Artifactassessment-risk-of-bias-example

Release 5 Ballot

This page is part of the FHIR Specification (v5.0.0-ballot: R5 Ballot - see ballot notes). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions

Example ArtifactAssessment/risk-of-bias-example (Narrative)

Clinical Decision Support Work Group

Maturity Level: N/A

Standards Status: Informative

Compartments: Not linked to any defined compartments

This is the narrative for the resource. See also the XML, JSON or Turtle format. This example conforms to the profile ArtifactAssessment.

Generated Narrative: ArtifactAssessment

Resource ArtifactAssessment "risk-of-bias-example"

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 (EvidenceCertaintyType[5.0.0]#RiskOfBias)
classifier: extremely serious concern (EvidenceCertaintyRating[5.0.0]#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
component
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 (EvidenceCertaintyRating[5.0.0]#no-concern)
author: : Brian S. Alper, Joanne Dehnbostel, Muhammad Afzal
component
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 (EvidenceCertaintyRating[5.0.0]#serious-concern)
author: : Brian S. Alper, Ilkka Kunnamo, Alfonso Iorio, Joanne Dehnbostel, Harold Lehmann, Kenneth Wilkins; clarifying explanation reviewed by Janice Tufte
component
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 (EvidenceCertaintyRating[5.0.0]#very-serious-concern)
author: : Brian S. Alper, Joanne Dehnbostel, Harold Lehmann, Muhammad Afzal
component
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 (EvidenceCertaintyRating[5.0.0]#no-concern)
author: : Brian S. Alper, Joanne Dehnbostel, Muhammad Afzal
component
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 (EvidenceCertaintyRating[5.0.0]#no-concern)
author: : Brian S. Alper, Joanne Dehnbostel, Muhammad Afzal
component
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 (EvidenceCertaintyRating[5.0.0]#very-serious-concern)
author: : Brian S. Alper, Joanne Dehnbostel, Muhammad Afzal, Janice Tufte

content
informationType: comment
summary: Results not consistent with critically ill cohort.
type: Inconsistency (EvidenceCertaintyType[5.0.0]#Inconsistency)
author: : Ilkka Kunnamo

Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.