Jhpiego Tanzania, Dar es Salaam, Tanzania.
Jhpiego, Baltimore, MD, USA.
J Int AIDS Soc. 2019 Jul;22(7):e25369. doi: 10.1002/jia2.25369.
Adverse events (AEs) rates in voluntary medical male circumcision (VMMC) are critical measures of service quality and safety. While these indicators are key, monitoring AEs in large-scale VMMC programmes is not without challenges. This study presents findings on AEs that occurred in eight years of providing VMMC services in three regions of Tanzania, to provide discussion both on these events and the structural issues around maintaining safety and quality in scaled-up VMMC services.
We look at trends over time, demographic characteristics, model of VMMC and type and timing of AEs for 1307 males who experienced AEs among all males circumcised in Tabora, Njombe and Iringa regions from 2009 to 2017. We analysed deidentified client data from a VMMC programme database and performed multivariable logistic regression with district clustering to determine factors associated with intraoperative and postoperative AEs among VMMC clients.
Among 741,146 VMMC clients, 0.18% (1307/741,146) experienced a moderate or severe AE. The intraoperative AE rate was 2.02 per 100,000 clients, and postoperative rate was 2.29 per 1000 return clients. Multivariable logistic regression showed that older age (20 to 29 years) was significantly associated with intraoperative AEs (aOR: 3.51, 95% CI: 1.17 to 10.6). There was no statistical significant difference in AE rates by surgical method. Mobile VMMC service delivery was associated with the lowest risk of experiencing postoperative AEs (aOR:0.64, 95% CI: 0.42 to 0.98). AE rates peaked in the first one to three years of the programme and then steadily declined.
In a programme with robust AE monitoring methodologies, AE rates reported in these three regions were very low and declined over time. While these findings support the safety of VMMC services, challenges in reporting of AEs in a large-scale VMMC programme are acknowledged. International and national standards of AE reporting in VMMC programmes are clear. As VMMC programmes transition to national ownership, challenges, strengths and learning from AE reporting systems are needed to support safety and quality of services.
不良事件（AE）发生率是自愿男性包皮环切（VMMC）服务质量和安全性的重要衡量标准。虽然这些指标是关键，但在大规模 VMMC 项目中监测不良事件并非没有挑战。本研究介绍了在坦桑尼亚三个地区提供 VMMC 服务八年来发生的不良事件发现，既讨论了这些事件，也讨论了在扩大的 VMMC 服务中保持安全性和质量的结构问题。
我们着眼于时间趋势、人口统计学特征、VMMC 模式以及 AE 的类型和发生时间，对 2009 年至 2017 年间在塔波拉、恩琼贝和伊林加地区接受包皮环切的 1307 名男性中发生 AE 的所有男性进行了分析。我们对 VMMC 项目数据库中的匿名客户数据进行了分析，并进行了多变量逻辑回归分析，对地区进行聚类，以确定与 VMMC 客户术中及术后不良事件相关的因素。
在 741146 名 VMMC 客户中，0.18%（1307/741146）经历了中度或重度 AE。术中不良事件发生率为每 10 万客户 2.02 例，术后不良事件发生率为每 1000 名复诊客户 2.29 例。多变量逻辑回归显示，年龄在 20 至 29 岁之间与术中不良事件显著相关（比值比：3.51，95%置信区间：1.17 至 10.6）。手术方法不同，不良事件发生率无统计学差异。移动 VMMC 服务提供与术后发生不良事件的风险最低相关（比值比：0.64，95%置信区间：0.42 至 0.98）。AE 发生率在项目开始后的第一至三年达到峰值，然后稳步下降。
在具有强大 AE 监测方法的项目中，这些地区报告的 AE 发生率非常低，并随时间推移而下降。尽管这些发现支持 VMMC 服务的安全性，但也承认在大规模 VMMC 项目中报告 AE 存在挑战。国际和国家 VMMC 项目的 AE 报告标准是明确的。随着 VMMC 项目向国家所有过渡，需要了解 AE 报告系统的挑战、优势和经验教训，以支持服务的安全性和质量。
