Objective A gluten-free diet is the only treatment option of coeliac disease, but recently an increasing number of trials have begun to explore alternative treatment strategies. We aimed to review the literature on coeliac disease therapeutic trials and issue recommendations for outcome measures. Design Based on a literature review of 10 062 references, we (17 researchers and 2 patient representatives from 10 countries) reviewed the use and suitability of both clinical and non-clinical outcome measures. We then made expert-based recommendations for use of these outcomes in coeliac disease trials and identified areas where research is needed. Results We comment on the use of histology, serology, clinical outcome assessment (including patient-reported outcomes), quality of life and immunological tools including gluten immunogenic peptides for trials in coeliac disease. Conclusion Careful evaluation and reporting of outcome measures will increase transparency and comparability of coeliac disease therapeutic trials, and will benefit patients, healthcare and the pharmaceutical industry.

中文翻译：

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乳糜泻试验的结果测量：坦佩雷建议


目的 无麸质饮食是乳糜泻的唯一治疗选择，但最近越来越多的试验开始探索替代治疗策略。我们的目的是回顾有关乳糜泻治疗试验的文献，并就结果措施提出建议。设计 基于对 10 062 篇参考文献的文献综述，我们（来自 10 个国家的 17 名研究人员和 2 名患者代表）审查了临床和非临床结果指标的使用和适用性。然后，我们提出了基于专家的建议，将这些结果用于乳糜泻试验，并确定了需要研究的领域。结果 我们对组织学、血清学、临床结果评估（包括患者报告的结果）、生活质量和免疫学工具（包括麸质免疫原性肽）在乳糜泻试验中的使用进行了评论。结论 仔细评估和报告结果指标将提高乳糜泻治疗试验的透明度和可比性，并将有利于患者、医疗保健和制药行业。