Purpose-To characterize the costs of caring for patients with open-angle glaucoma (OAG) in the Un... more Purpose-To characterize the costs of caring for patients with open-angle glaucoma (OAG) in the United States (US) over time and to identify factors that influence these costs. Design-Longitudinal cohort study. Methods-Claims data from 19,927 newly-diagnosed OAG patients enrolled in a large US managed care network were reviewed to identify glaucoma-related charges for all incident OAG patients from 2001-2009. Average glaucoma-related charges for enrollees with OAG were characterized in six month blocks from the date of initial OAG diagnosis through the following 5 years. Factors associated with being an enrollee in the costliest 5% for glaucoma-related charges (accruing ≥$5810 in charges in the first 2 years) were identified using logistic regression.
Chronic aortic regurgitation can lead to significant morbidity and mortality. For more than a cen... more Chronic aortic regurgitation can lead to significant morbidity and mortality. For more than a century, numerous eponymous signs of aortic regurgitation have been described in textbooks and the literature. To compare current textbook content with the peer-reviewed literature on the eponymous signs of aortic regurgitation and to assess the role of these signs in clinical practice. 11 textbooks, MEDLINE (1966 through October 2002), and bibliographies of textbooks and relevant papers. English-language reports that were related to the properties of a sign on physical examination, incorporated more than 10 adults, and did not involve prosthetic heart valves or acute aortic regurgitation. Three investigators independently analyzed relevant textbook extracts and 27 reports, using predetermined qualitative review criteria. Data relating to diagnostic accuracy and properties of the index test were also extracted. Twelve eponymous signs were described as having varying degrees of importance by textbook authors. Only the Austin Flint murmur, the Corrigan pulse, the Duroziez sign, and the Hill sign had sufficient original literature for detailed review. Most reports were low quality, with varying sensitivities for all signs. Except for the Hill sign, specificity tended to be poor. Evidence for the Hill sign also suggested a correlation between the popliteal-brachial gradient and aortic regurgitation severity. Prominent textbook support of the eponymous signs of aortic regurgitation is not matched by the literature. Clinicians and educators should update and improve the evidence for these signs to ensure their relevance in current medical practice.
Introduction: Droxidopa is approved to treat neurogenic orthostatic hypotension (nOH) symptoms in... more Introduction: Droxidopa is approved to treat neurogenic orthostatic hypotension (nOH) symptoms in patients with autonomic failure based on short-term clinical trial data. Additional data on the long-term efficacy of droxidopa are needed. We have evaluated the 12-week efficacy and tolerability of droxidopa in patients with nOH in an open-label period of an ongoing phase 4 study. Methods: Patients received 12 weeks of openlabel treatment with an individually optimized droxidopa dose (100-600 mg, 3 times daily) as identified during a preceding titration period. Patient-reported outcomes included the Orthostatic Hypotension Symptom Assessment (OHSA), Orthostatic Hypotension Daily Activity Scale (OHDAS), and clinician-and patient-rated Clinical Global Impression-Severity (CGI-S) scales. Supine blood pressure (BP) and adverse events (AEs) were recorded. Results: Data from 114 patients enrolled into the 12-week open-label period were available for analyses. After 12 weeks of droxidopa treatment, patients reported significant (P \ 0.0001) improvements from baseline in OHSA and OHDAS composite and individual item scores and on clinician and patient CGI-S scores. Mean ± SD supine systolic and diastolic BP at week 12 increased by 15.5 ± 22.9 and 7.8 ± 11.7 mmHg from baseline, respectively (P \ 0.0001 for both). The most frequently reported AEs were falls (17%), headache (13%), and dizziness (9%); one (0.9%) patient reported an AE of supine hypertension. Conclusion: During 12 weeks of open-label treatment, droxidopa was associated with significant improvement from baseline in nOH symptoms and activities of daily living. No clinically important changes in supine hypertension or AEs of concern were observed. These results support the efficacy of droxidopa beyond 2 weeks of treatment. Trial Registration: NCT02586623.
Patients with neurogenic orthostatic hypotension (nOH) due to autonomic dysfunction may also expe... more Patients with neurogenic orthostatic hypotension (nOH) due to autonomic dysfunction may also experience supine hypertension (defined as supine systolic blood pressure [SBP] ≥140 mmHg). Because pressor agents used to improve nOH symptoms by increasing standing blood pressure (BP) may exacerbate or cause supine hypertension, changes in supine BP with nOH treatments are of interest.
