The revised Cochrane risk of bias tool for randomized trials (RoB 2) showed low interrater reliability and challenges in its application

Minozzi, Silvia; Cinquini, Michela; Gianola, Silvia; González-Lorenzo, Marién; Banzi, Rita

doi:10.1016/j.jclinepi.2020.06.015

Cited by 231 publications

(150 citation statements)

References 12 publications

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“…To determine the risk of bias of each study we employed the CLEAR NPT checklist (Boutron et al, 2005), designed to measure the quality of RCTs evaluating nonpharmacological treatments (NPTs). The protocol for the meta-analysis intended to use the Revised Cochrane Risk-of-Bias tool (RoB 2); however, as the investigators became aware of issues raised in relation the RoB 2 (i.e., complexity of the tool, relatively low inter-rater reliability; Minozzi et al, 2020), along with the fact that the tool is still in the validation phase, it was decided to use another well-established, standard for assessing the quality of RCTs. The CLEAR NPT checklist has been successfully used in previous meta-analytic studies of Internet-delivered interventions for depression (Wright et al, 2019).…”

Section: Quality Assessment Of Included Studiesmentioning

confidence: 99%

The effectiveness of Internet‐delivered treatment for generalized anxiety disorder: An updated systematic review and meta‐analysis

Eilert

Enrique

Wogan

et al. 2020

Depression and Anxiety

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Background Generalized anxiety disorder (GAD) is a highly prevalent, chronic disorder associated with impaired quality of life, societal burden, and poor treatment rates. Internet‐delivered interventions may improve the accessibility of treatments and are increasingly being used. This study aimed to update a previous meta‐analysis to determine the effectiveness of available Internet‐delivered interventions in treating symptoms of GAD. Method Systematic literature searches were conducted (through April 2020) using Embase, PubMed, PsychINFO, and Cochrane to find randomized controlled trials of Internet‐delivered interventions for GAD. Risk of bias was evaluated, and Hedge's g was calculated at posttreatment and follow‐up. Results Twenty studies met eligibility criteria and were included in the meta‐analysis. Random‐effect models detected large effect sizes for primary outcomes of anxiety (g = 0.79) and worry (g = 0.75), favoring treatment. Effect sizes for depression, functional impairment, and quality of life were moderate to large. Maintenance of effects at follow‐up seems likely. Conclusions Results support the effectiveness of Internet‐delivered treatments for GAD. Considerable heterogeneity between studies appeared moderated by variability in the interventions themselves, highlighting the importance of further investigation into the characteristics that may optimize treatment outcomes. Overall, Internet‐delivery appears to be a viable mode of treatment for GAD with potential to relieve existing gaps in the provision of treatment.

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Section: Quality Assessment Of Included Studiesmentioning

confidence: 99%

The effectiveness of Internet‐delivered treatment for generalized anxiety disorder: An updated systematic review and meta‐analysis

Eilert

Enrique

Wogan

et al. 2020

Depression and Anxiety

View full text Add to dashboard Cite

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“…The reliability of the joint assessment is expected to be higher than the reliability of the independent assessments as the joint consensus involved extensive discussion process to reconciliate individual assessments. We therefore do not suggest that our assessment is an assessment of the reliability of the RoB2 tool, despite others having suggested reliability between two independent measures can assess the reliability of RoB2 [Minozzi 2020]. Nonetheless domains or signalling questions with low agreement might be indicative of domains or signalling questions which are less clearly amenable to an assessment of bias than those with higher agreement, and this might be translate more generally when others are using the RoB2 tool to assess risk of bias within the context of a review.…”

Section: Limitationsmentioning

confidence: 86%

Cluster randomized trials of individual-level interventions were at high risk of bias

Easter

Thompson

Eldridge

et al. 2021

Journal of Clinical Epidemiology

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This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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“…Publications accepted in the study were methodologically evaluated according to the revised Cochrane risk-of-bias tool for randomized trials ( 38 ). This system categorizes the studies in low, unclear or high risk of bias, according to the following parameters: random sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessment (self-reported outcomes and objective measures), incomplete outcome data, selective reporting and other bias.…”

Section: Methodsmentioning

confidence: 99%

A Comparison Between Chemo-Radiotherapy Combined With Immunotherapy and Chemo-Radiotherapy Alone for the Treatment of Newly Diagnosed Glioblastoma: A Systematic Review and Meta-Analysis

et al. 2021

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BackgroundImmunotherapy for GBM is an emerging field which is increasingly being investigated in combination with standard of care treatment options with variable reported success rates.ObjectiveTo perform a systematic review of the available data to evaluate the safety and efficacy of combining immunotherapy with standard of care chemo-radiotherapy following surgical resection for the treatment of newly diagnosed GBM.MethodsA literature search was performed for published clinical trials evaluating immunotherapy for GBM from January 1, 2000, to October 1, 2020, in PubMed and Cochrane using PICOS/PRISMA/MOOSE guidelines. Only clinical trials with two arms (combined therapy vs. control therapy) were included. Outcomes were then pooled using weighted random effects model for meta-analysis and compared using the Wald-type test. Primary outcomes included 1-year overall survival (OS) and progression-free survival (PFS), secondary outcomes included severe adverse events (SAE) grade 3 or higher.ResultsNine randomized phase II and/or III clinical trials were included in the analysis, totaling 1,239 patients. The meta-analysis revealed no statistically significant differences in group’s 1-year OS [80.6% (95% CI: 68.6%–90.2%) vs. 72.6% (95% CI: 65.7%–78.9%), p = 0.15] or in 1-year PFS [37% (95% CI: 26.4%–48.2%) vs. 30.4% (95% CI: 25.4%–35.6%) p = 0.17] when the immunotherapy in combination with the standard of care group (combined therapy) was compared to the standard of care group alone (control). Severe adverse events grade 3 to 5 were more common in the immunotherapy and standard of care group than in the standard of care group (47.3%, 95% CI: 20.8–74.6%, vs 43.8%, 95% CI: 8.7–83.1, p = 0.81), but this effect also failed to reach statistical significance.ConclusionOur results suggests that immunotherapy can be safely combined with standard of care chemo-radiotherapy without significant increase in grade 3 to 5 SAE; however, there is no statistically significant increase in overall survival or progression free survival with the combination therapy.

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The revised Cochrane risk of bias tool for randomized trials (RoB 2) showed low interrater reliability and challenges in its application

Cited by 231 publications

References 12 publications

The effectiveness of Internet‐delivered treatment for generalized anxiety disorder: An updated systematic review and meta‐analysis

The effectiveness of Internet‐delivered treatment for generalized anxiety disorder: An updated systematic review and meta‐analysis

Cluster randomized trials of individual-level interventions were at high risk of bias

A Comparison Between Chemo-Radiotherapy Combined With Immunotherapy and Chemo-Radiotherapy Alone for the Treatment of Newly Diagnosed Glioblastoma: A Systematic Review and Meta-Analysis

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