Gerber Felix, Tahirsylaj Thesar, Lejone Thabo Ishmael, Lee Tristan, Sanchez-Samaniego Giuliana, Raeber Fabian, Masike Sesale, Gupta Ravi, Molulela Manthabiseng, Khomolishoele Makhebe, Mota Mota, Bane Matumaole, Sematle Mamoronts'ane Pauline, Makabateng Retselisitsoe, Browne Jason Immanuel, Wittwer Jonas, Basler Dave Brian, Kindler Kevin, Labhardt Niklaus Daniel, Amstutz Alain
Division of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, Basel, Switzerland.
Faculty of Medicine, University of Basel, Basel, Switzerland.
Digit Health. 2024 Oct 1;10:20552076241288757. doi: 10.1177/20552076241288757. eCollection 2024 Jan-Dec.
Improving access to essential health services requires the development of innovative health service delivery models and their scientific assessment in often large-scale pragmatic trials. In many low- and middle-income countries, lay Community Health Workers (CHWs) play an important role in delivering essential health services. As trusted members of their communities with basic medical training, they may also contribute to health data collection. Digital clinical decision support applications may facilitate the involvement of CHWs in service delivery and data collection. Electronic consent (eConsent) can streamline the consent process that is required if the collected data is used for the scientific purposes. Here, we describe the experiences of using eConsent in the Community-Based chronic Care Lesotho (ComBaCaL) cohort study and multiple nested pragmatic cluster-randomized trials assessing CHW-led care delivery models for type 2 diabetes and arterial hypertension using the Trials within Cohorts (TwiCs) design. More than a hundred CHWs, acting both as service providers and data collectors in remote villages of Lesotho utilize an eConsent application that is linked to a tailored clinical decision support and data collection application. The eConsent application presents simplified consent information and generates personalized consent forms that are signed electronically on a tablet and then uploaded to the database of the clinical decision support application. This significantly streamlines the consent process and allows for quality consent documentation through timely central monitoring, facilitating the CHW-led management of a large-scale population-based cohort in a remote low-resource area with continuous enrollment-currently at more than 16,000 participants.
改善基本医疗服务的可及性需要开发创新的医疗服务提供模式，并在通常大规模的实用试验中对其进行科学评估。在许多低收入和中等收入国家，非专业社区卫生工作者（CHW）在提供基本医疗服务方面发挥着重要作用。作为接受过基础医学培训的社区中值得信赖的成员，他们也可能有助于健康数据的收集。数字临床决策支持应用程序可以促进社区卫生工作者参与服务提供和数据收集。如果收集的数据用于科学目的，电子同意书（eConsent）可以简化所需的同意程序。在此，我们描述了在基于社区的莱索托慢性护理（ComBaCaL）队列研究以及多项嵌套实用整群随机试验中使用电子同意书的经验，这些试验采用队列内试验（TwiCs）设计，评估由社区卫生工作者主导的2型糖尿病和动脉高血压护理提供模式。在莱索托偏远村庄担任服务提供者和数据收集者的一百多名社区卫生工作者使用了一个与定制的临床决策支持和数据收集应用程序相关联的电子同意书应用程序。该电子同意书应用程序呈现简化的同意信息，并生成个性化的同意书，这些同意书在平板电脑上以电子方式签署，然后上传到临床决策支持应用程序的数据库。这显著简化了同意程序，并通过及时的中央监测实现了高质量的同意文件记录，便于在资源匮乏的偏远地区对大规模基于人群的队列进行由社区卫生工作者主导的管理，目前该队列的参与者已超过16000人。
