Timothy F. Platts-Mills

Non-publication of large randomized clinical trials: cross sectional analysis

Objective To estimate the frequency with which results of large randomized clinical trials registered with ClinicalTrials.gov are not available to the public. Design Cross sectional analysis Setting Trials with at least 500 participants that were prospectively registered with ClinicalTrials.gov and completed prior to January 2009. Data sources PubMed, Google Scholar, and Embase were searched to identify published manuscripts containing trial results. The final literature search occurred in November 2012. Registry entries for unpublished trials were reviewed to determine whether results for these studies were available in the ClinicalTrials.gov results database. Main outcome measures The frequency of non-publication of trial results and, among unpublished studies, the frequency with which results are unavailable in the ClinicalTrials.gov database. Results Of 585 registered trials, 171 (29%) remained unpublished. These 171 unpublished trials had an estimated total enrollment of 299 763 study participants. The median time between study completion and the final literature search was 60 months for unpublished trials. Non-publication was more common among trials that received industry funding (150/468, 32%) than those that did not (21/117, 18%), P=0.003. Of the 171 unpublished trials, 133 (78%) had no results available in ClinicalTrials.gov. Conclusions Among this group of large clinical trials, non-publication of results was common and the availability of results in the ClinicalTrials.gov database was limited. A substantial number of study participants were exposed to the risks of trial participation without the societal benefits that accompany the dissemination of trial results.

A Comparison of GlideScope Video Laryngoscopy Versus Direct Laryngoscopy Intubation in the Emergency Department

OBJECTIVES The first-attempt success rate of intubation was compared using GlideScope video laryngoscopy and direct laryngoscopy in an emergency department (ED). METHODS A prospective observational study was conducted of adult patients undergoing intubation in the ED of a Level 1 trauma center with an emergency medicine residency program. Patients were consecutively enrolled between August 2006 and February 2008. Data collected included indication for intubation, patient characteristics, device used, initial oxygen saturation, and resident postgraduate year. The primary outcome measure was success with first attempt. Secondary outcome measures included time to successful intubation, intubation failure, and lowest oxygen saturation levels. An attempt was defined as the introduction of the laryngoscope into the mouth. Failure was defined as an esophageal intubation, changing to a different device or physician, or inability to place the endotracheal tube after three attempts. RESULTS A total of 280 patients were enrolled, of whom video laryngoscopy was used for the initial intubation attempt in 63 (22%) and direct laryngoscopy was used in 217 (78%). Reasons for intubation included altered mental status (64%), respiratory distress (47%), facial trauma (9%), and immobilization for imaging (9%). Overall, 233 (83%) intubations were successful on the first attempt, 26 (9%) failures occurred, and one patient received a cricothyrotomy. The first-attempt success rate was 51 of 63 (81%, 95% confidence interval [CI] = 70% to 89%) for video laryngoscopy versus 182 of 217 (84%, 95% CI = 79% to 88%) for direct laryngoscopy (p = 0.59). Median time to successful intubation was 42 seconds (range, 13 to 350 seconds) for video laryngoscopy versus 30 seconds (range, 11 to 600 seconds) for direct laryngoscopy (p < 0.01). CONCLUSIONS Rates of successful intubation on first attempt were not significantly different between video and direct laryngoscopy. However, intubation using video laryngoscopy required significantly more time to complete.

Accuracy of the Emergency Severity Index triage instrument for identifying elder emergency department patients receiving an immediate life-saving intervention.

OBJECTIVES The study objective was to determine the sensitivity and specificity of the Emergency Severity Index (ESI) triage instrument for the identification of elder patients receiving an immediate life-saving intervention in the emergency department (ED). METHODS The authors reviewed medical records for consecutive patients 65 years or older who presented to a single academic ED serving a large community of elders during a 1-month period. ESI triage scores were compared to actual ED course with attention to the occurrence of an immediate life-saving intervention. The sensitivity and specificity of an ESI triage level of 1 for the identification of patients receiving an immediate intervention was calculated. For 50 cases, the triage nurse ESI designation was compared to the triage level determined by an expert triage nurse based on retrospective record review. RESULTS Of 782 consecutive patients 65 years or older who presented to the ED, 18 (2%) had an ESI level of 1, 176 (23%) had an ESI level of 2, 461 (60%) had an ESI level of 3, 100 (13%) had an ESI level of 4, and 18 (2%) had an ESI level of 5. Twenty-six patients received an immediate life-saving intervention. ESI triage scores for these 26 individuals were as follows: ESI 1, 11 patients; ESI 2, nine patients; and ESI 3, six patients. The sensitivity of ESI to identify patients receiving an immediate intervention was 42.3% (95% confidence interval [CI]=23.3% to 61.3%); the specificity was 99.2% (95% CI=98.0% to 99.7%). For 17 of 50 cases in which actual triage nurse and expert nurse ESI levels disagreed, undertriage by the triage nurses was more common than overtriage (13 vs. 4 patients). CONCLUSIONS The ESI triage instrument identified fewer than half of elder patients receiving an immediate life-saving intervention. Failure to follow established ESI guidelines in the triage of elder patients may contribute to apparent undertriage.

