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Biomedical subjects

B L Strom

Publications and source records attributed to B L Strom.

177 records · Page 10Linked to original sources
PubMed1983

Sample size nomograms for interpreting negative clinical studies.

In recent years there has been increasing attention to the appropriate interpretation of a clinical study. One special concern has been the difficulty inherent in interpreting studies that were not statistically significant: Was the sample size sufficient to detect a clinically important effect if, in fact, it existed? This concern is further complicated because readers may have differing opinions of what size effect is clinically important. A pair of sample size nomograms has been developed, using common levels of statistical significance, to assist in this interpretation. The nomograms are intended to provide the clinician with a handy and easy-to-use reference for ascertaining whether an apparently negative study has a sample size adequate to detect reliably any difference between treatment groups that the clinician believes is clinically important. Examples are provided to show these principles and the use of the nomograms in interpreting negative studies.

Clinical Trials as Topic↗
PubMed1979

Can postmarketing surveillance help to effect optimal drug therapy?

Postmarketing drug surveillance (PMS) assesses the epidemiology of drug use and monitors beneficial or harmful effects of drugs following marketing. If used systematically, PMS can substantially improve drug therapy in the United States. This can be accomplished by generating information on drug use and effects otherwise unavailable, by enabling a more efficient drug approval process, and by educating drug prescribers. However, to be successful, any PMS system will need a good deal of input from such prescribers.

Animals↗
PubMed1978

Frequency and morbidity of invasive procedures: report of a pilot study from two teaching hospitals.

The medical services of two teaching hospitals were assessed for the frequency of and complications from invasive procedures. There were 231 procedures performed on 303 patients. The frequency of procedures was significantly higher at one hospital (62% vs 39%, P less than .01). Twenty-nine complications occurred in 20 cases: 14% of patients who underwent procedures had at least one complication. Left-sided cardiac catheterization was the most common procedure. Procedures with more than one complication included the following: left-sided cardiac catherization (18% probability of complication); arteriovenous shunt (60% probability); thoracentesis (19%); bronchoscopy (25%); and percutaneous liver biopsy (8%). While no permanent damage or deaths were observed, over three fourths of the complications either required specific therapy or prolonged hospitalization or both. This study suggests invasive procedures are common and carry appreciable risks of serious complications. Appropriate clinical decision making and medical-legal protection require accurate estimates of those risks.

California↗
PubMedDate not supplied

Naloxone-responsive hypotension in a patient with an ACTH-secreting tumor.

We report a case in which hypotension was corrected by the administration of naloxone in a patient with an ACTH-secreting mediastinal tumor. According to previous reports, reversal of hypotension would not be expected in patients with suppressed central ACTH secretion. The implications of this patient's response on the possible mechanisms for naloxone's action in reversing septic shock are discussed.

Adrenocorticotropic Hormone↗
PubMedDate not supplied

Data validity issues in using claims data.

This paper overviews the use of claims data in pharmacoepidemiology, examines problems related to claims data use, and focuses on the uncertain validity of diagnosis data. Two contrasting studies are provided of drug-induced neutropenia and Stevens-Johnson Syndrome; both studies were launched at the same time with similar designs. Neutropenia is a laboratory-driven diagnosis, easy to make and confirm. The neutropenia study yielded many useful results, ranging from incidence rates to results with specific drug classes and individual drugs. However, the medical records revealed major unexpected issues from chronic and cyclic neutropenia. In contrast, Stevens-Johnson Syndrome is harder to diagnose, and is represented poorly in the ICD-9-CM coding system. The result was a study productive of much less clinical information. These studies show the important implications of variable data validity to study interpretation. Uniquely problematic situations exist: the illness does not reliably come to medical attention; inpatient drug exposures; an outcome is poorly defined by the diagnostic coding system; descriptive studies; drug effects are delayed and patients lose eligibility; and there are important unknown confounders such as cigarette smoking, occupation, menarche, menopause, etc., about which information cannot be obtained without accessing the patient.

Adverse Drug Reaction Reporting Systems↗
PubMedDate not supplied

Impact of pharmaceutical underutilization: a study of insurance drug claims data.

