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1.
Acad Emerg Med ; 29(10): 1197-1204, 2022 10.
Article in English | MEDLINE | ID: mdl-35848052

ABSTRACT

BACKGROUND: Long-term follow-up for clinician-scientist training programs is sparse. We describe the outcomes of clinician-scientist scholars in the National Heart Lung and Blood Institute (NHLBI) K12 program in emergency care research up to 8.7 years after matriculation in the program. METHODS: This was a cohort study of faculty clinician-scientist scholars enrolled in a NHLBI K12 research training program at 6 sites across the US, with median follow-up 7.7 years (range 5.7-8.7 years) from the date of matriculation. Scholars completed electronic surveys in 2017 and 2019, with the 2019 survey collecting information for their current work setting, percent time for research, and grant funding from all sources. We used NIH RePorter and online resources to verify federal grants through March 2021. The primary outcome was a funded career development award (CDA) or research project grant (RPG) where the scholar was principal investigator. We included funding from all federal sources and national foundations. RESULTS: There were 43 scholars, including 16 (37%) women. Over the follow-up period, 32 (74%) received an individual CDA or RPG, with a median of 36 months (range 9-83 months) after entering the program. Of the 43 scholars, 23 (54%) received a CDA and 22 (51%) received an RPG, 7 (16%) of which were R01s. Of the 23 scholars who received a CDA, 13 (56%) subsequently had an RPG funded. Time to CDA or RPG did not differ by sex (women vs. men log-rank test p = 0.27) or specialty training (emergency medicine versus other specialties, p = 0.59). CONCLUSIONS: After 7 years of follow-up for this NHLBI K12 emergency care research training program, three quarters of clinician-scientist scholars had obtained CDA or RPG funding, with no notable differences by sex or clinical training.


Subject(s)
Awards and Prizes , Biomedical Research , Emergency Medical Services , Cohort Studies , Female , Follow-Up Studies , Humans , Male , National Heart, Lung, and Blood Institute (U.S.) , National Institutes of Health (U.S.) , United States
2.
JAMA Netw Open ; 4(8): e2121706, 2021 08 02.
Article in English | MEDLINE | ID: mdl-34410392

ABSTRACT

Importance: The prevalence of workplace mistreatment and its association with the well-being of emergency medicine (EM) residents is unclear. More information about the sources of mistreatment might encourage residency leadership to develop and implement more effective strategies to improve professional well-being not only during residency but also throughout the physician's career. Objective: To examine the prevalence, types, and sources of perceived workplace mistreatment during training among EM residents in the US and the association between mistreatment and suicidal ideation. Design, Setting, and Participants: In this survey study conducted from February 25 to 29, 2020, all residents enrolled in EM residencies accredited by the Accreditation Council for Graduate Medical Education (ACGME) who participated in the 2020 American Board of Emergency Medicine computer-based In-training Examination were invited to participate. A multiple-choice, 35-item survey was administered after the examination asking residents to self-report the frequency, sources, and types of mistreatment experienced during residency training and whether they had suicidal thoughts. Main Outcomes and Measures: The types and frequency of workplace mistreatment and the sources of the mistreatment were identified, and rates of self-reported suicidality were obtained. Multivariable logistic regression models were used to examine resident and program characteristics associated with suicidal thoughts. Results: Of 8162 eligible EM residents, 7680 (94.1%) responded to at least 1 question on the survey; 6503 (79.7%) completed the survey in its entirety. A total of 243 ACGME-accredited residency programs participated, and 1 did not. The study cohort included 4768 male residents (62.1%), 2698 female residents (35.1%), 4919 non-Hispanic White residents (64.0%), 2620 residents from other racial/ethnic groups (Alaska Native, American Indian, Asian or Pacific Islander, African American, Mexican American, Native Hawaiian, Puerto Rican, other Hispanic, or mixed or other race) (34.1%), 483 residents who identified as lesbian, gay, bisexual, transgender, queer, or other (LGBTQ+) (6.3%), and 5951 residents who were married or in a relationship (77.5%). Of the total participants, 3463 (45.1%) reported exposure to some type of workplace mistreatment (eg, discrimination, abuse, or harassment) during the most recent academic year. A frequent source of mistreatment was identified as patients and/or patients' families; 1234 respondents (58.7%) reported gender discrimination, 867 (67.5%) racial discrimination, 282 (85.2%) physical abuse, and 723 (69.1%) sexual harassment from patients and/or family members. Suicidal thoughts occurring during the past year were reported by 178 residents (2.5%), with similar prevalence by gender (108 men [2.4%]; 59 women [2.4%]) and race/ethnicity (113 non-Hispanic White residents [2.4%]; 65 residents from other racial/ethnic groups [2.7%]). Conclusions and Relevance: In this survey study, EM residents reported that workplace mistreatment occurred frequently. The findings suggest common sources of mistreatment for which educational interventions may be developed to help ensure resident wellness and career satisfaction.


