Afrin Lawrence B, Oates James C, Kamen Diane L
Division of Hematology, Oncology & Transplantation, University of Minnesota, Minneapolis, MN, USA.
Division of Rheumatology, Medical University of South Carolina, Charleston, SC, USA.
Int J Med Inform. 2015 Jan;84(1):15-23. doi: 10.1016/j.ijmedinf.2014.09.001. Epub 2014 Sep 16.
Poor accrual rates impede clinical trial efficiency and significantly contribute to development costs for new interventions. Many providers recognize investigational treatments are their patients' best opportunities for improvement, but operational clinical burdens impede providers' awareness of, and ability to leverage, such opportunities. We aimed to develop a new workflow for non-intrusively apprising providers of trial opportunities for their patients and enabling providers to efficiently refer potential trial candidates to study teams for preliminary eligibility review.
We developed a small information system to monitor institutional systems, identify patients potentially eligible for ongoing clinical trials, and give providers a non-intrusive, one-click method to refer such patients to study teams for preliminary eligibility vetting.
In 18 months of pilot experience, providers invited study teams to vet 11% of 1844 patients found potentially eligible for 38 trials registered with the system. Seventy-nine patients were conservatively estimated to be accrued. Accrual rates were boosted for several trials. Results of a survey indicated most users were satisfied with the system.
Providers' time constraints impede their pursuit of investigational opportunities for their patients. In pilot experience, our novel approach to facilitating such pursuits yielded improved accrual, benefiting trials and presumably patients, too. Our approach may bear particular fruit for cross-disciplinary referrals for screening.
Systems for assisting providers in making investigational opportunities available to their patients may benefit from careful attention to provider workflow and time constraints. Our system might further benefit from improved patient/trial matching and shorter messages.
低入组率阻碍了临床试验效率,并显著增加了新干预措施的开发成本。许多医疗服务提供者认识到研究性治疗是患者改善病情的最佳机会,但临床操作负担阻碍了他们对这些机会的认知以及利用这些机会的能力。我们旨在开发一种新的工作流程,以非侵入性方式告知医疗服务提供者其患者的试验机会,并使他们能够有效地将潜在的试验候选人转介给研究团队进行初步资格审查。
我们开发了一个小型信息系统,以监控机构系统,识别可能符合正在进行的临床试验资格的患者,并为医疗服务提供者提供一种非侵入性的一键式方法,将此类患者转介给研究团队进行初步资格审核。
在18个月的试点经验中,医疗服务提供者邀请研究团队对1844名患者中的11%进行资格审查,这些患者被发现可能符合该系统注册的38项试验的资格。据保守估计,有79名患者入组。多项试验的入组率得到了提高。一项调查结果表明,大多数用户对该系统感到满意。
医疗服务提供者的时间限制阻碍了他们为患者寻求研究性机会。在试点经验中,我们促进此类寻求的新方法提高了入组率,使试验受益,大概也使患者受益。我们的方法可能在跨学科筛查转介方面特别有成效。
协助医疗服务提供者为患者提供研究性机会的系统可能会受益于对医疗服务提供者工作流程和时间限制的仔细关注。我们的系统可能会从改善患者/试验匹配和缩短信息中进一步受益。