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ORIGINAL RESEARCH |
From the Center for Research on Women’s Health, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama.
Address reprint requests to: Jeffrey S. A. Stringer, MD, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, 340 Old Hillman Building, 618 South 20th Street, Birmingham, AL 35294, E-mail: uabobgyn{at}aol.com
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Abstract |
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Methods: A decision-analysis model was constructed to compare three management strategies for unregistered women presenting in labor: 1) the current standard of treating no one; 2) HIV testing with a rapid antibody assay, followed by zidovudine treatment according to AIDS Clinical Trial Group Protocol 076 if seropositive; and 3) treating all women without rapid testing. Cost and probability data were obtained from a literature review and local estimates. Sensitivity analyses were performed for pertinent uncertainties.
Results: Under baseline assumptions (5% HIV prevalence, treatment efficacy of an 18% reduction in transmission rate, and lifetime cost of pediatric HIV $103,708), giving no treatment resulted in 1275 infected infants per 100,000 mother-infant pairs. The rapid-test strategy prevented 183 cases of infant HIV infection and resulted in a net savings to the medical system of $57,997 per case averted. The treat-all strategy prevented an additional 46 cases per 100,000 mother-infant pairs, but at a cost of $342,068 per additional case averted. With other estimates at baseline, rapid testing was cost-saving when the HIV prevalence exceeded 0.97%, the treatment efficacy exceeded a 5.8% reduction in the transmission rate, and the lifetime cost of pediatric HIV infection exceeded $33,625.
Conclusion: Rapid HIV testing of unregistered parturients followed by zidovudine treatment if seropositive would be cost saving to the medical system.
Human immunodeficiency virus (HIV) infection of the newborn is a devastating and costly condition. In recent years, approximately 1500 new cases of HIV have been diagnosed annually among children in the United States, the majority of which occurred by passage of the virus from the infected mother to the perinate.1,2 The effectiveness of zidovudine in reducing this transmission is now well established. Reports from a variety of clinical settings3,4 have confirmed in real practice the two-thirds reduction in transmission first described in the AIDS Clinical Trial Group Protocol 076.5
Bringing the benefit of perinatal zidovudine prophylaxis to HIV-infected women who have little or no prenatal care is a challenge. Full adherence to the U.S. Centers for Disease Control and Prevention (CDC) recommendations6 requires antepartum determination of HIV status so that zidovudine therapy can be initiated between 14 and 34 weeks’ gestation. Thus, prenatal care is requisite. In a recent commentary, Minkoff and O’Sullivan7 proposed that unregistered women presenting in labor be offered testing for HIV infection with newly available, highly sensitive and specific rapid antibody tests, followed by treatment with intravenous (IV) zidovudine if seropositive. We created a decision-analysis model to assess the potential effectiveness and costs of such a program.
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Methods |
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After delivery, the sera of participating women are subjected to published, standard methods of HIV testing that involves sequential enzyme-linked immunosorbent assays (ELISAs) followed by confirmatory Western blot tests if two of three ELISA results are positive.11,12 Negative rapid tests are confirmed by a single negative ELISA. Because performance of most rapid tests is comparable to that of ELISA,8,10 the model requires two subsequent negative ELISAs or a negative Western blot to diagnose a false-positive rapid test.
Infants of all women whose rapid tests are positive begin therapy with zidovudine syrup according to the CDC recommendations.6 Infants whose mothers are found to be false positive by confirmatory testing receive only 2 days of inpatient zidovudine syrup. Infants whose mothers are false positive by confirmatory testing are begun on zidovudine therapy on the second day of life, thus receiving only a portion of the model’s therapeutic efficacy. All HIV-exposed infants, regardless of their ultimate serologic status, are diagnosed and treated according to CDC recommendations and are assumed to have a full 6 week course of zidovudine syrup, along with recommended laboratory evaluations.6,13,14
This analysis considered and compared three possible scenarios: 1) the current standard of not testing or treating unregistered parturients of unknown HIV status (treat none); 2) offering rapid HIV antibody testing and zidovudine treatment to all unregistered seropositive parturients, as described earlier (rapid test); and 3) treating all unregistered parturients without rapid testing (treat all).
Model Estimates: Clinical Factors
Model estimates (Table 1
) were obtained from review of the available published clinical data. When literature-derived estimates were not available, local sources were consulted. The quality of all model estimates was graded according to methods adapted from the U.S. Preventive Services Task Force.15 All baseline estimates were varied in sensitivity analyses according to their degree of uncertainty.
