Comparative Evaluation of Esthetic Outcomes in Unilateral Cleft Lip Repair Between the Mohler and Fisher Repair Techniques: A Prospective, Randomized, Observer-Blind Study.

PURPOSE: The Mohler and Fisher techniques are 2 of the most widely used surgical techniques of cleft lip repair showing satisfactory esthetic results. Their random use and preference by some surgeons irrespective of cleft severity have invited considerable doubt regarding whether one technique performs better than the other. The aim of this study was to measure and compare the esthetic outcomes between these 2 techniques of unilateral cleft lip repair. MATERIALS AND METHODS: This prospective, randomized, observer-blind study included 50 patients with unilateral cleft lip with or without cleft palate. Preoperative cleft severity was evaluated based on the Unilateral Cleft Lip Severity Index. All patients then underwent 1 of the 2 techniques of lip repair, assigned by randomization, performed by a single blinded surgeon. The postsurgical esthetic outcome was evaluated by 3 laymen using the Surgical Outcomes Evaluation Scale. Pearson product moment correlation was used to determine the correlation between cleft severity and esthetic outcome. A 1-way analysis of covariance was performed to determine the relation between the technique and the esthetic outcome using technique as the independent variable and esthetic outcome as the dependent variable, with the means adjusted using cleft severity as the covariate. A simple main effect (post hoc) test was performed to determine whether there was any difference in the mean esthetic outcome for different cleft severities with both techniques. RESULTS: The study included a total of 50 patients with unilateral cleft lip with or without cleft palate, among whom left-sided clefts predominated, at 68%. The median age was 8.50 months. We found significance when relating cleft severity with esthetic outcomes, with the latter worsening with increasing severity. A significant difference was measured in the mean esthetic outcome and repair technique even when means were adjusted for initial cleft severity: The Fisher technique had a significantly better mean esthetic outcome than the Mohler technique. CONCLUSIONS: Although both techniques showed satisfactory postoperative esthetics clinically, the Fisher technique fared better overall than the Mohler technique.

Dental Infection Cause of Flap Loss in Cleft Palate Repair.

Flap necrosis is a very common complication encountered after cleft palate repair, especially in uni-pedicled flaps. Many causes have been attributed to this complication but very limited data is available in the literature on dental infection as the cause of flap necrosis. This report of a case describes loss of flap caused due to a periapical granuloma of dental origin impinging on the pedicle causing suspected thrombosis of the pedicle resulting in flap necrosis. Since this is an important cause that can be easily prevented, it is reported.

Improved Early Cleft Lip and Palate Complications at a Surgery Specialty Center in the Developing World.

OBJECTIVE: To evaluate complication rates following cleft lip and cleft palate repairs during the transition from mission-based care to center-based care in a developing region. PATIENTS AND DESIGN: We performed a retrospective review of 3419 patients who underwent cleft lip repair and 1728 patients who underwent cleft palate repair in Guwahati, India between December 2010 and February 2014. Of those who underwent cleft lip repair, 654 were treated during a surgical mission and 2765 were treated at a permanent center. Of those who underwent cleft palate repair, 236 were treated during a surgical mission and 1491 were treated at a permanent center. SETTING: Two large surgical missions to Guwahati, India, and the Guwahati Comprehensive Cleft Care Center (GCCCC) in Assam, India. MAIN OUTCOME MEASURE: Overall complication rates following cleft lip and cleft palate repair. RESULTS: Overall complication rates following cleft lip repair were 13.2% for the first mission, 6.7% for the second mission, and 4.0% at GCCCC. Overall complication rates following cleft palate repair were 28.0% for the first mission, 30.0% for the second mission, and 15.8% at GCCCC. Complication rates following cleft palate repair by the subset of surgeons permanently based at GCCCC (7.2%) were lower than visiting surgeons ( P < .05). CONCLUSIONS: Our findings support the notion that transitioning from a mission-based model to a permanent facility-based model of cleft care delivery in the developing world can lead to decreased complication rates.

