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1.
Lancet ; 403(10445): 2709-2719, 2024 Jun 22.
Artículo en Inglés | MEDLINE | ID: mdl-38843860

RESUMEN

BACKGROUND: Tenosynovial giant cell tumour (TGCT) is a locally aggressive neoplasm for which few systemic treatment options exist. This study evaluated the efficacy and safety of vimseltinib, an oral, switch-control, CSF1R inhibitor, in patients with symptomatic TGCT not amenable to surgery. METHODS: MOTION is a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial done in 35 specialised hospitals in 13 countries. Eligible patients were adults (aged ≥18 years) with a histologically confirmed diagnosis of TGCT for which surgical resection could potentially worsen functional limitation or cause severe morbidity. Patients were randomly assigned (2:1) with interactive response technology to vimseltinib (30 mg orally twice weekly) or placebo, administrated in 28-day cycles for 24 weeks. Patients and site personnel were masked to treatment assignment until week 25, unless progressive disease was confirmed earlier. The primary endpoint was objective response rate by independent radiological review using Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST) at week 25 in the intention-to-treat population. Safety was assessed in all patients who received the study drug. The trial is registered with ClinicalTrials.gov, NCT05059262, and enrolment is complete. FINDINGS: Between Jan 21, 2022, and Feb 21, 2023, 123 patients were randomly assigned (83 to vimseltinib and 40 to placebo). 73 (59%) patients were female and 50 (41%) were male. Nine (11%) of 83 patients assigned to vimseltinib and five (13%) of 40 patients assigned to placebo discontinued treatment before week 25; one patient in the placebo group did not receive any study drug. Objective response rate per RECIST was 40% (33 of 83 patients) in the vimseltinib group vs 0% (none of 40) in the placebo group (difference 40% [95% CI 29-51]; p<0·0001). Most treatment-emergent adverse events (TEAEs) were grade 1 or 2; the only grade 3 or 4 TEAE that occurred in more than 5% of patients receiving vimseltinib was increased blood creatine phosphokinase (eight [10%] of 83). One patient in the vimseltinib group had a treatment-related serious TEAE of subcutaneous abscess. No evidence of cholestatic hepatotoxicity or drug-induced liver injury was noted. INTERPRETATION: Vimseltinib produced a significant objective response rate and clinically meaningful functional and symptomatic improvement in patients with TGCT, providing an effective treatment option for these patients. FUNDING: Deciphera Pharmaceuticals.


Asunto(s)
Tumor de Células Gigantes de las Vainas Tendinosas , Humanos , Método Doble Ciego , Masculino , Femenino , Persona de Mediana Edad , Adulto , Tumor de Células Gigantes de las Vainas Tendinosas/tratamiento farmacológico , Anciano , Antineoplásicos/uso terapéutico , Antineoplásicos/efectos adversos , Resultado del Tratamiento , Anilidas , Quinolinas
2.
Future Oncol ; 15(36): 4197-4206, 2019 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-31707856

RESUMEN

Aim: To assess real-world occurrence of common clinical trial-reported adverse events (AE) among patients with recurrent ovarian cancer initiating niraparib 200 mg/day. Materials & methods: This retrospective observational study used physician-extracted anonymized medical record data of eligible patients initiating niraparib 200 mg/day after platinum-based chemotherapy. Results: Of 153 patients, 57 (37%) experienced ≥1 of the three most common all-grade AEs within 3 months after niraparib initiation: nausea (16%; grade 3/4: 2%), thrombocytopenia (14%; grade 3/4: 3%) and fatigue (24%; grade 3/4: 3%). In the ENGOT-OV16/NOVA trial, these respective AEs occurred in 74, 61 and 59% of patients. Conclusion: Incidence of common clinical trial-reported AEs was lower among patients initiating niraparib 200 mg/day in real-world practice versus patients initiating niraparib 300 mg/day in ENGOT-OV16/NOVA.


