Cleft Summit 2022: The Impact of a Unified Voice.

OBJECTIVE: The inaugural Cleft Summit aimed to unite experts and foster interdisciplinary collaboration, seeking a collective understanding of velopharyngeal insufficiency (VPI) management. DESIGN: An interactive debate and conversation between a multidisciplinary cleft care team on VPI management. SETTING: A two-hour discussion within a four-day comprehensive cleft care workshop (CCCW). PARTICIPANTS: Thirty-two global leaders from various cleft disciplines. INTERVENTIONS: Cleft Summit that allows for meaningful interdisciplinary collaboration and knowledge exchange. MAIN OUTCOME MEASURES: Ability to reach consensus on a unified statement for VPI management. RESULTS: Participants agreed that a patient with significant VPI and a dynamic velum should first receive a surgery that lengthens the velum to optimize patient outcome. A global, multicenter prospective study should be done to test this hypothesis. CONCLUSION: The 1st Cleft Summit successfully distilled global expertise into actionable best-practice guidelines through iterative discussions, fostering interdisciplinary collaboration and paving the way for a transformative multi-center prospective study on VPI care.

The First Hybrid International Educational Comprehensive Cleft Care Workshop.

OBJECTIVE: Describe the first hybrid global simulation-based comprehensive cleft care workshop, evaluate impact on participants, and compare experiences based on in-person versus virtual attendance. DESIGN: Cross-sectional survey-based evaluation. SETTING: International comprehensive cleft care workshop. PARTICIPANTS: Total of 489 participants. INTERVENTIONS: Three-day simulation-based hybrid comprehensive cleft care workshop. MAIN OUTCOME MEASURES: Participant demographic data, perceived barriers and interventions needed for global comprehensive cleft care delivery, participant workshop satisfaction, and perceived short-term impact on practice stratified by in-person versus virtual attendance. RESULTS: The workshop included 489 participants from 5 continents. The response rate was 39.9%. Participants perceived financial factors (30.3%) the most significant barrier and improvement in training (39.8%) as the most important intervention to overcome barriers facing cleft care delivery in low to middle-income countries. All participants reported a high level of satisfaction with the workshop and a strong positive perceived short-term impact on their practice. Importantly, while this was true for both in-person and virtual attendees, in-person attendees reported a significantly higher satisfaction with the workshop (28.63 ± 3.08 vs 27.63 ± 3.93; P = .04) and perceived impact on their clinical practice (22.37 ± 3.42 vs 21.02 ± 3.45 P = .01). CONCLUSION: Hybrid simulation-based educational comprehensive cleft care workshops are overall well received by participants and have a positive perceived impact on their clinical practices. In-person attendance is associated with significantly higher satisfaction and perceived impact on practice. Considering that financial and health constraints may limit live meeting attendance, future efforts will focus on making in-person and virtual attendance more comparable.

Optimal Outcomes Reporting (OOR): A New Value-Based Metric for Outcome Reporting Following Cleft Palate Repair.

OBJECTIVE: Palatoplasty outcome measurements vary widely among institutions. A standardized outcome metric would help provide quality benchmarks. DESIGN: Retrospective review of primary palatoplasty patients from 2007 to 2013. SETTING: Tertiary care children's hospital. MAIN OUTCOME MEASURES: We created a novel conceptual quality metric called "OOR" (Optimal Outcome Reporting). Optimal Outcome Reporting is designed to reflect the percentage of patients with cleft palate who experience the best outcomes: one operation, velar competence by age 5 years, and no unintended palatal fistula. RESULTS: Optimal Outcome Reporting was 72.3% (68/94). Eight patients had "suboptimal" outcomes for having undergone more than one operation. Eighteen patients failed for velar incompetence. No additional patients fell out of the algorithm for fistula. A significantly higher proportion of nonsyndromic patients demonstrated an "optimal" result compared to syndromic patients (61/80, 76.3% vs 7/14, 50.0%; P = .04). Patients who required more than one procedure had significantly more clinic visits (32.6 vs 14.9; P < .01) and accrued higher costs compared to "optimal" patients (US$34 019.88 vs US$15 357.25; P < .01). CONCLUSIONS: Optimal Outcome Reporting represents a novel quality metric that can provide meaningful information for patients with cleft palate. Optimal Outcome Reporting utilization can help cleft centers adopt changes that matter to patients and their families. By allowing for cross-institutional comparisons in a clear and objective manner, OOR can promote competition, innovation, and value in cleft palate care.

