Evidence reviews for follow-up strategy after surgical treatment for OME-related hearing loss

Included studies

A systematic review of the literature was conducted but no studies were identified which were applicable to this review question.

See the literature search strategy in appendix B and study selection flow chart in appendix C.

Excluded studies

Studies not included in this review are listed, and reasons for their exclusion are provided in appendix J.

Included studies

A systematic review of the economic literature was conducted but no economic studies were identified which were applicable to this review question.

The outcomes that matter most

Hearing loss or hearing difficulty is often associated with OME, and this could impact on the child’s language and behavioural development. Effective follow-up strategy after surgical treatment for OME-related hearing loss may improve hearing and may reduce the need for additional intervention (for example, repeat ventilation tube insertion and antibiotics) by identifying potential issues earlier. Therefore, hearing and additional intervention were prioritised as critical outcomes. The committee agreed that parent, carer and child satisfaction is an important dimension of quality of care and may be impacted by different follow-up strategies; therefore, it was also prioritised as a critical outcome.

Otorrhoea is a common complication after surgery, which may both recur and lead to poor quality of life in children with OME. The committee agreed that this may be impacted by differences in follow-up as it may be identified and treated earlier if children are followed up more regularly. Therefore, persistent otorrhoea was selected as an important outcome. Similarly, perforation of the tympanic membrane was also selected as an important outcome because differences in follow-up may lead to differences in the identification and treatment of factors that may cause perforation, such as infection. In addition, quality of life was selected as an important outcome as this is a global measure that takes into account both beneficial and adverse effects of the interventions.

The quality of the evidence

No studies were identified which were applicable to this review question.

Benefits and harms

There was no available evidence on the effectiveness of the follow-up strategy after surgical treatment for OME-related hearing loss in children under 12 years. Therefore, the committee made recommendations based on current practice and their knowledge and experience.

The committee acknowledged that it is important for medico-legal reasons to detect complications of surgery as soon as possible, particularly hearing loss, to provide necessary treatment and avoid its harmful impacts. The committee were aware that post-operative hearing tests tend to be performed 6 weeks after surgery, which should allow sufficient time for post-operative bleeding to resolve. This may also give the opportunity to check if grommets have fallen out early which can happen, for example, if the hole made for the grommet is too large. Despite the lack of evidence, the committee made a strong recommendation that a post-operative hearing test should be carried out 6 weeks after surgery, as this is in line with current practice and there could be serious developmental consequences for the child if there is unidentified ongoing hearing loss, such as profound speech, language, and developmental delay.

The committee were aware that children may still experience hearing loss after grommet interventions, and one committee member knew of a local audit that showed about 10% of children may need further grommet surgery. The committee discussed that parents should have the opportunity to contact audiology services to discuss the need for further hearing assessment for their child when they are concerned about recurrence of hearing loss after surgery. The committee felt that it may reduce delays in identifying recurrent hearing loss and therefore, appropriate interventions to address this and avoid adverse effects on the child’s development and wellbeing as people will not have to go through GP referral. Additionally, recently published Patient Initiated Follow Up (PIFU) guidance could be followed if appropriate and available for patients, enabling children to be discharged to a PIFU pathway (NHS 2022). However, the committee were aware that there is variation in practice, and audiology services may or may not accept direct referrals depending on when reassessment is needed. They discussed that it is fairly common in practice that audiology services may only accept direct referrals for reassessment within one year after discharge, but reassessment may be carried out by GP if it is after one year. The committee agreed that the recommendation will give the flexibility for audiology services to accept direct referrals or to refer the child back to the GP if this is necessary.

In the committee’s experience, hearing loss is not always identified by parents and schoolteachers. If recurrent hearing loss is not noticed, the consequences for the child can be serious, as discussed above. Additionally, in the committee’s experience, grommets tend to fall out between 6 months and 18 months after surgery, with most grommets falling out about 6 months after surgery. However, children, parents or teachers may not necessarily know when grommets fall out. Therefore, children may be at risk of further hearing loss from about 6 months after surgery as hearing loss can return when grommets fall out. As a result, the committee agreed it may be important to have a 1-year follow-up with an age and developmentally appropriate hearing test (for example, audiogram) to pick up children with recurrent hearing loss that may not be obvious to the parents or teacher. It may also give the opportunity to identify other potential complications after grommet surgery, such as perforation of the tympanic membrane. The committee acknowledged there is current variation in practice regarding follow-up and were aware that a 1-year follow up plan may lead to a change in practice. It would lead to an increase in resources in places that currently discharge children from follow-up once it has been established that their hearing is normal (for example, 6 weeks post-surgery) but a decrease in resources for places that currently have a 3 to 6 month, or more regular, follow-up. The committee discussed that, given the lack of evidence and potentially significant change to practice, a strong recommendation in support of a 1-year follow-up could not be made. However, the committee agreed that having a 1-year follow-up after grommet surgery may help to reduce the risk of inequality that may otherwise occur if relying on families to identify and raise concerns. Some populations, for example parents and carers with their own communication difficulties, may be less likely to identify concerns or find it more difficult to raise any concerns they do identify which could disadvantage some children if a standard follow-up process is not followed. Therefore, the committee agreed that a 1-year follow-up with a hearing test should be considered.

