AxSpA

axSpA
  • 文章类型: Journal Article
    轴向脊柱关节炎(axSpA)的特征是17型免疫驱动的关节炎症,约70%的患者存在肠道炎症。在这项研究中,我们询问axSpA粪便中是否含有Th17相关细胞因子,以及这是否与全身Th17激活有关.我们通过ELISA检测粪便细胞因子和钙卫蛋白水平,发现axSpA患者粪便IL-17A升高,IL-23,GM-CSF,还有钙卫蛋白.我们进一步确定了与健康供体相比,axSpA患者中循环IL-17A和IL-17FT辅助细胞淋巴细胞的水平升高。我们最终通过无偏倚的核磁共振波谱评估了粪便代谢物,发现多种粪便氨基酸与粪便IL-23浓度呈负相关。这些数据提供了肠腔17型免疫的证据,并提示其与肠道微生物代谢有关。
    Axial spondyloarthritis (axSpA) is characterized by type-17 immune-driven joint inflammation, and intestinal inflammation is present in around 70% of patients. In this study, we asked whether axSpA stool contained Th17-associated cytokines and whether this related to systemic Th17 activation. We measured stool cytokine and calprotectin levels by ELISA and found that patients with axSpA have increased stool IL-17A, IL-23, GM-CSF, and calprotectin. We further identified increased levels of circulating IL-17A+ and IL-17F+ T-helper cell lymphocytes in patients with axSpA compared to healthy donors. We finally assessed stool metabolites by unbiased nuclear magnetic resonance spectroscopy and found that multiple stool amino acids were negatively correlated with stool IL-23 concentrations. These data provide evidence of type-17 immunity in the intestinal lumen, and suggest its association with microbial metabolism in the intestine.
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  • 文章类型: Journal Article
    近几十年来,轴性脊柱关节炎(AxSpA)的诊断和治疗取得了重大进展。对该疾病的免疫发病机制的更深入了解为靶向治疗的发展铺平了道路。其疗效已在随机对照试验中得到证实,荟萃分析和一项生物DMARDs的头对头研究。AxSpA的治疗决策目前受患者选择的影响,合并症,临床医生熟悉度和成本。
    我们回顾了支持AxSpA治疗证据基础的临床试验。我们还涵盖旨在支持临床医生个性化治疗决策的荟萃分析和头对头数据。Further,我们讨论了最近的国际指南,这些指南为临床医生提供了治疗途径和指导.
    我们得出的结论是,管理放射学和非放射学AxSpA的治疗决策应基于与患者的共同决策,药物类的临床有效性,合并症和成本。目前,我们有有限的头对头的数据,以优先考虑一个药物类别比另一个一线治疗,但可以推荐肿瘤坏死因子(TNF),白细胞介素17(IL17)和JAK抑制在临床上具有可比性,结构和患者报告的结果测量。进一步的真实世界数据可以指导个体患者的治疗决策。
    UNASSIGNED: Significant progress has been made in the diagnosis and management of axial spondyloarthritis (AxSpA) over recent decades. A greater understanding of the immunopathogenesis of the disease has paved the way for the development of targeted treatments. Their efficacy has been demonstrated in randomized controlled trials, meta-analyses and one head-to-head study of biologic DMARDs. Treatment decisions in AxSpA are currently influenced by patient choice, co-morbidity, clinician familiarity and cost.
    UNASSIGNED: We review the clinical trials that underpin the evidence base for treatments in AxSpA. We also cover the meta-analyses and head-to-head data that seek to support clinicians in personalizing treatment decisions. Further, we discuss the recent international guidelines that provide clinicians with treatment pathways and guidance.
    UNASSIGNED: We conclude that treatment decisions in managing both radiographic and non-radiographic AxSpA should be based on shared decision-making with patients, the clinical effectiveness of drug class, co-morbidity and cost. At present, we have limited head-to-head data to prioritize one drug class over another for first-line treatment but can recommend tumor necrosis factor (TNF), interleukin 17 (IL17) and JAK inhibition as being comparable in terms of clinical, structural and patient-reported outcome measures. Further real-world data may guide treatment decision-making in individual patients.
