Search PubMed⌕ Search

Biomedical subjects

B Kinosian

Publications and source records attributed to B Kinosian.

At least 19 recordsLinked to original sources
PubMed2001

Principles of effectiveness trials and their implementation in VA Cooperative Study #430: 'Reducing the efficacy-effectiveness gap in bipolar disorder'.

Despite the availability of efficacious treatments for bipolar disorder, their effectiveness in general clinical practice is greatly attenuated, resulting in what has been called an 'efficacy-effectiveness gap'. In designing VA Cooperative Studies Program (CSP) Study #430 to address this gap, nine principles for conducting an effectiveness (in contrast to an efficacy) study were identified. These principles are presented and discussed, with specific aspects of CSP #430 serving as illustrations of how they can be implemented in an actual study. CSP #430 hypothesizes that an integrated, clinic-based treatment delivery system that emphasizes (1) algorithm-driven somatotherapy, (2) standardized patient education, and (3) easy access to a single primary mental health care provider to maximize continuity-of-care, will address the efficacy-effectiveness gap and improve disease, functional, and economic outcome. It is an 11-site, randomized controlled clinical trial of this multi-modal, clinic-based intervention versus usual VA care running from 1997 to 2003. The trial has enrolled 191 subjects in each arm, using minimal exclusion criteria to maximize the external validity of the study. Subjects are followed for 3 years. The intervention is highly specified in a series of operations manuals for each of the three components. Several continuous quality improvement (CQI) interventions, process measures, and statistical techniques deal with drift of care in both the intervention and usual care arms to ensure the internal validity of the study. CSP #430 is designed to have impact well beyond the VA, since it evaluates a basic health care operational principle: that augmenting ambulatory access for major mental illness will improve outcome and reduce overall treatment costs. If results are positive, this study will provide a reason to reconsider the prevailing trend toward limitation of ambulatory services that is characteristic of many managed care systems today.

Activities of Daily Living↗
PubMed2000

The Internal State Scale: replication of its discriminating abilities in a multisite, public sector sample.

OBJECTIVE: The Internal State Scale (ISS) is a self-report instrument that has been validated for discriminating mood states in patients with bipolar disorder. This study a) extends investigation to a multisite public sector sample and b) tests a revised scoring algorithm that formally identifies patients in mixed states. METHODS: Eighty-six patients with bipolar disorder from four Veterans Affairs medical centers were assessed in a cross-sectional design. Physician-conducted semi-structured interviews used DSM-IV criteria to identify subjects as meeting criteria for euthymia, mania or hypomania, depression, or mixed state (mania or hypomania plus depression). A revised ISS scoring algorithm independently assigned mood state. Mean subscale scores were analyzed across groups. Receiver-operating characteristic (ROC) curve analysis was conducted to determine optimal algorithm structure. RESULTS: Analysis of mean scores for the ISS subscales replicated original results for Activation, Well-Being, and Perceived Conflict, but indicated differences from the original results for the Depression Index. The ROC curve analysis identified optimal cut-off scores for the revised algorithm. The overall kappa score indicated moderate agreement between ISS and physician ratings of mood state, including mixed states. LIMITATIONS: The study used a sample consisting primarily of male veterans. Mood state was assigned by experts using expert clinician diagnosis, not structured interviews. CONCLUSION: The performance of the ISS in this multisite, public sector sample was similar to the performance in the initial research clinic sample. This finding confirms the validity of the ISS as a discriminator of mood states in bipolar disorder. The development of a revised scoring algorithm makes feasible formal identification of mixed episodes with the ISS.

Affect↗
PubMed2000

The involvement of physicians in VA home care: results from a national survey.

OBJECTIVES: To examine the role of physicians in the Veteran Affairs (VA) home-based primary care (HBPC) program and to identify variables that predict whether physicians make home visits and volume of home visits made. DESIGN: Descriptive and regression analyses of responses from a mail survey. PARTICIPANTS: Forty-five physicians affiliated with VA HBPC programs. MAIN SURVEY TOPICS: Self-reported work load, attitudes toward home care, reasons for home visits, administrative policies regarding physicians' role in patient care management, and time commitment to home care. RESULTS: A majority of physicians believed strongly in the importance of home care and made home visits for reasons consistent with their training. Physician attitude toward home care and preoccupation with office or hospital practice were related to whether or not physicians made home visits. Degree of preoccupation with office practice and amount of salary support from VA HBPC were significant predictors of the number of visits made (R2 = 0.44). CONCLUSIONS: These findings indicate that most physicians will make home visits if they believe that home care is valuable and if their time commitment is supported financially. Managed care plans that own and operate home care programs and have the capacity to transfer primary care management to physicians who derive financial support from the programs should find this information particularly relevant.