Simulation-Based Comprehensive Cleft Care Workshops: A Reproducible Model for Sustainable Education.

OBJECTIVE: Evaluate simulation-based comprehensive cleft care workshops as a reproducible model for education with sustained impact. DESIGN: Cross-sectional survey-based evaluation. SETTING: Simulation-based comprehensive cleft care workshop. PARTICIPANTS: Total of 180 participants. INTERVENTIONS: Three-day simulation-based comprehensive cleft care workshop. MAIN OUTCOME MEASURES: Number of workshop participants stratified by specialty, satisfaction with the workshop, satisfaction with simulation-based workshops as educational tools, impact on cleft surgery procedural confidence, short-term impact on clinical practice, medium-term impact on clinical practice. RESULTS: The workshop included 180 participants from 5 continents. The response rate was 54.5%, with participants reporting high satisfaction with all aspects of the workshop and with simulation-based workshops as educational tools. Participants reported a significant improvement in cleft lip (33.3 ± 5.7 vs 25.7 ± 7.6; P < .001) and palate (32.4 ± 7.1 vs 23.7 ± 6.6; P < .001) surgery procedural confidence following the simulation sessions. Participants also reported a positive short-term and medium-term impact on their clinical practices. CONCLUSION: Simulation-based comprehensive cleft care workshops are well received by participants, lead to improved cleft surgery procedural confidence, and have a sustained positive impact on participants' clinical practices. Future efforts should focus on evaluating and quantifying this perceived positive impact, as well reproducing these efforts in other areas of need.

Protocols for Reporting Speech Outcomes following Palatoplasty or Velopharyngeal Surgery: A Literature Review.

BACKGROUND: To determine best practices, surgeons who perform cleft palate surgery or surgery for velopharyngeal insufficiency need to be able to compare their outcomes in normalizing the velopharyngeal valve. METHODS: We conducted a comprehensive review of articles that reported speech/resonance outcomes following palatoplasty or surgery for velopharyngeal insufficiency. We analyzed protocols that were used and how the results were reported. We found 170 articles, published between 1990 and 2014, that met our inclusion criteria. RESULTS: Most studies (66%) had a sample size of <50 subjects, were retrospective (67%), were not blinded (83%), and did not report the use of reliability (68%). Most studies included 1 evaluator (27%) or 2 evaluators (30%). Only 80% of the articles specified that at least one speech pathologist was an evaluator. Most articles (56%) did not specify the speech samples used, and 65% used an informal test or did not specify the type of test used. Most studies used a perceptual rating scale for articulation (75%) and resonance (83%). Only 39% of the studies included an evaluation of velopharyngeal function. Finally, objective measures were used in only 28% of the studies (9% used aerodynamic measures and 19% used nasometry). CONCLUSIONS: Because these articles showed significant variability in how speech/resonance is evaluated and how the outcomes are reported, it is virtually impossible to compare results to determine best surgical procedures. Suggestions are given to standardize outcome measures to improve comparability of data.

Sustainable Cleft Care Through Education: The First Simulation-Based Comprehensive Workshop in the Middle East and North Africa Region.

OBJECTIVE: To describe the conduct of the first multidisciplinary simulation-based workshop in the Middle East/North Africa region and evaluate participant satisfaction. DESIGN: Cross-sectional survey-based evaluation. SETTING: Educational comprehensive multidisciplinary simulation-based cleft care workshop. PARTICIPANTS: Total of 93 workshop participants from over 20 countries. INTERVENTIONS: Three-day educational comprehensive multidisciplinary simulation-based cleft care workshop. MAIN OUTCOME MEASURES: Number of workshop participants, number of participants stratified by specialty, satisfaction with workshop, number of workshop staff, and number of workshop staff stratified by specialty. RESULTS: The workshop included 93 participants from over 20 countries. The response rate was 47.3%, and participants reported high satisfaction with all aspects of the workshop. All participants reported they would recommend it to colleagues (100.0%) and participate again (100.0%). No significant difference was detected based on participant specialty or years of experience. The majority were unaware of other cleft practitioners in their countries (68.2%). CONCLUSION: Multidisciplinary simulation-based cleft care workshops are well received by cleft practitioners in developing countries, serve as a platform for intellectual exchange, and are only possible through strong collaborations. Advocates of international cleft surgery education should translate these successes from the regional to the global arena in order to contribute to sustainable cleft care through education.

