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Biomedical subjects

H A Glick

Publications and source records attributed to H A Glick.

At least 19 recordsLinked to original sources
PubMed2001

A comparison of scoring weights for the EuroQol derived from patients and the general public.

OBJECTIVE: General health state classification systems, such as the EuroQol instrument, have been developed to improve the systematic measurement and comparability of health state preferences. In this paper we generate valuations for EuroQol health states using responses to this instrument's visual analogue scale made by patients enrolled in a randomized clinical trial evaluating tirilazad mesylate, a new drug used to treat subarachnoid haemorrhage. We then compare these valuations derived from patients with published valuations derived from responses made by a sample from the general public. METHODS: The data were derived from two sources: (1) responses to the EuroQol instrument from 649 patients 3 months after enrollment in the clinical trial, and (2) from a published study reporting a scoring rule for the EuroQol instrument that was based upon responses made by the general public. We used a linear regression model to develop an additive scoring rule. This rule enables direct valuation of all 243 EuroQol health states using patients' scores for their own health states elicited using a visual analogue scale. We then compared predicted scores generated using our scoring rule with predicted scores derived from a sample from the general public. RESULTS: The predicted scores derived using the additive scoring rules met convergent validity criteria and explained a substantial amount of the variation in visual analogue scale scores (R(2)=0.57). In the pairwise comparison of the predicted scores derived from the study sample with those derived from the general public, we found that the former set of scores were higher for 223 of the 243 states. Despite the low level of correspondence in the pairwise comparison, the overall correlation between the two sets of scores was 87%. CONCLUSIONS: The model presented in this paper demonstrated that scoring weights for the EuroQol instrument can be derived directly from patient responses from a clinical trial and that these weights can explain a substantial amount of variation in health valuations. Scoring weights based on patient responses are significantly higher than those derived from the general public. Further research is required to understand the source of these differences.

Activities of Daily Living↗
PubMed2001

Comparison of length of hospital stay for patients with known or suspected methicillin-resistant Staphylococcus species infections treated with linezolid or vancomycin: a randomized, multicenter trial.

STUDY OBJECTIVE: To compare hospital length of stay (LOS), weekly discharges, and days of antibiotic treatment with linezolid (intravenous with oral follow-up) and vancomycin (intravenous only). DESIGN: Multinational, randomized, phase III trial. SETTINGS: Hospitals in North America, Latin America, and Europe. PATIENTS: Four hundred sixty hospitalized patients with infections of known or suspected methicillin-resistant Staphylococcus species. INTERVENTION: Administration of linezolid or vancomycin. MEASUREMENTS AND MAIN RESULTS: For linezolid recipients, median LOS was 5 and 8 days shorter (p=0.05 and 0.003) in the complicated skin and soft tissue infection intent-to-treat (230 patients) and clinically evaluable (144) samples, and slightly but not significantly shorter in the overall intent-to-treat (460) and clinically evaluable (254) samples. In all samples, linezolid recipients had more discharges in the first week of treatment and fewer days of intravenous therapy than vancomycin recipients. CONCLUSION: Our results support linezolid's ability to reduce medical resource use.

Acetamides↗
PubMed2000

Relationship between CD4 count, viral burden, and quality of life over time in HIV-1-infected patients.

BACKGROUND: Although surrogate markers such as CD4 counts and viral burden (HIV-1 RNA) are predictive of AIDS-related disease progression, little is known about the relationship between changes in surrogate markers and health-related quality of life (HRQOL) outcomes. This study investigated how changes in CD4/mm3 and viral burden (RNA copies/mL) are related to changes in HRQOL as indexed by the Medical Outcomes Study HIV Health Survey (MOS-HIV-30). METHODS: Subjects were HIV-1-infected patients with CD4 counts <300/mm3 enrolled in a double-blind, randomized clinical trial of delavirdine. As part of the clinical protocol, patients completed the MOS-HIV-30, from which the Physical Health (PHS) and Mental Health (MHS) summary scores were used for analyses. HRQOL and surrogate marker data assessed up to 2 years after randomization were analyzed for a total of 1,112 patients. RESULTS: Individual patients' initial status (intercepts) and rates of change (slopes) over time for log CD4, log RNA, PHS, and MHS were estimated with the use of empirical Bayes. Early response to treatment correlated with HRQOL better for RNA than for CD4. However, the relationship between weekly change and HRQOL was stronger for CD4 than for RNA. CONCLUSIONS: Surrogate markers are significantly associated with HRQOL outcomes. Improvements in HRQOL over time are associated with lower initial viral load and with increases in CD4 counts. Limitations concerning the restricted variability of the change scores are addressed.

