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ABSTRACT: OBJECTIVE: One-third of Americans are obese and an increasing number opt for bariatric surgery. This study estimates the cost-effectiveness of common bariatric surgical procedures from a healthcare system perspective. METHODS: We evaluated the three most common bariatric surgical procedures in the US: laparoscopic gastric bypass (LRYGB), conventional (open) Roux-en-Y gastric bypass (ORYGB), and laparoscopic adjustable gastric banding (LAGB) compared to no surgery. The reference case was defined as a 53-year old female with body mass index (BMI) of 44 kg/m(2). We developed a two-part model using a deterministic approach for the first 5-year period post-surgery and separate empirical forecasts for the natural history of BMI, costs and outcomes in the remaining years. We used a combination of datasets including Medicare and MarketScan(®) together with estimates from the literature to populate the model. RESULTS: Bariatric surgery produced additional life expectancy (80-81 years) compared to no surgery (78 years). The incremental cost-effectiveness ratios (ICERs) of the surgical procedures were US $6,600 per quality-adjusted life expectancy (QALY) gained for LRYGB, US $6,200 for LAGB, and US $17,300 for ORYGB (3 % discount rate for cost and QALYs). ICERs varied according to choice of BMI forecasting method and clinically plausible variation in parameter estimates. In most scenarios, the ICER did not exceed a threshold of US $50,000 per QALY gained.
The European Journal of Health Economics 03/2013; · 1.50 Impact Factor
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ABSTRACT: The objective of this study was to assess the value of research of the RxPONDER study, an ongoing comparative effectiveness RCT designed to evaluate a 21-gene profile in early stage, node-positive breast cancer.
We developed a disease-based decision-analytic model to compare use of the 21-gene profile versus standard care. Key clinical data were derived from SWOG-8814, an RCT of chemotherapy in lymph node-positive breast cancer. Other model parameters were obtained from published sources. Probabilistic simulations and value of information calculations were used to assess the expected value of sample information (EVSI) and the expected value of sample parameter information (EVSPI).
The cost of the RxPONDER trial is expected to be at least $27million. The expected value of research of the RxPONDER trial ranged from $450million to $1billion, representing a return of 17 to 39 times the projected cost of the trial. The primary objective of RxPONDER, to assess survival, had the largest estimated value relative to other model inputs. The value of RxPONDER increased by $50million to $100million after stakeholder input on additional data collection.
The RxPONDER study appears to represent a good investment of public research funds. Stakeholder engagement and assessment of the return on investment should be considered to optimize and quantify the value of comparative effectiveness studies.
Contemporary clinical trials 08/2012; 33(6):1117-23. · 1.51 Impact Factor
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ABSTRACT: Purpose:Genetic services policymakers and insurers often make coverage decisions in the absence of complete evidence of clinical utility and under budget constraints. We evaluated genetic services stakeholder opinions on the potential usefulness of decision-analytic modeling to inform coverage decisions, and asked them to identify genetic tests for decision-analytic modeling studies.Methods:We presented an overview of decision-analytic modeling to members of the Western States Genetic Services Collaborative Reimbursement Work Group and state Medicaid representatives and conducted directed content analysis and an anonymous survey to gauge their attitudes toward decision-analytic modeling. Participants also identified and prioritized genetic services for prospective decision-analytic evaluation.Results:Participants expressed dissatisfaction with current processes for evaluating insurance coverage of genetic services. Some participants expressed uncertainty about their comprehension of decision-analytic modeling techniques. All stakeholders reported openness to using decision-analytic modeling for genetic services assessments. Participants were most interested in application of decision-analytic concepts to multiple-disorder testing platforms, such as next-generation sequencing and chromosomal microarray.Conclusion:Decision-analytic modeling approaches may provide a useful decision tool to genetic services stakeholders and Medicaid decision-makers.Genet Med advance online publication 26 July 2012.
