From the Patient Perspective, Consent Forms Fall Short of Providing Information to Guide Decision Making.

OBJECTIVE: This study aimed to gather qualitative feedback on patient perceptions of informed consent forms and elicit recommendations to improve readability and utility for enhanced patient safety and engagement in shared decision making. METHODS: Sixty interviews in personal interviews were conducted consisting of a literacy and numeracy assessment, a comprehension quiz to assess retention of key information, and open-ended questions to determine reactions, clarity of information, and suggestions for improvement. RESULTS: Although 68% of the participants had education beyond high school, many still missed comprehension questions and found the forms difficult to read. Recurrent suggestions included specific formatting changes to enhance readability, a need for additional sources of information, mixed attitudes toward inclusion of risk information, and the recognized importance of physician-patient conversations. CONCLUSIONS: This study provides evidence from the patient perspective that consent forms are too complex and fail to achieve comprehension. Future studies should be conducted using patients' suggestions for form redesign and inclusion of supplemental educational tools to optimize communication and safety to achieve more informed health care decision making.

Key issues for elderly patients contemplating clinical trial participation.

This pilot study explored issues important to enrollment in clinical trials by elderly patients. We surveyed and interviewed elderly patients who had been asked to participate in trials. The information covered general attitudes toward research and specific aspects of trial recruitment. Elderly patients had favorable attitudes toward research. This favorable attitude was significantly stronger in men than in women and stronger in Whites than non-Whites but not significantly so. Altruistic motives, physician recommendations, and individual assessment of inconveniences, benefits, and risks of trial participation drove decisions. Elderly patients have positive views of research; however, this will only facilitate trial participation if patients perceive the commitment of enrolling, the potential risks, and possible side effects as reasonable.

Remote and interdisciplinary research in surgical knowledge production.

BACKGROUND: Surgical knowledge production has changed dramatically in the last 30 y, moving away from investigations by individual surgeon researchers and toward remote and interdisciplinary research. We investigated how surgeons make decisions about engaging in research and identify motivators, facilitators, and barriers to conducting research in an increasingly challenging environment. MATERIALS AND METHODS: We performed a qualitative analysis of semistructured interviews with surgeons from academic medical centers across the United States. We asked participants to describe their experiences and opinions regarding remote and interdisciplinary collaborations. RESULTS: Of 64 surgeon researchers invited, 21 (33%) agreed and participated in semistructured interviews. Each interview lasted an average (standard deviation) of 29 min (12). Surgeons were motivated by both internal and external factors, including some that might be identified as barriers. The internal desire to improve care and the need for collaboration to address increasingly complex questions requiring larger samples sizes emerged as most significant to interview participants. Social networks were identified as the dominant facilitator of multisite research, with technology playing a supporting role. Barriers to remote and interdisciplinary research ranged from individual, "micro" level barriers, through structural barriers that include institutional level challenges and competing priorities, to macrolevel system and policy-level barriers. CONCLUSIONS: Surgeons clearly recognize the importance of high-quality research aligned with current paradigms of clinical care and are using remote and interdisciplinary collaboration to improve the quality of the science they produce and align their work with the demand for increasingly high levels of evidence.

Structure and outcomes of interdisciplinary rounds in hospitalized medicine patients: A systematic review and suggested taxonomy.

