Autoinflation for otitis media with effusion (OME) in children

Classified as probably not a substantial claim. May combine two claims.

The aim of autoinflation is to introduce air into the middle ear via the Eustachian tube, equalising pressures either side of the tympanic membrane and promoting drainage of fluid.

“The aim of autoinflation is to introduce air into the middle ear, via the Eustachian tube, thus equalising the pressures either side of the tympanic membrane, and promoting drainage of fluid (Perera 2013).”

• cites Perera 2013 sourceSupported

May combine two claims.

A Cochrane Review assessing the effects of autoinflation on OME for adults and children was published in 2013, updating a review originally published in 2006.

“A Cochrane Review assessing the effects of autoinflation on OME for adults and children was published in 2013 (Perera 2013), updating a review originally published in 2006.”

• cites Perera 2013 sourceSupported

Probably not a substantial claim: may not pass S3 (load-bearing).

These outcomes were identified as the most important in two studies that aimed to develop a core outcome set for children with OME.

“These outcomes were identified as the most important in two studies that aimed to develop a core outcome set for children with OME (Bruce 2015; Liu 2020).”

• cites Bruce 2015 sourcePartly supported

  The Results report that a consensus process selected nine outcomes for a core outcome set. However, the study aimed to develop that set for children with both otitis media with effusion (OME) and cleft palate, not children with OME generally. This verdict addresses Bruce 2015 only, not the separately cited Liu 2020 study. (LLM, conf=0.84)

  Experimental — accuracy not yet measured
• cites Liu 2020 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing).

The previous Cochrane Review on this topic included eight studies with a total of 702 participants (Perera 2013).

“The previous Cochrane Review on this topic included eight studies, with a total of 702 participants (Perera 2013).”

• cites Perera 2013 sourceSupported

Probably not a substantial claim: may not pass S3 (load-bearing).

A core outcome set has been developed in this field.

“It is encouraging that a core outcome set has been developed in this field (Bruce 2015; Liu 2020).”

• cites Bruce 2015 sourceSupported
• cites Liu 2020 sourceNot checked — no full text of the source

Classified as probably not a substantial claim.

The previous review authors concluded that autoinflation has a beneficial effect on resolution of OME.

“The review authors concluded that autoinflation has a beneficial effect on resolution of OME.”

• cites Perera 2013 sourcePartly supported

  The Discussion says autoinflation appears to benefit resolution of glue ear (OME), so the review supports the direction of the claim. But the Authors’ conclusions say the analysis permits no firm conclusion and that evidence appears favourable at least in the short term; the citing sentence presents that qualified finding as definitive. (LLM, conf=0.87)

  Experimental — accuracy not yet measured

Classified as probably not a substantial claim. May combine two claims.

The previous review authors noted that none of the included studies were rated as high quality, and many effect estimates had wide confidence intervals and failed to reach conventional statistical significance.

“However, the authors noted that none of the included studies were rated as high quality, and many of the effect estimates had wide confidence intervals and failed to reach conventional statistical significance.”

• cites Perera 2013 sourceSupported

Probably not a substantial claim: may not pass S3 (load-bearing).

Most included studies required children to carry out autoinflation two to three times per day, for between 2 and 12 weeks.

“Most studies required children to carry out autoinflation two to three times per day, for between 2 and 12 weeks.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The majority of included studies included children aged between 3 and 11 years.

“The majority of studies included children aged between 3 and 11 years.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Most included studies were carried out in Europe or North America, and they were conducted in both hospital and community settings.

“Most were carried out in Europe or North America, and they were conducted in both hospital and community settings.”

May combine two claims.

The review identified 11 completed studies that met its inclusion criteria, involving 1036 participants.

“We identified 11 completed studies that met our inclusion criteria (1036 participants).”

• Also stated in: § What did we find? · p. 6 · plain

  “We found 11 studies that involved 1036 children with OME.”

Classified as probably not a substantial claim.

The authors of the quality-of-life study reported a change of 0.3 as clinically meaningful.

“the authors report a change of 0.3 as clinically meaningful”

Probably not a substantial claim: may not pass S3 (load-bearing).

Searches identified two clinical trial registrations relating to a Swedish study of the Otovent device.

“Searches also identified two clinical trial registrations relating to a Swedish study of the Otovent device (Ejnell 2015a; Ejnell 2015b).”

• cites Ejnell 2015aNot matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites Ejnell 2015bNot matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

Outcomes in the included studies were predominantly assessed just after the treatment phase had been completed.

“The outcomes were predominantly assessed just after the treatment phase had been completed.”

May combine two claims.

Due to problems with the website-based assessment and late ethics permission, insufficient numbers of children completed the receptive language follow-up test, and the data were not reported.

“However, due to problems with the website-based assessment and late ethics permission, insufficient numbers of children completed this follow-up test, and the data were not reported.”

May combine two claims.

The review did not assess the number of children who received further treatment for OME, so it does not have data to show whether autoinflation prevents children from ultimately receiving surgery and ventilation tube insertion.

“Finally, we did not assess the number of children who received further treatment for OME (including medical or surgical interventions) as part of this review. Therefore, we do not have data to show whether this intervention prevents children from ultimately receiving surgery and ventilation tube insertion as a treatment for OME.”

May combine two claims.

For hearing threshold at short-term follow-up (6 weeks to 3 months), data from two studies could not be pooled; at each frequency the direction of effect favored autoinflation, with mean differences between groups ranging from -9.04 to -12.88 dB HL (95% CI ranging from -2.83 to -17.85; 2 studies, 113 participants; I2 from 0% to 57%; low-certainty evidence).