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  • 文章类型: Journal Article
    随着我们在关节炎领域的研究兴趣和知识的增加,关于他们的治疗方法也出现了新的方面。JAK抑制剂(JAKI)是一种相对较新的治疗选择,JAK-STAT通路中的靶向分子,在银屑病关节炎和轴性关节炎的病理生理学中起主导作用。JAKi对JAK家族的四个不同成员(即JAK1,JAK2,JAK3和TYK2)表现出不同的选择性,可能反映了不同的疗效和安全性。尽管对于使用JAKi超过10年的类风湿性关节炎的知识更加巩固,PsA/SpA的数据仍在积累。在这篇综述中,我们旨在介绍和评估有关JAKi(重点是选择性JAKi)治疗SpA患者的疗效的最新知识,并评估其安全性,因为这种治疗选择可能会引起一些担忧。
    As our research interest and knowledge increases in the field of Spondyloarthritis, new aspects also emerge as regards to their therapeutic approach. JAK inhibitors (JAKi) are a relatively new treatment option, aiming molecules in the JAK-STAT pathway, which has a leading role in the pathophysiology of both Psoriatic Arthritis and Axial Spondyloarthritis. JAKi exhibit different selectivity towards the four different members of the JAK family (namely JAK1, JAK2, JAK3, and TYK2), possibly reflecting different efficacy and safety profile. Although knowledge is more consolidated for rheumatoid arthritis in which JAKi are being used for more than 10 years, data are still accumulating for PsA/SpA. In this review we aim to present and assess current knowledge about the efficacy of JAKi (with a focus on selective JAKi) in the treatment of patients with SpA and evaluate their safety profile as some concerns may arise around this therapeutic option.
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  • 文章类型: Journal Article
    轴性脊柱关节炎(axSpA)患者需要密切监测以实现疾病持续缓解的目标。远程医疗可以促进持续护理,同时缓解稀缺的医疗保健资源。在混合方法概念验证研究中,我们调查了6个月以上疾病稳定患者的混合远程医疗保健axSpA途径.患者使用医疗应用程序记录疾病活动(BASDAI和PtGA每两周一次,每周耀斑问卷)。要启用远程ASDAS-CRP(TELE-ASDAS-CRP),患者在家中使用毛细血管自取样装置。讨论了监测结果,并通过共同决策决定是否需要预先计划的3个月现场预约(T3)。10名患者完成了这项研究,八名患者还完成了额外的电话采访。问卷依从性高;BASDAI(82.3%),耀斑(74.8%),所有患者均成功完成TELE-ASDAS-CRP进行T3评估.在T3时,9/10的患者处于缓解或低疾病活动状态,所有患者均拒绝提供可选的T3现场预约。患者对所有研究成分的接受度很高,自我采样的净启动子评分(NPS)为50%(平均NPS8.8±1.5),电子问卷为70%(平均NPS9.0±1.6),T3远程咨询为90%(平均NPS9.7±0.6)。在采访中,患者报告的好处,如更好地概述他们的病情,易于使用的远程医疗工具,更大的自主权,and,最重要的是,节省旅行时间。据我们所知,这是第一项研究采用混合方法对axSpA患者进行随访,包括自我取样.在这项可扩展的概念验证研究中观察到的积极结果值得进行更大的验证性研究。
    Patients with axial spondyloarthritis (axSpA) require close monitoring to achieve the goal of sustained disease remission. Telehealth can facilitate continuous care while relieving scarce healthcare resources. In a mixed-methods proof-of-concept study, we investigated a hybrid telehealth care axSpA pathway in patients with stable disease over 6 months. Patients used a medical app to document disease activity (BASDAI and PtGA bi-weekly, flare questionnaire weekly). To enable a remote ASDAS-CRP (TELE-ASDAS-CRP), patients used a capillary self-sampling device at home. Monitoring results were discussed and a decision was reached via shared decision-making whether a pre-planned 3-month on-site appointment (T3) was necessary. Ten patients completed the study, and eight patients also completed additional telephone interviews. Questionnaire adherence was high; BASDAI (82.3%), flares (74.8%) and all patients successfully completed the TELE-ASDAS-CRP