RESUMO
PURPOSE: The purpose of this study was to analyze the efficacy of a social interaction intervention delivered during the early postoperative time period on the coping process in persons with a new ostomy. DESIGN: Randomized controlled trial. SUBJECTS AND SETTING: The sample comprised 52 persons who underwent surgical management of colorectal including a fecal ostomy; 27 were randomly allocated to the intervention group and 25 to the control group. One participant allocated to the control group died before data collection; thus, findings are based on data from 51 participants. The study setting is the Regional University Hospital of Malaga, located on the southern coast of Spain. METHODS: Ostomy visitors (persons living with an ostomy) were taught to listen to the experiences and the concerns of the participant and to serve as an example of an individual who has successfully learned to live with a fecal ostomy. The intervention was a visit with a person with a new ostomy during the early postoperative period. Control group participants were offered standard care that did not include the visit from a person with an ostomy. Outcome measures were taken from the Nursing Outcomes Classification taxonomy. The main outcome measure was coping; secondary outcome measures were health beliefs and acceptance of health status. Bivariate analyses were performed to evaluate differences between groups in terms of the primary and secondary outcomes. A multivariate linear regression analysis was performed to identify predictor variables of the primary outcome, and effect size calculations were used to differentiate statistical significance versus clinical relevance. RESULTS: There were no differences in demographic or pertinent characteristics of participants in the 2 groups. Participants who received the intervention achieved a higher mean coping process scores: 3.90 vs 3.19, P = .002 and Cohen d = 0.97. In addition, intervention group participants achieved a higher mean efficacy for the secondary outcomes: 3.78 versus 2.97 (P = .0004) and Cohen d = 1.11 for health beliefs, and 3.68 versus 2.83 (P = .0001) and Cohen d = 1.24 for acceptance of health status. Linear regression analysis indicated that the social interaction intervention (ß= .799; P = .000) and undergoing urgent versus routine ostomy surgery (ß=-.610; P = .005) were related to coping. CONCLUSIONS: Findings indicate that a visit with a trained person living with an ostomy facilitated coping and improved health beliefs and acceptance of health status.
Assuntos
Estomia , Interação Social , Adaptação Psicológica , Nível de Saúde , Humanos , Período Pós-OperatórioRESUMO
In order to achieve significant improvements in quality, cost, and accessibility (the health "iron triangle"), innovation in organizational and service delivery models is necessary to increase the value of healthcare. The aim of this study is to evaluate the efficiency of a model of organizational innovation based on advanced practice nurse in the care of people with ostomies (APN-O) versus usual care. An observational, exploratory, analytical, prospective study with a six-month follow-up was carried out at 12 hospitals that implemented this model in Andalusia. A total of 75 patients who had undergone a digestive elimination ostomy and/or a urinary ostomy were followed for six months. Clinical outcomes, healthcare resources, health-related quality of life, and willingness to pay (WTP) were analyzed. The economic evaluation was conducted from a societal perspective, including healthcare costs and indirect costs. The cost difference between the two models was 136.99 and the quality-adjusted life year (QALY) gained was 0.05965 (2297 per QALY gained). At six months, the mean of WTP was 69 per APN-O consultation. This model contributes to increasing the value-based healthcare in ostomies. Results of this study suggested that APN-O is an effective patient management model for improving their health status and is highly efficient.
Assuntos
Estomia , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Adulto , Idoso , Idoso de 80 Anos ou mais , Análise Custo-Benefício , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estomia/economia , Estomia/normas , Assistência ao Paciente/normas , Estudos ProspectivosRESUMO
The aim of this study was to analyze the efficacy of drugs used in relapsing-remitting multiple sclerosis, first- and second-line drugs, using the number needed to treat (NNT) as a measure of efficacy. METHODS: Data from randomized clinical trials were analyzed for 3 categories of clinical efficacy outcomes: relapse, change in Expanded Disability Status Scale, and number of new lesions in magnetic resonance imaging. Meta-analysis results are expressed as odds ratios. RESULTS: The global odds ratio was 0.41 (95% confidence interval [CI], 0.34-0.49). For analyzed clinical outcomes, the odds ratio was less for second-line drugs (odds ratio, 2.0). For all studied clinical conditions, in the control group, 47 of 100 patients do not get benefits, compared with 25 (95% CI, 18-32 patients) of 100 for the active treatment group. The NNT was 5 patients (95% CI, 4-7 patients). For the proportion of patients free of relapses, in the control group, 56 of 100 patients had a relapse at 2 years, compared with 37 of 100 patients in the treatment group, with an NNT of 6 patients (95% CI, 5-8 patients). CONCLUSIONS: Active treatments produced statistically significant improvements compared with placebo.
