Difference between revisions of "Packard"

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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 21px;">'''<span style="color: #003366;">Hyperbaric oxygenation improved parental reported disability inventory </span>'''</span>
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 21px;">'''<span style="color: #003366;">Hyperbaric oxygenation improved parental reported disability inventory</span>'''</span>
  
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 17px;">'''Clinical bottom line'''</span>
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 17px;">'''Clinical bottom line:'''</span>
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| <span style'''"font-family: Arial,Helvetica,sans-serif; font-size: 19px;">1. No reliable evidence of benefit from HBOT</span><br><span style'''"font-family: Arial,Helvetica,sans-serif; font-size: 19px;">2. Unblinded parental scores for disability were said to be improved by HBOT</span><br><span style="font-family: Arial,Helvetica,sans-serif; font-size: 19px;">3. High incidence of middle ear barotrauma in children and parents</span>
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| <span style="font-size:large;">1. No reliable evidence of benefit from HBOT<br/> 2. Unblinded parental scores for disability were said to be improved by HBOT<br/> <span style="font-family: Arial, Helvetica, sans-serif;">3. High incidence of middle ear barotrauma in children and parents</span></span>
 
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 19px;">'''Citation/s:''' Packard M. The Cornell Study. [[http://www.netnet.net/mums/]]</span>
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 19px;">'''Citation/s:''' Packard M. The Cornell Study. [[http://www.netnet.net/mums/ [1]]]</span>
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 19px;">'''Lead author's name and fax:''' Maureen Packard (no contacts given)</span>
 
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 19px;">'''Lead author's name and fax:''' Maureen Packard (no contacts given)</span>
  
 
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 19px;">'''Three-part Clinical Question:''' In moderate to severe cerebral palsy children (1 to 5 years), does HBOT improve neuro/psycho/motor function?</span>
 
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 19px;">'''Three-part Clinical Question:''' In moderate to severe cerebral palsy children (1 to 5 years), does HBOT improve neuro/psycho/motor function?</span>
 +
 
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 19px;">'''Search Terms:''' hyperbaric oxygen therapy, cerebral palsy, paediatric</span>
 
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 19px;">'''Search Terms:''' hyperbaric oxygen therapy, cerebral palsy, paediatric</span>
  
 
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 19px;">'''The Study:'''Non-blinded randomised controlled trial without intention-to-treat.</span>
 
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 19px;">'''The Study:'''Non-blinded randomised controlled trial without intention-to-treat.</span>
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 19px;">'''The Study Patients:''' Developmentally delayed by >33% in one area neurocognitive or motor skill assessment, and who have not had seizures in the last 6 months. Average age at commencement of study 30 months, average motor age 7.5 months, average cognitive age and language age 12 months.</span>
 
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 19px;">'''The Study Patients:''' Developmentally delayed by >33% in one area neurocognitive or motor skill assessment, and who have not had seizures in the last 6 months. Average age at commencement of study 30 months, average motor age 7.5 months, average cognitive age and language age 12 months.</span>
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 19px;">'''Control group''' (N = 14; 11 analysed): Nil specific (received delayed HBOT at 6 months after experimental group).</span>
 
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 19px;">'''Control group''' (N = 14; 11 analysed): Nil specific (received delayed HBOT at 6 months after experimental group).</span>
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 19px;">'''Experimental group''' (N = 12; 9 analysed): 40 one hour sessions HBOT at 1.5 ATA over 8 weeks</span>
 
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 19px;">'''Experimental group''' (N = 12; 9 analysed): 40 one hour sessions HBOT at 1.5 ATA over 8 weeks</span>
  
 
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 19px;">'''The Evidence:'''</span>
 
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 19px;">'''The Evidence:'''</span>
  