BACKGROUND: Interdisciplinary rounds (IDR) have been described to improve outcomes. However, there is limited understanding of optimal IDR design. PURPOSE: To systematically review published reports of IDR to catalog types of IDR and outcomes, and assess the influence of IDR design on outcomes. DATA SOURCES: Ovid MEDLINE, Ovid MEDLINE In-Process & Other Non-Indexed Citations, Journals Ovid, Cumulative Index to Nursing and Allied Health Literature (EBSCOhost), and PubMed from 1990 through December 2014, and hand searching of article bibliographies. STUDY SELECTION: Experimental, quasiexperimental, and observation studies in English-language literature where physicians rounded with another healthcare professional in inpatient medicine units. DATA EXTRACTION: Studies were abstracted for study setting and characteristics, and design and outcomes of IDR. DATA SYNTHESIS: Twenty-two studies were included in the qualitative analysis. Many were of low to medium quality with few high-quality studies. There is no clear definition of IDR in the literature. There was wide variation in IDR design and team composition across studies. We found three different models of IDR: pharmacist focused, bedside rounding, and interdisciplinary team rounding. There are reasonable data to support an association with length of stay and staff satisfaction but little data on patient safety or satisfaction. Positive outcomes may be related to particular components of IDR design, but the relationship between design and outcomes remains unclear. CONCLUSIONS: Future studies should be more deliberately designed and fully reported with careful attention to team composition and features of IDR and their impact on selected outcomes. We present a proposed IDR definition and taxonomy for future studies. Journal of Hospital Medicine 2016;11:513-523. © 2016 Society of Hospital Medicine.

Emergency codes: a study of hospital attitudes and practices.

Many hospitals use color codes to denote internal (i.e. patient respiratory distress), or external (i.e. natural disasters) emergencies, via public announcement systems. Variations in the codes used by different hospitals can create confusion among providers who may practice in more than one hospital. This study sought to understand emergency code practices in the Delaware Valley region, assess patient and provider knowledge of codes at one hospital in that region, and patient and provider preferences for emergency code standardization and format. Anonymous electronic surveys on procedural knowledge and perspectives of emergency codes were disseminated to hospital staff and patients located at a large regional hospital. Phone interviews were conducted with hospital administration at the regional hospital and other hospitals within a 50-mile radius. The author's research indicates that standardization would be accepted by patients and providers and its lack is considered a barrier to providing high quality care.

True "meaningful use": technology meets both patient and provider needs.

OBJECTIVES: Voluntary patient uptake and use of electronic health record (EHR) features have been low. It is unknown whether EHRs fully meet needs of providers or patients with chronic diseases. STUDY DESIGN: To explore in-depth user experiences, we conducted 6 focus groups: 3 of patients followed by 3 of providers discussing 2 key EHR components: the after-visit summary (AVS) and the patient portal (PP). Focus groups were audio-recorded, transcribed, and analyzed by 3 independent coders. METHODS: Participants with moderate-to-severe asthma and prevalent comorbidities were recruited from 4 primary care and 2 asthma clinics serving low-income urban neighborhoods. Participants discussed their expectations and experience using the AVS and PP, and responded to prototype formats of these features. Additionally, one-on-one interviews were conducted with 10 patients without PP experience to assess their ability to use the system. RESULTS: The 21 patient and 13 provider perspectives differed regarding AVS features and use. Patients wanted a unified view of their medical issues and health management tools, while providers wanted to focus on recommendations from 1 visit at a time. Both groups advocated improving the AVS format and content. Lack of awareness and knowledge about the PP was patients' largest barrier, and was traced back to providers' lack of PP training. CONCLUSIONS: Our results underscore the importance of user-centered design when constructing the content and features of the EHR. As technology evolves, an ongoing understanding of patient and provider experiences will be critical to improve uptake, increase use, and ensure engagement, optimizing the potential of EHRs.

Using EMS Dispatch to Trigger STEMI Alerts Decreases Door-to-Balloon Times.

