Out-of-Hospital Research in the Era of Electronic Health Records.

Conducting out-of-hospital research is unique and challenging and requires tracking patients across multiple phases of care, using multiple sources of patient records and multiple hospitals. The logistics and strategies used for out-of-hospital research are distinct from other forms of clinical research. The increasing use of electronic health records (EHRs) by hospitals and emergency medical services (EMS) agencies presents a large opportunity for accelerating out-of-hospital research, as well as particular challenges. In this study, we describe seven key aspects of designing and implementing out-of-hospital research in the era of EHRs: (1) selection of research sites, (2) defining the patient population, (3) patient sampling and sample size calculations, (4) EMS data, (5) hospital selection, (6) handling missing data, and (7) statistical analysis. We use examples from a recent prospective out-of-hospital cohort study to illustrate these topics, including lessons learned.

Prospective Validation of the National Field Triage Guidelines for Identifying Seriously Injured Persons.

BACKGROUND: The national field trauma triage guidelines have been widely implemented in US trauma systems, but never prospectively validated. We sought to prospectively validate the guidelines, as applied by out-of-hospital providers, for identifying high-risk trauma patients. STUDY DESIGN: This was an out-of-hospital prospective cohort study from January 1, 2011 through December 31, 2011 with 44 Emergency Medical Services agencies in 7 counties in 2 states. We enrolled injured patients transported to 28 acute care hospitals, including 7 major trauma centers (Level I and II trauma hospitals) and 21 nontrauma hospitals. The primary exposure term was Emergency Medical Services' use of one or more field triage criteria in the national field triage guidelines. Outcomes included Injured Severity Score ≥16 (primary) and critical resource use within 24 hours of emergency department arrival (secondary). RESULTS: We enrolled 53,487 injured children and adults transported by Emergency Medical Services to an acute care hospital, 17,633 of which were sampled for the primary analysis; 13.9% met field triage guidelines, 3.1% had Injury Severity Score ≥16, and 1.7% required early critical resources. The sensitivity and specificity of the field triage guidelines were 66.2% (95% CI, 60.2-71.7%) and 87.8% (95% CI, 87.7-88.0%) for Injury Severity Score ≥16 and 80.1% (95% CI, 65.8-89.4%) and 87.3% (95% CI 87.1-87.4%) for early critical resource use. Triage guideline sensitivity decreased with age, from 87.4% in children to 51.8% in older adults. CONCLUSIONS: The national field triage guidelines are relatively insensitive for identifying seriously injured patients and patients requiring early critical interventions, particularly among older adults.

Out-of-hospital cardiac arrest frequency and survival: evidence for temporal variability.

AIM: Some cardiac phenomena demonstrate temporal variability. We evaluated temporal variability in out-of-hospital cardiac arrest (OHCA) frequency and outcome. METHODS: Prospective cohort study (the Resuscitation Outcomes Consortium) of all OHCA of presumed cardiac cause who were treated by emergency medical services within 9 US and Canadian sites between 12/1/2005 and 02/28/2007. In each site, Emergency Medical System records were collected and analyzed. Outcomes were individually verified by trained data abstractors. RESULTS: There were 9667 included patients. Median age was 68 (IQR 24) years, 66.7% were male and 8.3% survived to hospital discharge. The frequency of cardiac arrest varied significantly across time blocks (p<0.001). Compared to the 0001-0600 hourly time block, the odds ratios and 95% CIs for the occurrence of OHCA were 2.02 (1.90, 2.15) in the 0601-1200 block, 2.01 (1.89, 2.15) in the 1201-1800 block, and 1.73 (1.62, 1.85) in the 1801-2400 block. The frequency of all OHCA varied significantly by day of week (p=0.03) and month of year (p<0.001) with the highest frequencies on Saturday and during December. Survival to hospital discharge was lowest when the OHCA occurred during the 0001-0600 time block (7.3%) and highest during the 1201-1800 time block (9.6%). Survival was highest for OHCAs occurring on Mondays (10.0%) and lowest for those on Wednesdays (6.8%) (p=0.02). CONCLUSION: There is temporal variability in OHCA frequency and outcome. Underlying patient, EMS system and environmental factors need to be explored to offer further insight into these observed patterns.

The random dialing survey as a tool for community consultation for research involving the emergency medicine exception from informed consent.

STUDY OBJECTIVE: In 1996, the Food and Drug Administration and the Department of Health and Human Services enacted rules allowing a narrow exception from informed consent for critically ill patients enrolled in emergency research. These include requirements for community consultation prior to trial implementation. Previous studies have noted difficulty in engaging the community. We seek to describe the experience with random dialing surveys as a tool for community consultation across 5 metropolitan regions in the United States. METHODS: Random dialing surveys were used as part of the community consultation for an out-of-hospital clinical trial sponsored by the Resuscitation Outcomes Consortium. The survey method was designed to obtain a representative sample of the community according to population demographics and geography. Logistics of survey administration, role of the survey in community consultation, and survey results by population demographics are discussed. RESULTS: Random dialing surveys were conducted in 5 of 8 US Resuscitation Outcomes Consortium sites. Overall, 70% to 79% of respondents indicated they would be willing to be enrolled in this study. Support for the inclusion of children (aged 15 to 18 years) ranged from 52% to 71%. Respondents aged 18 to 34 years were more willing to participate in the trial than older age groups. Women and racial minorities were less likely to favor the inclusion of minors. CONCLUSION: Random dialing surveys provide an additional tool to engage the community and obtain a sample of the opinion of the population about research conducted under the emergency exception from informed consent regulations. Similar results were obtained across 5 diverse communities in the United States.

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, and web-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); and 35 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) and for a family member (95.2% vs. 74.9% overall). The web-based survey generated the least feedback and had 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.