“At each frequency the direction of effect was in favour of autoinflation (mean differences between groups ranging from -9.04 to -12.88 dB HL, 95% CI ranging from -2.83 to -17.85; 2 studies, 113 participants; I 2 from 0% to 57%; Analysis 1.4; low-certainty evidence).”

May combine two claims.

The review did not identify any evidence on generic quality of life, expressive or receptive language skills, cognitive development, psychosocial outcomes, listening skills, parental stress, or vestibular function.

“We did not identify any evidence on generic quality of life, expressive or receptive language skills, cognitive development, psychosocial outcomes, listening skills, parental stress or vestibular function.”

May combine two claims.

All 11 trials assessing autoinflation versus no treatment provided data usable in the review except Scadding 2014, which did not provide data for any outcomes of interest.

“All provided data we could use in this review except for Scadding 2014, which did not provide data for any of our outcomes of interest.”

May combine two claims.

A substantial proportion of studies did not assess compliance, and the studies that did used different measures to assess it.

“However, we note that a substantial proportion of studies did not assess compliance. In addition, the studies that did provide an assessment of compliance used different measures to assess this.”

May combine two claims.

Many included studies enrolled children who had OME for at least three months, but children with a shorter duration of disease were also included.

“Many of the studies included in this review enrolled children who had OME for at least three months, however children with a shorter duration of disease were also included.”

Probably not a substantial claim: may not pass S3 (load-bearing).

One study reported on the presence of otalgia in both groups (Williamson 2015a).

“One study did report on the presence of otalgia in both groups (Williamson 2015a).”

May combine two claims.

Six studies did not report any information on adverse events, and it is not clear whether this was because no events occurred or because they were not assessed or reported.

“Six studies did not report any information on adverse events. It is not clear whether this was because no events occurred, or because they were not assessed or reported (Arick 2005; Blanshard 1993; Brooker 1992; Ercan 2005; Stangerup 1992; Williamson 2015a).”

May combine two claims.

The review did not assess the proportion of children who went on to receive medical or surgical treatment for OME, so it is not known whether autoinflation has any impact on this.

“As we did not assess the proportion of children who went on to receive medical or surgical treatment for OME, we do not know whether the use of autoinflation has any impact on this.”

May combine two claims.

There is considerable inconsistency in the very short-term persistence analysis, with one study appearing to favour no intervention and two studies showing little difference between groups.

“It should be noted that there is considerable inconsistency in this analysis, with one study appearing to favour no intervention, and two studies showing little difference between the two groups.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Of the 11 trials assessing autoinflation versus no treatment, five used an Otovent, one used an EarPopper, one used a modified Politzer device, three used devices designed by the trial authors, and one used a modified Valsalva technique.

“Of these 11 trials, five used an Otovent as the autoinflation intervention (Blanshard 1993; Ercan 2005; Scadding 2014; Williamson 2015a; Williamson 2015b), one used an EarPopper (Banigo 2016), and one used a modified Politzer device (Arick”

• Also stated in: § Comparison 1: autoinflation versus no treatment (watchful waiting) · p. 18 · plain

  “2005). Three trials used devices designed by the trial authors (Bidarian-Moniri 2014; Brooker 1992; Stangerup 1992) and one used a modified Valsalva technique (Chan 1989).”

May combine two claims.

The review did not have enough data to consider the variety of devices and techniques as part of a subgroup analysis, so it cannot say if one method works better than another.

“A variety of devices and techniques were used to carry out autoinflation, ranging from custom-made devices to commercially available products such as Otovent. We did not have enough data to consider this as part of a subgroup analysis, so cannot say if one method works better than another.”

Probably not a substantial claim: may not pass S3 (load-bearing).

We did not perform Egger's test due to the paucity of data available for meta-analysis.

“However, we did not perform this test due to the paucity of data available for meta-analysis.”

Classified as probably not a substantial claim. May combine two claims.

In nine trials, the comparison group received no treatment; in one trial both groups received nasal saline irrigation three times a day for six weeks (Ercan 2005); and Scadding 2014 had four treatment arms including autoinflation, autoinflation plus nasal steroids, nasal steroids, and placebo.

“In nine trials, the comparison group received no treatment (Arick 2005; Banigo 2016; Bidarian-Moniri 2014; Blanshard 1993; Brooker 1992; Chan 1989; Stangerup 1992; Williamson 2015a; Williamson 2015b). In one trial, both the intervention and control group were treated with nasal saline irrigation three times a day for six weeks (Ercan 2005), and in the trial Scadding 2014 there were”

• Also stated in: § Comparison 1: autoinflation versus no treatment (watchful waiting) · p. 18 · plain

  “four treatment arms including autoinflation, autoinflation and nasal steroids, nasal steroids and placebo.”

May combine two claims.

Blanshard 1993 reported that after three months, the mean change in hearing threshold for the Otovent group overall was a worsening of 0.98 dB HL, with improvement of -2.13 dB HL in high-adherence ears and worsening of 4.08 dB HL in low-adherence ears, compared with worsening of 0.52 dB HL in the control group; no standard deviations were reported, and the data were not included in meta-analysis.

“The mean change overall for the Otovent group (38 ears) was an increase (worsening) of hearing threshold by 0.98 dB HL, although outcomes were better for those with high adherence (an improvement of -2.13 dB HL in 19 ears) than those with low adherence (a worsening of 4.08 dB HL in 19 ears).”

