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Biomedical subjects

E Nord

Publications and source records attributed to E Nord.

At least 19 recordsLinked to original sources

Insulin lispro therapy in pregnancies complicated by type 1 diabetes mellitus.

OBJECTIVE: To compare the efficacy and safety of preprandial administration of rapid-acting lispro analogue with regular short-acting insulin to pregnant women with type 1 diabetes. STUDY DESIGN: Open randomised multicentre study. Women were treated with multiple insulin injections aiming at normoglycaemia. Blood glucose was determined six times daily, HbA(1c) every 4 weeks. Diurnal profiles of blood glucose were analysed at gestational week 14 and during the study period at weeks 21, 28 and 34. PARTICIPANTS: 33 pregnant women with type 1 DM were randomised to treatment with lispro insulin (n=16) or regular insulin (n=17). RESULTS: Blood glucose was significantly lower (P<0.01) after breakfast in the lispro group, while there were no significant group differences in glycemic control during the rest of the day. Severe hypoglycaemia occurred in two patients in the regular group but biochemical hypoglycaemia (blood glucose <3.0 mmol/l) was more frequent in the lispro than in the regular group (5.5 vs. 3.9%, respectively). HbA(1c) values at inclusion were 6.5 and 6.6% in the lispro and regular group respectively. HbA(1c) values declined during the study period and were similar in both groups. There was no perinatal mortality. Complications during pregnancy, route of delivery and foetal outcome did not differ between the groups. Retinopathy progressed in both groups, one patient in the regular group developed proliferative retinopathy. CONCLUSION: The results suggest that it is possible to achieve at least as adequate glycemic control with lispro as with regular insulin therapy in type 1 diabetic pregnancies.

Adult↗

The desirability of a condition versus the well being and worth of a person.

The desirability of a condition to people who are not in it themselves is only moderately correlated to the experienced well being of people with the condition and hardly correlated at all to the worth of those people. A single score for a health state, of the kind used in QALY calculations, cannot express all these three types of value. The history and current practice of health economics is highly problematic in this respect.

Cost-Benefit Analysis↗

Cost-utility analysis of high-dose melphalan with autologous blood stem cell support vs. melphalan plus prednisone in patients younger than 60 years with multiple myeloma.

We evaluated the costs and the cost utility of high-dose melphalan and autologous stem cell support followed by interferon maintenance relative to conventional treatment with melphalan and prednisone, in patients less than 60 yr of age with multiple myeloma. From March 1994 to July 1997, 274 patients with newly diagnosed, symptomatic multiple myeloma were enrolled in a prospective, non-randomized, population-based, multicenter study to evaluate the treatment with high-dose melphalan and autologous blood stem cell support. Health-related quality-of-life was measured prior to treatment and during follow-up, using the EORTC QLQ-C30 questionnaire. Resource consumption was also recorded prospectively. The intensive treatment yielded a significant increase in median survival time from 44 to 62 months compared to conventionally treated patients. The corresponding gain in quality-adjusted life years (QALY) was found to be 1.2. Cost per QALY gained by the treatment with high-dose melphalan and autologous blood stem cell support was estimated at NOK 249,000 (USD 27,000).

Cost-Benefit Analysis↗

Health state values from multiattribute utility instruments need correction.

Cost-utility analysis uses the quality-adjusted life year (QALY) as a measure of the benefit of health interventions. It presupposes the assignment of utility scores to different states of health on a scale from zero (dead) to unity (healthy). A number of so-called multiattribute utility (MAU) instruments are available for this purpose. Analysts who wish to use MAU instruments in economic evaluations of health programmes and technologies may improve their performance by conducting two different analyses: the first is a conventional cost-utility study, in which the utilities from MAU instruments are used as they stand, and the second is a study in which the utilities are transformed into numbers that also encapsulate concerns for giving priority to the worst off. The term 'cost-value analysis' is used for the latter, broader approach. A figure is offered as a preliminary tool to help conduct the required transformations.

Cost-Benefit Analysis↗

Cost savings and health losses from reducing inappropriate admissions to a department of internal medicine.

OBJECTIVES: Inappropriate hospital admissions are commonly believed to represent a potential for significant cost reductions. However, this presumes that these patients can be identified before the hospital stay. The present study aimed to investigate to what extent this is possible. METHODS: Consecutive admissions to a department of internal medicine were assessed by two expert panels. One panel predicted the appropriateness of the stays from the information available at admission, while final judgments of appropriateness were made after discharge by the other. RESULTS: The panels correctly classified 88% of the appropriate and 27% of the inappropriate admissions. If the elective admissions predicted to be inappropriate had been excluded, 9% of the costs would have been saved, and 5% of the gain in quality-adjusted life-years lost. The corresponding results for emergency admissions were 14% and 18%. CONCLUSIONS: The savings obtained by excluding admissions predicted to be inappropriate were small relative to the health losses. Programs for reducing inappropriate health care should not be implemented without investigating their effects on both health outcomes and costs.

