Disease management: what have we learned so far?

Disease management (DM) is becoming an increasingly important tool for use in end-stage renal disease (ESRD). The goal of a DM program is to offer a continuum of care that uses guidelines and case management protocols to prevent acute care episodes, achieve improved outcomes and reduce health care costs. This article reviews the theory behind DM, describes key components of DM programs and explains the financial incentives for DM in ESRD. Of key importance in the increasing role of DM for ESRD has been the development of nationally recognized guidelines, the effects of which are now beginning to emerge. At the same time, recent studies have identified targeted opportunities for DM programs to improve outcomes and costs, including anemia management, dialysis dose, and vascular access. DM, through the use of guidelines and targeted toward these and other areas, has the potential to significantly impact the quality of care provided to ESRD patients.

The economic impact of Staphylococcus aureus infection in New York City hospitals.

We modeled estimates of the incidence, deaths, and direct medical costs of Staphylococcus aureus infections in hospitalized patients in the New York City metropolitan area in 1995 by using hospital discharge data collected by the New York State Department of Health and standard sources for the costs of health care. We also examined the relative impact of methicillin-resistant versus -sensitive strains of S. aureus and of community-acquired versus nosocomial infections. S. aureus-associated hospitalizations resulted in approximately twice the length of stay, deaths, and medical costs of typical hospitalizations; methicillin-resistant and -sensitive infections had similar direct medical costs, but resistant infections caused more deaths (21% versus 8%). Community-acquired and nosocomial infections had similar death rates, but community-acquired infections appeared to have increased direct medical costs per patient ($35,300 versus $28,800). The results of our study indicate that reducing the incidence of methicillin-resistant and -sensitive nosocomial infections would reduce the societal costs of S. aureus infection.

Presacral cysts: transrectal excision in select patients.

Fourteen patients presenting with presacral cystic lesions were managed over a 20-year period. Retrospective review identified 12 females and 2 males. Fifty-seven per cent were symptomatic at diagnosis. Forty-three per cent presented with pain; half of these patients had infected cysts. All lesions were palpable on digital rectal exam. Computed tomography identified the cyst in all seven patients in which it was performed. The transrectal approach was used for cyst excision in ten patients. One patient had transrectal drainage and wall biopsy only. Three patients underwent posterior parasacral excision. Pathologic review demonstrated four dermoid cysts, four epidermoid cysts, four cyst hamartomas, and two benign teratomas. One cyst hamartoma had a focus of invasive adenocarcinoma. Two complications occurred. There were no deaths. Follow-up averaged 39 months, at which time there were no recurrences. Developmental cysts are the most common presacral tumors. Excision is recommended, and the transrectal approach may be used in select patients with low morbidity and minimal recurrence.

Outcomes and effectiveness research in the private sector.

Private-sector health care organizations increasingly tout the use of outcomes and effectiveness research in activities ranging from pharmaceutical research to insurance coverage determinations. The rapid development of this research raises important questions about the role of the Agency for Health Care Policy and Research (AHCPR) as the producer, funder, and champion of outcomes and effectiveness research. To address this issue, we reviewed the activities of pharmaceutical companies, insurers, managed care organizations, health information technology companies, and other private-sector actors in outcomes and effectiveness research. We found that it is being used in a focused way to promote business goals and other organizational objectives, particularly in the pharmaceutical, insurance, and managed care industries. We also found significant gaps in its application to important public health issues and virtually no overlap with prior federal activities in this area.

Clinical and economic impact of implementing a comprehensive diabetes management program in managed care.

