St John's wort for depression.

BACKGROUND: Extracts of the plant Hypericum perforatum L. (popularly called St. John's wort) have been used in folk medicine for a long time for a range of indications including depressive disorders. OBJECTIVES: To investigate whether extracts of hypericum are more effective than placebo and as effective as standard antidepressants in the treatment of depressive disorders in adults; and whether they have have less adverse effects than standard antidepressant drugs. SEARCH STRATEGY: Trials were searched in computerized databases (Cochrane Collaboration Depression, Anxiety & Neurosis Group Clinical Trials Registers; PubMed); by checking bibliographies of pertinent articles; and by contacting manufacturers and researchers. SELECTION CRITERIA: Trials were included if they: (1) were randomized and double-blind; (2) included patients with depressive disorders; (3) compared extracts of St. John's wort with placebo or standard antidepressants; and (4) included clinical outcomes such as scales assessing depressive symptoms. DATA COLLECTION AND ANALYSIS: Information on patients, interventions, outcomes and results was extracted by at least two independent reviewers using a standard form. The main outcome measure for comparing the effectiveness of hypericum with placebo and standard antidepressants was the responder rate ratio (responder rate in treatment group/responder rate in control group). The main outcome measure for adverse effects was the number of patients dropping out for adverse effects. MAIN RESULTS: A total of 37 trials, including 26 comparisons with placebo and 14 comparisons with synthetic standard antidepressants, met the inclusion criteria. Results of placebo-controlled trials showed marked heterogeneity. In trials restricted to patients with major depression, the combined response rate ratio (RR) for hypericum extracts compared with placebo from six larger trials was 1.15 (95% confidence interval (CI), 1.02-1.29) and from six smaller trials was 2.06 (95% CI, 1.65 to 2.59). In trials not restricted to patients with major depression, the RR from six larger trials was 1.71 (95% CI, 1.40-2.09) and from five smaller trials was 6.13 (95% CI, 3.63 to 10.38). Trials comparing hypericum extracts and standard antidepressants were statistically homogeneous. Compared with selective serotonin reuptake inhibitors (SSRIs) and tri- or tetracyclic antidepressants, respectively, RRs were 0.98 (95% CI, 0.85-1.12; six trials) and 1.03 (95% CI, 0.93-1.14; seven trials). Patients given hypericum extracts dropped out of trials due to adverse effects less frequently than those given older antidepressants (Odds ratio (OR) 0.25; 95% CI, 0.14-0.45); such comparisons were in the same direction, but not statistically significantly different, between hypericum extracts and SSRIs (OR 0.60, 95% CI, 0.31-1.15). AUTHORS' CONCLUSIONS: Current evidence regarding hypericum extracts is inconsistent and confusing. In patients who meet criteria for major depression, several recent placebo-controlled trials suggest that the tested hypericum extracts have minimal beneficial effects while other trials suggest that hypericum and standard antidepressants have similar beneficial effects. As the preparations available on the market might vary considerably in their pharmaceutical quality, the results of this review apply only to the products tested in the included studies.

Garlic shows promise for improving some cardiovascular risk factors.

