Patient factors associated with novel EAR-Q appearance, psychosocial, and social scales: A cross-sectional study and regression analysis.

INTRODUCTION: The EAR-Q is a rigorously validated patient-reported outcome measure, which evaluates ear appearance and health-related quality of life (HRQL) in patients with congenital or acquired ear conditions. The aim of this study was to conduct an exploratory analysis to examine the factors associated with EAR-Q appearance and HRQL scale scores. METHODS: In this study, 862 participants, aged 8-29 years, with congenital or acquired ear conditions, completed the EAR-Q as part of an international field-test study. Patients responded to demographic and clinical questions as well as the EAR-Q. Univariable and multivariable linear regression analyses were used to determine factors that were significant predictors for the scores on the EAR-Q Appearance, Psychological, and Social scales. RESULTS: Most participants were men (57.4%), awaiting treatment (55.0%), and had a microtia diagnosis (70.4%), with a mean age of 13 (±4) years. Worse ear appearance scores (p < 0.02) were associated with male gender, microtia, no history of treatment, ear surgery within 6 months, unilateral involvement, and greater self-reported ear asymmetry. Decreased psychological scores (p < 0.01) were associated with increasing participant age, no treatment history, recent ear surgery, and dissatisfaction with ears matching or overall dissatisfaction. Lower social scores (p ≤ 0.04) were associated with no treatment history, those awaiting surgery, ear surgery within the last 6 months, bilateral involvement, and self-reported ears matching or overall appearance. CONCLUSION: This analysis identified patient factors that may influence ear appearance and HRQL scale scores. These findings provide evidence of patient factors that should be adjusted for when undertaking future observational research designs using the EAR-Q in this patient population.

Cleft lip and/or palate mortality trends in the USA: a retrospective population-based study.

BACKGROUND: Cleft lip and/or palate (CL/P) is one of the most common congenital anomalies worldwide. Although CL/P management may require a series of interventions, mortality resulting from CL/P alone is rare. This study aims to examine recent trends of CL/P mortality rates in the USA. METHODS: A retrospective population-based study was conducted using official US birth and death certificate data from the Centers for Disease Control and Prevention from 2000 to 2019. Annual mortality rates per 1000 births with CL/P were calculated across sex and racial groups. Multivariable logistic regression models estimated the effects of sex and race on the risk of mortality with CL/P, and linear regression models were used to examine temporal changes in mortality rate across sex and race. RESULTS: From 2000 to 2019, 1119 deaths occurred in patients with documented CL/P, for an overall incidence of 20.3 deaths per 1000 births with CL/P (95% CI 18.9 to 22.8). Of these, Patau syndrome was the listed cause of death in 167 cases (14.9%). Black individuals (OR 1.93, 95% CI 1.85 to 2.01), Hispanic (1.54, 1.49 to 1.58) and American Indian individuals (1.28, 1.20 to 1.35) were at a greater risk of CL/P mortality compared with white individuals. Additionally, females were also at a greater risk (1.35, 1.21 to 1.49). A significant upward trend in CL/P mortality was observed in Hispanic (r2=0.70, p<0.01) and American Indian individuals (r2=0.81, p<0.01) from 2000 to 2019. CONCLUSIONS: Cleft birth and mortality surveillance is essential in healthcare and prevention planning. Future studies are required to understand the differences in CL/P mortality rates across various sociodemographic groups.

Development and Evaluation of a High-Fidelity Rhinoplasty Simulator.

