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Biomedical subjects

R S Woodward

Publications and source records attributed to R S Woodward.

At least 19 recordsLinked to original sources

Effect of extended coverage of immunosuppressive medications by medicare on the survival of cadaveric renal transplants.

Between 1993 and 1995, Medicare extended its coverage of maintenance immunosuppression medications following renal transplantation from 1 to 3 years. We hypothesized that Medicare's extension of immunosuppressive coverage would improve graft survival among low-income transplant recipients. We merged patient-level clinical data from the USRDS-distributed UNOS registry of kidney transplants throughout the USA with median family income for each patient's ZIP code from the 1990 Census. We were able to merge median incomes to 10,837 first cadaveric renal transplants performed in 1992-93 and 16,732 performed in 1995-97. Each of these chronological cohorts was divided into two groups, those with family incomes above (high-income group) and those below (low-income group) $36,033. There were no differences in graft survival at 1 year based on income in either chronological era. However, when Medicare covered immunosuppression medications for just 1 year, the low-income group of 1-year graft survivors had a 4.5% lower graft survival at the end of 3 years post-transplant (p < 0.001). During the 1995-97 period, during which Medicare provided 3 years' immunosuppression coverage, the low-income and high-income groups had equivalent graft survival at 3 years post-transplant.

Cadaver↗

The economic impact of preservation time in cadaveric liver transplantation.

There has been considerable recent debate concerning the reconfiguration of the cadaveric liver allocation system with the intent to allocate livers to more severely ill patients over greater distances. We sought to assess the economic implications of longer preservation times in cadaveric liver transplantation that may be seen in a restructured allocation system. A total of 683 patients with nonfulminant liver disease, aged 16 years or older, receiving a cadaveric donor liver as their only transplant, were drawn from a prospective cohort of patients who received transplants between January 1991 and July 1994 at the University of California, San Francisco, the Mayo Clinic, Rochester, Minnesota, or the University of Nebraska, Omaha. The primary outcome measure was standardized hospitalization resource utilization from the day of transplantation through discharge. Secondary outcome measures included 2-year patient survival, and 2-year retransplantation rates. Results indicated that each 1-h increase in preservation time was associated with a 1.4% increase in standardized hospital resource utilization (p = 0.014). The effects on 2-year patient survival and retransplantation rates were not measurably affected by an increase in preservation time. We conclude that policies that increase preservation time may be expected to increase the cost of liver transplantation.

Body Constitution↗

Economic cost of expanded criteria donors in cadaveric renal transplantation: analysis of Medicare payments.

BACKGROUND: The use of expanded criteria donors (ECDs) in cadaveric renal transplantation is increasing in the US. We assess the economic impact of the use of ECDs to the Medicare end stage renal disease program. METHODS: The United Nations for Organ Sharing renal transplant registry was merged to Medicare claims data for 42,868 cadaveric renal transplants performed between 1991-1996 using USRDS identifiers. Only recipients for whom Medicare was the primary payer were considered, leaving 34,534 transplants. An ECD was defined as (1) age < or =5 or > or =55 years, (2) nonheart-beating donors, donor history of (3) hypertension or (4) diabetes. High-risk recipients (HRR) were age >60 years, or a retransplant. Medicare payments from the pretransplant dialysis period were projected forward to provide a financial "breakeven point" with transplantation. RESULTS: There were 25,600 non-HRR transplants, with 5,718 (22%) using ECDs, and 8,934 HRR transplants, of which 2,200 (25%) used ECDs. The 5-year present value of payments for non-ECD/non-HRR donor/recipient pairings was $121,698 vs. $143,329 for ECD/non-HRR pairings (P<0.0001) and, similarly was $134,185 for non-ECD/HRR pairings vs. $165,716 for ECD/HRR pairings (P<0.0001). The break even point with hemodialysis ranged from 4.4 years for non-ECD/ non-HRR pairings to 13 years for the ECD/HRR combinations but was sensitive to small changes in graft survival. Transplantation was always less expensive than hemodialysis in the long run. CONCLUSIONS: The impact of ECDs on Medicare payments is most pronounced in high-risk recipients. Cadaveric renal transplantation is a cost-saving treatment strategy for the Medicare ESRD program regardless of recipient risk status or the use of ECDs.

Aged↗

The economic benefit of allocation of kidneys based on cross-reactive group matching.

