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Cochrane Database of Systematic Reviews

Tecnología de imagenología intraoperatoria para maximizar el grado de resección del glioma

Información

DOI:
https://doi.org/10.1002/14651858.CD012788.pub2Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 22 enero 2018see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:
  1. Grupo Cochrane de Cáncer ginecológico, neurooncología y otros cánceres

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

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Autores

  • Michael D Jenkinson

    Correspondencia a: Department of Neurosurgery & Institute of Systems Molecular and Integrative Biology, The Walton Centre & University of Liverpool, Liverpool, UK

    [email protected]

  • Damiano Giuseppe Barone

    Department of Clinical Neurosciences, University of Cambridge School of Clinical Medicine, Cambridge, UK

  • Andrew Bryant

    Institute of Health & Society, Newcastle University, Newcastle upon Tyne, UK

  • Luke Vale

    Institute of Health & Society, Newcastle University, Newcastle upon Tyne, UK

  • Helen Bulbeck

    Director of Services, brainstrust, Cowes, UK

  • Theresa A Lawrie

    The Evidence-Based Medicine Consultancy Ltd, Bath, UK

  • Michael G Hart

    Academic Division of Neurosurgery, Department of Clinical Neurosciences, Addenbrookes Hospital, Cambridge, UK

  • Colin Watts

    Chair Birmingham Brain Cancer Program, University of Birmingham, Edgbaston, UK

Contributions of authors

Damiano G Barone and Michael G Hart conceptualised the review and wrote the original protocol and the review. Michael D Jenkinson and Colin Watts provided senior clinical commentary. Andrew Bryant and Theresa Lawrie provided expert methodological and statistical commentary. Luke Vale provided the brief economic commentary. Helen Bulbeck contributed to the writing of the review.

Sources of support

Internal sources

  • None, Other

External sources

  • NIHR SRPG Project: 16/114/18, UK

Declarations of interest

Michael Jenkinson: no conflict of interest related to this review.
Damiano Barone: no conflict of interest related to this review.
Andrew Bryant: no conflict of interest related to this review.
Luke Vale: no conflict of interest related to this review.
Helen Bulbeck: no conflict of interest related to this review.
Theresa Lawrie: no conflict of interest related to this review.
Michael Hart: no conflict of interest related to this review.
Colin Watts: no conflict of interest related to this review.

Acknowledgements

We would like to thank Robin Grant (Co‐ordinating Editor), Gail Quinn, Clare Jess (Managing Editors), and Tracey Harrison (Assistant Managing Editor), for the Cochrane Gynaecological, Neuro‐oncology, and Orphan Cancer Group, for providing editorial support, as well as Jo Platt, Information Specialist, for devising the MEDLINE search strategy. We would also like to thank Ian Shemilt, EPPI‐Centre, UCL, and Luke Vale, Institute of Health & Society, Newcastle University, for support provided in development of economic search strategies and associated methods.

This project was supported by the National Institute for Health Research (NIHR), via Cochrane Programme Grant funding (SRPG Project: 16/114/18), to the Cochrane Gynaecological, Neuro‐oncology, and Orphan Cancer Group. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, the NHS, or the Department of Health.

Version history

Published

Title

Stage

Authors

Version

2018 Jan 22

Intraoperative imaging technology to maximise extent of resection for glioma

Review

Michael D Jenkinson, Damiano Giuseppe Barone, Andrew Bryant, Luke Vale, Helen Bulbeck, Theresa A Lawrie, Michael G Hart, Colin Watts

https://doi.org/10.1002/14651858.CD012788.pub2

2017 Sep 04

Intraoperative imaging technology to maximise extent of resection for glioma

Protocol

Michael D Jenkinson, Damiano Giuseppe Barone, Michael G Hart, Andrew Bryant, Theresa A Lawrie, Colin Watts

https://doi.org/10.1002/14651858.CD012788

Differences between protocol and review

There were no differences between the protocol and review.

Notes

This review has been superseded as an NMA: https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD013630.pub2/full

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 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 included studies.

