35 results on '"Peneva D"'
Search Results
2. Short-term Costs of Preeclampsia to the United States Health Care System
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Stevens, W., primary, Shih, T., additional, Incerti, D., additional, Ton, T.G.N., additional, Lee, H.C., additional, Peneva, D., additional, Macones, G.A., additional, Sibai, B.M., additional, and Jena, A.B., additional
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- 2018
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3. An Empirical Analysis of The Role of Learning by Doing in Dynamic Cost-Effectiveness
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Incerti, D, primary, Peneva, D, additional, Shrestha, A, additional, Ramaswamy, K, additional, Smith, G, additional, and Stevens, W, additional
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- 2017
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4. The Social Value of Immunotherapy in Non-Small Cell Lung Cancer
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Sullivan, J, primary, Sexton Ward, A, additional, Korytowsky, B, additional, Peneva, D, additional, Benner, J, additional, Lakdawalla, DN, additional, Bolinder, B, additional, Figlin, RA, additional, and Jena, AB, additional
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- 2016
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5. Estimating the Future Burden of Cardiovascular Disease in China and the Potential Value of Universal Lipid and Blood Pressure Control
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Stevens, W, primary, Peneva, D, additional, Li, JZ, additional, Liu, LZ, additional, Liu, GG, additional, Gao, R, additional, and Lakdawalla, DN, additional
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- 2016
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6. 1212 Improvements in progression-free survival and real-world cost: A study of treatments for five tumor sites
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Shafrin, J., primary, Brookmeyer, R., additional, Peneva, D., additional, Park, J., additional, Zhang, J., additional, Figlin, R.A., additional, and Lakdawalla, D.N., additional
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- 2015
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7. PCN132 - An Empirical Analysis of The Role of Learning by Doing in Dynamic Cost-Effectiveness
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Incerti, D, Peneva, D, Shrestha, A, Ramaswamy, K, Smith, G, and Stevens, W
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- 2017
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8. PCN190 - The Social Value of Immunotherapy in Non-Small Cell Lung Cancer
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Sullivan, J, Sexton Ward, A, Korytowsky, B, Peneva, D, Benner, J, Lakdawalla, DN, Bolinder, B, Figlin, RA, and Jena, AB
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- 2016
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9. PCV81 - Estimating the Future Burden of Cardiovascular Disease in China and the Potential Value of Universal Lipid and Blood Pressure Control
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Stevens, W, Peneva, D, Li, JZ, Liu, LZ, Liu, GG, Gao, R, and Lakdawalla, DN
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- 2016
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10. Accumulation, storage and obtainment of generalized net tokens characteristics history.
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Peneva, D., Tasseva, V., Popov, E., Petrounias, I., Kodogiannis, V.S., Anwar, F., and Shannon, A.
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- 2008
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11. Generalized Net Model for Outpatient Care in Bulgaria.
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Tasseva, V., Peneva, D., Atanassov, K., El-Darzi, E., Chountas, P., and Vasilakis, C.
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- 2007
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12. Generalized Nets as an Instrument for Description of the Process of Expert System Construction.
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Peneva, D., Tasseva, V., Kodogiannis, V., Sotirova, E., and Atanassov, K.
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- 2006
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13. Efficient periodicity mining of sequential patterns in a post-mining environment.
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Anwar, F., Petrounias, I., Kodogiannis, V.S., Tasseva, V., and Peneva, D.
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- 2008
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14. Comprehensive Review on the Clinical Impact of Next-Generation Sequencing Tests for the Management of Advanced Cancer.
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Gibbs SN, Peneva D, Cuyun Carter G, Palomares MR, Thakkar S, Hall DW, Dalglish H, Campos C, and Yermilov I
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- Humans, United States, Progression-Free Survival, High-Throughput Nucleotide Sequencing, Neoplasms diagnosis, Neoplasms genetics, Neoplasms therapy
- Abstract
Purpose: This review summarizes the published evidence on the clinical impact of using next-generation sequencing (NGS) tests to guide management of patients with cancer in the United States., Methods: We performed a comprehensive literature review to identify recent English language publications that presented progression-free survival (PFS) and overall survival (OS) of patients with advanced cancer receiving NGS testing., Results: Among 6,475 publications identified, 31 evaluated PFS and OS among subgroups of patients who received NGS-informed cancer management. PFS and OS were significantly longer among patients who were matched to targeted treatment in 11 and 16 publications across tumor types, respectively., Conclusion: Our review indicates that NGS-informed treatment can have an impact on survival across tumor types.
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- 2023
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15. Recommendations to address key recruitment challenges of Alzheimer's disease clinical trials.
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Langbaum JB, Zissimopoulos J, Au R, Bose N, Edgar CJ, Ehrenberg E, Fillit H, Hill CV, Hughes L, Irizarry M, Kremen S, Lakdawalla D, Lynn N, Malzbender K, Maruyama T, Massett HA, Patel D, Peneva D, Reiman EM, Romero K, Routledge C, Weiner MW, Weninger S, and Aisen PS
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- Humans, Patient Selection, Alzheimer Disease drug therapy
- Abstract
Clinical trials for Alzheimer's disease (AD) are slower to enroll study participants, take longer to complete, and are more expensive than trials in most other therapeutic areas. The recruitment and retention of a large number of qualified, diverse volunteers to participate in clinical research studies remain among the key barriers to the successful completion of AD clinical trials. An advisory panel of experts from academia, patient-advocacy organizations, philanthropy, non-profit, government, and industry convened in 2020 to assess the critical challenges facing recruitment in Alzheimer's clinical trials and develop a set of recommendations to overcome them. This paper briefly reviews existing challenges in AD clinical research and discusses the feasibility and implications of the panel's recommendations for actionable and inclusive solutions to accelerate the development of novel therapies for AD., (© 2022 The Authors. Alzheimer's & Dementia published by Wiley Periodicals LLC on behalf of Alzheimer's Association.)
