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Biomedical subjects

Bruce R Schackman

Publications and source records attributed to Bruce R Schackman.

At least 19 recordsLinked to original sources
PubMed2006

Overcoming policy and financing barriers to integrated buprenorphine and HIV primary care.

Treatment for substance abuse and human immunodeficiency virus (HIV) infection historically have come from different providers, often in separate locations, and have been reimbursed through separate funding streams. We describe policy and financing challenges faced by health care providers seeking to integrate buprenorphine, a new treatment for opioid dependence, into HIV primary care. Regulatory challenges include licensing and training restrictions imposed by the Drug Addiction Treatment Act of 2000 and confidentiality regulations for alcohol and drug treatment records. Potential responses include the development of local training programs and electronic medical records. Addressing the complexity of funding sources for integrated care will require administrative support, up-front investments, and federal and state leadership. A policy and financing research agenda should address evidence gaps in the rationales for regulatory restrictions and should include cost-effectiveness studies that quantify the "value for money" of investments in integrated care to improve health outcomes for HIV-infected patients with opioid dependence.

Antiretroviral Therapy, Highly Active↗
PubMed2006

Expanded HIV screening in the United States: effect on clinical outcomes, HIV transmission, and costs.

BACKGROUND: An extensive literature supports expanded HIV screening in the United States. However, the question of whom to test and how frequently remains controversial. OBJECTIVE: To inform the design of HIV screening programs by identifying combinations of screening frequency and HIV prevalence and incidence at which screening is cost-effective. DESIGN: Cost-effectiveness analysis linking simulation models of HIV screening to published reports of HIV transmission risk, with and without antiretroviral therapy. DATA SOURCES: Published randomized trials, observational cohorts, national cost and service utilization surveys, the Red Book, and previous modeling results. TARGET POPULATION: U.S. communities with low to moderate HIV prevalence (0.05% to 1.0%) and annual incidence (0.0084% to 0.12%). TIME HORIZON: Lifetime. PERSPECTIVE: Societal. INTERVENTIONS: One-time and increasingly frequent voluntary HIV screening of all adults using a same-day rapid test. OUTCOME MEASURES: HIV infections detected, secondary transmissions averted, quality-adjusted survival, lifetime medical costs, and societal cost-effectiveness, reported in discounted 2004 dollars per quality-adjusted life-year (QALY) gained. RESULTS OF BASE-CASE ANALYSIS: Under moderately favorable assumptions regarding the effect of HIV patient care on secondary transmission, routine HIV screening in a population with HIV prevalence of 1.0% and annual incidence of 0.12% had incremental cost-effectiveness ratios of 30,800 dollars/QALY (one-time screening), 32,300 dollars/QALY (screening every 5 years), and 55,500 dollars/QALY (screening every 3 years). In settings with HIV prevalence of 0.10% and annual incidence of 0.014%, one-time screening produced cost-effectiveness ratios of 60,700 dollars/QALY. RESULTS OF SENSITIVITY ANALYSIS: The cost-effectiveness of screening policies varied within a narrow range as assumptions about the effect of screening on secondary transmission varied from favorable to unfavorable. Assuming moderately favorable effects of antiretroviral therapy on transmission, cost-effectiveness ratios remained below 50,000 dollars/QALY in settings with HIV prevalence as low as 0.20% for routine HIV screening on a one-time basis and at prevalences as low as 0.45% and annual incidences as low as 0.0075% for screening every 5 years. LIMITATIONS: This analysis does not address the difficulty of determining the prevalence and incidence of undetected HIV infection in a given patient population. CONCLUSIONS: Routine, rapid HIV testing is recommended for all adults except in settings where there is evidence that the prevalence of undiagnosed HIV infection is below 0.2%.

Adult↗
PubMed2006

Cost-effectiveness of an intervention to improve adherence to antiretroviral therapy in HIV-infected patients.

Adherence to antiretroviral medications has been shown to be an important factor in predicting viral suppression and clinical outcomes. The objective of this analysis was to assess the cost-effectiveness of a nursing intervention on antiretroviral adherence using data from a randomized controlled clinical trial as input to a computer-based simulation model of HIV disease. For a cohort of HIV-infected patients similar to those in the clinical trial (mean initial CD4 count of 319 cells/mm), implementing the nursing intervention in addition to standard care yielded a 63% increase in virologic suppression at 48 weeks. This produced increases in expected survival (from 94.5 to 100.9 quality-adjusted life months) and estimated discounted direct lifetime medical costs ($253,800 to $261,300). The incremental cost-effectiveness ratio for the intervention was $14,100 per quality-adjusted life year gained compared with standard care. Adherence interventions with modest effectiveness are likely to provide long-term survival benefit to patients and to be cost-effective compared with other uses of HIV care funds.

