未被充分代表和已被充分代表的纤维肌痛患者参与临床试验的障碍与促进因素：一项横断面网络调查
Barriers and facilitators for clinical trial participation of underrepresented and non-underrepresented fibromyalgia patients: A cross-sectional internet survey.
作者信息
Cardenas-Rojas Alejandra, Pacheco-Barrios Kevin, Castelo-Branco Luis, Giannoni-Luza Stefano, Balbuena-Pareja Ana, Luna-Cuadros Maria Alejandra, Vasconcelos Felippe Luna, Uygur-Kucukseymen Elif, Gonzalez-Mego Paola, Gunduz Muhammed Enes, Shaikh Emad Salman, Gianlorenco Anna Carolyna Lepesteur, Fregni Felipe
机构信息
Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Universidad San Ignacio de Loyola, Vicerrectorado de Investigación, Unidad de Investigación para la Generación y Síntesis de Evidencias en Salud, Lima, Peru.
出版信息
Heliyon. 2021 Jul 5;7(7):e07475. doi: 10.1016/j.heliyon.2021.e07475. eCollection 2021 Jul.
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.
CONCLUSION
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.
背景
纤维肌痛需要有充足样本量的随机临床试验。然而，招募工作面临挑战。本研究旨在描述和评估未被充分代表和已被充分代表的纤维肌痛患者参与试验的障碍、促进因素及相关因素的认知情况。
方法
我们于2020年4月7日至7月3日在新冠疫情居家令期间，通过REDCap（研究电子数据采集）对美国的纤维肌痛患者进行了一项在线调查。我们描述并比较了未被充分代表和已被充分代表的参与者的调查特征，并进行逻辑回归模型分析以评估与参与临床试验相关的因素。
结果
共有481人完成了调查，其中包括168名未被充分代表的纤维肌痛患者。只有（1）11.09%的人报告曾参与过临床试验，主要的感知障碍与研究者相关（研究人员缺乏友好度以及获得结果的机会）和中心相关（隐私和保密政策以及机构声誉）；（2）未被充分代表和已被充分代表的患者在参与率、感知障碍和促进因素方面相似；（3）参与率与低收入、较高年龄以及从医生处获得的临床试验认知呈正相关，与对研究者相关障碍的认知呈负相关；（4）对于未被充分代表的人群，存在情感支持。
结论
我们的研究结果表明，无论是否属于未被充分代表的人群，参与率都较低。对于这一人群，应考虑采取策略，如让他们的医生作为联络人以提高对临床试验的认知，以及改善患者与研究人员之间的沟通。
Zotero 插件