OBJECTIVES: To summarize the effects of garlic on several cardiovascular-related factors and to note its adverse effects. METHODS: English and non-English citations were identified from 11 electronic databases, references, manufacturers, and experts from January 1966 through February 2000 (depending on the database searched). Reports of cardiovascular-related effects were limited to randomized controlled trials lasting at least 4 weeks. Reports of adverse effects were not limited by study design. From 1798 pertinent records, 45 randomized trials and 73 additional studies reporting adverse events were identified. Two physicians abstracted outcomes and assessed adequacy of randomization, blinding, and handling of dropouts. Standardized mean differences of lipid outcomes from placebo-controlled trials were adjusted for baseline differences and pooled using random effects methods. RESULTS: Compared with placebo, garlic preparations may lead to small reductions in the total cholesterol level at 1 month (range of average pooled reductions, 0.03-0.45 mmol/L [1.2-17.3 mg/dL]) and at 3 months (range of average pooled reductions 0.32-0.66 mmol/L [12.4-25.4 mg/dL]), but not at 6 months. Changes in low-density lipoprotein levels and triglyceride levels paralleled total cholesterol level results; no statistically significant changes in high-density lipoprotein levels were observed. Trials also reported significant reductions in platelet aggregation and mixed effects on blood pressure outcomes. No effects on glycemic-related outcomes were found. Proven adverse effects included malodorous breath and body odor. Other unproven effects included flatulence, esophageal and abdominal pain, allergic reactions, and bleeding. CONCLUSIONS: Trials suggest possible small short-term benefits of garlic on some lipid and antiplatelet factors, insignificant effects on blood pressure, and no effect on glucose levels. Conclusions regarding clinical significance are limited by the marginal quality and short duration of many trials and by the unpredictable release and inadequate definition of active constituents in study preparations.

Need for insulin therapy in type II diabetes mellitus. A randomized trial.

To identify patients with type II diabetes mellitus for whom insulin therapy is most beneficial, we conducted a randomized controlled trial in the general medicine clinic of a university hospital. Asymptomatic, obese, insulin-treated patients were given diet and diabetes education and, in half of these patients, insulin therapy was withdrawn. Over six months, patients developing hyperglycemic symptoms or acetonemia were counted as study failures. Failure criteria developed in 13 of 25 insulin-withdrawal patients, at a median of four weeks after withdrawal, compared with two of 24 control subjects. Elevated stimulated glucose levels predicted the need for insulin therapy. Hyperglycemia worsened in insulin-withdrawal patients who did not meet study failure criteria, but it improved in control patients. Study patients were insulin deficient as shown by low baseline C peptide values (0.43 +/- 0.05 nmol/L). The prompt metabolic decompensation precipitated by insulin withdrawal suggests that insulin-deficient patients may benefit from insulin therapy and may need it to prevent symptomatic hyperglycemia.

Efficacy of newer medications for treating depression in primary care patients.

PURPOSE: Several medications have recently been introduced for the treatment of depression. We reviewed the literature to summarize their efficacy in the treatment of depression in adult patients in primary care settings. METHODS: We searched the literature published from 1980 to January 1998 using the Cochrane Collaboration Depression Anxiety and Neurosis Group's specialized registry of 8,451 clinical trials, references from trials and 46 pertinent meta-analyses, and consultation with experts. We included randomized controlled trials of at least 6 weeks' duration that measured clinical outcomes and compared one of 32 newer medications with another newer antidepressant, an older antidepressant, a placebo, or a psychosocial intervention for the treatment of depressed patients in primary care settings. The primary outcome was response rate, defined as the proportion of patients experiencing a 50% or greater improvement in depressive symptoms. RESULTS: There were 28 randomized controlled trials involving 5,940 adult primary care patients with major depression, depression requiring treatment, dysthymia, or mixed anxiety depression. Newer agents, including selective serotonin re-uptake inhibitors, serotonin norepinephrine inhibitors, reversible inhibitors of monoamine oxidase, and dopamine antagonists, were usually compared with tricyclic agents. Average response rates were 63% for newer agents, 35% for placebo, and 60% for tricyclic agents. Newer agents were significantly more effective than placebo [risk ratio = 1.6; 95% confidence interval (CI), 1.2 to 2.1), but similar to tricyclic agents (risk ratio = 1.0; 95% CI, 0.9 to 1.1). Response rates were similar in the different types of depressive disorders, except that two small trials in frail older patients showed no significant effects of newer agents compared with placebo. Dropout rates as a result of adverse effects were 8% with newer agents and 13% with tricyclic agents (P <0.05). CONCLUSIONS: In primary care settings, newer antidepressants are more effective than placebo and have similar efficacy compared with tricyclic agents in the acute treatment of depression. Dropout rates as a result of adverse effects are lower with newer compared with tricyclic agents. Future studies should compare the effectiveness of different therapies among primary care patients with less severe depression and greater medical and psychiatric comorbidity.

