Methods to identify and prioritize patient-centered outcomes for use in comparative effectiveness research

Background: We used various methods for identifying and prioritizing patient-centered outcomes (PCOs) for comparative effectiveness research (CER).

Methods: We considered potential PCOs (“benefits” and “harms”) related to (1) gabapentin for neuropathic pain and (2) quetiapine for bipolar depression. Part 1 (April 2014 to March 2015): we searched for PCO research and core outcome sets (COSs). We conducted electronic searches of bibliographic databases and key websites and examined FDA prescribing information and reports of clinical trials and systematic reviews. We asked patient and clinician co-investigators to identify PCOs. Part 2 (not part of our original study protocol): in 2015, we surveyed members of The TMJ Association, Ltd., a patient group associated with temporomandibular disorders (4130 invitations sent). Participants prioritized (1) the importance of six potential benefits and (2) 21 potential harms selected by the investigators in part 1, using stated preference methods....

背景：本研究采用多种方法，为比较效果研究（Comparative Effectiveness Research, CER）识别并排序患者中心结局（Patient-Centered Outcomes, PCOs）。
方法：本研究纳入与以下两类药物相关的潜在患者中心结局（即「获益」与「损害」）：(1) 用于治疗神经病理性疼痛的加巴喷丁，以及(2) 用于治疗双相抑郁的喹硫平。
第一阶段（2014年4月至2015年3月）：我们检索了患者中心结局相关研究及核心结局集（Core Outcome Sets, COSs）。通过电子检索书目数据库与重点网站，审阅美国食品药品监督管理局（FDA）处方信息、临床试验报告及系统评价文献，并邀请患者与临床医师作为共同研究者识别患者中心结局。
第二阶段（不属于本研究初始方案范畴）：2015年，我们对颞下颌关节协会有限公司（The TMJ Association, Ltd.）的会员开展问卷调查，该组织为面向颞下颌关节紊乱病患者的患者团体，本次共发出4130份邀请。参与者采用陈述偏好法，对第一阶段研究者筛选出的(1) 6项潜在获益与(2) 21项潜在损害的重要性进行排序。