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Challenges in recruiting participants in a multi-centre study on symptom experiences and self care strategies of bowel symptoms following colo-rectal surgery

机译:结肠直肠手术后肠症状症状体验和自我护理策略多中心研究中招募参与者的挑战

摘要

Aim: The purpose of this paper is to present some of the challenges found to be problematic in recruiting individuals following sphincter saving surgery for rectal cancer for a multicentre study. While the focus of the study is on symptom experiences and management of bowel symptoms following colo-rectal surgery, the paper will concentrate solely on the challenges experienced in recruiting a sample for the study. Background Recruitment of an adequate number of participants is a challenge for researchers in any area of research involving patients. Enrolment of patients treated for rectal cancer poses particular challenges because the total population of this group in a given country can be small. The use of multiple centres was required to obtain the required number of participants for the current study. Findings: In multicentre studies, researchers can encounter substantial challenges in obtaining ethical approval, accessing clinical sites and gaining direct access to patients. These challenges are embedded in a convoluted process involving many systems of communication, which can vary from one centre to another. Conclusions: The process of obtaining ethical approval is prolonged in the absence of a central ethical review committee. A review process based on a standard application for researchers seeking ethical approval for multi- centred studies central is necessary. Establishing and maintaining access to clinical sites requires co-operation from many individuals during the development of the proposal and continuing throughout the data collection process.
机译:目的:本文的目的是提出一些挑战,这些挑战被认为是在进行括约肌保存手术治疗直肠癌后招募个体时存在问题的,并且需要进行多中心研究。虽然研究的重点是结肠直肠手术后的症状经验和肠道症状的处理,但本文将仅集中于为研究收集样本时遇到的挑战。背景技术在涉及患者的任何研究领域中,招募足够多的参与者对于研究人员都是一个挑战。接受直肠癌治疗的患者的入院面临特别的挑战,因为该组在特定国家/地区的总人口可能很小。需要使用多个中心来获得当前研究所需的参与者数量。研究结果:在多中心研究中,研究人员在获得伦理批准,进入临床场所以及直接与患者接触方面会遇到重大挑战。这些挑战被嵌入到一个复杂的过程中,该过程涉及许多通信系统,从一个中心到另一个中心可能会有所不同。结论:在没有中央道德审查委员会的情况下,获得道德批准的过程得以延长。对于寻求针对多中心研究中心的伦理批准的研究人员,有必要基于标准应用程序进行审查。建立和维护对临床站点的访问权限需要在提案的开发过程中以及整个数据收集过程中许多人的合作。

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