The Informed Consent Process and the Use of the Exception to Informed Consent in the Clinical Trial of Diaspirin

In the clinical trial of diaspirin crosslinked hemoglobin (DCLHb), optimal therapy required the immediate enrollment of patients with severe, uncompensated, traumatic hemorrhagic shock. When it was not feasible to obtain prospective consent, an exception to informed consent was used according to FDA regulation 21 CFR 50.24. Objectives: To examine the informed consent process and the use of the consent exception and consent to continue (CTC), and to describe the patients for whom this process was used. Methods: This was a multicenter, randomized, controlled, single-blinded efficacy trial of DCLHb as an adjunct to standard therapy in the treatment of severe, traumatic hemorrhagic shock. Patients with unstable vital signs or a critical base deficit were treated, with a primary study endpoint of 28-day mortality. Results: During the 11-month study period, 112 patients were randomized in 18 U.S. trauma centers, and data from 98 of the infused patients were analyzed. Prospective consent was obtained from two patients, three family members, and one legally authorized representative (LAR) (6%). Consent to continue was requested for 89 patients (89%), and full participation was granted for 87 of these patients (98%). Consent to continue was provided by 54 (98%) of the 55 patients approached. The mean number of days for family/LAR CTC was 1.1 ± 3.8 days, and 50% of the time it was obtained on the day of study enrollment. Patient CTC was obtained in an average of 13 ± 23 days, with a median of four days. Patients treated in this protocol were more likely to have sustained penetrating trauma than the overall trauma patient population treated in these trauma centers (44% vs 21%, p = 0.002). Conclusions: Informed consent in this study of an emergent therapy most often involved the use of the consent exception and consent to continue, the latter of which occurred in a timely manner. Nearly all of those who were approached for CTC approved full participation in the study, suggesting acceptance of the process outlined in the new regulations. Patients treated in a hemorrhagic shock clinical trial may differ from the general trauma patient population.     

Examining emergency medical services' prehospital transport times for trauma patients during COVID-19

IntroductionLonger prehospital times were associated with increased odds for survival in trauma patients. The purpose of this study was to determine how the COVID-19 pandemic affected emergency medical services (EMS) prehospital times for trauma patients.MethodsThis retrospective cohort study compared trauma patients transported via EMS to six US level I trauma centers admitted 1/1/19–12/31/19 (2019) and 3/16/20–6/30/20 (COVID-19). Outcomes included: total EMS pre-hospital time (dispatch to hospital arrival), injury to dispatch time, response time (dispatch to scene arrival), on-scene time (scene arrival to scene departure), and transportation time (scene departure to hospital arrival). Fisher's exact, chi-squared, or Kruskal-Wallis tests were used, alpha = 0.05. All times are presented as median (IQR) minutes.ResultsThere were 9400 trauma patients transported by EMS: 79% in 2019 and 21% during the COVID-19 pandemic. Patients were similar in demographics and transportation mode. Emergency room deaths were also similar between 2019 and COVID-19 [0.6% vs. 0.9%, p = 0.13].There were no differences between 2019 and during COVID-19 for total EMS prehospital time [44 (33, 63) vs. 43 (33, 62), p = 0.12], time from injury to dispatch [16 (6, 55) vs. 16 (7, 77), p = 0.41], response time [7 (5, 12) for both groups, p = 0.27], or on-scene time [16 (12−22) vs. 17 (12,22), p = 0.31]. Compared to 2019, transportation time was significantly shorter during COVID-19 [18 (13, 28) vs. 17 (12, 26), p = 0.01].ConclusionThe median transportation time for trauma patients was marginally significantly shorter during COVID-19; otherwise, EMS prehospital times were not significantly affected by the COVID-19 pandemic.     

