Exploration of the Utility of the Generic ICHOM Standard Set Measures in Evaluating the Speech of Patients with Cleft Lip/Palate.

Background: The International Consortium of Health Outcome Measurements (ICHOM) standard set for cleft care appraisal recommends clinicians assess articulation with percentage consonants correct (PCC) and velopharyngeal function with velopharyngeal competency rating (VPC-R). This study explores the utility and limitations of these generic measures in detecting cleft speech sound disorders by comparing them with two cleft-specific speech-rating systems, cleft audit protocol of speech-augmented Americleft modification (CAPS-A-AM) and Pittsburgh weighted speech scale (PWSS). Methods: Consecutive children with repaired, nonsyndromic cleft lip/palate, aged 5 years or older (n = 27) underwent prospective speech evaluations conducted at a single academic institution. These evaluations were conducted, recorded, and evaluated by blinded speech-language pathologists experienced with all tools. Results: When comparing measures of articulation, PCC scores correlated better with scores for relevant subcomponents of CAPS-A-AM than PWSS. When comparing measures of velopharyngeal function, VPC-R scores correlated well with relevant components of both scales. Using a "screening test versus diagnostic test" analogy, VPC-R ratings were 87.5% sensitive and 73.7% specific for detecting velopharyngeal dysfunction according to subcomponents of CAPS-A-AM, and 70.6% sensitive and 100% specific according to subcomponents of PWSS. Conclusions: This exploratory study demonstrates that PCC and VPC-R perform moderately well in detecting articulatory and velopharyngeal dysfunction in patients with cleft lip/palate; however, these tools cannot describe nuances of cleft speech sound disorder. Thus, although PCC and VPC-R adequately track basic minimum outcomes, we encourage teams to consider extending the standard set by adopting a cleft-specific measurement system for further evaluation of the tools.

Most Efficient and Meaningful Patient-Reported Appearance Assessment in Different Cleft Types and Age Groups with CLEFT-Q.

BACKGROUND: The CLEFT-Q, a questionnaire developed and validated specifically for cleft patients, contains seven appearance scales. The International Consortium of Health Outcomes Measurement (ICHOM) has incorporated only some CLEFT-Q appearance scales in the Standard Set to minimize burden. This study evaluates which appearance scales provide the most meaningful information in the different cleft types at specific ages, for the most efficient cleft appearance outcome assessment. METHODS: Within this international multicenter study, outcomes of the seven appearance scales were collected, either as part of the ICHOM Standard Set, or as part of the field test study performed to validate the CLEFT-Q. Analyses were performed in separate age groups and cleft types, and involved univariate regression analyses, trend analyses, t tests, correlations, and floor and ceiling effects. RESULTS: A total of 3116 patients were included. Scores for most appearance scales showed a downward trend by age group, with the exception of the Teeth and Jaw scales. In all cleft types, several scales correlated strongly with each other. No floor effects were observed, but ceiling effects were found in several scales in different age groups, most often in the CLEFT-Q Jaw scale. CONCLUSIONS: A proposition for the most meaningful and efficient appearance outcome assessment in cleft patients is made. It was composed so that recommendations are of value for different cleft protocols and initiatives. Suggestions for the use of scales in the ICHOM Standard Set at different ages are given, and also from a clinical perspective. Use of the CLEFT-Q Scar, Lips, and Nose scales will provide additional relevant information.

Measuring the Unilateral Cleft Lip Nasal Deformity: Lateral Deviation of Subnasale Is a Clinical and Morphologic Index of Unrepaired Severity.

