Lim S Sam, Kivitz Alan J, McKinnell Doug, Pierson M Edward, O'Brien Faye S
Division of Rheumatology, Department of Medicine, Emory University, Atlanta, GA, USA.
Altoona Center for Clinical Research, Altoona, PA, USA.
Patient Prefer Adherence. 2017 Jul 31;11:1295-1307. doi: 10.2147/PPA.S137416. eCollection 2017.
We elicited patient experiences from clinical trial simulations to aid in future trial development and to improve patient recruitment and retention.
Two simulations of draft Phase II and Phase III anifrolumab studies for systemic lupus erythematosus (SLE)/lupus nephritis (LN) were performed involving African-American patients from Grady Hospital, an indigent care hospital in Atlanta, GA, USA, and white patients from Altoona Arthritis and Osteoporosis Center in Altoona, PA, USA. The clinical trial simulation included an informed consent procedure, a mock screening visit, a mock dosing visit, and a debriefing period for patients and staff. Patients and staff were interviewed to obtain sentiments and perceptions related to the simulated visits.
The Atlanta study involved 6 African-American patients (5 female) aged 27-60 years with moderate to severe SLE/LN. The Altoona study involved 12 white females aged 32-75 years with mild to moderate SLE/LN. Patient experiences had an impact on four patient-centric care domains: 1) information, communication, and education; 2) responsiveness to needs; 3) access to care; and 4) coordination of care; and continuity and transition. Patients in both studies desired background material, knowledgeable staff, family and friend support, personal results, comfortable settings, shorter wait times, and greater scheduling flexibility. Compared with the Altoona study patients, Atlanta study patients reported greater preferences for information from the Internet, need for strong community and online support, difficulties in discussing SLE, emphasis on transportation and child care help during the visits, and concerns related to financial matters; and they placed greater importance on time commitment, understanding of potential personal benefit, trust, and confidentiality of patient data as factors for participation. Using these results, we present recommendations to improve study procedures to increase retention, recruitment, and compliance for clinical trials.
Insights from these two studies can be applied to the development and implementation of future clinical trials to improve patient recruitment, retention, compliance, and advocacy.
我们从临床试验模拟中获取患者体验，以助力未来试验的开展，并改善患者的招募与留存情况。
针对系统性红斑狼疮（SLE）/狼疮性肾炎（LN）的II期和III期阿尼鲁单抗研究草案进行了两次模拟，涉及来自美国佐治亚州亚特兰大一家贫困护理医院格雷迪医院的非裔美国患者，以及来自美国宾夕法尼亚州阿尔图纳关节炎与骨质疏松中心的白人患者。临床试验模拟包括知情同意程序、模拟筛查访视、模拟给药访视，以及针对患者和工作人员的汇报期。对患者和工作人员进行了访谈，以获取与模拟访视相关的感受和看法。
亚特兰大的研究纳入了6名年龄在27至60岁之间、患有中度至重度SLE/LN的非裔美国患者（5名女性）。阿尔图纳的研究纳入了12名年龄在32至75岁之间、患有轻度至中度SLE/LN的白人女性。患者体验对四个以患者为中心的护理领域产生了影响：1）信息、沟通与教育；2）对需求的响应；3）医疗服务可及性；4）护理协调以及连续性与过渡。两项研究中的患者都希望获得背景资料、知识渊博的工作人员、家人和朋友的支持、个人结果、舒适的环境、更短的等待时间以及更大的日程安排灵活性。与阿尔图纳研究的患者相比，亚特兰大研究的患者表示更倾向于从互联网获取信息，需要强大的社区和在线支持，在讨论SLE方面存在困难，强调访视期间的交通和儿童护理帮助，以及对财务问题的担忧；并且他们更重视时间投入、对潜在个人益处的理解、信任以及患者数据的保密性，将其作为参与的因素。利用这些结果，我们提出了改进研究程序的建议，以提高临床试验的留存率、招募率和依从性。
这两项研究的见解可应用于未来临床试验的开发与实施，以改善患者招募、留存、依从性及宣传工作。
