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Cochrane Database of Systematic Reviews

Ventilasi mekanikal untuk sklerosis lateral amiotrofik/penyakit neuron motor

Información

DOI:
https://doi.org/10.1002/14651858.CD004427.pub4Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 05 octubre 2017see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:

  1. Grupo Cochrane de Neuromuscular

Copyright:
  1. Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Autores

  • Aleksandar Radunovic

    Correspondencia a: Barts MND Centre, Royal London Hospital, London, UK

    [email protected]

  • Djillali Annane

    Department of Critical Care, Hyperbaric Medicine and Home Respiratory Unit, Center for Neuromuscular Diseases; Raymond Poincaré Hospital (AP‐HP), Garches, France

  • Muhammad K Rafiq

    Academic Neurology Unit, University of Sheffield, Sheffield, UK

  • Ruth Brassington

    MRC Centre for Neuromuscular Diseases, National Hospital for Neurology and Neurosurgery, London, UK

  • Naveed Mustfa

    Department of Respiratory Medicine, Royal Stoke University Hospital, University Hospital of North Midlands, Stoke‐on‐Trent, UK

Contributions of authors

Aleksandar Radunovic drafted the first version of the review, with Naveed Mustfa and Djillali Annane. Kate Jewitt edited the protocol and the original version of the review. Muhammad K Rafiq with Djillali Annane selected studies for the first update; the other authors approved the text. Muhammad K Rafiq with Naveed Mustfa assessed studies for the 2017 update of the review, and Ruth Brassington assisted with updating the text and extraction of additional data. All authors approved the final text.

Sources of support

Internal sources

  • Institute of Psychiatry, UK.

  • Guy's, King's & St. Thomas' School of Medicine, King's College London, UK.

  • Hopital Raymond Poincaré, Garches, France.

  • National Institute of Health Research, UK.

External sources

  • Motor Neurone Disease Association, UK.

  • Muscular Dystrophy Association, USA.

Declarations of interest

Aleksandar Radunovic: Member of the Data and Ethics Monitoring Committee for the NIHR Health Technology Assessment RCT of diaphragm pacing in ALS (DiPALS). Member of the NICE Guideline Development Group on management of MND.

Djillali Annane: no conflicts of interest.

Muhammad K Rafiq: no conflicts of interest.

Ruth Brassington: I have no known financial conflicts of interest. I am Managing Editor of Cochrane Neuromuscular, of which the National Institute for Health Research (NIHR) is the largest single funder. Upon joining the author team, I withdrew from the editorial process for this review, in accordance with Cochrane policy. The Motor Neurone Disease Association also supported Cochrane Neuromuscular with a small grant that contributed to my salary.

Naveed Mustfa: no conflicts of interest.

Acknowledgements

We thank Dr EA Oppenheimer for his comments on earlier drafts of the protocol. We are grateful to Professor Nigel Leigh, who developed the protocol for this review and contributed to the original assessment of studies, and Kate Jewitt, former Managing Editor of the Cochrane Neuromuscular Disease Group, who was an author of the original review. Angela Gunn, Information Specialist at Cochrane Neuromuscular, performed the searches.

This project was supported by the National Institute for Health Research (NIHR) via Cochrane Infrastructure funding to Cochrane Neuromuscular. The views and opinions expressed herein are those of the review authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, National Health Service, or the Department of Health. Cochrane Neuromuscular is also supported by the MRC Centre for Neuromuscular Diseases and the Motor Neurone Disease Association.

Version history

Published

Title

Stage

Authors

Version

2017 Oct 05

Mechanical ventilation for amyotrophic lateral sclerosis/motor neuron disease

Review

Aleksandar Radunovic, Djillali Annane, Muhammad K Rafiq, Ruth Brassington, Naveed Mustfa

https://doi.org/10.1002/14651858.CD004427.pub4

2013 Mar 28

Mechanical ventilation for amyotrophic lateral sclerosis/motor neuron disease

Review

Aleksandar Radunovic, Djillali Annane, Muhammad K Rafiq, Naveed Mustfa

https://doi.org/10.1002/14651858.CD004427.pub3

2009 Oct 07

Mechanical ventilation for amyotrophic lateral sclerosis/motor neuron disease

Review

Aleksandar Radunovic, Djillali Annane, Kate Jewitt, Naveed Mustfa

https://doi.org/10.1002/14651858.CD004427.pub2

2009 Jul 08

Mechanical ventilation for amyotrophic lateral sclerosis/motor neuron disease

Protocol

P Nigel Leigh, Djillali Annane, Kate Jewitt, Naveed Mustfa

https://doi.org/10.1002/14651858.CD004427

Differences between protocol and review

P Nigel Leigh withdrew from authorship after protocol publication. Kate Jewitt withdrew following publication of the full review. Muhammad K Rafiq became an author for the previous update, and Ruth Brassington joined as an author at this update.

