Delays in reporting and publishing trial results during pandemics: cross sectional analysis of 2009 H1N1, 2014 Ebola, and 2016 Zika clinical trials.

BACKGROUND: Pandemic events often trigger a surge of clinical trial activity aimed at rapidly evaluating therapeutic or preventative interventions. Ensuring rapid public access to the complete and unbiased trial record is particularly critical for pandemic research given the urgent associated public health needs. The World Health Organization (WHO) established standards requiring posting of results to a registry within 12 months of trial completion and publication in a peer reviewed journal within 24 months of completion, though compliance with these requirements among pandemic trials is unknown. METHODS: This cross-sectional analysis characterizes availability of results in trial registries and publications among registered trials performed during the 2009 H1N1 influenza, 2014 Ebola, and 2016 Zika pandemics. We searched trial registries to identify clinical trials testing interventions related to these pandemics, and determined the time elapsed between trial completion and availability of results in the registry. We also performed a comprehensive search of MEDLINE via PubMed, Google Scholar, and EMBASE to identify corresponding peer reviewed publications. The primary outcome was the compliance with either of the WHO's established standards for sharing clinical trial results. Secondary outcomes included compliance with both standards, and assessing the time elapsed between trial completion and public availability of results. RESULTS: Three hundred thirty-three trials met eligibility criteria, including 261 H1N1 influenza trials, 60 Ebola trials, and 12 Zika trials. Of these, 139 (42%) either had results available in the trial registry within 12 months of study completion or had results available in a peer-reviewed publication within 24 months. Five trials (2%) met both standards. No results were available in either a registry or publication for 59 trials (18%). Among trials with registered results, a median of 42 months (IQR 16-76 months) elapsed between trial completion and results posting. For published trials, the median elapsed time between completion and publication was 21 months (IQR 9-34 months). Results were available within 24 months of study completion in either the trial registry or a peer reviewed publication for 166 trials (50%). CONCLUSIONS: Very few trials performed during prior pandemic events met established standards for the timely public dissemination of trial results.

A hybrid model of acute unscheduled cancer care provided by a hospital-based acute care clinic and the emergency department: a descriptive study.

PURPOSE: Patients with cancer often experience medical events that require immediate evaluation. These evaluations typically occur in an emergency department (ED), but there is increasing interest in providing this care in other settings. We report on a novel care model whereby a nursing hotline is used to triage patients to the ED or to the North Carolina Cancer Hospital Infusion Center (NCCHIC). METHODS: A retrospective study of adult patients with a neoplasm diagnosis seeking acute care at a large academic hospital pre- and post-initiation of the novel care model in January of 2016. Patients were identified by querying the electronic medical record and clinic administrative data during matched 6 month pre- and post-periods. RESULTS: During the pre-initiation period, 1346 patients visited the ED on 1651 occasions (76.1% admission rate). In the post-initiation period, 1434 patients visited the ED on 1797 occasions (81.5% admission rate), and 246 patients visited the NCCHIC on 322 occasions (68.9% admission rate). The emergency severity index (ESI) in the pre-initiation ED group was primarily ESI 2 (30.6%) and ESI 3 (65.4%). In the post-initiation ED group, the ESI was similar (32.6% ESI 2 and 64.2% ESI 3). In contrast, the NCCHIC predominantly treated lower acuity patients (65.8% calculated ESI of 4/5). CONCLUSIONS: This model demonstrates a multidisciplinary partnership to providing acute unscheduled care for patients with cancer. In the early implementation phase of this model, approximately 15% of patients, generally of lower acuity, were seen in the NCCHIC.

Forecasting emergency department hourly occupancy using time series analysis.

