GRADE guidelines: 7. Rating the quality of evidence—inconsistency

Guyatt, Gordon; Oxman, Andrew D; Kunz, Regina; Woodcock, James; Brožek, Jan; Helfand, Mark; Alonso‐Coello, Pablo; Glasziou, Paul; Jaeschke, Roman; Akl, Elie A.; Norris, Susan L.; Vist, Gunn Elisabeth; Dahm, Philipp; Shukla, Vijay Kumar; Higgins, Julian P T; Falck‐Ytter, Yngve; Schünemann, Holger J.

doi:10.1016/j.jclinepi.2011.03.017

Cited by 1,878 publications

(1,133 citation statements)

References 16 publications

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“…To examine the stability of the main estimates, we conducted sensitivity analyses by including high ROB studies or imputing missing binary data under best‐ and worst‐case scenarios 28, 29. We combined OBSs with similar study methods and clinical variability 30 and calculated summary treatment effect estimates separately by study design 28, 29. We estimated inconsistency (heterogeneity) across studies using the I 2 statistic 28 and investigated sources of clinical and/or methodological variation when we suspected heterogeneity that might affect the results 31.…”

Section: Methodsmentioning

confidence: 99%

Buprenorphine compared with methadone to treat pregnant women with opioid use disorder: a systematic review and meta‐analysis of safety in the mother, fetus and child

et al. 2016

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AimsTo assess the safety of buprenorphine compared with methadone to treat pregnant women with opioid use disorder.MethodsWe searched PubMed, Embase and the Cochrane Library from inception to February 2015 for randomized controlled trials (RCT) and observational cohort studies (OBS) that compared buprenorphine with methadone for treating opioid‐dependent pregnant women. Two reviewers assessed independently the titles and abstracts of all search results and full texts of potentially eligible studies reporting original data for maternal/fetal/infant death, preterm birth, fetal growth outcomes, fetal/congenital anomalies, fetal/child neurodevelopment and/or maternal adverse events. We ascertained each study's risk of bias using validated instruments and assessed the strength of evidence for each outcome using established methods. We computed effect sizes using random‐effects models for each outcome with two or more studies.ResultsThree RCTs (n = 223) and 15 cohort OBSs (n = 1923) met inclusion criteria. In meta‐analyses using unadjusted data and methadone as comparator, buprenorphine was associated with lower risk of preterm birth [RCT risk ratio (RR) = 0.40, 95% confidence interval (CI) = 0.18, 0.91; OBS RR = 0.67, 95% CI = 0.50, 0.90], greater birth weight [RCT weighted mean difference (WMD) = 277 g, 95% CI = 104, 450; OBS WMD = 265 g, 95% CI = 196, 335] and larger head circumference [RCT WMD = 0.90 cm, 95% CI = 0.14, 1.66; OBS WMD = 0.68 cm, 95% CI = 0.41, 0.94]. No treatment differences were observed for spontaneous fetal death, fetal/congenital anomalies and other fetal growth measures, although the power to detect such differences may be inadequate due to small sample sizes.ConclusionsModerately strong evidence indicates lower risk of preterm birth, greater birth weight and larger head circumference with buprenorphine treatment of maternal opioid use disorder during pregnancy compared with methadone treatment, and no greater harms.

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Section: Methodsmentioning

confidence: 99%

Buprenorphine compared with methadone to treat pregnant women with opioid use disorder: a systematic review and meta‐analysis of safety in the mother, fetus and child

et al. 2016

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“…Even though intuitively this criterion looks similar to the downgrading criterion "inconsistency", a number of participants found this to be a useful and important criterion that embraces the concept of complementary evidence, which entails more than just the opposite of inconsistency. That is, whereas in the GRADE approach "inconsistency" refers to heterogeneity of effect measures for a given outcome [15], "consistency across settings and study designs" means that consistent results have been obtained under a variety of conditions (study design and setting), which might increase confidence in the overall assessment unless it has to be assumed that an unmeasured confounder influenced the results in all settings in a similar way.…”