• Also stated in: § Short-term follow-up (6 weeks to 3 months) · p. 21 · hedged

  “This compared to a worsening of 0.52 dB HL in the control group (34 ears). As no standard deviations were reported, we were unable to include these data in the meta-analysis, although they are suggestive of a trivial difference between the groups.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Five studies reported some information regarding adverse events (Banigo 2016; Bidarian-Moniri 2014; Chan 1989; Scadding 2014; Williamson 2015a).

“Five studies reported some information regarding adverse events (Banigo 2016; Bidarian-Moniri 2014; Chan 1989; Scadding 2014; Williamson 2015a).”

The quote only partly states this claim.

The review included 11 completed RCTs (15 records) with results available.

“We included 11 studies (15 records) where results were available (Arick 2005; Banigo 2016; Bidarian-Moniri 2014; Blanshard 1993; Brooker 1992; Chan 1989; Ercan 2005; Scadding 2014; Stangerup 1992; Williamson 2015a; Williamson 2015b).”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

No study was rated at high risk of bias for four or more domains, therefore we did not conduct the planned sensitivity analysis excluding such studies.

“However, no study was rated at high risk of bias for four or more domains, therefore we did not conduct this analysis.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Results for hearing for the active intervention in Arick 2005 were very considerable (an improvement of between -14.8 and -18.3 dB HL at different frequencies, compared to -0.9 to -4.3 for the control group).

“Results for hearing for the active intervention were noted to be very considerable (an improvement of between -14.8 and -18.3 dB HL at different frequencies, compared to -0.9 to -4.3 for the control group)”

May combine two claims.

The review did not look for evidence regarding the need for additional treatment in children with OME, and longer-term follow-up data were sparse; therefore, it does not know whether autoinflation has any impact on the requirement for medical treatment or the number of children who require surgery for OME.

“We did not look for evidence regarding the need for additional treatment in children with OME, and the data on longer-term follow-up were sparse. Therefore, we do not know whether the use of autoinflation has any impact on the requirement for medical treatment (such as antibiotics or steroids), or any effect on the number of children who require surgery for O”

• Also stated in: § Participants · p. 17 · plain

  “ME.”

May combine two claims.

For some analyses very few participants were included, resulting in extremely wide confidence intervals and more uncertainty in the overall result.

“For some analyses very few participants were included, which resulted in extremely wide confidence intervals and more uncertainty in the overall result.”

May combine two claims. The quote only partly states this claim.

In the sensitivity analysis using per child data where available, the per ear data subtotal risk ratio for short-term persistence of OME (>6 weeks to ≤3 months) was 0.85 (95% CI 0.68 to 1.06), Z=1.47 (P=0.14).

“0.85 [0.68 , 1.06]”

• Also stated in: § Risk of bias legend · p. 77 · plain

  “Test for overall effect: Z = 1.47 (P = 0.14)”

The quote only partly states this claim.

In children with otitis media with effusion, autoinflation compared with no treatment improved hearing threshold at 4.0 kHz in the short term (>6 weeks to ≤3 months) based on right ear data, with a mean difference of -13.37 dB (95% CI -20.66 to -6.08).

“| 1.12.4 4.0 kHz | 2 | 117 | Mean Difference (IV, Ran- dom, 95% CI) | -13.37 [-20.66, -6.08] |”

Probably not a substantial claim: may not pass S1 (asserted), S3 (load-bearing). The quote only partly states this claim.

In children with OME, autoinflation compared with watchful waiting/no treatment reduces persistence of OME in the very short term (<6 weeks) in per-ear data (RR 0.85, 95% CI 0.69 to 1.04; 6 studies, 670 participants).

“1.7.1 Per ear data | 6 | 670 | Risk Ratio (M-H, Random, 95% CI) | 0.85 [0.69, 1.04]”

The quote only partly states this claim.

In children with otitis media with effusion, autoinflation compared with no treatment improved hearing threshold at 4.0 kHz in the short term (>6 weeks to ≤3 months) based on left ear data, with a mean difference of -10.92 dB (95% CI -15.42 to -6.41).

“| 1.13.4 4.0 kHz | 2 | 115 | Mean Difference (IV, Ran- dom, 95% CI) | -10.92 [-15.42, -6.41] |”

The quote only partly states this claim.

In children with OME, autoinflation compared with watchful waiting/no treatment reduces persistence of OME in the very short term (<6 weeks) (RR 0.86, 95% CI 0.72 to 1.04; 7 studies, 688 participants).

“1.7 Persistence of OME (very short-term, < 6 weeks) | 7 | 688 | Risk Ratio (M-H, Random, 95% CI) | 0.86 [0.72, 1.04]”

Probably not a substantial claim: may not pass S1 (asserted), S3 (load-bearing). The quote only partly states this claim.

In children with otitis media with effusion, autoinflation compared with no treatment reduced persistence of OME in the short term (>6 weeks to ≤3 months) when analysed per ear data, with a risk ratio of 0.85 (95% CI 0.68 to 1.06).

“| 1.19.1 Per ear data | 2 | 179 | Risk Ratio (M-H, Random, 95% CI) | 0.85 [0.68, 1.06] |”

The quote only partly states this claim.

In the subgroup of Williamson 2015a and Williamson 2015b, the pooled odds ratio for persistent OME was 0.82 (95% CI 0.66 to 1.02; P = 0.08).

“| Subtotal (95% CI) | | 133 | | 129 | 22.5% | 0.”

• Also stated in: § Risk of bias legend · p. 77 · plain

  “Test for overall effect: Z = 1.77 (P = 0.08)”

• cites Williamson 2015aNot matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites Williamson 2015bNot matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• AssumptionRests on an assumption: The included studies are sufficiently clinically homogeneous to be pooled in a meta-analysis.
• AssumptionRests on an assumption: The outcome definitions across studies are comparable enough to combine in a meta-analysis.