STUDY OBJECTIVE: To develop a novel predictive model for emergency department (ED) hourly occupancy using readily available data at time of prediction with a time series analysis methodology. METHODS: We performed a retrospective analysis of all ED visits from a large academic center during calendar year 2012 to predict ED hourly occupancy. Due to the time-of-day and day-of-week effects, a seasonal autoregressive integrated moving average with external regressor (SARIMAX) model was selected. For each hour of a day, a SARIMAX model was built to predict ED occupancy up to 4-h ahead. We compared the resulting model forecast accuracy and prediction intervals with previously studied time series forecasting methods. RESULTS: The study population included 65,132 ED visits at a large academic medical center during the year 2012. All adult ED visits during the first 265 days were used as a training dataset, while the remaining ED visits comprised the testing dataset. A SARIMAX model performed best with external regressors of current ED occupancy, average department-wide ESI, and ED boarding total at predicting up to 4-h-ahead ED occupancy (Mean Square Error (MSE) of 16.20, and 64.47 for 1-hr- and 4-h- ahead occupancy, respectively). Our 24-SARIMAX model outperformed other popular time series forecasting techniques, including a 60% improvement in MSE over the commonly used rolling average method, while maintaining similar prediction intervals. CONCLUSION: Accounting for current ED occupancy, average department-wide ESI, and boarding total, a 24-SARIMAX model was able to provide up to 4 h ahead predictions of ED occupancy with improved performance characteristics compared to other forecasting methods, including the rolling average. The prediction intervals generated by this method used data readily available in most EDs and suggest a promising new technique to forecast ED occupancy in real time.

Characteristics, clinical care, and disposition barriers for mental health patients boarding in the emergency department.

BACKGROUND AND OBJECTIVES: Lack of mental health resources, such as inpatient psychiatric beds, has increased frequency and duration of boarding for mental health patients presenting to U.S. emergency departments (EDs). The purpose of this study is to describe characteristics of mental health patients with an ED length of stay of one week or longer and to identify barriers to their disposition. METHODS: This study was conducted in an academic ED in which emergency psychiatric evaluations and care are provided by a Psychiatric Emergency Services (PES) team contained within the Department of Emergency Medicine. Prolonged boarding was defined as an ED length of stay of 7 days or more. Pediatric, adult, and geriatric mental health patients with prolonged ED boarding from January 1 to August 31, 2019 were included. This study includes prospective data collection of the boarding group and retrospective identification and data collection of a comparison group of non-barding patients over the same 8-month period to compare patient characteristics and outcomes for each group. RESULTS: Between January 1 and August 31, 2019, the PES team completed 2,745 new assessments of mental health patients, of whom 39 met criteria for prolonged ED boarding. The following characteristics were associated with boarding: child (8%), male (64%), having Medicaid (49%) or both Medicaid and Medicare (18%), and having either a neurodevelopmental (15%) or neurocognitive disorder (15%) with a median stay of 18 days. Barriers to discharge included being declined from all state inpatient psychiatric hospitals (69%), declined from community living environments (21%), or declined from both (10%). The most common ED non-boarding patients were: Caucasian (64%), have a diagnosis of unspecified mental disorder (including suicidal ideation) or other specified mental disorder (59%) and have private insurance (42%) with a median stay of 1 day. CONCLUSION: In this study of mental health patients with prolonged ED stays, the primary barrier to disposition was the lack of patient acceptance to inpatient psychiatric hospitals, community settings, or other housing. Early identification of potential prolonged boarding, quality treatment and care for those patients, and effective case management, may resolve the ongoing challenges of boarding within the ED.

Reliability of the longitudinal experts all data (LEAD) methodology for determining the presence of elder mistreatment.

Developing reliable screening tools to identify elder mistreatment requires an accurate and reproducible reference standard. This study sought to investigate the reliability of the Longitudinal, Experts, All Data (LEAD) methodology as a reference standard in confirming presence of elder mistreatment. We analyzed data from a large, emergency department-based study that used a LEAD panel to determine the reference standard. For this study, a second, blinded LEAD panel reviewed clinical material for 40 patients. For each panel, five content experts voted on whether elder mistreatment was present. We found moderate agreement between the two LEAD panels in determining presence of elder mistreatment: 85% agreement; k = 0.58; 95% Confidence Interval 0.28-0.87. Individual raters for both LEAD panels reported being mostly certain or certain >90% of votes. Efforts to further characterize and improve the reliability of the LEAD methodology in this context are warranted.

