Difference between revisions of "Churchill"
(Created page with " <span style="line-height:normal">'''<span style="font-size:18.0pt"><span style="font-family:" times="" new="" roman",serif"=""><span style="color:black">Rates of adverse even...") |
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| − | <span style="line-height:normal">'''<span style="font-size:18.0pt"><span style="font-family: | + | <span style="line-height:normal">'''<span style="font-size:18.0pt"><span style="font-family:"><span style="color:black">Rates of adverse events from both sham and hyperbaric oxygen exposures in two mild traumatic brain injury trials were low and not serious.</span></span></span>'''</span> |
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| − | <span style="line-height:normal"><span style="height:43.7pt">'''<span style="font-size:14.0pt"><span style="font-family: | + | <span style="line-height:normal"><span style="height:43.7pt">'''<span style="font-size:14.0pt"><span style="font-family:">Clinical bottom line:</span></span>'''</span></span> |
| − | <span style="line-height:normal"><span style="height:43.7pt">'''<span style="font-size:12.0pt"><span style="font-family: | + | <span style="line-height:normal"><span style="height:43.7pt">'''<span style="font-size:12.0pt"><span style="font-family:">1. The rates of adverse events were low per individual patient sessionin both HBO and sham treatment arms <br/> 2. Blinding was effective.</span></span>'''</span></span> |
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| − | <span style="line-height:normal">'''<span style="font-size:13.5pt"><span style="font-family: | + | <span style="line-height:normal">'''<span style="font-size:13.5pt"><span style="font-family:"><span style="color:black">Citation/s:</span></span></span>'''<span style="font-size:13.5pt"><span style="font-family:"><span style="color:black">1. Churchill S, Deru K, Weaver LK, Wilson SH, Hebert D, Miller RS, Lindblad AS. Adverse events and blinding in two randomized trials of hyperbaric oxygen for persistent post-concussive symptoms. Undersea & hyperbaric medicine: journal of the Undersea and Hyperbaric Medical Society, Inc. 2019;46(3):331<br/> '''Lead author's name and fax: '''Susan Churchill via Lindell Weaver lindell.weaver@imail.org</span></span></span></span> |
| − | <span style="line-height:normal">'''<span style="font-size:13.5pt"><span style="font-family: | + | <span style="line-height:normal">'''<span style="font-size:13.5pt"><span style="font-family:"><span style="color:black">Three-part Clinical Question:</span></span></span>'''<span style="font-size:13.5pt"><span style="font-family:"><span style="color:black">For patients with mild traumatic brain injury being treated or receiving sham in a randomised clinical trial, do those receiving hyperbaric oxygen have more adverse events and can they distinguish treatment from sham control?<br/> '''Search Terms:''' Adverse events; mild traumatic brain injury; sham</span></span></span></span> |
| − | <span style="line-height:normal">'''<span style="font-size:13.5pt"><span style="font-family: | + | <span style="line-height:normal">'''<span style="font-size:13.5pt"><span style="font-family:"><span style="color:black">The Study:</span></span></span>'''<span style="font-size:13.5pt"><span style="font-family:"><span style="color:black">Double-blinded concealed randomised controlled trial with intention-to-treat.<br/> '''The Study Patients:''' Patients enrolled in two trials of hyperbaric oxygen for the treatment of mild traumatic brain injury.<br/> '''Control group''' (N = 60 ; 60 analysed): 40 sessions once daily for five days/week breathing air at 1.2 ATA<br/> '''Experimental group''' (N = 60 ; 60 analysed): As above, but breathing 100% oxygen at 1.5 ATA</span></span></span></span> |
| − | <span style="line-height:normal">'''<span style="font-size:13.5pt"><span style="font-family: | + | <span style="line-height:normal">'''<span style="font-size:13.5pt"><span style="font-family:"><span style="color:black">The Evidence:</span></span></span>'''</span> |
{| class="Table" style="border:solid windowtext 1.0pt" | {| class="Table" style="border:solid windowtext 1.0pt" | ||
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| − | | style="width:61.3pt; border:solid windowtext 1.0pt" width="82" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:10.0pt"><span style="font-family: | + | | style="width:61.3pt; border:solid windowtext 1.0pt" width="82" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:10.0pt"><span style="font-family:">Outcome</span></span>'''</span></p> |
| − | | style="width:48.1pt; border:solid windowtext 1.0pt" width="64" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:10.0pt"><span style="font-family: | + | | style="width:48.1pt; border:solid windowtext 1.0pt" width="64" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:10.0pt"><span style="font-family:">Time to Outcome</span></span>'''</span></p> |