The Time Cost of Prehospital Intubation andIntravenous Access in Trauma Patients

Objectives. The prehospital management of trauma patients remains controversial. Little is known about the time each procedure contributes to the on-scene duration, andthis information would be helpful in prioritizing which procedures to perform in the prehospital setting. We sought to estimate the contribution of procedures to on-scene duration focusing on intubation andestablishment of intravenous (IV) access. Methods. Data were provided by the Office of Emergency Planning andResponse at the Mississippi Department of Health. Real-time prehospital patient-level data are collected by emergency medical services (EMS) providers for all 9-1-1 calls statewide. Linear regression was performed to determine the overall additional time for an average procedure andto calculate marginal increases in on-scene time associated with the establishment of IV access andwith endotracheal intubation. Analyses were performed using Stata 9. Results. During 2001–2005, 192,055 prehospital runs were made for trauma patients. 121,495 (63%) included prehospital procedures. Average on-scene duration for those runs was 15:24 (minutes:seconds). On average, each procedure was associated with an addition of 1 minute to the on-scene duration (95% confidence interval [CI]: 58–62 seconds). A scene involving the establishment of IV access was 5:04 longer, while one involving tracheal intubation was 2:36 longer. Conclusions. We estimate the marginal increase in on-scene duration associated with the performance of an average procedure, establishment of IV access, andendotracheal intubation. There are policy andplanning implications for the time trade-off of prehospital procedures, especially discretionary ones.     

Longer Prehospital Time was not Associated with Mortality in Major Trauma: A Retrospective Cohort Study

Objective: The objective of this study was to determine the association between prehospital time and outcomes in adult major trauma patients, transported by ambulance paramedics. Methods: A retrospective cohort study of major trauma patients (Injury Severity Score >15) attended by St John Ambulance paramedics in Perth, Western Australia, who were transported to hospital between January 1, 2013 and December 31, 2016. Inverse probability of treatment weighting (IPTW) using the propensity score was performed to limit selection bias and confounding. The primary outcome was 30-day mortality and the secondary outcome was the length of hospital stay (LOS) for 30-day survivors. Multivariate logistic and log-linear regression analyses with IPTW were used to determine if prehospital time of more than the one hour (from receipt of the emergency call to arrival at hospital) or any individual prehospital time interval (response, on-scene, transport, or total time) was associated with 30-day mortality or LOS. Results: A total of 1,625 major trauma patients were included and 1,553 included in the IPTW sample. No significant association between prehospital time of one hour and 30-day mortality was found (adjusted odds ratio 1.10, 95% confidence interval (CI) 0.71–1.69). No association between any individual prehospital time interval and 30-day mortality was identified. In the 30-day survivors, one-minute increase of on-scene time was associated with 1.16 times (95% CI 1.03–1.31) longer LOS. Conclusion: Longer prehospital times were not associated with an increased likelihood of 30-day mortality in major trauma patients transported to hospital by ambulance paramedics. We found no evidence to support the hypothesis that prehospital time longer than one hour resulted in an increased risk of 30-day mortality. However, longer on-scene time was associated with longer hospital LOS (for 30-day survivors). Our recommendation is that prehospital care is delivered in a timely fashion and delivery of the patient to hospital is reasonably prompt.     

Emergency Medical Service Providers' Attitudes andExperiences Regarding Enrolling Patients in Clinical Research Trials

