Biogen, Cambridge, MA, USA.
NYU Grossman School of Medicine, New York, NY, USA.
Epilepsy Behav. 2021 May;118:107925. doi: 10.1016/j.yebeh.2021.107925. Epub 2021 Apr 5.
To analyze electronic diary (e-diary) use in a phase 2, randomized, controlled clinical trial (OPUS; NCT03283371) of natalizumab in adult participants with drug-resistant focal epilepsy.
We developed an e-diary, which incorporated an episodic seizure diary and a daily diary reminder, for use as the primary source to record participants' daily seizure activity in the OPUS phase 2 clinical trial. Participants and/or their designated caregivers made e-diary entries by selecting seizure descriptions generated in the participants' and/or caregivers' own words at the time of screening. Seizures and seizure-free days were reported for the current day and for up to 5 and 4 retrospective days, respectively. A record of seizure symptoms entered within the prior 5-day period was displayed on accessing the diary. Changes were not permitted in the e-diary once a seizure record was saved unless a data change request was made. A paper backup diary was available.
E-diary entries (N = 15,176) from the 6-week baseline period and subsequent 24-week placebo-controlled period were analyzed for 66 adults who were randomized and dosed in the OPUS trial. The overall e-diary compliance, defined as the total number of days with any entry out of the total number of days in the baseline and placebo-controlled periods for all participants combined, was 83.6%. Caregivers made 190 (1.3%) e-diary entries. Day-of-event e-diary entries totaled 11,248 (74.1%). At least one paper backup diary was used by 36 (54.5%) participants.
Our data highlight that good e-diary compliance can be achieved across participants in randomized clinical trials in adult focal epilepsy. In addition to identifying and addressing any barriers that may prevent a minority of participants from achieving good e-diary compliance, consideration of e-diary elements, such as recall period and reporting of seizure-free days, will facilitate the most accurate data capture in epilepsy clinical trials.
分析在一项针对耐药性局灶性癫痫成年参与者的纳替珠单抗 2 期、随机、对照临床试验（OPUS；NCT03283371）中电子日记（e-diary）的使用情况。
我们开发了一种 e-diary，其中包含发作性癫痫日记和每日日记提醒，作为主要来源，用于记录 OPUS 2 期临床试验中参与者的日常癫痫发作活动。参与者和/或其指定的护理人员通过在筛选时选择参与者和/或护理人员自己的语言生成的癫痫描述来进行 e-diary 条目记录。当前日和最多 5 日和 4 日回溯日分别报告发作和无发作日。访问日记时会显示前 5 天内输入的癫痫症状记录。除非提出数据更改请求，否则保存癫痫记录后，e-diary 中的更改将不被允许。可提供纸质备份日记。
对参与 OPUS 试验的 66 名随机分组和接受安慰剂治疗的成年人的 6 周基线期和随后的 24 周安慰剂对照期的 e-diary 条目（N=15176）进行了分析。总体 e-diary 依从性定义为所有参与者的基线期和安慰剂对照期总天数中任何一天有记录的天数之和，为 83.6%。护理人员进行了 190 次（1.3%）e-diary 条目记录。事件当天的 e-diary 条目总计 11248 次（74.1%）。36 名（54.5%）参与者至少使用了一份纸质备份日记。
我们的数据突出表明，在成人局灶性癫痫的随机临床试验中，大多数参与者可以实现良好的 e-diary 依从性。除了识别和解决可能阻止少数参与者达到良好 e-diary 依从性的任何障碍外，考虑 e-diary 元素，如回忆期和无发作日的报告，将有助于在癫痫临床试验中更准确地捕获数据。