OBJECTIVE: Objective measurement of pre-operative severity is important to optimize evidence-based practices given that the wide spectrum of presentation likely influences outcomes. The purpose of this study was to determine the correlation of objective measures of form with a subjective standard of cleft severity. DESIGN: 3D images were ranked according to severity of nasal deformity by 7 cleft surgeons so that the mean rank could be used as the severity standard. PATIENTS: 45 patients with unilateral cleft lip and 5 normal control subjects. INTERVENTIONS: Each image was assessed using traditional anthropometric analysis, 3D landmark displacements, and shape-based analysis to produce 81 indices for each subject. MAIN OUTCOME: The correlation of objective measurements with the clinical severity standard. RESULTS: Lateral deviation of subnasale from midline was the best predictor of severity (0.86). Other strongly-correlated anthropometric measurements included columellar angle, nostril width ratio, and lateral lip height ratio (0.72, 0.80, 0.79). Almost all shape-based measurements had tight correlation with the severity standard, however, dorsum deviation and point difference nasolabial symmetry were the most predictive (0.84, 0.82). CONCLUSIONS: Quantitative measures of severity transcend cleft type and can be used to grade clinical severity. Lateral deviation of subnasale was the best measure of severity and may be used as a surrogate of uncoupled premaxillary growth; it should be recorded as an index of pre-operative severity with every cleft lip repair. The correlation of other measures evaluated clarify treatment priorities and could potentially be used to grade outcomes.

Using "Real-World Data" to Study Cleft Lip/Palate Care: An Exploration of Speech Outcomes from a Multi-Center US Learning Health Network.

OBJECTIVE: To assess the ability of a cleft-specific multi-site learning health network registry to describe variations in cleft outcomes by cleft phenotypes, ages, and treatment centers. Observed variations were assessed for coherence with prior study findings. DESIGN: Cross-sectional analysis of prospectively collected data from 2019-2022. SETTING: Six cleft treatment centers collected data systematically during routine clinic appointments according to a standardized protocol. PARTICIPANTS: 714 English-speaking children and adolescents with non-syndromic cleft lip/palate. INTERVENTION: Routine multidisciplinary care and systematic outcomes measurement by cleft teams. OUTCOME MEASURES: Speech outcomes included articulatory accuracy measured by Percent Consonants Correct (PCC), velopharyngeal function measured by Velopharyngeal Competence (VPC) Rating Scale (VPC-R), intelligibility measured by caregiver-reported Intelligibility in Context Scale (ICS), and two CLEFT-Q™ surveys, in which patients rate their own speech function and level of speech distress. RESULTS: 12year-olds exhibited high median PCC scores (91-100%), high frequency of velopharyngeal competency (62.50-100%), and high median Speech Function (80-91) relative to younger peers parsed by phenotype. Patients with bilateral cleft lip, alveolus, and palate reported low PCC scores (51-91%) relative to peers at some ages and low frequency of velopharyngeal competency (26.67%) at 5 years. ICS scores ranged from 3.93-5.0 for all ages and phenotypes. Speech Function and Speech Distress were similar across phenotypes. CONCLUSIONS: This exploration of speech outcomes demonstrates the current ability of the cleft-specific registry to support cleft research efforts as a source of "real-world" data. Further work is focused on developing robust methodology for hypothesis-driven research and causal inference.

Aesthetic Outcomes in Cleft Care: Exploring Patterns in Patient-Reported Outcomes Across Adolescence.

BACKGROUND: For patients with cleft lip/palate, adolescence is a time of maxillofacial growth and complex psychosocial stressors. The personal significance of facial differences may change, making patient-reported outcomes measures (PROMs) invaluable. In this study, we use several scales from CLEFT-Q™ and FACE-Q™ to explore how aesthetic outcomes differ by age and by sex among patients with unilateral cleft lip/palate. MATERIALS AND METHODS: This was a multi-center, cross-sectional study that prospectively collected CLEFT-Q™ and FACE-Q™ data across six cleft treatment centers during clinical appointments from 2019-2022. Subjects were aged 8-22y with unilateral cleft lip, alveolus, and palate who had not undergone tertiary operative care (maxillary advancement or septorhinoplasty) at the time of survey response. Data cross-sections were prepared by age (8-10y, 11-13y, 14y+), by sex, and by age and sex together. RESULTS: Older age groups reported poorer aesthetic outcomes and worse appearance-related distress compared to younger groups. Although male and female subjects reported similar aesthetic outcomes, female subjects reported more appearance-related distress. When considered simultaneously, age and sex appear to have an intersectional impact on perceived aesthetic outcome and appearance-related distress during adolescence. CONCLUSIONS: This exploratory project suggests that patients with cleft lip/palate may perceive worsening of facial aesthetic throughout the course of adolescence, the exact pattern of which may be dependent on sex. Future work will evaluate this hypothesis using longitudinal cohorts. It will be important to investigate psychosocial factors that may impact these outcomes, and also to quantify the impact of tertiary operative care on these outcomes.

