背景:建立LOwRISkDCIS(LORIS)研究,以比较常规手术治疗与主动监测女性导管原位癌(DCIS)。众所周知,用监视部门招募试验是具有挑战性的,所以最大化患者招募的策略,针对患者和招募中心,已实施。
方法:年龄≥46岁、经组织学证实诊断为非高级别DCIS的女性有资格1:1随机分入手术或主动监测。在随机化之前,邀请所有符合条件的妇女完成:(1)临床试验问卷(CTQ)检查参与或反对参与的原因,(2)访谈,深入探索关于研究信息表和电影的意见。同意随机化的妇女完成了评估健康状况的有效问卷,身心健康,和焦虑水平。医院现场工作人员被邀请参加交流讲习班和复习现场初始访问,以支持招聘。他们对LORIS招聘的看法是通过调查和访谈收集的。
结果:80%(181/227)的合格女性同意随机分组。超过40%的参与者在基线时焦虑水平很高。在CTQ上,接受随机化的最常见最重要的原因是利他主义和认为试验提供了最好的治疗方法,而对随机化和他人影响的担忧是下降的最常见最重要的原因。大多数女性发现研究信息提供了清晰和有用的信息。现场工作人员的交流研讨会提高了知识和信心,但只有大约一半的人表示,如果符合条件,他们自己会加入LORIS。工作人员发现的最常见的招募障碍是合格患者数量少和患者偏好。
结论:尽管针对患者和研究中心工作人员的策略,对LORIS的招募仍具有挑战性。确保招募人员支持研究可以改善未来类似试验的招募。
背景:ISRCTN27544579,预期于2014年5月22日注册。
BACKGROUND: The LOw RISk DCIS (LORIS) study was set up to compare conventional surgical treatment with active monitoring in women with ductal carcinoma in situ (DCIS). Recruitment to
trials with a surveillance arm is known to be challenging, so strategies to maximise patient recruitment, aimed at both patients and recruiting centres, were implemented.
METHODS: Women aged ≥ 46 years with a histologically confirmed diagnosis of non-high-grade DCIS were eligible for 1:1 randomisation to either surgery or active monitoring. Prior to randomisation, all eligible women were invited to complete: (1) the Clinical
Trials Questionnaire (CTQ) examining reasons for or against participation, and (2) interviews exploring in depth opinions about the study information sheets and film. Women agreeing to randomisation completed validated questionnaires assessing health status, physical and mental health, and anxiety levels. Hospital site staff were invited to communication workshops and refresher site initiation visits to support recruitment. Their perspectives on LORIS recruitment were collected via surveys and interviews.
RESULTS: Eighty percent (181/227) of eligible women agreed to be randomised. Over 40% of participants had high anxiety levels at baseline. On the CTQ, the most frequent most important reasons for accepting randomisation were altruism and belief that the
trial offered the best treatment, whilst worries about randomisation and the influences of others were the most frequent most important reasons for declining. Most women found the
study information provided clear and useful. Communication workshops for site staff improved knowledge and confidence but only about half said they themselves would join LORIS if eligible. The most common recruitment barriers identified by staff were low numbers of eligible patients and patient preference.
CONCLUSIONS: Recruitment to LORIS was challenging despite strategies aimed at both patients and site staff. Ensuring that recruiting staff support the
study could improve recruitment in similar future
trials.
BACKGROUND: ISRCTN27544579, prospectively registered on 22 May 2014.