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Increased Risks for Random Errors are Common in Outcomes Graded as High Certainty of Evidence

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Gartlehner, Gerald ; Nussbaumer-Streit, Barbara ; Wagner, Gernot ; Patel, Sheila ; Swinson-Evans, Tammeka ; Dobrescu, Andreea ; Gluud, Christian. / Increased Risks for Random Errors are Common in Outcomes Graded as High Certainty of Evidence. I: Journal of Clinical Epidemiology. 2019 ; Bind 106. s. 50-59.

Bibtex

@article{d6b7615468c043b58c6c684811cacb1b,
title = "Increased Risks for Random Errors are Common in Outcomes Graded as High Certainty of Evidence",
abstract = "OBJECTIVE: To assess the risk for random errors in outcomes graded as high certainty of evidence (CoE).STUDY DESIGN AND SETTING: We randomly selected 100 Cochrane reviews with dichotomous outcomes rated as high CoE using GRADE (Grading of Recommendations Assessment, Development, and Evaluation). To detect increased risks for random errors, two investigators independently conducted Trial Sequential Analysis (TSA) employing conventional thresholds for type I (α = 0.05) and type II (β = 0.10) errors. We dually re-graded all outcomes with increased risks for random errors and conducted multivariate logistic regression analyses to determine predictors of increased risks for random errors.RESULTS: Overall, 38{\%} (95{\%} confidence interval: 28{\%} to 47{\%}) of high CoE outcomes had increased risks for random errors. Outcomes assessing harms were more frequently affected than outcomes assessing benefits (47{\%} vs. 12{\%}). Re-grading of outcomes with increased random errors showed that 74{\%} should have been downgraded based on current guidance. Regression analyses rendered small absolute risk differences (p = 0.009) and low number of events (p = 0.001) as significant predictors of increased risks for random errors.CONCLUSION: Decisionmakers need to be aware that outcomes rated as high CoE often have increased risks for false-positive or false-negative findings.",
author = "Gerald Gartlehner and Barbara Nussbaumer-Streit and Gernot Wagner and Sheila Patel and Tammeka Swinson-Evans and Andreea Dobrescu and Christian Gluud",
note = "Copyright {\circledC} 2018 Elsevier Inc. All rights reserved.",
year = "2019",
doi = "10.1016/j.jclinepi.2018.10.009",
language = "English",
volume = "106",
pages = "50--59",
journal = "Journal of Clinical Epidemiology",
issn = "0895-4356",
publisher = "Elsevier Inc",

}

RIS

TY - JOUR

T1 - Increased Risks for Random Errors are Common in Outcomes Graded as High Certainty of Evidence

AU - Gartlehner, Gerald

AU - Nussbaumer-Streit, Barbara

AU - Wagner, Gernot

AU - Patel, Sheila

AU - Swinson-Evans, Tammeka

AU - Dobrescu, Andreea

AU - Gluud, Christian

N1 - Copyright © 2018 Elsevier Inc. All rights reserved.

PY - 2019

Y1 - 2019

N2 - OBJECTIVE: To assess the risk for random errors in outcomes graded as high certainty of evidence (CoE).STUDY DESIGN AND SETTING: We randomly selected 100 Cochrane reviews with dichotomous outcomes rated as high CoE using GRADE (Grading of Recommendations Assessment, Development, and Evaluation). To detect increased risks for random errors, two investigators independently conducted Trial Sequential Analysis (TSA) employing conventional thresholds for type I (α = 0.05) and type II (β = 0.10) errors. We dually re-graded all outcomes with increased risks for random errors and conducted multivariate logistic regression analyses to determine predictors of increased risks for random errors.RESULTS: Overall, 38% (95% confidence interval: 28% to 47%) of high CoE outcomes had increased risks for random errors. Outcomes assessing harms were more frequently affected than outcomes assessing benefits (47% vs. 12%). Re-grading of outcomes with increased random errors showed that 74% should have been downgraded based on current guidance. Regression analyses rendered small absolute risk differences (p = 0.009) and low number of events (p = 0.001) as significant predictors of increased risks for random errors.CONCLUSION: Decisionmakers need to be aware that outcomes rated as high CoE often have increased risks for false-positive or false-negative findings.

AB - OBJECTIVE: To assess the risk for random errors in outcomes graded as high certainty of evidence (CoE).STUDY DESIGN AND SETTING: We randomly selected 100 Cochrane reviews with dichotomous outcomes rated as high CoE using GRADE (Grading of Recommendations Assessment, Development, and Evaluation). To detect increased risks for random errors, two investigators independently conducted Trial Sequential Analysis (TSA) employing conventional thresholds for type I (α = 0.05) and type II (β = 0.10) errors. We dually re-graded all outcomes with increased risks for random errors and conducted multivariate logistic regression analyses to determine predictors of increased risks for random errors.RESULTS: Overall, 38% (95% confidence interval: 28% to 47%) of high CoE outcomes had increased risks for random errors. Outcomes assessing harms were more frequently affected than outcomes assessing benefits (47% vs. 12%). Re-grading of outcomes with increased random errors showed that 74% should have been downgraded based on current guidance. Regression analyses rendered small absolute risk differences (p = 0.009) and low number of events (p = 0.001) as significant predictors of increased risks for random errors.CONCLUSION: Decisionmakers need to be aware that outcomes rated as high CoE often have increased risks for false-positive or false-negative findings.

U2 - 10.1016/j.jclinepi.2018.10.009

DO - 10.1016/j.jclinepi.2018.10.009

M3 - Journal article

VL - 106

SP - 50

EP - 59

JO - Journal of Clinical Epidemiology

JF - Journal of Clinical Epidemiology

SN - 0895-4356

ER -

ID: 55554437