BACKGROUND: Recently the United Network for Organ Sharing (UNOS) began a pilot study to evaluate prospectively the merits of an allocation of cadaveric kidneys based on broader classes of HLA antigens, called cross-reactive groups (CREG). The objectives of the pilot study consider patient outcomes, but not the potential economic impact of a CREG-based allocation. This study predicts the impact of a CREG-based local allocation of cadaveric kidneys on 3-year Medicare payments and graft survival. METHODS: The UNOS renal transplant registry was merged to Medicare claims data for 1991-1997 by the United States Renal Data System. Average accumulated Medicare payments and graft survival up to 3 years posttransplant for first cadaveric renal transplant recipients were stratified by cross-reactive group mismatch categories. The economic impact was defined as the difference in average 3-year costs per transplant between the current and proposed allocation algorithms. Average 3-year costs were computed as a weighted average of costs, where the weights were the actual and predicted distributions of transplants across cross-reactive group categories. RESULTS: Results suggest that an organ allocation based on cross-reactive group matching criteria would result in a 3-year cost savings of $1,231 (2%) per transplant, and an average 3-year graft survival improvement of 0.6%. CONCLUSIONS: Cost savings and graft survival improvements can be expected if CREG criteria were to replace current criteria in the current allocation policy for cadaveric kidneys, although the savings appear to be smaller than may be achievable through expanded HLA matching.

Algorithms↗

Cadaveric versus living donor kidney transplantation: a Medicare payment analysis.

BACKGROUND: We found previously that the clinical advantages of living donor (LD) renal transplantation lead to financial cost savings compared to either cadaveric donation (CAD) or dialysis. Here, we analyze the sources of the cost savings of LD versus CAD kidney transplantation. METHODS: We used United States Renal Data System data to merge United Network for Organ Sharing registry information with Medicare claims data for 1991-1996. Information was available for 42,868 CAD and 13,754 LD transplants. More than 5 million Medicare payment records were analyzed. We calculated the difference in average payments made by Medicare for CAD and LD for services provided during the first posttransplant year. RESULTS: Average total payments were $39,534 and $24,652 for CAD and LD, respectively (P<0.0001) during the first posttransplant year. The largest source of the difference in payments was in inpatient hospitals, representing $10,653.67 (P<0.0001). For patients who had Medicare as the primary payer, average transplant charges were significantly higher for CAD donation ($79,730 vs. $69,547, P<0.0001); average transplant payments demonstrated no statistical differences ($28,483 vs. $28,447, P = 0.858). Therefore, inferred profitability was significantly higher for LD. CONCLUSIONS: Medicare payments are remarkably lower for LD compared to CAD in every category. The single largest cost saving comes from inpatient hospital services. A portion of the savings from LD could be invested in programs to expand living kidney donation.

Cadaver↗

The clinical and economic impact of deep chest surgical site infections following coronary artery bypass graft surgery.

STUDY OBJECTIVES: To examine how deep chest surgical site infections following coronary artery bypass graft (CABG) surgery impact hospital inpatient length of stay (LOS), costs, and mortality. SETTING: A large, Midwestern community medical center. DESIGN: All CABG patients who developed deep chest infection (n = 41) were compared to a set of control subjects (n = 160) systematically selected as every tenth uninfected CABG patient. Clinical data were abstracted from patient records, and cost information was obtained from the cost accounting database of the hospital. RESULTS: Variables that significantly increased the risk of deep chest surgical site infection included obesity (odds ratio [OR], 11; p = 0. 0001), renal insufficiency (OR, 8.9; p = 0.0001), connective tissue disease (OR, 25.4; p = 0.0003), reexploration for bleeding (OR, 8.2; p = 0.0015), and the timing of antibiotic prophylaxis (> 60 min before incision; OR, 5.3; p = 0.0128). Within 1 year postoperatively, patients with deep chest surgical site infection had a mortality rate of 22%, vs 0.6% for uninfected patients (p = 0.0001). Infected patients also incurred an average of 20 additional hospital days (p = 0.0001). Univariate analysis indicated that patients who developed deep chest surgical site infection incurred $20,012 in additional costs in the first year (p = 0.0001). Infected patients who died incurred on average $60,547 more than infected patients who survived (p = 0.034). Multivariate analysis confirmed the magnitude of the estimate of the cost for deep chest surgical site infection ($18, 938; p = 0.0001). CONCLUSIONS: Deep chest surgical site infections following CABG surgery are associated with significant increases in LOS, hospitalization costs, and mortality. These results suggest the need for improved infection control measures to reduce deep chest surgical site infection rates.