Case-finding for depression in primary care: a randomized trial.

PURPOSE: Depression is a highly prevalent, morbid, and costly illness that is often unrecognized and inadequately treated. Because depression questionnaires have the potential to improve recognition, we evaluated the accuracy and effects on primary care of two case-finding instruments compared to usual care. SUBJECTS AND METHODS: The study was conducted at three university-affiliated and one community-based medical clinics. Consecutive patients were randomly assigned to be asked a single question about mood, to fill out the 20-item Center for Epidemiologic Studies Depression Screen, or to usual care. Within 72 hours, patients were assessed for Diagnostic and Statistical Manual of Mental Disorders Third Revised Edition (DSM-III-R) disorders by an assessor blinded to the screening results. Process of care was assessed using chart audit and administrative databases; patient and physician satisfaction was assessed using Likert scales. At 3 months, depressed patients and a random sample of nondepressed patients were re-assessed for DSM-III-R disorders and symptom counts. RESULTS: We approached 1,083 patients, of whom 969 consented to screening and were assigned to the single question (n = 330), 20-item questionnaire (n = 323), or usual care (n = 316). The interview for DSM-III-R diagnosis was completed in 863 (89%) patients; major depression, dysthymia, or minor depression was present in 13%. Both instruments were sensitive, but the 20-item questionnaire was more specific than the single question (75% vs 66%, P = 0.03). The 20-item questionnaire was less likely to be self-administered (54% vs 90%) and took significantly more time to complete (15 vs 248 seconds). Case-finding with the 20-item questionnaire or single question modestly increased depression recognition, 30/77 (39%) compared with 11/38 (29%) in usual care (P = 0.31) but did not affect treatment (45% vs 43%, P = 0.88). Effects on DSM-III-R symptoms were mixed. Recovery from depression was more likely in the case-finding than usual care groups, 32/67 (48%) versus 8/30 (27%, P = 0.03), but the mean improvement in depression symptoms did not differ significantly (1.6 vs 1.5 symptoms, P = 0.21). CONCLUSIONS: A simple question about depression has similar performance characteristics as a longer 20-item questionnaire and is more feasible because of its brevity. Case-finding leads to a modest increase in recognition rates, but does not have consistently positive effects on patient outcomes.

Estimating and testing an index of responsiveness and the relationship of the index to power.

Responsiveness has been proposed as a criterion, in addition to reliability and validity, to evaluate instruments that measure quality of life or functional status. The responsiveness index measures the change in a quality of life score due to a treatment relative to the variability of changes in that score within a stable control group. We derive the expected value, variance and distribution of the responsiveness index and give a large sample distribution for comparing the responsiveness of two different instruments. We also give the relationship between the responsiveness index and the power of a test of treatment effect.

Functional status of Mexican American nursing home residents.

OBJECTIVE: To compare sociodemographic characteristics, physical function, and cognition of Mexican American and non-Hispanic white nursing home residents. DESIGN AND SETTING: Cross-sectional survey of residents in eight proprietary nursing homes and one Veterans Affairs nursing home in San Antonio, Texas. SUBJECTS: Residents with lengths of stay greater than or equal to 90 days. MEASUREMENTS: Sociodemographic characteristics, residence prior to admission, and dependency in activities of daily living (ADL) were abstracted from the medical record. The Folstein Mini-Mental State Examination (MMSE) was administered in the resident's self-selected language to a subset of residents. MAIN RESULTS: There were 1160 participants, 261 Mexican American (23%) and 899 non-Hispanic white residents (77%). Mexican Americans were younger (77.1 vs 80.7 years), more often men (44% vs 30%), less educated (6.2 vs 10.8 years), and more often dependent on Medicaid funding (66% vs 40%) than non-Hispanic whites. Mexican Americans were less independent in feeding (34% vs 49%), transfers (18% vs 30%), toileting (19% vs 29%), and dressing (12% vs 19%). Mean MMSE scores were different in Mexican Americans and non-Hispanic whites (8.93 vs 11.85), and this difference remained significant after adjustment for age and education (P = 0.04). ADL function was strongly associated with MMSE (P = 0.0001) and less strongly associated with ethnicity (P = 0.056) in multiple regression analysis. CONCLUSIONS: This study provides the strongest evidence to date that Mexican American nursing home residents are more cognitively and functionally impaired than non-Hispanic white residents. Further studies should explore whether medical conditions, selection and referral patterns or cultural factors explain functional differences between Mexican American and non-Hispanic white nursing home residents.