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- 2023
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16. Estimating Productivity Loss from Breast and Non-Small-Cell Lung Cancer among Working-Age Patients and Unpaid Caregivers: A Survey Study Using the Multiplier Method.
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Chiu K, MacEwan JP, May SG, Bognar K, Peneva D, Zhao LM, Yong C, Amin S, Bolinder B, Batt K, and Baumgardner JR
- Abstract
Background. Traditional approaches to capturing health-related productivity loss (e.g., the human capital method) focus only on the foregone wages of affected patients, overlooking the losses caregivers can incur. This study estimated the burden of productivity loss among breast cancer (BC) and non-small-cell lung cancer (NSCLC) patients and individuals caring for such patients using an augmented multiplier method. Design. A cross-sectional survey of BC and NSCLC patients and caregivers measured loss associated with time absent from work (absenteeism) and reduced effectiveness (presenteeism). Respondents reported pre- and postcancer diagnosis income, hours worked, and time to complete tasks. Exploratory multivariable analyses examined correlations between respondents' clinical/demographic characteristics-including industry of employment-and postdiagnosis productivity. Results. Of 204 patients (104 BC, 100 NSCLC) and 200 caregivers (100 BC, 100 NSCLC) who completed the survey, 319 participants (162 BC, 157 NSCLC) working ≥40 wk/y prediagnosis were included in the analysis. More than one-third of the NSCLC (33%) and BC (43%) patients left the workforce postdiagnosis, whereas only 15% of caregivers did. The traditional estimate for the burden of productivity loss was 66% lower on average than the augmented estimate (NSCLC patients: 60%, BC patients: 69%, NSCLC caregivers: 59%, and BC caregivers: 73%). Conclusions. Although patients typically experience greater absenteeism, productivity loss incurred by caregivers is also substantial. Failure to account for such impacts can result in substantial underestimation of productivity gains novel cancer treatments may confer by enabling patients and caregivers to remain in the workforce longer. Our results underscore the importance of holistic approaches to understanding this impact on both patients and their caregivers and accounting for such considerations when making decisions about treatment and treatment value., Highlights: Cancer can have a profound impact on productivity. This study demonstrates how the disease affects not only patients but also the informal or unpaid individuals who care for patients.An augmented approach to calculating health-related productivity loss suggests that productivity impacts are much larger than previously understood.A more comprehensive understanding of the economic burden of cancer for both patients and their caregivers suggests the need for more support in the workplace for these individuals and a holistic approach to accounting for these impacts in treatment decision making., (© The Author(s) 2022.)
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- 2022
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17. An empirical investigation of time-varying cost-effectiveness across the product life cycle.
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Stevens W, Incerti D, Peneva D, Shrestha A, Smith G, and Ramaswamy K
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- Aged, Animals, Cost-Benefit Analysis, Humans, Life Cycle Stages, Medicare, Quality-Adjusted Life Years, United States, Antineoplastic Combined Chemotherapy Protocols, Organoplatinum Compounds
- Abstract
Cost-effectiveness is traditionally treated as a static estimate driven by clinical trial efficacy and drug price at launch. Prior studies suggest that cost-effectiveness varies over the drug's lifetime. We examined the impact of "learning by doing," one of the least studied drivers of changes in cost-effectiveness across the product life cycle. We combined time-series trends in effectiveness over time by cancer regimen using the Surveillance, Epidemiology, and End Results-Medicare database. We estimated the time-varying effects of treatments in colorectal and pancreatic cancer over their life cycle, including FOLFOX (leucovorin, 5-fluorouracil, and oxaliplatin) and gemcitabine, on survival of patients. Mean prices over time by strength and dosage form were calculated using historical wholesale acquisition costs. We found consistent downward trends in the mortality hazard ratios, which suggest that effectiveness improves over time. In the case of first-line FOLFOX for colorectal cancer, the implied incremental cost-effectiveness ratio based on the observational data fell from $610,000 per life year gained in 2004 to $27,000 per life year gained in 2011. Cost-effectiveness estimated at launch is unlikely to be representative of cost-effectiveness over the drug's lifetime. In the drugs studied, the impact of time-varying clinical effectiveness dominated the impact of changing prices overtime., (© 2020 John Wiley & Sons, Ltd.)
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- 2020
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18. Maternal and Infant Adverse Outcomes Associated with Mild and Severe Preeclampsia during the First Year after Delivery in the United States.
