Difference between revisions of "Lacey"
(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">No evidence of any be...") |
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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">No evidence of any benefit from a course of hyperbaric oxygen for children with spastic cerebral palsy.</span></span></span>'''</span> |
| − | <span style="line-height:normal">'''<span style="font-size:16.0pt"><span style="font-family: | + | <span style="line-height:normal">'''<span style="font-size:16.0pt"><span style="font-family:"><span style="color:black">Clinical Bottom Line:</span></span></span>'''</span> |
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| − | <span style="line-height:normal"><span style="height:59.15pt">'''<span style="font-size:14.0pt"><span style="font-family: | + | <span style="line-height:normal"><span style="height:59.15pt">'''<span style="font-size:14.0pt"><span style="font-family:">1. Hyperbaric oxygen did not improve gross motor function measures compared to a sham treatment.<br/> 2. The Paediatric Evaluation of Disability scores improved in both groups, but was not clinically important.</span></span>'''</span></span> |
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| − | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family: | + | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:"><span style="color:black">Citation/s:</span></span></span>'''<span style="font-size:12.0pt"><span style="font-family:"><span style="color:black">1. Lacey DJ, Stolfi A, Pilati LE. Effects of hyperbaric oxygen on motor function in children with cerebral palsy. Annals of neurology. 2012 Nov 1;72(5):695-703<br/> '''Lead author's name and fax: '''Daniel Lacey: laceyd@childrensdayton.org</span></span></span></span> |
| − | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family: | + | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:"><span style="color:black">Three-part Clinical Question:</span></span></span>'''<span style="font-size:12.0pt"><span style="font-family:"><span style="color:black">For children with spastic cerebral palsy, does the addition of a course of hyperbaric oxygen to standard therapy result in any improvement in gross motor function?<br/> '''Search Terms:''' Cerebral Palsy; motor function; paediatrics</span></span></span></span> |
| − | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family: | + | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:"><span style="color:black">The Study:</span></span></span>'''<span style="font-size:12.0pt"><span style="font-family:"><span style="color:black">Double-blinded concealed randomised controlled trial with intention-to-treat.<br/> '''The Study Patients:''' Children aged 3 to 8 years with spastic cerebral palsy<br/> '''Control group''' (N = 24; 22 analysed): 14% oxygen breathing at 1.5 ATA for 80 minutes daily, Monday to Friday to a total of 40 sessions over 8 weeks.<br/> '''Experimental group''' (N = 25; 24 analysed): As above but breathing 100% oxygen.</span></span></span></span> |
| − | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family: | + | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:"><span style="color:black">The Evidence:</span></span></span>'''</span> |
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{| class="Table" style="border:solid windowtext 1.0pt" | {| class="Table" style="border:solid windowtext 1.0pt" | ||
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| − | | rowspan="2" style="width:167.6pt; border:solid windowtext 1.0pt" width="223" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family: | + | | rowspan="2" style="width:167.6pt; border:solid windowtext 1.0pt" width="223" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:">Measure</span></span>'''</span></p> |
| − | | colspan="2" style="width:69.4pt; border:solid windowtext 1.0pt" width="93" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family: | + | | colspan="2" style="width:69.4pt; border:solid windowtext 1.0pt" width="93" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:">Sham Group</span></span>'''</span></p> |
| − | | colspan="2" 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:12.0pt"><span style="font-family: | + | | colspan="2" 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:12.0pt"><span style="font-family:">HBO Group</span></span>'''</span></p> |
| − | | rowspan="2" style="width:55.2pt; border:solid windowtext 1.0pt" width="74" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family: | + | | rowspan="2" style="width:55.2pt; border:solid windowtext 1.0pt" width="74" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:">Difference</span></span>'''</span></p> |
| − | | rowspan="2" style="width:80.25pt; border:solid windowtext 1.0pt" width="107" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family: | + | | rowspan="2" style="width:80.25pt; border:solid windowtext 1.0pt" width="107" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:">95% CI</span></span>'''</span></p> |
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| − | | 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:12.0pt"><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:12.0pt"><span style="font-family:">Mean</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:12.0pt"><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:12.0pt"><span style="font-family:">SD</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:12.0pt"><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:12.0pt"><span style="font-family:">Mean</span></span>'''</span></p> |
| − | | style="width:33.9pt; 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:12.0pt"><span style="font-family: | + | | style="width:33.9pt; 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:12.0pt"><span style="font-family:">SD</span></span>'''</span></p> |
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| style="width:167.6pt; border:solid windowtext 1.0pt" width="223" | | | style="width:167.6pt; border:solid windowtext 1.0pt" width="223" | | ||
| − | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family: | + | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:">Gross Motor Function Measure-88 (end of treatment)</span></span>'''</span> |
| − | | 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:12.0pt"><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:12.0pt"><span style="font-family:">41.2</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:12.0pt"><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:12.0pt"><span style="font-family:">29.6</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:12.0pt"><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:12.0pt"><span style="font-family:">40.8</span></span></span></p> |
| − | | style="width:33.9pt; 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:12.0pt"><span style="font-family: | + | | style="width:33.9pt; 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:12.0pt"><span style="font-family:">33.4</span></span></span></p> |
