Plastic Surgery Outreach Clinics Expand Access to Cleft and Craniofacial Care in Mississippi.

ABSTRACT: Accessing treatment at ACPA (American Cleft Palate-Craniofacial Association)-approved centers is challenging for individuals in rural communities. This study aims to assess how pediatric plastic surgery outreach clinics impact access for patients with orofacial cleft and craniosynostosis in Mississippi. An isochrone map was used to determine mean travel times from Mississippi counties to the sole pediatric hospital and the only ACPA-approved team in the state. This analysis was done before and after the establishment of two outreach clinics to assess differences in travel times and cost of travel to specialized plastic surgery care. Two sample t-tests were used for analysis.The addition of outreach clinics in North and South Mississippi led to a significant reduction in mean travel times for patients with cleft and craniofacial diagnoses across the state's counties (1.81 hours vs 1.46 hours, P < 0.001). Noteworthy travel cost savings were observed after the introduction of outreach clinics when considering both the pandemic gas prices ($15.27 vs $9.80, P < 0.001) and post-pandemic prices ($36.52 vs $23.43, P < 0.001).The addition of outreach clinics in Mississippi has expanded access to specialized healthcare for patients with cleft and craniofacial differences resulting in reduced travel time and cost savings for these patients. Establishing specialty outreach clinics in other rural states across the United States may contribute significantly to reducing burden of care for patients with clefts and craniofacial differences. Future studies can further investigate whether the inclusion of outreach clinics improves follow-up rates and surgical outcomes for these patients.

Geographic Financial Analysis of Craniosynostosis Surgery in the United States.

BACKGROUND: The purpose of this study was to investigate the financial implications of demographic and socioeconomic factors upon the cost of surgical procedures for craniosynostosis. METHODS: A retrospective cohort study was conducted of admissions for craniosynostosis surgery in the United States from 2015 through 2020 using the Pediatric Health Information System. Patient demographics, case volume, and surgical approach were analyzed in context of hospital charges. RESULTS: During the study interval, 3869 patients were admitted for surgery for craniosynostosis. In multivariate regression accounting for demographic and socioeconomic factors, hospital admission charges were significantly higher in patients with longer hospital length of stay ( P < 0.001), longer ICU length of stay ( P < 0.001), living in an underserved area ( P = 0.046), preoperative risk factors ( P = 0.016), and those undergoing open procedures ( P < 0.001); hospital admission charges were significantly lower in patients with White race ( P = 0.020) and those treated at high-volume centers ( P < 0.001). In multivariate regression, ICU length of stay was significantly higher in patients with preoperative risk factors ( P < 0.001), undergoing open procedures ( P < 0.001), government insurance ( P = 0.018), and not treated at high-volume centers ( P = 0.005). There were significant differences in admission charges ( P < 0.001), charge-to-cost ratios ( P < 0.001), and likelihood of being treated at high-volume craniofacial centers ( P < 0.001) across geographic regions of the country. CONCLUSIONS: In the United States, there is significant sociodemographic variability in charges for craniosynostosis care, with increased hospital charges independently associated with non-White race, preoperative risk factors, and living in an underserved area.

Treatment of Craniosynostosis: The Impact of Hospital Surgical Volume on Cost, Resource Utilization, and Outcomes.

The authors aim to quantify the impact of hospital volume of craniosynostosis surgery on inpatient complications and resource utilization using national data. Children <12 months with nonsyndromic craniosynostosis who underwent surgery in 2012 at academic hospitals in the United States were identified from the Kids' Inpatient Database (KID) developed by the Healthcare Cost and Utilization Project (HCUP). Hospital craniosynostosis surgery volume was stratified into tertiles based on total annual hospital cases: low volume (LV, 1-13), intermediate volume (IV, 14-34), and high volume (HV, ≥35). Outcomes of interest include major complications, blood transfusion, charges, and length of stay (LOS). In 2012, 154 hospitals performed 1617 total craniosynostosis surgeries. Of these 580 cases (35.8%) were LV, 549 cases (33.9%) were IV, and 488 cases (30.2%) were HV. There was no difference in major complications between hospital volume tertiles (4.3% LV; 3.8% IV; 3.1% HV; P = 0.487). The highest blood transfusion rates were seen at LV hospitals (47.8% LV; 33.9% IV; 26.2%; P < 0.001). Hospital charges were lowest at HV hospitals ($55,839) compared with IV hospitals ($65,624; P < 0.001) and LV hospitals ($62,325; P = 0.005). Mean LOS was shortest at HV hospitals (2.96 days) compared with LV hospitals (3.31 days; P = 0.001); however, there was no difference when compared with IV hospitals (3.07 days; P = 0.282). Hospital case volume may be an important associative factor of blood transfusion rates, LOS, and hospital charges; however, there is no difference in complication rates. These results may be used to guide quality improvement within the surgical management of craniosynostosis.