Genetics in medicine: official journal of the American College of Medical Genetics 07/2012; · 3.92 Impact Factor
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ABSTRACT: Introduction The objective of this analysis was to examine the relationship between genomic variation and health outcomes in studies performed
in non-small cell lung cancer (NSCLC) patients treated with single agent epidermal growth factor receptor-tyrosine kinase
inhibitors (EGFR-TKIs) using a systematic review with statistical pooling of data.
MethodsWe performed a systematic search of the literature using the MEDLINE, BIOSIS, and EMABASE databases from July 1997 to July
2007. Eligible studies were evaluated for quality and clinical, methodological, and statistical heterogeneity. Abstracted
data judged to be sufficiently homogenous were pooled using a fixed effect model.
Results
ConclusionIn conclusion, EGFR mutation and protein expression status may provide useful clinical information in terms of the likelihood
of tumor response and disease prognosis. EGFR gene copy number and to a lesser extent, EGFR protein expression status, appear
to be promising biomarkers for predicting a survival benefit with EGFR-TKI therapy in second line NSCLC, but further evidence
is needed.
Journal of Cancer Research and Clinical Oncology 04/2012; 135(11):1483-1493. · 2.56 Impact Factor
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ABSTRACT: BACKGROUND: There is very little evidence regarding the real world experience and outcomes after laparoscopic adjustable gastric banding (LAGB). Our objective was to estimate the amount of postoperative weight loss, change in co-morbidity status, and complications after LAGB. The setting was LAGB surgical centers in Washington state. METHODS: A cross-sectional survey was developed to collect primary data from patients who had undergone LAGB in Washington state from 2004 to 2010. The survey contained questions on patient characteristics, weight change, co-morbidities, and complications after LAGB surgery. We used descriptive and other statistical tests to evaluate our key research questions by the period since LAGB. RESULTS: A total of 1556 surveys were sent out, and 790 were returned (response rate 50.8%). Responders were categorized into 4 groups according to the follow-up period: <2, 2-3, 3-4, and >4 years. The corresponding average body mass index reduction in each group was 21.0%, 22.5%, 21.3%, and 20.4%. Of the respondents, 21.7%, 34.8%, 44.6%, and 38.7% indicated they did not have any adjustments in the year preceding the survey. The percentage of respondents who had undergone additional operations related to LAGB was 8.6%. Specifically, 3.6% of the respondents had undergone either band removal or conversion to another type of bariatric operation. CONCLUSION: We found that although LAGB appeared to be beneficial for weight reduction and improving co-morbidities, the underuse of band adjustments and significant rate of treatment failure might limit the long-term effectiveness of LAGB.
Surgery for Obesity and Related Diseases 04/2012; · 3.93 Impact Factor
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ABSTRACT: Genomic-based diagnostics can play a key role in creating a more efficient healthcare system by directing patients toward beneficial therapies and away from therapies that pose substantial risk or are unlikely to improve outcomes for the patient. We outline how the value provided by diagnostics is closely linked to a range of factors including magnitude of health outcome improvement, avoiding adverse effect, diagnostic parameters, process of care, resource utilization, and costs. Comparative effectiveness approaches to evidence generation, including health outcome measurements, quality of life, economic analyses, decision modeling, and pragmatic clinical trials, can be used to provide stakeholders with a range of information to inform treatment, guidelines, coverage, and reimbursement decisions. Evidence of comparative effectiveness can also help support value-based reimbursement of cancer biomarkers and treatment strategies as means of paying for personalized medicine.
Molecular oncology 03/2012; 6(2):260-6. · 4.10 Impact Factor
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ABSTRACT: Epidemiological studies have documented the growing prevalence of severe obesity during the past three decades. The primary goal of this study was to estimate the trajectory of BMI change over 5+ years in a cohort of subjects identified as severely obese (BMI ≥35). We conducted a retrospective cohort study among adults enrolled in Group Health (GH) in Washington State. We tracked 11,735 subjects with at least one BMI measure of 35 or greater in the calendar year 2005 through April 2010. Population averaged BMI trajectories were estimated as a quadratic function of time using a marginal regression model, adjusting for gender and baseline BMI and age. For the average male in GH, the estimated BMI trajectory exhibited a slightly inverted U-shaped pattern and a 0.17 increase in BMI over the sample period. For the average female, the BMI trajectory was slightly U-shaped with BMI decreasing 0.03 units over the sample period. We found a high degree of heterogeneity in the shape of estimated trajectories across baseline characteristics with larger 5-year BMI increases among younger subjects with a lower initial BMI. We conclude that BMI changes over 5 years among individuals classified as severely obese are generally small and consistent with studies documenting BMI changes for individuals in other lower BMI categories. Our results also suggest that once the 35 BMI threshold is reached, individuals will continue to remain severely obese, especially at younger ages.
