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Base de datos Cochrane de Revisiones Sistemáticas Protocolo - Intervención

Tocilizumab for thyroid eye disease

Declaraciones de intereses de los autores

Versión publicada: 25 marzo 2018 Historial de versiones

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

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ver la versión actual 27 noviembre 2018

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Temas

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
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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