Age at Time of Craniosynostosis Repair Predicts Increased Complication Rate.

OBJECTIVE: This study uses administrative data to assess the optimal timing for surgical repair of craniosynostosis and to identify factors associated with risk of perioperative complications. DESIGN: Statistical analysis of the Healthcare Cost and Utilization Project Kids' Inpatient Database (2006, 2009, 2012). SETTING: KID-participating hospitals in 44 states. PATIENTS: Children 0 to 3 years of age with ICD-9 codes for surgical correction of craniosynostosis (756 and 0124, 0125, 0201, 0203, 0204, or 0206). MAIN OUTCOME MEASURE: Age-based cohorts were assessed for perioperative complications. We performed a multivariable analysis to determine characteristics associated with increased risk of complications. RESULTS: 21 million admissions were screened and 8417 visits met criteria for inclusion. Seventy-five percent of procedures occurred before age 1. Complications occurred in 8.6% of patients: 6.6% of patients at age 0 to 6 months, 10.3% of patients aged 7 to 12 months, and 13.9% of patients 12 to 36 months. Patients with acrocephalosyndactyly or associated congenital anomalies experienced complications in 22.9% of cases (OR = 3.07, 95% CI = 2.33, 4.03). CONCLUSION: Craniosynostosis repair is safe; however, the risk of complications increases with age at intervention. Presence of a syndromic congenital deformity at any age carries the greatest increased risk of perioperative complications. This suggests that optimal timing of intervention is within the first year of life, especially in those cases with additional factors increasing perioperative risk. These data support the importance of counseling patients of the increased risk associated with delaying craniosynostosis repair.

Is Postoperative Intensive Care Unit Care Necessary following Cranial Vault Remodeling for Sagittal Synostosis?

BACKGROUND: Of U.S. craniofacial and neurosurgeons, 94 percent routinely admit patients to the intensive care unit following cranial vault remodeling for correction of sagittal synostosis. This study aims to examine the outcomes and cost of direct ward admission following primary cranial vault remodeling for sagittal synostosis. METHODS: An institutional review board-approved retrospective review was undertaken of the records of all patients who underwent primary cranial vault remodeling for isolated sagittal craniosynostosis from 2009 to 2015 at a single pediatric hospital. Patient demographics, perioperative course, and outcomes were recorded. RESULTS: One hundred ten patients met inclusion criteria with absence of other major medical problems. Average age at operation was 6.7 months, with a mean follow-up of 19.8 months. Ninety-eight patients (89 percent) were admitted to a general ward for postoperative care, whereas the remaining 12 (11 percent) were admitted to the intensive care unit for preoperative or perioperative concerns. Among ward-admitted patients, there were four (3.6 percent) minor complications; however, there were no major adverse events, with none necessitating intensive care unit transfers from the ward and no mortalities. Average hospital stay was 3.7 days. The institution's financial difference in cost of intensive care unit stay versus ward bed was $5520 on average per bed per day. Omitting just one intensive care unit postoperative day stay for this patient cohort would reduce projected health care costs by a total of $540,960 for the study period. CONCLUSION: Despite the common practice of postoperative admission to the intensive care unit following cranial vault remodeling for sagittal craniosynostosis, the authors suggest that postoperative care be considered on an individual basis, with only a small percentage requiring a higher level of care. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Craniosynostosis Surgery: Does Hospital Case Volume Impact Outcomes or Cost?

