Are Patients With Longer Emergency Department Wait Times Less Likely to Consent to Research?

Objectives: There are unique challenges to enrolling patients in emergency department (ED) clinical research studies, including the time-sensitive nature of emergency conditions, the acute care environ- ment, and the lack of an established relationship with patients. Prolonged ED wait times have been asso- ciated with a variety of adverse effects on patient care. The objective of this study was to assess the effect of ED wait times on patient participation in ED clinical research. The hypothesis was that increased ED wait times would be associated with reduced ED clinical research consent rates. Methods: This was a retrospective cohort study of all patients eligible for two diagnostic clinical research studies from January 1, 2008, through December 31, 2008, in an urban academic ED. Sex, age, race, study eligibility, and research consent decisions were recorded by trained study personnel. The wait times to registration and to be seen by a physician were obtained from administrative databases and compared between consenters and nonconsenters. An analysis of association between patient wait times for the outcome of consent to participate was performed using a multivariate logistic regression model. Results: A total of 903 patients were eligible for enrollment and were asked for consent. Overall, 589 eligible patients (65%) gave consent to research participation. The consent rates did not change when patients were stratified by the highest and lowest quartile wait times for both time from arrival to regis- tration (68% vs. 65%, p = 0.35) and time to be seen by a physician (65% vs. 66%, p = 0.58). After adjusting for patient demographics (age, race, and sex) and study, there was still no relationship between wait times and consent (p > 0.4 for both wait times). Furthermore, median time from arrival to registration did not differ between those who consented to participate (15 minutes; interquartile range [IQR] = 9 to 36 minutes) versus those who did not (15.5 minutes; IQR = 10 to 39 minutes; p = 0.80; odds ratio [OR] = 1.00, 95% confidence interval [CI] = 0.99 to 1.01). Similarly, there was no difference in the median time to be seen by a physician between those who consented (25 minutes; IQR = 15 to 55 minutes) versus those who did not (25 minutes; IQR = 15 to 56 minutes; p = 0.70; OR = 1.00, 95% CI = 0.99 to 1.01). Conclusions: Regardless of wait times, nearly two-thirds of eligible patients were willing to consent to diagnostic research studies in the ED. These findings suggest that effective enrollment in clinical research is possible in the ED, despite challenges with prolonged wait times

Key stakeholder perceptions about consent to participate in acute illness research: a rapid, systematic review to inform epi/pandemic research preparedness

Background A rigorous research response is required to inform clinical and public health decision-making during an epi/pandemic. However, the ethical conduct of such research, which often involves critically ill patients, may be complicated by the diminished capacity to consent and an imperative to initiate trial therapies within short time frames. Alternative approaches to taking prospective informed consent may therefore be used. We aimed to rapidly review evidence on key stakeholder (patients, their proxy decision-makers, clinicians and regulators) views concerning the acceptability of various approaches for obtaining consent relevant to pandemic-related acute illness research. Methods We conducted a rapid evidence review, using the Internet, database and hand-searching for English language empirical publications from 1996 to 2014 on stakeholder opinions of consent models (prospective informed, third-party, deferred, or waived) used in acute illness research. We excluded research on consent to treatment, screening, or other such procedures, non-emergency research and secondary studies. Papers were categorised, and data summarised using narrative synthesis. Results We screened 689 citations, reviewed 104 full-text articles and included 52. Just one paper related specifically to pandemic research. In other emergency research contexts potential research participants, clinicians and research staff found third-party, deferred, and waived consent to be acceptable as a means to feasibly conduct such research. Acceptability to potential participants was motivated by altruism, trust in the medical community, and perceived value in medical research and decreased as the perceived risks associated with participation increased. Discrepancies were observed in the acceptability of the concept and application or experience of alternative consent models. Patients accepted clinicians acting as proxy-decision makers, with preference for two decision makers as invasiveness of interventions increased. Research regulators were more cautious when approving studies conducted with alternative consent models; however, their views were generally under-represented. Conclusions Third-party, deferred, and waived consent models are broadly acceptable to potential participants, clinicians and/or researchers for emergency research. Further consultation with key stakeholders, particularly with regulators, and studies focused specifically on epi/pandemic research, are required. We highlight gaps and recommendations to inform set-up and protocol development for pandemic research and institutional review board processes

Impact of renal dysfunction on acute coronary syndrome evaluation in observation unit patients.

