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Cochrane Database of Systematic Reviews

Corticosteroides sistémicos para la otitis media aguda en niños

Information

DOI:
https://doi.org/10.1002/14651858.CD012289.pub2Copy DOI
Database:
  1. Cochrane Database of Systematic Reviews
Version published:
  1. 15 March 2018see what's new
Type:
  1. Intervention
Stage:
  1. Review
Cochrane Editorial Group:
  1. Cochrane Acute Respiratory Infections Group

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

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Authors

  • Respati W Ranakusuma

    Correspondence to: Centre for Research in Evidence‐Based Practice (CREBP), Bond University, Gold Coast, Australia

    [email protected]

    [email protected]

    Clinical Epidemiology & Evidence‐Based Medicine Unit, Dr Cipto Mangunkusumo Hospital ‐ Faculty of Medicine Universitas Indonesia, Jakarta, Indonesia

  • Yupitri Pitoyo

    Clinical Epidemiology & Evidence‐Based Medicine Unit, Dr Cipto Mangunkusumo Hospital ‐ Faculty of Medicine Universitas Indonesia, Jakarta, Indonesia

  • Eka D Safitri

    Clinical Epidemiology & Evidence‐Based Medicine Unit, Dr Cipto Mangunkusumo Hospital ‐ Faculty of Medicine Universitas Indonesia, Jakarta, Indonesia

  • Sarah Thorning

    GCUH Library, Gold Coast University Hospital, Southport, Australia

  • Elaine M Beller

    Centre for Research in Evidence‐Based Practice (CREBP), Bond University, Gold Coast, Australia

  • Sudigdo Sastroasmoro

    Clinical Epidemiology & Evidence‐Based Medicine Unit, Dr Cipto Mangunkusumo Hospital ‐ Faculty of Medicine Universitas Indonesia, Jakarta, Indonesia

    Department of Pediatrics, Dr. Cipto Mangunkusumo Hospital ‐ Faculty of Medicine Universitas Indonesia, Jakarta, Indonesia

  • Chris B Del Mar

    Centre for Research in Evidence‐Based Practice (CREBP), Bond University, Gold Coast, Australia

Contributions of authors

Respati W Ranakusuma (RR) drafted the protocol and contributed as a primary review author, selected studies for inclusion, extracted data, assessed the risk of bias, entered data into Review Manager 5, and carried out and interpreted the analysis.
Yupitri Pitoyo (YP) selected studies for inclusion, extracted data, and assessed the risk of bias.
Eka Dian Safitri (EDS) selected studies for inclusion, extracted data, and assessed the risk of bias.
Sarah Thorning (ST) developed and ran the search strategy, and obtained copies of studies.
Elaine M Beller (EMB) carried out and interpreted the analysis, contributed as the fourth review author for disagreements on methodological/statistical issues, and checked the correct use of grammar.
Sudigdo Sastroasmoro (SS) drafted the protocol, contributed to drafting the final review, and checked the correct use of grammar.
Chris B Del Mar (CDM) drafted the protocol and contributed as the fifth review author for disagreements on clinical issues (if needed), drafted the final review, and checked the correct use of grammar.

Declarations of interest

Respati W Ranakusuma: none known
Yupitri Pitoyo: none known
Eka Dian Safitri: none known
Sarah Thorning: none known
Elaine M Beller: her work on this review was supported by a grant from the National Health and Medical Research Council, Australia, to the Centre for Research in Evidence‐Based Practice, Bond University
Sudigdo Sastroasmoro: none known
Chris B Del Mar: none known

Acknowledgements

This review is part of a PhD project at the Centre for Research in Evidence‐Based Practice, Bond University (CREBP) Faculty of Health Sciences and Medicine, Bond University, Gold Coast, Australia. It is supported by the CREBP, Bond University.

We would especially like to thank Clare Dooley and Liz Dooley for their assistance in the preparation of the protocol. We wish to thank the following people for commenting on the draft protocol: Jean Symes, Zaina AlBalawi, Brian Westerberg, Simona Nistor‐Grahl, Ravi Shankar, and Michelle Guppy. We thank the following people for commenting on the draft review: Shunjie Chua, Esther Martin Anna Granath, Mark Jones, and Michelle Guppy.

The methods section of this protocol is based on a standard template developed by Cochrane Airways and adapted by the Cochrane Acute Respiratory Infections Group.