The past, present and future of ACS NSQIP-Pediatric: Evolution from a quality registry to a comparative quality performance platform.

Quality and process improvement (QI/PI) in children's surgical care require reliable data across the care continuum. Since 2012, the American College of Surgeons' (ACS) National Surgical Quality Improvement Program-Pediatric (NSQIP-Pediatric) has supported QI/PI by providing participating hospitals with risk-adjusted, comparative data regarding postoperative outcomes for multiple surgical specialties. To advance this goal over the past decade, iterative changes have been introduced to case inclusion and data collection, analysis and reporting. New datasets for specific procedures, such as appendectomy, spinal fusion for scoliosis, vesicoureteral reflux procedures, and tracheostomy in children less than 2 years old, have incorporated additional risk factors and outcomes to enhance the clinical relevance of data, and resource utilization to consider healthcare value. Recently, process measures for urgent surgical diagnoses and surgical antibiotic prophylaxis variables have been developed to promote timely and appropriate care. While a mature program, NSQIP-Pediatric remains dynamic and responsive to meet the needs of the surgical community. Future directions include introduction of variables and analyses to address patient-centered care and healthcare equity.

The Development, Deployment, and Evaluation of the CLEFT-Q Computerized Adaptive Test: A Multimethods Approach Contributing to Personalized, Person-Centered Health Assessments in Plastic Surgery.

BACKGROUND: Routine use of patient-reported outcome measures (PROMs) and computerized adaptive tests (CATs) may improve care in a range of surgical conditions. However, most available CATs are neither condition-specific nor coproduced with patients and lack clinically relevant score interpretation. Recently, a PROM called the CLEFT-Q has been developed for use in the treatment of cleft lip or palate (CL/P), but the assessment burden may be limiting its uptake into clinical practice. OBJECTIVE: We aimed to develop a CAT for the CLEFT-Q, which could facilitate the uptake of the CLEFT-Q PROM internationally. We aimed to conduct this work with a novel patient-centered approach and make source code available as an open-source framework for CAT development in other surgical conditions. METHODS: CATs were developed with the Rasch measurement theory, using full-length CLEFT-Q responses collected during the CLEFT-Q field test (this included 2434 patients across 12 countries). These algorithms were validated in Monte Carlo simulations involving full-length CLEFT-Q responses collected from 536 patients. In these simulations, the CAT algorithms approximated full-length CLEFT-Q scores iteratively, using progressively fewer items from the full-length PROM. Agreement between full-length CLEFT-Q score and CAT score at different assessment lengths was measured using the Pearson correlation coefficient, root-mean-square error (RMSE), and 95% limits of agreement. CAT settings, including the number of items to be included in the final assessments, were determined in a multistakeholder workshop that included patients and health care professionals. A user interface was developed for the platform, and it was prospectively piloted in the United Kingdom and the Netherlands. Interviews were conducted with 6 patients and 4 clinicians to explore end-user experience. RESULTS: The length of all 8 CLEFT-Q scales in the International Consortium for Health Outcomes Measurement (ICHOM) Standard Set combined was reduced from 76 to 59 items, and at this length, CAT assessments reproduced full-length CLEFT-Q scores accurately (with correlations between full-length CLEFT-Q score and CAT score exceeding 0.97, and the RMSE ranging from 2 to 5 out of 100). Workshop stakeholders considered this the optimal balance between accuracy and assessment burden. The platform was perceived to improve clinical communication and facilitate shared decision-making. CONCLUSIONS: Our platform is likely to facilitate routine CLEFT-Q uptake, and this may have a positive impact on clinical care. Our free source code enables other researchers to rapidly and economically reproduce this work for other PROMs.

Optimizing the Psychosocial Function Measures in the International Consortium for Health Outcomes Measurement Standard Set for Cleft.