Research priorities for elder abuse screening and intervention: A Geriatric Emergency Care Applied Research (GEAR) network scoping review and consensus statement.

The Geriatric Emergency Care Applied Research (GEAR) Network (1) conducted a scoping review of the current literature on the identification of and interventions to address elder abuse among patients receiving care in emergency departments and (2) used this review to prioritize research questions for knowledge development. Two questions guided the scoping review: What is the effect of universal emergency department screening compared to targeted screening or usual practice on cases of elder abuse identified, safety outcomes, and health care utilization?; and What is the safety, health, legal, and psychosocial impact of emergency department-based interventions vs. usual care for patients experiencing elder abuse? We searched five article databases. Additional material was located through reference lists of identified publications, PsychInfo, and Google Scholar. The results were discussed in a consensus conference; and stakeholders voted to prioritize research questions. No studies were identified that directly addressed the first question regarding assessment strategies, but four instruments used for elder abuse screening in the emergency department were identified. For the second question, we located six articles on interventions for elder abuse in the emergency department; however, none directly addressed the question of comparative effectiveness. Based on these findings, GEAR participants identified five questions as priorities for future research - two related to screening, two related to intervention, and one encompassed both. In sum, research to identify best practices for elder abuse assessment and intervention in emergency departments is still needed. Although there are practical and ethical challenges, rigorous experimental studies are needed.

Multicenter Validation of an Emergency Department-Based Screening Tool to Identify Elder Abuse.

STUDY OBJECTIVE: Emergency department (ED) visits provide an important opportunity for elder abuse identification. Our objective was to assess the accuracy of the ED Senior Abuse Identification (ED Senior AID) tool for the identification of elder abuse. METHODS: We conducted a study of the ED Senior AID tool in 3 US EDs. Participants were English-speaking patients 65 years old and older who provided consent or for whom a legally authorized representative provided consent. Research nurses administered the screening tool, which includes a brief mental status assessment, questions about elder abuse, and a physical examination for patients who lack the ability to report abuse or for whom the presence or absence of abuse was uncertain. The reference standard was based on the majority opinion of a longitudinal, expert, all data (LEAD) panel following review and discussion of medical records, clinical social worker notes, and a structured social and behavioral evaluation. For the reference standard, LEAD panel members were blinded to the results of the screening tool. RESULTS: Of 916 enrolled patients, 33 (3.6%) screened positive for elder abuse. The LEAD panel reviewed 125 cases: all 33 with positive screen results and a 10% random sample of negative screen results. Of these, the panel identified 17 cases as positive for elder abuse, including 16 of the 33 cases that screened positive. The ED Senior AID tool had a sensitivity of 94.1% (95% confidence interval [CI] 71.3% to 99.9%) and specificity of 84.3% (95% CI 76.0% to 90.6%). CONCLUSION: This multicenter study found the ED Senior AID tool to have a high sensitivity and specificity as a screening tool for elder abuse, albeit with wide CIs.

Screening for elder mistreatment in emergency departments: current progress and recommendations for next steps.

Emergency Department (ED) visits provide an important but seldom realized opportunity to identify elder mistreatment. Many screening tools exist, including several that are brief and may be effective, but few have been specifically designed for or tested in EDs. In addition to the absence of validated tools, other challenges with implementing ED elder mistreatment screening include difficulty integrating anything longer than a few questions into a busy clinical encounter and resources required to respond to positive screens. The Electronic Health Record (EHR) offers a critical tool to facilitate elder mistreatment screening through required data entry and real-time monitoring of compliance and results. We describe current work in the field and recommend next steps including design and testing of a two-step screening process, implementation research to accelerate adoption, development of ED-based interventions and referral protocols for positive cases, and consideration of the important role of pre-hospital providers in case identification.

