University of Alabama at Birmingham, Birmingham, Alabama, United States of America.
Birmingham VA Medical Center, Birmingham, Alabama, United States of America.
PLoS Med. 2019 May 8;16(5):e1002800. doi: 10.1371/journal.pmed.1002800. eCollection 2019 May.
Treatment decision-making regarding immunosuppressive therapy is challenging for individuals with lupus. We assessed the effectiveness of a decision aid for immunosuppressive therapy in lupus nephritis.
In a United States multicenter, open-label, randomized controlled trial (RCT), adult women with lupus nephritis, mostly from racial/ethnic minority backgrounds with low socioeconomic status (SES), seen in in- or outpatient settings, were randomized to an individualized, culturally tailored, computerized decision aid versus American College of Rheumatology (ACR) lupus pamphlet (1:1 ratio), using computer-generated randomization. We hypothesized that the co-primary outcomes of decisional conflict and informed choice regarding immunosuppressive medications would improve more in the decision aid group. Of 301 randomized women, 298 were analyzed; 47% were African-American, 26% Hispanic, and 15% white. Mean age (standard deviation [SD]) was 37 (12) years, 57% had annual income of <$40,000, and 36% had a high school education or less. Compared with the provision of the ACR lupus pamphlet (n = 147), participants randomized to the decision aid (n = 151) had (1) a clinically meaningful and statistically significant reduction in decisional conflict, 21.8 (standard error [SE], 2.5) versus 12.7 (SE, 2.0; p = 0.005) and (2) no difference in informed choice in the main analysis, 41% versus 31% (p = 0.08), but clinically meaningful and statistically significant difference in sensitivity analysis (net values for immunosuppressives positive [in favor] versus negative [against]), 50% versus 35% (p = 0.006). Unresolved decisional conflict was lower in the decision aid versus pamphlet groups, 22% versus 44% (p < 0.001). Significantly more patients in the decision aid versus pamphlet group rated information to be excellent for understanding lupus nephritis (49% versus 33%), risk factors (43% versus 27%), medication options (50% versus 33%; p ≤ 0.003 for all); and the ease of use of materials was higher in the decision aid versus pamphlet groups (51% versus 38%; p = 0.006). Key study limitations were the exclusion of men, short follow-up, and the lack of clinical outcomes, including medication adherence.
An individualized decision aid was more effective than usual care in reducing decisional conflict for choice of immunosuppressive medications in women with lupus nephritis.
Clinicaltrials.gov, NCT02319525.
对于狼疮患者来说，免疫抑制治疗的决策制定具有挑战性。我们评估了狼疮肾炎免疫抑制治疗决策辅助工具的有效性。
在美国一项多中心、开放标签、随机对照试验（RCT）中，纳入了在门诊或住院环境中接受治疗的狼疮肾炎成年女性，这些患者主要来自少数民族背景且社会经济地位较低（SES），按 1:1 的比例随机分配至个体化、文化适配的计算机化决策辅助工具组或美国风湿病学会（ACR）狼疮小册子组（计算机生成的随机分组）。我们假设，在免疫抑制药物治疗的决策冲突和知情选择方面，主要结局指标中的两个次要结局指标在决策辅助工具组中会得到更大改善。在 301 名随机女性中，对 298 名进行了分析；47%为非裔美国人，26%为西班牙裔，15%为白人。平均年龄（标准差[SD]）为 37（12）岁，57%的人年收入<40,000 美元，36%的人只有高中学历。与提供 ACR 狼疮小册子相比（n = 147），随机分配至决策辅助工具的参与者（n = 151）：（1）在决策冲突方面有临床意义且统计学显著的降低，21.8（标准误差[SE]，2.5）比 12.7（SE，2.0；p = 0.005）；（2）在主要分析中，知情选择方面没有差异，41%比 31%（p = 0.08），但在敏感性分析中，差异有临床意义且统计学显著（支持免疫抑制治疗的净数值阳性[有利]与阴性[不利]），50%比 35%（p = 0.006）。决策辅助工具组中未解决的决策冲突低于小册子组，22%比 44%（p < 0.001）。与小册子组相比，决策辅助工具组中有更多的患者认为信息有助于理解狼疮肾炎（49%比 33%）、风险因素（43%比 27%）、药物选择（50%比 33%；所有 p 值均≤0.003）；且决策辅助工具组的材料易用性更高（51%比 38%；p = 0.006）。研究的主要局限性是排除了男性、随访时间短以及缺乏药物依从性等临床结局。
与常规护理相比，狼疮肾炎女性患者选择免疫抑制药物时，个体化决策辅助工具在降低决策冲突方面更有效。
Clinicaltrials.gov，NCT02319525。