Topiramate use during pregnancy and major congenital malformations in multiple populations.

BACKGROUND: We measured birth prevalence of major congenital malformations (MCMs) after topiramate use during pregnancy to screen for a possible signal of increased risk. METHODS: Using four healthcare databases, we identified three cohorts of pregnant women: cohort 1, used topiramate during the first trimester; cohort 2, used topiramate or another antiepileptic drug previously but not during pregnancy; and cohort 3, were pregnant and did not use topiramate but had indications for use individually matched to those of users. Cohort 1 was compared with cohorts 2 and 3. MCMs were a code for any major congenital malformation dated within 30 days of the delivery date on the mother's claims or within 365 days after infant birth date, excluding a genetic or syndromic basis, and with procedure or healthcare usage consistent with the MCM diagnosis code in the 365 days after infant birth. RESULTS: Of the 10 specific common MCMs evaluated, 1 (conotruncal heart defects) had a prevalence ratio greater than 1.5 for both primary comparisons, and 4 (ventricular septal defect, atrial septal defect, hypospadias, coarctation of the aorta) had a prevalence ratio greater than 1.5 for one of the two comparisons. Following screening of organ systems with elevated MCMs, the prevalence ratio was greater than 1.5 for patent ductus arteriosus in both comparisons and for obstructive genitourinary defects in one comparison. CONCLUSION: To evaluate a large number of MCMs across many pregnancies, we used crude methods for detecting potential signals. Therefore, these results should be seen as potential signals, not causal.

Topiramate use in pregnancy and the birth prevalence of oral clefts.

PURPOSE: First marketed in the USA in 1996, topiramate (TPM) is an antiepileptic drug later approved for migraine prophylaxis, and in 2012 for weight loss in combination with phentermine. Some studies indicate an elevated prevalence of oral cleft (OC) in infants exposed to TPM in utero. We evaluated the association between TPM use in early pregnancy and the risk of OC. METHODS: This retrospective cohort study used 1997-2011 automated data from four sources: HealthCore and OptumInsight (commercial insurance claims), Truven Health (Medicaid claims), and Kaiser Permanente Northern California Region (electronic medical records). We compared the prevalence of OCs in infants of women exposed to TPM in the first trimester (TPM cohort) with the prevalence in infants of women formerly exposed to TPM or other antiepileptic drugs (formerly exposed [FE] cohort) and infants of women with similar medical profiles (SMPs) to the TPM cohort that were not exposed to TPM (SMP cohort). To control for confounding, we used stratification and standardization for individual variables and propensity score deciles. RESULTS: The birth prevalence of OCs was 0.36% (7/1945) in the TPM cohort, 0.14% (20/13 512) in the FE cohort, and 0.07% (9/13 614) in the SMP cohort. Standardized by site, the prevalence ratio (PR) for TPM versus FE was 2.5 (95% CI: 1.0-6.0) and for TPM versus SMP was 5.4 (95% CI: 2.0-14.6). Adjustment for covariates one at a time or by propensity score yielded similar results. CONCLUSION: Consistent with other recent epidemiologic research, first-trimester TPM exposure was associated with an elevated birth prevalence of OC.

Longitudinal treatment of cleft lip and palate in developing countries: dentistry as part of a multidisciplinary endeavor.

Cleft lip and palate affects roughly 1 in 600 children and predisposes patients to a lifetime of functional and esthetic discrepancies. Disparities in access as well as quality of care exist worldwide, with many children in developing countries unable to receive treatment. In the late 20th century, humanitarian medical missions emerged as a means of delivering surgical expertise to patients in resource-limited settings. These early missions took on a patient-centered approach focused solely on cleft repair, with little emphasis on treating the dental abnormalities that arose after the initial surgery. However, modern cleft care is characterized by a multidisciplinary, team-based approach with significant dental involvement. Recent cleft lip and palate endeavors have shifted from a mission-based approach to a developmental approach facilitating growth of an independent care center. This strategy focuses on creating an institution with expanded access to dental services, thus facilitating the long-term treatment inherent in modern cleft care. One clinic in a developing country that has experienced successful transitioning from a mission site to an independent craniofacial clinic is Operation Smile's Cleft Comprehensive Care Clinic in Guwahati, India. This article will summarize the rationale and planning of the clinic, underscore the team-based approach required in longitudinal treatment of cleft lip and palate, and demonstrate how treatment methodology may differ in resource-limited settings by outlining the therapeutic considerations of each provider in the Guwahati Clinic.