Subject(s)
Emergency Medicine/statistics & numerical data , Health Personnel/psychology , Internship and Residency/statistics & numerical data , Occupational Stress/psychology , Racism/psychology , Sexism/psychology , Sexual Harassment/psychology , Adult , Cohort Studies , Female , Health Personnel/statistics & numerical data , Humans , Male , Occupational Stress/epidemiology , Prevalence , Racism/statistics & numerical data , Sexism/statistics & numerical data , Sexual Harassment/statistics & numerical data , Surveys and Questionnaires , United States/epidemiology , Young Adult
3.
J Am Coll Emerg Physicians Open ; 2(6): e12546, 2021 Dec.
Article in English | MEDLINE | ID: mdl-34984412

ABSTRACT

OBJECTIVE: Professional satisfaction is associated with career longevity, individual well-being, and patient care and safety. Lack of physician engagement promotes the opposite. This study sought to identify important facets contributing to decreased career satisfaction using a large national data set of practicing emergency physicians. METHODS: We performed a secondary analysis of the national Longitudinal Study of Emergency Physicians survey conducted by the American Board of Emergency Medicine. The survey was composed of 57 variables including career satisfaction as well as occupational and psychological variables potentially associated with career satisfaction. Factor analysis was used to determine the important latent variables. Ordinal logistic regression was performed to determine statistical significance among the latent variables with overall career satisfaction. RESULTS: A total of 863 participants were recorded. The overall mean career satisfaction rate was 3.9 on a 5-point Likert scale with 1 and 5 indicating "least satisfied" and "most satisfied," respectively. Our analysis revealed 9 factors related to job satisfaction. Two latent factors, exhaustion/stress and administration/respect, were statistically significant. When comparing satisfaction scores between sex, there was a statistically significant difference with men reporting a higher satisfaction rate (P = 0.0092). Age was also statistically significant with overall satisfaction lower for younger physicians than older physicians. CONCLUSION: Our study found that emergency physicians are overall satisfied with emergency medicine, although with variability depending on sex and age. In addition, we characterized job satisfaction into 9 factors that significantly contribute to job satisfaction. Future work exploring these factors may help elucidate the development of targeted interventions to improve professional well-being in the emergency medicine workforce.

4.
West J Emerg Med ; 21(5): 1131-1139, 2020 Aug 21.
Article in English | MEDLINE | ID: mdl-32970566

ABSTRACT

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.


Subject(s)
Emergency Medicine/statistics & numerical data , Physicians/statistics & numerical data , Adult , Burnout, Professional/epidemiology , Female , Humans , Intention , Job Satisfaction , Longitudinal Studies , Male , Middle Aged , Personal Satisfaction , Professional Autonomy , Salaries and Fringe Benefits , Surveys and Questionnaires , United States/epidemiology
6.
J Grad Med Educ ; 11(6): 649-653, 2019 Dec.
Article in English | MEDLINE | ID: mdl-31871563