Many policy makers believe that health status would be improved and health care spending reduced ... more Many policy makers believe that health status would be improved and health care spending reduced if people managed their health better. This study examined the effectiveness of a program put in place by BJC HealthCare, a hospital system based in St. Louis, Missouri, that tied employees’ eligibility to participate in the system’s most generous health plan with participation in a wellness program. The intervention, which began in 2005, was associated with a 41 percent decrease, relative to a comparison group, in hospitalizations for conditions targeted by the wellness program but with no significant decrease in other hospitalizations. We found reductions in inpatient costs but similar increases in non-inpatient costs. Therefore, we conclude that although the program did cut some hospitalizations, it did not save money for the employer in the short term. This finding underscores that wellness program incentives under the Affordable Care Act are unlikely to greatly reduce health care sp...
Valuing state-funded mental health programs in a policy-relevant context requires consideration o... more Valuing state-funded mental health programs in a policy-relevant context requires consideration of how much benefit from other programs the public is willing to forgo to increase mental health program benefits and how much the public is willing to be taxed for such program benefits. r Taxpayer resistance to increased taxes to pay for publicly funded mental health programs and perceived benefits of such programs vary with state population size. r In all states, taxpayers seem to support increased public funding for mental health programs such as state Medicaid services, suggesting such programs are underfunded from the perspective of the average taxpayer. Context: The direct and indirect impacts of serious mental illness (SMI) on health care systems and communities represents a significant burden. However, the value that community members place on alleviating this burden is not known, and SMI treatment must compete with a long list of other publicly
Introduction Schizophrenia is a condition that places a significant burden on individuals with th... more Introduction Schizophrenia is a condition that places a significant burden on individuals with the condition, their family, and society. A large proportion of those treated for schizophrenia do not experience treatment response and are referred to as having "treatment-resistant schizophrenia" (TRS). Expert opinion has long held that the prevalence of TRS among individuals with schizophrenia is 30%, but the basis of this estimate is unclear. This article presents a model developed for estimating the prevalence of TRS in the United States 2014. Methods An incidence-prevalence-mortality model was developed to estimate the prevalence of TRS in the United States. The model was populated with data from public health agencies and published literature. Prevalence in 2014 was modelled using a Markov cohort simulation for each birth cohort between 1930 to 2014. Results Using different scenarios for baseline incidence, relative risks of mortality, it was estimated that approximately 22% of individuals with schizophrenia would be considered treatmentresistant in 2014. Discussion The results suggests that prevalence of TRS may be somewhat lower than the 30% often reported, however this is highly dependent on the definition of treatment resistance. Methods such as this may help answer epidemiological and health policy questions as well as test the influence of key underlying assumptions.
4738 Introduction: High-dose chemotherapy in conjunction with autologous peripheral stem cell tra... more 4738 Introduction: High-dose chemotherapy in conjunction with autologous peripheral stem cell transplantation (ASCT) has emerged as a preferred treatment modality for a variety of relapsed hematological malignancies including non-Hodgkin lymphoma (NHL). Failure rates with current mobilization regimens are estimated to be between 5% and 30%. This failure adds substantially to the cost of this already costly procedure due to the need for multiple apheresis sessions following initial mobilization, as well as the implementation of costly rescue protocols. An additional economic burden of this reduced efficacy is increased mortality as fewer patients proceed to transplantation. Plerixafor with G-CSF (G+P) has been shown to be superior to G-CSF (G) alone for stem cell mobilization in heavily pretreated patients with NHL. This increased efficacy reduces the required number of apheresis sessions, reduces the likelihood of rescue, and increases the likelihood of successful engraftment, all o...