Early complications after cleft palate repair: a multivariate statistical analysis of 709 patients.

This study presents a large consecutive institutional experience with primary cleft palate repairs. The purpose of this study was to determine the incidence of early complications after cleft palate surgery in a series of nonsyndromic children treated at the authors' comprehensive cleft center. This retrospective analysis includes 709 consecutive patients with cleft palate treated by 6 different staff surgeons at Guwahati Comprehensive Cleft Care Center between April 2011 and December 2012. Secondary cases were excluded from this study. The patients were initially followed up between 1 week and 1 month after surgery. The overall incidence of early complications was determined, and the effect of the extent of clefting, the type of repair, the age at repair, and the operating surgeon were analyzed. Early complications in this study include dehiscence of the wound, fistula formation, hanging palate, and total or partial flap necrosis. There was a 2.4% rate (17/709) of take-back to the operating room in the immediate postoperative period for control of bleeding, although no blood transfusions were required. The incidence of postoperative fistulas in this series was 3.9% (20/512). There was a statistically significant increase in the incidence of cleft palatal fistula for Veau IV clefts, but there were no significant differences with respect to operating surgeon, patient sex, patient age, and type of palatoplasty. The complication and fistula rate is consistent with other published reports from developed countries and provides evidence for the value of this model for surgical delivery in the developing world.

Surgical education through video broadcasting.

Surgical training is facing new obstacles. As advancements in medicine are made, surgeons are expected to know more and to be able to perform more procedures. In the western world, increasing restrictions on residency work hours are adding a new hurdle to surgical training. In low-resource settings, a low attending-to-resident ratio results in limited operative experience for residents. Advances in telemedicine may offer new methods for surgical training. In this article, the authors share their unique experience using live video broadcasting of surgery for educational purposes at a comprehensive cleft care center in Guwahati, India.

Scalable, sustainable cost-effective surgical care: a model for safety and quality in the developing world, part I: challenge and commitment.

BACKGROUND: With an estimated backlog of 4,000,000 patients worldwide, cleft lip and cleft palate remain a stark example of the global burden of surgical disease. The need for a new paradigm in global surgery has been increasingly recognized by governments, funding agencies, and professionals to exponentially expand care while emphasizing safety and quality. This three-part article examines the evolution of the Operation Smile Guwahati Comprehensive Cleft Care Center (GCCCC) as an innovative model for sustainable cleft care in the developing world. METHODS: The GCCCC is the result of a unique public-private partnership between government, charity, and private enterprise. In 2009, Operation Smile, the Government of Assam, the National Rural Health Mission, and the Tata Group joined together to work towards the common goal of creating a center of excellence in cleft care for the region. RESULTS: This partnership combined expertise in medical care and training, organizational structure and management, local health care infrastructure, and finance. A state-of-the-art surgical facility was constructed in Guwahati, Assam which includes a modern integrated operating suite with an open layout, advanced surgical equipment, sophisticated anesthesia and monitoring capabilities, central medical gases, and sterilization facilities. CONCLUSION: The combination of established leaders and dreamers from different arenas combined to create a synergy of ambitions, resources, and compassion that became the backbone of success in Guwahati.

Scalable, sustainable cost-effective surgical care: a model for safety and quality in the developing world, part II: program development and quality care.