Patient navigation for complex care patients in the emergency department: a survey of oncology patient navigators.

PURPOSE: Emergency departments (EDs) care for patients with complex medical problems who require a coordinated care approach. Patient navigation services, which help assist patients with care coordination, have been widely implemented for patients with cancer in a variety of settings, but this approach has not been described in the ED. We sought to better understand the potential for ED-based patient navigation services from the perspective of individuals currently providing these services in other settings. METHODS: A survey was conducted of participants at a regional conference for patient navigation services of patients with cancer. RESULTS: Eighty-five completed surveys were returned representing a response rate of 64%. Ninety-one percent of responses indicated that lay navigation services would be either very helpful or moderately helpful for either ED patients with cancer or for ED patients aged 65 years or older with or without cancer in an ED. Coordination of care, the provision of emotional support and educational resources relevant to their medical conditions, and providing companionship to older patients during the ED visits were identified as priorities for an ED-based lay navigation program. The lack of navigators with experience in the ED, the physical space constraints of the ED, and the time constraints associated with an ED visit were identified as the primary barriers to establishing a lay navigation program in the ED. CONCLUSIONS: These results identify the care priorities and barriers to be overcome during the development of an ED-based lay navigation program from the perspective of those currently providing patient navigator services.

Predictors of 30-Day Return Following an Emergency Department Visit for Older Adults.

BACKGROUND Older adults who are discharged following emergency department evaluation are at increased risk for functional decline and health care utilization, and are likely to benefit from close follow-up and additional care services. Understanding factors associated with a return emergency department visit within 30 days among older fee-for-service Medicare beneficiaries discharged to the community may assist in identifying patients at greatest need for interventions.METHOD Predictors from Medicare data and public sources were evaluated in a retrospective data analysis of North and South Carolina residents (2011-2012) aged ≥ 65 years using Cox regression proportion hazards ratios (HR) and 95% confidence intervals (CI) for time-to-30-day return events.RESULTS 30-day return rates varied markedly among the 167 emergency department facilities studied (18%-39%). Predictors of 30-day return included: age (85+ versus 65-74; HR, 1.24; 95% CI, 1.22-1.27); male sex (HR, 1.11; 95% CI, 1.14-1.10); non-white race (HR, 1.07; 95% CI, 1.05-1.09); Medicaid eligibility (HR, 1.20; 95% CI, 1.18-1.22); Charlson Score (3+ vs. 0; HR, 1.33; 95% CI, 1.30-1.36); and prior emergency department encounter (3+ vs. 0; HR, 2.35; 95% CI 2.30-2.41).LIMITATIONS This study was limited to Medicare beneficiaries in North Carolina and South Carolina, 2011-2012. Administrative claims data are limited to information required for financial reimbursement. Because we limited our study to older fee-for-service patients, our findings may not be generalizable to managed care patients and other age groups. Patients transferred to another emergency department or facility were not included in the analysis.CONCLUSION Factors predicting 30-day return to the emergency department or hospitalization suggest the potential for care transition improvement efforts to better meet patient needs, thereby potentially improving post-emergency department outcomes.

Measuring a Crisis: Questioning the Use of Naloxone Administrations as a Marker for Opioid Overdoses in a Large U.S. EMS System.

