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评估全科医生背书对提高英格兰国民保健署结直肠癌筛查计划参与率的有效性:一项随机对照试验研究方案。

Evaluating the effectiveness of GP endorsement on increasing participation in the NHS Bowel Cancer Screening Programme in England: study protocol for a randomized controlled trial.

机构信息

Primary Care Clinical Sciences, University of Birmingham, Edgbaston, West Midlands, B15 2TT, UK.

出版信息

Trials. 2012 Feb 20;13:18. doi: 10.1186/1745-6215-13-18.

Abstract

BACKGROUND

The success and cost-effectiveness of bowel cancer screening depends on achieving and maintaining high screening uptake rates. The involvement of GPs in screening has been found to improve patient compliance. Therefore, the endorsement of screening by GPs may increase uptake rates amongst non-responders.

METHODS/DESIGN: A two-armed randomised controlled trial will evaluate the effectiveness of a GP endorsed reminder in improving patient participation in the NHS Bowel Cancer Screening Programme (NHSBCSP). Up to 30 general practices in the West Midlands with a screening uptake rate of less than 50% will be recruited and patients identified from the patient lists of these practices. Eligible patients will be those aged 60 to 74, who have previously been invited to participate in bowel screening but who have been recorded by the Midlands and North West Bowel Cancer Screening Hub as non-responders. Approximately 4,380 people will be randomised in equal numbers to either the intervention (GP letter and duplicate FOBt kit) or control (no additional contact) arms of the trial. The primary outcome measure will be the difference in the uptake rate of FOBt screening for bowel cancer between the intervention and control groups at 13 weeks after the GP endorsed reminder and duplicate FOBt kit are sent. Secondary outcome measures will be subgroup analyses of uptake according to gender, age and deprivation quartile, and the validation of methods for collecting GP, NHSBCSP and patient costs associated with the intervention. Qualitative work (30 to 40 semi-structured interviews) will be undertaken with individuals in the intervention arm who return a FOBt kit, to investigate the relative importance of the duplicate FOBt kit, reminder to participate, and GP endorsement of that reminder in contributing to individuals' decisions to participate in screening.

DISCUSSION

Implementing feasible, acceptable and cost-effective strategies to improve screening uptake amongst non-responders to invitations to participate is fundamentally important for the success of screening programmes. If this feasibility study demonstrates a significant increase in uptake of FOBt screening in individuals receiving the intervention, a definitive, appropriately powered future trial will be designed.

TRIAL REGISTRATION NUMBER

ISRCTN: ISRCTN86784060.

摘要

背景

结直肠癌筛查的成功率和成本效益取决于实现和维持高筛查参与率。发现全科医生参与筛查可以提高患者的依从性。因此,全科医生对筛查的认可可能会增加非应答者的参与率。

方法/设计:一项双臂随机对照试验将评估 GP 认可的提醒在提高 NHS 结直肠癌筛查计划(NHSBCSP)患者参与度方面的有效性。将从西米德兰兹和西北地区结直肠癌筛查中心记录的参与率低于 50%的 30 家全科实践中招募参与者,并从这些实践的患者名单中确定患者。合格的患者将是年龄在 60 至 74 岁之间的人,他们之前曾被邀请参加结直肠癌筛查,但被 Midlands 和 North West Bowel Cancer Screening Hub 记录为未回复者。大约 4380 人将被随机平均分配到试验的干预(GP 信函和重复 FOBt 试剂盒)或对照(无额外联系)组。主要结局测量将是在 GP 认可的提醒和重复 FOBt 试剂盒发送后 13 周,干预组和对照组之间 FOBt 筛查结直肠癌的参与率差异。次要结局测量将是根据性别、年龄和贫困四分位组进行的亚组分析,以及收集与干预相关的 GP、NHSBCSP 和患者成本的方法的验证。将对参与组中返回 FOBt 试剂盒的个体进行 30 到 40 次半结构化访谈的定性工作,以调查重复 FOBt 试剂盒、参与提醒以及 GP 对该提醒的认可对个人参与筛查决策的相对重要性。

讨论

实施可行、可接受和具有成本效益的策略来提高对邀请参与筛查的非应答者的筛查参与率,对于筛查计划的成功至关重要。如果这项可行性研究表明,接受干预的个体中 FOBt 筛查的参与率显著增加,将设计一项具有适当效力的未来试验。

试验注册号

ISRCTN: ISRCTN86784060。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/73ee/3305373/9f3ac4250028/1745-6215-13-18-1.jpg

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