- Author
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Ton TGN, Bennett MV, Incerti D, Peneva D, Druzin M, Stevens W, Butwick AJ, and Lee HC
- Subjects
- Datasets as Topic, Female, Follow-Up Studies, Gestational Age, Humans, Infant, Infant, Newborn, Infant, Premature, Male, Pregnancy, Pregnancy Complications, Pregnancy Outcome, Risk Factors, United States, Infant, Newborn, Diseases etiology, Pre-Eclampsia, Premature Birth, Puerperal Disorders etiology
- Abstract
Objective: The burden of preeclampsia severity on the health of mothers and infants during the first year after delivery is unclear, given the lack of population-based longitudinal studies in the United States., Study Design: We assessed maternal and infant adverse outcomes during the first year after delivery using population-based hospital discharge information merged with vital statistics and birth certificates of 2,021,013 linked maternal-infant births in California. We calculated sampling weights using the National Center for Health Statistics data to adjust for observed differences in maternal characteristics between California and the rest of the United States. Separately, we estimated the association between preeclampsia and gestational age and examined collider bias in models of preeclampsia and maternal and infant adverse outcomes., Results: Compared with women without preeclampsia, women with mild and severe preeclampsia delivered 0.66 weeks (95% confidence interval [CI]: 0.64, 0.68) and 2.74 weeks (95% CI: 2.72, 2.77) earlier, respectively. Mild preeclampsia was associated with an increased risk of having any maternal adverse outcome (relative risk [RR] = 1.95; 95% CI: 1.93, 1.97), as was severe preeclampsia (RR = 2.80; 95% CI: 2.78, 2.82). The risk of an infant adverse outcome was increased for severe preeclampsia (RR = 2.15; 95% CI: 2.14, 2.17) but only marginally for mild preeclampsia (RR = 0.99; 95% CI: 0.98, 1). Collider bias produced an inverse association for mild preeclampsia and attenuated the association for severe preeclampsia in models for any infant adverse outcome., Conclusion: Using multiple datasets, we estimated that severe preeclampsia is associated with a higher risk of maternal and infant adverse outcomes compared with mild preeclampsia, including an earlier preterm delivery., Competing Interests: D. I. and D. P. are employees, and T. G. N. T. and W. S. are former employees of Precision Health Economics, which provides consulting and other research services to pharmaceutical, device, governmental, and nongovernmental organizations. The remaining authors report no conflict of interest., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)
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- 2020
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19. A Review of Available Treatments, Clinical Evidence, and Guidelines for Diagnosis and Treatment of Pediatric Multiple Sclerosis in the United States.
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Krupp LB, Vieira MC, Toledano H, Peneva D, Druyts E, Wu P, and Boulos FC
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- Adolescent, Child, Consensus Development Conferences as Topic, Humans, Observational Studies as Topic, Practice Guidelines as Topic, Randomized Controlled Trials as Topic, United States, Multiple Sclerosis diagnosis, Multiple Sclerosis therapy
- Abstract
Pediatric multiple sclerosis is associated with challenges in prompt diagnosis and uncertainty regarding optimal treatment. This review aimed to identify treatment guidelines or consensus statements for pediatric patients with multiple sclerosis, US Food and Drug Administration (FDA)-approved treatment options for pediatric multiple sclerosis, and any randomized controlled trials and observational studies examining available pharmacologic treatments in the pediatric multiple sclerosis population. Literature searches were performed in MEDLINE (1946-2016), EMBASE (1974-2016), and the Cochrane Central Register of Controlled Trials to identify treatment guidelines or consensus statements, pediatric multiple sclerosis treatment approvals, and randomized controlled trials and observation studies that examine the safety and effectiveness of available disease-modifying therapies. Only 3 consensus statements provided recommendations for pharmacologic treatments for children, all 3 published before the most recent revisions of the pediatric multiple sclerosis diagnostic guidelines. Despite the changes to the clinical landscape of pediatric multiple sclerosis with the introduction of diagnostic guidelines, fingolimod is the only FDA-approved treatment for pediatric multiple sclerosis in the United States. The effectiveness and safety of other disease-modifying therapies suggested by consensus statements have been reported in relatively small prospective and retrospective observational studies. Clinical evidence from a recently completed randomized controlled trial and future global registries can inform treatment decisions for the pediatric multiple sclerosis population.
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- 2019
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20. Patient Commitment to Health (PACT-Health) in the Heart Failure Population: A Focus Group Study of an Active Communication Framework for Patient-Centered Health Behavior Change.
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Meeker D, Goldberg J, Kim KK, Peneva D, Campos HO, Maclean R, Selby V, and Doctor JN
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- Adult, Aged, California, Female, Focus Groups, Heart Failure rehabilitation, Humans, Male, Middle Aged, Patient-Centered Care, Communication, Health Behavior, Heart Failure prevention & control, Medication Adherence, Telemedicine
- Abstract
Background: Over 6 million Americans have heart failure, and 1 in 8 deaths included heart failure as a contributing cause in 2016. Lifestyle changes and adherence to diet and exercise regimens are important in limiting disease progression. Health coaching and public commitment are two interactive communication strategies that may improve self-management of heart failure., Objective: This study aimed to conduct patient focus groups to gain insight into how best to implement health coaching and public commitment strategies within the heart failure population., Methods: Focus groups were conducted in two locations. We studied 2 patients in Oakland, California, and 5 patients in Los Angeles, California. Patients were referred by local cardiologists and had to have a diagnosis of chronic heart failure. We used a semistructured interview tool to explore several patient-centered themes including medication adherence, exercise habits, dietary habits, goals, accountability, and rewards. We coded focus group data using the a priori coding criteria for these domains., Results: Medication adherence barriers included regimen complexity, forgetfulness, and difficulty coping with side effects. Participants reported that they receive little instruction from care providers on appropriate exercise and dietary habits. They also reported personal and social obstacles to achieving these objectives. Participants were in favor of structured goal setting, use of online social networks, and financial rewards as a means of promoting health lifestyles. Peers were viewed as better motivating agents than family members., Conclusions: An active communication framework involving dissemination of diet- and exercise-related health information, structured goal setting, peer accountability, and financial rewards appears promising in the management of heart failure., (©Daniella Meeker, Jordan Goldberg, Katherine K Kim, Desi Peneva, Hugo De Oliveira Campos, Ross Maclean, Van Selby, Jason N Doctor. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 06.08.2019.)
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- 2019
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21. The Importance of Economic Trade-offs in Cancer Drug Pricing.
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Fonseca R, Peneva D, Clancy Z, Abouzaid S, and Jena AB
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- Biomedical Research economics, Cost-Benefit Analysis, Humans, Life Expectancy, Neoplasms psychology, Quality-Adjusted Life Years, United States, Antineoplastic Agents economics, Drug Costs, Drug Discovery economics
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- 2018
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22. Economic burden of multiple myeloma among patients in successive lines of therapy in the United States.