Background: Treatment-resistant schizophrenia (TRS) affects about one-third of individuals with s... more Background: Treatment-resistant schizophrenia (TRS) affects about one-third of individuals with schizophrenia. People with TRS do not experience sustained symptom relief and at the same time have the most severe diseaserelated disability and associated costs among individuals with severe mental disorders. Like caregivers of people with treatment-responsive schizophrenia, caregivers of individuals with TRS experience the disease burden along with their care recipients; however, for those providing care for individuals with TRS, the stress of the burden is unrelenting due to uncontrolled symptoms and a lack of effective treatment options. The objective of this study is to better understand the burden of TRS from the caregiver perspective and to explore their perception of available treatments. Methods: Eight focus groups with non-professional, informal caregivers of individuals with TRS were conducted in 5 US locations. TRS was defined as failure of ≥2 antipsychotics and persistent moderate-to-severe positive symptoms of schizophrenia, per caregiver report. Results: The 27 caregivers reported an average of 37 h/week providing direct care, and 21 reported being on call "24/7." Caregivers commonly reported that their care recipients exhibited symptoms of auditory hallucinations (89%), agitation/irritability/hostility (81%), suspiciousness (78%), tangentiality (74%), and cognitive impairment (74%); 70% of caregivers ranked suspiciousness/persecution as the most challenging symptom category. Caring for an individual with TRS impacted many caregivers' finances, career prospects, social relationships, and sense of freedom. Additionally, multiple medication failures led to a sense of hopelessness for many caregivers. Conclusions: Persistent positive symptoms caused significant perceived burden, feelings of being overwhelmed and having no relief, and substantial negative impacts on caregivers' emotional and physical health. To address these substantial unmet needs, policy makers should be aware of the need for practical, social, and emotional support for these caregivers and their families. Additionally, new treatment options for TRS should be developed.
Journal of the American Pharmacists Association, 2016
Background: A new service model integrates the specialty pharmacy's comprehensive service with th... more Background: A new service model integrates the specialty pharmacy's comprehensive service with the retail pharmacy's patient contact, giving patients options for medication delivery to home, pharmacy, or doctor's office. Objective: Evaluate the impact of the new service model on medication adherence. Design: Retrospective cohort study Settings: One hundred fifteen CVS retail stores in Philadelphia participated in a pilot from May 2012 to October 2013, and 115 matched CVS retail stores from around the nation served as controls. Patients: All eligible patients from the intervention and control stores received specialty medications through CVS retail pharmacies prior to implementation of the new service model. Intervention: The intervention patients were transitioned from retail pharmacy service to the specialty pharmacy with delivery options. The control patients received standard retail pharmacy services. Main outcome measures: Proportion of days covered and first fill persistence were tracked for 12 months before and after program implementation. Results: Under the new service model, 228 patients new to therapy in the post period had a 17.5% increase in the rate of obtaining a second fill as compared to matched controls. Patients on therapy in both the pre-and the post-periods had a pre-post increase of 6.6% in average adherence rates and a pre-post increase of 10.8% in optimal adherence rates as compared to 326 matched controls. Conclusion: The study demonstrated significant improvement in both adherence to therapy and first-fill persistence among patients in the new service model integrating specialty pharmacy's comprehensive services with the retail pharmacy's patient contact and medication delivery choices.
The objective of this retrospective cohort study is to analyze the effect of the iPLEDGE program ... more The objective of this retrospective cohort study is to analyze the effect of the iPLEDGE program on rates of fetal exposure to isotretinoin in females of childbearing potential (FCBP). METHODS: This study used databases from Kaiser Permanente Southern California, which includes prescription records, laboratory results, and outpatient/inpatient visit procedures and diagnoses. All FCBP who filled isotretinoin during the study period of March 1, 2004 to February 29, 2008 were identified. Chart review was performed to validate pregnancy in patients with positive pregnancy indicators. The analysis was performed at the treatment course-level. Treatment courses were excluded if they straddled both before and after iPLEDGE implementation on March 1, 2006. Poisson regression was used to analyze the impact of iPLEDGE on the rate of fetal exposures, controlling for age, prior utilization of acne prescription medications, and other risk factors. RESULTS: There were a total of 8 fetal exposures during 2585 treatment courses before iPLEDGE and 6 fetal exposures during 1595 treatment courses after iPLEDGE implementation. Unadjusted fetal exposure rates increased slightly from 3.09 per 1000 treatment courses to 3.76 per 1000 treatment courses with iPLEDGE. When controlling for other factors, the rate ratio for fetal exposure after compared to before iPLEDGE implementation was 0.45 [95%CI: 0.31, 0.67] in FCBP less than 21 years of age. In FCBP greater than or equal to 21 years of age, the rate ratio was 1.46 [95%CI: 1.10, 1.94]. CONCLUSIONS: The risk of fetal exposure among treatment courses filled by younger FCBP significantly decreased by 55% after the implementation of iPLEDGE. In contrast, the risk of fetal exposure significantly increased by 46% after iPLEDGE began among treatment courses filled by older FCBP. Our results suggest that the iPLEDGE program had a differential effect on the rate of fetal exposures to isotretinoin depending on patient age group.