Effects of physical therapy on functional status of nursing home residents.

Nursing home residents typically have decreased functional and physical status and high health care utilization and costs. This randomized trial evaluates whether physical therapy is beneficial for frail debilitated long-stay residents of nursing homes. Subjects are recruited from a cohort of academic and community nursing home residents who have resided in the nursing home for greater than 3 months and are over age 60 and dependent in at least two activities of daily living. Subjects randomized to the intervention group receive one-on-one physical therapy sessions three times weekly for 4 months, while control group subjects receive structured social visits three times weekly to control for potential Hawthorne effects. Physical therapy sessions generally last 30 minutes and consist of functional activity and general conditioning exercises; these exercises are individually tailored to the subject's level of physical and functional disability. Prime outcome variables are physical function assessed by an observer-administered, performance-based instrument and self-perceived health status assessed by the Sickness Impact Profile. Health care utilization and associated costs are calculated for the following areas: the nursing home, hospitalizations, outpatient visits and procedures, medications, and the intervention. A cost-effectiveness ratio dividing incremental health care utilization and physical therapy intervention costs by the observed improvement in physical function is calculated. It is expected that results of this study can be used to help determine whether long-stay nursing home residents should be eligible for physical therapy.

Function and medical comorbidity in south Texas nursing home residents: variations by ethnic group.

OBJECTIVE: To evaluate differences in functional status and burdens of medical conditions in Mexican American and non-Hispanic white nursing home residents. DESIGN AND SETTING: Cross-sectional survey of 17 nursing homes in south Texas. PARTICIPANTS: A total of 617 older nursing home residents, of whom 366 were Mexican American and 251 were non-Hispanic white. MEASURES: Activities of Daily Living (ADL) status abstracted from standard nurses notes and Burden of Disease abstracted from medical records. RESULTS: Mexican American residents had greater numbers of ADL dependencies and poorer overall ADL scores than non-Hispanic white residents. This poor functioning was not explained by age, gender, or marital or educational status. The average number of medical conditions was greater, and specific conditions, such as cerebrovascular disease, recent acute infections, diabetes, hypertension, and anemia, were more common in Mexican American residents compared with non-Hispanic white residents. In models relating function with medical conditions and ethnic group, ADL scores and dependencies were significantly related to bowel and bladder incontinence, cerebrovascular disease, dementia, recent infections, and skin decubiti, but not to ethnic group. CONCLUSION: Mexican American nursing home residents are more functionally dependent than non-Hispanic white residents. The difference in function is explained by a greater burden of medical conditions in the Mexican American residents.

The relationship between disease and function and perceived health in very frail elders.

OBJECTIVE: To study associations between disease and observed function and self-perceived health in very frail elders. DESIGN AND SETTING: Cross-sectional survey of nine nursing homes in San Antonio, TX. PARTICIPANTS: 194 elderly long-stay nursing home residents dependent in at least two ADLs and without severe cognitive impairment. MEASURES: Burden of disease (BOD) was chart abstracted using a standardized protocol that assessed types and severities of 59 categorizations of chronic and acute medical conditions. Observed function and self-perceived health status were assessed independently by the Katz Activities of Daily Living scale (ADL) and the Sickness Impact Profile (SIP), respectively. RESULTS: Summary BOD scores had a low, but statistically significant, univariate correlation with ADL scores (r = 0.21, P = 0.003) and no significant correlation with SIP scores (R = -0.008). Multiple linear regression analyses, including the 24 most frequent disease categories, showed that disease explained significant amounts of ADL (r2 = 0.25, P = 0.001) and borderline significant amounts of SIP (r2 = 0.16, P = 0.11). Models including both disease and sociodemographic, cognitive, and affective variables showed disease added significant incremental explantation beyond the other factors to ADL (incremental r2 = 0.14, P = 0.04), but not to SIP (incremental r2 = 0.08, P > 0.10). CONCLUSIONS: Disease, observed function, and self-perceived health status are separate, but interrelated entities, with disease having a stronger relationship to observed function than self-perceived health. Comprehensive assessment of frail elders may need to include all three areas, and studies that focus on one area should take into account the other two as potential important covariates.

