**9. Clinical guidelines**

#### **9.1. NICE clinical guideline**

The UK National Institute for Health and Clinical Excellence has published clinical guide‐ lines for the surgical treatment of OME in children with or without CLP [45]. Those guide‐ lines indicate that there is currently insufficient evidence to prove that simultaneous cleft palate repair surgery and ventilation tube surgery are effective approaches to the alle‐ viation of OME. Thus, the simultaneous insertion of a ventilation tube during the surgi‐ cal repair of a cleft palate is not recommended unless careful otological and audiological assessments have been performed. The guidelines recommend that treatment be based on the needs and desires of children and their parents and that ventilation tube surgery be viewed as an alternative to hearing aids in CLP children with persistent bilateral OME and hearing loss.

#### **9.2. Clinical guidelines of AAO‐HNSF, AAP, and AAFP**

Updated clinical guidelines have recently been published for OME. These guidelines were codeveloped by the American Academy of Otolaryngology‐Head and Neck Surgery Foundation (AAO‐HNSF), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP) [94]. The guideline update group claims that it may be appropriate to offer tympanostomy tubes on an individualized basis for cleft palate infants with OME that persists after failing hearing tests. They claim that resolving the issue of mid‐ dle ear effusion could facilitate the assessment of hearing status.

It is also recommended that clinicians evaluate children with cleft palate for OME and hear‐ ing loss at the time at which cleft palate is first diagnosed. Monitoring for OME and hearing loss should continue throughout childhood, including after palate repair. Specifically, the guideline update group recommends that middle ear status be assessed at 12–18 months of age, considering that this is a critical period in the development of language skills, speech, balance, and coordination. By 18 months of age, delays in language and speech development are easily identified.

In these guidelines, it is recommended that VTI be considered when type B tympanogram or OME persists for 3 months or longer. These recommendations are based on the assumption that the likelihood of spontaneous resolution is low. For children who do not receive tympa‐ nostomy tubes, the follow‐up schedule to monitor OME and hearing loss until OME resolves should be more frequent than the 3‐ to 6‐month intervals recommended for children without cleft palate.

#### **9.3. PRISMA‐compliant systematic review**

Most studies in this review were retrospective studies. Only otologic findings during a par‐ ticular month, or interpolation from examinations in adjoining months, were used in arriving at the monthly status of each ear. Thus, patient history was of limited value because it was difficult to determine when grommets had been extruded and if ear drainage was occurring. Due to mixed results, statistical differences could not be calculated for each complication, such that it is unclear whether the differences reached statistical significance. Finally, the issue

A review of previous studies shows that there is currently no consensus as to the optimal method of treating OME, and many researchers are at odds regarding their views on the subject [46]. Most previous studies are based on retrospective analysis and vary widely in their design; therefore, it is difficult to make an informative comparison. Even in prospec‐ tive studies on OME in CLP children [51, 58, 59], there remains a lack of high‐quality, ade‐ quately powered randomized controlled trials. One reason may be that most parents require recommendations pertaining to treatment, rather than allowing their child to be randomly included in an experimental or control group, particularly children who have undergone or will undergo a series of major invasive surgeries. Thus, it is currently impossible to conduct a meta‐analysis of previous research, which could be used to summarize treatment methods

The UK National Institute for Health and Clinical Excellence has published clinical guide‐ lines for the surgical treatment of OME in children with or without CLP [45]. Those guide‐ lines indicate that there is currently insufficient evidence to prove that simultaneous cleft palate repair surgery and ventilation tube surgery are effective approaches to the alle‐ viation of OME. Thus, the simultaneous insertion of a ventilation tube during the surgi‐ cal repair of a cleft palate is not recommended unless careful otological and audiological assessments have been performed. The guidelines recommend that treatment be based on the needs and desires of children and their parents and that ventilation tube surgery be viewed as an alternative to hearing aids in CLP children with persistent bilateral OME and

Updated clinical guidelines have recently been published for OME. These guidelines were codeveloped by the American Academy of Otolaryngology‐Head and Neck Surgery Foundation (AAO‐HNSF), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP) [94]. The guideline update group claims that it may

of missing data was not taken into account.

