Departments of Medicine, University of Washington, Seattle, WA, 98104, USA.
Global Health, University of Washington, Seattle, WA, USA.
Implement Sci. 2023 Nov 27;18(1):66. doi: 10.1186/s13012-023-01322-y.
Cervical cancer is the leading cause of cancer death in Kenyan women. Integrating cervical cancer screening into family planning (FP) clinics is a promising strategy to improve health for reproductive-aged women. The objective of this cluster randomized trial was to test the efficacy of an implementation strategy, the Systems Analysis and Improvement Approach (SAIA), as a tool to increase cervical cancer screening in FP clinics in Mombasa County, Kenya.
Twenty FP clinics in Mombasa County were randomized 1:1 to SAIA versus usual procedures. SAIA has five steps: (1) cascade analysis tool to understand the cascade and identify inefficiencies, (2) sequential process flow mapping to identify bottlenecks, (3) develop and implement workflow modifications (micro-interventions) to address identified bottlenecks, (4) assess the micro-intervention in the cascade analysis tool, and (5) repeat the cycle. Prevalence ratios were calculated using Poisson regression with robust standard errors to compare the proportion of visits where women were screened for cervical cancer in SAIA clinics compared to control clinics.
In the primary intent-to-treat analysis in the last quarter of the trial, 2.5% (37/1507) of visits with eligible FP clients at intervention facilities included cervical cancer screening compared to 3.7% (66/1793) in control clinics (prevalence ratio [PR] 0.67, 95% CI 0.45-1.00). When adjusted for having at least one provider trained to perform cervical cancer screening at baseline, there was no significant difference between screening in intervention clinics compared to control clinics (adjusted PR 1.14, 95% CI 0.74-1.75).
The primary analysis did not show an effect on cervical cancer screening. However, the COVID-19 pandemic and a healthcare worker strike likely impacted SAIA's implementation with significant disruptions in FP care delivery during the trial. While SAIA's data-informed decision-making and clinic-derived solutions are likely important, future work should directly study the mechanisms through which SAIA operates and the influence of contextual factors on implementation.
ClinicalTrials.gov, NCT03514459. Registered on April 19, 2018.
在肯尼亚，宫颈癌是导致女性癌症死亡的主要原因。将宫颈癌筛查纳入计划生育（FP）诊所是改善育龄妇女健康的一项有前途的策略。本项整群随机试验的目的是测试实施策略——系统分析和改进方法（SAIA）的效果，该方法旨在增加肯尼亚蒙巴萨县 FP 诊所的宫颈癌筛查率。
蒙巴萨县的 20 家 FP 诊所按 1:1 随机分配至 SAIA 组或常规程序组。SAIA 有五个步骤：（1）级联分析工具，用于了解级联并确定效率低下的环节；（2）顺序流程映射，以确定瓶颈；（3）制定和实施工作流程修改（微观干预），以解决确定的瓶颈；（4）在级联分析工具中评估微观干预；（5）重复循环。使用泊松回归计算粗比值，以比较 SAIA 诊所与对照诊所中筛查宫颈癌的就诊比例。
在试验最后一个季度的主要意向治疗分析中，干预设施中符合条件的 FP 客户就诊中，有 2.5%（37/1507）接受了宫颈癌筛查，而对照诊所中这一比例为 3.7%（66/1793）（患病率比 [PR]0.67，95%CI0.45-1.00）。在调整基线时至少有一名医务人员接受过宫颈癌筛查培训后，干预诊所与对照诊所之间的筛查率无显著差异（调整后 PR1.14，95%CI0.74-1.75）。
主要分析并未显示对宫颈癌筛查有影响。然而，COVID-19 大流行和医护人员罢工可能会对 SAIA 的实施产生影响，导致试验期间 FP 护理服务的严重中断。虽然 SAIA 的基于数据的决策制定和诊所提出的解决方案可能很重要，但未来的工作应直接研究 SAIA 运作的机制以及环境因素对实施的影响。
ClinicalTrials.gov，NCT03514459。于 2018 年 4 月 19 日注册。
