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互动性炎症性肠病生物制剂决策辅助工具并不能改善患者结局优于静态教育:来自随机试验的结果。

Interactive Inflammatory Bowel Disease Biologics Decision Aid Does Not Improve Patient Outcomes Over Static Education: Results From a Randomized Trial.

机构信息

Karsh Division of Gastroenterology and Hepatology, Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, California, USA.

Cedars-Sinai Center for Outcomes Research and Education (CS-CORE), Los Angeles, California, USA.

出版信息

Am J Gastroenterol. 2022 Sep 1;117(9):1508-1518. doi: 10.14309/ajg.0000000000001866. Epub 2022 Jun 10.

Abstract

INTRODUCTION

To support shared decision-making (SDM) between patients and providers surrounding biologic treatments, we created IBD&me ( ibdandme.org )-a freely available, unbranded, interactive decision aid. We performed a multicenter comparative effectiveness trial comparing the impact of IBD&me on SDM vs a biologics fact sheet developed by the Crohn's & Colitis Foundation.

METHODS

We enrolled patients with inflammatory bowel disease (IBD) being seen at a clinic within IBD Qorus-a multicenter adult IBD learning health system-between March 5, 2019, and May 14, 2021. Eligible patients included those with recent IBD-related symptoms who reported that they wanted to discuss biologics with their provider during their upcoming visit. Patients were randomized 1:1 using stratified block randomization and received an e-mail 1 week before their visit inviting them to review either IBD&me or a fact sheet. The primary outcome was patient perception of SDM as measured by the 9-Item SDM Questionnaire (0-100 scale; higher = better); the Student t test was used to compare outcomes between arms.

RESULTS

Overall, 152 patients were randomized (biologics fact sheet 75, IBD&me 77); most patients had Crohn's disease (66.4%) and were biologic-experienced (82.9%). No differences were seen between groups regarding SDM (fact sheet 72.6 ± 25.6, IBD&me 75.0 ± 20.8; P = .57). Most patients stated they would be likely to recommend the fact sheet (79.6%) or IBD&me (84.9%; P = .48) to another patient with IBD.

DISCUSSION

No differences in outcomes were seen between IBD&me and the biologics fact sheet in this comparative effectiveness study; patients reported high satisfaction with both resources. Further study, particularly among biologic naïve patients, is needed to determine the utility of interactive components to IBD decision aids.

摘要

介绍

为了支持患者和提供者在生物治疗方面进行共同决策(SDM),我们创建了 IBD&me(ibdandme.org)-一个免费的、无品牌的、互动的决策辅助工具。我们进行了一项多中心比较效果试验,比较了 IBD&me 对 SDM 的影响与克罗恩病和结肠炎基金会(CCFA)开发的生物制剂情况说明书的影响。

方法

我们招募了在 IBD Qorus 中的一个诊所就诊的炎症性肠病(IBD)患者,该诊所是一个多中心成人 IBD 学习健康系统-2019 年 3 月 5 日至 2021 年 5 月 14 日期间。符合条件的患者包括最近有 IBD 相关症状的患者,他们报告说他们希望在即将到来的就诊期间与他们的提供者讨论生物制剂。患者使用分层块随机化进行 1:1 随机分组,并在就诊前一周收到一封电子邮件,邀请他们查看 IBD&me 或情况说明书。主要结局是通过 9 项 SDM 问卷(0-100 分;分数越高越好)衡量的患者对 SDM 的感知;使用学生 t 检验比较两组之间的结果。

结果

总体而言,共有 152 名患者被随机分配(生物制剂情况说明书 75 名,IBD&me 77 名);大多数患者患有克罗恩病(66.4%)且有生物制剂治疗经验(82.9%)。两组之间在 SDM 方面没有差异(情况说明书 72.6 ± 25.6,IBD&me 75.0 ± 20.8;P =.57)。大多数患者表示他们可能会向另一位患有 IBD 的患者推荐情况说明书(79.6%)或 IBD&me(84.9%;P =.48)。

讨论

在这项比较效果研究中,IBD&me 和生物制剂情况说明书之间没有观察到结局差异;患者对两种资源的满意度都很高。需要进一步研究,特别是在生物制剂初治患者中,以确定交互式组件对 IBD 决策辅助工具的效用。

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