Adult↗
PubMed2006

Three- vs four-drug antiretroviral regimens for the initial treatment of HIV-1 infection: a randomized controlled trial.

CONTEXT: Three-drug antiretroviral regimens are standard of care for initial treatment of human immunodeficiency virus 1 (HIV-1) infection, but a 4-drug regimen could improve antiretroviral activity and be more effective than a 3-drug regimen. OBJECTIVE: To compare the safety/efficacy of 3-drug vs 4-drug regimens for initial treatment of HIV-1 infection. DESIGN: The AIDS Clinical Trials Group (ACTG) A5095 study, a randomized, double-blind, placebo-controlled study with enrollment and follow-up conducted from March 22, 2001, to March 1, 2005, and enrolling treatment-naive, HIV-1-infected patients with HIV-1 RNA levels of 400 copies/mL or greater from US clinical trials units of the ACTG. INTERVENTIONS: Zidovudine/lamivudine plus efavirenz (3-drug regimen) vs zidovudine/lamivudine/abacavir plus efavirenz (4-drug regimen). MAIN OUTCOME MEASURES: Time to virologic failure (defined as time to first of 2 successive HIV-1 RNA levels > or =200 copies/mL at or after week 16), CD4 cell count changes, and grade 3 or 4 adverse events. HIV-1 RNA data were intent-to-treat, regardless of treatment changes. RESULTS: Seven hundred sixty-five patients with a baseline mean HIV-1 RNA level of 4.86 log10 (72,444) copies/mL and CD4 cell count of 240 cells/mm3 were randomized. After a median 3-year follow-up, 99 (26%) of 382 and 94 (25%) of 383 patients receiving the 3-drug and 4-drug regimens, respectively, reached protocol-defined virologic failure; time to virologic failure was not significantly different (hazard ratio, 0.95; 97.5% confidence interval, 0.69-1.33; P = .73). In planned subgroup analyses, increased risk for virologic failure was seen in non-Hispanic black patients (adjusted hazard ratio, 1.66; 95% confidence interval, 1.18-2.34; P = .003). At 3 years, the HIV-1 RNA level was less than 200 copies/mL in 152 (90%) of 169 and 143 (92%) of 156 patients receiving the 3-drug and 4-drug regimens, respectively (P = .59), and less than 50 copies/mL in 144 (85%) of 169 and 137 (88%) of 156 patients (P = .39). CD4 cell count increases and grade 3 or 4 adverse events were not significantly different. CONCLUSIONS: In treatment-naive patients, there were no significant differences between the 3-drug and 4-drug antiretroviral regimens; overall, at least approximately 80% of patients had HIV-1 RNA levels less than 50 copies/mL through 3 years. These results support current guidelines recommending 2 nucleosides plus efavirenz for initial treatment of HIV-1 infection; adding abacavir as a fourth drug provided no additional benefit. CLINICAL TRIALS REGISTRATION: clinicaltrials.gov Identifier: NCT00013520.

Adult↗
PubMed2006

The use of an educational video during informed consent in an HIV clinical trial in Haiti.

BACKGROUND: Research volunteers from developing countries who enroll in HIV clinical trials may be illiterate and unfamiliar with the conduct of medical research. Educating volunteers about the contents of the consent form is essential but can be difficult and time consuming. We evaluated the feasibility and effectiveness of an educational video during the informed consent process for an HIV clinical trial conducted in Port-au-Prince, Haiti. METHODS: HIV-seronegative volunteers were recruited into a longitudinal cohort to study rates of high-risk sexual behavior and incidence of HIV-1 infection. Before enrollment, all volunteers received information about the consent form during 2 educational sessions. In the first session, groups of 5 to 10 volunteers viewed an educational video on the essential elements of the consent form. In the second, the volunteers met one-on-one with a social worker. Volunteers' comprehension was then evaluated orally by 16 true-false questions and 4 open-ended questions. Volunteers who failed the first evaluation received additional education and had a second evaluation. RESULTS: Two hundred fifty volunteers received education, and 186 (74%) passed the first evaluation. Higher formal education was a significant predictor of passing the first evaluation (odds ratio, 1.60; 95% confidence interval, 1.05-2.44). Of the 64 who failed, 47 returned for a repeat one-on-one education session and a second evaluation. Among these 47, 39 (83%) passed, and 8 (7%) failed the second evaluation. In total, 225 (90%) of 250 individuals passed either the first or second evaluation and were eligible to enroll in the study. CONCLUSIONS: Informed consent using an educational video ensured good comprehension in most of the volunteers. Additional educational sessions may be necessary for some participants with lower educational level.