Probably not a substantial claim: may not pass S3 (load-bearing).

In children with otitis media with effusion, autoinflation compared with no treatment reduced persistence of OME in the very short term (<6 weeks) when analysed per ear with an ICC of 0, with a risk ratio of 0.84 (95% CI 0.68 to 1.04).

“| 1.14 Sensitivity analysis: Persistence of OME (very short-term, < 6 weeks). Per ear data (ICC of 0) | 6 | 862 | Risk Ratio (M-H, Random, 95% CI) | 0.84 [0.68, 1.04] |”

Probably not a substantial claim: may not pass S1 (asserted), S3 (load-bearing). The quote only partly states this claim.

In children with otitis media with effusion, autoinflation compared with no treatment reduced persistence of OME in the short term (>6 weeks to ≤3 months) when analysed per child data, with a risk ratio of 1.12 (95% CI 0.61 to 2.07).

“| 1.17.2 Per child data | 1 | 17 | Risk Ratio (M-H, Random, 95% CI) | 1.12 [0.61, 2.07] |”

• Also stated in: § Comparison 1.   Autoinflation versus watchful waiting/no treatment · p. 65 · plain

  “| 1.18.2 Per child data | 1 | 17 | Risk Ratio (M-H, Random, 95% CI) | 1.12 [0.61, 2.07] |”

Probably not a substantial claim: may not pass S1 (asserted), S3 (load-bearing).

In children with otitis media with effusion, autoinflation compared with no treatment reduced persistence of OME in the very short term (<6 weeks) when analysed per child data for persistence in any affected ear, with a risk ratio of 1.05 (95% CI 0.88 to 1.25).

“| 1.16.2 Per child data: persistence in any affected ear | 1 | 40 | Risk Ratio (M-H, Random, 95% CI) | 1.05 [0.88, 1.25] |”

The quote only partly states this claim.

In children with OME, autoinflation compared with watchful waiting/no treatment has no effect on persistence of OME in the very short term (<6 weeks) in per-child data (RR 1.00, 95% CI 0.72 to 1.39; 1 study, 18 participants).

“1.7.2 Per child data | 1 | 18 | Risk Ratio (M-H, Random, 95% CI) | 1.00 [0.72, 1.39]”

Probably not a substantial claim: may not pass S1 (asserted), S3 (load-bearing), S4 (based). May combine two claims. The quote only partly states this claim.

In the main analysis of autoinflation versus no treatment for short-term persistence of OME (>6 weeks to ≤3 months), the pooled risk ratio was 0.89 (95% CI 0.82 to 0.97), a statistically significant effect favoring autoinflation (Z=2.69, P=0.007).

“0.89 [0.82 , 0.97]”

• Also stated in: § Analysis 1.7.   Comparison 1: Autoinflation versus watchful waiting/ no treatment, Outcome 7: Persistence of OME (very short-term, &lt; 6 weeks) · p. 75 · plain

  “Test for overall effect: Z = 2.69 (P = 0.007)”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Arick 2005, complete compliance was achieved in 46 of 47 experimental patients (97.9%).

“Complete compliance in 46 of 47 ex- perimental patients (97.9%), moder- ate compliance in remaining patient”

• cites Arick 2005 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing).

In Williamson 2015a, the odds ratio for persistent OME was 0.82 (95% CI 0.65 to 1.02).

“| Williamson 2015a (3) | 63 | 125 | 74 | 120 | 21.2% | 0.”

• cites Williamson 2015aNot matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

In Banigo 2016, average compliance with autoinflation was 94%.

“94% on average”

• cites Banigo 2016 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing).

In the main analysis, the risk ratio for episodes of acute otitis media (short-term, >6 weeks to ≤3 months) was 0.82 (95% CI 0.49 to 1.36).

“1.9 Episodes of acute otitis media (short-term, > 6 weeks to ≤ 3 months) | RR 0.82 (0.49 to 1.36) | Fixed-effect model | RR 0.85 (0.51 to 1.41)”

Classified as probably not a substantial claim.

Some studies gave information on the number of children experiencing otalgia.

“However, some studies gave information on the number of children experiencing otalgia.”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Blanshard 1993, 19 of 42 children (45%) in the treatment group used the device as prescribed (>70%).

“Of 42 children in the treatment group, 19 (45%) used it as pre- scribed (> 70%)”

• cites Blanshard 1993 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing).

There was no significant subgroup difference between Williamson 2015a and Williamson 2015b (P = 0.84).

“Test for subgroup differences: Chi² = 0.04, df = 1 (P = 0.84), I² = 0%”

• cites Williamson 2015aNot matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites Williamson 2015bNot matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

In a fixed-effect sensitivity analysis, the risk ratio for episodes of acute otitis media (short-term, >6 weeks to ≤3 months) was 0.85 (95% CI 0.51 to 1.41).

“1.9 Episodes of acute otitis media (short-term, > 6 weeks to ≤ 3 months) | RR 0.82 (0.49 to 1.36) | Fixed-effect model | RR 0.85 (0.51 to 1.41)”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Williamson 2015b, the odds ratio for persistent OME was 0.90 (95% CI 0.36 to 2.23).

“| Williamson 2015b (3) | 4 | 8 | 5 | 9 | 1.3% | 0.”

• cites Williamson 2015bNot matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

Autoinflation may result in an increased risk of ear pain (otalgia), but the evidence was very uncertain.

“Autoinflation may result in an increased risk of ear pain, but the evidence was very uncertain.”

