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Biomedical subjects

Michelle H Biros

Publications and source records attributed to Michelle H Biros.

15 recordsLinked to original sources
PubMed2006

Patient and physician perceptions as risk factors for oligoanalgesia: a prospective observational study of the relief of pain in the emergency department.

OBJECTIVES: Previous studies have reported that pain is undertreated in the emergency department (ED), but few physician-dependent risk factors have been identified. In this study, the authors determine whether pain treatment and relief in ED patients are negatively associated with the physician's perception of whether the patient was exaggerating symptoms, and with the patient and physician's perceptions of the interaction between them, as well as whether demographic characteristics were associated with these perceptions. METHODS: This was a prospective observational study of patients who were undergoing treatment for painful disorders in the ED. Before treatment for pain, patients were asked to complete a 100-mm visual analog scale (VAS) describing their pain. Demographic information and pain treatments administered were recorded. Patients completed a second pain VAS before discharge from the ED. Patients were then asked to complete three queries describing their perception of their interaction with the physician. After the patient had left the department, the patient's physician was asked to complete a query describing his or her perception of the interaction and to complete a VAS describing how likely it was that the patient was exaggerating symptoms to obtain pain medicines for nonmedical purposes. RESULTS: There were 1,695 patients enrolled in the study; 32 patients were excluded because of missing or incomplete data, leaving 1,663 for analysis. Of these patients, 71.9% received a pain medication while in the ED. There was no association between the physician's VAS for perceived exaggeration of symptoms, the queries describing physician-patient interactions, and patient ethnicity and whether patients received pain treatment in the ED. There was a negative correlation between the physician's VAS for perceived exaggeration of symptoms and the change in the patient's pre- and posttreatment pain VAS scores. The physician's VAS score for perceived exaggeration of symptoms was higher among Native American patients than among other ethnic groups (p < or = 0.001). The patient and physician queries rating their interaction show a decreased absolute reduction of VAS pain scores (p > or = 0.001) and a reduction in the number of patients having at least a 50% reduction in their pain VAS score when interactions were rated "bad" and "very bad" (p < or = 0.001). CONCLUSIONS: The physician's perception of whether a patient was exaggerating symptoms was associated with the patient's ethnic background and with both the physician's and patient's perception of their interaction. These perceptions were negatively associated with the achievement of pain relief and the change in the patient's pain VAS scores, but not with whether a patient was treated with a pain medication.

Adolescent↗
PubMed2005

Procedural sedation of critically ill patients in the emergency department.

OBJECTIVES: Procedural sedation is routinely performed in the emergency department (ED). However, some authors believe it is unsafe in nonintubated, critically ill patients. The objective of this study was to determine the safety of ED procedural sedation in the American Society of Anesthesiologists (ASA) physical status classification P3 and P4 patients. METHODS: This was a prospective observational study of patients undergoing procedural sedation in the ED between August 2002 and December 2003 who were classified as ASA physical status score P3 or P4. Patients received either propofol or etomidate at the discretion of the treating physician before their painful procedure. Doses, vital signs, end-tidal CO(2) (ETCO(2)) by nasal cannulae, and pulse oximetry were recorded. Respiratory depression (RD) was defined as a change from baseline ETCO(2) >10 mm Hg, an oxygen saturation of < 90%, or an absent ETCO(2) waveform at any time. RESULTS: Sixty-two critically ill, nonintubated patients were enrolled. Thirty-one patients received propofol, and 31 patients received etomidate. No cardiac rhythm abnormalities were detected. RD was seen in 37 of 62 patients (59.7%): 19 of the 31 (61.3%) who received propofol and 18 of the 31 (58.1%) who received etomidate. The mean decrease from baseline systolic blood pressure was 11.3% (95% confidence interval [CI] = 7.3% to 15.5%): 5.0% (95% CI = 3.0% to 8.1%) for those receiving etomidate and 17.1% (95% CI = 9.9% to 24.3%) for those receiving propofol. No adverse events were reported. CONCLUSIONS: The rate of subclinical RD detected by these criteria was similar to previous reports for noncritically ill patients. Procedural sedation of nonintubated ASA physical status score P3 and P4 patients in the ED with either propofol or etomidate appears to be safe.

Adult↗
PubMed2005

The utility of the bispectral index in procedural sedation with propofol in the emergency department.

