Potential economic impact of glycoprotein IIb-IIIa inhibitors in improving outcomes of patients with acute ischemic coronary syndromes.

Despite the institution of various cost control measures in the 1980s, healthcare costs have continued to rise. Following the adoption of the Medicare prospective payment system, the Health Care Financing Administration (HFCA) recognized the need to assess medical effectiveness as well as the cost of care. Coronary artery bypass graft (CABG) and percutaneous transluminal coronary angioplasty (PTCA) procedures have been reported as the primary cost drivers in hospitalized patients with unstable angina, a form of acute ischemic coronary syndromes. Evaluation of glycoprotein IIb-IIIa inhibitors as primary therapy for these patients suggests that good value for money is possible, especially if the use of these agents results in a reduction in revascularization procedures.

Analysis of indications for intensive care unit admission. Clinical efficacy assessment project: American College of Physicians.

OBJECTIVE: To formulate recommendations for the development of intensive care unit (ICU) admission policies. DESIGN: Literature review of published reports over the period 1966 to 1991 pertaining to admission criteria for intensive care or coronary care units (CCUs). PATIENTS: Studies identifying patients least likely to benefit from ICU or CCU admission were analyzed. Patient populations of interest included adults (> or = 18 years of age) with medical conditions possibly requiring intensive care; trauma patients were excluded. MEASUREMENTS AND MAIN RESULTS: Of 970 articles identified as being pertinent to intensive care, only two case-control studies used the direct method of measuring the effect of ICU intervention on mortality. No studies were found that compared outcomes of low-risk patients treated in a CCU vs those treated in alternative hospital locations, and none identified patients with a very high probability of a bad outcome. CONCLUSIONS: The use of decision-making models for ICU and CCU admissions must be tested in prospective, randomized clinical trials. Critical care units and ICUs should be studied separately. Existing studies of early discharge from CCUs need to be summarized and evaluated. The triaging of ICU patients to alternative hospital locations needs to be evaluated, as do existing predictive models for early triage decision-making.

Analysis of indications for early discharge from the intensive care unit. Clinical efficacy assessment project: American College of Physicians.

OBJECTIVE: To formulate recommendations for the development of early intensive care unit (ICU) discharge criteria for low-risk monitor patients. DESIGN: Literature review of published reports over the period 1966 to 1991 pertaining to ICU discharge criteria. PATIENTS: Studies identifying patients admitted to ICUs who could be characterized as low risk. Patient populations of interest included adults (> or = 18 years of age) with low-risk medical or mixed medical/surgical conditions; cardiac care unit and burn patients were excluded. MEASUREMENTS AND MAIN RESULTS: Of 1,492 articles identified as being pertinent to ICU discharge, only 2 studies (by the same group of investigators) were found that distinguished low-risk populations among medical and mixed medical/surgical ICU patients. The physiologic component of the Acute Physiology and Chronic Health Evaluation (APACHE) was used in both of these studies to ascertain the degree of risk. No studies were found that compared outcomes of low-risk patients remaining in the ICU after 24 h with those transferred to other hospital locations. CONCLUSIONS: Objective methods (such as APACHE III) should be used to identify low-risk patients at 24 h post-ICU admission. A multicenter study should be conducted to compare outcomes on patients identified as low risk who are randomly assigned to alternative hospital locations for treatment versus those assigned to continued ICU treatment until routine ICU discharge. Mortality and quality of life data should be used as outcome measures (prior to ICU admission and 6 months post-ICU discharge).

An observational study of isotretinoin recipients treated for acne in a health maintenance organization.