Adult↗

Human T-cell lymphotropic virus testing of blood donors in Norway: a cost-effect model.

BACKGROUND: Human T-cell lymphotropic virus type I and II (HTLV-I and II) are human retroviruses that can be transmitted by transfusion of whole blood. An HTLV-I infection is associated with adult T-cell leukaemia (ATL) and with tropical spastic paraparesis (TSP). Antibody tests from 5.5 million European blood donors have shown that the HTLV prevalence is low, ranging from 0 to 0.02%. This paper examines costs and effects associated with the intervention of testing all new blood donors for HTLV. METHODS: A mathematical model was used to calculate the number of cases prevented by the intervention. For a given prevalence of HTLV in the blood donor population, the model calculates the number of recipients infected by transfusion, and the number of partners and offspring that will in turn be infected. The model then calculates the number of subjects with disease due to HTLV-I infection and the number of deaths from disease. From these numbers the measures of cost and effect are calculated. RESULTS: Testing all new blood donors for HTLV is calculated to cost US$ 9.2 million per life saved, or US$ 420,000 per quality adjusted life year gained by the intervention, when the HTLV prevalence among donors is 1 per 100,000. When the prevalence among donors is 10 per 100,000 the intervention will cost US$ 0.9 million per life saved, or US$ 41,000 per quality adjusted life year gained. The same analysis shows that testing blood donors for human immunodeficiency virus (HIV) saves money when the HIV prevalence among donors is above 0.7 per 100,000. CONCLUSION: For Norway, studies suggest a willingness to pay to save a statistical life of approximately US$ 1.2 million. The costs fall under this value when the number of infected persons is > or = 8 per 100,000 donors. The results are uncertain because of the uncertainty in HTLV infection and disease parameters.

Blood Donors↗

Improving value measurement in cost-effectiveness analysis.

OBJECTIVE: Before cost-effectiveness analysis (CEA) can fulfill its promise as a tool to guide health care allocation decisions, the method of incorporating societal values into CEA may need to be improved. DESIGN: The study design was a declarative exposition of potential fallacies in the theoretical underpinnings of CEA. Two values held by many people-preferences for giving priority to severely ill patients and preferences to avoid discrimination against people who have limited treatment potential because of disability or chronic illness-that are not currently incorporated into CEA are discussed. CONCLUSIONS: Traditional CEA, through the measurement of quality-adjusted life years (QALYs), is constrained because of a "QALY trap." If, for example, saving the life of a person with paraplegia is equally valuable as saving the life of a person without paraplegia, then current QALY methods force us to conclude that curing paraplegia brings no benefit. Basing cost-effectiveness measurement on societal values rather than QALYs may allow us to better capture public rationing preferences, thereby escaping the QALY trap. CEA can accommodate a wider range of such societal values about fairness in its measurements by amending its methodology.

Attitude to Health↗

Incorporating societal concerns for fairness in numerical valuations of health programmes.

The paper addresses some limitations of the QALY approach and outlines a valuation procedure that may overcome these limitations. In particular, we focus on the following issues: the distinction between assessing individual utility and assessing societal value of health care; the need to incorporate concerns for severity of illness as an independent factor in a numerical model of societal valuations of health outcomes; similarly, the need to incorporate reluctance to discriminate against patients that happen to have lesser potentials for health than others; and finally, the need to combine measurements of health-related quality of life obtained from actual patients (or former patients) with measurements of distributive preferences in the general population when estimating societal value. We show how equity weights may serve to incorporate concerns for severity and potentials for health in QALY calculations. We also suggest that for chronically ill or disabled people a life year gained should count as one and no less than one as long as the year is considered preferable to being dead by the person concerned. We call our approach 'cost-value analysis'.

Cost-Benefit Analysis↗

Cost effectiveness of replacing diclofenac with a fixed combination of misoprostol and diclofenac in patients with rheumatoid arthritis.