To elicit utilities on a perfect health and perfect vision scale for 5 common eye diseases. Desig... more To elicit utilities on a perfect health and perfect vision scale for 5 common eye diseases. Design: Cross-sectional observational preference study. Participants: We included 434 patients: 58 with diabetic retinopathy, 99 with glaucoma, 44 with age-related macular degeneration (AMD), 124 with cataract; 109 with refractive error. Testing: Standard gamble utilities were estimated using a computer-based preference assessment interview platform. Main Outcome Measures: Standard gamble utilities, a quality-of-life measure that examines the willingness to accept a risk of death or unilateral blindness in return for perfect health or perfect vision. Results: Using the standard policy scale, where health equivalent to death is 0 and perfect health is 1, participants with asymptomatic diabetic retinopathy had a utility of 0.93. By comparison, symptomatic diabetics had a further utility loss of 0.14. Asymptomatic glaucoma participants had a utility of 0.92 with a decrease of 0.03 for early field loss and a further decrease of 0.03 with central field loss. Participants with AMD who had Ն20/100 better-eye visual acuity reported a utility of 0.89, whereas those with more severe AMD reported 0.76. However, neither clinical cataract opacity score nor refractive error correlated with utility. Adjustment for age and comorbidity did not alter these relationships. For the same participants, utilities measured with different anchor points-monocular blindness as 0 and perfect vision as 1-were lower, especially among participants with increased disease severity. The difference between utility assessed on this perfect vision-blindness scale and the perfect health-death scale ranged from 0.04 for those with severe refractive error to 0.19 for symptomatic diabetics and 0.37 for those with severe AMD. Conclusions: This paper elicits utilities with different anchor points from a previously unreported sample of 434 patients. Lower utility scores normally imply greater benefit with successful treatment or prevention of disease, but switching from the conventional policy scale to the perfect vision scale also consistently results in lower scores. Because most previous ophthalmic studies have used perfect vision as the upper anchor, the resulting utilities may not have been accurate.
Purpose-To characterize the costs of caring for patients with open-angle glaucoma (OAG) in the Un... more Purpose-To characterize the costs of caring for patients with open-angle glaucoma (OAG) in the United States (US) over time and to identify factors that influence these costs. Design-Longitudinal cohort study. Methods-Claims data from 19,927 newly-diagnosed OAG patients enrolled in a large US managed care network were reviewed to identify glaucoma-related charges for all incident OAG patients from 2001-2009. Average glaucoma-related charges for enrollees with OAG were characterized in six month blocks from the date of initial OAG diagnosis through the following 5 years. Factors associated with being an enrollee in the costliest 5% for glaucoma-related charges (accruing ≥$5810 in charges in the first 2 years) were identified using logistic regression.
Chronic aortic regurgitation can lead to significant morbidity and mortality. For more than a cen... more Chronic aortic regurgitation can lead to significant morbidity and mortality. For more than a century, numerous eponymous signs of aortic regurgitation have been described in textbooks and the literature. To compare current textbook content with the peer-reviewed literature on the eponymous signs of aortic regurgitation and to assess the role of these signs in clinical practice. 11 textbooks, MEDLINE (1966 through October 2002), and bibliographies of textbooks and relevant papers. English-language reports that were related to the properties of a sign on physical examination, incorporated more than 10 adults, and did not involve prosthetic heart valves or acute aortic regurgitation. Three investigators independently analyzed relevant textbook extracts and 27 reports, using predetermined qualitative review criteria. Data relating to diagnostic accuracy and properties of the index test were also extracted. Twelve eponymous signs were described as having varying degrees of importance by textbook authors. Only the Austin Flint murmur, the Corrigan pulse, the Duroziez sign, and the Hill sign had sufficient original literature for detailed review. Most reports were low quality, with varying sensitivities for all signs. Except for the Hill sign, specificity tended to be poor. Evidence for the Hill sign also suggested a correlation between the popliteal-brachial gradient and aortic regurgitation severity. Prominent textbook support of the eponymous signs of aortic regurgitation is not matched by the literature. Clinicians and educators should update and improve the evidence for these signs to ensure their relevance in current medical practice.