Adult↗
PubMed2006

The survival benefits of AIDS treatment in the United States.

BACKGROUND: As widespread adoption of potent combination antiretroviral therapy (ART) reaches its tenth year, our objective was to quantify the cumulative survival benefits of acquired immunodeficiency syndrome (AIDS) care in the United States. METHODS: We defined eras corresponding to advances in standards of human immunodeficiency virus (HIV) disease care, including opportunistic infection prophylaxis, treatment with ART, and the prevention of mother-to-child transmission (pMTCT) of HIV. Per-person survival benefits for each era were determined using a mathematical simulation model. Published estimates provided the number of adult patients with new diagnoses of AIDS who were receiving care in the United States from 1989 to 2003. RESULTS: Compared with survival associated with untreated HIV disease, per-person survival increased 0.26 years with Pneumocystis jiroveci pneumonia prophylaxis alone. Four eras of increasingly effective ART in addition to prophylaxis resulted in per-person survival increases of 7.81, 11.05, 11.57, and 13.33 years, compared with the absence of treatment. Treatment for patients with AIDS in care in the United States since 1989 yielded a total survival benefit of 2.8 million years. pMTCT averted nearly 2900 infant infections, equivalent to 137,000 additional years of survival benefit. CONCLUSIONS: At least 3.0 million years of life have been saved in the United States as a direct result of care of patients with AIDS, highlighting the significant advances made in HIV disease treatment.

Acquired Immunodeficiency Syndrome↗
PubMed2006

Variations in self-rated health among patients with HIV infection.

PURPOSE: To assess how patients with HIV who are enrolled in a clinical trials cohort rate their health and to compare their ratings with those of patients with HIV from 2 other cohorts: the HIV Cost and Services Utilization Study (HCSUS), and Adult AIDS Clinical Trials Group protocol 320 (ACTG 320). METHODS: We analyzed baseline information for the 1649 subjects enrolled in the Adult AIDS Clinical Trials Group Longitudinal Linked Randomized Trials (ALLRT) study prior to March 2002 who had self-rated health data available. We compared those results with results from 2 other groups: HCSUS, the only nationally representative sample of people in care for HIV in the U.S., which conducted baseline interviews in 1996 and 1997, and ACTG 320, a randomized, double-blinded, placebo-controlled trial comparing a 3-drug antiretroviral regimen with a 2-drug combination, which enrolled subjects in the same general time frame as HCSUS. We used t tests, Pearson correlations, and linear regression to determine factors associated with self-rated health and z scores to compare results between cohorts. RESULTS: The mean (SD) rating scale value on a 0-100 scale for ALLRT participants was 79.8 (16.8). Values were significantly lower for subjects who were older, had a history of injection drug use, had lower CD4 cell counts, or were beginning salvage antiretroviral therapy. Subjects in ALLRT reported significantly better self-rated health at baseline than those in HCSUS or ACTG 320 (11-12% higher rating scale values in ALLRT; p<0.05). When cohort differences were accounted for through regression and stratification, the differences in scores between subjects in ALLRT and HCSUS increased and the differences in scores between subjects in ALLRT and ACTG 320 diminished. CONCLUSIONS: Self-rated health varied significantly by age, CD4 count, injection drug use history, and salvage therapy status. Differences in self-rated health for clinical trials and non-clinical trials samples appear to be substantial and should be considered when applying trial results to clinical populations.

Adult↗
PubMed2006

The lifetime cost of current human immunodeficiency virus care in the United States.

