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An open randomised study of autoinflation in 4- to 11-year-old school children with otitis media with effusion in primary care

An open randomised study of autoinflation in 4- to 11-year-old school children with otitis media with effusion in primary care
An open randomised study of autoinflation in 4- to 11-year-old school children with otitis media with effusion in primary care

Background: otitis media with effusion (OME) is a very common problem in primary care, but one that lacks an evidence-based non-surgical treatment.

Objective: to determine the clinical effectiveness of nasal balloon autoinflation for the treatment of OME in children.

Design: a pragmatic, two-arm, open randomised controlled trial.

Setting: forty-three general practices from 17 UK primary care trusts recruited between January 2012 and February 2013.

Participants: school children aged 4-11 years with a history of OME symptoms or related concerns in the previous 3 months, and a type B tympanogram, diagnostic of a middle ear effusion, in one or both ears.

Intervention: three hundred and twenty children were randomised, 160 to each group, using independent web-based computer-generated randomisation (with minimisation based on age, sex and baseline severity of OME) to either nasal balloon autoinflation performed three times per day for 1-3 months plus usual care, or usual care alone.

Main outcome measures: the proportion of children demonstrating clearance of middle ear fluid in at least one ear (with normal tympanograms) at 1 and 3 months, assessed blind to treatment. An ear-related measure of quality of life (QoL) [a 14-point questionnaire on the impact of OME (OMQ-14)], weekly diary recorded symptoms, compliance and adverse events were all secondary outcomes.

Results: at 1 month, the proportion of children with normal tympanograms was 47.3% (62/131) in those allocated to autoinflation and 35.6% (47/132) in those receiving usual care [adjusted relative risk (RR) 1.36, 95% confidence interval (CI) 0.99 to 1.88]. At 3 months, the proportions were 49.6% (62/125) and 38.3% (46/120), respectively (adjusted RR 1.37, 95% CI 1.03 to 1.83; number needed to treat = 9). The change in OMQ-14 also favoured the intervention arm (adjusted global score difference -0.42; p = 0.001). Reported compliance was good: 89% in the first month and 80% in months 2 and 3. Adverse events included otalgia in 4% of treated children compared with 1% in the control group. Minor nosebleeds (14% vs. 15%) and respiratory tract infections (18% vs. 13%) were noted.

Conclusion: we found the use of autoinflation in young children with OME to be feasible in primary care and effective in both clearing effusions and improving child and parent ear-related QoL and symptoms. This method has scope to be used more widely. Further research is needed for very young children, and to inform prudent use in different health settings.

Child, Child, Preschool, Female, Humans, Insufflation, Male, Nose, Otitis Media with Effusion, Primary Health Care, Quality of Life, Treatment Outcome, United Kingdom, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
1366-5278
1-150
Williamson, Ian
12381296-edbf-4ac5-969b-dcb559c22f27
Vennik, Jane
6ee78166-5a7a-433b-87fc-018771f20b19
Harnden, Anthony
bbb10d37-b475-4c3c-b669-427d4d7ead8c
Voysey, Merryn
fd433353-cd7b-41af-bc72-69781e8a0f81
Perera, Rafael
72025ce5-fb66-42f1-9a38-1694e485e754
Breen, Maria
9e8651fc-1ac8-4405-9f1d-5db4147c87f8
Bradley, Brendan
bdacaa6c-528b-4086-9448-27ebfe463514
Kelly, Sadie
00c2d18c-403a-41f2-a83d-007e0f7cb7b8
Yao, Guiqing
d777f84c-cf3d-4fad-bbc1-ea01dec01695
Raftery, James
27c2661d-6c4f-448a-bf36-9a89ec72bd6b
Mant, David
d2e30212-70ec-48c9-b80a-a45cf4bcc46e
Little, Paul
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
Williamson, Ian
12381296-edbf-4ac5-969b-dcb559c22f27
Vennik, Jane
6ee78166-5a7a-433b-87fc-018771f20b19
Harnden, Anthony
bbb10d37-b475-4c3c-b669-427d4d7ead8c
Voysey, Merryn
fd433353-cd7b-41af-bc72-69781e8a0f81
Perera, Rafael
72025ce5-fb66-42f1-9a38-1694e485e754
Breen, Maria
9e8651fc-1ac8-4405-9f1d-5db4147c87f8
Bradley, Brendan
bdacaa6c-528b-4086-9448-27ebfe463514
Kelly, Sadie
00c2d18c-403a-41f2-a83d-007e0f7cb7b8
Yao, Guiqing
d777f84c-cf3d-4fad-bbc1-ea01dec01695
Raftery, James
27c2661d-6c4f-448a-bf36-9a89ec72bd6b
Mant, David
d2e30212-70ec-48c9-b80a-a45cf4bcc46e
Little, Paul
1bf2d1f7-200c-47a5-ab16-fe5a8756a777