for the T3 evaluation. At T3, 9/10 patients were in remission or low disease activity and all patients declined the offer of an optional T3 on-site appointment. Patient acceptance of all study components was high with a net promoter score (NPS) of +50% (mean NPS 8.8 ± 1.5) for self-sampling, +70% (mean NPS 9.0 ± 1.6) for the electronic questionnaires and +90% for the T3 teleconsultation (mean NPS 9.7 ± 0.6). In interviews, patients reported benefits such as a better overview of their condition, ease of use of telehealth tools, greater autonomy, and, most importantly, travel time savings. To our knowledge, this is the first study to investigate a hybrid approach to follow-up axSpA patients including self-sampling. The positive results observed in this scalable proof-of-concept study warrant a larger confirmatory study.
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  • 文章类型: Journal Article
    背景:轴性脊柱关节炎(axSpA)患者缺乏评估体力活动的结果指标。对于这件事,开发并验证了修改后的“健康评估短QUestionnaire”(MSQUASH),最初是荷兰语。
    目的:将mSQUASH翻译和跨文化改编成西班牙语,并评估翻译版本在axSpA患者中的等效性。
    方法:mSQUASH按照Beaton协议的前后向过程进行翻译。两名双语翻译人员将mSQUASH独立向前翻译成西班牙语,这些版本在协商一致的版本中得到了统一。另一位翻译者将合成版本翻译成荷兰语。一个科学委员会就差异达成了共识,并制定了问卷的最终版本。认知汇报的现场测验涉及10例不同性别的axSpA患者,年龄,疾病持续时间,教育水平和工作状态。
    结果:mSQUASH的翻译过程已完成,没有重大问题。由于措辞上的差异很小,第一次翻译需要多次迭代。回译没有困难,科学委员会同意了问卷的最终版本。认知汇报显示西班牙问卷很清楚,相关,可以理解和全面。初步版本接受了较小的修改。
    结论:根据现场测试,mSQUASH的西班牙语版本显示出良好的语言和面部有效性,揭示在临床实践和研究中使用的潜力。为了结束mSQUASH到西班牙语的跨文化适应,下一步是评估西班牙语版本的心理测量特性。
    BACKGROUND: There is a lack of outcome measures for the assessment of physical activity in patients with axial spondyloarthritis (axSpA). For this matter, the modified Short QUestionnaire to Assess Health (mSQUASH) was developed and validated, originally in Dutch.
    OBJECTIVE: To translate and cross-culturally adapt the mSQUASH into Spanish and to evaluate the equivalence of the translated version in patients with axSpA.
    METHODS: The mSQUASH was translated following forward-backward procedure according to the protocol of Beaton. Two bi-lingual translators produced independent forward translations of the mSQUASH into Spanish, and the versions were harmonized in a consensual version. Another translator back translated the synthesized version into Dutch. A scientific committee reached consensus on discrepancies and developed a pre-final version of the questionnaire. The field test with cognitive debriefing involved 10 patients with axSpA with different gender, age, disease duration, educational level and working status.
    RESULTS: The translation process of the mSQUASH was completed without major issues. The first translation needed several iterations due to small discrepancies in the wording. Back-translation was performed without difficulties, and the scientific committee agreed upon a final version of the questionnaire. Cognitive debriefing showed the Spanish questionnaire to be clear, relevant, understandable and comprehensive. The preliminary version was accepted with minor modifications.
