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克罗恩病共同决策干预措施导致更多患者选择联合治疗:一项聚类随机对照试验。

Crohn's disease shared decision making intervention leads to more patients choosing combination therapy: a cluster randomised controlled trial.

机构信息

Department of Social and Behavioral Sciences, College of Public Health, Temple University, Philadelphia, Pennsylvania, USA.

Department of Clinical, Educational and Health Psychology, Division of Psychology and Language Sciences, University College London, London, UK.

出版信息

Aliment Pharmacol Ther. 2023 Jan;57(2):205-214. doi: 10.1111/apt.17286. Epub 2022 Nov 14.

DOI:10.1111/apt.17286
PMID:36377259
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9790033/
Abstract

BACKGROUND

Crohn's disease requires effective patient-clinician communication for successful illness and medication management. Shared decision making (SDM) has been suggested to improve communication around early intensive therapy. However, effective evidence-based SDM interventions for Crohn's disease are lacking, and the impact of SDM on Crohn's disease decision making and choice of therapy is unclear.

AIM

To test the impact of SDM on choice of therapy, quality of the decision and provider trust compared to standard Crohn's disease care.

METHODS

We conducted a multi-site cluster randomised controlled trial in 14 diverse gastroenterology practices in the US.

RESULTS

A total of 158 adult patients with Crohn's disease within 15 years of their diagnosis, with no prior Crohn's disease complications, and who were candidates to receive immunomodulators or biologics, participated in the study. Among these, 99 received the intervention and 59 received standard care. Demographics were similar between groups, although there were more women assigned to standard care, and a slightly shorter disease duration among those in the intervention group. Participants in the intervention group more frequently chose combination therapy (25% versus 5% control, p < 0.001), had a significantly lower decisional conflict (p < 0.05) and had greater trust in their provider (p < 0.05).

CONCLUSIONS

With rapidly expanding medication choices for Crohn's disease and slow uptake of early intensive therapy, SDM can personalise treatment strategies and has the potential to move the field of Crohn's disease management forward with an ultimate goal of consistently treating this disease early and intensively in appropriate patients.

TRIAL REGISTRATION

Evaluating a Shared Decision Making Program for Crohn's Disease, ClinicalTrials.gov Identifier NCT02084290 https://clinicaltrials.gov/ct2/show/NCT02084290.

摘要

背景

为了成功管理克罗恩病和药物治疗,克罗恩病患者需要与临床医生进行有效的沟通。有研究表明,共同决策(SDM)可以改善早期强化治疗方面的沟通。然而,目前缺乏有效的、基于循证的克罗恩病 SDM 干预措施,并且 SDM 对克罗恩病决策制定和治疗选择的影响尚不清楚。

目的

与标准克罗恩病护理相比,测试 SDM 对治疗选择、决策质量和提供者信任的影响。

方法

我们在美国 14 家不同的胃肠病学诊所进行了一项多站点集群随机对照试验。

结果

共有 158 名患有克罗恩病且确诊时间不超过 15 年、没有克罗恩病并发症且适合接受免疫调节剂或生物制剂治疗的成年患者参与了这项研究。其中,99 名患者接受了干预,59 名患者接受了标准护理。两组患者的人口统计学特征相似,尽管标准护理组中女性较多,而干预组患者的疾病持续时间略短。干预组患者更频繁地选择联合治疗(25%比 5%的对照组,p<0.001),决策冲突显著降低(p<0.05),对提供者的信任度更高(p<0.05)。

结论

随着克罗恩病药物选择的迅速扩大和早期强化治疗的缓慢采用,SDM 可以个性化治疗策略,并有可能推动克罗恩病管理领域的发展,最终目标是在适当的患者中尽早、更积极地治疗这种疾病。

试验注册

评估克罗恩病的共同决策制定计划,ClinicalTrials.gov 标识符 NCT02084290 https://clinicaltrials.gov/ct2/show/NCT02084290。

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