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MacEwan JP, Batt K, Yin W, Peneva D, Sison S, Vine S, and Chen C
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- Administrative Claims, Healthcare statistics & numerical data, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Female, Humans, Male, Middle Aged, Multiple Myeloma drug therapy, Retrospective Studies, United States, Young Adult, Antineoplastic Combined Chemotherapy Protocols economics, Cost of Illness, Drug Costs statistics & numerical data, Multiple Myeloma economics
- Abstract
This study characterized the costs of multiple myeloma (MM) during first-line (1L), second-line (2L) and third-line (3L) treatment from the US payer perspective. Patients with ≥2 outpatient or ≥1 inpatient claims with a primary MM diagnosis and 12 months continuous enrollment post index were identified in a retrospective claims database between 1 July 2006 and 30 June 2013. A cost per-patient per-month (PPPM) metric was used to calculate total all-cause and anti-MM pharmacy costs in 1L, 2L, and 3L treatment. Of 5704 patients included, 3626 initiated 1L treatment, 1797 initiated 2L and 817 initiated 3L. Average total all-cause PPPM costs were $22,527 in 1L, $35,266 in 2L and $47,417 in 3L. Anti-MM pharmacy costs represented 22%, 29% and 29% of total all-cause costs PPPM in 1L, 2L and 3L, respectively. Study results suggest that delaying 2L and/or 3L treatment initiation may result in lower treatment costs for patients with MM.
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- 2018
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23. Assessing Variation in the Cost of Palivizumab for Respiratory Syncytial Virus Prevention in Preterm Infants.
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Shahabi A, Peneva D, Incerti D, McLaurin K, and Stevens W
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Background: The variability in cost of palivizumab treatment, indicated for prevention of respiratory syncytial virus (RSV) infections in high-risk infants, has not been robustly estimated in prior studies. This study aimed to determine the cost variations of palivizumab from a US payer perspective for otherwise healthy preterm infants born 29-35 weeks gestational age (wGA) using infant characteristics and applied dosing regimens., Methods: Fenton Growth Charts were merged with World Health Organization Child Growth Standards to estimate preterm infant growth patterns. The merged growth chart was applied to infants who received palivizumab from a prospective, observational registry to determine future body weight using each infant's wGA and birth weight. Using quarter 3 (Q3) 2016-Q2 2017 vial cost, treatment costs at monthly dosing intervals were estimated using expected weights and averaged by age to derive expected mean 2016-2017 RSV seasonal costs per infant under various dosing scenarios., Results: Given different dosing scenarios (two to five doses), birth month, and growth patterns for preterm infants 29-35 wGA, the estimated average 2016-2017 seasonal cost of palivizumab treatment ranged from $3221 to $12,568. Outpatient-only cost (excluding first dose at hospital discharge) ranged from $1733 to $11,862. The main drivers of costs were dosing regimen (74% of variance), dosing interacted with birth month (17%), and wGA (6%)., Conclusion: The considerable variability in the average cost of palivizumab treatment for preterm infants is driven by choice of dosing regimen, wGA, and birth month. Therefore, when estimating the cost of palivizumab, it is important to consider both infant characteristics at each dose and potential dosing regimens.
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- 2018
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24. Short-term costs of preeclampsia to the United States health care system.
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Stevens W, Shih T, Incerti D, Ton TGN, Lee HC, Peneva D, Macones GA, Sibai BM, and Jena AB
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- Adult, Bronchopulmonary Dysplasia economics, Bronchopulmonary Dysplasia epidemiology, Cerebral Hemorrhage economics, Cerebral Hemorrhage epidemiology, Cohort Studies, Female, Fetal Distress economics, Fetal Distress epidemiology, Gestational Age, Humans, Infant, Infant, Newborn, Leukomalacia, Periventricular economics, Leukomalacia, Periventricular epidemiology, Male, Middle Aged, Postpartum Hemorrhage economics, Postpartum Hemorrhage epidemiology, Pre-Eclampsia epidemiology, Pregnancy, Regression Analysis, Respiratory Distress Syndrome, Newborn economics, Respiratory Distress Syndrome, Newborn epidemiology, Retrospective Studies, Seizures economics, Seizures epidemiology, Sepsis economics, Sepsis epidemiology, Thrombocytopenia economics, Thrombocytopenia epidemiology, United States epidemiology, Young Adult, Health Care Costs, Pre-Eclampsia economics
- Abstract
Background: Preeclampsia is a leading cause of maternal morbidity and mortality and adverse neonatal outcomes. Little is known about the extent of the health and cost burden of preeclampsia in the United States., Objective: This study sought to quantify the annual epidemiological and health care cost burden of preeclampsia to both mothers and infants in the United States in 2012., Study Design: We used epidemiological and econometric methods to assess the annual cost of preeclampsia in the United States using a combination of population-based and administrative data sets: the National Center for Health Statistics Vital Statistics on Births, the California Perinatal Quality Care Collaborative Databases, the US Health Care Cost and Utilization Project database, and a commercial claims data set., Results: Preeclampsia increased the probability of an adverse event from 4.6% to 10.1% for mothers and from 7.8% to 15.4% for infants while lowering gestational age by 1.7 weeks (P < .001). Overall, the total cost burden of preeclampsia during the first 12 months after birth was $1.03 billion for mothers and $1.15 billion for infants. The cost burden per infant is dependent on gestational age, ranging from $150,000 at 26 weeks gestational age to $1311 at 36 weeks gestational age., Conclusion: In 2012, the cost of preeclampsia within the first 12 months of delivery was $2.18 billion in the United States ($1.03 billion for mothers and $1.15 billion for infants), and was disproportionately borne by births of low gestational age., (Copyright © 2017 Elsevier Inc. All rights reserved.)
