Global Health Institute, University of Antwerp, Antwerpen, Belgium.
Centre for the Evaluation of Vaccination, University of Antwerp, Antwerpen, Belgium.
BMJ Glob Health. 2024 Jun 10;9(6):e015259. doi: 10.1136/bmjgh-2024-015259.
Clear guidelines to implement ancillary care (AC) in clinical trials conducted in resource-constrained settings are lacking. Here, we evaluate an AC policy developed for a vaccine trial in the Democratic Republic of the Congo and formulate policy recommendations.
To evaluate the AC policy, we performed a longitudinal cohort study, nested in an open-label, single-centre, randomised Ebola vaccine trial conducted among healthcare personnel. Participants' demographic information, residence distance to the study site and details on the financial and/or medical support provided for any (serious) adverse events ((S)AE) were combined and analysed. To assess the feasibility of the AC policy, an expenditure analysis of the costs related to AC support outcomes was performed.
Enrolment in this evaluation study started on 29 November 2021. The study lasted 11 months and included 655 participants from the Ebola vaccine trial. In total, 393 participants used the AC policy, mostly for AE management (703 AE and 94 SAE) via medication provided by the study pharmacy (75.3%). Men had a 35.2% (95% CI 4.0% to 56.6%) lower likelihood of reporting AE compared with women. Likewise, this was 32.3% lower (95% CI 5.8% to 51.4%) for facility-based compared with community-based healthcare providers. The daily AE reporting was 78.8% lower during the passive vs the active trial stage, and 97.4% lower during unscheduled vs scheduled visits (p<0.001). Participants living further than 10 km from the trial site more frequently reported the travel distance as a reason for not using the policy (p<0.04). In practice, only 1.1% of the operational trial budget was used for AC policy support.
The trial design, study population and local health system impacted the use of the AC policy. Nonetheless, the AC policy implementation in this remote and resource-constrained setting was feasible, had negligible budgetary implications and contributed to participants' healthcare options and well-being.
在资源有限的环境中开展临床试验时，缺乏明确的辅助医疗（Ancillary Care，AC）实施指南。在此，我们评估了刚果民主共和国一项疫苗试验中制定的 AC 政策，并提出了相关政策建议。
为了评估 AC 政策，我们进行了一项纵向队列研究，嵌套在一项在卫生保健工作者中开展的、开放性标签、单中心、随机埃博拉疫苗试验中。将参与者的人口统计学信息、居住地点与研究现场的距离以及任何（严重）不良事件（Adverse Event，AE）的财务和/或医疗支持细节相结合进行分析。为了评估 AC 政策的可行性，对与 AC 支持结果相关的成本进行了支出分析。
这项评估研究的入组时间为 2021 年 11 月 29 日。研究持续了 11 个月，共纳入了 655 名来自埃博拉疫苗试验的参与者。共有 393 名参与者使用了 AC 政策，主要用于通过研究药房提供的药物管理 AE（703 次 AE 和 94 次 SAE）。与女性相比，男性报告 AE 的可能性低 35.2%（95%CI 4.0% 至 56.6%）。同样，与社区医疗工作者相比，机构医疗工作者的可能性低 32.3%（95%CI 5.8% 至 51.4%）。与主动试验阶段相比，被动试验阶段 AE 的每日报告率降低了 78.8%，与计划就诊相比，非计划就诊的报告率降低了 97.4%（p<0.001）。居住地点距离试验地点超过 10 公里的参与者更频繁地报告旅行距离是不使用该政策的原因（p<0.04）。实际上，仅 1.1%的运营试验预算用于 AC 政策支持。
试验设计、研究人群和当地卫生系统影响了 AC 政策的使用。尽管如此，在这个偏远且资源有限的环境中实施 AC 政策是可行的，对预算的影响可以忽略不计，并为参与者提供了更多的医疗选择和福祉。
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