Smith Shannon M, Gewandter Jennifer S, Kitt Rachel A, Markman John D, Vaughan Janet A, Cowan Penney, Kopecky Ernest A, Malamut Richard, Sadosky Alesia, Tive Leslie, Turk Dennis C, Dworkin Robert H
Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, New York.
Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, New York.
J Pain. 2016 Nov;17(11):1198-1206. doi: 10.1016/j.jpain.2016.07.008. Epub 2016 Aug 20.
Barriers to clinical trial recruitment can delay study completion, potentially resulting in increased costs and an unrepresentative sample. In the current study of 150 participants with chronic pain, we used a computerized adaptive choice-based conjoint survey that included 8 characteristics that may affect enrollment in pharmacologic pain treatment trials (ie, treatment allocation, frequency of pain ratings, treatment administration method, current medications, number of study visits, availability of evening and weekend visits, invasiveness of laboratory procedures, payment). These data were analyzed using Sawtooth Software ver. 8.4.8 (Sawtooth Software, Inc, Orem, UT), which identifies the characteristics that dominate participants' decisions across multiple sets of potential trials. Three characteristics had the largest relative importance in participants' trial preferences: 1) invasiveness of required laboratory procedures (ie, 22%), with no procedures or blood tests preferred over ice-water sensory testing or skin biopsy; 2) ability to continue current pain medications (21%); and 3) payment for study participation (21%), with higher payment preferred. The fourth most important characteristic was number of study visits (13%), with participants preferring fewer in-person visits and more phone contacts. Understanding the preferences of potential participants is an important step toward enhancing enrollment in pain treatment trials.
This article presents the preferences of individuals with chronic pain conditions regarding modifiable pain treatment trial characteristics (eg, number of study visits, payment, treatment allocation). These findings may help to improve enrollment into analgesic clinical trials and in turn accelerate the development of new pain treatments.
临床试验招募的障碍可能会延迟研究完成,可能导致成本增加和样本缺乏代表性。在当前一项针对150名慢性疼痛患者的研究中,我们使用了基于选择的计算机自适应联合调查,该调查包括8个可能影响药物疼痛治疗试验入组的特征(即治疗分配、疼痛评分频率、治疗给药方式、当前用药、研究访视次数、晚上和周末访视的可及性、实验室检查的侵入性、报酬)。使用Sawtooth Software ver. 8.4.8(Sawtooth Software公司,犹他州奥勒姆)对这些数据进行分析,该软件可识别在多组潜在试验中主导参与者决策的特征。在参与者的试验偏好中,有三个特征具有最大的相对重要性:1)所需实验室检查的侵入性(即22%),比起冰水感觉测试或皮肤活检,参与者更倾向于无检查或血液检查;2)继续使用当前疼痛药物的能力(21%);3)参与研究的报酬(21%),报酬越高越受青睐。第四重要的特征是研究访视次数(13%),参与者更喜欢较少的面对面访视和较多的电话联系。了解潜在参与者的偏好是提高疼痛治疗试验入组率的重要一步。
本文介绍了慢性疼痛患者对可改变的疼痛治疗试验特征(如研究访视次数、报酬、治疗分配)的偏好。这些发现可能有助于改善镇痛临床试验的入组情况,进而加速新疼痛治疗方法的研发。