Objective: The purpose of this study was to evaluate Emergency Medical Services (EMS) providers' attitudes andexperiences about enrolling patients in clinical research trials utilizing the federal rules for exception from informed consent. We hypothesized that Emergency Medical Technicians (EMTs) would have varied attitudes about research using an exception from informed consent which could have an impact on the research. Methods andsetting: Since January 2007, the EMS system has been participating in a randomized, multi-center interventional trial in which out-of-hospital providers enroll critically injured trauma patients using exception from informed consent.A voluntary, anonymous, written survey was administered to EMS providers during an in-service. The survey included demographics andLikert-type questions about their experiences with andattitudes towards research in general, andresearch using an exception from informed consent for an out-of-hospital clinical trial. Results: The response rate was 79.3% (844/1067). Most respondents, 93.3%, agreed that “research in EMS care is important.” However, 38.5% also agreed that individual EMTs/paramedics should maintain the personal right of refusal to enroll patients in EMS trials. Fifty-four percent of respondents agreed with the statement that “the right of research subjects to make their own choices is more important than the interests of the general community.” In response to statements about the current study, 11.3% agreed that “the study is unethical because the patient cannot consent” and69.2% responded that they would personally be willing to be enrolled in the study before they were able to give consent if they were seriously injured. Those who had not enrolled a patient into the study (681 respondents) were asked their reasons: 76.8% had not encountered an eligible patient or did not work for an agency that carried the fluid; 4.3% did not have time; 4.1% forgot and1.1% stated that they were opposed to enrolling patients in studies without their consent. Conclusion: The majority of EMS personnel in one community support EMS research andthis specific out-of-hospital clinical trial being conducted under an exception from informed consent. Potential barriers to enrollment were identified. Further study in other systems is warranted to better understand EMS provider perspectives about exception from informed consent research.     

The informed consent process and the use of the exception to informed consent in the clinical trial of diaspirin cross-linked hemoglobin (DCLHb) in severe traumatic hemorrhagic shock. DCLHb Traumatic Hemorrhagic Shock study group.

In the clinical trial of diaspirin cross-linked hemoglobin (DCLHb), optimal therapy required the immediate enrollment of patients with severe, uncompensated, traumatic hemorrhagic shock. When it was not feasible to obtain prospective consent, an exception to informed consent was used according to FDA regulation 21 CFR 50.24. OBJECTIVES: To examine the informed consent process and the use of the consent exception and consent to continue (CTC), and to describe the patients for whom this process was used. METHODS: This was a multicenter, randomized, controlled, single-blinded efficacy trial of DCLHb as an adjunct to standard therapy in the treatment of severe, traumatic hemorrhagic shock. Patients with unstable vital signs or a critical base deficit were treated, with a primary study endpoint of 28-day mortality. RESULTS: During the 11-month study period, 112 patients were randomized in 18 U.S. trauma centers, and data from 98 of the infused patients were analyzed. Prospective consent was obtained from two patients, three family members, and one legally authorized representative (LAR) (6%). Consent to continue was requested for 89 patients (89%), and full participation was granted for 87 of these patients (98%). Consent to continue was provided by 54 (98%) of the 55 patients approached. The mean number of days for family/LAR CTC was 1.1 +/-3.8 days, and 50% of the time it was obtained on the day of study enrollment. Patient CTC was obtained in an average of 13 +/- 23 days, with a median of four days. Patients treated in this protocol were more likely to have sustained penetrating trauma than the overall trauma patient population treated in these trauma centers (44% vs 21%, p = 0.002). CONCLUSIONS: Informed consent in this study of an emergent therapy most often involved the use of the consent exception and consent to continue, the latter of which occurred in a timely manner. Nearly all of those who were approached for CTC approved full participation in the study, suggesting acceptance of the process outlined in the new regulations. Patients treated in a hemorrhagic shock clinical trial may differ from the general trauma patient population.     

Consent in clinical trials: What do patients know?