ABSTRACT

BACKGROUND: Graduates of emergency medicine residency programs can seek certification from the American Board of Emergency Medicine (ABEM), yet the costs and perceived value by residents is not clear. OBJECTIVE: This report sought to better define the value of board certification by asking physicians taking the ABEM Oral Certification Examination (OCE) to describe its costs (eg, time, money) and perceived benefits. METHODS: A descriptive, cross-sectional, voluntary, anonymous survey was administered to physicians taking the 2018 spring and fall ABEM OCEs. Response frequencies were used to report response rates. RESULTS: There were 2016 physicians who participated in the 2018 OCEs, of whom 1565 (78%) completed a survey. With respect to preparation, 38% (599 of 1565 responses) spent more than 30 hours preparing for the examination. Regarding the expense of preparing for the examination, 21% (328) spent nothing, 50% (776) spent less than $1,000, and 2% (38) spent more than $3,000. Most physicians (80%, 1254) reported a learning benefit to preparing for and taking the OCE. There were 49% (765) of respondents who reported that preparing for the examination reinforced their knowledge of emergency medicine; 20% (311) reported no learning benefit. Most physicians (92%, 1442) reported that ABEM certification provided a career benefit, the most common of which was more career opportunities (69%, 1076). CONCLUSIONS: Initial certification requires a considerable investment of time and money. Physicians seeking initial ABEM certification found both learning and professional benefits, with the most frequently reported being reinforcement of medical knowledge and more career opportunities.


Subject(s)
Certification/economics , Emergency Medicine/education , Physicians/statistics & numerical data , Cost-Benefit Analysis , Cross-Sectional Studies , Humans , Surveys and Questionnaires , United States
7.
Acad Emerg Med ; 26(12): 1346-1356, 2019 12.
Article in English | MEDLINE | ID: mdl-31183919

ABSTRACT

BACKGROUND: Resuscitation with crystalloid fluid is a cornerstone of pediatric septic shock treatment. However, the optimal type of crystalloid fluid is unknown. We aimed to determine the feasibility of conducting a pragmatic randomized trial to compare balanced (lactated Ringer's [LR]) with 0.9% normal saline (NS) fluid resuscitation in children with suspected septic shock. METHODS: Open-label pragmatic randomized controlled trial at a single academic children's hospital from January to August 2018. Eligible patients were >6 months to <18 years old who were treated in the emergency department for suspected septic shock, operationalized as blood culture, parenteral antibiotics, and fluid resuscitation for abnormal perfusion. Screening, enrollment, and randomization were carried out by the clinical team as part of routine care. Patients were randomized to receive either LR or NS for up to 48 hours following randomization. Other than fluid type, all treatment decisions were at the clinical team's discretion. Feasibility outcomes included proportion of eligible patients enrolled, acceptability of enrollment via the U.S. federal exception from informed consent (EFIC) regulations, and adherence to randomized study fluid administration. RESULTS: Of 59 eligible patients, 50 (85%) were enrolled and randomized. Twenty-four were randomized to LR and 26 to NS. Only one (2%) of 44 patients enrolled using EFIC withdrew before study completion. Total median (interquartile range [IQR]) crystalloid fluid volume received during the intervention window was 107 (60 to 155) mL/kg and 98 (63 to 128) mL/kg in the LR and NS arms, respectively (p = 0.50). Patients randomized to LR received a median (IQR) of only 20% (13 to 32) of all study fluid as NS compared to 99% (64% to 100%) of study fluid as NS in the NS arm (absolute difference = 79%, 95% CI = 48% to 85%). CONCLUSIONS: A pragmatic study design proved feasible to study comparative effectiveness of LR versus NS fluid resuscitation for pediatric septic shock.


