Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions
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<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: ArtifactAssessment 307449</b></p><a name="307449"> </a><a name="hc307449"> </a><a name="307449-en-US"> </a><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">version: 5; Last updated: 2025-03-01 19:14:10+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/307449">https://fevir.net/resources/ArtifactAssessment/307449</a></p><p><b>Artifact Description</b>: </p><div><p>This is an example of the RiskOfBias Profile.</p>
</div><p><b>Artifact Status</b>: draft</p><p><b>identifier</b>: FEvIR Object Identifier/https://fevir.net/FOI/307449</p><p><b>title</b>: Risk of Bias Assessment of PARACHUTE trial</p><p><b>copyright</b>: </p><div><p>https://creativecommons.org/licenses/by-nc-sa/4.0/</p>
</div><p><b>artifact</b>: <a href="Citation-306957.html">30545967 Parachute use to prevent death and major trauma when jumping from aircraft: randomized controlled trial.</a></p><blockquote><p><b>content</b></p><p><b>type</b>: <span title="Codes:{https://fevir.net/sevco SEVCO:00001}">Bias</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Summary</b></td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td><div><p>Assignment was done by order of enrollment.</p>
</div></td><td><span title="Codes:{https://fevir.net/sevco SEVCO:00278}">Inadequate random sequence generation</span></td><td><span title="Codes:{https://fevir.net/sevco SEVCO:00194}">Factor present</span>, <span title="Codes:{https://fevir.net/sevco SEVCO:00208}">Factor likely has potential to impact results</span>, <span title="Codes:{https://fevir.net/sevco SEVCO:00205}">Risk of bias direction unpredictable</span>, <span title="Codes:{https://fevir.net/sevco SEVCO:00187}">Moderate risk of bias</span></td></tr><tr><td style="display: none">*</td><td><div><p>The investigator who assigned the treatment was aware of the assignment which was reported verbally to the participant.</p>
</div></td><td><span title="Codes:{https://fevir.net/sevco SEVCO:00031}">Inadequate allocation concealment</span></td><td><span title="Codes:{https://fevir.net/sevco SEVCO:00194}">Factor present</span>, <span title="Codes:{https://fevir.net/sevco SEVCO:00208}">Factor likely has potential to impact results</span>, <span title="Codes:{https://fevir.net/sevco SEVCO:00205}">Risk of bias direction unpredictable</span>, <span title="Codes:{https://fevir.net/sevco SEVCO:00187}">Moderate risk of bias</span></td></tr><tr><td style="display: none">*</td><td><div><p>Participants could discern the difference between a parachute and an empty backpack. Knowing that they have only an empty backpack might change jumping behavior which would have an unpredictable effect on the outcome.</p>
</div></td><td><span title="Codes:{https://fevir.net/sevco SEVCO:00035}">Inadequate blinding of participants</span></td><td><span title="Codes:{https://fevir.net/sevco SEVCO:00195}">Factor likely present</span>, <span title="Codes:{https://fevir.net/sevco SEVCO:00208}">Factor likely has potential to impact results</span>, <span title="Codes:{https://fevir.net/sevco SEVCO:00205}">Risk of bias direction unpredictable</span>, <span title="Codes:{https://fevir.net/sevco SEVCO:00187}">Moderate risk of bias</span></td></tr><tr><td style="display: none">*</td><td><div><p>Intervention deliverers could discern the difference between the parachute and the empty backback. This likely made no difference in the outcome.</p>
</div></td><td><span title="Codes:{https://fevir.net/sevco SEVCO:00036}">Inadequate blinding of intervention deliverers</span></td><td><span title="Codes:{https://fevir.net/sevco SEVCO:00195}">Factor likely present</span>, <span title="Codes:{https://fevir.net/sevco SEVCO:00209}">Factor likely does not have potential to impact results</span>, <span title="Codes:{https://fevir.net/sevco SEVCO:00205}">Risk of bias direction unpredictable</span>, <span title="Codes:{https://fevir.net/sevco SEVCO:00186}">Low risk of bias</span></td></tr><tr><td style="display: none">*</td><td><div><p>Although outcome determination was done with full knowledge of exposure status, it was not likely that this changed the determination of death or injury</p>
</div></td><td><span title="Codes:{https://fevir.net/sevco SEVCO:00048}">Bias due to lack of masking for outcome determination</span></td><td><span title="Codes:{https://fevir.net/sevco SEVCO:00195}">Factor likely present</span>, <span title="Codes:{https://fevir.net/sevco SEVCO:00209}">Factor likely does not have potential to impact results</span>, <span title="Codes:{https://fevir.net/sevco SEVCO:00205}">Risk of bias direction unpredictable</span>, <span title="Codes:{https://fevir.net/sevco SEVCO:00186}">Low risk of bias</span></td></tr><tr><td style="display: none">*</td><td><div><p>Attrition was much higher in the intervention group.</p>
</div></td><td><span title="Codes:{https://fevir.net/sevco SEVCO:00019}">Attrition Bias</span></td><td><span title="Codes:{https://fevir.net/sevco SEVCO:00195}">Factor likely present</span>, <span title="Codes:{https://fevir.net/sevco SEVCO:00208}">Factor likely has potential to impact results</span>, <span title="Codes:{https://fevir.net/sevco SEVCO:00205}">Risk of bias direction unpredictable</span>, <span title="Codes:{https://fevir.net/sevco SEVCO:00187}">Moderate risk of bias</span></td></tr><tr><td style="display: none">*</td><td><div><p>Study was only published in a satirical journal issue.</p>
</div></td><td><span title="Codes:{https://fevir.net/sevco SEVCO:00023}">Reporting Bias</span></td><td><span title="Codes:{https://fevir.net/sevco SEVCO:00194}">Factor present</span>, <span title="Codes:{https://fevir.net/sevco SEVCO:00208}">Factor likely has potential to impact results</span>, <span title="Codes:{https://fevir.net/sevco SEVCO:00205}">Risk of bias direction unpredictable</span>, <span title="Codes:{https://fevir.net/sevco SEVCO:00187}">Moderate risk of bias</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>type</b>: <span title="Codes:">Profile</span></p><p><b>classifier</b>: <span title="Codes:">ROB1</span></p></blockquote></div>
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