OBJECTIVE: The United States is currently experiencing a public health crisis of opioid overdoses. To determine where resources may be most needed, many public health officials utilize naloxone administration by EMS as an easily-measured surrogate marker for opioid overdoses in a community. Our objective was to evaluate whether naloxone administration by EMS accurately represents EMS calls for opioid overdose. We hypothesize that naloxone administration underestimates opioid overdose. METHODS: We conducted a chart review of suspected overdose patients and any patients administered naloxone in Wake County, North Carolina, from January 2013 to December 2015. Patient care report narratives and other relevant data were extracted from electronic patient care records and the resultant database was analyzed by two EMS physicians. Cases were divided into categories including "known opioid use," "presumed opioid use," "no known opioid," "altered mental status," "cardiac arrest with known opioid use," "cardiac arrest with no known opioid use," or "suspected alcohol intoxication," and then further separated based on whether naloxone was administered. Patient categories were compared by patient demographics and incident year. Using the chart review classification as the gold standard, we calculated the sensitivity and positive predictive value (PPV) of naloxone administration for opioid overdose. RESULTS: A total of 4,758 overdose cases from years 2013-15 were identified. During the same period, 1,351 patients were administered naloxone. Of the 1,431 patients with known or presumed opioid use, 57% (810 patients) received naloxone and 43% (621 patients) did not. The sensitivity of naloxone administration for the identification of patients with known or presumed opioid use was 57% (95% CI: 54%-59%) and the PPV was 60% (95% CI: 57%-63%). CONCLUSION: Among patients receiving care in this large urban EMS system in the United States, the overall sensitivity and positive predictive value for naloxone administration for identifying opioid overdoses was low. Better methods of identifying opioid overdose trends are needed to accurately characterize the burden of opioid overdose within and among communities.

Development of the Emergency Department Senior Abuse Identification (ED Senior AID) tool.

Emergency departments (EDs) are an important health care setting for the identification of elder abuse (EA). Our objective was to develop an ED-based tool to identify EA. The initial tool included a brief cognitive assessment, questions to detect multiple domains of EA, and a physical examination. Refinement of the tool was based on input from clinical experts and nurse and patient feedback. The revised tool, which included 15 questions about EA, was then tested in an academic ED. We calculated the inter-rater reliability, sensitivity, and specificity of individual EA questions. Among ED patients age≥65 (N = 259), 17 (7%) screened positive for suspicion of EA. We identified a combination of six questions that cover the included domains of EA, demonstrated good or excellent inter-rater reliability, and had a sensitivity and specificity of 94% (95% confidence interval (CI) 71-100%) and 90% (95% CI 85-93%), respectively. These results inform a proposed screening tool for multisite validation testing.

Post-Traumatic Stress Disorder among Older Adults Experiencing Motor Vehicle Collision: A Multicenter Prospective Cohort Study.

OBJECTIVE: To characterize risk factors for and consequences of post-traumatic stress disorder (PTSD) among older adults evaluated in the emergency department (ED) following motor vehicle collision (MVC). DESIGN: Prospective multicenter longitudinal study (2011-2015). SETTING: 9 EDs across the United States. PARTICIPANTS: Adults aged 65 years and older who presented to an ED after MVC without severe injuries. MEASUREMENTS: PTSD symptoms were assessed 6 months after the ED visit using the Impact of Event Scale-Revised. RESULTS: Of 223 patients, clinically significant PTSD symptoms at 6 months were observed in 21% (95% CI 16%-26%). PTSD symptoms were more common in patients who did not have a college degree, had depressive symptoms prior to the MVC, perceived the MVC as life-threatening, had severe ED pain, and expected their physical or emotional recovery time to be greater than 30 days. Three factors (ED pain severity [0-10 scale], perceived life-threatening MVC [0-10 scale], and pre-MVC depressive symptoms [yes to either of two questions]), predicted 6-month PTSD symptoms with an area under the curve of 0.76. Compared to patients without PTSD symptoms, those with PTSD symptoms were at higher risk for persistent pain (72% versus 30%), functional decline (67% versus 42%), and new disability (49% versus 18%). CONCLUSIONS: Among older adults treated in the ED following MVC, clinically significant PTSD symptoms at 6 months were present in 21% of patients and were associated with adverse health outcomes. Increased risk for PTSD development can be identified with moderate accuracy using information readily available in the ED.