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The zidovudine regimen currently recommended by the CDC consists of three parts.6 Antenatal oral therapy is initiated between 14 and 34 weeks’ gestation and continued until the onset of labor. Upon presentation in labor, the patient receives IV zidovudine, first as a 2-mg/kg loading dose given over 1 hour, followed by a continuous IV infusion of 1 mg/kg/hour until delivery. After delivery, the mother does not breast-feed, and the infant receives zidovudine syrup 2 mg/kg every 6 hours. Neonatal therapy is initiated within 6 hours of birth and continued for 6 weeks. Our model incorporated the intrapartum and postpartum components of this regimen at the recommended doses.
The precise therapeutic efficacy of such a partial regimen has not been fully established. The AIDS Clinical Trial Group Protocol 076 reported a 67% reduction in perinatal transmission with the full regimen described,5 whereas a CDC trial conducted in Thailand achieved a 51% reduction by administering an abbreviated course of zidovudine in the late antenatal period and in labor.18 A recent observational report from the New York State Department of Health19 described the serologic status of a cohort of 939 infants exposed to a variety of abbreviated zidovudine regimens. Of those 50 infants whose mothers received only intrapartum zidovudine, five (10%) seroconverted, compared with 26.6% of those who received no therapy. This corresponds to a 62% reduction in vertical transmission, with a reported 95% confidence interval (CI) of 18, 87.
In light of the uncontrolled, observational nature of the New York data,19 and in keeping with a generally conservative approach to model inputs, we elected to use the lower 95% confidence limit described by this study for our baseline treatment efficacy estimate (an 18% reduction). The model also included a small subgroup who received only the postpartum zidovudine syrup as a consequence of false-negative rapid tests that were discovered upon confirmatory testing. We estimated the efficacy of this therapy to be half that of the intrapartum dose (a 9% reduction), which is a conservative estimate given the suggestion19 that postpartum zidovudine may be equivalent in efficacy to intrapartum administration. In addition, the model accounted for the possibility that the additional time necessary for laboratory processing of test results and pharmacy preparation might decrease the overall therapeutic efficacy of the rapid-test strategy compared with the treat-all strategy. We estimated this decrement in treatment efficacy to be 20%; thus, the baseline reduction in vertical transmission in the rapid-test arm was 14.4% and in the treat-all arm was 18% (versus 67% for the full AIDS Clinical Trial Group Protocol 076 regimen).
Rapid HIV antibody assays are available in a number of commercial preparations.10 The performance characteristics of these tests have been evaluated in a variety of clinical settings.8,9,10,20 Irwin et al,8 in a direct comparison of rapid and nonrapid assays in a hospital with an HIV prevalence of 5.4%, found the rapid assay to be highly sensitive (1.00; 95% CI 0.921, 1.00) and specific (0.991; 95% CI 0.982, 0.996). Our model adopted these values as baseline estimates and varied the performance over the 95% CI in sensitivity analyses.
Model Estimates: Costs
A generally conservative approach was taken toward estimating costs. Pharmacy costs were calculated using published, average wholesale drug costs,21 and pharmacist charges of $40.00 per hour, the current local standard. For laboratory cost estimates, we consulted the University of Alabama Hospital Laboratory, which collects excellent surveillance data on its marginal costs (reagents and labor), total costs (quality control, repeat assays, and overhead), and patient charges. We elected to use total costs for our estimations. All values are expressed in 1998 dollars.
Intravenous zidovudine is prepared by mixing 1 g of zidovudine in 1 L of dextrose 5% in water. We calculated drug costs21 to be $86.15, the cost of necessary IV fluids and tubing to be $17.50, and the cost of 20 minutes of pharmacist time to be $12.00. From review of our experience of the last 50 unregistered women who presented in labor to the University of Alabama Hospital, approximately 30% of women needed a second bottle of zidovudine. Thus, the average cost of maternal inpatient zidovudine therapy was calculated to be $154.20.
Using published, average wholesale prices and pharmacist labor charges, we estimated the cost of 12 doses of inpatient pediatric zidovudine syrup to be $64.20. The cost of drug plus preparation for an additional 6 weeks of outpatient therapy would be $50.23 for an infant weighing an average of 5000 g over the treatment period. The cost discrepancy between inpatient and outpatient preparations arose from the specifics of drug packaging, making it necessary to waste a portion of the inpatient drug, as well as additional pharmacist time for preparation. Drug costs for both mother and infant are in agreement with other published estimates.22,23
Currently, the CDC and the American Academy of Pediatrics recommend that all HIV-exposed infants receiving zidovudine therapy have a complete blood count with differential at birth, followed by repeat hemoglobin measurements at 6 and 12 weeks of age.6,13,14 Diagnosis of HIV in exposed infants requires a specific virologic test, usually HIV DNA polymerase chain reaction (PCR), performed at 48 hours of life and again at 1–2 months and 3–6 months. Our model accounted for all of these costs, as follows: $11.86 for the rapid test, $11.86 for ELISA, $49.05 for Western blot, $95.00 for HIV DNA PCR, $11.71 for complete blood count with differential, and $6.00 for hemoglobin measurement.
