RoB 2: a revised tool for assessing risk of bias in randomised trials

Sterne, Jonathan A C; Savović, Jelena; Page, Matthew J.; Elbers, Roy G.; Blencowe, Natalie S; Boutron, Isabelle; Cates, Christopher J; Cheng, Hung-Yuan; Corbett, Mark; Eldridge, Sandra; Emberson, Jonathan; Hernán, Miguel A.; Hopewell, Sally; Hróbjartsson, Asbjørn; Junqueira, Daniela R; Jüni, Peter; Kirkham, Jamie J; Lasserson, Toby J; Li, Tianjing; McAleenan, Alexandra; Reeves, Barnaby C; Shepperd, Sasha; Shrier, Ian; Stewart, Lesley; Tilling, Kate; White, Ian R.; Whiting, Penny; Higgins, Julian P T

doi:10.1136/bmj.l4898

Cited by 15,392 publications

(11,456 citation statements)

References 21 publications

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“…For example, in physiotherapy and other nonpharmaceutical interventions, the blinding of study participants may be impossible even in studies that otherwise meet high methodological standards. The Cochrane risk of bias (RoB) tool exclusively focuses on the internal validity of trials . Others extend quality assessment to include elements of external validity and the precision of estimates or sample size or to items related to the completeness of the reporting of trials …”

Section: Introductionmentioning

confidence: 99%

“…In contrast to scales, checklists may relate to different constructs, and they may include both indicators of effects of the underlying construct and indicators of causes of the construct . For example, the Cochrane RoB tool assesses the blinding or lack of blinding of study participants and personnel, which may prevent or cause performance bias . Similarly, it assesses concealment of allocation to treatment, which may prevent selection bias.…”

Section: Introductionmentioning

confidence: 99%

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Construct validity of the Physiotherapy Evidence Database (PEDro) quality scale for randomized trials: Item response theory and factor analyses

Albanese

Bütikofer

Armijo‐Olivo

et al. 2020

Research Synthesis Methods

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Background There is an agreement that the methodological quality of randomized trials should be assessed in systematic reviews, but there is a debate on how this should be done. We conducted a construct validation study of the Physiotherapy Evidence Database (PEDro) scale, which is widely used to assess the quality of trials in physical therapy and rehabilitation. Methods We analyzed 345 trials that were included in Cochrane reviews and for which a PEDro summary score was available. We used one‐ and two‐parameter logistic item response theory (IRT) models to study the psychometric properties of the PEDro scale and assessed the items' difficulty and discrimination parameters. We ran goodness of fit post estimations and examined the IRT unidimensionality assumption with a multidimensional IRT (MIRT) model. Results Out of a maximum of 10, the mean PEDro summary score was 5.46 (SD = 1.51). The allocation concealment and intention‐to‐treat scale items contributed most of the information on the underlying construct (with discriminations of 1.79 and 2.05, respectively) at similar difficulties (0.63 and 0.65, respectively). The other items provided little additional information and did not distinguish trials of different quality. There was substantial evidence of departure from the unidimensionality assumption, suggesting that the PEDro items relate to more than one latent trait. Conclusions Our findings question the construct validity of the PEDro scale to assess the methodological quality of clinical trials. PEDro summary scores should not be used; rather, the physiotherapy community should consider working with the individual items of the scale.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Construct validity of the Physiotherapy Evidence Database (PEDro) quality scale for randomized trials: Item response theory and factor analyses

Albanese

Bütikofer

Armijo‐Olivo

et al. 2020

Research Synthesis Methods

View full text Add to dashboard Cite

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“…Adverse events (possible harms) reported in the articles were included regardless of assessment of causality in the original research. RCTs were assessed for risk of bias using the Cochrane Collaboration risk‐of‐bias tool v.2.0 that has five domains: randomization, deviation from intervention, missing data, measurement of outcome, and selective reporting. Each domain and overall were rated “high risk,” “some concerns,” and “low risk.” For observational studies, we used the Newcastle‐Ottawa Scale for cohort studies with domains selection, comparability, and exposure/outcome.…”

Section: Methodsmentioning

confidence: 99%

Benefits and Harms of Statins in People with Dementia: A Systematic Review and Meta‐Analysis

