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Biomedical subjects

Eugene M Laska

Publications and source records attributed to Eugene M Laska.

6 recordsLinked to original sources

Safety and efficacy of gamma-vinyl GABA (GVG) for the treatment of methamphetamine and/or cocaine addiction.

This study examined the safety and efficacy of gamma vinyl-GABA (GVG, vigabatrin) for the treatment of methamphetamine and/or cocaine addiction. A total of 30 subjects, who met DSM-IV criteria for methamphetamine and/or cocaine dependence, were enrolled in an open label 9-week safety study. The protocol was specifically designed to include extensive visual field monitoring as well as outcome measures of therapeutic efficacy. Patients were screened twice weekly for the presence of urinary cocaine, methamphetamine, heroin, alcohol, and marijuana. In total, 18/30 subjects completed the study and 16/18 tested negative for methamphetamine and cocaine during the last 6 weeks of the trial. GVG did not produce any visual field defects or alterations in visual acuity. Furthermore, it did not produce changes in vital signs even with continued use of methamphetamine and cocaine. Thus, under conditions that appear to be appropriate for the successful treatment of methamphetamine and/or cocaine addiction, GVG is safe.

Cocaine-Related Disorders↗

Estimating population size and duplication rates when records cannot be linked.

The capture-recapture approach to estimating the size of a population is a well-studied area of statistics. The number of distinct individuals, N(A) and N(B), on each of two lists, A and B, and the number common to both lists, N(AB), are used to form an estimate of the binomial probability of being on one of the lists, which then allows an estimate to be made of the size of the population. Critical to the method is an accurate count of N(AB). We consider situations in which this count is not available. Such problems arise in a variety of behavioural health contexts in which the need for protection of privacy may prevent sharing identifying information, so it is not possible to specifically match an individual who appears on one list with an individual on the other. Suppose that the birth dates and/or other demographics of individuals on each list are known. We introduce two methods for estimating the duplication rates and the size of the population. Conditioning on the set beta of birth dates of those on list B, N(A) and N(B), the maximum likelihood estimators (MLEs) and their variance are derived. The MLEs are based on the proportion of individuals on list A whose birth dates fall in beta. This approach is particularly useful if list B itself contains duplicates. The second model utilizes the full sample distribution of the birth dates. We generalize this approach to accommodate multiple demographic characteristics. The approaches are applied to the problem of estimating duplication rates and the population size of veterans who have mental illness in Kings County, NY. The data are lists of those receiving service from the Veterans Administration system and from providers funded or certified by the New York State Office of Mental Health.

Adolescent↗

National Depressive and Manic-Depressive Association consensus statement on the use of placebo in clinical trials of mood disorders.

A consensus conference on the use of placebo in mood disorder studies consisted of expert presentations on bioethics, biostatistics, unipolar depression, and bipolar disorder. Work groups considered evidence and presented statements to the group. Although it was not possible to write a document for which there was complete agreement on all issues, the final document incorporated input from all authors. There was consensus that placebo has a definite role in mood disorder studies. Findings of equivalence between a new drug and standard treatment in active control studies is not evidence of efficacy unless the new drug is also significantly more effective than placebo. Add-on studies in which patients are randomized to standard therapy plus the investigational drug or standard therapy plus placebo are especially indicated for high-risk patients. Mood disorders in elderly and pediatric patients are understudied, and properly designed trials are urgently needed. Research is needed on the ethical conduct of studies to limit risks of medication-free intervals and facilitate poststudy treatment. Patients must fully understand the risks and lack of individualized treatment involved in research.

Bipolar Disorder↗

The familywise error rate of a simultaneous confidence band for the incremental net health benefit.

Interest in the use of net health benefit in cost-effectiveness analysis derives from its optimality property for decision-making. A description of the results of an economic evaluation of health care interventions is incomplete if it does not include point and interval estimates of this outcome measure. A simultaneous confidence band for the incremental net health benefit, INHB(lambda), for all lambda may be obtained by forming a confidence interval based on student's t statistic, and letting the willingness-to-pay value, lambda, run over all values. The familywise error rate (FWER) of the simultaneous confidence band is the probability that the confidence interval does not cover the true INHB(lambda) for some value of lambda. We show that the FWER equals P(T(2)>t(2)), where T(2) follows Hotelling's central distribution and that the simultaneous confidence band does not cover the true INHB(lambda) if and only if a T(2) based confidence ellipsoid does not cover the true mean c-e vector.

Cost-Benefit Analysis↗

Statistical determination of cost-effectiveness frontier based on net health benefits.

Statistical methods are given for producing a cost-effectiveness frontier for an arbitrary number of programs. In the deterministic case, the net health benefit (NHB) decision rule is optimal; the rule funds the program with the largest positive NHB at each lambda, the amount a decision-maker is willing to pay for an additional unit of effectiveness. For bivariate normally distributed cost and effectiveness variables and a specified lambda, a statistical procedure is presented, based on the method of constrained multiple comparisons with the best (CMCB), for determining the program with the largest NHB. A one-tailed t test is used to determine if the NHB is positive. To obtain a statistical frontier in the lambda-NHB plane, we develop a method to produce the region in which each program has the largest NHB, by pivoting a CMCB confidence interval. A one-sided version of Fieller's theorem is used to determine the region where the NHB of each program is positive. At each lambda, the pointwise error rate is bounded by a prespecified alpha. Upper bounds on the familywise error rate, the probability of an error at any value of lambda, are given. The methods are applied to a hypothetical clinical trial of antipsychotic agents.

Algorithms↗