Obesity 02/2012; 20(10):2107-12. · 4.28 Impact Factor
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ABSTRACT: Over two thirds of women who need contraception in Uganda lack access to modern effective methods. This study was conducted to estimate the potential cost-effectiveness of achieving universal access to modern contraceptives in Uganda by implementing a hypothetical new contraceptive program (NCP) from both societal and governmental (Ministry of Health (MoH)) perspectives.
A Markov model was developed to compare the NCP to the status quo or current contraceptive program (CCP). The model followed a hypothetical cohort of 15-year old girls over a lifetime horizon. Data were obtained from the Uganda National Demographic and Health Survey and from published and unpublished sources. Costs, life expectancy, disability-adjusted life expectancy, pregnancies, fertility and incremental cost-effectiveness measured as cost per life-year (LY) gained, cost per disability-adjusted life-year (DALY) averted, cost per pregnancy averted and cost per unit of fertility reduction were calculated. Univariate and probabilistic sensitivity analyses were performed to examine the robustness of results. Mean discounted life expectancy and disability-adjusted life expectancy (DALE) were higher under the NCP vs. CCP (28.74 vs. 28.65 years and 27.38 vs. 27.01 respectively). Mean pregnancies and live births per woman were lower under the NCP (9.51 vs. 7.90 and 6.92 vs. 5.79 respectively). Mean lifetime societal costs per woman were lower for the NCP from the societal perspective ($1,949 vs. $1,987) and the MoH perspective ($636 vs. $685). In the incremental analysis, the NCP dominated the CCP, i.e. it was both less costly and more effective. The results were robust to univariate and probabilistic sensitivity analysis.
Universal access to modern contraceptives in Uganda appears to be highly cost-effective. Increasing contraceptive coverage should be considered among Uganda's public health priorities.
PLoS ONE 01/2012; 7(2):e30735. · 4.09 Impact Factor
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ABSTRACT: To systematically assess clinical and economic evidence for oncology orphan drugs marketed in the United States and to highlight the challenges and opportunities for evidence development within this pharmaceutical category.
Systematic review.
We conducted systematic literature searches of the Medline and Embase databases for clinical and cost-effectiveness studies published before June 2010 for all oncology orphan drugs marketed in the United States. We used the Grading of Recommendations Assessment, Development and Evaluation method and the Quality of Health Economic Studies criteria to assess the quality of the selected studies.
We identified 60 randomized controlled trials and 21 cost-effectiveness analyses to support 47 oncology orphan drugs. A total of 21 drugs had moderate or high-quality bodies of clinical evidence, 11 had low-quality or very low quality clinical evidence, and 15 drugs could not be evaluated because we were unable to identify clinical evidence that met our inclusion criteria. The Spearman rank correlation coefficient for the level of evidence for oncology orphan drugs and disease prevalence was 0.3 (95% confidence interval, 0.0-0.5). The cost-effectiveness analyses received quality scores between 72 and 100 (range 0-100), with a mean score of 85.
The results of our study show that oncology orphan drugs marketed in the United States have varying levels and quality of clinical evidence and a paucity of evidence regarding economic value. Innovative analytic and policy approaches are needed to develop and implement a decision-making framework for this pharmaceutical category that is consistent with evidence-based medicine and comparative effectiveness research.
