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老年新诊断癌症患者参与一项观察性前瞻性试点研究:招募与留存实例

Participation of older newly-diagnosed cancer patients in an observational prospective pilot study: an example of recruitment and retention.

作者信息

Puts Martine T E, Monette Johanne, Girre Veronique, Wolfson Christina, Monette Michele, Batist Gerald, Bergman Howard

机构信息

Solidage Research Group, Université de Montréal/McGill University Research Group on Frailty and Aging, Montreal, Canada.

出版信息

BMC Cancer. 2009 Aug 10;9:277. doi: 10.1186/1471-2407-9-277.

DOI:10.1186/1471-2407-9-277
PMID:19664289
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3087334/
Abstract

BACKGROUND

There have been few prospective observational studies which recruited older newly-diagnosed cancer patients, and of these only some have reported information on the number needed to screen to recruit their study sample, and the number and reasons for refusal and drop-out. This paper reports on strategies to recruit older newly-diagnosed cancer patients prior to treatment into an observational prospective pilot study and to retain them during a six-month period.

METHODS

Medical charts of all patients in the Segal Cancer Centre aged 65 and over were screened and evaluated for inclusion. Several strategies to facilitate recruitment and retention were implemented. Reasons for exclusion, refusal and loss to follow-up were recorded. Descriptive statistics were used to report the reasons for refusal and loss to follow-up. A non-response analysis using chi-square tests and t-tests was conducted to compare respondents to those who refused to participate and to compare those who completed the study to those who were lost to follow-up. A feedback form with open-ended questions was administered following the last interview to obtain patient's opinions on the length of the interviews and conduct of this pilot study.

RESULTS

3060 medical charts were screened and 156 eligible patients were identified. Of these 112 patients participated for a response rate of 72%. Reasons for refusal were: feeling too anxious (40%), not interested (25%), no time (12.5%), too sick (5%) or too healthy (5%) or other reasons (5%). Ninety-one patients participated in the six-month follow-up (retention 81.3%), seven patients refused follow-up (6.2%) and fourteen patients died (12.5%) during the course of the study. The median time to conduct the baseline interview was 45 minutes and 57% of baseline interviews were conducted at home. Most patients enjoyed participation and only five felt that the interviews were too long.

CONCLUSION

It was feasible to recruit newly-diagnosed cancer patients prior to treatment although it required considerable time and effort. Once patients were included, the retention rate was high despite the fact that most were undergoing active cancer treatment.

摘要

背景

招募老年新诊断癌症患者的前瞻性观察性研究较少,其中只有一些报告了为招募研究样本所需的筛查人数,以及拒绝和退出的人数及原因。本文报告了在一项前瞻性观察性试点研究中,在治疗前招募老年新诊断癌症患者并在六个月期间留住他们的策略。

方法

对西格尔癌症中心所有65岁及以上患者的病历进行筛查和评估以确定是否纳入。实施了几种促进招募和留住患者的策略。记录排除、拒绝和失访的原因。使用描述性统计报告拒绝和失访的原因。进行了卡方检验和t检验的无应答分析,以比较应答者与拒绝参与者,并比较完成研究的患者与失访患者。在最后一次访谈后发放了一份包含开放式问题的反馈表,以获取患者对访谈时长及本试点研究实施情况的意见。

结果

筛查了3060份病历,确定了156名符合条件的患者。其中112名患者参与,应答率为72%。拒绝的原因包括:感到过于焦虑(40%)、不感兴趣(25%)、没有时间(12.5%)、病得太重(5%)或身体太健康(5%)或其他原因(5%)。91名患者参与了为期六个月的随访(留存率81.3%),7名患者拒绝随访(6.2%),14名患者在研究过程中死亡(12.5%)。进行基线访谈的中位时间为45分钟,57%的基线访谈在家中进行。大多数患者喜欢参与,只有5人觉得访谈时间太长。

结论

在治疗前招募新诊断癌症患者是可行的,尽管这需要大量的时间和精力。一旦患者被纳入,尽管大多数患者正在接受积极的癌症治疗,但留存率很高。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/25fa/3087334/3c141478a7c2/1471-2407-9-277-2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/25fa/3087334/9b0e66e075e1/1471-2407-9-277-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/25fa/3087334/3c141478a7c2/1471-2407-9-277-2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/25fa/3087334/9b0e66e075e1/1471-2407-9-277-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/25fa/3087334/3c141478a7c2/1471-2407-9-277-2.jpg

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