The role of lumbar puncture in the evaluation of dementia: the Durham Veterans Administration/Duke University Study.

The use of lumbar puncture (LP) and cerebrospinal fluid (CSF) analysis in the routine, initial evaluation of patients with dementia continues to be questioned. This is especially true in the investigation of infectious causes of dementia. To explore this question further, the authors performed a retrospective analysis of 672 hospitalized patients specifically evaluated for dementia. LP and CSF analysis were performed on 402 patients (60 per cent); routine bacteriologic, acid-fast, and fungal cultures were also obtained for 333 of these patients. Most patients were white (64 per cent) and male (63 per cent), their mean age being 66 +/- 11 years. Four patients were diagnosed as having meningitis--two with Cryptococcus neoformans, one with apparent Mycobacterium tuberculosis, and one with coagulase-positive Staphylococcus aureus. These patients were characterized by a subacute change in mental status, fever or meningismus, and CSF pleocytosis with abnormal CSF chemistries. None of the patients were found to have newly diagnosed neurosyphilis. The authors conclude that LP and CSF analysis should not be part of the routine evaluation of patients with dementia and should be performed only in the presence of such indications as a subacute duration of dementia, fever, and signs of meningeal irritation.

Falls: an examination of three reporting methods in nursing homes.

OBJECTIVE: To examine the concordance of various fall reporting methods and to use the results to recommend a preferred method of ascertaining fall frequency for residents of nursing homes, both for research and in the collection of federally mandated nursing home data. DESIGN: A cohort study followed for 858 patient months, with a mean individual follow-up of 6.6 months. MEASUREMENTS: Falls were independently ascertained monthly by three methods: review of administrative incident reports, nursing home chart abstraction, and structured interview of subjects. Concordance of events was assessed using measures of simple agreement and Kendall's Tau-b. Simple correlation and multiple regression were used to evaluate the relation of age, sex, gender, depression, mental status, and functional status with degree of concordance between self-reported falls and chart-recorded falls. SETTING: One academic and six community nursing homes in San Antonio, Texas. PARTICIPANTS: 131 long-stay nursing home residents, greater than 60 years of age, dependent in at least two activities of daily living, and mildly cognitively impaired. RESULTS: Falls were ascertained in 74 of the 131 individuals; 53 subjects fell 124 times by incident report, 58 had 140 falls according to chart review, and 66 subjects self-reported 232 falls. Greatest agreement between reporting methods was shown for incident report and chart review, with a Kendall's Tau-b of 0.88; self-report and chart-review agreement was 0.56; and self-report and incident agreement was 0.53. Estimated total fall events were more often (P = 0.001) identified by chart review (92%) than incident report (82%). Although concordance was higher for non-fallers, no significant relationships were observed between concordance and age, sex, race, depression, mental status, and functional status. Also, there was no systematic relationship between length of follow-up and degree of concordance. CONCLUSIONS: Fall frequency varies by ascertainment method, with chart review reflecting a greater number of fall events than the traditionally counted incident reports.

Relationship between physical performance and self-perceived physical function.