Aged↗

Economics of the antithymocyte globulins Thymoglobulin and Atgam in the treatment of acute renal transplant rejection.

OBJECTIVE: To evaluate the economic implications for transplant centres, Medicare and society of treatment of corticosteroid-resistant Banff Grades I, II and III acute kidney transplant rejection with the antithymocyte globulins Thymoglobulin or Atgam. DESIGN AND SETTING: This was a cost analysis of a randomised double-blind multicentre clinical trial comparing the safety and efficacy of Thymoglobulin and Atgam that was performed at 25 centres in the US in 1994 to 1996. PATIENTS AND PARTICIPANTS: The study enrolled 163 patients, 82 in the Thymoglobulin arm and 81 in the Atgam arm. METHODS: Estimates of the cost of care from the initiation of rejection therapy to 90 days post-therapy were derived from various publicly available sources and applied to patient-specific clinical events documented in the clinical trial. Patients received either intravenous Thymoglobulin (1.5 mg/kg/day) for an average of 10 days or intravenous Atgam (15 mg/kg/day) for an average of 9.7 days. RESULTS: On average, Thymoglobulin provided significant cost savings compared with Atgam from the perspective of society [$US5977 (1996 values); 95% confidence interval (CI) $US3719 to $US8254], Medicare ($US4967; 95% CI $US3256 to $US6678) and the transplant centre ($US3087; 95% CI $US1512 to $US4667). The overall advantage attributable to Thymoglobulin was primarily due to savings from fewer recurrent rejection treatments and less frequent return to dialysis. CONCLUSIONS: Treatment of acute renal transplant rejection with Thymoglobulin is a cost saving strategy when compared with treatment with Atgam.

Acute Disease↗

The economic implications of HLA matching in cadaveric renal transplantation.

BACKGROUND: The potential economic effects of the allocation of cadaveric kidneys on the basis of tissue-matching criteria is controversial. We analyzed the economic costs associated with the transplantation of cadaveric kidneys with various numbers of HLA mismatches and examined the potential economic benefits of a local, as compared with a national, system designed to minimize HLA mismatches between donor and recipient in first cadaveric renal transplantations. METHODS: All data were supplied by the U.S. Renal Data System. Data on all payments made by Medicare from 1991 through 1997 for the care of recipients of a first cadaveric renal transplant were analyzed according to the number of HLA-A, B, and DR mismatches between donor and recipient and the duration of cold ischemia before transplantation. RESULTS: Average Medicare payments for renal transplant recipients in the three years after transplantation increased from 60,436 dollars per patient for fully HLA-matched kidneys (those with no HLA-A, B, or DR mismatches) to 80,807 dollars for kidneys with six HLA mismatches between donor and recipient, a difference of 34 percent (P<0.001). By three years after transplantation, the average Medicare payments were 64,119 dollars for transplantations of kidneys with less than 12 hours of cold ischemia time and 74,997 dollars for those with more than 36 hours (P<0.001). In simulations, the assignment of cadaveric kidneys to recipients by a method that minimized HLA mismatching within a local geographic area (i.e., within one of the approximately 50 organ-procurement organizations, which cover widely varying geographic areas) produced the largest cost savings (4,290 dollars per patient over a period of three years) and the largest improvements in the graft-survival rate (2.3 percent) when the potential costs of longer cold ischemia time were considered. CONCLUSIONS: Transplantation of better-matched cadaveric kidneys could have substantial economic advantages. In our simulations, HLA-based allocation of kidneys at the local level produced the largest estimated cost savings, when the duration of cold ischemia was taken into account. No additional savings were estimated to result from a national allocation program, because the additional costs of longer cold ischemia time were greater than the advantages of optimizing HLA matching.

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Criteria for outpatient management of proximal lower extremity deep venous thrombosis.