SUMMARY: Rhinoplasty is a challenging procedure with a steep learning curve. Surgical simulators provide a safe platform to gain hands-on experience without compromising patient outcomes. Therefore, rhinoplasty is an ideal procedure to benefit from an effective surgical simulator. A high-fidelity rhinoplasty simulator was developed using three-dimensional computer modeling, three-dimensional printing, and polymer techniques. The simulator was tested by six surgeons with experience in rhinoplasty to assess realism, anatomic accuracy, and value as a training tool. The surgeons performed common rhinoplasty techniques and were provided a Likert-type questionnaire assessing the anatomic features of the simulator. A variety of surgical techniques were performed successfully using the simulator, including open and closed approaches. Bony techniques performed included endonasal osteotomies and rasping. Submucous resection with harvest of septal cartilage, cephalic trim, and tip suturing, as well as grafting techniques including alar rim, columellar strut, spreader, and shield grafts, were performed successfully. Overall, there was agreement on the simulator's anatomic accuracy of bony and soft-tissue features. There was strong agreement on the simulator's overall realism and value as a training tool. The simulator provides a high-fidelity, comprehensive training platform to learn rhinoplasty techniques to augment real operating experience without compromising patient outcomes.

Outcomes of Digit Replantation in Children: A Systematic Review.

Background: Children have been suggested to benefit from digit replantation due to a greater neurogenerative capacity. We aimed to conduct a systematic review on digit replantation in children to provide a comprehensive overview of survival rates and functional outcomes. Methods: A systematic literature search was conducted on Ovid MEDLINE, Embase, and the Cochrane Controlled Register of Trials for studies published between 1980 and 2023. We included peer-reviewed studies reporting on digit survival rates in pediatric patients under the age of 18 years who underwent single or multiple digit replantations distal to the metacarpophalangeal joint. Preoperative, intraoperative, and postoperative outcomes were extracted, and pooled estimates were derived using univariable analysis. Results: Twenty-two studies reporting on 761 patients and 814 digit replantations were included in our study. Most replantations occurred in the index (n = 74), Tamai zone I (n = 168), and from clean-cut injuries (n = 190). The mean survival rate was 76% (n = 618/814), with a mean range of motion at the distal interphalangeal joint ranging from 64 degrees to 90 degrees and two-point discrimination ranging from 3.8 mm to 6.4 mm. Compared with clean-cut injuries, digit replantations from avulsion [odds ratio (OR), 0.81; 95% confidence interval (CI), 0.74-0.89] or crush (OR, 0.71; 95% CI, 0.59-0.82) injuries were associated with a lower odds of survival. Digit replantations performed with two venous (OR, 1.43, 95% CI; 1.28-1.59) or arterial anastomoses (OR, 1.65; 95% CI, 1.48-1.81) were associated with a higher odds of survival. Conclusions: Our systematic review suggests that digit replantation may be a viable option in children. Further research is required to explore functionality after digit replantation in diverse pediatric populations.

Determining Construct Validity of a Patient-Reported Outcome Measure for Birthmarks on the Face and Body.

Background: The FACE-Q Craniofacial module includes a scale that measures how bothered an individual is by the appearance of a birthmark on the face or body. Objective: To determine if the Birthmark scale measuring appearance of the birthmark has evidence of construct validity among children and young adults, aged 8-29 years old, with a birthmark on the face or body. Methods: Participants were recruited as part of the field test of the FACE-Q Craniofacial module. Construct validity of the Birthmark scale was examined using a priori hypotheses testing. Results: Two hundred seventy participants were included, who were predominantly female (60.4%) and had a facial birthmark (71.5%). The Birthmark scale correlated (p ≤ 0.01) with scale scores for Face, Appearance Distress, Psychological, School, and Social. Scores for participants with more "noticeable" birthmarks were (p ≤ 0.01) associated with worse Birthmark scale scores. Conclusion: The findings support that the Birthmark scale can be used to measure the patient's perspective of the appearance of their birthmark, providing a means for clinicians to incorporate the patient's view in shared decision-making and research.

The First Alveolar Bone Graft Simulator.