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

Figuras y tablas -
Figure 3

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

Summary of findings 1. iMRI image‐guided surgery compared to standard surgery for high‐grade glioma

iMRI image‐guided surgery compared to standard surgery for high‐grade glioma

Patient or population: high‐grade glioma
Settings: specialist centres
Intervention: iMRI image‐guided surgery (based on post‐operative MRI)
Comparison: standard surgery

Outcomes

Illustrative comparative risk* (95% CI)

Relative effect
(95% CI)

No. of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Control

Image‐guided surgery

Extent of resection: complete resection

321 per 100

4 per 100
(1 to 31)

RR 0.13 (0.02 to 0.96)

49 participants
(1 study)

⊕⊝⊝⊝1,2,3
verylow

Small trial of highly selected participants with potential bias in allocation and performance. One other trial reported this outcome but did not contribute towards the analysis.

Adverse events

Inadequately and inconsistently reported in the trial

⊕⊝⊝⊝4
verylow

Adverse events were reported in an inconsistent manner and not according to the manner prespecified in our protocol. Additionally, we were mainly interested in identifying serious adverse events, which were inadequately reported

Overall survival

Not estimable

⊕⊝⊝⊝4
verylow

Not reported by trial authors so graded as very low quality evidence

Progression‐free survival

Not estimable

⊕⊝⊝⊝4
verylow

Progression‐free survival or time to progression was not adequately reported in the trial

Quality of life

Not estimable

⊕⊝⊝⊝4
verylow

Quality of life was not reported in the trial

*The basis for the assumed risk is only based on individual trials as only single trial reports were available. 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; iMRI: intraoperative magnetic resonance imaging; RR: risk ratio

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.

1Expressed in terms of risk of incomplete resection (bad outcome).
2Small trial so quality of the evidence downgraded by one level.
3Highly selected participants with potential bias in allocation and performance as well as in other 'Risk of bias' domains, thus downgraded by two levels.
4Outcome was not reported (or inadequately reported for meaningful conclusions to be drawn), therefore giving lowest quality of evidence judgement.

Figuras y tablas -
Summary of findings 1. iMRI image‐guided surgery compared to standard surgery for high‐grade glioma
Summary of findings 2. 5‐ALA image‐guided surgery compared to standard surgery for high‐grade glioma

5‐ALA image‐guided surgery compared to standard surgery for high‐grade glioma

Patient or population: high‐grade glioma
Settings: specialist centres
Intervention: 5‐ALA image‐guided surgery (based on post‐operative MRI)
Comparison: standard surgery

Outcomes

Illustrative comparative risk* (95% CI)

Relative effect
(95% CI)

No. of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Control

Image‐guided surgery

Extent of resection: complete resection

641 per 100

35 per 100
(27 to 45)

RR 0.55 (0.42 to 0.71)

270 participants

(1 study)

⊕⊕⊝⊝2
low

Highly selected participants with potential bias in allocation and performance

Adverse events

Inadequately and inconsistently reported in the trial

⊕⊝⊝⊝3
verylow

Adverse events were reported in an inconsistent manner and not according to the manner prespecified in our protocol. Additionally, we were mainly interested in identifying serious adverse events, which were inadequately reported

Overall survival

Not estimable due to reporting of HR and since just a single trial reported on this outcome we did not arbitrarily choose a snap shot in time in which to use as basis to calculate the assumed and corresponding risks as this may be misleading.

HR 0.82

(0.62 to 1.07)

270 participants

(1 study)

⊕⊕⊝⊝2
low

The overall quality of this outcome was low in this trial and was downgraded for highly selected participants with potential bias in allocation and performance

Progression‐free survival

Not adequately reported in the trials

⊕⊝⊝⊝3
verylow

Progression‐free survival or time to progression was not adequately reported in the trial

Quality of life

Inadequately reported or not assessed at all in the included trials

⊕⊝⊝⊝3
verylow

Quality of life was not reported in the trial

*The basis for the assumed risk is only based on individual trials as only single trial reports were available. 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).
5‐ALA: 5‐aminolevulinic acid; CI: confidence interval; HR: hazard ratio; RR: risk ratio

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.

