Shared Decision-Making: Process for Design and Implementation of a Decision Aid for Patients With Craniosynostosis.

To describe the process of developing a craniosynostosis decision aid.We conducted a mixed-methods exploratory study between August 2019 and March 2020 to develop a decision aid about surgical treatment for single suture craniosynostosis.A single tertiary care academic children's hospital.The decision aid development team consisted of surgeons, research fellows, a clinical nurse practitioner, clinical researchers with expertise in decision science, and a university-affiliated design school. Qualitative interviews (N = 5) were performed with families, clinicians (N = 2), and a helmeting orthotist to provide feedback on decision aid content, format, and usability.After cycles of revisions and iterations, 3 related decision aids were designed and approved by the marketing arm of our institution. Distinct booklets were created to enable focused discussion of treatment options for the 3 major types of single suture craniosynostosis (sagittal, metopic, unicoronal).Three decision aids representing the 3 most common forms of single suture craniosynostosis were developed. Clinicians found the decision aids could help facilitate discussions about families' treatment preferences, goals, and concerns.We developed a customizable decision aid for single suture craniosynostosis treatment options. This tool lays the foundation for shared decision-making by assessing family preferences and providing clear, concise, and credible information regarding surgical treatment. Future research can evaluate this tool's impact on patient-clinician discussions about families' goals and preferences for treatment.

Factors contributing to delay or absence of alveolar bone grafting.

INTRODUCTION: Alveolar bone grafting (ABG) delay can lead to suboptimal outcomes. This study seeks to categorize reasons patients with cleft lip and palate have no record of ABG or who underwent later than typical ABG (≥13 years). METHODS: At a single tertiary care center, a retrospective review was performed of all patients with unilateral, complete cleft lip and palate, born 1998-2005. Database query identified which patients had timely, late, or no record of ABG. The retrospective cohort study was performed to categorize ABG delay or absence of recorded ABG. RESULTS: Of 135 participants, 82 (61%) had timely, 8 (6%) had late, and 45 (33%) had no record of ABG. The primary factor for late ABG was noncompliance or refusal (n = 5 of 8, 63%), comorbidity or medical complexity (n = 1 of 8, 13%), orthodontic unpreparedness (n = 1 of 8, 13%), or inaccurate prior assessment of alveolar sufficiency (n = 1 of 8, 13%). The primary factor for ABG record absence was loss to follow-up (n = 40 of 45, 89%), noncompliance or refusal (n = 3 of 45, 7%), comorbidity or medical complexity (n = 1 of 45, 2%), or orthodontic unpreparedness (n = 1 of 45, 2%). Racial majority (White, Asian) patients received preferred care (timely ABG or medically appropriate absence or delay) at a significantly higher rate (67%) than underrepresented minorities (African American, Hispanic, Native American, other) (35%, P = 0.016). Families with private insurance and those who were self-pay received preferred care at a significantly higher rate (77%) than families with Medicaid (42%) (P <0.001). CONCLUSIONS: The high number of patients lost to follow-up highlights the impact of poor retention on ABG completion. Possible health disparities based on race and insurance status warrant clinical focus.

Family-Centered Pediatric Plastic Surgery Care.

Our multidisciplinary cleft palate and craniofacial center was established in 1978 and manages more than 5,000 active patients from birth to skeletal maturity. Over the past four years we have implemented a complex family-centered reorganization, with the goal of improving care and patient retention. Through our implementation of a familycentered approach, we have also decreased treatment burden, need for secondary procedures and cost of care. 1-12.

Presurgical Orthopedic Intervention Prior to Cleft Lip and Palate Repair: Nasoalveolar Molding Versus Passive Molding Appliance Therapy.