Alveolar bone graft (ABG) surgery in cleft patients is technically challenging. The procedure requires design, dissection and release of soft tissue flaps to create a seal around the bone graft. In addition, visualization during the procedure is challenging within the confines of the cleft. These features make ABG surgery difficult to learn and teach, and it is, therefore, a suitable procedure for the use of a simulator. A high-fidelity cleft ABG simulator was developed using three-dimensional printing, polymer, and adhesive techniques. Simulated ABG surgery was performed by two expert cleft surgeons for a total of five simulation sessions to test the simulator's features and the ability to perform the critical steps of an ABG. ABG surgery was successfully performed on the simulator. The simulations involved interacting with realistic dissection planes as well as multi-layered synthetic soft (periosteum, mucosa, gingiva, adipose tissue) and hard (teeth, bone) tissue. The simulator allowed performance of cleft marginal incisions, dissection, and elevation of a muco-gingival-periosteal flap, creation of nasal upturned and palatal downturned flaps, nasal and palatal side closure, insertion of simulated bone graft material, and advancement of the muco-gingival-periosteal flap for closure of the anterior wall of the cleft. The ABG simulator allowed performance of the critical steps of ABG surgery. This is the first ABG simulator developed, which incorporates the features necessary to practice the procedure from start to finish.

Impact of Completing FACE-Q Craniofacial Module Scales on Children and Young Adults with Facial Differences: An International Study.

BACKGROUND: The FACE-Q Craniofacial Module measures outcomes that matter to patients with diverse craniofacial conditions. However, it is not known whether completing a patient-reported outcome measure (PROM) has a negative impact on patients, particularly children. This study aims to investigate the impact of completing the FACE-Q Craniofacial Module and identify factors associated with a negative impact. METHODS: Participants were between 8 and 29 years of age, had a facial difference, and completed at least one module of the FACE-Q Craniofacial Module as part of the international field-test study between December of 2016 and 2019. Participants were asked three questions: "Did you like or dislike answering this questionnaire?" "Did answering these questions change how you feel about how you look?" and "Did answering this questionnaire make you feel unhappy or happy?" Univariate and multivariable logistic regression analyses were used to evaluate variables associated with a negative response. RESULTS: The sample included 927 participants. Most patients responded neutrally to all impact questions: 42.7% neither disliked nor liked the questionnaire; 76.6% felt the same about how they looked; and 72.7% felt neither unhappy nor happy after completion. Negative responses represented a small proportion of patients across all three impact questions (<13.2%). Increased craniofacial severity, more scales completed, and lower scores on all FACE-Q scales were associated with negative responses for all three impact questions ( P <0.01). CONCLUSIONS: This study provides evidence that the FACE-Q Craniofacial Module is acceptable for most participants. Clinicians and study investigators should follow up with patients after completing this PROM to address areas of concern in scale scores. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, III.

Psychometric Validation of the FACE-Q Craniofacial Module for Facial Nerve Paralysis.

Background: Systematic reviews have identified the need for a patient-reported outcome measure for facial nerve paralysis (FNP). The aim of this study was to determine the psychometric properties of FACE-Q Craniofacial module scales when used in a combined sample of children and older adults with FNP. Methods: Data were collected between December 2016 and December 2019. We conducted qualitative interviews with children and adults with FNP. FACE-Q data were collected from patients aged 8 years and older with FNP. Rasch measurement theory analysis was used to examine the reliability and validity of the relevant scales in the FNP sample. Results: Twenty-five patients provided 2052 qualitative codes related to appearance, physical, psychological, and social function. Many patient concerns were common across age. The field-test sample included 235 patients aged 8-81 years. Of the 13 scales examined, all 122 items had ordered thresholds and good item fit to the Rasch model. For 12 scales, person separation index values were ≥0.79 and Cronbach's alpha values were ≥0.82. The 13th scale's reliability values were ≥0.71. Conclusion: The FACE-Q Craniofacial module scales described in this study can be used to collect and compare evidence-based outcome data from children and adults with FNP.

Deeper Understanding of Appearance in Orofacial Clefts: A Structural Equation Model of the CLEFT-Q Appearance Scales.