BACKGROUND: To ensure the feasibility of implementing PROMs in clinical practice, they must be continually appraised for undue burden placed on patients and clinicians and their usefulness for decision-making. This study assesses correlations between the CLEFT-Q psychosocial scales in the International Consortium for Health Outcomes Measurement Standard Set for cleft and explores their associations with patient characteristics and psychosocial care referral. METHODS: Spearman correlation coefficients were calculated for CLEFT-Q psychological function, social function, school function, face, speech function, and speech-related distress scales. Logistic regressions were used to assess the association of cleft phenotype, syndrome, sex, and adoption status on scale scores and clinical referral to psychosocial care for further evaluation and management. RESULTS: Data were obtained from 3067 patients with cleft lip and/or palate at three centers. Strong correlations were observed between social function and psychological function (r > 0.69) and school function (r > 0.78) scales. Correlation between school function and psychological function scales was lower (r = 0.59 to 0.68). Genetic syndrome (OR, 2.37; 95% CI, 1.04 to 5.41), psychological function (OR, 0.92; 95% CI, 0.88 to 0.97), school function (OR, 0.94; 95% CI, 0.90 to 0.98), and face (OR, 0.96; 95% CI, 0.94 to 0.98) were significant predictors for referral to psychosocial care. CONCLUSIONS: Because social function as measured by the CLEFT-Q showed strong correlations with both school and psychological function, its additional value for measuring psychosocial function within the Standard Set is limited, and it is reasonable to consider removing this scale from the International Consortium for Health Outcomes Measurement Standard Set for cleft.

Systematic Review and Critical Appraisal of the Evidence Base for Nasoalveolar Molding (NAM).

OBJECTIVE: To critically appraise the body of scientific literature supporting the risks and efficacy of nasoalveolar molding (NAM), specifically in contrast to alternative methods of presurgical infant orthopedics (PSIO) or to treatment without PSIO. MAIN OUTCOME MEASURES: Five outcome domains were considered: nasolabial aesthetics; dentoalveolar relationship; midfacial growth; cost and burden of care; and number of anesthetic events. DESIGN: MEDLINE, Embase, and Scopus were queried for articles from the first description of the Grayson-Santiago NAM technique (1993) through December 13, 2021. After the application of inclusionary and exclusionary criteria, selected articles were critically appraised using a systematic framework that included risk of bias assessment using the Cochrane RoB 2.0 and ROBINS-I tools. RESULTS: A total of 88 studies were included. Level-I and -II evidence showed on par or better approximation and alveolar alignment achieved by NAM compared to other PSIO. Level-II and -III evidence showed improved nasolabial aesthetics compared to other PSIOs. Level-II and -III evidence supported no harm to maxillofacial skeletal growth through age 12. Sparse level-III evidence supported a reduced number of labial or nasal revisions following NAM. Level-II and -III evidence showed NAM requiring upfront cost and frequent appointments but reducing caregiver psychosocial burden and reducing long-term costs compared to select alternatives. Many studies carried a high risk of bias. CONCLUSIONS: Current evidence supports the overall efficacy of NAM regarding short/mid-term outcomes, with a low risk of negative effects on midfacial growth or dental development. The high risk of bias discovered in many papers underscores the need for robust study design in future research.

Correlation Between Postoperative Antimicrobial Prophylaxis Use and Surgical Site Infection in Children Undergoing Nonemergent Surgery.