Assuntos
Imunossupressores/uso terapêutico , Esclerose Múltipla/tratamento farmacológico , Avaliação da Deficiência , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , RecidivaRESUMO
No disponible
Assuntos
Humanos , Metotrexato/farmacocinética , Artrite Reumatoide/tratamento farmacológico , Análise Custo-Benefício , Antirreumáticos/farmacocinéticaRESUMO
Objetivo: Comparar dos fármacos para la artritis reumatoide (AR): leflunomida y metotrexato subcutáneo (sc) (jeringas precargadas), considerando tanto costes anuales de tratamiento como la efectividad medida a través del número de pacientes que es necesario tratar (NNT). Métodos: Los datos de eficacia y dosis fueron extraídos del ensayo clínico US310, ensayo aleatorizado y a doble ciego, que tuvo por objetivo comparar la eficacia y la seguridad del tratamiento a 12 meses con leflunomida (20mg/día) frente a placebo y metotrexato (7,515mg/semana) en 482 pacientes con AR activa. La información sobre los actos médicos para los seguimientos de control se obtuvo de la ficha técnica del producto. El estudio de costes se ha realizado con la perspectiva del Sistema Nacional de Salud español. Resultados: Considerando el criterio de ACR20, el NNT de leflunomida es 4 (intervalo de confianza [IC] del 95%, 2,567,71) y el de metotrexato sc, 5 (IC del 95%, 3,0314,3); para el criterio de ACR50, el NNT de leflunomida es 4 (IC del 95%, 2,726,54) y el de metotrexato sc, 7 (IC del 95%, 4,0319,3). El coste anual del fármaco fue 1.112,52 euros para la leflunomida y 1.438,91 euros para metotrexato sc. Los costes anuales de monitorización fueron 680,76 euros para la leflunomida y 710,26 euros para el metotrexato sc. Conclusiones: Combinando la información, el coste de un paciente respondedor según ACR20 sería de 7.173 euros con leflunomida y 10.746 euros con metotrexato sc; los resultados considerando ACR50 oscilarían entre los 7.173 euros para leflunomida y 15.044 euros para metotrexato sc (AU)
Objective: To compare, in the Spanish setting, two drugs for adults with rheumatoid artritis (RA): leflunomide and subcutaneous methotrexate (SC). The high price of methotrexate SC compared with traditional presentations of methotrexate justifies conducting an economic evaluation comparing it with leflunomide. Methods: The analysis considered the annual costs of the drugs and their effectiveness, measured with a Number Needed to Treat (NNT) approach, considering both the ACR20 and ACR50 criteria for effectiveness. Data about efficacy and dosage were derived from the clinical trial US310, a randomized, doble-blinded controlled trial, which compared efficacy and safety of leflunomide (20mg/daily) vs placebo vs methotrexate (7.515mg/weekly) in 482 patients with active RA. Data about use of medical resources for drug monitoring (visits to rheumatologists and diagnostic procedures) were derived from the manufacturers summary of product characteristics. Direct costs (drugs and monitoring) were obtained from two Spanish databases. The analysis has been performed under the Spanish National Health System perspective. Results: Using the ACR20 criteria, the NNT with leflunomide and methotrexate are 4 (95% CI, 2.567.71) and 5 (95% CI, 3.0314.3) respectively. Using the ACR50 criteria, NNT are 4 (95% CI, 2.726.54) and 7 (95% CI, 4.0319.3). In the case of leflunomide, annual treatment costs per patient-year equals 1,793.30; in the case of methotrexate total treatment costs amounts to 2,149.20. Conclusions: Combining these results the cost of a controlled patient according to ACR20 would amount 7,173 for leflunomide and 10,746 for methotrexate SC. Results considering ACR50 are 7,173 and 15,044 for leflunomide and methotrexate respectively (AU)
Assuntos
Humanos , Metotrexato/farmacocinética , Artrite Reumatoide/tratamento farmacológico , Antirreumáticos/farmacocinética , Análise Custo-Eficiência , Farmacoeconomia , Imunossupressores/farmacocinéticaRESUMO
OBJECTIVE: To compare, in the Spanish setting, two drugs for adults with rheumatoid artritis (RA): leflunomide and subcutaneous methotrexate (SC). The high price of methotrexate SC compared with traditional presentations of methotrexate justifies conducting an economic evaluation comparing it with leflunomide. METHODS: The analysis considered the annual costs of the drugs and their effectiveness, measured with a Number Needed to Treat (NNT) approach, considering both the ACR20 and ACR50 criteria for effectiveness. Data about efficacy and dosage were derived from the clinical trial US310, a randomized, doble-blinded controlled trial, which compared efficacy and safety of leflunomide (20mg/daily) vs placebo vs methotrexate (7.5-15mg/weekly) in 482 patients with active RA. Data about use of medical resources for drug monitoring (visits to rheumatologists and diagnostic procedures) were derived from the manufacturers' summary of product characteristics. Direct costs (drugs and monitoring) were obtained from two Spanish databases. The analysis has been performed under the Spanish National Health System perspective. RESULTS: Using the ACR20 criteria, the NNT with leflunomide and methotrexate are 4 (95% CI, 2.56-7.71) and 5 (95% CI, 3.03-14.3) respectively. Using the ACR50 criteria, NNT are 4 (95% CI, 2.72-6.54) and 7 (95% CI, 4.03-19.3). In the case of leflunomide, annual treatment costs per patient-year equals 1,793.30; in the case of methotrexate total treatment costs amounts to 2,149.20. CONCLUSIONS: Combining these results the cost of a controlled patient according to ACR20 would amount 7,173 for leflunomide and 10,746 for methotrexate SC. Results considering ACR50 are 7,173 and 15,044 for leflunomide and methotrexate respectively.