1Expressed in terms of risk of incomplete resection (bad outcome).
2Highly selected participants with potential bias in allocation and performance as well as in other 'Risk of bias' domains, thus downgraded by two levels.
3Outcome was not reported (or inadequately reported for meaningful conclusions to be drawn), therefore giving lowest quality of evidence judgement.

Figuras y tablas -
Summary of findings 2. 5‐ALA image‐guided surgery compared to standard surgery for high‐grade glioma
Summary of findings 3. Neuronavigation image‐guided surgery compared to standard surgery for high‐grade glioma

Neuronavigation image‐guided surgery compared to standard surgery for high‐grade glioma

Patient or population: high‐grade glioma
Settings: specialist centres
Intervention: neuronavigation image‐guided surgery (based on post‐operative MRI)
Comparison: standard surgery

Outcomes

Illustrative comparative risk* (95% CI)

Relative effect
(95% CI)

No. of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Control

Image‐guided surgery

Extent of resection: complete resection

Not estimable

Not estimable

Not reported

45 participants
(1 study)

⊕⊝⊝⊝1,2,4
verylow

Small study of highly selected participants at very high risk of allocation bias.Complete resection was achieved in three participants in the control group and five participants in the neuronavigation group. However, there was significant attrition, with not all participants completing imaging, and the denominators for these figures were not stated, precluding formal analysis

Adverse events

Inadequately and inconsistently reported in the trial

⊕⊝⊝⊝2
verylow

Adverse events were reported in an inconsistent manner and not according to the manner prespecified in our protocol. Additionally, we were mainly interested in identifying serious adverse events, which were inadequately reported

Overall survival

Not estimable

⊕⊝⊝⊝3
verylow

Not reported by trial authors so graded as very low quality evidence

Progression‐free survival

Not estimable

⊕⊝⊝⊝2
verylow

Progression‐free survival or time to progression was not reported in the trial

Quality of life

Inadequately reported or not assessed at all in the included trials

⊕⊝⊝⊝3
verylow

Quality of life was reported in the trial but only 19 participants (8 in the neuronavigation arm and 11 in the standard surgery arm) completed questionnaires postoperatively at 3 months', constituting only 64.5% of all eligible participants, and no statistical analysis was presented

*The basis for the assumed risk is only based on individual trials as only single trial reports were available. 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

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.

1Small trial so quality of the evidence downgraded by one level.
2Highly selected participants with potential bias in allocation and performance as well as in other 'Risk of bias' domains, thus downgraded by two levels.
3Outcome was not reported (or inadequately reported for meaningful conclusions to be drawn), therefore giving lowest quality of evidence judgement.

Figuras y tablas -
Summary of findings 3. Neuronavigation image‐guided surgery compared to standard surgery for high‐grade glioma
Table 1. Karnofsky performance score

Score

Definition

100

Normal, no complaints, no evidence of disease

90

Able to carry on normal activity: minor symptoms of disease

80

Normal activity with effort: some symptoms of disease

70

Cares for self: unable to carry on normal activity or active work

60

Requires occasional assistance but is able to care for needs

50

Requires considerable assistance and frequent medical care

40

Disabled: requires special care and assistance

30

Severely disabled: hospitalisation is indicated, death is not imminent

20

Very sick, hospitalisation is necessary: active treatment is necessary

10

Moribund, fatal processes are progressing rapidly

0

Dead

Figuras y tablas -
Table 1. Karnofsky performance score
Table 2. WHO performance score

Grade

Definition

0

Fully active, able to carry on all pre‐disease performance without restriction

1

Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g.
light house work, office work

2

Ambulatory and capable of all self care, but unable to carry out any work activities. Up and about more than 50% of
waking hours

3

Capable of only limited self care, confined to bed or chair more than 50% of waking hours

4

Completely disabled. Cannot carry out any self care. Totally confined to bed or chair

5

Dead

Figuras y tablas -
Table 2. WHO performance score