ObjectiveTo assess participants' knowledge of key aspects about the clinical trials in which they are enrolled, describe the consent process, and assess the importance that investigators give to various aspects of trial information when verbally informing candidates.DesignProspective study based on a structured questionnaire interview of participants within 3 months after trial enrollment and an anonymous questionnaire sent to clinical trial investigators.SubjectsA total of 140 participants included in 40 clinical trials were interviewed, and 51 investigators answered the questionnaire.ResultsThe formal steps to obtain informed consent were usually carried out. Participants were aware of the purpose of the trial and the right to discontinue participation, but only 23% knew that treatment was randomly allocated, 57% knew they might receive a placebo, and 42% was aware that adverse effects could occur. Patients who had read the information sheet had better knowledge of most aspects, except for the risk of adverse effects. The investigators considered that compensation, insurance coverage, possibility of receiving a placebo, and treatment allocation were the least important aspects of the trial when informing candidates for participation.ConclusionsAlthough the formal steps for obtaining informed consent were usually carried out, a relevant percentage of patients included in clinical trials were unaware of important aspects of their participation. Patients showed more limited knowledge about the same points that investigators considered less important when informing potential participants. Deferring signature on the consent form and encouraging reading of the information sheet may improve participants' knowledge about clinical trials.     

Implementing the Food and Drug Administration's Final Rule for Waiver of Informed Consent in Certain Emergency Research Circumstances

In 1996, the Food and Drug Administration released its Final Rule for Waiver of Informed Consent in Certain Emergency Research Circumstances (the Final Rule). The Department of Health and Human Services (DHHS) also released an update of its regulations related to waiver of informed consent in emergency research. These new regulations allow resuscitation research to proceed with a waiver of informed consent under very narrow and specific clinical research circumstances. Waiving informed consent for research participation has profound ethical and scientific implications. However, in unpredictable life-threatening clinical situations for which current therapy is unproven or unsatisfactory, patients usually are unable to consent on their own behalf to participate in clinical trials of potentially beneficial but experimental interventions. Because of the time-dependent nature of most resuscitation interventions, it is usually not feasible to identify and contact the legally authorized representative who can speak on behalf of the patient within the presumed therapeutic window of the intervention under investigation. For such clinical trials to proceed, a waiver of informed consent is usually necessary. Patients who are critically ill or injured and unable to provide meaningful prospective informed consent because of their current life-threatening condition are vulnerable and require additional protections beyond those for research subjects who can speak on their own behalf. The Final Rule and the DHHS-updated regulations incorporate a number of additional patient safeguards that must occur if a clinical trial is to proceed with waiver of informed consent. Specific means of adequately meeting these requirements are not described in the regulations. Although this was intentional on the part of the federal regulators so that individual protocols and research environments would direct the development of these patient safeguards, the lack of specific guidance has led to confusion on the appropriate implementation of the new regulations. This article reviews some of the key concepts of the Final Rule, with suggestions on their purpose and meaning. It also reviews the studies that have been approved to date to proceed with waiver of informed consent, and offers suggestions for the process of implementing the requirements of the Final Rule for research involving patients who are unable to give prospective informed consent.     

Public opinion of a stroke clinical trial using exception from informed consent

Background

Acute stroke is a leading cause of morbidity and mortality. Clinical trials in stroke are challenging because victims often do not have the capacity to provide informed consent, excluding those patients most likely to benefit from the research.

Aim

We evaluated patient willingness to participate in a hypothetical acute stroke trial using an exception from informed consent.

Methods

Consecutive patients presenting to four emergency departments (EDs) underwent structured interviews regarding a hypothetical stroke trial using an exception from informed consent.

Results

Of 461 (72% of eligible) participants, 55% (95% CI, 50%–59%) were willing to be enrolled in the hypothetical study without giving informed consent. After multivariable analysis, independent predictors of willingness to enroll included Catholic religion (OR 1.57, 95% CI 1.17–2.10) and belief that current therapy offers a >50% chance of full recovery (OR 1.29, 95% CI 1.05–1.57). There was no difference between the proportion willing to enroll in a cardiac arrest study vs. a stroke study (55% vs. 55%, p?=?0.83)

Conclusions

Fifty-five percent of ED patients would be willing to be enrolled in a stroke trial using exception from informed consent.     

