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Cochrane Database of Systematic Reviews

Hipotermia por lesión cerebral traumática

Información

DOI:
https://doi.org/10.1002/14651858.CD001048.pub5Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 21 septiembre 2017see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:
  1. Grupo Cochrane de Lesiones

Copyright:
  1. Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Autores

  • Sharon R Lewis

    Correspondencia a: Patient Safety Research Department, Royal Lancaster Infirmary, Lancaster, UK

    [email protected]

    [email protected]

  • David JW Evans

    Lancaster Health Hub, Lancaster University, Lancaster, UK

  • Andrew R Butler

    Patient Safety Research Department, Royal Lancaster Infirmary, Lancaster, UK

  • Oliver J Schofield‐Robinson

    Research and Development, Royal Lancaster Infirmary, University Hospitals of Morecambe Bay, NHS, Lancaster, UK

  • Phil Alderson

    National Institute for Health and Care Excellence, Manchester, UK

Contributions of authors

David Signorini wrote the protocol, performed the searches and reviewed the titles and abstracts, extracted the data, performed the analyses and wrote the draft of the review. Phil Alderson (PA) reviewed the manuscripts of potential trials, extracted the data and edited the draft review.

For the 2001 update, the Injuries Group performed the search and screened studies. PA and Chirag Gadkary assessed eligibility, extracted data, performed the analysis and redrafted the text.

For the 2004 update, the Injuries Group performed the search and screened studies. PA and the Injuries Group extracted data, and PA performed the analysis and rewrote the text.

For the 2008 update, the search was carried out by Karen Blackhall (KB) of the Cochrane Injuries Group. Emma Sydenham (ES) and Ian Roberts (IR) assessed trial eligibility and applied the selection criteria. ES extracted data, and IR checked for accuracy. ES updated the text of the review. IR and ES performed the analysis and edited the manuscript. PA checked the final manuscript of the update.

KB performed the search for the January 2009 update. ES and IR assessed trial eligibility and applied the selection criteria. ES extracted the data and IR checked the extracted data for accuracy. ES updated the text of the review. IR and ES performed the analysis and edited the manuscript. PA checked the final manuscript of the update.

In April 2009, KB updated the search for trials. ES and IR assessed trial eligibility and applied the selection criteria. ES and IR re‐assessed all previously included trials against the inclusion criteria. All authors agreed that the Meissner 1998 study should be excluded. ES updated the text of the review. IR and PA checked the final manuscript of the update.

ES included data from the Harris 2009 trial for the July 2009 update. IR and PA checked the extracted data. All authors approved the manuscript for publication.

Sharon R Lewis (SRL) co‐ordinated the 2017 review update. Database searches were carried out by Deidre Beecher. SRL screened titles and abstracts, assessed full‐text publications for eligibility, carried out data extraction and updated the text of the review. Second review authors at each stage were one of: Andrew Butler; David Evans; Oliver Schofield‐Robinson; and PA. PA checked the final manuscript of the update.

Sources of support

Internal sources

  • DFS was supported by MRC project grant G9604637, UK.

  • NHS R&D Programme, UK.

External sources

  • CG was supported by the Doris Duke Research Fellowship, USA.

  • National Institute for Health Research (NIHR), UK.

    This project was supported by the UK National Institute for Health Research, through Cochrane Infrastructure funding to the Cochrane Injuries Group. The views and opinions expressed are those of the authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, NHS or the Department of Health.

Declarations of interest

Phil Alderson: None known

Sharon R Lewis: None known

David JW Evans: None known

Andrew R Butler: None known

Oliver J Schofield‐Robinson: None known

Acknowledgements

Thanks to:

  • Brenda Thomas (Cochrane Stroke) for help and advice with the original Embase search strategy.

  • Ian Whittle, Kate Signorini, Elena Telaro, Yoichi Nagayama, Irene Kwan, Frank Del Vecchio, Lisa Xue and Cynthia To for help with manuscripts in languages other than English.

  • Reinhard Wentz and Irene Kwan of Cochrane Injuries for the original searches.

  • Katharine Ker of Cochrane Injuries for work on previous versions of the review.

  • Karen Blackhall, Information Specialist of Cochrane Injuries for updating the searches in 2003, 2005, 2008 and 2009.

  • Odette Harris and Monique Surles for providing additional data for the Harris 2009 trial.