• Also stated in: § Autoinflation compared to no treatment for otitis media with effusion (OME) in children · p. 7 · hedged

  “Autoinflation may slightly increase the risk of ear pain (otalgia), but the evidence is very uncertain.”

May combine two claims.

Each time autoinflation is repeated, it promotes aeration of the middle ear, mitigating abnormal Eustachian tube function until normal functioning returns.

“Each time the procedure is repeated, it promotes aeration of the middle ear, thereby mitigating any abnormal Eustachian tube function until normal functioning returns (Berkman 2013).”

• cites Berkman 2013Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

When symptoms persist, they may lead to poor school performance and affect a child's daily activities, social interactions and emotions, possibly leading to poorer quality of life.

“When symptoms persist, they may lead to poor school performance and affect a child's daily activities, social interactions and emotions, possibly leading to a poorer quality of life for the child (Rosenfeld 2000).”

• cites Rosenfeld 2000 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

When hearing loss persists, it may affect speech and language development and lead to behavioural problems in some children.

“When hearing loss persists, this may affect speech and language development, and lead to behavioural problems in some children (NICE 2008).”

• cites NICE 2008Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

The evidence is up-to-date to January 2023.

“The evidence is up-to-date to January 2023.”

• Also stated in: § Search methods · p. 4 · plain

  “The date of the search was 20 January 2023.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Autoinflation is considered suitable for children aged four years and over.

“Given the manipulation required for successful autoinflation, it is considered suitable for children aged four years and over (Williamson 2015).”

• cites Williamson 2015Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

Two review authors used the Cochrane Pregnancy and Childbirth screening tool to assess the trustworthiness of the included studies.

“Two review authors (of KG, CM, MR, KW) used the screening tool developed by Cochrane Pregnancy and Childbirth to assess the trustworthiness of the included studies.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Two review authors independently screened the remaining titles and abstracts to identify potentially relevant studies.

“Two review authors (KG, CM) independently screened the remaining titles and abstracts to identify potentially relevant studies.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

NICE and AAO-HNS do not currently recommend antibiotics, antihistamines, decongestants or corticosteroids for OME because there is insufficient evidence to suggest they are effective treatments.

“The National Institute for Health and Care Excellence (NICE) and the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) do not currently recommend the use of antibiotics, antihistamines, decongestants or corticosteroids for OME as there is insufficient evidence to suggest they are effective treatments (NICE 2008; Rosenfeld 2016).”

• cites NICE 2008Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites Rosenfeld 2016 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Autoinflation is a low-cost intervention that can be used during an active observation period post-diagnosis and may avoid the need for a surgical intervention.

“It is a low-cost intervention that can be used during an active observation period post-diagnosis and may avoid the need for a surgical intervention (NICE 2016).”

• cites NICE 2016Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

A key clinical feature of OME is hearing loss, due to decreased mobility of the tympanic membrane and consequent loss of sound conduction.

“A key clinical feature of OME is hearing loss, due to decreased mobility of the tympanic membrane and consequent loss of sound conduction (Rosenfeld 2016).”

• cites Rosenfeld 2016 sourceNot checked — no full text of the source

May combine two claims.

The 2013 Cochrane Review included eight studies that were small and had a short follow-up.

“Searches were run to 2013 and the review included eight studies. The studies were small and had a short follow-up.”

Probably not a substantial claim: may not pass S3 (load-bearing).

At least two review authors independently evaluated the full text of each potentially relevant study to determine whether it met the inclusion/exclusion criteria.

“At least two review authors (of KG, SM, CM and KW) then independently evaluated the full text of each potentially relevant study to determine whether it met the inclusion/exclusion criteria for this review.”

Probably not a substantial claim: may not pass S2 (checkable).

Given the number of relevant studies published in recent years, it is timely to update the evidence.

“Given the number of relevant studies published in recent years, it is timely to update the evidence.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Other symptoms attributable to OME include balance (vestibular) problems and ear discomfort.

“Other symptoms that may be attributable to OME include balance (vestibular) problems and ear discomfort (Rosenfeld 2016).”

• cites Rosenfeld 2016 sourceNot checked — no full text of the source

Classified as probably not a substantial claim.

The review's primary outcomes were determined following a multi-stakeholder prioritisation exercise and were hearing, OME-specific quality of life, and pain and distress.

“Our primary outcomes were determined following a multi-stakeholder prioritisation exercise and were: 1) hearing, 2) OME-specific quality of life and 3) pain and distress.”

May combine two claims.

Overall, autoinflation may slightly increase the proportion of children whose hearing returns to normal at up to three months follow-up, but the evidence was very uncertain.

“Overall, autoinflation may slightly increase the proportion of children whose hearing returns to normal at up to three months follow-up, but the evidence was very uncertain.”

Probably not a substantial claim: may not pass S3 (load-bearing).

At least two review authors independently extracted outcome data from each study using a standardised data collection form.

“At least two review authors (of KG, CM, MR, KW) independently extracted outcome data from each study using a standardised data collection form.”

May combine two claims.

Inclusion of raw data for the number of ears is likely to overestimate the precision of any effect and result in an excessively narrow confidence interval.

“Therefore inclusion of the raw data (for the number of ears) is likely to overestimate the precision of any effect, and result in an excessively narrow confidence interval.”

• AssumptionThe authors state this as an assumption: Outcomes for ears within the same individual are correlated (not completely independent).

Classified as probably not a substantial claim.

It is not clear whether the efficacy of the intervention may vary depending on the duration of the disease or prior treatment.

“It is not clear whether the efficacy of the intervention may vary depending on the duration of the disease, or perhaps according to prior treatment.”