Introduction: Droxidopa is approved to treat neurogenic orthostatic hypotension (nOH) symptoms in... more Introduction: Droxidopa is approved to treat neurogenic orthostatic hypotension (nOH) symptoms in patients with autonomic failure based on short-term clinical trial data. Additional data on the long-term efficacy of droxidopa are needed. We have evaluated the 12-week efficacy and tolerability of droxidopa in patients with nOH in an open-label period of an ongoing phase 4 study. Methods: Patients received 12 weeks of openlabel treatment with an individually optimized droxidopa dose (100-600 mg, 3 times daily) as identified during a preceding titration period. Patient-reported outcomes included the Orthostatic Hypotension Symptom Assessment (OHSA), Orthostatic Hypotension Daily Activity Scale (OHDAS), and clinician-and patient-rated Clinical Global Impression-Severity (CGI-S) scales. Supine blood pressure (BP) and adverse events (AEs) were recorded. Results: Data from 114 patients enrolled into the 12-week open-label period were available for analyses. After 12 weeks of droxidopa treatment, patients reported significant (P \ 0.0001) improvements from baseline in OHSA and OHDAS composite and individual item scores and on clinician and patient CGI-S scores. Mean ± SD supine systolic and diastolic BP at week 12 increased by 15.5 ± 22.9 and 7.8 ± 11.7 mmHg from baseline, respectively (P \ 0.0001 for both). The most frequently reported AEs were falls (17%), headache (13%), and dizziness (9%); one (0.9%) patient reported an AE of supine hypertension. Conclusion: During 12 weeks of open-label treatment, droxidopa was associated with significant improvement from baseline in nOH symptoms and activities of daily living. No clinically important changes in supine hypertension or AEs of concern were observed. These results support the efficacy of droxidopa beyond 2 weeks of treatment. Trial Registration: NCT02586623.
Patients with neurogenic orthostatic hypotension (nOH) due to autonomic dysfunction may also expe... more Patients with neurogenic orthostatic hypotension (nOH) due to autonomic dysfunction may also experience supine hypertension (defined as supine systolic blood pressure [SBP] ≥140 mmHg). Because pressor agents used to improve nOH symptoms by increasing standing blood pressure (BP) may exacerbate or cause supine hypertension, changes in supine BP with nOH treatments are of interest.
Many policy makers believe that health status would be improved and health care spending reduced ... more Many policy makers believe that health status would be improved and health care spending reduced if people managed their health better. This study examined the effectiveness of a program put in place by BJC HealthCare, a hospital system based in St. Louis, Missouri, that tied employees’ eligibility to participate in the system’s most generous health plan with participation in a wellness program. The intervention, which began in 2005, was associated with a 41 percent decrease, relative to a comparison group, in hospitalizations for conditions targeted by the wellness program but with no significant decrease in other hospitalizations. We found reductions in inpatient costs but similar increases in non-inpatient costs. Therefore, we conclude that although the program did cut some hospitalizations, it did not save money for the employer in the short term. This finding underscores that wellness program incentives under the Affordable Care Act are unlikely to greatly reduce health care sp...
Valuing state-funded mental health programs in a policy-relevant context requires consideration o... more Valuing state-funded mental health programs in a policy-relevant context requires consideration of how much benefit from other programs the public is willing to forgo to increase mental health program benefits and how much the public is willing to be taxed for such program benefits. r Taxpayer resistance to increased taxes to pay for publicly funded mental health programs and perceived benefits of such programs vary with state population size. r In all states, taxpayers seem to support increased public funding for mental health programs such as state Medicaid services, suggesting such programs are underfunded from the perspective of the average taxpayer. Context: The direct and indirect impacts of serious mental illness (SMI) on health care systems and communities represents a significant burden. However, the value that community members place on alleviating this burden is not known, and SMI treatment must compete with a long list of other publicly
Introduction Schizophrenia is a condition that places a significant burden on individuals with th... more Introduction Schizophrenia is a condition that places a significant burden on individuals with the condition, their family, and society. A large proportion of those treated for schizophrenia do not experience treatment response and are referred to as having "treatment-resistant schizophrenia" (TRS). Expert opinion has long held that the prevalence of TRS among individuals with schizophrenia is 30%, but the basis of this estimate is unclear. This article presents a model developed for estimating the prevalence of TRS in the United States 2014. Methods An incidence-prevalence-mortality model was developed to estimate the prevalence of TRS in the United States. The model was populated with data from public health agencies and published literature. Prevalence in 2014 was modelled using a Markov cohort simulation for each birth cohort between 1930 to 2014. Results Using different scenarios for baseline incidence, relative risks of mortality, it was estimated that approximately 22% of individuals with schizophrenia would be considered treatmentresistant in 2014. Discussion The results suggests that prevalence of TRS may be somewhat lower than the 30% often reported, however this is highly dependent on the definition of treatment resistance. Methods such as this may help answer epidemiological and health policy questions as well as test the influence of key underlying assumptions.
