Translation, cross-cultural and construct validity of the Dutch-Flemish PROMIS® upper extremity item bank v2.0.
- 作者列表："Haan EA","Terwee CB","Van Wier MF","Willigenburg NW","Van Deurzen DFP","Pisters MF","Kaat AJ","Roorda LD
PURPOSE:To develop a Dutch-Flemish translation of the PROMIS® upper extremity (PROMIS-UE) item bank v2.0, and to investigate its cross-cultural and construct validity as well as its floor and ceiling effects in patients with musculoskeletal UE disorders. METHODS:State of the art translation methodology was used to develop the Dutch-Flemish PROMIS-UE item bank v2.0. The item bank and four legacy instruments were administered to 205 Dutch patients with musculoskeletal UE disorders visiting an orthopedic outpatient clinic. The validity of cross-cultural comparisons between English and Dutch patients was evaluated by studying differential item functioning (DIF) for language (Dutch vs. English) with ordinal logistic regression models and McFadden's pseudo R2-change of ≥ 2% as critical value. Construct validity was assessed by formulating a priori hypotheses and calculating correlations with legacy instruments. Floor/ceiling effects were evaluated by determining the proportion of patients who achieved the lowest/highest possible raw score. RESULTS:Eight items showed DIF for language, but their impact on the test score was negligible. The item bank correlated, as hypothesized, moderately with the Dutch-Flemish PROMIS pain intensity item (Pearson's r = - 0.43) and strongly with the Disabilities of the Arm, Shoulder and Hand questionnaire, Subscale Disability/Symptoms (Spearman's ρ = - 0.87), the Functional Index for Hand Osteoarthritis (ρ = - 0.86), and the Michigan Hand Outcomes Questionnaire, Subscale Activities of Daily Living (ρ = 0.87). No patients achieved the lowest or highest possible raw score. CONCLUSIONS:A Dutch-Flemish PROMIS-UE item bank v2.0 has been developed that showed sufficient cross-cultural and construct validity as well as absence of floor and ceiling effects.
目的: 开发PROMIS的荷兰语-佛兰德翻译®上肢 (PROMIS-UE) 题库v2.0，并调查其在肌肉骨骼疾病患者中的跨文化和结构效度及其地板和天花板效应。 方法: 使用最先进的翻译方法开发荷兰语-佛兰芒PROMIS-UE题库v2.0。项目库和四种遗留器械被用于 205 名访问骨科门诊的荷兰肌肉骨骼疾病患者。通过研究语言 (荷兰语vs.英语) 的差异项目功能 (DIF) 来评估英语和荷兰患者跨文化比较的有效性以有序logistic回归模型和McFadden伪R2-change ≥ 2% 为临界值。通过制定先验假设并计算与遗留工具的相关性来评估结构效度。通过确定达到最低/最高原始评分的患者比例来评价地板/天花板效应。 结果: 8 个项目对语言有DIF，但对test成绩的影响可忽略不计。题库与荷兰-佛兰芒PROMIS疼痛强度项目 (Pearson's r = - 0.43) 中度相关，与手臂残疾强烈相关，肩、手问卷、亚量表残疾/症状 (Spearman' s ρ = - 0.87) 、手骨关节炎功能指数 (ρ = -0.86) 、和密歇根手部结果问卷，日常生活活动分量表 (ρ = 0.87)。没有患者达到最低或最高的原始评分。 结论: 开发了荷兰-佛兰芒PROMIS-UE题库v2.0，显示了足够的跨文化和结构效度以及没有地板和天花板效应。
METHODS:OBJECTIVE:Patients with immune-mediated inflammatory diseases such as rheumatoid arthritis or systemic lupus erythematosus are at increased risk of cardiovascular disease. However, the cardiovascular risk of patients with primary Sjögren's syndrome (SS) remains poorly studied. We aimed to investigate the association between primary SS and cardiovascular morbidity and mortality. METHODS:We performed a systematic review of articles in Medline and the Cochrane Library and recent abstracts from US and European meetings, searching for reports of randomized controlled studies of cardiovascular morbidity and cardiovascular mortality in primary SS. The relative risk (RR) values for cardiovascular morbidity and mortality associated with primary SS were collected and pooled in a meta-analysis with a random-effects model by using Review Manager (Cochrane collaboration). RESULTS:The literature search revealed 484 articles and abstracts of interest; 14 studies (67,124 patients with primary SS) were included in the meta-analysis. With primary SS versus control populations, the risk was significantly increased for coronary morbidity (RR 1.34 [95% confidence interval (95% CI) 1.06-1.38]; P = 0.01), cerebrovascular morbidity (RR 1.46 [95% CI 1.43-1.49]; P < 0.00001), heart failure rate (odds ratio 2.54 [95% CI 1.30-4.97]; P < 0.007), and thromboembolic morbidity (RR 1.78 [95% CI 1.41-2.25]; P < 0.00001), with no statistically significant increased risk of cardiovascular mortality (RR 1.48 [95% CI 0.77-2.85]; P = 0.24). CONCLUSION:This meta-analysis demonstrates that primary SS is associated with increased cardiovascular morbidity, which suggests that these patients should be screened for cardiovascular comorbidities and considered for preventive interventions, in a multidisciplinary approach with cardiologists.
