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Biomedical subjects

T O Stair

Publications and source records attributed to T O Stair.

At least 19 recordsLinked to original sources

Variation in institutional review board responses to a standard protocol for a multicenter clinical trial.

UNLABELLED: Multicenter clinical trials require approval by multiple local institutional review boards (IRBs). The Multicenter Airway Research Collaboration mailed a clinical trial protocol to its U.S. investigators and 44 IRBs ultimately reviewed it. OBJECTIVE: To describe IRB responses to one standard protocol and thereby gain insight into the advantages and disadvantages of local IRB review. METHODS: Two surveys were mailed to participants, with telephone follow-up of nonrespondents. Survey 1 was mailed to 82 investigators across North AMERICA: Survey 2 was mailed to investigators from 44 medical centers in 17 U.S. states. Survey 1 asked about each investigator's local IRB (e.g., frequency of meetings, membership), whereas survey 2 asked about IRB queries and concerns related to the submitted clinical trial. RESULTS: Both surveys had 100% response rate. Investigators submitted applications a median of 58 days (interquartile range [IQR], 40--83) after receipt of the protocol, and IRB approval took an additional 38 days (IQR, 26--62). Although eight applications were approved with little or no changes, IRBs requested an average of 3.5 changes per site. Changes involved study logistics and supervision for 45%, the research process for 43%, and the consent form for 91%. Despite these numerous requests, all eventually approved the basic protocol, including inclusion criteria, intervention, and data collection. CONCLUSIONS: The IRBs showed extreme variability in their initial responses to a standard protocol, but ultimately all gave approval. Almost all IRBs changed the consent form. A national, multicenter IRB process might streamline ethical review and warrants further consideration.

Androstadienes↗

Medical clearance and screening of psychiatric patients in the emergency department.

OBJECTIVES: To study the frequency of medical complaints and need for routine ED medical, laboratory, and toxicologic clearance for patients presenting with psychiatric chief complaints. METHODS: A retrospective, observational analysis of psychiatric patients seen in an urban teaching hospital ED over a 2-month period was performed. The individual sensitivities of history, physical examination, vital signs, and complete blood counts and chemistry panels for identifying medical problems were determined. The sensitivities and predictive values of patient self-reporting of recent illicit drug and ethanol use were also determined. RESULTS: 352 patients were seen with psychiatric chief complaints. A complete data set was available for 345 patients (98%). Of those with complete data, 65 (19%) had medical problems of any type. History, physical examination, vital signs, and laboratory testing had sensitivities of 94%, 51%, 17%, and 20%, respectively, for identifying these medical problems. Screening without universal laboratory testing would have missed 2 asymptomatic patients with mild hypokalemia. Patient self-reporting had a 92% sensitivity, a 91% specificity, an 88% positive predictive value (PPV), and a 94% negative predictive value (NPV) for identifying those with a positive drug screen, and a 96% sensitivity, an 87% specificity, a 73% PPV, and a 98% NPV for identifying those with a positive ethanol level. CONCLUSION: The vast majority of medical problems and substance abuse in ED psychiatric patients can be identified by initial vital signs and a basic history and physical examination. Universal laboratory and toxicologic screening of all patients with psychiatric complaints is of low yield.

Adolescent↗

Infrared emission detection tympanic thermometry may be useful in diagnosing acute otitis media.

To determine the utility of infrared emission detection (IRED) tympanic thermometry in diagnosing acute suppurative otitis media (ASOM), a prospective, nonblinded sampling of ear temperatures was performed. Children between the ages of 6 months and 6 years presenting to an urban emergency department were included in the study. Tympanic temperatures were determined in all subjects. Clinical data, tympanic audiometry, and telephone follow-up were used to define ASOM. Temperature differences were determined for children with unilateral ASOM and those without ear infection. Data from 48 patients were analyzed. The mean temperature difference in the control group, 0.23 degrees +/- 0.15 degrees C (95% confidence interval [CI], 0.17 degree to 0.29 degree C) differed from those with ASOM: 0.39 degree +/- 0.29 degree C (95% CI, 0.25 degree to 0.53 degree C, P = .047). Logistic regression was used to describe the predictive relationship between temperature difference and probability of ASOM. We conclude that IRED tympanic thermometry may be useful in diagnosing ASOM when used with other clinical data.

