Kaiser Permanente Northern California, Oakland, CA.
Acad Emerg Med. 2013 Apr;20(4):403-7. doi: 10.1111/acem.12117.
The objective was to describe the rate of successful consent using an altered (deferred telephone) consent process in emergency department (ED) patients.
This study evaluated the consent process employed during a prospective, multicenter, observational study of outcomes in anticoagulated patients with blunt head trauma. The study was approved by the institutional review boards (IRBs) at all participating centers. Patients were not informed of the study during their enrollment at their index ED visit. Patient names, clinical findings, and contact information were collected at the time of initial ED visits. The patients or their legally designated surrogates were contacted by telephone at least 14 days after ED discharge, given all the elements of informed consent, and then consented for study participation. Study results are presented with simple descriptive statistics.
A total of 506 patients with a mean (±SD) age of 75.8 (±12.2) years including 274 female subjects (54.2%; 95% confidence interval [CI] = 49.7% to 58.6%) were enrolled into the study. Patients or their surrogates were successfully contacted by telephone in 501 of 506 cases (99.0%; 95% CI = 97.7% to 99.7%). Consent was obtained in 500 of 501 cases at time of telephone follow-up (99.8%; 95% CI = 98.9% to 100.0%). Surrogates provided consent in 199 cases (39.7%; 95% CI = 35.4% to 44.2%). Median time from ED visit to phone contact was 21 days (interquartile range [IQR] = 17 to 27 days). The median number of phone attempts for successful contact was 1 (IQR = 1 to 2 attempts).
The authors achieved a very high rate of successful telephone follow-up in this predominantly older ED population. Obtaining consent to participate in a research study using a deferred telephone contact process was effective and well received by both subjects and surrogates. IRBs should consider deferred telephone consent for minimal-risk studies requiring telephone follow-up, as opposed to a consent process requiring written documentation at the time of initial ED visit.
描述在急诊科（ED）患者中使用修改后的（延迟电话）同意过程的同意率。
这项研究评估了一项前瞻性、多中心、观察性研究中采用的同意过程，该研究评估了抗凝的钝性头部创伤患者的结局。该研究得到了所有参与中心机构审查委员会（IRB）的批准。在患者首次 ED 就诊时，患者未被告知该研究。在初始 ED 就诊时收集患者的姓名、临床发现和联系信息。患者或其法定指定代理人在 ED 出院后至少 14 天通过电话联系，告知所有知情同意书内容，然后同意参与研究。研究结果采用简单描述性统计方法呈现。
共纳入 506 例平均（±标准差）年龄为 75.8（±12.2）岁的患者，其中 274 例女性（54.2%；95%置信区间[CI]：49.7%至 58.6%）。506 例患者中，501 例（99.0%；95%CI：97.7%至 99.7%）通过电话成功联系。在电话随访时，500 例（99.8%；95%CI：98.9%至 100.0%）获得同意。199 例（39.7%；95%CI：35.4%至 44.2%）由代理人提供同意。ED 就诊至电话联系的中位数时间为 21 天（四分位间距[IQR]：17 至 27 天）。成功联系的中位数电话尝试次数为 1 次（IQR=1 至 2 次尝试）。
作者在这一以老年人为主的 ED 人群中实现了非常高的电话随访成功率。使用延迟电话联系过程获得参与研究的同意是有效的，并且得到了患者和代理人的认可。IRB 应考虑对需要电话随访的低风险研究采用延迟电话同意，而不是在 ED 首次就诊时采用需要书面文件的同意过程。