BACKGROUND: The relationships between hospital/surgeon characteristics and operative outcomes and cost are being scrutinized increasingly. In patients with craniosynostosis specifically, the relationship between hospital volume and outcomes has yet to be characterized. METHODS: Subjects undergoing craniosynostosis surgery between 2004 and 2015 were identified in the Pediatric Health Information System. Outcomes were compared between two exposure groups, those undergoing treatment at a high-volume institution (>40 cases per year), and those undergoing treatment at a low-volume institution (40 cases per year). Primary outcomes were any complication, prolonged length of stay, and increased total cost. RESULTS: Over 13,000 patients (n = 13,112) from 49 institutions met inclusion criteria. In multivariate regression analyses, subjects treated in high-volume centers were less likely to experience any complication (OR, 0.764; p < 0.001), were less likely to have an extended length of stay (OR, 0.624; p < 0.001), and were less likely to have increased total cost (OR, 0.596; p < 0.001). Subjects undergoing strip craniectomy in high-volume centers were also less likely to have any complication (OR, 0.708; p = 0.018) or increased total cost (OR, 0.51; p < 0.001). Subjects undergoing midvault reconstruction in high-volume centers were less likely to experience any complications (OR, 0.696; p = 0.002), have an extended length of stay (OR, 0.542; p < 0.001), or have increased total cost (OR, 0.495; p < 0.001). CONCLUSION: In hospitals performing a high volume of craniosynostosis surgery, subjects had significantly decreased odds of experiencing a complication, prolonged length of stay, or increased total cost compared with those undergoing treatment in low-volume institutions. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Sagittal craniosynostosis: a utility outcomes study.

OBJECTIVE Sagittal craniosynostosis results in a characteristic scaphocephalic head shape that is typically corrected surgically during a child's 1st year of life. The authors' objective was to determine the potential impact of being born with sagittal craniosynostosis by using validated health state utility assessment measures. METHODS An online utility assessment was designed to generate health utility scores for scaphocephaly, monocular blindness, and binocular blindness using standardized utility assessment tools, namely the visual analog scale (VAS) and the standard gamble (SG) and time trade-off (TTO) tests. Utility scores were compared between health states using the Wilcoxon and Kruskal-Wallis tests. Univariate regression was performed using age, sex, income, and education as independent predictors of utility scores. RESULTS Over a 2-month enrollment period, 122 participants completed the online survey. One hundred eighteen participants were eligible for analysis. Participants rated scaphocephaly due to sagittal craniosynostosis with significantly higher (p < 0.001) median utility scores (VAS 0.85, IQR 0.76-0.95; SG 0.92, IQR 0.84-0.98; TTO 0.91, IQR 0.84-0.95) than both monocular blindness (VAS 0.60, IQR 0.50-0.70; SG 0.84, IQR 0.68-0.94; TTO 0.84, IQR 0.67-0.91) and binocular blindness (VAS 0.25, IQR 0.20-0.40; SG 0.51, IQR 0.18-0.79; TTO 0.55, IQR 0.36-0.76). No differences were noted in utility scores based on participant age, sex, income, or education. CONCLUSIONS Using objective health state utility scores, authors of the current study demonstrated that the preoperatively perceived burden of scaphocephaly in a child's 1st year of life is less than that of monocular blindness. These relatively high utility scores for scaphocephaly suggest that the burden of disease as perceived by the general population is low and should inform surgeons' discussions when offering morbid corrective surgery, particularly when driven by aesthetic concerns.

Comparing Outcomes and Cost of 3 Surgical Treatments for Sagittal Synostosis: A Retrospective Study Including Procedure-Related Cost Analysis.

BACKGROUND: Neurosurgical techniques for repair of sagittal synostosis include total cranial vault (TCV) reconstruction, open sagittal strip (OSS) craniectomy, and endoscopic strip (ES) craniectomy. OBJECTIVE: To evaluate outcomes and cost associated with these 3 techniques. METHODS: Via retrospective chart review with waiver of informed consent, the last consecutive 100 patients with sagittal synostosis who underwent each of the 3 surgical correction techniques before June 30, 2013, were identified. Clinical, operative, and process of care variables and their associated specific charges were analyzed along with overall charge. RESULTS: The study included 300 total patients. ES patients had fewer transfusion requirements (13% vs 83%, P < .001) than TCV patients, fewer days in intensive care (0.3 vs 1.3, P < .001), and a shorter overall hospital stay (1.8 vs 4.2 d, P < .001), and they required fewer revisions (1% vs 6%, P = .05). The mean charge for the endoscopic procedure was $21 203, whereas the mean charge for the TCV reconstruction was $45 078 (P < .001). ES patients had more preoperative computed tomography scans (66% vs 44%, P = .003) than OSS patients, shorter operative times (68 vs 111 min, P < .001), and required fewer revision procedures (1% vs 8%, P < .001). The mean charge for the endoscopic procedure was $21 203 vs $20 535 for the OSS procedure (P = .62). CONCLUSION: The ES craniectomy for sagittal synostosis appeared to have less morbidity and a potential cost savings compared with the TCV reconstruction. The charges were similar to those incurred with OSS craniectomy, but patients had a shorter length of stay and fewer revisions.

