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Abstract：
BACKGROUND: There is a need of well-powered randomized clinical trials in fibromyalgia. However, challenges for recruitment are presented. This study aims to describe and assess the perception of barriers and facilitators and the associated factors for the participation of underrepresented and non-underrepresented fibromyalgia patients.
METHODS: We performed an online survey through REDCap (Research Electronic Data Capture) targeting fibromyalgia patients from April 7 to July 3, 2020 during the COVID-19 stay home mandate and it was restricted to the United States of America. We described and compared the survey characteristics between underrepresented and non-underrepresented participants, and we performed logistic regression models to assess the associated factors with clinical trial participation.
RESULTS: In total, 481 completed the survey including 168 underrepresented fibromyalgia patients. Only (1) 11.09 % reported previous participation in clinical trials and the significant perceived barriers were investigator-related (lack of friendliness of research staff and the opportunity to receive the results) and center-related (privacy and confidentiality policies, and the institution\'s reputation); (2) the participation rate and perceived barriers and facilitators were similar between underrepresented and non-underrepresented patients; and was positively associated with low income, higher age, and clinical trial awareness from their physician; and negatively associated with the perception of investigator-related barriers; and (4) for the underrepresented population, the presence of emotional support.
CONCLUSIONS: Our findings suggest low rates of participation, regardless of underrepresented population status. Strategies as involving their physician as liaison to increase the awareness of clinical trials, as well as improving patient-researcher communication should be considered in this population.
METHODS: We performed an online survey through REDCap (Research Electronic Data Capture) targeting fibromyalgia patients from April 7 to July 3, 2020 during the COVID-19 stay home mandate and it was restricted to the United States of America. We described and compared the survey characteristics between underrepresented and non-underrepresented participants, and we performed logistic regression models to assess the associated factors with clinical trial participation.
RESULTS: In total, 481 completed the survey including 168 underrepresented fibromyalgia patients. Only (1) 11.09 % reported previous participation in clinical trials and the significant perceived barriers were investigator-related (lack of friendliness of research staff and the opportunity to receive the results) and center-related (privacy and confidentiality policies, and the institution\'s reputation); (2) the participation rate and perceived barriers and facilitators were similar between underrepresented and non-underrepresented patients; and was positively associated with low income, higher age, and clinical trial awareness from their physician; and negatively associated with the perception of investigator-related barriers; and (4) for the underrepresented population, the presence of emotional support.
CONCLUSIONS: Our findings suggest low rates of participation, regardless of underrepresented population status. Strategies as involving their physician as liaison to increase the awareness of clinical trials, as well as improving patient-researcher communication should be considered in this population.
摘要：
■需要在纤维肌痛中进行有力的随机临床试验。然而,招聘面临的挑战。这项研究旨在描述和评估障碍和促进者的感知以及参与代表性不足和非代表性不足的纤维肌痛患者的相关因素。
我们在2020年4月7日至7月3日期间，通过REDCap（研究电子数据捕获）针对纤维肌痛患者进行了一项在线调查，该调查仅限于美国。我们描述并比较了代表性不足和代表性不足的参与者之间的调查特征，我们采用logistic回归模型评估参与临床试验的相关因素.
■总共，481人完成了调查，其中包括168名代表性不足的纤维肌痛患者。只有（1）11.09％的人报告说以前参与过临床试验，并且明显的障碍与研究人员相关（缺乏研究人员的友好性和获得结果的机会）和中心相关（隐私和保密政策，和机构的声誉);(2)参与率和感知障碍和促进者在代表性不足和代表性不足的患者之间是相似的;并且与低收入正相关,年龄较高,和他们的医生对临床试验的认识；与研究者相关障碍的感知呈负相关；(4)对于代表性不足的人群，情感支持的存在。
■我们的研究结果表明参与率低，无论代表性不足的人口状况如何。策略，包括他们的医生作为联络人，以提高临床试验的意识，在这一人群中，还应考虑改善患者与研究人员的沟通。
我们在2020年4月7日至7月3日期间，通过REDCap（研究电子数据捕获）针对纤维肌痛患者进行了一项在线调查，该调查仅限于美国。我们描述并比较了代表性不足和代表性不足的参与者之间的调查特征，我们采用logistic回归模型评估参与临床试验的相关因素.
■总共，481人完成了调查，其中包括168名代表性不足的纤维肌痛患者。只有（1）11.09％的人报告说以前参与过临床试验，并且明显的障碍与研究人员相关（缺乏研究人员的友好性和获得结果的机会）和中心相关（隐私和保密政策，和机构的声誉);(2)参与率和感知障碍和促进者在代表性不足和代表性不足的患者之间是相似的;并且与低收入正相关,年龄较高,和他们的医生对临床试验的认识；与研究者相关障碍的感知呈负相关；(4)对于代表性不足的人群，情感支持的存在。
■我们的研究结果表明参与率低，无论代表性不足的人口状况如何。策略，包括他们的医生作为联络人，以提高临床试验的意识，在这一人群中，还应考虑改善患者与研究人员的沟通。
