Background and Purpose
The IMS III study tested the effect of IV t-PA alone as compared to IV t-PA followed by endovascular therapy and collected cost data to assess the economic implications of the two therapies. This report describes the factors affecting the costs of the initial hospitalization for acute stroke subjects from the US.
Prospective cost analysis of US subjects treated with IV t-PA alone or IV t-PA followed by endovascular therapy in the IMS III trial. Results compared to expected Medicare payments.
The adjusted cost of a stroke admission in the study was $35,130 for subjects treated with endovascular therapy following IV t-PA treatment and $25,630 for subjects treated with IV t-PA alone (p<0.0001). Significant factors related to costs included treatment group, baseline NIH Stroke Scale, time from stroke onset to IV t-PA, age, stroke location, and comorbid diabetes. The mean cost for subjects who had routine use of general anesthesia as part of endovascular therapy was $46,444 as compared to $30,350 for those who did not have general anesthesia. The costs of embolectomy for IMS III subjects and patients from the NIS cohort exceeded the Medicare DRG payment in more than 75% of patients.
Minimizing the time to start of IV t-PA and decreasing the use of routine general anesthesia, may improve the cost-effectiveness of medical and endovascular therapy for acute stroke.
stroke; cost; hospital; acute; ischemic; reperfusion; arterial; IMS III
The prevalence of HIV drug resistance varies with geographic location, year, and treatment exposure. This study generated yearly estimates of nonnucleoside reverse transcriptase inhibitor (NNRTI) resistance in treatment-naive (TN) and treatment-experienced (TE) patients in the United States (US), Europe (EU), and Canada. Studies reporting NNRTI resistance identified in electronic databases and 11 conferences were analyzed in three groups: (1) TN patients in one of four geographic regions [US, Canada, EU countries with larger surveillance networks (“EU1”), and EU countries with fewer data (“EU2”)]; (2) TE patients from any region; and (3) TN patients failing NNRTI-based treatments in clinical trials. Analysis data included 158 unique studies from 22 countries representing 84 cohorts of TN patients, 21 cohorts of TE patients, and 8 trials reporting resistance at failure. From 1995 to 2000, resistance prevalence in TN patients increased in US and EU1 from 3.1% to 7.5% and 0.8% to 3.6%, respectively. Resistance in both regions stabilized in 2006 onward. Little resistance was identified in EU2 before 2000, and increased from 2006 (5.0%) to 2010 (13.7%). One TN Canadian study was identified and reported resistance of 8.1% in 2006. Half of TN clinical trial patients had resistance after treatment failure at weeks 48–144. Resistance in TE patients increased from 1998 (10.1%) to 2001 (44.0%), then decreased after 2004. Trends in NNRTI resistance among TN patients show an increased burden in the US and some EU countries compared to others. These findings signify a need for alternate first-line treatments in some regions.
Background and Purpose
Little is known about the contribution of aphasia to the cost of care for patients who experience stroke.
We retrospectively examined a cohort of South Carolina Medicare beneficiaries who experienced an ischemic stroke in 2004 to determine the attributable cost of aphasia. Univariate analyses were used to compare demographic, comorbidity, and severity differences between individuals with post-stroke aphasia and those without aphasia. Differences in payments by Medicare due to stroke were examined using a Gamma distributed generalized linear multivariable model.
3,200 Medicare beneficiaries experienced an ischemic stroke in South Carolina in 2004 and 398 had post-stroke aphasia. Patients with aphasia experienced longer length of stays, greater morbidity, and greater mortality. In adjusted models that controlled for relevant covariates, the attributable one-year cost of aphasia was estimated at $1703.
Aphasia adds to the cost of stroke-related care, above the cost of stroke alone.
The purpose of this investigation was to examine the economic impact of performing elective repeat cesarean during the 37th or 38th week of gestation relative to the ACOG recommendation of 39 week delivery.
Decision analysis modeling was used to estimate economic outcomes for a hypothetical cohort of neonates using data from the NICHD/MFMU study entitled “Timing of elective repeat cesarean delivery at term and neonatal outcomes.” Costs and charges were estimated using the Florida Healthcare Cost and Utilization Project.