BACKGROUND: Nasoalveolar molding (NAM) is a widely used presurgical orthopedic device, despite disputes over its effectiveness. This study compares the outcomes after cleft lip and nose repair in patients who received NAM versus those who underwent passive alveolar molding with lip taping. METHODS: A retrospective review of patients with complete unilateral cleft lip and palate who received either NAM (n = 16) or passive molding (n = 10) treatments was conducted. Alveolar gap width was measured on maxillary casts until time of palatoplasty. Nasolabial symmetry was assessed by examining anthropometric ratios on post-operative three-dimensional photographs. Burden of care was evaluated by analyzing the number of patient appointments attended, treatment costs, and caregiver satisfaction surveys. RESULTS: No statistically significant difference existed in alveolar gap at time of initial appointment or palatoplasty, however the gap was smaller in the NAM cohort at time of lip and nose repair. No statistically significant difference existed in postsurgical heminasal width, nostril width, nostril height, labial height or nasal ala projection asymmetry between the NAM and the passive molding cohort. Patients in the NAM group attended more dental appointments and incurred higher treatment costs compared to the passive molding group. Caregivers reported high satisfaction with treatment outcomes in both cohorts. CONCLUSIONS: There were no differences between NAM and passive molding regarding postsurgical nasolabial appearance and patient satisfaction. Both treatments narrow the alveolar gap. However, NAM places a higher burden of care on families.

Using an Intake Form and Clinic Dashboard to Tailor and Improve the Cleft Team Clinic Visit for Families.

BACKGROUND: Multidisciplinary cleft care protocols commonly do not incorporate family needs, concerns, and preferences. SOLUTION: A family-centered model would incorporate family needs, concerns, and preferences with a view toward lessening burden of care while achieving outcomes important to families. WHAT WE DO: Our Intake Form helps us adapt visits to better meet families' needs, and our Dashboard enables Team Coordinators to direct efficient patient flows, lessening wait times and care burden.

Evaluation of the Patient-Practitioner Consultation on Surgical Treatment Options for Patients With Craniosynostosis.

INTRODUCTION: Endoscope-assisted craniectomy and spring-assisted cranioplasty with post-surgical helmet molding are minimally invasive alternatives to the traditional craniosynostosis treatment of open cranial vault remodeling. Families are often faced with deciding between techniques. This study aimed to understand providers' practice patterns in consulting families about surgical options. METHODS: An online survey was developed and distributed to 31 providers. The response rate was 84% (26/31). RESULTS: Twenty-six (100%) respondents offer a minimally invasive surgical option for sagittal craniosynostosis, 21 (81%) for coronal, 20 (77%) for metopic, 18 (69%) for lambdoid, and 12 (46%) for multi-suture. Social issues considered in determining whether to offer a minimally invasive option include anticipated likelihood of compliance (23 = 88%), distance traveled for care (16 = 62%) and financial considerations (6 = 23%). Common tools to explain options include verbal discussion (25 = 96%), 3D reconstructed CT scans (17 = 65%), handouts (13 = 50%), 3D models (12 = 46%), hand drawings (11 = 42%) and slides (10 = 38%). Some respondents strongly (7 = 27%) or somewhat (3 = 12%) encourage a minimally invasive option over open repair. Others indicate they remain neutral (7 = 27%) or tailor their approach to meet perceived needs (8 = 31%). One (4%) somewhat encourages open repair. Despite this variation, all completely (17 = 65%), strongly (5 = 19%) or somewhat agree (4 = 15%) they use shared decision making in presenting surgical options. CONCLUSION: This survey highlights the range of practice patterns in presenting surgical options to families and reveals possible discrepancies in the extent providers believe they use shared decision making and the extent it is actually used.

Proposed Federal Bill to Mandate Insurance Coverage for Children With Congenital Anomalies.

The Ensuring Lasting Smiles Act was reintroduced in United States Congress in March 2019. If enacted, the bill will substantially limit private insurers' ability to deny coverage for the medically necessary treatment of congenital anomalies, including cleft palate and craniofacial anomalies. Coverage denials are currently a barrier to care for these individuals, especially for patients residing in states lacking coverage mandates. The purpose of this article is to describe the issues underlying the proposed federal legislation and provide a policy discussion to better inform cleft and craniofacial providers about pending legislation relevant to their practice.