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- 2017
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25. Cost-effectiveness of sequenced treatment of rheumatoid arthritis with targeted immune modulators.
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Jansen JP, Incerti D, Mutebi A, Peneva D, MacEwan JP, Stolshek B, Kaur P, Gharaibeh M, and Strand V
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- Abatacept economics, Abatacept therapeutic use, Adalimumab economics, Adalimumab therapeutic use, Age Factors, Antibodies, Monoclonal, Humanized economics, Antibodies, Monoclonal, Humanized therapeutic use, Antirheumatic Agents administration & dosage, Antirheumatic Agents adverse effects, Biological Products administration & dosage, Biological Products adverse effects, Certolizumab Pegol economics, Certolizumab Pegol therapeutic use, Cost-Benefit Analysis, Drug Therapy, Combination, Etanercept economics, Etanercept therapeutic use, Humans, Infliximab economics, Infliximab therapeutic use, Models, Economic, Piperidines economics, Piperidines therapeutic use, Pyrimidines economics, Pyrimidines therapeutic use, Pyrroles economics, Pyrroles therapeutic use, Quality-Adjusted Life Years, Severity of Illness Index, Sex Factors, Time Factors, Tumor Necrosis Factor-alpha antagonists & inhibitors, United States, Antirheumatic Agents economics, Antirheumatic Agents therapeutic use, Arthritis, Rheumatoid drug therapy, Biological Products economics, Biological Products therapeutic use
- Abstract
Aims: To determine the cost-effectiveness of treatment sequences of biologic disease-modifying anti-rheumatic drugs or Janus kinase/STAT pathway inhibitors (collectively referred to as bDMARDs) vs conventional DMARDs (cDMARDs) from the US societal perspective for treatment of patients with moderately to severely active rheumatoid arthritis (RA) with inadequate responses to cDMARDs., Materials and Methods: An individual patient simulation model was developed that assesses the impact of treatments on disease based on clinical trial data and real-world evidence. Treatment strategies included sequences starting with etanercept, adalimumab, certolizumab, or abatacept. Each of these treatment strategies was compared with cDMARDs. Incremental cost, incremental quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs) were calculated for each treatment sequence relative to cDMARDs. The cost-effectiveness of each strategy was determined using a US willingness-to-pay (WTP) threshold of $150,000/QALY., Results: For the base-case scenario, bDMARD treatment sequences were associated with greater treatment benefit (i.e. more QALYs), lower lost productivity costs, and greater treatment-related costs than cDMARDs. The expected ICERs for bDMARD sequences ranged from ∼$126,000 to $140,000 per QALY gained, which is below the US-specific WTP. Alternative scenarios examining the effects of homogeneous patients, dose increases, increased costs of hospitalization for severely physically impaired patients, and a lower baseline Health Assessment Questionnaire (HAQ) Disability Index score resulted in similar ICERs., Conclusions: bDMARD treatment sequences are cost-effective from a US societal perspective.
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- 2017
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26. Predicting Real-World Effectiveness of Cancer Therapies Using Overall Survival and Progression-Free Survival from Clinical Trials: Empirical Evidence for the ASCO Value Framework.
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Lakdawalla DN, Shafrin J, Hou N, Peneva D, Vine S, Park J, Zhang J, Brookmeyer R, and Figlin RA
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- Biomarkers analysis, Clinical Trials, Phase III as Topic, Disease-Free Survival, Humans, Proportional Hazards Models, SEER Program, Survival Rate, Treatment Outcome, Antineoplastic Agents therapeutic use, Neoplasms drug therapy, Randomized Controlled Trials as Topic methods
- Abstract
Objectives: To measure the relationship between randomized controlled trial (RCT) efficacy and real-world effectiveness for oncology treatments as well as how this relationship varies depending on an RCT's use of surrogate versus overall survival (OS) endpoints., Methods: We abstracted treatment efficacy measures from 21 phase III RCTs reporting OS and either progression-free survival or time to progression endpoints in breast, colorectal, lung, ovarian, and pancreatic cancers. For these treatments, we estimated real-world OS as the mortality hazard ratio (RW MHR) among patients meeting RCT inclusion criteria in Surveillance and Epidemiology End Results-Medicare data. The primary outcome variable was real-world OS observed in the Surveillance and Epidemiology End Results-Medicare data. We used a Cox proportional hazard regression model to calibrate the differences between RW MHR and the hazard ratios on the basis of RCTs using either OS (RCT MHR) or progression-free survival/time to progression surrogate (RCT surrogate hazard ratio [SHR]) endpoints., Results: Treatment arm therapies reduced mortality in RCTs relative to controls (average RCT MHR = 0.85; range 0.56-1.10) and lowered progression (average RCT SHR = 0.73; range 0.43-1.03). Among real-world patients who used either the treatment or the control arm regimens evaluated in the relevant RCT, RW MHRs were 0.6% (95% confidence interval -3.5% to 4.8%) higher than RCT MHRs, and RW MHRs were 15.7% (95% confidence interval 11.0% to 20.5%) higher than RCT SHRs., Conclusions: Real-world OS treatment benefits were similar to those observed in RCTs based on OS endpoints, but were 16% less than RCT efficacy estimates based on surrogate endpoints. These results, however, varied by tumor and line of therapy., (Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)
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- 2017
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27. The relationship between adherence and total spending among Medicare beneficiaries with type 2 diabetes.