82,541 deliveries occurring between 37–39 complete weeks gestation were analyzed for the incidence of adverse outcomes and their hospital costs and charges. The model demonstrated increased costs through increasing adverse outcomes among elective repeat cesarean deliveries performed prior to 39 weeks gestation.
Our findings suggest that there are benefits to waiting until 39 weeks of gestation to perform an elective repeat cesarean delivery.
cost effectiveness; adverse outcomes; economic; neonatal intensive care
Limited research exists that investigates hospital admissions for ambulatory care sensitive conditions (ACSCs) among the homeless, who frequently lack a usual source of care. This study profiled ACSC admissions for homeless patients.
Bivariate analyses and logistic regression were completed to investigate ACSC and non-ACSC admissions among homeless patients using the 2010 California State Inpatient Database.
Homeless patients admitted for an ACSC were mostly male, non-Hispanic white, and on average 49.9 years old. In the predictive model, the odds of an ACSC admission among homeless patients increased when they were black, admitted to the emergency department or transferred from another health facility. Having Medicare was associated with a decreased odds of an ACSC admission.
Specific characteristics are associated with a greater likelihood of an ACSC admission. Research should examine how these characteristics contribute to ACSC hospitalizations and findings should be linked to programs designed to serve as a safety-net for homeless patients to reduce hospitalizations.
Homeless; Ambulatory care sensitive conditions; Primary care access
A critical shortage in the supply of physicians in the United States has necessitated innovative approaches to physician service delivery. Telemedicine is a viable service delivery model for a variety of physician and health services. Telemedicine is most effective when applied where physician resources are scarce, patient care is time sensitive, and service volume may be distributed across a network. Shortages in critical care and neurology specialists have led to the use of tele-intensive care unit and telestroke services in hospital settings. These hospital-based telemedicine services have gained acceptance and recommendation. Hospitalist staffing shortages may provide an opportunity to apply similar telemedicine models to hospitalist medicine. This study assesses the potential market for a nighttime telehospitalist service.
Materials and Methods:
An analysis of the Florida state hospital discharge dataset investigated the potential market for a new nighttime telehospitalist service. Admissions were filtered and stratified for common hospitalist metrics, time of day, and age of patients. Admissions were further expressed by hour of day and location.
Nineteen percent of common hospitalist admissions occurred between 7:00 p.m. and 7:00 a.m., with a range of 17%–27% or 0.23–10.09 admissions per night per facility. Eighty percent of admissions occurred prior to midnight. Nonrural facilities averaged 6.69 hospitalist admissions per night, whereas rural facilities averaged 1.35 admissions per night.
The low volume of nighttime admissions indicates an opportunity to leverage a telehospitalist physician service to deliver inpatient medical admission services across a network. Lower volumes of nighttime admissions in rural facilities may indicate a market for telehospitalist solutions to address the dilemma of hospitalist staffing shortages.
business administration/economics; telemedicine; telehealth; commercial telemedicine
Chronic Kidney disease (CKD) is prevalent in the population, but also disproportionately affects African Americans. Disparities in care of chronic kidney disease and transplant for African Americans have also been reported. The purpose of this study is to determine the knowledge and reactions of chronic kidney disease patients regarding their disease, as perceived by nephrologists and clinic nurses in South Carolina.
Using a qualitative approach, key informant interviews were conducted with nephrologists, and three focus groups were held with nurses who specialize in chronic kidney disease. The results were recorded, transcribed, and analyzed using Qualrus software and the Grounded Theory Method.
Dominant themes in the interviews and focus groups include: reaction to chronic kidney disease, differences in race, patient thoughts on dialysis, patient knowledge of types of treatment available, information availability, compliance to treatment, information source, and thoughts on kidney transplantation. The study found that the majority of clinicians agreed that there is typically a wide range of reactions in patients with chronic kidney disease.