Importance: Use of postoperative antimicrobial prophylaxis is common in pediatric surgery despite consensus guidelines recommending discontinuation following incision closure. The association between postoperative prophylaxis use and surgical site infection (SSI) in children undergoing surgical procedures remains poorly characterized. Objective: To evaluate whether use of postoperative surgical prophylaxis is correlated with SSI rates in children undergoing nonemergent surgery. Design, Setting, and Participants: This is a multicenter cohort study using 30-day postoperative SSI data from the American College of Surgeons' Pediatric National Surgical Quality Improvement Program (ACS NSQIP-Pediatric) augmented with antibiotic-use data obtained through supplemental medical record review from June 2019 to June 2021. This study took place at 93 hospitals participating in the ACS NSQIP-Pediatric Surgical Antibiotic Prophylaxis Stewardship Collaborative. Participants were children (<18 years of age) undergoing nonemergent surgical procedures. Exclusion criteria included antibiotic allergies, conditions associated with impaired immune function, and preexisting infections requiring intravenous antibiotics at time of surgery. Exposures: Continuation of antimicrobial prophylaxis beyond time of incision closure. Main Outcomes and Measures: Thirty-day postoperative rate of incisional or organ space SSI. Hierarchical regression was used to estimate hospital-level odds ratios (ORs) for SSI rates and postoperative prophylaxis use. SSI measures were adjusted for differences in procedure mix, patient characteristics, and comorbidity profiles, while use measures were adjusted for clinically related procedure groups. Pearson correlations were used to examine the associations between hospital-level postoperative prophylaxis use and SSI measures. Results: Forty thousand six hundred eleven patients (47.3% female; median age, 7 years) were included, of which 41.6% received postoperative prophylaxis (hospital range, 0%-71.2%). Odds ratios (ORs) for postoperative prophylaxis use ranged 190-fold across hospitals (OR, 0.10-19.30) and ORs for SSI rates ranged 4-fold (OR, 0.55-1.90). No correlation was found between use of postoperative prophylaxis and SSI rates overall (r = 0.13; P = .20), and when stratified by SSI type (incisional SSI, r = 0.08; P = .43 and organ space SSI, r = 0.13; P = .23), and surgical specialty (general surgery, r = 0.02; P = .83; urology, r = 0.05; P = .64; plastic surgery, r = 0.11; P = .35; otolaryngology, r = -0.13; P = .25; orthopedic surgery, r = 0.05; P = .61; and neurosurgery, r = 0.02; P = .85). Conclusions and Relevance: Use of postoperative surgical antimicrobial prophylaxis was not correlated with SSI rates at the hospital level after adjusting for differences in procedure mix and patient characteristics.

A systematic analysis of surgical interventions for the airway in the mature unilateral cleft lip nasal deformity: a single case study.

PURPOSE: Individuals with unilateral cleft lip nasal deformity (uCLND) often require rhinoplasty in adolescence to correct nasal obstruction. The intent of this study is to identify sites of greatest nasal obstruction and evaluate the effects of isolated and combinations of simulated surgical procedures on these sites using computational fluid dynamics (CFD). METHODS: Computed tomography imaging of an adolescent subject with uCLND was converted to an anatomically accurate three-dimensional nasal airway model. Initial analysis was performed to identify anatomic sites of obstruction based on CFD computed resistance values. Virtual surgery procedures corresponding to common uCLND surgical interventions were simulated. Resulting airspace models were then analyzed after conducting airflow and heat transfer simulations. RESULTS: The preoperative model had 21 obstructed sites with a nasal resistance of 0.075 Pa s/mL. Following simulated surgical procedures with functional interventions alone and in combinations, the three virtual surgery models with most improved nasal airflow were inferior turbinate reduction (ITR) with posterior septoplasty (resistance = 0.054 Pa s/ml, reduction in 14 of 21 obstructed sites), ITR with anterior septoplasty (resistance = 0.058 Pa s/ml, reduction in 8 of 21 obstructed sites), and ITR with both anterior and posterior septoplasty (resistance = 0.052 Pa s/ml, reduction in 17 of 21 obstructed sites). CONCLUSION: This study introduces a new technique for analysis of the impact of different simulated surgical interventions on uCLND-induced nasal obstruction. In this subject, simulated septoplasty with ITR on the non-cleft side provided maximal relief of nasal obstruction. The proposed technique can be further studied for possible utility in analyzing potential surgical interventions for optimal relief of nasal obstruction in patients with uCLND.

Barriers and Facilitators to the International Implementation of Standardized Outcome Measures in Clinical Cleft Practice.