The American journal of managed care 01/2012; 18(1):47-62. · 2.46 Impact Factor
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ABSTRACT: Many previous studies estimating the relationship between body mass index (BMI) and mortality impose assumptions regarding the functional form for BMI and result in conflicting findings. This study investigated a flexible data driven modelling approach to determine the nonlinear and asymmetric functional form for BMI used to examine the relationship between mortality and obesity. This approach was then compared against other commonly used regression models.
This study used data from the National Health Interview Survey, between 1997 and 2000. Respondents were linked to the National Death Index with mortality follow-up through 2005. We estimated 5-year all-cause mortality for adults over age 18 using the logistic regression model adjusting for BMI, age and smoking status. All analyses were stratified by sex. The multivariable fractional polynomials (MFP) procedure was employed to determine the best fitting functional form for BMI and evaluated against the model that includes linear and quadratic terms for BMI and the model that groups BMI into standard weight status categories using a deviance difference test. Estimated BMI-mortality curves across models were then compared graphically.
The best fitting adjustment model contained the powers -1 and -2 for BMI. The relationship between 5-year mortality and BMI when estimated using the MFP approach exhibited a J-shaped pattern for women and a U-shaped pattern for men. A deviance difference test showed a statistically significant improvement in model fit compared to other BMI functions. We found important differences between the MFP model and other commonly used models with regard to the shape and nadir of the BMI-mortality curve and mortality estimates.
The MFP approach provides a robust alternative to categorization or conventional linear-quadratic models for BMI, which limit the number of curve shapes. The approach is potentially useful in estimating the relationship between the full spectrum of BMI values and other health outcomes, or costs.
BMC Medical Research Methodology 12/2011; 11:175. · 2.67 Impact Factor
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ABSTRACT: The demand for induced abortions in Uganda is high despite legal and moral proscriptions. Abortion seekers usually go to illegal, hidden clinics where procedures are performed in unhygienic environments by under-trained practitioners. These abortions, which are usually unsafe, lead to a high rate of severe complications and use of substantial, scarce healthcare resources. This study was performed to estimate the costs associated with induced abortions in Uganda.
A decision tree was developed to represent the consequences of induced abortion and estimate the costs of an average case. Data were obtained from a primary chart abstraction study, an on-going prospective study, and the published literature. Societal costs, direct medical costs, direct non-medical costs, indirect (productivity) costs, costs to patients, and costs to the government were estimated. Monte Carlo simulation was used to account for uncertainty.
The average societal cost per induced abortion (95% credibility range) was $177 ($140-$223). This is equivalent to $64 million in annual national costs. Of this, the average direct medical cost was $65 ($49-86) and the average direct non-medical cost was $19 ($16-$23). The average indirect cost was $92 ($57-$139). Patients incurred $62 ($46-$83) on average while government incurred $14 ($10-$20) on average.
Induced abortions are associated with substantial costs in Uganda and patients incur the bulk of the healthcare costs. This reinforces the case made by other researchers--that efforts by the government to reduce unsafe abortions by increasing contraceptive coverage or providing safe, legal abortions are critical.
BMC Public Health 12/2011; 11:904. · 2.00 Impact Factor
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ABSTRACT: To determine the impact of the Centers for Medicare and Medicaid Services' (CMS) bariatric surgery national coverage decision (NCD) on the use, safety, and cost of care CMS beneficiaries.
In February 2006, the CMS issued a NCD restricting reimbursement for bariatric surgery to accredited centers and including coverage for laparoscopic adjustable gastric band (LAGB).
A pre/postinterrupted time-series cohort study using nationwide Medicare data (2004-2008) evaluating rates of bariatric procedures/100,000 enrollees, 90-day mortality, readmission rate and payments.
