Assessing Pain by the painDETECT Questionnaire (PDQ) to Evaluate Drug Retention in Patients With Inflammatory Arthritis: A Danish Nationwide Prospective DANBIO Registry Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 7,056
- 主要终点
- Differences in bDMARDs drug retention rates
研究概览
简要总结
Prospective cohort study using drug survival rates to assess the predictive value of the PDQ when used to classify patients into a non-neuropathic pain phenotype group (score <13) or a neuropathic pain phenotype group (score ≥13)
详细描述
The original painDETECT questionnaire (PDQ) DANBIO study was a survey among all DANBIO users having an arthritis diagnosis 'Pain and pain mechanisms in patients with inflammatory arthritis: A Danish nationwide cross-sectional DANBIO registry survey'. The PDQ was implemented onto the DANBIO touch screens for a period of 6 months in 2013-14 and data from more than 7000 individual patients were collected. The overall background for the study was that central pain mechanisms may be prominent in subsets of patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and other spondyloarthritis (SpA). The study showed that approximately 50 % of patients experienced significant pain levels and that a high PDQ score was associated with higher levels of pain and DAS28 but not with markers of inflammatory activity such as CRP and swollen joint count. Furthermore, indications of more frequent bio-switch in the PDQ groups showing neuropathic pain features were found.
The aim of this study is to examine the association between drug retention of biological DMARDs (bDMARDs) and the PDQ pain classification categories (i.e. non-neuropathic vs. neuropathic features) and to investigate whether this categorization is predictive of drug retention and changes in clinical outcomes over a 5-year period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Registered in DANBIO
- •Having inflammatory arthritis (Specific diagnoses include RA, PsA and other SpA)
- •At time of the PDQ assessment and up to 4 months thereafter being on ongoing bDMARDs treatment or on switch of bDMARD treatment.
排除标准
- •Missing answer to PDQ
研究组 & 干预措施
Non-Neuropathic pain phenotype
Based on the PainDETECT Questionnaire (PDQ), patients scoring <13 will be classified as "exposed" as they are considered a group with non-neuropathic pain (Non-neuropathic pain phenotype)
干预措施: bDMARDS (Drug)
Neuropathic pain phenotype
Based on the PainDETECT Questionnaire (PDQ), patients scoring ≥13 will be classified as "un-exposed" as they are considered a group with neuropathic pain (neuropathic pain phenotype)
干预措施: bDMARDS (Drug)
结局指标
主要结局
Differences in bDMARDs drug retention rates
时间窗: From baseline to 5 years followup
Drug retention rates will be described using Kapan-Mayer curves. Differences in changes in bDMARDs drug retention rates over 5 years between patients with a non-neuropathic phenotype and patients with a neuropathic pain phenotype based on the PainDETECT Questionnaire.
次要结局
- Differences in TenderJoint Count (TJC, 0-28)(From baseline to 5 years followup)
- Differences in Doctors' global assessment (VAS 0-100 mm.)(From baseline to 5 years followup)
- Differences in VAS fatigue (0-100 mm) (Higher indicates more fatigue)(From baseline to 5 years followup)
- Differences in HAQ (0-3) (higher indicates a more impaired functional level)(From baseline to 5 years followup)
- The prognostic value of pain phenotype classification by PainDETECT (PDQ) on number of bioswitches.(Measured at baseline)
- The prognostic value of pain phenotype classification by PainDETECT (PDQ) on Doctors' global assessment (VAS: 0-100 mm)(Measured at baseline)
- Differences in Patient acceptable symptom state (Pass)(From baseline to 5 years followup)
- Differences in Swollen Joint Count (SJC, 0-28)(From baseline to 5 years followup)
- The prognostic value of pain phenotype classification by PainDETECT (PDQ) on RA diagnosis.(Measured at baseline)
- The prognostic value of pain phenotype classification by PainDETECT (PDQ) on PsA diagnosis.(Measured at baseline)
- The prognostic value of pain phenotype classification by PainDETECT (PDQ) on Patient acceptable symptom score (PASS (y/n))(Measured at baseline)
- The prognostic value of pain phenotype classification by PainDETECT (PDQ) on VAS pain (0-100 mm)(Measured at baseline)
- Differences in VAS pain (0-100 mm) (Higher indicates more pain)(From baseline to 5 years followup)
- Differences in VAS global (0-100 mm) (Higher indicates more global disease activity)(From baseline to 5 years followup)
- The prognostic value of pain phenotype classification by PainDETECT (PDQ) on PASS (y/n)(Measured at baseline)
- The prognostic value of pain phenotype classification by PainDETECT (PDQ) on VAS fatigue (0-100 mm)(Measured at baseline)
- The prognostic value of pain phenotype classification by PainDETECT (PDQ) on the Health assessment questionnaire (HAQ (0-3))(Measured at baseline)
- Differences in CRP (mg/L)(From baseline to 5 years followup)
- The prognostic value of pain phenotype classification by PainDETECT (PDQ) on SpA diagnosis.(Measured at baseline)
- The prognostic value of pain phenotype classification by PainDETECT (PDQ) on Swollen Joint Count (SJC, 0-28)(Measured at baseline)
- The prognostic value of pain phenotype classification by PainDETECT (PDQ) on VAS global (0-100 mm)(Measured at baseline)
- The prognostic value of pain phenotype classification by PainDETECT (PDQ) on TenderJoint Count (TJC, 0-28)(Measured at baseline)
- The prognostic value of pain phenotype classification by PainDETECT (PDQ) on C- reactive protein (CRP (mg/L))(Measured at baseline)
研究者
Elisabeth Ginnerup-Nielsen
Post doctoral researcher
University Hospital Bispebjerg and Frederiksberg