RESUMEN
Serogroup B (MenB) is the leading cause of meningococcal disease among 16- to 23-year-olds in the United States and has been responsible for all 10 college outbreaks between 2011 and 2017. Outbreak-associated costs levy a substantial and unforeseen burden on colleges/universities and surrounding communities, in part because they involve collaboration with local and state health departments to develop points-of-dispensing (PODs) outbreak response plans and rapid mass vaccination of a large at-risk student population. The MenB outbreak at Providence College in 2015 was used as a case study to develop an Excel-based Meningococcal Outbreak Cost Calculator that uses target populations for mass vaccination to estimate the costs and resources associated with a meningococcal disease outbreak response. Resources include labor, medical supply, and other nonlabor costs (eg, vaccine-related adverse event costs) over an 18-month period following the outbreak declaration. Based on the actual Providence College population partially or fully vaccinated with MenB-FHbp (Trumenba®, Bivalent rLP2086) (3-dose schedule), the calculator estimated aggregate direct costs of $1,350,963 over 18 months post-outbreak for 4,418 individuals. For planned full vaccination of the enrolled undergraduate population (4,795 individuals), the tool estimated total costs of $1,798,399. In both cases, the majority of costs were for medical supplies (88%-89%) and contract services (7%-9%). This calculator can help to plan a mass vaccination campaign for MenB outbreak control, and underscores the need to vaccinate pre-emptively against diverse disease-causing strains before an outbreak occurs.
Asunto(s)
Brotes de Enfermedades/economía , Vacunación Masiva/economía , Infecciones Meningocócicas/prevención & control , Vacunas Meningococicas/economía , Universidades/estadística & datos numéricos , Adolescente , Brotes de Enfermedades/prevención & control , Humanos , Meningitis Meningocócica/prevención & control , Vacunas Meningococicas/administración & dosificación , Neisseria meningitidis Serogrupo B/inmunología , Serogrupo , Estudiantes/estadística & datos numéricos , Estados Unidos , Adulto JovenRESUMEN
PURPOSE: To create and validate a statistical model predicting progression of primary open-angle glaucoma (POAG) assessed by loss of visual field as measured in mean deviation (MD) using 3 landmark studies of glaucoma progression and treatment. DESIGN: A Markov decision analytic model using patient level data described longitudinal MD changes over 7 years. PARTICIPANTS: Patient-level data from the Collaborative Initial Glaucoma Treatment Study (n = 607), the Ocular Hypertension Treatment Study (OHTS; n = 148; only those who developed POAG in the first 5 years of OHTS) and Advanced Glaucoma Intervention Study (n = 591), the COA model. METHODS: We developed a Markov model with transition matrices stratified by current MD, age, race, and intraocular pressure categories and used a microsimulation approach to estimate change in MD over 7 years. Internal validation compared model prediction for 7 years to actual MD for COA participants. External validation used a cohort of glaucoma patients drawn from university clinical practices. MAIN OUTCOME MEASURES: Change in visual field as measured in MD in decibels (dB). RESULTS: Regressing the actual MD against the predicted produced an R(2) of 0.68 for the right eye and 0.63 for the left. The model predicted ending MD for right eyes of 65% of participants and for 63% of left eyes within 3 dB of actual results at 7 years. In external validation the model had an R(2) of 0.79 in the right eye and 0.77 in the left at 5 years. CONCLUSIONS: The COA model is a validated tool for clinicians, patients, and health policy makers seeking to understand longitudinal changes in MD in people with glaucoma.
