Risk of bias versus quality assessment of randomised controlled trials: cross sectional study

Hartling, Lisa; Ospina, Maria; Liang, Yuanyuan; Dryden, Donna M; Hooton, Nicola; Seida, Jennifer C; Klassen, Terry P.

doi:10.1136/bmj.b4012

Cited by 296 publications

(274 citation statements)

References 33 publications

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“…Recent reviews confirm that reporting of PRO endpoints remains unsatisfactory overall; particularly regarding the reporting of PRO hypotheses, methodology, missing data, and generalisability of results [19][20][21][22][23][24][25][26]. Failing to report this information is wasteful as it limits the potential for readers to appraise the effect of interventions on patient health status, and the potential for PRO systematic reviews to impact clinical recommendations and health policy [27,28]. It may also decrease clinicians' confidence in the value of PRO data [29].…”

Section: Discussionmentioning

confidence: 99%

Preliminary evidence on the uptake, use and benefits of the CONSORT-PRO extension

et al. 2017

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Section: Discussionmentioning

confidence: 99%

Preliminary evidence on the uptake, use and benefits of the CONSORT-PRO extension

et al. 2017

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“…6 Three studies have specifically examined risk of bias in pediatric trials by using the Cochrane Risk of Bias tool. [7][8][9] The results are summarized in Table 1 by risk of bias domain. In 2 reviews, the overall risk of bias was unclear or high for the vast majority of trials.…”

Section: Dilemmamentioning

confidence: 99%

Standard 2: Containing Risk of Bias

et al. 2012

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DILEMMAThere is a crisis of credibility facing the child health research community because of the paucity of reliable estimates of the effects of interventions in children. Associations between risk of bias assessments and treatment effect estimates have important implications, for the clinician, and the families face important challenges as decisionmakers stemming from results that exaggerate treatment effectiveness or safety. Consequently, interventions that are not efficacious and potentially harmful may be prescribed, whereas interventions that truly are efficacious may be withheld. [1][2][3][4][5] Positive trends in pediatric research have been observed since the first trial was published in 1948. Specifically, there has been a substantial increase in the number of trials published over time, the proportion of randomized to nonrandomized controlled trials, and the proportion of child to adult trials. 6 Reporting of methods has also improved; however, methodological quality remains modest. 6 Three studies have specifically examined risk of bias in pediatric trials by using the Cochrane Risk of Bias tool. [7][8][9] The results are summarized in Table 1 by risk of bias domain. In 2 reviews, the overall risk of bias was unclear or high for the vast majority of trials. 7,8 Both of these articles also revealed that trials at high or unclear risk of bias had exaggerated treatment effects compared with those at low risk of bias. Sequence generation and allocation concealment appear to be the domains that are consistently problematic. Importantly, several variables have been found to be associated with risk of bias including source of funding (industry-sponsored research revealing higher risk of bias), nature of the interventions (behavioral/educational interventions having higher risk of bias), and number of authors (higher risk of bias with fewer authors). 9 These analyses demonstrate that there is substantial room for improvement in the methodological and reporting quality of pediatric trials. The association between risk of bias assessments and treatment effect estimates has important implications for decision-making both in terms of false-positive and false-negative results. In practice, this may result in unrealistic expectations of treatment benefit and safety. Inadequate reporting can also have an impact on systematic reviews, which are being used increasingly as a basis for informed decisionmaking. Although systematic reviews aim to be comprehensive and include all relevant studies, the number of studies contributing to various analyses, be they qualitative or quantitative, is often considerably smaller due to inadequate reporting.Ensuring methodological rigor and complete reporting is essential for informed clinical decision-making. It is critical that issues of bias are recognized and addressed by every person who conducts trials, reviews trials, funds trials, or uses trials to guide practice. This standards article was motivated by 2 key factors: (1) emerging evidence demonstrating methodological flaws a...

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“…"Quality," "bias," and "validity" are three terms often used interchangeably in assessing studies, though none of them is completely descriptive of the others (Hartling et al, 2009). "Quality" is an abstract concept that is highly subjective and difficult to quantify.…”

Section: Introductionmentioning

confidence: 99%

“…"Quality" is an abstract concept that is highly subjective and difficult to quantify. It is often interpreted as the strength of study design and implementation, and the ability to preclude systematic errors or bias (Centre for Reviews and Dissemination, 2009;Hartling et al, 2009;Higgins and Green, 2011). Quality is also viewed from various perspectives including, but not limited to, appropriateness of study design, risk of bias, choice of outcome measure, statistical issues, reporting quality, intervention quality, and generalizability (Centre for Reviews and Dissemination, 2009).…”

Section: Introductionmentioning

confidence: 99%

Development of the Anatomical Quality Assessment (AQUA) Tool for the quality assessment of anatomical studies included in meta‐analyses and systematic reviews

Henry¹,

Tomaszewski²,

et al. 2016

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Critical appraisal of anatomical studies is essential before the evidence from them undergoes meta-epidemiological synthesis. However, no instrument for appraising anatomical studies with inherent applicability to different study designs is available. We aim to develop a generic yet comprehensive tool for assessing the quality of anatomical studies using a formal consensus method. The study steering committee formulated an initial conceptual design and generated items for a preliminary tool on the basis of a literature review and expert opinion. A Delphi procedure was then adopted to assess the validity of the preliminary tool. Feedback from the Delphi panelists was used to improve it. The Delphi procedure involved 12 experts in anatomical research. It comprised two rounds, after which unanimous consensus was reached about the items to be included. The preliminary tool consisted of 20 items, which were phrased as signaling questions and organized into five domains: 1. Aim and subject characteristics, 2. Study design, 3. Characterization of methods, 4. Descriptive anatomy, and 5. Results reporting. Each domain was set to end with a risk of bias question. Following round 1, some of the items underwent major revision, although agreement was reached regarding inclusion of all the domains and signaling questions in the preliminary tool. The tool was revised only for minor language inaccuracies after round 2. The AQUA Tool was designed to assess the quality and reliability of anatomical studies. It is currently undergoing a validation process. Clin. Anat. 30:6-13,

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Risk of bias versus quality assessment of randomised controlled trials: cross sectional study

Cited by 296 publications

References 33 publications

Preliminary evidence on the uptake, use and benefits of the CONSORT-PRO extension

Preliminary evidence on the uptake, use and benefits of the CONSORT-PRO extension

Standard 2: Containing Risk of Bias

Development of the Anatomical Quality Assessment (AQUA) Tool for the quality assessment of anatomical studies included in meta‐analyses and systematic reviews

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