Abstract

BACKGROUND:

Only 31% of Americans with hypertension have their blood pressure (BP) under effective control. We describe a study that tests 3 different interventions in a randomized controlled trial using home BP telemedicine monitoring.

METHODS:

A sample of hypertensive patients with poor BP control at baseline (N = 600) are randomized to 1 of 4 arms: (1) control group--a group of hypertensive patients who receive usual care; (2) nurse-administered tailored behavioral intervention; (3) nurse-administered medication management according to a hypertension decision support system; (4) combination of the 2 interventions. The interventions are triggered based on home BP values transmitted via telemonitoring devices over standard telephone lines. The tailored behavioral intervention involves promoting adherence with medication and health behaviors. Patients randomized to the medication management or the combined arm have their hypertension regimen changed by the study team using a validated hypertension decision support system based on evidence-based hypertension treatment guidelines and individualized to patients' comorbid illnesses. The primary outcome is BP control: < or = 140/90 mm Hg (nondiabetic) and < or = 130/80 mm Hg (diabetics) measured at 6-month intervals over 18 months (4 total measurements).

CONCLUSIONS:

Given the increasing prevalence of hypertension and our inability to achieve adequate BP control using traditional models of care, testing novel interventions in patients' homes may improve access, quality, and outcomes.

Black patients receiving dialysis for end-stage renal disease in the United States have lower mortality rates than white patients. Whether racial differences exist in mortality after acute renal failure is not known. We studied acute renal failure in patients hospitalized between 2000 and 2003 using the Nationwide Inpatient Sample and found that black patients had an 18% (95% confidence interval [CI] 16 to 21%) lower odds of death than white patients after adjusting for age, sex, comorbidity, and the need for mechanical ventilation. Similarly, among those with acute renal failure requiring dialysis, black patients had a 16% (95% CI 10 to 22%) lower odds of death than white patients. In stratified analyses of patients with acute renal failure, black patients had significantly lower adjusted odds of death than white patients in settings of coronary artery bypass grafting, cardiac catheterization, acute myocardial infarction, congestive heart failure, pneumonia, sepsis, and gastrointestinal hemorrhage. Black patients were more likely than white patients to be treated in hospitals that care for a larger number of patients with acute renal failure, and black patients had lower in-hospital mortality than white patients in all four quartiles of hospital volume. In conclusion, in-hospital mortality is lower for black patients with acute renal failure than white patients. Future studies should assess the reasons for this difference.

BACKGROUND: The elderly constitute the fastest-growing segment of the end-stage renal disease (ESRD) population, but the epidemiology and outcomes of dialysis among the very elderly, that is, those 80 years of age and older, have not been previously examined at a national level. OBJECTIVE: To describe recent trends in the incidence and outcomes of octogenarians and nonagenarians starting dialysis. DESIGN: Observational study. SETTING: U.S. Renal Data System, a comprehensive, national registry of patients with ESRD. PARTICIPANTS: Octogenarians and nonagenarians initiating dialysis between 1996 and 2003. MEASUREMENTS: Rates of dialysis initiation and survival. RESULTS: The number of octogenarians and nonagenarians starting dialysis increased from 7054 persons in 1996 to 13,577 persons in 2003, corresponding to an average annual increase in dialysis initiation of 9.8%. After we accounted for population growth, the rate of dialysis initiation increased by 57% (rate ratio, 1.57 [95% CI, 1.53 to 1.62]) between 1996 and 2003. One-year mortality for octogenarians and nonagenarians after dialysis initiation was 46%. Compared with octogenarians and nonagenarians initiating dialysis in 1996, those starting dialysis in 2003 had a higher glomerular filtration rate and less morbidity related to chronic kidney disease but no difference in 1-year survival. Clinical characteristics strongly associated with death were older age, nonambulatory status, and more comorbid conditions. LIMITATIONS: Survival of patients with incident ESRD who did not begin dialysis could not be assessed. CONCLUSIONS: The number of octogenarians and nonagenarians initiating dialysis has increased considerably over the past decade, while overall survival for patients on dialysis remains modest. Estimates of prognosis based on patient characteristics, when considered in conjunction with individual values and preferences, may aid in dialysis decision making for the very elderly.