Asunto(s)
Antineoplásicos/uso terapéutico , Indazoles/uso terapéutico , Neoplasias Ováricas/tratamiento farmacológico , Piperidinas/uso terapéutico , Inhibidores de Poli(ADP-Ribosa) Polimerasas/uso terapéutico , Adulto , Anciano , Antineoplásicos/administración & dosificación , Antineoplásicos/efectos adversos , Femenino , Humanos , Indazoles/administración & dosificación , Indazoles/efectos adversos , Quimioterapia de Mantención , Persona de Mediana Edad , Estadificación de Neoplasias , Neoplasias Ováricas/diagnóstico , Piperidinas/administración & dosificación , Piperidinas/efectos adversos , Inhibidores de Poli(ADP-Ribosa) Polimerasas/administración & dosificación , Inhibidores de Poli(ADP-Ribosa) Polimerasas/efectos adversos , Estudios Retrospectivos , Resultado del Tratamiento
3.
Drugs Real World Outcomes ; 11(2): 195-207, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38265633

RESUMEN

BACKGROUND AND OBJECTIVE: The tyrosine kinase inhibitors cabozantinib and axitinib have been widely used in England to treat advanced renal cell carcinoma following prior vascular endothelial growth factor-targeted therapy, but data on real-world usage remain limited. Our objective was to describe the real-world treatment patterns and outcomes of patients with advanced renal cell carcinoma who received second-line or later-line (≥ 2L) cabozantinib or axitinib after vascular endothelial growth factor-targeted therapy in clinical practice in England. METHODS: This retrospective cohort study used clinical practice data (collected 2011-20) from the English Cancer Analysis System database. Patient characteristics, treatment sequence and duration, and overall survival (time from initiation of cabozantinib/axitinib treatment to death) were evaluated. RESULTS: Data from 1485 eligible adults with advanced renal cell carcinoma were analyzed: 440 received ≥  2L cabozantinib (2L for 88.6% of them); 1045 received ≥  2L axitinib (2L for 89.5%). The most common first-line treatments were sunitinib (2L cabozantinib subcohort, 48%; 2L axitinib subcohort, 46%) and pazopanib (46% and 54%, respectively); nivolumab was the most common third-line treatment (18% and 19%, respectively). Median (interquartile range) 2L therapy duration was 5.52 (2.73-11.74) months for cabozantinib and 4.60 (1.45-12.36) months for axitinib. Following adjustment for potential confounders using inverse probability weighting, overall survival (median [interquartile range]) was longer for ≥ 2L cabozantinib (11.2 [5.7-28.0] months) than for ≥  2L axitinib (10.4 [4.7-22.0] months; log-rank p = 0.0034). CONCLUSIONS: The Cancer Analysis System database is a valuable research resource providing extensive real-world clinical data. Real-world overall survival was longer with ≥  2L cabozantinib than with axitinib. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT04637204; registered November 2020.


Cabozantinib and axitinib are anticancer drugs called tyrosine kinase inhibitors. They work by blocking the activity of proteins that cancer cells use to help them divide and grow. Cabozantinib and axitinib are treatment options for a common type of kidney cancer called renal cell carcinoma (RCC). There is evidence about how well cabozantinib and axitinib work in clinical trials, but it is less clear how well they work in standard practice outside of clinical trials. We investigated how cabozantinib and axitinib are used and how well they work as part of 'real-world' RCC care. We did this by analyzing patient data from an English cancer database. All patients in the study had advanced RCC and had been treated with at least one previous anticancer drug. This includes a type of drug that blocks new blood vessels forming, which tumors need for rapid growth. Most of the 1485 patients received cabozantinib or axitinib after receiving only one previous anticancer drug. These patients were treated for a median of 5.5 months with cabozantinib and 4.6 months with axitinib. Patients lived for a median of 11.2 months after starting cabozantinib treatment and a median of 10.4 months after starting axitinib treatment. This study provides new evidence showing how well cabozantinib and axitinib work in everyday RCC care. The results add to those from clinical trials and show the value of the English cancer registry for conducting studies of routine cancer care.