| − | | style="width:33.95pt; border:solid windowtext 1.0pt" width="45" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:10.0pt"><span style="font-family: | + | | style="width:33.95pt; border:solid windowtext 1.0pt" width="45" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:10.0pt"><span style="font-family:">Sham group</span></span>'''</span></p> |
| − | | style="width:41.05pt; border:solid windowtext 1.0pt" width="55" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:10.0pt"><span style="font-family: | + | | style="width:41.05pt; border:solid windowtext 1.0pt" width="55" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:10.0pt"><span style="font-family:">HBO group</span></span>'''</span></p> |
| − | | style="width:69.35pt; border:solid windowtext 1.0pt" width="92" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:10.0pt"><span style="font-family: | + | | style="width:69.35pt; border:solid windowtext 1.0pt" width="92" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:10.0pt"><span style="font-family:">Relative risk reduction</span></span>'''</span></p> |
| − | | style="width:76.45pt; border:solid windowtext 1.0pt" width="102" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:10.0pt"><span style="font-family: | + | | style="width:76.45pt; border:solid windowtext 1.0pt" width="102" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:10.0pt"><span style="font-family:">Absolute risk reduction</span></span>'''</span></p> |
| − | | style="width:108.6pt; border:solid windowtext 1.0pt" width="145" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:10.0pt"><span style="font-family: | + | | style="width:108.6pt; border:solid windowtext 1.0pt" width="145" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:10.0pt"><span style="font-family:">NNT</span></span>'''</span></p> |
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| − | | rowspan="2" style="width:61.3pt; border:solid windowtext 1.0pt" width="82" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:10.0pt"><span style="font-family: | + | | rowspan="2" style="width:61.3pt; border:solid windowtext 1.0pt" width="82" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:10.0pt"><span style="font-family:">Any adverse event</span></span>'''</span></p> |
| − | | style="width:48.1pt; border:solid windowtext 1.0pt" width="64" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family: | + | | style="width:48.1pt; border:solid windowtext 1.0pt" width="64" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family:">13 weeks</span></span></span></p> |
| − | | style="width:33.95pt; border:solid windowtext 1.0pt" width="45" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family: | + | | style="width:33.95pt; border:solid windowtext 1.0pt" width="45" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family:">0.38</span></span></span></p> |
| − | | style="width:41.05pt; border:solid windowtext 1.0pt" width="55" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family: | + | | style="width:41.05pt; border:solid windowtext 1.0pt" width="55" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family:">0.50</span></span></span></p> |
| − | | style="width:69.35pt; border:solid windowtext 1.0pt" width="92" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family: | + | | style="width:69.35pt; border:solid windowtext 1.0pt" width="92" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family:">31%</span></span></span></p> |
| − | | style="width:76.45pt; border:solid windowtext 1.0pt" width="102" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family: | + | | style="width:76.45pt; border:solid windowtext 1.0pt" width="102" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family:">0.12</span></span></span></p> |
| − | | style="width:108.6pt; border:solid windowtext 1.0pt" width="145" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family: | + | | style="width:108.6pt; border:solid windowtext 1.0pt" width="145" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family:">9</span></span></span></p> |
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| − | | colspan="3" style="width:126.1pt; border:solid windowtext 1.0pt" width="168" | <p align="right" style="margin-bottom:0cm; text-align:right; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family: | + | | colspan="3" style="width:126.1pt; border:solid windowtext 1.0pt" width="168" | <p align="right" style="margin-bottom:0cm; text-align:right; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family:">95% CIs:</span></span></span></p> |
| − | | style="width:69.35pt; border:solid windowtext 1.0pt" width="92" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family: | + | | style="width:69.35pt; border:solid windowtext 1.0pt" width="92" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family:">-16% to 77%</span></span></span></p> |
| − | | style="width:76.45pt; border:solid windowtext 1.0pt" width="102" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family: | + | | style="width:76.45pt; border:solid windowtext 1.0pt" width="102" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family:">-0.06 to 0.29</span></span></span></p> |