Version history

Published

Title

Stage

Authors

Version

2017 Sep 21

Hypothermia for traumatic brain injury

Review

Sharon R Lewis, David JW Evans, Andrew R Butler, Oliver J Schofield‐Robinson, Phil Alderson

https://doi.org/10.1002/14651858.CD001048.pub5

2009 Apr 15

Hypothermia for traumatic head injury

Review

Emma Sydenham, Ian Roberts, Phil Alderson

https://doi.org/10.1002/14651858.CD001048.pub4

2009 Jan 21

Hypothermia for traumatic head injury

Review

Emma Sydenham, Ian Roberts, Phil Alderson

https://doi.org/10.1002/14651858.CD001048.pub3

2004 Oct 18

Therapeutic hypothermia for head injury

Review

Phil Alderson, David Signorini, Chirag Patil

https://doi.org/10.1002/14651858.CD001048.pub2

2002 Jan 21

Therapeutic hypothermia for head injury

Review

Chirag Gadkary, Phil Alderson, David F Signorini

https://doi.org/10.1002/14651858.CD001048

Differences between protocol and review

Differences between the current version and previous version of the review (Sydenham 2009b)

Previous versions of the review were titled Hypothermia for traumatic head injury (Alderson 2004; Gadkary 2002; Sydenham 2009a; Sydenham 2009b). We changed the title to Hypothermia for traumatic brain injury and made appropriate edits throughout the review to reflect this change.

We edited the review Background and Methods sections to incorporate all Methodological Expectations of Cochrane Intervention Reviews (MECIR).

We edited the inclusion criteria to include studies with mixed head injuries if fewer than 10% of participants were described as having an open head injury, as we did not want to exclude important studies on the basis that a very small proportion of participants had an open head injury.

We re‐assessed studies that were excluded due to insufficient information on methods of randomisation in Sydenham 2009b. We included five of these studies; we added the remaining three studies to Excluded studies. We removed the references of studies excluded in previous versions of the review; the studies in Excluded studies relate to searches and decisions made for this update.

We updated the 'Risk of bias' tables to incorporate assessment of all domains for all studies. We updated the Characteristics of included studies tables to incorporate all MECIR requirements.

The 2008 update of this review evaluated study quality by allocation concealment only. The incidence of pneumonia was also stratified by study quality.

Keywords

MeSH

PICO

Population
Intervention
Comparison
Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all 37 included studies.
Figuras y tablas -
Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all 37 included studies.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.Note: blank spaces in risk of bias table indicate that the relevant outcome was not reported by study authors
Figuras y tablas -
Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Note: blank spaces in risk of bias table indicate that the relevant outcome was not reported by study authors

Funnel plot of comparison 1: Therapeutic cooling versus no cooling, outcome: 1.1 Mortality.
Figuras y tablas -
Figure 4

Funnel plot of comparison 1: Therapeutic cooling versus no cooling, outcome: 1.1 Mortality.

Comparison 1 Therapeutic cooling versus no cooling, Outcome 1 Mortality.
Figuras y tablas -
Analysis 1.1

Comparison 1 Therapeutic cooling versus no cooling, Outcome 1 Mortality.

Comparison 1 Therapeutic cooling versus no cooling, Outcome 2 Unfavourable outcome.
Figuras y tablas -
Analysis 1.2

Comparison 1 Therapeutic cooling versus no cooling, Outcome 2 Unfavourable outcome.

Comparison 1 Therapeutic cooling versus no cooling, Outcome 3 Pneumonia.
Figuras y tablas -
Analysis 1.3

Comparison 1 Therapeutic cooling versus no cooling, Outcome 3 Pneumonia.

Comparison 2 Therapeutic cooling versus no cooling: by duration, Outcome 1 Mortality.
Figuras y tablas -
Analysis 2.1

Comparison 2 Therapeutic cooling versus no cooling: by duration, Outcome 1 Mortality.

Comparison 2 Therapeutic cooling versus no cooling: by duration, Outcome 2 Unfavourable outcome.
Figuras y tablas -
Analysis 2.2

Comparison 2 Therapeutic cooling versus no cooling: by duration, Outcome 2 Unfavourable outcome.

Comparison 2 Therapeutic cooling versus no cooling: by duration, Outcome 3 Pneumonia.
Figuras y tablas -
Analysis 2.3

Comparison 2 Therapeutic cooling versus no cooling: by duration, Outcome 3 Pneumonia.

