PubMed Health⌕ Search

Biomedical subjects

W G Troutman

Publications and source records attributed to W G Troutman.

At least 19 recordsLinked to original sources

Variability in the assessment of adverse events in a multicenter clinical trial.

BACKGROUND: Consistent documentation, characterization, and evaluation of adverse events (AEs) are needed during multicenter clinical trials to ensure accuracy of data reported to the US Food and Drug Administration and in the medical literature. OBJECTIVE: The purpose of this study was to identify and characterize variations in the assessment of AEs by clinical trial personnel. METHODS: During the annual meeting of personnel from a multicenter, controlled clinical trial of an investigational new drug treatment for opioid dependence, an oral presentation of procedures for AE data collection was given to 25 principal investigators and ancillary study personnel who assessed AEs for the study. A post-test using 3 hypothetical AE cases in which AEs were categorized by type of reaction, relatedness to study drug, severity, action taken, and outcome was completed by study participants. Cases and expected responses were reviewed for content and validity by clinical research pharmacists who were not involved with the study. The level of agreement with expected responses was assessed using McNemar symmetry chi-square tests. RESULTS: Assessments of type of AE, relatedness to study drug, and severity were less frequently aligned with expected responses than were action taken and outcome (P < 0.013). Less consistency with expected responses was found in I case than in the other 2, suggesting that certain types of AEs may be more difficult to assess. CONCLUSIONS: There was considerable variability in categorization of AEs in an exercise following training for AE data collection. Type of report, relatedness, and severity were found to have more variability in reporting than did action taken or outcome. The results suggest that unless data are gathered to verify reliability of reporting, subcategorization of AE data should be undertaken cautiously. Further research is needed regarding methods for improving consistency in reporting of AEs.

Clinical Trials as Topic↗

Minocycline-associated tooth staining.

OBJECTIVE: To describe a case of tooth discoloration in an adult after minocycline treatment for arthritis. CASE SUMMARY: A 68-year-old white women presented with blue-black staining of her lower anterior teeth after 4 months of minocycline therapy for arthritis. Her other medications are not known to cause discoloration of teeth. While the patient continued taking minocycline, her dentist was not able to remove the discoloration. Within 1 month after discontinuation of the minocycline, the dentist was able to remove the discoloration entirely. DISCUSSION: Minocycline, a synthetic derivative of tetracycline, has been shown to cause abnormal pigmentation of the skin, thyroid gland, nails, bone, sclera, and conjunctiva in adults. It also has been shown to cause tooth discoloration in a few patients. This case is unusual in that the tooth discoloration disappeared after discontinuing minocycline therapy. CONCLUSIONS: This complication of minocycline is more commonly thought of in the pediatric population. However, clinicians need to be aware of this adverse drug reaction, as this agent may be used increasingly in the treatment of adults with arthritis.

Aged↗

Fatal poisoning among American Indian, Hispanic, and non-Hispanic white children in New Mexico, 1958 to 1982.

Childhood fatalities from unintentional poisoning are a substantial health problem in New Mexico, which ranks second in the nation in injury-related mortality rates. To determine the extent of poison-related mortality in children in this state, and to examine time trends and differences in mortality rates in New Mexico's American Indian, Hispanic, and non-Hispanic white children aged 0 to 14 years, we analyzed vital records collected from 1958 to 1982. New Mexican children experienced higher mortality rates than US white children of similar age--approximately eight times higher for children under 5 years old. Of the three ethnic groups, American Indian children had the highest mortality rates from unintentional poisoning during the 25-year period. Children less than 5 years old were at the highest risk for poison-related fatalities among all three ethnic groups.

Adolescent↗

An estimation of the annual incidence of poisoning using automated telephone polling.

An automated telephone poll was conducted in Bernalillo County NM during February, 1988. The equipment made 33,458 telephone calls and 2,703 households responded to the eight items included in the poll. The results included a minimum of 810 poisoning incidents in these households in the previous year, giving an annual incidence of poisoning in this population of 108 per 1,000. This rate is considerably higher than previous estimates. Other results included a trend toward delaying poisoning therapy until symptoms developed or taking the poisoned patient directly to an emergency department. If these results are confirmed by conventional polling, poisoning is a major public health problem. Furthermore, confirmation would establish automated telephone polling as a valuable tool for rapidly and inexpensively surveying large populations.

Automation↗

Topical ophthalmic exposure to rattlesnake venom.

An 18-year-old woman was struck in the eye from a distance of about 1 m by a stream of venom projected by a western diamond-back rattlesnake. She experienced an immediate burning sensation in the eye. The eye was irrigated first with tap water and later with a commercial eye wash solution. The patient's symptoms abated and no further eye injury was noted. Topical ophthalmic exposures to North American snake venom usually produce only transient symptoms, but the venom from tropical snakes has produced significant eye injury.

Adolescent↗

Patterns of public access to a regional poison control center: 1979 through 1986.

A routine part of the service provided by the New Mexico Poison and Drug Information Center is to perform at least 1 follow-up call on each poisoning case. Whenever practicable, public callers are asked an open-ended question during follow-up that determines where they found the poison center telephone number at the time of the original call. From 1979 through 1986, telephone number source data were collected from 101,905 public callers and categorized by 26 possible descriptors. Annual data capture rates varied from 99% (1979) to 48% (1986). These data were examined to note any changes in public access to the Center in response to the initiation and implementation of a more aggressive public outreach program in 1982 and 1983, which were considered transition years. The other years were grouped as either pre-transition (1979-81) or post-transition (1984-1986). Statistically significant (P less than 0.05) changes from the pre-transition years to the post-transition years included increased utilization of telephone labels (4.6% to 19.5%) and emergency department referrals (4.0% to 7.0%), while use of telephone directory listings and hospital operator referrals decreased (47.1% to 41.7% and 5.2% to 1.9%, respectively). In 1986, the most frequently used telephone number sources were the telephone directory (41.6%), telephone labels (23.5%), emergency department referrals (7.8%) and directory assistance (5.0%).