Williamson, Ian, Vennik, Jane, Harnden, Anthony, Voysey, Merryn, Perera, Rafael, Breen, Maria, Bradley, Brendan, Kelly, Sadie, Yao, Guiqing, Raftery, James, Mant, David and Little, Paul (2015) An open randomised study of autoinflation in 4- to 11-year-old school children with otitis media with effusion in primary care. Health Technology Assessment, 19 (72), 1-150. (doi:10.3310/hta19720).

Record type: Article

Abstract

Background: otitis media with effusion (OME) is a very common problem in primary care, but one that lacks an evidence-based non-surgical treatment.

Objective: to determine the clinical effectiveness of nasal balloon autoinflation for the treatment of OME in children.

Design: a pragmatic, two-arm, open randomised controlled trial.

Setting: forty-three general practices from 17 UK primary care trusts recruited between January 2012 and February 2013.

Participants: school children aged 4-11 years with a history of OME symptoms or related concerns in the previous 3 months, and a type B tympanogram, diagnostic of a middle ear effusion, in one or both ears.

Intervention: three hundred and twenty children were randomised, 160 to each group, using independent web-based computer-generated randomisation (with minimisation based on age, sex and baseline severity of OME) to either nasal balloon autoinflation performed three times per day for 1-3 months plus usual care, or usual care alone.

Main outcome measures: the proportion of children demonstrating clearance of middle ear fluid in at least one ear (with normal tympanograms) at 1 and 3 months, assessed blind to treatment. An ear-related measure of quality of life (QoL) [a 14-point questionnaire on the impact of OME (OMQ-14)], weekly diary recorded symptoms, compliance and adverse events were all secondary outcomes.

Results: at 1 month, the proportion of children with normal tympanograms was 47.3% (62/131) in those allocated to autoinflation and 35.6% (47/132) in those receiving usual care [adjusted relative risk (RR) 1.36, 95% confidence interval (CI) 0.99 to 1.88]. At 3 months, the proportions were 49.6% (62/125) and 38.3% (46/120), respectively (adjusted RR 1.37, 95% CI 1.03 to 1.83; number needed to treat = 9). The change in OMQ-14 also favoured the intervention arm (adjusted global score difference -0.42; p = 0.001). Reported compliance was good: 89% in the first month and 80% in months 2 and 3. Adverse events included otalgia in 4% of treated children compared with 1% in the control group. Minor nosebleeds (14% vs. 15%) and respiratory tract infections (18% vs. 13%) were noted.

Conclusion: we found the use of autoinflation in young children with OME to be feasible in primary care and effective in both clearing effusions and improving child and parent ear-related QoL and symptoms. This method has scope to be used more widely. Further research is needed for very young children, and to inform prudent use in different health settings.

Full text not available from this repository.

More information

e-pub ahead of print date: September 2015
Published date: September 2015
Keywords: Child, Child, Preschool, Female, Humans, Insufflation, Male, Nose, Otitis Media with Effusion, Primary Health Care, Quality of Life, Treatment Outcome, United Kingdom, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't

Identifiers

Local EPrints ID: 416401
URI: https://eprints.soton.ac.uk/id/eprint/416401
ISSN: 1366-5278
PURE UUID: 460a49d8-d8e0-41cc-aa23-d494370a6e74
ORCID for Jane Vennik: ORCID iD orcid.org/0000-0003-4602-9805
ORCID for Brendan Bradley: ORCID iD orcid.org/0000-0003-2801-4271

Catalogue record

Date deposited: 15 Dec 2017 17:30
Last modified: 17 Jul 2019 00:27

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