The Cochrane Collaboration's tool for assessing risk of bias in randomised trials

Higgins, Julian P T; Altman, Douglas G.; Gøtzsche, Peter C; Jüni, Peter; Moher, David; Oxman, Andrew D; Savović, Jelena; Schulz, Kenneth F.; Weeks, Laura; Sterne, Jonathan A C

doi:10.1136/bmj.d5928

Cited by 26,533 publications

(20,676 citation statements)

References 16 publications

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“…The methodological quality was assessed by using the Cochrane tool of risk of bias for RCTs [22]. To assess potential bias existing in selection, performance, detection, attrition, and reporting processes, six items were focused on: random sequence generation; allocation concealment; blinding (of participant and personal, of outcome assessment); incomplete outcome data; selective reporting; and other biases [22].…”

Section: Methodsmentioning

confidence: 99%

“…To assess potential bias existing in selection, performance, detection, attrition, and reporting processes, six items were focused on: random sequence generation; allocation concealment; blinding (of participant and personal, of outcome assessment); incomplete outcome data; selective reporting; and other biases [22]. Each item was judged as low risk, unclear risk, or high risk.…”

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

Effect of garlic supplement in the management of type 2 diabetes mellitus (T2DM): a meta-analysis of randomized controlled trials

Wang

Zhang

HaiLi

et al. 2017

Food & Nutrition Research

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The present study was designed to systematically evaluate the clinical efficacy and safety of garlic supplement in the management of type 2 diabetes mellitus (T2DM). PubMed, EMBASE, the Cochrane Library, and China National Knowledge Internet (CNKI) were searched for relevant randomized controlled trials (RCTs) by using the terms garlic and T2DM up to April 2017. The quality of included RCTs was assessed by the Cochrane tool of risk of bias, and data of outcomes were pooled by REVMAN 5.3. Clinical factors were handled by meta-regression and subgroup analysis, and risk of publication bias was explored by inverted funnel plots. Nine RCTs involving 768 T2DM patients were included in the meta-analysis, and the dose of daily garlic (allicin) supplement ranged from 0.05g to 1.5g. A significant reduction in the level of fasting blood glucose in 1–2 weeks [SMD = −1.61, 95%CI (−2.89, −0.32)], 3–4 weeks [SMD = −2.87, 95%CI (−4.74, −1.00)], 12 weeks [SMD = −9.57, 95%CI (−12.39, −6.75)], and 24 weeks [SMD = −21.02, 95%CI (−32.47, −9.57)] was achieved in favour of the garlic group rather than the control group. Significantly decreased fructosamine and glycated hemoglobin (both in 12 and 24 weeks) were also found in garlic group. Meanwhile, significantly improved blood liquids of total cholesterol [SMD = −1.93, 95%CI (−2.98, −0.87), 3–4 weeks], high density lipoprotein [SMD = −0.41, 95%CI (−0.83, −0.00), 3–4 weeks] and low density lipoprotein [SMD = −3.47, 95%CI (−5.76, −1.18), 12 weeks] were confirmed after garlic administration. There was no significant difference in complications. Current data confirms that garlic supplement plays positive and sustained roles in blood glucose, total cholesterol, and high/low density lipoprotein regulation in the management of T2DM. Abbreviations: T2DM = type 2 diabetes mellitus; RCT = randomized controlled trial; SMD = standard mean difference; CI = confidence interval; FBG = fasting blood glucose; HbA1c = glycated hemoglobin; HDL = high density lipoprotein; LDL = low density lipoprotein.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Effect of garlic supplement in the management of type 2 diabetes mellitus (T2DM): a meta-analysis of randomized controlled trials

Wang

Zhang

HaiLi

et al. 2017

Food & Nutrition Research

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“…Two authors independently assessed the quality of evidence using Cochrane's Collaboration tool for evaluating study bias (Higgins et al. 2011). Details about the methodologies of the included studies and a graph of publication bias are provided in Table S5 and Figure S18, respectively.…”

Section: Methodsmentioning

confidence: 99%

Efficacy and safety of different regimens for primary open‐angle glaucoma or ocular hypertension: a systematic review and network meta‐analysis

