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INTRODUCTION Community Consultation (CC) is a key step for Exception from Informed Consent (EFIC) research. Using social media to conduct CC is becoming more widely accepted, but has largely been conducted by single sites. We describe our experience of a social media-based CC for a multicenter clinical trial, coordinated by the lead clinical site. METHODS Multicenter CC administered by the lead site and conducted in preparation for a three-site prehospital randomized clinical trial. We utilized Facebook and Instagram advertisements targeted to the population of interest. When "clicked" the advertisements directed individuals to study-specific websites, providing additional information and the opportunity to opt out. The lead institution and one other hospital relied on a single website, whereas the third center set up their own website. Site views were evaluated using Google analytics. RESULTS The CC took 8 weeks to complete for each site. The advertisements were displayed 9.8 million times, reaching 332,081 individuals, of whom 1,576 viewed one of the study-specific websites. There were no opt-outs. The total cost was $3,000. The costs per person reached were $1.88, $2.00 and $1.85 for each of the three sites. A number of site-specific issues (multiple languages, hosting of study-specific websites) were easily resolved. CONCLUSION This study suggests it is possible for one institution to conduct multiple, simultaneous, social media-based CC campaigns, on behalf of participating trial sites. Our results suggest this social media CC model reaches many more potential subjects and is economical and more efficient than traditional methods. LEVEL OF EVIDENCE IV, Epidemiological.

Background‘Community consultation’ (CC) is a key step when conducting Exception From Informed Consent research. Social-media-based CC has been shown to reach more people than traditional methods, but it is unclear whether those reached are representative of the community as a whole.MethodsThis is a retrospective analysis of the CC performed in preparation for the PHOXSTAT trial. Social media advertisement campaigns were conducted in the catchment areas of the three participating trauma centers and evaluated by examining Facebook user statistics. We compared these data to georeferenced population data obtained from the U.S. Census Bureau. We examined variations in the proportion of each age group reached, by gender.ResultsOur social media advertisements reached a total of 332 081 individuals in Los Angeles, Birmingham, and Nashville. Although there were differences in the proportion of individuals reached within each age group and gender groups, compared with the population in each area, these were small (within 5%). In Birmingham, participants 55 to 64 years old, 25 to 34 years old, and females 18 to 24 years old were slightly over-represented (a larger proportion of individuals in this age group were reached by the social media campaign, compared with the population resident in this area). In contrast, in Nashville, female participants 45 to 64 years old, and males 25 to 64 years old were over-represented. In Los Angeles, females 45 to 64 years old, and males 25 to 64 years and over were over-represented.DiscussionIn conclusion, this study demonstrates that social media CC campaigns can be used to reach a sample of the community broadly representative of the population as a whole, in terms of age and gender. This finding is helpful to IRBs and investigators, as it lends further support to the use of social media to conduct CC. Further work is needed to analyze how representative community samples are in terms of other characteristics, such as race, ethnicity, and socioeconomic status.Level III evidenceEconomic & Value-based Evaluations.

