格拉斯哥大学Robert J C Steele研究小组在研究中取得进展。他们报道了行为干预提高苏格兰FIT结直肠筛查（TEMPO）的接受率。2025年3月12日出版的《柳叶刀》杂志发表了这项成果。

背景:结直肠癌筛查的接受度是次优的。TEMPO试验评估了两种以证据为基础、理论为依据、共同设计的行为干预措施对粪便免疫化学试验（FIT）结肠直肠癌筛查的影响。

方法:TEMPO是一项2×4析因、八臂、随机对照试验，纳入了全国性的苏格兰肠道筛查计划。所有40000名符合结直肠筛查条件的连续成年人（50-74岁）都使用区块随机分配到八组中的一组：（1）标准邀请；（2） 建议1周的FIT退货截止日期；（3） 2周的截止日期；（4） 4周的截止日期；（5） 问题解决计划工具（无截止日期）；（6） 计划工具加上1周的截止日期；（7） 计划工具加上2周的截止日期；（8） 计划工具加上4周的截止日期。主要结局是在FIT邮寄给某人后的3个月内，正确完成返回的FIT比例，由结直肠筛查实验室进行检测，提供阳性或阴性结果。该试验已在clinicaltrials.gov注册，NCT05408169。

发现:2022年6月19日至7月3日，每组随机分配5000名参与者，随访无损失。266名参与者符合排除标准；39734人（其中女性1909[50.1%]，男性19825[49.9%]）；平均年龄61.2[SD 7.3]岁）。对照组（没有截止日期，也没有计划工具）的3个月FIT回报率为66.0%（3275/4965）。在没有计划工具的情况下，2周的截止日期的回报率最高（4964人中有3376人[68.0%]；与对照组的差异为2.0%[95%CI 0.2至3.9]）。当计划工具没有截止日期时，回报率最低（4958人中有3134人[63.2%]；与对照组的差异为-2.8%[-4.7至-0.8]）。主要分析假设两种干预措施的独立影响，表明设定最后期限具有明显的积极作用（调整后的比值比[aOR]1.13[1.08至1.19]；p<0.0001），而使用计划工具没有影响（aOR 0.98[0.94至1.02]；p=0.34），尽管这因两种干预措施之间的相互作用而变得复杂（pinteraction=0.0041）；在那些有截止日期的人中，没有证据表明接受计划工具有任何效果（aOR 1.02[0.97至1.07]；p=0.53），但在没有截止日期的情况下，使用计划工具似乎是有害的（aOR 0.88[0.81至0.96]；p=0.0030）。在没有规划工具的情况下，几乎没有证据表明使用截止日期对3个月的回报率有任何影响。然而，二次分析表明，使用截止日期提高了早期返回率（在1、2和4周内，特别是在截止日期前后），并减少了在6周后发出提醒信的需要，没有证据表明规划工具有任何积极影响，也没有证据表明干预措施之间存在相互作用。

研究结果表明，在FIT结直肠癌筛查的邀请函中增加一句建议FIT返回截止日期的句子，使FIT返回更及时，减少了发出提醒信的需要。这是一种极具成本效益的干预措施，可以很容易地在常规实践中实施。计划工具对FIT收益无正向影响。

附：英文原文

Title: Behavioural interventions to increase uptake of FIT colorectal screening in Scotland (TEMPO): a nationwide, eight-arm, factorial, randomised controlled trial

Author: Kathryn A Robb, Ben Young, Marie K Murphy, Patrycja Duklas, Alex McConnachie, Gareth J Hollands, Colin McCowan, Sara Macdonald, Ronan E OCarroll, Rory C OConnor, Robert J C Steele

Issue&Volume: 2025-03-12

Abstract: Background

Uptake of colorectal cancer screening is suboptimal. The TEMPO trial evaluated the impact of two evidence-based, theory-informed, and co-designed behavioural interventions on uptake of faecal immunochemical test (FIT) colorectal screening.

Methods

TEMPO was a 2×4 factorial, eight-arm, randomised controlled trial embedded in the nationwide Scottish Bowel Screening Programme. All 40000 consecutive adults (aged 50–74 years) eligible for colorectal screening were allocated to one of eight groups using block randomisation: (1) standard invitation; (2) 1-week suggested FIT return deadline; (3) 2-week deadline; (4) 4-week deadline; (5) problem-solving planning tool (no deadline); (6) planning tool plus 1-week deadline; (7) planning tool plus 2-week deadline; (8) planning tool plus 4-week deadline. The primary outcome was the proportion of FITs returned correctly completed to be tested by the colorectal screening laboratory providing a positive or negative result, within 3 months of the FIT being mailed to a person. The trial is registered with clinicaltrials.gov, NCT05408169.

Findings

From June 19 to July 3, 2022, 5000 participants were randomly assigned per group, with no loss to follow-up. 266 participants met the exclusion criteria; 39734 (19909 [50·1%] female and 19825 [49·9%] male; mean age 61·2 [SD 7·3] years) were included in the analysis. The control group (no deadline, and no planning tool) had a 3-month FIT return rate of 66·0% (3275 of 4965). The highest return rate was seen with a 2-week deadline without the planning tool (3376 [68·0%] of 4964; difference vs control of 2·0% [95% CI 0·2 to 3·9]). The lowest return rate was seen when the planning tool was given without a deadline (3134 [63·2%] of 4958; difference vs control of –2·8% [–4·7 to –0·8]). The primary analysis, assuming independent effects of the two interventions, suggested a clear positive effect of giving a deadline (adjusted odds ratio [aOR] 1·13 [1·08 to 1·19]; p<0·0001), and no effect for use of a planning tool (aOR 0·98 [0·94 to 1·02]; p=0·34), though this was complicated by an interaction between the two interventions (pinteraction=0·0041); among those who were given a deadline, there was no evidence that receiving a planning tool had any effect (aOR 1·02 [0·97 to 1·07]; p=0·53), but in the absence of a deadline, giving the planning tool appeared detrimental (aOR 0·88 [0·81 to 0·96]; p=0·0030). In the absence of the planning tool, there was little evidence that the use of a deadline had any effect on return rates at 3 months. However, secondary analyses indicated that the use of deadlines boosted earlier return rates (within 1, 2, and 4 weeks, particularly around the time of the deadline), and reduced the need to issue a reminder letter after 6 weeks, with no evidence that the planning tool had any positive impact, and without evidence of interactions between interventions.

Interpretation

Adding a single sentence suggesting a deadline for FIT return in the invitation letter to FIT colorectal screening resulted in more timely FIT return and reduced the need to issue reminder letters. This is a highly cost-effective intervention that could be easily implemented in routine practice. A planning tool had no positive effect on FIT return.

DOI: 10.1016/S0140-6736(24)02813-7

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)02813-7/abstract