OBJECTIVES: The impact of renal disease on risk stratification of patients at low risk for potential acute coronary syndrome has not been well defined. The objective of this study was to document the prevalence of renal dysfunction and assess the association between renal impairment and abnormal cardiac evaluation in observation unit (OU) patients. METHODS: Retrospective cohort study at an academic medical center OU. Data were abstracted using predetermined definitions of data outcomes by trained abstractors. Patients had symptoms consistent with acute coronary syndrome and did not have obvious evidence of acute MI or ischemia on electrocardiogram, unstable vital signs, abnormal cardiac markers, serious arrhythmias, or uncontrollable chest pain. Observation patients received serial cardiac markers and electrocardiograms, with the majority receiving stress testing at treating physician discretion. Patients were stratified by glomerular filtration rates (GFR) at cut-off points of less than 60 and less than 90 mL/min per 1.73 m(2). Odds ratios were calculated for stress test findings of inducible ischemia or hospital admission. RESULTS: Five hundred and twenty-nine out of 545 patients had complete data and were enrolled. Sixty-nine (13%) patients had a GFR of less than 60 and 300 (56%) patients had a GFR of less than 90. An abnormal cardiac evaluation was found in 64 (12%) patients, of whom 31 (49%) had some renal impairment. The odds ratio of an abnormal cardiac evaluation with a GFR of less than 90 is 1.65 (95% confidence interval, 0.95-2.88) and 1.65 (95% confidence interval, 0.83-3.28) for GFR less than 60. CONCLUSIONS: Renal dysfunction is common in OU patients. In these patients, renal dysfunction did not confer higher risk for abnormal cardiac evaluation

Critical Care Air Transport Team severe traumatic brain injury short-term outcomes during flight for Operation Iraqi Freedom/Operation Enduring Freedom.

Our understanding of the expertise and equipment required to air transport injured soldiers with severe traumatic brain injuries (TBIs) continue to evolve.We conducted a retrospective chart review of characteristics, interventions required and short-term outcomes of patients with severe TBI managed by the US Air Force Critical Care Air Transport Teams (CCATTs) deployed in support of Operation Iraqi Freedom and Operation Enduring Freedom between 1 June 2007 and 31 August 2010. Patients were cared for based on guidelines given by the Brain Trauma Foundation and the Joint Theater Trauma System by non-neurosurgeon physicians with dedicated neurocritical care training. We report basic characteristics, injuries, interventions required and complications during transport.Intracranial haemorrhage was the most common diagnosis in this cohort. Most injuries were weapon related. During this study, there were no reported in-flight deaths. The majority of patients were mechanically ventilated. There were 45 patients who required at least one vasopressor to maintain adequate tissue perfusion, including four patients who required three or more. Some patients required intracranial pressure (ICP) management, treatment of diabetes insipidus and/or seizure prophylaxis medications.Air transport personnel must be prepared to provide standard critical care but also care specific to TBIs, including ICP control and management of diabetes insipidus. Although these patients and their potential complications are traditionally managed by neurosurgeons, those providers without neurosurgical backgrounds can be provided this training to help fill a wartime need. This study provides data for the future development of air transport guidelines for validating and clearing flight surgeons

Left ventricular dysfunction screening in hypertensive patients with N-terminal pro-B-type natriuretic peptide and electrocardiogram.