INTRODUCTION: We sought to determine the potential reduction in door-to-balloon time (DTB) by allowing paramedics to perform prehospital ST-Elevation Myocardial Infarction (STEMI) notification using brief communications via emergency medical services (EMS) 9-1-1 dispatchers as soon as they saw a STEMI on 12-lead electrocardiogram (EKG). Our hypothesis was that earlier cardiac catheterization lab (CCL) activation would improve overall DTB and avoid delays arising from on-scene issues or the time required to deliver a full report. METHODS: The study setting was a single suburban community teaching hospital, which is a regional percutaneous coronary intervention (PCI) center with more than 120,000 Emergency Department (ED) visits/year and is serviced by a single tiered-response, advanced life support (ALS) paramedic-level agency. STEMI notifications from July 2009 to July 2012 occurred by either standard direct EMS-to-physician notification or by immediate 9-1-1 dispatch notification. In the 9-1-1 dispatcher-aided notification method, paramedics were asked to provide a brief one-sentence report using their lapel microphones upon immediate realization of a diagnostic EKG (usually within 1-2 minutes of patient contact). This report to the 9-1-1 dispatcher included the patient's sex, age, and cardiologist (if known). The dispatcher then called the emergency department attending and informed them that a STEMI was being transported and that CCL activation was needed. We used retrospective chart review of a consecutive sample of patients from an existing STEMI registry to determine whether there was a statistically significant difference in DTB between the groups. RESULTS: Eight hundred fifty-six total STEMI alert patients arrived by EMS during the study. We excluded 730 notifications due to events such as cardiac arrest, arrhythmia, death, resolution of EKG changes and/or symptoms, cardiologist decision not to perform PCI, arrival as a transfer after prior stabilization at a referring facility or arriving by an EMS agency other than New Castle County EMS (NCC*EMS). Sixty-four (64) sequential patients from each group comprised the study sample. The average DTB (SD) for the standard communication method was 57.6 minutes (17.9), while that for dispatcher-aided communication was 46.1 minutes (12.8), (mean difference 57.6-46.1 minutes=11.5 minutes with a 95% CI [6.06,16.94]) p=0.0001. In the dispatcher-aided group, 92% of patients (59/64) met standards of ≤60 minute DTB time. Only 64% (41/64) met this goal in the standard communication group (p=0.0001). CONCLUSION: Brief, early notification of STEMI by paramedics through 9-1-1 dispatchers achieves earlier CCL activation in a hospital system already using EMS-directed CCL activation. This practice significantly decreased DTB and yielded a higher percentage of patients meeting the DTB≤60 minutes quality metric.

Comparison of percutaneous coronary intervention with drug eluting stents versus coronary artery bypass grafting in patients with multivessel coronary artery disease: Meta-analysis of six randomized controlled trials.

OBJECTIVE: To compare outcomes of percutaneous coronary intervention (PCI) with drug eluting stent (DES) and Coronary Artery Bypass Grafting (CABG) in patients with multivessel Coronary Artery Disease (CAD) using data from randomized controlled trials (RCT). BACKGROUND: PCI and CABG are established strategies for coronary revascularization in the setting of ischemic heart disease. Multiple RCTs have compared outcomes of the two modalities in patients with multivessel CAD. METHODS: We did a meta-analysis from six RCTs in the contemporary era comparing the effectiveness of PCI with DES to at 1 year, 2 years and 5 years respectively. RESULTS: Compared to CABG, at one year PCI was associated with a significantly higher incidence of TVR (RR=2.31; 95% CI: [1.80-2.96]; P=<0.0001), lower incidence of stroke (RR=0.35; 95% CI: [0.19-0.62]; P=0.0003), and no difference in death (RR=1.02; 95% CI: [0.77-1.36]; P=0.88) or MI (RR=1.16; 95% CI: [0.72-1.88]; P=0.53). At 5 years, PCI was associated with a higher incidence of death (RR=1.3; 95% CI: [1.10-1.54]; P=0.0026) and MI (RR=2.21; 95% CI: [1.75-2.79]; P=<0.0001). While the higher incidence of MI with PCI was noticed in both diabetic and non-diabetics, death was increased mainly in diabetic patients. CONCLUSION: In patients with multi-vessel CAD, PCI with DES is associated with no significant difference in death or MI at 1 or 2 years. However at 5 years, PCI is associated with higher incidence of death and MI.

Short, Intermediate and long term outcomes of CABG vs. PCI with DES in Patients With Multivessel Coronary Artery Disease. Meta-Analysis of Six Randomized Controlled Trials.

