Evidence from diverse clinical populations supported clinical validity of PROMIS pain interference and pain behavior.
Evidence from diverse clinical populations supported clinical validity of PROMIS pain interference and pain behavior.
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DOI：
10.1016/j.jclinepi.2015.08.035
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发表时间：
2016-05
影响因子：
7.2
通讯作者：
Amtmann D
中科院分区：
文献类型：
--
作者：
Askew RL;Cook KF;Revicki DA;Cella D;Amtmann D
评估PROMIS®疼痛干预(PROIS-PI)和疼痛行为(PROIS-PB)T评分的临床有效性，包括反应性。数据来自对癌症、慢性下腰痛(CLBP)、类风湿性关节炎(RA)、慢性阻塞性肺疾病(COPD)和严重抑郁障碍(MDD)的纵向研究。使用线性混合效应模型来比较基线得分差异和得分随时间的变化。我们计算了由自我报告的总体健康和疼痛变化定义的亚组的标准化反应平均值(SRM)。1357人在基线时参与，1225人在随访时参与。在干预组(cLBP和MDD)中，PROMIS-PI和PROMIS-PB得分显著变化的假设得到支持。与稳定期COPD患者相比，COPD加重患者的基线评分差异在假设的方向上，但在统计学上没有显着差异。报告健康状况较好的亚组显示相应的负SRM值，支持T分数对改善的反应性。对减量的反应在一些但不是所有的临床组中得到支持，并因锚定而不同。当使用疼痛特定的锚时，获得了更一致的值。这项研究提供的证据表明，在预期影响疼痛的干预研究中，PROMIS-PI和-PB评分对疼痛的变化很敏感。其结果有助于估计有意义的变化，并支持比较有效性研究的能力分析。
To evaluate clinical validity, including responsiveness, of PROMIS® Pain Interference (PROMIS-PI) and Pain Behavior (PROMIS-PB) T-scores. Data were aggregated from longitudinal studies of cancer, chronic low back pain (cLBP), rheumatoid arthritis (RA), chronic obstructive pulmonary disease (COPD), and major depressive disorder (MDD). Linear mixed-effects models were used to compare baseline score differences and score changes over time. We calculated standardized response means (SRMs) for subgroups defined by self-reported change in general health and pain. 1357 individuals participated at baseline and 1225 at follow-up. Hypotheses of significant change in PROMIS-PI and PROMIS-PB scores were supported in the intervention groups (cLBP and MDD). Differences in baseline scores for COPD-exacerbators compared to stable-COPD patients were in the hypothesized direction but were not statistically significant. Subgroups reporting better health showed corresponding negative SRM values supporting responsiveness of T-scores to improvement. Responsiveness to decrements was supported in some but not all clinical groups and varied by anchor. More congruent values were obtained when using a pain-specific anchor. This study provides evidence that PROMIS-PI and –PB scores are sensitive to changes in pain in studies of interventions expected to impact pain. The results inform estimation of meaningful change and support power analyses for comparative effectiveness research.