Geriatric Emergency Department guidelines

INTRODUCTION According to the 2010 Census, more than 40 million Americans were over the age of 65, which was “more people than in any previous census.” In addition, “between 2000 and 2010, the population 65 years and over increased at a faster rate than the total U.S. population.” The census data also demonstrated that the population 85 and older is growing at a rate almost three times the general population. The subsequent increased need for health care for this burgeoning geriatric population represents an unprecedented and overwhelming challenge to the American health care system as a whole and to emergency departments (EDs) specifically. Geriatric EDs began appearing in the United States in 2008 and have become increasingly common. The ED is uniquely positioned to play a role in improving care to the geriatric population. As an ever-increasing access point for medical care, the ED sits at a crossroads between inpatient and outpatient care (Figure 1). Specifically, the ED represents 57% of hospital admissions in the United States, of which almost 70% receive a non-surgical diagnosis. The expertise which an ED staff can bring to an encounter with a geriatric patient can meaningfully impact not only a patient’s condition, but can also impact the decision to utilize relatively expensive inpatient modalities, or less expensive outpatient treatments. Emergency medicine experts recognize similar challenges around the world. Geriatric ED core principles have been described in the United Kingdom. Furthermore, as the initial site of care for both inpatient and outpatient events, the care provided in the ED has the opportunity to “set the stage” for subsequent care provided. More accurate diagnoses and improved therapeutic measures can not only expedite and improve inpatient care and outcomes, but can effectively guide the allocation of resources towards a patient population that, in general, utilizes significantly more resources per event than younger populations. Geriatric ED patients

Predicting hospital admission and returns to the emergency department for elderly patients.

OBJECTIVES Methods to accurately identify elderly patients with a high likelihood of hospital admission or subsequent return to the emergency department (ED) might facilitate the development of interventions to expedite the admission process, improve patient care, and reduce overcrowding. This study sought to identify variables found among elderly ED patients that could predict either hospital admission or return to the ED. METHODS All visits by patients 75 years of age or older during 2007 at an academic ED serving a large community of elderly were reviewed. Clinical and demographic data were used to construct regression models to predict admission or ED return. These models were then validated in a second group of patients 75 and older who presented during two 1-month periods in 2008. RESULTS Of 4,873 visits, 3,188 resulted in admission (65.4%). Regression modeling identified five variables statistically related to the probability of admission: age, triage score, heart rate, diastolic blood pressure, and chief complaint. Upon validation, the c-statistic of the receiver operating characteristic (ROC) curve was 0.73, moderately predictive of admission. We were unable to produce models that predicted ED return for these elderly patients. CONCLUSIONS A derived and validated triage-based model is presented that provides a moderately accurate probability of hospital admission of elderly patients. If validated experimentally, this model might expedite the admission process for elderly ED patients. Our models failed, as have others, to accurately predict ED return among elderly patients, underscoring the challenge of identifying those individuals at risk for early ED returns.

Emergency Medical Services Use by the Elderly: Analysis of a Statewide Database

Abstract Background. Elderly patients use emergency medical services (EMS) at a high rate. Objectives. To test the hypothesis that EMS use for emergency department (ED) transports increases across the life span and to estimate changes in the EMS volume in North Carolina (NC) during the next 20 years due to the aging of the population. Methods. We conducted a retrospective observational study of EMS transports to EDs in the state of NC in 2007. Data were obtained from the North Carolina Disease Event Tracking and Epidemiologic Collection Tool (NC DETECT), which records data for all visits to 105 of the 112 EDs in the state. The association between EMS use and age was assessed using the chi-square test for trend. State demographic projections (U.S. Census Bureau) were used to estimate the increase in EMS use over the next 20 years due to population aging. Results. There were 3,853,866 NC ED visits recorded in 2007. Complete arrival and disposition data were available for 2,743,221 visits (71.2%). Patient visits with and without complete data were similar in mean age (37.4 vs. 37.8 years), percentage female (55.4% vs. 56.1%), and use of EMS (16.9% vs. 16.8%). Visits with complete data were used in the analyses. The proportion of ED visits in which the patient was brought by EMS increased steadily across the life span (p < 0.001). Visits by individuals 65 years of age or older accounted for 14.7% of all visits and 38.3% of all EMS transports to the ED. For those patients aged 85 years and older, EMS was the most common mode of ED arrival (60.6%). We estimate that by 2030, total EMS transports to NC EDs will increase by 47%. Patients 65 years of age and older are projected to account for 70% of this increase and to compose 49% of all EMS transports by 2030. Conclusions. The proportion of patients using EMS to reach NC EDs increases steadily with age. By 2030, older patients will account for approximately half of EMS transports to NC EDs. The changes likely exemplify national trends and highlight the growth of EMS service needs for the elderly and the importance of emphasizing geriatric care in EMS training.

Evolving Prehospital, Emergency Department, and "Inpatient" Management Models for Geriatric Emergencies

Alternative management methods are essential to ensure high-quality and efficient emergency care for the growing number of geriatric adults worldwide. Protocols to support early condition-specific treatment of older adults with acute severe illness and injury are needed. Improved emergency department care for older adults will require providers to address the influence of other factors on the patients health. This article describes recent and ongoing efforts to enhance the quality of emergency care for older adults using alternative management approaches spanning the spectrum from prehospital care, through the emergency department, and into evolving inpatient or outpatient processes of care.