4738 Introduction: High-dose chemotherapy in conjunction with autologous peripheral stem cell tra... more 4738 Introduction: High-dose chemotherapy in conjunction with autologous peripheral stem cell transplantation (ASCT) has emerged as a preferred treatment modality for a variety of relapsed hematological malignancies including non-Hodgkin lymphoma (NHL). Failure rates with current mobilization regimens are estimated to be between 5% and 30%. This failure adds substantially to the cost of this already costly procedure due to the need for multiple apheresis sessions following initial mobilization, as well as the implementation of costly rescue protocols. An additional economic burden of this reduced efficacy is increased mortality as fewer patients proceed to transplantation. Plerixafor with G-CSF (G+P) has been shown to be superior to G-CSF (G) alone for stem cell mobilization in heavily pretreated patients with NHL. This increased efficacy reduces the required number of apheresis sessions, reduces the likelihood of rescue, and increases the likelihood of successful engraftment, all o...
Background: Treatment-resistant schizophrenia (TRS) affects about one-third of individuals with s... more Background: Treatment-resistant schizophrenia (TRS) affects about one-third of individuals with schizophrenia. People with TRS do not experience sustained symptom relief and at the same time have the most severe diseaserelated disability and associated costs among individuals with severe mental disorders. Like caregivers of people with treatment-responsive schizophrenia, caregivers of individuals with TRS experience the disease burden along with their care recipients; however, for those providing care for individuals with TRS, the stress of the burden is unrelenting due to uncontrolled symptoms and a lack of effective treatment options. The objective of this study is to better understand the burden of TRS from the caregiver perspective and to explore their perception of available treatments. Methods: Eight focus groups with non-professional, informal caregivers of individuals with TRS were conducted in 5 US locations. TRS was defined as failure of ≥2 antipsychotics and persistent moderate-to-severe positive symptoms of schizophrenia, per caregiver report. Results: The 27 caregivers reported an average of 37 h/week providing direct care, and 21 reported being on call "24/7." Caregivers commonly reported that their care recipients exhibited symptoms of auditory hallucinations (89%), agitation/irritability/hostility (81%), suspiciousness (78%), tangentiality (74%), and cognitive impairment (74%); 70% of caregivers ranked suspiciousness/persecution as the most challenging symptom category. Caring for an individual with TRS impacted many caregivers' finances, career prospects, social relationships, and sense of freedom. Additionally, multiple medication failures led to a sense of hopelessness for many caregivers. Conclusions: Persistent positive symptoms caused significant perceived burden, feelings of being overwhelmed and having no relief, and substantial negative impacts on caregivers' emotional and physical health. To address these substantial unmet needs, policy makers should be aware of the need for practical, social, and emotional support for these caregivers and their families. Additionally, new treatment options for TRS should be developed.
Journal of the American Pharmacists Association, 2016
Background: A new service model integrates the specialty pharmacy's comprehensive service with th... more Background: A new service model integrates the specialty pharmacy's comprehensive service with the retail pharmacy's patient contact, giving patients options for medication delivery to home, pharmacy, or doctor's office. Objective: Evaluate the impact of the new service model on medication adherence. Design: Retrospective cohort study Settings: One hundred fifteen CVS retail stores in Philadelphia participated in a pilot from May 2012 to October 2013, and 115 matched CVS retail stores from around the nation served as controls. Patients: All eligible patients from the intervention and control stores received specialty medications through CVS retail pharmacies prior to implementation of the new service model. Intervention: The intervention patients were transitioned from retail pharmacy service to the specialty pharmacy with delivery options. The control patients received standard retail pharmacy services. Main outcome measures: Proportion of days covered and first fill persistence were tracked for 12 months before and after program implementation. Results: Under the new service model, 228 patients new to therapy in the post period had a 17.5% increase in the rate of obtaining a second fill as compared to matched controls. Patients on therapy in both the pre-and the post-periods had a pre-post increase of 6.6% in average adherence rates and a pre-post increase of 10.8% in optimal adherence rates as compared to 326 matched controls. Conclusion: The study demonstrated significant improvement in both adherence to therapy and first-fill persistence among patients in the new service model integrating specialty pharmacy's comprehensive services with the retail pharmacy's patient contact and medication delivery choices.