4.
Eur J Cancer ; 192: 113245, 2023 10.
Artículo en Inglés | MEDLINE | ID: mdl-37598656

RESUMEN

PURPOSE: In the INTRIGUE trial, ripretinib showed no significant difference versus sunitinib in progression-free survival for patients with advanced gastrointestinal stromal tumour (GIST) previously treated with imatinib. We compared the impact of these treatments on health-related quality of life (HRQoL). PATIENTS AND METHODS: Patients were randomised 1:1 to once-daily ripretinib 150 mg or once-daily sunitinib 50 mg (4 weeks on/2 weeks off). Patient-reported outcomes were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer-30 (EORTC QLQ-C30) questionnaire at day (D)1, and D29 of all cycles until treatment discontinuation. Change from baseline was calculated. Time without symptoms or toxicity (TWiST) was estimated as the mean number of days without progression, death, or grade ≥3 treatment-emergent adverse events per patient over 1 year of follow-up. RESULTS: Questionnaire completion at baseline was 88.1% (199/226) for ripretinib and 87.7% (199/227) for sunitinib and remained high for enrolled patients throughout treatment. Patients receiving sunitinib demonstrated within-cycle variation in self-reported HRQoL, corresponding to the on/off dosing regimen. Patients receiving ripretinib reported better HRQoL at D29 assessments than patients receiving sunitinib on all scales except constipation. HRQoL was similar between treatments at D1 assessments, following 2 weeks without treatment for sunitinib patients. TWiST was greater for ripretinib patients (173 versus 126 days). CONCLUSION: Patients receiving ripretinib experienced better HRQoL than patients receiving sunitinib during the dosing period and similar HRQoL to patients who had not received sunitinib for 2 weeks for all QLQ-C30 domains except constipation. Ripretinib may provide clinically meaningful benefit to patients with advanced GIST previously treated with imatinib.


Asunto(s)
Tumores del Estroma Gastrointestinal , Humanos , Sunitinib/efectos adversos , Tumores del Estroma Gastrointestinal/tratamiento farmacológico , Mesilato de Imatinib/efectos adversos , Calidad de Vida , Medición de Resultados Informados por el Paciente , Estreñimiento/inducido químicamente
5.
Adv Ther ; 39(4): 1754-1771, 2022 04.
Artículo en Inglés | MEDLINE | ID: mdl-35190997

RESUMEN

INTRODUCTION: Long-acting somatostatin analogues such as lanreotide autogel (LAN) and octreotide long-acting release (OCT) are recommended as first-line treatment for patients with neuroendocrine tumors (NETs). However, only few real-world studies have compared the two medications. This retrospective, observational cohort study used a French claims database to compare patterns of use with LAN vs. OCT in patients with NETs. METHODS: Data on LAN and OCT patterns of use were obtained retrospectively from the National System of Health Data (SNDS), a national French claims database. Patients 18 years of age or older who initiated treatment for NETs between 2009 and 2016, and who received at least six subsequent dispensings of first-line LAN or OCT during the first year of treatment, were included. A subgroup analysis was performed on patients with gastroenteropancreatic (GEP)-NETs. RESULTS: Patients receiving LAN (n = 2327) vs. OCT (n = 2090) had greater median treatment duration (31.8 months vs. 22.1 months, respectively; p < 0.0001; log-rank test) and were less likely to discontinue treatment; adjusted hazard ratio (HR) 0.74 (95% confidence interval [CI] 0.69-0.80). In year 1, a significantly lower percentage of patients receiving LAN vs. OCT switched treatments (10.4% vs. 22.2%, respectively; p < 0.0001), received an average monthly dose per trimester above recommended dose (3.0% vs. 7.3%, respectively; p < 0.0001), and used rescue medication (3.1% vs. 10.0%, respectively; p < 0.0001). Dispensing of pancreatic enzymes was significantly higher in patients receiving LAN than OCT (16.4% vs. 13.9%, respectively). In the subgroup of patients with GEP-NETs, those receiving LAN (n = 1478) vs. OCT (n = 1278) had greater treatment duration and less treatment discontinuation, switching, dosage above the recommended dose, and rescue medication use, but no significant difference in dispensing of pancreatic enzymes or time to second-line treatment. CONCLUSION: These real-world data suggest potential clinical and economic advantages of LAN over OCT in the management of patients with NETs in the French population.