108 Designing Strategies for Cleft Lip and Palate Care

**9. Clinical guidelines**

**9.1. NICE clinical guideline**

hearing loss.

**8. Debate concerning selection of treatment strategy**

and/or provide guidance with regard to treatment choices [2, 45].

**9.2. Clinical guidelines of AAO‐HNSF, AAP, and AAFP**

Many clinical guidelines fail to provide clear recommendations with regard to treatment approaches, due to a lack of conclusive studies [27, 95]. Despite the fact that a number of reviews have been published on treatment choices for the management of OME in CLP chil‐ dren, a number of these are narrative reviews [3, 6, 96–98], whereas others are systematic reviews pertaining mainly to otherwise healthy children [27, 45, 77, 95, 99–105]. The lack of research on the CLP subgroup of children means that there is currently no evidence‐based information for clinicians or parents with regard to the effectiveness of grommets for OME in CLP children.

Ponduri et al. performed a systematic review on the routine early insertion of grommets for OME in CLP children [2]. The authors concluded that there is currently insufficient evidence on which to base recommendations pertaining to clinical practice in this area. However, they did not perform data synthesis with regard to patient‐centered outcomes, nor did they provide a detailed, well‐described protocol, such as The Cochrane [106] and PRISMA [107]. A systematic review based on predefined eligibility criteria conducted in accordance with a predefined methodological approach could facilitate the appraisal of review methods and reveal modifications to methods and selective reporting in completed reviews [108].

A recent systematic review by Kuo et al. published in *Pediatrics* addressed the effects of VTI in children with cleft palate and OME with regard to patient‐centered outcomes [109]. The review followed the protocol outlined in Preferred Reporting Items for Systematic Reviews and Meta‐analyses (PRISMA) to enable full and transparent assessment of the existing litera‐ ture, in order to provide evidence‐based information pertaining to the management of OME in children with cleft palate.

That review indicated that 38–53% of CLP children underwent VTI for OME and that more severe cases were more likely to undergo grommet insertion. Compared with a conserva‐ tive approach, it appears that VTI may improve hearing outcomes in CLP children and that these improvements could remain for at least 1–9 years after surgery. In addition, children who have undergone VTI face a higher risk of complications than do those who have not received this form of treatment. The most common post‐VTI complications include eardrum retraction and tympanosclerosis, with incidence rates of 11–37%. Of particular importance is the need to perform grommet insertion within a highly specified time frame. The authors concluded that existing evidence is insufficient to support any assertions with regard to the use of grommets, either therapeutically or prophylactically, at the time of palatoplasty or afterward.

#### **9.4. Future research needs**

In the future, there may be a need to develop rigorous methodologies for the examination of functional outcomes in CLP children after VTI. Further multi‐institute prospective studies or well‐designed randomized controlled trials are needed to develop a comprehensive base of evidence sufficient to clarify the effectiveness of VTI for OME in CLP children.

### **10. Recommendations for management**

Strategies related to the treatment of OME in CLP children are still under debate, and there is insufficient evidence with which to establish absolute guidelines. We believe that the lack of consensus regarding the optimal treatment for OME in CLP children should prompt a rela‐ tively conservative approach. Patients and parents should also be given a range of treatment options based on their individual needs and desires.

**Figure 1** presents a flowchart of recommended OME management in CLP children. From the time of birth, children with CLP should undergo continual and regular otologic exami‐ nations and audiological monitoring for the assessment of OME. Children with delayed speech and/or language development should be suspected of having OME, such that oto‐ laryngology referral is indicated. Once OME is confirmed, the coexisting sensorineural component of hearing loss should be further investigated. It is recommended that chil‐ dren suffering from middle ear effusion without significant hearing loss (hearing threshold ≤30 dB) remain under observation [45]. Children with hearing loss exceeding 30 dB can be managed through active observation for 3 months or alternatively referred for surgery, in accordance with the child's developmental, social, and educational status. If a patient suffers OME in only one ear, the observation period may be extended to 6 months [49]. During the observation period, hearing aids could be considered [110]. Patients suffering from recurrent OME following surgery may undergo repeated ventilation tube surgery, and those in whom the disease persists after an observation period of 3–6 months may be referred for surgery.