OBJECTIVE: To estimate the costs and health consequences of replacing treatment with diclofenac 50 mg with a fixed combination of diclofenac 50 mg and misoprostol 0.2 mg 3 times a day in patients with rheumatoid arthritis (RA). METHODS: A decision tree was developed to simulate 6 months of nonsteroidal antiinflammatory drug (NSAID) treatment for RA. The probabilities of the clinical outcomes were based on a literature review. A survey of Norwegian rheumatologists was undertaken to explore their clinical management of dyspepsia in RA patients taking NSAIDs. Valuation of health states was based on results of the Short Form 36 health survey. RESULTS: In female RA patients without any risk factors associated with serious gastrointestinal (GI) complications, the incremental cost of replacing diclofenac with the fixed misoprostol/diclofenac combination therapy was $72,700 per quality-adjusted life-year gained. For patients with 1 risk factor, the cost was less than $16,000. With 2 or 3 risk factors, the use of misoprostol was cost saving. The cost-effectiveness ratios in males were approximately 20% higher than in females. CONCLUSION: Replacing diclofenac with a fixed diclofenac/misoprostol combination is cost effective when restricted to RA patients at increased risk of serious GI events.

Anti-Inflammatory Agents, Non-Steroidal↗

The cost of inappropriate admissions: a study of health benefits and resource utilization in a department of internal medicine.

OBJECTIVES: High rates of inappropriate hospital admissions have been found in numerous studies, suggesting that a high percentage of hospital resources are, in effect, wasted. The degree to which this is true depends on how costly inappropriate admissions are compared to other admissions. This study aimed to estimate both the percentage and cost of inappropriate admissions. SETTING: Department of internal medicine at a teaching hospital. SUBJECTS: Consecutively admitted patients during a six-week study period. MAIN OUTCOME MEASURES: Assessments of inappropriateness were based on estimates of health benefit and necessary care level. These estimates were made by expert panels using a structured consensus method. Health benefit was estimated as gain in quality-adjusted life years, or degree of short-term improvement in quality of life during or shortly after the hospital stay. The direct costs to the hospital of each stay were estimated by allocating the costs of labour, 'hotel' and overhead according to length of stay and adding to this the cost of ancillary resources used by each individual patient. RESULTS: A total of 422 admissions were included. The 102 (24%) judged to be inappropriate had a lower mean cost (US$ 2532) than the other 320 (US$ 5800) (difference 3268; 95% confidence interval 1025-5511). The inappropriate admissions accounted for 12% of the total costs. CONCLUSIONS: Denying care for inappropriate admissions does not generate cost reductions of the same magnitude. Policy makers should be cautious in projecting the cost savings potential of excluding inappropriate admissions.

Cost Savings↗

Leptin concentrations in cord blood in normal newborn infants and offspring of diabetic mothers.

Leptin has been implicated in the regulation of body weight and energy balance; Leptin is produced by adipocytes and placental tissue. Chronic fetal hyperinsulinemia and accelerated fetal growth with increased amounts of body fat are frequent findings in the offspring of diabetic mothers. In this study, we examined whether leptin levels in cord blood of infants of type 1 diabetic mothers (n = 29), gestational diabetic mothers (n = 6 and controls (n = 96) correlated with level of maternal glucose control, maternal leptin level at delivery, gender, fetal and placental size, and C-peptide in cord blood at birth. Leptin was significantly elevated in infants of type 1 diabetic (24.7 ng/ml) and gestational diabetic mothers (29.3 ng/ml) as compared to controls (7.9 ng/ml). C-peptide was also significantly higher in infants of type 1 diabetic (0.91 nmol/l) and gestational diabetic mothers (0.99 nmol/l) vs controls (0.34 nmol/l). Infants of type 1 diabetic mothers with a leptin level in cord blood above the upper normal range, i.e. > 30 ng/ml (n = 13), had an average maternal HbA1c level of 5.4% (normal < 5.5%) that was not different from 5.2% in infants with a leptin level < 30 ng/ml (n = 15). In both neonatal groups of diabetic mothers, leptin in cord blood did not correlate with maternal leptin concentrations, placental weight, birthweight, gender and cord blood C-peptide. In controls, leptin in cord blood was higher in girls than in boys (p = 0.044) and correlated significantly with birthweight (p = 0.41, p < 0.001) and cord blood C-peptide (p = 0.44, p < 0.001) but not with maternal leptin level or placental weight. The 3-4 times higher leptin levels in the offspring of diabetic mothers than normal could reflect increased adipose tissue mass and/or increased contribution from other sources such as placental tissue.

Birth Weight↗

Therapeutic options in the treatment of multiple myeloma: pharmacoeconomic and quality-of-life considerations.