UNLABELLED: The bispectral index (BIS) may be a useful monitor to predict the level of awareness in patients undergoing procedural sedation in the emergency department (ED). OBJECTIVES: The authors hypothesized that using the BIS during procedural sedation in the ED would increase the recognition of adequately sedated patients, thus reducing oversedation and the corresponding increased rate of respiratory depression (RD). As a result, the occurrence of RD would be reduced. METHODS: This was a prospective randomized study of ED procedural sedation with propofol. Sedations were randomized to have the treating physician either blinded or not blinded to information from the BIS monitor. Vital signs, pulse oximetry, end-tidal carbon dioxide (ETCO(2)), propofol dosage, and the BIS score were recorded. RD was defined as a change in ETCO(2) greater than 10 mm Hg, an oxygen saturation of less than 90% at any time, or an absent ETCO(2) waveform. The RD rates were compared with chi-square tests. RESULTS: One hundred five patients were enrolled in the study; five were excluded due to study protocol violations. No serious adverse events were reported. RD was seen in 29 of 100 (29%) patients; 18 of 48 in the BIS-blinded group and 11 of 52 in the BIS-unblinded group had RD (p = 0.06). For patients requiring only a single dose of propofol, three of 15 in the BIS-blinded group and four of 18 in the BIS-unblinded group met the criteria for RD (p = 0.87). For patients requiring multiple doses of propofol, 15 of 33 patients in the BIS-blinded group and seven of 34 patients in the BIS-unblinded group met criteria for RD (p = 0.02). The mean BIS nadir for BIS-blinded patients was 60.9 (95% CI = 56.9 to 65.0) and that for BIS-unblinded patients was 63.2 (95% CI = 57.7 to 65.3) (p = 0.22). CONCLUSIONS: There was a lower rate of RD when physicians had access to the BIS during procedural sedations. This difference was greater in sedations requiring multiple doses of propofol. There was no difference in the rate of RD when only a single dose was given.

Adult↗
PubMed2005

The prevalence and perceived health consequences of hunger in emergency department patient populations.

OBJECTIVES: Hunger is associated with chronic poor health and may force patients to make choices that acutely impact their health. This study was conducted to determine the prevalence of hunger, some of the choices it forces, and its perceived health effects among emergency department (ED) patients. METHODS: A validated survey about hunger, choosing between food and medicine, and perceived adverse health outcomes was administered in English, Spanish, and Somali to non-critically ill ED patients or their parents. Demographics, rates of hunger, numbers of yearly ED visits, and decisions between buying commodities or medications were assessed. Relationships between variables were summarized with odds ratios (ORs), 95% confidence intervals, and logistic regression. RESULTS: Of 930 respondents, 23.7% screened positive for hunger and 17.6% bought food instead of medications. Among the hunger-positive respondents, 44% believed this choice caused illness, and of these, 69% sought ED assessment and 35% believed they were hospitalized because of this choice. Predictors of hunger were low income (OR = 3.3), illicit drug use (OR = 5.5), chronic illness (OR = 2.1), Hispanic ethnicity (OR = 1.9), and lack of insurance (OR = 1.8). Buying food instead of medicine was predicted by low income (OR = 2.5), chronic illness (OR = 2.4), and lack of insurance (OR = 3.4). Predictors of illness were chronic illness (OR = 1.8), lack of insurance (OR = 2.8), African American race (OR = 2.0), and "poor" health (OR = 1.9). CONCLUSIONS: These ED patients have high rates of hunger and often choose to buy food instead of medications. Many believe that this choice results in ED visits and hospitalizations. Socioeconomic factors may predict hunger and subsequent ill health.

Adolescent↗
PubMed2005

Assessment of the onset and persistence of amnesia during procedural sedation with propofol.