The majority of chronic kidney disease patients remain in denial of their diagnosis and do not want to agree to the necessary treatment to improve their condition. In addition, the clinicians reported that the incidence of chronic kidney disease is highest in the African American population and this population of patients typically gets their information on the disease from peers, others they have known that have had renal failure. We find clinicians report that patients typically do not remain compliant to recommended treatment regimens due to lack of knowledge and feelings of denial and fear, and frequently use religiosity as a coping mechanism. Silent progression and complexity of chronic kidney disease frequently result in many patients lacking essential knowledge and developing poor coping mechanisms to seek appropriate follow-up care and prevent progression and optimize outcome. Health care providers are aware of the barriers but may lack the tools and resources to overcome them.
Chronic kidney disease; African American; Disparities
Patient-reported outcomes (PROs) may provide valuable information to clinicians and patients when choosing initial antiretroviral therapy.
To identify and classify PRO instruments used to measure treatment effects in clinical trials evaluating NNRTIs.
We conducted a structured literature review using PubMed to identify NNRTI trials published from March 2003 to February 2013. Studies identified--based on disease, instrument, PRO, and NNRTI medication terms were reviewed--to identify PRO instruments. Domains measured within each instrument were recorded to understand key areas of interest in NNRTIs.
Of 189 articles reviewed, 27 validated instruments were administered in 26 unique trials, with a mean of 1.9 instruments (median: 1; range: 1–7) per trial. The Medical Outcomes Study HIV Health Survey (MOS-HIV) was the most commonly used instrument (n = 8 trials). Seventeen trials (65%) included at least one multidimensional health-related quality of life (HRQL) instrument (HIV-targeted, n = 11; general, n = 8). Other validated instruments measured sleep (n = 5), depression (n = 5), anxiety (n = 4), psychiatric symptoms (n = 2), beliefs about HIV medications (n = 2), HIV symptoms (n = 1), and stress (n = 1).
Although review of recent NNRTI trials suggests a lack of consensus on the optimal PRO instruments, a typical battery is comprised of a multidimensional HRQL measure coupled with one or more symptom measures. Further work is needed to clarify advantages and disadvantages of using specific PRO instruments to measure relevant constructs and to identify the most useful batteries of instruments for NNRTI trials.
HIV; Patient-reported outcome (PRO); Instrument; NNRTI
End stage renal disease impacts many Americans, however, transplant is the best treatment option increasing life years and offering a higher quality of life than possible with dialysis. Ironically, many who are eligible for transplant do not follow through on the complex work-up protocols required to be placed on the transplant waiting list. Here we surveyed vascular access clinic patients at an academic medical center referred for transplant that did not follow up on the needed work-up to be added to the national transplant waiting list. The most frequent responses of 83 patients for not pursuing transplantation were that the patients did not think they would pass the medical tests, they were scared of getting a transplant, and they could not afford the medicine or the transplantation. These impediments may result from unclear provider communication, misinformation received from peers or other sources, misperceptions related to transplant surgery, or limited health literacy/health decision making capacity. Thus, patients with end stage renal disease lost to follow up after referral for kidney transplant faced both real and perceived barriers pursuing transplantation.
Lost to follow up; ESRD; Access to Kidney Transplant; Barriers to Transplant
Stroke is the fourth leading cause of death in the United States, and its incidence is especially high in South Carolina. Recombinant tissue plasminogen activator (rtPA) has been given to patients with acute ischemic stroke since 1996 and has shown overall improved outcomes relative to patients who are not treated with rtPA.
A 1998 study by Fagan and colleagues reported the economic impact of the use of rtPA. The purpose of this current article is to present an updated economic analysis of the impact of rtPA.
In the current analysis, an updated estimate of the economic and health benefits of treatment with rtPA in South Carolina was provided using estimates of cost, incidence, and course of treatment from several data sources. The Markov model in the 1998 study was used as a guide in this current study; we sought to replicate the methodology, while providing updated economic figures and applying it to the state of South Carolina. We estimated the costs per 1000 patients who are eligible for treatment with rtPA compared with 1000 untreated patients, as well as routine medical practice and outcomes of quality-adjusted life-years (QALYs) and economic costs based on whether a patient was treated with rtPA or not. We calculated the number of stroke cases that would be treated with rtPA if the rate were to increase from 3% to 20%, using the most recent number of strokes in South Carolina and prorating for 5 years to estimate the total expected cost-savings with increased rtPA use.