Tailoring hypothermia duration to ischemia duration may improve outcome from out-of-hospital cardiac arrest. We investigated the association between the hypothermia/ischemia ratio and functional outcome in a secondary analysis of data from the Resuscitation Outcomes Consortium Amiodarone, Lidocaine, or Placebo Study trial.Cohort study of out-of-hospital cardiac arrest patients screened for Resuscitation Outcomes Consortium-Amiodarone, Lidocaine, or Placebo Study.Multicenter study across North America.Adult, nontraumatic, out-of-hospital cardiac arrest patients screened for Resuscitation Outcomes Consortium-Amiodarone, Lidocaine, or Placebo Study who survived to hospital admission and received targeted temperature management between May 2012 and October 2015.Targeted temperature management in comatose survivors of out-of-hospital cardiac arrest. We defined hypothermia/ischemia ratio as total targeted temperature management time (initiation through rewarming) divided by calculated total ischemia time (approximate time of arrest [9-1-1 call or emergency medical services-witnessed] to return of spontaneous circulation).The primary outcome was hospital survival with good functional status (modified Rankin Score, 0-3) at hospital discharge. We fitted logistic regression models to estimate the association between hypothermia/ischemia ratio and the primary outcome, adjusting for demographics, arrest characteristics, and Resuscitation Outcomes Consortium enrolling site. A total of 3,429 patients were eligible for inclusion, of whom 36.2% were discharged with good functional outcome. Patients had a mean age of 62.0 years (SD, 15.8), with 69.7% male, and 58.0% receiving lay-rescuer cardiopulmonary resuscitation. Median time to return of spontaneous circulation was 21.1 minutes (interquartile range, 16.1-26.9), and median duration of targeted temperature management was 32.9 hours (interquartile range, 23.7-37.8). A total of 2,579 had complete data and were included in adjusted regression analyses. After adjustment for patient characteristics and Resuscitation Outcomes Consortium site, a greater hypothermia/ischemia ratio was associated with increased survival with good functional outcome (odds ratio, 2.01; 95% CI, 1.82-2.23). This relationship, however, appears to be primarily driven by time to return of spontaneous circulation in this patient cohort.Although a larger hypothermia/ischemia ratio was associated with good functional outcome after out-of-hospital cardiac arrest in this cohort, this association is primarily driven by duration of time to return of spontaneous circulation. Tailoring duration of targeted temperature management based on duration of time to return of spontaneous circulation or patient characteristics requires prospective study.

Airway management is an important component of resuscitation from out-of-hospital cardiac arrest (OHCA). The optimal approach to advanced airway management is unknown. The Pragmatic Airway Resuscitation Trial (PART) will compare the effectiveness of endotracheal intubation (ETI) and Laryngeal Tube (LT) insertion upon 72-hour survival in adult OHCA. Encompassing United States Emergency Medical Services agencies affiliated with the Resuscitation Outcomes Consortium (ROC), PART will use a cluster-crossover randomized design. Participating subjects will include adult, non-traumatic OHCA requiring bag-valve-mask ventilation. Trial interventions will include 1) initial airway management with ETI and 2) initial airway management with LT. The primary and secondary trial outcomes are 72-hour survival and return of spontaneous circulation. Additional clinical outcomes will include airway management process and adverse events. The trial will enroll a total of 3,000 subjects. Results of PART may guide the selection of advanced airway management strategies in OHCA.

IMPORTANCE: There is wide variability among emergency medical systems (EMS) with respect to transport to hospital during out-of-hospital cardiac arrest (OHCA) resuscitative efforts. The benefit of intra-arrest transport during resuscitation compared with continued on-scene resuscitation is unclear. OBJECTIVE: To determine whether intra-arrest transport compared with continued on-scene resuscitation is associated with survival to hospital discharge among patients experiencing OHCA. DESIGN, SETTING, AND PARTICIPANTS: Cohort study of prospectively collected consecutive nontraumatic adult EMS-treated OHCA data from the Resuscitation Outcomes Consortium (ROC) Cardiac Epidemiologic Registry (enrollment, April 2011-June 2015 from 10 North American sites; follow-up until the date of hospital discharge or death [regardless of when either event occurred]). Patients treated with intra-arrest transport (exposed) were matched with patients in refractory arrest (at risk of intra-arrest transport) at that same time (unexposed), using a time-dependent propensity score. Subgroups categorized by initial cardiac rhythm and EMS-witnessed cardiac arrests were analyzed. EXPOSURES: Intra-arrest transport (transport initiated prior to return of spontaneous circulation), compared with continued on-scene resuscitation. MAIN OUTCOMES AND MEASURES: The primary outcome was survival to hospital discharge, and the secondary outcome was survival with favorable neurological outcome (modified Rankin scale