BACKGROUND: The Guwahati Comprehensive Cleft Care Center (GCCCC) is committed to free medical and surgical care to patients afflicted with facial deformities in Assam, India. A needs-based approach was utilized to assemble numerous teams, processes of care, and systems aimed at providing world-class care to the most needy of patients, and to assist them with breaking through the barriers that prohibit them from obtaining services. METHODS: A team of international professionals from various disciplines served in Guwahati full time to implement and oversee patient care and training of local counterparts. Recruitment of local professionals in all disciplines began early in the scheme of the program and led to gradual expansion of all medical teams. Emphasis was placed on achieving optimal outcome for each patient treated, as opposed to treating the maximum number of patients. RESULTS: The center is open year round to offer full-time services and follow-up care. Along with surgery, GCCCC provides speech therapy, child life counseling, dental care, otolaryngology, orthodontics, and nutrition services for the cleft patients under one roof. Local medical providers participated in a model of graded responsibility commiserate with individualized skill and progress, and gradually assumed all leadership positions and now account for 92% of the workforce. Institutional infrastructure improvements positioned and empowered teams of skilled local providers while implementing systemized perioperative processes. CONCLUSION: This needs-based approach to program development in Guwahati was successful in optimization of quality and safety in all clinical divisions.

Scalable, sustainable cost-effective surgical care: a model for safety and quality in the developing world, part III: impact and sustainability.

BACKGROUND: The Guwahati Comprehensive Cleft Care Center (GCCCC) utilizes a high-volume, subspecialized institution to provide safe, quality, and comprehensive and cost-effective surgical care to a highly vulnerable patient population. METHODS: The GCCCC utilized a diagonal model of surgical care delivery, with vertical inputs of mission-based care transitioning to investments in infrastructure and human capital to create a sustainable, local care delivery system. Over the first 2.5 years of service (May 2011-November 2013), the GCCCC made significant advances in numerous areas. Progress was meticulously documented to evaluate performance and provide transparency to stakeholders including donors, government officials, medical oversight bodies, employees, and patients. RESULTS: During this time period, the GCCCC provided free operations to 7,034 patients, with improved safety, outcomes, and multidisciplinary services while dramatically decreasing costs and increasing investments in the local community. The center has become a regional referral cleft center, and governments of surrounding states have contracted the GCCCC to provide care for their citizens with cleft lip and cleft palate. Additional regional and global impact is anticipated through continued investments into education and training, comprehensive services, and research and outcomes. CONCLUSION: The success of this public private partnership demonstrates the value of this model of surgical care in the developing world, and offers a blueprint for reproduction. The GCCCC experience has been consistent with previous studies demonstrating a positive volume-outcomes relationship, and provides evidence for the value of the specialty hospital model for surgical delivery in the developing world.

The Impact of Cleft Lip/Palate and Surgical Intervention on Adolescent Life Outcomes.

Background: Cleft lip/palate (CLP) is a congenital orofacial anomaly appearing in approximately one in 700 births worldwide. While in high-income countries CLP is normally addressed surgically during infancy, in developing countries CLP is often left unoperated, potentially impacting multiple dimensions of life quality. Previous research has frequently compared CLP outcomes to those of the general population. But because local environmental and genetic factors contribute to the risk of CLP and also may influence life outcomes, such studies may downwardly bias estimates of both CLP status and correction. Objectives: This research represents the first study to use causal econometric methods to estimate the effects of both CLP status and CLP correction on the physical, social, and mental well-being of children. Methods: Data were collected first-hand from 1,118 Indian children, where we obtained first-hand data on height, weight, grip strength, cognitive ability, reading, and math ability. A professional speech therapist reviewed digital recordings of speech taken at the interview to obtain four measures of speech quality. Using this data, the household fixed-effects model we employ jointly estimates effects of CLP status and CLP surgical intervention. Findings: Our results indicate that adolescents with median-level CLP severity show statistically significant losses in indices of speech quality (-1.59σ), physical well-being (0.32σ), academic and cognitive ability (-0.37σ), and social integration (-0.32σ). We find strong evidence that CLP surgery significantly restores speech if performed before five years of age. The first surgeries performed on less-severe CLP cases significantly restore social integration, psychological well-being, academic/cognitive ability, and a general index of human flourishing. Conclusions: Children born with CLP in India face statistically significant losses in speech, physical health, mental health, and social inclusion. CLP surgical intervention significantly restores speech quality if carried out at an early age. Surgeries with the most significant impact on life outcomes are the first surgeries performed on less-severe CLP cases.