The results indicate that the use of rtPA in South Carolina accounts for a cost-savings of $3454 per treated patient over a 6-year period. The model estimates an increase of 0.425 QALYs (or 5.1 quality-adjusted months) of survival per patient treated with rtPA. Over the lifetime of a treated patient, the estimated cost-savings are $4084, with an accrued health benefit of 0.692 QALYs (or 8.3 quality-adjusted months). For every 100 patients treated with rtPA, there is a gain of 69.17 QALYs and of $408,419 over the lifetime of 100 treated patients with acute ischemic stroke. We calculated that the cost-savings gained by increasing the rtPA treatment rate in a state with a high incidence of stroke from the current 3% rate to an achievable 20% rate over a 5-year period would be $16,615,723.
This new analysis demonstrates a significant savings associated with the use of rtPA for patients with stroke and provides great support for the increased systematic use of rtPA in the state of South Carolina for patients with acute ischemic stroke. For every additional 100 patients who are treated with rtPA in South Carolina, a robust savings supports the wider economic benefit that would be gained with an increased use of rtPA.
Selection of an appropriate patient-reported outcome (PRO) instrument for a clinical trial requires knowledge of the instrument’s responsiveness to detecting treatment effects. The purpose of this study was to examine the responsiveness of two health-related quality of life (HRQL) instruments used in clinical trials involving HIV-infected adults: the HIV-targeted Medical Outcomes Study HIV Health Survey (MOS-HIV), and a generic measure, the EuroQol-5D (EQ-5D).
A systematic review identified clinical trials using the MOS-HIV or EQ-5D to assess outcomes for HIV-infected adults. Data abstracted from each study included study type, treatment regimen(s), PRO results, and effect size (either reported or calculated). Effect size was calculated as the difference between baseline and follow-up mean scores divided by the baseline standard deviation. Magnitude was categorized as small (d=0.20), medium (d=0.50), and large (d=0.80).
Between 2005 and 2010, the MOS-HIV was administered in 12 trials. Significant differences were observed between groups and over time in physical health summary (PHS) and mental health summary (MHS) scores (P<0.05) in subjects switching therapy after experiencing Grade-2 adverse events. Effect sizes were medium (0.55 and 0.49 for PHS and MHS, respectively) among treatment-naïve adults beginning therapy (two studies), but negligible among treatment-experienced adults (0.04 and 0.13 for PHS and MHS, respectively; three studies). The EQ-5D was used in five trials between 2001 and 2010. It was responsive to occurrences of adverse events and opportunistic infections, with small-to-medium effect sizes (range 0.30–0.50) in each of its five dimensions.
A systematic review of PRO study results showed both the MOS-HIV and EQ-5D were responsive to changes between groups and/or over time in treatment-naïve HIV-infected patients. These instruments may be used either individually or together in clinical trials to measure changes in HRQL.
HIV; Patient-reported outcome (PRO); MOS-HIV; EQ-5D; NNRTI
Objective. To project the increased incidence of HIV and subsequent costs resulting from the expected decreased rate of circumcision due to Medicaid defunding in one southeastern state. Methods. Using 2009 South Carolina (SC) Medicaid birth cohort (n = 29, 316), we calculated expected heterosexually acquired HIV cases at current circumcision rates. To calculate age/race/gender specific HIV incidence rates, we used 2009 South Carolina Department of Health and Environmental Control reported gender and race specific HIV cases, CDC reported age distribution of HIV cases, and 2009 S.C. population data. Accounting for current circumcision rates, we calculated the change in incidence of heterosexually acquired HIV assuming circumcision provides 60% protection against HIV transmission to males and 46% protection against male to female transmission. Published lifetime cost of HIV was used to calculate the cost of additional HIV cases. Results. Assuming Medicaid circumcision rates decrease from current nationally reported levels to zero secondary to defunding, we project an additional 55 male cases of HIV and 47 female cases of HIV among this birth cohort. The total cost discounted to time of infection of these additional HIV cases is $20,924,400 for male cases and $17,711,400 for female cases. The cost to circumcise males in this birth cohort at currently reported rates is $4,856,000. Conclusions. For every year of decreased circumcision rates due to Medicaid defunding, we project over 100 additional HIV cases and $30,000,000 in net medical costs.