Subject(s)
Fluid Therapy/methods , Resuscitation/methods , Ringer's Lactate/therapeutic use , Shock, Septic/drug therapy , Adolescent , Child , Child, Preschool , Emergency Service, Hospital , Feasibility Studies , Female , Humans , Infant , Male , Pilot Projects , Pragmatic Clinical Trials as Topic , Saline Solution/therapeutic use , Shock, Septic/diagnosis
8.
Ann Emerg Med ; 72(6): 679-690, 2018 12.
Article in English | MEDLINE | ID: mdl-30078658

ABSTRACT

STUDY OBJECTIVE: We assess the productivity, outcomes, and experiences of participants in the National Institutes of Health/National Heart, Lung, and Blood Institute-funded K12 institutional research training programs in emergency care research. METHODS: We used a mixed-methods study design to evaluate the 6 K12 programs, including 2 surveys, participant interviews, scholar publications, grant submissions, and funded grants. The training program lasted from July 1, 2011, through June 30, 2017. We tracked scholars for a minimum of 3 years and up to 5 years, beginning with date of entry into the program. We interviewed program participants by telephone using open-ended prompts. RESULTS: There were 94 participants, including 43 faculty scholars, 13 principal investigators, 30 non-principal investigator primary mentors, and 8 program administrators. The survey had a 74% overall response rate, including 95% of scholars. On entry to the program, scholars were aged a median of 37 years (interquartile range [IQR] 34 to 40 years), with 16 women (37%), and represented 11 disciplines. Of the 43 scholars, 40 (93%) submitted a career development award or research project grant during or after the program; 26 (60%) have secured independent funding as of August 1, 2017. Starting with date of entry into the program, the median time to grant submission was 19 months (IQR 11 to 27 months) and time to funding was 33 months (IQR 27 to 39 months). Cumulative median publications per scholar increased from 7 (IQR 4 to 15.5) at program entry to 21 (IQR 11 to 33.5) in the first post-K12 year. We conducted 57 semistructured interviews and identified 7 primary themes. CONCLUSION: This training program produced 43 interdisciplinary investigators in emergency care research, with demonstrated productivity in grant funding and publications.


Subject(s)
Emergency Medicine/education , National Institutes of Health (U.S.)/organization & administration , Adult , Age Distribution , Female , Humans , Male , Middle Aged , Program Evaluation , Surveys and Questionnaires , United States
9.
Ann Emerg Med ; 71(5): 636-648, 2018 May.
Article in English | MEDLINE | ID: mdl-29681310

ABSTRACT

The American Board of Emergency Medicine (ABEM) gathers extensive background information on emergency medicine-sponsored residency and fellowship programs, as well as the residents and fellows training in those programs. We present the 2018 annual report on the status of US emergency medicine training programs.


Subject(s)
Emergency Medicine/education , Fellowships and Scholarships , Internship and Residency , Emergency Medicine/statistics & numerical data , Fellowships and Scholarships/statistics & numerical data , Humans , Internship and Residency/statistics & numerical data , Specialty Boards , United States
10.
11.
Clin Trials ; 14(2): 180-186, 2017 Apr.
Article in English | MEDLINE | ID: mdl-28359192