OBJECTIVE: We sought to project the lifetime cost of medical care for human immunodefiency virus (HIV)-infected adults using current antiretroviral therapy (ART) standards. METHODS: Medical visits and hospitalizations for any reason were from the HIV Research Network, a consortium of high-volume HIV primary care sites. HIV treatment drug regimen efficacies were from clinical guidelines and published sources; data on other drugs used were not available. In a computer simulation model, we projected HIV medical care costs in 2004 U.S. dollars. RESULTS: From the time of entering HIV care, per person projected life expectancy is 24.2 years, discounted lifetime cost is Dollars 385,200, and undiscounted cost is Dollars 618,900 for adults who initiate ART with CD4 cell count < 350/microL. Seventy-three percent of the cost is antiretroviral medications, 13% inpatient care, 9% outpatient care, and 5% other HIV-related medications and laboratory costs. For patients who initiate ART with CD4 cell count < 200/microL, projected life expectancy is 22.5 years, discounted lifetime cost is Dollars 354,100 and undiscounted cost is Dollars 567,000. Results are sensitive to drug manufacturers' discounts, ART efficacy, and use of enfuvirtide for salvage. If costs are discounted to the time of infection, the discounted lifetime cost is Dollars 303,100. CONCLUSIONS: Effective ART regimens have substantially improved survival and have increased the lifetime cost of HIV-related medical care in the U.S.

AIDS-Related Opportunistic Infections↗
PubMed2006

Can hip protector use cost-effectively prevent fractures in community-dwelling geriatric populations?

OBJECTIVES: To estimate the cost-effectiveness from a societal perspective of a hip protector (HP) program over the remaining lifetime of individuals initially living at home. DESIGN: A state-transition Markov model considering outcomes of HP use in cohorts stratified by age, sex, and functional and residential status. Costs, transition probabilities, HP adherence, and efficacy were derived from published sources. SETTING: Community and nursing homes in the United States. PARTICIPANTS: Hypothetical cohort of individuals aged 65 and older without a hip fracture and initially living at home. INTERVENTION: HP program. MEASUREMENTS: Fractures, life years, and dollars saved, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICER). RESULTS: HP use prevented fractures and increased life expectancy in all cohorts. HP use saved costs and improved QALYs in women initiating HP use at age 80 and in men at age 85. In women initiating HP use at age 75, the HP ICER was 19,000 dollars/QALY. In men initiating HP use at age 80, HP use saved costs but slightly decreased QALYs. In younger cohorts, HP use was neither cost saving nor QALY improving. In sensitivity analyses, if there was no QALY loss from wearing a HP, the ICER was less than 50,000 dollars/QALY for all age and sex cohorts. If HP cost was reduced 50%, HP use was cost saving for women initiating HP use at age 75. In probabilistic sensitivity analyses, the HP ICER was less than 50,000 dollars/QALY in 68% of simulations for women initiating HP use at age 75 and 61% of simulations for men initiating at age 85. CONCLUSION: HP use saved costs and QALYs for older age cohorts of both sexes. Additional research on the quality-of-life effects and obstacles to wearing HP is warranted.

Adult↗
PubMed2005

A synthesis of cost-utility analysis literature in infectious disease.

The purpose of this review is to understand infectious disease-related cost-utility analyses by describing published analyses, examining growth and quality trends over time, examining factors related to quality, and summarising standardised results. 122 cost-utility analyses and 352 cost-utility ratios were identified. Pharmaceutical interventions were most common (47.5%); three author groups accounted for 42.8% of pharmaceutical ratios. High-volume journals (three or more published cost-utility analyses) published higher quality analyses than low-volume journals (p<0.001). Use of probabilistic sensitivity analysis and discounting at 3% were more frequently found in the years after the US Public Health Service Panel on Cost-Effectiveness in Health and Medicine recommendations (p<0.01). Median ratios varied from US13,500 dollars/quality-adjusted life year (QALY) for immunisations to US810,000 dollars/QALY for blood safety. Publication of infectious disease cost-utility analyses is increasing. The results of cost-utility analyses have important implications for the development of clinical guidelines and resource allocation decisions. More trained investigators and better peer-review processes are needed.

Anti-Bacterial Agents↗
PubMed2005

A cost-benefit analysis of external hip protectors in the nursing home setting.

