The minimally important difference and patient acceptable symptom state for the Raynaud's condition score in patients with Raynaud's phenomenon in a large randomised controlled clinical trial.
The minimally important difference and patient acceptable symptom state for the Raynaud's condition score in patients with Raynaud's phenomenon in a large randomised controlled clinical trial.
复制标题
DOI：
10.1136/ard.2009.107706
复制
发表时间：
2010-03
影响因子：
27.4
通讯作者：
Khanna D
中科院分区：
文献类型：
--
作者：
Khanna PP;Maranian P;Gregory J;Khanna D
雷诺状态评分(RCS)是雷诺现象(RP)有效的结局测量方法。我们的目标是评估RP患者RCS的最小重要差异(MID)和患者可接受的症状状态(PASS)。活动期RP患者(N=162)[平均RCS和GT；25(0-100 VAS)]参加了一项安慰剂对照、交叉随机临床试验(RCT)。来自两个处理组的数据被结合在一起进行分析。在随机对照试验期间，我们进行了回顾和预期锚定。MID组被定义为报告稍好的组(锚1)，以及从“无法忍受”到“非常严重”等一步改变的组(锚2)。我们认为，如果患者在最后一次研究访问中将他们的雷诺病情评为“非常轻微”或“轻微”，则认为他们达到了及格。参与者的平均年龄为48.9岁，平均基线RCS评分为46.4。MID改善组的RCS值变化范围为−13.9~−14.3分，及格估计为34.0分。在活动性RP患者的大型RCT中，RCS的中值和及格估计分别为14-15分和34分，0-100分。这些信息有助于在未来的RP试验中解释RCS。
The Raynaud’s Condition Score (RCS) is a validated outcome measure for Raynaud’s phenomenon (RP). Our objective was to assess the minimally important difference (MID) and Patient Acceptable Symptom State (PASS) for RCS in patients with RP. Patients with active RP (N=162) [mean RCS > 25 (0–100 VAS)] participated in a placebo-controlled, cross over randomized clinical trial (RCT). Data from the 2 treatment groups were combined for this analysis. We administered retrospective and prospective anchors during the RCT. MID groups were defined as the group who reported being somewhat better (anchor#1) and a 1-step change from “unbearable” to “very severe” etc. (anchor#2). We considered patients as achieving PASS if they rated their Raynaud’s condition as ‘very mild’ or ‘mild’ at the last study visit. The mean age of participants was 48.9 years and the mean baseline RCS score was 46.4. The RCS change score for the MID improvement group ranged from − 13.9 to − 14.3 points and PASS estimate was 34.0 points. The MID and PASS estimates for RCS are 14–15 points for improvement and 34 points, respectively on a 0–100 scale in a large RCT of patients with active RP. This information can aid in interpreting RCS in future RP trials.
登录
查看更多内容
DOI：
10.3899/jrheum.080375
发表时间：
2008-12
期刊：
The Journal of rheumatology
影响因子：
--
作者：
Khanna D;Pope JE;Khanna PP;Maloney M;Samedi N;Norrie D;Ouimet G;Hays RD
通讯作者：
Hays RD
影响因子：
27.4
作者：
Heiberg, T.;Kvien, T. K.;Hagen, K. B.
通讯作者：
Hagen, K. B.
影响因子：
4.7
作者：
Gaertner, J;Elsner, F;Sabatowski, R
通讯作者：
Sabatowski, R
影响因子：
--
作者：
Chung, Lorinda;Shapiro, Lee;Wigley, Fredrick M.
通讯作者：
Wigley, Fredrick M.
影响因子：
2.3
作者：
Medsger, TA
通讯作者：
Medsger, TA