PREVALENCE OF PROSTATE CANCER AMONG MEN WITH A PSA LEVEL OF ≤ 4.0 ng/mL

The most favorable level of the normal range for prostate-specific antigen (PSA) is unknown. This study examined the prevalence of prostate cancer among men in the Prostate Cancer Prevention Trial who had a PSA level of 4.0 ng/mL or less. Out of 18,882 participants in the prevention trial, 9459 were randomly selected to receive placebo, an annual measurement of PSA, and a digital rectal examination. Among this group, the PSA level for 2950 of them (age range, 62-91) was never more than 4.0 ng/mL, nor did they have an abnormal digital rectal examination. They had a final PSA determination and underwent a prostate biopsy after participating in the study for 7 years. Prostate cancer was diagnosed in 449 (15.2%) of the 2950 men; 67 of these 449 cancers (14.9%) had a Gleason score of > 7. The prevalence of prostate cancer was 6.6% among men with a PSA level of up to 0.5 ng/mL, 10.1% among those with values of 0.6-1.0 ng/mL, 17.0% among those with values of 1.1-2.0 ng/mL, 23.9% among those with values of 2.1-3.0 ng/mL, and 26.9% among those with values of 3.1-4.0 ng/mL. The prevalence of high-grade cancers increased from 12.5% of cancers associated with a PSA level of < 0.5 ng/mL to 25.0% of cancers associated with a PSA level of 3.1-4.0 ng/mL. The authors concluded that biopsy-detected prostate cancer, including high-grade cancers, is not rare among men with PSA levels of ≤ 4.0 ng/mL÷levels generally thought to be in the normal range.

Thompson IM, Pauler DK, Goodman PJ, Tangen CM, Lucia MS, Parnes HL, Minasian LM, Ford LG, Lippman SM, Crawford ED, Crowley JJ, Coltman CA Jr. Prevalence of prostate cancer among men with a prostate-specific antigen level < 4.0 ng per milliliter. N Engl J Med 2004;350:2239-2246.


ESTIMATING PROGNOSIS FOR NURSING HOME RESIDENTS WITH ADVANCED DEMENTIA

Many nursing home residents with end-stage dementia do not receive optimal palliative care, yet palliation is thought to be the most appropriate treatment goal for patients dying with this illness. Survival rates vary among patients with advanced dementia, and accurate prognostic tools have not been developed. A small proportion of patients admitted to hospice have dementia, in part because of the difficulty in predicting survival. Less than 1% of enrollees have a primary diagnosis of dementia. The authors conducted a retrospective cohort study of data from the Minimum Data Set (MDS) in order to identify factors associated with 6-month mortality in newly admitted nursing home residents with advanced dementia, and to create a practical risk score to predict 6-month mortality in this population. All Medicare or Medicaid licensed nursing homes in New York and Michigan were included in the study. Participants were those with advanced dementia who were admitted to New York nursing homes between June 1, 1994, and December 30, 1998 (derivation cohort, n = 6799), and to Michigan nursing homes from October 1, 1998, through July 30, 2000 (validation cohort, n = 4631). MDS factors associated with 6-month mortality were determined in the derivation group, and the resulting mortality risk score was evaluated in the validation cohort. The National Hospice Organization eligibility guidelines for patients with dementia are based primarily on the Functional Assessment Staging (FAST) criteria, which have been criticized because they do not derive from empirical data, do not accurately predict 6-month survival, and cannot be applied to the majority of patients whose dementia does not have a linear progression. Risk score performance was compared with the cut point of 7c on the FAST scale. Among residents with advanced dementia, 28.3% (n = 1922) died within 6 months of nursing home admission in the derivation cohort; 35.1% (n = 1626) died in the validation cohort. The 6-month mortality rate increased across risk scores (possible range, 0-19): 0 points, 8.9% mortality; 1-2, 10.8%; 3-5, 23.2%; 6-8, 40.4%; 9-11, 57.0%; and at least 12, 70.0% in the validation cohort. The area under the receiver operating characteristic (AUROC) curve for predicting 6-month mortality was 0.74 and 0.70 in the derivation and validation cohorts, respectively. The risk score showed better discrimination to predict 6-month mortality (AUROC, 0.64 for a cutoff of > 6 points vs 0.51 for FAST stage 7c). In conclusion, the authors found that a risk score based on 12 variables from the MDS more accurately estimates 6-month mortality in nursing home residents with advanced dementia than the existing prognostic guidelines.

