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急性脊髓损伤患者及其照护者的研究参与者招募策略:一项前后研究。

Research Participant Recruitment Strategies Among Individuals with Acute Spinal Cord Injury and Their Caregivers: A Pre-Post Study.

机构信息

Virginia Commonwealth University, Richmond, VA.

Central Virginia Veterans Affairs Health Care System, Richmond, VA.

出版信息

Spine (Phila Pa 1976). 2021 Aug 15;46(16):1111-1117. doi: 10.1097/BRS.0000000000004032.

Abstract

STUDY DESIGN

Pre-post study.

OBJECTIVE

To evaluate the efficiency of a series of recruitment strategies in a longitudinal study of individuals with SCI and their informal caregivers. Primary strategies included (a) rapport building in advance, (b) warm handoffs from another healthcare provider who already had a relationship with the potential participant, (c) ensuring the potential participant had information about the study prior to the initial contact by the research coordinator (RC), (d) attempting informed consent only when both the patient and informal caregiver were present, and (e) ensuring the RC had at least 30 minutes to explain the study when attempting recruitment.

SUMMARY OF BACKGROUND DATA

While a fairly large body of research has been conducted on general recruitment strategies for clinical trials, very little has examined the efficacy of these strategies within neurological conditions and almost none within SCI.

METHODS

Individuals with an acute SCI and their informal caregivers were recruited from acute spinal cord rehabilitation units with a Veteran's Affairs medical center and an academic medical center in the same urban area. Of 49 eligible dyads, 41 were approached for consent, with 27 consenting to join the study (9 from the academic medical center; 18 from the VA).

RESULTS

There was a significant difference in enrollment rates after implementing the recruitment strategies, χ2(1) = 7.572, P = 0.006, with the per month participant enrollment rate nearly doubling after implementation.

CONCLUSION

Using a multiteam and multidisciplinary approach to recruitment may increase the likelihood that individuals with an acute SCI and their caregivers enroll in research.Level of Evidence: 3.

摘要

研究设计

前后研究。

目的

评估一系列招募策略在 SCI 患者及其非专业照顾者的纵向研究中的效果。主要策略包括:(a) 预先建立关系,(b) 由已经与潜在参与者建立关系的另一位医疗保健提供者进行热情交接,(c) 确保潜在参与者在研究协调员 (RC) 首次联系之前了解研究信息,(d) 仅在患者和非专业照顾者都在场的情况下尝试知情同意,(e) 确保 RC 在尝试招募时至少有 30 分钟时间来解释研究。

背景数据概述

虽然已经进行了相当多的关于临床试验一般招募策略的研究,但很少有研究在神经疾病中检验这些策略的效果,几乎没有在 SCI 中进行研究。

方法

从退伍军人事务医疗中心和同一城市地区的学术医疗中心的急性脊髓康复病房招募急性 SCI 患者及其非专业照顾者。在 49 对符合条件的患者及其照顾者中,有 41 对接受了同意书的请求,其中 27 对同意加入研究(9 对来自学术医疗中心;18 对来自 VA)。

结果

实施招募策略后,入组率有显著差异,χ2(1) = 7.572,P = 0.006,实施后每月参与者入组率几乎翻了一番。

结论

采用多团队和多学科的招募方法可能会增加急性 SCI 患者及其照顾者参与研究的可能性。证据水平:3。

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