Effect of One-Stage versus Two-Stage Palatoplasty on Hypernasality and Fistula Formation in Children with Complete Unilateral Cleft Lip and Palate: A Randomized Controlled Trial.

BACKGROUND: Is one-stage or two-stage palatoplasty more effective for preventing fistula formation and hypernasality in patients with complete unilateral cleft lip and palate? METHODS: This parallel blocked randomized controlled trial included 100 patients with nonsyndromic complete unilateral cleft lip and palate with a repaired cleft lip, divided into two equal groups. Group A had one-stage palatoplasty patients at age 12 to 13 months while group B had two-stage palatoplasty patients with soft palatoplasty at age 12 to 13 months and hard palatoplasty at age 24 to 25 months. Presence of a fistula was tested clinically at 3 years and speech was tested using nasometry and perceptual analyses at 6 years. Group C consisted of noncleft controls (n = 20, age 6 years) for speech using nasometry. Fistula rates, hypernasality ratings, and nasalance scores were compared between groups A and B. Nasometry recordings of groups A and B were compared with control group C. RESULTS: There was no difference in fistula rates between groups A and B (p = 0.409; 95 percent CI, 0.365 to 11.9). Mean nasalance scores of group A showed higher nasalance than group B (p = 0.006; 95 percent CI, 1.16 to 6.53). Perceptual analysis showed no difference between groups A and B (p = 0.837 and p = 1.000). Group A showed higher mean nasalance than group C (p = 0.837 and p = 1.000), whereas group B showed no difference (p = 0.088; 95 percent CI, -0.14 to 2.02). CONCLUSIONS: There was no difference in fistula rates between groups. Nasalance was slightly higher in patients in the one-stage palatoplasty group than two-stage palatoplasty group, but the difference was not clinically significant. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

Placement of an antibiotic oral pack on the hard palate after primary cleft palatoplasty: a randomized controlled trial into the effect on fistula rates.

OBJECTIVE: The objective of this study is to determine whether placement of an antibiotic oral pack on the hard palate reduces fistula rates after primary cleft palatoplasty. SUBJECTS AND METHODS: This study was a parallel blocked randomized controlled trial. The study consisted of two groups of 100 patients each with non-syndromic unilateral complete cleft lip, alveolus, and hard and soft palate that underwent primary palatoplasty. Group A had an oral pack placed on the hard palate for 5 days postoperatively while group B did not. Occurrence of fistulae between both groups was tested using odds ratios (OR). RESULTS: In 2% of the patients in group A, a fistula was found 6 months after palatal surgery. In contrast, in 21% of the patients in group B, a palatal fistula could be confirmed. The fistula occurrence in group A was statistically significantly lower than that in group B (OR = 0.0768, CI = [0.02 … 0.34], p < 0.001). CONCLUSION: The findings of this study provide evidence that the rate of fistula formation after primary palatoplasty is significantly reduced if a pack soaked with antibiotic cream is placed on the palate postoperatively for 5 days. CLINICAL RELEVANCE: The use of an antibiotic pack after cleft palate repair can be recommended to prevent occurrence of oronasal fistulae.

Evaluation of Speech and Resonance for Children with Craniofacial Anomalies.

Children with craniofacial anomalies often demonstrate disorders of speech and/or resonance. Anomalies that affect speech and resonance are most commonly caused by clefts of the primary palate and secondary palate. This article discusses how speech-language pathologists evaluate the effects of dental and occlusal anomalies on speech production and the effects of velopharyngeal insufficiency on speech sound production and resonance. How to estimate the size of a velopharyngeal opening based on speech characteristics is illustrated. Nasometry, nasopharyngoscopy, and low-tech tools are discussed as adjunct methods to aid in the evaluation, treatment planning, and measurement of outcomes.

Clinical Practice Guideline: Otitis Media with Effusion Executive Summary (Update).