Repeated Emergency Medical Services Use by Older Adults: Analysis of a Comprehensive Statewide Database.

STUDY OBJECTIVE: The objective of this study is to characterize repeated emergency medical services (EMS) transports among older adults across a large and socioeconomically diverse region. METHODS: Using the North Carolina Prehospital Medical Information System, we analyzed the frequency of repeated EMS transports within 30 days of an index EMS transport among adults aged 65 years and older from 2010 to 2015. We used multivariable logistic regressions to determine characteristics associated with repeated EMS transport. RESULTS: During the 6-year period, EMS performed 1,711,669 transports for 689,664 unique older adults in North Carolina. Of these, 303,099 transports (17.7%) were followed by another transport of the same patient within 30 days. The key characteristics associated with an increased adjusted odds ratio of repeated transport within 30 days include transport from an institutionalized setting (odds ratio [OR] 1.42; 95% confidence interval [CI] 1.38 to 1.47), blacks compared with whites (OR 1.29; 95% CI 1.24 to 1.33), a dispatch complaint of psychiatric problems (OR 1.38; 95% CI 1.25 to 1.52), back pain (OR 1.35; 95% CI 1.26 to 1.45), breathing problems (OR 1.21; 95% CI 1.15 to 1.30), and diabetic problems (OR 1.14; 95% CI 1.06 to 1.22). Falls accounted for 15.6% of all transports and had a modest association with repeated transports (OR 1.07; 95% CI 1.00 to 1.14). CONCLUSION: More than 1 in 6 EMS transports of older adults in North Carolina are followed by a repeated transport of the same patient within 30 days. Patient characteristics and chief complaints may identify increased risk for repeated transport and suggest the potential for targeted interventions to improve outcomes and manage EMS use.

Prehospital Fluid Administration in Trauma Patients: A Survey of State Protocols.

OBJECTIVE: The optimal resuscitation approach during the initial treatment of hypotensive trauma patients remains unknown, but some clinical trials have observed a survival benefit from restricting fluid administration prior to definitive hemorrhage control. We sought to characterize emergency medical services (EMS) protocols for the administration of intravenous fluids in this setting. METHODS: Publicly accessible statewide EMS protocols for the treatment of hypotensive trauma patients were included and characterized by: 1) goal of fluid administration, 2) dosing strategy, 3) maximum dose, 4) type of fluid, and 5) specific protocols for head trauma, if present. RESULTS: Of the 27 states with a publicly available, statewide protocol, 21 have a numeric systolic blood pressure (SBP) target for resuscitation. Of these, 16 describe a goal of maintaining SBP ≥90 mmHg with or without additional goals, three specify a goal that is less than 90 mmHg, and two specify a goal ≥100 mHg. Dosing strategies also vary and include both standard bolus strategies (200 mL, 250 mL, 500 mL, and 1 L with repeat) as well as weight-based strategies (20 mL/kg). Nine states specify a maximum dose of 2 L without medical control. Fifteen protocols recommend the use of normal saline, 1 recommends the use of lactated Ringer's, and 11 recommend the use of either normal saline or lactated Ringer's. Nine states have distinct protocols for patients with head trauma, all of which indicate maintaining a higher SBP than for trauma patients without head trauma. CONCLUSION: State EMS protocols for fluid administration for hypotensive trauma patients vary in regard to SBP goal, fluid dose, and fluid type. Clinical trials to determine the optimal use of intravenous fluids for hypotensive trauma patients are needed to define the optimal approach.

Musculoskeletal Injures in Older Adults: Preventing the Transition to Chronic Pain and Disability.

The increase in the number of active and independent older adults has, unfortunately, led to an epidemic of musculoskeletal injuries in this population. Chronic pain and functional decline are common sequelae from these injuries and have a major impact on quality of life. Optimizing care for these patients will likely require educating patients about analgesic risks and benefits, promoting physical activity, identifying and addressing the psychological impacts of the injury, and coordinating care between emergency physicians, orthopedists, and primary providers. Active management of acute musculoskeletal pain has the potential to prevent the transition to chronic pain and disability in this vulnerable population.