    CONCLUSIONS: The resulting Spanish version of the mSQUASH showed good linguistic and face validity according to the field test, revealing potential for use in clinical practice and research. In order to conclude the cross-cultural adaptation of the mSQUASH into Spanish, the next step is the assessment of psychometric properties of the Spanish version.
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  • 文章类型: Journal Article
    轴性脊柱关节炎(axSpA)是一种慢性炎症性疾病,主要影响轴向骨骼,导致慢性背痛和僵硬。根据指导方针,一线治疗包括非甾体抗炎药(NSAIDs),常规合成抗风湿药(csDMARDs)和非药物治疗。二线治疗涉及生物疾病缓解抗风湿药(bDMARD),例如肿瘤坏死因子和白介素17抑制剂。
    这个社交媒体听力研究项目的目的是分析药物的转换及其原因,以获得对axSpA患者现实生活旅程的宝贵见解。
    在Permea平台上扫描了axSpA患者在德语区特定疾病论坛中公开发布的帖子中的特定疾病关键字和常用药物。选择包含至少两个关键字的帖子,并手动标记药物之间的转换。分析了2010年7月1日至2022年2月4日期间共287个被裁减的职位。
    所描述的药物转换的最大组最初是使用bDMARD。切换到不同的bDMARD,终止药物治疗和改用糖皮质激素是最常见的.服用NSAIDs的患者改用糖皮质激素,不同的NSAID或BDMARD,而使用csDMARDs的患者最常改为bDMARDs。在所有药物组中,转换的主要原因是疗效不足和副作用。此外,对于药物组bDMARDs,csDMARDs和皮质类固醇,怀孕和哺乳被认为是转换的原因,而NSAID组患者从未提及妊娠和母乳喂养作为转换治疗的原因.
    我们的分析显示,根据在社交倾听环境中与同龄人分享的真实患者体验,进行药物转换。我们还显示了与建议指南不同的药物转换。收集现实生活中的见解,以病人的旅程处理慢性疾病,让我们了解,从而改善病人的护理和治疗。
    UNASSIGNED: Axial spondyloarthritis (axSpA) is a chronic inflammatory disease which primarily affects the axial skeleton resulting in chronic back pain and stiffness. According to the guideline, the first-line treatment includes non-steroidal anti-inflammatory drugs (NSAIDs), conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and non-pharmacological treatment. Second line treatment involves biological disease-modifying antirheumatic drugs (bDMARDs) such as tumour necrosis factor and interleukin-17 inhibitors.
    UNASSIGNED: The aim of this social media listening research project was to analyse switches of medication and the reasons thereof to gain valuable insights into real-life journeys of patients suffering from axSpA.
    UNASSIGNED: Publicly available posts in German-speaking disease-specific forums were scanned for disease-specific keywords and commonly used drugs by axSpA patients on the Permea platform. Posts containing at least two key words were selected and switches between medications were manually labelled. A total of 287 scraped posts between 01 July 2010 and 04 Feb 2022 were analysed.
    UNASSIGNED: The largest group of described medication switches was initially using bDMARDs. Switches to a different bDMARD, termination of medication and switches to glucocorticoids were most frequently named. Patients on NSAIDs switched to glucocorticoids, a different NSAID or bDMARD, whereas patients on csDMARDs most frequently changed to bDMARDs. In all medication groups the main reason for switching was insufficient efficacy and side effects. Additionally, for the medication groups bDMARDs, csDMARDs and corticosteroids, pregnancy and lactation were given as a reason for switching, whereas patients in the NSAID group never mentioned pregnancy and breastfeeding as a reason for switching treatment.
    UNASSIGNED: Our analysis shows medication switches based on real-life patient experiences shared with peers in a social listening setting. We also show medication switches differing from advised guidelines. Gathering real-life insights into patients\' journey dealing with chronic diseases allows us to understand, and thereby improve patient care and treatment.