OBJECTIVE: To identify barriers and facilitators to international implementation of a prospective system for standardized outcomes measurement in cleft care. DESIGN: Cleft teams that have implemented the International Consortium for Health Outcomes Measurement Standard Set for cleft care were invited to participate in this 2-part qualitative study: (1) an exploratory survey among clinicians, health information technology professionals, and project coordinators, and (2) semistructured interviews of project leads. Thematic content analysis was performed, with organization of themes according to the dimensions of the reach, effectiveness, adoption, implementation and maintenance (RE-AIM) framework: reach, effectiveness, adoption, implementation, and maintenance. RESULTS: Four cleft teams in Europe and North America participated in this study. Thirteen participants completed exploratory questionnaires and 5 interviewees participated in follow-up interviews. Survey responses and thematic content analysis revealed common facilitators and barriers to implementation at all sites. Teams reach patients either via email or during the clinic visit to capture patient-reported outcomes. Adopting routine data collection is enhanced by aligning priorities at the organizational and cleft team level. Streamlining workflows and developing an efficient data collection platform are necessary early on, followed by pilot testing or stepwise implementation. Regular meetings and financial resources are crucial for implementing, sustaining, analyzing collected data, and providing feedback to health care professionals and patients. Fostering patient-centered care was articulated as a positive outcome, whereas time presented challenges across all RE-AIM dimensions. CONCLUSIONS: Identified themes can inform ongoing implementation efforts. Intentionally investing time to lay a sound foundation early on will benefit every phase of implementation and help overcome barriers such as lack of support or motivation.

Rasch Analysis of Patient- and Parent-Reported Outcome Measures in the International Consortium for Health Outcomes Measurement Standard Set for Cleft Lip and Palate.

OBJECTIVES: The aim of this study was to evaluate the psychometric performance of the patient- and parent-reported measures in the International Consortium for Health Outcomes Measurement (ICHOM) Standard Set for Cleft Care, and to identify ways of improving concept coverage. METHODS: Data from 714 patients with cleft lip and/or palate, aged 8 to 9, 10 to 12.5, and 22 years were collected between November 2015 and April 2019 at Erasmus University Medical Center, Boston Children's Hospital, Duke Children's Hospital, and from participating sites in the CLEFT-Q Phase 3 study. The Standard Set includes 9 CLEFT-Q scales, the Nasal Obstruction Symptom Evaluation (NOSE) questionnaire, the Child Oral Health Impact Profile-Oral Symptoms Scale (COHIP-OSS), and the Intelligibility in Context Scale (ICS). Targeting, item-fit statistics, thresholds for item responses, and measurement precision (PSI) were analyzed using Rasch measurement theory. RESULTS: The proportion of the sample to score within each instruments range of measurement varied from 69% (ICS) to 92% (CLEFT-Q teeth and COHIP-OSS). Specific problems with individual items within the NOSE and COHIP-OSS questionnaires were noted, such as poor item fit to the Rasch model and disordered thresholds (6 of 10). Reliability measured with PSI was above 0.82 for the ICS and all but one CLEFT-Q scale (speech distress). PSIs were lowest for the COHIP-OSS (0.43) and NOSE questionnaire (0.35). CONCLUSION: The patient- and parent-reported components within the facial appearance, psychosocial function, and speech domains are valid measures; however, the facial function and oral health domains are not sufficiently covered by the CLEFT-Q eating and drinking, NOSE, and COHIP-OSS, and these questionnaires may not be accurate enough to stratify cleft-related outcomes.

Time-Driven, Activity-Based Costing of Presurgical Infant Orthopedics: A Critical Component of Establishing Value of Latham Appliance and Nasoalveolar Molding.

BACKGROUND: Value-based health-care reform requires assessment of outcomes and costs of medical interventions. In cleft care, presurgical infant orthopedics is still being evaluated for clinical benefits and risks; however, the cost of these procedures has been largely ignored. This study uses robust accounting methods to quantify the cost of providing two types of presurgical infant orthopedics: Latham appliance treatment and nasoalveolar molding. METHODS: This is a prospective study of patients with nonsyndromic cleft lip and/or palate who underwent treatment with presurgical infant orthopedics from 2017 to 2019 at two academic centers. Costs were measured using time-driven activity-based costing. Personnel costs, facility costs (operating room, clinic, and inpatient ward), and equipment costs were included. Travel expenses were incorporated as an estimate of direct costs borne by the family, but indirect costs (e.g., time off from work) were not considered. RESULTS: Twenty-three patients were treated with Latham appliance treatment and 14 were treated with nasoalveolar molding. For Latham appliance treatment, average total cost was $7553 per patient ($1041 for personnel, $637 for equipment, $4871 for facility, and $1004 for travel over 6.5 visits). Unilateral and bilateral costs were $6891 and $8860, respectively. For nasoalveolar molding, average cost totaled $2541 ($364 for personnel, $151 for equipment, $300 for facility, and $1726 for travel over 13 visits); $2120 for unilateral and $3048 for bilateral treatment. CONCLUSIONS: The major difference in cost is attributable to operative placement of the Latham device. Travel cost for nasoalveolar molding is often higher because of frequent clinical encounters required. Future investigation should focus on whether outcomes achieved by presurgical infant orthopedics justify the $2100 to $8900 expenditure for these adjunctive procedures.