Diabetes mellitus places a significant burden on the U.S. healthcare system. Because of the potential to reduce diabetic complications and costs through intensive management, diabetes has become a primary target for disease management programs. We performed a retrospective analysis of short-term baseline and follow-up clinical, economic, and member and provider satisfaction data from approximately 7,000 people with diabetes being treated through seven managed care plans using Diabetes Treatment Centers of America's Diabetes NetCare, (Nashville, TN), a comprehensive diabetes management program. Our analysis indicates that Diabetes NetCare achieved gross economic adjusted savings of $50 per diabetic member per month (12.3%), with gross unadjusted savings of $44 (10.9%) per diabetic member per month. Hospital admissions per 1,000 diabetic member years decreased by 18%, and bed days fell by 21%. Patients with diabetes were more likely to get HbAlc tests, foot exams, eye exams, and cholesterol screenings while enrolled in the program. These data suggest that implementation of a comprehensive healthcare management program for people with diabetes can lead to substantial improvements in costs and clinical outcomes in the short-term. It is expected that improvements will increase over time, with continuing improvements in health status and a reduction in the number of future diabetic complications.

In vitro and skin testing for allergy: comparable clinical utility and costs.

Controversy exists concerning the appropriate use of skin testing and in vitro testing for the diagnosis of allergy, particularly inhalant allergy. Earlier comparisons of skin testing and in vitro testing concluded that skin testing had superior accuracy at lower expense. In light of new developments with in vitro allergy testing, however, this issue should be reconsidered. A review of the recent scientific literature indicates that in vitro and skin testing are highly correlated. However, without the existence of an independent gold standard for inhalant allergy, it is not possible to determine which test is more accurate. The accuracy of either test can be compromised if conducted using different protocols or having insufficient quality control. Given their respective trajectories for technological advancement, quantification, and quality control, in vitro testing may offer the more standardized approach. Although the cost per test of in vitro testing remains greater than that of skin testing, the per-patient costs of the two modalities appear to be comparable, given the greater number of allergens typically used in skin testing. In summary, both skin testing and in vitro testing are acceptable as frontline diagnostic tools.

Extracorporeal membrane oxygenation exposes infants to the plasticizer, di(2-ethylhexyl)phthalate.

OBJECTIVES: To determine the exposure to, and evaluate the potential toxicity from, the plasticizer, di(2-ethylhexyl)phthalate (DEHP) during extracorporeal membrane oxygenation (ECMO) therapy. DESIGN: Protocol 1 consisted of a prospective comparison of three ECMO circuit designs in vitro. Protocol 2 consisted of a prospective, comparative clinical study evaluating DEHP plasma concentrations in ECMO vs. non-ECMO patients with respiratory failure. SETTING: Neonatal intensive care unit at The Children's National Medical Center, Washington, DC. PATIENTS: In protocol 2, 28 consecutive term infants were referred for ECMO therapy. Eighteen infants required ECMO; ten control patients received conventional ventilation and improved without ECMO. INTERVENTIONS: In protocol 1, three ECMO circuit designs were primed in vitro with normal saline, albumin, and human blood, which was maintained at 37 degrees C and recirculated at 400 mL/min for 48 hrs. Plasma samples were obtained at time 0, 1 hr, and every 6 hrs. In protocol 2, ventilatory and cardiovascular management of the patients in the study was conducted by the attending physician. Patients were placed on ECMO when they met the institutional criteria for ECMO therapy. Daily plasma concentrations for DEHP were collected until 3 days after decannulation from bypass in the ECMO group. Control patients were sampled daily until extubation. Evidence of cardiac, liver, or lung toxicity was evaluated by Chest Radiographic Scores, liver function studies, and echocardiograms obtained on day 1, day 3, and the day of decannulation in the ECMO group, or at the time of extubation in the control group. Sedation, blood product transfusions as indicated, antibiotics, and hyperalimentation were administered to all patients. MEASUREMENTS AND MAIN RESULTS: All DEHP plasma concentrations were measured by gas chromatography. In protocol 1, three circuits were studied: circuit A (small surface area); circuit B (larger surface area); and circuit C (surface area of A but with heparin-bonded tubing in the circuit). DEHP leached from circuit A at 0.32 +/- 0.12 microgram/ mL/hr, compared with 0.57 +/- 0.14 microgram/mL/hr from circuit B (p < .05). This amount of DEHP extrapolates in the ECMO patient to a potential exposure of 20 to 70 times that exposure from other medical devices or procedures, such as transfusions, dialysis, or short-term cardiopulmonary bypass. Circuit C showed almost no leaching from the circuit; DEHP concentrations decreased at a rate of 0.2 +/- 0.04 microgram/mL/ hr. In protocol 2, DEHP was undetected in the control patients. DEHP concentrations in ECMO patients were greater in the early course of ECMO. However, most patients cleared this compound from the plasma before decannulation. In contrast to the in vitro results in protocol 1, the average highest concentration at any time on bypass was 8.3 +/- 5.7 micrograms/mL or 2 mg/kg. CONCLUSIONS: DEHP leaches from ECMO circuits, with potential exposure concentrations related to the surface area of the tubing in the ECMO circuit. Heparin bonding of the tubing eliminates this risk. Although significant concentrations of DEHP leach from the nonheparin-bonded circuits over time, our in vivo studies showed that the DEHP plasma concentrations were less than the previously reported values and do not correlate with any observable short-term toxicity. This compound may be either efficiently metabolized by the newborn, or redistributed into various tissues. Although signs of toxicity were not found in this study, long-term complications from chronic exposure to DEHP have not been determined.