May combine two claims.

Two studies were rated at low risk of reporting bias because a published protocol was found (Williamson 2015a; Williamson 2015b), and the remaining nine were rated unclear because protocols could not be located.

“We rated two studies at low risk of reporting bias as we found a published protocol for the trials (Williamson 2015a; Williamson 2015b). We rated the remaining nine trials at unclear risk of reporting bias as we could not locate protocols for these trials.”

May combine two claims.

Consequently, the change in hearing threshold for most children will be similar across groups, as many children will improve with or without treatment.

“Consequently, we would anticipate that the change in hearing threshold for most children will be similar across the groups - as many children will improve with or without treatment.”

• AssumptionRests on an assumption: OME has a high spontaneous resolution rate.

May combine two claims.

After three months of follow-up, there may be a very slight reduction in the proportion of children who experience acute otitis media, but the evidence was very uncertain.

“After three months of follow-up, there may be a very slight reduction in the proportion of children who experience acute otitis media, but the evidence was very uncertain.”

May combine two claims.

Seven studies were rated at low risk of bias for random sequence generation, and the remaining five were rated unclear.

“We rated seven of the studies at low risk of bias when assessing random sequence generation (Banigo 2016; Bidarian-Moniri 2014; Blanshard 1993; Chan 1989; Scadding 2014; Williamson 2015a; Williamson 2015b), but we rated the risk as unclear for the remaining five studies.”

May combine two claims.

Six studies were rated at high risk of detection bias because they did not state that outcome assessors were blinded; Arick 2005 was rated unclear and the remaining studies were rated at low risk.

“We rated six studies at high risk of detection bias (Blanshard 1993; Brooker 1992; Chan 1989; Ercan 2005; Scadding 2014; Stangerup 1992). These studies did not state that outcome assessors were blinded, therefore we considered that it is unlikely that they were. We rated Arick 2005 as unclear and the remaining studies as at low risk of detection bias.”

May combine two claims.

A number of studies specifically excluded children with craniofacial anomalies or conditions such as Down syndrome, and the remaining studies did not state exclusion but none specifically recruited children with these high-risk conditions; therefore, it is not known whether the efficacy of autoinflation may differ for these children.

“However, a number of studies specifically excluded children with these conditions (Bidarian-Moniri 2014; Blanshard 1993; Chan 1989; Ercan 2005; Scadding 2014; Williamson 2015a; Williamson 2015b). The remaining studies did not state that children with these conditions were excluded, but none specifically recruited children with these high-risk conditions. Therefore, we do not”

• Also stated in: § Overall completeness and applicability of evidence · p. 23 · hedged

  “know whether the efficacy of autoinflation may differ for these children.”

May combine two claims.

Eight studies were rated at low risk of attrition bias; Scadding 2014 and Stangerup 1992 were rated high risk; Williamson 2015a was rated unclear.

“We rated eight studies at low risk of attrition bias. We rated Scadding 2014 and Stangerup 1992 as high risk.”

• Also stated in: § Incomplete outcome data · p. 21 · plain

  “We rated Williamson 2015a at unclear risk of attrition bias: although loss to follow-up was similar across the groups, sensitivity analyses from the main publication indicated that imputation for missing data resulted in a loss of the significant difference between the two groups for some outcome measures.”

May combine two claims.

Autoinflation may result in a reduction in the proportion of children with persistent OME at six weeks to three months of follow-up, although the evidence at the earlier time point (less than six weeks) was very uncertain.

“Autoinflation may also result in a reduction in the proportion of children with persistent OME at six weeks to three months of followup, although the evidence at the earlier time point (less than six weeks) was very uncertain.”

May combine two claims.

The evidence about ear pain was very uncertain, but the occurrence of pain may increase with the use of autoinflation.

“The evidence about ear pain was also very uncertain, but the occurrence of pain may increase with the use of autoinflation.”

May combine two claims.

Stangerup 1992 used a per-protocol analysis, reporting data only for participants who regularly underwent autoinflation, not for the whole allocated group, so these data were not included in the review.

“Stangerup 1992 used a 'per protocol' analysis - data were only reported for participants who regularly underwent autoinflation, not for the whole group of individuals who were allocated to autoinflation. Therefore, these data were not included in the review.”

May combine two claims.

Scadding 2014 reported an attrition rate of 38%, and Stangerup 1992 reported many results as a per-protocol analysis only for those who successfully carried out autoinflation.

“Scadding 2014 reported an attrition rate of 38% and Stangerup 1992 reported many results as a 'per protocol' analysis - only for those who successfully carried out autoinflation.”

May combine two claims.

Only three studies were rated at low risk of bias for allocation concealment, and the remaining six were rated unclear due to insufficient information.

“We rated only three studies at low risk of bias for allocation concealment (Scadding 2014; Williamson 2015a; Williamson 2015b); we rated the remaining six at unclear risk, due to insufficient information.”

May combine two claims.

Seven trials were rated at low risk of other bias; Banigo 2016, Bidarian-Moniri 2014, Brooker 1992 and Chan 1989 were rated unclear due to a short follow-up period that did not allow sufficient time for changes in the control groups.

“We rated seven trials at low risk of other bias. We rated Banigo 2016, Bidarian-Moniri 2014, Brooker 1992 and Chan 1989 at unclear risk of other bias due to a short follow-up period that did not allow sufficient time for changes in the control (no treatment) groups.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Autoinflation may simply hasten recovery for children in whom OME would have resolved anyway.

“It may simply hasten recovery for children in whom OME would have resolved anyway.”

• AssumptionRests on an assumption: OME has a high spontaneous resolution rate.

