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)
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.
Study Type
OBSERVATIONAL
Enrollment
7,056
Patients at time of the PDQ assessment and up to 4 months thereafter being on ongoing bDMARDs treatment or on switch of bDMARD treatment.
Differences in bDMARDs drug retention rates
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.
Time frame: From baseline to 5 years followup
Differences in Patient acceptable symptom state (Pass)
Differences in changes in patients having an acceptable symptom state at 5 years follow-up between patients with a non-neuropathic phenotype and patients with a neuropathic pain phenotype based on the PainDETECT Questionnaire. The PASS is defined as the highest symptom level below which a patient considers his/her symptom state as acceptable. it is answered via a yes or a no.
Time frame: From baseline to 5 years followup
Differences in Swollen Joint Count (SJC, 0-28)
Differences in changes in SJC 0-28 at 5 years follow-up between patients with a non-neuropathic phenotype and patients with a neuropathic pain phenotype based on the PainDETECT Questionnaire.
Time frame: From baseline to 5 years followup
Differences in TenderJoint Count (TJC, 0-28)
Differences in changes in TJC 0-28 at 5 years follow-up between patients with a non-neuropathic phenotype and patients with a neuropathic pain phenotype based on the PainDETECT Questionnaire.
Time frame: From baseline to 5 years followup
Differences in Doctors' global assessment (VAS 0-100 mm.)
Differences in changes in Doctors' global assessment 0-100 at 5 years follow-up between patients with a non-neuropathic phenotype and patients with a neuropathic pain phenotype based on the PainDETECT Questionnaire.
Time frame: From baseline to 5 years followup
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Differences in VAS pain (0-100 mm) (Higher indicates more pain)
Differences in changes in VAS pain (0-100 mm) at 5 years follow-up between patients with a non-neuropathic phenotype and patients with a neuropathic pain phenotype based on the PainDETECT Questionnaire.
Time frame: From baseline to 5 years followup
Differences in VAS fatigue (0-100 mm) (Higher indicates more fatigue)
Differences in changes in VAS fatigue (0-100 mm) at 5 years follow-up between patients with a non-neuropathic phenotype and patients with a neuropathic pain phenotype based on the PainDETECT Questionnaire.
Time frame: From baseline to 5 years followup
Differences in VAS global (0-100 mm) (Higher indicates more global disease activity)
Differences in changes in VAS global (0-100 mm) at 5 years follow-up between patients with a non-neuropathic phenotype and patients with a neuropathic pain phenotype based on the PainDETECT Questionnaire.
Time frame: From baseline to 5 years followup
Differences in HAQ (0-3) (higher indicates a more impaired functional level)
Differences in changes in HAQ (0-3) at 5 years follow-up between patients with a non-neuropathic phenotype and patients with a neuropathic pain phenotype based on the PainDETECT Questionnaire. 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section, i.e. if one question is scored 1 and another 2, then the score for the section is 2. In addition, if an aide or device is used or if help is required from another individual, then the minimum score for that section is 2. If the section score is already 2 or more then no modification is made. The 8 scores of the 8 sections are summed and divided by 8. The result is the DI disability index index. In the event that one section is not completed by a subject then the summed score would be divided by 7.
Time frame: From baseline to 5 years followup
Differences in CRP (mg/L)
Differences in changes in CRP (mg/L) at 5 years follow-up between patients with a non-neuropathic phenotype and patients with a neuropathic pain phenotype based on the PainDETECT Questionnaire.
Time frame: From baseline to 5 years followup
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on RA diagnosis.
The probability of having an RA diagnosis when having a non-neuropathic pain phenotype.
Time frame: Measured at baseline
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on PsA diagnosis.
The probability of having an PsA diagnosis when having a non-neuropathic pain phenotype.
Time frame: Measured at baseline
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on SpA diagnosis.
The probability of having an SpA diagnosis when having a non-neuropathic pain phenotype.
Time frame: Measured at baseline
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on number of bioswitches.
The probability of having bioswitches when having a non-neuropathic pain phenotype.
Time frame: Measured at baseline
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on Swollen Joint Count (SJC, 0-28)
The probability of having less swollen joints on the SJC 0-28 when having a non-neuropathic pain phenotype.
Time frame: Measured at baseline
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on TenderJoint Count (TJC, 0-28)
The probability of having less tender joints on the TJC 0-28 when having a non-neuropathic pain phenotype.
Time frame: Measured at baseline
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on Doctors' global assessment (VAS: 0-100 mm)
The probability of having a favourable score on Doctors' global assessment (VAS: 0-100 mm) when having a non-neuropathic pain phenotype.
Time frame: Measured at baseline
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on PASS (y/n)
The probability of having an acceptable symptom state (PASS) when having a non-neuropathic pain phenotype.
Time frame: Measured at baseline
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on Patient acceptable symptom score (PASS (y/n))
The probability of having a favourable score on Patient acceptable symptom score (PASS) (yes/no) when having a non-neuropathic pain phenotype.
Time frame: Measured at baseline
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on VAS pain (0-100 mm)
The probability of having a favourable score on VAS pain (0-100 mm) when having a non-neuropathic pain phenotype.
Time frame: Measured at baseline
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on VAS fatigue (0-100 mm)
The probability of having a favourable score on VAS fatigue (0-100 mm) when having a non-neuropathic pain phenotype.
Time frame: Measured at baseline
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on VAS global (0-100 mm)
The probability of having a favourable score on VAS global (0-100 mm) when having a non-neuropathic pain phenotype.
Time frame: Measured at baseline
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on the Health assessment questionnaire (HAQ (0-3))
The probability of having a favourable score on HAQ (0-3 mm) when having a non-neuropathic pain phenotype.
Time frame: Measured at baseline
The prognostic value of pain phenotype classification by PainDETECT (PDQ) on C- reactive protein (CRP (mg/L))
The probability of having a favourable CRP when having a non-neuropathic pain phenotype.
Time frame: Measured at baseline