Osterhaus Jane T, Purcaru Oana
Arthritis Res Ther. 2014 Jul 4;16(4):R140. doi: 10.1186/ar4602.
The novel arthritis-specific Work Productivity Survey (WPS) was developed to estimate patient productivity limitations associated with arthritis within and outside the home, which is an unmet need in psoriatic arthritis (PsA). The WPS has been validated in rheumatoid arthritis. This report assesses the discriminant validity, responsiveness and reliability of the WPS in adult-onset PsA.
Psychometric properties were assessed using data from the RAPID-PsA trial (NCT01087788) investigating certolizumab pegol (CZP) efficacy and safety in PsA. WPS was completed at baseline and every 4 weeks until Week 24. Validity was evaluated at baseline via known-groups defined using first and third quartiles of patients' Disease Activity Score 28 based on C-reactive protein (DAS28(CRP)), Health Assessment Questionnaire-Disability Index (HAQ-DI), Short Form-36 (SF-36) items and PsA Quality of Life (PsAQoL) scores. Responsiveness and reliability were assessed by comparing WPS mean changes at Week 12 in American College of Rheumatology 20% improvement criteria (ACR20) or HAQ-DI Minimal Clinically Important Difference (MCID) 0.3 responders versus non-responders, as well as using standardized response means (SRM). All comparisons were conducted on the observed cases in the Randomized Set, regardless of the randomization group, using a non-parametric bootstrap-t method.
Compared with patients with a better health state, patients with a worse health state had on average 2 to 6 times more household work days lost, more days with reduced household productivity, more days missed of family/social/leisure activities, more days with outside help hired and a significantly higher interference of arthritis per month. Among employed patients, those with a worse health state had 2 to 4 times more workplace days lost, more days with patient workplace productivity reduced, and a significantly higher interference of arthritis on patient workplace productivity versus patients with a better health state. WPS was also responsive to clinical changes, with responders having significantly larger improvements at Week 12 in WPS scores versus non-responders. The effect sizes for changes in productivity in ACR20 or HAQ-DI MCID responders were moderate (0.5 < SRM < 0.8) or small.
These analyses demonstrate the validity, responsiveness and reliability of the WPS, as an instrument for the measurement of patient productivity within and outside the home in an adult-onset PsA population.
新型关节炎特异性工作效率调查(WPS)旨在评估与关节炎相关的患者在家中和家外的工作效率受限情况,这是银屑病关节炎(PsA)领域尚未满足的需求。WPS已在类风湿关节炎中得到验证。本报告评估了WPS在成人起病的PsA中的区分效度、反应性和可靠性。
使用来自RAPID-PsA试验(NCT01087788)的数据评估心理测量特性,该试验研究了赛妥珠单抗(CZP)在PsA中的疗效和安全性。在基线时以及每4周直至第24周完成WPS。通过已知组在基线时评估效度,已知组使用基于C反应蛋白的患者疾病活动评分28(DAS28(CRP))、健康评估问卷残疾指数(HAQ-DI)、简明健康状况调查(SF-36)项目和PsA生活质量(PsAQoL)评分的第一和第三四分位数来定义。通过比较美国风湿病学会20%改善标准(ACR20)或HAQ-DI最小临床重要差异(MCID)0.3的应答者与无应答者在第12周时WPS的平均变化,以及使用标准化反应均值(SRM)来评估反应性和可靠性。所有比较均在随机分组中的观察病例上进行,无论随机分组情况如何,采用非参数自助抽样t检验方法。
与健康状况较好的患者相比,健康状况较差的患者平均家庭工作日损失多2至6倍,家庭生产效率降低的天数更多,家庭/社交/休闲活动缺勤天数更多,雇佣外部帮助的天数更多,且每月关节炎干扰显著更高。在就业患者中,健康状况较差的患者工作场所工作日损失多2至4倍,患者工作场所生产效率降低的天数更多,且与健康状况较好的患者相比,关节炎对患者工作场所生产效率的干扰显著更高。WPS对临床变化也有反应,应答者在第12周时WPS评分的改善明显大于无应答者。ACR20或HAQ-DI MCID应答者的生产效率变化效应大小为中等(0.5 < SRM < 0.8)或较小。
这些分析证明了WPS作为一种测量成人起病的PsA患者在家中和家外工作效率的工具的效度、反应性和可靠性。