OBJECTIVES: To estimate potential cost savings generated by a program of hip protectors in the nursing home from a Medicare perspective. DESIGN: A state-transition Markov model considering short-term and long-term outcomes of hip protectors for a hypothetical nursing home population, stratified by age, sex, and functional status. Costs, transition probabilities between health states, and estimates of hip protectors' effectiveness were derived from published secondary data. SETTING: Nursing home facilities in the United States. PARTICIPANTS: Hypothetical cohort of permanent nursing home residents aged 65 and older without a previous hip fracture. INTERVENTION: Program of hip protectors reimbursed by Medicare. MEASUREMENTS: Number of fractures, life years, and dollars saved. RESULTS: Three pairs of hip protectors replaced annually would result in a weighted average lifetime absolute risk reduction for hip fracture of 8.5%, with net lifetime savings to Medicare of 223 dollars per resident. When the annual cost of hip protectors is less than 151 dollars per person, relative risk of fracture is less than or equal to 0.65 with hip protectors, or adherence is greater than 42%, hip protectors are cost saving to Medicare over a wide range of assumptions. Extrapolating these results to the estimated population of U.S. nursing home residents without a previous hip fracture, Medicare could save 136 million dollars in the first year of a hip-protector reimbursement program. CONCLUSION: From a Medicare perspective, hip protectors are a cost-saving intervention in the nursing home setting when hip protector effectiveness is less than or equal to 0.65 over the remaining lifetime of subjects.

Aged↗
PubMed2005

Variation in orthopaedic surgeons' perceptions about the indications for rotator cuff surgery.

BACKGROUND: Epidemiologic studies have demonstrated substantial variations in per capita rates of many surgical procedures, including rotator cuff repair. The purpose of the current study was to characterize orthopaedic surgeons' attitudes concerning medical decision-making about rotator cuff surgery and to investigate the associations between these beliefs and reported surgical volumes. METHODS: A survey was mailed to randomly selected orthopaedic surgeons listed in the American Academy of Orthopaedic Surgeons directory. Only individuals who had treated patients for a rotator cuff tear, or had referred patients for such treatment, within the previous year were asked to complete the two-page survey. The survey comprised fifteen questions regarding clinical opinion, including four regarding hypothetical cases. Clinical agreement was defined as >80% of the respondents answering similarly. RESULTS: Of the 1100 surveys that were mailed, 539 were returned (a response rate of 49%). Of the 539 respondents, 316 (58.6%) had treated or referred patients with a rotator cuff tear in the previous year. There was a significant negative correlation between the surgeon's estimation of the failure rate of cuff repairs in the United States and that surgeon's procedure volume (r = -0.21, p = 0.0003), indicating that surgeons with a lower procedure volume are more pessimistic about the results of surgery than are those with a higher procedure volume. Arthroscopic, mini-open, and open cuff repairs were preferred by 14.5%, 46.2%, and 36.6% of the respondents, respectively. Surgeons who performed a higher volume of procedures were less likely to perform open surgery (p < 0.0001). There was clinical agreement regarding only four of the nine clinical questions and none of the four questions about the hypothetical vignettes. CONCLUSIONS: We found significant variation in surgical decision-making and a lack of clinical agreement among orthopaedic surgeons about rotator cuff surgery. There was a positive correlation between the volume of procedures performed by the surgeon and the surgeon's perception of outcome, with surgeons who had a higher procedure volume being more enthusiastic about rotator cuff surgery than those who had a lower procedure volume.

Analysis of Variance↗
PubMed2004

The cost-effectiveness of elective Cesarean delivery to prevent hepatitis C transmission in HIV-coinfected women.

OBJECTIVES: To determine the net health consequences, costs, and cost-effectiveness of elective Cesarean delivery (C-section) to prevent perinatal transmission of hepatitis C virus (HCV) in HIV/HCV-coinfected women with suppressed HIV RNA but detectable HCV RNA. DESIGN: Cost-effectiveness analysis using a probabilistic decision model. METHODS: The model compared two strategies: (i) C-section for all coinfected women with suppressed HIV RNA but detectable HCV RNA; (ii) C-section only when indicated based on fetal status. Outcomes included vertical transmission of HCV, maternal mortality, quality-adjusted life expectancy, delivery and HCV treatment costs, and incremental cost-effectiveness ratios. Data were obtained from the literature and national databases. Delivery cost data were from a hospital consortium database. Probability distributions were derived from published confidence intervals or estimated ranges, or calculated using reported sample sizes. RESULTS: Elective C-section in coinfected women with suppressed HIV RNA but detectable HCV RNA would avoid 45 vertical HCV transmissions per 1000 deliveries and increase maternal mortality by one death per 100 000 deliveries. The incremental cost-effectiveness ratio of a recommendation for C-section versus current practice was 3900-6100 dollars per quality-adjusted life year for the mother-child pair. Results are sensitive to the efficacy of C-section in preventing transmission, the probability of vaginal delivery without a recommendation, and rates of maternal acceptance of the recommendation. CONCLUSIONS: Assuming 2000 births/year among HIV/HCV-coinfected women in the United States, a recommendation for elective C-section in these women could avoid an additional 90 perinatal HCV transmissions per year with a risk of one maternal death in 50 years.

