Impact of the treatment of isolated systolic hypertension on behavioral variables. Results from the systolic hypertension in the elderly program.

BACKGROUND: Little information has been published on the impact of antihypertensive medications on quality of life in older persons. Particular concern has existed that lowering systolic blood pressure in older persons might have adverse consequences on cognition, mood, or leisure activities. METHODS: A multicenter double-blind randomized controlled trial was conducted over an average of 5 years' followup involving 16 academic clinical trial clinics. Participants consisted of 4736 persons (1.06%) selected from 447,921 screenees aged 60 years and older. Systolic blood pressure at baseline ranged from 160 to 219 mm Hg, while diastolic blood pressure was less than 90 mm Hg. Participants were randomized to active antihypertensive drug therapy or matching placebo. Active treatment consisted of 12.5 to 25 mg of chlorthalidone for step 1, while step 2 consisted of 25 to 50 mg of atenolol. If atenolol was contraindicated, 0.05 to 0.10 mg of reserpine could be used for the second-step drug. The impact of drug treatment on measures of cognitive, emotional, and physical function and leisure activities was assessed. RESULTS: Our analyses demonstrate that active treatment of isolated systolic hypertension in the Systolic Hypertension in the Elderly Program cohort had no measured negative effects and, for some measures, a slight positive effect on cognitive, physical, and leisure function. The positive findings in favor of the treatment group were small. There was no effect on measures related to emotional state. Measures of cognitive and emotional function were stable in both groups for the duration of the study. Both treatment groups showed a modest trend toward deterioration of some measures of physical and leisure function over the study period. CONCLUSIONS: The overall study cohort exhibited decline over time in activities of daily living, particularly the more strenuous ones, and some decline in certain leisure activities. However, mood, cognitive function, basic self-care, and moderate leisure activity were remarkably stable for both the active and the placebo groups throughout the entire study. Results of this study support the inference that medical treatment of isolated systolic hypertension does not cause deterioration in measures of cognition, emotional state, physical function, or leisure activities.

Nutrient intake and blood pressure in the Dietary Intervention Study in Children.

Delineating the role that diet plays in blood pressure levels in children is important for guiding dietary recommendations for the prevention of hypertension. The purpose of this study was to investigate relationships between dietary nutrients and blood pressure in children. Data were analyzed from 662 participants in the Dietary Intervention Study in Children who had elevated low-density lipoprotein cholesterol and were aged 8 to 11 years at baseline. Three 24-hour dietary recalls, systolic pressure, diastolic pressure, height, and weight were obtained at baseline, 1 year, and 3 years. Nutrients analyzed were the micronutrients calcium, magnesium, and potassium; the macronutrients protein, carbohydrates, total fat, saturated fat, polyunsaturated fat, and monounsaturated fat; dietary cholesterol; and total dietary fiber. Baseline and 3-year longitudinal relationships were examined through multivariate models on diastolic and systolic pressures separately, controlling for height, weight, sex, and total caloric intake. The following associations were found in longitudinal analyses: analyzing each nutrient separately, for systolic pressure, inverse associations with calcium (P < .05); magnesium, potassium, and protein (all P < .01); and fiber (P < .05), and direct associations with total fat and monounsaturated fat (both P < .05); for diastolic pressure, inverse associations with calcium (P < .01); magnesium and potassium (both P < .05), protein (P < .01); and carbohydrates and fiber (both P < .05), and direct associations with polyunsaturated fat (P < .01) and monounsaturated fat (P < .05). Analyzing all nutrients simultaneously, for systolic pressure, direct association with total fat (P < .01); for diastolic pressure, inverse associations with calcium (P < .01) and fiber (P < .05), and direct association with total and monounsaturated fats (both P < .05). Results from this sample of children with elevated low-density lipoprotein cholesterol indicate that dietary calcium, fiber, and fat may be important determinants of blood pressure level in children.

Vasectomy, serum assays, and coronary heart disease symptoms and risk factors.

We compared three serum assays (two antisperm antibody assays and one assay for circulating immune complexes) and a number of CHD-related variables in 69 vasectomized (V) and 126 non-vasectomized (NV) participants in the Portland Center for the Multiple Risk Factor Intervention Trial. Significant differences between the V and NV men were found in sperm agglutination (SA) and sperm immobilization (SI) titers, as well as in several CHD risk factors, symptoms, and treatments; men in the V group had higher titers for SA and SI, smoked more, and had lower diastolic and systolic blood pressure than men in the NV group. Differences between V and NV in SA and SI activity remained even after we controlled for any effects that CHD risk factors, symptoms, and treatments may have had on the serum assays. Antibody development tended to decrease with age-at-vasectomy and increase with time-post-vasectomy. In the case of SA the antibodies clearly increased with time-post-vasectomy.

