Biomedical subjects
Publications and source records attributed to E M Laska.
Linear multivariate theory is applied to the problem of combining several multivariate bioassays. Results are an asymptotic test of the hypothesis of a common log relative potency; the maximum likelihood estimator of the common log relative potency; and an exact and asymptotic confidence interval estimator for log relative potency.
Thirty clinical studies involving more than 10,000 patients conducted during the last 20 years have been analyzed to assess the value of caffeine as an analgesic adjuvant. Although most studies included patients with postpartum uterine cramping or episiotomy pain, some involved patients with pain from oral surgery or headache. In 21 of 26 studies, the relative potency estimates of an analgesic with caffeine to an analgesic without caffeine is greater than one. The pooled relative potency estimates in each of several major categories of combination analgesics are significantly greater than one. The overall pooled relative potency estimate is 1.41, with 95% confidence limits of 1.23 to 1.63; that is, to obtain the same amount of response from an analgesic without caffeine requires a dose that is approximately 40% greater than one with caffeine.
Our purpose was to compare the analgesic efficacy of single oral doses of ibuprofen, zomepirac, aspirin, and placebo in severe postepisiotomy pain. One hundred twenty subjects participated in a double-blind, single-dose, parallel-group, 4-hr trial comparing 400 mg ibuprofen, 100 mg zomepirac sodium, 600 mg aspirin, and placebo. For most parameters, including the sum of the pain intensity differences (SPID) and the sum of the hourly pain relief values (TOTAL), which are summary variables, each of the drugs was more effective than placebo. Ibuprofen was more effective than aspirin and zomepirac. Zomepirac and aspirin were equally effective for most of the analgesic variables. There were no adverse effects. Ibuprofen, 400 mg, is an effective oral analgesic and is more effective than 100 mg zomepirac and 600 mg aspirin in most parameters of pain.
Our objective was to determine the value of caffeine in combination with acetaminophen in the relief of pain from uterine cramping, episiotomy, and third molar extraction. In the dental study, 173 patients received two or four tablets of 500 mg acetaminophen or the combination of 500 mg acetaminophen and 65 mg caffeine. In the three postpartum studies, 1345 patients received one, two, or three tablets of acetaminophen, the combination, or a placebo. The mean scores for the summary variable percent sum of the pain intensity differences (% SPID) were higher in all for the combination than for acetaminophen alone, and in two studies the null hypothesis of no differences was rejected. The relative potency estimates for % SPID were 1.9, 1.8, and 1.3 for the three studies in which bioassays could be performed and the pooled relative potency was 1.7 with a 95% confidence interval of 1.1 to 3.1. The results were essentially the same among pain models and among patient groups with similar habitual caffeine consumption. Onset of analgesia was also faster with the combination. We conclude that caffeine enhances the analgesic efficacy of acetaminophen.
The purpose of this study was to evaluate the analgesic efficacy and safety of single oral doses of suprofen 200 and 400 mg, compared with aspirin 650 plus codeine 60 mg, aspirin 650 mg, and placebo in the relief of moderate to severe pain resulting from the surgical removal of impacted third molars. 157 patients completed a randomized, double-blind, single-dose, stratified, parallel-groups trial, and were observed for at least 4 h. Based upon each of the summary efficacy measures, sum pain intensity difference (SPID), percent SPID, TOTPAR and a global evaluation, all four active treatments were approximately equally effective and all were statistically superior to placebo. In addition, suprofen at both dose levels was significantly more effective than placebo beginning at the 0.5-hour observation for mean pain intensity, whereas the two aspirin treatments were not superior to placebo until the 1-hour observation. Side effects were minimal; there was one in the suprofen 200 mg, three in the aspirin 650 mg, and one in the placebo treatment group. Thus, it appears that suprofen at 200 and 400 mg is a safe and effective oral analgesic for the relief of moderate or severe postoperative dental pain, and it is possible that compared to aspirin 650 mg and aspirin 650 mg plus codeine 60 mg, it has a more rapid onset of action.
