Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot - ballot
This page is part of the Evidence Based Medicine on FHIR Implementation Guide (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
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<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ArtifactAssessment</b><a name="179692"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ArtifactAssessment "179692" Version "5" Updated "2023-12-08 00:46:44+0000" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-risk-of-bias.html">RiskOfBias</a></p></div><p><b>Artifact URL</b>: <a href="https://fevir.net/resources/ArtifactAssessment/179692">https://fevir.net/resources/ArtifactAssessment/179692</a></p><p><b>Artifact Description</b>: The ArtifactAssessment Resource is used here to show a complex risk of bias assessment with multiple recursive components.</p><p><b>identifier</b>: FEvIR Object Identifier: 179692</p><p><b>title</b>: 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</p><p><b>date</b>: 2021-12-29 22:35:49+0000</p><p><b>copyright</b>: https://creativecommons.org/licenses/by-nc-sa/4.0/</p><p><b>artifact</b>: <a href="Evidence-7637.html">Evidence/7637: Critically appraised summary of primary outcome of multi-platform RCT of anticoagulation for non-critically ill patients with COVID-19</a> "Critically_appraised_summary_of_primary_outcome_of_multi_platform_RCT_of_anticoagulation_for_non_critically_ill_patients_with_COVID_19"</p><blockquote><p><b>content</b></p><p><b>informationType</b>: rating</p><p><b>type</b>: Bias <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-181513.html">Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide</a>#SEVCO:00001)</span></p><p><b>classifier</b>: Critical risk of bias <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-181513.html">Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide</a>#SEVCO:00190)</span></p><p><b>author</b>: <span>: Brian S. Alper, Harold Lehmann, Ahmad Sofi-Mahmudi, Joanne Dehnbostel, Ilkka Kunnamo, Alfonso Iorio</span></p><p><b>freeToShare</b>: true</p><blockquote><p><b>component</b></p><p><b>informationType</b>: rating</p><p><b>summary</b>: Inclusion of suspected COVID-19 in 1 of 3 trials may introduce selection bias, but the impact appears limited.</p><p><b>type</b>: Participant Selection Bias <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-181513.html">Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide</a>#SEVCO:00003)</span></p><p><b>classifier</b>: Factor likely does not have potential to impact results <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-181513.html">Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide</a>#SEVCO:00209)</span>, Low risk of bias <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-181513.html">Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide</a>#SEVCO:00186)</span></p><blockquote><p><b>component</b></p></blockquote></blockquote><blockquote><p><b>component</b></p><p><b>informationType</b>: rating</p><p><b>summary</b>: 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.</p><p><b>type</b>: Confounding Covariate Bias <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-181513.html">Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide</a>#SEVCO:00016)</span></p><p><b>classifier</b>: Serious risk of bias <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-181513.html">Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide</a>#SEVCO:00189)</span></p><blockquote><p><b>component</b></p></blockquote><blockquote><p><b>component</b></p></blockquote><blockquote><p><b>component</b></p></blockquote><blockquote><p><b>component</b></p></blockquote><blockquote><p><b>component</b></p></blockquote></blockquote><blockquote><p><b>component</b></p><p><b>informationType</b>: rating</p><p><b>summary</b>: Awareness of treatment assignment may reduce clinical decision to initiate some types of "organ support" in patients with higher risk of major bleeding.</p><p><b>type</b>: Performance Bias <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-181513.html">Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide</a>#SEVCO:00017)</span></p><p><b>classifier</b>: Factor has potential to impact results <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-181513.html">Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide</a>#SEVCO:00207)</span>, Risk of bias favoring experimental <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-181513.html">Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide</a>#SEVCO:00201)</span>, Critical risk of bias <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-181513.html">Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide</a>#SEVCO:00190)</span></p><blockquote><p><b>component</b></p></blockquote><blockquote><p><b>component</b></p></blockquote><blockquote><p><b>component</b></p></blockquote><blockquote><p><b>component</b></p></blockquote></blockquote><blockquote><p><b>component</b></p><p><b>informationType</b>: rating</p><p><b>summary</b>: 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.</p><p><b>type</b>: Detection Bias <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-181513.html">Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide</a>#SEVCO:00020)</span></p><p><b>classifier</b>: Low risk of bias <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-181513.html">Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide</a>#SEVCO:00186)</span></p></blockquote><blockquote><p><b>component</b></p><p><b>informationType</b>: rating</p><p><b>summary</b>: Only 19 of 1190 (1.6%) therapeutic group and 6 of 1054 (0.6%) prophylactic group were excluded after randomization.