Huang

Zhang

2017

Acta Ophthalmologica

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PurposeTo assess the efficacy and safety of different regimens, including monotherapy and double therapy, for primary open‐angle glaucoma (POAG) or ocular hypertension.MethodsWe searched PubMed, EMBASE and clinicaltrials.gov for studies that fit our inclusion criteria in this network meta‐analysis. Randomized controlled trials that report data on efficacy and safety of medications for POAG or ocular hypertension are included. Data on intra‐ocular pressure (IOP) lowering effect and incidence of adverse events including hyperaemia and ocular discomfort were extracted and used in mixed‐comparison analysis.ResultsThis study includes 72 randomized trials. Data were available on 12 medical treatments of POAG or ocular hypertension. Of 66 possible comparisons of outcome efficacy, 15 treatments were compared directly. Compared to prostaglandin analogues (PGA), beta‐blockers (BB) showed relatively weaker ability to lower IOP, followed by α2‐adrenergic agonists (AA) and carbonic anhydrase inhibitors (CAI). For dual therapy, regimens composed of a combination of PGA with another treatment demonstrated more powerful IOP lowering efficacy, while the combination of two non‐PGA drugs had lower efficacy in controlling IOP than PGA alone. There was no statistical significance in combinations that did not include PGA on efficacy of IOP control. In terms of tolerance, PGA alone leads to more severe hyperaemia than any other monotherapy regimen, while BBs have the lowest effect on the incidence of hyperaemia. Most dual therapy regimens containing PGA also lead to serious hyperaemia, with the exception of PGA + AA. Compared to regimens containing PGA, those with BB are less likely to cause hyperaemia.ConclusionOur network meta‐analysis showed that PGAs provide best IOP lowering effect among all the monotherapy regimen. Combination of PGA and other category of drugs leads to better IOP decrease. Combination of BB and another non‐PGA drug may have less ocular side‐effects than PGA alone.

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“…For multiple studies published from a single data set, the largest study with primary findings was included in the analysis. Risk of bias was assessed using the Cochrane risk of bias assessment tool 34. Discrepancies between reviewers were resolved through discussion and consensus.…”

Section: Methodsmentioning

confidence: 99%

Effect of Mineralocorticoid Receptor Antagonists on Cardiac Structure and Function in Patients With Diastolic Dysfunction and Heart Failure With Preserved Ejection Fraction: A Meta‐Analysis and Systematic Review

Pandey

Garg

Matulevicius

et al. 2015

JAHA

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BackgroundThere has been an increasing interest in use of mineralocorticoid receptor antagonists (MRAs) in patients with heart failure with preserved ejection fraction (HFPEF). However, a comprehensive evaluation of MRA effects on left ventricular (LV) structure and function in these patients is lacking. In this meta‐analysis, we evaluated the effects of MRAs on LV structure and function among patients with diastolic dysfunction or HFPEF.Methods & ResultsRandomized, controlled clinical trials evaluating the efficacy of MRAs in patients with diastolic dysfunction or HFPEF were included. The primary outcome was change in E/e’, a specific measure of diastolic function. Secondary outcomes included changes in other measures of diastolic function, LV structure, surrogate markers for myocardial fibrosis (carboxy‐terminal peptide of procollagen type I [PICP] and amino‐terminal peptide of pro‐collagen type‐II [PIIINP]), blood pressure, and exercise tolerance. In the pooled analysis, MRA use was associated with significant reduction in E/e’ (weighted mean difference [WMD] [95% confidence interval {CI}]: −1.68 [−2.03 to −1.33]; P<0.0001) and deceleration time (WMD [95% CI]: −12.0 ms [−23.3 to −0.7]; P=0.04) as compared with control, suggesting and improvement in diastolic function. Furthermore, blood pressure and levels of PIIINP and PICP were also significantly reduced with MRA therapy with no significant change in LV mass or dimensions.Conclusion MRA therapy in patients with asymptomatic diastolic dysfunction or HFPEF is associated with significant improvement in diastolic function and markers of cardiac fibrosis without a significant change in LV mass or dimensions.

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The Cochrane Collaboration's tool for assessing risk of bias in randomised trials

Abstract: Flaws in the design, conduct, analysis, and reporting of randomised trials can cause the effect of an intervention to be underestimated or overestimated. The Cochrane Collaboration’s tool for assessing risk of bias aims to make the process clearer and more accurate

Cited by 26,533 publications

References 16 publications

Effect of garlic supplement in the management of type 2 diabetes mellitus (T2DM): a meta-analysis of randomized controlled trials

Effect of garlic supplement in the management of type 2 diabetes mellitus (T2DM): a meta-analysis of randomized controlled trials

Efficacy and safety of different regimens for primary open‐angle glaucoma or ocular hypertension: a systematic review and network meta‐analysis

Effect of Mineralocorticoid Receptor Antagonists on Cardiac Structure and Function in Patients With Diastolic Dysfunction and Heart Failure With Preserved Ejection Fraction: A Meta‐Analysis and Systematic Review

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