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  ["project_title"]=>
  string(108) "Assessment of peripheral arthritis and related disease activity measurement instruments in spondyloarthritis"
  ["project_narrative_summary"]=>
  string(655) "Currently the recommended instruments for the assessment of disease activity due to peripheral arthritis in axial spondyloarthritis (axSpA) is the number of swollen joint from the 44-joint count (SJC44).

Nevertheless, no composite score was formally assessed in axSpA or peripheral SpA (pSpA)

The aim of the project is to compare the psychometric properties (construct validity and discrimination) of different measurement instruments to assess disease activity due to peripheral arthritis in patients with SpA (either axSpA or pSpA), with the aim of selecting the most adequate and best performing measurement instrument to be recommended. "
  ["project_learn_source"]=>
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    ["first_name"]=>
    string(6) "Dafne "
    ["last_name"]=>
    string(10) "Capelusnik"
    ["degree"]=>
    string(2) "MD"
    ["primary_affiliation"]=>
    string(70) "Care and Public Health Research Institute, Maastricht, The Netherlands"
    ["email"]=>
    string(25) "capelusnikdafne@gmail.com"
    ["state_or_province"]=>
    string(10) "Maastricht"
    ["country"]=>
    string(15) "The Netherlands"
  }
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      ["p_pers_f_name"]=>
      string(6) "Sofia "
      ["p_pers_l_name"]=>
      string(6) "Ramiro"
      ["p_pers_degree"]=>
      string(7) "MD, PhD"
      ["p_pers_pr_affil"]=>
      string(85) "Department of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands"
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      ["requires_data_access"]=>
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      ["p_pers_f_name"]=>
      string(5) "Anna "
      ["p_pers_l_name"]=>
      string(5) "Molto"
      ["p_pers_degree"]=>
      string(7) "MD, PhD"
      ["p_pers_pr_affil"]=>
      string(62) "3Rheumatology Department, Hospital Cochin, APHP, Paris, France"
      ["p_pers_scop_id"]=>
      string(0) ""
      ["requires_data_access"]=>
      string(2) "no"
    }
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      ["p_pers_f_name"]=>
      string(10) "Clementina"
      ["p_pers_l_name"]=>
      string(12) "Lopez Medina"
      ["p_pers_degree"]=>
      string(5) "Prof."
      ["p_pers_pr_affil"]=>
      string(61) "Rheumatology, Reina Sofia University Hospital, Cordoba, Spain"
      ["p_pers_scop_id"]=>
      string(0) ""
      ["requires_data_access"]=>
      string(2) "no"
    }
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  ["project_ext_grants"]=>
  array(2) {
    ["value"]=>
    string(3) "yes"
    ["label"]=>
    string(65) "External grants or funds are being used to support this research."
  }
  ["project_date_type"]=>
  string(18) "full_crs_supp_docs"
  ["property_scientific_abstract"]=>
  string(1581) "Background. Spondyloarthritis (SpA) is a chronic disease that can present in different physical and clinical forms such as axial SpA (axSpA) which mainly presents as back pain, or peripheral SpA (pSpA) which is characterized by inflammation and pain in joints located outside the spine. 

Currently the recommended instrument for the peripheral arthritis assessment is the 44-count of swollen joints (SJC44). 

Objective. To compare the psychometric properties (construct validity and discrimination) of different measurement instruments to assess disease activity due to peripheral arthritis in patients with spondyloarthritis (either axSpA or pSpA), with the aim of selecting the most adequate and best performing measurement instrument to be endorsed by Assessment of SpondyloArthritis International Society (ASAS).  

Study design. Measurement properties to be assessed for disease activity measurement instruments: Construct validity -  hypotheses for strength of correlation between the assessed instrument and other instruments assessing disease domains and discriminatory capacity between known groups; Discrimination – Test-retest reliability, longitudinal construct validity and discrimination in clinical trials.

Participants. axSpA and pSpA

Primary and secondary Outcomes: SJC and Tender joint count (TJC)44, SJC66, TJC68, PGA, CRP, DAS28, DAS44, BASDAI, ASDAS, DAPSA, SDAI, CDAI.

Statistical analyses: Spearman correlation,  standardised mean difference (SMD), Guyatt's effect size (ES), standardized responsiveness mean (SRM)."
  ["project_brief_bg"]=>
  string(3205) "Spondyloarthritis (SpA) is a chronic disease in which the spine and other areas of the body become inflamed. SpA can present in different physical and clinical forms such as axial SpA (axSpA) which mainly presents as back pain, or peripheral SpA (pSpA) which is characterized by inflammation and pain in joints located outside the spine. 

A clinician’s instrument called the ASAS-OMERACT core outcome set (The Assessment of Spondylarthritis international Society-Outcomes Measures in Rheumatology core outcome set (COS)) has recently been updated to allow it to be used to assess axSpA, however for pSpA the 44-swollen joint count (SJC44), which looks at 44 joints in the body to assess swelling, was chosen as the preferred instrument recommended for use in clinical trials, but no combination of scoring systems were assessed in that project. 