Assessing Risk Factors for Hospital-Based, Acute Care Within Thirty Days of Craniosynostosis Surgery Using the Healthcare Cost and Utilization Project.

While in-hospital outcomes and long-term results of craniosynostosis surgery have been described, no large studies have reported on postoperative readmission and emergency department (ED) visits. The authors conducted this study to describe the incidence, associated diagnoses, and risk factors for these encounters within 30 days of craniosynostosis surgery.Using 4 state-level databases, the authors conducted a retrospective cohort study of patients <3 years of age who underwent surgery for craniosynostosis. The primary outcome was any hospital based, acute care (HBAC; ED visit or hospital readmission) within 30 days of discharge. Multivariate logistic regression modeling was used to identify factors associated with this outcome.The final sample included 1120 patients. On average, patients were ages 4.6 months with the majority being male (67.3%) and having Medicaid (52%) or private (48.0%) insurance. Ninety-nine patients (8.8%) had at least 1 HBAC encounter within 30 days and 13 patients (1.2%) had 2 or more. The majority of encounters were managed in the ED without hospital admission (56.6%). In univariate analysis, age, race, insurance status, and initial length of stay significantly differed between the HBAC and non-HBAC groups. In multivariate analysis, only African-American race (adjusted odds ratio [AOR] = 5.98 [1.49-23.94]) and Hispanic ethnicity (AOR = 5.31 [1.88-14.97]) were associated with more frequent HBAC encounters.Nearly 10% of patients with craniosynostosis require HBAC postoperatively with ED visits accounting for the majority of these encounters. Race is independently associated with HBAC, the cause of which is unknown and will be the focus of future research.

Differences in surgical outcomes for patients with craniosynostosis in the US: impact of socioeconomic variables and race.

OBJECT Craniosynostosis is often treated with neurosurgical intervention. The aim of this study was to report and analyze the clinical and socioeconomic characteristics of patients with craniosynostosis and to present current national trends. METHODS Using the Kids' Inpatient Database for the years 2000, 2003, 2006, and 2009, the authors identified patients with craniosynostosis using International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis codes and their associated procedure codes. Clinical features, demographics, inpatient procedures, outcomes, and charges were collected and analyzed. RESULTS Of the 3415 patients identified, 65.8% were White, 21.4% were Hispanic, and 3.2% were Black. More than 96% were treated at urban teaching hospitals and 54.2% in southern or western regions. White patients were younger (mean 6.1 months) as compared with Blacks (mean 10.9 months) and Hispanics (mean 9.1 months; p < 0.0001) at the time of surgery. A higher fraction of Whites had private insurance (70.3%) compared with nonwhites (34.0%-41.6%; p < 0.001). Approximately 12.2% were nonelective admissions, more so among Blacks (16.9%). Mean hospital length of stay (LOS) was 3.5 days with no significant differences among races. Following surgical treatment, 12.1% of patients developed complications, most commonly pulmonary/respiratory (4.8%), wound infection (4.4%), and hydrocephalus (1.4%). The mean overall hospital charges were significantly lower for Whites than nonwhites ($34,527 vs $44,890-$48,543, respectively; p < 0.0001). CONCLUSIONS The findings of this national study suggest a higher prevalence of craniosynostosis in Hispanics. The higher predisposition among males was less evident in Hispanics and Blacks. There was a significant percentage of nonelective admissions, more commonly among Blacks. Additionally, Hispanics and Blacks were more likely to receive surgery at an older age, past the current recommendation of the optimum age for surgical intervention. These findings are likely associated with a lack of early detection. Although mean LOS and rate of complications did not significantly differ among different races, nonwhites had, on average, higher hospital charges of $10,000-$14,000. This discrepancy may be due to differences in type of insurance, craniosynostosis type, rates of comorbidities, and delay in treatment. Although there are several limitations to this analysis, the study reports on relevant disparities regarding a costly neurosurgical intervention, and ways to diminish these disparities should be further explored.