OBJECTIVES: To assess patients' ability to repeat and recall words presented to them while undergoing procedural sedation with propofol, and correlate their recall with their level of awareness as measured by bispectral index (BIS) monitoring. METHODS: This was a prospective, single-intervention study of consenting adult patients undergoing procedural sedation with propofol between December 28, 2002, and October 31, 2003. BIS monitoring was initiated starting 3 minutes before the procedure and continuing until the patient had regained baseline mental status. At 1-minute intervals during the procedural sedation, until the patient regained baseline mental status at the end of the procedure, a word from a standardized list was read aloud, and the patient was asked to immediately repeat the word to the investigator. The BIS score at the time the word was read and the patient's ability to repeat the word were recorded. After the procedure, the patient was asked to state all of the words from the list that he or she could recall, and to identify the last word recalled from prior to the start of the procedure and the first word recalled from after the procedure was completed. RESULTS: Seventy-five consenting patients were enrolled; one patient was excluded from data analysis for a protocol violation. No serious adverse events were noted during the procedural sedations. The mean (+/-standard deviation) time of data collection was 16.4 minutes (+/-7.1; range 5 to 34 minutes). The mean initial (preprocedure) BIS score was 97.1 (+/-2.3; range 92 to 99). The mean lowest BIS score occurring during these procedural sedations was 66.9 (+/-14.4; range 33 to 91). The mean lowest BIS score corresponding to the ability of the patient to immediately repeat words read from the list was 77.1 (95% CI = 74.3 to 80.0). The mean highest BIS score corresponding to the inability to repeat words was 81.5 (95% CI = 78.1 to 84.8). The mean BIS score corresponding to the last word recalled from prior to the initiation of the sedation was 96.7 (+/-2.4; range 84 to 98). The mean BIS score corresponding to the first word recalled after the procedure was completed was 91.2 (95% CI = 88.1 to 94.3). All patients recalled at least one word that had been read to them during the protocol. The mean lowest BIS score for any recalled word was 91.5 (+/-11.1; range 79 to 98), and no words were recalled when the corresponding BIS score was less than 90. CONCLUSIONS: There is a range of BIS scores during which sedated patients are able to repeat words read to them but are not able to subsequently recall these words. Furthermore, patients had no recall of words repeated prior to procedural sedation in BIS ranges associated with recall after procedural sedation, suggestive of retrograde amnesia.

Adult↗
PubMed2005

Minimal-risk waiver of informed consent and exception from informed consent (Final Rule) studies at institutional review boards nationwide.

BACKGROUND: Federal regulations allow waiver of informed consent for minimal-risk research (waiver). More than minimal-risk emergency research is allowed with an exception from informed consent (EFIC) under specific guidelines called the Final Rule. Performance of research without consent is controversial; however, chances for public health improvements are significant. OBJECTIVES: 1) To describe the number and demographics of academic medical institutions that have reviewed and approved minimal-risk waiver and EFIC studies; 2) to describe associations between National Institutes of Health (NIH) funding percentile and whether an academic medical institution reviews EFIC studies; and 3) to describe associations between geographic region and review of EFIC studies, and the interaction of region and NIH funding percentile with review of EFIC studies. The hypothesis was that schools with a higher NIH funding percentile (more funding) reviewed more EFIC studies research, and that this effect did not vary based on region. METHODS: This was an e-mail and telephone survey of all 122 MD-degree-granting medical schools in the continental United States. Descriptive data were collected on the number of schools reviewing and approving EFIC research. Sites were split into those that have reviewed EFIC studies and those that have not. A multivariable logistic regression examined the effects of 1) funding percentile and 2) region (Northeast, North Central, Southeast, and West) on the likelihood of EFIC study reviews at the sites. Odds ratios (ORs) and 95% confidence intervals (95% CIs) were determined. RESULTS: Ninety-eight of 118 eligible institutional review boards (IRBs) (83%) responded. Ninety-nine percent (97/98) approved waiver studies; 51% (50/98) had reviewed and approved EFIC studies. Academic medical institutions with higher funding percentile were significantly more likely to have reviewed/approved EFIC studies (interaction p = 0.01) in all regions except the Northeast, where higher funding percentile was associated with IRBs significantly less likely to have reviewed/approved EFIC studies (OR 0.25; 95% CI = 0.08 to 0.81). CONCLUSIONS: Almost all medical school IRBs review minimal-risk waiver studies. About half of IRBs at medical schools have reviewed and approved an EFIC study. The higher the NIH funding percentile (more NIH funding), the more likely a site has reviewed EFIC studies, except in the Northeast region.

Academic Medical Centers↗
PubMed2003

Research without consent: current status, 2003.