Community Consultation Methods in a Study Using Exception to Informed Consent

Objective. The most effective means of community consultation is unknown. We evaluated differences in community opinion elicited by varying means of consultation. Methods. We compared responses with a cross-sectional, standardized survey administered as part of the community consultation for the Resuscitation Outcomes Consortium (ROC) hypertonic saline trial. Surveys were obtained from four sources: two sets of random-digit dialing phone surveys, paper surveys from community meetings, andweb-based surveys. Results. Three hundred sixty-one usable surveys were obtained: 186 from phone survey 1; 86 from phone survey 2 (using slightly modified wording); 54 from community meetings (8 from open forums; 46 from existing meetings); and35 from a web site. Demographics were similar between the sets except that the surveys obtained from community meetings had the highest minority representation (63.3% nonwhite). Community meeting respondents were more willing than phone or web respondents to receive experimental treatment for themselves (93.6% vs. 77.5% overall) andfor a family member (95.2% vs. 74.9% overall). The web-based survey generated the least feedback andhad the most higher-income responders. Conclusions. Responses varied by method of consultation. The open forums were very poorly attended, despite heavy advertising by investigators. Furthermore, attendees at those meetings provided the least objection to proposed research without informed consent. Phone surveys elicited the most objections. We suggest that an efficient method of community consultation is random-digit dialing supplemented with discussion at already scheduled events to target special populations.     

Utilization of Intravenous Catheters by Prehospital Providers during Pediatric Transports

Introduction: Prehospital intravenous (IV) access in children may be difficult and time-consuming. Emergency Medical Service (EMS) protocols often dictate IV placement; however, some IV catheters may not be needed. The scene and transport time associated with attempting IV access in children is unknown. The objective of this study is to examine differences in scene and transport times associated with prehospital IV catheter attempt and utilization patterns of these catheters during pediatric prehospital encounters. Methods: Three non-blinded investigators abstracted EMS and hospital records of children 0–18 years of age transported by EMS to a pediatric emergency department (ED). We compared patients in which prehospital IV access was attempted to those with no documented attempt. Our primary outcome was scene time. Secondary outcomes include utilization of the IV catheter in the prehospital and ED settings and a determination of whether the catheter was indicated based on a priori established criteria (prehospital IV medication administration, hypotension, GCS < 13, and ICU admission). Results: We reviewed 1,138 records, 545 meeting inclusion criteria. IV catheter placement was attempted in 27% (n = 149) with success in 77% (n = 111). There was no difference in the presence of hypotension or median GCS between groups. Mean scene time (12.5 vs. 11.8 minutes) and transport time (16.9 vs. 14.6 minutes) were similar. Prehospital IV medications were given in 38.7% (43/111). One patient received a prehospital IV medication with no alternative route of administration. Among patients with a prehospital IV attempt, 31% (46/149) received IV medications in the ED and 23% (34/396) received IV fluids in the ED. Mean time to use of the IV in the ED was 70 minutes after arrival. Patients with prehospital IV attempt were more likely to receive IV medication within 30 minutes of ED arrival (39.1% vs. 19.0%, p = 0.04). Overall, 34.2% of IV attempts were indicated. Conclusions: Prehospital IV catheter placement in children is not associated with an increase in scene or transport time. Prehospital IV catheters were used in approximately one-third of patients. Further study is needed to determine which children may benefit most from IV access in the prehospital setting.     

Contemporary Prehospital Emergency Medical Services Response Times for Suspected Stroke in the United States