BACKGROUND: The CLEFT-Q is a patient-reported outcome measure with seven scales measuring elements of facial appearance in cleft lip and/or palate. We built on the validated CLEFT-Q structural model to describe conceptual relationships between these scales, and tested our hypothesis through structural equation modeling (SEM). In our hypothesized model, the appearance of the nose, nostrils, teeth, jaw, lips, and cleft lip scar all contribute to overall facial appearance. METHODS: We included 640 participants from the international CLEFT-Q field test. Model fit was assessed using weighted least squares mean and variance adjusted regression. The model was then refined through modification indices. The fit of the hypothesized model was confirmed in an independent sample of 452 participants. RESULTS: The refined model demonstrated excellent fit to the data (comparative fit index 0.999, Tucker-Lewis index 0.999, root mean square error of approximation 0.036 and standardized root mean square residual 0.036). The confirmatory analysis also demonstrated excellent model fit. CONCLUSION: Our structural model, based on a clinical understanding of appearance in orofacial clefting, aligns with CLEFT-Q field test data. This supports the instrument's use and the exploration of a wider range of applications, such as multidimensional computerized adaptive testing.

Recursive Partitioning vs Computerized Adaptive Testing to Reduce the Burden of Health Assessments in Cleft Lip and/or Palate: Comparative Simulation Study.

BACKGROUND: Computerized adaptive testing (CAT) has been shown to deliver short, accurate, and personalized versions of the CLEFT-Q patient-reported outcome measure for children and young adults born with a cleft lip and/or palate. Decision trees may integrate clinician-reported data (eg, age, gender, cleft type, and planned treatments) to make these assessments even shorter and more accurate. OBJECTIVE: We aimed to create decision tree models incorporating clinician-reported data into adaptive CLEFT-Q assessments and compare their accuracy to traditional CAT models. METHODS: We used relevant clinician-reported data and patient-reported item responses from the CLEFT-Q field test to train and test decision tree models using recursive partitioning. We compared the prediction accuracy of decision trees to CAT assessments of similar length. Participant scores from the full-length questionnaire were used as ground truth. Accuracy was assessed through Pearson's correlation coefficient of predicted and ground truth scores, mean absolute error, root mean squared error, and a two-tailed Wilcoxon signed-rank test comparing squared error. RESULTS: Decision trees demonstrated poorer accuracy than CAT comparators and generally made data splits based on item responses rather than clinician-reported data. CONCLUSIONS: When predicting CLEFT-Q scores, individual item responses are generally more informative than clinician-reported data. Decision trees that make binary splits are at risk of underfitting polytomous patient-reported outcome measure data and demonstrated poorer performance than CATs in this study.

Establishing content validity of an orthodontic subset of the FACE-Q Craniofacial Module in children and young adults with malocclusion.

OBJECTIVE: The FACE-Q Craniofacial Module for children and young adults is a patient-reported outcome measure (PROM) designed to measure outcomes for patients aged 8 to 29 years with facial conditions. The aim of this study was to establish content validity of a relevant subset of the module for its use in orthodontic patients with malocclusion. SETTING AND SAMPLE POPULATION: Experts in orthodontics were emailed and invited to provide feedback through a Research Electronic Data Capture survey. Patient feedback was obtained through cognitive interviews with patients aged 8 to 29 years recruited from a university-based orthodontic clinic in Canada. MATERIALS AND METHODS: Expert opinion and patient interviews were used to obtain feedback on the content of 4 appearance (face, smile, teeth and jaws) and 1 function (eating and drinking) scales hypothesized to be relevant to orthodontic malocclusions, and to elicit new concepts. Interviews were audio-recorded, transcribed, and coded using a line-by-line approach. RESULTS: Twenty-one experts and 15 patients participated. Expert feedback led us to drop 9, retain 40, revise 4 and add 16 new items. At the conclusion of cognitive interviews no items were dropped, 55 were retained, 5 were revised and 8 new items were added. The final set of 68 items demonstrated content validity for orthodontic patients. CONCLUSION: Expert feedback and cognitive interviews enabled us to revise and refine 5 scales as part of the FACE-Q Craniofacial Module for use in orthodontic patients. These scales were included in the internationalfield-test of the FACE-Q Craniofacial Module.

