Challenges and Benefits in Using Productivity Data from Clinical Trials for VBP Decisions

Making value based purchasing decisions in healthcare requires balancing data from several sources. Information on effectiveness of interventions often comes from clinical trials, with less reliance on observational studies. Historically, the opposite has been true of information on the cost of interventions. More recently, providers of healthcare interventions such as drugs, devices, and disease management programs have begun to understand and appreciate the importance of costs in healthcare decision making. Because of this, the clinical trials used to demonstrate effectiveness have begun to gather data on costs. This article describes some benefits and detriments of collecting cost data as a component of clinical trials, focusing specifically on the data related to productivity

Cost Effectiveness of a Home-Based Intervention That Helps Functionally Vulnerable Older Adults Age in Place at Home

Evaluating cost effectiveness of interventions for aging in place is essential for adoption in service settings. We present the cost effectiveness of Advancing Better Living for Elders (ABLE), previously shown in a randomized trial to reduce functional difficulties and mortality in 319 community-dwelling elders. ABLE involved occupational and physical therapy sessions and home modifications to address client-identified functional difficulties, performance goals, and home safety. Incremental cost-effectiveness ratio (ICER), expressed as additional cost to bring about one additional year of life, was calculated. Two models were then developed to account for potential cost differences in implementing ABLE. Probabilistic sensitivity analyses were conducted to account for variations in model parameters. By two years, there were 30 deaths (9: ABLE; 21: control). Additional costs for 1 additional year of life was $13,179 for Model 1 and$14,800 for Model 2. Investment in ABLE may be worthwhile depending on society's willingness to pay

From product dispensing to patient care: The role of the pharmacist in providing pharmaceutical care as part of an integrated disease management approach

During the past decade, the profession of pharmacy has changed dramatically. The Doctor of Pharmacy degree has replaced the Bachelor of Science degree as the first professional degree offered at most accredited U.S. pharmacy schools. Advanced clinical training is now a mainstay of pharmacy training, and this has enabled pharmacists to contribute to disease management efforts. In addition, technological improvements in prescription processing have afforded pharmacists more time to participate in disease management activities. This paper describes how the role of the pharmacist has changed and reviews the results of programs involving pharmacists as disease management providers in the areas of asthma, hypertension, diabetes, and hyperlipidemia. Pharmacists\u27 contributions in various practice settings are also discussed

How does quality enter into health care purchasing decisions?

A number of employers, business consortia, and public purchasers are promoting value-based purchasing as a way to improve the quality of patient care. Some purchasers are using publicly available information on health plan and provider performance to make their health plan and provider choices, while others are using their market power to drive improvements in patient care and safety. This article examines six key strategies used by purchasers

Non-adherence to eye care in people with diabetes

Objective Evaluate individual factors that impact adherence to eye care follow-up in patients with diabetes. Design and methods A 4-year retrospective chart review was conducted for 1968 patients with diabetes over age 40 from an urban academic center. Data collected included demographics, insurance, visual acuity, smoking status, medications, dates of dilated fundus examinations (DFE), and reported hemoglobin A1C and blood glucose levels. The primary outcome was timely DFE follow-up adherence following the initial eye exam visit. Results Overall, 41.6% of patients adhered to initial follow-up eye care recommendations. Multivariable analysis demonstrated that patients with severe diabetic retinopathy (DR) were more adherent than patients with mild DR (OR 1.86). Other variables associated with increased adherence were visual impairment and reported A1C or blood glucose. Smoking was associated with decreased adherence. Ethnicity and insurance were also significantly associated with adherence. Longitudinal follow-up rates were influenced by additional factors, including ethnicity and neighborhood deprivation index. Conclusions Patients with moderate to severe DR and/ or visual impairment were more likely to adhere to timely DFE follow-up. This could relate to the presence of visual symptoms and/or other systemic manifestations of diabetes. Smokers were less likely to adhere to timely DFE follow-up. One hypothesis is patients who smoke have other symptomatic health problems which patients prioritize over asymptomatic ocular disorders. In order to reduce vision loss from DR, practitioners should be aware that patients with mild and moderate DR, patients with normal vision, and smokers are at greater risk for poor follow-up eye care adherence. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved

Ferric Gluconate Yields Cost-Savings in Hemodialysis Patients with High Ferritin and Low TSAT: Results from the DRIVE Studies