Acute Disease↗

Comparison of effects of suture and cyanoacrylate tissue adhesive on bacterial counts in contaminated lacerations.

We studied the effects of closing lacerations with suture or cyanoacrylate tissue adhesive on staphylococcal counts in inoculated guinea pig lacerations. Wounds closed with adhesive alone had lower counts than wounds containing suture material (P < 0.05). The results of a time-kill study were consistent with a bacteriostatic adhesive effect of the adhesive against Staphylococcus aureus.

Animals↗

Host response to multiple skin lacerations on the albino guinea pig.

Investigators have studied methods of treating skin lacerations by placing multiple incisions on each albino guinea pig. Theoretically, host responses to laceration sites may differ on the basis of anatomic location and local cytokine effects. We used cytokine values and histologic examination to identify differences when multiple lacerations were placed on each animal. Four 3-cm lacerations were made on the dorsum of each male albino guinea pig: two incisions on either side and parallel to the spine. Each laceration was closed with staples. In five animals a sponge technique was used to assay wound cytokines 48 h later. In an additional four animals, wounds were excised at 96 h and stained for cells and new collagen. We identified no statistically significant differences among laceration sites based on polymorphonuclear and mononuclear cellularity, number of fibroblasts, new collagen deposition, or wound interleukin (IL)-6 activities. Using this model minimizes the number of animals needed to generate statistically significant findings in wound research.

Animals↗

Urinary thromboxane A2 metabolites in patients presenting in the emergency room with acute chest pain.

OBJECTIVES: The diagnosis of acute myocardial infarction (MI) is difficult in emergency rooms where large groups of patients present with chest pain. Confirmation of the diagnosis of MI based on the myocardial band of creatine phosphokinase may take a day. A more rapid diagnostic screening procedure is desirable and for this reason we evaluated urine thromboxane. DESIGN: The study consisted of patients presenting with chest pain. Urine samples were obtained in the emergency room and on the following 5 days for those patients who were admitted to the hospital. The urine samples were used to determine the levels of immunoreactive 11-dehydro-thromboxane B2 (i-11-dehydro-TXB2) and 2,3-dinor-thromboxane B2 (i-2,3-dinor-TXB2). Myocardial infarction was defined as an increase in the myocardial band fraction of plasma creatine phosphokinase (> 5% of the total) and changes in the electrocardiogram. The patients' diagnoses were retrospectively correlated with thromboxane metabolite levels. SETTING: The present study took place in the emergency rooms of two major hospitals: Georgetown University Medical Center, Washington DC, and Fairfax Hospital, Virginia, USA. SUBJECTS: The study comprised 369 patients presenting with acute chest pain and consisted of 247 men and 122 women aged 30-94 years. MAIN OUTCOME MEASURES: The outcome measure of this study was the predictive value of i-11-dehydro TXB2 and i-2,3-dinor-TXB2, for the diagnosis of MI, in patients presenting in the emergency room with chest pain. RESULTS: Patients undergoing an MI had significantly higher levels of both thromboxane metabolites in their urine in the emergency room, when compared to patients undergoing a cardiac event other than an MI or to patients with unstable angina. Thromboxane metabolite levels rapidly returned to normal on the days following admission to the hospital. Aspirin intake appeared to significantly decrease the levels of i-11-dehydro-TXB2, but not that of i-2,3-dinor-TXB2. CONCLUSIONS: The measurement of thromboxane metabolites in the urine may provide a more rapid, accurate and cost-effective means of diagnosing MIs in patients presenting with chest pain.

Adult↗

The effect of scrubbing and irrigation with normal saline, povidone iodine, and cefazolin on wound bacterial counts in a guinea pig model.

