Experiences of trial participants and site staff of participating in and running a large randomised trial within fertility (the endometrial scratch trial): a qualitative interview study

Author:

Chatters RobinORCID,White David,Pye Clare,Petrovic Ana,Sizer Anya,Kumar Pavithra,Metwally Mostafa

Abstract

ObjectivesTo explore the experiences of endometrial scratch (ES) trial participants and site staff of trial recruitment and participation, in order to improve the experience of participants in future trials.DesignQualitative study of a subset of participants in the ES randomised controlled trial and a subset of trial site staff.SettingA purposeful sample of 9 of the 16 UK Fertility Units that participated in the trial.ParticipantsA purposeful sample of 27 trial participants and 7 site staff.ResultsParticipants were largely happy with the recruitment practices, however, some were overwhelmed with the amount of information received. Interviewees had positive preconceptions regarding the possible effect of the ES on the outcome of their in vitro fertilisation (IVF) cycle, which often originated from their own internet research and seemed to be exacerbated by how site staff described the intervention. Some participants appeared to not understand that receiving the ES could potentially reduce their chances of a successful IVF outcome. Those randomised to the control arm discussed feeling discontent; site staff developed mechanisms of dealing with this.ConclusionsA lack of equipoise in both study participants and the recruiting site staff led to trial participants having positive preconceptions of the potential impact of the ES on their upcoming IVF cycle. Trial participants may not have understood the potential harms of participating in a randomised trial. The trial information sheet did not clearly state this; further research should assess how such information should be presented to potential participants, to proportionately present the level of risk, but to not unduly discourage participation. The amount of information fertility patients require about a research study should also be investigated, in order to avoid participants feeling overwhelmed by the amount of information they receive prior to starting IVF.Trial registration numberISRCTN23800982.

Funder

Health Technology Assessment Programme

Publisher

BMJ

Subject

General Medicine

Reference30 articles.

1. Therapeutic misconception and the appreciation of risks in clinical trials

2. The internal thoracic artery skeletonization study: A paired, within-patient comparison [NCT00265499]

3. Facilitating trial recruitment: a qualitative study of patient and staff experiences of an orthopaedic trauma trial;Phelps;Trials,2019

4. Kirkby HM . What do potential participants want to know about low risk interventional research? A feasibility study of electronic information provision and a randomised controlled trial of an interactive information sheet 2013.

5. Personal experiences of taking part in clinical trials - a qualitative study;Locock;Patient Educ Couns,2011

Cited by 3 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3