PIP: A comparative study of 69 vasectomized and 126 nonvasectomized men enrolled in the Portland (Oregon, US) Center for the Multiple Risk Factor Intervention Trial evaluated vasectomy as a risk factor for cardiovascular disease. In animal studies, atherosclerosis development has been linked to circulating anti-sperm antibodies and immune complexes formed in response to sperm breakdown products released in the body after vasectomy. Vasectomized men smoked more and had lower diastolic and systolic blood pressure than men in the control group. As expected, both sperm immobilization and sperm agglutination assays were significantly higher among vasectomized men than controls; 29.4% of vasectomized men compared with only 2.5% of nonvasectomized men had sperm immobilization values of 0.3 or less, while 54.1% of vasectomized men compared with 12.5% of nonvasectomized men had sperm agglutination values of 20.0 or above. These significant differences persisted even when a variety of coronary heart disease risk factors and treatments were controlled. Multivariate analysis showed that antibody development tended to decrease with age at vasectomy and increase with time since vasectomy. In the case of sperm agglutination, the antibodies clearly increased with time since vasectomy.

Integrating acute and long-term care.

Advocates of health system reform are striving to assure that a valuable new benefit for home- and community-based long-term care is included. Yet in many legislative proposals, a long-term care benefit is kept separate from the rest of the benefit package. Experience from the social health maintenance organization (social HMO) demonstration shows that for the elderly at least, community long-term care can be integrated with acute care, at a manageable cost. Acute and chronic disease and disability are experienced concurrently. Moreover, disability is not confined to a small group of permanently disabled persons but affects many other persons for short periods. Integration of long-term and acute care in a managed care model serving a broad population may promote more effective acute care and more efficient and affordable long-term care.

Mode of payment, practice characteristics, and physician support for patient self care.

PURPOSE: The purpose of this study was to assess the influence of payment mode and practice characteristics on physicians' attitudes toward and support of self-care among their patients. It is a common practice for health plans and health insurance companies to distribute and make available various self-care services and products to members. These self-care products are generally part of a larger demand-management strategy. The adoption and dissemination of self-care products by both fee-for-service and capitated systems of care suggest an implicit assumption that there is no connection between physician payment mode and the support of self-care products by physicians for their patients. This study empirically examines this assumption. METHODS: Physicians from three Northwest communities were sampled and face-to-face interviews were conducted (N=448). RESULTS: The findings show that younger, primary care, and female physicians are more supportive of self care for their patients. Physicians with more income from capitation or salary are also more supportive of self care for their patients. After controlling for other factors, physician mode of payment is the only statistically significant predictor of support for self care. Research and policy implications are discussed. CONCLUSION: The findings suggest that physicians who are paid on a capitation basis have more motivation to have patients be less reliant on the formal care structure. It is unclear whether the payment mode generates this support, or if physicians supportive of patient self care self-select themselves into capitated systems of care.

Relation of life events to blood pressure control in the SHEP pilot trial.

The Systolic Hypertension in the Elderly (SHEP) pilot trial was a five-center study in which 551 persons aged 60 years or older with isolated systolic hypertension were given antihypertensive drugs or placebos in order to determine the effects on blood pressure control and possible side effects of therapy. A life events inventory was administered to the cohort one year into the study. Results of this inventory were then compared to blood pressure and changes in blood pressure in the placebo and active therapy groups. One or more of the life events assessed were present in about 65% of the population. Although the sample was too small to detect very subtle effects, there was no evidence in this study that either individual or groups of life events play a major role in blood pressure regulation of persons with isolated systolic hypertension.

Collaboration in health services research: on developing relationships between VA researchers and those in other institutions.

This article explores the potential for collaboration between investigators in institutions outside of the VA and those engaged in research within the VA. The focus is on the potential for collaborative work in health services research; our perspective is that of researchers in a freestanding HMO research center affiliated with the Veterans Administration's Northwest Health Services Research and Development Field Program. The paper begins with a review of the reasons that make collaboration between VA researchers and other health services researchers so appropriate at this time. An example of collaboration is presented, drawing on the experience of the Northwest Field Program and the Kaiser Permanente Center for Health Research. Finally, some difficulties inherent in collaboration between VA and other health services researchers are discussed.