Evaluation of Multidisciplinary Team Clinic for Patients With Isolated Cleft Lip.

OBJECTIVE: To report the incidences of secondary lip and nose operations, otolaryngology procedures, speech-language therapy, neurodevelopmental concerns, and dental and orthodontic issues in children with isolated cleft lip to inform multidisciplinary cleft team protocols. SETTING: An American Cleft Palate-Craniofacial Association-approved team at a tertiary academic children's hospital. DESIGN: Retrospective cohort study of patients evaluated through longitudinal clinic visits by a multidisciplinary cleft palate and craniofacial team between January 2000 and June 2018. PATIENTS, PARTICIPANTS: Children with nonsyndromic cleft lip with or without cleft alveolus (n = 92). RESULTS: Median age at final team visit was 4.9 years (interquartile range: 2.4-8.2 years). Secondary plastic surgery procedures were most common between ages 3 and 5 (135 per 1000 person-years), and the majority of these procedures were minor lip revisions. The rate of tympanostomy tube insertion was highest before age 3 (122 per 1000 person-years). By their final team visit, 88% of patients had normal hearing and 11% had only slight to mild conductive hearing loss. No patients had speech errors attributable to lip abnormalities. Psychological interventions, learning disabilities, and dental or orthodontic concerns were uncommon. CONCLUSIONS: Most patients with isolated cleft lip may not require long-term, longitudinal evaluation by cleft team specialists. Cleft teams should develop limited follow-up protocols for these children to improve resource allocation and promote value-based care in this patient population.

One Multidisciplinary Cleft and Craniofacial Team's Experience in Shifting to Family-Centered Care.

Family-centered care is a high-priority focus area in health care and is associated with increased family satisfaction and quality of life, better health outcomes and family follow-up, decreased burden of care, and improved efficiency of resource utilization. Motivated by our aim to improve clinic efficiency and patient retention, our multidisciplinary cleft palate and craniofacial center has been undergoing a complex family-centered reorganization over the past 3 years. We seek to share our experience in hope the information will be a useful starting point to other teams in structuring their own family-centered improvements. We suggest the following stepwise method to achieve a more family-centered process: (1) gathering preintervention data, (2) brainstorming challenges with stakeholders, (3) brainstorming solutions with stakeholders, (4) implementation, (5) follow-up and troubleshooting, (6) further implementation, and (7) gathering postintervention data. Additionally, we found the use of institutional resources added substantial value to our efforts.

Cleft and Craniofacial Multidisciplinary Team Clinic: A Look at Attrition Rates for Patients With Complete Cleft Lip and Palate and Nonsyndromic Single-Suture Craniosynostosis.

OBJECTIVE: To evaluate attrition rates prior to expected completion of team care for children with complete cleft lip and palate (cleft) or nonsyndromic single-suture craniosynostosis (synostosis). DESIGN: A single-institution retrospective review of attendance data from 2002 to 2016. SETTING: Single cleft and craniofacial center in the United States. PATIENTS/PARTICIPANTS: A sample of 983 patients with either cleft or synostosis. Patients who were more than 2 to 3 years from their last visit were considered lost to follow-up. Patients with cleft older than 16 years or synostosis over 11 years were considered graduated from team care. RESULTS: Survival analysis shows that in our patients with cleft, 25% leave before age 8 and over 60% are lost from team by age 16. In patients with synostosis, 25% leave before age 6 and 45% are lost by age 11. Cox regression showed underrepresented minorities being 1.7 times more likely to become lost in the cleft group (hazard ratio: 1.66, 95% confidence interval [CI]: 1.01-2.74). CONCLUSIONS: Overall, attrition rates were high at our institution. Many patients are lost to follow-up prior to receiving key medical interventions. Improved family education and personalized care are needed to help ensure continuity of care.

Survey of North American Multidisciplinary Cleft Palate and Craniofacial Team Clinic Administration.

