患者报告的影响临床试验参与的因素:对狼疮和类风湿性关节炎患者的深入分析。

IF 2.8 Q2 RHEUMATOLOGY
Aliza Bloostein, Roberto Caricchio
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引用次数: 0

摘要

系统性红斑狼疮(SLE)是一种慢性系统性自身免疫性疾病,尽管临床试验数量迅速增加,但仅有三种获批治疗方法。SLE试验难以招募患者,且未能完全入组。类风湿关节炎(RA)是另一种慢性自身免疫性疾病,在临床试验中取得了更大的成功。本文的目的是分析文献,比较患者对SLE和RA人群参与临床试验的因素的看法。对临床试验患者的态度、看法、观点和障碍进行了文献综述。RA文献多采用定量方法,而SLE文献多采用定性方法。文献显示,SLE患者和RA患者报告的激励参与试验的因素相似,如利他主义、个人利益和对医生的信任,但SLE患者的独特动机是强大的社会网络。就参与试验的不利因素而言,SLE和RA患者同样报告了对未知干预措施、并发症和副作用的恐惧;只有在SLE患者人群中存在疾病爆发的恐惧和不合格的报告。SLE文献特别强调影响黑人患者参与的因素。本综述为未来的研究提供了信息,以更好地评估SLE患者临床试验的看法,并为增加SLE试验参与的方法提供了框架,包括认识到对改变治疗方案的恐惧是SLE试验参与不足的原因,将临床试验作为SLE患者的常规护理,并使用不那么严格的纳入和排除标准。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Patient-Reported Factors Influencing Clinical Trial Participation: An In-depth Analysis of Patients With Lupus and Rheumatoid Arthritis.

Patient-Reported Factors Influencing Clinical Trial Participation: An In-depth Analysis of Patients With Lupus and Rheumatoid Arthritis.

Patient-Reported Factors Influencing Clinical Trial Participation: An In-depth Analysis of Patients With Lupus and Rheumatoid Arthritis.

Systemic lupus erythematosus (SLE), a chronic systemic autoimmune disease, has only three approved therapies, despite a rapidly expanding number of clinical trials. Trials in SLE struggle to recruit patients and fail to fully enroll. Rheumatoid arthritis (RA), another chronic autoimmune disease, has had more success in clinical trial enrollment. This article's goal is to analyze literature to compare patient perspectives on factors determining clinical trial participation in SLE and RA populations. A literature review regarding patient attitudes, perceptions, perspectives about, and barriers toward clinical trials was conducted. RA literature used more quantitative methods, whereas SLE literature used more qualitative methods. Literature revealed that patients with SLE and patients with RA reported similar factors motivating trial participation, such as altruism, personal benefit, and trust in physician, but patients with SLE were uniquely motivated by strong social networks. In terms of disadvantages to trial participation, patients with SLE and RA similarly reported fear of unknown interventions, complications, and side effects; only in the population of patients with SLE were fears of a disease flare and of not qualifying reported. SLE literature had a specific emphasis on factors influencing Black patient participation. This review informs steps for future research to better evaluate perceptions of clinical trials in patients with SLE and provides a framework for methods to increase SLE trial participation, including recognizing fear of changing treatment regimen as an explanation for the paucity of SLE trial participation, incorporating clinical trials as usual care for patients with SLE, and using less stringent inclusion and exclusion criteria for trials.

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