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  • 文章类型: Journal Article
    我们旨在调查(1)由学生主导的诊所和(2)电子患者报告的结果(ePROs),以加速诊断和治疗轴性脊柱关节炎(axSpA)患者。疑似axSpA的患者在计划的实际风湿病专家访问(T0)之前完成了最初的学生主导的诊所访问(T-1)。加速患者预约和NSAID治疗开始,诊断结果的可用性,并评估T0时的治疗反应。从T-1开始,患者每2周完成一次电子BASDAI问卷。评估了纸质和电子BASDAI的一致性。使用净启动子评分(NPS)测量患者对ePRO报告和学生主导诊所的接受度。17/36(47.2%)患者被诊断为axSpA。以学生为主导的诊所(T-1)显着加快了患者的预约时间超过2个月(T0,T-1,p<0.0001),并且axSpA指南符合NSAID治疗(p<0.0001)。在T0时,所有患者均完成了诊断检查,7/17(41.2%)axSpA患者表现出临床上重要的改善或缓解。34/36(94.4%)患者在T-1和T0之间完成了至少80%的ePro。电子和纸质给药的BASDAI相关性良好(r=0.8p<0.0001)。NPS评分分别为+62.0%(平均值±SD9.2/10.0±0.9)和+30.5%(平均值±SD8.0/10.0±1.7),分别。总之,学生主导的诊所和ePRO监测被广泛接受,加速axSpA患者的诊断检查和治疗。
    We aimed to investigate (1) student-led clinics and (2) electronic patient-reported outcomes (ePROs) to accelerate diagnosis and treatment of patients with axial spondyloarthritis (axSpA). Patients with suspected axSpA completed an initial student-led clinic visit (T-1) prior to their planned actual rheumatologist visit (T0). Acceleration of patient appointment and NSAID therapy start, availability of diagnostic findings, and treatment response at T0 were evaluated. Beginning at T-1, patients completed electronic BASDAI questionnaires every 2 weeks. Concordance of paper-based and electronic BASDAI was evaluated. Patient acceptance of ePRO reporting and student-led clinics was measured using the net promoter score (NPS). 17/36 (47.2%) included patients were diagnosed with axSpA. Student-led clinics (T-1) significantly accelerated patient appointments by more than 2 months (T0, T-1, p < 0.0001) and axSpA guideline-conform NSAID treatment (p < 0.0001). At T0, diagnostic workup was completed for all patients and 7/17 (41.2%) axSpA patients presented with a clinically important improvement or were in remission. 34/36 (94.4%) patients completed at least 80% of the ePROs between T-1 and T0. Electronic and paper-administered BASDAI correlated well (r = 0.8 p < 0.0001). Student-led clinics and ePROs were well accepted by patients with NPS scores of + 62.0% (mean ± SD 9.2/10.0 ± 0.9) and + 30.5% (mean ± SD 8.0/10.0 ± 1.7), respectively. In conclusion, student-led clinics and ePRO monitoring were well accepted, accelerated diagnostic workup and treatment in patients with axSpA.