| − | | style="width:108.6pt; border:solid windowtext 1.0pt" width="145" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family: | + | | style="width:108.6pt; border:solid windowtext 1.0pt" width="145" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family:">NNT = 17 to INF;</span></span></span></p> <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family:">NNH = 3 to INF</span></span></span></p> |
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| − | | rowspan="2" style="width:61.3pt; border:solid windowtext 1.0pt" width="82" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:10.0pt"><span style="font-family: | + | | rowspan="2" style="width:61.3pt; border:solid windowtext 1.0pt" width="82" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:10.0pt"><span style="font-family:">Ear barotrauma</span></span>'''</span></p> |
| − | | style="width:48.1pt; border:solid windowtext 1.0pt" width="64" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family: | + | | style="width:48.1pt; border:solid windowtext 1.0pt" width="64" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family:">13 weeks</span></span></span></p> |
| − | | style="width:33.95pt; border:solid windowtext 1.0pt" width="45" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family: | + | | style="width:33.95pt; border:solid windowtext 1.0pt" width="45" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family:">0.10</span></span></span></p> |
| − | | style="width:41.05pt; border:solid windowtext 1.0pt" width="55" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family: | + | | style="width:41.05pt; border:solid windowtext 1.0pt" width="55" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family:">0.23</span></span></span></p> |
| − | | style="width:69.35pt; border:solid windowtext 1.0pt" width="92" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family: | + | | style="width:69.35pt; border:solid windowtext 1.0pt" width="92" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family:">133%</span></span></span></p> |
| − | | style="width:76.45pt; border:solid windowtext 1.0pt" width="102" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family: | + | | style="width:76.45pt; border:solid windowtext 1.0pt" width="102" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family:">-0.133</span></span></span></p> |
| − | | style="width:108.6pt; border:solid windowtext 1.0pt" width="145" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family: | + | | style="width:108.6pt; border:solid windowtext 1.0pt" width="145" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family:">8</span></span></span></p> |
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| − | | colspan="3" style="width:126.1pt; border:solid windowtext 1.0pt" width="168" | <p align="right" style="margin-bottom:0cm; text-align:right; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family: | + | | colspan="3" style="width:126.1pt; border:solid windowtext 1.0pt" width="168" | <p align="right" style="margin-bottom:0cm; text-align:right; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family:">95% CIs:</span></span></span></p> |
| − | | style="width:69.35pt; border:solid windowtext 1.0pt" width="92" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family: | + | | style="width:69.35pt; border:solid windowtext 1.0pt" width="92" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family:">-2% to 264%</span></span></span></p> |
| − | | style="width:76.45pt; border:solid windowtext 1.0pt" width="102" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family: | + | | style="width:76.45pt; border:solid windowtext 1.0pt" width="102" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family:">-0.002 to -0.26</span></span></span></p> |
| − | | style="width:108.6pt; border:solid windowtext 1.0pt" width="145" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family: | + | | style="width:108.6pt; border:solid windowtext 1.0pt" width="145" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family:">4 to 545</span></span></span></p> |
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| − | | rowspan="2" style="width:61.3pt; border:solid windowtext 1.0pt" width="82" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:10.0pt"><span style="font-family: | + | | rowspan="2" style="width:61.3pt; border:solid windowtext 1.0pt" width="82" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:10.0pt"><span style="font-family:">Headache</span></span>'''</span></p> |
| − | | style="width:48.1pt; border:solid windowtext 1.0pt" width="64" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family: | + | | style="width:48.1pt; border:solid windowtext 1.0pt" width="64" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family:">13 weeks</span></span></span></p> |
