Braun-Courville Debra K, Schlecht Nicolas F, Burk Robert D, Strickler Howard D, Rojas Mary, Lorde-Rollins Elizabeth, Nucci-Sack Anne, Hollman Dominic, Linares L Oriana, Diaz Angela
The Mount Sinai Medical Center, Department of Pediatrics, New York, NY.
The Albert Einstein College of Medicine, Department of Epidemiology & Population Health, Bronx, NY.
J Pediatr Adolesc Gynecol. 2014 Oct;27(5):e103-8. doi: 10.1016/j.jpag.2013.08.004. Epub 2013 Dec 12.
Clinical research with adolescents can be challenging due to issues of informed consent, parental involvement, institutional review board requirements, and adolescent psychosocial development. These requirements present a dilemma, particularly in the area of sexual health research, as adolescents are disproportionately affected by sexually transmitted infections such as human papillomavirus (HPV). To successfully conduct adolescent research in the clinical setting, one requires an awareness of state statutes regarding adolescent confidentiality and consent for medical care, and a close partnership with the IRB.
In 2007, the Mount Sinai Adolescent Health Center in collaboration with the Albert Einstein College of Medicine developed a longitudinal research study to examine the natural history of oral, cervical, and anal HPV in an adolescent female population engaged in high-risk sexual behaviors. We use this research project as a case study to explore the ethical, methodological, and clinical issues related to conducting adolescent health research.
Several strategies were identified to promote adolescent study participation, including: (1) building a research team that is motivated to work with adolescents; (2) combining research and patient care visits to avoid duplication of services; and (3) establishing a personalized communication network with participants. Using these methods, adolescent sexual health research can successfully be integrated into the clinical setting. While retaining a prospective cohort of adolescents has its challenges, a persistent and multi-disciplinary approach can help improve recruitment, sustain participation, and acquire critical data that will lead to improved healthcare knowledge applicable to understudied populations of adolescents.
由于知情同意、家长参与、机构审查委员会要求以及青少年心理社会发展等问题,针对青少年的临床研究可能具有挑战性。这些要求带来了一个两难困境,尤其是在性健康研究领域,因为青少年受到诸如人乳头瘤病毒(HPV)等性传播感染的影响尤为严重。要在临床环境中成功开展青少年研究,需要了解有关青少年医疗保密和同意的州法规,并与机构审查委员会建立密切的合作关系。
2007年,西奈山青少年健康中心与阿尔伯特·爱因斯坦医学院合作开展了一项纵向研究,以调查从事高风险性行为的青少年女性人群口腔、宫颈和肛门HPV的自然病史。我们以这个研究项目作为案例研究,探讨与开展青少年健康研究相关的伦理、方法和临床问题。
确定了几种促进青少年参与研究的策略,包括:(1)组建一支有动力与青少年合作的研究团队;(2)将研究与患者护理就诊相结合以避免服务重复;(3)与参与者建立个性化的沟通网络。使用这些方法,可以成功地将青少年性健康研究纳入临床环境。虽然保留一个青少年前瞻性队列存在挑战,但持续和多学科的方法有助于改善招募、维持参与度,并获取关键数据,从而增进适用于未得到充分研究的青少年人群的医疗保健知识。