This study examines the cost and consequences of initiating an ARV regimen including Lopinavir/ritonavir (LPV/r) or Efavirenz (EFV), using data from a recent clinical trial in a previously published model of HIV-disease.
We populated the Markov model of HIV-disease with data from ACTG 5142 study to estimate the economic outcomes of starting ARV therapy with a PI-containing regimen as compared to an NNRTI-containing regimen, given their virologic and immunologic efficacy and effects on cholesterol and lipoatrophy. CNS toxicities and GI tolerability were not included in the model because of their transient nature or low cost remedies, and therefore lack of economic impact. CD4+ T-cell counts and the HIV-1 RNA (viral load) values from the study were used to assign a specific health state (HS) to each patient for each quarter year. The resulting frequencies used as "raw" data directly into the model obviate the reliance on statistical tests, and allow the model to reflect actual patient behavior in the clinical trial. An HS just below the last observed HS was used to replace a missing value.
The modeled estimates (undiscounted) for the LPV/r-based regimen resulted in 1.41 quality-adjusted life months (QALMs) gained over a lifetime compared to the EFV-based regimen. The LPV/r-based regimen incurred $7,458 (1.8%) greater cost over a lifetime due to differences in drug costs and survival. The incremental cost effectiveness ratio using the discounted cost and QALYs was $88,829/QALY. Most of the higher costs accrue before the 7th year of treatment and were offset by subsequent savings. The estimates are highly sensitive to the effect of lipoatrophy on Health-related Quality of Life (HRQOL), but not to the effect of cholesterol levels.
The cost effectiveness of ARV regimens may be strongly affected by enduring AEs, such as lipoatrophy. It is important to consider specific AE effects from all drugs in a regimen when ARVs are compared.
(ClinicalTrials.gov number, NCT00050895http://[ClinicalTrials.gov]).
lopinavir/ritonavir; efavirenz; antiretroviral therapy; HIV; AIDS; Markov model; economics
Stroke is a common and costly condition where an effective early reatment may be expected to affect patients’ future quality of life, the cost of acute medical treatment, and the cost of rehabilitation and any supportive care needed for their remaining lifetime. To assist in informing discussions on early adoption of potential treatments, economic analyses should accompany investigations that seek to improve outcomes for stroke patients.
The primary aim is to assess whether IV/IA rt-PA therapy is cost-effective at 3 months compared to IV rt-PA, and provides cost-savings or is cost-neutral by 12 months.
Cost-effectiveness of the two treatment arms will be measured at months 3, 6, 9, and 12. Cost-effectiveness will be calculated using 1) standard cost-effectiveness methodology (Incremental Cost-Effectiveness Ratios), and 2) an econometric model to assess multiple outcome measures while controlling for multiple subject and treatment-related factors that are known to affect both outcomes and costs.
Total cost for the initial hospitalization of treating stroke subjects randomized to either IV/IA or IV rt-PA treatment arms will be measured, as will differences in types of resource utilization over 12 months between the two arms of the trial. Quality-of-life data (EuroQol EQ-5D) will be collected over a 12-month period and quality adjusted life years (QALYs) will be used as a morbidity-adjusted measure of effectiveness. Subgroup analyses will include dichotomized NIH Stroke Scale (<20, ≥20), country, time between onset and randomization, and IA devices.
