since the quality of SRs/MAs providing evidence is generally low.

scholarly journals Efficacy and Safety of Iguratimod for the Treatment of Rheumatoid Arthritis

2013 ◽  
Vol 2013 ◽  
pp. 1-16 ◽  
Author(s):  
Jiangtao Li ◽  
Hejuan Mao ◽  
Yan Liang ◽  
Yanrong Lu ◽  
Shuo Chen ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Meta Analysis ◽  
Tender Joint Count ◽  
Efficacy And Safety ◽  
Tender Joint ◽  
Evidence Quality ◽  
The Difference ◽  
Meta Analyses

All randomized controlled trials (RCTs) of iguratimod for rheumatoid arthritis (RA) to assess its efficacy and safety are included in this paper. The Review Manager software was used for meta-analysis to assess risk bias of the studies included, and GRADE profiler software was used for the evidence quality of the studies included. Four RCTs involving 1407 patients with RA were included. Meta-analyses showed that, after 24-week therapy, ACR20, tender joint count, swollen joint count, rest pain, physician and patient global assessment of disease activity, HAQ score, ESR, and CRP in iguratimod group were better than those in placebo group and that the difference between those of iguratimod group and those of other DMARDs (MTX and SASP) group was not significant. GRADE evidence classification of the studies included was moderate. Iguratimod for RA had few adverse events, and its efficacy and safety were the same as those of MTX and SASP for RA. The results of this systematic review suggest that more high-quality and large-scaled RCTs were needed to determine the efficacy of iguratimod for RA and whether iguratimod is as effective as other DMARDs besides MTX and SASP.

scholarly journals Effectiveness and Safety of Acupuncture and Moxibustion for Primary Dysmenorrhea: An Overview of Systematic Reviews and Meta-Analyses

2020 ◽  
Vol 2020 ◽  
pp. 1-15
Author(s):  
Jun Yang ◽  
Jun Xiong ◽  
Ting Yuan ◽  
Xue Wang ◽  
Yunfeng Jiang ◽  
...  
Keyword(s):  
Systematic Reviews ◽  
Methodological Quality ◽  
Treatment Options ◽  
Primary Dysmenorrhea ◽  
Efficacy And Safety ◽  
China National Knowledge Infrastructure ◽  
Acupuncture And Moxibustion ◽  
Meta Analyses ◽  
Quality Evidence

Background. Acupuncture and moxibustion have been accepted as treatment options for primary dysmenorrhea (PD). So far, several systematic reviews (SRs) and meta-analyses (MAs) have reported on the efficacy and safety of acupuncture and moxibustion in treating PD. Objectives. The aim of this study was to critically summarize the evidence from relevant SRs and MAs reporting on the efficacy and safety of acupuncture and moxibustion in treatment of PD. Materials and Methods. Seven electronic databases, including Cochrane Database of Systematic Reviews, EMBASE, PubMed, SinoMed, China National Knowledge Infrastructure (CNKI), Chinese Science and Technology Periodical Database (VIP), and Wanfang database, were systematically searched. SRs or MAs about acupuncture for PD published up to May 2019 were included in the analysis. More than two authors independently assessed the quality of the evidence by AMSTAR2, PRISMA, PRISMA-A, and GRADE approach. Results. A total of 28 SRs and MAs, 281 original studies, reporting on 26,459 female patients were analyzed. The majority of the SRs were of moderate reporting quality and poor methodological quality. Moderate-quality evidence suggested that acupuncture and moxibustion were more effective compared to indomethacin or Fenbid in treating PD. Low-quality evidence suggested that, compared to NSAIDs, acupuncture and moxibustion could relieve pain with less adverse effects. Conclusion. Acupuncture and moxibustion seem to be effective and safe approaches in treatment of PD; yet, the methodological quality of most of the studies and the quality of evidence were low. Thus, additional studies are required to further confirm these results.

scholarly journals Benefits and Safety of Chinese Herbal Medicine in Treating Psoriasis: An Overview of Systematic Reviews

2021 ◽  
Vol 12 ◽  
Author(s):  
Jie Zhang ◽  
Qianying Yu ◽  
Li Peng ◽  
Yuesi Qin ◽  
Mingyi Jing ◽  
...  
Keyword(s):  
Systematic Reviews ◽  
Methodological Quality ◽  
Reporting Quality ◽  
Risk Of Bias ◽  
High Quality ◽  
Chinese Herbal ◽  
Evidence Quality ◽  
Meta Analyses ◽  
Quality Evidence