A framework for cost-sharing policy analysis.

To assess the effect of cost sharing, a framework for describing and evaluating cost-sharing programmes was constructed, followed by a comprehensive search of the international literature on the subject. The results indicated that cost sharing carries many potential advantages, one of which includes increased consumer attention to healthcare costs. However, proper design of cost-sharing programmes is necessary to mitigate regressivity and other common problems associated with many current programmes. These findings should help policy makers to understand and anticipate the effects of cost sharing, and to create innovative benefit design solutions that are targeted to promote health system goals.

State involvement in medical technology assessment.

State governments are reevaluating their role in the assessment of medical technologies. This paper outlines a range of state technology assessment activities, highlighting programs in Minnesota, Oregon, and Washington, and discusses the issues associated with state government involvement. Clinically oriented activities on the state level can inform efforts to contain costs, educate consumers and providers, and facilitate local consensus on the appropriate uses of new and existing technologies. Although current programs are still in their infancy and their viability remains uncertain, the importance of technology assessment is growing as technology continues to fuel increasing costs. The future of state-level technology assessment may lie in collaborative ventures with other states, the federal government, or private industry.

Reappraisal of partial lateral internal sphincterotomy.

PURPOSE: The aim of this study was to delineate the results, mortality, and morbidity of partial lateral internal sphincterotomy for the treatment of chronic anal fissure. METHOD: A retrospective review of 500 patients undergoing partial lateral internal sphincterotomy for chronic anal fissure between 1980 and 1990 was performed. Patients were identified by a review of an office surgical ledger and included all patients whose diagnosis was anal fissure and for whom a partial lateral internal sphincterotomy was performed as treatment. RESULTS: Over an average follow-up of 5.6 years, only 1 percent of patients failed to health their fissures after performance of this operation. Minor complications included pain, pruritus, wound abscess, discharge, delayed healing, bleeding, fecal impaction, minor incontinence, and urgency and were present in 16 percent of patients, postoperatively. Two percent of patients who initially healed their fissures suffered a recurrence. Complication rates in open vs. closed sphincterotomy were 15 percent vs. 8 percent (P < 0.01). Disorders of fecal continence occurred in 8 percent of patients over the long term. CONCLUSION: Extended follow-up after partial lateral internal sphincterotomy demonstrates a higher complication rate than was seen in patients being followed for shorter periods. However, the complication of impaired fecal continence only occurred in 8 percent of our patients, compared with 15 percent reported in the current literature, although using the same evaluative criteria. Patient satisfaction with the results of surgery was 98 percent. Careful patient selection, absence of preoperative continence problems, and meticulous surgical techniques are necessary to achieve this type of result.