To analyze temporal patterns of antiretroviral (ARV) prescribing practices relative to nationally defined guidelines in treatment-naive patients with HIV-1 infection. DESIGN: Retrospective cohort study. METHODS: We evaluated ARV prescribing patterns among ARV treatment-naive veterans who were receiving care within the US Department of Veterans Affairs (VA) from 1992 through 2004 in comparison to evolving adult HIV-1 treatment guidelines. RESULTS: A total of 15,934 patients initiated ARV treatment. Since 1999, >94% of patients initiated at least a 3-ARV medication combination, although the percentage of patients who initiated a guideline "preferred" or "alternative" regimen never rose to greater than 72% and was significantly associated with being black and with region of care. After 1999, 20% of patients started 4 or more active ARV agents in combination, which was significantly associated with lower baseline CD4 cell count, higher viral load, and receiving care in the western United States. The proportion of patients receiving guideline "not recommended" regimens (virologically undesirable or overlapping toxicities) was <1% after 1997. VA prescribing trends generally predated guideline recommendations by 6 to 12 months. CONCLUSIONS: VA prescribing patterns for ARV initiation adhere to treatment guidelines that maximize safety. Guidelines designed to maximize efficacy were not followed as stringently. Evaluating clinical practice patterns against contemporary treatment guidelines can inform guideline development.

Methods: The current medical literature that is applicable to this issue was identified by a computerized search and was evaluated using standardized methods. Recommendations were framed using the approach described by the Health and Science Policy Committee of the American College of Chest Physicians.

Results: Patients with lung cancer usually present with multiple symptoms, both respiratory related and constitutional. There is usually a time delay between symptom recognition by the patient and the ultimate diagnosis of lung cancer by the physician. Whether this time delay impacts prognosis is unclear, but delivering timely and efficient care is an important component in its own right. Lung cancer may be accompanied by a variety of paraneoplastic syndromes. These syndromes may not necessarily preclude treatment with a curative intent.

Conclusions: The initial evaluation of the patient with known or suspected lung cancer should include an assessment of symptoms, signs, and laboratory test results in a standardized manner as a screen for identifying those patients with paraneoplastic syndromes and a higher likelihood of metastatic disease.

Background: As many as 10% of Asian and Pacific Islander adults in the United States are chronically infected with hepatitis B virus (HBV), and up to two thirds are unaware that they are infected. Without proper medical management and antiviral therapy, up to 25% of Asian and Pacific Islander persons with chronic HBV infection will die of liver disease.

Objective: To assess the cost-effectiveness of 4 HBV screening and vaccination programs for Asian and Pacific Islander adults in the United States.

Design: Markov model with costs and benefits discounted at 3%.

Data Source: Published literature and expert opinion. TARGET

Population: Asian and Pacific Islander adults (base-case age, 40 years; sensitivity analysis conducted on ages 20 to 60 years).

Time Horizone: Lifetime.

Perspective: U.S. societal.

Interventions: A universal vaccination strategy in which all individuals are given a 3-dose vaccination series; a screen-and-treat strategy, in which individuals are given blood tests to determine whether they are chronically infected, and infected persons are monitored and treated; a screen, treat, and ring vaccinate strategy, in which all individuals are tested for chronic HBV infection and close contacts of infected persons are screened and vaccinated if needed; and a screen, treat, and vaccinate strategy, in which all individuals are tested and then vaccinated with a 3-dose series if needed. In all cases, persons found to be chronically infected are monitored and treated if indicated.

Outcome Measure: Costs (2006 U.S. dollars), quality-adjusted life-years (QALYs), and incremental cost-effectiveness.

Results of Base-case Analysis: Compared with the status quo, the screen-and-treat strategy has an incremental cost-effectiveness ratio of $36,088 per QALY gained. The screen, treat, and ring vaccinate strategy gains more QALYs than the screen and treat strategy and incurs modest incremental costs, leading to incremental cost-effectiveness of $39,903 per QALY gained compared with the screen and treat strategy. The universal vaccination and screen, treat, and vaccinate strategies were weakly dominated by the other 2 strategies.

Results of Sensitivity Analysis: Over a wide range of variables, the incremental cost-effectiveness ratios of the screen and treat and screen, treat, and ring vaccinate strategies were less than $50,000 per QALY gained.

Limitations: Results depend on the accuracy of the underlying data and assumptions. The long-term effectiveness of new and future HBV treatments is uncertain.

Conclusions: Screening programs for HBV among Asian and Pacific Islander adults are likely to be cost effective. Clinically significant benefits accrue from identifying chronically infected persons for medical management and vaccinating their close contacts. Such efforts can greatly reduce the burden of HBV-associated liver cancer and chronic liver disease in the Asian and Pacific Islander population.

Purpose: One-year adjuvant trastuzumab (AT) therapy, with or without anthracyclines, increases disease-free and overall survival in early-stage HER2/neu-positive breast cancer. We sought to evaluate the cost effectiveness of these regimens, which are expensive and potentially toxic.

