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Biomedical subjects

B L Strom

Publications and source records attributed to B L Strom.

At least 127 records · Page 7Linked to original sources

Descriptive epidemiology of agranulocytosis.

BACKGROUND: To determine the incidence of agranulocytosis, a descriptive epidemiologic study was performed. METHODS: With the use of computerized Medicaid billing data from 1980 through 1985 from Minnesota, Michigan, and Florida, the ratio of persons hospitalized with a discharge diagnosis of neutropenia to persons with any claim for medical service was first used as an estimate of the incidence rate of the condition. Patients with cancer and patients receiving cytotoxic and immunosuppressive drugs were excluded. The information provided by a review of medical records for a subset of neutropenia cases was used to determine the proportion with neutropenia after excluding cases with recurrent or chronic neutropenia, and to determine the proportion with agranulocytosis. RESULTS: The incidence rates (95% confidence intervals) of agranulocytosis, excluding recurrent or chronic disease, were 2.3 (1.4 to 3.7), 7.7 (6.6 to 8.9), and 15.4 (11.3 to 20.4) per million per year in each state, respectively. The overall incidence was 7.2 (6.3 to 8.1) per million per year. CONCLUSIONS: Agranulocytosis is an extremely uncommon condition. The excess risk of agranulocytosis due to any drug other than cytotoxic drugs must, therefore, be very low.

Adolescent↗

Risk factors for falls as a cause of hip fracture in women. The Northeast Hip Fracture Study Group.

BACKGROUND: Although even in the elderly most falls are not associated with fractures, over 90 percent of hip fractures are the result of a fall. Few studies have assessed whether the risk factors for falls are also important risk factors for hip fracture. METHODS: To examine the importance of risk factors for falls in the epidemiology of hip fracture, we performed a case-control study of 174 women (median age, 80 years) admitted with a first hip fracture to 1 of 30 hospitals in New York and Philadelphia. Controls, matched to the case patients according to age and hospital, were selected from general surgical and orthopedic surgical hospital services. Information was obtained by direct interview. RESULTS: As measured by the odds ratio, increased risks for hip fracture were associated with lower-limb dysfunction (odds ratio = 1.7; 95 percent confidence interval, 1.1 to 2.8), visual impairment (odds ratio = 5.1; 95 percent confidence interval, 1.9 to 13.9), previous stroke (odds ratio = 2.0; 95 percent confidence interval, 1.0 to 4.0), Parkinson's disease (odds ratio = 9.4; 95 percent confidence interval, 1.2 to 76.1), and use of long-acting barbiturates (odds ratio = 5.2; 95 percent confidence interval, 0.6 to 45.0). Of the controls, 44 (25 percent) had had a recent fall. The case patients were more likely than these controls to have fallen from a standing height or higher (odds ratio = 2.4; 95 percent confidence interval, 1.0 to 5.7). Of those with hip fracture the younger patients (less than 75 years old) were more likely than the older ones (greater than or equal to 75 years old) to have fallen on a hard surface (odds ratio = 1.9; 95 percent confidence interval, 1.04 to 3.7). CONCLUSIONS: A number of factors that have been identified as risk factors for falls are also associated with hip fracture, including lower-limb dysfunction, neurologic conditions, barbiturate use, and visual impairment. Given the prevalence of these problems among the elderly, who are at highest risk, programs to prevent hip fracture should include measures to prevent falls in addition to measures to slow bone loss.

Accidental Falls↗

Using a claims database to investigate drug-induced Stevens-Johnson syndrome.