In November 1996, regulations developed by the US Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) went into effect to allow certain emergency and resuscitation human subjects research to proceed without prospective informed consent. These new regulations brought harmonization to the requirements of the 2 federal agencies charged with research oversight and ended a moratorium that had essentially shut down resuscitation research for almost 4 years. However, the FDA's emergency exception from informed consent and the HHS's waiver of informed consent have been used infrequently. Many perceived obstacles to implementation of the regulations have been described, including the additional regulatory burden for investigators and institutional review boards, the extra expense and time required to adequately fulfill the regulatory requirements, and the reluctance of institutional review boards to allow these studies to move forward because of concerns about potential legal ramifications. Regardless of the arguments advanced, these regulations are essentially the only current regulatory options that have been provided for research without consent. This article presents a brief history of the development of the FDA's Final Rule, a summary of its requirements and its use so far, and suggestions for its implementation. Some strategies to allow the resuscitation research community to suggest fine tuning of the regulations are suggested in hopes that research requiring an exception from informed consent is allowed to proceed in a manner acceptable to regulators, is stringent in patient protection, and yet is sensitive to the practical aspects of performing resuscitation research.

Clinical Protocols↗
PubMed2003

Bispectral electroencephalographic analysis of patients undergoing procedural sedation in the emergency department.

OBJECTIVE: To determine whether there is a correlation between the level of sedation achieved during procedural sedation (PS) in the emergency department as determined by bispectral electroencephalographic (EEG) analysis (BIS) and the rate of respiratory depression (RD), the patient's perception of pain, recall of the procedure, and satisfaction. METHODS: This was a prospective observational study conducted in an urban county hospital of adult patients undergoing PS using propofol, methohexital, etomidate, and the combination of fentanyl and midazolam. Consenting patients were monitored by vital signs, pulse oximetry, nasal-sample end-tidal carbon dioxide (ETCO(2)), and BIS monitors during PS. Respiratory depression (RD) was defined as an oxygen saturation <90%, a change from baseline ETCO(2) of >10 mm Hg, or an absent ETCO(2) waveform at any time during the procedure. After the procedure, patients were asked to complete three 100-mm visual analog scales (VASs) concerning their perception of pain, recall of the procedure, and satisfaction with the procedure. Patients were divided into four groups based on the lowest BIS score recorded during the procedure, group 1, >85; group 2, 70-85; group 3, 60-69; group 4, <60. Rates of RD and VAS outcomes were compared between groups using chi-square statistics. RESULTS: One hundred eight patients were enrolled in the study. No serious adverse events were noted. RD was seen in three of 14 (21.4%) of the patients in group 1, seven of 34 (20.6%) in group 2, 16 of 26 (61.5%) in group 3, and 18 of 34 (52.9%) in group 4. The rate of RD in patients in group 2 was not significantly different from that in group 1 (p = 0.46). The rate of RD in group 2 was significantly lower than that in groups 3 (p = 0.0003) and 4 (p = 0.006). For the VAS data, when group 1 was compared with the combined groups 2, 3, and 4, it had significantly higher rates of pain (p = 0.003) and recall (p = 0.001), and a dissatisfaction rate (p = 0.085) that approached significance. When groups 2, 3, and 4 were compared with chi-square test, there was not a significant difference in pain (p = 0.151), recall (p = 0.27), or satisfaction (p = 0.25). CONCLUSIONS: Patients with a lowest recorded BIS score between 70 and 85 had the same VAS outcomes as more deeply sedated patients and the same rate of RD as less deeply sedated patients. This range of scores represented the optimally sedated patients in this study.

Adolescent↗
PubMed2003

Attitudes of emergency department patients and visitors regarding emergency exception from informed consent in resuscitation research, community consultation, and public notification.

OBJECTIVE: To assess public views on emergency exception to informed consent in resuscitation research, public awareness of such studies, and effective methods of community consultation and public notification. METHODS: A face-to-face survey was conducted in two academic Level I trauma center emergency departments (EDs) in Oregon and Minnesota from June through August 2001. RESULTS: Five hundred thirty people completed the survey, with an 82% response rate. The mean age of the respondents was 41 years (range 18-95) with a standard deviation of 14.5; 46% were female and 64% white. Most (88%) believed that research subjects should be informed prior to being enrolled, while 49% believed enrolling patients without prior consent in an emergency situation would be acceptable and 70% (369) would not object to be entered into such a study without providing prospective informed consent. Informing and consulting the community as a substitute for patient consent in emergency research was thought to be reasonable by 45% of the respondents. Most respondents would prefer to be informed about a study using emergency exception from informed consent by radio and television media (42%). Two hundred fifty-eight respondents (49%) stated they would attend a community meeting; the less educated were more likely to attend than those with college degrees (OR = 0.53; 95% CI = 0.33 to 0.85, p = 0.008). However, only 5% knew of ongoing studies in their community using emergency exception from informed consent. CONCLUSIONS: Most respondents disagreed with foregoing prospective informed consent for research participation even in emergency situations; however, many would be willing to participate in studies using emergency exception from informed consent. Most respondents would not attend community meetings, and would prefer to rely upon the media for information. Very few were aware of emergency exception from informed consent studies in their community. This suggests that current methods of community notification may not be effective.