Background and Purpose: There are no contemporary national-level data on Emergency Medical Services (EMS) response times for suspected stroke in the United States (US). Because effective stroke treatment is time-dependent, we characterized response times for suspected stroke, and examined whether they met guideline recommendations. Methods: Using the National EMS Information System dataset, we included 911 calls for patients ≥ 18 years with an EMS provider impression of stroke. We examined variation in the total EMS response time by dispatch notification of stroke, age, sex, race, region, time of day, day of the week, as well as the proportion of EMS responses that met guideline recommended response times. Total EMS response time included call center dispatch time (receipt of call by dispatch to EMS being notified), EMS dispatch time (dispatch informing EMS to EMS starts moving), time to scene (EMS starts moving to EMS arrival on scene), time on scene (EMS arrival on scene to EMS leaving scene), and transport time (EMS leaving scene to reaching treatment facility). Results: We identified 184,179 events with primary impressions of stroke (mean age 70.4 ± 16.4 years, 55% male). Median total EMS response time was 36 (IQR 28.7–48.0) minutes. Longer response times were observed for patients aged 65–74 years, of white race, females, and from non-urban areas. Dispatch identification of stroke versus “other” was associated with marginally faster response times (36.0 versus 36.7 minutes, p < 0.01). When compared to recommended guidelines, 78% of EMS responses met dispatch delay of <1 minute, 72% met time to scene of <8 minutes, and 46% met on-scene time of <15 minutes. Conclusions: In the United States, time from receipt of 9-1-1 calls to treatment center arrival takes a median of 36 minutes for stroke patients, an improvement upon previously published times. The fact that 22%–46% of EMS responses did not meet stroke guidelines highlights an opportunity for improvement. Future studies should examine EMS diagnostic accuracy nationally or regionally using outcomes based approaches, as accurate recognition of prehospital strokes is vital in order to improve response times, adhere to guidelines, and ultimately provide timely and effective stroke treatment.     

T HE E FFECTS OF P REHOSPITAL A DVANCED L IFE S UPPORT D RUG T REATMENT ON P ATIENT I MPROVEMENT AND I N-HOSPITAL U TILIZATION

Objective. There is little published evidence to support the benefits of prehospital drug administration by ambulance personnel in reducing subsequent hospital utilization by the medical patients receiving such drugs. The authors studied the outcome of patients treated by Ontario's Emergency Health Services “Symptom Relief Drug Program,” which was developed to relieve patient symptoms in the field for specific medical emergencies. Methods. A retrospective study spanning a three-year period from January 1996 to December 1998 was undertaken in a mid-sized southern Ontario community. From a review of ambulance call reports (ACRs), eligible patients were recruited by mail and divided into two groups: those treated before the introduction of the program (pre) and those treated after (post). Out-of-hospital data were retrieved from ACRs and in-hospital data were gathered from medical chart reviews. Outcomes included emergency department (ED) length of stay (LOS), frequency of admissions, and departmental use. Secondary endpoints included differences in prehospital improvement, ED interventions, and ambulance scene times. Results. For the unpaired analysis, 406 patients provided consent (pre: 215 vs post: 191). Ambulance time on scene was longer in the post group, 14.2 minutes (95% CI 13.7–14.8), versus the pre group, 12.3 minutes (95% CI 11.7–12.9), p < 0.001. A larger proportion of patients receiving prehospital drug treatment were judged to have improved on ED arrival (pre: 19.5% vs post: 48.2%, χ² p < 0.0001). The ED LOSs did not differ between groups (pre: 206.9?min, 95% CI 185.9–230.4, vs post: 220.9?min, 95% CI 196.9–247.7, p = 0.42) but were shorter within the post group for hypoglycemic patients receiving glucagon. The overall proportion of admissions was significantly lower in the post group (pre: 145 [67.4%] vs post: 102 [54.3%], χ² p < 0.01), and this was driven by chest pain patients. Conclusions. The lower rate of admissions for chest pain patients is the first published evidence of prehospital drug treatment's reducing hospital utilization in a subgroup of such medical patients. The “Symptom Relief Drug Program” is effective in improving patients' field conditions and can decrease ED LOS in hypoglycemic persons receiving glucagon injections. More outcome research pertaining to ambulance-administered prehospital drug treatment is warranted.     