Asunto(s)
Tumores Neuroendocrinos , Neoplasias Pancreáticas , Adolescente , Adulto , Estudios de Cohortes , Humanos , Neoplasias Intestinales , Tumores Neuroendocrinos/tratamiento farmacológico , Neoplasias Pancreáticas/tratamiento farmacológico , Neoplasias Pancreáticas/patología , Péptidos Cíclicos , Estudios Retrospectivos , Somatostatina , Neoplasias Gástricas
6.
Value Health ; 14(4): 555-63, 2011 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-21669380

RESUMEN

OBJECTIVES: The purpose of our study was to use health-related quality of life data from the Women's Health Initiative to calculate health-related utility weights and examine differences in these health utility weights across different hemoglobin (Hgb) levels. These utility weights could then be used in future cost-effectiveness studies. METHODS: Health utility weights were measured by the Short Form-6D (SF-6D), a health utility index derived from the Short Form Medical Outcomes questionnaire. Adjusted least square means were calculated for each level of Hgb at baseline and in longitudinal regression analysis the relationship between change in Hgb and change in the SF-6D was examined. Both baseline and longitudinal analyses were performed for all postmenopausal women and separately for those with self-reported heart failure, cancer, and osteoarthritis. RESULTS: Women with Hgb in the anemic range had lower health utility weights than those with higher Hgb levels. Longitudinally, a loss of of 2 g/dl Hgb or more was associated with a statistically significant and clinically meaningfully decline in SF-6D in all participants and also in the group of participants with cancer and osteoarthritis, but not in those with heart failure. CONCLUSIONS: Lower levels of Hgb and a loss of Hgb are associated with a statistically significant and clinically meaningful decrement in health utility in all postmenopausal women we studied and also in those with chronic conditions.


Asunto(s)
Indicadores de Salud , Hemoglobinas/metabolismo , Posmenopausia/sangre , Calidad de Vida , Salud de la Mujer , Anciano , Anemia/sangre , Anemia/diagnóstico , Anemia/psicología , Recuento de Células Sanguíneas/métodos , Femenino , Estudios de Seguimiento , Humanos , Estudios Longitudinales , Persona de Mediana Edad , Posmenopausia/psicología , Calidad de Vida/psicología , Encuestas y Cuestionarios
7.
J Comp Eff Res ; 8(8): 577-587, 2019 06.
Artículo en Inglés | MEDLINE | ID: mdl-30935213

RESUMEN

Aim: To estimate financial implications of adopting niraparib as maintenance treatment in recurrent ovarian cancer. Materials & methods: A model was developed to estimate the budget impact of treating patients with niraparib compared with alternative maintenance treatment options (olaparib, rucaparib, bevacizumab or 'watch and wait') over 3 years. Results: For a hypothetical plan with 1 million lives representative of US/Medicare-only populations, projected cost savings with niraparib were US$78,721/$293,723, $276,671/$1,009,729 and $353,585/$1,289,712 at years 1, 2 and 3, respectively. Sensitivity analyses showed prices of niraparib, rucaparib and olaparib to have the most significant impact on the budget. Conclusion: Factoring in all treatment-related costs, the use of niraparib could result in significant cost savings compared with other maintenance treatment options.


Asunto(s)
Antineoplásicos/economía , Presupuestos , Carcinoma Epitelial de Ovario/economía , Indazoles/economía , Neoplasias Ováricas/economía , Piperidinas/economía , Inhibidores de Poli(ADP-Ribosa) Polimerasas/economía , Anciano , Antineoplásicos/uso terapéutico , Carcinoma Epitelial de Ovario/tratamiento farmacológico , Ensayos Clínicos como Asunto , Costos de los Medicamentos , Sustitución de Medicamentos/economía , Femenino , Humanos , Indazoles/uso terapéutico , Indoles/economía , Indoles/uso terapéutico , Medicare/economía , Modelos Económicos , Recurrencia Local de Neoplasia/tratamiento farmacológico , Recurrencia Local de Neoplasia/economía , Neoplasias Ováricas/tratamiento farmacológico , Ftalazinas/economía , Ftalazinas/uso terapéutico , Piperazinas/economía , Piperazinas/uso terapéutico , Piperidinas/uso terapéutico , Compuestos de Platino/economía , Compuestos de Platino/uso terapéutico , Inhibidores de Poli(ADP-Ribosa) Polimerasas/uso terapéutico , Estados Unidos
10.
Ethn Dis ; 16(2): 443-51, 2006.
Artículo en Inglés | MEDLINE | ID: mdl-17682247

