Suppr超能文献

在一项全国性移动健康随机对照试验中检测欺骗行为并确保数据完整性:析因设计调查研究

Detecting Deception and Ensuring Data Integrity in a Nationwide mHealth Randomized Controlled Trial: Factorial Design Survey Study.

作者信息

Kezbers Krista M, Robertson Michael C, Hébert Emily T, Montgomery Audrey, Businelle Michael S

机构信息

Tobacco Settlement Endowment Trust Health Promotion Research Center, Stephenson Cancer Center, University of Oklahoma Health Sciences, Oklahoma City, OK, United States.

Department of Family and Preventive Medicine, University of Oklahoma Health Sciences, Oklahoma, OK, United States.

出版信息

J Med Internet Res. 2025 Jan 28;27:e66384. doi: 10.2196/66384.

Abstract

BACKGROUND

Social behavioral research studies have increasingly shifted to remote recruitment and enrollment procedures. This shifting landscape necessitates evolving best practices to help mitigate the negative impacts of deceptive attempts (eg, fake profiles and bots) at enrolling in behavioral research.

OBJECTIVE

This study aimed to develop and implement robust deception detection procedures during the enrollment period of a remotely conducted randomized controlled trial.

METHODS

A 32-group (2×2×2×2×2) factorial design study was conducted from November 2021 to September 2022 to identify mobile health (mHealth) survey design features associated with the highest completion rates of smartphone-based ecological momentary assessments (n=485). Participants were required to be at least 18 years old, live in the United States, and own an Android smartphone that was compatible with the Insight app that was used in the study. Recruitment was conducted remotely through Facebook advertisements, a 5-minute REDCap (Research Electronic Data Capture) prescreener, and a screening and enrollment phone call. The research team created and implemented a 12-step checklist (eg, address verification and texting a copy of picture identification) to identify and prevent potentially deceptive attempts to enroll in the study. Descriptive statistics were calculated to understand the prevalence of various types of deceptive attempts at study enrollment.

RESULTS

Facebook advertisements resulted in 5236 initiations of the REDCap prescreener. A digital deception detection procedure was implemented for those who were deemed pre-eligible (n=1928). This procedure resulted in 26% (501/1928) of prescreeners being flagged as potentially deceptive. Completing multiple prescreeners (301/501, 60.1%) and providing invalid addresses (156/501, 31.1%) were the most common reasons prescreeners were flagged. An additional 1% (18/1928) of prescreeners were flagged as potentially deceptive during the subsequent study screening and enrollment phone call. Reasons for exclusion at the screening and enrollment phone call level included having an invalid phone type (6/18, 33.3%), completing multiple prescreeners (6/18, 33.3%), and providing an invalid address (5/18, 27.7%). This resulted in 1409 individuals being eligible after all deception checks were completed. Postenrollment social security number checks revealed that 3 (0.6%) fully enrolled participants out of 485 provided erroneous social security numbers during the screening process.

CONCLUSIONS

Implementation of a deception detection procedure in a remotely conducted randomized controlled trial resulted in a substantial proportion of cases being flagged as potentially engaging in deceptive attempts at study enrollment. The results of the deception detection procedures in this study confirmed the need for vigilance in conducting remote behavioral research in order to maintain data integrity. Implementing systematic deception detection procedures may support study administration, data quality, and participant safety in remotely conducted behavioral research.

TRIAL REGISTRATION

ClinicalTrials.gov NCT05194228; https://clinicaltrials.gov/study/NCT05194228.

摘要

背景

社会行为研究越来越多地转向远程招募和入组程序。这种不断变化的情况需要不断发展最佳实践,以帮助减轻在行为研究入组过程中欺骗行为(如虚假资料和机器人程序)的负面影响。

目的

本研究旨在在一项远程进行的随机对照试验的入组期间制定并实施强大的欺骗检测程序。

方法

2021年11月至2022年9月进行了一项32组(2×2×2×2×2)析因设计研究,以确定与基于智能手机的生态瞬时评估的最高完成率相关的移动健康(mHealth)调查设计特征(n = 485)。参与者需年满18岁,居住在美国,且拥有一部与本研究中使用的Insight应用程序兼容的安卓智能手机。通过Facebook广告、一个5分钟的REDCap(研究电子数据采集)预筛选器以及一次筛选和入组电话进行远程招募。研究团队创建并实施了一个12步清单(如地址验证和发送照片身份证明副本的短信),以识别和防止潜在的欺骗性入组尝试。计算描述性统计数据以了解研究入组时各种类型欺骗尝试的发生率。

结果

Facebook广告导致5236人启动了REDCap预筛选器。对那些被认为初步符合条件的人(n = 1928)实施了数字欺骗检测程序。该程序导致26%(501/1928)的预筛选器被标记为可能具有欺骗性。完成多个预筛选器(301/501,60.1%)和提供无效地址(156/501,31.1%)是预筛选器被标记的最常见原因。另外1%(18/1928)的预筛选器在随后的研究筛选和入组电话中被标记为可能具有欺骗性。筛选和入组电话层面被排除的原因包括电话类型无效(6/18,33.3%)、完成多个预筛选器(6/18,33.3%)以及提供无效地址(5/18,27.7%)。这使得在完成所有欺骗检查后有1409人符合条件。入组后进行的社会保障号码检查显示,在485名完全入组的参与者中,有3人(0.6%)在筛选过程中提供了错误的社会保障号码。

结论

在远程进行的随机对照试验中实施欺骗检测程序导致相当一部分案例被标记为可能在研究入组时进行欺骗性尝试。本研究中欺骗检测程序的结果证实了在进行远程行为研究时保持警惕以维护数据完整性的必要性。实施系统的欺骗检测程序可能有助于远程行为研究中的研究管理、数据质量和参与者安全。

试验注册

ClinicalTrials.gov NCT05194228;https://clinicaltrials.gov/study/NCT05194228

相似文献

本文引用的文献

3
Mobile Health Interventions for Substance Use Disorders.
Annu Rev Clin Psychol. 2024 Jul;20(1):49-76. doi: 10.1146/annurev-clinpsy-080822-042337. Epub 2024 Jul 2.
4
Multilevel Determinants of Digital Health Equity: A Literature Synthesis to Advance the Field.
Annu Rev Public Health. 2023 Apr 3;44:383-405. doi: 10.1146/annurev-publhealth-071521-023913. Epub 2022 Dec 16.
5
Remote Methods for Conducting Tobacco-Focused Clinical Trials.
Nicotine Tob Res. 2020 Dec 12;22(12):2134-2140. doi: 10.1093/ntr/ntaa105.
6
Deception in clinical trials and its impact on recruitment and adherence of study participants.
Contemp Clin Trials. 2018 Sep;72:146-157. doi: 10.1016/j.cct.2018.08.002. Epub 2018 Aug 21.
7
A Framework for Ethical Payment to Research Participants.
N Engl J Med. 2018 Feb 22;378(8):766-771. doi: 10.1056/NEJMsb1710591.
8
Deception by Research Participants.
N Engl J Med. 2015 Sep 24;373(13):1192-3. doi: 10.1056/NEJMp1506985.
9
Digital health interventions: widening access or widening inequalities?
Public Health. 2014 Dec;128(12):1118-20. doi: 10.1016/j.puhe.2014.10.008. Epub 2014 Nov 20.
10
Randomized, controlled pilot trial of a smartphone app for smoking cessation using acceptance and commitment therapy.
Drug Alcohol Depend. 2014 Oct 1;143:87-94. doi: 10.1016/j.drugalcdep.2014.07.006. Epub 2014 Jul 17.

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型,支持多种主流文档格式。

立即体验