Aged↗
PubMed1998

The cost and cardioprotective effects of enalapril in hypertensive patients with left ventricular dysfunction.

This study examined the effect of enalapril on survival, resource use, and cost of care in patients with left ventricular dysfunction and hypertension using a retrospective analysis of patients who participated in the Studies of Left Ventricular Dysfunction (SOLVD). Among the 6797 SOLVD participants, 1917 patients had either elevated systolic (> or = 140 mm Hg) or diastolic (> or = 90 mm Hg) blood pressure. Therapy with enalapril was associated with a significant relative risk reduction for mortality (RR = 0.819, 95% CI: 0.68 to 0.98; P = .03). This resulted in a gain of 0.11 years (95% CI: 0.00 to 0.20 years) of survival during the average 2.8 year follow-up for this subgroup and was projected to result in a gain of 2.14 years (95% CI: 0.05 to 4.21 years) during the patient's lifetime. Enalapril significantly reduced the risk of first hospitalization for heart failure by 37%. For all types of hospitalizations, there was an average reduction of 32 hospitalizations per 100 patients treated with enalapril during the trial period (95% CI: 11.8 to 52.2 hospitalizations avoided per 100 patients), resulting in an estimated net savings of $1656 per patient during the trial period (95% CI: increased cost of $191 to savings of $3502). Although the projected lifetime net savings of $1456 was not significant (95% CI: increased cost of $9243 to saving of $12,527), evaluation of the cost per life year saved indicated that enalapril represented a cost-effective strategy. The estimated clinical benefit of enalapril among the hypertensive subgroup in SOLVD supports the recommendation that angiotensin converting enzyme (ACE) inhibitors should be considered as first line pharmacologic therapy for hypertensive patients with left ventricular dysfunction. From both the clinical and economic viewpoints, ACE inhibitors provide important clinical benefits and are cost-effective.

Angiotensin-Converting Enzyme Inhibitors↗
PubMed1998

Clinical trials and external validity.

Although a number of clinical trials are available estimating the benefits of lipid-lowering therapies that include economic end-points, development of modeling methodologies are essential to extend results of those trials over time and to other populations. We reviewed the key issues to be considered when extending trial data to real-world situations. The availability of recent randomized controlled trials of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors in primary and secondary prevention has demonstrated the limitations of earlier modeling efforts to project benefits of lipid modification. The importance of risk stratification is demonstrated, particularly the importance of both LDL and HDL cholesterol either together or as a ratio measure. The selection of modeling methodology to extend benefits of a treatment beyond the end of a trial and over a lifetime is discussed. The relationship between benefits from lipid reduction and risk difference is described, demonstrating that for individuals with established coronary heart disease (CHD) and those older than age 58, benefits from lipid reduction are greater than those predicted from baseline lipid-related risk differences alone. The implications of these data for primary prevention of CHD in the elderly are discussed.

Journal Article↗
PubMed1998

A tale of two walls.

Explore the source record for details and available documents.

Eligibility Determination↗
PubMed1998

Relationship of self-reported oral health and nutritional risk among hospitalized older adults.

Oral health and nutritional risk were assessed in 300 hospitalized older adults using self-reported instruments. Patients who self-reported poor oral health status were at greatest nutritional risk. Study results suggest that self reported oral health and nutritional risk are multidimensional and that screening instruments may help identify patients who could benefit from a dental referral. The combination of nutritional and oral health screening methods may be an efficient and cost-effective method for nondental health care providers to identify and refer older adults for oral health care.

Aged↗
PubMed1998

Economic benefits of aggressive lipid lowering: a managed care perspective.