Asunto(s)
Técnicas de Apoyo para la Decisión , Glaucoma de Ángulo Abierto/fisiopatología , Modelos Estadísticos , Anciano , Ensayos Clínicos como Asunto , Progresión de la Enfermedad , Femenino , Glaucoma de Ángulo Abierto/diagnóstico , Humanos , Presión Intraocular/fisiología , Masculino , Cadenas de Markov , Persona de Mediana Edad , Hipertensión Ocular/diagnóstico , Hipertensión Ocular/fisiopatología , Trastornos de la Visión/fisiopatología , Agudeza Visual/fisiología , Campos Visuales/fisiologíaRESUMEN
BACKGROUND: Because latanoprost and the original formulation of travoprost that included benzalkonium chloride (BAK) have been shown to be similar with regard to tolerability, we compared initial topical intraocular pressure (IOP)-lowering medication change rates in patients newly treated with latanoprost or travoprost-Z monotherapy. METHODS: At 14 clinical practice sites, medical records were abstracted for patients with a diagnosis of open-angle glaucoma or ocular hypertension and who were ≥40 years of age, had a baseline and at least one follow-up visit, and had no prior history of ocular prostaglandin use. Data regarding demographics, ocular/systemic medical histories, clinical variables, therapy initiations and reasons for changes, adverse events, and resource utilization were recorded from randomly chosen eligible charts. Primary outcomes were rates of and reasons for changing from the initial therapy within six months and across the full study period (1000 days). RESULTS: Data from 900 medical charts (latanoprost, 632; travoprost-Z, 268) were included. For both cohorts, average follow-up was >1 year. Cohorts were similar with regard to age (median ~67 years), gender distribution (>50% female), and diagnosis (~80% with open-angle glaucoma). Within six months, rates of index therapy change for latanoprost versus travoprost-Z were 21.2% (134/632) and 28.7% (77/268), respectively (p = 0.0148); across the full study period, rates were 34.5% (218/632) and 45.2% (121/268), respectively (p = 0.0026). Among those who changed their index therapy, insufficient IOP control was the most commonly reported reason followed by adverse events; hyperemia was the most commonly reported adverse event at index therapy change. CONCLUSIONS: In this "real world" study of changes in therapy in patients prescribed initial monotherapy with latanoprost with BAK or travoprost-Z with SofZia, medication changes were common in both treatment groups but statistically significantly more frequent with travoprost-Z.
Asunto(s)
Antihipertensivos/uso terapéutico , Cloprostenol/análogos & derivados , Glaucoma de Ángulo Abierto/tratamiento farmacológico , Hipertensión Ocular/tratamiento farmacológico , Prostaglandinas F Sintéticas/uso terapéutico , Adulto , Anciano , Anciano de 80 o más Años , Antihipertensivos/efectos adversos , Cloprostenol/efectos adversos , Cloprostenol/uso terapéutico , Estudios de Cohortes , Femenino , Glaucoma de Ángulo Abierto/fisiopatología , Humanos , Hiperemia/inducido químicamente , Presión Intraocular/efectos de los fármacos , Latanoprost , Masculino , Persona de Mediana Edad , Hipertensión Ocular/fisiopatología , Prostaglandinas F Sintéticas/efectos adversos , Retratamiento , Estudios Retrospectivos , TravoprostRESUMEN
BACKGROUND: To investigate the clinical relevance of two different preservative formulations, we compared 1-year incidence rates of additional coding of dry eye, ocular infection, or ocular surface disease (either dry eye or ocular infection) in open-angle glaucoma and ocular hypertension patients newly treated with latanoprost with benzalkonium chloride (BAK) or with travoprost-Z with SofZia®. METHODS: This was a retrospective study of three U.S.-based patient-centric medical/pharmacy claims databases (MedStat, PharMetrics, i3-Ingenix). Patients were eligible if they filled a prescription for latanoprost or travoprost-Z between October 2006 and Q2 2008 (prescription date = index date) AND were continuously enrolled 6 months prior through 12 months after the index date AND had any open-angle glaucoma or ocular hypertension diagnosis within 90 days prior to the index date AND did not have an ocular surface disease diagnosis during the 180 days prior to the index date AND if they had not had a prescription for the index agent in the 180 days prior to the index date. Time to incidence of new coding for ocular surface disease in the first year post-index was estimated with a composite endpoint: diagnosis of dry eye or ocular infection by ICD-9-CM or Current Procedural Terminology code OR by prescription for cyclosporine ophthalmic emulsion or ocular antibiotics. RESULTS: In all, 15,933 patients were treated with latanoprost and 7670 with travoprost-Z. Over 1 year, 4.3% of latanoprost and 4.5% of travoprost-Z patients were identified with dry eye (p = 0.28), and 10.9% and 11.1%, respectively, were identified with an ocular infection (p = 0.79). The 1-year incidence of new coding for ocular surface disease also was similar across treatments (13.9% vs 14.3%, respectively; p = 0.48). CONCLUSIONS: The retrospective analysis of three large prescription databases revealed that open-angle glaucoma and ocular hypertension patients newly treated with latanoprost preserved with BAK or travoprost-Z preserved with SofZia did not differ statistically in rates of dry eye, ocular infection, or ocular surface disease (either dry eye or ocular infection) during the first year post-index. Claims-based analyses are limited by nonrandomization and the inability to account for over-the-counter use or samples.