ABSTRACT

BACKGROUND: Evidence suggests that patients are generally accepting of their enrollment in trials for emergency care conducted under exception from informed consent. It is unknown whether individuals with more severe initial injuries or worse clinical outcomes have different perspectives. Determining whether these differences exist may help to structure post-enrollment interactions. METHODS: Primary clinical data from the Progesterone for the Treatment of Traumatic Brain Injury trial were matched to interview data from the Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study. Answers to three key questions from Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study were analyzed in the context of enrolled patients' initial injury severity (initial Glasgow Coma Scale and Injury Severity Score) and principal clinical outcomes (Extended Glasgow Outcome Scale and Extended Glasgow Outcome Scale relative to initial injury severity). The three key questions from Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study addressed participants' general attitude toward inclusion in the Progesterone for the Treatment of Traumatic Brain Injury trial (general trial inclusion), their specific attitude toward being included in Progesterone for the Treatment of Traumatic Brain Injury trial under the exception from informed consent (personal exception from informed consent enrollment), and their attitude toward the use of exception from informed consent in the Progesterone for the Treatment of Traumatic Brain Injury trial in general (general exception from informed consent enrollment). Qualitative analysis of interview transcripts was performed to provide contextualization and to determine the extent to which respondents framed their attitudes in terms of clinical experience. RESULTS: Clinical data from Progesterone for the Treatment of Traumatic Brain Injury trial were available for all 74 patients represented in the Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study (including 46 patients for whom the surrogate was interviewed due to the patient's cognitive status or death). No significant difference was observed regarding acceptance of general trial inclusion or acceptance of general exception from informed consent enrollment between participants with favorable neurological outcomes and those with unfavorable outcomes relative to initial injury. Agreement with personal enrollment in Progesterone for the Treatment of Traumatic Brain Injury trial under exception from informed consent, however, was significantly higher among participants with favorable outcomes compared to those with unfavorable outcomes (89% vs 59%, p = 0.003). There was also a statistically significant relationship between more severe initial injury and increased acceptance of personal exception from informed consent enrollment ( p = 0.040) or general exception from informed consent use ( p = 0.034) in Progesterone for the Treatment of Traumatic Brain Injury trial. Many individuals referenced personal experience as a basis for their attitudes, but these references were not used to support negative views. CONCLUSION: Patients and surrogates of patients with unfavorable clinical outcomes were somewhat less accepting of their own inclusion in the Progesterone for the Treatment of Traumatic Brain Injury trial under exception from informed consent than were patients or surrogates of patients with favorable clinical outcomes. These findings suggest a need to identify optimal strategies for communicating with patients and their surrogates regarding exception from informed consent enrollment when clinical outcomes are poor.


Subject(s)
Attitude to Health , Biomedical Research , Brain Injuries, Traumatic/drug therapy , Emergencies , Informed Consent , Progesterone/therapeutic use , Progestins/therapeutic use , Clinical Trials, Phase III as Topic , Glasgow Coma Scale , Glasgow Outcome Scale , Humans , Injury Severity Score , Multicenter Studies as Topic , Proxy , Randomized Controlled Trials as Topic , Treatment Outcome
12.
Acad Emerg Med ; 24(1): 31-39, 2017 01.
Article in English | MEDLINE | ID: mdl-27618167

ABSTRACT

OBJECTIVES: In 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. METHODS: We 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. RESULTS: We 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. CONCLUSION: Enrolling 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.


Subject(s)
Head Injuries, Closed/diagnostic imaging , Head Injuries, Closed/therapy , Informed Consent , Patient Selection , Adolescent , Child , Child, Preschool , Emergency Service, Hospital , Female , Glasgow Coma Scale , Humans , Infant , Male , Prospective Studies , Time Factors , Tomography, X-Ray Computed
15.
Ann Emerg Med ; 67(5): 654-66, 2016 05.
Article in English | MEDLINE | ID: mdl-27106370

ABSTRACT

The American Board of Emergency Medicine (ABEM) gathers extensive background information on emergency medicine residency programs and the residents training in those programs. We present the 2016 annual report on the status of US emergency medicine training programs.


Subject(s)
Emergency Medicine/education , Internship and Residency/statistics & numerical data , Specialty Boards , Adult , Emergency Medicine/statistics & numerical data , Female , Humans , Male , Middle Aged , United States , Young Adult
16.
J Hand Surg Am ; 40(12): 2435-9, 2015 Dec.
Article in English | MEDLINE | ID: mdl-26612637

ABSTRACT

PURPOSE: To survey emergency medicine (EM) residency and hand surgery fellowship program directors (PDs) to identify consensus in their perceptions of appropriate emergency care of upper extremity emergencies. METHODS: We created a framework to group common upper extremity emergency diagnoses and surveyed PDs to evaluate the training background--EM, general orthopedic or plastic surgery, or hand fellowship--most appropriate to provide acute, point-of-care management for each of these diagnostic groupings. Responses were pooled and consensus was established with greater than 75% agreement between groups. RESULTS: We received 79 responses from hand fellowship PDs (90% response rate) and 151 responses from EM PDs (49% response rate). We identified consensus for the training background that PDs in both specialties felt was appropriate to care for 17 of 21 diagnostic groupings in the framework. CONCLUSIONS: There was a high level of consensus between EM and hand surgery PDs regarding diagnoses that acutely require training in hand surgery versus those that can be managed by an EM physician. Our diagnostic framework may help reduce unnecessary hand surgery consultation and may help to identify patients who do not require more specialized acute care and thus decrease unnecessary transfers. TYPE OF STUDY/LEVEL OF EVIDENCE: Economic and Decision Analyses IV.