Economic Evaluation; Quality of Life; Cost-effectiveness; Resource Utilization
The percentage of the population described as elderly is growing, and a higher prevalence of multiple, chronic disease states must be managed concurrently. Healthcare practitioners must appropriately use medication for multiple diseases and avoid risks often associated with multiple medication use such as adverse effects, drug/drug interactions, drug/disease interactions, and inappropriate dosing. The purpose of this study is to identify a consensus definition for polypharmacy and evaluate its prevalence among elderly outpatients. The authors also sought to identify or develop a clinical tool which would assist healthcare practitioners guard against inappropriate drug therapy in elderly patients. The most commonly cited definition was a medication not matching a diagnosis. Inappropriate was part of definitions used frequently. Some definitions placed a numeric value on concurrent medications. Two common definitions (ie, 6 or more medications or a potentially inappropriate medication) were used to evaluate polypharmacy in elderly South Carolinians (n = 1027). Data analysis demonstrates that a significant percentage of this population is prescribed six or more concomitant drugs and/or uses a potentially inappropriate medication. The findings are 29.4% are prescribed 6 or more concurrent drugs, 15.7% are prescribed one or more potentially inappropriate drugs, and 9.3% meet both definitions of polypharmacy used in this study. The authors recommend use of less ambiguous terminology such as hyperpharmacotherapy or multiple medication use. A structured approach to identify and manage inappropriate polypharmacy is suggested and a clinical tool is provided.
hyperpharmacotherapy; polypharmacy; geriatrics; inappropriate medication; inappropriate pharmacy; multiple medication use
This study compares the costs and effects of a regimen with ritonavir-boosted tipranavir (TPV/r) to a physician-selected genotypically-defined standard-of-care comparator protease inhibitor regimen boosted with ritonavir (CPI/r) in HIV infected patients that were previously exposed to antiretroviral therapy in the Netherlands.
We compared the projected lifetime costs and effects of two theoretical groups of 1000 patients, one receiving a standard of care regimen with TPV/r as a component and the other receiving a standard of care regimen with CPI/r. A 3-stage Markov model was formulated to represent three different consecutive HAART regimens. The model uses 12 health states based on viral load and CD4+ count to simulate disease progression. The transition probabilities for the Markov model were derived from a United States cohort of treatment experienced HIV patients. Furthermore, the study design was based on 48-week data from the RESIST-2 clinical trial and local Dutch costing data. Cost and health effects were discounted at 4% and 1.5% respectively according to the Dutch guideline. The analysis was conducted from the Dutch healthcare perspective using 2006 unit cost prices.
Our model projects an accumulated discounted cost to the Dutch healthcare system per patient receiving the TPV/r regimen of €167,200 compared to €145,400 for the CPI/r regimen. This results in an incremental cost of €21,800 per patient. The accumulated discounted effect is 7.43 life years or 6.31 quality adjusted life years (QALYs) per patient receiving TPV/r, compared to 6.91 life years or 5.80 QALYs per patient receiving CPI/r. This translates into an incremental effect of TPV/r over CPI/r of 0.52 life years gained (LYG) or 0.51 QALYs gained. The corresponding incremental cost effectiveness ratios (iCERs) are €41,600 per LYG and €42,500 per QALY.
We estimated the iCER for TPV/r compared to CPI/r at approximately €40,000 in treatment experienced HIV-1 infected patients in the Netherlands. This ratio may well be in range of what is acceptable and warrants reimbursement for new drug treatments in the Netherlands, in particular in therapeutic areas as end-stage oncology and HIV and other last-resort health-care interventions.
OBJECTIVE: Racial disparities exist across most major disease categories, which result in a disproportionately large number of hospital admissions for many conditions. Estimates for the financial impact of the racial admission differences for the State of South Carolina are assessed. METHODS: South Carolina hospital discharge data for 1998-2002 was used for the analysis. The database includes all-payer billing data for inpatient hospital admissions as received on the UB-92 billing file for the covered episode. Charges were inflation adjusted to 2002 constant dollars. RESULTS: For 1998-2002, there were an estimated dollar 1.6 billion in total charges for hospital admissions in South Carolina that were attributed to higher age-adjusted admission rates for African-American patients. In addition, African Americans had consistently higher hospital admission rates for disease categories that are often associated with a failure to obtain ambulatory and preventive care. CONCLUSION: This simple analysis reveals that age-adjusted hospital admission rates for African Americans in South Carolina are higher than for Caucasians, and the gap appears to be widening over time. Given the magnitude of the financial implication, interventions with even a small impact on the conditions underlying the racial disparities in hospital admissions are likely to be cost effective.