RESUMEN

OBJECTIVES: To compare the effectiveness and cost effectiveness of minimal contact nutrition interventions that varied in intensity on lowering total blood cholesterol (BC) levels. DESIGN: A randomized trial in which public, work, religious, and medical sites were randomly assigned to one of six minimal-contact nutrition interventions for lowering total BC. SETTING: 36 public, work, religious, and medical sites in southern New England (total sites = 144). PARTICIPANTS: The number of eligible participants at baseline was 10,144, which included 1425 Hispanics, who were over-recruited for this study. INTERVENTION: One of six brief interventions was provided to participants: 1) feedback tip sheet only; 2) tip sheet plus Rate Your Plate (RYP); 3) tip sheet, RYP, plus Let's Eat Kit (LEK); 4) all written materials plus CD audio intervention (AUD); 5) all written materials plus counseling from a trained lay person (LAY-C); and 6) all written materials plus counseling by a nutritionist (NUT-C). The educational materials were adapted to be culturally and linguistically appropriate for a Hispanic audience, and the counselors for the Hispanic participants were bilingual. MEASURES: Total blood cholesterol levels were measured using fingerstick methods at baseline, 3 months, and 12 months after the intervention. RESULTS: Blood cholesterol (BC) was significantly reduced from baseline to 12-month follow-up among most experimental groups. Only LAY-C and NUT-C conditions demonstrated significant BC reductions at three months. The BC change in the NUT-C group was statistically different from the feedback only condition at three months only. At three-month followup, BC was reduced 1.6% for the total sample, 2.8% for participants with borderline-high BC levels, and 3.4% for participants with high BC. Generally, the two conditions receiving counseling resulted in the largest percentage changes in BC levels. When examining BC change data by ethnicity, Hispanic participants in the audio condition achieved the largest overall 12-month change (4%). Generally, total costs increased as the intensity of the experimental condition increased. When comparing 3-month and 12-month cost effectiveness, LAY-C and NUT-C were approximately the same, whereas LEK and AUD conditions tended to become more expensive than the other interventions. CONCLUSIONS: Brief nutrition counseling is an effective component of BC reduction programs. Culturally tailoring programs can result in substantial reductions in BC among Hispanic participants. Overall, even the most expensive intervention was fairly inexpensive compared to other, more intensive clinical interventions.


Asunto(s)
Hispánicos o Latinos , Hipercolesterolemia/dietoterapia , Evaluación de Programas y Proyectos de Salud , Colesterol/análisis , Colesterol/sangre , Análisis Costo-Beneficio , Femenino , Humanos , Hipercolesterolemia/etnología , Masculino , Persona de Mediana Edad , New England
11.
J Manag Care Spec Pharm ; 22(12): 1426-1436, 2016 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-27882840