Morbidity and medical care utilization of old and very old persons.

This report compares the morbidity, health care and drug utilization, and health status of random samples of HMO-enrolled Medicare beneficiaries ages 65-79, and 80 and over. The population represented 3,683 person-years of Kaiser Permanente eligibility (59.2 percent female). Those 80 and over were 20 percent of the person-years (64.1 percent female). The effects of age and sex on morbidity and utilization were analyzed using log linear models that controlled for eligibility, and using two-way analyses of variance of rates. Few differences were found in the morbidity experiences and utilization rates of the two age groups. Indicators of self-reported health status did differ. The findings support the idea that noninstitutionalized very old persons are the healthy survivors of their cohort. Their health care needs may not be much different than younger old persons in terms of the types and amounts of health care services needed.

Do-not-admit versus inpatient surgery in an HMO: determinants of choice and the implications for medical care costs.

We develop a model for investigating the implications of policies that have encouraged a shift from inpatient to do-not-admit (DNA) surgery. We use discriminant function analysis on date for two surgical procedures from the Kaiser Permanente Medical Care Program of Portland, Oregon. Case attributes found to be significantly associated with the choice of surgery mode are surgeons' rate of inpatient surgery, number of chronic conditions per patient, time in surgery, number of procedures performed, and type of anesthesia used. Our estimates of cost savings provide support on economic grounds for the use of DNA surgery, for the types of surgery investigated. Our results also suggest that simple evaluation methods, based on the mean length of stay and on extrapolation of proportion of DNA cases from the base year to the current year, may overestimate the cost savings derived from the shift to DNA surgery.

Educating physicians for the twenty-first century.

The author reviews the fundamental changes that have taken place in the U.S. health care system since 1935, predicts what that system will be like in the early part of the next century, and discusses the implications for academic medicine. Specifically, he maintains that physicians being trained today will practice within the context of large organizations, with payment for care being either by employment-based insurance or by some form of government-subsidized insurance. Care will be delivered across diffuse networks, and most physicians will be paid according to capitation or salary schemes. The role of technology will be high and will revolutionize the health care system, which will be focused on prevention and maintenance of function rather than cure. The success of the system will be measured by its cost-effectiveness and by how well it works to maintain the mental, social, and physical functions of its participants. Finally, the obligation of the physician will be not only to individual patients but also to the populations and communities from which patients come. Training physicians to meet these obligations and to function effectively in the revolutionized system will involve changes in medical education to more appropriately socialize students into the next century's medical culture. The author reviews in detail the various elements of the medical culture that must be addressed by medical education, gives examples of the kinds of changes that must be made, and describes efforts at his school to reinforce across the curriculum the population-based model of clinical practice.

Kaiser-Permanente's Medicare Plus Project: a successful Medicare prospective payment demonstration.

The Medicare Plus project of the Oregon Region Kaiser-Permanente Medical Care Program was designed as a model for prospective payment to increase Health Maintenance Organization (HMO) participation in the Medicare program. The project demonstrated that it is possible to design a prospective payment system that costs the Medicare program less than services purchased in the community from fee-for-service providers; would provide appropriate payment to the HMO; and in addition, creates a "savings" to return to beneficiaries in the form of comprehensive benefits to motivate them to enroll in the HMO. Medicare Plus was highly successful in recruiting 5,500 new and 1,800 conversion members into the demonstration, through use of a media campaign, a recruitment brochure, and a telephone information center. Members recruited were a representative age and geographic cross section of the senior citizen population in the Portland, Oregon metropolitan area. Utilization of inpatient services by Medicare Plus members in the first full year (1981) was 1679 days per thousand members and decreased to 1607 in the second full year (1982). New members made an average of eight visits per year to ambulatory care facilities.

Preventing falls among community-dwelling older persons: results from a randomized trial.

A randomized trial of falls prevention program that addressed home safety, exercise, and behavioral risks was conducted with 3,182 independently living HMO members age 65 and older. The intervention decreased the odds of falling by 0.85, but only reduced the average number of falls among those who fell by 7%. The effect was strongest among men age 75 and older. The likelihood of avoiding falls requiring medical treatment was not significantly affected by the intervention. We conclude that the intervention dose was not of sufficient intensity or duration to have a marked protective effect on older persons. Future research should focus on more intensive intervention approaches because serious falls do not appear to be amendable to low-intensity environment/behavioral efforts.