Coronary heart disease (CHD) has high prevalence in the United States and is associated with significant mortality as well as costs to society. Hyperlipidemia is a major and common modifiable risk factor for CHD. In clinical trials, cholesterol-lowering strategies have a dramatic impact on CHD risk, cardiovascular events, and mortality. Cost-effectiveness data have established that clinical and economic benefits are gained by instituting early and aggressive lipid-lowering therapy. We present new evidence for the clinical benefits and cost effectiveness of aggressive lipid-lowering therapy as primary or secondary prevention of CHD and describe strategies that managed care organizations can take to benefit from a lipid management program.

Angioplasty, Balloon, Coronary↗
PubMed1996

Polymerase chain reaction for the diagnosis of HIV infection in adults. A meta-analysis with recommendations for clinical practice and study design.

PURPOSE: To do a meta-analysis of studies that have evaluated the sensitivity and specificity of polymerase chain reaction (PCR) assay for the diagnosis of human immunodeficiency virus (HIV) infection in adults. Evaluating the performance of PCR is difficult because in certain clinical situations, the sensitivity or specificity of PCR may exceed those of the current reference standard tests (enzyme immunoassay followed by confirmatory Western blot analysis). Therefore, an additional goal was to develop recommendations for 1) the design of future evaluative studies of PCR and 2) the use of PCR in persons with suspected HIV infection. DATA SOURCES: Studies published between 1988 and 1994 that were identified in a search of 17 computer databases, including MEDLINE, and abstracts identified from conference proceedings. STUDY SELECTION: Studies were included if DNA amplification by PCR was done on peripheral blood mononuclear cells from adults. Ninety-six studies met the inclusion criteria. DATA EXTRACTION: Data were extracted independently by two reviewers. Study design was assessed independently by two investigators blinded to study results. RESULTS: Reported sensitivities for PCR range from 10% to 100%, and specificities range from 40% to 100%. A summary receiver-operating characteristic curve based on all 96 studies has a maximum joint sensitivity and specificity (upper left point on the curve, where sensitivity equals specificity) of 97.0% to 98.1%. If the threshold value that defines a positive PCR result is chosen so that sensitivity is higher than 98.1%, specificity will decrease to less than 98.1%. Conversely, if the threshold value that defines a positive PCR result is chosen so that specificity is greater than 98.1%, sensitivity will decrease to less than 98.1%. If sensitivity and specificity are chosen to be equal, the corresponding false-positive rate is 1.9% to 3.0%. At the maximum joint sensitivity and specificity, the positive predictive value of PCR ranges from 34% to 85% as the prevalence of HIV increases from 1.0% to 10%. We identified seven areas in which study design could be modified to 1) reduce susceptibility to bias in estimates of the sensitivity and specificity of PCR and 2) to increase the generalizability of the study results. These modifications will also help to overcome methodologic problems created by the lack of a reference standard test. CONCLUSIONS: The PCR assay is not sufficiently accurate to be used for the diagnosis of HIV infection without confirmation. Use of PCR for the diagnosis of HIV in adults should be limited to situations in which antibody tests are known to be insufficient. Future studies of PCR performance should be sufficiently large and should use adequate reference standard tests and standardized methods for the performance of PCR. Specimens should be evaluated by persons blinded to clinical status and to the results of other diagnostic tests for HIV infection.

Adult↗
PubMed1995

Costs and effects of enalapril therapy in patients with symptomatic heart failure: an economic analysis of the Studies of Left Ventricular Dysfunction (SOLVD) Treatment Trial.

The clinical results of the Studies of Left Ventricular Dysfunction (SOLVD) Treatment Trial have been published previously, but no evaluation of cost-effectiveness based on the primary data has been reported. The authors used a decision analytic model based on primary data from SOLVD to estimate years of survival (overall, by New York Heart Association Class, and quality-adjusted) and to estimate costs of nonfatal hospitalizations, ambulatory care, therapy with enalapril, and deaths. Clinical and resource utilization data were derived from participants in SOLVD, and cost data were derived from the United States. Therapy with enalapril during the approximate 48-month follow-up period in SOLVD resulted in a gain of 0.16 year of life and savings of dollars 718. During the patient's lifetime, a survival benefit of 0.40 year, a cost per year of life saved of dollars 80, and a cost per quality-adjusted life year of dollars 115 with the use of enalapril were projected. The results indicated a net savings and gain in life expectancy during the SOLVD treatment trial. The lifetime projection suggests that therapy with angiotensin-converting enzyme inhibitors, such as enalapril, is extremely attractive when compared with many commonly used interventions in patients with cardiovascular disease or heart failure.