Review of the literature revealed wide variation in estimates of the lifetime treatment cost of pediatric HIV infection. Using yearly data for health care charges from the same study,24 different authors have estimated the undiscounted lifetime cost to be between $98,915 (1994 dollars)25 and $224,334 (1996 dollars).24 A 1991 report from Harlem Hospital in New York City estimated the lifetime cost of HIV infection in children to be $90,347.26
Using methods adapted from Mauskopf et al25 and yearly inflation factors derived from the medical consumer price index, we estimated the undiscounted lifetime cost of pediatric HIV infection to be $103,708 in 1998 dollars. Assuming a mean 60-month life expectancy27 and assuming that two-thirds of the total costs will be incurred during the last 24 months of life,24,25 discounting these costs at a rate of 5% yielded a present value of $86,130. This estimate, which we used as the baseline assumption for our analysis, is lower than any we could identify in the literature, and if inaccurate would likely bias the results toward diminished cost-effectiveness. We further examined the importance of this estimate in sensitivity analyses.
The primary point of view of our analysis was that of the health care system and third-party payers. We calculated cost-effectiveness28 as the overall cost of implementing a given strategy per case of infant HIV prevented (cost per case averted). The overall cost of implementing a strategy included both programmatic costs (eg, testing and drug) and cost savings to the medical system associated with averted cases of HIV. We calculated incremental cost-effectiveness as the cost of preventing an additional case of HIV with the treat-all strategy that was not prevented with the rapid-test strategy (cost per additional case averted). By convention, a negative cost-effectiveness ratio indicates an overall cost savings. The analysis was performed using DATA 3.0.5 decision-analysis software (TreeAge Software, Williamstown, MA).
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Results |
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). Use of the current standard of neither testing nor treating resulted in 1275 infected infants. The proposed rapid-test strategy prevented 183 cases of infant HIV infection and required $5,148,329 in programmatic costs to implement. At a discounted lifetime cost of $86,130 per HIV-infected infant, prevention of these 183 cases would result in a savings to the medical system of $15,761,790. Thus, the net result of implementing the rapid-test strategy was a savings to the medical system of $10,613,461 per 100,000 mother-infant pairs, which translates into a savings of $57,997 per case averted.
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One-Way Sensitivity Analyses
A series of one-way sensitivity analyses was performed in which the value for a single estimate was varied across some range while all other estimates were maintained at their baselines, thus allowing us to determine the impact of the altered variable on the modeled outcome (Table 3). The estimate for HIV prevalence was varied between the published national HIV prevalence for all obstetric patients (0.0017)2 and three times our baseline prevalence estimate (0.15). At the lower limit of prevalence, the rapid-test strategy was not cost saving ($360,747 per case averted). The HIV prevalence above which the rapid-test strategy became cost saving was approximately 1% (0.0097). At the upper limit of prevalence, both strategies were cost saving compared with the treat-none strategy; however, the positive incremental cost-effectiveness value associated with the treat-all strategy ($39,956 per case averted) indicated that it was not cost saving when compared with rapid testing.
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To account for possible variations in pharmacy costs from one institution to another, we varied the total of all pharmaceutical costs in the model simultaneously over a range of 33–300%. Over the entire range, the rapid-test strategy was cost saving. The treat-all strategy was not cost saving compared with the rapid-test strategy, even at the lowest pharmacy costs. We likewise varied the costs of all test assays (rapid, ELISA, and Western blot) over a range of 33–300% and found the rapid-test strategy to be cost saving over all values. We found a less than 20% change in all cost-effectiveness outcomes when the sensitivity and specificity values of the rapid assay were varied over the 95% CI.
Multiway Sensitivity Analyses
Treatment efficacy and lifetime cost of HIV infection were the least certain variables in the model, and HIV prevalence was the variable to which it was most sensitive. Therefore, we calculated the threshold prevalences above which the rapid-test strategy became cost saving over a range of treatment efficacy values and lifetime HIV costs. With both factors set to their minimum (treatment efficacy of an 18% reduction in baseline transmission rate; undiscounted lifetime cost of HIV of $70,000), the rapid-test strategy was cost saving at HIV prevalences of 0.016 and above. With both variables set at their maximum (treatment efficacy of an 87% reduction in baseline transmission rate; undiscounted lifetime cost of HIV of $130,000), the rapid-test strategy was cost saving at HIV prevalences of 0.0014 and above. Table 4 demonstrates the interrelation of treatment efficacy, HIV prevalence, and lifetime cost of pediatric infection.