Mitchell SL, Kiely DK, Hamel MB, Park PS, Morris JN, Fries BE. Estimating prognosis for nursing home residents with advanced dementia. JAMA 2004;291(22):2734-2740.


ASSESSING THE NEW MEDICARE PRESCRIPTION DRUG LAW

The Medicare Modernization Act (MMA) is a bill designed by Congressional leaders to attract enough votes from Democrats and moderate Republicans without losing the support of too many Republican conservatives. This political compromise offered more private health plans to beneficiaries while maintaining and improving traditional Medicare benefits. The debate over the legislation was not settled, which is a major issue in the 2004 elections. Polls show that voters do not fully understand the law because of its complexity. This article examines how the policy decisions made by the U.S. Congress have contributed to the lawâs complexity and controversy. The author discusses new private health plan options that will be offered to beneficiaries, improvements made to traditional Medicare, and the impact of introducing income-based determinations into Medicare. The impact of the drug benefit on beneficiariesâ categories of income and assets was explored, as well as the decision of Congress to prohibit the federal government from directly negotiating prices with drug manufacturers. The article assessed major claims made by critics and supporters, who may be more cautious in evaluating the impact of the MMA, since it is impossible to predict how a law of such complexity, with so many human variables, will work out in the end. The MMA is a worthwhile but imperfect effort to extend drug coverage to seniors who are most in need. It deserves neither condemnation nor indiscriminate praise, but instead a commitment to help it succeed.

Doherty RB. Assessing the new Medicare prescription drug law. Ann Intern Med 2004;141(5):391-395.

DRUG TREATMENT OF HYPERLIPIDEMIA IN WOMEN

Many of the clinical trials that have evaluated the effects of lipid-lowering medications on coronary heart disease (CHD) have not included enough women to allow sex-specific analyses or have not reported the results in women separately. The authors synthesized the evidence regarding drug treatment of hyperlipidemia for the prevention of CHD events in women and conducted a meta-analysis of the effect of drug treatment on mortality. They reviewed literature published from 1966 through December 2003. The studies that were included assessed the impact of lipid lowering on clinical outcomes, had outpatients with a treatment duration of at least 1 year, and reported results by sex. The outcomes evaluated included total mortality, CHD mortality, nonfatal myocardial infarction, revascularization, and total CHD events. Summary estimates of the relative risks with therapy were calculated using a random-effects model for patients with and without a previous history of cardiovascular disease. Of the 13 studies included, six had a total of 11,435 women without cardiovascular disease and assessed the effects of lipid-lowering medications. Lipid lowering did not reduce any of the outcomes measured. However, some analyses were limited by too few CHD events in the available studies. Eight of the trials included 8272 women with cardiovascular disease and assessed the effects of lipid-lowering medications. Lipid lowering did not reduce total mortality in women with cardiovascular disease. However, lipid lowering reduced CHD mortality, nonfatal myocardial infarction, revascularization, and total CHD events. The investigators concluded that for women without cardiovascular disease, lipid lowering does not affect total or CHD mortality. Lipid lowering may reduce CHD events, but the current evidence is insufficient to determine this conclusively. For women with known cardiovascular disease, treatment of hyperlipidemia is effective in reducing CHD events, CHD mortality, nonfatal myocardial infarction, and revascularization, but it does not affect total mortality.

Walsh JM, Pignone M. Drug treatment of hyperlipidemia in women. JAMA 2004;291(18):2243-2252.


