Challenges Enrolling Children Into Traumatic Brain Injury Trials: An Observational Study

ObjectivesIn preparation for a clinical trial of therapeutic agents for children with moderate‐to‐severe blunt traumatic brain injuries (TBIs) in emergency departments (EDs), we conducted this feasibility study to (1) determine the number and clinical characteristics of eligible children, (2) determine the timing of patient and guardian arrival to the ED, and (3) describe the heterogeneity of TBIs on computed tomography (CT) scans.MethodsWe conducted a prospective observational study at 16 EDs of children ≤ 18 years of age presenting with blunt head trauma and Glasgow Coma Scale scores of 3–12. We documented the number of potentially eligible patients, timing of patient and guardian arrival, patient demographics and clinical characteristics, severity of injuries, and cranial CT findings.ResultsWe enrolled 295 eligible children at the 16 sites over 6 consecutive months. Cardiac arrest and nonsurvivable injuries were the most common characteristics that would exclude patients from a future trial. Most children arrived within 2 hours of injury, but most guardians did not arrive until 2–3 hours after the injury. There was a substantial range in types of TBIs, with subdural hemorrhages being the most common.ConclusionEnrolling children with moderate‐to‐severe TBI into time‐sensitive clinical trials will require large numbers of sites and meticulous preparation and coordination and will prove challenging to obtain informed consent given the timing of patient and guardian arrival. The Federal Exception from Informed Consent for Emergency Research will be an important consideration for enrolling these children.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/135996/1/acem13085_am.pdfhttp://deepblue.lib.umich.edu/bitstream/2027.42/135996/2/acem13085.pdfhttp://deepblue.lib.umich.edu/bitstream/2027.42/135996/3/acem13085-sup-0001-DataSupplementS1.pd

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

Pediatric Emergency Medicine Volume 2

xxii, 676-1320 hlm.; 25.5 x 18.5 c

Pediatric Emergency Medicine Volume 1

xxiii, 675 hlm.; 26 x 18.5 c

Pediatric emergency medicine

xxxi+1320hlm.;28c

Intention to Leave Emergency Medicine: Mid-career Women Are at Increased Risk

Introduction: Burnout is prevalent among emergency physicians and may cause physicians to consider leaving the practice of emergency medicine (EM). This study sought to determine whether there is a gender difference in reporting burnout and seriously considering leaving the specialty of EM, and secondarily to explore the factors reported as contributing to burnout.Methods: This was a secondary analysis of the 2014 American Board of Emergency Medicine Longitudinal Survey of Emergency Physicians. We used multiple logistic regression to determine which factors were associated with reporting serious consideration of leaving EM, when stratified by years in practice and adjusting for individual, departmental, and institutional factors.Results: The response rate was 82%, (n = 868); 22.6% (194) were female and 77.4% (664) were males; and 83.9% (733) White. The mean age of men responding was significantly higher than women (52.7±11.9 vs. 44.9±10.4, p<0.001). Overall, there were no significant gender differences in reporting having had serious thoughts of leaving EM in either unmatched or age-matched analyses. More women reported that burnout was a significant problem, while men more often were equivocal as to whether it was a problem. When stratified by years in practice, mid-career women had a seven-fold increase in the odds ratio (OR) of seriously considered leaving EM, compared to men of similar years in practice (OR 7.07, 95% confidence interval, 2.45-20.39).  Autonomy at work, control over working conditions, fair compensation, personal reward, and a sense of ownership were factors associated with a lower rate of reporting considering leaving EM.Conclusion: Our findings suggest that the intention to leave EM is not more prevalent in women.  However, mid-career women more often reported seriously considering leaving the specialty than mid-career men.  Further research on the factors behind this finding in mid-career women in EM is needed

Intention to Leave Emergency Medicine: Mid-career Women Are at Increased Risk

Introduction: Burnout is prevalent among emergency physicians and may cause physicians to consider leaving the practice of emergency medicine (EM). This study sought to determine whether there is a gender difference in reporting burnout and seriously considering leaving the specialty of EM, and secondarily to explore the factors reported as contributing to burnout.Methods: This was a secondary analysis of the 2014 American Board of Emergency Medicine Longitudinal Survey of Emergency Physicians. We used multiple logistic regression to determine which factors were associated with reporting serious consideration of leaving EM, when stratified by years in practice and adjusting for individual, departmental, and institutional factors.Results: The response rate was 82%, (n = 868); 22.6% (194) were female and 77.4% (664) were males; and 83.9% (733) White. The mean age of men responding was significantly higher than women (52.7±11.9 vs. 44.9±10.4, p<0.001). Overall, there were no significant gender differences in reporting having had serious thoughts of leaving EM in either unmatched or age-matched analyses. More women reported that burnout was a significant problem, while men more often were equivocal as to whether it was a problem. When stratified by years in practice, mid-career women had a seven-fold increase in the odds ratio (OR) of seriously considered leaving EM, compared to men of similar years in practice (OR 7.07, 95% confidence interval, 2.45-20.39).  Autonomy at work, control over working conditions, fair compensation, personal reward, and a sense of ownership were factors associated with a lower rate of reporting considering leaving EM.Conclusion: Our findings suggest that the intention to leave EM is not more prevalent in women.  However, mid-career women more often reported seriously considering leaving the specialty than mid-career men.  Further research on the factors behind this finding in mid-career women in EM is needed