In order to explore a priori hypotheses about drug-induced Stevens-Johnson Syndrome (SJS), a case-control study was initiated using data from COMPASS, a computerized data base consisting of Medicaid claims data. The records of 3.8 million patients in five U.S. states were searched to identify patients with an inpatient diagnosis of ICD-9-CM code 695.1 (erythema multiforme-EM). Out of the total of 367 cases that were identified, primary medical records for 249 were sought and 128 (51.4 per cent) of these were obtained. The remainder could not be obtained because: in 36 (29.8 per cent) the hospital refused to provide medical records; in 33 (27.3 per cent) there were transcription errors; in 20 (16.5 per cent) the state could not translate the identification number, primarily because the patients lost Medicaid eligibility too long before our request; in 27 (22.3 per cent) the hospital could not locate the patient's record; and in 5 (4.1 per cent) there were other reasons. Of those with a medical record, 121 (94.5 per cent) had a skin diagnosis and 109 (85.2 per cent) had a diagnosis compatible with ICD-9-CM code 695.1 specified on their discharge summary. However, in 35 (27.3 per cent) an expert reviewer felt that the discharge diagnosis was incorrect. In 50 (39 per cent) the computer diagnosis was incorrect. Only 19 (14.8 per cent) were judged by the expert reviewer to truly have Stevens-Johnson Syndrome, and an additional 37 (28.9 per cent) were judged to have erythema multiforme minor. Thus, the computerized diagnosis agreed very well with the diagnoses specified on the discharge summary. However, EM is frequently misdiagnosed, ICD-9-CM code 695.1 contains multiple other diagnoses which are not EM, and much of hospitalized EM is EM minor. Thus, studies of SJS cannot be performed except in patients whose medical records are available.

Adolescent↗

The low risk of upper gastrointestinal bleeding in patients dispensed corticosteroids.

PURPOSE: To determine the incidence of upper gastrointestinal bleeding in patients treated with corticosteroids. PATIENTS AND METHODS: The incidence of upper gastrointestinal tract bleeding was assessed in a cohort of 19,880 patients from the Michigan Medicaid billing database with dermatitis and/or asthma treated with corticosteroids during 1980 to 1984. The frequency of upper gastrointestinal bleeding was assessed within 60 days after each corticosteroid prescription. RESULTS: The incidence of upper gastrointestinal bleeding in patients without a past history of upper gastrointestinal bleeding who were exposed to corticosteroids was only 2.8 cases per 10,000 person-months. The rate of upper gastrointestinal bleeding was notably higher in patients receiving anticoagulants and those with a prior history of upper gastrointestinal bleeding (23.0 and 15.9 cases per 10,000 person-months, respectively). CONCLUSION: Because the incidence of upper gastrointestinal bleeding in ambulatory patients treated with corticosteroids is so low, prophylactic therapy should be restricted to high-risk patients, if it is to be used at all.

Adolescent↗

Pharmacoepidemiology as a focus for clinical epidemiology in developing countries.

We present a concept of pharmacoepidemiology as a branch of clinical epidemiology having particular relevance to public health in developing countries. Planning to incorporate pharmacoepidemiology into the clinical epidemiology curriculum of the International Clinical Epidemiology Network (INCLEN) is discussed and an outline of training programs in pharmacoepidemiology at INCLEN universities is given.

Curriculum↗

No causal relationship between transdermal scopolamine and seizures: methodologic lessons for pharmacoepidemiology.

Because of case reports suggesting that use of transdermal scopolamine might be associated with the subsequent development of seizures, a retrospective cohort study was performed with computerized Medicaid claims data. Patients receiving transdermal scopolamine were compared with patients receiving diphenhydramine, meclizine, prochlorperazine, and promethazine. A four-fold increased risk of seizures after transdermal scopolamine use was observed in the claims data. However, this was not supported by the primary medical records. All patients who had seizures after using transdermal scopolamine either had seizures before receiving the drug as well or did not really suffer from seizures. The original finding appeared to be the result of the use of transdermal scopolamine for "dizziness, rule out seizures"; the ICD-9-CM coding system does not include "rule out" diagnoses. Thus these data do not confirm the existence of an association between seizures and the use of transdermal scopolamine. In addition, this study demonstrates the usefulness of pharmacoepidemiology studies in documenting drug safety and the importance of obtaining primary medical records when performing pharmacoepidemiologic studies with claims data.