The committee discussed that some children could be at increased risk of having unrecognised recurrent OME with hearing loss. For example, cognitive or communication difficulties may inhibit a child’s ability to recognise or communicate that they have recurrent hearing loss, so they may need more frequent follow-up or targeted follow-up plans. Therefore, the committee agreed that after surgery an individualised follow-up plan should be considered in these children as it is good clinical practice, in particular for children with a learning disability or craniofacial anomalies.

In the event the child continues to have hearing loss at the 6-week postoperative follow-up, the committee agreed investigations should be done into why this has happened (for example due to surgical complications or because grommets have fallen out early) to enable further appropriate treatment.

The committee acknowledged that it is important to understand the follow-up strategy required for children who undergo grommet insertion as this may have a significant impact on patient experience, NHS resources, and health outcomes, including hearing and quality of life. The committee also acknowledged that understanding the appropriate follow-up strategy for children with cognitive or communication difficulties is important as they may need targeted follow-up plans. However, there was no available evidence on the follow-up strategy after surgical treatment for OME-related hearing loss in children under 12 years. Therefore, the committee agreed that research is needed to inform appropriate follow-up strategy and made a research recommendation on the follow-up strategy after surgical treatment for OME-related hearing loss in children under 12 years (see Appendix K).

Cost effectiveness and resource use

This review question was not prioritised for economic analysis and therefore the committee made a qualitative assessment of the likely cost-effectiveness of their recommendations. The committee considered that it would be cost-effective to offer post-operative hearing tests at 6 weeks after surgery as they reasoned that unidentified ongoing hearing loss could result in serious developmental harms, which would impact negatively on quality of life and be costly to address. They noted that this was current practice and therefore their recommendation would not have any cost impact to the NHS.

The committee agreed it was difficult to determine the most cost-effective time for subsequent follow-up and they also noted there was considerable variation in practice. They did not recommend regular 3–6 month follow up, as occurs in some places, as they were unconvinced that such a resource intensive approach would be commensurate with any benefits obtained. However, the committee did make a weak recommendation for routine 1-year follow-up which would represent a change in practice and increase in resources for those areas where children are discharged once it is established that hearing is normal. The committee reasoned that some families may not identify and raise concerns in the absence of any such follow-up. However, the committee recognised there was not clinical or cost-effectiveness evidence to support this approach and this was reflected in the strength of the recommendation. The committee also recommended that a more regular and individualised follow-up plan could be considered for children with an increased risk of unrecognised OME with hearing loss. They reasoned that this was a relatively small population and so would not have a significant resource impact and that it would help mitigate adverse impacts on health-related quality of life.

The committee also made a recommendation to advise parents to seek reassessment of their child by audiology services if they have concerns about recurrence of hearing loss after surgery. Ideally, the committee believed that this should be possible from self-referral but recognised that direct referrals were not always possible. Again, the committee considered that this would only apply to a subset of the population having surgery and therefore they did not anticipate a large resource impact to the NHS whilst facilitating early identification of hearing loss.

Excluded effectiveness studies

Table 3

Excluded studies and reasons for their exclusion.

Excluded economic studies

No economic evidence was identified for this review.

K.1.1. Research recommendation

What should the follow-up strategy be after surgical treatment for OME-related hearing loss in children under 12 years?

K.1.2. Why this is important

It is important to understand the follow up required for patients who undergo ventilation tube insertion as this can have a significant impact on patient experience and NHS resources. However, there was no available evidence on the follow-up strategy after surgical treatment for OME-related hearing loss in children under 12 years, and research is needed to inform appropriate follow-up strategy.

K.1.3. Rationale for research recommendation

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K.1.4. Modified PICO table

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