Data_Sheet_5_Cervical cancer screening uptake: A randomized controlled trial assessing the effect of sending invitation letters to non-adherent women combined with sending their general practitioners a list of their non-adherent patients (study protocol).DOCX

IntroductionCervical cancer (CC) is the fourth most common cancer among women. It can be cured if diagnosed at an early stage and treated promptly. The World Health Organization suggests that 70% of women should be screened with a high-performance test by the age of 35. This paper reports a protocol to assess the effect of two modalities of organized CC screening programmes on CC screening uptake.
Methods and analysisDesign and setting: The design involves a 3-arm randomized controlled study performed in a French geographic area on the west coast. A total of 1,395 general practitioners will be randomized, depending on their general practice surgeries. Participants: The design is based on a total of 94,393 women aged 40 to 65 years who are eligible for CC screening. Intervention: In the “optimized cancer screening” group, the intervention will combine sending invitation letters to non-adherent women with sending general practitioners (GPs) a list of their non-adherent patients. In the “standard cancer screening” group, the intervention will be limited to sending invitation letters to non-adherent women. In the “usual care” group, no letter will be sent either to women or to their GPs. Primary endpoint: CC screening test uptake will be assessed after a 6-month follow-up period. Statistical analysis: The percentage of women who are up-to-date with their screening at 6 months after the intervention will be compared across arms using a generalized mixed linear model.
DiscussionA large-scale randomized trial of this nature is unprecedented. The study will enable us to assess a strategy relying on GPs, identified as the coordinators in this screening strategy. The study results should help policy makers to implement organized CC screening programs in the future.
Ethics and disseminationThe study was approved was approved by the Ethics Committee of the National College of Teaching General practitioners (IRB00010804). It was recorded in ClinicalTrials.gov on the number NCT04689178 (28 December 2020). The study findings will be used for publication in peer-reviewed scientific journals and presentations in scientific meetings.

引言
宫颈癌（Cervical cancer, CC）是全球女性第四大常见恶性肿瘤。若能在早期阶段确诊并及时接受治疗，该病可实现治愈。世界卫生组织建议，70%的女性应在35岁前通过高性能检测手段完成宫颈癌筛查。本研究报告了一项评估两种组织化宫颈癌筛查方案对筛查参与率影响的研究方案。

研究设计与分析
本研究的设计与实施场景为：一项开展于法国西海岸某地理区域的三臂随机对照试验，研究将依据全科医师（general practitioners, GPs）的执业诊所，对共计1395名全科医师进行随机分组。研究对象为共计94393名符合宫颈癌筛查资格的40至65岁女性。干预措施方面，“优化癌症筛查”组将同时开展两项工作：向未参与筛查的女性发送筛查邀请函，以及向其全科医师发送该医师名下未参与筛查的患者清单；“标准癌症筛查”组的干预仅为向未参与筛查的女性发送筛查邀请函；“常规护理”组则既不向女性发送邀请函，也不向其全科医师发送相关清单。本研究的主要终点指标为：干预后随访6个月时，评估宫颈癌筛查检测的参与率。统计分析将采用广义混合线性模型，对三组干预后6个月时筛查依从的女性占比进行组间比较。

讨论
此类大规模随机对照试验尚属首次。本研究将助力评估以全科医师为协调核心的筛查策略效果，研究结果可为政策制定者未来推行组织化宫颈癌筛查项目提供科学参考依据。

伦理与传播
本研究已通过全国全科医学教学学院伦理委员会（IRB00010804）的审查批准，并于2020年12月28日在ClinicalTrials.gov完成注册，注册号为NCT04689178。研究成果将发表于同行评议的科学期刊，并将在学术会议上进行展示。