Administration, Cutaneous↗

Postmarketing surveillance and other epidemiologic uses of drug prescription data in the United States.

Currently the data resources available for conducting pharmacoepidemiology studies in the United States include spontaneous case reports of adverse reactions, aggregate population-based data resources, computerized collections of data from organized medical care programs, data collected for pharmacoepidemiolgy on an ongoing basis, existing data collected as part of other ad hoc studies, and data collected de novo for pharmacoepidemiology studies. The advantages and disadvantages of each and the particular contributions of drug prescription data to each approach are described.

Adverse Drug Reaction Reporting Systems↗

A population-based study of Stevens-Johnson syndrome. Incidence and antecedent drug exposures.

To determine the incidence of Stevens-Johnson syndrome, a descriptive epidemiology study was performed using computerized Medicaid billing data from 1980 to 1984 from the states of Michigan, Minnesota, and Florida. The ratio of persons hospitalized with a discharge diagnosis of erythema multiforme (ICD-9-CM code 695.1) to persons with any claim for medical service was first used as an estimate of the incidence rate of the disease. Then, since the ICD-9-CM code for erythema multiforme includes other illnesses in addition to Stevens-Johnson syndrome and because these illnesses are frequently misdiagnosed, the information provided by a review of medical records for a subset of cases of erythema multiforme was used to determine the proportion of patients with true Stevens-Johnson syndrome. The incidence rates of Stevens-Johnson syndrome were 7.1 (6.1 to 8.2), 2.6 (1.6 to 4.0), and 6.8 (4.3 to 10.3) per million per year in each state, respectively. Penicillins, especially aminopenicillins, were frequently used in the 19 patients judged to be true cases of Stevens-Johnson syndrome. In conclusion, Stevens-Johnson syndrome is a uncommon condition. The excess risk of Stevens-Johnson syndrome due to any drug must, therefore, be very low.

Adolescent↗

Serum CEA and CA 19-9: potential future diagnostic or screening tests for gallbladder cancer?

The poor prognosis of gallbladder cancer and the presence of high-risk populations make the identification of a screening test for this disease very desirable. As part of an ongoing case-control study of gallbladder cancer being conducted in Mexico City, Mexico, and in La Paz, Bolivia, blood specimens were sought from all patients with cancer of the gallbladder and on controls of similar age and sex undergoing upper abdominal surgery. Each sample was analyzed for carcino-embryonic antigen (CEA) and CA 19-9. Using the specimens from Bolivia, a serum CEA cutoff of 4.0 ng/ml yielded a sensitivity of 50.0% and a specificity of 92.7%, while a serum CA 19-9 cutoff of 20.0 units/ml yielded a sensitivity of 79.4% and a specificity of 79.2%. Using ROC curve analysis, the latter was a much better test than the former (p less than 0.05). Using the tests in series or in parallel did not substantively improve the results. The specimens from Mexico were used for validation purposes, and yielded very similar results. In conclusion, serum CA 19-9 and CEA are fairly good tests for discriminating patients with gallbladder cancer from patients with gallstones and no cancer, the former being a better test than the latter. These tests may be useful in identifying disease recurrences. In addition, if a sufficiently high-risk population could be identified, this could potentially become a useful screening test for this serious disease, allowing early intervention. However, additional data are needed prior to recommending this clinically.

Antigens, Tumor-Associated, Carbohydrate↗

Gastrointestinal bleeding from the nonsteroidal anti-inflammatory drugs.

Nonsteroidal anti-inflammatory drugs (NSAIDs) represent a remarkably frequently used class of drugs. The major motivation for the use of these drugs is the known gastrointestinal (GI) toxicity of aspirin. From premarketing studies it was known that NSAIDs could cause subclinical GI bleeding, but there were no controlled studies of the association between NSAID use and clinically apparent upper GI bleeding. In part because of the frequent use of these drugs and in part because of the potential seriousness of this adverse reaction, this association has been the subject of a considerable amount of postmarketing pharmacoepidemiology research. Despite this, many questions remain unanswered. This paper reviews the existing data on GI bleeding from NSAIDs and provides suggestions for future studies which could address some of the deficiencies in the data.