Background 911 Emergency Medical Services (EMS) systems utilize supraglottic devices for either primary advanced airway management, or for airway rescue following failed attempts at direct laryngoscopy endotracheal intubation. There is, however, limited data on objective confirmation of supraglottic airway placement in the prehospital environment. Furthermore, the ability of EMS field providers to recognize a misplaced airway is unknown. Methods Retrospective review of patients who underwent airway management using the King LTS-D supraglottic airway in a large urban EMS system, between 3/1/15-9/30/2015. Subjective success was defined as documentation of successful airway placement by the EMS provider. Objective success was confirmed by review of waveform capnography, with the presence of a 4-phase waveform greater than 5 mmHg. Sensitivity and specificity of the field provider’s assessment of success were then calculated. Results A total of 344 supraglottic airway attempts were reviewed. No patients met obvious death criteria. 269 attempts (85.1%) met criteria for both subjective and objective success. 19 attempts (5.6%) were recognized failures by the EMS provider. 47 (13.8%) airways were misplaced but unrecognized by the EMS provider. 4 attempts (1.2%) were correctly placed but misidentified as failures, leading to the unnecessary removal and replacement of the airway. Sensitivity of the provider’s assessment was 98.5%; specificity was 28.7%. Conclusion The use of supraglottic airway devices results in unrecognized failed placement. Appropriate utilization and review of waveform capnography may remedy a potential blind-spot in patient safety, and systemic monitoring/feedback processes may therefore be used to prevent unrecognized misplaced airways.

Importance Emergency medical services (EMS) deliver essential initial care for patients with out-of-hospital cardiac arrest (OHCA), but the extent to which patient outcomes vary between different EMS agencies is not fully understood. Objective To quantify variation in patient outcomes after OHCA across EMS agencies. Design, Setting, and Participants This observational cohort study was conducted in the Resuscitation Outcomes Consortium (ROC) Epistry, a prospective multicenter OHCA registry at 10 sites in North America. Any adult with OHCA treated by an EMS from April 2011 through June 2015 was included. Data analysis occurred from May 2017 to March 2018. Exposure Treating EMS agency. Main Outcomes and Measures The primary outcome was survival to hospital discharge. Secondary outcomes were return of spontaneous circulation at emergency department arrival and favorable functional outcome at hospital discharge (defined as a modified Rankin scale score ≤3). Multivariable hierarchical logistic regression models were used to adjust confounders and clustering of patients within EMS agencies, and calculated median odds ratios (MORs) were used to quantify the extent of residual variation in outcomes between EMS agencies. Results We identified 43 656 patients with OHCA treated by 112 EMS agencies. At EMS agency level, we observed large variations in survival to hospital discharge (range, 0%-28.9%; unadjusted MOR, 1.43 [95% CI, 1.34-1.54]), return of spontaneous circulation on emergency department arrival (range, 9.0%-57.1%; unadjusted MOR, 1.53 [95% CI, 1.43-1.65]), and favorable functional outcome (range, 0%-20.4%; unadjusted MOR, 1.54 [95% CI, 1.40-1.73]). This variation persisted despite adjustment for patient-level and EMS agency–level factors known to be associated with outcomes (adjusted MOR for survival 1.56 [95% CI 1.44-1.73]; adjusted MOR for return of spontaneous circulation at emergency department arrival, 1.50 [95% CI, 1.41-1.62]; adjusted MOR for functionally favorable survival, 1.53 [95% CI, 1.37-1.78]). After restricting analysis to those who survived more than 60 minutes after hospital arrival and including hospital treatment characteristics, the variation persisted (adjusted MOR for survival, 1.49 [95% CI, 1.36-1.69]; adjusted MOR for functionally favorable survival, 1.34 [95% CI, 1.20-1.59]). Conclusions and Relevance We found substantial variations in patient outcomes after OHCA between a large group of EMS agencies in North America that were not explained by documented patient-level and EMS agency–level variables.

