Cost-effectiveness of respiratory syncytial virus prophylaxis in various indications.

OBJECTIVES: To evaluate the cost-effectiveness of immunoprophylaxis against respiratory syncytial virus (RSV) infections with palivizumab based on actual cost and observed incidence rates in various pediatric risk groups. DESIGN: Decision tree analysis comparing children with various combinations of the following indications: chronic lung disease, congenital heart disease, or prematurity (≤32 weeks gestation), and children with none of these indications. One-way sensitivity analyses and Monte Carlo simulations were used to quantify parameter uncertainty. SETTING: Florida during the 2004-2005 RSV season. PARTICIPANTS: A total of 159,790 Medicaid-eligible children aged 0 to 2 years. INTERVENTION: Palivizumab prophylaxis compared with no prophylaxis. OUTCOMES MEASURE: Incremental cost (2010 US dollars) per hospitalization for RSV infection avoided. RESULTS: The mean cost of palivizumab per dose ranged from $1661 for infants younger than 6 months of age to $2584 for children in their second year of life. Among preterm infants younger than 6 months of age without other indications, immunoprophylaxis with palivizumab cost $302,103 (95% confidence interval, $141,850-$914,798) to prevent 1 RSV-related hospitalization. Given a mean cost of $8910 for 1 RSV-related hospitalization in this subgroup, palivizumab would be cost-neutral at a per-dose cost of $47. Incremental cost-effectiveness ratios for the other subgroups ranged from $361,727 to more than $1.3 million per RSV-related hospitalization avoided in children up to 2 years of age with chronic lung disease and no additional risk factors. Younger age and multiple indications were associated with improvements in the incremental cost-effectiveness ratio. CONCLUSIONS: The cost of immunoprophylaxis with palivizumab far exceeded the economic benefit of preventing hospitalizations, even in infants at highest risk for RSV infection.

Palivizumab utilization and compliance: trends in respiratory syncytial virus prophylaxis in Florida.

OBJECTIVES: To analyze adherence to guidelines to prevent respiratory syncytial virus hospitalization and to a monthly immunoprophylaxis schedule in the absence of prior authorization requirements. STUDY DESIGN: Among Florida Medicaid fee-for-service recipients 0 to 2 years of age from the 1998/1999 season through the 2004/2005 season with available birth certificates, we identified indications for palivizumab prophylaxis based on claims data. At least 4 doses of palivizumab in the 5 core season-months were considered full season coverage. RESULTS: Of 302 101 children-seasons, 6089 were associated with 24 469 doses of palivizumab. In the 2004/2005 season, 73.6% of children with chronic lung disease received immunoprophylaxis, 67.6% children with gestational age <32 weeks, 37% with congenital heart disease, 26.4% with cystic fibrosis, and 19.4% with severe immunodeficiency. Multiple indications increased the likelihood for prophylaxis from 34.9% to 80.4%. Full season coverage was consistent across indications at approximately 70%. From the 1998/1999 season through the 2004/2005 season, 8038 doses were administered during 2051 children-seasons without any indication; mostly (69.6%) where premature children had exceeded the recommended age range for prophylaxis. CONCLUSIONS: High utilization rates were found in children with multiple indications, and compliance with a monthly schedule was consistently high. One third of doses were administered outside of guidelines, suggesting suboptimal utilization of resources in the absence of prior authorization.

Attitude toward and current practice of transfer and transition of adolescents with congenital heart disease in the United States of America and Europe.

The objective of this study was to explore the current practice and attitudes of pediatric cardiologists in the United States and Europe on the transfer and transition of children with congenital heart disease (CHD). A survey among pediatric cardiology programs in the United States and Europe was undertaken. Sixty-nine centers completed and returned the 61-item questionnaire that was specifically devised for this survey. Of 69 participating centers, 74% reported that they transfer their patients to adult-focused care. When a center transfers its patients, 80% transfer them to a formalized Adult Congenital Heart Disease Program. The median age of transfer is 18 years. Comorbidities, pregnancy, and patient/family request to leave pediatric cardiology were identified as initiators for transfer. Complexity of the heart defect was relatively less important when deciding whether to transfer patients. Only one-third of the centers that transfer their patients provide a structured preparation for patients and family. Development of a formal transition program is planned at 59% of the centers that transfer patients. In conclusion, timely transfer and a structured transition process of children with CHD are not implemented in all pediatric cardiology programs. Health-care providers working in pediatric cardiology should make their transfer policies explicit and transition programs ought to be developed.