Influence of Severity on Aesthetic Outcomes of Unilateral Cleft Lip Repair in 1,823 Patients.

BACKGROUND: Although efforts to improve access to care for patients with cleft lip in the developing world have grown tremendously, there is a dearth of data regarding aesthetic outcomes after cleft lip repairs in this setting. Defining severity-outcome relationships has the potential to improve efficiency of care delivery in resource-limited settings, and to improve overall results. In this study, we investigate the relationship between initial cleft lip severity and early aesthetic outcomes following surgical repair of primary unilateral cleft lip. METHODS: Using previously validated tools to assess unilateral cleft lip severity and aesthetic outcome after repair, we evaluated 1,823 consecutive patients who underwent primary unilateral cleft lip/nose (UCL/N) repair. Three separate evaluators scored each case for a total of 5,469 total independent evaluations. RESULTS: Our results show that with increasing severity of UCL/N deformity, there is a corresponding decrease in early aesthetic outcome scores. Using our results, we established normative early aesthetic outcomes following repair for each severity grade of UCL/N deformity. CONCLUSIONS: In conclusion, this study has achieved a standardized, timely, and cost-effective evaluation of 1,823 surgical cases of primary UCL/N repair. This data set provides a normal distribution of aesthetic results according to initial cleft severity and defines a standard of "expected" aesthetic results after primary UCL/N repair. Our results also show a clear correlation between initial severity and immediate aesthetic result after surgery, though we also show that excellent results are possible regardless of initial cleft severity.

Health Plan Enrollment and Disenrollment of Individuals With and Without Established Chronic Disease in a U.S. Commercially Insured and Medicare Advantage Population.

BACKGROUND: Chronic disease is associated with increased health care resource utilization and costs. Effective development and implementation of health care management and clinical intervention programs require an understanding of health plan member enrollment and disenrollment behavior. OBJECTIVE: To examine the health plan enrollment and disenrollment behavior of commercially insured and Medicare Advantage members with established chronic disease compared with matched members without the disease of interest, using data from a large national health insurer in the United States. METHODS: This retrospective matched cohort study used administrative claims data from the HealthCore Integrated Research Database from January 1, 2006, to November 30, 2015, to identify adults with chronic disease (type 2 diabetes mellitus [T2DM], cardiovascular disease [CVD], chronic obstructive pulmonary disease [COPD], rheumatoid arthritis [RA], and breast cancer [BC]). Members with no established chronic disease (controls) were directly matched to members with established chronic disease (cases) on demographic characteristics. The earliest date on which members met the criteria for a given disease was defined as the index date. Controls had the same index date as the matched cases. All members had ≥ 12 months of continuous health plan enrollment before the index date. Outcomes included health plan member disenrollment and enrollment duration. Incidence rates per 1,000 member-years for member disenrollment were evaluated along with incidence rate ratios (relative risk) using a Poisson model. Time to disenrollment was analyzed by Cox proportional hazard models and Kaplan-Meier survival curves. Sensitivity analyses were conducted where death was included as a disenrollment event. RESULTS: 70,907 health plan members with BC (99.7% female, mean age 60.5 years); 28,883 members with COPD (52.3% female, mean age 66.7); 835,358 members with CVD (50.5% female, mean age 62.7 years); 210,936 members with T2DM (45.2% female, mean age 53.6 years); and 31,954 members with RA (72.0% female, mean age 55.5 years) were matched to controls and met the study criteria. The incidence rates of health plan disenrollment ranged from 155 to 192 members per 1,000 members per year. Compared with controls, members with chronic disease were 30%-40% less likely to disenroll from a health plan (P < 0.001 for all comparisons). Among those who disenrolled, enrollment duration ranged from 2.3 to 2.7 years among cases and 1.5 to 1.8 years among matched controls (P ≤ 0.001 for all comparisons). CONCLUSIONS: This real-world study demonstrated that members with chronic disease had a significantly lower rate of disenrollment and a longer duration of enrollment compared with matched controls and were continuously enrolled for almost a year longer than members without a diagnosed chronic disease. Understanding health plan enrollment and disenrollment behavior may provide a valuable context for determining the time frame for the effect of health care programs and initiatives. DISCLOSURES: Funding for this study was provided by HealthCore, a wholly owned subsidiary of Anthem. Chung, Deshpande, Zolotarjova, Quimbo, and Willey are employees of HealthCore. Kern and Cochetti are former employees of HealthCore. Quimbo, Cochetti, and Willey are shareholders of Anthem. HealthCore receives funding from multiple pharmaceutical companies to perform various research studies outside of the submitted work. The preliminary results of this study were presented at AMCP Nexus 2015; March 26-29, 2015; Orlando, FL, and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2017 Conference; May 20-24, 2017; Boston, MA.