OBJECTIVE: Comparing outcomes of percutaneous coronary intervention (PCI) with drug eluting stent (DES) and Coronary Artery Bypass Grafting (CABG) in patients with multivessel Coronary Artery Disease (CAD) using data from randomized controlled trials (RCT). BACKGROUND: PCI and CABG are established strategies for coronary revascularization in the setting of ischemic heart disease. Multiple RCT have compared outcomes of the two modalities in patients with multivessel CAD. METHODS: We did a meta-analysis from six RCT in the contemporary era comparing the effectiveness of PCI with DES to at 1 year, 2 years and 5 years respectively. RESULTS: Compared to CABG, at one year PCI was associated with a significantly higher incidence of TVR (RR= 2.31; 95% CI: [1.80 - 2.96]; P=<0.0001), lower incidence of stroke (RR= 0.35; 95% CI: [0.19 - 0.62]; P=0.0003), and no difference in death (RR= 1.02; 95% CI: [0.77 - 1.36]; P= 0.88) or MI (RR= 1.16; 95% CI: [0.72 - 1.88]; P= 0.53). At 5 years, PCI was associated with a higher incidence of death (RR= 1.3; 95% CI: [1.10 - 1.54]; P= 0.0026) and MI (RR= 2.21; 95% CI: [1.75 - 2.79]; P=<0.0001). While the higher incidence of MI with PCI was noticed in both diabetic and non-diabetics, death was increased mainly in diabetic patients. CONCLUSION: In patients with multi-vessel CAD, PCI with DES is associated with no significant difference in death or MI at 1 or 2 years. However at 5 years, PCI is associated with higher incidence of death and MI.

Do patients accurately perceive their fall risk?

BACKGROUND: In U.S. hospitals, from 700,000 to 1 million inpatients fall each year. About a third of these falls could have been prevented. OBJECTIVES: This project's purpose was to document patient perceptions of their inpatient fall risk and determine how these perceptions were associated with clinical indicators of fall risk. METHODS: From six medical-surgical units, 193 patients were randomly selected and surveyed about their perceived fall risk during their hospital stay. For 101 of them, the Schmid fall risk assessment score, age, and gender were recorded. A retrospective review of the Schmid scores of all patients who fell during a 6-month historical sample period was reviewed for comparison. RESULTS: Most patients (88%) reported that they didn't feel at risk for falling during their hospital stay. No correlation between their Schmid score and their perceived fall risk was found. Historical review of all inpatients who'd fallen in a prior period showed that the 358 patients with known Schmid scores had a full range of scores. These are normally distributed from 0 to 6, with over 40% of patients experiencing falls having Schmid scores of less than 3. CONCLUSIONS: Patient perceptions of falls match neither their clinical risk nor their actual likelihood of falling. When designing fall prevention strategies, it may be important to remind providers of this gap in patient knowledge, which includes overconfidence in the role of the care team in preventing falls

Meta-analysis of three randomized controlled trials comparing coronary artery bypass grafting with percutaneous coronary intervention using drug-eluting stenting in patients with diabetes.

OBJECTIVES: Coronary artery bypass grafting (CABG) was found to be the preferred strategy of revascularization in patients with diabetes in the bare-metal stent (BMS) era. The introduction of drug-eluting stents (DESs) led to a significant reduction in the rates of repeat revascularization (RRV) when compared with BMSs. We did a collaborative analysis of data from randomized controlled trials in the contemporary era to compare CABG versus percutaneous coronary intervention using DESs in diabetic patients. METHODS: We performed a systematic review and meta-analysis from randomized trials in the contemporary era comparing PCI with DESs with CABG in diabetic patients with multivessel disease. A comprehensive literature search (1 January 2003 to 18 May 2013) identified randomized controlled trials that reported long-term outcomes comparing PCI using DESs with CABG in 2974 diabetic patients. RESULTS: At 1 year, PCI was associated with a significant increase in the incidence of RRV [2.48 (1.56-3.94); P ≤0.0001], lower incidence of stroke [relative risk (RR) = 0.43 (0.19-0.81); P = 0.017], and no difference in death or myocardial infarction (MI). At 5 years, PCI was still associated with a lower incidence of stroke, but was associated with a significant increase in the incidence of death [RR = 1.36 (1.11-1.66); P = 0.0033] and MI [RR = 2.01 (1.54-2.62); P ≤0.0001]. CONCLUSIONS: In patients with diabetes, PCI was associated with no difference in death and MI at 1 year. However, at 5 years, PCI was associated with a higher incidence of death and MI. PCI was associated with a higher incidence of RRV but a lower incidence of stroke.

