估计抗逆转录病毒治疗依从性的新方法：一项纵向研究的方案
Novel methods to estimate antiretroviral adherence: protocol for a longitudinal study.
作者信息
Saberi Parya, Ming Kristin, Legnitto Dominique, Neilands Torsten B, Gandhi Monica, Johnson Mallory O
机构信息
Department of Medicine, University of California San Francisco, San Francisco, CA, USA.
出版信息
Patient Prefer Adherence. 2018 Jun 18;12:1033-1042. doi: 10.2147/PPA.S166380. eCollection 2018.
BACKGROUND
There is currently no gold standard for assessing antiretroviral (ARV) adherence, so researchers often resort to the most feasible and cost-effective methods possible (eg, self-report), which may be biased or inaccurate. The goal of our study was to evaluate the feasibility and acceptability of innovative and remote methods to estimate ARV adherence, which can potentially be conducted with less time and financial resources in a wide range of clinic and research settings. Here, we describe the research protocol for studying these novel methods and some lessons learned.
METHODS
The 6-month pilot study aimed to examine the feasibility and acceptability of a remotely conducted study to evaluate the correlation between: 1) text-messaged photographs of pharmacy refill dates for refill-based adherence; 2) text-messaged photographs of pills for pill count-based adherence; and 3) home-collected hair sample measures of ARV concentration for pharmacologic-based adherence. Participants were sent monthly automated text messages to collect refill dates and pill counts that were taken and sent via mobile telephone photographs, and hair collection kits every 2 months by mail. At the study end, feasibility was calculated by specific metrics, such as the receipt of hair samples and responses to text messages. Participants completed a quantitative survey and qualitative exit interviews to examine the acceptability of these adherence evaluation methods. The relationship between the 3 novel metrics of adherence and self-reported adherence will be assessed.
DISCUSSION
Investigators conducting adherence research are often limited to using either self-reported adherence, which is subjective, biased, and often overestimated, or other more complex methods. Here, we describe the protocol for evaluating the feasibility and acceptability of 3 novel and remote methods of estimating adherence, with the aim of evaluating the relationships between them. Additionally, we note the lessons learned from the protocol implementation to date. We expect that these novel measures will be feasible and acceptable. The implications of this research will be the identification and evaluation of innovative and accurate metrics of ARV adherence for future implementation.
背景
目前尚无评估抗逆转录病毒（ARV）依从性的金标准，因此研究人员常常采用最可行且最具成本效益的方法（如自我报告），但这些方法可能存在偏差或不准确。我们研究的目的是评估创新的远程方法在估计ARV依从性方面的可行性和可接受性，这些方法有可能在广泛的临床和研究环境中以更少的时间和财力资源进行。在此，我们描述了研究这些新方法的研究方案以及一些经验教训。
方法
这项为期6个月的试点研究旨在检验一项远程开展的研究的可行性和可接受性，该研究旨在评估以下各项之间的相关性：1）基于药品 refill 日期的依从性，通过短信发送药房 refill 日期的照片；2）基于药丸计数的依从性，通过短信发送药丸的照片；3）基于药理学的依从性，通过在家采集的头发样本测量ARV浓度。每月向参与者发送自动短信，以收集通过手机拍照获取并发送的 refill 日期和药丸计数，每两个月通过邮件发送头发采集试剂盒。在研究结束时，通过特定指标计算可行性，如头发样本的接收情况和对短信的回复情况。参与者完成定量调查和定性退出访谈，以检验这些依从性评估方法的可接受性。将评估这三种新的依从性指标与自我报告的依从性之间的关系。
讨论
进行依从性研究的调查人员通常限于使用主观、有偏差且往往被高估的自我报告依从性，或其他更复杂的方法。在此，我们描述了评估三种新颖的远程估计依从性方法的可行性和可接受性的方案，目的是评估它们之间的关系。此外，我们指出了迄今为止从方案实施中吸取的经验教训。我们预计这些新措施将是可行且可接受的。这项研究的意义在于识别和评估用于未来实施的创新且准确的ARV依从性指标。
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