Purpose: One third of hemodialysis patients have high serum ferritin levels and low transferrin saturation (TSAT). The purpose of this analysis was to determine the cost effectiveness of administering 1g of sodium ferric gluconate complex (SFGC: also referred to as ferric gluconate) to patients with serum ferritin \u3e500ng/mL and TSAT ≤25% based on the Dialysis Patients Response to IV Iron with Elevated Ferritin (DRIVE) study and its 6-week observational extension (DRIVE-II). In these studies, IV iron administration resulted in reduced epoetin requirements. Methods: Decision analysis was performed using a time horizon of 12 weeks, consistent with the combined duration of DRIVE and DRIVE II. Treatment effectiveness was based on mean increase in hemoglobin (Hb) for each group (SFGC plus epoetin or epoetin alone) in the intention to treat populations. Costs included drugs (SFGC and epoetin) and hospitalizations due to serious adverse events (SAEs) reported. The primary cost effectiveness measure was cost per g/dL of Hb increase at 12 weeks. Costs were computed from a Medicare perspective using projected 2007 reimbursements. Sensitivity analyses were performed to test the impact of using the safety population, median epoetin and SFGC doses, actual 2005 Medicare reimbursements, median increases in Hb, and SAE rate changes. The model was constructed using TreeAge Pro software. Results: Total cost per patient receiving SFGC plus epoetin was $3675 per g/dL Hb increase, while the total cost per patient receiving epoetin alone was$5065 per g/dL Hb increase. Net savings for SFGC plus epoetin was $1390 per g/dL Hb increase over the 12 week period Sensitivity analyses affirmed the robustness of the model. Conclusion: Administering 1g of SFGC plus epoetin in patients with high ferritin and low TSAT as defined in the DRIVE studies resulted in significant cost-savings compared to epoetin alone

Diagnosing Crohn\u27s Disease: An economic analysis comparing wireless capsule endoscopy with traditional diagnostic procedures

The purpose of this study was to review economic considerations related to establishing a diagnosis of Crohn\u27s disease, and to compare the costs of a diagnostic algorithm incorporating wireless capsule endoscopy (WCE) with the current algorithm for diagnosing Crohn\u27s disease suspected in the small bowel. Published literature, clinical trial data on WCE in comparison to other diagnostic tools, and input from clinical experts were used as data sources for (1) identifying contributors to the costs of diagnosing Crohn\u27s disease; (2) exploring where WCE should be placed within the diagnostic algorithm for Crohn\u27s; and (3) constructing decision tree models with sensitivity analyses to explore costs (from a payor perspective) of diagnosing Crohn\u27s disease using WCE compared to other diagnostic methods. Literature review confirms that Crohn\u27s disease is a significant and growing public health concern from clinical, humanistic and economic perspectives, and results in a long-term burden for patients, their families, providers, insurers, and employers. Common diagnostic procedures include radiologic studies such as small bowel follow through (SBFT), enteroclysis, CT scans, ultrasounds, and MRIs, as well as serologic testing, and various forms of endoscopy. Diagnostic costs for Crohn\u27s disease can be considerable, especially given the cycle of repeat testing due to the low diagnostic yield of certain procedures and the inability of current diagnostic procedures to image the entire small bowel. WCE has a higher average diagnostic yield than comparative procedures due to imaging clarity and the ability to visualize the entire small bowel. Literature review found the average diagnostic yield of SBFT and colonoscopy for work-up of Crohn\u27s disease to be 53.87%, whereas WCE had a diagnostic yield of 69.59%. A simple decision tree model comparing two arms--colonoscopy and SBFT, or WCE--estimates that WCE produces a cost savings of 291dollars for each case presenting for diagnostic work-up for Crohn\u27s. Sensitivity analysis varying diagnostic yields of colonoscopy and SBFT vs. WCE demonstrates that WCE is still less costly than SBFT and colonoscopy even at their highest reported yields, as long as the diagnostic yield of WCE is 64.10% or better. Employing WCE as a first-line diagnostic procedure appears to be less costly, from a payor perspective, than current common procedures for diagnosing suspected Crohn\u27s disease in the small bowel. Although not addressed in this model, earlier diagnosis with WCE (due to higher diagnostic yield) also could lead to earlier management, improved quality of life and workplace productivity for people with Crohn\u27s disease

Cost-Benefit Analysis of the COPE Program for Persons Living With Dementia: Toward a Payment Model

Background and objectives: There is a critical need for effective interventions to support quality of life for persons living with dementia and their caregivers. Growing evidence supports nonpharmacologic programs that provide care management, disease education, skills training, and support. This cost-benefit analysis examined whether the Care of Persons with Dementia in their Environments (COPE) program achieves cost savings when incorporated into Connecticut\u27s home- and community-based services (HCBS), which are state- and Medicaid-funded. Research design and methods: Findings are based on a pragmatic trial where persons living with dementia and their caregiver dyads were randomly assigned to COPE with HCBS, or HCBS alone. Cost measures included those relevant to HCBS decision makers: intervention delivery, health care utilization, caregiver time, formal care, and social services. Data sources included care management records and caregiver report. Results: Per-dyad mean cost savings at 12 months were $2 354 for those who received COPE with a mean difference-in-difference of -$6 667 versus HCBS alone (95% CI: -$15 473,$2 734; not statistically significant). COPE costs would consume 5.6%-11.3% of Connecticut\u27s HCBS annual spending limit, and HCBS cost-sharing requirements align with participants\u27 willingness to pay for COPE. Discussion and implications: COPE represents a potentially cost-saving dementia care service that could be financed through existing Connecticut HCBS. HCBS programs represent an important, sustainable payment model for delivering nonpharmacological dementia interventions such as COPE