Overall ED efficiency is associated with decreased time to percutaneous coronary intervention for ST-segment elevation myocardial infarction.

BACKGROUND: Performance of percutaneous coronary intervention (PCI) within 90 minutes of hospital arrival for ST-segment elevation myocardial infarction patients is a commonly cited clinical quality measure. The Centers for Medicare and Medicaid Services use this measure to adjust hospital reimbursement via the Value-Based Purchasing Program. This study investigated the relationship between hospital performance on this quality measure and emergency department (ED) operational efficiency. METHODS: Hospital-level data from Centers for Medicare and Medicaid Services on PCI quality measure performance was linked to information on operational performance from 272 US EDs obtained from the Emergency Department Benchmarking Alliance annual operations survey. Standard metrics of ED size, acuity, and efficiency were compared across hospitals grouped by performance on the door-to-balloon time quality measure. RESULTS: Mean hospital performance on the 90-minute arrival to PCI measure was 94.0% (range, 42-100). Among hospitals failing to achieve the door-to-balloon time performance standard, median ED length of stay was 209 minutes, compared with 173 minutes among those hospitals meeting the benchmark standard (P < .001). Similarly, median time from ED patient arrival to physician evaluation was 39 minutes for hospitals below the performance standard and 23 minutes for hospitals at the benchmark standard (P < .001). Markers of ED size and acuity, including annual patient volume, admission rate, and the percentage of patients arriving via ambulance did not vary with door-to-balloon time. CONCLUSION: Better performance on measures associated with ED efficiency is associated with more timely PCI performance.

Early hospital readmission in the trauma population: are the risk factors different?

INTRODUCTION: Hospital readmission rates will soon impact Medicare reimbursements. While risk factors for readmission have been described for medical and elective surgical patients, little is known about their predictive value specifically in trauma patients. PATIENTS AND METHODS: We retrospectively identified all admissions after trauma resuscitation to our urban level 1 trauma centre from 1/1/2004 to 8/31/2010. All patients discharged alive were included. Data collected included demographics, Injury Severity Score (ISS), and length of stay (LOS). We analyzed these index admissions for the development of complications that have previously been shown to be associated with readmission. Readmissions that occurred within 30 days of index admission were identified. Univariable and multivariable analyses were performed. p<0.05 was considered significant. RESULTS: We identified 10,306 index admissions, with 447 (4.3%) early (within 30 days) readmissions. Mean ISS was 11.1 (SD 10.4). On multivariable analysis, African-American race (OR 1.3, p=0.009), pre-existing chronic obstructive pulmonary disease (COPD) (OR 1.5, p=0.02), and diabetes mellitus (OR 1.8, p<0.001) were associated with readmission, along with higher ISS (OR 1.01, p<0.001), ICU admission (OR 2.1, p<0.001), and increased LOS (OR 1.01, p<0.001). Among many in-hospital complications examined, only the development of surgical site infection (SSI) (OR 1.9, p=0.02) was associated with increased risk of readmission. CONCLUSIONS: Trauma patients have a low risk of readmission. In contrast to elective surgical patients, the only modifiable risk factor for readmission in our trauma population was SSI. Other risk factors may present clinicians with opportunities for targeted interventions, such as proactive follow up or early phone contact. With future changes to health care policy, clinicians may have even greater motivation to prevent readmission.

Recommendations for the design of Phase 3 pharmaceutical trials that are more informative for patients, clinicians, and payers.

