Proxy Identification: A Time‐dependent Analysis

Abstract

Objectives: To describe the availability of next-of-kin (NOK) for proxy consent over the 24-hour time period following presentation of major trauma patients to a Level I trauma center. Methods: The study was conducted by using a prospective, observational study design. Consecutive patients meeting predefined major trauma criteria during a threemonth study period were enrolled and followed until NOK were contacted, or up to 24 hours. Survival analysis was used to determine the probability of NOK contact during the 24-hour follow-up period. Results: Three hundred fifty (92%) of 382 subjects had NOK contacted during the follow-up period. The probabilities (95% confidence intervals [CIs]) of NOK contact at the time of arrival (t = 0) and 2, 4, 6, and 24 hours postpresentation were 0.25 (95% CI = 0.21 to 0.30), 0.68 (95% CI = 0.63 to 0.72), 0.77 (95% CI = 0.73 to 0.82), 0.80 (95% CI = 0.76 to 0.84), and 0.87 (95% CI = 0.84 to 0.90), respectively. The median time to contact was 40 minutes (95% CI = 27 to 54 min). Conclusions: One third of the trauma patients in this study did not have NOK available two hours following arrival in the emergency department. For time-critical research protocols, the time to NOK contact can significantly impact the ability to ensure prompt enrollment and treatment in clinical trials. Further studies are needed to assess the generalizability and consistency of these data.

Finding family for prospective consent in emergency research

“…For example, with a 6 h time window in the multicenter hypothermia trial for traumatic brain injury, 38% of patients were enrolled by prospective consent [3]. In contrast, studies that require prehospital randomization or involve a condition that requires immediate treatment, have enrolled almost all patients using the emergency consent exception [7][8][9]. For example, in the diaspirin cross-linked hemoglobin trial for hemorrhagic shock, only 6% of patients were enrolled by prospective consent [9].…”

Recommendations in relation to the EU Clinical Trials Directive and Medical Research Involving Incapacitated Adults

“…Some treatments must be provided as soon as possible and within several hours. Family members cannot be found, ambulance officers are unwilling to take on the responsibility for making a decision, and doctors on hand are usually connected with the treatment (and thus would be deemed to be connected with the conduct of the trial) [14][15][16]. Research studying cardiac arrest is a key example.…”