Physician and plan effects on satisfaction of Medicaid managed care patients with their health care and providers.

As many Medicaid patients move into managed care, it is important that physicians competing to serve these patients understand the factors that lead to patient satisfaction. This study uses survey data from 7,313 Oregon Medicaid managed care patients to create a model describing how provider effects and health plan effects relate to patients' satisfaction with their medical care and provider. Path analysis was used to test the explanatory power and strength of relationships in the model. Perceived technical and interpersonal physician quality and health plan rating were most strongly linked with these patients' satisfaction with their care and provider.

Validity and usefulness of medical chart weights in the long-term evaluation of weight loss programs.

The high rate of delayed recidivism seen in behavioral weight loss studies makes follow-up over a number of years essential. Unfortunately, these data are both expensive and difficult to collect. This report examines the validity of body weights routinely recorded in medical charts and their usefulness in the long-term evaluation of weight control programs. Comparison of 123 pairs of chart weights and research clinic weights recorded within 30 days of each other showed a mean difference of .06 lb (.03 kg) and a standard deviation of 2.38 lb (1.08 kg). This measurement error is considerably less than that seen in self-reported weights of obese adults. The accuracy, economy and relative ease of collection make the use of medical chart weights well suited for long-term evaluations of weight loss studies and other research purposes.

Telemedicine for the Medicare population: pediatric, obstetric, and clinician-indirect home interventions.

