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黑色素瘤监测随机对照试验中的参与者招募与保留:一项范围综述。

Participant recruitment and retention in randomised controlled trials of melanoma surveillance: A scoping review.

作者信息

Ackermann Deonna M, Bracken Karen, Hersch Jolyn K, Janda Monika, Turner Robin M, Bell Katy J L

机构信息

Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Australia.

Kolling Institute, Faculty of Medicine and Health, The University of Sydney, Australia.

出版信息

Contemp Clin Trials Commun. 2025 Feb 16;44:101461. doi: 10.1016/j.conctc.2025.101461. eCollection 2025 Apr.

DOI:10.1016/j.conctc.2025.101461
PMID:40051673
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11883296/
Abstract

BACKGROUND

This scoping review aims to collate and describe data on recruitment, retention, and strategies used to improve these, in randomised controlled trials of melanoma surveillance.

METHODS

We searched MEDLINE, EMBASE, CINAHL and CENTRAL databases from inception until October 23, 2023. Two reviewers screened titles and abstracts, and full-texts, and one reviewer extracted data (convenience sample (n = 5) checked by a second). Eligibility criteria included: (i) RCT design, (ii) clinical setting, (iii) participants at increased risk of melanoma, (iv) interventions for early melanoma detection, and (v) early detection outcomes or surrogates such as improved skin self-examination. We calculated summary statistics and undertook qualitative data synthesis.

RESULTS

From 1746 records, 21 trials (reported in 28 papers) were included. Recruitment sources included dermatology clinics, general practice sites, and hospital databases or registries. Trials reported proportions of those screened who were eligible (mean 75 %, range 24-100 %), proportions of those eligible who were randomised (mean 63 %, range 24-95 %), numbers randomised per month (mean 25 participants, range 2-74), and proportion of those randomised who completed outcome measurements (mean 85 %, range 59-100 %) for self-report questionnaires at primary timepoints). Recruitment strategies included targeted participant identification and flexible consent processes. Retention strategies included setting narrow eligibility criteria, reminders, and financial incentives. Reporting on strategies was limited and there were no reports on effectiveness. Few studies reported recruiter facing initiatives or public and patient involvement.

DISCUSSION

More consistent and detailed reporting of recruitment and retention strategies in RCTs is needed, alongside evaluations of their effectiveness.

摘要

背景

本范围综述旨在整理和描述黑色素瘤监测随机对照试验中关于招募、保留以及用于改善这些方面的策略的数据。

方法

我们检索了MEDLINE、EMBASE、CINAHL和CENTRAL数据库,检索时间从建库至2023年10月23日。两名 reviewers 筛选标题、摘要和全文,一名 reviewer 提取数据(由第二名 reviewer 检查的便利样本(n = 5))。纳入标准包括:(i)随机对照试验设计,(ii)临床环境,(iii)黑色素瘤风险增加的参与者,(iv)早期黑色素瘤检测的干预措施,以及(v)早期检测结果或替代指标,如改善皮肤自我检查。我们计算了汇总统计数据并进行了定性数据综合分析。

结果

从1746条记录中,纳入了21项试验(在28篇论文中报告)。招募来源包括皮肤科诊所、全科医疗场所以及医院数据库或登记处。试验报告了筛选出的符合条件者的比例(平均75%,范围24%-100%)、符合条件者中被随机分组者的比例(平均63%,范围24%-95%)、每月随机分组的人数(平均25名参与者,范围2-74),以及在主要时间点自我报告问卷中完成结局测量的随机分组者的比例(平均85%,范围59%-100%)。招募策略包括针对性的参与者识别和灵活的同意程序。保留策略包括设定狭窄的纳入标准、提醒和经济激励。关于策略的报告有限,且没有关于有效性的报告。很少有研究报告面向招募者的举措或公众及患者的参与情况。

讨论

随机对照试验中需要更一致、详细地报告招募和保留策略,同时对其有效性进行评估。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cf05/11883296/3cdc275740f6/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cf05/11883296/02bb918861a3/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cf05/11883296/3cdc275740f6/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cf05/11883296/02bb918861a3/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cf05/11883296/3cdc275740f6/gr2.jpg

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