Davis

Bishara

Perera

et al. 2020

J American Geriatrics Society

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OBJECTIVES More people with dementia also fall into the category of high vascular risk, for which a statin is usually prescribed. However, these recommendations are based on studies in people without dementia. We aimed to evaluate the evidence for the long‐term effectiveness and harm of statin therapy in patients with dementia. DESIGN Systematic review of randomized controlled trials and observational research. SETTING Publications from developed countries indexed in the PubMed, Web of Science, and Cochrane trial database between 2007 and 2019. PARTICIPANTS Trials including people with all types of dementia with a mean age older than 65 years. INTERVENTION Treatment with a statin for 6 months or longer. MEASUREMENTS Major adverse cardiovascular events, dementia progression, and general health at 2 years, or medication adverse events (AEs) at any time. Each article was assessed for bias using the Newcastle‐Ottawa or Cochrane Collaboration tools. A narrative synthesis and pooled analyses are reported. RESULTS Five articles met the inclusion criteria. They reported only on dementia of the Alzheimer's type. There was no evidence regarding cardiovascular events or general health. We made a very low confidence finding that statins reduce dementia progression based on three cohort studies of heterogeneous design. We made a very low confidence finding of no significant difference in AEs based on two randomized controlled trials of 18 months: odds ratios of any AE = 1.21 (95% confidence interval [CI] = .83‐1.77), serious AE = 1.03 (95% CI = .76‐1.87), and death = 1.69 (95% CI = .79‐3.62). CONCLUSION Evidence was insufficient to fully evaluate the efficacy of statins in people with dementia. We found that statins may have a small benefit delaying progression in Alzheimer's dementia, although this conflicted with previous findings from shorter randomized trials. For safety, the trial data lacked power to show clinically important differences between the groups. We recommend that clinical data be leveraged for further observational studies to inform prescribing decisions. J Am Geriatr Soc 68:650–658, 2020

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“…Currently, there is no existing risk‐of‐bias assessment tool that is specific for basket and umbrella trials. As these trials may be conducted with randomized or nonrandomized trial designs, the readers can use 2 of Cochrane's existing risk‐of‐bias assessment tools: Cochrane's revised risk of bias assessment tool (RoB 2) and risk of bias in nonrandomized studies of interventions (ROBINS‐I) . The RoB 2 tool, which is intended for bias assessment of individually randomized clinical trials, covers important bias domains of randomization, deviation from intended interventions, missing outcome, measurement of outcome, and selective reporting .…”

Section: Key Considerations For Basket and Umbrella Trialsmentioning

confidence: 99%

“…As these trials may be conducted with randomized or nonrandomized trial designs, the readers can use 2 of Cochrane's existing risk‐of‐bias assessment tools: Cochrane's revised risk of bias assessment tool (RoB 2) and risk of bias in nonrandomized studies of interventions (ROBINS‐I) . The RoB 2 tool, which is intended for bias assessment of individually randomized clinical trials, covers important bias domains of randomization, deviation from intended interventions, missing outcome, measurement of outcome, and selective reporting . The ROBINS‐1 tool, which has been developed for bias assessment of nonrandomized intervention studies, covers similar bias domains as the RoB 2 tool (ie, deviation of intended interventions, missing outcome, measurement of outcome, and selective reporting) and 3 additional bias domains: confounding prognostic variables, selection of participants, and misclassification of interventions that are related and unrelated to the outcome .…”

Section: Key Considerations For Basket and Umbrella Trialsmentioning

confidence: 99%

An overview of precision oncology basket and umbrella trials for clinicians

Park

Hsu

Siden

et al. 2020

CA A Cancer J Clinicians

150

115

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With advancements in biomarkers and momentum in precision medicine, biomarker‐guided trials such as basket trials and umbrella trials have been developed under the master protocol framework. A master protocol refers to a single, overarching design developed to evaluate multiple hypotheses with the general goal of improving the efficiency of trial evaluation. One type of master protocol is the basket trial, in which a targeted therapy is evaluated for multiple diseases that share common molecular alterations or risk factors that may help predict whether the patients will respond to the given therapy. Another variant of a master protocol is the umbrella trial, in which multiple targeted therapies are evaluated for a single disease that is stratified into multiple subgroups based on different molecular or other predictive risk factors. Both designs follow the core principle of precision medicine—to tailor intervention strategies based on the patient's risk factor(s) that can help predict whether they will respond to a specific treatment. There have been increasing numbers of basket and umbrella trials, but they are still poorly understood. This article reviews common characteristics of basket and umbrella trials, key trials and recent US Food and Drug Administration approvals for precision oncology, and important considerations for clinical readers when critically evaluating future publications on basket trials and umbrella trials and for researchers when designing these clinical trials.

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RoB 2: a revised tool for assessing risk of bias in randomised trials

Cited by 15,392 publications

References 21 publications

Construct validity of the Physiotherapy Evidence Database (PEDro) quality scale for randomized trials: Item response theory and factor analyses

Construct validity of the Physiotherapy Evidence Database (PEDro) quality scale for randomized trials: Item response theory and factor analyses

Benefits and Harms of Statins in People with Dementia: A Systematic Review and Meta‐Analysis

An overview of precision oncology basket and umbrella trials for clinicians

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