From September 1982 to June 1987, all members (N = 513) of the Group Health Cooperative of Puget Sound, Seattle, Wash, who were prescribed isotretinoin for acne were observed throughout the first 4- to 5-month course of therapy for effectiveness and adverse effects. The highest rates of use were among male subjects aged 15 to 24 years. Excluding 47 subjects whose prescriptions were stopped because of noncompliance or who left the care of Group Health Cooperative physicians, 39 (8.4%) of the remaining 466 discontinued taking the drug because of the following adverse effects: mucous/skin/musculoskeletal effects (17); elevated triglyceride levels (eight); headaches (five); increased liver enzyme levels (three); amenorrhea (two); and other (four). One subject, excluded from the 466 because of noncompliance, became pregnant while using medication from a previous prescription and had a therapeutic abortion; she was not under the care of a physician at the time of pregnancy. Most subjects (97%) developed a mucocutaneous symptom, and 42% developed musculoskeletal symptoms. Moderate elevations in liver enzyme levels developed in six (1.8%) of 341 subjects with normal baseline values. Of 389 subjects with normal baseline triglyceride values (less than 2.25 mmol/L), nine (2.3%) developed moderate elevations (4.5 to 9.0 mmol/L), and one (0.3%) developed a severe elevation (greater than or equal to 9.0 mmol/L). Of 24 subjects with elevated baseline triglyceride levels, three (12.5%) developed moderate elevations. Of an additional 53 subjects whose baseline serum triglyceride levels were not determined, two developed elevations during therapy, one up to 13.4 mmol/L. Subjects who were overweight or had elevated baseline serum triglyceride values had an increased risk of developing elevations in triglyceride levels during therapy (odds ratio, 6.0; 95% confidence interval, 1.6 to 22.0; and odds ratio, 4.35; 95% confidence interval, 0.9 to 20.2, respectively). Acne was improved for at least 94.0% of subjects.

A proposal for integrated efficacy-to-effectiveness (E2E) clinical trials.

We propose an "efficacy-to-effectiveness" (E2E) clinical trial design, in which an effectiveness trial would commence seamlessly upon completion of the efficacy trial. Efficacy trials use inclusion/exclusion criteria to produce relatively homogeneous samples of participants with the target condition, conducted in settings that foster adherence to rigorous clinical protocols. Effectiveness trials use inclusion/exclusion criteria that generate heterogeneous samples that are more similar to the general patient spectrum, conducted in more varied settings, with protocols that approximate typical clinical care. In E2E trials, results from the efficacy trial component would be used to design the effectiveness trial component, to confirm and/or discern associations between clinical characteristics and treatment effects in typical care, and potentially to test new hypotheses. An E2E approach may improve the evidentiary basis for selecting treatments, expand understanding of the effectiveness of treatments in subgroups with particular clinical features, and foster incorporation of effectiveness information into regulatory processes.

Use of clinical toxicology resources by emergency physicians and its impact on poison control centers.

STUDY OBJECTIVE: The need for clinical toxicology resources by emergency physicians is unclear and may have implications for future training and resource availability. This study was designed to assess current emergency physician use of available resources. DESIGN: Prospective evaluation by mail using a 49-item questionnaire. TYPE OF PARTICIPANTS: All 170 emergency physicians in Utah. INTERVENTIONS: None. RESULTS: The response rate was 75.3% (128 of 170). Resources "outside their own fund of knowledge" were consulted "occasionally" to "frequently" by 98.3%. They used the following resources "occasionally" to "frequently": poison control center (PCC) (93.7%), toxicology textbook (77.6%), "expert colleague" (34.0%), and "in-house POISINDEX" (23.9%). They often contacted the PCC for toxicity information (93.7%) and management recommendations (87.3%) and for acute, symptomatic overdose cases (88.3%). They "almost never" contacted the PCC for adverse drug reactions (76.6%), pill identification (70.2%), consultation with physician toxicologist (68.1%), asymptomatic exposures (62.9%), chronic toxicity (50.4%), or solely to report the case to the American Association of Poison Control Centers data base (90.2%). Those who had access to in-house POISINDEX often did not consult the PCC (82.6%). Of those who did not have in-house POISINDEX, 42.8% contacted the PCC to access it. Providing access to physician toxicologist consultations was thought to be an important role for the PCC by 86.7%, but only 32% of physicians were using this option. CONCLUSION: The vast majority of emergency physicians in Utah consult the PCC only for acute, symptomatic overdoses. They view access to physician toxicologist consultation as an important role for the PCC but seldom use it. The availability of in-house POISINDEX decreases the likelihood of PCC consultations from emergency departments. The frequency of emergency physician consultation with the PCC may decrease as POISINDEX becomes available at more hospitals.

International Poison Information Center data collection capabilities.