Importance Emergency medical services (EMS) commonly perform endotracheal intubation (ETI) or insertion of supraglottic airways, such as the laryngeal tube (LT), on patients with out-of-hospital cardiac arrest (OHCA). The optimal method for OHCA advanced airway management is unknown. Objective To compare the effectiveness of a strategy of initial LT insertion vs initial ETI in adults with OHCA. Design, Setting, and Participants Multicenter pragmatic cluster-crossover clinical trial involving EMS agencies from the Resuscitation Outcomes Consortium. The trial included 3004 adults with OHCA and anticipated need for advanced airway management who were enrolled from December 1, 2015, to November 4, 2017. The final date of follow-up was November 10, 2017. Interventions Twenty-seven EMS agencies were randomized in 13 clusters to initial airway management strategy with LT (n = 1505 patients) or ETI (n = 1499 patients), with crossover to the alternate strategy at 3- to 5-month intervals. Main Outcomes and Measures The primary outcome was 72-hour survival. Secondary outcomes included return of spontaneous circulation, survival to hospital discharge, favorable neurological status at hospital discharge (Modified Rankin Scale score ≤3), and key adverse events. Results Among 3004 enrolled patients (median [interquartile range] age, 64 [53-76] years, 1829 [60.9%] men), 3000 were included in the primary analysis. Rates of initial airway success were 90.3% with LT and 51.6% with ETI. Seventy-two hour survival was 18.3% in the LT group vs 15.4% in the ETI group (adjusted difference, 2.9% [95% CI, 0.2%-5.6%]; P = .04). Secondary outcomes in the LT group vs ETI group were return of spontaneous circulation (27.9% vs 24.3%; adjusted difference, 3.6% [95% CI, 0.3%-6.8%]; P = .03); hospital survival (10.8% vs 8.1%; adjusted difference, 2.7% [95% CI, 0.6%-4.8%]; P = .01); and favorable neurological status at discharge (7.1% vs 5.0%; adjusted difference, 2.1% [95% CI, 0.3%-3.8%]; P = .02). There were no significant differences in oropharyngeal or hypopharyngeal injury (0.2% vs 0.3%), airway swelling (1.1% vs 1.0%), or pneumonia or pneumonitis (26.1% vs 22.3%). Conclusions and Relevance Among adults with OHCA, a strategy of initial LT insertion was associated with significantly greater 72-hour survival compared with a strategy of initial ETI. These findings suggest that LT insertion may be considered as an initial airway management strategy in patients with OHCA, but limitations of the pragmatic design, practice setting, and ETI performance characteristics suggest that further research is warranted. Trial Registration ClinicalTrials.gov Identifier:NCT02419573

The PAD Trial is a prospective, multicenter, randomized clinical study testing whether volunteer, non-medical responders can improve survival from out-of-hospital cardiac arrest (OOH-CA) by using automated external defibrillators (AEDs). These lay volunteers, who have no traditional responsibility to respond to a medical emergency as part of their primary job description, will form part of a comprehensive, integrated community approach to the treatment of OOH-CA. The study is being conducted at 24 field centers in the United States and Canada. Approximately 1000 community units (e.g. apartment or office buildings, gated communities, sports facilities, senior centers, shopping malls, etc.) were randomized to treatment by trained laypersons who will provide either cardiopulmonary resuscitation (CPR) alone or CPR plus use of an AED, while awaiting arrival of the community's emergency medical services responders. The primary endpoint is the number of OOH-CA victims who survive to hospital discharge. Secondary endpoints include neurological status, health-related quality of life (HRQL), cost, and cost-effectiveness. Data collection will last approximately 15 months and is expected to be completed in September 2003.

Background The Public Access Defibrillation (PAD) Trial was a randomized, controlled trial designed to measure survival to hospital discharge following out-of-hospital cardiac arrest (OOH-CA) in community facilities trained and equipped to provide PAD, compared with community facilities trained to provide cardiopulmonary resuscitation (CPR) without any capacity for defibrillation. Objectives To report the implementation of community-based lay responder emergency response programs in 1,260 participating facilities recruited for the PAD Trial in the United States and Canada. Methods This was a descriptive study of the characteristics of participating facilities, volunteers, and automated external defibrillator (AED) placements compiled by the PAD Trial, and a qualitative study of factors that facilitated or impeded implementation of emergency lay responder programs using focus groups of PAD Trial site coordinators. Results The PAD Trial enrolled 1,260 community facilities (14.8% residential), with 20,400 lay volunteers (mean +/- standard deviation = 13.4 +/- 10.7 per facility) trained to respond to OOH-CA. The 598 locations randomized to receive AEDs required 2.7 +/- 1.8 AEDs per facility. Volunteer attrition was high, 36% after two years. Barriers to recruitment and implementation included identification of appropriate "at-risk" facilities, lack of interest or fear of litigation by a facility key decision maker, lack of motivated potential volunteer responders, training and retraining resource requirements, and lack of an existing communication/response infrastructure. Conclusions These data indicate that implementation of community-based lay responder programs is feasible in many types of facilities, although these programs require substantial resources and commitment, and many barriers to implementation of effective PAD programs exist.