Impact of medical and/or pharmacy reimbursement on adult vaccination rates.

OBJECTIVES: To evaluate whether adults enrolled in commercial health insurance plans that provide reimbursement for herpes zoster vaccine (HZV) and pneumococcal vaccine (PV) through the medical and pharmacy benefits have higher vaccination rates compared with those whose health plans cover vaccines under the medical benefit alone. STUDY DESIGN: Retrospective claims analysis using medical and pharmacy claims data from January 1, 2012, through December 31, 2014. Separate but parallel analyses were conducted for HZV and PV. METHODS: Previously unvaccinated patients were divided into exposed (those in employer groups with both medical and pharmacy benefits for vaccinations) and unexposed (those in employer groups that covered vaccination under the medical benefit only) cohorts. RESULTS: For HZV, 32,506 and 1299 patients received vaccinations in the exposed and unexposed cohorts, respectively. The vaccination rate was significantly higher in the exposed (42 vaccinations per 1000 eligible person-years) than the unexposed cohort (15 vaccinations per 1000 eligible person-years; P <.001). For PV, 16,409 and 1386 received vaccinations in the exposed and unexposed cohorts, respectively. The vaccination rate was significantly higher in the exposed (22 vaccinations per 1000 eligible person-years) than the unexposed cohort (17 vaccinations per 1000 eligible person-years; P <.001). CONCLUSIONS: Among members with commercial health insurance, HZV and PV rates were significantly higher among those whose insurance covered vaccinations under both medical and pharmacy benefits, compared with members whose insurance covered vaccines under the medical benefit only. Pharmacy-based vaccination coverage from commercial health insurance plans may help improve adult vaccination rates.

Patient and prescriber characteristics among patients with type 2 diabetes mellitus continuing or discontinuing sulfonylureas following insulin initiation: data from a large commercial database.

OBJECTIVE: To describe patient and provider characteristics for patients with type 2 diabetes (T2DM) initiating basal insulin and describe basal insulin's impact on sulfonylurea (SU) discontinuation. METHODS: A retrospective cohort study was conducted using the HealthCore Integrated Research Database. Patients had ≥12 months of continuous coverage prior to initiating insulin, and were utilizing at least one anti-hyperglycemic drug at the time of insulin initiation. Predictors for SU discontinuation were evaluated utilizing Cox proportional hazards models. RESULTS: Among the 74,334 individuals aged ≥18 years with T2DM who initiated basal insulin from 2006-2015, 30% were taking metformin (MET) and SU when initiating insulin. Among the 22,418 MET/SU patients, 31% discontinued SU within 3 months of insulin initiation and, by 12 months, 55% had discontinued SU. Sulfonylurea discontinuation was similar among many patient and provider characteristics, while being modestly positively associated (p < .05; HRs <1.5) with female gender, more co-morbidities, cardiac revascularization, chronic liver disease, hospitalizations with a T2DM diagnosis, and hypoglycemia prior to insulin initiation. SU discontinuation was modestly inversely associated with receiving an insulin prescription from an endocrinologist (HR = 0.90, 95% CI = 0.85-0.95). CONCLUSIONS: Roughly half of commercially-insured T2DM patients discontinued SU within 1 year after insulin initiation, and SU discontinuation was not strongly associated with a range of patient and provider characteristics.