Forty-seven thousand thirty patients underwent procedures at 928 sites pre-NCD and 662 post-NCD. The procedure rate/100,000 patients dropped after the NCD to 17.8 (from 21.9 in 2005) increasing to 23.8 and 29.1 in 2007 and 2008, respectively. Open roux-en-y gastric bypass (ORYGB) and laparoscopic roux-en-y gastric bypass (LRYGB) were common pre-NCD (56.0% ORYGB, 35.5% LRYGB) changing post-NCD with LAGB inclusion (12.8% ORYGB, 48.7% LRYGB, 36.7% LAGB). 90-day mortality pre-NCD was 1.5% (1.8% ORYGB, 1.1% LRYGB) and post-NCD was 0.7% (1.7% ORYGB, 0.8% LRYGB, 0.3% LAGB; P < 0.001). The 90-day rates of readmission decreased post-NCD (19.9% to 15.4%), reoperation (3.2% to 2.1%) and payments ($24,363 to $19,746; P for all <0.001). Differences in outcome and cost were largely explained by a shift in procedure type and patient characteristics.
The NCD was associated with a temporary reduction in procedure rate and a shift in types of procedures and patients undergoing bariatric surgery. It was associated with a significant decrease in the risk of death, complications, readmissions, and per patient payments.
Annals of surgery 12/2011; 254(6):860-5. · 7.90 Impact Factor
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ABSTRACT: Personalized medicine requires diagnostic tests that stratify patients into distinct groups that may differentially benefit from targeted treatment approaches. This study compared the costs and benefits of two approaches for identifying those at high risk of developing type 2 diabetes for entry into a diabetes prevention program. The first approach identified high risk patients using impaired fasting glucose (IFG). The second approach used the PreDx Diabetes Risk Score (DRS) to further stratify IFG patients into high-risk and moderate-risk groups.
A Markov model was developed to simulate the incidence and disease progression of diabetes and consequent costs and quality-adjusted life expectancy (QALY), comparing alternative approaches for identifying high-risk patients. We modeled direct medical costs, including the costs of the stratification testing, over a 10-year time horizon from a US payer perspective.
Stratification of IFG patients by the DRS method leads to improved identification and prevention among those at highest risk. At 5 years, the number needed to treat (NNT) in the IFG-only approach was 39 patients to prevent one case of diabetes compared to an NNT of 15 in the IFG + DRS approach. When compared to IFG alone, the IFG + DRS approach results in an incremental cost-effectiveness ratio (ICER) of $17,100/QALY gained at 5 years and would become cost saving in 10 years. In contrast and as compared to no stratification, the IFG-only approach would produce an ICER of $235,500/QALY gained at 5 years and $94,600/QALY gained at 10 years. The study findings are limited by the generalizability of the DRS validation study and uncertainty regarding the long-term effectiveness of diabetes prevention.
The analysis indicates that the cost-effectiveness of diabetes prevention can be improved by better identification of patients at highest risk for diabetes using the DRS.
Journal of Medical Economics 07/2011; 14(5):609-16.
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ABSTRACT: Several potential measles vaccine innovations are in development to address the shortcomings of the current vaccine. Funders need to prioritize their scarce research and development resources. This article demonstrates the usefulness of cost-effectiveness analysis to support these decisions.
This study had 4 major components: (1) identifying potential innovations, (2) developing transmission models to assess mortality and morbidity impacts, (3) estimating the unit cost impacts, and (4) assessing aggregate cost-effectiveness in United Nations Children's Fund countries through 2049.
Four promising technologies were evaluated: aerosol delivery, needle-free injection, inhalable dry powder, and early administration DNA vaccine. They are projected to have a small absolute impact in terms of reducing the number of measles cases in most scenarios because of already improving vaccine coverage. Three are projected to reduce unit cost per dose by $0.024 to $0.170 and would improve overall cost-effectiveness. Each will require additional investments to reach the market. Over the next 40 years, the aggregate cost savings could be substantial, ranging from $98.4 million to $689.4 million.
Cost-effectiveness analysis can help to inform research and development portfolio prioritization decisions. Three new measles vaccination technologies under development hold promise to be cost-saving from a global perspective over the long-term, even after considering additional investment costs.
The Journal of Infectious Diseases 07/2011; 204 Suppl 1:S124-32. · 6.41 Impact Factor
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ABSTRACT: Measles control has succeeded worldwide, and many countries have substantially reduced incidence and mortality. This has led to consideration of the feasibility of measles elimination in Uganda within the context of global eradication. Before an elimination program is initiated, it is important to consider its potential economic impact, including its cost-effectiveness.