The American Academy of Otolaryngology-Head and Neck Surgery Foundation has published a supplement to this issue of Otolaryngology-Head and Neck Surgery featuring the updated "Clinical Practice Guideline: Otitis Media with Effusion." To assist in implementing the guideline recommendations, this article summarizes the rationale, purpose, and key action statements. The 18 recommendations developed emphasize diagnostic accuracy, identification of children who are most susceptible to developmental sequelae from otitis media with effusion, and education of clinicians and patients regarding the favorable natural history of most otitis media with effusion and the lack of efficacy for medical therapy (eg, steroids, antihistamines, decongestants). An updated guideline is needed due to new clinical trials, new systematic reviews, and the lack of consumer participation in the initial guideline development group.

Clinical Practice Guideline: Otitis Media with Effusion (Update).

OBJECTIVE: This update of a 2004 guideline codeveloped by the American Academy of Otolaryngology-Head and Neck Surgery Foundation, the American Academy of Pediatrics, and the American Academy of Family Physicians, provides evidence-based recommendations to manage otitis media with effusion (OME), defined as the presence of fluid in the middle ear without signs or symptoms of acute ear infection. Changes from the prior guideline include consumer advocates added to the update group, evidence from 4 new clinical practice guidelines, 20 new systematic reviews, and 49 randomized control trials, enhanced emphasis on patient education and shared decision making, a new algorithm to clarify action statement relationships, and new and expanded recommendations for the diagnosis and management of OME. PURPOSE: The purpose of this multidisciplinary guideline is to identify quality improvement opportunities in managing OME and to create explicit and actionable recommendations to implement these opportunities in clinical practice. Specifically, the goals are to improve diagnostic accuracy, identify children who are most susceptible to developmental sequelae from OME, and educate clinicians and patients regarding the favorable natural history of most OME and the clinical benefits for medical therapy (eg, steroids, antihistamines, decongestants). Additional goals relate to OME surveillance, hearing and language evaluation, and management of OME detected by newborn screening. The target patient for the guideline is a child aged 2 months through 12 years with OME, with or without developmental disabilities or underlying conditions that predispose to OME and its sequelae. The guideline is intended for all clinicians who are likely to diagnose and manage children with OME, and it applies to any setting in which OME would be identified, monitored, or managed. This guideline, however, does not apply to patients <2 months or >12 years old. ACTION STATEMENTS: The update group made strong recommendations that clinicians (1) should document the presence of middle ear effusion with pneumatic otoscopy when diagnosing OME in a child; (2) should perform pneumatic otoscopy to assess for OME in a child with otalgia, hearing loss, or both; (3) should obtain tympanometry in children with suspected OME for whom the diagnosis is uncertain after performing (or attempting) pneumatic otoscopy; (4) should manage the child with OME who is not at risk with watchful waiting for 3 months from the date of effusion onset (if known) or 3 months from the date of diagnosis (if onset is unknown); (5) should recommend against using intranasal or systemic steroids for treating OME; (6) should recommend against using systemic antibiotics for treating OME; and (7) should recommend against using antihistamines, decongestants, or both for treating OME.The update group made recommendations that clinicians (1) should document in the medical record counseling of parents of infants with OME who fail a newborn screening regarding the importance of follow-up to ensure that hearing is normal when OME resolves and to exclude an underlying sensorineural hearing loss; (2) should determine if a child with OME is at increased risk for speech, language, or learning problems from middle ear effusion because of baseline sensory, physical, cognitive, or behavioral factors; (3) should evaluate at-risk children for OME at the time of diagnosis of an at-risk condition and at 12 to 18 months of age (if diagnosed as being at risk prior to this time); (4) should not routinely screen children for OME who are not at risk and do not have symptoms that may be attributable to OME, such as hearing difficulties, balance (vestibular) problems, poor school performance, behavioral problems, or ear discomfort; (5) should educate children with OME and their families regarding the natural history of OME, need for follow-up, and the possible sequelae; (6) should obtain an age-appropriate hearing test if OME persists for 3 months or longer OR for OME of any duration in an at-risk child; (7) should counsel families of children with bilateral OME and documented hearing loss about the potential impact on speech and language development; (8) should reevaluate, at 3- to 6-month intervals, children with chronic OME until the effusion is no longer present, significant hearing loss is identified, or structural abnormalities of the eardrum or middle ear are suspected; (9) should recommend tympanostomy tubes when surgery is performed for OME in a child <4 years old; adenoidectomy should not be performed unless a distinct indication exists (nasal obstruction, chronic adenoiditis); (10) should recommend tympanostomy tubes, adenoidectomy, or both when surgery is performed for OME in a child ≥4 years old; and (11) should document resolution of OME, improved hearing, or improved quality of life when managing a child with OME.

