The impact of internet connectivity when conducting a virtual clinical trial with participants living in rural areas

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL
Diane E. Holland , Catherine E. Vanderboom , Jay Mandrekar , William S. Harmsen , Allison M. Gustavson , Brystana G. Kaufman , Ann Marie Dose , Ellen M. Wild , Cory Ingram , Joan M. Griffin
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引用次数: 0

Abstract

Aim

The purpose of this secondary analysis was to describe issues related to internet connections during a virtual randomized clinical trial (v-RCT) that included family caregiver participants living in rural areas.

Background

Success of v-RCTs depends on reliable, high-quality internet access, which can be problematic in rural areas.

Methods

Interventionists documented connectivity issues and corrections made to address connectivity in a narrative note after each virtual visit with family caregivers enrolled in a v-RCT. Notes were reviewed for descriptions of the internet connection during the visit and then coded into those with and without connectivity problems. Two investigators reviewed notes and codes to assure reliability. Discrepancies in codes were discussed or arbitrated by a third investigator until consensus was reached. Analysis was completed using descriptive statistics.

Results

Of the 1003 visits reviewed, only 11 % of visits (115/1003) contained a documented problem with internet connectivity. Visits with documented connectivity problems were experienced by 27 % of participants (58/215). However, 60 % (35/58) of participants with a documented issue had a problem with only one visit. None of the participants withdrew from the v-RCT due to problems with their internet connections.

Conclusions

The findings support the effective use of virtual visits in research involving participants living in rural locations. V-RCTs provide a strategy that enables participation for individuals who may not otherwise have access to clinical trials conducted in-person in urban settings. Utilizing internet access to connect with and support people who live in rural areas is critically needed to advance clinical research.

为农村地区参与者开展虚拟临床试验时互联网连接的影响
背景v-RCT的成功取决于可靠、高质量的互联网接入,而这在农村地区可能存在问题。方法干预者在每次对参加v-RCT的家庭照顾者进行虚拟访问后,都会在叙述性笔记中记录连接问题以及为解决连接问题而采取的纠正措施。研究人员审查了笔记中关于访问期间网络连接的描述,然后将其编码为有连接问题和无连接问题。两名调查人员审查了笔记和编码,以确保可靠性。代码中的差异由第三位调查员进行讨论或仲裁,直至达成共识。结果 在审查的 1003 次就诊中,只有 11% 的就诊(115/1003)记录了互联网连接问题。27%的参与者(58/215)在就诊时遇到了记录在案的连接问题。然而,60%(35/58)的记录在案的参与者只在一次访问中遇到问题。没有一位参与者因网络连接问题退出虚拟研究。V-RCT提供了一种策略,使那些在城市环境中无法亲自参加临床试验的人也能参与其中。利用互联网连接和支持生活在农村地区的人们是推进临床研究的迫切需要。
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来源期刊
Contemporary Clinical Trials Communications
Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology
CiteScore
2.70
自引率
6.70%
发文量
146
审稿时长
20 weeks
期刊介绍: Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.
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