Background: In recent years, systematic reviews/meta-analyses (SRs/MAs) of Chinese herbal medicine (CHM) for psoriasis have continuously emerged. Their methods and evidence quality, however, are yet to be evaluated, and whether their conclusions can provide clinicians with reliable evidence is still debatable.Objectives: This overview aims to evaluate the methodological quality, risk of bias, and reporting quality of relevant SRs/MAs, as well as the current evidence of CHM for treating psoriasis.Methods: We searched nine electronic databases from their respective time of establishment to January 20, 2021, as well as the reference lists of the included SRs/MAs, protocol registries, and gray literature. Two reviewers independently used the following: A Measurement Tool to Assess Systematic Reviews (AMSTAR) 2, Risk of Bias in Systematic Reviews (ROBIS), the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA), and Grades of Recommendations, Assessment, Development and Evaluation (GRADE) to evaluate the methodological quality, risk of bias, reporting quality, and evidence quality of the included SRs/MAs.Results: This review included 14 SRs/MAs involving 45 outcomes, of which 12 (85.71%) SRs/MAs had a very low quality evaluated by AMSTAR 2 and 7 (50.00%) SRs/MAs had a high risk of bias assessed by ROBIS. The protocol and registration and funding statements were the major reporting flaws according to the PRISMA checklist. The evaluation with the GRADE system demonstrated no outcome of high-quality evidence, and inconsistent efficacy evaluations were found in this overview. Only 15 (33.33%) outcomes were moderate-quality evidence, supporting the claim that CHM plus Western medicine (WM) was superior to WM. Generally low quality of evidence showed no difference in the incidence of adverse events between the combined therapy and WM. However, the conclusion that CHM was superior to WM cannot be drawn due to the inconsistent results.Conclusion: Despite that CHM has the potential benefit and safety in the adjuvant treatment of psoriasis, the conclusion should be treated with caution because of the generally low quality of methodology and evidence. In the future, high-quality randomized controlled trials (RCTs) should be carried out, and the quality of relevant SRs should also be improved to promote their clinical application.

scholarly journals Efficacy and Safety of Oral Chinese Patent Medicine Combined with Conventional Therapy for Heart Failure: An Overview of Systematic Reviews

2020 ◽  
Vol 2020 ◽  
pp. 1-13
Author(s):  
Shan-Shan Lin ◽  
Chun-Xiang Liu ◽  
Jun-Hua Zhang ◽  
Xian-Liang Wang ◽  
Jing-Yuan Mao
Keyword(s):  
Heart Failure ◽  
Systematic Reviews ◽  
Conventional Therapy ◽  
Efficacy And Safety ◽  
Chinese Patent Medicine ◽  
Evidence Quality ◽  
Chinese Patent ◽  
Meta Analyses ◽  
Patent Medicine

Objectives. By performing an overview of systematic reviews and meta-analyses of the efficacy and safety of oral Chinese patent medicine combined with conventional therapy in the treatment of heart failure, to evaluate the reliability and applicability of the conclusions of the current studies and provide evidence for clinical decision-making. Methods. Systematic reviews and meta-analyses of oral Chinese patent medicine combined with conventional therapy treating heart failure were searched based on standardized search strategy in six electronic databases including PubMed, Embase, Cochrane Library (No. 2 of 2020), China National Knowledge Infrastructure (CNKI), Wanfang Database (Wanfang), and Chinese Scientific Journal Database (VIP) from inception to February 2020. The literature was independently screened and extracted by two researchers. The methodological quality of the included literature was evaluated using the AMSTAR-2 (A Measurement Tool to Assess Systematic Review 2). If necessary, we would summarize the original research data and further perform data synthesis using RevMan software (version 5.3), and the evidence quality of the included literature was graded using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. Results. A total of 38 systematic reviews and meta-analyses were included, involving 11 kinds of oral Chinese patent medicines, including Qili Qiangxin Capsules (11/38), Qishen Yiqi Dropping Pills (9/38), Shexiang Baoxin Pills (4/38), Wenxin Keli (2/38), Tongxinluo Capsules (2/38), Compound Danshen Dripping Pills (2/38), Zhenyuan Capsules (3/38), Buyi Qiangxin Tablets (2/38), Yangxinshi Tablets (1/38), Xuezhikang (1/38), and Yixinshu Capsules (1/38). The methodological quality of all literature was rated as critically low. The grading of the quality of evidence was 43 moderate, 101 low, and 40 very low. The main reason for the degradation of evidence quality was the risk of bias. In the evaluation of efficacy, there was no statistically significant difference between the two groups in terms of mortality, which is a piece of low-quality evidence. Qili Qiangxin Capsules or Qishen Yiqi Dripping Pills combined with conventional therapy can significantly reduce the hospitalization rate of patients with chronic heart failure, and the quality of the evidence is moderate. The overall efficacy of oral Chinese patent medicine combined with conventional therapy in improving the clinical symptoms, quality of life, exercise endurance, laboratory tests, physical examination, and other indicators of patients with heart failure is confirmed. In the evaluation of safety, there was no significant difference between the two groups. Conclusions. Oral Chinese patent medicine combined with conventional therapy has good clinical efficacy and safety in the treatment of heart failure. However, due to its low level of methodological quality and evidence quality, the current evidence-based conclusions need to be further verified.

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