BACKGROUND: Pharmaceutical pragmatic clinical trials (PCTs) are designed to provide the type of evidence that is desired by patients, clinicians and payers but too often missing from traditional regulatory trials. PURPOSE: This paper presents framework for designing pragmatic trials incorporating evidence desired by post-regulatory decision makers while remaining within acceptable standards for regulatory approval. METHODS: Following a stakeholder meeting convened in May of 2009 to identify gaps in information collected in Phase 3 trials, CMTP staff and the authors drafted recommendations for Pragmatic Phase 3 Pharmaceutical Trials. This draft was circulated first to technical working group members for their comments. After revising the document based on these comments, it was distributed electronically to other select experts and then made available for public comment. The final version of the EGD appears on the CMTP website. RESULTS: The process resulted in a set of 10 recommendations for conducting Phase 3 trials that met regulatory needs while addressing information important to physicians, patients, payers, and policy-makers. These recommendations encompassed three primary areas: generalizability from the trial participants to the clinical population of interest; effectiveness relative to active comparators; and consistently measured relevant outcomes for coverage and treatment decisions. LIMITATIONS: While stakeholders were involved throughout the process, not all recommendations will meet the needs of all stakeholders. CONCLUSIONS: Pragmatic trial design need not be deferred until a product is in widespread use. Incremental movement toward the more pragmatic design of Phase 3 trials is desirable.

Influence of surgical and minimally invasive facial cosmetic procedures on psychosocial outcomes: a systematic review.

IMPORTANCE: Millions of surgical and minimally invasive cosmetic procedures of the face are performed each year, but objective clinical measures that evaluate surgical procedures, such as complication rates, have limited utility when applied to cosmetic procedures. While there may be subjective improvements in appearance, it is important to determine if these interventions have an impact on patients in other realms such as psychosocial functioning. This is particularly important in light of the Patient Protection and Affordable Care Act and its emphasis on patient-centered outcomes and effectiveness. OBJECTIVES: To review the literature investigating the impact of facial cosmetic surgery and minimally invasive procedures on relevant psychological variables to guide clinical practice and set norms for clinical performance. EVIDENCE REVIEW: English-language randomized clinical trials and prospective cohort studies that preoperatively and postoperatively assessed psychological variables in at least 10 patients seeking surgical or minimally invasive cosmetic procedures of the face. FINDINGS: Only 1 study investigating minimally invasive procedures was identified. Most studies reported modest improvement in psychosocial functioning, which included quality of life, self-esteem, and body image. Unfortunately, the overall quality of evidence is limited owing to an absence of control groups, short follow-up periods, or loss to follow-up. CONCLUSIONS AND RELEVANCE: The current literature suggests that a number of psychosocial domains may improve following facial cosmetic surgery, although the quality of this evidence is limited (grade of recommendation 2A). Despite the dramatic rise in nonsurgical cosmetic procedures, there is a paucity of information regarding the impact of chemodenervation and soft-tissue augmentation on psychosocial functioning.

Feasibility, acceptability and preliminary effectiveness of patient advocates for improving asthma outcomes in adults.

BACKGROUND: Asthmatic adults from low-income urban neighborhoods have inferior health outcomes which in part may be due to barriers accessing care and with patient-provider communication. We adapted a patient advocate (PA) intervention to overcome these barriers. OBJECTIVE: To conduct a pilot study to assess feasibility, acceptability and preliminary evidence of effectiveness. METHODS: A prospective randomized design was employed with mixed methods evaluation. Adults with moderate or severe asthma were randomized to 16 weeks of PA or a minimal intervention (MI) comparison condition. The PA, a non-professional, modeled preparations for a medical visit, attended the visit and confirmed understanding. The PA facilitated scheduling, obtaining insurance coverage and overcoming barriers to implementing medical advice. Outcomes included electronically-monitored inhaled corticosteroid (ICS) adherence, asthma control, quality of life, FEV1, emergency department (ED) visits and hospitalizations. Mixed-effects models guided an intention-to-treat analysis. RESULTS: 100 adults participated: age 47 ± 14 years, 75% female, 71% African-American, 16% white, baseline FEV1 69% ± 18%, 36% experiencing hospitalizations and 56% ED visits for asthma in the prior year. Ninety-three subjects completed all visits; 36 of 53 PA-assigned had a PA visit. Adherence declined significantly in the control (p = 0.001) but not significantly in the PA group (p = 0.30). Both PA and MI groups demonstrated improved asthma control (p = 0.01 in both) and quality of life (p = 0.001, p = 0.004). Hospitalizations and ED visits for asthma did not differ between groups. The observed changes over time tended to favor the PA group, but this study was underpowered to detect differences between groups. CONCLUSION: The PA intervention was feasible and acceptable and demonstrated potential for improving asthma control and quality of life.