The review authors assessed risk of bias expressed as ‘low risk’, ‘high risk’, or ‘unclear risk’ of bias in accordance with Higgins 2011.

We included a statement in Types of interventions that we will include comparisons with no intervention or the best standard care, and clarified that adverse events will be collected from included trials. We reworded the review objective in accordance with current guidance. In addition, we clarified that all forms of NIV irrespective of pressure settings and timings are eligible for inclusion.

We added an appendix describing methods that will be used if meta‐analysis becomes possible.

We included a 'Summary of findings' table and searched clinical trials databases, according to current Cochrane requirements.

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

Humans;

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.

A flow diagram illustrating the study selection process.
Figuras y tablas -
Figure 1

A flow diagram illustrating the study selection process.

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Methodological quality summary: review authors' judgements about each methodological quality item for each included study. A green plus sign indicates low risk of bias; a red minus sign indicates high risk of bias; and a yellow question mark indicates unclear risk of bias.
Figuras y tablas -
Figure 2

Methodological quality summary: review authors' judgements about each methodological quality item for each included study. A green plus sign indicates low risk of bias; a red minus sign indicates high risk of bias; and a yellow question mark indicates unclear risk of bias.

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Summary of findings for the main comparison. Non‐invasive ventilation compared with standard care for amyotrophic lateral sclerosis (ALS)

Non‐invasive ventilation compared with standard care for amyotrophic lateral sclerosis (ALS)

Patient or population: people with ALS

Settings: people with ALS attending a single regional care centre

Intervention: non‐invasive ventilation

Comparison: standard care

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No. of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Standard care

Non‐invasive ventilation (NIV)

Survival

All participants

Median survival was 171 days.

All participants

Median survival was 48 days longer (12 to 91 days1 longer).

‐

41 (1 study)

⊕⊕⊕⊝

Moderate2

21 of the 41 participants had poor bulbar function.

P = 0.0059 better bulbar function, P = 0.92 poor bulbar function

Participants with better (good or moderately impaired) bulbar function

Median survival was 11 days.

Participants with better (good or moderately impaired) bulbar function

Median survival was 205 days longer (CI not given).

Participants with poor bulbar function

Median survival was 261 days.

Participants with poor bulbar function

Median survival was 39 days shorter (CI not given).

Quality of life (SF‐36 MCS)

All participants

Median duration that SF‐36 MCS remained above 75% of baseline was 99 days.

All participants

Median duration that SF‐36 MCS remained above 75% of baseline was 69 days longer (45 to 667 days longer).

‐

41 (1 study)

⊕⊕⊝⊝

Low2,3

‐

Participants with better (good or moderately impaired) bulbar function

Median duration that SF‐36 MCS remained above 75% of baseline was 4 days.

Participants with better (good or moderately impaired) bulbar function

Median duration that SF‐36 MCS remained above 75% of the baseline was 195 days longer (P = 0.001, CI not given).

Participants with poor bulbar function

Median duration that SF‐36 MCS remained above 75% of baseline was 164 days.

Participants with poor bulbar function

Median duration that SF‐36 MCS remained above 75% of the baseline was 37 days shorter (P = 0.64, CI not given).

Quality of life (SF‐36 PCS)

All participants

Median duration that SF‐36 PCS remained above 75% of baseline was 81 days.

All participants

Median duration that SF‐36 PCS remained above 75% of baseline was 69 days longer (P = 0.004).

‐

‐

‐

CI not given

Participants with better (good or moderately impaired) bulbar function

Median duration that SF‐36 PCS remained above 75% of baseline was 4 days.

Participants with better (good or moderately impaired) bulbar function

Median duration that SF‐36 PCS remained above 75% of the baseline was 175 days longer (P < 0.001).

Participants with poor bulbar function

Median duration that SF‐36 PCS remained above 75% of baseline was 132 days.

Participants with poor bulbar function

Median duration that SF‐36 PCS remained above 75% of the baseline was 18 days longer (P = 0.88).

Quality of life (SAQLI)

All participants

Median duration that SAQLI remained above 75% of baseline was 99 days.

All participants

Median duration that SAQLI remained above 75% of baseline was 74 days longer (P = 0.031).

‐

41 (1 study)

⊕⊕⊝⊝

Low2,3

CI not given

Participants with good or moderately impaired bulbar function

Median duration that SAQLI remained above 75% of baseline was 4 days.