METHODS:OBJECTIVE:We aimed to evaluate the comparative risk of hospitalized infection among patients with rheumatoid arthritis (RA) who initiated abatacept versus a tumor necrosis factor inhibitor (TNFi). METHODS:Using claims data from Truven MarketScan database (2006-2015), we identified patients with RA ages ≥18 years with ≥2 RA diagnoses who initiated treatment with abatacept or a TNFi. The primary outcome was a composite end point of any hospitalized infection. Secondary outcomes included bacterial infection, herpes zoster, and infections affecting different organ systems. We performed 1:1 propensity score (PS) matching between the groups in order to control for baseline confounders. We estimated incidence rates (IRs) and hazard ratios (HRs) with 95% confidence intervals (95% CIs) for hospitalized infection. RESULTS:We identified 11,248 PS-matched pairs of patients who initiated treatment with abatacept and TNFi with a median age of 56 years (83% were women). The IR per 1,000 person-years for any hospitalized infection was 37 among patients who initiated treatment with abatacept and 47 in those who initiated treatment with TNFi. The HR for the risk of any hospitalized infection associated with abatacept versus TNFi was 0.78 (95% CI 0.64-0.95) and remained lower when compared to infliximab (HR 0.63 [95% CI 0.47-0.85]), while no significant difference was seen when compared to adalimumab and etanercept. The risk of secondary outcomes was lower for abatacept for pulmonary infections, and similar to TNFi for the remaining outcomes. CONCLUSION:In this large cohort of patients with RA who initiated treatment with abatacept or TNFi as a first- or second-line biologic agent, we found a lower risk of hospitalized infection after initiating abatacept versus TNFi, which was driven mostly by infliximab.
METHODS:OBJECTIVE:Reducing pain is one of the main health priorities for children and young people with juvenile idiopathic arthritis (JIA); however, some studies indicate that pain is not routinely assessed in this patient group. The aim of this study was to explore health care professionals' (HCPs) beliefs about the role of pain and the prioritization of its assessment in children and young people with JIA. METHODS:Semi-structured interviews were conducted with HCPs who manage children and young people with JIA in the UK (including consultant and trainee pediatric rheumatologists, nurses, physical therapists, and occupational therapists). Data were analyzed qualitatively following a framework analysis approach. RESULTS:Twenty-one HCPs participated. Analyses of the data identified 6 themes, including lack of training and low confidence in pain assessment, reluctance to engage in pain discussions, low prioritization of pain assessment, specific beliefs about the nature of pain in JIA, treatment of pain in JIA, and undervaluing pain reports. Assessment of pain symptoms was regarded as a low priority and some HCPs actively avoided conversations about pain. CONCLUSION:These findings indicate that the assessment of pain in children and young people with JIA may be limited by knowledge, skills, and attitudinal factors. HCPs' accounts of their beliefs about pain in JIA and their low prioritization of pain in clinical practice suggest that a shift in perceptions about pain management may be helpful for professionals managing children and young people with this condition.