一款用于评估知情同意决策能力的数字健康应用程序：一项随机对照试验方案

A Digital Health App to Assess Decisional Capacity to Provide Informed Consent: Protocol for a Randomized Controlled Trial.

作者信息

Furberg Robert D, Raspa Melissa, Wheeler Anne C, McCormack Lauren A, Bailey Donald B

机构信息

Digital Health & Clinical Informatics, RTI International, Research Triangle Park, NC, United States.

Center for Newborn Screening, Ethics, and Disability Studies, RTI International, Research Triangle Park, NC, United States.

出版信息

JMIR Res Protoc. 2018 Nov 19;7(11):e10360. doi: 10.2196/10360.

DOI:10.2196/10360

PMID:30455171

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6277828/

Abstract

BACKGROUND

Any study with human subjects must have a robust consent process to ensure that participants understand the study and can decide whether they want to be involved. Investigators must determine whether a potential study participant is able to make an informed decision and what modifications or supports are needed to maximize participation in decision making. A variety of approaches have been used to modify consent forms and the consent process to increase the research participants' decisional capacity. This protocol describes a randomized controlled trial (RCT) of a digital health app to support decision making among individuals contemplating providing consent to participate in a clinical trial.

OBJECTIVE

The objective of this RCT will be to determine if the use of a tablet-based app facilitates greater participation in and satisfaction with the consent process compared with standard practice and identify which individual factors are associated with better response to the decision aid. We hypothesize that the tablet-based version of the consent process will promote more informed decision making, including decisions that are more consistent with individual preferences and values expressed during qualitative data collection.

METHODS

A two-arm RCT will be conducted in a sample of approximately 100 individuals with fragile X syndrome in their homes across the United States.

RESULTS

Data analysis will be completed by late 2018.

CONCLUSIONS

By developing and testing a novel consent decision aid, we will have a better understanding of whether and how technological support can optimize the fit between the decisional capacity and the decisional process.

TRIAL REGISTRATION

ClinicalTrials.gov NCT02465931; https://clinicaltrials.gov/ct2/show/NCT02465931 (Archived by WebCite at http://www.webcitation.org/72Q3xJQAw).

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/10360.

摘要

背景

任何涉及人类受试者的研究都必须有一个完善的知情同意程序，以确保参与者了解研究内容，并能决定是否愿意参与。研究人员必须确定潜在的研究参与者是否有能力做出明智的决定，以及需要哪些修改或支持来最大限度地提高其参与决策的程度。人们已经采用了多种方法来修改知情同意书和知情同意程序，以提高研究参与者的决策能力。本方案描述了一项关于数字健康应用程序的随机对照试验（RCT），该应用程序旨在支持那些考虑同意参与临床试验的个人做出决策。