Speech evaluation for patients with cleft palate.

Children with cleft palate are at risk for speech problems, particularly those caused by velopharyngeal insufficiency. There may be an additional risk of speech problems caused by malocclusion. This article describes the speech evaluation for children with cleft palate and how the results of the evaluation are used to make treatment decisions. Instrumental procedures that provide objective data regarding the function of the velopharyngeal valve, and the 2 most common methods of velopharyngeal imaging, are also described. Because many readers are not familiar with phonetic symbols for speech phonemes, Standard English letters are used for clarity.

Current practice in assessing and reporting speech outcomes of cleft palate and velopharyngeal surgery: a survey of cleft palate/craniofacial professionals.

OBJECTIVE: To determine methods by which professionals serving cleft palate/craniofacial teams are evaluating velopharyngeal function and to ascertain what they consider as a successful speech outcome of surgery. DESIGN: A 12-question survey was developed for professionals involved in management of velopharyngeal dysfunction. PARTICIPANTS: The survey was distributed through E-mail lists for the American Cleft Palate-Craniofacial Association and Division 5 of the American Speech-Language-Hearing Association. Only speech-language pathologists and surgeons were asked to complete the survey. A total of 126 questionnaires were completed online. RESULTS: Standard speech evaluations include perceptual evaluation (99.2%), intraoral examination (96.8%), nasopharyngoscopy (59.3%), nasometry (28.9%), videofluoroscopy (19.2%), and aerodynamic measures (4.3%). Significant variation existed in the types and levels of perceptual rating scales. Pharyngeal flap (52.9%) is the most commonly performed procedure for velopharyngeal insufficiency, followed by sphincter pharyngoplasty (27.5%). Criteria for surgical success included normal speech (50.8%), acceptable speech (27.9%), and "improved" speech (8%). However, most respondents felt that success should be defined as normal speech (71.2%). Most respondents believed that surgical success should be determined by the team speech-language pathologist (81.5%); although, some felt success should be determined by the patient/family (17.7%). CONCLUSION: This survey shows considerable variability in the methods for evaluating and reporting speech outcomes following surgery. There is inconsistency in what is considered a successful surgical outcome, making comparison studies impossible. Most respondents thought that success should be defined as normal speech, but this is not happening in current practice.

Perceptual assessment of resonance and velopharyngeal function.

Cleft lip is an anomaly that primarily affects aesthetics, whereas cleft palate is an anomaly that primarily affects function, particularly speech. In fact, the main reason for repairing the palate is to provide adequate structure and function for normal speech production. Despite undergoing palatoplasty surgery, 20 to 30% of children with repaired cleft palate will demonstrate some degree of velopharyngeal dysfunction, resulting in abnormal speech. Velopharyngeal dysfunction is also seen in individuals without a history of cleft palate for various reasons. Because the symptoms of velopharyngeal dysfunction have a variety of causes, a comprehensive evaluation is very important to make the appropriate recommendations for treatment. The purpose of this article is to discuss the clinical assessment of velopharyngeal function for speech, using low-tech and "no-tech" procedures.

Speech therapy for errors secondary to cleft palate and velopharyngeal dysfunction.

Individuals with a history of cleft lip/palate or velopharyngeal dysfunction may demonstrate any combination of speech sound errors, hypernasality, and nasal emission. Speech sound distortion can also occur due to other structural anomalies, including malocclusion. Whenever there are structural anomalies, speech can be affected by obligatory distortions or compensatory errors. Obligatory distortions (including hypernasality due to velopharyngeal insufficiency) are caused by abnormal structure and not by abnormal function. Therefore, surgery or other forms of physical management are needed for correction. In contrast, speech therapy is indicated for compensatory articulation productions where articulation placement is changed in response to the abnormal structure. Speech therapy is much more effective if it is done after normalization of the structure. When speech therapy is appropriate, the techniques involve methods to change articulation placement using standard articulation therapy principles. Oral-motor exercises, including the use of blowing and sucking, are never indicated to improve velopharyngeal function. The purpose of this article is to provide information regarding when speech therapy is appropriate for individuals with a history of cleft palate or other structural anomalies and when physical management is needed. In addition, some specific therapy techniques are offered for the elimination of common compensatory articulation productions.