The Impact of Insurance, Race, and Ethnicity on Age at Surgical Intervention among Children with Nonsyndromic Craniosynostosis.

OBJECTIVE: To examine the impact of demographic factors, including insurance type, family income, and race/ethnicity, on patient age at the time of surgical intervention for craniosynostosis surgery in the US. STUDY DESIGN: The Kids' Inpatient Database was queried for admissions of children younger than 3 years of age undergoing craniosynostosis surgery in 2009. Descriptive data regarding age at surgery for various substrata are reported. Multivariate regression was used to evaluate the effect of patient and hospital characteristics on the age at surgery. RESULTS: Children with private insurance were, on average, 6.8 months of age (95% CI 6.2-7.5) at the time of surgery; children with Medicaid were 9.1 months old (95% CI 8.4-9.8). White children received surgery at mean age of 7.2 months (95% CI 6.5-8.0) and black and Hispanic children at a mean age of 9.1 months (95% CI 8.2-10.1). Multivariate regression analysis found Medicaid insurance (beta coefficient [B]=1.93, P<.001), black or Hispanic race/ethnicity (B=1.34, P=.022), and having 2 or more chronic conditions (B=2.86, P<.001) to be significant independent predictors of older age at surgery. CONCLUSION: Public insurance and nonwhite race/Hispanic ethnicity were statistically significant predictors for older age at surgery, adjusted for sex, zip code median family income, year, and hospital factors such as size, type, region, and teaching status. Further research into these disparities is warranted.

Improvements in patient blood management for pediatric craniosynostosis surgery using a ROTEM(®) -assisted strategy - feasibility and costs.

BACKGROUND: Moderate to severe intraoperative bleeding and the presence of acquired coagulopathy remain serious problems in the management of major pediatric craniosynostosis surgery. After implementation of a ROTEM(®) -assisted patient blood management (PBM) strategy, using primarily purified coagulation factor concentrates, feasibility and costs of this new regimen were analyzed. METHODS: Retrospective analysis of all consecutive children who underwent primary elective major craniofacial surgery for craniosynostosis repair was carried out at the Children's University Hospital, Zurich, between 2007 and 2013. Laboratory workup and transfusion requirements were compared. RESULTS: A total of 47 children (36 in the historic group and 11 after implementation of PBM) were analyzed. Although all patients in this study needed transfusion of red blood cell concentrates, there was a total avoidance of perioperative transfusion of fresh frozen plasma and a reduction in transfused platelets (one of nine children vs nine of 36 children in the historic group) after implementation of the PBM strategy. Based on a predefined ROTEM(®) threshold in the PBM group (FibTEM MCF <8 mm), administration of fibrinogen concentrate was necessary in all of these children. The mean total costs per patient consisting of transfused allogeneic blood products and coagulation factor concentrates were reduced by 17.1% after implementation of PBM (1071.82 EUR per patient before vs 888.93 EUR after implementation). CONCLUSIONS: The implementation of a ROTEM(®) -assisted PBM is feasible and is associated with a considerable reduction in intraoperative transfusion requirements and thereby a decrease in transfusion-related direct costs.

A comparison of costs associated with endoscope-assisted craniectomy versus open cranial vault repair for infants with sagittal synostosis.

