Solomon Daniel H, Weissman Joel S, Choi Hyon, Atlas Steven J, Berardinelli Cesar, Dedier Julien, Fischer Michael A, Fitzgerald John, Hinteregger Erica, Johnsen Brianne, Marini Diana D, McLean Robert, Murray Fred, Neogi Tuhina, Oertel Lynn B, Pillinger Michael H, Riggs Kevin R, Saag Ken, Suh Dong, Watkins James, Barry Michael J
Brigham and Women's Hospital, Boston, Massachusetts.
Massachusetts General Hospital, Boston.
ACR Open Rheumatol. 2021 May;3(5):341-348. doi: 10.1002/acr2.11243. Epub 2021 May 1.
Disagreement exists between rheumatology and primary care societies regarding gout management. This paper describes a formal process for gathering input from stakeholders in the planning of a trial to compare gout management strategies.
We recruited patients, nurses, physician assistants, primary care clinicians, and rheumatologists to participate in a modified Delphi panel (mDP) to provide input on design of a trial focused on optimal management for primary care patients with gout. The 16 panelists received a plain-language briefing document that discussed the rationale for the trial, key clinical issues in gout, and aspects of trial design. The panelists also received information and considerations on nine voting questions (VQs), judged to be the key design questions. Cognitive interviews with panelists ensured that the VQs were understood by the range of panelists involved in the mDP. Panelists were asked to score all VQs from 1 (definitely no) to 9 (definitely yes). Two voting rounds were conducted-round 1 by email and round 2 by video conference.
The VQs were modified through the cognitive interviews. The round 1 voting resulted in consensus on eight items, with consensus defined as median voting score in the same tercile (1-3, 4-6 or 7-9). Re-voting at the meeting (round 2) reached consensus on the remaining item.
An mDP with various stakeholders facilitated consensus on the design of a trial of different management strategies for chronic gout. This method may be useful for designing trials of clinical questions with substantial disagreement across stakeholders.
在痛风管理方面，风湿病学协会和初级保健协会之间存在分歧。本文描述了一个在比较痛风管理策略试验规划过程中收集利益相关者意见的正式流程。
我们招募了患者、护士、医师助理、初级保健临床医生和风湿病学家参与一个改良的德尔菲小组（mDP），以就一项针对痛风初级保健患者最佳管理的试验设计提供意见。16名小组成员收到了一份通俗易懂的简报文件，该文件讨论了试验的基本原理、痛风的关键临床问题以及试验设计的各个方面。小组成员还收到了关于九个投票问题（VQ）的信息和考量因素，这些问题被判定为关键设计问题。对小组成员进行的认知访谈确保了参与mDP的各类小组成员都理解这些VQ。要求小组成员对所有VQ从1分（绝对不）到9分（绝对是）进行评分。进行了两轮投票——第一轮通过电子邮件，第二轮通过视频会议。
通过认知访谈对VQ进行了修改。第一轮投票在八个项目上达成了共识，共识定义为中位数投票分数处于同一三分位数区间（1 - 3、4 - 6或7 - 9）。在会议上进行的第二轮投票（第二轮）就其余项目达成了共识。
一个由不同利益相关者参与的mDP促进了关于慢性痛风不同管理策略试验设计的共识。这种方法可能有助于设计在利益相关者之间存在重大分歧的临床问题试验。