OBJECTIVE: The objective of this study was to compare two methods of measuring physical function in subjects with a broad range of abilities and to evaluate the effects of cognitive, social, educational, and age factors on the relationship between the two methods. DESIGN: Multiple regression analysis was used to compare self-perceived (dependent variables) with performance measures (independent variables). Covariates included age, gender, Mini-Mental State Exam score, education, living status, and depression score. SETTING: Five community-dwelling and two nursing home sites. PARTICIPANTS: 417 community-dwelling subjects and 200 nursing home residents aged 62-98 years. MEASUREMENTS: Self-perceived physical function was assessed with the physical dimension summary score of the Sickness Impact Profile, which comprises three subscales: ambulation, mobility, and body care and movement. Physical performance was evaluated by self-selected gait speed, chair-stand time, maximal grip strength, and a balance score. RESULTS: Nursing home residents and community-dwellers were significantly different (P < .0001) in all variables except age and gender. Self-perceived and performance-based measures were moderately correlated, with a range from r = -.194 to r = -.625 (P < .05). Gait speed was the strongest independent predictor of self-perceived physical function in both groups. Symptoms of depression were also an independent predictor of self-perceived function in nursing home residents; subjects who had such symptoms report more self-perceived dysfunction than would be predicted based on performance tests. CONCLUSIONS: Self-selected gait speed is a global indicator of self-perceived physical function over a broad range of abilities. External determinants (depressive symptoms, cognitive function, marital status, etc.) affect self-perceived function in both groups, but gait speed is the greatest single predictor of self-perceived function. In nursing home residents depressive symptomatology is related to self-perceived.

Performance of case-finding tools for depression in the nursing home: influence of clinical and functional characteristics and selection of optimal threshold scores.

OBJECTIVE: To compare case-finding tools for depression in the nursing home setting and to evaluate effects of subject function, cognition, and disease number on test performance. DESIGN: Cross-sectional survey. SETTING: One academic and four community homes. SUBJECTS: One hundred thirty-four randomly selected, mildly cognitively impaired, functionally dependent residents. METHODS AND MEASURES: The Geriatric Depression Scale (GDS), Short Geriatric Depression Scale (SGDS), Center for Epidemiologic Studies Depression Scale (CES-D), and Brief Carrol Depression Rating Scale (BCDRS) were administered. The Structured Clinical Interview for DSM-III-R diagnoses was administered independently,. Operating characteristics and the effects of subject characteristics on test performance were evaluated using McNemar's test and logistic regression. Selection of "optimal" threshold scores was guided by Kraemer's quality indices and clinical judgment. RESULTS: Thirty-five subjects (26%) had major depression. No differences were found among the instruments in sensitivity (range 0.74-0.89), specificity (range 0.62-0.77), or area under the receiver operating curve (ROC) (range 0.85-0.91). Resident characteristics did not affect test performance. Quality indices showed the GDS and BCDRS met criteria for moderate to substantial agreement with the criterion standard, whereas the SGDS and the CES-D achieved only fair agreement. No change in threshold scores was warranted. CONCLUSIONS: The GDS and BCDRS performed well in the nursing home. As the GDS can serve as a both a case-finding and severity instrument, it is preferred. Use of brief, interviewer-administered tools may improve detection of depression in the nursing home.

Association between hearing impairment and the quality of life of elderly individuals.

Hearing impairment is one of the most common chronic health problems of elderly Americans. Although adverse effects on quality of life are thought to be considerable, they have not been rigorously evaluated. This study was designed to identify the types and extent of dysfunction experienced by elderly individuals with hearing loss, and to define the most appropriate measures for assessing this dysfunction. Elderly male veterans attending a primary care clinic were screened for hearing loss and had their quality of life assessed with a comprehensive battery of disease-specific and generic measures. Of 472 people who had their hearing tested, 106 had hearing loss. Hearing loss was associated with significant emotional (P = .0001), social (P = .0001), and communication (P = .02) dysfunction. Most individuals (66%) perceived these dysfunctions as severe handicaps even though audiologic loss revealed only mild to moderate impairment (pure tone average loss, 27-55 dB). Adverse effects were best detected with disease-specific rather than generic functional status measures. We conclude that hearing impairment is associated with important adverse effects on the quality of life of elderly individuals, and that these effects are perceived as severe handicaps even by individuals with only mild to moderate degrees of hearing loss.

