Applicability Tables

David O Francis; Sivakumar Chinnadurai; Anna Morad; Richard A Epstein; Sahar Kohanim; Shanthi Krishnaswami; Nila A Sathe; Melissa L McPheeters

Appendix IApplicability Tables

Publication Details

References

1.: Berry J, Griffiths M, Westcott C. A double-blind, randomized, controlled trial of tongue-tie division and its immediate effect on breastfeeding. Breastfeed Med. 2012 Jun;7(3):189–93. [PubMed: 21999476]

2.: Buryk M, Bloom D, Shope T. Efficacy of neonatal release of ankyloglossia: a randomized trial. Pediatrics. 2011 Aug;128(2):280–8. [PubMed: 21768318]

3.: Emond A, Ingram J, Johnson D, et al. Randomised controlled trial of early frenotomy in breastfed infants with mild-moderate tongue-tie. Arch Dis Child Fetal Neonatal Ed. 2013 Nov 18;99(3):F189–95. [PMC free article: PMC3995264] [PubMed: 24249695]

4.: Puthussery FJ, Shekar K, Gulati A, et al. Use of carbon dioxide laser in lingual frenectomy. Br J Oral Maxillofac Surg. 2011 Oct;49(7):580–1. [PubMed: 20728254]

5.: Marchesan IQ, Martinelli RL, Gusmao RJ. Lingual frenulum: changes after frenectomy. J Soc Bras Fonoaudiol. 2012;24(4):409–12. [PubMed: 23306695]

6.: Lalakea ML, Messner AH. Ankyloglossia: the adolescent and adult perspective. Otolaryngol Head Neck Surg. 2003 May;128(5):746–52. [PubMed: 12748571]

7.: Messner AH, Lalakea ML. The effect of ankyloglossia on speech in children. Otolaryngol Head Neck Surg. 2002 Dec;127(6):539–45. [PubMed: 12501105]

8.: Choi YS, Lim JS, Han KT, et al. Ankyloglossia correction: Z-plasty combined with genioglossus myotomy. J Craniofac Surg. 2011 Nov;22(6):2238–40. [PubMed: 22134257]

9.: Walls A, Pierce M, Wang H, et al. Parental perception of speech and tongue mobility in three-year olds after neonatal frenotomy. Int J Pediatr Otorhinolaryngol. 2014 Jan;78(1):128–31. [PubMed: 24315215]

10.: Dollberg S, Manor Y, Makai E, et al. Evaluation of speech intelligibility in children with tongue-tie. Acta Paediatr. 2011 Sep;100(9):e125–7. [PubMed: 21401716]

Publication Details

Copyright

Publisher

Agency for Healthcare Research and Quality (US), Rockville (MD)

NLM Citation

Francis DO, Chinnadurai S, Morad A, et al. Treatments for Ankyloglossia and Ankyloglossia With Concomitant Lip-Tie [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2015 May. (Comparative Effectiveness Reviews, No. 149.) Appendix I, Applicability Tables.