Room for Improvement: A Systematic Review and Meta-analysis on the Informed Consent Process for Emergency Surgery

ObjectiveTo compare recall of complications and surgical details discussed during informed consent and perception of the consent process in patients undergoing emergent vs elective surgery.MethodsStudies were identified from PubMed, Cochrane, Web of Science, and Scopus from January 1, 1966, through April 18, 2018. Included studies compared patient recall and perception regarding informed consent in those undergoing emergent vs elective surgery. Pooled odds ratios (ORs) were calculated for recall of complications and surgical details, patient satisfaction, perception of sufficient information being delivered on surgical risks, report of having read written consent, and factors that interfered with consent.ResultsEleven observational studies (3178 patients) were included. The rate of recall of surgical complications (255 of 504 [50.6%] vs 321 of 446 [72.0%]; OR, 0.29; 95% CI, 0.11-0.80) was lower in patients undergoing emergent vs elective surgery. Meta-analysis revealed a decreased rate of patient satisfaction with the consent process (319 of 459 [69.5%] vs 882 of 1064 [82.9%]; OR. 0.53; 95% CI, 0.34-0.83) and fewer patients having read the consent form (130 of 395 [32.9%] vs 424 of 714 [59.4%]; OR, 0.35; 95% CI, 0.27-0.46) when undergoing emergent compared with elective surgery. Patients undergoing emergent surgery listed pain, analgesic medications, and fatigue as factors likely to interfere with consent.ConclusionPatients undergoing emergent surgery have poor recall of the informed consent process and surgical complications. Furthermore, patients report lower rates of satisfaction, and with fewer patients reading written consent documentation, our findings illuminate problems with the current communication process. There is a need to develop effective tools to improve informed consent in emergency surgery.     

Prehospital time intervals and management of ischemic stroke patients

ObjectiveQuantify prehospital time intervals, describe prehospital stroke management, and estimate potential time saved if certain procedures were performed en route to the emergency department (ED).MethodsAcute ischemic stroke patients who arrived via emergency medical services (EMS) between 2012 and 2016 were identified. We determined the following prehospital time intervals: chute, response, on-scene, transport, and total prehospital times. Proportions of patients receiving the following were determined: Cincinnati Prehospital Stroke Scale (CPSS) assessment, prenotification, glucose assessment, vascular access, and 12-lead electrocardiography (ECG). For glucose assessment, ECG acquisition, and vascular access, the location (on-scene vs. en route) in which they were performed was described. Difference in on-scene times among patients who had these three interventions performed on-scene vs. en route was assessed.ResultsData from 870 patients were analyzed. Median total prehospital time was 39 min and comprised the following: chute time: 1 min; response time: 9 min; on-scene time: 15 min; and transport time: 14 min. CPSS was assessed in 64.7% of patients and prenotification was provided for 52.0% of patients. Glucose assessment, vascular access initiation, and ECG acquisition was performed on 84.1%, 72.6%, and 67.2% of patients, respectively. 59.0% of glucose assessments, 51.2% of vascular access initiations, and 49.8% of ECGs were performed on-scene. On-scene time was 9 min shorter among patients who had glucose assessments, vascular access initiations, and ECG acquisitions all performed en route vs. on-scene.ConclusionsOn-scene time comprised 38.5% of total prehospital time. Limiting on-scene performance of glucose assessments, vascular access initiations, and ECG acquisitions may decrease prehospital time.     

Community attitudes towards emergency research and exception from informed consent

Objective

To determine public attitudes towards emergency research, exception from informed consent (EFIC) and a specific proposed clinical trial using EFIC.

Methods

As part of a planned community consultation activity, a survey was conducted at a popular public venue. Participants answered demographic questions and then were asked their opinions on specifically described consent circumstances in emergency research, including the proposed EFIC trial. Multiple logistic and linear regression were used to determine respondent characteristics associated with specific attitudes.