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MacEwan JP, Sheehan JJ, Yin W, Vanderpuye-Orgle J, Sullivan J, Peneva D, Kalsekar I, and Peters AL
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- Aged, Cost Sharing, Diabetes Mellitus, Type 2 economics, Female, Humans, Male, Medicare, Retrospective Studies, United States, Diabetes Mellitus, Type 2 drug therapy, Medication Adherence
- Abstract
Objectives: This study examined the relationship between medication adherence, cost sharing measured as out-of-pocket spending, and total annual spending in Medicare beneficiaries with type 2 diabetes (T2D) to evaluate whether pharmacy cost-sharing programs have the potential to decrease adherence. These programs may unintentionally increase the risk of medical complications and may result in higher spending overall., Study Design: This retrospective study used 2006 to 2009 Medicare claims data. The sample included patients 65 years or older with T2D (at least 1 claim with International Classification of Diseases, 9th Revision, Clinical Modification codes 250.x0 and 250.x2 and at least 1 antidiabetes drug claim)., Methods: Medication adherence was measured as proportion of days covered over the first 12 months of observation. Spending and adherence outcomes were defined in deciles., Results: The sample included 12,305 patient-year observations. Pharmacy spending for patients in the most adherent (10th) decile was 59% higher than that for patients in the least adherent (1st) decile ($4839 vs $3046). Yet, patients in the 10th decile had 49% lower total ($12,531 vs $24,468) and 64% lower medical spending ($7692 vs $21,421) than patients in the 1st decile. Greater out-of-pocket spending was correlated with lower adherence and higher total and medical spending., Conclusions: This study describes a widespread variation in medication adherence, pharmacy cost sharing, and medical spending in a sample of Medicare beneficiaries with T2D. We found that lower adherence was correlated with higher cost sharing in the Medicare population, perhaps because of unobserved confounding factors. However, the existing literature on patients with employer-sponsored insurance suggests some of this correlation may be indicative of causal relationships.
- Published
- 2017
28. The Impact of State AIDS Drug Assistance Policies on Clinical and Economic Outcomes of People With HIV.
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Snider JT, Goldman DP, Rosenblatt L, Seekins D, Juday T, Sanchez Y, Wu Y, Peneva D, and Romley JA
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- Anti-HIV Agents therapeutic use, HIV Infections economics, Health Policy economics, Health Services Accessibility economics, Health Services Accessibility statistics & numerical data, Humans, Poverty, Retrospective Studies, United States, Anti-HIV Agents economics, HIV Infections drug therapy, Medical Assistance economics, Medical Assistance statistics & numerical data, State Government
- Abstract
We investigated the effect of changes to state AIDS Drug Assistance Programs (ADAP) policies, which govern access to antiretroviral therapy (ART), on clinical and economic outcomes among low-income people living with HIV/AIDS. Retrospective analyses of ART access were conducted on state ADAP policies, using data from ADAP Monitoring Reports and Kaiser Family Foundation from 2006 to 2010. We found stricter eligibility requirements reduce the number of HIV-positive individuals with ART access through ADAP, and decreased ART use increases mortality by 2.67 quality-adjusted life years (QALYs) per beneficiary. If the ADAP income eligibility cutoff were decreased by 50 percentage points in each state, 4,626 individuals would lose ART access nationwide. Based on a $22,143 cost/QALY, this policy would save $274 million in health care expenditures (2012 dollars), but result in 12,352 QALYs lost, valued at $1.2 billion. Therefore, states should exercise caution in restricting programs that increase ART access for low-income people living with HIV/AIDS., (© The Author(s) 2015.)
- Published
- 2016
- Full Text
- View/download PDF
29. Estimating the future burden of cardiovascular disease and the value of lipid and blood pressure control therapies in China.
- Author
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Stevens W, Peneva D, Li JZ, Liu LZ, Liu G, Gao R, and Lakdawalla DN
- Subjects
- Adult, Aged, Blood Pressure physiology, Cardiovascular Diseases economics, Cardiovascular Diseases epidemiology, China epidemiology, Female, Government Programs, Health Care Costs, Humans, Hyperlipidemias economics, Hyperlipidemias epidemiology, Hypertension economics, Hypertension epidemiology, Lipids blood, Male, Middle Aged, Morbidity, Myocardial Infarction economics, Myocardial Infarction epidemiology, Myocardial Infarction prevention & control, Prevalence, Risk Factors, Stroke economics, Stroke epidemiology, Stroke prevention & control, Cardiovascular Diseases prevention & control, Cost of Illness, Hyperlipidemias prevention & control, Hypertension prevention & control
- Abstract
Background: Lifestyle and dietary changes reflect an ongoing epidemiological transition in China, with cardiovascular disease (CVD) playing an ever-increasing role in China's disease burden. This study assessed the burden of CVD and the potential value of lipid and blood pressure control strategies in China., Methods: We estimated the likely burden of CVD between 2016 and 2030 and how expanded use of lipid lowering and blood pressure control medication would impact that burden in the next 15 years. Accounting for the costs of drug use, we assessed the net social value of a policy that expands the utilization of lipid and blood pressure lowering therapies in China., Results: Rises in prevalence of CVD risk and population aging would likely increase the incidence of acute myocardial infarctions (AMIs) by 75 million and strokes by 118 million, while the number of CVD deaths would rise by 39 million in total between 2016 and 2030. Universal treatment of hypertension and dyslipidemia patients with lipid and blood pressure lowering therapies could avert between 10 and 20 million AMIs, between 8 and 30 million strokes, and between 3 and 10 million CVD deaths during the 2016-2030 period, producing a positive social value net of health care costs as high as $932 billion., Conclusions: In light of its aging population and epidemiological transition, China faces near-certain increases in CVD morbidity and mortality. Preventative measures such as effective lipid and blood pressure management may reduce CVD burden substantially and provide large social value. While the Chinese government is implementing more systematic approaches to health care delivery, prevention of CVD should be high on the agenda.