Comparison 3 Therapeutic cooling versus no cooling: by length of follow‐up, Outcome 1 Mortality.
Figuras y tablas -
Analysis 3.1

Comparison 3 Therapeutic cooling versus no cooling: by length of follow‐up, Outcome 1 Mortality.

Comparison 3 Therapeutic cooling versus no cooling: by length of follow‐up, Outcome 2 Unfavourable outcome.
Figuras y tablas -
Analysis 3.2

Comparison 3 Therapeutic cooling versus no cooling: by length of follow‐up, Outcome 2 Unfavourable outcome.

Summary of findings for the main comparison. Hypothermia for traumatic brain injury

Hypothermia for traumatic brain injury

Patient or population: patients with traumatic brain injury
Settings: hospitals; in Australia, Canada, China, Czech Republic, Germany, Japan, Malaysia, New Zealand, UK, USA
Intervention: hypothermia versus normothermia

Outcomes

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Mortality at end of follow‐up

2944
(32 studiesa)

⊕⊝⊝⊝
very lowb

Data not combined in meta‐analysis. Visual inspection of data showed variation in differences of effect not explained by subgroup analysis

Unfavourable outcome at end of follow‐up

2620
(27 studiesc)

⊕⊝⊝⊝
very lowd

Data not combined in meta‐analysis. Visual inspection of data showed variation in differences of effect not explained by subgroup analysis

Pneumonia

693
(14 studiese)

⊕⊕⊝⊝
lowf

Data not combined in meta‐analysis. Visual inspection of data showed variation in differences of effect

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

aWe identified 33 studies that reported data for mortality, with comparable data available for 32 studies
bFew studies had sufficiently described random sequence generation and concealment; downgraded one level for study limitations. Some inconsistencies between studies, not explained by per protocol subgroup analyses; downgraded one level for inconsistency. Some differences in study population between studies; Andrews 2015 included participants with less severe head injury, and with a longer delay in treatment; downgraded one level for indirectness.
cWe identified 29 studies that reported data for unfavourable outcome, with comparable data available for 26 studies.
dFew studies had sufficiently described random sequence generation and concealment; downgraded one level for study limitations. Some inconsistencies between studies not explained by per protocol subgroup analyses and we noted a moderate level of statistical heterogeneity; downgraded two levels for inconsistency. Some differences in study population between studies; Andrews 2015 included participants with less severe head injury, and with a longer delay in treatment; downgraded one level for indirectness.
eWe identified 14 studies that reported data for pneumonia, with comparable data available for 12 studies.
fSome inconsistencies between studies, not explained by per protocol subgroup analyses; downgraded one level for inconsistency. Some differences in study population between studies; Andrews 2015 included participants with less severe head injury, and with a longer delay in treatment; downgraded one level for indirectness.

Figuras y tablas -
Summary of findings for the main comparison. Hypothermia for traumatic brain injury
Comparison 1. Therapeutic cooling versus no cooling

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mortality Show forest plot

32

Odds Ratio (M‐H, Fixed, 95% CI)

Subtotals only

2 Unfavourable outcome Show forest plot

27

Odds Ratio (M‐H, Fixed, 95% CI)

Subtotals only

3 Pneumonia Show forest plot

12

Odds Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Figuras y tablas -
Comparison 1. Therapeutic cooling versus no cooling
Comparison 2. Therapeutic cooling versus no cooling: by duration

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mortality Show forest plot

32

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

1.1 24 hours

4

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.2 More than 24 hours

28

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 Unfavourable outcome Show forest plot

26

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

2.1 24 hours

3

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.2 More than 24 hours

23

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3 Pneumonia Show forest plot

12

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

3.1 24 hours

2

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.2 More than 24 hours

10

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 2. Therapeutic cooling versus no cooling: by duration
Comparison 3. Therapeutic cooling versus no cooling: by length of follow‐up

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mortality Show forest plot

32

Risk Ratio (IV, Fixed, 95% CI)

Totals not selected

1.1 One month

13

Risk Ratio (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.2 Three months

6

Risk Ratio (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.3 Six months

14

Risk Ratio (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.4 Twelve months or more

7

Risk Ratio (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 Unfavourable outcome Show forest plot

26

Risk Ratio (IV, Fixed, 95% CI)

Totals not selected

2.1 Three months

9

Risk Ratio (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.2 Six months

15

Risk Ratio (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.3 Twelve months

6

Risk Ratio (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 3. Therapeutic cooling versus no cooling: by length of follow‐up