OBJECT: The surgical management of infants with sagittal synostosis has traditionally relied on open cranial vault remodeling (CVR) techniques; however, minimally invasive technologies, including endoscope-assisted craniectomy (EAC) repair followed by helmet therapy (HT, EAC+HT), is increasingly used to treat various forms of craniosynostosis during the 1st year of life. In this study the authors determined the costs associated with EAC+HT in comparison with those for CVR. METHODS: The authors performed a retrospective case-control analysis of 21 children who had undergone CVR and 21 who had undergone EAC+HT. Eligibility criteria included an age less than 1 year and at least 1 year of clinical follow-up data. Financial and clinical records were reviewed for data related to length of hospital stay and transfusion rates as well as costs associated with physician, hospital, and outpatient clinic visits. RESULTS: The average age of patients who underwent CVR was 6.8 months compared with 3.1 months for those who underwent EAC+HT. Patients who underwent EAC+HT most often required the use of 2 helmets (76.5%), infrequently required a third helmet (13.3%), and averaged 1.8 clinic visits in the first 90 days after surgery. Endoscope-assisted craniectomy plus HT was associated with shorter hospital stays (mean 1.10 vs 4.67 days for CVR, p < 0.0001), a decreased rate of blood transfusions (9.5% vs 100% for CVR, p < 0.0001), and a decreased operative time (81.1 vs 165.8 minutes for CVR, p < 0.0001). The overall cost of EAC+HT, accounting for hospital charges, professional and helmet fees, and clinic visits, was also lower than that of CVR ($37,255.99 vs $56,990.46, respectively, p < 0.0001). CONCLUSIONS: Endoscope-assisted craniectomy plus HT is a less costly surgical option for patients than CVR. In addition, EAC+HT was associated with a lower utilization of perioperative resources. Theses findings suggest that EAC+HT for infants with sagittal synostosis may be a cost-effective first-line surgical option.

Endoscopic-assisted correction of metopic synostosis.

Our 6-year experience with correction of metopic synostosis using a minimally invasive endoscopic-assisted technique followed by postoperative cranial vault helmet molding is presented. In addition, a simple, objective method for quantification of the frontal vault contour is described.A total of 16 patients, 13 males and 3 females, with nonsyndromic, single-suture synostosis were included in the study. Patient age at operation averaged 2.9 months and the mean weight was 6 kg. The mean operative time was 79 minutes. The estimated blood loss during the procedure was 82.8 mL. Three patients required blood transfusions (18.7%). There were no significant postoperative complications. The mean hospitalization was 1.6 days. The average surgical cost, including the helmets, was $12,400, in contrast to $33,000 charged for the equivalent open procedure.Very good esthetic results, judged by physical examination and photograph comparison, were obtained in all patients. No relapses were noted. Objectively, the outcome of the operative repair was evaluated using laser scanning. For quantification of the distortion and the postoperative level of correction, the metopic angle was defined and used. This angle changed from preoperative value of 104.9 degrees to 111.3 degrees at 3 months (P = 1.59E-06) and to 114.9 degrees at 1 year postoperatively (P = 2.51E-09).Due to its promising attributes, minimally invasive strip craniectomy emerges as an ideal modality for correction of metopic synostosis. Furthermore, the metopic angle should provide clinicians with an objective measure of the frontal cranial vault deformity and its correction.

Endoscope-assisted versus open repair of craniosynostosis: a comparison of perioperative cost and risk.

BACKGROUND: Craniosynostosis, the premature closure of calvarial sutures, results in characteristic skull deformations. Correction of craniosynostosis has traditionally involved an open cranial vault remodeling procedure. A technique recently developed uses an endoscope to perform a strip craniectomy in conjunction with a postoperative molding helmet to guide cranial growth. Few studies compare these 2 approaches to the treatment of the various forms of craniosynostosis. In this study, we present a single institution's experience with open cranial vault remodeling and endoscope-assisted strip craniectomy. METHODS: This study is a retrospective review of 57 patients that underwent craniosynostosis repair by either the endoscope-assisted or open techniques, and compared operating room times, blood loss, volume of transfused blood, length of hospital stay, and overall costs. RESULTS: The endoscopic technique is performed on younger children (4.7 months vs 10.6 months, P = 0.001), has shorter operating room times (2 hours 13 minutes vs 5 hours 42 minutes, P = 0.001), lower estimated blood loss (74.4 mL vs 280.2 mL, P = 0.001), less transfused blood (90.6 mL vs 226.9 mL), shorter hospital stays (1.2 days vs 4.9 days, P = 0.001), and decreased cost ($24,404 vs $42,744, P = 0.008) relative to the traditional open approach. CONCLUSIONS: Issues with the endoscope-assisted procedure primarily concerned the postoperative helmet regimen, specifically patient compliance (17.1% noncompliance rate) and minor skin breakdown (5.7%). The endoscope-assisted repair with postoperative helmet molding therapy is a cost-effective procedure with less operative risk and minimal postoperative morbidity. This is a valuable treatment option in younger patients with compliant caregivers.