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- 2016
- Full Text
- View/download PDF
30. The Rising Burden of Preeclampsia in the United States Impacts Both Maternal and Child Health.
- Author
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Shih T, Peneva D, Xu X, Sutton A, Triche E, Ehrenkranz RA, Paidas M, and Stevens W
- Subjects
- Child Health, Female, Gestational Age, Humans, Incidence, Infant, Infant, Newborn, Maternal Health, Pregnancy, Pregnancy Outcome, Risk Factors, United States, Cost of Illness, Infant Mortality trends, Maternal Mortality trends, Pre-Eclampsia epidemiology, Premature Birth epidemiology
- Abstract
Objective: Preeclampsia is one of the top six causes of maternal mortality in the United States (US) and is associated with considerable perinatal morbidity and mortality. Evidence suggests the US incidence of preeclampsia has increased dramatically over the past two decades. This study aims to compile, summarize, and critique the literature on the health and economic burden of preeclampsia and early-onset preeclampsia., Study Design: We reviewed the literature for estimates of burden of preeclampsia and early-onset preeclampsia to both mother and child, summarized the evidence on economic and social burden, and highlighted current gaps in the literature., Results: No recent studies comprehensively assess the costs and health consequences of preeclampsia or early-onset preeclampsia for both mother and child. Where it exists, the literature suggests preeclampsia and early-onset preeclampsia cause numerous adverse health consequences, but these conditions currently lack effective treatment. The need for preterm delivery from early-onset preeclampsia suggests its costs are substantial: very (28-31 weeks) and extremely (<28 weeks) preterm birth cost approximately 40 and 100 times a term pregnancy, respectively., Conclusion: Given the severity of outcomes from preeclampsia, further research on its health and economic consequences is essential to inform policy and resource allocation decisions in health care., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)
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- 2016
- Full Text
- View/download PDF
31. The value of surrogate endpoints for predicting real-world survival across five cancer types.
- Author
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Shafrin J, Brookmeyer R, Peneva D, Park J, Zhang J, Figlin RA, and Lakdawalla DN
- Subjects
- Aged, Clinical Trials, Phase III as Topic, Databases, Factual, Disease Progression, Disease-Free Survival, Female, Humans, Kaplan-Meier Estimate, Linear Models, Male, Medicare, Middle Aged, Odds Ratio, Prognosis, Randomized Controlled Trials as Topic, SEER Program, Survival Analysis, Treatment Outcome, United States, Biomarkers, Neoplasms epidemiology, Neoplasms mortality
- Abstract
Objective: It is unclear how well different outcome measures in randomized controlled trials (RCTs) perform in predicting real-world cancer survival. We assess the ability of RCT overall survival (OS) and surrogate endpoints - progression-free survival (PFS) and time to progression (TTP) - to predict real-world OS across five cancers., Methods: We identified 20 treatments and 31 indications for breast, colorectal, lung, ovarian, and pancreatic cancer that had a phase III RCT reporting median OS and median PFS or TTP. Median real-world OS was determined using a Kaplan-Meier estimator applied to patients in the Surveillance and Epidemiology End Results (SEER)-Medicare database (1991-2010). Performance of RCT OS and PFS/TTP in predicting real-world OS was measured using t-tests, median absolute prediction error, and R(2) from linear regressions., Results: Among 72,600 SEER-Medicare patients similar to RCT participants, median survival was 5.9 months for trial surrogates, 14.1 months for trial OS, and 13.4 months for real-world OS. For this sample, regression models using clinical trial OS and trial surrogates as independent variables predicted real-world OS significantly better than models using surrogates alone (P = 0.026). Among all real-world patients using sample treatments (N = 309,182), however, adding trial OS did not improve predictive power over predictions based on surrogates alone (P = 0.194). Results were qualitatively similar using median absolute prediction error and R(2) metrics., Conclusions: Among the five tumor types investigated, trial OS and surrogates were each independently valuable in predicting real-world OS outcomes for patients similar to trial participants. In broader real-world populations, however, trial OS added little incremental value over surrogates alone.
- Published
- 2016
- Full Text
- View/download PDF
32. HIV care providers emphasize the importance of the Ryan White Program for access to and quality of care.
- Author
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Sood N, Juday T, Vanderpuye-Orgle J, Rosenblatt L, Romley JA, Peneva D, and Goldman DP
- Subjects
- Adult, Case Management statistics & numerical data, HIV Infections prevention & control, HIV Infections therapy, HIV Infections transmission, Health Surveys, Humans, Insurance Coverage statistics & numerical data, Medicaid legislation & jurisprudence, Medically Uninsured legislation & jurisprudence, Medically Uninsured statistics & numerical data, Patient Protection and Affordable Care Act legislation & jurisprudence, Poverty legislation & jurisprudence, Poverty statistics & numerical data, Quality Assurance, Health Care legislation & jurisprudence, Safety-net Providers statistics & numerical data, United States, Utilization Review, Attitude of Health Personnel, HIV Infections epidemiology, Health Services Accessibility legislation & jurisprudence, Medicaid statistics & numerical data, Patient Protection and Affordable Care Act statistics & numerical data, Quality Assurance, Health Care statistics & numerical data, Safety-net Providers legislation & jurisprudence
- Abstract
With the implementation of the Affordable Care Act (ACA) under way, some policy makers have questioned the continued relevance of the Ryan White HIV/AIDS Program as a safety net for people living with HIV/AIDS. We surveyed HIV care providers to understand the role of the Ryan White Program and to identify concerns regarding the ACA implementation. We also addressed whether the program is still relevant after ACA implementation and, if so, what elements should be retained. We found that providers consider the Ryan White Program to be critical in facilitating high-quality care for people living with HIV/AIDS. Most of the providers highlighted the program's support for providing medical and nonmedical case management as especially valuable and important to the entire continuum of care and for all patient subpopulations. Whether care is supplied by the Ryan White Program, Medicaid, or other means, our findings suggest that case management services will remain critical in treating HIV/AIDS as the health care landscape continues to evolve.
