Cost-effectiveness of Apligraf in the treatment of venous leg ulcers.

Venous ulcers are the most common chronic wounds of the lower leg. Skin substitutes recently have been introduced to stimulate nonhealing wounds. To conduct an incremental cost-effectiveness analysis, a model was developed to compare the four-layer bandage system, with and without one application of skin substitute, for the outpatient treatment of venous leg ulcers. The model estimated the costs and consequences of treatment with and without the skin substitute application. Two analytic horizons were explored: 3 months and 6 months. Determined by seven physicians, data and assumptions for the 3-month model were based on information from a clinical trial, published studies, and clinical experience. Data for the 6-month model were extrapolated from the shorter model. The model results indicate that over 3 months, the use of the skin substitute provided a benefit of 22 ulcer days averted per patient at an incremental cost of $304 (societal). The incremental cost-effectiveness ratio was $14 per ulcer day averted. Over 6 months, the incremental cost-effectiveness ratio was less than $5 per ulcer-day averted. The skin substitute plus a four-layer bandage was more costly and more effective than the four-layer bandage alone. The skin substitute is increasingly cost-effective over a longer analytic horizon and in a subgroup of patients with ulcers of long duration (greater than 1-year duration at baseline). The results come from a model that is based on a series of estimates and assumptions, and accordingly, confirmation of this finding in a prospective study is encouraged.

Inter-provincial variation in government drug formularies.

In Canada, coverage for ambulatory prescription drug expenditures is provided to some groups by provincial drug plans through a provincial formulary. Little is known about the drugs provincial formularies give access to. We report the variation in availability of new drug molecules (NDM) across provincial formularies. We identified 108 NDM approved in Canada between 1991 and 1998. From each drug plan bulletin or formulary, we abstracted names of NDM listed as per 15 January 1999. We compared the level of listing across provinces using kappa coefficients. In the Quebec, BC, Manitoba and Saskatchewan formularies, more than 70% of the NDM were listed. In four provinces, this proportion was lower than 50%. In general, the agreement between formularies was poor. There is a wide variation across provinces in terms of NDM listed in the formularies. This variation reflects inter-provincial differences in the way drugs are selected for coverage.

Economic evaluation of the use of octreotide for prevention of complications following pancreatic resection.

Recent studies have concluded that octreotide can prevent complications in patients undergoing pancreatic resections. Given the acquisition cost of octreotide, a cost-effectiveness analysis was performed to establish whether if the additional cost associated with its use was justified by a decrease in the consumption of other resources. To evaluate success rates and complication rates, a meta-analysis of double-blind, randomized, controlled clinical trials was conducted. The rates for pancreatic fistula and fluid collection were 10.7% (95% confidence interval [CI] 7.9 to 13.4) and 3.6% (95% CI 1.9 to 5.2) for octreotide vs. 23.4% (95% CI 19.7 to 27. 1) and 8.8% (95% CI 6.2 to 11.3) for placebo. In a second phase we evaluated the treatment cost for patients with and without complications using two different models of cost savings. In the first model the cost to treat a pancreatic fistula was calculated as the per diem rate (as determined by Statistics Canada) multiplied by the incremental length of stay associated with the complication. In the second model we used data from institutions participating in the Ontario Case Costing Project. In model 1 the estimated incremental length of hospital stay attributed to a pancreatic fistula was 7 days, based on a review of the literature, and the per diem was $552. In model 2 the average cost of care for patients with or without complication was $32,347 (n = 17; 95% CI $20,882 to $43,812) and $11, 169 (n = 18; 95% CI $7558 to $14,779), respectively. The data suggest that when compared to placebo, octreotide is a dominant treatment strategy. In model 1, in a cohort of 100 patients, octreotide saved an average of $853 per patient while allowing 16 incremental patients to avoid complications. In model 2 use of octreotide resulted in an average savings of $1642 per patient while still allowing 16 patients to avoid complications. Detailed one-way and two-way sensitivity analyses suggest that both models were robust. The use of octreotide is a cost-effective strategy in patients undergoing elective pancreatic resection. Consideration should be given to extending its use to patients who are at high risk for development of complications following pancreatic surgery and who do not have any contraindications to the use of this drug.

Economic aspects of hypercholesterolemia treatment with HMG-CoA reductase inhibitors: a review of recent developments.

Recent literature on the cost effectiveness of hepatic hydroxy-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors in the treatment of hypercholesterolemia is reviewed with a twofold objective. First, the relative cost effectiveness of treatment with HMG-CoA reductase inhibitors is compared with that of other interventions based on recent long term morbidity and mortality trials; and second, drugs within this therapeutic class are identified that produce the desired effect at minimum cost. Given the limited resources available to treat hypercholesterolemia, the question of establishing which subgroup of the population is most likely to benefit from treatment with statins is legitimate. The latest economic evidence is used to demonstrate that the most cost effective public health strategy is to identify the patient population that needs to be treated and to select the most cost effective treatment.

The 1993 General Social Survey II: alcohol problems in Canada.

