Mody Lona, Miller Douglas K, McGloin Joanne M, Freeman Marcie, Marcantonio Edward R, Magaziner Jay, Studenski Stephanie
Geriatrics Research Education and Clinical Center (GRECC) VA Ann Arbor Healthcare System, University of Michigan, Ann Arbor, MI, USA.
J Am Geriatr Soc. 2008 Dec;56(12):2340-8. doi: 10.1111/j.1532-5415.2008.02015.x.
Older adults continue to be underrepresented in clinical research despite their burgeoning population in the United States and worldwide. Physicians often propose treatment plans for older adults based on data from studies involving primarily younger, more-functional, healthier participants. Major barriers to recruitment of older adults in aging research relate to their substantial health problems, social and cultural barriers, and potentially impaired capacity to provide informed consent. Institutionalized older adults offer another layer of complexity that requires cooperation from the institutions to participate in research activities. This paper provides study recruitment and retention techniques and strategies to address concerns and overcome barriers to older adult participation in clinical research. Key approaches include early in-depth planning; minimizing exclusion criteria; securing cooperation from all interested parties; using advisory boards, timely screening, identification, and approach of eligible patients; carefully reviewing the benefit:risk ratio to be sure it is appropriate; and employing strategies to ensure successful retention across the continuum of care. Targeting specific strategies to the condition, site, and population of interest and anticipating potential problems and promptly employing predeveloped contingency plans are keys to effective recruitment and retention.
尽管在美国和全球范围内老年人数量不断增加,但他们在临床研究中的代表性仍然不足。医生通常根据主要涉及更年轻、功能更强、更健康参与者的研究数据,为老年人制定治疗方案。在衰老研究中招募老年人的主要障碍涉及他们大量的健康问题、社会和文化障碍,以及提供知情同意的能力可能受损。机构养老的老年人带来了另一层复杂性,这需要机构合作参与研究活动。本文提供了研究招募和保留技术及策略,以解决相关问题并克服老年人参与临床研究的障碍。关键方法包括早期深入规划;尽量减少排除标准;确保所有感兴趣的各方合作;利用咨询委员会,及时筛选、识别和接触符合条件的患者;仔细审查受益与风险比以确保其合适;以及采用策略确保在整个护理过程中成功保留患者。针对特定疾病、地点和感兴趣人群制定具体策略,并预测潜在问题并及时采用预先制定的应急计划,是有效招募和保留患者的关键。