Development and implementation of COVID-19 safety protocols for conducting a randomized trial in global mental health: Field report from Central India.
Development and implementation of COVID-19 safety protocols for conducting a randomized trial in global mental health: Field report from Central India.
复制标题
DOI：
10.1016/j.ajp.2021.102750
复制
发表时间：
2021-09
影响因子：
9.5
通讯作者：
Bhan A
中科院分区：
文献类型：
--
作者：
Joshi U;Khan A;Muke S;Choubey S;Tugnawat D;Naslund JA;Bhan A
COVID-19大流行影响了全球正在进行的临床试验，导致研究暂停、取消或过渡到完全远程实施。在印度，从2020年3月至2020年6月分阶段实施了第一次全国范围的封锁，随后继续限制包括研究程序在内的面对面活动，这导致“ESSENCE”（使科学转化为服务以加强抑郁症护理）试验活动暂停，如招募、同意、基线评估、数字培训指导、面对面培训和终点评估评估。这种情况使得必须修改程序，以减轻风险并解决参与者和研究团队的安全要求。本文总结了以降低风险和增强安全性为重点的方案的需求、制定和实施，目的是在确保研究参与者和研究人员安全的同时恢复和继续研究活动。这些方案由基于现有文献的指导方针和建议组成，根据试验的每个部分的不同组成部分量身定制，例如主管、旅行者、培训/招聘场所安全程序、个人安全程序的指导方针；学习活动的实施程序。研究人员可以在其他环境中调整这些方案，以便在COVID-19等大流行期间进行研究试验。
The COVID-19 pandemic impacted ongoing clinical trials globally resulting in the suspension, cancellation or transition to entirely remote implementation of studies. In India, the first countrywide lockdown was imposed in phases starting from March 2020 to June 2020, followed by a continued restriction on in-person activities including study procedures, which halted the ESSENCE (Enabling translation of Science to Service to ENhance Depression CarE) trial activities such as recruitment, consenting, baseline assessment, digital training orientation, face to face training and end-line assessment evaluation. This situation made it imperative to amend procedures in order to mitigate the risk and address safety requirements for participants and the research team. This paper summarizes the need, development and implementation of the protocols focused on risk reduction and safety enhancement with an objective to resume and continue the research activities while ensuring the safety of study participants and research staff. These protocols are comprised of guidelines and recommendations based on existing literature tailored according to different components in each arm of the trial such as guidelines for supervisors, travellers, training/recruitment venue safety procedures, individual safety procedures; and procedures to implement the study activities. These protocols can be adapted by researchers in other settings to conduct research trials during pandemics such as COVID-19.
影响因子：
3.1
作者：
Sagar, Rajesh;Pattanayak, Raman Deep;Chatterji, Somnath
通讯作者：
Chatterji, Somnath
影响因子：
2.2
作者：
Naslund, John A.;Tugnawat, Deepak;Patel, Vikram
通讯作者：
Patel, Vikram
影响因子：
--
作者：
Gugnani, Neeraj;Gugnani, Shalini
通讯作者：
Gugnani, Shalini