Angiotensin-Converting Enzyme Inhibitors↗
PubMed1995

Cholesterol and coronary heart disease: predicting risks in men by changes in levels and ratios.

BACKGROUND: Little is known about the relative ability of different measures of change in cholesterol to discriminate coronary heart disease risk. We evaluated this ability for changes in low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, LDL/HDL ratios, and total cholesterol/HDL ratios. METHODS: We predicted risks of coronary heart disease using data from 3641 men in the Lipid Research Clinics Coronary Primary Prevention Trial. Treating these patients as a cohort, we estimated risks associated with changes in cholesterol levels independent of the patients' randomization group. RESULTS: Changes in LDL and HDL cholesterol when used in combination were each significant predictors of coronary heart disease risk (odds ratios [OR] for 10% increases, 1.15 and 0.84, respectively; P < 0.001). Changes in LDL/HDL and total cholesterol/HDL ratios had similar discriminating ability (OR for 10% increases, 1.17 and 1.21, respectively; P < 0.0001). In the best discriminating models, changes in ratios added information about risks to changes in LDL cholesterol, although changes in LDL cholesterol levels failed to add information to changes in ratios. CONCLUSIONS: Changes in total cholesterol/HDL and LDL/HDL ratios were better predictors of risk for coronary heart disease than were changes in LDL cholesterol levels alone. When assessed as percentage changes averaged during the first two months of intervention, they were among the best discriminators of risk. Clinicians selecting treatments for intervention should include among their considerations the treatment's effect on both LDL and HDL cholesterol rather than their effects on LDL cholesterol levels alone.

Cholesterol↗
PubMed1994

Cholesterol and coronary heart disease: predicting risks by levels and ratios.

OBJECTIVE: Comparison of four measures of cholesterol for predicting men and women who will develop coronary heart disease within 8 to 10 years. DESIGN: Cohort study. PATIENTS: 1898 men who received placebo (the placebo group of the Lipid Research Clinics [LRC] Coronary Primary Prevention Trial [CPPT]), 1025 men and 1442 women who participated in the 1970-1971 Framingham Heart Study biennial examination, and 1911 men and 1767 women without coronary heart disease who were from the LRC Population Prevalence Study. MEASUREMENTS: Total cholesterol, low-density lipoprotein (LDL) cholesterol, ratio of total cholesterol to high-density lipoprotein (HDL) cholesterol, and the ratio of LDL to HDL. Outcomes were coronary heart disease in the CPPT and Framingham studies and death from coronary heart disease in the Prevalence Study. RESULTS: Independent information in the total cholesterol/HDL ratio added risk-discriminating ability to total cholesterol and LDL cholesterol measures (P < 0.02), but the reverse was not true. Among women, a high-risk threshold of 5.6 for the total cholesterol/HDL ratio identified a 0% to 15% larger group at 25% to 45% greater risk in the Prevalence and Framingham studies, respectively, than did current guidelines. Among men in the same studies, a risk threshold of 6.4 for the total cholesterol/HDL ratio identified a 69% to 95% larger group at 2% to 14% greater risk than did LDL cholesterol levels alone. Eight-year likelihood ratios for coronary heart disease ranged from 0.32 to 3.11 in men and from 0.59 to 2.98 in women for total cholesterol/HDL ratios (grouped from < 3 to > or = 9). CONCLUSIONS: The total cholesterol/HDL ratio is a superior measure of risk for coronary heart disease compared with either total cholesterol or LDL cholesterol levels. Current practice guidelines could be more efficient if risk stratification was based on this ratio rather than primarily on the LDL cholesterol level.

Adult↗
PubMed1994

Long-term treatment of hypercholesterolemia with dietary fiber.