Self-Reported Versus Performance-Based Assessments of a Simple Mobility Task Among Older Adults in the Emergency Department.

STUDY OBJECTIVE: Accurate information about the mobility of independently living older adults is essential in determining whether they may be safely discharged home from the emergency department (ED). We assess the accuracy of self-reported ability to complete a simple mobility task among older ED patients. METHODS: This was a cross-sectional study of cognitively intact patients aged 65 years and older who were neither nursing home residents nor critically ill, conducted in 2 academic EDs. Consenting participants were asked whether they could get out of bed, walk 10 feet, turn around, and get back in bed without assistance, and if not, whether they could perform this task with a cane, walker, or assistance. Each participant was then asked to perform the task and was provided with a mobility device or assistance as needed. RESULTS: Of 272 patients who met eligibility criteria and answered the physical task question, 161 (59%) said they could do the task unassisted, 45 (17%) said they could do it with a cane or walker, 21 (8%) said they could do it with assistance, and 45 (17%) said they would be unable to do it even with assistance. Among those who said they could do the task either with or without assistance and who were subsequently willing to attempt the task (N=172), discrepancies between self-reported ability and actual performance were common. Of those who said they could perform the task without assistance, 12% required some assistance or were unable to complete the task. Of those who said they could perform the task with a cane or walker, 48% required either assistance or were unable to perform the task. Of those who said they could perform the task with assistance, 24% were unable to perform the task even with assistance. CONCLUSION: In this sample of older adults receiving care in the ED, the accuracy of their self-reported ability to perform a simple mobility task was poor, particularly for those who reported some need for assistance. For older adults being considered for discharge who report a need for assistance with mobility, direct observation of the patient's mobility by a member of the emergency care team should be considered.

Persistent Pain Among Older Adults Discharged Home From the Emergency Department After Motor Vehicle Crash: A Prospective Cohort Study.

STUDY OBJECTIVE: Motor vehicle crashes are the second most common form of trauma among older adults. We seek to describe the incidence, risk factors, and consequences of persistent pain among older adults evaluated in the emergency department (ED) after a motor vehicle crash. METHODS: We conducted a prospective longitudinal study of patients aged 65 years or older who presented to one of 8 EDs after motor vehicle crash between June 2011 and June 2014 and were discharged home after evaluation. ED evaluation was done through in-person interview; follow-up data were obtained through mail-in survey or telephone call. Pain severity (0 to 10 scale) overall and for 15 parts of the body were assessed at each follow-up point. Principal component analysis was used to assess the dimensionality of the locations of pain data. Participants reporting pain severity greater than or equal to 4 attributed to the motor vehicle crash at 6 months were defined as having persistent pain. RESULTS: Of the 161 participants, 72% reported moderate to severe pain at the ED evaluation. At 6 months, 26% of participants reported moderate to severe motor vehicle crash-related pain. ED characteristics associated with persistent pain included acute pain severity; pain located in the head, neck, and jaw or lower back and legs; poor self-rated health; less formal education; pre-motor vehicle crash depressive symptoms; and patient's expected time to physical recovery more than 30 days. Compared with individuals without persistent pain, those with persistent pain were substantially more likely at 6-month follow-up to have also experienced a decline in their capacity for physical function (73% versus 36%; difference=37%; 95% confidence interval [CI] 19% to 52%), a new difficulty with activities of daily living (42% versus 17%; difference=26%; 95% CI 10% to 43%), a 1-point or more reduction in overall self-rated health on a 5-point scale (54% versus 30%; difference=24%; 95% CI 6% to 41%), and a change in their living situation to obtain additional help (23% versus 8%; difference=15%; 95% CI 2% to 31%). CONCLUSION: Among older adults discharged home from the ED post-evaluation after a motor vehicle crash, persistent pain is common and frequently associated with functional decline and disability.