Adult↗
PubMed2000

Predicting 10-year care requirements for older people with suspected Alzheimer's disease.

OBJECTIVE: To describe the types and costs of care received for 10 years after the identification of an older person with suspected Alzheimer's disease (AD) by using data from 3254 patients with suspected AD who participated in the National Long Term Care Survey (NLTCS). METHODS: By using a Markov model derived using grade of membership techniques, the following were determined: survival probabilities at 10 years; years of survival during the 10 years; years in institutions; years with two or more impairments in basic activities of daily living; hours of paid and informal care while the older person lived in the community; and costs of paid community, institutional, and medical care. RESULTS: Greater degrees of cognitive impairment present when AD was identified were associated with reduced predicted probability of surviving 10 years, increased predicted number of years spent in institutions, increased hours of care required while affected individuals remained in the community, and increased costs of paid community, institutional, and medical care. Substantial differences between men and women were seen: severity-adjusted 10-year costs were almost two times higher for women with AD than for men ($75,000 compared with $44,000); according to sensitivity analysis, average 10-year costs might be as high as $109,000 for women and $67,000 for men. CONCLUSIONS: AD imposes a substantial burden on older persons. Interventions that slow the progression of the disease may therefore affect community survival as well as healthcare costs.

Activities of Daily Living↗
PubMed1999

Clinical and economic impact of a combination Haemophilus influenzae and Hepatitis B vaccine: estimating cost-effectiveness using decision analysis.

BACKGROUND: Compliance with hepatitis B virus (HBV) vaccine remains suboptimal, despite a recommendation by the Advisory Committee on Immunization Practices of the US Public Health Service that all newborns be vaccinated. Although a combined HBV-Haemophilus influenzae type b (Hib) vaccine may improve acceptance of the HBV vaccine, the clinical and economic consequences of this intervention are uncertain. OBJECTIVES: To compare the health impact and cost-effectiveness of the following 2 immunization strategies: current practice of administering HBV vaccine separately (75% compliance) and Hib vaccine alone or as part of a multivalent vaccine (95% compliance); and strategy of delivering a combined HBV-Hib vaccine (95% compliance). DESIGN: A Markov model simulated the natural history of acute and chronic HBV and Hib disease in a cohort of US newborns. Clinical and economic variables were obtained from published reports. RESULTS: The Hib-related outcomes were the same in both strategies, because the efficacy and compliance with Hib vaccine were assumed to be equivalent in both. A 53% reduction in the number of cases of HBV infection with the combination strategy (n = 8541) was estimated when compared with current practice (n = 18 044), along with 205 fewer HBV-related deaths per 1 million infants. Immunization costs of the combination strategy were $11.5 million higher than for current practice ($108.4 million compared with $96.9 million), whereas the cost of HBV-related disease was $4.0 million lower than in current practice. The incremental cost-effectiveness ratio for the combination strategy was $17700 per year of life saved. CONCLUSION: An HBV-Hib vaccine in US infants yields substantial benefits, with a cost-effectiveness ratio that is lower than that of many commonly used medical interventions.

Adolescent↗
PubMed1999

Expression of delta F508 cystic fibrosis transmembrane conductance regulator protein and related chloride transport properties in the gallbladder epithelium from cystic fibrosis patients.

Cystic fibrosis transmembrane conductance regulator (CFTR), the cystic fibrosis (CF) gene product, functions as an adenosine 3', 5'-cyclic monophosphate (cAMP)-regulated chloride channel in the apical membrane of biliary epithelial cells, including gallbladder epithelial cells. It has been shown that triangle upF508, the most common CF mutation, impedes CFTR trafficking to the apical surface of epithelial cells. To elucidate the mechanisms of CF biliary disease, we examined structural features, CFTR expression, and chloride transport properties in gallbladder epithelial cells from nine triangle upF508 homozygous liver transplant recipients. Three CF patients had microgallbladders, characterized by severe histological abnormalities. Microgallbladder epithelial cells displayed aberrant immunolocalization of CFTR and of other normally apical proteins in the lateral domain of their plasma membrane and in their cytoplasm. This pattern was mimicked by chronic cholecystitis in non-CF patients. In the 6 remaining CF patients, CFTR was predominantly apical in the gallbladder epithelium, consistent with the detection of a fully glycosylated form by Western blot. In CF as compared with non-CF gallbladder epithelial cells in primary culture, chloride efflux was lower in response to cAMP and tended to be higher in response to exogenous adenosine 5'-triphosphate (ATP). The CF cells exhibited a residual cAMP-dependent chloride secretion that was inversely correlated with ATP-induced chloride secretion, and almost completely blunted in the cells derived from microgallbladders. Our results suggest that epithelial structural alterations aggravate triangle upF508 CFTR mislocalization in the gallbladder epithelium. The associated decrease in residual cAMP-dependent chloride secretion may contribute to biliary damage despite the up-regulation of alternative chloride transport pathways.