| − | | style="width:33.95pt; border:solid windowtext 1.0pt" width="45" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family: | + | | style="width:33.95pt; border:solid windowtext 1.0pt" width="45" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family:">0.08</span></span></span></p> |
| − | | style="width:41.05pt; border:solid windowtext 1.0pt" width="55" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family: | + | | style="width:41.05pt; border:solid windowtext 1.0pt" width="55" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family:">0.05</span></span></span></p> |
| − | | style="width:69.35pt; border:solid windowtext 1.0pt" width="92" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family: | + | | style="width:69.35pt; border:solid windowtext 1.0pt" width="92" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family:">40%</span></span></span></p> |
| − | | style="width:76.45pt; border:solid windowtext 1.0pt" width="102" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family: | + | | style="width:76.45pt; border:solid windowtext 1.0pt" width="102" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family:">0.03</span></span></span></p> |
| − | | style="width:108.6pt; border:solid windowtext 1.0pt" width="145" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family: | + | | style="width:108.6pt; border:solid windowtext 1.0pt" width="145" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family:">30</span></span></span></p> |
|- | |- | ||
| − | | colspan="3" style="width:126.1pt; border:solid windowtext 1.0pt" width="168" | <p align="right" style="margin-bottom:0cm; text-align:right; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family: | + | | colspan="3" style="width:126.1pt; border:solid windowtext 1.0pt" width="168" | <p align="right" style="margin-bottom:0cm; text-align:right; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family:">95% CIs:</span></span></span></p> |
| − | | style="width:69.35pt; border:solid windowtext 1.0pt" width="92" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family: | + | | style="width:69.35pt; border:solid windowtext 1.0pt" width="92" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family:">-67% to 100%</span></span></span></p> |
| − | | style="width:76.45pt; border:solid windowtext 1.0pt" width="102" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family: | + | | style="width:76.45pt; border:solid windowtext 1.0pt" width="102" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family:">-0.06 to 0.12</span></span></span></p> |
| − | | style="width:108.6pt; border:solid windowtext 1.0pt" width="145" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family: | + | | style="width:108.6pt; border:solid windowtext 1.0pt" width="145" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family:">NNT = 8 to INF;</span></span></span></p> <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:10.0pt"><span style="font-family:">NNH = 18 to INF</span></span></span></p> |
|} | |} | ||
| − | <span style="line-height:normal">'''<span style="font-size:13.5pt"><span style="font-family: | + | <span style="line-height:normal">'''<span style="font-size:13.5pt"><span style="font-family:"><span style="color:black">Comments:</span></span></span>'''<br/> <span style="font-size:13.5pt"><span style="font-family:"><span style="color:black">1. Note these are composite results from two separately conducted RCTs. See Miller 2015 and Weaver 2018.<br/> 2. The overall rate of AEs per participant session in Miller 2015 was 1.1% and in Weaver 2016 was 2.2%.<br/> 3. No serious adverse events related to chamber sessions were reported in either study. Ear barotrauma was more common in the HBOT group.<br/> 4. Blinding success difficult to interpret. The authors conclude blinding was protected. Overall 16/56 of those receiving HBO correctly picked allocation and 19/51 receiving sham similarly correctly identified their allocation. The questionnaires were administered differently in each study.<br/> 5. Participants largely identified their group allocation according to the improvement or otherwise of their symptoms.</span></span></span></span> |
| − | <span style="line-height:normal">'''<span style="font-size:13.5pt"><span style="font-family: | + | <span style="line-height:normal">'''<span style="font-size:13.5pt"><span style="font-family:"><span style="color:black">Appraised by:</span></span></span>'''<span style="font-size:13.5pt"><span style="font-family:"><span style="color:black">Mike Bennett m.bennett@unsw.edu.au; Friday, 1 January 2021<br/> '''Kill or Update By:''' January 2023</span></span></span></span> |
| + | <p style="text-align: center;"> </p> <p style="text-align: center;">[[File:Sumhorsa.gif|center|Sumhorsa.gif]]</p> <p style="text-align: center;"><span style="font-size:xx-large;">[[Head_Injury|BACK]]</span></p> | ||
Latest revision as of 01:48, 1 January 2021
Rates of adverse events from both sham and hyperbaric oxygen exposures in two mild traumatic brain injury trials were low and not serious.
