RESUMO
BACKGROUND: Desensitization protocols for HLA-incompatible living donor kidney transplantation (ILDKT) vary across centers. The impact of these, as well as other practice variations, on ILDKT outcomes remains unknown. METHODS: We sought to quantify center-level variation in mortality and graft loss following ILDKT using a 25-center cohort of 1358 ILDKT recipients with linkage to Scientific Registry of Transplant Recipients for accurate outcome ascertainment. We used multilevel Cox regression with shared frailty to determine the variation in post-ILDKT outcomes attributable to between-center differences and to identify any center-level characteristics associated with improved post-ILDKT outcomes. RESULTS: After adjusting for patient-level characteristics, only 6 centers (24%) had lower mortality and 1 (4%) had higher mortality than average. Similarly, only 5 centers (20%) had higher graft loss and 2 had lower graft loss than average. Only 4.7% of the differences in mortality (P < 0.01) and 4.4% of the differences in graft loss (P < 0.01) were attributable to between-center variation. These translated to a median hazard ratio of 1.36 for mortality and 1.34 of graft loss for similar candidates at different centers. Post-ILDKT outcomes were not associated with the following center-level characteristics: ILDKT volume and transplanting a higher proportion of highly sensitized, prior transplant, preemptive, or minority candidates. CONCLUSIONS: Unlike most aspects of transplantation in which center-level variation and volume impact outcomes, we did not find substantial evidence for this in ILDKT. Our findings support the continued practice of ILDKT across these diverse centers.
Assuntos
Rejeição de Enxerto/prevenção & controle , Sobrevivência de Enxerto/efeitos dos fármacos , Antígenos HLA/imunologia , Disparidades em Assistência à Saúde , Histocompatibilidade , Imunossupressores/uso terapêutico , Isoanticorpos/sangue , Transplante de Rim , Doadores Vivos , Padrões de Prática Médica , Adulto , Feminino , Rejeição de Enxerto/sangue , Rejeição de Enxerto/imunologia , Rejeição de Enxerto/mortalidade , Humanos , Imunossupressores/efeitos adversos , Transplante de Rim/efeitos adversos , Transplante de Rim/mortalidade , Masculino , Pessoa de Meia-Idade , Indicadores de Qualidade em Assistência à Saúde , Sistema de Registros , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Estados UnidosRESUMO
BACKGROUND: Generic ciclosporin A modified (CsA) does not have an equivalent pharmacokinetic profile to branded CsA in some transplant populations, potentially leading to negative clinical consequences and increased long-term costs. OBJECTIVE: To assess direct healthcare costs for de novo renal transplant recipients in the US receiving branded versus generic CsA in the first month after transplantation. METHODS: Administrative claims data from eight private US health plans were linked to the Organ Procurement and Transplantation Network data. A total of 227 renal transplant cases between 1996 and 2004 were included: 183 were dispensed branded CsA and 44 received generic CsA. Log transformed multiple linear regression was used to model total first-year healthcare costs after the initial CsA claim, controlling for both patient demographics and clinical characteristics and clustering at the transplant centre level. RESULTS: After controlling for patient factors and pre-CsA costs, total healthcare costs were significantly higher (p = 0.04) for patients receiving generic CsA versus branded CsA. The main driver for the difference was the cost associated with immunosuppressants other than CsA (p = 0.01). CONCLUSION: Despite initial perceived cost savings associated with generic CsA, de novo renal transplant recipients incurred greater total healthcare costs than those treated with branded CsA. Patients receiving generic CsA may need higher doses or other immunosuppressants to maintain the transplanted kidney than patients receiving branded CsA. Providers and payers need to be aware of potential differences in total healthcare costs between formulations of bioequivalent critical-dose drugs to make the best choice for patient care.
Assuntos
Ciclosporina/economia , Custos de Cuidados de Saúde , Transplante de Rim/economia , Adulto , Redução de Custos/métodos , Ciclosporina/farmacocinética , Ciclosporina/uso terapêutico , Medicamentos Genéricos/economia , Medicamentos Genéricos/farmacocinética , Medicamentos Genéricos/uso terapêutico , Feminino , Humanos , Revisão da Utilização de Seguros , Masculino , Pessoa de Meia-Idade , Equivalência Terapêutica , Estados UnidosRESUMO
OBJECTIVE: In the United States, data on transplanted and waitlisted patients collected by the Organ Procurement and Transplantation Network (OPTN) have been widely used in transplantation research. Administrative claims data, collected by health plans for reimbursement purposes, are also commonly used in health-services research. This study linked OPTN and private payer claims data to assess the relationship between data elements common to both sources. METHODS: All transplanted or waitlisted patients in the registry were considered for inclusion. A multistep match algorithm was employed to link OPTN and payer data from years 1995 to 2004. Variables common to both datasets that contained relevant information for similar time periods were compared. RESULTS: A total of 21,419 solid organ transplant recipients and 8808 waitlist patients were included in the final linked database. Organ type and demographic variable distributions in the linked dataset were similar to the overall OPTN database. Using claims as the reference group, sensitivity and specificity values were on average 0.72 and 0.69, respectively, and were highest for the indicators of immunosuppression use at discharge and follow-up. CONCLUSION: This comparison of payer data with information reported by transplant centers to the OPTN provides important insight into the value of both data sources. Using administrative claims to augment the registry data with utilization and cost information will be useful for evaluation of both economic and clinical endpoints in solid organ transplantation.