Exception from informed consent for emergency research: consulting the trauma community.

BACKGROUND: Research investigating the resuscitation and management of unstable trauma patients is necessary to improve care and save lives. Because informed consent for research is impossible in emergencies, the Federal Drug Administration has established an Exception from Informed Consent (EFIC) Policy that mandates "community consultation" as a means of protecting patient autonomy. We hypothesized that the trauma community represents a heterogeneous population whose attitudes regarding EFIC and willingness to participate in emergency research are influenced by status as a patient, family, or geographic community member. METHODS: In the context of an upcoming trial, trauma patients as well as family and community members were asked to rank statements regarding EFIC and willingness to participate in emergency research using a 5-point Likert-type scale. Higher total scores reflected a more positive attitude regarding EFIC (range, 4-20; neutral = 12) and willingness (range, 21-105, neutral = 63). The influence of demographics, education, and interpersonal violence were evaluated by Kruskal-Wallis and Mann-Whitney U-tests (p < 0.05). RESULTS: Overall, the 309 participants (trauma patients, n = 172; family, n = 73; community, n = 64) were positive about EFIC (median, 16; interquartile range, [IQR], 14-18) and demonstrated high willingness scores (median, 82; IQR, 76-88.5). EFIC and willingness were not influenced by age, sex, race, or education. Victims of interpersonal violence and their family members had lower EFIC scores than those with other mechanisms (median [IQR], 16 [14-18] vs. 16 [13-16]; p = 0.04) but similar willingness. Although EFIC scores were similar between groups, trauma patients had significantly lower willingness than family (median [IQR], 74 [68-77] vs. 77 [70-85]; p = 0.03) or community members (median [IQR], 76 [70-84]; p = 0.01). CONCLUSION: Trauma patients, families, and the geographic community expressed a high degree of support for EFIC and willingness to participate in emergency research, although support was influenced by injury mechanism and group status. Consultation efforts for emergency research should extend beyond the geographic community to include trauma victims and their families. LEVEL OF EVIDENCE: Epidemiologic, level III.

Mineralocorticoid deficiency in hemorrhagic shock.

BACKGROUND: In the critically ill, mineralocorticoid deficiency (MD) is associated with greater disease severity, the development of acute renal insufficiency, and increased mortality. We hypothesized that severely injured trauma patients presenting with hemorrhagic shock would demonstrate a high degree of MD. We also hypothesized that MD in these patients would be associated with increased length of stay, hypotension, fluid requirements, and acute kidney injury (AKI). MATERIALS AND METHODS: Thirty-two trauma patients in hemorrhagic shock on admission to the trauma bay (SBP <90 mm Hg × 2) were enrolled. Blood samples were obtained on ICU admission and 8, 16, 24, and 48 hours later. Plasma aldosterone (PA) and renin (PR) were assayed by radioimmunoassay. MD was defined as a ratio of PA/PR ≤2. Demographic data, injury severity score, ICU and hospital length of stay, fluid requirements, mean arterial pressure, serum sodium, hypotension, and risk for AKI were compared for patients with and without MD. RESULTS: At ICU admission, 48% of patients met criteria for MD. Patients with MD were significantly more likely to experience hypotension (MAP ≤60 mm Hg) during the study period. MD patients required significantly more units of blood in 48 h than non-MD patients (13 [7-22] versus 5 [2-7], P = 0.015) and had increased crystalloid requirements (18L [14-23] versus 9L [6-10], P < 0.001). MD patients were at higher risk for AKI according to RIFLE and AKIN criteria. CONCLUSIONS: MD is a common entity in trauma patients presenting in hemorrhagic shock. Patients with MD required a more aggressive resuscitative effort, were more likely to experience hypotension, and had a higher risk of AKI than non-MD patients. Future studies are needed to fully understand the impact of MD following trauma and the potential role for hormonal replacement therapy.