Despite vigorous efforts at deinstitutionalization, the state mental hospital continues to be the locus of care for a wide variety of patient populations. The authors examined the changes in one state hospital's clientele between 1972 and 1980 and discovered a 50 percent reduction in long-stay patients, a 27 percent increase in admissions, and the emergence of a new long-stay population. The authors say that the modern state hospital can be conceptualized as several different facilities under a single administrative roof rather than as a monolithic structure. They conclude that mental health planners must acknowledge the continued existence of a group of patients whose needs are perhaps best served by the state hospital. Strategies must be developed to use the existing hospital resources in the most efficient and effective manner.
Studies were conducted on postpartum and postoperative patients to estimate the dose-response line of fenoprofen and to contrast it with codeine and placebo. The postpartum patients included women with episiotomy pain and with uterine cramping. This mix allowed contrast of ability of the various pain models to distinguish codeine from placebo. The methodology for the studies was single-dose parallel groups design with interviews conducted by trained nurse observers to obtain subjective responses. More than 850 patients participated in the trial. The results indicate that fenoprofen at doses as low as 12.5 mg has analgesic properties. In each of the five studies, the mean value of 100- and/or 200-mg doses of fenoprofen for the variable sum of the pain intensity difference (SPID) was higher than that of 65 mg codeine. The pooled relative potency calculation based on SPID suggests that 100 mg fenoprofen is approximately equivalent to 60 mg codeine. In their ability to distinguish codeine from placebo, patients with uterine cramp, episiotomy, or surgical pain did not appear to differ.
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The Multi-State Information System for Psychiatric Patients (MSIS) is a computer based, clinical and administrative management information system used by numerous mental health programs and facilities for patient and program management. Structured forms are used for the collection of core information on patients, on services rendered, on affiliated agencies, and on fiscal and administrative processes. A variety of output reports and general retrieval techniques are being used to help administer and evaluate patient care programs, monitor clinical and program management functions, refer clients to other service agencies, and review individual cases, as well as for administrative functions such as cost finding, rate setting, billing, and inventory control. MSIS is currently field testing an automated problem-oriented psychiatric record, and a goal-oriented record to be used with the mentally retarded is under development.
This paper reports on an analysis of psychiatric population. 55 female patients with breast cancer were matched with non-cancer patients on age, year of admission, psychiatric diagnosis, race, and religion. Reserpine use was examined for yearly use by each year preceding the diagnosis of breast cancer, by cumulative yearly use, and by other defined time periods. Regardless of the definition of reserpine user, there were no significant increased relative risks of breast cancer for those women on reserpine. There was a fairly low proportion of patients from each group who were on the drug in any given year, and a fairly wide range of total dosage received. Over half of the women used reserpine at some time during their hospital stay.
A multistate, cooperative program seeking to develop better methods for the effective and efficient gathering. storing, analyzing, and utilizing of mental patient records has made a comprehensive effort to protect the confidentiality and privacy of these psychiatric patient records. Administrative, technical, and legal safeguards have been implemented. The discussion of legal safeguards involves two areas: the protection of the system itself, located at Rockland State Hospital; and the specific legal environment of confidentiality and privacy of mental health records and information in the group of cooperating jurisdictions. On the whole, adequate legal and administrative protection can be afforded the confidentiality and privacy of an electronic data system in the mental health field, and access to the records can be restricted for the welfare of the patients. At the same time, access to aggregate data in the system can be allowed, under proper standards, for important research and planning purposes. The methods adopted by MSIS to preserve confidentiality and privacy by limiting access to such records could well prove an important model for the development of protective methods in other electronic data programs-not only those in psychiatry, but those in other fields where the data collected are sensitive and confidential.