Subject(s)
Emergency Medicine/education , Orthopedics/education , Surgery, Plastic/education , Upper Extremity/surgery , Education, Medical, Graduate , Emergencies , Fellowships and Scholarships , Female , Humans , Internship and Residency , Male , Physician Executives , Surveys and Questionnaires , United States
17.
Acad Emerg Med ; 22(12): 1506-10, 2015 Dec.
Article in English | MEDLINE | ID: mdl-26568385

ABSTRACT

OBJECTIVES: The Choosing Wisely campaign was launched in 2011 to promote stewardship of medical resources by encouraging patients and physicians to speak with each other regarding the appropriateness of common tests and procedures. Medical societies including the American College of Emergency Physicians (ACEP) have developed lists of potentially low-value practices for their members to address with patients. No research has described the awareness or attitudes of emergency physicians (EPs) regarding the Choosing Wisely campaign. The study objective was to assess these beliefs among leaders of academic departments of emergency medicine (EM). METHODS: This was a Web-based survey of emergency department (ED) chairs and division chiefs at institutions with allopathic EM residency programs. The survey examined awareness of Choosing Wisely, anticipated effects of the program, and discussions of Choosing Wisely with patients and professional colleagues. Participants also identified factors they associated with the use of potentially low-value services in the ED. Questions and answer scales were refined using iterative pilot testing with EPs and health services researchers. RESULTS: Seventy-eight percent (105/134) of invited participants responded to the survey. Eighty percent of respondents were aware of Choosing Wisely. A majority of participants anticipate the program will decrease costs of care (72% of respondents) and use of ED diagnostic imaging (69%) but will have no effect on EP salaries (94%) or medical-legal risks (65%). Only 45% of chairs have ever addressed Choosing Wisely with patients, in contrast to 88 and 82% who have discussed it with faculty and residents, respectively. Consultant-requested tests were identified by 97% of residents as a potential contributor to low-value services in the ED. CONCLUSIONS: A substantial majority of academic EM leaders in our study were aware of Choosing Wisely, but only slightly more than half could recall any ACEP recommendations for the program. Respondents familiar with Choosing Wisely anticipated generally positive effects, but chairs reported only infrequently discussing Choosing Wisely with patients. Future research should identify potentially low-value tests requested by consultants and objectively measure the utility and cost of these tests among ED patient populations.


Subject(s)
Attitude of Health Personnel , Emergency Medicine/education , Faculty, Medical , Medical Overuse/prevention & control , Adult , Female , Health Expenditures , Health Services Research , Humans , Male , Practice Patterns, Physicians' , Risk Factors , Salaries and Fringe Benefits
19.
Crit Care Med ; 43(3): 603-12, 2015 Mar.
Article in English | MEDLINE | ID: mdl-25574795