PURPOSE: To evaluate the hypocholesterolemic effects of long-term treatment (36 to 51 weeks) with a mixture of dietary fibers (guar gum, pectin, soy, pea, corn bran) administered twice a day. PATIENTS AND METHODS: Fifty-nine subjects with moderate hypercholesterolemia who completed a 15-week, placebo-controlled study with the dietary fiber were treated for an additional 36 weeks with 20 g/day of fiber. Subjects were counseled and monitored on a National Cholesterol Education Program (NCEP) Step-One Diet before starting and during treatment. Analyses of changes in lipoprotein values during the additional 36 weeks of treatment took into account changes in weight, diet, and other variables that might have affected the response to treatment. RESULTS: There were no significant effects on the levels of either triglycerides or high-density lipoprotein cholesterol (HDL-C). Levels of total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) and the LDL/HDL ratio were significantly reduced during treatment. The mean percentage reductions from baseline after 51 weeks of treatment were approximately 5% for TC, 9% for LDL-C, and 11% for the LDL/HDL ratio. Changes were apparent after 3 weeks of treatment, with the maximum reductions occurring by the 15th week of treatment. CONCLUSIONS: For subjects on a Step-One Diet who complied with the treatment regimen, the moderate cholesterol-lowering effects of the fiber persisted throughout the 36-to-51 week treatment period.

Chi-Square Distribution↗
PubMed1994

Hypocholesterolemic effects of a dietary fiber supplement.

The cholesterol-lowering effects of a fiber supplement were evaluated in patients with mild to moderate hypercholesterolemia. After a 9-wk diet stabilization period, patients were randomly assigned to treatment with 10 or 20 g/d of the fiber supplement or with a matching placebo. Among patients who completed the 15-wk treatment period, total cholesterol, LDL cholesterol, and the ratio of LDL to HDL (LDL/HDL) were significantly reduced (P < 0.05) for the 10- (n = 40) and 20-g/d (n = 39) groups compared with the placebo group (n = 48). In the placebo group and 10- and 20-g/d groups, the percent changes in total cholesterol were 0.4%, -5.8%, and -4.9%, in LDL cholesterol were -0.4%, -8.1%, and -7.3%, and in LDL/HDL were 1.0%, -5.6%, and -8.7%, respectively. The fiber supplement had no significant effects (P > 0.05) on HDL cholesterol or triglycerides. The changes in lipoprotein concentrations could not be attributed to changes in diet or body weight because there were no significant changes in these variables during the 15-wk treatment period.

Adolescent↗
PubMed1993

The economic impact of infections. An analysis of hospital costs and charges in surgical patients with cancer.

We performed an economic analysis of the care provided to patients undergoing major abdominal surgical procedures to determine the effect of postoperative infection on hospital resource use. Patients' clinical and demographic characteristics and their use of medical care services were determined from a review of hospital bills and medical records. Hospital charges were obtained from the hospital billing system and costs were determined by use of Medicare cost-charge ratios obtained from the hospital's Medicare Cost Report. The care of patients with postoperative infections was significantly more expensive than that of uninfected patients (multivariate analysis indicated that a surgical infection added $12,542 to the cost of patient care). Patients with postoperative fever but without documented infection were also more expensive to care for than afebrile, uninfected patients (fever added $9145 to the cost of care). Increased costs for infected patients were found among microbiology tests, radiology services, pharmaceutical costs, and room costs. For these patients, we found that use of departmental cost-charge ratios, instead of hospital-wide cost-charge ratios, had no substantial impact on comparison of the cost of care for infected and uninfected patients.

Academic Medical Centers↗
PubMed1992

Cost and health implications of cholesterol lowering.

BACKGROUND: A broad, scientific consensus supports the role of cholesterol as a risk factor for coronary heart disease and agrees that lowering cholesterol levels will reduce coronary heart disease incidence. Cost-effectiveness analysis is a potentially powerful method for measuring the benefits to be achieved by expenditures of health care dollars. METHODS AND RESULTS: The literature related to the effectiveness and cost-effectiveness of cholesterol lowering was reviewed. Application of cost-effectiveness methodology to the question of cholesterol reduction generally supports the use of population-wide educational programs and the aggressive use of cholesterol-lowering therapy for the secondary prevention of subsequent coronary events in persons with preexisting coronary heart disease. For primary prevention, however, therapy with medication has a favorable cost-effectiveness ratio only in identifiable high-risk persons, and the different costs of the various available medications should be taken into account. Therapy with medications, especially for primary prevention, would be more appealing if the price of the available medications were lower. CONCLUSIONS: High priority should be given to research that could validate these cost-effectiveness projections as well as to further studies of the elderly and women, in whom direct data on the precise costs, risks, and benefits of interventions to lower cholesterol remain sparse.

Anticholesteremic Agents↗