BACKGROUND: This report is a supplement to an earlier evidence report, Telemedicine for the Medicare Population, which was intended to help policymakers weigh the evidence relevant to coverage of telemedicine services under Medicare. That report focused on telemedicine programs and clinical settings that had been used with or were likely to be applied to Medicare beneficiaries. While we prepared that report, it became apparent that there are also telemedicine studies among non-Medicare beneficiaries--e.g., children and pregnant women--that could inform policymakers and provide more comprehensive evidence of the state of the science regarding telemedicine applications. In addition, the first evidence report only partially included a class of telemedicine applications (called self-monitoring/testing telemedicine) in which the beneficiary used a home computer or modern-driven telephone system to either report information or access information and support from Internet resources and indirectly interact with a clinician. Self-monitoring/testing applications in the first report required direct interaction with a clinician. The goal of this report is to systematically review the evidence in the clinical areas of pediatric and obstetric telemedicine as well as home-based telemedicine where there is indirect involvement of the health care professional. (In this report, we will refer to the latter as clinician-indirect home telemedicine.) Specifically, the report summarizes scientific evidence on the diagnostic accuracy, access, clinical outcomes, satisfaction, and cost-effectiveness of services provided by telemedicine technologies for these patient groups. It also identifies gaps in the evidence and makes recommendations for evaluating telemedicine services for these populations in the future. The evidence is clustered according to three categories of telemedicine service defined in our original report: store-and-forward, self-monitoring/testing, and clinician-interactive services. The three clinical practice areas reviewed in this report are defined as follows. The term pediatric applies to any telemedicine study in which the sample consisted wholly or partially of persons aged 18 or younger, including studies with neonatal samples. The term obstetric applies to any telemedicine study in which the sample consisted entirely of women seeking pregnancy-related care. The term clinician-indirect home telemedicine applies to home-based telemedicine (called self-monitoring/testing in our original report) where a telemedicine application used in the home has only indirect involvement by the health care professional. Interactive home telemedicine was applied in this report to all patient populations. KEY QUESTIONS: The key questions that served as a guide for reviewing the literature in the evaluation of pediatric, obstetric, and clinician-indirect home telemedicine applications were derived by consensus among the evidence-review team based on the analytic framework established for the original evidence report. For the current report, the questions were applied to studies in all three practice areas as a whole group within each of the three categories of telemedicine services: store-and-forward; self-monitoring/testing; and clinician-interactive. The specific key questions were: 1. Does telemedicine result in comparable diagnosis and appropriateness of recommendations for management? 2. Does the availability of telemedicine provide comparable access to care? 3. Does telemedicine result in comparable health outcomes? 4. Does telemedicine result in comparable patient or clinician satisfaction with care? 5. Does telemedicine result in comparable costs of care and/or cost-effectiveness? METHODS: We searched for peer-reviewed literature using several bibliographic databases. In addition, we conducted hand searches of leading telemedicine journals and identified key papers from the reference lists of journal articles. For our original evidence report on telemedicine for the Medicare population, we designed a search to find any publications about telemedicine and used it to search the MEDLINE, CINAHL, and HealthSTAR databases for all years the databases were available. Through this process, we captured studies of pediatric, obstetric, and clinician-indirect home telemedicine; however, they were excluded from the original report since they were outside its scope. For this supplemental report, we reviewed our original search results and identified studies relevant to this report. We identified additional studies from the reference lists of included papers and from hand searching two peer-reviewed telemedicine publications, the Journal of Telemedicine and Telecare and Telemedicine Journal. We critically appraised the included studies for each study area and key question and discussed the strengths and limitations of the most important studies at weekly meetings of the research team. We also developed recommendations for research to address telemedicine knowledge gaps. To match these gaps with the capabilities of specific research methods, we classified the telemedicine services according to the type of evidence that would be needed to determine whether the specific goals of covering such services had been met. We emphasized the relationship between the type and level of evidence found in the systematic review of effectiveness and the types of studies that might be funded to address the gaps in knowledge in this growing field of research. FINDINGS: We identified a total of 28 eligible studies. In the new clinical areas, we found few studies in store-and-forward telemedicine. There is some evidence of comparable diagnosis and management decisions made using store-and-forward telemedicine from the areas of pediatric dental screening, pediatric ophthalmology, and neonatalogy. In self-monitoring/testing telemedicine for the areas of pediatrics, obstetrics, and clinician-indirect home telemedicine, there is evidence that access to care can be improved when patients and families have the opportunity to receive telehealth care at home rather than in-person care in a clinic or hospital. Access is particularly enhanced when the telehealth system enables timely communication between patients or families and care providers that allows self-management and necessary adjustments that may prevent hospitalization. There is some evidence that this form of telemedicine improves health outcomes, but the study sample sizes are usually small, and even when they are not, the treatment effects are small. There is also some evidence for the efficacy of clinician-interactive telemedicine, but the studies do not clearly define which technologies provide benefit or cost-efficiency. Some promising areas for diagnosis include emergency medicine, psychiatry, and cardiology. Most of the studies measuring access to care provide evidence that it is improved. Although none of these studies were randomized controlled trials, they provide some evidence of access improvement over prior conditions. Clinician-interactive telemedicine was the only area for which any cost studies were found. The three cost studies did not adequately demonstrate that telemedicine reduces costs of care (except comparing only selected costs). No study addressed cost-effectiveness. CONCLUSIONS: This supplemental report covering the areas of pediatrics, obstetrics, and indirect-clinician home telemedicine echoes the findings of our initial report for the Medicare domain, which is that while the use of telemedicine is small but growing, the evidence for its efficacy is incomplete. Many of the studies are small and/or methodologically limited, so it cannot be determined whether telemedicine is efficacious. Future studies should focus on the use of telemedicine in conditions where burden of illness and/or barriers to access for care are significant. Use of recent innovations in the design of randomized controlled trials for emerging technologies would lead to higher quality studies. Journals publishing telemedicine evaluation studies must set high standards for methodologic quality so that evidence reports need not rely on studies with marginal methodologies.

Systolic Hypertension in the Elderly Program, Pilot Study (SHEP-PS): morbidity and mortality experience.

SHEP-Pilot Study, a randomized, double-blind, placebo-controlled trial of drug therapy for isolated systolic hypertension, followed 551 participants aged 60 years or more with untreated blood pressures of greater than or equal to 160/less than 90 mmHg for an average of 34 months. Mean age was 72 years, 63% were female and 82% white. Pretreatment blood pressures averaged 172/75 mmHg. As their Step I drug, 443 participants were assigned chlorthalidone and 108 placebo. Of 512 surviving participants, 80% and 84% of the chlorthalidone and placebo groups, respectively, attended their last clinic visit; 71% and 60% were still taking blinded drug; and 60% and 33% had systolic blood pressures less than 160 mmHg. Final blood pressures averaged 140/67 and 154/72 mmHg for the chlorthalidone and placebo groups, respectively. All-cause mortality rates were 25 and 23 deaths per 1000 participant-years of risk, respectively; rates for 'definite' first strokes were 8.3 and 13 deaths. Differences between chlorthalidone and placebo groups were significant for blood pressure but not for event rates.