Furimsky Ivana, Cheung Amy H, Dewa Carolyn S, Zipursky Robert B
Mental Health and Addictions Program, St Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
Contemp Clin Trials. 2008 Nov;29(6):862-6. doi: 10.1016/j.cct.2008.07.005. Epub 2008 Jul 31.
Recruitment and retention of research participants is often the most labor-intensive and difficult component of clinical trials. Poor recruitment and retention frequently pose as a major barrier in the successful completion of clinical trials. In fact, many studies are prematurely terminated, or their findings questioned due to low recruitment and retention rates. The conduct of clinical trials involving youth with a first episode of mental illness comes with additional challenges in recruitment and retention including barriers associated with engagement and family involvement. To develop effective early interventions for first episode mental illness, it is necessary to develop strategies to enhance recruitment and retention in this patient population. This article presents the recruitment and retention challenges experienced in two clinical trials: one involving participants experiencing a first episode of depression and one involving participants experiencing a first episode psychosis. Challenges with recruitment and retention are identified and reviewed at both the patient level and clinician level. Strategies that were implemented to enhance recruitment and retention in these two studies are also discussed. Finally, ethical issues to consider when implementing these strategies are also highlighted.
招募和留住研究参与者通常是临床试验中最耗费人力且困难的部分。招募和留住参与者不力常常成为成功完成临床试验的主要障碍。事实上,许多研究由于招募和留住率低而提前终止,或者其研究结果受到质疑。针对首次发作精神疾病的青少年开展临床试验,在招募和留住参与者方面还面临额外挑战,包括与参与度和家庭参与相关的障碍。为了开发针对首次发作精神疾病的有效早期干预措施,有必要制定策略以提高该患者群体的招募和留住率。本文介绍了两项临床试验中在招募和留住参与者方面遇到的挑战:一项涉及首次发作抑郁症的参与者,另一项涉及首次发作精神病的参与者。在患者层面和临床医生层面都识别并审视了招募和留住参与者方面的挑战。还讨论了在这两项研究中为提高招募和留住率而实施的策略。最后,还强调了实施这些策略时需要考虑的伦理问题。