The objective of this retrospective cohort study is to analyze the effect of the iPLEDGE program ... more The objective of this retrospective cohort study is to analyze the effect of the iPLEDGE program on rates of fetal exposure to isotretinoin in females of childbearing potential (FCBP). METHODS: This study used databases from Kaiser Permanente Southern California, which includes prescription records, laboratory results, and outpatient/inpatient visit procedures and diagnoses. All FCBP who filled isotretinoin during the study period of March 1, 2004 to February 29, 2008 were identified. Chart review was performed to validate pregnancy in patients with positive pregnancy indicators. The analysis was performed at the treatment course-level. Treatment courses were excluded if they straddled both before and after iPLEDGE implementation on March 1, 2006. Poisson regression was used to analyze the impact of iPLEDGE on the rate of fetal exposures, controlling for age, prior utilization of acne prescription medications, and other risk factors. RESULTS: There were a total of 8 fetal exposures during 2585 treatment courses before iPLEDGE and 6 fetal exposures during 1595 treatment courses after iPLEDGE implementation. Unadjusted fetal exposure rates increased slightly from 3.09 per 1000 treatment courses to 3.76 per 1000 treatment courses with iPLEDGE. When controlling for other factors, the rate ratio for fetal exposure after compared to before iPLEDGE implementation was 0.45 [95%CI: 0.31, 0.67] in FCBP less than 21 years of age. In FCBP greater than or equal to 21 years of age, the rate ratio was 1.46 [95%CI: 1.10, 1.94]. CONCLUSIONS: The risk of fetal exposure among treatment courses filled by younger FCBP significantly decreased by 55% after the implementation of iPLEDGE. In contrast, the risk of fetal exposure significantly increased by 46% after iPLEDGE began among treatment courses filled by older FCBP. Our results suggest that the iPLEDGE program had a differential effect on the rate of fetal exposures to isotretinoin depending on patient age group.
To elicit utilities on a perfect health and perfect vision scale for 5 common eye diseases. Desig... more To elicit utilities on a perfect health and perfect vision scale for 5 common eye diseases. Design: Cross-sectional observational preference study. Participants: We included 434 patients: 58 with diabetic retinopathy, 99 with glaucoma, 44 with age-related macular degeneration (AMD), 124 with cataract; 109 with refractive error. Testing: Standard gamble utilities were estimated using a computer-based preference assessment interview platform. Main Outcome Measures: Standard gamble utilities, a quality-of-life measure that examines the willingness to accept a risk of death or unilateral blindness in return for perfect health or perfect vision. Results: Using the standard policy scale, where health equivalent to death is 0 and perfect health is 1, participants with asymptomatic diabetic retinopathy had a utility of 0.93. By comparison, symptomatic diabetics had a further utility loss of 0.14. Asymptomatic glaucoma participants had a utility of 0.92 with a decrease of 0.03 for early field loss and a further decrease of 0.03 with central field loss. Participants with AMD who had Ն20/100 better-eye visual acuity reported a utility of 0.89, whereas those with more severe AMD reported 0.76. However, neither clinical cataract opacity score nor refractive error correlated with utility. Adjustment for age and comorbidity did not alter these relationships. For the same participants, utilities measured with different anchor points-monocular blindness as 0 and perfect vision as 1-were lower, especially among participants with increased disease severity. The difference between utility assessed on this perfect vision-blindness scale and the perfect health-death scale ranged from 0.04 for those with severe refractive error to 0.19 for symptomatic diabetics and 0.37 for those with severe AMD. Conclusions: This paper elicits utilities with different anchor points from a previously unreported sample of 434 patients. Lower utility scores normally imply greater benefit with successful treatment or prevention of disease, but switching from the conventional policy scale to the perfect vision scale also consistently results in lower scores. Because most previous ophthalmic studies have used perfect vision as the upper anchor, the resulting utilities may not have been accurate.
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Papers by Steven Kymes