Development of the common data base for the FICSIT trials.

The eight FICSIT (Frailty and Injuries: Cooperative Studies of Intervention Techniques) sites test different intervention strategies in selected target groups of older adults. To compare the relative potential of these interventions to reduce frailty and fall-related injuries, all sites share certain descriptive (risk-adjustment) measures and outcome measures. This article describes the shared measures, which are referred to as the FICSIT Common Data Base (CDB). The description is divided into four sections according to the four FICSIT committees responsible for the CDB: (1) psychosocial health and demographic measures; (2) physical health measures; (3) fall-related measures; and (4) cost and cost-effectiveness measures. Because the structure of the FICSIT trial is unusual, the CDB should expedite secondary analyses of various research questions dealing with frailty and falls.

Captopril-stimulated renin secretion in the diagnosis of renovascular hypertension.

Evidence concerning the clinical utility of single dose captopril in the diagnosis of renovascular hypertension was evaluated. Of 173 identified papers, 16 were specifically selected because they used single dose oral captopril and obtained pre-dose and post-dose peripheral renin levels in at least one patient with renovascular hypertension. These 16 studies were appraised independently by three reviewers using standardized forms for evaluation of diagnostic tests. The 16 studies included 805 patients. All studies involved referred hypertensive populations; detailed demographics and clinical characteristics were not provided. Captopril test procedures varied in all studies. Thirteen of 16 studies used arteriography as a gold standard for the diagnosis of renovascular hypertension, and three of 16 used surgical outcome data. In ten studies, patients with renovascular hypertension clearly had a significantly greater increase in plasma renin activity than patients with essential hypertension. In the remaining six, plasma renin activity was increased in patients with renovascular hypertension but control comparisons were not made adequately. Existing data suggest that the captopril test may be useful in identifying patients with renovascular hypertension. However, specific clinical recommendations regarding its use cannot be made until future research better defines test cutoff points and identifies which patients are most likely to benefit from the test.

Management of mild chronic hypertension during pregnancy: a review.

OBJECTIVE: To conduct a systematic review of evidence relating to management of mild chronic hypertension during pregnancy, including associated risks, benefits, and harms of treatment with antihypertensive agents, nonpharmacologic measures, and aspirin and benefits of various monitoring strategies. DATA SOURCES: Using four broad search strategies, we searched English and non-English-language citations in 16 electronic databases from their inception to February 1999 and consulted relevant textbooks, references, and experts. STUDY SELECTION: Reviewers screened 6228 abstracts and found 215 articles that met multiple prespecified patient selection, study population, and design criteria. TABULATION, INTEGRATION, AND RESULTS: Forty-six studies consistently showed that chronic hypertension triples the risk for perinatal mortality (odds ratio [OR] 3.4; 95% confidence interval [CI] 3.0, 3.7) and doubles the risk for placental abruption (OR 2.1; 95% CI 1.1, 3.9). Thirteen small, randomized controlled trials had inadequate power to rule in or rule out moderate-to-large (20%-50%) benefits of antihypertensive treatment. Possible adverse effects were fetal renal failure when angiotensin-converting enzyme inhibitors are used in the second or third trimester and growth restriction when atenolol is used early in pregnancy. Trials showed that aspirin neither reduces nor increases perinatal and maternal morbidity, but they did not rule out possible small-to moderate beneficial or adverse effects. No studies provide guidance on benefits or consequences of various nonpharmacologic therapies or monitoring strategies. CONCLUSION: Mild chronic hypertension is associated with increased maternal and fetal risks. Beneficial treatment and monitoring regimens are not clear, but some treatments, such as angiotensin-converting enzyme inhibitors, are best avoided.

Current methods of the US Preventive Services Task Force: a review of the process.