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  • 文章类型: Journal Article
    目的:轴性脊柱关节炎(axSpA)的延迟诊断已得到充分证实;对于非放射学axSpA(nr-axSpA)的美国患者的诊断过程和障碍知之甚少。假设障碍是变化的,并且在医疗保健提供者(HCP)和患者级别都存在。这项研究旨在了解美国患者的经历和延迟nr-axSpA诊断的原因。
    方法:对风湿病学家诊断为nr-axSpA的成年人进行访谈,通过美国脊柱炎协会外展和患者小组招募,和风湿病学家,探索诊断旅程和诊断障碍。在一项在线患者调查中进一步探讨了新兴主题。多元逻辑回归分析评估了主要结果变量,影响nr-axSpA诊断时间的因素。
    结果:对25名患者和16名风湿病专家进行了访谈。来自186名合格患者的调查答复显示,从症状发作到诊断nr-axSpA的中位时间为3.25年。对于农村地区的妇女和人民来说,延迟诊断的可能性更大。大多数患者在风湿病学家之前咨询了≥4种不同类型的HCP,在诊断之前咨询了≥2位风湿病学家。及时诊断的障碍包括隐匿的慢性疼痛;归因于活动的偶发性症状模式;需要医疗咨询的慢性腰s背痛以外的症状;以及HCP对nr-axSpA的不熟悉和误解,放射科医生,和风湿病学家。
    结论:nr-axSpA诊断延迟是常见的,并反映了HCP知识空白和频繁的患者表现为主要的非轴向症状。有针对性的HCP教育,对早期疾病模式的研究,需要对更广泛的nr-axSpA表现敏感的干预措施来提高及时诊断。要点•患有nr-axSpA的患者通常会看到多种类型的HCP,和多个风湿病学家,在接受诊断之前。•患者和HCP都不熟悉nr-axSpA及其症状,缺乏了解nr-axSpA可以发生在年轻人身上,女性,以及那些表现出正常X射线的人。•非风湿病HCPs的疾病识别是早期转诊的关键。•关于基本特征的教育,流行病学,负担,对于通常治疗背痛的HCP,及时诊断nr-axSpA的益处是必要的。
    OBJECTIVE: Delayed diagnosis of axial spondyloarthritis (axSpA) is well documented; little is known about the diagnostic journey and impediments for US patients with nonradiographic axSpA (nr-axSpA). It is hypothesized that impediments are varied and exist at both the healthcare provider (HCP) and patient levels. This study aims to understand patient experiences and contributors to delayed nr-axSpA diagnosis in the USA.
    METHODS: Interviews of adults with rheumatologist-diagnosed nr-axSpA, recruited through Spondylitis Association of America outreach and patient panels, and of rheumatologists, explored the diagnostic journey and diagnostic barriers. Emerging themes were further explored in an online patient survey. A multiple logistic regression analysis evaluated the main outcome variable, factors affecting time to nr-axSpA diagnosis.
    RESULTS: Interviews were conducted with 25 patients and 16 rheumatologists. Survey responses from 186 eligible patients revealed median time from symptom onset to diagnosis of nr-axSpA was 3.25 years. Delayed diagnosis was significantly more likely for women and people in rural areas. Most patients consulted ≥4 different types of HCPs before a rheumatologist and ≥2 rheumatologists before diagnosis. Impediments to timely diagnosis included insidious chronic pain; episodic symptom patterns attributed to activity; symptoms other than chronic lumbosacral back pain requiring medical consultation; and unfamiliarity with and misperceptions about nr-axSpA among HCPs, radiologists, and rheumatologists.
    CONCLUSIONS: Delayed nr-axSpA diagnosis is common and reflects HCP knowledge gaps and frequent patient presentation with dominant nonaxial symptoms. Targeted HCP education, research into early disease patterns, and interventions sensitive to the broader spectrum of nr-axSpA manifestations are needed to improve timely diagnosis. Key Points • Patients with nr-axSpA often see multiple types of HCPs, and multiple rheumatologists, before receiving a diagnosis. • Both patients and HCPs are unfamiliar with nr-axSpA and its symptoms, lacking understanding that nr-axSpA can occur in young people, females, and those presenting with normal x-rays. • Disease recognition by nonrheumatology HCPs is key for early referral. • Education on cardinal features, epidemiology, burden, and benefits of timely nr-axSpA diagnosis is warranted for HCPs who commonly manage back pain.
