Nowbar Alexandra N, Howard James P, Shun-Shin Matthew J, Rajkumar Christopher, Foley Michael, Basu Arunima, Goel Akshit, Patel Sapna, Adnan Ahmer, Beattie Catherine J, Keeble Thomas R, Sohaib Afzal, Collier David, McVeigh Patrick, Harrell Frank E, Francis Darrel P, Al-Lamee Rasha K
National Heart and Lung Institute, Imperial College London, London W12 0HS, UK.
Imperial College Healthcare NHS Trust, Hammersmith Hospital, London W12 0HS, UK.
Eur Heart J Digit Health. 2022 Apr 11;3(2):276-283. doi: 10.1093/ehjdh/ztac015. eCollection 2022 Jun.
The traditional approach to documenting angina outcomes in clinical trials is to ask the patient to recall their symptoms at the end of a month. With the ubiquitous availability of smartphones and tablets, daily contemporaneous documentation might be possible.
The ORBITA-2 symptom smartphone app was developed with a user-centred iterative design and testing cycle involving a focus group of previous ORBITA participants. The feasibility and acceptability were assessed in an internal pilot of participants in the ongoing ORBITA-2 trial. Seven days of app entries by ORBITA-2 participants were compared with subsequent participant recall at the end of the 7-day period. The design focus group tested a prototype app. They reported that the final version captured their symptoms and was easy to use. In the completion assessment group, 141 of 142 (99%) completed the app in full and 47 of 141 (33%) without reminders. In the recall assessment group, 29 of 29 (100%) participants said they could recall the previous day's symptoms, and 82% of them recalled correctly. For 2 days previously, 88% said they could recall and of those, 87% recalled correctly. The proportion saying they could recall their symptoms fell progressively thereafter: 89, 67, 61, 50%, and at 7 days, 55% ( < 0.001 for trend). The proportion of recalling correctly also fell progressively to 55% at 7 days ( = 0.04 for trend).
Episode counts of angina are difficult to recall after a few days. For trials such as ORBITA-2 focusing on angina, daily symptom collection via a smartphone app will increase the validity of the results.
在临床试验中记录心绞痛结果的传统方法是要求患者在一个月末回忆其症状。随着智能手机和平板电脑的广泛普及,每日同步记录或许可行。
ORBITA-2症状智能手机应用程序采用以用户为中心的迭代设计和测试周期进行开发,其中包括一个由之前的ORBITA参与者组成的焦点小组。在正在进行的ORBITA-2试验的内部试点中评估了其可行性和可接受性。将ORBITA-2参与者7天的应用程序记录与7天结束时参与者随后的回忆进行了比较。设计焦点小组测试了应用程序原型。他们报告称最终版本能够记录他们的症状且易于使用。在完成评估组中,142名参与者中有141名(99%)完整完成了应用程序,其中47名(33%)在没有提醒的情况下完成。在回忆评估组中,29名参与者中有29名(100%)表示他们能够回忆起前一天的症状,其中82%回忆正确。对于前两天,88%的人表示他们能够回忆起症状,其中87%回忆正确。此后表示能够回忆起症状的比例逐渐下降:分别为89%、67%、61%、50%,到7天时为55%(趋势<0.001)。正确回忆的比例到7天时也逐渐下降至55%(趋势=0.04)。
几天后心绞痛发作次数很难回忆起来。对于像ORBITA-2这样关注心绞痛的试验,通过智能手机应用程序每日收集症状将提高结果的有效性。