Asunto(s)
Current Procedural Terminology , Síndromes de Ojo Seco/inducido químicamente , Infecciones del Ojo/inducido químicamente , Glaucoma de Ángulo Abierto/tratamiento farmacológico , Clasificación Internacional de Enfermedades , Hipertensión Ocular/tratamiento farmacológico , Prostaglandinas Sintéticas/efectos adversos , Prostaglandinas Sintéticas/uso terapéutico , Anciano , Anciano de 80 o más Años , Antihipertensivos/efectos adversos , Antihipertensivos/uso terapéutico , Compuestos de Benzalconio , Cloprostenol/efectos adversos , Cloprostenol/análogos & derivados , Cloprostenol/uso terapéutico , Bases de Datos Factuales , Femenino , Humanos , Estimación de Kaplan-Meier , Latanoprost , Masculino , Medicina , Persona de Mediana Edad , Soluciones Oftálmicas , Farmacia , Prescripciones , Conservadores Farmacéuticos , Prostaglandinas F Sintéticas/efectos adversos , Prostaglandinas F Sintéticas/uso terapéutico , Estudios Retrospectivos , TravoprostRESUMEN
BACKGROUND: Although in vitro and in vivo laboratory studies have suggested that benzalkonium chloride (BAK) in topical ophthalmic solutions may be detrimental to corneal epithelial cells, multiple short- and long-term clinical studies have provided evidence supporting the safety of BAK. Despite the conflicting evidence, BAK is the most commonly used preservative in ophthalmic products largely due to its proven antimicrobial efficacy. This study was designed to characterize the antimicrobial performance of two commonly used topical ocular hypotensive agents that employ different preservative systems: latanoprost 0.005% with 0.02% BAK and travoprost 0.004% with sofZia, a proprietary ionic buffer system. METHODS: Each product was tested for antimicrobial effectiveness by European Pharmacopoeia A (EP-A) standards, the most stringent standards of the three major compendia, which specify two early sampling time points (6 and 24 hours) not required by the United States Pharmacopeia or Japanese Pharmacopoeia. Aliquots were inoculated with between 10(5) and 10(6) colony-forming units of the test organisms: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Candida albicans and Aspergillus brasiliensis. Sampling and enumeration were conducted at protocol-defined time points through 28 days. RESULTS: BAK-containing latanoprost met EP-A criteria by immediately reducing all bacterial challenge organisms to the test sensitivity and fungal challenges within the first six hours while the preservative activity of travoprost with sofZia did not. Complete bacterial reduction by travoprost with sofZia was not shown until seven days into the test, and fungal reduction never exceeded the requisite 2 logs during the 28-day test. Travoprost with sofZia also did not meet EP-B criteria due to its limited effectiveness against Staphylococcus aureus. Both products satisfied United States and Japanese pharmacopoeial criteria. CONCLUSIONS: Latanoprost with 0.02% BAK exhibited more effective microbial protection than travoprost with sofZia using rates of microbial reduction, time to no recovery for all challenges and evaluation against EP-A criteria as measures. The rapid and complete reduction of all microbial challenges demonstrates that antimicrobial activity of latanoprost with 0.02% BAK exceeds that of travoprost with sofZia preservative system in these products and provides a more protective environment in the event of contamination and subsequent exposure to microorganisms during use.