Restricted activity and persistent pain following motor vehicle collision among older adults: a multicenter prospective cohort study.

BACKGROUND: Restricted physical activity commonly occurs following acute musculoskeletal pain in older adults and may influence long-term outcomes. We sought to examine the relationship between restricted physical activity after motor vehicle collision (MVC) and the development of persistent pain. METHODS: We examined data from a prospective study of adults ≥65 years of age presenting to the emergency department (ED) after MVC without life-threatening injuries. Restricted physical activity 6 weeks after MVC was defined in three different ways: 1) by a ≥25 point decrease in Physical Activity Scale in the Elderly (PASE) score, 2) by the answer "yes" to the question, "during the past two weeks, have you stayed in bed for at least half a day?", and 3) by the answer "yes" to the question, "during the past two weeks, have you cut down on your usual activities as compared to before the accident?" We examined relationships between each definition of restricted activity and pain severity, pain interference, and functional capacity at 6 months with adjustment for confounders. RESULTS: Within the study sample (N = 164), adjusted average pain severity scores at 6 months did not differ between patients with and without restricted physical activity based on decreased PASE score (2.54 vs. 2.07, p = 0.32). In contrast, clinically and statistically important differences in adjusted average pain severity at 6 months were observed for patients who reported spending half a day in bed vs. those who did not (3.56 vs. 1.91, p < 0.01). In adjusted analyses, both decreased PASE score and cutting down on activity were associated with functional capacity at 6 months, but only decreased PASE score was associated with increased ADL difficulty at 6 months (0.70 vs. -0.01, p = 0.02). CONCLUSIONS: Among older adults experiencing MVC, those reporting bed rest or reduced activity 6 weeks after the collision reported higher pain and pain interference scores at 6 months. More research is needed to determine if interventions to promote activity can improve outcomes after MVC in older adults.

Comparison of registered and published outcomes in randomized controlled trials: a systematic review.

BACKGROUND: Clinical trial registries can improve the validity of trial results by facilitating comparisons between prospectively planned and reported outcomes. Previous reports on the frequency of planned and reported outcome inconsistencies have reported widely discrepant results. It is unknown whether these discrepancies are due to differences between the included trials, or to methodological differences between studies. We aimed to systematically review the prevalence and nature of discrepancies between registered and published outcomes among clinical trials. METHODS: We searched MEDLINE via PubMed, EMBASE, and CINAHL, and checked references of included publications to identify studies that compared trial outcomes as documented in a publicly accessible clinical trials registry with published trial outcomes. Two authors independently selected eligible studies and performed data extraction. We present summary data rather than pooled analyses owing to methodological heterogeneity among the included studies. RESULTS: Twenty-seven studies were eligible for inclusion. The overall risk of bias among included studies was moderate to high. These studies assessed outcome agreement for a median of 65 individual trials (interquartile range [IQR] 25-110). The median proportion of trials with an identified discrepancy between the registered and published primary outcome was 31%; substantial variability in the prevalence of these primary outcome discrepancies was observed among the included studies (range 0% (0/66) to 100% (1/1), IQR 17-45%). We found less variability within the subset of studies that assessed the agreement between prospectively registered outcomes and published outcomes, among which the median observed discrepancy rate was 41% (range 30% (13/43) to 100% (1/1), IQR 33-48%). The nature of observed primary outcome discrepancies also varied substantially between included studies. Among the studies providing detailed descriptions of these outcome discrepancies, a median of 13 % of trials introduced a new, unregistered outcome in the published manuscript (IQR 5-16%). CONCLUSIONS: Discrepancies between registered and published outcomes of clinical trials are common regardless of funding mechanism or the journals in which they are published. Consistent reporting of prospectively defined outcomes and consistent utilization of registry data during the peer review process may improve the validity of clinical trial publications.