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| <span style'''"display: block; text-align: center;">'''<span style'''"display: block; font-family: Arial,Helvetica,sans-serif; font-size: 110%; text-align: center;">Outcome</span>'''</span> || <span style'''"display: block; text-align: center;">'''<span style'''"display: block; font-family: Arial,Helvetica,sans-serif; font-size: 110%; text-align: center;">Time to Outcome</span>'''</span> || <span style'''"display: block; text-align: center;">'''<span style'''"display: block; font-family: Arial,Helvetica,sans-serif; font-size: 110%; text-align: center;">Overall patients</span>'''</span> || <span style'''"display: block; text-align: center;">'''<span style'''"display: block; font-family: Arial,Helvetica,sans-serif; font-size: 110%; text-align: center;">Overall parents</span>'''</span> || '''<span style="font-family: Arial,Helvetica,sans-serif; font-size: 110%;"> Difference</span>'''
 
 
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| <span style'''"display: block; text-align: center;"><span style'''"display: block; font-family: Arial,Helvetica,sans-serif; font-size: 110%; text-align: center;">'''Middle ear barotrauma requiring intervention''' </span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; font-family: Arial,Helvetica,sans-serif; font-size: 110%; text-align: center;">any time </span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; font-family: Arial,Helvetica,sans-serif; font-size: 110%; text-align: center;">45% </span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; font-family: Arial,Helvetica,sans-serif; font-size: 110%; text-align: center;">35% </span></span> || 
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| <span style'''"display: block; text-align: center;">'''<span style'''"display: block; font-family: Arial,Helvetica,sans-serif; font-size: 110%; text-align: center;">Improved parental disability inventory (PEDI) </span>'''</span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; font-family: Arial,Helvetica,sans-serif; font-size: 110%; text-align: center;">8 weeks </span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; font-family: Arial,Helvetica,sans-serif; font-size: 110%; text-align: center;">P<0.05 </span></span> ||  || 
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{| class="Table" style="border:solid windowtext 1.0pt"
 
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| style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-family:" times="" new="" roman",serif"="">Outcome</span>'''</span></p>
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| style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-family:" times="" new="" roman",serif"="">Time to Outcome</span>'''</span></p>
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| style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-family:" times="" new="" roman",serif"="">Overall patients</span>'''</span></p>
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| style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-family:" times="" new="" roman",serif"="">Overall parents</span>'''</span></p>
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| style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-family:" times="" new="" roman",serif"="">Difference</span>'''</span></p>
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| rowspan="2" style="border:solid windowtext 1.0pt" |
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<span style="line-height:normal"><span style="height:12.65pt">'''<span style="font-family:" times="" new="" roman",serif"="">Middle ear barotrauma requiring intervention</span>'''</span></span>
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| rowspan="2" style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="height:12.65pt"><span style="font-family:" times="" new="" roman",serif"="">any time</span></span></span></p>
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| rowspan="2" style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="height:12.65pt"><span style="font-family:" times="" new="" roman",serif"="">45%</span></span></span></p>
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| rowspan="2" style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="height:12.65pt"><span style="font-family:" times="" new="" roman",serif"="">35%</span></span></span></p>
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| rowspan="2" style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="height:12.65pt"><span style="font-family:" times="" new="" roman",serif"="">?</span></span></span></p>
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<span style="line-height:normal"><span style="height:29.8pt">'''<span style="font-family:" times="" new="" roman",serif"="">Improved parental disability inventory (PEDI)</span>'''</span></span>
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| style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="height:29.8pt"><span style="font-family:" times="" new="" roman",serif"="">8 weeks</span></span></span></p>
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| style="border:solid windowtext 1.0pt; padding:.75pt .75pt .75pt .75pt; height:29.8pt" | &nbsp;
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| style="border:solid windowtext 1.0pt; padding:.75pt .75pt .75pt .75pt; height:29.8pt" | &nbsp;
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| style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="height:29.8pt"><span style="font-family:" times="" new="" roman",serif"="">P<0.05</span></span></span></p>
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| height="40" style="height:29.8pt; border:none" width="0" | &nbsp;
 
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 19px;">In the whole study, 9 of 20 children compressed (45%) required myringotomy or ventilation tubes for middle ear barotrauma, while 7 parents also required this intervention. We have assumed one parent compressed for each child.</span>
 
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 19px;">In the whole study, 9 of 20 children compressed (45%) required myringotomy or ventilation tubes for middle ear barotrauma, while 7 parents also required this intervention. We have assumed one parent compressed for each child.</span>
  