STUDY OBJECTIVES: To develop and to evaluate selection criteria for outpatient management of deep venous thrombosis (DVT). DESIGN: We developed outpatient treatment eligibility criteria that incorporated demographic and clinical data. We aimed to exclude patients at high risk for bleeding or recurrent clotting, as well as those with pulmonary embolism, limited cardiopulmonary reserve, or need for hospitalization due to another illness. Then, we retrospectively applied the criteria to hospitalized patients with newly diagnosed proximal lower extremity DVT to determine the fraction of patients eligible for outpatient therapy; patients were classified as eligible, possibly eligible, or ineligible for home treatment based on the selection criteria. SETTING: University hospital. PATIENTS: One hundred ninety-five hospitalized patients diagnosed as having proximal lower extremity DVT by duplex ultrasound over a 1-year period. MEASUREMENTS: Frequency of complications during initial DVT therapy, including major bleeding, symptomatic thromboembolism, and death. RESULTS: Eighteen (9%) patients were classified as eligible, and 18 (9%) were classified as possibly eligible for outpatient therapy. None of these patients developed complications. Of the 159 (82%) patients classified as ineligible, 13 (8%; 95% confidence interval [CI], 4 to 12%) died or developed serious complications. Therefore, the eligibility criteria had a sensitivity of 100% (95% CI, 92 to 100%) and a negative predictive value of 100% (95% CI, 92 to 100%) for predicting serious complications. CONCLUSIONS: Specific eligibility criteria may identify a subset of patients with acute DVT who can be treated safely at home.

Acute Disease↗

Integrating the Internet into health administration education: a report from AUPHA's Faculty Internet integration task force.

HRSA funded a survey to determine what Internet resources would be most useful to AUPHA membership. This manuscript describes the Internet-intensive survey methodology, reports the survey results, and lists the task force recommendations. The task force used sequential questionnaires posted on the Web to gather both potentially useful Internet resource ideas and membership perceptions of the importance of each idea. Resources recommended by survey participants and the Task Force members emphasized potential improvements to the AUPHA and AUPHA-member Web pages.

Data Collection↗

Reduced uncertainty as a diagnostic benefit: an initial assessment of somatostatic receptor scintigraphy's value in detecting distant metastases of carcinoid liver tumours.

This paper employs classical concepts of diminishing marginal utility to demonstrate that risk-aversion can increase the perceived value of diagnostic procedures and thus raise optimum diagnostic expenditures. The theory is applied to a model in the spirit of Phelps and Mushlin's initial technology assessments. The specific evaluation is the cost-effectiveness of somatostatin receptor scintigraphy used to detect distant metastases of carcinoid liver tumours in a patient otherwise eligible for surgical resection of the liver. Data for the model are taken from published sources and financial databases, when available, and otherwise from a senior clinician's experience (LKK). The quantitative results indicate that receptor scintigraphy may have two beneficial impacts to risk-neutral individuals. First, it may reduce the combined costs of therapy and treatment because the diagnostic procedure costs less than the expected savings generated by avoiding inappropriate surgeries. Second, it may improve the patient's expected health-status-adjusted life years (HSALY) because the information allows physicians to better match treatment to the cancer's stage. Finally the paper demonstrates that risk aversion, as embodied in classical diminishing marginal utility applied to health status, can increase the value of the diagnostic tests and can lead the patient to choose a less beneficial treatment. An illustrative risk-averse utility function changed the optimum treatment from surgery to chemotherapy and increased scintigraphy's benefit by 500%.

Carcinoid Tumor↗

A new product pricing model using intracorporate market perceptions to extract the value of additional information.

OBJECTIVE: This model introduces a unique and inexpensive technique to estimate profit increases that might be expected from: (i) an additional clinical trial to establish a drug's second clinical indication; and (ii) a survey of market demand. DESIGN: Microsoft Excel spreadsheets are used to solicit selected expert opinions about the new product's annual market share under scenarios reflecting different pricing points, promotional expenditures and clinical advantage. MAIN OUTCOME MEASURES AND RESULTS: The preprogrammed model returns profit-maximising price, promotional expenditure and market differentiation for each expert and the group as a whole. The extent of disagreement among the experts is used to estimate the additional profits which might be expected from a clinical trial and a market survey. Results from an illustrative application indicated greater incremental profits could be expected from the survey of market demand. The clinical trial generated smaller expected incremental profits because several experts felt that the trial's potential results would not affect the drug's profit-maximising price. CONCLUSIONS: With a 1-day meeting between 6 experts, the model provided a recommendation about the new product's profit-maximising market price and promotional expenditure. Furthermore, it estimated profit increases that might be expected from additional clinical trials and a survey of market demand.