Cesarean Section↗
PubMed2004

Triple-nucleoside regimens versus efavirenz-containing regimens for the initial treatment of HIV-1 infection.

BACKGROUND: Regimens containing three nucleoside reverse-transcriptase inhibitors offer an alternative to regimens containing nonnucleoside reverse-transcriptase inhibitors or protease inhibitors for the initial treatment of human immunodeficiency virus type 1 (HIV-1) infection, but data from direct comparisons are limited. METHODS: This randomized, double-blind study involved three antiretroviral regimens for the initial treatment of subjects infected with HIV-1: zidovudine-lamivudine-abacavir, zidovudine-lamivudine plus efavirenz, and zidovudine-lamivudine-abacavir plus efavirenz. RESULTS: We enrolled a total of 1147 subjects with a mean baseline HIV-1 RNA level of 4.85 log10 (71,434) copies per milliliter and a mean CD4 cell count of 238 per cubic millimeter were enrolled. A scheduled review by the data and safety monitoring board with the use of prespecified stopping boundaries led to a recommendation to stop the triple-nucleoside group and to present the results in the triple-nucleoside group in comparison with pooled data from the efavirenz groups. After a median follow-up of 32 weeks, 82 of 382 subjects in the triple-nucleoside group (21 percent) and 85 of 765 of those in the combined efavirenz groups (11 percent) had virologic failure; the time to virologic failure was significantly shorter in the triple-nucleoside group (P<0.001). This difference was observed regardless of the pretreatment HIV-1 RNA stratum (at least 100,000 copies per milliliter or below this level; P< or =0.001 for both comparisons). Changes in the CD4 cell count and the incidence of grade 3 or grade 4 adverse events did not differ significantly between the groups. CONCLUSIONS: In this trial of the initial treatment of HIV-1 infection, the triple-nucleoside combination of abacavir, zidovudine, and lamivudine was virologically inferior to a regimen containing efavirenz and two or three nucleosides.

Adult↗
PubMed2004

The quality of highly regarded adolescent substance abuse treatment programs: results of an in-depth national survey.

BACKGROUND: Drug and alcohol abuse and dependence are the most prevalent causes of adolescent morbidity and mortality in the United States. Effective, accessible treatment for adolescents with substance abuse problems is urgently needed. OBJECTIVE: To conduct the first systematic evaluation of the quality of highly regarded adolescent substance abuse treatment programs in the United States. METHODS: An advisory panel of 22 experts defined 9 key elements of effective treatment for adolescent substance abuse based on a review of the literature. In-depth telephone and written surveys were conducted with 144 highly regarded adolescent substance abuse treatment programs identified by panel members and by public and private agencies. There was a 100% response rate to the initial interviews, and a 65% response rate to the follow-up surveys. The open-ended survey responses were coded by defining 5 components deemed to be crucial in addressing each of the 9 key elements, and quality scores were calculated overall and for each of the 9 key elements. RESULTS: Out of a possible total score of 45, the mean score was 23.8 and the median was 23. Top-quartile programs were not more likely to be accredited. The majority of programs scored at least 4 of a possible 5 on only 1 of the 9 key elements (qualified staff). The elements with the poorest-quality performance were assessment and treatment matching, engaging and retaining teens in treatment, gender and cultural competence, and treatment outcomes. CONCLUSIONS: Most of the highly regarded programs we surveyed are not adequately addressing the key elements of effective adolescent substance abuse treatment. Expanded use of standardized assessment instruments, improved ability to engage and retain youths, greater attention to gender and cultural competence, and greater investment in scientific evaluation of treatment outcomes are among the most critical needs. Expanding awareness of effective elements in treating adolescents will lead the way to program improvement.