Results

1901 surveys were completed. The majority of respondents supported emergency research (88%) and the concept of surrogate consent by a legally authorized representative (78%). The concept of EFIC was less well supported (35%) but the application of EFIC was more accepted, especially when EFIC was applied to the respondent themselves (51%). The community believed the proposed EFIC study was acceptable (82%); a minority had concerns but most were related to patient safety and not to EFIC. Respondents with less education and lower incomes were less likely to express opinions about the consent and research concepts described.

Conclusions

Emergency research and the proposed EFIC trial is supported in this community. The concept of EFIC is less well supported but is more acceptable when a specific trial is described or when respondents consider EFIC for themselves. Specific respondent characteristics are associated with attitudes about research; this can assist in development of meaningful community consultation activities.     

Pre-hospital freeze-dried plasma for critical bleeding after trauma: A pilot randomized controlled trial

Objectives

Transfusion of a high ratio of plasma to packed red blood cells (PRBCs), to treat or prevent acute traumatic coagulopathy, has been associated with survival after major trauma. However, the effect of prehospital plasma on patient outcomes has been inconsistent. The aim of this pilot trial was to assess the feasibility of transfusing freeze-dried plasma with red blood cells (RBCs) using a randomized controlled design in an Australian aeromedical prehospital setting.

Methods

Patients attended by helicopter emergency medical service (HEMS) paramedics with suspected critical bleeding after trauma managed with prehospital RBCs were randomized to receive 2 units of freeze-dried plasma (Lyoplas N-w) or standard care (no plasma). The primary outcome was the proportion of eligible patients enrolled and provided the intervention. Secondary outcomes included preliminary data on effectiveness, including mortality censored at 24 h and at hospital discharge, and adverse events.

Results

During the study period of June 1 to October 31, 2022, there were 25 eligible patients, of whom 20 (80%) were enrolled in the trial and 19 (76%) received the allocated intervention. Median time from randomization to hospital arrival was 92.5 min (IQR 68–101.5 min). Mortality may have been lower in the freeze-dried plasma group at 24 h (RR 0.24, 95% CI 0.03–1.73) and at hospital discharge (RR 0.73, 95% CI 0.24–2.27). No serious adverse events related to the trial interventions were reported.

Conclusions

This first reported experience of freeze-dried plasma use in Australia suggests prehospital administration is feasible. Given longer prehospital times typically associated with HEMS attendance, there is potential clinical benefit from this intervention and rationale for a definitive trial.     

The "Vertical Response Time": Barriers to Ambulance Response in an Urban Area

Background: Ambulance response time is typically reported as the time interval from call dispatch to arrival on-scene. However, the often unmeasured "vertical response time" from arrival on-scene to arrival at the patient's side may be substantial, particularly in urban areas with high-rise buildings or other barriers to access.
Objectives: To measure the time interval from arrival on-scene to the patient in a large metropolitan area and to identify barriers to emergency medical services arrival.
Methods: This was a prospective observational study of response times for high-priority call types in the New York City 9-1-1 emergency medical services system. Research assistants riding with paramedics enrolled a convenience sample of calls between 2001 and 2003.
Results: A total of 449 paramedic calls were included, with a median time from call dispatch to arrival on-scene of 5.2 minutes. The median on-scene to patient arrival interval was 2.1 minutes, leading to an actual response interval (dispatch to patient) of 7.6 minutes. The median on-scene to patient interval was 2.8 minutes for residential buildings, 2.7 minutes for office complexes, 1.3 minutes for private homes (less than four stories), and 0.5 minutes for outdoor calls. Overall, for all calls, the on-scene to patient interval accounted for 28% of the actual response interval. When an on-scene escort provided assistance in locating and reaching the patient, the on-scene to patient interval decreased from 2.3 to 1.9 minutes. The total dispatch to patient arrival interval was less than 4 minutes in 8.7%, less than 6 minutes in 28.5%, and less than 8 minutes in 55.7% of calls.
Conclusions: The time from arrival on-scene to the patient's side is an important component of overall response time in large urban areas, particularly in multistory buildings.