HElmet therapy Assessment in infants with Deformed Skulls (HEADS): protocol for a randomised controlled trial.

BACKGROUND: In The Netherlands, helmet therapy is a commonly used treatment in infants with skull deformation (deformational plagiocephaly or deformational brachycephaly). However, evidence of the effectiveness of this treatment remains lacking. The HEADS study (HElmet therapy Assessment in Deformed Skulls) aims to determine the effects and costs of helmet therapy compared to no helmet therapy in infants with moderate to severe skull deformation. METHODS/DESIGN: Pragmatic randomised controlled trial (RCT) nested in a cohort study. The cohort study included infants with a positional preference and/or skull deformation at two to four months (first assessment). At 5 months of age, all children were assessed again and infants meeting the criteria for helmet therapy were asked to participate in the RCT. Participants were randomly allocated to either helmet therapy or no helmet therapy. Parents of eligible infants that do not agree with enrolment in the RCT were invited to stay enrolled for follow up in a non-randomisedrandomised controlled trial (nRCT); they were then free to make the decision to start helmet therapy or not. Follow-up assessments took place at 8, 12 and 24 months of age. The main outcome will be head shape at 24 months that is measured using plagiocephalometry. Secondary outcomes will be satisfaction of parents and professionals with the appearance of the child, parental concerns about the future, anxiety level and satisfaction with the treatment, motor development and quality of life of the infant. Finally, compliance and costs will also be determined. DISCUSSION: HEADS will be the first study presenting data from an RCT on the effectiveness of helmet therapy. Outcomes will be important for affected children and their parents, health care professionals and future treatment policies. Our findings are likely to influence the reimbursement policies of health insurance companies.Besides these health outcomes, we will be able to address several methodological questions, e.g. do participants in an RCT represent the eligible target population and do outcomes of the RCT differ from outcomes found in the nRCT? TRIAL REGISTRATION: ISRCTN18473161.

Cost of treating sagittal synostosis in the first year of life.

BACKGROUND: Endoscopically assisted suturectomy (EAS) has been reported to reduce the morbidity and cost of treating sagittal synostosis when compared with traditional open cranial vault remodeling (CVR) procedures. Whereas the former claim is well substantiated and intuitive, the latter has not been validated by rigorous cost analysis. METHODS: Patient medical records and financial database reports were culled retrospectively to determine the total cost associated with both EAS and CVR during 1 year of care. Recorded cost data included physician and hospital services, orthotic equipment and fittings, and indirect patient cost. RESULTS: Ten patients treated with CVR were compared with 10 patients who underwent EAS. The CVR patients incurred greater costs in nearly all categories studied, including overall 1-year costs, physician services, hospital services, supplies/equipment, medications/intravenous fluids, and laboratory and blood bank services. Postoperative costs were greater in the EAS group, primarily because of the cost associated with orthotic services and indirect patient costs for travel and lost work. However, overall indirect patient costs for the whole year did not differ between the groups. One-year median costs were $55,121 for CVR and $23,377 for EAS. Early clinical results were similar for the 2 groups. CONCLUSIONS: Cranial vault remodeling was more costly in the first year of treatment than EAS, although indirect patient costs were similar. The favorable cost of EAS compared with CVR provides further justification to consider this procedure as first-line treatment of sagittal synostosis in young infants.

Why do we behave as we do?

It is important for surgeons to have insight into themselves, their life stories, and the rationales they use to convince themselves that their actions are unselfish and well motivated. The battle between Philanthropia and Philotechnica was recognized by Hippocrates and is still a source of internal strife for many surgeons: the need to perform an operation that they are poorly equipped to do offset against the knowledge that it could be better done by someone else. In the treatment or referral for treatment of children with craniosynostosis and craniofacial syndromes, appropriate referrals are often not made or are made only after some problem has occurred as a result of surgical intervention. Several instances of children receiving extensive surgery for wrongly diagnosed craniosynostosis are explored. The thesis is that only by knowing our own internal motivations can we avoid falling into a posture that is good for our own egos and pocketbooks but bad for our patients.