Section: Summary Of Discussion: From Quality Appraisal To Evidence Smentioning

confidence: 99%

Towards a framework for evaluating and grading evidence in public health

et al. 2015

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The Project on a Framework for Rating Evidence in Public Health (PRECEPT) is an international collaboration of public health institutes and universities which has been funded by the European Centre for Disease Prevention and Control (ECDC) since 2012. Main objective is to define a framework for evaluating and grading evidence in the field of public health, with particular focus on infectious disease prevention and control. As part of the peer review process, an international expert meeting was held on 13-1 4 June 2013 in Berlin. Participants were members of the PRECEPT team and selected experts from national public health institutes, World Health Organization (WHO), and academic institutions. The aim of the meeting was to discuss the draft framework and its application to two examples from infectious disease prevention and control. This article introduces the draft PRECEPT framework and reports on the meeting, its structure, most relevant discussions and major conclusions

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“…By using this method, the level of evidence is assessed for the following domains: risk of bias, 16 inconsistency, 17 indirectness, 18 imprecision, 19 and publication bias. 20 …”

Section: Assessment Of Quality Of Evidence and Confi Dence In Estimatmentioning

confidence: 99%

“…The quality of pooled data for each outcome was high in the domains of inconsistency, 17 indirectness, 18 imprecision, 19 or publication bias. 20 The quality of evidence across all outcomes was assigned as moderate because of the overlap between the intervention and control groups.…”

Section: Quality Of Pooled Data For Each Outcomementioning

confidence: 99%

Oxygen Saturation Targets in Preterm Infants and Outcomes at 18–24 Months: A Systematic Review

2017

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CONTEXT: The optimal oxygen saturation target for extremely preterm infants remains unclear.OBJECTIVE: To systematically review evidence evaluating the effect of lower (85%-89%) versus higher (91%-95%) pulse oxygen saturation (SpO 2 ) target on mortality and neurodevelopmental impairment (NDI) at 18 to 24 months. DATA SOURCES:Electronic databases and all published randomized trials evaluating lower versus higher SpO 2 target in preterm infants. STUDY SELECTION:A total of 2896 relevant citations were identified; 5 trials were included in the final analysis.DATA EXTRACTION: Data from 5 trials were analyzed for quality of evidence and risk of bias. LIMITATIONS:Limitations include heterogeneity in age at enrollment and comorbidities between trials and change in oximeter algorithm midway through 3 trials. RESULTS:There was no difference in the incidence of primary outcome (death/NDI at 18-24 months) in the 2 groups; risk ratio, 1.05, 95% confidence interval 0.98-1.12, P = .18. Mortality before 18 to 24 months was higher in the lower-target group (risk ratio, 1.16, 95% confidence interval 1.03-1.31, P = .02). Rates of NDI and severe visual loss did not differ between the 2 groups. Proportion of time infants spent outside the target range while on supplemental oxygen ranged from 8.2% to 27.4% <85% and 8.1% to 22.4% >95% with significant overlap between the 2 groups.CONCLUSIONS: There was no difference in primary outcome between the 2 SpO 2 target groups. The collective data suggest that risks associated with restricting the upper SpO 2 target limit to 89% outweigh the benefits. The quality of evidence was moderate. We speculate that a wider target range (lower alarm limit, 89% and upper, 96%) may increase time spent within range, but the safety profile of this approach remains to be determined. Dr Manja conceptualized and designed the study, reviewed the literature, carried out the initial analyses, and reviewed and revised the manuscript; Dr Saugstad critically reviewed and extensively revised the manuscript; Dr Lakshminrusimha was the second reviewer of the literature and drafted the initial manuscript; and all authors approved the fi nal manuscript as submitted and agree to be accountable for all aspects of work.

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GRADE guidelines: 7. Rating the quality of evidence—inconsistency

Cited by 1,878 publications

References 16 publications

Buprenorphine compared with methadone to treat pregnant women with opioid use disorder: a systematic review and meta‐analysis of safety in the mother, fetus and child

Buprenorphine compared with methadone to treat pregnant women with opioid use disorder: a systematic review and meta‐analysis of safety in the mother, fetus and child

Towards a framework for evaluating and grading evidence in public health

Oxygen Saturation Targets in Preterm Infants and Outcomes at 18–24 Months: A Systematic Review

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