Optimising the computerised adaptive test to reliably reduce the burden of administering the CLEFT-Q: A Monte Carlo simulation study.

BACKGROUND: Computerised adaptive testing (CAT) has the potential to transform plastic surgery outcome measurement by making patient-reported outcome measures (PROMs) shorter, individualised and more accurate than pen-and-paper questionnaires. OBJECTIVES: This paper reports the results of two optimisation studies for the CLEFT-Q CAT, a CAT intended for use in the field of cleft lip and/or palate. Specifically, we aimed to identify the optimal score estimation and item selection methods for using this CAT in clinical practice. These represent two major components of any CAT algorithm. METHOD: Monte Carlo simulations were performed using simulated data in the R statistical computing environment and incorporated a range of score estimation and item selection techniques. The performance and accuracy of the CAT was assessed by mean items administered, correlation between CAT scores and paired linear assessment scores, and the root mean squared deviation (RMSD) of these score pairs. RESULTS: The accuracy of the CLEFT-Q CAT was not significantly affected by the choice of score estimation or item selection method. Sub-scales which originally contain more items were amenable to greater item reduction with CAT. CONCLUSION: This study shows that score estimation and item selection methods that need minimal processing power can be used in the CLEFT-Q CAT without compromising accuracy. This means that the CLEFT-Q CAT could be administered quickly and efficiently with basic hardware demands. We recommend the use of less computationally intensive techniques in future CLEFT-Q CAT studies.

Further construct validation of the CLEFT-Q: Ability to detect differences in outcome for four cleft-specific surgeries.

BACKGROUND: The CLEFT-Q is a patient-reported outcome measure developed for use in patients with cleft lip and/or palate. A significant indicator of the CLEFT-Q's validity relates to its ability to detect differences between the impact of specific aspects of clefting before and after surgery. This study compares relevant sub-scale scores of the CLEFT-Q for patients requiring four specific surgical treatments against those who either have had surgery or never needed surgery. METHODS: CLEFT-Q scores and clinical information regarding the past and future need for jaw surgery, lip revision, rhinoplasty, and speech surgery were obtained from the CLEFT-Q field-test data. Eight one-way analysis of variance (ANOVA) models were developed to compare mean scores of relevant CLEFT-Q scales between those who needed surgery, those who have had surgery, and those who never needed surgery. Only patients from high-income countries were included to minimize the impact of any economic confounders that could result in treatment variation. In the rhinoplasly and lip revision models, patients without a cleft lip were excluded. In the jaw surgery and speech surgery models, patients without a cleft palate or alveolus were excluded. RESULTS: The CLEFT-Q field test included 1938 participants from high-income countries. Participants who needed surgery scored significantly lower (worse) than those who have had surgery in each of the eight relevant CLEFT-Q scales (p < 0.001 in each ANOVA). CONCLUSION: The ability of the CLEFT-Q to detect differences between groups based on surgical status further supports its validity.

CLEFT-Q: Detecting Differences in Outcomes among 2434 Patients with Varying Cleft Types.

BACKGROUND: Measuring the patient perspective is important in evaluating outcomes of cleft care. Understanding how treatment outcomes vary depending on cleft type may allow for better planning of treatments, setting of expectations, and more accurate benchmarking efforts. The CLEFT-Q is a patient-reported outcome measure for patients with cleft lip and/or palate. METHODS: The 12 CLEFT-Q scales measuring appearance (i.e., face, nose, nostrils, lips, cleft lip scar, teeth, and jaws), function (i.e., speech), and health-related quality of life (i.e., psychological, school, social, and speech-related distress) were field tested in a cross-sectional study in 30 centers in 12 countries. Patients with cleft lip and/or cleft palate aged 8 to 29 years were recruited from clinical settings. Differences in CLEFT-Q scores by cleft subtypes were evaluated using one-way analysis of variance or Kruskal-Wallis H tests, with Tukey or Dunn procedure with Bonferroni corrections post hoc analyses, respectively. Scores are presented using radar charts to visualize all outcomes simultaneously. RESULTS: The field test included 2434 patients. Scores on all CLEFT-Q scales varied significantly with cleft subtype. Patients with unilateral or bilateral cleft lip and/or palate scored lower on all appearance scales compared with patients with cleft palate or unilateral incomplete cleft lip. Scores on the speech function and speech-related distress scales decreased with each progressive group in the Veau classification. Patients with complete bilateral cleft lip and palate scored lowest on the social, school, and psychological scales. CONCLUSIONS: Patient-reported outcomes measured with the CLEFT-Q vary significantly with cleft type. Visualizing multiple outcomes simultaneously with radar charts allows for an understanding of a patient's overall status in a single graph.

