Monitoring and modifying recruitment and retention strategies for an ongoing randomised clinical trial with venous leg ulcer patients: Overcoming barriers to participation.
Monitoring and modifying recruitment and retention strategies for an ongoing randomised clinical trial with venous leg ulcer patients: Overcoming barriers to participation.
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DOI：
10.1111/iwj.13957
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发表时间：
2023-04
影响因子：
3.1
通讯作者：
McGowan, Dina Rose
中科院分区：
文献类型：
--
作者：
McDaniel, Jodi Christine;Rausch, Jamie Ann;McGowan, Dina Rose
静脉性小腿溃疡(VLU)是小腿的开放性皮肤病变，发生在受静脉性高血压影响的区域，与相当高的发病率相关。测试创新方法以改善愈合结果的临床试验是至关重要的，因为标准疗法往往无效。然而，VLU患者经常面临多种生理、情感和社会经济挑战，这些挑战可能会对他们参加临床试验的决定产生负面影响。为了使临床研究人员和最终慢性创面患者社区受益，本文描述了正在进行的临床试验中对招募策略的监测和修改，以测试omega-3脂肪酸口服补充剂对老年成年人VLU愈合的影响(n=10208)。随着时间的推移，这项研究中的多次修改针对通过数据监测确定的参与障碍，包括扩大纳入标准、增加招募地点、加强沟通方法，以及满足患者的交通需求。从2019年1月至2022年6月的招募活动共产生57名参与者(平均年龄：63.7 岁)。总体而言，在面对面就诊期间接触的患者中，招聘率为42.5%。克服参与障碍是帮助对研究感兴趣的VLU患者参加临床试验的关键，该临床试验旨在改善这一脆弱人群的治疗结果。
Venous leg ulcers (VLUs) are open skin lesions of the lower legs arising in areas affected by venous hypertension that are associated with substantial morbidity. Clinical trials testing innovative approaches to improve healing outcomes are critically needed because standard therapies are often ineffective. However, patients with VLUs frequently have multiple physical, emotional and socioeconomic challenges that can negatively impact their decision to enrol in a clinical trial. To benefit clinical researchers and ultimately the community of patients with chronic wounds, this paper describes the monitoring and modification of recruitment strategies in an ongoing clinical trial testing effects of omega‐3 fatty acid oral supplementation on VLU healing in ageing adults (n = 208). Multiple modifications over time in this study have targeted participation barriers identified through data monitoring and include expanding inclusion criteria, adding recruitment sites, enhancing communication methods, and meeting patients' transportation needs. Recruitment activities from January 2019 to June 2022 have resulted in 57 participants (mean age: 63.7 years). Overall, the recruitment rate is 42.5% of patients contacted during face‐to‐face visits. Overcoming barriers to participation is key to helping patients with VLUs interested in research enrol in clinical trials aiming to improve healing outcomes in this vulnerable population.
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影响因子：
5
作者：
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通讯作者：
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影响因子：
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发表时间：
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影响因子：
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