Drug Costs↗

Impact of cytomegalovirus serology on graft survival in living related kidney transplantation: implications for donor selection.

BACKGROUND: The impact of cytomegalovirus in living related kidney transplantation remains controversial. This study considers the implications of donor and recipient cytomegalovirus (CMV) serology for the selection of living related donor. METHODS: Graft survival was estimated by using the bivariate Kaplan-Meier method and multivariate Cox proportional hazards analysis for 7659 living related first transplantations performed in the United States between 1989 and 1994. The effects of donor CMV serology were estimated with respect to recipient CMV serology and compared with human leukocyte antigen (HLA) matching, transplantation, donor, and recipient characteristics. The implications of these estimates for the selection of living related donors were considered. RESULTS: From Kaplan-Meier estimates, donor CMV-seropositive kidneys were associated with significantly reduced graft survival for CMV-seronegative recipients (p = 0.0002) but not CMV-seropositive recipients (p = 0.1623). These findings were verified by use of Cox proportional hazards analysis accounting for covariate factors. The impact of donor CMV-seropositive kidneys on CMV-seronegative recipients was similar to one HLA-DR match, greater than one HLA-B match, and significantly greater than one HLA-A match (p = 0.0331). CONCLUSIONS: Results identify donor CMV serology as an important determinant of transplantation outcome for living related first kidney transplant recipients who are themselves CMV seronegative. Consideration should be given to donor and recipient CMV serology when selecting an appropriate donor for living related kidney transplantation.

Adult↗

Cytomegalovirus and HLA-A, B, and DR locus interactions: impact on renal transplant graft survival.

Graft failure rates for renal transplantations performed between 1989 and 1994 and recorded in the US Renal Data System database were retrospectively evaluated for interactions between cytomegalovirus and HLA-A, B, and DR loci. Twelve significant interactions were observed. There were significantly greater risks of graft failure for the total effect of cytomegalovirus and donor or matched HLA-DR9, recipient or matched HLA-B-51, and matched HLA-B13. We conclude that further study of renal transplants with these combinations of cytomegalovirus and HLA loci is needed to determine whether the observed interactions should be taken into consideration when matching donors with recipients.

Adult↗

The effects of cytomegalovirus serology on graft and recipient survival in cadaveric renal transplantation: implications for organ allocation.

The potential benefits from allocating donated cadaveric kidneys based on donor and recipient cytomegalovirus (CMV) serology remain controversial. We estimated graft survival and recipient survival using bivariate Kaplan-Meier models and multivariate Cox proportional hazards models for 24,543 first cadaveric renal transplantations performed in the United States between 1989, coinciding with the introduction of ganciclovir, and 1994. The effects of donor and recipient CMV serology were estimated, and the implications of these estimates for CMV-based allocation of cadaveric kidneys were considered. From Kaplan-Meier estimates, the 3-year impact of CMV-seropositive donor kidneys was a 3.6% reduction in graft survival and a 2.4% reduction in recipient survival for CMV-seronegative recipients, and a 3.9% reduction in graft survival and a 3.0% reduction in recipient survival for CMV-seropositive recipients. Multivariate Cox analysis demonstrated an adverse impact of donor CMV seropositivity regardless of recipient CMV status. D-/R- CMV serologic pairs had the best 3-year outcomes, with 73.4% graft survival and 87.7% recipient survival. D+/R+ CMV serologic pairs were found to have the worst 3-year outcomes, with 68.4% graft survival and 83.1% recipient survival, and were significantly worse than D+/R- pairs in terms of recipient survival. The maximum estimated impact of a program allocating donor kidneys to maximize the number of D-/R- CMV serologic pairs, assuming no impact on HLA mismatches, was a 0.1% reduction in aggregate 3-year graft survival and a 0.2% reduction in aggregate recipient survival. An alternative program allocating donor kidneys to minimize the number of D+/R+ pairs had no estimated effect on either graft or recipient survival. We conclude that during the ganciclovir era, CMV continues to have an important impact on first cadaveric renal transplantation. However, even under ideal conditions, CMV-based kidney allocation to either maximize the number of D-/R- pairs or minimize the number of D+/R+ pairs is likely to provide little benefit to the population of cadaveric renal transplant recipients.

Antibodies, Viral↗