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  • 文章类型: Journal Article
    T1加权被破坏的3D梯度被召回的回波脉冲序列,以体积加速柔性MRI(LAVA-Flex)的肝脏采集为例,是目前用于检测骶髂关节侵蚀(SIJ)的优选MR序列。然而,最近报道了零回波时间MRI(ZTE)提供皮质骨的极好的可视化。
    为了直接比较ZTE和LAVA-Flex在检测SIJ的结构性病变方面的诊断准确性,包括侵蚀,硬化和关节空间的变化。
    两位读者独立回顾了LDCT,ZTE和LAVA-Flex对53例诊断为axSpA患者的图像进行了评分,硬化和关节空间的变化。灵敏度,计算了ZTE和LAVA-Flex的特异性和Cohen\sκ(κ),而McNemar检验用于比较两个序列检测结构性病变的阳性。
    对诊断准确性的分析表明,与LAVA-Flex相比,ZTE在描绘侵蚀方面的灵敏度更高(92.5%vs81.5%,p<0.001),尤其是一级侵蚀(p<0.001)和二级侵蚀(p<0.001),以及硬化症(90.6%和71.2%,p<0.001),但没有关节空间变化(95.2%对93.8%,p=0.332)。与ldCT的一致性在中兴通讯的侵蚀检测中也高于LAVA-Flex,如κ值所示(0.73vs0.47),以及在硬化的检测(0.92vs0.22)。
    以ldCT为参考标准,ZTE可以提高疑似axSpA患者的SIJ糜烂和硬化的诊断准确性,与LAVA-Flex相比。
    T1-weighted spoiled 3D Gradient Recalled Echo pulse sequences, exemplified by Liver Acquisition with Volume Acceleration-flexible MRI (LAVA-Flex), are currently the preferred MR sequence for detecting erosions of the sacroiliac joint (SIJ). However, zero echo time MRI (ZTE) is recently reported to provide excellent visualization of the cortical bone.
    To directly compare the diagnostic accuracy of ZTE and LAVA-Flex in the detection of structural lesions of the SIJ, including erosions, sclerosis and joint space changes.
    Two readers independently reviewed the ldCT, ZTE and LAVA-Flex images of 53 patients diagnosed as axSpA and scored the erosions, sclerosis and joint space changes. Sensitivity, specificity and Cohen\'s kappa (κ) of ZTE and LAVA-Flex were calculated, while McNemar\'s test was employed to compare the two sequences for the positivity of detecting the structural lesions.
    Analysis of diagnostic accuracy showed a higher sensitivity of ZTE in comparison with LAVA-Flex in the depiction of erosions (92.5% vs 81.5%, p<0.001), especially first-degree erosions (p<0.001) and second-degree erosions (p<0.001), as well as sclerosis (90.6% vs 71.2%, p<0.001), but not joint space changes (95.2% vs 93.8%, p=0.332). Agreement with ldCT was also higher in ZTE in the detection of erosions than LAVA-Flex as indicated by the κ values (0.73 vs 0.47), as well as in the detection of sclerosis (0.92 vs 0.22).
    With ldCT as the reference standard, ZTE could improve diagnostic accuracy of erosions and sclerosis of the SIJ in patients suspected of axSpA, in comparison with LAVA-Flex.