Health Education↗

Additional deaths associated with the intentional inhalation of typewriter correction fluid.

The previously published literature contains at least 27 deaths associated with the intentional concentration and inhalation of typewriter correction fluid (TCF). The solvent systems of TCF products include volatile halogenated hydrocarbons such as 1,1,1-trichloroethane and trichloroethylene. This report describes 3 additional deaths resulting from TCF abuse, including 1 case in which the addition of mustard oil to the product failed to deter abuse.

Adolescent↗

Household treatment for "chile burns" of the hands.

In New Mexico, chile peppers (Capsicum annum) are prepared by roasting and manually removing the skin from the fruit. Peeling is often done barehanded and may cause prolonged burning pain, irritation, and erythema but not vesication. In a survey of elderly Hispanic women, treatment with oils or cool tap water were frequently used home remedies. Twenty female subjects immersed their hands in a standardized slurry of green chile for 40 minutes, afterwards one hand was placed in cool tap water and the other in vegetable oil for a total of 75 minutes. Pain was scored using a visual analog scale while the hands were immersed in the chile slurry, test baths, and after drying. The difference in pain score was calculated for each subject. Analysis was by pooled regression. Cool tap water immersion initially provided more relief while vegetable oil provided better long-term relief from the pain of "chile burns".

Adult↗

Sudden death in adolescents resulting from the inhalation of typewriter correction fluid.

Inhalation abuse of various toxic agents continues to be a significant health problem among the younger segment of our society. We describe four cases of sudden death in adolescents associated with recreational sniffing of typewriter correction fluid occurring during the period 1979 through mid-1984. The solvents used in most of these fluids, 1,1,1-trichloroethane and trichloroethylene, are known to induce potentially fatal arrhythmias. Sniffing typewriter correction fluid poses a significant and underappreciated danger to the lives of these abusers. School health officials, public health departments, and law enforcement personnel should be alerted to the need for surveillance of this type of activity.

Adolescent↗

Amoxapine overdose. Seizures and fatalities.

Thirty-three amoxapine overdoses, including five fatalities, were reported to two regional poison centers over an 18-month study period. The 15.2% mortality rate stands in alarming contrast to the 0.7% death rate for all other cyclic antidepressant overdoses reported to these same two centers during the study. Seizure activity was noted in 36.4% of amoxapine overdoses, compared with 4.3% of other cyclic antidepressant poisonings. Amoxapine appears to be responsible for a disproportionate share of seizures and deaths resulting from cyclic antidepressant overdose.

Adolescent↗

Advantages and disadvantages of combining poison control and drug information centers.

The advantages and disadvantages of combining poison control and drug information centers are discussed. A major advantage of combining programs is a reduction in the overall cost of operation. Combined programs can share personnel, information resources, and sometimes space and utility charges. Combining programs can give the drug information service easier access to and justification for improved communication equipment and data-management equipment, and if it has an all-pharmacist staff, it can provide around-the-clock services. Combining programs can give the poison control service speedy access to the literature searching and evaluation skills of the drug-information specialist. One disadvantage, however, of a single staff providing both services, is that the staff may never achieve maximum skills in either discipline. Also, "jurisdictional" disputes can arise if there are two separate staffs. The more emergent nature of poison information requests may impair the efficiency of the drug-information component. The 24-hour expectation of drug information services can also place pressure on the poison information providers. The advantages of combining poison control and drug information services outweigh the disadvantages.

Cost Control↗

Emergency induction of emesis using liquid detergent products: a report of 15 cases.

Solutions of liquid detergent products were used to induce emesis in 15 patients who could not or would not obtain syrup of ipecac. Four patients refused to drink any of the solution and two others refused part, one of whom vomited. In the patients who drank all or part of the solution, 91% (10/11) vomited with a mean time to the onset of emesis of 6.5 min. None of these patients developed symptoms attributable to the ingested poison or the detergent solution. Liquid detergent solutions may be a useful alternative emetic for the poison center when a patient cannot be given syrup of ipecac.

Adult↗

Mouthwash: a source of acute ethanol intoxication.

Treatment of a 33-month-old girl who sustained severe ethanol intoxication resulting from mouthwash ingestion prompted us to review the ingestions, compositions, and sales of these common household products. Mouthwashes contain up to 26.9% ethanol (53.8 proof), and each of the leading brands markets single containers that can supply a lethal ethanol dose to a toddler. Mouthwashes are particularly hazardous because they are thought to be innocuous, and they are widely available, attractive, and kept within easy reach of children. Parent education, and restrictions on packaging and ethanol concentration are recommended.

Accidents, Home↗

Effect of hemodialysis on plasma naproxen concentration.

A case describing the effect of hemodialysis on naproxen plasma levels in a 48-year-old anuric man with chronic glomerulonephritis is reported. The patient received 500 mg of naproxen daily for rheumatoid arthritis while undergoing hemodialysis thrice weekly. The patient's mean pre-dialysis plasma concentrations were similar to those seen in normal volunteers, suggesting no accumulation of the drug. Plasma concentrations were higher after dialysis, probably because of fluid loss during dialysis. Naproxen is not cleared from the body during hemodialysis and, therefore, a post-dialysis naproxen dose is not necessary.

Arthritis, Rheumatoid↗