Adolescent↗
PubMed1999

Towards a composite scoring solution for the Neurobehavioral Functioning Inventory.

Little research has been conducted towards the development and evaluation of a measure of quality of life specific to head/brain injury populations. Accordingly, we examined responses to the Neurobehavioral Functioning Inventory in the context of a clinical trial for head injury patients (n = 655) conducted in 14 countries. To reduce the 66 item scale into a smaller number of composite scales, principal components analysis was conducted. Scales were constructed assessing four categories of symptoms: cognitive deficits, depression, aggression and somatization. The internal reliabilities (alpha coefficient) of the four scales were generally acceptable (range = 0.79-0.92). Scores on all four scales correlated significantly with patient-rated overall quality of life and all but the aggression scale correlated significantly with overall clinical severity. The need for more formal evaluation of this and other disease-specific measures is discussed.

Activities of Daily Living↗
PubMed1999

Clinical economics in clinical trials: the measurement of cost and outcomes in the assessment of clinical services through clinical trials.

As the population ages and more expensive high-technology services become available, health care costs continue to spiral upward. Because the financial resources for health care are limited, economic analysis can help to evaluate expenditures and set priorities. Economic analysis of medical technology or medical care evaluates a medical service by comparing its dollar cost with its dollar benefit (cost-benefit), by measuring its dollar cost in relation to its outcomes (cost-effectiveness) as well as in relation to its utility or quality-adjusted outcomes (cost-utility), or simply by tabulating the costs involved (cost-identification). Direct costs are generated as services are provided. In addition, patients' productivity is affected, and these costs can be considered, especially in determining the benefit of a service that decreases morbidity or mortality. Intangible costs are those of pain, suffering, and grief. The point of view, or perspective, of the study determines the costs and benefits that will be measured in the analysis. Sensitivity analysis, which can evaluate the stability of the conclusions to the data used, is an important assessment within economic analysis. Economic analysis of new pharmaceutical therapies is increasingly being incorporated into clinical trials. Although there are some limitations of pharmacoeconomic information in clinical studies of drug safety and efficacy, these trials are often the only opportunity for economic data collection before adoption and reimbursement decisions are made. Validation after the drug has been introduced should complement economic information developed from clinical trials.

Clinical Trials as Topic↗
PubMed1999

Determining an episode of care using claims data. Diabetic foot ulcer.

OBJECTIVE: Amid changes in the organization and financing of health care, health care decision makers are increasingly interested in episodes of care. We sought to determine an episode of care for diabetic foot ulcer using an administrative claims database. RESEARCH DESIGN AND METHODS: We used 1993-1995 claims data to assess resource utilization for privately insured patients with diabetic foot ulcers. Over a 26-week period, we determined the episode length by comparing differences in average daily charges and proportion of patients with charges before and after foot ulcer diagnosis. All 13 weeks before diagnosis were used to calculate baseline values. Significance was determined by CIs, which were calculated by a nonparametric bootstrap technique. Costs associated with the episode were also calculated. A sensitivity analysis using weeks with highest and lowest values as baseline was also conducted. RESULTS: Based on average daily charges, the episode of care for diabetic foot ulcer was 5 weeks. Using proportion of patients with charges, the episode was longer than 13 weeks. The cost for an episode of care ranged from $900 to $2,600. In the sensitivity analyses, episodes of care ranged from 1 to 13 weeks. CONCLUSIONS: Episodes of care can be defined by the period beginning with increased resource consumption and ending when resource consumption returns to baseline levels. With the growth of managed care and disease management programs, episode-of-care analysis may have an increasingly important role in health care provision and delivery.

Costs and Cost Analysis↗
PubMed1998

Estimating country-specific cost-effectiveness from multinational clinical trials.