Estimating the Real-World Cost of Diabetes Mellitus in the United States During an 8-Year Period Using 2 Cost Methodologies.

BACKGROUND: Diabetes is associated with substantial clinical and economic burdens on patients and on the US healthcare system. Treatment options for patients with type 1 or type 2 diabetes have increased significantly, from only 3 drug classes in 1995 to more than 12 distinct classes today. Although several of the newer treatments are reported to have improved efficacy and safety profiles, they are often substantially more costly than older medications. Consequently, as drug options increase, the cost of diabetes management continues to grow. OBJECTIVES: To estimate the annual real-world costs of type 1 and 2 diabetes, as well as diabetes prevalence, treatment patterns, care quality, and resource utilization during 8 years. METHODS: In this cross-sectional study, we examined 8 annual cohorts of patients with type 1 or type 2 diabetes, on a biennial basis, using claims data from the HealthCore Integrated Research Database between 2006 and 2014. Patients were matched with controls by age, sex, residency, and health plan type. We assessed the prevalence of diabetes, treatment patterns, care quality measures, and all-cause and diabetes-related healthcare costs using 2 methods. Method 1 calculated the annual costs as the difference in all-cause costs between patients with diabetes and matched controls. Method 2 calculated the costs for healthcare encounters based on specific codes for a diabetes diagnosis or for antidiabetes medications. RESULTS: Between 346,486 and 410,234 patients with type 2 diabetes and between 21,176 and 26,228 patients with type 1 diabetes were included in each study year cohort. Between 2007 and 2014, the prevalence of type 2 diabetes increased from 4.9% to 6.3%. The costs associated with using Method 1 were almost double the cost estimates in Method 2 during most of the study period. For patients with type 1 diabetes, the associated costs were twice greater with Method 1 than with Method 2. Projections to the entire US population in 2014 indicated a total of 19.3 million individuals with diabetes and associated direct costs of $314.8 billion that year. CONCLUSION: Cost estimates can guide the prioritization of healthcare expenditures. The results of this study showed that costs attributable to diabetes differed by approximately 2-fold, depending on the estimation method. The management of the escalating expenses for diabetes management in the United States requires judicious selection of the methods for estimating costs.

Demographics, treatment patterns, and healthcare utilization and cost of repository corticotropin injection in patients with systemic lupus erythematosus or rheumatoid arthritis.

OBJECTIVE: To evaluate healthcare resource utilization (HRU) and costs among patients who initiated repository corticotropin injection (RCI; H.P. Acthar Gel) treatment for rheumatoid arthritis (RA) or systemic lupus erythematosus (SLE). METHODS: Patients aged ≥18 years with ≥2 diagnoses for either RA or SLE between July 1, 2006 and April 30, 2015 were identified in the HealthCore Integrated Research Database. Index RCI date was the earliest date of a medical or pharmacy claim for RCI after diagnosis. Baseline characteristics, pre- and post-initiation HRU and costs were assessed using descriptive statistics. RESULTS: This study identified 180 RA patients (mean age = 60 years, 56% female) and 29 SLE patients (mean age = 45 years, 90% female) who initiated RCI. First RCI use averaged 7.1 and 22.6 months after the initial RA and SLE diagnosis, respectively. After RCI initiation, RA patients incurred significantly lower per-patient-per-month (PPPM) all-cause medical costs ($1,881 vs $682, p < .01) vs the pre-initiation period, driven by lower PPPM hospitalizations costs ($1,579 vs $503, p < .01). Overall PPPM healthcare costs were higher ($2,751 vs $5,487, p < .01) due to higher PPPM prescription costs ($869 vs $4,805, p < .01). Similarly, SLE patients had decreased PPPM hospitalization costs ($3,192 vs $799, p = .04) and increased PPPM prescription costs ($905 vs $7,443, p < .01) after initiating RCI; the difference in overall PPPM healthcare costs was not statistically significant likely, due to small sample size. CONCLUSION: This study, across a heterogeneous population of variable disease duration, described clinical and healthcare utilization and costs of RA and SLE patients initiating RCI in a real-world setting. We observed that patients receiving RCI had lower utilization and costs for medical services in both disease populations, which partially offset the increased prescription costs by 30% and 37%. Future research is needed to explore factors associated with RCI initiation and its impact on long-term outcomes.