ABSTRACT

OBJECTIVE: Research in acute illness often requires an exception from informed consent. Few studies have assessed the views of patients enrolled in exception from informed consent trials. This study was designed to assess the views of patients and their surrogates of exception from informed consent enrollment within the context of a randomized, placebo-controlled trial of an investigational agent for traumatic brain injury. DESIGN: Interactive interview study. SETTING: Nested within the Progesterone for the Treatment of Traumatic Brain Injury trial, a Phase III randomized controlled trial in acute traumatic brain injury. SUBJECTS: Patients and surrogates (for patients incapable of being interviewed) enrolled in Progesterone for the Treatment of Traumatic Brain Injury under exception from informed consent at 12 sites. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Interviews focused on respondents' acceptance of exception from informed consent enrollment in Progesterone for the Treatment of Traumatic Brain Injury, use of placebo and randomization, understanding of major study elements, and views regarding regulatory protections. Descriptive statistical analysis was performed; textual data were analyzed thematically. Eighty-five individuals were interviewed. Eighty-four percent had positive attitudes toward Progesterone for the Treatment of Traumatic Brain Injury inclusion. Seventy-eight percent found their inclusion under exception from informed consent acceptable, and 72% found use of exception from informed consent in Progesterone for the Treatment of Traumatic Brain Injury acceptable in general. Only two respondents clearly disagreed with both personal and general exception from informed consent enrollment. The most common concerns (26%) related to absence of consent. Eighty percent and 92% were accepting of placebo use and randomization, respectively. Although there were few black respondents (n = 11), they were less accepting of personal exception from informed consent enrollment than white respondents (55% vs 83%; p = 0.0494). CONCLUSIONS: Acceptance of exception from informed consent in this placebo-controlled trial of an investigational agent was high and exceeded acceptance among community consultation participants. Exception from informed consent enrollment appears generally consistent with patients' preferences.


Subject(s)
Biomedical Research/methods , Brain Injuries/drug therapy , Emergencies , Informed Consent/psychology , Patients/psychology , Progesterone/therapeutic use , Adult , Aged , Female , Humans , Interviews as Topic , Male , Middle Aged , Perception , Placebos , Racial Groups , Research Subjects/psychology , Sex Factors , Socioeconomic Factors
20.
Clin Trials ; 12(1): 67-76, 2015 Feb.
Article in English | MEDLINE | ID: mdl-25369796

ABSTRACT

BACKGROUND: The US federal regulation "Exception from Informed Consent for Emergency Research," 21 Code of Federal Regulations 50.24, permits emergency research without informed consent under limited conditions. Additional safeguards to protect human subjects include requirements for community consultation and public disclosure prior to starting the research. Because the regulations are vague about these requirements, Institutional Review Boards determine the adequacy of these activities at a local level. Thus, there is potential for broad interpretation and practice variation. AIM: To describe the variation of community consultation and public disclosure activities approved by Institutional Review Boards, and the effectiveness of this process for a multi-center, Exception from Informed Consent, pediatric status epilepticus clinical research trial. METHODS: Community consultation and public disclosure activities were analyzed for each of the 15 participating sites. Surveys were conducted with participants enrolled in the status epilepticus trial to assess the effectiveness of public disclosure dissemination prior to study enrollment. RESULTS: Every Institutional Review Board, among the 15 participating sites, had a varied interpretation of Exception from Informed Consent regulations for community consultation and public disclosure activities. Institutional Review Boards required various combinations of focus groups, interviews, surveys, and meetings for community consultation, and news releases, mailings, and public service announcements for public disclosure. At least 4335 patients received information about the study from these efforts. In all, 158 chose to be included in the "Opt Out" list. Of the 304 participants who were enrolled under Exception from Informed Consent, 12 (5%) had heard about the study through community consultation or public disclosure activities. The activities reaching the highest number of participants were surveys and focus groups associated with existing meetings. Public disclosure activities were more efficient and cost-effective if they were part of an in-hospital resource for patients and families. CONCLUSION: There is substantial variation in Institutional Review Boards' interpretations of the federal regulations for community consultation and public disclosure. One of the goals of community consultation and public disclosure efforts for emergency research is to provide community members an opportunity to opt out of Exception from Informed Consent research; however, rarely do patients or their legally authorized representatives report having learned about a study prior to enrollment.


Subject(s)
Disclosure/legislation & jurisprudence , Informed Consent/legislation & jurisprudence , Multicenter Studies as Topic/methods , Pediatrics , Randomized Controlled Trials as Topic/legislation & jurisprudence , Adolescent , Biomedical Research/legislation & jurisprudence , Child , Child, Preschool , Double-Blind Method , Emergency Medical Services/legislation & jurisprudence , Emergency Medical Services/organization & administration , Female , Focus Groups , Humans , Infant , Infant, Newborn , Male , Population Surveillance , Referral and Consultation/organization & administration , Research Design , Third-Party Consent/legislation & jurisprudence , United States
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