A Toolbox of Surgical Techniques for Palatal Fistula Repair.

OBJECTIVE: To provide an inventory of oronasal fistula repair techniques alongside expert commentary on which techniques are appropriate for each fistula type. DESIGN: A 4-stage approach was used to develop a consensus on surgical techniques available for fistula repair: (1) in-person discussion of oronasal fistula cases among cleft surgeons, (2) development of a schema for fistula management using transcripts of the in-person case discussion, (3) evaluation of the preliminary schema via a web-based survey of additional cleft surgeons, and (4) revision of the management schema using survey responses. PARTICIPANTS: Six cleft surgeons participated in the in-person case discussion. Eleven additional surgeons participated in the web-based survey. Participants had diverse training experiences, having completed residency and fellowship at 20 different hospitals. RESULTS: A schema for fistula management was developed, organized by fistula location. The schema catalogues all viable approaches for each location. For fistulae involving the soft palate, the schema stresses the importance of evaluating for velopharyngeal insufficiency (VPI) and incorporating VPI management into fistula repair. For fistulae involving the hard palate, the schema separately enumerates the techniques available for nasal lining repair and for oral lining repair in each region. The schema also catalogues the diversity of approaches to lingual- and labioalveolar fistula, including variation in timing, orthodontic preparation, and simultaneous alveolar bone grafting. CONCLUSIONS: This study employed consensus methods to create a comprehensive inventory of available fistula repair techniques and to identify preferential techniques among a diverse group of surgeons.

Videoscope-Assisted Cleft Palate Surgery: Rationale, Experience, and Technical Implementation.

Limited visibility characteristic of cleft palate repair presents both ergonomic and educational challenges to cleft surgeons. Despite widespread recognition and reporting, posture-related spine disorders continue to represent a significant and potentially career-limiting problem for cleft/craniofacial surgeons. In addition, education and participation during palate repairs is difficult because of visual field constraints. At the authors' institution, a novel videoscope system was designed and implemented to (1) provide visualization for all surgical team members during palate operations, (2) facilitate active resident education, and (3) improve surgeon ergonomics. The authors' prior report demonstrated proof of concept for this method, which is now used in all cleft palate operations at their center. The purpose of this report is to share the detailed methodology to facilitate implementation by others and a retrospective review of the authors' experience before and after implementation. Video demonstration of the videoscope setup and a representative, recorded case are provided. The use of the videoscope was feasible in palatoplasties regardless of palatal phenotype and repair technique and did not have an effect on operative time. Subjectively, the authors report reduced procedure time in cervical flexion and subjectively improved musculoskeletal strain associated with videoscope use. Importantly, use of this system also provided complete visualization for all operating room team members and enabled enhanced resident autonomy during palate operations. Finally, it has facilitated the creation and archive of high-definition educational videos with unparalleled perspective. The equipment required to implement the system is likely already available in many medical centers. Adoption of this system may provide an opportunity to improve posture and teaching capabilities for cleft surgeons. CLINICAL QUESTION/LEVEL OF EVIDENCE:: Therapeutic, III.

Provision and Utilization of Team- and Community-Based Operative Care for Patients With Cleft Lip/Palate in North Carolina.