Validation of a Unilateral Cleft Lip Surgical Outcomes Evaluation Scale for Surgeons and Laypersons.

BACKGROUND: A standardized evaluation tool is needed for the assessment of surgical outcomes in cleft lip surgery. Current scales for evaluating unilateral cleft lip/nose (UCL/N) aesthetic outcomes are limited in their reliability, ease of use, and application. The Unilateral Cleft Lip Surgical Outcomes Evaluation (UCL SOE) scale measures symmetry of 4 components and sums these for a total score. The purpose of this study was to validate the SOE as a reliable tool for use by both surgeons and laypersons. METHODS: Twenty participants (9 surgeons and 12 laypeople) used the SOE to evaluate 25 sets of randomly selected presurgical and postsurgical standardized photographs of UCL/N patients. Interrater reliability for surgeon and laypeople was determined using an intraclass correlation coefficient (ICC). RESULTS: Individual surgeons and laypeople both reached an ICC in the "fair to good" range (ICC = 0.42 and 0.59, respectively). Averaging 2 evaluators in the surgeon group improved the ICC to 0.58 and in the laypeople group to 0.74, respectively. Averaging 3 evaluators increased the ICC for surgeons to the "good" range (ICC = 0.71) and the ICC for laypeople to the "very good" range (ICC = 0.82). CONCLUSIONS: Surgeon and layperson raters can reliably use the SOE to assess the aesthetics results after surgical repair of UCL/N, and improved reliability and reproducibility is achieved by averaging the scores of multiple reviewers.

Validation of the Unilateral Cleft Lip Severity Index for Surgeons and Laypersons.

BACKGROUND: Severity of the primary unilateral cleft lip/nose deformity (UCL/N) is postulated to play a key role in postoperative complications, aesthetic result, and need for secondary surgery. There is no validated and widely accepted classification scheme of initial cleft severity. The purpose of this study was to validate the Unilateral Cleft Lip Cleft Severity Index as a reliable tool for evaluating presurgical UCL/N deformity by both surgeons and laypersons. METHODS: Twenty-five participants (10 surgeons and 15 laypeople) evaluated 25 sets of randomly selected presurgical standardized photographs of UCL/N patients. Each participant rated patients on a scale of 1-4 using the Cleft Severity Index. Interrater reliability for surgeons, laypersons, and all participants was determined using an intraclass correlation coefficient. Histograms and regression analysis were performed to compare average ratings between groups. RESULTS: Interrater reliability for all groups was classified as "very good" determined by intraclass correlation coefficients of 0.837 (laymen), 0.885 (surgeons), and 0.848 (all participants). These results indicate that there was a high degree of interrater across all 3 groups and that both surgeons and laypersons can reliability rate cleft severity using the Cleft Severity Index. CONCLUSIONS: This study validates the use of the Cleft Severity Index by both surgeons and laypersons as a reliable tool for evaluating the degree of presurgical severity of patients with UCL/N. The Unilateral Cleft Lip Cleft Severity Index can thus serve as a reproducible and reliable grading system for primary UCL/N deformity and to categorize patients for future outcomes studies.