RESUMEN

BACKGROUND: Allergic rhinitis (AR) is a common condition that can be treated with a number of different therapies. Treatments such as intranasal antihistamines (INAs) and intranasal steroids (INSs) are widely used by AR patients. For some allergy sufferers, a combination of therapies, specifically an INA and an INS, is required to address their symptoms. A new treatment, the formulation of azelastine hydrochloride and fluticasone pro-pionate used as a single spray (MP-AzeFlu), has become available for AR patients who need both types of treatment. In this regard, the comparison with the alternative concomitant use of INAs and INSs is of interest. The current study examines the health care resource utilization and costs for each cohort. OBJECTIVE: To examine the resource utilization and costs associated with AR for patients treated with MP-AzeFlu or concurrent therapy with single-ingredient INA and INS sprays (free-combination therapy). METHODS: A retrospective administrative claims study for commercially insured patients from a large U.S. health plan was performed. Patients with an AR diagnosis and a prescription claim for MP-AzeFlu or free-combination therapy between September 1, 2012, and September 30, 2013, were identified. Patients were aged at least 12 years at index date (first prescription fill for intranasal therapy) and were required to have 12 months pre-index and 6 months post-index of continuous enrollment. Health care resource utilization and costs were assessed for the post-index period. The cohorts were adjusted on baseline demographic and clinical characteristics using inverse propensity treatment weights. Other covariates, prescriber specialty, product switching during the post-index period, and pre-index total costs were included in the regression models measuring outcomes. One clinical characteristic of interest was the presence of asthma as comorbidity. A subset analysis of AR patients with asthma was also performed. RESULTS: All-cause-related pharmacy fills as well as pharmacy, medical, and total costs were significantly reduced by using MP-AzeFlu (N = 810) instead of the free combination of drugs (N = 726). For AR-related health care resource utilization, the MP-AzeFlu cohort had significantly fewer pharmacy fills than the free-combination cohort (1.01 and 1.17, respectively; P < 0.001) with no significant difference in outpatient services and specialist visits (P = 0.139 and P = 0.117, respectively). Six-month AR-related pharmacy and total costs were significantly lower (P < 0.001 and P = 0.001) for the MP-AzeFlu cohort ($128 and $334, respectively) than the free-combination cohort ($268 and $458, respectively). There was no statistically significant difference in AR-related medical costs between the 2 cohorts (P = 0.454). For the subcohort of AR patients with asthma, the MP-AzeFlu cohort had lower 6-month asthma resource utilization and costs than the free-combination cohort. CONCLUSIONS: These findings suggest that, for AR patients needing INAs and INSs, the single-spray formulation MP-AzeFlu had better economic outcomes than for patients who rely on the free combination of these agents. MP-AzeFlu also appears to keep asthma-related utilization and costs down for those AR patients who also suffer from asthma. Potential explanations for these findings are explored. DISCLOSURES: This study was funded by Meda Pharmaceuticals. Authors were either employed by Meda Pharmaceuticals or received consulting fees from Meda Pharmaceuticals. Comprehensive Health Insights and Sedaghat received funding from Meda Pharmaceuticals as a consultant to participate in this study. Dufour and Caldwell-Tarr are employees of Comprehensive Health Insights. Harrow is currently employed by TESARO. This study was conceived by Harrow, Dufour, and Caldwell-Tarr. All authors contributed to the design of the study. Dufour took the lead in data collection, along with Caldwell-Tarr, and data interpretion was performed by Harrow, along with the other authors. Analyses were performed by Dufour. The manuscript was written and revised by all authors.


Asunto(s)
Gastos en Salud , Antagonistas de los Receptores Histamínicos/economía , Aceptación de la Atención de Salud , Rinitis Alérgica/tratamiento farmacológico , Rinitis Alérgica/economía , Esteroides/economía , Administración Intranasal , Adulto , Estudios de Cohortes , Quimioterapia Combinada , Femenino , Costos de la Atención en Salud , Antagonistas de los Receptores Histamínicos/administración & dosificación , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Rinitis Alérgica/epidemiología , Esteroides/administración & dosificación
12.
World Allergy Organ J ; 8(1): 26, 2015.
Artículo en Inglés | MEDLINE | ID: mdl-26417397