Development of a New Patient-reported Outcome Measure for Ear Conditions: The EAR-Q.

BACKGROUND: Patient-reported outcome measures are widely used to improve health services and patient outcomes. The aim of our study was to describe the development of 2 ear-specific scales designed to measure outcomes important to children and young adults with ear conditions, such as microtia and prominent ears. METHODS: We used an interpretive description qualitative approach. Semi-structured qualitative and cognitive interviews were performed with participants with any type of ear condition recruited from plastic surgery clinics in Canada, Australia, United States, and United Kingdom. Participants were interviewed to elicit new concepts. Interviews were audio-recorded, transcribed, and coded using the constant comparison approach. Experts in ear reconstruction were invited to provide input via an online Research Electronic Data Capture survey. RESULTS: Participants included 25 patients aged 8-21 years with prominent ears (n = 9), microtia (n = 14), or another condition that affected ear appearance (n = 2). Analysis of participant qualitative data, followed by cognitive interviews and expert input, led to the development and refinement of an 18-item ear appearance scale (eg, size, shape, look up close, look in photographs) and a 12-item adverse effects scale (eg, itchy, painful, numb). CONCLUSIONS: The EAR-Q in currently being field-tested internationally. Once finalized, we anticipate the EAR-Q will be used in clinical practice and research to understand the patient's perspective of outcomes following ear surgery.

What Matters to Patients With Cleft Lip and/or Palate: An International Qualitative Study Informing the Development of the CLEFT-Q.

OBJECTIVE: The goal of treatment for individuals with cleft lip and/or palate (CL/P) is to improve physical, psychological, and social health. Outcomes of treatment are rarely measured from the patient's perspective. The aim of the study was to develop a conceptual framework for a patient-reported outcome (PRO) instrument for individuals with clefts (CLEFT-Q) by developing an in-depth understanding of issues that individuals consider to be important. DESIGN: The qualitative methodology of interpretive description was used. Setting, Participants, and Intervention: We performed 136 individual in-depth interviews with participants with clefts of any age, presenting for cleft care, across 6 countries. Parents were involved if the child was more comfortable. Interviews were audio-recorded, transcribed verbatim, and coded using constant comparison. The data were used to develop a refined conceptual framework. RESULTS: Participants described concepts of interest in 3 top-level domains, each of which included subdomains: appearance (face, nose, nostrils, teeth, lips, jaw, cleft lip scar), health-related quality of life (psychological, social, school, speech-related distress), and facial function (speech, eating/drinking). Participants were able to describe changes over time with regard to the 3 domains. CONCLUSIONS: A conceptual framework of concepts of interest to individuals with CL/P formed the basis of the scales in the CLEFT-Q. Each subdomain represents an independently functioning scale. Understanding what matters to patients is essential in guiding PRO measurement.

Content Validity of Patient-Reported Outcome Instruments used with Pediatric Patients with Facial Differences: A Systematic Review.

