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1.  Patient reported outcome instruments used in clinical trials of HIV-infected adults on NNRTI-based therapy: a 10-year review 
Background
Patient-reported outcomes (PROs) may provide valuable information to clinicians and patients when choosing initial antiretroviral therapy.
Objective
To identify and classify PRO instruments used to measure treatment effects in clinical trials evaluating NNRTIs.
Methods
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.
Results
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).
Conclusions
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.
doi:10.1186/1477-7525-11-164
PMCID: PMC3852266  PMID: 24090055
HIV; Patient-reported outcome (PRO); Instrument; NNRTI
2.  Barriers facing patients referred for kidney transplant cause loss to follow-up 
Kidney international  2012;82(9):1018-1023.
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.
doi:10.1038/ki.2012.255
PMCID: PMC3472088  PMID: 22832516
Lost to follow up; ESRD; Access to Kidney Transplant; Barriers to Transplant
3.  The Cost of Medicaid Savings: The Potential Detrimental Public Health Impact of Neonatal Circumcision Defunding 
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.
doi:10.1155/2012/540295
PMCID: PMC3483825  PMID: 23125519
4.  Economic modeling of the combined effects of HIV-disease, cholesterol and lipoatrophy based on ACTG 5142 trial data 
Background
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.
Methods
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.
Results
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.
Conclusions
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.
Trial registration
(ClinicalTrials.gov number, NCT00050895http://[ClinicalTrials.gov]).
doi:10.1186/1478-7547-9-5
PMCID: PMC3117802  PMID: 21548986
lopinavir/ritonavir; efavirenz; antiretroviral therapy; HIV; AIDS; Markov model; economics
5.  Design of the Economic Evaluation for the Interventional Management of Stroke (III) Trial 
SUMMARY
Rationale
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.
Aims
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.
Design
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.
Study Outcomes
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.
doi:10.1111/j.1747-4949.2008.00190.x
PMCID: PMC3052984  PMID: 18706008
Economic Evaluation; Quality of Life; Cost-effectiveness; Resource Utilization
6.  Polypharmacy: Misleading, but manageable 
Clinical Interventions in Aging  2008;3(2):383-389.
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.
PMCID: PMC2546482  PMID: 18686760
hyperpharmacotherapy; polypharmacy; geriatrics; inappropriate medication; inappropriate pharmacy; multiple medication use
7.  Charges for hospital admissions attributable to health disparities for African-American patients, 1998-2002. 
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.
PMCID: PMC2569291  PMID: 16749643
8.  Responsiveness of the MOS-HIV and EQ-5D in HIV-infected adults receiving antiretroviral therapies 
Background
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).
Methods
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).
Results
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.
Conclusions
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.
doi:10.1186/1477-7525-11-42
PMCID: PMC3602001  PMID: 23497257
HIV; Patient-reported outcome (PRO); MOS-HIV; EQ-5D; NNRTI
9.  Cost-effectiveness of tipranavir versus comparator protease inhibitor regimens in HIV infected patients previously exposed to antiretroviral therapy in the Netherlands 
Background
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.
Methods
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.
Results
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.
Conclusion
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.
doi:10.1186/1478-7547-5-15
PMCID: PMC2211743  PMID: 18034881

Results 1-9 (9)