Anti-Inflammatory Agents, Non-Steroidal↗

Pathophysiology of tumor progression in human gallbladder: flow cytometry, CEA, and CA 19-9 levels in bile and serum in different stages of gallbladder disease.

Gallbladder epithelium is unique among the gastrointestinal cell types because proteins and protein levels in the fluid bathing the luminal side of the cells (bile) are different from and can be compared with those in the fluid bathing the basal side (serum). To help identify cellular changes that occur during the development of gallbladder cancer, we obtained gallbladder tissue, serum, and bile specimens from 20 patients with invasive adenocarcinoma of the gallbladder, three with high-grade dysplasia (carcinoma in situ), six with low-grade dysplasia, 12 with hyperplasia, and 10 with acute or chronic cholecystitis. We obtained serum samples from 40 patients with invasive adenocarcinoma and bile samples from 29 of these patients; serum samples from three with high-grade dysplasia and bile specimens from two of these; serum and bile samples from five with low-grade dysplasia; serum or bile samples from 126 with metaplasia, hyperplasia, or cholecystitis, including serum samples from 121 and bile samples from 110; and serum and bile samples from eight with normal biliary tracts. The study was conducted in Mexico City, Mexico, and La Paz, Bolivia. We performed flow cytometric DNA analysis on gallbladder tissue specimens and measured levels of carcinoembryonic antigen (CEA) and CA 19-9 antigen in the serum and bile specimens. Analysis of the cell cycle compartments by flow cytometry revealed marked variations of the proliferation index for the different disease states (P less than .0001). The proliferation index increased with progression from cholecystitis to invasive adenocarcinoma. Of the bile and serum measurements, only serum CA 19-9 values were correlated with flow cytometry measurements (r = -.49, P = .005). Overall, the serum and bile measurements were in agreement (P less than .01). However, with the exception of the correlations among serum measurements for the patients with invasive adenocarcinoma, most of the correlations could be explained by differences in the disease state. In particular, the progression from normal tissue to invasive adenocarcinoma involved no change in bile CA 19-9 level and only a slight change in bile CEA level but much larger changes in serum CEA and CA 19-9 levels. It appears that the progression from normal tissue to invasive adenocarcinoma results in increased production of these antigens and often in loss of cell polarity as well, i.e., inability to prevent leakage of the antigens into the serum.

Antigens, Tumor-Associated, Carbohydrate↗

Prothrombin time ratio and other factors associated with bleeding in patients treated with warfarin.

We previously showed that the risk of major hemorrhage in patients with venous thromboembolism treated with warfarin was strongly related to duration of anticoagulant therapy. We here report the results of a more detailed analysis of factors other than duration of warfarin therapy associated with the risk of hemorrhage in these patients. Almost 7% of patients had a major hemorrhage on warfarin and an additional 23.7% had at least one minor bleeding episode. Age, female sex, and congestive heart failure were associated with small increases in the risk of major hemorrhage but not with the risk of minor bleeding. A prothrombin time ratio greater than 2.5 was associated with a fourteen-fold increase in the risk of a major hemorrhage (95% CI 5.1, 42.7), but major hemorrhages occurred in patients on warfarin at all measured values of the prothrombin time ratio. Taken together with the findings from our previous analysis, the study suggests that prevention of bleeding in patients on warfarin would best be accomplished by minimizing the duration of warfarin therapy, by scrupulous monitoring of the prothrombin time ratio, and by considering the "therapeutic range" for the prothrombin time ratio to be somewhat less than 2.0-2.5.

Adult↗

Risk factors for nosocomial candidemia: a case-control study in adults without leukemia.