OBJECTIVES: To operationalize the measurement and interpretation of pharmaceutical underutilization using private insurance medical and drug claims data. This study also examined the relationship between underutilization of pharmaceuticals and patient outcomes. DESIGN: Five definitions of pharmaceutical underutilization were used to identify underutilizers of 14 pharmaceuticals in a population of people aged 55 and over. Definitions 1 to 4 required the calculation of the apparent daily dose of the drug versus a standard dose. Definition 5 identified underutilization by the variation in apparent daily dose. Average monthly health services utilization figures were compared among appropriate utilizers and both moderate and severe pharmaceutical underutilizers for each of the five definitions. RESULTS: The most consistent results were found using Definition 5, variability in dosage. There were statistically significant (p < 0.05) differences in use of medical services among patients whose use of the pharmaceutical was more variable than other patients taking the same medication. CONCLUSION: Viewing noncompliance from the perspective of stability of consumption rather than the absolute value of the consumption may be a better predictor of increased health services utilization.

Aged↗
PubMedDate not supplied

Interobserver agreement, sensitivity, and specificity of a "healed" chronic wound.

The primary end point of most wound healing studies is the clinically subjective evaluation of whether a wound is healed. Recently the Wound Healing Society proposed a definition of an acceptably healed wound. With the use of color transparencies of wounds with known clinical outcomes, the investigation presented here evaluated the reliability and validity of this definition as interpreted by 16 untrained observers. Interobserver reliability (Kappa statistic) was 0.68 (95% confidence interval: 0.66, 0.70), sensitivity 0.84 (confidence interval: 0.81, 0.90), specificity 0.92 (confidence interval: 0.88, 0.97), and positive predictive value 0.93 (confidence interval: 0.89, 0.97). We conclude that reliability and validity of judgments of wound healing are good using this definition of a healed wound, permitting its use in clinical investigations and routine clinical care.

Journal Article↗
PubMedDate not supplied

Utilisation of drugs for diabetes mellitus.

This article reviews the data from drug utilisation research on antidiabetic agents, oral hypoglycaemics and insulin. Study methods specific to this type of pharmacoepidemiological research are discussed and critiqued. A brief overview of the sources of drug utilisation data is presented, followed by a review of specific pharmacoepidemiological investigations. We evaluate the usefulness of these studies in assessing true drug consumption, in evaluating comorbidity in diabetic patients and in measuring the prevalence of diabetes. International comparisons of antidiabetic drug utilisation, also reviewed and analysed, demonstrate wide variations in the use of hypoglycaemic agents, which have arisen for reasons which are unclear. Drug utilisation research thus far has been limited by the paucity of studies relating these variations in antidiabetic drug use to specific clinical outcomes. There is a need to expand the applications of research on the use of antidiabetic agents, including assessment of patterns of morbidity across geographic boundaries and over time.

Diabetes Mellitus↗
PubMedDate not supplied

Gastrointestinal tract bleeding associated with naproxen sodium vs ibuprofen.

BACKGROUND: The risk of gastrointestinal tract bleeding requiring hospitalization associated with naproxen sodium was compared with that with ibuprofen, using a prescription database to approximate over-the-counter dosing. OBJECTIVE: To evaluate the safety of naproxen sodium. METHODS: A claims database containing Ohio Medicaid data from January 1986 through February 1993 and Michigan Medicaid data from April 1983 through July 1993 was used to compare 101,318 patients dispensed naproxen sodium with 277,601 patients dispensed ibuprofen. Using a case-cohort design, all 59 patients from the full cohort who had been hospitalized with upper gastrointestinal tract bleeding (UGIB) that developed within 14 days after the first prescription for the study drugs were compared with a subcohort made up of a 10% random sample of subjects selected from the combined drug cohorts. RESULTS: The incidence of UGIB occurring within 14 days after the first prescription in the naproxen sodium cohort was 26 (0.026%) of 101,318 (95% confidence interval [CI], 0.017%-0.038%), compared with 33 (0.012%) of 277,601 patients (95% CI, 0.008%-0.017%) in the ibuprofen cohort. Overall, the use of naproxen sodium vs ibuprofen was associated with an adjusted relative risk of 2.0 (95% CI, 1.1-3.8). Among people with multiple prescriptions, the crude relative risk for those receiving therapy in a dose typical of over-the-counter use was 4.1 (95% CI, 1.2-13.8). CONCLUSIONS: The overall incidence of UGIB is low with both drugs. There is little additional absolute risk posed by the use of low-dose naproxen sodium, compared with low-dose ibuprofen, despite an increased relative risk. However, given the widespread use of these drugs, a substantial number of additional cases of UGIB could result from use of naproxen sodium. This increased risk should be considered, especially for patients whose baseline risk of UGIB is elevated.

Adolescent↗