Asunto(s)
Antiinfecciosos/farmacología , Bacterias/efectos de los fármacos , Compuestos de Benzalconio/farmacología , Cloprostenol/análogos & derivados , Hongos/efectos de los fármacos , Soluciones Oftálmicas/farmacología , Conservadores Farmacéuticos/farmacología , Prostaglandinas F Sintéticas/farmacología , Antihipertensivos/farmacología , Cloprostenol/farmacología , Evaluación Preclínica de Medicamentos , Humanos , Latanoprost , Células Madre/efectos de los fármacos , TravoprostRESUMEN
PURPOSE: Glaucoma accounts for more than 11% of all cases of blindness in the United States, but there have been few studies of economic impact. We examine incremental cost of primary open-angle glaucoma considering both visual and nonvisual medical costs over a lifetime of glaucoma. DESIGN: A decision analytic approach taking the payor's perspective with microsimulation estimation. METHODS: We constructed a Markov model to replicate health events over the remaining lifetime of someone newly diagnosed with glaucoma. Costs of this group were compared with those estimated for a control group without glaucoma. The cost of management of glaucoma (including medications) before the onset of visual impairment was not considered. The model was populated with probability data estimated from Medicare claims data (1999 through 2005). Cost of nonocular medications and nursing home use was estimated from California Medicare claims, and all other costs were estimated from Medicare claims data. RESULTS: We found modest differences in the incidence of comorbid conditions and health service use between people with glaucoma and the control group. Over their expected lifetime, the cost of care for people with primary open-angle glaucoma was higher than that of people without primary open-angle glaucoma by $1688 or approximately $137 per year. CONCLUSIONS: Among Medicare beneficiaries, glaucoma diagnosis not found to be associated with significant risk of comorbidities before development of visual impairment. Further study is necessary to consider the impact of glaucoma on quality of life, as well as aspects of physical and visual function not captured in this claims-based analysis.
Asunto(s)
Costo de Enfermedad , Técnicas de Apoyo para la Decisión , Glaucoma de Ángulo Abierto/economía , Costos de la Atención en Salud , Gastos en Salud , Trastornos de la Visión/economía , Anciano , Anciano de 80 o más Años , Comorbilidad , Femenino , Investigación sobre Servicios de Salud , Humanos , Masculino , Cadenas de Markov , Medicare/estadística & datos numéricos , Años de Vida Ajustados por Calidad de Vida , Estados Unidos , Personas con Daño VisualRESUMEN
PURPOSE: To validate the treatment-specific Treatment Satisfaction Survey for Intraocular Pressure (TSS-IOP). METHODS: Item content was developed by 4 heterogeneous patient focus groups (n = 32). Instrument validation involved 250 patients on ocular hypotensive medications recruited from ophthalmology practices in the Southern USA. Participants responded to demographic and test questions during a clinic visit. Standard psychometric analyses were performed on the resulting data. SAMPLE: Of the 412 patients screened, 253 consented to participate, and 250 provided complete datasets. The sample included 44% male (n = 109), 44% Black (n = 109) and 57% brown eyed (n = 142) participants, with a mean age of 64.6 years (SD 13.1) and a history of elevated IOP for an average of 8.4 yrs (SD 7.8). A majority was receiving monotherapy (60%, n = 151). RESULTS: A PC Factor analysis (w/ varimax rotation) of the 31 items yielded 5 factors (Eigenvalues > 1.0) explaining 70% of the total variance. Weaker and conceptually redundant items were removed and the remaining 15 items reanalyzed. The satisfaction factors were; Eye Irritation (EI; 4 items), Convenience of Use (CofU; 3 items), Ease of Use (EofU; 3 items), Hyperemia (HYP; 3 items), and Medication Effectiveness (EFF; 2 items). Chronbach's Alphas ranged from.80 to.86. Greater distributional skew was found for less common experiences (i.e., HYP & EI with 65% & 48.4% ceilings) than for more common experiences (i.e., EofU, CofU, EFF with 10.8%, 20.8% & 15.9% ceilings). TSS-IOP scales converged with conceptually related scales on a previously validated measure of treatment satisfaction, the TSQM (r =.36 to.77). Evidence of concurrent criterion-related validity was found. Patients' symptomatic ratings of eye irritation, hyperemia and difficulties using the medication correlated with satisfaction on these dimensions (r =.30-.56, all p <.001). Clinicians' ratings of IOP control, severity of side effects and problematic medication use correlated with patients' satisfaction scores on these dimensions (r =.13-.26, all p <.01). CONCLUSIONS: This study provides initial evidence that the TSS-IOP is a reliable and valid measure, assessing patients' satisfaction with ocular hypotensive medications.