OBJECTIVE: The aim of this systematic review was to identify patient-reported outcome (PRO) instruments used in research with children/youth with conditions associated with facial differences to identify the health concepts measured. DESIGN: MEDLINE, EMBASE, CINAHL, and PsycINFO were searched from 2004 to 2016 to identify PRO instruments used in acne vulgaris, birthmarks, burns, ear anomalies, facial asymmetries, and facial paralysis patients. We performed a content analysis whereby the items were coded to identify concepts and categorized as positive or negative content or phrasing. RESULTS: A total of 7,835 articles were screened; 6 generic and 11 condition-specific PRO instruments were used in 96 publications. Condition-specific instruments were for acne (four), oral health (two), dermatology (one), facial asymmetries (two), microtia (one), and burns (one). The PRO instruments provided 554 items (295 generic; 259 condition specific) that were sorted into 4 domains, 11 subdomains, and 91 health concepts. The most common domain was psychological (n = 224 items). Of the identified items, 76% had negative content or phrasing (e.g., "Because of the way my face looks I wish I had never been born"). Given the small number of items measuring facial appearance (n = 19) and function (n = 22), the PRO instruments reviewed lacked content validity for patients whose condition impacted facial function and/or appearance. CONCLUSIONS: Treatments can change facial appearance and function. This review draws attention to a problem with content validity in existing PRO instruments. Our team is now developing a new PRO instrument called FACE-Q Kids to address this problem.

Establishing Content Validity of the CLEFT-Q: A New Patient-reported Outcome Instrument for Cleft Lip/Palate.

BACKGROUND: The CLEFT-Q is a new patient-reported outcome instrument designed to measure outcomes that matter to patients. The aim of this qualitative study was to establish content validity of the CLEFT-Q in patients who differ by age and culture. METHODS: Patients aged between 6 and 29 years were recruited from plastic surgery clinics in Canada, India, Ireland, the Philippines, the Netherlands and the United States. Healthcare providers and other experts participated in a focus group or provided individual feedback. Input was sought on all aspects of the CLEFT-Q (item wording, instructions, and response options), and to identify missing content. Patient interviews and expert feedback took place between September 2013 and September 2014. RESULTS: Sixty-nine patients and 44 experts participated. The first draft of the CLEFT-Q consisted of 163 items measuring 12 constructs. The first round of feedback identified 92 items that required revision. In total, 3 rounds of interviews, and the involvement of an artist to create pictures for 17 items, were needed to establish content validity. At the conclusion of cognitive interviews, the CLEFT-Q consisted of 13 scales (total 171 items) that measure appearance, health-related quality of life, and facial function. The mean Flesch-Kincaid readability statistic for items was 1.4 (0 to 5.2). CONCLUSION: Cognitive interviews and expert review allowed us to identify items that required re-wording, re-conceptualizing, or to be removed, as well as any missing items. This process was useful for refining the CLEFT-Q scales for further testing.

Infant Robotic Cleft Palate Surgery: A Feasibility Assessment Using a Realistic Cleft Palate Simulator.

BACKGROUND: A surgical robot offers enhanced precision, visualization, and access and the potential to improve outcomes in cleft palate surgery. The goal of this study was to investigate the feasibility of using the da Vinci robot for cleft palate repair in infants using a cleft palate simulator test bed. METHODS: A high-fidelity cleft palate simulator was developed that allows performance of a robotic cleft palate repair procedure. A complete cleft palate repair was performed with the da Vinci Si with 5-mm instruments and the da Vinci Xi with 8-mm instruments. The advantages of the robotic approach were assessed in comparison with using standard instruments. For each system, arm repositioning, collisions, instrument and endoscope excursion, wrist orientation, and vision were compared for 12 steps of the repair. RESULTS: The cleft palate simulator provided a reproducible platform for testing robotic cleft palate surgery. The advantages of the robotic approach were the ability to articulate a miniature wrist intraorally with superior visualization, increased ambidexterity, and improved ergonomics compared with using standard instruments. Cleft palate repair with the Xi was superior to the Si with respect to arm repositioning, instrument collisions and excursion, and wrist orientation. However, Xi performance remained suboptimal because of the larger instruments. CONCLUSIONS: Robotic cleft palate repair using the da Vinci system offers advantages compared with the traditional approach. Cleft palate repair is more feasible with the Xi and 8-mm instruments. However, performance is limited by the instrumentation, which requires modification to ensure safety and efficacy. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, V.