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  • 文章类型: Journal Article
    背景:睡眠障碍,疼痛,和疲劳是轴性脊柱关节炎(axSpA)的主要症状/影响。三个定制的患者报告结果测量信息系统(PROMIS®)简短表格(睡眠障碍,疼痛干扰,和疲劳)已被提议用于axSpA以评估这些关键疾病概念。本研究旨在进一步了解axSpA的患者体验,并评估三种定制的PROMIS®ShortForms的内容有效性,以支持其在axSpA临床试验中的使用。
    方法:非介入,横截面,定性(概念启发[CE]和认知汇报[CD])研究。参与者参加了90分钟的电话采访。CE部分使用开放式问题来引出有关axSpA症状和影响的信息。CD部分涉及“大声思考”练习,参与者宣读每个指令,item,和定制的PROMIS®简短表单的响应选项,并分享了他们的反馈。与会者还讨论了项目的相关性,响应选项和召回期。逐字访谈笔录要经过主题和内容分析。
    结果:总计,有28名参与者(非放射学axSpA,n=12;强直性脊柱炎,n=16),来自美国(n=20)和德国(n=8)。平均年龄52.8岁,57%为男性;自诊断以来的平均时间为9.5年。CE部分确定了以axSpA为特征的12种不同症状:疼痛,睡眠问题,疲劳/疲倦,刚度,肿胀,视力/眼睛问题,限制身体运动,头痛/偏头痛,痉挛,姿势/身材的变化,平衡/协调问题,和麻木。疼痛,睡眠问题,≥90%的参与者经历了疲劳/疲劳,同时发生并使彼此恶化。参与者报告axSpA影响了他们的生活,涉及健康相关生活质量(HRQoL)的六个领域:身体功能(100%),情绪健康(89%),工作/志愿服务(79%),社会功能(75%),日常生活活动(61%)和认知功能(54%)。影响最常见的是疼痛,刚度,和疲劳。CD显示PROMIS®仪器在概念上是全面的,并且很好理解,所有项目与≥50%的参与者相关。
    结论:疼痛,睡眠问题和疲劳是axSpA的主要症状,并与HRQoL影响相关.这些结果用于更新axSpA的概念模型,该模型最初是基于有针对性的文献综述而开发的。确认了定制的PROMIS®简短表单的可解释性和内容有效性,每个人都被认为充分评估了与axSpA相关的关键影响,使它们适用于axSpA临床试验。
    Sleep disturbance, pain, and fatigue are key symptoms/impacts of axial spondyloarthritis (axSpA). Three customized Patient-Reported Outcomes Measurement Information System (PROMIS®) Short Forms (Sleep Disturbance, Pain Interference, and Fatigue) have been proposed for use in axSpA to assess these key disease concepts. This study was designed to further understand the patient experience of axSpA and evaluate the content validity of the three customized PROMIS® Short Forms to support their use in axSpA clinical trials.
    Non-interventional, cross-sectional, qualitative (concept elicitation [CE] and cognitive debriefing [CD]) study. Participants took part in 90-min telephone interviews. The CE section used open-ended questions to elicit information about axSpA symptoms and impacts. The CD section involved a \'think-aloud\' exercise where participants read out each instruction, item, and response option for the customized PROMIS® Short Forms and shared their feedback. Participants also discussed the relevance of the items, response options and recall period. Verbatim interview transcripts were subject to thematic and content analysis.
    In total, there were 28 participants (non-radiographic axSpA, n = 12; ankylosing spondylitis, n = 16), from the US (n = 20) and Germany (n = 8). Mean age was 52.8 years, and 57% were male; mean time since diagnosis was 9.5 years. The CE section identified 12 distinct symptoms that characterized axSpA: pain, sleep problems, fatigue/tiredness, stiffness, swelling, vision/eye issues, restricted body movements, headache/migraine, spasms, change in posture/stature, balance/coordination problems, and numbness. Pain, sleep problems, and fatigue/tiredness were experienced by ≥ 90% of participants, occurring simultaneously and exacerbating one another. Participants reported axSpA impacted their lives across six domains of health-related quality of life (HRQoL): physical functioning (100%), emotional wellbeing (89%), work/volunteering (79%), social functioning (75%), activities of daily living (61%) and cognitive functioning (54%). Impacts were most frequently associated with pain, stiffness, and fatigue. CD showed the PROMIS® instruments were conceptually comprehensive and well understood, with all items relevant to ≥ 50% of participants.
    Pain, sleep problems and fatigue are pivotal symptoms of axSpA and associated with HRQoL impacts. These results were used to update a conceptual model of axSpA which was originally developed based on a targeted literature review. Interpretability and content validity of the customized PROMIS® Short Forms were confirmed, with each deemed to adequately assess key impacts associated with axSpA, making them suitable for use in axSpA clinical trials.
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