Incremental cost-effectiveness ratios (ICERs) were estimated for measles mortality reduction and measles elimination in Uganda. A dynamic age-structured compartmental model of measles transmission was used to simulate scenarios and estimate health outcomes and costs. The main outcome measures were costs, measles cases, measles deaths, disability-adjusted life-years (DALYs), and ICERs measured as cost per DALY averted through either the year 2030 or 2050.
Measles elimination by 2020 averted 130,232 measles cases, 3520 measles deaths, and 106,330 DALYs through the year 2030, compared with the next best scenario (95% mortality reduction by 2015), and it was the most cost-effective strategy, with ICERs of $556 per DALY averted (2030 time horizon) and $284 per DALY averted (2050 time horizon).
Measles elimination in Uganda, as part of a global eradication program, is projected to be highly cost-effective and should be considered among the available policy options for dealing with the disease.
The Journal of Infectious Diseases 07/2011; 204 Suppl 1:S116-23. · 6.41 Impact Factor
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ABSTRACT: Measles remains an important cause of morbidity and mortality in children in developing countries. Due to the success of the measles mortality reduction and elimination efforts thus far, the WHO has raised the question of whether global eradication of measles is economically feasible.
The cost-effectiveness of various measles mortality reduction and eradication scenarios was evaluated vis-à-vis the current mortality reduction goal in six countries and globally. Data collection on costs of measles vaccination were conducted in six countries in four regions: Bangladesh, Brazil, Colombia, Ethiopia, Tajikistan, and Uganda. The number of measles cases and deaths were projected from 2010 to 2050 using a dynamic, age-structured compartmental model. The incremental cost-effectiveness ratios were then calculated for each scenario vis a vis the baseline.
Measles eradication by 2020 was the found to be the most cost-effective scenario, both in the six countries and globally. Eradicating measles by 2020 is projected to cost an additional discounted $7.8 billion and avert a discounted 346 million DALYs between 2010 and 2050.
In conclusion, the study found that, compared to the baseline, reaching measles eradication by 2020 would be the most cost-effective measles mortality reduction scenario, both for the six countries and on a global basis.
The Journal of Infectious Diseases 07/2011; 204 Suppl 1:S98-106. · 6.41 Impact Factor
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ABSTRACT: Innovation in the field of diagnostic imaging is based primarily on the availability of new and improved equipment that opens the door for new clinical applications. Payments for these imaging procedures are subject to complex Medicare price control schemes, affecting incentives for appropriate use and innovation. Achieving a "dynamically efficient" health care system-one that elicits a socially optimal amount of innovation-requires that innovators be rewarded in relation to the value they add and can demonstrate with evidence. The authors examine how and whether value-based reimbursement for diagnostic imaging services might better reward innovation explicitly for expected improvements in health and economic outcomes.
Academic radiology 06/2011; 18(9):1109-14. · 2.09 Impact Factor
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ABSTRACT: To assess change in patient-reported outcomes in subjects with type 2 diabetes treated with exenatide once weekly compared with those treated with sitagliptin or pioglitazone.
In this 26-week randomized, multicenter, double-dummy study, 491 subjects received 2 mg of exenatide once weekly or maximum daily doses of sitagliptin (100 mg) or pioglitazone (45 mg) on a background of metformin. Weight-related quality of life, health utility, psychological well-being, and diabetes treatment satisfaction were assessed at baseline and week 26. Mean group changes from baseline to week 26 were estimated by ANCOVA.
Weight-related quality of life total scores improved significantly in the exenatide once weekly and sitagliptin arms only; the exenatide once weekly group experienced significantly greater improvement than the pioglitazone group in weight-related quality of life total scores and in several domain scores. Health utility scores improved significantly for exenatide once weekly and sitagliptin groups (P < 0.05) with no significant difference between the exenatide once weekly group and either comparison group. All groups experienced significant improvements on the psychological well-being global scale and all six domain scores, with no significant difference between the exenatide once weekly group and either comparator. All groups experienced significant improvements in total diabetes treatment satisfaction scores. The exenatide once weekly group experienced greater improvement than the sitagliptin group in treatment satisfaction total scores.