Tympanostomy Tube Placement for Otitis Media with Effusion in Children with Cleft Lip and Palate http://dx.doi.org/10.5772/67122 111

**Figure 1.** Flowchart of recommended management guidance for OME in CLP children. OME, otitis media with effusion; CLP, cleft lip/palate; MEE, middle ear effusion; DDX, differential diagnosis; dB, decibel; SNHL, sensorineural hearing loss.

#### **11. Summary**

That review indicated that 38–53% of CLP children underwent VTI for OME and that more severe cases were more likely to undergo grommet insertion. Compared with a conserva‐ tive approach, it appears that VTI may improve hearing outcomes in CLP children and that these improvements could remain for at least 1–9 years after surgery. In addition, children who have undergone VTI face a higher risk of complications than do those who have not received this form of treatment. The most common post‐VTI complications include eardrum retraction and tympanosclerosis, with incidence rates of 11–37%. Of particular importance is the need to perform grommet insertion within a highly specified time frame. The authors concluded that existing evidence is insufficient to support any assertions with regard to the use of grommets, either therapeutically or prophylactically, at the time of palatoplasty or

In the future, there may be a need to develop rigorous methodologies for the examination of functional outcomes in CLP children after VTI. Further multi‐institute prospective studies or well‐designed randomized controlled trials are needed to develop a comprehensive base of

Strategies related to the treatment of OME in CLP children are still under debate, and there is insufficient evidence with which to establish absolute guidelines. We believe that the lack of consensus regarding the optimal treatment for OME in CLP children should prompt a rela‐ tively conservative approach. Patients and parents should also be given a range of treatment

**Figure 1** presents a flowchart of recommended OME management in CLP children. From the time of birth, children with CLP should undergo continual and regular otologic exami‐ nations and audiological monitoring for the assessment of OME. Children with delayed speech and/or language development should be suspected of having OME, such that oto‐ laryngology referral is indicated. Once OME is confirmed, the coexisting sensorineural component of hearing loss should be further investigated. It is recommended that chil‐ dren suffering from middle ear effusion without significant hearing loss (hearing threshold ≤30 dB) remain under observation [45]. Children with hearing loss exceeding 30 dB can be managed through active observation for 3 months or alternatively referred for surgery, in accordance with the child's developmental, social, and educational status. If a patient suffers OME in only one ear, the observation period may be extended to 6 months [49]. During the observation period, hearing aids could be considered [110]. Patients suffering from recurrent OME following surgery may undergo repeated ventilation tube surgery, and those in whom the disease persists after an observation period of 3–6 months may be

evidence sufficient to clarify the effectiveness of VTI for OME in CLP children.

afterward.

**9.4. Future research needs**

110 Designing Strategies for Cleft Lip and Palate Care

referred for surgery.

**10. Recommendations for management**

options based on their individual needs and desires.

Otitis media with effusion associated with Eustachian tube dysfunction can seriously affect hearing in children with CLP, which can lead to linguistic and speech disorders, and ulti‐ mately to the disruption of learning and development. Compared with watchful waiting or hearing aids, VTI has been shown to improve hearing in more than half of CLP children 5–15 years after surgery. VTI and the conservative approach do not appear to differ with regard to speech and language outcomes. CLP children that undergo VTI present a higher risk of complications than do children without VTI. It has been shown that VTI is beneficial in helping CLP patients to recover from OME. There is insufficient evidence with regard to the timing of VTI (e.g., prophylactic insertion during repair of lip or palate). This summary is based on underpowered studies, and the evidence for each outcome is inconclusive. The lack of concrete evidence regarding the optimal treatment for OME in CLP children should prompt a relatively conservative approach. Most importantly, the needs of children and their parents must be taken into consideration. Only a consensus between patients/parents and surgeons regarding the most suitable treatment strategy for OME can ensure the great‐ est benefits.

#### **Disclosures**

#### **Competing interests: None**

Funding/support: This study was sponsored by grants from Taoyuan Armed Forces General Hospital (No. 10507 and No. 10626), Taoyuan, Taiwan, ROC.