PURPOSE: The purpose of this study was to define risk factors for nosocomial candidemia in adult patients without leukemia at a tertiary care medical center. PATIENTS AND METHODS: All patients with nosocomial candidemia between August 1, 1981, and October 31, 1984, were included if they met strict selection criteria and did not have acute or chronic leukemia. For each case, one control was selected from among patients admitted during the same month/year and matched for hospital service and duration of hospitalization up to the first blood culture that grew Candida species. Logistic regression was used to obtain estimates of risk after simultaneously controlling for other variables. RESULTS: Candida albicans caused 24 of the 48 fungemias studied. The risk factors identified included the presence of a central line (odds ratio, 26.4; 95% confidence interval, 1.5 to 451.1); bladder catheter (13.0 1.3 to 131.4); two or more antibiotics (25.1, 2.1 to 318); azotemia (22.1, 2.2 to 223.2); transfer from another hospital (21.3, 1.7 to 274.5); diarrhea (10.2, 1.03 to 101.4); and candiduria (27.0, 1.7 to 423.5). A prior surgical procedure was associated with lowered risk (0.1, 0.01 to 0.9), suggesting perhaps that medical service patients are at higher risk than those on surgical services. Because total parenteral nutrition was always administered by means of a central line, it could not be shown to increase the risk over that conferred by a central line alone. CONCLUSIONS: This study has defined seven major risk factors for nosocomial candidemia. These findings should facilitate development of rational approaches to preventing infection and may assist clinicians in identifying those patients in whom this life-threatening complication is likely to occur.

Adolescent↗

Risk factors for Amphotericin B-associated nephrotoxicity.

PURPOSE: A case-control study was performed to identify and quantify risk factors for amphotericin B-associated nephrotoxicity. PATIENTS AND METHODS: Thirty-five patients receiving intravenous amphotericin B for treatment of proven or suspected fungal infection who developed nephrotoxicity (greater than 100% increase in baseline serum creatinine to a level above the normal range) were compared with 60 control patients receiving amphotericin B who did not develop nephrotoxicity. Amphotericin B dosing variables and other potential risk factors were analyzed in a logistic regression model. RESULTS: Cases of nephrotoxicity received a significantly higher average daily dose of amphotericin B (0.49 +/- 0.18 mg/kg/day) than did controls (0.34 +/- 0.17 mg/kg/day). In a multivariate model, the risk of nephrotoxicity increased 3.7-fold for each 50-mg increase in total dose for a fixed duration of therapy and patient weight. Risk decreased by a factor of 0.4 for each extra day of therapy for a fixed total dose and weight. An increase in weight was also protective when the two other dosage variables were held constant. Each 0.10 mg/kg/day dose increment was associated with a 1.8-fold (95% confidence interval, 1.2 to 2.7) increase in the risk of nephrotoxicity. Other significant risk factors included diuretic use during amphotericin B therapy (12.5, 1.7 to 94.7), for which a linear dose-response relationship was demonstrated, and an abnormal baseline serum creatinine level (15.4, 1.4 to 173.2). CONCLUSION: Risk factors for amphotericin B-associated nephrotoxicity include higher average daily doses (approximately a doubling for each 0.10 mg/kg/day increment), diuretic use, and abnormal baseline renal function. These data suggest possible protective interventions and will aid clinicians in assessing the risk-benefit ratio of amphotericin B therapy for deep fungal infection.

Adult↗

Reprocessing of hemodialyzers: a critical appraisal.

The reprocessing of hemodialysis equipment was originally developed to conserve scarce resources and to reduce the time necessary to construct early dialyzers. Although most dialyzers in current use are marketed as disposable items, the majority of dialysis facilities in the United States reprocess these devices and use them multiple times on the same patient. Recent studies have shown that certain reprocessing techniques confer improved biological properties on dialyzers compared with new membranes as prepared by manufacturers. Several studies have suggested that these biological properties may lead to improved clinical outcomes. However, critics of dialyzer reprocessing argue that it may expose patients to risks that produce increased morbidity and mortality. This article critically reviews the available scientific information regarding reprocessing hemodialyzers.

Cellulose↗