OBJECTIVE: To characterize operative care for cleft lip and/or palate (CL/P) based on location (ie, from American Cleft Palate Craniofacial Association [ACPA]-approved multidisciplinary teams or from community providers). DESIGN: Cross-sectional analysis of Healthcare Cost and Utilization Project State Inpatient Database and State Ambulatory Surgery & Services Database databases for North Carolina from 2012 to 2015. SETTING/PATIENTS AND MAIN OUTCOME MEASURES: Clinical encounters for children with CL/P undergoing operative procedures were identified, classified by location as "Team" versus "Community," and characterized by demographic, geographic, clinical, and procedural factors. A secondary evaluation reviewed concordance of team and community practices with an ACPA guideline related to coordination of care. RESULTS: Three teams and 39 community providers performed a total of 3010 cleft-related procedures across 2070 encounters. Teams performed 69.7% of total volume and performed the majority of cleft procedures, including cleft lip repair, palate repair, alveolar bone grafting, and correction of velopharyngeal insufficiency. Community locations principally offered myringotomy and rhinoplasty. Team care was associated with higher guideline concordance. CONCLUSIONS: American Cleft Palate Craniofacial Association -approved team-based care accounts for the majority of cleft-related care in North Carolina; however, a substantial volume of cleft-related procedures was provided by community providers, with 3 providers accounting for the vast majority of community cases.

Feasibility of Surgeon-Delivered Audit and Feedback Incorporating Peer Surgical Coaching to Reduce Fistula Incidence following Cleft Palate Repair: A Pilot Trial.

BACKGROUND: Improving surgeons' technical performance may reduce their frequency of postoperative complications. The authors conducted a pilot trial to evaluate the feasibility of a surgeon-delivered audit and feedback intervention incorporating peer surgical coaching on technical performance among surgeons performing cleft palate repair, in advance of a future effectiveness trial. METHODS: A nonrandomized, two-arm, unblinded pilot trial enrolled surgeons performing cleft palate repair. Participants completed a baseline audit of fistula incidence. Participants with a fistula incidence above the median were allocated to an intensive feedback intervention that included selecting a peer surgical coach, observing the coach perform palate repair, reviewing operative video of their own surgical technique with the coach, and proposing and implementing changes in their technique. All others were allocated to simple feedback (receiving audit results). Outcomes assessed were proportion of surgeons completing the baseline audit, disclosing their fistula incidence to peers, and completing the feedback intervention. RESULTS: Seven surgeons enrolled in the trial. All seven completed the baseline audit and disclosed their fistula incidence to other participants. The median baseline fistula incidence was 0.4 percent (range, 0 to 10.5 percent). Two surgeons were unable to receive the feedback intervention. Of the five remaining surgeons, two were allocated to intensive feedback and three to simple feedback. All surgeons completed their assigned feedback intervention. Among surgeons receiving intensive feedback, fistula incidence was 5.9 percent at baseline and 0.0 percent following feedback (adjusted OR, 0.98; 95 percent CI, 0.44 to 2.17). CONCLUSION: Surgeon-delivered audit and feedback incorporating peer coaching on technical performance was feasible for surgeons.

Decision-Making in Middle Vault Reconstruction following Dorsal Hump Reduction in Primary Rhinoplasty.

BACKGROUND: Dorsal hump reduction during open rhinoplasty disrupts the continuity between the upper lateral cartilages and the dorsal septum. Options to reconstitute the midvault include primary closure of the upper lateral cartilages to the dorsal aspect of the septum, placement of spreader grafts, and creation of spreader flaps. The authors sought to clarify from highly experienced rhinoplasty surgeons their decision-making rationale for midvault reconstruction, distilling down the group consensus into algorithmic guidelines. METHODS: A panel of internationally recognized rhinoplasty surgeons participated in a two-part organized communication method. An introductory summit consisted of open discussions on various topics in midvault reconstruction. The summit transcription was analyzed by thematic content analysis to develop a survey encompassing clinical scenarios for primary rhinoplasty, which was then individually administered to each panelist. Data gathered from both parts were used to generate technical guidelines and a decision-making algorithm. RESULTS: The panelists identified the following anatomical features as pertinent to their selection of midvault reconstruction method: size of the dorsal hump reduction, width of the midvault relative to the upper vault, presence of dorsal angulation, and presence of nasal obstructive symptoms. Individual panelist preference was gathered from the 24-scenario survey divided into either cosmetic or functional rhinoplasty cases. CONCLUSIONS: Management of the midvault after dorsal hump reduction is important to establish proper aesthetic relationships and to provide functional integrity of the internal valve. Our authors present an algorithmic approach to decision-making based on the systematic analysis practiced by senior rhinoplasty surgeons.