The U.S. Preventive Services Task Force (USPSTF/Task Force) represents one of several efforts to take a more evidence-based approach to the development of clinical practice guidelines. As methods have matured for assembling and reviewing evidence and for translating evidence into guidelines, so too have the methods of the USPSTF. This paper summarizes the current methods of the third USPSTF, supported by the Agency for Healthcare Research and Quality (AHRQ) and two of the AHRQ Evidence-based Practice Centers (EPCs). The Task Force limits the topics it reviews to those conditions that cause a large burden of suffering to society and that also have available a potentially effective preventive service. It focuses its reviews on the questions and evidence most critical to making a recommendation. It uses analytic frameworks to specify the linkages and key questions connecting the preventive service with health outcomes. These linkages, together with explicit inclusion criteria, guide the literature searches for admissible evidence. Once assembled, admissible evidence is reviewed at three strata: (1) the individual study, (2) the body of evidence concerning a single linkage in the analytic framework, and (3) the body of evidence concerning the entire preventive service. For each stratum, the Task Force uses explicit criteria as general guidelines to assign one of three grades of evidence: good, fair, or poor. Good or fair quality evidence for the entire preventive service must include studies of sufficient design and quality to provide an unbroken chain of evidence-supported linkages, generalizable to the general primary care population, that connect the preventive service with health outcomes. Poor evidence contains a formidable break in the evidence chain such that the connection between the preventive service and health outcomes is uncertain. For services supported by overall good or fair evidence, the Task Force uses outcomes tables to help categorize the magnitude of benefits, harms, and net benefit from implementation of the preventive service into one of four categories: substantial, moderate, small, or zero/negative. The Task Force uses its assessment of the evidence and magnitude of net benefit to make a recommendation, coded as a letter: from A (strongly recommended) to D (recommend against). It gives an I recommendation in situations in which the evidence is insufficient to determine net benefit. The third Task Force and the EPCs will continue to examine a variety of methodologic issues and document work group progress in future communications.

Screening and treating adults for lipid disorders.

CONTEXT: Screening and treatment of lipid disorders in people at high risk for future coronary heart disease (CHD) events has gained wide acceptance, especially for patients with known CHD, but the proper role in people with low to medium risk is controversial. OBJECTIVE: To examine the evidence about the benefits and harms of screening and treatment of lipid disorders in adults without known cardiovascular disease for the U.S. Preventive Services Task Force. DATA SOURCES: We identified English-language articles on drug therapy, diet and exercise therapy, and screening for lipid disorders from comprehensive searches of the MEDLINE database from 1994 through July 1999. We used published systematic reviews, hand searching of relevant articles, the second Guide to Clinical Preventive Services, and extensive peer review to identify important older articles and to ensure completeness. DATA SYNTHESIS: There is strong, direct evidence that drug therapy reduces CHD events, CHD mortality, and possibly total mortality in middle-aged men (35 to 65 years) with abnormal lipids and a potential risk of CHD events greater than 1% to 2% per year. Indirect evidence suggests that drug therapy is also effective in other adults with similar levels of risk. The evidence is insufficient about benefits and harms of treating men younger than 35 years and women younger than 45 years who have abnormal lipids but no other risk factors for heart disease and low risk for CHD events (less than 1% per year). Trials of diet therapy for primary prevention have led to long-term reductions in cholesterol of 3% to 6% but have not demonstrated a reduction in CHD events overall. Exercise programs that maintain or reduce body weight can produce short-term reductions in total cholesterol of 3% to 6%, but longer-term results in unselected populations have found smaller or no effect. To identify accurately people with abnormal lipids, at least two measurements of total cholesterol and high-density lipoprotein cholesterol are required. The role of measuring triglycerides and the optimal screening interval are unclear from the available evidence. CONCLUSIONS: On the basis of the effectiveness of treatment, the availability of accurate and reliable tests, and the likelihood of identifying people with abnormal lipids and increased CHD risk, screening appears to be effective in middle-aged and older adults and in young adults with additional cardiovascular risk factors.