Adolescent↗
PubMed2002

Selective tomographic imaging of patients with new-onset seizure disorders.

OBJECTIVE: Significant benefit could be realized by developing a clinical decision rule for new-onset seizure victims that would be capable of discriminating between patients having relevant structural lesions visible on computed tomographic (CT) imaging and those who do not. This study sought to determine whether a reliable decision rule could be developed using a limited number of clinical and demographic characteristics. METHODS: Chi-squared recursive partitioning was applied in a secondary analysis of the EMERGEncy ID NET database of new-onset seizure victims. Variables in this database (age, sex, race, ethnicity, seizure type, history of HIV or cysticercosis, and presence or absence of lateralizing neurologic findings or altered mentation) provided the partitioning variables, while CT imaging results provided outcome measures. The study sought to develop a decision rule with 100% sensitivity for detecting any intracranial lesions, and a separate rule with 100% sensitivity for detecting lesions of emergent concern. RESULTS: A decision rule using age > or = 65 years, lateralizing neurologic findings, altered mentation, high risk or known HIV infection, history of cysticercosis, and Hispanic ethnicity showed a sensitivity of 91.9% [95% confidence interval (95% CI) = 88.8% to 94.9%] in detecting individuals who had any tomographic finding. This rule had a sensitivity of 90.1% (95% CI = 83.4% to 96.7%) in detecting individuals with emergent tomographic findings. CONCLUSIONS: Recursive partitioning failed to produce a decision rule capable of reliably identifying new-onset seizure patients who have important lesions identified on CT. Future attempts to formulate such an instrument may need to include additional variables. In the interim, physicians should use liberal tomographic imaging in evaluating patients who present with new-onset seizures.

Acute Disease↗
PubMed2002

A retrospective review of the use and safety of droperidol in a large, high-risk, inner-city emergency department patient population.

UNLABELLED: Droperidol (DROP) is used in the emergency department (ED) for sedation, analgesia, and its antiemetic effect. Its ED safety profile has not yet been reported in patients (pts). OBJECTIVES: To document the use of DROP in high-risk pts (those with head injury, alcohol or cocaine intoxication, and/or remote or recent seizures), and to determine the number of serious and minor adverse events (AEs)-seizures, hypotension, extrapyramidal side effects (EPSEs)-after DROP. METHODS: The ED database (EmSTAT) was queried to determine who received intramuscular or intravenous DROP in the ED in 1998; further chart review was done if the patient was considered high risk for or had experienced an AE. Multiple regression analysis using a random-effects model determined the significance of each variable in the occurrence of AEs. RESULTS: 2,468 patients (aged 20 months to 98 years; 112 < or =17 years; 141 > or =66 years) received DROP for agitation (n = 1,357), pain (1,135), anxiety (99), vomiting (173), or other reasons (50). There were 945 pts considered high risk; 933 charts were reviewed (DROP mean dose 4.1 +/- 2.0 mg); of these, 50 patient visits did not meet the criteria for high risk. There were 622 pts with head trauma (401 with alcohol use), including 47 with computed tomography (CT) scans positive for brain injury, 64 with cocaine use, and 197 with recent or remote seizures (137 with alcohol use). Minor AEs such as transient hypotension occurred in 96 pts after DROP (73 with alcohol use); 20 received intravenous fluids, while an additional 28 pts (8 with alcohol use) received rescue medications for EPSEs. Six possible serious AEs occurred in pts with serious comorbidities; 2 cases of respiratory depression, 3 post-DROP seizures, and 1 cardiac arrest (resuscitated) 11 hours after DROP in a cocaine-intoxicated pt (normal QT interval). There was no significant difference among high-risk groups in the occurrence of AEs. CONCLUSIONS: The vast majority of pts who received DROP in the ED did not experience an AE. A few serious AEs were noted following DROP in patients with serious comorbidities; it is not clear that DROP was causative.

Adult↗