RESUMEN

BACKGROUND: Inhaled asthma medications are the mainstay of treatment for chronic asthma. However, nonadherence rates for long-term inhaler therapy among adults are estimated to exceed 50 %. Nonadherence is associated with unfavorable clinical outcomes and diminished quality of life. Research suggests that adherence is associated with patients' satisfaction with their treatment regimen and other factors, such as concomitant allergic rhinitis and tobacco use. METHODS: This prospective, cross-sectional survey of physicians and their patients evaluated the relationship between patient satisfaction with attributes of inhaler devices, treatment adherence, and clinical outcomes. Primary care and specialist physicians completed a physician-reported patient record form for patients with a confirmed asthma diagnosis. Patients for whom a physician-reported form was completed were invited to complete a patient-reported form. Both surveys collected information about demographics, symptoms, exacerbation history, treatment, smoking status, comorbidities, type of inhaler device, and treatment adherence. Patients also indicated the degree to which they were satisfied with attributes of their currently prescribed inhaler device(s). Partial least squares path modeling quantified relationships between latent variables and clinical outcomes. RESULTS: A total of 243 patients were included in our analysis and 41 % had poorly controlled asthma. More favorable clinical outcomes were significantly associated with greater patient satisfaction with drug delivery (P = 0.002), higher medication adherence (P = 0.049), no history of tobacco use (P < 0.001), and absence of comorbid allergic rhinitis (P = 0.005). Attributes associated with device satisfaction included patient perceptions of consistency in the amount of drug delivery to the lungs, ease of use, and feedback about the number of remaining doses. CONCLUSIONS: Higher patient satisfaction with their asthma drug delivery inhaler device is a significant predictor of more favorable clinical outcomes while allergic rhinitis and smoking history were negatively associated with optimal control of asthma. These findings provide clinicians with opportunities to improve patients' clinical outcomes by tailoring choice of inhaler device therapy and providing education about the correct way to use the device to ensure optimal outcomes. Patients will likely benefit from medical therapy to manage comorbid allergic rhinitis and smoking cessation interventions. Patients unable to stop smoking may require alternative medical therapies to improve their clinical outcomes.

13.
Am Health Drug Benefits ; 8(5): 273-82, 2015.
Artículo en Inglés | MEDLINE | ID: mdl-26380034

RESUMEN

BACKGROUND: Chemotherapy-induced nausea and vomiting (CINV) can lead to increased emergency department visits and hospitalizations, which may contribute to increased cost of care. Antiemetic agents, such as neurokinin-1 (NK1) receptor antagonists and 5-hydroxytryptamine (5-HT3) receptor antagonists, are prescribed for patients receiving highly emetogenic chemotherapy (HEC) and moderately emetogenic chemotherapy (MEC). The current guidelines recommend a 3-drug combination of an NK1 receptor antagonist, a 5-HT3 receptor antagonist, and dexamethasone with HEC regimens and certain MEC regimens. OBJECTIVE: To compare the incidence of CINV and CINV-related resource utilization among patients who receive guideline-adherent HEC and MEC regimens and patients who receive non-guideline-adherent regimens. METHODS: In this retrospective, claims-based study, Inovalon's Medical Outcomes Research for Effectiveness and Economics Registry (MORE2 Registry) Research Edition database was used to identify 8089 patients with solid tumors receiving therapy with anthracycline plus cyclophosphamide (AC), cisplatin, or carboplatin from June 2013 to December 2013. The patients were stratified according to the use of an NK1 receptor antagonist regimen. International Classification of Diseases, Ninth Revision, Clinical Modification codes were used to identify CINV events associated with hospital, emergency department, and outpatient office visits among patients in the NK1 receptor antagonist group and the non-NK1 receptor antagonist group. RESULTS: A total of 1059 patients were included in the analysis, of whom 51% (N = 536) used an NK1 receptor antagonist-based regimen and 49% (N = 523) used non-NK1 receptor antagonist therapy. A higher percentage of patients receiving AC (73%) than cisplatin (56%) or carboplatin (23%) received an NK1 receptor antagonist. The incidence rates of total CINV events and CINV-related emergency department visits were lower in the group receiving an NK1 receptor antagonist (44% and 9%, respectively) than in the group receiving a non-NK1 receptor antagonist (50% and 15%, respectively). CONCLUSION: The patients receiving an NK1 receptor antagonists had a lower rate of resource utilization, suggesting that the use of NK1 receptor antagonist-containing regimens according to current national guidelines may reduce healthcare resource utilization, such as CINV-related office, hospital, and emergency department visits for patients receiving highly and moderately emetogenic chemotherapy.