|
Clinical bottom line: 1. The rates of adverse events were low per individual patient sessionin both HBO and sham treatment arms |
Citation/s:1. Churchill S, Deru K, Weaver LK, Wilson SH, Hebert D, Miller RS, Lindblad AS. Adverse events and blinding in two randomized trials of hyperbaric oxygen for persistent post-concussive symptoms. Undersea & hyperbaric medicine: journal of the Undersea and Hyperbaric Medical Society, Inc. 2019;46(3):331
Lead author's name and fax: Susan Churchill via Lindell Weaver lindell.weaver@imail.org
Three-part Clinical Question:For patients with mild traumatic brain injury being treated or receiving sham in a randomised clinical trial, do those receiving hyperbaric oxygen have more adverse events and can they distinguish treatment from sham control?
Search Terms: Adverse events; mild traumatic brain injury; sham
The Study:Double-blinded concealed randomised controlled trial with intention-to-treat.
The Study Patients: Patients enrolled in two trials of hyperbaric oxygen for the treatment of mild traumatic brain injury.
Control group (N = 60 ; 60 analysed): 40 sessions once daily for five days/week breathing air at 1.2 ATA
Experimental group (N = 60 ; 60 analysed): As above, but breathing 100% oxygen at 1.5 ATA
The Evidence:
Outcome |
Time to Outcome |
Sham group |
HBO group |
Relative risk reduction |
Absolute risk reduction |
NNT |
Any adverse event |
13 weeks |
0.38 |
0.50 |
31% |
0.12 |
9 |
95% CIs: |
-16% to 77% |
-0.06 to 0.29 |
NNT = 17 to INF; NNH = 3 to INF | |||
Ear barotrauma |
13 weeks |
0.10 |
0.23 |
133% |
-0.133 |
8 |
95% CIs: |
-2% to 264% |
-0.002 to -0.26 |
4 to 545 | |||
Headache |
13 weeks |
0.08 |
0.05 |
40% |
0.03 |
30 |
95% CIs: |
-67% to 100% |
-0.06 to 0.12 |
NNT = 8 to INF; NNH = 18 to INF | |||
Comments:
1. Note these are composite results from two separately conducted RCTs. See Miller 2015 and Weaver 2018.
2. The overall rate of AEs per participant session in Miller 2015 was 1.1% and in Weaver 2016 was 2.2%.
3. No serious adverse events related to chamber sessions were reported in either study. Ear barotrauma was more common in the HBOT group.
4. Blinding success difficult to interpret. The authors conclude blinding was protected. Overall 16/56 of those receiving HBO correctly picked allocation and 19/51 receiving sham similarly correctly identified their allocation. The questionnaires were administered differently in each study.
5. Participants largely identified their group allocation according to the improvement or otherwise of their symptoms.
Appraised by:Mike Bennett m.bennett@unsw.edu.au; Friday, 1 January 2021
Kill or Update By: January 2023