</p><p><b>type</b>: Attrition Bias <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-181513.html">Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide</a>#SEVCO:00019)</span></p><p><b>classifier</b>: Low risk of bias <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-181513.html">Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide</a>#SEVCO:00186)</span></p></blockquote><blockquote><p><b>component</b></p><p><b>informationType</b>: rating</p><p><b>summary</b>: 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.</p><p><b>type</b>: Analysis Bias <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-181513.html">Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide</a>#SEVCO:00021)</span></p><p><b>classifier</b>: Critical risk of bias <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-181513.html">Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide</a>#SEVCO:00190)</span></p><blockquote><p><b>component</b></p></blockquote></blockquote></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: Profile for use with Risk of Bias Assessment Tool <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-179423.html">Evidence Based Medicine on FHIR Implementation Guide Code System</a>#defined-in-text "Defined in text")</span></p><p><b>classifier</b>: Randomized trial <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-179423.html">Evidence Based Medicine on FHIR Implementation Guide Code System</a>#defined-in-text "Defined in text")</span></p></blockquote></div>
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<summary
value="Participant Selection Bias Definition: A selection bias resulting from methods used to select participating subjects, factors that influence initial study participation, or differences between the study participants and the population of interest."/>
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<component>
<informationType value="rating"/>
<summary
value="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."/>
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<summary
value="Adaptive randomization is not a concern by itself, only if it results in a confounding difference."/>
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value="Definition of Allocation Bias = A confounding covariate bias resulting from methods for assignment of the independent variable by the investigator to evaluate a response or outcome."/>
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<summary
value="ATTACC implemented response-adaptive randomization on December 15, 2020, which led to imbalanced randomization."/>
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<summary
value="There is an unequal distribution of calendar time between the groups being compared."/>
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<code value="SEVCO:00034"/>
<display value="Confounding difference"/>
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<code value="SEVCO:00207"/>
<display value="Factor has potential to impact results"/>
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<coding>
<system value="https://fevir.net/resources/CodeSystem/181513"/>
<code value="SEVCO:00201"/>
<display value="Risk of bias favoring experimental"/>
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<code value="SEVCO:00189"/>
<display value="Serious risk of bias"/>
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<summary
value="Definition of Confounding difference = A confounding covariate bias in which the unequal distribution of a potentially distorting variable is recognized."/>
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<summary
value="Incomplete reporting limits the determination of the potential degree of influence of calendar time."/>
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value="There is evidence of potential for calendar time to influence the results: In an observational study of 18,508 adults with laboratory-confirmed, COVID-19 associated hospitalization 'The percentage of hospitalized patients admitted to the ICU decreased from 37.8% in March to 20.5% in December' (Ann Intern Med 2021 Aug 10 https://www.acpjournals.org/doi/10.7326/M21-1991)."/>
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<summary
value="Definition of Confounding Covariate Bias = A situation in which the effect or association between an exposure and outcome is distorted by another variable. For confounding covariate bias to occur the distorting variable must be (1) associated with the exposure and the outcome, (2) not in the causal pathway between exposure and outcome, and (3) unequally distributed between the groups being compared."/>
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<summary
value="ATTACC implemented response-adaptive randomization on December 15, 2020, which led to imbalanced randomization. No data reported to determine if intervention-specific outcome rates were similar or different before and after December 15, 2020 in the ATTACC cohort."/>
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<component>
<informationType value="comment"/>
<summary
value="Insufficient details reported to judge whether there is an imbalance in outcomes related to the adaptive randomization which in turn could be used to judge the validity of adjustment methods in the statistical model for this concern and the appropriateness of any sensitivity analyses."/>
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<informationType value="rating"/>
<summary
value="Awareness of treatment assignment may reduce clinical decision to initiate some types of "organ support" in patients with higher risk of major bleeding."/>
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<system value="https://fevir.net/resources/CodeSystem/181513"/>
<code value="SEVCO:00017"/>
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<code value="SEVCO:00207"/>
<display value="Factor has potential to impact results"/>