 
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 19px;">'''Comments:'''</span>
 
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 19px;">'''Comments:'''</span>
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 19px;">1. A non-blinded study where the only reported significant differences were of parental assessment.</span>
 
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 19px;">1. A non-blinded study where the only reported significant differences were of parental assessment.</span>
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 19px;">2. Small study with low power to detect important clinical differences.</span>
 
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 19px;">2. Small study with low power to detect important clinical differences.</span>
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 19px;">3. Results poorly reported and usually for whole study rather than between group comparison.</span>
 
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 19px;">3. Results poorly reported and usually for whole study rather than between group comparison.</span>
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 19px;">4. No peer review and internet publication only.</span>
 
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 19px;">4. No peer review and internet publication only.</span>
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 19px;">5. No account of the fate of dropouts.</span>
 
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 19px;">5. No account of the fate of dropouts.</span>
  
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 19px;">'''Appraised by:''' Shamani Singham Prince of Wales Hospital, Sydney ; Thursday, 18 November 2004Email: [[mailto:singhams@sesahs.nsw.gov.au | singhams@sesahs.nsw.gov.au]]</span>
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 19px;">'''Appraised by:''' Shamani Singham Prince of Wales Hospital, Sydney&nbsp;; Thursday, 18 November 2004Email: [[mailto:singhams@sesahs.nsw.gov.au| singhams@sesahs.nsw.gov.au]]</span>
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 19px;">'''Kill or Update By:''' November 2015</span>
 
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 19px;">'''Kill or Update By:''' November 2015</span>
  
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[[File:http://www.hboevidence.com/_themes/copy-of-sumi-painting/sumhorsa.gif|center|external]]
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<span style="color: #7c00ff; display: block; font-family: arial,helvetica,sans-serif; font-size: 26px; text-align: center;">[[Cerebral_Palsy|BACK]]</span>
  
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<span style="color: #7c00ff; display: block; font-family: arial,helvetica,sans-serif; font-size: 26px; text-align: center;">[[Cerebral Palsy  |  BACK]]</span>
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Revision as of 02:12, 4 January 2021

Hyperbaric oxygenation improved parental reported disability inventory

Clinical bottom line:

1. No reliable evidence of benefit from HBOT
2. Unblinded parental scores for disability were said to be improved by HBOT
3. High incidence of middle ear barotrauma in children and parents

Citation/s: Packard M. The Cornell Study. [[1]]

Lead author's name and fax: Maureen Packard (no contacts given)

Three-part Clinical Question: In moderate to severe cerebral palsy children (1 to 5 years), does HBOT improve neuro/psycho/motor function?

Search Terms: hyperbaric oxygen therapy, cerebral palsy, paediatric

The Study:Non-blinded randomised controlled trial without intention-to-treat.

The Study Patients: Developmentally delayed by >33% in one area neurocognitive or motor skill assessment, and who have not had seizures in the last 6 months. Average age at commencement of study 30 months, average motor age 7.5 months, average cognitive age and language age 12 months.

Control group (N = 14; 11 analysed): Nil specific (received delayed HBOT at 6 months after experimental group).

Experimental group (N = 12; 9 analysed): 40 one hour sessions HBOT at 1.5 ATA over 8 weeks

The Evidence:

         

Outcome

Time to Outcome

Overall patients

Overall parents

Difference

 

Middle ear barotrauma requiring intervention

any time

45%

35%

?

 
 

Improved parental disability inventory (PEDI)

8 weeks

   

P<0.05

 

In the whole study, 9 of 20 children compressed (45%) required myringotomy or ventilation tubes for middle ear barotrauma, while 7 parents also required this intervention. We have assumed one parent compressed for each child.

Comments:

1. A non-blinded study where the only reported significant differences were of parental assessment.

2. Small study with low power to detect important clinical differences.

3. Results poorly reported and usually for whole study rather than between group comparison.

4. No peer review and internet publication only.

5. No account of the fate of dropouts.

Appraised by: Shamani Singham Prince of Wales Hospital, Sydney ; Thursday, 18 November 2004Email: [singhams@sesahs.nsw.gov.au]

Kill or Update By: November 2015

 

BACK