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Discussion |
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A potential limitation of our analysis is the narrowness of its scope. We simplified the model and its outcomes to the extent possible, considering only the immediately foreseeable costs to a medical system charged with the care of HIV-infected mothers and infants. We did not account for life-years lost or gained, productivity lost or gained, or future costs to the medical system unrelated to HIV. This approach, chosen primarily for its analytic simplicity, is common among economic analyses of perinatal HIV transmission.25,26,28
Among the most uncertain calculations in the analysis was the lifetime cost of pediatric HIV infection. Although we used a cautious approach in arriving at our estimate and discounted at a rate of 5%, this figure drives the model’s cost-effectiveness. Further, to keep the model as simple as possible, we excluded from our analysis the related costs associated with the early diagnosis of maternal HIV disease. Because of the rapidly changing environment of HIV therapeutics, the overall costs of caring for HIV-infected individuals (children and adults), will likely increase in the future. However, it is not as clear whether the early diagnosis of maternal disease will increase costs to the medical system, or simply delay (and therefore further discount and potentially lower) medical costs. Among published economic analyses on this issue, some have included the costs of early maternal diagnosis in the baseline analysis,23 whereas others have not.22,25
The strengths of our analysis include its use of conservative baseline assumptions. We adopted as our therapeutic efficacy estimate a reduction in vertical transmission that is less than one-third that observed in the AIDS Clinical Trial Group Protocol 076, and at the lower boundary of the 95% CI for intrapartum-only zidovudine courses. Not only was the rapid-test strategy found to be cost saving using this conservative estimate, but sensitivity analyses demonstrated that the analysis was minimally sensitive to significant variation in this characteristic. Likewise, for our cost inputs we adopted a generally cautious approach toward estimation that was biased against cost-effectiveness, including the lowest available estimate for lifetime cost of pediatric HIV infection, discounted at an annual rate of 5%.
Our analysis provides some practical insights into the attributes of a labor and delivery unit that would be capable of efficiently implementing the rapid-test strategy. A setting of moderate HIV prevalence among eligible women (at least 1%) was required for the strategy’s cost-effectiveness; thus, a high-risk population is necessary. Although we have proposed that the strategy be applied to women without prenatal care, in actuality the strategy should be cost-effective in any undiagnosed population of women with sufficient disease prevalence. Thus, in some settings it may be appropriate to offer the rapid-test strategy to all parturients not previously tested for HIV.
The ideal labor ward to implement this strategy would serve enough eligible women that its personnel would maintain familiarity with the specifics of the program. A unit that treats several eligible women per week, for instance, would likely be better prepared to offer expeditious enrollment than one that rarely treats unregistered (or untested) patients. A laboratory committed to timely processing of rapid assays, and a pharmacy capable of prompt drug dispensation, would be necessary as well. Thus, busy inner-city hospitals serving large numbers of high-risk women would seem to be optimal for this strategy.
Finally, we emphasize that a rapid HIV testing and treatment program would operate within the present recommendations of the CDC, which advocates that partial zidovudine regimens be administered to those obstetric patients who, for whatever reason, are unable to avail themselves of the full regimen.6 The rapid-test strategy simply uses a newly available testing technology for rapid serologic diagnosis upon presentation in labor, thereby making the current standard of care for all obstetric patients in the United States available to unregistered women.
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Footnotes |
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Received September 22, 1998. Received in revised form December 7, 1998. Accepted January 7, 1999.
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2. Davis SF, Byers RH Jr, Lindegren ML, Caldwell MB, Karon JM, Gwinn M. Prevalence and incidence of vertically acquired HIV infection in the United States. JAMA 1995;274:952–5.[Abstract]
3. Wilfert CM. Prevention of perinatal transmission of human immunodeficiency virus: A progress report 2 years after completion of AIDS Clinical Trials Group trial 076. Clin Infect Dis 1996;23:438–41.[Medline]
4. Fiscus SA, Adimora AA, Schoenbach VJ, Lim W, McKinney R, Rupar D, et al. Perinatal HIV infection and the effect of zidovudine therapy on transmission in rural and urban counties. JAMA 1996;275:1483–8.[Abstract]
5. Connor EM, Sperling RS, Gelber R, Kiselev P, Scott G, O’Sullivan MJ, et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. N Engl J Med 1994;331:1173–80.