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<display value="Risk of bias favoring experimental"/>
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<code value="SEVCO:00190"/>
<display value="Critical risk of bias"/>
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<summary
value="Lack of blinding may explain reported differences in the primary outcome."/>
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<code value="SEVCO:00036"/>
<display value="Inadequate blinding of intervention deliverers"/>
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<code value="SEVCO:00190"/>
<display value="Critical risk of bias"/>
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<summary
value="The absolute difference in survival without intubation was 1%, so 3% of the 4% absolute difference in the primary outcome can be considered "organ support without intubation"."/>
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<component>
<informationType value="comment"/>
<summary
value="The specific "organ support without intubation" was not reported. The methods for one of the included trials stated "Organ Support is defined as receipt of invasive or non-invasive mechanical ventilation, high flow nasal oxygen, vasopressor therapy, or ECMO support""/>
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<informationType value="comment"/>
<summary
value="Awareness of treatment assignment may reduce clinical decision to initiate "organ support without intubation" in patients with higher risk of major bleeding."/>
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<summary value="Crossover to other intervention in 20%"/>
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<code value="SEVCO:00192"/>
<display value="Unclear risk of bias"/>
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<informationType value="comment"/>
<summary
value="Therapeutic dose anticoagulation (in the first 24-48 hours following randomization) was reported in 79.6% of the therapeutic arm and 0.9% of the usual care arm. (Table S3)"/>
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<component>
<informationType value="comment"/>
<summary
value="Definition of Deviation from study intervention protocol = A performance bias in which the intervention received differs from the intervention specified in the study protocol."/>
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<component>
<informationType value="rating"/>
<summary
value="We discussed whether they may be a bias related to limited adherence to anticoagulation. Because this was an inpatient population, we did not expect adherence problems that are more common with outpatient thromboprophylaxis."/>
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<system value="https://fevir.net/resources/CodeSystem/181513"/>
<code value="SEVCO:00039"/>
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<system value="https://fevir.net/resources/CodeSystem/181513"/>
<code value="SEVCO:00186"/>
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<summary
value="Initial adherence to the protocol-assigned anticoagulation dose after randomization was 88.3% in the therapeutic-dose anticoagulation group and 98.3% in the thromboprophylaxis group (Table S3)."/>
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<summary
value="Definition of Performance Bias = A bias resulting from differences between the received exposure and the intended exposure."/>
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<summary
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<code value="SEVCO:00186"/>
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<code value="SEVCO:00019"/>
<display value="Attrition Bias"/>
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<code value="SEVCO:00190"/>
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<code value="SEVCO:00212"/>
<display value="Early termination bias affecting enrollment"/>
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<coding>
<system value="https://fevir.net/resources/CodeSystem/181513"/>
<code value="SEVCO:00190"/>
<display value="Critical risk of bias"/>
</coding>
</classifier>
<component>
<informationType value="comment"/>
<summary
value="There was no “minimally important difference”. So a 99% probability of having an odds ratio > 1 (even if the magnitude of effect is infinitesimal) was used to decide it was time to stop the trial."/>
</component>
</component>
<component>
<informationType value="comment"/>
<summary
value="Definition of Bias related to selection of the analysis = An analysis bias due to inappropriate choice of analysis methods before the analysis is applied."/>
</component>
<component>
<informationType value="comment"/>
<summary
value="There was no pre-specified frequentist analysis. There was no posthoc frequentist analysis reported."/>
</component>
<component>
<informationType value="comment"/>
<summary
value="It is uncertain what a frequentist analysis would show and uncertain whether the choice of Bayesian analysis or frequentist analysis has a substantial influence on the results."/>
</component>
</component>
</component>
</content>
<content>
<informationType value="classifier"/>
<type>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="defined-in-text"/>
<display value="Defined in text"/>
</coding>
<text value="Profile for use with Risk of Bias Assessment Tool"/>
</type>
<classifier>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="defined-in-text"/>
<display value="Defined in text"/>
</coding>
<text value="Randomized trial"/>
</classifier>
</content>
</ArtifactAssessment>
IG © 2022+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#1.0.0-ballot based on FHIR 5.0.0. Generated 2023-12-17
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