Generated Narrative: ArtifactAssessment

Artifact URL: https://fevir.net/resources/ArtifactAssessment/179692

Artifact Description: The ArtifactAssessment Resource is used here to show a complex risk of bias assessment with multiple recursive components.

identifier: FEvIR Object Identifier: 179692

title: Risk of Bias Assessment of Critically appraised summary of primary outcome of multi-platform RCT of anticoagulation for non-critically ill patients with COVID-19

date: 2021-12-29 22:35:49+0000

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

artifact: Evidence/7637: Critically appraised summary of primary outcome of multi-platform RCT of anticoagulation for non-critically ill patients with COVID-19 "Critically_appraised_summary_of_primary_outcome_of_multi_platform_RCT_of_anticoagulation_for_non_critically_ill_patients_with_COVID_19"

content

informationType: rating

type: Bias (Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide#SEVCO:00001)

classifier: Critical risk of bias (Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide#SEVCO:00190)

author: : Brian S. Alper, Harold Lehmann, Ahmad Sofi-Mahmudi, Joanne Dehnbostel, Ilkka Kunnamo, Alfonso Iorio

freeToShare: true

component

informationType: rating

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

type: Participant Selection Bias (Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide#SEVCO:00003)

classifier: Factor likely does not have potential to impact results (Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide#SEVCO:00209), Low risk of bias (Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide#SEVCO:00186)

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informationType: rating

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 (Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide#SEVCO:00016)

classifier: Serious risk of bias (Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide#SEVCO:00189)

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informationType: rating

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 (Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide#SEVCO:00017)

classifier: Factor has potential to impact results (Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide#SEVCO:00207), Risk of bias favoring experimental (Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide#SEVCO:00201), Critical risk of bias (Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide#SEVCO:00190)

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informationType: rating

summary: The influence of awareness of treatment assignment by the treating clinicians on the initiation 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 (Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide#SEVCO:00020)

classifier: Low risk of bias (Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide#SEVCO:00186)

component

informationType: rating

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

type: Attrition Bias (Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide#SEVCO:00019)

classifier: Low risk of bias (Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide#SEVCO:00186)

component

informationType: rating

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 (Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide#SEVCO:00021)

classifier: Critical risk of bias (Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide#SEVCO:00190)

component

content

informationType: classifier

type: Profile for use with Risk of Bias Assessment Tool (Evidence Based Medicine on FHIR Implementation Guide Code System#defined-in-text "Defined in text")

classifier: Randomized trial (Evidence Based Medicine on FHIR Implementation Guide Code System#defined-in-text "Defined in text")