6. Centers for Disease Control and Prevention. Recommendations of the US Public Health Service Task Force on the use of zidovudine to reduce perinatal transmission of human immunodeficiency virus. MMWR Morb Mortal Wkly Rep 1994;43:1–20.
7. Minkoff H, O’Sullivan MJ. The case for rapid HIV testing during labor. JAMA 1998;279:1743–4.
8. Irwin K, Olivo N, Schable CA, Weber JT, Janssen R, Ernst J, et al. Performance characteristics of a rapid HIV antibody assay in a hospital with a high prevalence of HIV infection. Ann Intern Med 1996;125:471–5.
9. Kassler WJ, Dillon BA, Haley C, Jones WK, Goldman A. On-site, rapid HIV testing with same-day results and counseling. AIDS 1997;11:1045–51.[Medline]
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12. Centers for Disease Control and Prevention. Interpretation and use of the Western blot assay for serodiagnosis of human immunodeficiency virus type 1 infections. MMWR Morb Mortal Wkly Rep 1989;38:1–7.
13. American Academy of Pediatrics, Committee on Pediatric AIDS. Evaluation and medical treatment of the HIV-exposed infant. Pediatrics 1997;99:909–17.
14. Centers for Disease Control and Prevention. Guidelines for the use of antiretroviral agents in pediatric HIV infection. MMWR Morb Mortal Wkly Rep 1998;47:1–43.[Medline]
15. U.S. Preventive Services Task Force. Guide to clinical preventative services: An assessment of the effectiveness of 169 interventions. Baltimore: Williams & Wilkins, 1989.
16. Gwinn M, Pappaioanou M, George JR, Hannon WH, Wasser SC, Redus MA, et al. Prevalence of HIV infection in childbearing women in the United States: Surveillance using newborn blood samples. JAMA 1991;265:1704–8.[Abstract]
17. Donegan SP, Steger KA, Lakambini R, Hoff RS, Werner BG, Rice PA, et al. Seroprevalence of human immunodeficiency virus in parturients at Boston City Hospital: Implications for public health and obstetric practice. Am J Obstet Gynecol 1992;167:622–9.[Medline]
18. Centers for Disease Control and Prevention. Administration of zidovudine during late pregnancy and delivery to prevent perinatal HIV transmission—Thailand, 1996–1998. MMWR Morb Mortal Wkly Rep 1998;47:151–4.[Medline]
19. Wade NA, Birkhead GS, Warren BL, Charbonneau TT, French T, Wang L, et al. Abbreviated regimens of zidovudine prophylaxis and perinatal transmission of the human immunodeficiency virus. N Engl J Med 1998;339:1409–14.
20. Wilkinson D, Wilkinson N, Lombard C, Martin D, Smith A, Floyd K, et al. On-site HIV testing in resource-poor settings: Is one rapid test enough? AIDS 1997;11:377–81.[Medline]
21. Garrett HM, ed. 1998 red book. Montvale, New Jersey: Medical Economics Data, 1994:488.
22. Gorsky RD, Farnham PG, Straus WL, Caldwell B, Holtgrave DR, Simonds RJ, et al. Preventing perinatal transmission of HIV—costs and effectiveness of a recommended intervention. Public Health Rep 1996;111:335–41.[Medline]
23. Myers ER, Thompson JW, Simpson K. Cost-effectiveness of mandatory compared with voluntary screening for human immunodeficiency virus in pregnancy. Obstet Gynecol 1998;91:174–81.[Abstract]
24. Hsia DC, Fleishman JA, East JA, Hellinger FJ. Pediatric human immunodeficiency virus infection. Recent evidence on the utilization and costs of health services. Arch Pediatr Adolesc Med 1995;149:489–96.[Abstract]
25. Mauskopf JA, Paul JE, Wichman DS, White AD, Tilson HH. Economic impact of treatment of HIV positive pregnant women and their newborns with zidovudine: Implications for HIV screening. JAMA 1996;276:132–8.[Abstract]
26. Hegarty JD, Abrams EJ, Hutchinson VE, Nicholas SW, Suarez MS, Heagarty MC. The medical care cost of human immunodeficiency virus-infected children in Harlem. JAMA 1988;260:1901–5.[Abstract]
27. European Collaborative Study. Natural history of vertically acquired human immunodeficiency virus-1 infection. Pediatrics 1994;94:815–9.
28. Gold MR, Seigel JE, Russell LB, Weinstein MC. Cost-effectiveness in health and medicine. New York: Oxford University Press, 1996:54–79.
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