OBJECTIVE: Early recognition of left ventricular hypertrophy is important because antihypertensive treatment decreases morbidity and mortality. The ideal screening method for left ventricular hypertrophy in hypertensive emergency department (ED) patients has not been identified. Our objective was to determine the diagnostic accuracies of electrocardiogram (ECG) and N-terminal Pro-B-type natriuretic peptide (pro-BNP) for left ventricular hypertrophy individually and in combination in hypertensive ED patients. METHODS: Prospective diagnostic study in an academic urban tertiary care hospital ED with annual census of 65,000 visits. Inclusion criteria are as follows: adult ED patients with systolic blood pressure greater than or equal to 160 mm Hg or diastolic blood pressure greater than or equal to 100 mm Hg on 2 or more measurements taken 60 minutes apart. Exclusion criteria are as follows: patients with heart failure, renal insufficiency/failure, acute myocardial infarction, or without recent or scheduled echocardiograms. All patients received echocardiograms and had pro-BNP levels measured using a RAMP point-of-care device (Response Biomedical, Vancouver, BC, Canada). We calculated diagnostic test characteristics with 95% confidence intervals (CIs). RESULTS: A total of 49 patients were enrolled. The average age was 57.9 years, 26.5% were male, and 63.3% were African American. Thirty-two patients (65%) had left ventricular hypertrophy by echocardiogram. Twenty-one (43%) had ECG evidence of left ventricular hypertrophy. Median pro-BNP level was 268 pg/mL. The combination of the 2 tests provided the greatest specificity (94%; 95% CI, 69%-99.7%) and positive predictive value (94%; 95% CI, (68%-99.7%). CONCLUSIONS: The combination of ECG and pro-BNP is a promising screening algorithm for identification of hypertensive ED patients with left ventricular hypertrophy

Thrombolysis in myocardial infarction risk score in an observation unit setting.

OBJECTIVE: The Thrombolysis in Myocardial Infarction (TIMI) score is a validated tool for risk stratification of acute coronary syndrome. We hypothesized that the TIMI risk score would be able to risk stratify patients in observation unit for acute coronary syndrome. METHODS: STUDY DESIGN: Retrospective cohort study of consecutive adult patients placed in an urban academic hospital emergency department observation unit with an average annual census of 65,000 between 2004 and 2007. Exclusion criteria included elevated initial cardiac biomarkers, ST segment changes on ECG, unstable vital signs, or unstable arrhythmias. A composite of significant coronary artery disease (CAD) indicators, including diagnosis of myocardial infarction, percutaneous coronary intervention, coronary artery bypass surgery, or death within 30 days and 1 year, were abstracted via chart review and financial record query. The entire cohort was stratified by TIMI risk scores (0-7) and composite event rates with 95% confidence interval were calculated. RESULTS: In total 2228 patients were analyzed. Average age was 54.5 years, 42.0% were male. The overall median TIMI risk score was 1. Eighty (3.6%) patients had 30-day and 119 (5.3%) had 1-year CAD indicators. There was a trend toward increasing rate of composite CAD indicators at 30 days and 1 year with increasing TIMI score, ranging from a 1.2% event rate at 30 days and 1.9% at 1 year for TIMI score of 0 and 12.5% at 30 days and 21.4% at 1 year for TIMI ≥ 4. CONCLUSIONS: In an observation unit cohort, the TIMI risk score is able to risk stratify patients into low-, moderate-, and high-risk groups

Wireless, Web-Based Interactive Control of Optical Coherence Tomography with Mobile Devices

PURPOSE: Optical coherence tomography (OCT) is widely used in ophthalmology clinics and has potential for more general medical settings and remote diagnostics. In anticipation of remote applications, we developed wireless interactive control of an OCT system using mobile devices. METHODS: A web-based user interface (WebUI) was developed to interact with a handheld OCT system. The WebUI consisted of key OCT displays and controls ported to a webpage using HTML and JavaScript. Client-server relationships were created between the WebUI and the OCT system computer. The WebUI was accessed on a cellular phone mounted to the handheld OCT probe to wirelessly control the OCT system. Twenty subjects were imaged using the WebUI to assess the system. System latency was measured using different connection types (wireless 802.11n only, wireless to remote virtual private network [VPN], and cellular). RESULTS: Using a cellular phone, the WebUI was successfully used to capture posterior eye OCT images in all subjects. Simultaneous interactivity by a remote user on a laptop was also demonstrated. On average, use of the WebUI added only 58, 95, and 170 ms to the system latency using wireless only, wireless to VPN, and cellular connections, respectively. Qualitatively, operator usage was not affected. CONCLUSIONS: Using a WebUI, we demonstrated wireless and remote control of an OCT system with mobile devices. TRANSLATIONAL RELEVANCE: The web and open source software tools used in this project make it possible for any mobile device to potentially control an OCT system through a WebUI. This platform can be a basis for remote, teleophthalmology applications using OCT