Participants with good or moderately impaired bulbar function

Median duration that SAQLI remained above 75% of the baseline was 195 days longer (P = < 0.001).

Participants with poor bulbar function

Median duration that SAQLI remained above 75% of baseline was 132 days.

Participants with poor bulbar function

Median duration that SAQLI remained above 75% of the baseline was 29 days shorter (P = 0.77).

Adverse events (not reported)

‐

‐

‐

‐

‐

‐

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; SAQLI: Sleep Apnea Quality of Life Index; SF‐36 MCS: 36‐Item Short‐Form Health Survey Mental Component Summary; SF‐36 PCS: 36‐Item Short‐Form Health Survey Physical Component Summary

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.

1Calculated CIs are approximate.
2We assessed the evidence as of moderate quality, as it was based on a single randomised trial of 41 participants.
3For quality of life outcomes, we further downgraded the evidence due to lack of blinding.

Figuras y tablas -
Summary of findings for the main comparison. Non‐invasive ventilation compared with standard care for amyotrophic lateral sclerosis (ALS)
Ir a la tabla de la revisión
Table 1. Duration that quality of life was maintained above 75% of baseline (median days)

All participants (n = 41)

Better bulbar function (n = 20)

Poor bulbar function (n = 21)

NIV (n = 22)

Standard care
(n = 19)

P

NIV
(n = 11)

Standard care
(n = 9)

P

NIV (n = 11)

Standard care
(n = 10)

P value

SF‐36 MCS

168 (45 to 1357)

99 (0 to 690)

0.0017

199 (48 to 552)

4 (0 to 196)

0.001

127 (45 to 1357)

164 (2 to 690)

0.64

SF‐36 PCS

150 (27 to 908)

81 (0 to 273)

0.0014

179 (36 to 548)

4 (0 to 94)

< 0.001

150 (27 to 908)

132 (2 to 273)

0.88

SAQLI symptoms

192 (48 to 1357)

46 (0 to 703)

0.0013

205 (69 to 629)

4 (0 to 143)

< 0.001

143 (48 to 1357)

100 (2 to 703)

0.26

SAQLI score

173 (25 to 1357)

99 (0 to 645)

0.031

199 (61 to 595)

4 (0 to 193)

< 0.001

103 (25 to 1357)

132 (2 to 645)

0.77

Data are median (range). Data from Bourke 2006.

Abbreviations: NIV: non‐invasive ventilation; SAQLI: Sleep Apnea Quality of Life Index; SF‐36 MCS: 36‐Item Short‐Form Health Survey Mental Component Summary; SF‐36 PCS: 36‐Item Short‐Form Health Survey Physical Component Summary

Figuras y tablas -
Table 1. Duration that quality of life was maintained above 75% of baseline (median days)
Ir a la tabla de la revisión
Table 2. Time‐weighted mean improvement in quality of life domains

All participants (n = 41)

Better bulbar function (n = 20)

Poor bulbar function (n = 21)

NIV
(n = 22)

Standard care (n = 19)

P

NIV (n = 11)

Standard care (n = 9)

P

NIV
(n = 11)

Standard care (n = 10)

P value

SF‐36 MCS

2.31 (0 to 11.54)

0 (0 to 5.23)

0.0082

2.18 (0 to 11.54)

0 (0 to 1.39)

0.0052

4.47 (0 to 7.75)

0.88 (0 to 5.23)

0.24

SF‐36 PCS

0.18 (0 to 10.62)

0 (0 to 6.73)

0.51

0.14 (0 to 10.62)

0 (0 to 0.39)

0.031

0.21 (0 to 5.41)

0.48 (0 to 6.73)

0.37

SAQLI symptoms

1.07 (0 to 3.20)

0 (0 to 1.14)

< 0.001

1.73 (0.52 to 2.95)

0 (0 to 0)

< 0.001

0.90 (0 to 3.20)

0.04 (0 to 1.14)

0.018

SAQLI score

0.44 (0 to 1.59)

0 (0 to 0.42)

< 0.001

0.50 (0 to 0.88)

0 (0 to 0.07)

< 0.001

0.28 (0 to 1.59)

0.04 (0 to 0.42)

0.066

Data are median (range) values of area under the curve above baseline divided by time from randomisation to death. Data from Bourke 2006.

Abbreviations: NIV: non‐invasive ventilation; SAQLI: Sleep Apnea Quality of Life Index; SF‐36 MCS: 36‐Item Short‐Form Health Survey Mental Component Summary; SF‐36 PCS: 36‐Item Short‐Form Health Survey Physical Component Summary

Figuras y tablas -
Table 2. Time‐weighted mean improvement in quality of life domains
Ir a la tabla de la revisión