| − | | style="width:55.2pt; border:solid windowtext 1.0pt" width="74" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family: | + | | style="width:55.2pt; border:solid windowtext 1.0pt" width="74" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:">-0.4</span></span></span></p> |
| − | | style="width:80.25pt; border:solid windowtext 1.0pt" width="107" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family: | + | | style="width:80.25pt; border:solid windowtext 1.0pt" width="107" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:">-595 to 595</span></span></span></p> |
|- | |- | ||
| style="width:167.6pt; border:solid windowtext 1.0pt" width="223" | | | style="width:167.6pt; border:solid windowtext 1.0pt" width="223" | | ||
| − | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family: | + | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:">Pediatric Evaluation of Disability -self care category (end of treatment)</span></span>'''</span> |
| − | | 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:12.0pt"><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:12.0pt"><span style="font-family:">49.5</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:12.0pt"><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:12.0pt"><span style="font-family:">15.2</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:12.0pt"><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:12.0pt"><span style="font-family:">52.1</span></span></span></p> |
| − | | style="width:33.9pt; 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:12.0pt"><span style="font-family: | + | | style="width:33.9pt; 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:12.0pt"><span style="font-family:">20.5</span></span></span></p> |
| − | | style="width:55.2pt; border:solid windowtext 1.0pt" width="74" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family: | + | | style="width:55.2pt; border:solid windowtext 1.0pt" width="74" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:">2.6</span></span></span></p> |
| − | | style="width:80.25pt; border:solid windowtext 1.0pt" width="107" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family: | + | | style="width:80.25pt; border:solid windowtext 1.0pt" width="107" | <p align="center" style="margin-bottom:0cm; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:">-199 to 194</span></span></span></p> |
|} | |} | ||
| − | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family: | + | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:"><span style="color:black">Comments:</span></span></span>'''<br/> <span style="font-size:12.0pt"><span style="font-family:"><span style="color:black">1. 14% oxygen breathing at 1.5 ATA was to achieve the same P<sub>I</sub>O<sub>2</sub> as breathing air at 1 ATA.<br/> 2. Sample size calculation suggested 42 patients in each group was required to find a 5% improvement in the HBO group versus the sham group. The trial was stopped early for futility on a planned interim analysis. Six month follow-up did not suggest a different outcome.<br/> 3. Patients randomised in permuted blocks of various sizes with allocation concealment and not likely subject to bias.<br/> 4. GMFM-88 has been validated in this group. PEDI scores improved statistically significantly but not to a clinically important extent in both groups, but did not differ between groups and this seemed to persist through to the six month follow-up on. Authors suggest this is a participation effect.<br/> 5. About one third of children experienced ear pain during the course of treatment and two required withdrawal of treatment (one in each group).</span></span></span></span> |
| − | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family: | + | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:"><span style="color:black">Appraised by:</span></span></span>'''<span style="font-size:12.0pt"><span style="font-family:"><span style="color:black">Mike Bennett POWH m.bennett@unsw.edu.au; Saturday, 25 September 2021<br/> <br/> '''Kill or Update By:''' September 2026</span></span></span></span> |
| + | <p style="text-align: center;"> </p> <p style="text-align: center;">http://hboevidence.wikis.unsw.edu.au/images/8/89/Sumhorsa.gif</p> <p style="text-align: center;"><span style="font-size:xx-large;">[[Cerebral_Palsy|BACK]]</span></p> | ||
Latest revision as of 22:14, 24 September 2021
No evidence of any benefit from a course of hyperbaric oxygen for children with spastic cerebral palsy.
Clinical Bottom Line:
|
1. Hyperbaric oxygen did not improve gross motor function measures compared to a sham treatment. |
Citation/s:1. Lacey DJ, Stolfi A, Pilati LE. Effects of hyperbaric oxygen on motor function in children with cerebral palsy. Annals of neurology. 2012 Nov 1;72(5):695-703
Lead author's name and fax: Daniel Lacey: laceyd@childrensdayton.org
Three-part Clinical Question:For children with spastic cerebral palsy, does the addition of a course of hyperbaric oxygen to standard therapy result in any improvement in gross motor function?
Search Terms: Cerebral Palsy; motor function; paediatrics
The Study:Double-blinded concealed randomised controlled trial with intention-to-treat.
The Study Patients: Children aged 3 to 8 years with spastic cerebral palsy
Control group (N = 24; 22 analysed): 14% oxygen breathing at 1.5 ATA for 80 minutes daily, Monday to Friday to a total of 40 sessions over 8 weeks.
Experimental group (N = 25; 24 analysed): As above but breathing 100% oxygen.
The Evidence:
Measure |
Sham Group |
HBO Group |
Difference |
95% CI | ||
Mean |
SD |
Mean |
SD | |||
|
Gross Motor Function Measure-88 (end of treatment) |
41.2 |
29.6 |
40.8 |
33.4 |
-0.4 |
-595 to 595 |
|
Pediatric Evaluation of Disability -self care category (end of treatment) |
49.5 |
15.2 |
52.1 |
20.5 |
2.6 |
-199 to 194 |
Comments:
1. 14% oxygen breathing at 1.5 ATA was to achieve the same PIO2 as breathing air at 1 ATA.
2. Sample size calculation suggested 42 patients in each group was required to find a 5% improvement in the HBO group versus the sham group. The trial was stopped early for futility on a planned interim analysis. Six month follow-up did not suggest a different outcome.
3. Patients randomised in permuted blocks of various sizes with allocation concealment and not likely subject to bias.
4. GMFM-88 has been validated in this group. PEDI scores improved statistically significantly but not to a clinically important extent in both groups, but did not differ between groups and this seemed to persist through to the six month follow-up on. Authors suggest this is a participation effect.
5. About one third of children experienced ear pain during the course of treatment and two required withdrawal of treatment (one in each group).
Appraised by:Mike Bennett POWH m.bennett@unsw.edu.au; Saturday, 25 September 2021
Kill or Update By: September 2026