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Methods for statistical inference for cost-effectiveness (C/E) ratios for individual treatment and for incremental cost-effectiveness (delta C/ delta E) ratios when two treatments are compared are presented. In a lemma, we relate the relative magnitude of two C/E ratios to the delta C/ delta E ratio. We describe a statistical procedure to test for dominance, or admissibility, that can be used to eliminate an inferior treatment. The one-sided Bonferroni's confidence interval procedure is generalized to the two-sided case. The method requires only that two confidence intervals be available, one for cost and one for effectiveness. We describe Fieller-based confidence intervals and show them to be shorter than Bonferroni intervals. When distribution assumptions hold and variance and covariance estimates are available, Fieller intervals are preferable. However, Bonferroni intervals can be applied in more diverse situations and are easier to calculate. A simple Bonferroni based technique, and a likelihood ratio statistic given by Siegel, Laska and Meisner, for testing the null hypothesis that the C/E ratios of two treatments are equal is presented. The approaches are applied to the data from a phase II clinical trial of a new treatment for sepsis considered previously by others.
We demonstrate that average cost-effectiveness ratios (CERs) play an important role in the evaluation of the cost-effectiveness of treatments. Criticisms of the usefulness of CERs derive mostly from the context of resource allocation under a constrained budget in which some decisions are based on incremental CERs. However, we show that in many cases, these decision rules are equivalent to decision rules on CERs. This follows for mutually exclusive treatments first, because a treatment is eliminated by extended dominance if and only if there is a mixed treatment with a smaller CER, where the mixing parameter lies in a certain interval. Second, after elimination of treatments by dominance and by extended dominance, resources can be allocated in order of increasing CERs. Moreover, the CER is a parameter that characterizes clinical and economical properties of a treatment independent of its comparators.
An analysis was made of data from over 4000 postepisiotomy, uterine cramping, and postsurgical patients complaining of moderate or severe pain. They had received 325, 650, or 1300 mg aspirin or placebo while they were subjects in 10 analgesic clinical trials. On the average, for the same verbally expressed pain intensity level and the same treatment, more relief was obtained by a patient with uterine cramping than one with episiotomy pain, who in turn obtained more relief than a patient with surgical pain. A new mathematical model which characterizes the probability that an analgesic provides complete relief as a function of dose, severity of pain intensity, and pain etiology is developed. The model utilizes the data itself to estimate the numerical score corresponding to verbal pain intensities. The results indicate that the numerical score quantifying severe surgical pain is 1.4 times greater than the score for severe episiotomy pain, which in turn is 3.2 times greater than the score for severe uterine cramping. Clinical trials must be designed to take these differences into account. Also, clinicians must be cognizant of such differences when choosing among drugs and dosages for patients with different pain intensity and etiology.
Our purpose was to evaluate the analgesic efficacy and safety of single oral doses of flurbiprofen 25, 50 and 100 mg, aspirin 600 mg, and placebo in the relief of moderate to severe post-episiotomy pain. One hundred and fifty-two evaluable patients completed a randomized, double-blind, stratified, parallel groups study. They were observed over a six hour period by one nurse-observer. Based upon each of the summary efficacy measures SPID, TOTAL and PEAK % and most of the hourly direct measures of pain intensity and pain relief, each of the four active treatments were statistically superior to placebo. Flurbiprofen 25 mg appeared to be slightly less effective than aspirin 600 mg, but the differences were not statistically significant. Flurbiprofen 50 and 100 mg were quite similar and were significantly more effective than aspirin 600 mg and flurbiprofen 25 mg. There were no observed or reported adverse effects.
Our purpose was to evaluate the analgesic efficacy and safety of single oral doses of propiram fumarate 50 mg, codeine sulfate 60 mg and placebo in the relief of moderate to severe postoperative pain. One hundred and twenty patients completed a randomized, double-blind, single-dose, stratified, parallel-groups trial and were observed for either 4 or 6 hours. Based upon each of the summary efficacy measures--SPID, % SPID and TOTAL--propiram and codeine were approximately equally effective and both were statistically superior to placebo. Propiram was significantly more effective than codeine at hour 5 for Pain Intensity Difference. Two adverse effects were attributed to propiram. Propiram fumarate 50 mg is an effective oral analgesic similar to codeine sulfate 60 mg, with the possibility of a longer duration of action.