14.
Am J Alzheimers Dis Other Demen ; 19(5): 299-308, 2004.
Artículo en Inglés | MEDLINE | ID: mdl-15553986

RESUMEN

This study used a geographically diverse sample to estimate the total cost of informal care and formal services for community-residing Alzheimer's disease (AD) care recipients. Baseline data were used for 1200 family caregivers from the Resources for Enhancing Alzheimer's Caregiver Health (REACH) study, a multisite intervention trial. The replacement-wage-rate approach estimated informal cost. Formal services were assigned a cost based on secondary sources. Annual cost per care recipient amounted to 23,436 dollars for informal care and 8064 dollars for formal services. Variation in informal cost was almost entirely due to instrumental activities of daily living (IADLs) assistance. Cross-site differences in cost persisted after controlling for caregiver and care-recipient characteristics. Geographic variation may suggest regional preferences or ethnic/cultural values. Further study is needed to determine whether this reflects differences in access or availability or how including a control group for care recipients with nondementia diagnoses might have affected these findings.


Asunto(s)
Enfermedad de Alzheimer/economía , Cuidadores/economía , Servicios de Atención de Salud a Domicilio/economía , Actividades Cotidianas , Anciano , Enfermedad de Alzheimer/terapia , Costos y Análisis de Costo , Femenino , Humanos , Masculino , Persona de Mediana Edad , Análisis Multivariante , Características de la Residencia , Estados Unidos
15.
Prof Case Manag ; 15(3): 124-34; quiz 135-6, 2010.
Artículo en Inglés | MEDLINE | ID: mdl-20467273

RESUMEN

PURPOSE OF THE STUDY: The purpose of this study was to examine correlates of case managers' satisfaction with their work, services, and service network and to identify connections to service performance and service costs. PRIMARY PRACTICE SETTING: A decentralized public health program that exemplifies the trend toward more diverse clients and networked services. METHODOLOGY AND SAMPLE: A mixed method design with 34 case managers. RESULTS: As hypothesized, the case managers' experiences with clients and the service network, and their service effectiveness, were associated with their satisfaction with their jobs and the services they provide. Satisfaction was also positively associated with more timely service delivery. These associations were explained in part by case managers' education and training. IMPLICATIONS FOR CASE MANAGEMENT PRACTICE: Case managers can achieve high levels of job and service satisfaction in outreach programs serving a diverse client population in a decentralized service network. Case managers' job and service satisfaction improves with reduced service problems and service delays and when case managers can devise work-arounds for persistent service problems. Using advanced practice nurses (APN) and providing more on-the-job training may increase case manager satisfaction with their jobs and the services they provide. Special efforts may be needed to prevent a decline in job satisfaction with years of experience.


Asunto(s)
Manejo de Caso , Satisfacción en el Trabajo , Salud Pública , Humanos , Pautas de la Práctica en Medicina/organización & administración , Encuestas y Cuestionarios
16.
Am J Drug Alcohol Abuse ; 32(3): 379-98, 2006.
Artículo en Inglés | MEDLINE | ID: mdl-16864469

RESUMEN

This study compares the 12-month changes in substance use following admission to substance abuse treatment in Massachusetts between adolescents enrolled in Medicaid managed care and other publicly funded adolescents. Two hundred and fifty-five adolescents were interviewed as they entered substance abuse treatment and at 6 and 12 month follow-ups. Medicaid enrollment data were used to determine the managed care enrollment status. One hundred forty two (56%) adolescents were in the managed care group and 113 (44%) comprise the comparison group. Substance use outcomes include a count of negative consequences of substance use, days of alcohol use, days of cannabis use, and days of any substance use in the previous 30 days. Repeated measures analysis of covariance (ANCOVA) was used to assess change with time of measurement and managed care status as main effects and the interaction of time and managed care included to measure differences between the groups over time. Although several changes across time were detected for all four outcomes, we found no evidence of an impact of managed care for any of the outcomes. The results of our study do not support the fears that behavioral managed care, by imposing limits on services provided, would substantially reduce the effectiveness of substance abuse treatment for adolescents. At the same time, the results do not support those who believe that the continuity of care and improved resource utilization claimed for managed care would improve outcomes.


Asunto(s)
Servicios de Salud del Adolescente/economía , Programas Controlados de Atención en Salud/economía , Servicios de Salud Mental/economía , Salud Pública/economía , Trastornos Relacionados con Sustancias/economía , Trastornos Relacionados con Sustancias/terapia , Adolescente , Niño , Femenino , Estudios de Seguimiento , Humanos , Masculino , Resultado del Tratamiento
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