Methods: We used a Markov health-state transition model to simulate three adjuvant therapy options for a cohort of 49-year-old women with HER2/neu-positive early-stage breast cancer: conventional chemotherapy without trastuzumab; anthracycline-based AT regimens used in the National Surgical Adjuvant Breast and Bowel Project B-31 and North Central Cancer Treatment Group N9831 trials; and the nonanthracycline AT regimen used in the Breast Cancer International Research group 006 trial. The base case used treatment efficacy measures reported in the randomized clinical trials of AT. We measured health outcomes in quality-adjusted life-years (QALYs) and costs in 2005 United States dollars (US$) and subjected results to probabilistic sensitivity analysis.

Results: In the base case, the anthracycline-based AT arm has an incremental cost-effectiveness ratio (ICER) of $39,982/QALY, whereas the nonanthracycline AT arm is more expensive and less effective; this result is insensitive to changes in recurrence rates, but if there is no benefit after 4 years, ICERs exceed $100,000/QALY for both AT arms. Results are moderately sensitive to variation in breast cancer survival rates and trastuzumab cost, and less sensitive to variations in cardiac toxicity.

Conclusion: AT has an ICER comparable to those for other widely used interventions. Longer clinical follow-up is warranted to evaluate the long-term efficacy and toxicity of different AT regimens.

Objectives: We examined the utility of the Veterans Health Administration (VHA) universal screening program for military sexual violence.

Methods: We analyzed VHA administrative data for 185 880 women and 4139888 men who were veteran outpatients and were treated in VHA health care settings nationwide during 2003.

Results: Screening was completed for 70% of patients. Positive screens were associated with greater odds of virtually all categories of mental health comorbidities, including posttraumatic stress disorder (adjusted odds ratio [AOR]=8.83; 99% confidence interval [CI] = 8.34, 9.35 for women; AOR = 3.00; 99% CI = 2.89, 3.12 for men). Associations with medical comorbidities (e.g., chronic pulmonary disease, liver disease, and for women, weight conditions) were also observed. Significant gender differences emerged.

Conclusions: The VHA policies regarding military sexual trauma represent a uniquely comprehensive health care response to sexual trauma. Results attest to the feasibility of universal screening, which yields clinically significant information with particular relevance to mental health and behavioral health treatment. Women’s health literature regarding sexual trauma will be particularly important to inform health care services for both male and female veterans.

Context: Without detailed evidence of their effectiveness, pedometers have recently become popular as a tool for motivating physical activity.

Objective: To evaluate the association of pedometer use with physical activity and health outcomes among outpatient adults.

Data Sources: English-language articles from MEDLINE, EMBASE, Sport Discus, PsychINFO, Cochrane Library, Thompson Scientific (formerly known as Thompson ISI), and ERIC (1966-2007); bibliographies of retrieved articles; and conference proceedings.

Study Selection: Studies were eligible for inclusion if they reported an assessment of pedometer use among adult outpatients, reported a change in steps per day, and included more than 5 participants.

Data Extraction and Data Synthesis: Two investigators independently abstracted data about the intervention; participants; number of steps per day; and presence or absence of obesity, diabetes, hypertension, or hyperlipidemia. Data were pooled using random-effects calculations, and meta-regression was performed.

Results: Our searches identified 2246 citations; 26 studies with a total of 2767 participants met inclusion criteria (8 randomized controlled trials [RCTs] and 18 observational studies). The participants' mean (SD) age was 49 (9) years and 85% were women. The mean intervention duration was 18 weeks. In the RCTs, pedometer users significantly increased their physical activity by 2491 steps per day more than control participants (95% confidence interval [CI], 1098-3885 steps per day, P .001). Among the observational studies, pedometer users significantly increased their physical activity by 2183 steps per day over baseline (95% CI, 1571-2796 steps per day, P .0001). Overall, pedometer users increased their physical activity by 26.9% over baseline. An important predictor of increased physical activity was having a step goal such as 10,000 steps per day (P = .001). When data from all studies were combined, pedometer users significantly decreased their body mass index by 0.38 (95% CI, 0.05-0.72; P = .03). This decrease was associated with older age (P = .001) and having a step goal (P = .04). Intervention participants significantly decreased their systolic blood pressure by 3.8 mm Hg (95% CI, 1.7-5.9 mm Hg, P .001). This decrease was associated with greater baseline systolic blood pressure (P = .009) and change in steps per day (P = .08).

Conclusions: The results suggest that the use of a pedometer is associated with significant increases in physical activity and significant decreases in body mass index and blood pressure. Whether these changes are durable over the long term is undetermined.