Although scarce, there is some evidence of the good performance of composite scores when assessing disease activity in the pSpA population. For example, in a study addressing the sensitivity to change and discriminatory aspects of different measurement instruments, the combination of Axial Spondyloarthritis Disease Activity (ASDAS), Bath Ankylosing Spondylitis Disease Index (BASDAI), patient global assessment (PGA), and physician global assessment (PhGA) had the highest performance, whereas the SJC, tender joint count (TJC) and C-reactive protein (CRP) performance was not good enough. In another attempt at assessing the validity of measurement instruments in pSpA, good performance was found for the Disease Activity Index for Psoriatic Arthritis (DAPSA), Psoriatic Arthritis (PsA) Disease Activity Score (PASDAS) and Ankylosing spondylitis disease activity score (ASDAS), although the agreement among the three instruments when classifying disease activity states was not sufficient. This finding emphasized the need of further analysis of the existing thresholds of those instruments in pSpA.

Recently, a study was conducted, called ASAS-perSpA, which included patients with axSpA, pSpA and PsA, and the validity of several measurement instruments was assessed, including the SJC, but also different composite scores validated for SpA and even in other inflammatory diseases such as the Disease Activity Score (DAS) 28 and 44. Results from this analysis showed that composite scores including joint counts have superior construct by discriminating better between active/inactive patients. Simultaneously, the psychometric properties of 9 measurement instruments were assessed in the CRESPA trial. In this study, conducted in patients with pSpA, both the ASDAS and DAPSA showed good validity and clinical trial discrimination.

The aim of this study is to compare the construct validity (the degree to which an outcome measure measures the construct it purports to measure) and discrimination (capacity to discriminate between different groups and scenarios) of different measurement instruments to assess disease activity due to peripheral arthritis in patients with spondyloarthritis (either axSpA or pSpA), with the aim of selecting the most adequate and best performing measurement instrument to be endorsed by ASAS. "
  ["project_specific_aims"]=>
  string(292) "To compare the psychometric properties of different measurement instruments to assess disease activity due to peripheral arthritis in patients with spondyloarthritis (either axSpA or pSpA), with the aim of selecting the most adequate and best performing measurement instrument to recommended."
  ["project_study_design"]=>
  array(2) {
    ["value"]=>
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    ["label"]=>
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  }
  ["project_purposes"]=>
  array(1) {
    [0]=>
    array(2) {
      ["value"]=>
      string(5) "other"
      ["label"]=>
      string(5) "Other"
    }
  }
  ["project_purposes_exp"]=>
  string(340) "To compare the psychometric properties -construct validity and discrimination- of different measurement instruments to assess disease activity due to peripheral arthritis in patients with spondyloarthritis (either axSpA or pSpA), with the aim of selecting the most adequate and best performing measurement instrument to be endorsed by ASAS."
  ["project_research_methods"]=>
  string(512) "All axSpA and pSpA patients from RCTs without missing data will be included in the analysis. There will be none exclusion criteria. 

Besides the Janssen trials requested in this platform the following RCTs were requested in Vivli: 

NCT01064856, NCT03178487, NCT02696785, NCT02696798, NCT02757352, NCT01258738, NCT00247962, NCT03502616, NCT02552212, NCT01087762, NCT00195819, NCT00085644, NCT00939003. 

We would like to perform the analyses of all the studies together in the Vivli platform. "
  ["project_main_outcome_measure"]=>
  string(601) "The candidate disease activity measurement instruments to be assessed in the domain peripheral (articular) manifestations will be: Swollen joint count (SJC) with 66 and with 44 joints (SJC66 and SJC44), Disease Activity Score-28 for Rheumatoid Arthritis (DAS28), Disease Activity Score-44 for Rheumatoid Arthritis (DAS44), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Ankylosing Spondylitis Disease Activity Score (ASDAS), Disease Activity in PSoriatic Arthritis (DAPSA), Simplify Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), C-reactive protein (CRP).

"
  ["project_main_predictor_indep"]=>
  string(881) "Construct validity:

-Construct validity will be considered as “good” if ≥75% of the hypotheses are confirmed; “adequate” if 50-75% of the hypotheses are confirmed; or poor, if <50% of the hypotheses are confirmed, as recommended by the Outcome Measures in Rheumatology (OMERACT) Handbook and the core outcome set (COS) exercise. The correlation cut-offs used will be: weak <0.30, moderate 0.30 to 0.69 and strong ≥0.70. For discrimination between known-groups, a SMD above 0.8 will be considered as ‘good’.(3)

Discrimination: 

-For longitudinal construct validity, a Guyatt's effect size (ES), standardized responsiveness mean (SRM) and ES ≥0.8 will be considered as good performance; ≥0.5 and <0.75 adequate performance and <0.5 poor performance. The same cut-off points will be used for the Clinical trial discrimination."
  ["project_other_variables_interest"]=>
  string(219) "For the calculation of some of the composite scores (mainly DAPSA, DAS28/44, SDAI, CDAI) we will need the following variables:



Physician global assessment

Peripheral pain (and/or BASDAI Question 3)"
  ["project_stat_analysis_plan"]=>
  string(2604) "Construct validity - To assess construct validity, hypotheses for strength of correlation between the assessed instrument and other instruments assessing disease domains (other than disease activity, i.e. BASFI, ASAS HI, ASQoL and EuroQoL) will be used. The hypotheses will be derived from the ASAS-perSpA ancillary analysis (Capelusnik, 2024) where they were previously defined by the working group. The Spearman correlation coefficients will be estimated.