This study examines the effects of povidone iodine, normal saline, and cefazolin alone and after scrubbing on bacterial counts in contaminated animal lacerations. Twelve albino guinea pigs each received four lacerations inoculated with a standard inoculum of Staphylococcus aureus. Twelve hours after inoculation, each wound was biopsied to ensure contamination and then either treated or left as an untreated control. One wound on each animal was an untreated control. The remaining three lacerations on six pigs were irrigated with cefazolin (CZ) solution, normal saline, or 1% (wt/vol) povidone iodine solution (PI). Three lacerations on another six pigs were treated with 20% poloxamer 188 scrub (scrub) alone, scrub followed by PI irrigation (SCR/PI), or scrub followed by CZ irrigation (SCR/CZ). Quantitative bacteriology was performed on tissue biopsies 2 hours (time 1), 7 hours (time 2), and 12 hours (time 3) after irrigation. Posttreatment counts for PI, CZ, and normal saline irrigation were not different from control or one another (P > .05). Bacterial counts for SCR/PI were significantly lower than control (P < .05) for all posttreatment biopsies (1.8 to 2.9 mean log(10) decrease). SCR/CZ was significantly lower than control (P < .05) at times 2 and 3 only (1.7 to 2.0 mean log(10) decrease). In this guinea pig model, cleansing 12-hour-old lacerations contaminated with S aureus using SCR/PI or SCR/CZ significantly reduced bacterial counts over 12 hours.

Animals↗

First year's experience of the MAClinical Computer Workstations Project.

We have an installed base of MAClinical workstations available on hospital wards, which have been used for patient care, education, and research 24 hours a day for the past year. We began with eight machines in the hospital but now have distributed ten more machines to faculty. We have recently increased the programming staff so we can develop more software. The machines and their installation were costly, but have already proven useful for teaching and patient care. Plans for the second and third years of the MAClinical project include workstations for the faculty coordinators of clinical clerkships and expansion of workstations to affiliated hospitals where our students and residents rotate. Software will be expanded to include patient simulations and expert consultations. Medical practice, research, and teaching in the future will need to make more use of information technology. It is not yet clear exactly how and where computers will best serve clinical medicine, but the teaching hospital can be both a laboratory for developing applications and a school for training physicians to use them.

Clinical Clerkship↗

Tetanus immunity in emergency department patients.

Demographic data and blood samples were collected from 278 patients seen at two District of Columbia emergency departments, and tetanus antitoxin assays by hemagglutination were performed at the Centers for Disease Control. Twenty-seven patients (10%) had antibody levels below the 0.01 U/mL considered protective. Four demographic characteristics were different in the patients with inadequate immunity (in decreasing order of significance): advanced age, fewer years of education, female sex, and non-US origin. Fourteen of the inadequately immunized patients were over 70 years of age. Of the 84 patients who reported their immunization histories, five reported no complete series of tetanus shots but had adequate antibody levels, while three reported a complete series but had inadequate levels. Twenty-two patients with inadequate immunity were not offered immunization in the emergency department because they did not have wounds. Patient recall of immunization history is not a reliable guide to tetanus immunization in the emergency department, but patients in certain demographic groups, such as older women, are more likely to have inadequate immunity.

Adolescent↗

Litigation against the emergency physician: common features in cases of missed myocardial infarction.

Adverse outcome data from two insurance companies were retrospectively studied to determine whether a constellation of clinical circumstances, data-gathering behaviors, or physician variables were common to cases of missed acute myocardial infarction (AMI) and, if so, to formulate quality assurance recommendations to decrease future occurrences of misdiagnosis. We studied AMI because missing this diagnosis accounts for the highest dollar losses in emergency department malpractice cases. Our study group consisted of 65 patients with undiagnosed AMI seen in EDs between 1982 and 1986. Univariate differences between undiagnosed cases and correctly diagnosed concurrent controls were analyzed using Student's t test and chi 2 analysis. Insurance losses for our cases averaged $113,806 +/- $178,330 (SD). Compared with concurrent controls, study patients were significantly younger, presented more atypically, and had fewer ECGs that were diagnostic of AMI. Undiagnosed patients were evaluated by physicians who documented less detailed histories, misread more ECGs, had less ED experience, and admitted fewer patients to the hospital. Preventive strategies are outlined.

Diagnostic Errors↗