Generated Narrative: ArtifactAssessment

identifier: FEvIR Object Identifier/27751

date: 2021-11-02T14:31:30.239Z

copyright: https://creativecommons.org/licenses/by-nc-sa/4.0/

lastReviewDate: 2021-08-11

artifact: http://fevir.net/resources/Evidence/7637

content

informationType: rating

type: Risk of bias (Evidence Certainty Type[6.0.0]#RiskOfBias)

classifier: extremely serious concern (Evidence Certainty Rating[6.0.0]#extremely-serious-concern)

author: : COVID-19 Knowledge Accelerator Evidence 7637 Authors (Brian S. Alper, Harold Lehmann, Ahmad Sofi-Mahmudi, Joanne Dehnbostel, Ilkka Kunnamo)

freeToShare: true

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summary: Inclusion of suspected COVID-19 in 1 of 3 trials may introduce selection bias, but the impact appears limited.

type: Selection Bias ()

classifier: no serious concern (Evidence Certainty Rating[6.0.0]#no-concern)

author: : Brian S. Alper, Joanne Dehnbostel, Muhammad Afzal

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summary: The study design used response-adaptive randomization in which group assignment ratios could be modified during the trial on the basis of response-adaptive interim analyses to favor the assignment of patients to the treatment group showing greater benefit. The confounding by time (imbalanced randomization with time period) is not adequately reported to determine the potential influence on results or adequacy of adjusted analyses.

type: Confounding Covariate Bias ()

classifier: serious concern (Evidence Certainty Rating[6.0.0]#serious-concern)

author: : Brian S. Alper, Ilkka Kunnamo, Alfonso Iorio, Joanne Dehnbostel, Harold Lehmann, Kenneth Wilkins; clarifying explanation reviewed by Janice Tufte

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summary: Awareness of treatment assignment may reduce clinical decision to initiate some types of "organ support" in patients with higher risk of major bleeding.

type: Performance Bias ()

classifier: very serious concern (Evidence Certainty Rating[6.0.0]#very-serious-concern)

author: : Brian S. Alper, Joanne Dehnbostel, Harold Lehmann, Muhammad Afzal

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summary: The influence of awareness of treatment assignment by the treating clinicians on the initaition of organ support (which is the primary outcome) was already addressed as Performance Bias so is not repeated here as a bias in detecting the outcome.

type: Detection Bias ()

classifier: no serious concern (Evidence Certainty Rating[6.0.0]#no-concern)

author: : Brian S. Alper, Joanne Dehnbostel, Muhammad Afzal

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summary: Only 19 of 1190 (1.6%) therapeutic group and 6 of 1054 (0.6) prophylactic group were excluded after randomization.

type: Attrition Bias ()

classifier: no serious concern (Evidence Certainty Rating[6.0.0]#no-concern)

author: : Brian S. Alper, Joanne Dehnbostel, Muhammad Afzal

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summary: It is unknown if the results are sensitive to the analytic method, and the stopping criteria were based on statistical significance and not magnitude of effect.

type: Analysis Bias ()

classifier: very serious concern (Evidence Certainty Rating[6.0.0]#very-serious-concern)

author: : Brian S. Alper, Joanne Dehnbostel, Muhammad Afzal, Janice Tufte

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informationType: comment

summary: Results not consistent with critically ill cohort.

type: Inconsistency (Evidence Certainty Type[6.0.0]#Inconsistency)

author: : Ilkka Kunnamo