May combine two claims.

All 11 studies were rated at high risk of performance bias because it was not possible to blind study participants and personnel to treatment group.

“We rated all 11 studies to be at high risk of performance bias as it was not possible to blind study participants and personnel to treatment group.”

May combine two claims.

At less than six weeks there appeared to be little difference in mean hearing threshold between those who received autoinflation and no treatment, but the evidence was very uncertain.

“Nonetheless, at less than six weeks there appeared to be little difference in the mean hearing threshold between those who received autoinflation and no treatment, but the evidence was very uncertain.”

Classified as probably not a substantial claim.

The authors of the quality-of-life study report that a change of 0.3 on the OMQ-14 scale would be regarded as clinically meaningful, indicating a moderate improvement in quality of life.

“The authors report that a change of 0.3 on this scale would be regarded as clinically meaningful, indicating that this would represent a moderate improvement in quality of life.”

• cites Williamson 2015aNot matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

Most included studies lasted up to three months, required children to perform autoinflation two to three times per day, and reported outcomes just after treatment had been completed; therefore, it is uncertain whether any effects of autoinflation persist into the longer term.

“It should be noted that most of the studies included in this review lasted up to three months, and required children to perform autoinflation two to three times per day. Furthermore, outcomes were reported just after treatment had been completed. Therefore, we are uncertain whether any effects of autoinflation persist into the longer term.”

Probably not a substantial claim: may not pass S3 (load-bearing).

At least two authors independently used the GRADE approach to rate the overall certainty of evidence.

“At least two authors (KG, CM, KW) independently used the GRADE approach to rate the overall certainty of evidence using GRADEpro GDT (gradepro.org/).”

Probably not a substantial claim: may not pass S3 (load-bearing).

The risk of bias for allocation concealment in Arick 2005 is unclear.

“Comment: no further information.”

Probably not a substantial claim: may not pass S3 (load-bearing).

No implausible results were reported in Bidarian-Moniri 2014.

“No implausible results were reported”

Probably not a substantial claim: may not pass S3 (load-bearing).

The risk of bias for random sequence generation in Arick 2005 is unclear.

“Quote: 'Of this group, 47 patients (88 ears) were randomly assigned to the experimental group and 47 patients (86 ears) were assigned to the control group'.”

Probably not a substantial claim: may not pass S3 (load-bearing).

There was no description of block randomisation in Arick 2005.

“without any description of block randomisation”

Probably not a substantial claim: may not pass S3 (load-bearing).

The risk of bias for allocation concealment in Brooker 1992 is unclear.

“No description of allocation concealment.”

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

No retraction notices or expressions of concern were identified for Bidarian-Moniri 2014.

“No retraction notices or expressions of concern were identified”

Probably not a substantial claim: may not pass S3 (load-bearing).

There was no description of block randomisation in Banigo 2016.

“without any description of block randomisation”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The review conducted comprehensive searches and made significant efforts to locate and include all relevant studies on this topic.

“As part of the development of this review we conducted comprehensive searches, and made significant efforts to locate and include all relevant studies on this topic.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Only 1 participant was lost to follow-up in Banigo 2016.

“Only 1 participant was lost to follow-up”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Not all outcomes of interest were reported by every study; if outcome data were assessed but not reported, there is a risk of bias in the meta-analysis results.

“Not all of our outcomes of interest were reported by every study. If these outcome data were assessed but not reported, then there is a risk of bias in the metaanalysis results.”

Probably not a substantial claim: may not pass S3 (load-bearing).

No implausible results were reported in Banigo 2016.

“No implausible results were reported”

Probably not a substantial claim: may not pass S3 (load-bearing).

As all participants in Banigo 2016 were awaiting surgery, the loss to follow-up is not an implausible result.

“but as all participants were awaiting surgery this is not an implausible result”

Probably not a substantial claim: may not pass S3 (load-bearing).

The number randomised to each group is not reported in Blanshard 1993.

“The number randomised to each group is not reported”

Probably not a substantial claim: may not pass S3 (load-bearing).

No implausible results were reported in Blanshard 1993.

“No implausible results were reported”

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

No retraction notices or expressions of concern were identified for Arick 2005.

“No retraction notices or expressions of concern were identified”

May combine two claims.

There may be some small benefit from the use of autoinflation for OME with regard to persistence of OME and quality of life, although whether this benefit persists in the long term is unclear.

“There may be some small benefit from the use of autoinflation for otitis media with effusion (OME) with regard to persistence of OME and quality of life, although whether this benefit persists in the long term is unclear.”

Probably not a substantial claim: may not pass S3 (load-bearing).

No declaration was made regarding conflicts of interest in Arick 2005.

“No declaration made”

Probably not a substantial claim: may not pass S3 (load-bearing).

The risk of bias for blinding of participants and personnel in Brooker 1992 is high.

“It is not possible to blind participants and personnel.”

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

Block randomisation was used to allocate equal numbers to the groups in Bidarian-Moniri 2014.

“Block randomisation was used to allocate equal numbers to the groups”

Probably not a substantial claim: may not pass S3 (load-bearing).

We cannot assess whether the groups in Brooker 1992 were excessively similar.

“therefore we cannot assess whether the groups were excessively similar”

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

No retraction notices or expressions of concern were identified for Banigo 2016.

“No retraction notices or expressions of concern were identified”

Probably not a substantial claim: may not pass S3 (load-bearing).

Some loss to follow-up was reported over longer follow-up (12 months) in Bidarian-Moniri 2014.

“Some loss to follow-up was reported over longer follow-up (12 months)”

Classified as probably not a substantial claim. May combine two claims.