In combination with clinical outcomes from this study, these results indicate it is possible for patients treated with metformin to initiate exenatide therapy with potential benefits in both clinical and patient-reported outcomes.
Diabetes care 02/2011; 34(2):314-9. · 8.09 Impact Factor
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ABSTRACT: A key to accelerating the appropriate integration of genomic applications into healthcare in the coming decades will be the ability to assess the tradeoffs between clinical benefits and clinical risks of genetic tests in a timely manner. Several factors limit the ability of stakeholders to achieve this objective, including the lack of direct evidence, the lack of a framework to quantitatively assess risk and benefit, and the lack of a formal analytic approach to assess uncertainty. We propose that a formal, quantitative risk-benefit framework may be particularly useful for assessing genetic tests intended to influence health outcomes, and communicating the potential clinical benefits, harms, and uncertainty to stakeholders. As part of the development process for such a framework, a stakeholder meeting was held in Seattle (Wash., USA) in December of 2008, with the objective of discussing a risk-benefit framework, using warfarin pharmacogenomics as a case study. Participants engaged in focused discussion to elucidate the potential role of genetic test risk-benefit analysis in informing decision-making, categorizing genetic tests and directing research prioritization. This research investigation focuses on qualitative analysis of responses elicited from workshop participants during the proceedings of the workshop session. The major findings of the workshop were: (1) stakeholder support for risk-benefit modeling as a tool to structure discussion of the clinical utility of genetic tests; (2) desire for the modeling process to be iterative, transparent, and parsimonious in its presentation to stakeholders, and (3) some concern with the use of quality-adjusted life-years in the evaluation process. The meeting's findings emphasize the potential utility of risk-benefit analysis in genetic test evaluation, and highlight key areas for future research and stakeholder consensus-building.
Public Health Genomics 01/2011; 14(2):59-67. · 2.33 Impact Factor
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ABSTRACT: HIV/AIDS clinics in Uganda and other low-income countries face increasing numbers of patients and workforce shortages. We performed a cost-effectiveness analysis comparing a Pharmacy-only Refill Program (PRP), a form of task-shifting, to the Standard of Care (SOC) at a large HIV/AIDS clinic in Uganda, the Infectious Diseases Institute (IDI). The PRP was started to reduce workforce shortages and optimize patient care by substituting pharmacy visits for SOC involving monthly physician visits for accessing antiretroviral medicines.
We used a retrospective cohort analysis to compare the effectiveness of the PRP compared to SOC. Effectiveness was defined as Favorable Immune Response (FIR), measured as having a CD4 lymphocyte count of over 500 cells/µl at follow-up. We used multivariate logistic regression to assess the difference in FIR between patients in the PRP and SOC. We incorporated estimates of effectiveness into an incremental cost-effectiveness analysis performed from a limited societal perspective. We estimated costs from previous studies at IDI and conducted univariate and probabilistic sensitivity analyses. We identified 829 patients, 578 in the PRP and 251 in SOC. After 12.8 months (PRP) and 15.1 months (SOC) of follow-up, 18.9% of patients had a FIR, 18.6% in the PRP and 19.6% in SOC. There was a non-significant 9% decrease in the odds of having a FIR for PRP compared to SOC after adjusting for other variables (OR 0.93, 95% CI 0.55-1.58). The PRP was less costly than the SOC (US$ 520 vs. 655 annually, respectively). The incremental cost-effectiveness ratio comparing PRP to SOC was US$ 13,500 per FIR. PRP remained cost-effective at univariate and probabilistic sensitivity analysis.
The PRP is more cost-effective than the standard of care. Similar task-shifting programs might help large HIV/AIDS clinics in Uganda and other low-income countries to cope with increasing numbers of patients seeking care.
PLoS ONE 01/2011; 6(3):e18193. · 4.09 Impact Factor