Motor Vehicle Collision-related Emergency Department Visits by Older Adults in the United States

OBJECTIVES Motor vehicle collisions (MVCs) are the second most common cause of nonfatal injury among U.S. adults age 65 years and older. However, the frequency of emergency department (ED) visits, disposition, pain locations, and pain severity for older adults experiencing MVCs have not previously been described. The authors sought to determine these characteristics using information from two nationally representative data sets. METHODS Data from the 2008 Healthcare Cost and Utilization Project Nationwide Emergency Department Sample (NEDS) and the National Hospital Ambulatory Medical Care Survey (NHAMCS) were used to estimate MVC-related ED visits and ED disposition for patients 65 years and older. NHAMCS data from 2004 through 2008 were used to further characterize MVC-related ED visits. RESULTS   In 2008, the NEDS contained 28,445,564 patient visits, of which 760,356 (2.7%) were due to MVCs. The NHAMCS contained 34,134 patient visits, of which 1,038 (3.0%) were due to MVCs. National estimates of MVC-related ED visits by patients 65 years and older in 2008 are 226,000 (95% confidence interval [CI]=210,000 to 240,000) for NEDS and 270,000 (95% CI=185,000 to 355,000) for NHAMCS. Most older adults with MVC-related ED visits were sent home from the ED (proportion discharged NEDS 78%, 95% CI=78% to 79%; NHAMCS 77%, 95% CI=66% to 86%). During the years 2004 through 2008, of MVC-related ED visits by older adults not resulting in hospital admission, moderate or severe pain was reported in 61% (95% CI=52% to 70%) of those with recorded pain scores. Older patients sent home after MVC-related ED visits were less likely than younger patients to receive analgesics (35%, 95% CI=26% to 43% vs. 47%, 95% CI=44% to 50%) during their ED evaluations or as discharge prescriptions (52%, 95% CI=41% to 62% vs. 65%, 95% CI=61% to 68%). CONCLUSIONS In 2008, adults age 65 years or older made more than 200,000 MVC-related ED visits. Approximately 80% of these visits were discharged home from the ED, but the majority of discharged patients reported moderate or severe pain. Further studies of pain and functional outcomes in this population are needed.

Using emergency department-based inception cohorts to determine genetic characteristics associated with long term patient outcomes after motor vehicle collision: Methodology of the CRASH study

BackgroundPersistent musculoskeletal pain and psychological sequelae following minor motor vehicle collision (MVC) are common problems with a large economic cost. Prospective studies of pain following MVC have demonstrated that demographic characteristics, including female gender and low education level, and psychological characteristics, including high pre-collision anxiety, are independent predictors of persistent pain. These results have contributed to the psychological and social components of a biopsychosocial model of post-MVC pain pathogenesis, but the biological contributors to the model remain poorly defined. Recent experimental studies indicate that genetic variations in adrenergic system function influence the vulnerability to post-traumatic pain, but no studies have examined the contribution of genetic factors to existing predictive models of vulnerability to persistent pain.Methods/DesignThe Project CRASH study is a federally supported, multicenter, prospective study designed to determine whether variations in genes affecting synaptic catecholamine levels and alpha and beta adrenergic receptor function augment social and psychological factors in a predictive model of persistent musculoskeletal pain and posttraumatic stress disorder (PTSD) following minor MVC. The Project CRASH study will assess pain, pain interference and PTSD symptoms at 6 weeks, 6 months, and 1 year in approximately 1,000 patients enrolled from 8 Emergency Departments in four states with no-fault accident laws.DiscussionThe results from this study will provide insights into the pathophysiology of persistent pain and PTSD following MVC and may serve to improve the ability of clinicians and researchers to identify individuals at high risk for adverse outcomes following minor MVC.

Optimal older adult emergency care: introducing multidisciplinary geriatric emergency department guidelines from the American College of Emergency Physicians, American Geriatrics Society, Emergency Nurses Association, and Society for Academic Emergency Medicine.

In the United States and around the world, effective, efficient, and reliable strategies to provide emergency care to aging adults is challenging crowded emergency departments (EDs) and strained healthcare systems. In response, geriatric emergency medicine clinicians, educators, and researchers collaborated with the American College of Emergency Physicians, American Geriatrics Society, Emergency Nurses Association, and Society for Academic Emergency Medicine to develop guidelines intended to improve ED geriatric care by enhancing expertise, educational, and quality improvement expectations, equipment, policies, and protocols. These Geriatric Emergency Department Guidelines represent the first formal society‐led attempt to characterize the essential attributes of the geriatric ED and received formal approval from the boards of directors of each of the four societies in 2013 and 2014. This article is intended to introduce emergency medicine and geriatric healthcare providers to the guidelines while providing recommendations for continued refinement of these proposals through educational dissemination, formal effectiveness evaluations, cost‐effectiveness studies, and eventually institutional credentialing.