Rates and correlates of problems associated with the use of alcohol are reported from the 1993 General Social Survey in Canada. Approximately 1 in 11 drinkers (9.2%) reported that drinking has had an adverse effect on his or her social life, physical health, happiness, home life or marriage, work, or finances in the past year. The most commonly reported problems concerned physical health (5.1%), and financial position (4.7%). Approximately one in eight drinkers (12.9%) had driven a car within an hour after consuming two or more drinks in the previous year. Furthermore, more than two of every five respondents reported that they had experienced some problem due to other people's drinking. In a multivariate analysis, age, marital status, gender, religious attendance and employment status were the strongest predictors of problem drinking. The number of heavy drinking occasions is a stronger predictor of drinking problems than is overall level of consumption.

The 1993 General Social Survey I: alcohol use in Canada.

Rates and correlates of alcohol use are reported from the 1993 General Social Survey, a household telephone survey of 10,385 Canadians carried out by Statistics Canada. Continuing a recent trend, alcohol use has declined. The portrait of the Canadian who is most likely to drink and drink heavily is that of a young adult male who is not married, relatively well-off, and rarely or never attends religious services. In a multivariate analysis of the combined impact of sociodemographic factors on drinking and drinking levels, it was found that the frequency of religious attendance and age were the strongest predictors of current drinking. Gender was the strongest predictor of volume of alcohol consumption, while religious attendance, age, marital status and employment status were also significant predictors.

The validity of a province-wide student drug use survey: lessons in design.

This study assesses the validity and reliability of a province-wide survey on drug use by high school students in Nova Scotia in 1991. The Nova Scotia instrument was derived from the prototype provided in the Canadian guidelines for self-reported adolescent drug use surveys. To our knowledge, this is the first study on the validity and reliability of the Canadian instrument, as applied in a province, since 1978. Two new methods are proposed as validity and reliability checks: a statistical method to assess possible exaggeration by the group claiming to have used a fictitious drug, and a method to review the entire instrument based on responding error distributions. Overall, this study provides strong evidence of the validity and reliability of the items specifically about drug use. The major source of error uncovered using the responding error distributions, was related to instrument design and occurred in items considered to be explanatory variables for drug use.

Computerized tracking of emergency medicine resident clinical experience.

Although we commonly assume that because residents spend a given number of months in the emergency department they achieve adequate exposure to all necessary clinical entities, this has never been shown. We suspect, rather, that great variability exists among residents in the number and variety of patients they see; and that with respect to the ED, there are important diagnoses that are rare or absent in the clinical pathology of a training program. To confirm these hypotheses, we implemented a computerized system of recording patients and diagnoses managed in the ED by the 33 residents of the University of Illinois Affiliated Hospitals Emergency Medicine Residency. We collected data for nine months and accumulated 2,152 shifts of clinical experience. These data confirm our hypotheses. We found that senior residents managed an average of 11.9 +/- 2.3 patients per ten-hour shift, but the quickest resident saw almost twice as many patients as the slowest. Junior residents saw fewer patients, 8.5 +/- 1.4 patients per shift, but maintained a twofold difference between the fastest and slowest. Furthermore, there are important diagnoses that present too rarely for each resident to become facile in their management. We found that 22.7% of the 554 diagnoses listed in the Emergency Medicine Core Content never once presented to the ED. An additional 34.7% of these diagnoses did present, but so rarely that each resident could not possibly manage one case during a residency. The Length of Training Report of the American College of Emergency Physicians provides objective guidelines for the number of encounters a resident should have with 283 clinical entities. In this study, residents fell short of these guidelines with 50.5% of diagnoses. While absolute quantity of exposure does not assure competence in management, we recommend that each residency monitor the experience of its residents. This allows a residency to change its curriculum to make optimum use of available pathology, as well as to supplement deficiencies in clinical experience with case simulations.

Separate effects of ischemia, hypoxia, and contractility on thallium-201 kinetics in rabbit myocardium.

The effects of hypoxia and ischemia, as well as altered contractility, on thallium-201 (201TI) kinetics were evaluated in 42 isolated isovolumetrically contracting rabbit hearts. In Group A, three subgroups (n = 7 each) were studied that had either normal flow and oxygenation, hypoxia and normal flow, or ischemic flow and normal perfusate oxygen content. In Group B, three subgroups (n = 7 each) were studied and all hearts had normal flow but the contractile state was either enhanced with isoproterenol or impaired by hypocalcemia. A hemoglobin-free buffer perfusate was used in all experiments and multiple timed collections of arterial and coronary sinus effluent were used to model myocardial isotope activity during 30 min of constant uptake followed by 30 min of tracer clearance. During ischemia, hypoxia and hypocalcemia peak developed pressure and peak positive and negative dP/dt were all significantly reduced when compared to normal hemodynamic parameters (p less than 0.01). As expected, isoproterenol significantly elevated these parameters (p less than 0.04). Myocardial 201TI kinetics were adequately described utilizing a bi-exponential model having a fast and slow component. Only ischemic hearts had significantly lower rate constants for 201TI uptake and clearance than normal hearts (p less than 0.001). The mean (+/- s.d.) myocardial uptake and clearance rates for 201TI (%/min) varied between 4.86 +/- 0.87 and 7.18 +/- 1.45 for the remaining groups of hearts. Therefore, myocardial 201TI kinetics appear to be dominated by coronary flow and may not reflect marked alterations in the metabolic and contractile state. These data suggest that normal 201TI uptake in impaired or hypercontractile cells, receiving normal flow, may not represent normal cellular function.