Systematic review and metasummary of attitudes toward research in emergency medical conditions

Emergency departments are challenging research settings, where truly informed consent can be difficult to obtain. A deeper understanding of emergency medical patients' opinions about research is needed. We conducted a systematic review and meta-summary of quantitative and qualitative studies on which values, attitudes, or beliefs of emergent medical research participants influence research participation. We included studies of adults that investigated opinions toward emergency medicine research participation. We excluded studies focused on the association between demographics or consent document features and participation and those focused on non-emergency research. In August 2011, we searched the following databases: MEDLINE, EMBASE, Google Scholar, Scirus, PsycINFO, AgeLine and Global Health. Titles, abstracts and then full manuscripts were independently evaluated by two reviewers. Disagreements were resolved by consensus and adjudicated by a third author. Studies were evaluated for bias using standardised scores. We report themes associated with participation or refusal. Our initial search produced over 1800 articles. A total of 44 articles were extracted for full-manuscript analysis, and 14 were retained based on our eligibility criteria. Among factors favouring participation, altruism and personal health benefit had the highest frequency. Mistrust of researchers, feeling like a 'guinea pig' and risk were leading factors favouring refusal. Many studies noted limitations of informed consent processes in emergent conditions. We conclude that highlighting the benefits to the participant and society, mitigating risk and increasing public trust may increase research participation in emergency medical research. New methods for conducting informed consent in such studies are needed

Potential Cost-effectiveness of Early Identification of Hospital-acquired Infection in Critically Ill Patients

RATIONALE: Limitations in methods for the rapid diagnosis of hospital-acquired infections often delay initiation of effective antimicrobial therapy. New diagnostic approaches offer potential clinical and cost-related improvements in the management of these infections. OBJECTIVES: We developed a decision modeling framework to assess the potential cost-effectiveness of a rapid biomarker assay to identify hospital-acquired infection in high-risk patients earlier than standard diagnostic testing. METHODS: The framework includes parameters representing rates of infection, rates of delayed appropriate therapy, and impact of delayed therapy on mortality, along with assumptions about diagnostic test characteristics and their impact on delayed therapy and length of stay. Parameter estimates were based on contemporary, published studies and supplemented with data from a four-site, observational, clinical study. Extensive sensitivity analyses were performed. The base-case analysis assumed 17.6% of ventilated patients and 11.2% of nonventilated patients develop hospital-acquired infection and that 28.7% of patients with hospital-acquired infection experience delays in appropriate antibiotic therapy with standard care. We assumed this percentage decreased by 50% (to 14.4%) among patients with true-positive results and increased by 50% (to 43.1%) among patients with false-negative results using a hypothetical biomarker assay. Cost of testing was set at $110/d. MEASUREMENTS AND MAIN RESULTS: In the base-case analysis, among ventilated patients, daily diagnostic testing starting on admission reduced inpatient mortality from 12.3 to 11.9$1,640 per patient, resulting in an incremental cost-effectiveness ratio of $21,389 per life-year saved. Among nonventilated patients, inpatient mortality decreased from 7.3 to 7.1$1,381 with diagnostic testing. The resulting incremental cost-effectiveness ratio was $42,325 per life-year saved. Threshold analyses revealed the probabilities of developing hospital-acquired infection in ventilated and nonventilated patients could be as low as 8.4 and 9.8$50,000 per life-year saved. CONCLUSIONS: Development and use of serial diagnostic testing that reduces the proportion of patients with delays in appropriate antibiotic therapy for hospital-acquired infections could reduce inpatient mortality. The model presented here offers a cost-effectiveness framework for future test development