OBJECTIVE: This study aims to provide an understanding of the ways cleft palate (CP) and craniofacial teams address billing, administration, communication of clinical recommendations, appointment scheduling, and diagnosis-specific protocols. DESIGN: An online clinic administration survey was developed using data from an open-ended telephone questionnaire. The online survey was distributed by e-mail to the American Cleft Palate-Craniofacial Association (ACPA) nurse coordinator electronic mailing list, used regularly by the ACPA and its members to communicate with teams. The response was 34.1% (42/123). Two incomplete records were excluded, as were any inconsistent responses of 3 teams submitting duplicate records. RESULTS: Six (15.8%) of 38 teams do not charge for clinic visits. For all other teams, some or all providers bill individually for services (68.4%) or a single lump sum applies (10.5%). Patients of 34 (89.5%) of 38 teams occasionally or often neglect to schedule or attend follow-up appointments. Twenty-six (66.7%) of 39 team directors were plastic surgeons. Phone is a common method of contacting families for scheduling (60.0%) and appointment reminders (82.5%). Most teams' providers (90.0%) routinely communicate findings to each other during postclinical conference. Most teams saw patients with isolated cleft lip (43.6%), cleft lip and palate (64.1%), or isolated CP (59.0%) annually. CONCLUSIONS: The breadth of strategies team clinic administration strategies warrants further exploration of the variations and their effects on patient-centered outcomes including the quality of life, satisfaction, cost, and resource utilization.

Assessing calvarial vault constriction associated with helmet therapy in deformational plagiocephaly.

OBJECTIVE Deformational plagiocephaly and/or brachycephaly (DPB) is a cranial flattening frequently treated in pediatric craniofacial centers. The standard of care for DPB involves patient positioning or helmet therapy. Orthotic therapy successfully reduces cranial asymmetry, but there is concern over whether the orthotics have the potential to restrict cranial growth. Previous research addressing helmet safety was limited by lack of volume measurements and serial data. The purpose of this study was to directly compare head growth data in patients with DPB between those who underwent helmet therapy and those who received repositioning therapy. METHODS This retrospective cohort study analyzed pre- and posttherapy 3D photographs of 57 patients with DPB who had helmet therapy and a control group of 57 patients with DPB who underwent repositioning therapy. The authors determined the change in cranial vault volume and cranial circumference between each patient's photographs using 3D photogrammetry. They also computed a cubic volume calculated by multiplying anterior-posterior diameter, biparietal diameter, and height. Linear regressions were used to quantify effects of age and therapy type on these quantities. RESULTS A comparison of the following variables between the two groups yielded nonsignificant results: age at the beginning (p = 0.861) and end (p = 0.539) of therapy, therapy duration (p = 0.161), and the ratio of males to females (p = 0.689). There was no significant difference between patients who underwent helmeting versus positioning therapy with respect to change in either volume calculation or head circumference z-score (p ≥ 0.545). Pretherapy photograph age was a significant predictor of cranial growth (p ≤ 0.001), but therapy type was not predictive of the change in the study measurements (p ≤ 0.210). CONCLUSIONS The authors found no evidence that helmet therapy was associated with cranial constriction in the study population of patients with DPB. These results strengthen previous research supporting helmet safety and should allow health care providers and families to choose the appropriate therapy without concern for potential negative effects on cranial growth.

Primer on State Statutory Mandates of Third-Party Orthodontic Coverage for Cleft Palate and Craniofacial Care in the United States.

Provision and timing of orthodontic treatment is a crucial part of comprehensive cleft palate and craniofacial care. Some states statutorily mandate orthodontic coverage for the medically necessary care of cleft palate and craniofacial anomalies. However, application of the medically necessary standard varies broadly. Disputes over medical necessity lead to orthodontic coverage denials and surgical intervention delays. Provider-friendly statutory definitions of medical necessity enable patients and providers to avoid such hurdles. The objective of this study is to evaluate state mandates and highlight language favorable to patients and providers.