A community-integrated home based depression intervention for older African Americans: descripton of the Beat the Blues randomized trial and intervention costs

ABSTRACT: BACKGROUND: Primary care is the principle setting for depression treatment; yet many older African Americans in the United States fail to report depressive symptoms or receive the recommended standard of care. Older African Americans are at high risk for depression due to elevated rates of chronic illness, disability and socioeconomic distress. There is an urgent need to develop and test new depression treatments that resonate with minority populations that are hard-to-reach and underserved and to evaluate their cost and cost-effectiveness. METHODS/DESIGN: Beat the Blues (BTB) is a single-blind parallel randomized trial to assess efficacy of a non-pharmacological intervention to reduce depressive symptoms and improve quality of life in 208 African Americans 55+ years old. It involves a collaboration with a senior center whose care management staff screen for depressive symptoms (telephone or in-person) using the Patient Health Questionnaire (PHQ-9). Individuals screened positive (PHQ-9 ≥ 5) on two separate occasions over 2 weeks are referred to local mental health resources and BTB. Interested and eligible participants who consent receive a baseline home interview and then are randomly assigned to receive BTB immediately or 4 months later (wait-list control). All participants are interviewed at 4 (main study endpoint) and 8 months at home by assessors masked to study assignment. Licensed senior center social workers trained in BTB meet with participants at home for up to 10 sessions over 4 months to assess care needs, make referrals/linkages, provide depression education, instruct in stress reduction techniques, and use behavioral activation to identify goals and steps to achieve them. Key outcomes include reduced depressive symptoms (primary), reduced anxiety and functional disability, improved quality of life, and enhanced depression knowledge and behavioral activation (secondary). Fidelity is enhanced through procedure manuals and staff training and monitored by face-to-face supervision and review of taped sessions. Cost and cost effectiveness is being evaluated. DISCUSSION: BTB is designed to bridge gaps in mental health service access and treatments for older African Americans. Treatment components are tailored to specific care needs, depression knowledge, preference for stress reduction techniques, and personal activity goals. Total costs are $584.64/4 months; or$146.16 per participant/per month. TRIAL REGISTRATION: ClinicalTrials.gov #NCT00511680

1B/(−)IRE DMT1 Expression during Brain Ischemia Contributes to Cell Death Mediated by NF-κB/RelA Acetylation at Lys310

The molecular mechanisms responsible for increasing iron and neurodegeneration in brain ischemia are an interesting area of research which could open new therapeutic approaches. Previous evidence has shown that activation of nuclear factor kappa B (NF-κB) through RelA acetylation on Lys310 is the prerequisite for p50/RelA-mediated apoptosis in cellular and animal models of brain ischemia. We hypothesized that the increase of iron through a NF-κB-regulated 1B isoform of the divalent metal transporter-1 (1B/DMT1) might contribute to post-ischemic neuronal damage. Both in mice subjected to transient middle cerebral artery occlusion (MCAO) and in neuronally differentiated SK-N-SH cells exposed to oxygen-glucose-deprivation (OGD), 1A/DMT1 was only barely expressed while the 1B/DMT1 without iron-response-element (−IRE) protein and mRNA were early up-regulated. Either OGD or over-expression of 1B/(−)IRE DMT1 isoform significantly increased iron uptake, as detected by total reflection X-ray fluorescence, and iron-dependent cell death. Iron chelation by deferoxamine treatment or (−)IRE DMT1 RNA silencing displayed significant neuroprotection against OGD which concomitantly decreased intracellular iron levels. We found evidence that 1B/(−)IRE DMT1 was a target gene for RelA activation and acetylation on Lys310 residue during ischemia. Chromatin immunoprecipitation analysis of the 1B/DMT1 promoter showed there was increased interaction with RelA and acetylation of H3 histone during OGD exposure of cortical neurons. Over-expression of wild-type RelA increased 1B/DMT1 promoter-luciferase activity, the (−)IRE DMT1 protein, as well as neuronal death. Expression of the acetylation-resistant RelA-K310R construct, which carried a mutation from lysine 310 to arginine, but not the acetyl-mimic mutant RelA-K310Q, down-regulated the 1B/DMT1 promoter, consequently offering neuroprotection. Our data showed that 1B/(−)IRE DMT1 expression and intracellular iron influx are early downstream responses to NF-κB/RelA activation and acetylation during brain ischemia and contribute to the pathogenesis of stroke-induced neuronal damage