Because costs and outcomes of medical treatments may vary from country to country in important ways, decision makers are increasingly interested in having data based on their own country's health care situations. This paper proposes methods for estimating country-specific cost-effectiveness ratios from data available from multinational clinical trials. It examines how clinical and economic outcomes interact when estimating treatment effects on cost and proposes empirical methods for capturing these interactions and incorporating them when making country-specific estimates. We use data from a multinational phase III trial of tirilazad mesylate for the treatment of subarachnoid haemorrhage to illustrate these methods. Our findings suggest that it is possible for meaningful country-by-country differences to be found in such trial data. These differences can be useful in informing reimbursement, utilization, and other decisions taken at the country level.

Clinical Trials as Topic↗
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

Empirical criteria for the selection of quality-of-life instruments for the evaluation of peripheral blood progenitor cell transplantation.

We propose a method for selecting quality-of-life instruments for use in phase III trials using the convergent validity of patient responses collected in phase I and II clinical trials. Two generic and two disease-specific instruments were administered to patients with breast cancer undergoing peripheral blood progenitor cell mobilization and transplantation. They included the visual analog scale from the EuroQoL EQ5D instrument, the SF-36, the European Organization for Research and Treatment of Cancer (EORTC)-QLQ-C30, and the Functional Assessment of Cancer Therapy instrument. No single instrument was found to have superior convergent validity in all domains, but the EORTC-QLQ-C30 seemed to perform better than the SF-36.

Adult↗
PubMed1998

Prospective economic evaluation accompanying a trial of GM-CSF/IL-3 in patients undergoing autologous bone marrow transplantation for Hodgkin's and non-Hodgkin's lymphoma. IL-3 BMT Study Team.

Our objective was to assess the economic impact of a new cytokine therapy that was being compared to standard therapy as supportive care in patients receiving autologous bone marrow transplantation for treatment of lymphoma. We performed an economic study accompanying a multicenter, randomized, controlled clinical trial in academic medical centers. One hundred and fifteen patients consented to participate in a parallel economic study of a randomized controlled trial of sequential IL-3 followed by GM-CSF vs GM-CSF alone after autologous bone marrow transplantation. We measured costs and quality-adjusted survival over a 13-month follow-up period. For the 13-month study period, the total cost estimates were $79892 (95% CI $69343 to $90544) for patients receiving GM-CSF alone and $89651 (95% CI $79769 to $102114) for patients receiving IL-3/GM-CSF. The difference was not statistically significant. During the 13-month study period, the total number of quality-adjusted life-months in the GM-CSF arm was 6.67 (95% CI 5.75 to 7.56) months, while the total number of quality-adjusted life-months in the IL-3 arm was 6.26 (95% CI 5.34 to 7.15) months. The difference in quality-adjusted life-months between the two treatment arms was not statistically significant. We conclude that economic analysis of a phase III clinical trial of IL-3/GM-CSF compared with GM-CSF alone showed no significant effect of IL-3 on the costs of care for patients undergoing bone marrow transplantation for a period of up to 13 months after the procedure. This study demonstrates the feasibility of prospective economic evaluation within phase III trials of new cancer therapies. Data from this type of economic protocol could be used to help physicians, patients and managed care organizations understand the effect of new treatments from both a clinical and an economic perspective.

Bone Marrow Transplantation↗
PubMed1998

Quality of life effects of alprostadil therapy for erectile dysfunction: results of a trial in Europe and South Africa.

OBJECTIVES: Quality of life (QOL) data were used to evaluate the effects of self-administered intracavernosal injection of alprostadil for erectile dysfunction, when used for up to 18 months during a 13 country Phase III clinical trial. METHODS: The Duke Health Profile was used to measure patients' physical and psychosocial QOL at baseline, 3, 6, 12 and 18 months. Changes from baseline were measured using paired t-tests, with additional analyses by cause of dysfunction, starting dosage, and prior treatment. RESULTS: Patients displayed significant improvements in mental and social health and self-esteem at six months (P < 0.01, n = 570), with greater improvements at 12 and 18 months. Anxiety and depression measures also improved significantly at 12 and 18 months, as did the summary general health score. Worse pain scores were observed in the first year but not at 18 months. Those with a starting dosage of 10-20 micrograms, those with psychogenic causes of dysfunction, and those with no prior treatment for erectile dysfunction generally showed the greatest improvements. CONCLUSION: In this study, the clinical improvements in erectile function due to intracavernosal alprostadil therapy were complemented by QOL improvements, particularly in the mental health, of many patients.