Depression and anxiety in adult congenital heart disease: predictors and prevalence.

BACKGROUND: Adult congenital heart disease (ACHD) patients face unique medical and social challenges that may contribute to psychological difficulties. The goals of this study were to identify predictors of symptoms of depression and anxiety and evaluate the prevalence of mood and anxiety disorders among North American ACHD patients. METHODS: In this cross-sectional study, consecutive patients were recruited from two ACHD outpatient clinics. All patients completed self-report psychosocial measures and a subset was randomly selected to participate in structured clinical interviews. Linear regression models were used to predict symptoms of depression and anxiety. RESULTS: A total of 280 patients (mean age=32 years; 52% female) completed self-report measures. Sixty percent had defects of moderate complexity and 31% had defects of great complexity. Significant predictors of depressive symptoms were loneliness (p<0.001), perceived health status (p<0.001), and fear of negative evaluation (p=0.02). Predictors of anxiety symptoms were loneliness (p<0.001) and fear of negative evaluation (p<0.001). Disease severity and functional class did not predict mood or anxiety symptoms. Fifty percent of interviewed patients (29/58) met diagnostic criteria for at least one lifetime mood or anxiety disorder, of whom 39% had never received any mental health treatment. CONCLUSIONS: The results confirm an increased risk and under-treatment of mood and anxiety disorders in ACHD patients. Social adjustment and patient-perceived health status were more predictive of depression and anxiety than medical variables. These factors are modifiable and therefore a potential focus of intervention.

Biomedical and psychosocial evaluation of "cured" adults with congenital heart disease.

As a result of significant advances in diagnostic, surgical, interventional, and pharmacological approaches, up to 95% of infants born with a congenital heart defect now survive into adulthood and there are at least 800,000 adult congenital heart disease patients living in the United States. Unfortunately, many of these individuals consider themselves "cured" or "fixed" and might have the misperception of a cure for a variety of reasons. The "cured" label is problematic and congenital heart disease is most accurately considered a chronic condition. This article outlines the concerns associated with the cured label. This is followed by the presentation of 4 illustrating case studies. Members of an adult congenital cardiology healthcare team must be prepared to address the full spectrum of concerns faced by patients who experience unexpected health deterioration. This spectrum includes both biomedical and psychosocial factors.

Implantable cardioverter defibrillator implant-explant-implant case study: addressing the psychological adjustment to multiple shocks.

This case study details the multidisciplinary approach to a patient who underwent implantable cardioverter defibrillator (ICD) explantation for psychological reasons. The patient was unable to manage the stress associated with multiple shocks. He had a class I indication for an ICD but initially refused to undergo reimplantation. Treatment included the provision of comprehensive medical, nursing, and psychological care, with emphasis on patient autonomy and respect for the patient's experience.

Biopsychosocial experiences of adults with congenital heart disease: review of the literature.

BACKGROUND: Approximately 1% of all newborns display some form of congenital heart disease (CHD). Successful medical and surgical management of CHD has allowed 85% of these children to survive into adulthood and produced a new set of challenges for both patients and doctors with an emphasis on quality of life and psychosocial functioning. METHODS: The current paper has 3 aims: (1) to summarize the research literature examining the emotional adjustment among this population, (2) to detail the psychological, social, and quality-of-life factors that might result in an increased risk of psychological maladjustment, and (3) to provide clinical management strategies to optimize health outcomes. RESULTS: Current empirical evidence has suggested that compared with same aged reference norms in US studies, adults with CHD had scores indicative of worse emotional functioning as assessed by both clinical interviews and self-report measures. Similar European studies have generally not demonstrated such differences. Additional research suggests that areas of functioning that may be particularly affected include neurocognitive functioning, body image, social and peer relationships, and mild delays in developmental functioning. CONCLUSIONS: These studies suggest that patients with CHD are successfully engaging in full adult responsibilities and roles but do experience specific psychosocial challenges that may impact emotional functioning, self-perception, and peer relationships. Lifestyle considerations in young adulthood are significant and impinge on pregnancy considerations and exercise capabilities. Clinical management strategies include increased awareness and dialogue between patients with CHD and physicians regarding psychosocial concerns.