Version history

Published

Title

Stage

Authors

Version

2018 Mar 15

Systemic corticosteroids for acute otitis media in children

Review

Respati W Ranakusuma, Yupitri Pitoyo, Eka D Safitri, Sarah Thorning, Elaine M Beller, Sudigdo Sastroasmoro, Chris B Del Mar

https://doi.org/10.1002/14651858.CD012289.pub2

2016 Jul 20

Systemic corticosteroids for acute otitis media in children

Protocol

Respati W Ranakusuma, Yupitri Pitoyo, Eka D Safitri, Sarah Thorning, Elaine M Beller, Sudigdo Sastroasmoro, Chris B Del Mar

https://doi.org/10.1002/14651858.CD012289

Keywords

MeSH

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

Study flow diagram.
Figures and Tables -
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.
Figures and Tables -
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.
Figures and Tables -
Figure 3

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

Comparison 1 Systemic corticosteroids versus placebo for children with acute otitis media, Outcome 1 Reduction of overall or specific symptoms at various time points.
Figures and Tables -
Analysis 1.1

Comparison 1 Systemic corticosteroids versus placebo for children with acute otitis media, Outcome 1 Reduction of overall or specific symptoms at various time points.

Comparison 1 Systemic corticosteroids versus placebo for children with acute otitis media, Outcome 2 Changes in tympanometry measurement at various time points.
Figures and Tables -
Analysis 1.2

Comparison 1 Systemic corticosteroids versus placebo for children with acute otitis media, Outcome 2 Changes in tympanometry measurement at various time points.

Comparison 1 Systemic corticosteroids versus placebo for children with acute otitis media, Outcome 3 AOM recurrence at various time points.
Figures and Tables -
Analysis 1.3

Comparison 1 Systemic corticosteroids versus placebo for children with acute otitis media, Outcome 3 AOM recurrence at various time points.

Summary of findings for the main comparison. Systemic corticosteroids compared to placebo for children with acute otitis media

Systemic corticosteroids versus placebo for children with acute otitis media

Patient or population: children with acute otitis media
Setting: paediatric outpatient clinics
Intervention: systemic corticosteroids
Comparison: placebo

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with placebo

Risk with systemic corticosteroids

Proportion of children with pain at various time points

Day 5

Study population

Not estimable

(0 studies)

Only pre‐treatment data were available. We could not retrieve post‐treatment data.

0 per 1000

0 per 1000
(0 to 0)

Day 14

Study population

Not estimable

(0 studies)

Only pre‐treatment data were available. We could not retrieve post‐treatment data.

0 per 1000

0 per 1000
(0 to 0)

Reduction of overall or specific symptoms at various time points

Day 5

Study population

RR 1.06
(0.97 to 1.16)

179
(1 RCT)

⊕⊕⊝⊝
LOW 1

This outcome was represented as the proportion of children for whom symptoms and inflamed eardrum(s) resolved and who did not require additional antibiotic treatment.

889 per 1000

942 per 1000
(862 to 1000)

Day 14

Study population

RR 1.05
(0.95 to 1.17)

179
(1 RCT)

⊕⊕⊝⊝
LOW 1

This outcome was represented as the proportion of children for whom symptoms and inflamed eardrum(s) resolved and who did not require additional antibiotic treatment.

867 per 1000

910 per 1000
(823 to 1000)

Reduction in overall or specific symptom duration

Study population

Not estimable

(0 studies)

No study provided data for this outcome.

0 per 1000

0 per 1000
(0 to 0)

Adverse effects

Study population

Not estimable

(0 studies)

The available data were reported as an overall result. We could not retrieve data from each individual group (overall side effects across all groups: drowsiness (22% to 34%), dry mouth (16% to 27%), increased urine amount (14% to 27%), nappy rash (7% to 32%), nervousness (7% to 20%), and decreased urine amount (0% to 11%)).

0 per 1000

0 per 1000
(0 to 0)

*The risk in the intervention group (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; RCT: randomised controlled trial; RR: risk ratio

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect.
Moderate quality: We are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
Low quality: Our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.
Very low quality: We have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

1Downgraded one level due to study limitations (unclear description of the allocation concealment and evidence of selective reporting) and one level due to indirectness (differences between the outcome of interest (i.e. in reporting, measurements) and reported outcomes).

Figures and Tables -
Summary of findings for the main comparison. Systemic corticosteroids compared to placebo for children with acute otitis media
Comparison 1. Systemic corticosteroids versus placebo for children with acute otitis media

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Reduction of overall or specific symptoms at various time points Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

1.1 Day 5

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.2 Day 14

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 Changes in tympanometry measurement at various time points Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

2.1 Month 1

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.2 Month 2

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.3 Month 3

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3 AOM recurrence at various time points Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

3.1 Month 1

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.2 Month 2

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.3 Month 3

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.4 During Month 4 to Month 6

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

Figures and Tables -
Comparison 1. Systemic corticosteroids versus placebo for children with acute otitis media