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Cochrane Database of Systematic Reviews

Tocilizumab for thyroid eye disease

Esta versión no es la más reciente

ver la versión actual 27 noviembre 2018

Información

DOI:
https://doi.org/10.1002/14651858.CD012984Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 25 marzo 2018see what's new
Tipo:
  1. Intervention
Etapa:
  1. Protocol
Grupo Editorial Cochrane:

  1. Grupo Cochrane de Salud ocular y de la visión

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

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Autores

  • Shirin Hamed Azzam

    Correspondencia a: Moorfields Eye Hospital NHS Foundation Trust, London, UK

    [email protected]

  • Swan Kang

    Moorfields Eye Hospital NHS Foundation Trust, London, UK

  • Mario Salvi

    Milan, Italy

  • Daniel G Ezra

    Moorfields and UCL Institute of Ophthalmology BMRC, Moorfields Eye Hospital NHS Foundation Trust, London, UK

Contributions of authors

Drafting the protocol: SHA, SK
Drafting the final version of the protocol: DE, MS

Sources of support

Internal sources

  • No sources of support supplied

External sources

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

    • Richard Wormald, Co‐ordinating Editor for Cochrane Eyes and Vision (CEV) acknowledges financial support for his CEV research sessions from the Department of Health through the award made by the National Institute for Health Research to Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology for a Specialist Biomedical Research Centre for Ophthalmology.

    • This protocol was supported by the NIHR, via Cochrane Infrastructure funding to the CEV UK editorial base.

    The views and opinions expressed therein 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

None

Acknowledgements

The Cochrane Eyes and Vision has created and will execute the electronic search strategies. We would like to thank Faye Wellington and Jennifer Evans for their comments on the protocol, and Anupa Shah and the editorial team for helping with registration and preparation of the protocol.

Version history

Published

Title

Stage

Authors

Version

2018 Nov 27

Tocilizumab for thyroid eye disease

Review

Shirin Hamed Azzam, Swan Kang, Mario Salvi, Daniel G Ezra

https://doi.org/10.1002/14651858.CD012984.pub2

2018 Mar 25

Tocilizumab for thyroid eye disease

Protocol

Shirin Hamed Azzam, Swan Kang, Mario Salvi, Daniel G Ezra

https://doi.org/10.1002/14651858.CD012984

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.

Table 1. Type of intervention: intravenous tocilizumab treatment versus standard treatment. Type of studies: randomised controlled trials

Outcomes

Measure

Relative effect

Number of participants
(studies)

Quality of evidence
(GRADE*)

Comments

Change in TED as defined by investigators

Measured in CAS/EUGOGO/NOSPECS/VISA classification at 12 months (range 6 to 18 months) post treatment.

Change in proptosis

Measured in millimetres at 12 months (range 6 to 18 months) post treatment.

Change in extraocular motility

Measured in degrees at 12 months (range 6 to 18 months) post treatment.

Number of relapses

per participant at 12 months (range 6 to 18 months) post treatment.

Development of optic neuropathy

as defined by the trial investigators at 12 months (range 6 to 18 months) post treatment.

Change in quality‐of‐life score

GO‐QOL score or EQ‐5D score at 12 months (range 6 to 18 months) post treatment.

MCID = 6 points

Adverse effects

Any adverse effect that is reported at 12 months (range 6 to 18 months) post treatment.

*The GRADE approach defines the quality of a body of evidence as the extent to which one can be confident that an estimate of effect or association is close to the quantity of specific interest. Quality of a body of evidence involves consideration of within‐study risk of bias (methodological quality), directness of evidence, heterogeneity, precision of effect estimates and risk of publication bias.
TED= Thyroid Eye Disease.

CAS = Clinical Activity Score.

EUGOGO= European Group On Graves' Orbitopathy.
NOSPECS = No symptoms or signs, Only signs, Soft tissue involvement, Proptosis, Extraocular muscle involvement, Corneal involvement and Sight loss. It is graded as 0, a, b or c.

VISA= Vision, Inflammation, Strabismus, and Appearance classification.
GO‐QOL = Graves' Orbitopathy Quality of Life questionnaire.

EQ‐5D= European Quality of life questionnaire.

The treatment effect for each continuous outcomes will be expressed as a mean difference (MD) with 95% CI. Where continuous outcomes are measured using different scales, the treatment effect will be expressed as a standardised mean difference (SMD) with 95% CI.

Figuras y tablas -
Table 1. Type of intervention: intravenous tocilizumab treatment versus standard treatment. Type of studies: randomised controlled trials
Ir a la tabla del protocolo
Table 2. Type of intervention: intravenous tocilizumab treatment versus placebo. Type of studies: randomised controlled trials

Outcomes

Measure

Relative
effect

Number of participants
(studies)

Quality of evidence
(GRADE*)

Comments

Change in TED as defined by investigators

Measured in CAS/EUGOGO/NOSPECS/VISA classification at 12 months (range 6 to 18 months) post treatment.

Change in proptosis

Measured in millimetres at 12 months (range 6 to 18 months) post treatment.

Change in extraocular motility

Measured in degrees at 12 months (range 6 to 18 months) post treatment.

Number of relapses

per participant at 12 months (range 6 to 18 months) post treatment.

Development of optic neuropathy

as defined by the trial investigators at 12 months (range 6 to 18 months) post treatment.

Change in quality‐of‐life score

GO‐QOL score or EQ‐5D score at 12 months (range 6 to 18 months) post treatment.

MCID = 6 points

Adverse effects

Any adverse effect that is reported at 12 months (range 6 to 18 months) post treatment.

*The GRADE approach defines the quality of a body of evidence as the extent to which one can be confident that an estimate of effect or association is close to the quantity of specific interest. Quality of a body of evidence involves consideration of within‐study risk of bias (methodological quality), directness of evidence, heterogeneity, precision of effect estimates and risk of publication bias.
TED= Thyroid Eye Disease.

CAS = Clinical Activity Score.

EUGOGO= European Group On Graves' Orbitopathy.
NOSPECS = No symptoms or signs, Only signs, Soft tissue involvement, Proptosis, Extraocular muscle involvement, Corneal involvement and Sight loss. It is graded as 0, a, b or c.

VISA= Vision, Inflammation, Strabismus, and Appearance classification.
GO‐QOL = Graves' Orbitopathy Quality of Life questionnaire.

EQ‐5D= European Quality of life questionnaire.

The treatment effect for each continuous outcomes will be expressed as a mean difference (MD) with 95% CI. Where continuous outcomes are measured using different scales, the treatment effect will be expressed as a standardised mean difference (SMD) with 95% CI.

Figuras y tablas -
Table 2. Type of intervention: intravenous tocilizumab treatment versus placebo. Type of studies: randomised controlled trials
Ir a la tabla del protocolo