Division of Infectious Diseases, Department of Medicine at School of Medicine.
Departments of Nutrition, University of Alabama at Birmingham, Birmingham, AL.
J Clin Rheumatol. 2020 Aug;26(5):181-191. doi: 10.1097/RHU.0000000000001018.
The aim of this study was to report patient-centered outcomes and finalization of key study procedures from a 9-month pilot internet randomized controlled trial of cherry extract versus diet modification.
We randomized 84 people with physician-confirmed gout in an internet study to cherry extract (n = 41) or dietitian-assisted diet modification for gout (n = 43). All study outcomes were collected via internet and phone calls. We finalized key study procedures. We assessed acceptability and feasibility of the intervention and satisfaction with study website.
Study participant satisfaction with the intervention was high. The intervention was perceived as easy, enjoyable, understandable, and helpful (scores 65-88 for all; higher = better). The amount of time spent for the study was acceptable. Participant satisfaction with website interaction and content was very high; 85% or more were moderately to extremely satisfied. Significantly lower total calories, total carbohydrate, and saturated fat intake were noted at 6 months in the diet modification versus cherry extract group; differences were insignificant at 9 months. Six of the 8 Health Assessment Questionnaire sections/domains improved significantly from baseline to 9 months in cherry extract versus 2 Health Assessment Questionnaire sections/domains in the diet modification group. Key study procedures were finalized for a future trial, including an internet diet assessment tool, gout flare assessment, provider confirmation of gout diagnosis, patient reporting of classification criteria, and centralized laboratory-assisted serum urate testing.
High patient acceptability and feasibility of study/intervention and finalization of key study procedures indicate that hypothesis-testing internet gout trials of cherry extract and/or diet modification can be conducted in the future.
本研究旨在报告为期 9 个月的樱桃提取物与饮食调整治疗痛风的互联网随机对照试验的试点研究中患者为中心的结局和关键研究程序的完成情况。
我们在互联网研究中随机分配 84 名经医生确诊的痛风患者，分别接受樱桃提取物（n=41）或营养师辅助的痛风饮食调整（n=43）。所有研究结局均通过互联网和电话收集。我们完成了关键研究程序。我们评估了干预措施的可接受性和可行性以及对研究网站的满意度。
研究参与者对干预措施的满意度很高。干预措施被认为简单、愉快、易懂且有帮助（所有评分 65-88；分数越高越好）。研究所需时间是可接受的。参与者对网站互动和内容的满意度非常高，85%或更多的人表示中度至非常满意。在饮食调整组，与樱桃提取物组相比，6 个月时总卡路里、总碳水化合物和饱和脂肪摄入量明显降低；9 个月时差异不显著。在樱桃提取物组中，8 个健康评估问卷（HAQ）中有 6 个部分/领域从基线到 9 个月时显著改善，而在饮食调整组中只有 2 个 HAQ 部分/领域改善。为未来的试验完成了关键研究程序，包括互联网饮食评估工具、痛风发作评估、医生确认痛风诊断、患者报告分类标准以及集中实验室辅助的血清尿酸检测。
患者对研究/干预措施的高度接受和可行性以及关键研究程序的完成表明，未来可以进行樱桃提取物和/或饮食调整治疗痛风的互联网假设检验试验。