Adolescent↗
PubMed2004

How often do sensitivity analyses for economic parameters change cost-utility analysis conclusions?

BACKGROUND: There is limited evidence about the extent to which sensitivity analysis has been used in the cost-effectiveness literature. Sensitivity analyses for health-related QOL (HR-QOL), cost and discount rate economic parameters are of particular interest because they measure the effects of methodological and estimation uncertainties. AIM: To investigate the use of sensitivity analyses in the pharmaceutical cost-utility literature in order to test whether a change in economic parameters could result in a different conclusion regarding the cost effectiveness of the intervention analysed. METHODS: Cost-utility analyses of pharmaceuticals identified in a prior comprehensive audit (70 articles) were reviewed and further audited. For each base case for which sensitivity analyses were reported (n = 122), up to two sensitivity analyses for HR-QOL (n = 133), cost (n = 99), and discount rate (n = 128) were examined. Article mentions of thresholds for acceptable cost-utility ratios were recorded (total 36). Cost-utility ratios were denominated in US dollars for the year reported in each of the original articles in order to determine whether a different conclusion would have been indicated at the time the article was published. Quality ratings from the original audit for articles where sensitivity analysis results crossed the cost-utility ratio threshold above the base-case result were compared with those that did not. RESULTS: The most frequently mentioned cost-utility thresholds were $US20,000/QALY, $US50,000/QALY, and $US100,000/QALY. The proportions of sensitivity analyses reporting quantitative results that crossed the threshold above the base-case results (or where the sensitivity analysis result was dominated) were 31% for HR-QOL sensitivity analyses, 20% for cost-sensitivity analyses, and 15% for discount-rate sensitivity analyses. Almost half of the discount-rate sensitivity analyses did not report quantitative results. Articles that reported sensitivity analyses where results crossed the cost-utility threshold above the base-case results (n = 25) were of somewhat higher quality, and were more likely to justify their sensitivity analysis parameters, than those that did not (n = 45), but the overall quality rating was only moderate. CONCLUSIONS: Sensitivity analyses for economic parameters are widely reported and often identify whether choosing different assumptions leads to a different conclusion regarding cost effectiveness. Changes in HR-QOL and cost parameters should be used to test alternative guideline recommendations when there is uncertainty regarding these parameters. Changes in discount rates less frequently produce results that would change the conclusion about cost effectiveness. Improving the overall quality of published studies and describing the justifications for parameter ranges would allow more meaningful conclusions to be drawn from sensitivity analyses.

Costs and Cost Analysis↗
PubMed2002

Cost-effectiveness implications of the timing of antiretroviral therapy in HIV-infected adults.

BACKGROUND: The appropriate time to initiate antiretroviral therapy is controversial for human immunodeficiency virus (HIV)-infected patients with CD4 cell counts between 200/microL and 350/microL and low levels of HIV RNA, potentially leading to barriers to treatment access. OBJECTIVE: To examine the effect of cholesterol changes and fat redistribution symptoms on the clinical benefits and cost-effectiveness of early antiretroviral therapy in these patients. METHODS: We used a state-transition model to compare initiating antiretroviral therapy at CD4 cell counts of 350/microL (early therapy) with initiating therapy at CD4 cell counts of 200/microL (deferred therapy) in patients with HIV RNA levels of 10,000 to 30,000 copies/mL. Data were from randomized clinical trials, cohort studies, and other published literature. RESULTS: If cholesterol changes associated with antiretroviral therapy resulted in a permanent increase in coronary heart disease risk, life expectancy with early therapy was 16.54 years (vs 16.66 years without this risk) and with deferred therapy was 13.73 years (vs 13.80 years without this risk). Early therapy was a more efficient use of resources (ie, dominated) compared with deferred therapy. Early therapy cost $13,000 per quality-adjusted life-year compared with no therapy with or without increased coronary heart disease risk, and $17,000 to $24,000 per quality-adjusted life-year taking into account the quality-of-life reduction in patients with fat distribution symptoms. Early therapy had a higher quality-adjusted life expectancy than deferred therapy as long as this quality-of-life reduction was 70% or less. CONCLUSIONS: Changes in cholesterol or quality of life associated with antiretroviral therapy do not justify limiting access to early HIV treatment. The effect of fat redistribution symptoms on quality of life will determine the optimal choice of early vs deferred therapy for an individual patient.

AIDS-Related Opportunistic Infections↗