Adult↗
PubMed1998

Comparison of the use of medical resources and outcomes in the treatment of aneurysmal subarachnoid hemorrhage between Canada and the United States.

OBJECTIVE: Using data from a randomized trial of tirilazad mesylate, we assessed the differences between Canada and the United States in the use of medical resources and outcomes in the treatment of aneurysmal subarachnoid hemorrhage during the first 90 days after admission to the hospital. METHODS: Of the 877 patients for whom economic data were available, 194 were enrolled in Canada and 683 were enrolled in the United States. The differences between the countries in patient characteristics, use of medical resources, and outcomes were analyzed by comparing means and the 95% confidence intervals (CIs) around the differences in means. These differences also were predicted with use of multivariable regression analysis. RESULTS: The average hospital stay was 4.2 days longer (95% CI, 1.3 to 7.1 days) in Canada, but most of the extra stay was among patients admitted to the study in poor neurological condition. In general, however, hospital stays in Canada were substantially less intensive. Patients treated in Canada spent 3.7 fewer days (95% CI, 1.2 to 6.1 days) in nursing homes and rehabilitation centers than did patients in the United States. No statistically significant differences were seen for Glasgow Outcome Scale score, death, and occurrence of vasospasm. CONCLUSIONS: For patients admitted to the study in good neurological condition, the apparent difference in length of stay between Canada and the United States was caused by a shift in the sites of formal care rather than to the length of this care. For those admitted in poor neurological condition, both the length and sites of care differed between the two countries. No significant difference in outcomes appeared to justify these differences in the use of medical resources.

Canada↗
PubMed1997

Construction of scales for the Center for Marital and Sexual Health (CMASH) Sexual Functioning Questionnaire.

The objective of this study was to identify a set of scales for summarizing the results of the Center for Marital and Sexual Health Sexual Functioning Questionnaire (CMASH SFQ). Scales for this instrument were constructed using patients' responses to the CMASH SFQ in a recent clinical trial of prostaglandin E1 (PGE1, alprostadil), an injectable vasodilator used to treat erectile dysfunction. A set of items was identified as a scale if they met predetermined standards of internal consistency, discriminant validity, and convergent validity. The reproducibility of the scales was then evaluated, and the extent to which the scales reliably measured change in treatment-related quality of life was assessed. Reliable and responsive scales for four domains related to sexual functioning were identified. Items in these scales were generally internally consistent; items in the scales and the scores for the scales generally satisfied criteria of discriminant validity; and the scales generally satisfied the standard for convergent validity. Evaluating patients' responses to the CMASH SFQ with scores for four reliable and responsive scales allows easier summarization of patients' sexual functioning and increases the statistical power of evaluations of the effects of interventions designed to improve sexual functioning.

Adult↗
PubMed1997

Routine portable chest radiographs in the medical intensive care unit: effects and costs.

OBJECTIVE: To determine the effects and net costs of routine chest radiographs in a medical intensive care unit (ICU). DESIGN: A prospective, cohort study. A survey of experts in critical care and pulmonary diseases was undertaken to assess the effect of routine radiographs on patient management. SETTING: Medical ICU of a university hospital. PATIENTS: Eighty randomly selected patients admitted to a medical ICU. Two hundred fourteen experts were surveyed; 118 (55%)/214 responded. MEASUREMENTS AND MAIN RESULTS: Daily interviews with medical ICU clinicians were conducted to assess the radiographic findings in the routine radiographs and actions taken based on these findings. Experts evaluated the findings, their importance, the actions taken, and the probability of complications if the actions had not been taken at that time. Experts also predicted increases in length of stay associated with these complications. Presence of radiographic findings, changes in management because of the findings, net costs of routine chest radiographs, cost per finding that prompted an action, and expected changes in length of stay resulting from the actions were also assessed. Seventy-two (33%) of 221 routine radiographs (95% confidence interval: 25% to 39%) had findings, of which 44 (61%) were judged important, and 18 (8%, 95% confidence interval: 5% to 12%) prompted actions. Experts predicted that each action averted, on average, 2.1 +/- 1.7 days (SD) in the medical ICU. Mean savings per routine radiograph was $98. Net savings from routine chest radiographs remained after sensitivity analysis for expected change in length of stay, percentage of patients with routine radiographs, and percentage of routine radiographs that produce changes in management. CONCLUSION: The policy of obtaining routine chest radiographs in the medical ICU is effective and results in net savings.

APACHE↗