A review of current treatment options in multiple myeloma is presented, including data on health-related quality of life and pharmacoeconomics. For induction chemotherapy, no combination of cytostatic drugs has been shown to be consistently superior to the simple cyclic oral treatment with melphalan and prednisone that has been available for 30 years. The total resource consumption and direct costs per patient treated with melphalan and prednisone is approximately $US10,000 (1995 values). As median survival is prolonged from less than a year in untreated patients to 30 to 36 months, this treatment must be considered cost effective. Interferon-alpha has a modest effect on progression-free and overall survival when added to chemotherapy regimens. However, the high cost and toxicity of this drug results in an unfavourable cost-utility ratio, estimated to be between $US50,000 to $US100,000 per quality-adjusted life-year gained. Clinical trials suggest that high dose chemotherapy followed by autologous stem cell support administered to patients who have achieved disease stabilisation or objective response to conventional induction chemotherapy, prolongs median survival by about 1.5 years. Preliminary cost-utility analyses suggest a cost per life-year gained of $US30,000 to $US40,000. Further potential improvements of this therapeutic modality are under way. Several bisphosphonates have been tested for the ability to prevent the skeletal complications of multiple myeloma. Monthly infusions of pamidronate have been shown in 1 randomised trial to significantly reduce the rate of skeletal complications. Unfortunately, the rapid and widespread acceptance of this therapy seems to preclude further prospective, placebo-controlled trials with cost-utility evaluation.

Antineoplastic Combined Chemotherapy Protocols↗

Methodological and statistical issues of quality of life (QoL) and economic evaluation in cancer clinical trials: report of a workshop.

In recent years, quality of life (QoL) and economic evaluations have become increasingly important as additional outcome measures in cancer clinical trials. However, both fields of research are relatively new and in need of finding solutions to a substantial number of specific methodological problems. This paper reports on the proceedings of a symposium aimed at summarising and discussing some of the most contentious methodological and statistical issues in QoL and economic evaluations. In addition, possible solutions are indicated and the most pertinent areas of research are identified. Issues specific to QoL evaluations that are addressed include clinically meaningful changes in QoL scores; how to analyse QoL data and to handle missing and censored data and integration of length of life and QoL outcomes. Issues specific to economic evaluations are the advantages and disadvantages of various outcome measures; statistical methods to analyse economic data and choice of decision criteria and analytical perspective. How to perform QoL and economic evaluations in large and simple trials and whether the gap between QoL and utility measures can be bridged are also discussed.

Clinical Trials as Topic↗

Does admission to a department of internal medicine improve patients' quality of life?

OBJECTIVES: The Tromsø Medical Department Health Benefit Study was designed to estimate health gains from admissions to a department of internal medicine. We have previously reported that the hospital stays had no effect on the life expectancy of 61% of the patients. However, it has been claimed that modern medicine has a greater effect on quality of life (QoL) than on life expectancy. The aim of the present study was to investigate this issue by estimating gains in QoL for patients admitted to a department of internal medicine. DESIGN: The time trade-off method (TTO) was used for assessing QoL gain from consecutive admissions during a 6-week period. The assessments were made by one of two expert panels, each consisting of an internist, a surgeon and a general practitioner, on the basis of summaries of all relevant clinical information about the patients. Short-term improvements in QoL during the stay or shortly after discharge were scored on an ordinal scale. RESULTS: Of the admitted patients, 41% had gains in QoL measured with the TTO (mean gain = 0.06; 95% confidence interval = 0.05-0.07; n = 422), and eight of these had gains equal to or greater than 0.50. Another 40% had gains in health-related short-term QoL measured with the ordinal scale. In a multivariate linear regression analysis, emergency admissions, high age and the disease categories 'endocrinological diseases' and 'pneumonia and influenza', were associated with higher gain, and 'undiagnosed symptoms' and 'cerebrovascular diseases' with lower gain. CONCLUSIONS: As judged by the expert panels, the investigated department of internal medicine was effective in improving the QoL of 81% of the admitted patients. Whilst most of the patients achieved small gains, a minority had gains in QoL corresponding to the treatment of life-threatening diseases.

Adolescent↗

[Norwegian physicians--affluent and reputed, but not particularly happy].

Norwegian doctors enjoy a high standard of living. A comparison of doctors' work environment and living conditions with those of the general population (Survey of Norwegian physicians' work environment and living conditions 1993 (Nord-Trøndelag Health survey 1986, Survey of work environment 1989, General Household Survey 1991) shows that doing better does not necessarily mean feeling better. In almost all sex and age groups doctors score significantly lower than the rest of the population do on all our quality-of-life indicators. The mismatch may reflect the nature of their work. Although a larger share of doctors than others consider their work interesting and not physically tiresome, they work longer hours, and more them report feeling worn out, and that they have sleeping problems. Fewer of them describe their sociopsychological work environment as good. Possibly, as much effort should be put into improving doctors' jobs as into raising their salaries.

Adult↗