Table I-1Applicability for KQ 1

Domain	Description of applicability of evidence
Population	Studies examining the effectiveness of ankyloglossia treatment had significant differences in population. Specifically, there was age heterogeneity between the 3 good quality trials: ranging from group means of 28d and 33d for patients treated with frenotomy versus sham in one study¹, an overall median 6d +/- 6.9 in another ², and group medians 11d (IQR 8 – 14) and 11d (IQR 8 – 16) in the third.³ Gender distribution was ∼2:1 in 2 trials,¹^,² and not reported in the third. ³ Finally, ankyloglossia severity was only rated in 1 trial, which also excluded the most severe cases (HATLFF > 6), thus potentially biasing its results toward the null hypothesis³.
Intervention	All comparative studies assessed the role of surgical intervention. Procedural specifics were consistent across studies although tongue-tie division terminology differed (i.e. frenotomy, frenulotomy). No comparative study considered alternative treatments for ankyloglossia and its effect on breastfeeding.
Comparators	Two comparators were used: sham¹^,² and no intervention³. These are synonymous except in relation to blinding of participants since no intervention was performed even in either group. No treatment is a common alternative to frenotomy and therefore its use is broadly applicable to the overall population at risk for ankyloglossia and its sequelae.
Outcomes	There was fair homogeneity among outcome measures used in these studies, which consisted of assessment of breastfeeding effectiveness and maternal nipple pain. However, the means of measuring breastfeeding effectiveness differed among studies. In one RCT, effectiveness was assessed both by maternal-report and objective observer immediately after frenotomy or sham.¹ A second RCT employed an objective observer to assess breastfeeding effectiveness (IBFAT) compared to sham immediately post-procedure.² The third RCT had an objective observer score breast latch using the LATCH and IBFAT outcome measures.³ Nipple pain was assessed using either a visual analog scale (VAS) or the Short-form Montreal Pain Questionnaire (SF-MPQ). While VAS-type scales are commonly used for pain, specific levels may not be widely applicable to other populations of women breastfeeding a newborn with ankyloglossia.
Setting	The setting was variably reported in these studies. Frenotomy were performed in tertiary care hospitals and clinics and performed by pediatric surgeons, lactation consultants, and otolaryngologists. Two of three RCTs were not explicit whether frenotomy was performed as an inpatient or outpatient.

Table I-2Applicability for KQ 2a

Domain	Description of applicability of evidence compared to question
Population	Neonates born with congenital ankylglossia between January 2010 and December 2010
Intervention	Frenotomy within first month of life
Comparators	Offered but declined frenotomy within first month of life; may or may not have received non-surgical interventions
Outcomes	Paternal (typically maternal) report of the 3 year old's difficulty: (1) cleaning teeth with the tongue, (2) licking the outside of the lips, and (3) eating ice cream
Timing	Outcomes measured at 3 years of age
Setting	Academic medical center hospital in a large, urban area

Table I-3Applicability for KQ 2b

Domain	Description of applicability of evidence compared to question
Population	The study population primarily consisted of children with tongue-tie and perceived speech impairment, though inclusion criteria were not explicit. There was a small subset of pre-lingual patients who were treated for fear of speech impediment, though no speech concern had been diagnosed at the time of intervention.
Intervention	All interventions in this group were surgical. A variety of surgical techniques were utilized, included simple division with scalpel, scissors, and CO2 laser ⁴, frenulectomy/frenulotomy,⁵ frenuloplasty,⁶^,⁷ and the addition of genioglossus myotomy.⁸
Comparators	The majority of studies were non-comparative case series. Among the comparative studies, two cohort studies compared children with ankyloglossia after surgical management to those with ankyloglossia without surgical management and non-tongue-tied controls. A single RCT compared 4-flap frenuloplasty to horizontal to vertical frenuloplasty
Outcomes	Follow-up intervals ranged from several months to 3 years. Many studies evaluated speech improvement using parental self-report, including one of the cohort studies.⁹ The second cohort study¹⁰ measured articulation, and speech understandability with word, sentence and connected speech, as evaluated by blinded speech pathologists.
Setting	The setting was varied and variably reported in these studies. Procedures were performed in nurseries, outpatient clinics and in operating rooms, with no anesthetic, local and general anesthetic all being used. Pediatric surgeons, plastic surgeons and otolaryngologists performed the surgeries. Most studies were based in the United States, with a single study from each India, Korea, China and the United Kingdom.

Table I-4Applicability for KQ 3

Domain	Description of applicability of evidence for a key question
Population	The population studied in the question of benefit of ankyloglossia repair for social concerns included children and adults with wide variation in ages. The patients were selected either by retrospective chart review or as they presented to otolaryngology clinics.
Intervention	Surgical repair only
Comparators	None
Outcomes	Outcomes measured were not consistent between studies with social concerns measured as a secondary outcome and the types of social outcomes considered were not consistent
Setting	Setting was inconsistently reported but most often surgeries occurred in outpatient settings.