Additionally, as part of the “hypothesis testing” from the construct validity, the mean (SD) and discriminatory capacity between known groups (i.e. active/inactive disease defined based on existing constructs, e.g. PGA, SJC, combination of both) will be also calculated through the standardised mean difference (SMD). The SMD represents the difference between the group means divided by the pooled standard deviation (SD). It is unitless, representing the higher value, the higher discriminatory capacity. 



Discrimination – For the Test-retest reliability analysis, to assess how much day-to-day variability there is in the score in a situation when the patients should not be changing, screening and baseline data from randomized controlled trials (RCTs) will be used to calculate the Intraclass correlation coefficient (ICC) (two-way random effect model with absolute agreement, which is designed to deal with paired data-same people, two measures over time-). Bland and Altman plots will be created for each instrument to assess mean difference and 95% limits of agreement and to evaluate homoscedasticity. Measurement error as a measure of the scale will be assessed by analysing the smallest detectable change (SDC) based on the 95% limits of agreement. 

For the Responsiveness analysis (Longitudinal construct validity), to assess to what extent the instruments can detect changes in the domain of interest over time (can measure change accurately) the Guyatt’s effect size (ES) and the standardized response mean (SRM) will be calculated using data from RCTs (from baseline to the timing of the primary endpoint). 

For the Discrimination in Clinical Trials, to assess the degree to which the instruments are sensitive to the related change between the arms of a trial (i.e., a comparative effectiveness study or a placebo-controlled trial, or active comparison arm), the standardised mean difference (SMD) will be calculated using data from RCTs. 



We are not aiming at pooling the different studies, but simply at analysing them separately. 

Missing data will be excluded. "
  ["project_software_used"]=>
  array(2) {
    ["value"]=>
    string(5) "stata"
    ["label"]=>
    string(5) "STATA"
  }
  ["project_timeline"]=>
  string(298) "Target Analysis Start Date 2/1/25

Estimated Analysis Completion Date 10/30/25

Presentation in the ASAS community: 01/15/2026

Date manuscript drafted: 03/01/2026

First submitted for publication: 06/01/2026

Date results reported back to the YODA Project: 06/01/2026"
  ["project_dissemination_plan"]=>
  string(156) "Submission to the American Congress of Rheumatology, the EULAR (European Congress of Rheumatology), and Publication on a high-impact Rheumatology Journal.  "
  ["project_bibliography"]=>
  string(791) "
Navarro-Compán V, Boel A, Boonen A, Mease PJ, Dougados M, et al. Instrument selection for the ASAS core outcome set for axial spondyloarthritis. Ann Rheum Dis. 2023 Jun;82(6):763-772. doi: 10.1136/annrheumdis-2022-222747. Epub 2022 Jun 9. PMID: 35680390.

Turina MC, Ramiro S, Baeten DL, Mease P, Paramarta JE, et al. A psychometric analysis of outcome measures in peripheral spondyloarthritis. Ann Rheum Dis. 2016 Jul;75(7):1302-7. doi: 10.1136/annrheumdis-2014-207235. Epub 2015 Aug 5. PMID: 26245756; PMCID: PMC4941177.

Beckers E, Been M, Webers C, Boonen A, Ten Klooster PM, et al. Performance of 3 Composite Measures for Disease Activity in Peripheral Spondyloarthritis. J Rheumatol. 2022 Mar;49(3):256-264. doi: 10.3899/jrheum.210075. Epub 2021 Sep 1. PMID: 34470791.
"
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Navarro-Compán V, Boel A, Boonen A, Mease PJ, Dougados M, et al. Instrument selection for the ASAS core outcome set for axial spondyloarthritis. Ann Rheum Dis. 2023 Jun;82(6):763-772. doi: 10.1136/annrheumdis-2022-222747. Epub 2022 Jun 9. PMID: 35680390.

Turina MC, Ramiro S, Baeten DL, Mease P, Paramarta JE, et al. A psychometric analysis of outcome measures in peripheral spondyloarthritis. Ann Rheum Dis. 2016 Jul;75(7):1302-7. doi: 10.1136/annrheumdis-2014-207235. Epub 2015 Aug 5. PMID: 26245756; PMCID: PMC4941177.

Beckers E, Been M, Webers C, Boonen A, Ten Klooster PM, et al. Performance of 3 Composite Measures for Disease Activity in Peripheral Spondyloarthritis. J Rheumatol. 2022 Mar;49(3):256-264. doi: 10.3899/jrheum.210075. Epub 2021 Sep 1. PMID: 34470791.