The summary of both reviews is similar: there may be some small benefit from autoinflation for some outcomes, but longer follow-up is required, including assessment of quality of life and developmental outcomes.

“However, despite these differences, the summary of both reviews is similar - that there may be some small benefit from autoinflation for some outcomes, but that longer follow-up is required, including an assessment of quality of life and developmental outcomes.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Prospective trial registration is not applicable for Arick 2005 because it was published prior to 2010.

“This study was published prior to 2010, therefore prospective trial registration is not applicable”

Probably not a substantial claim: may not pass S3 (load-bearing).

No prospective trial registration was identified for Banigo 2016.

“No prospective trial registration was identified”

Probably not a substantial claim: may not pass S3 (load-bearing).

The results for hearing for the active intervention in Arick 2005 may be implausible.

“which may be implausible”

Probably not a substantial claim: may not pass S3 (load-bearing).

The risk of bias for allocation concealment in Blanshard 1993 is unclear.

“No information on allocation concealment.”

Classified as probably not a substantial claim.

This review used the GRADE approach to formally assess the certainty of the evidence for each outcome.

“This review differs slightly, as we have used the GRADE approach to formally assess the certainty of the evidence for each outcome.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The risk of bias for other bias in Arick 2005 is low.

“No other concerns identified.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Equal numbers of participants were randomised to each group in Arick 2005.

“Equal numbers of participants were randomised to each group”

Classified as probably not a substantial claim.

Small changes in mean hearing thresholds may be consistent with a substantial improvement in the number of children whose hearing returns to normal, particularly in a condition with a high spontaneous resolution rate.

“Small changes in mean hearing thresholds may be consistent with a substantial improvement in the number of children whose hearing returns to normal - particularly in a condition with a high spontaneous resolution rate.”

• AssumptionRests on an assumption: Comparison of mean hearing thresholds is widely used in research to assess the impact of different interventions on hearing.

Probably not a substantial claim: may not pass S1 (asserted), S3 (load-bearing), S4 (based).

The risk of bias for blinding of participants and personnel in Bidarian-Moniri 2014 is high.

“It is not possible to blind participants and personnel.”

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

Baseline characteristics of the groups in Bidarian-Moniri 2014 were not excessively similar.

“Baseline characteristics of the groups were not excessively similar”

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

Follow-up of 7 weeks in Banigo 2016 is insufficient time for follow-up of no treatment.

“Follow-up is 7 weeks and therefore this is insufficient time for follow-up of no treatment.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Different definitions of 'autoinflation' could lead to inclusion of different studies and potentially impact on the findings of the review.

“Different definitions of 'autoinflation' could therefore lead to inclusion of different studies, and potentially impact on the findings of the review.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Equal numbers of participants were randomised to each group in Banigo 2016.

“Equal numbers of participants were randomised to each group”

Probably not a substantial claim: may not pass S3 (load-bearing).

The risk of bias for blinding of participants and personnel in Blanshard 1993 is high.

“It is not possible to blind participants and personnel.”

Probably not a substantial claim: may not pass S3 (load-bearing).

No prospective trial registration was identified for Bidarian-Moniri 2014.

“No prospective trial registration was identified”

Probably not a substantial claim: may not pass S3 (load-bearing).

Arick 2005 described limited baseline characteristics.

“Limited baseline characteristics were described”

Probably not a substantial claim: may not pass S3 (load-bearing).

Some data on hearing sensitivity were missing in Arick 2005.

“although some data on hearing sensitivity were missing”

Probably not a substantial claim: may not pass S3 (load-bearing).

This research was supported by a grant (No. 5R44DC0036 I3-03) from the Small Business Innovation Research Program, National Institute on Deafness and Other Communication Disorders, National Institutes of Health to Arisil Instruments.

“This research was supported by a grant (No. 5R44DC0036 I3-03) from the Small Business Innovation Research Program, National Institute on Deafness and Other Communication Disorders, National Institutes of Health to Arisil Instruments”

Probably not a substantial claim: may not pass S3 (load-bearing).

The risk of bias for selective reporting in Arick 2005 is unclear.

“No protocol has been found to enable assessment of selective reporting.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The principal investigators in Arick 2005 appear to own a business to develop the instrument (Arisil Instruments).

“the principal investigators appear to own a business to develop this instrument (Arisil Instruments)”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The trial was published prior to 2010, therefore prospective registration is not applicable for Brooker 1992.

“The trial was published prior to 2010, therefore prospective registration is not applicable”

Probably not a substantial claim: may not pass S3 (load-bearing).

The risk of bias for other bias in Blanshard 1993 is low.

“No other concerns.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Very few baseline characteristics were reported in Brooker 1992.

“Very few baseline characteristics were reported”

Probably not a substantial claim: may not pass S3 (load-bearing).

If the review had rigidly used a definition of ≤20 dB HL, the data included would have been even more sparse.

“If we had rigidly used a definition of ≤ 20 dB HL then the data included in this review would have been even more sparse.”

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

Follow-up at 1 month in Bidarian-Moniri 2014 is insufficient time for follow-up of no treatment.

“Follow-up is at 1 month - this is insufficient time for follow-up of no treatment.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The risk of bias for selective reporting in Brooker 1992 is unclear.

“No protocol was identified.”

Probably not a substantial claim: may not pass S3 (load-bearing).

No loss to follow-up was reported in Arick 2005.

“No loss to follow-up was reported”

Probably not a substantial claim: may not pass S3 (load-bearing).

The risk of bias for selective reporting in Bidarian-Moniri 2014 is unclear.

“No protocol or trial registration was found.”