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- 2014
- Full Text
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33. Influence of health information levels on postpartum depression.
- Author
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Youash S, Campbell MK, Avison W, Penava D, Sharma V, and Xie B
- Subjects
- Adult, Depression, Postpartum epidemiology, Depression, Postpartum psychology, Female, Health Care Surveys, Humans, Parity, Patient Education as Topic, Postnatal Care, Pregnancy, Prenatal Care, Risk Factors, Socioeconomic Factors, Consumer Health Information, Health Knowledge, Attitudes, Practice, Mothers psychology
- Abstract
While extensive research has been conducted on postpartum depression (PPD), the majority has been focused on psychological risk factors and treatments. There is limited research on the explicit relationship between the degree to which individuals are informed about relevant prenatal and postnatal health topics and whether this level of knowledge influences psychological outcome. This study assesses health information levels of new mothers and their influence on PPD as measured by Edinburgh Postnatal Depression Scale (EPDS) scores. Data from the 2006 Maternity Experiences Survey developed by the Canadian Perinatal Surveillance System (N = 6,421) were used. The study population included mothers ≥15 years of age at the time of the birth, who had a singleton live birth in Canada during a 3-month period preceding the 2006 Census and who lived with their infants at the time of the survey. Pre- and postnatal health information components were measured using latent variables constructed by structural equation modeling. EPDS score was added to the model, adjusting for known covariates to assess the effects of information levels on EPDS score. Pre- and postnatal health information levels are associated with decreased EPDS scores. More specifically, information on topics such as postnatal concerns and negative feelings was associated with the largest decrease in score for primiparous and multiparous women, respectively (p < 0.0001 for both). The pre-established predictors of PPD were confirmed for both samples, with life stress associated with the largest change in EPDS score for both samples (p < 0.0001 for both). This study demonstrates a distinct role for pre- and postnatal health information in influencing EPDS scores, supplementing previous literature. Primiparous and multiparous women benefited from different information content, with information on postnatal concerns had the largest effect on the primiparous group while information on negative feelings had the largest effect on the multiparous group. Therefore, information provision should be tailored to these two groups.
- Published
- 2013
- Full Text
- View/download PDF
34. Substantial health and economic returns from delayed aging may warrant a new focus for medical research.
- Author
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Goldman DP, Cutler D, Rowe JW, Michaud PC, Sullivan J, Peneva D, and Olshansky SJ
- Subjects
- Age Factors, Persons with Disabilities statistics & numerical data, Humans, Life Expectancy, Medicare economics, Social Security, United States, Aging, Biomedical Research, Cost Savings, Longevity, Population Dynamics
- Abstract
Recent scientific advances suggest that slowing the aging process (senescence) is now a realistic goal. Yet most medical research remains focused on combating individual diseases. Using the Future Elderly Model--a microsimulation of the future health and spending of older Americans--we compared optimistic "disease specific" scenarios with a hypothetical "delayed aging" scenario in terms of the scenarios' impact on longevity, disability, and major entitlement program costs. Delayed aging could increase life expectancy by an additional 2.2 years, most of which would be spent in good health. The economic value of delayed aging is estimated to be $7.1 trillion over fifty years. In contrast, addressing heart disease and cancer separately would yield diminishing improvements in health and longevity by 2060--mainly due to competing risks. Delayed aging would greatly increase entitlement outlays, especially for Social Security. However, these changes could be offset by increasing the Medicare eligibility age and the normal retirement age for Social Security. Overall, greater investment in research to delay aging appears to be a highly efficient way to forestall disease, extend healthy life, and improve public health.
- Published
- 2013
- Full Text
- View/download PDF
35. Examining the pathways of pre- and postnatal health information.
- Author
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Youash S, Campbell MK, Avison W, Peneva D, and Xie B
- Subjects
- Adolescent, Adult, Canada, Female, Health Knowledge, Attitudes, Practice, Humans, Infant, Needs Assessment, Parity, Pregnancy, Socioeconomic Factors, Young Adult, Consumer Health Information statistics & numerical data, Postnatal Care, Prenatal Care
- Abstract
Objectives: The objectives of our study were to 1) assess Canadian women's health information levels regarding pre- and postnatal topics in both primiparous and multiparous samples, and 2) identify factors associated with levels of health information in both groups and the pathways of such associations., Methods: Data from the 2006 Maternity Experiences Survey developed by the Canadian Perinatal Surveillance System (N=6,421) were used. The study population included mothers ≥15 years of age at the time of the birth, who had a singleton live birth in Canada during a three-month period preceding the 2006 Census and who lived with their infants at the time of the survey. Structural equation modeling was used to identify and examine pre- and postnatal acquired health information components in both samples and to assess factors that may influence this level of information., Results: Primiparous and multiparous women perceived insufficient levels of information on similar topics: pain medication/anesthesia, warning signs/complications, formula feeding and changes in sexual responses. This common finding underscored that these informational needs had a large impact on the entire population of pregnant women, rather than being parity-specific. Level of perceived social support was positively associated with information acquisition on all health topics studied in both samples (p<0.0001 for both). Income was also positively associated with information levels to a similar extent on a range of topics in both samples (p<0.0001 - p<0.05)., Conclusions: Canadian primiparous and multiparous women perceived an inadequate level of information on the same topics, identifying knowledge gaps that should be addressed. Perceived level of social support and income significantly influenced information levels on pre- and postnatal health topics. Therefore women with low income and those with perceived lack of social support may be identified by health care providers as requiring additional health information.
- Published
- 2012
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