Hundreds of poison information centers are in operation throughout the world. Their common objective is to reduce the morbidity and mortality associated with accidental and intentional poisoning exposures. However, there is little information available which describes the impact of the centers on the outcome of poisonings or on poisoning trends. The objective of this project was to determine the data collection capabilities of poison information centers outside of the US with a goal of ascertaining whether a common database existed and if an international database of poisoning exposures could be developed. A survey was developed which requested information on the specific instrument used to document poisoning exposures, how that information was compiled, whether it was available in a computer database, the type of database, and whether it was available to external agencies and at what cost. The survey was sent to 75 poison information centers outside of the US. The data were compiled and analyzed using Paradox 3.5. Twenty-four of the 75 poison information centers completed and returned the surveys. Four of the 24 had no computer capabilities and only 9 centers indicated a willingness to share data. The majority of the databases were in a DOS format, but no consistent type of database software was used. If the sample that responded to the survey is representative of the international poison information center community, there is neither a common data collection instrument nor a common toxic exposure surveillance system which can be used to identify poisoning trends or to track the outcome of poisonings. A concerted effort to create a universal database on poisoning exposures should be considered.

Interpretation and uses of data collected in poison control centres in the United States.

Clinical toxicology and poison control have not benefited from the same epidemiological and demographical scrutiny that other health care disciplines have, because of the lack of a meaningful, appropriate database from which to undertake those analyses. Since the creation of the American Association of Poison Control Centers National Data Collection System in 1982 many of the former obstacles of data collection have been overcome. A system has been devised which apparently meets the needs of busy regional poison control centres willing to participate in data collection, and thus provide a large database of human poisoning experience. The data collected by poison control centres and maintained in the National Data Collection System afford a new, powerful tool with which to address issues of demography, epidemiology, risk assessment, product surveillance and regulatory affairs. While the system affords these potentials, certain limitations of the data must be understood so that the data are not misinterpreted. Additionally, we have attempted to identify strengths of the system as well as areas in need of improvement and refinement.

Pediatric coin ingestion. A prospective study on the utility of routine roentgenograms.

It has been recommended that all children with a history of coin ingestion immediately undergo roentgenography to locate the coin, regardless of symptoms. We performed a prospective evaluation of these ingestions to determine the risk of asymptomatic esophageal impaction and the need for routine roentgenography. One hundred sixty-two children (mean +/- SD age, 3.6 +/- 2.1 years) were evaluated. All were referred for immediate roentgenography after ingestion and followed up daily by telephone for 5 days. Sixty-six patients (41%) did comply and 96 (59%) did not comply with the roentgenogram recommendation. A coin was visualized in the esophagus of 13 patients (20%); 11 were symptomatic and 2 were asymptomatic at the time of ingestion. Symptomatic patients had a 42% risk of a coin later being located in the esophagus compared with a 5% risk for asymptomatic patients. The asymptomatic patients with lodged coins passed them without difficulty after the administration of oral fluids. Nineteen percent of the patients who did not undergo roentgenography were symptomatic and all became asymptomatic within 24 hours of ingestion. There was no difference in morbidity between the group that underwent roentgenography and the group that did not undergo roentgenography at 5 days after ingestion. Children who are asymptomatic at the time of coin ingestion may not need routine roentgenography if they can tolerate oral fluids and telephone follow-up is available.

A prospective, population-based study of acute ibuprofen overdose: complications are rare and routine serum levels not warranted.

The availability of ibuprofen without a prescription requires assessment of its acute toxicity in the general population. We report results from a prospective study of 329 cases of ibuprofen overdose from a statewide cohort that were reported to our poison center between April 1985 and November 1986; 85 patients had ibuprofen serum concentrations measured. Gastrointestinal disturbances and central nervous system depression were the most common clinical findings (42% and 30% of patients, respectively), but the severity was mild; only one patient had severe symptoms that could be attributed to ibuprofen. Ibuprofen serum concentrations correlated poorly with gastrointestinal symptoms (r = -.177), central nervous system findings (r = .176), presence of coingestants (r = .078), and presence of potentially life-threatening symptoms (r = .087). We evaluated the usefulness of a previously published nomogram to predict ibuprofen toxicity; the positive predictive value for severe symptoms was 6% for all patients and 0% for patients ingesting ibuprofen alone. We conclude that the frequency of life-threatening complications from ibuprofen overdose is low, the nomogram is not predictive of toxicity, and routine serum concentration determinations are not useful as an adjunct in the management of overdose cases.