MEDICAL AND SURGICAL COMANAGEMENT AFTER ELECTIVE HIP AND KNEE ARTHROPLASTY

There are now 6000 hospitalists in the U.S. who are assuming an increasing role in the care of surgical inpatients. Other studies have analyzed the effects of hospitalist models on patient outcomes in medical settings. These authors studied the impact of providing a collaborative, hospitalist-led model of care on postoperative outcomes and costs among patients having hip or knee arthroplasty. A randomized, controlled trial was conducted at Rochester Methodist Hospital involving 526 participants undergoing elective orthopedic surgery who were at elevated risk for postoperative morbidity. Investigators evaluated length of stay, inpatient postoperative medical complications, health care provider satisfaction, and inpatient costs. Patients were divided into two groups: one treated by a comanagement medical Hospitalist-Orthopedic Team, and the other treated with standard postoperative care by orthopedic surgeons with medical consultation. More patients in the hospitalist group were discharged from the hospital with no complications as compared to the standard treatment group (61.6% vs 49.8%). There were fewer minor complications among the hospitalist group than the standard treatment group (30.2% vs 44.3%). Observed length of stay and total costs were not statistically different between the treatment groups. However, when adjusted for discharge delays, mean length of stay for patients in the hospitalist model of care was shorter (5.1 days vs 5.6 days). It was found that orthopedic surgeons and nurses preferred the hospitalist model. A limitation of this trial was that care providers and patients were aware of intervention assignments, and the study could not capture all costs associated with the hospitalist model. In summary, the comanagement medical Hospitalist-Orthopedic Team model of care reduced minor postoperative complication rates with no statistically significant difference in length of stay or cost. While nurses and surgeons did prefer the hospitalist model, additional research is needed regarding the clinical and economic impact of this treatment on other surgical populations.

Huddleston JM, Long KH, Naessens JM, Vanness D, Larson D, Trousdale R, Plevak M, Cabanela M, Ilstrup D, Wachter RM; Hospitalist-Orthopedic Team Trial Investigators. Medical and surgical comanagement after elective hip and knee arthroplasty: A randomized, controlled trial. Ann Intern Med 2004;141 (1):28-38.


WITHHOLDING ANTICOAGULATION AFTER A NEGATIVE RESULT ON DUPLEX ULTRASONOGRAPHY FOR SUSPECTED SYMPTOMATIC DEEP VENOUS THROMBOSIS

Ultrasonography is the most commonly used test in the United States for the diagnosis of deep venous thrombosis (DVT). Negative results on simplified compression ultrasonography cannot rule out symptomatic DVT without further testing, such as repeated ultrasonography several days later. Repeated testing is costly and inconvenient, and patients are sometimes less likely to return for follow-up tests. The authors conducted a prospective clinical cohort study to determine the rate of venous thromboembolism when anticoagulation is withheld in patients with symptoms of DVT of the leg after negative results from a single examination with comprehensive duplex ultrasonography were received. At a peripheral vascular laboratory of a tertiary care academic hospital, 445 consecutive patients were enrolled in whom a first episode of symptomatic DVT was suspected. Pregnant patients were excluded from the study. Each patientâs entire leg was examined with comprehensive duplex ultrasonography using compression and Doppler techniques. Anticoagulation was withheld from the group with negative results. Patients were observed for thromboembolic events for 3 months. Objective testing was performed for all patients with new or progressive symptoms or signs of DVT during follow-up. Comprehensive duplex ultrasonography produced normal results in 384 patients (86.3%) and showed DVT in 61 patients (13.7%). In 19 cases (31.1%), DVT was isolated to the deep veins of the calf. Nine of the 384 patients in the negative cohort (2.3%) were excluded from analysis because they received anticoagulation for reasons unrelated to venous thromboembolism, and all patients in this cohort completed follow-up. Three out of 375 patients (0.80%) in the normal cohort had symptomatic venous thrombosis during the 3-month follow-up. A limitation of the study was that it was conducted at a single tertiary care center by a peripheral vascular staff with substantial experience in duplex ultrasonography, which may limit the applicability of the results to other institutions. The authors concluded that it is safe to withhold anticoagulation after negative results are received from comprehensive duplex ultrasonography in nonpregnant patients with a suspected first episode of symptomatic DVT of the leg. Further testing should be conducted with any new or progressive symptoms.

Stevens SM, Elliott CG, Chan KJ, Egger MJ, Ahmed KM. Withholding anticoagulation after a negative result on duplex ultrasonography for suspected symptomatic deep venous thrombosis. Ann Intern Med 2004;140(12): 985-991.