TY - JOUR
T1 - Cohort profile
T2 - The Applied Public-Private Research enabling OsteoArthritis Clinical Headway (IMI-APPROACH) study: a 2-year, European, cohort study to describe, validate and predict phenotypes of osteoarthritis using clinical, imaging and biochemical markers
AU - van Helvoort, Eefje M.
AU - van Spil, Willem E.
AU - Jansen, Mylène P.
AU - Welsing, Paco M.J.
AU - Kloppenburg, Margreet
AU - Loef, Marieke
AU - Blanco, Francisco J.
AU - Haugen, Ida K.
AU - Berenbaum, Francis
AU - Bacardit, Jaume
AU - Ladel, Christoph H.
AU - Loughlin, John
AU - Bay-Jensen, Anne C.
AU - Mobasheri, Ali
AU - Larkin, Jonathan
AU - Boere, Janneke
AU - Weinans, Harrie H.
AU - Lalande, Agnes
AU - Marijnissen, Anne C.A.
AU - Lafeber, Floris P.J.G.
N1 - Publisher Copyright:
© 2020 Author(s) (or their employer(s)).
PY - 2020/7/28
Y1 - 2020/7/28
N2 - PURPOSE: The Applied Public-Private Research enabling OsteoArthritis Clinical Headway (APPROACH) consortium intends to prospectively describe in detail, preselected patients with knee osteoarthritis (OA), using conventional and novel clinical, imaging, and biochemical markers, to support OA drug development.PARTICIPANTS: APPROACH is a prospective cohort study including 297 patients with tibiofemoral OA, according to the American College of Rheumatology classification criteria. Patients were (pre)selected from existing cohorts using machine learning models, developed on data from the CHECK cohort, to display a high likelihood of radiographic joint space width (JSW) loss and/or knee pain progression.FINDINGS TO DATE: Selection appeared logistically feasible and baseline characteristics of the cohort demonstrated an OA population with more severe disease: age 66.5 (SD 7.1) vs 68.1 (7.7) years, min-JSW 2.5 (1.3) vs 2.1 (1.0) mm and Knee injury and Osteoarthritis Outcome Score pain 31.3 (19.7) vs 17.7 (14.6), except for age, all: p<0.001, for selected versus excluded patients, respectively. Based on the selection model, this cohort has a predicted higher chance of progression.FUTURE PLANS: Patients will visit the hospital again at 6, 12 and 24 months for physical examination, pain and general health questionnaires, collection of blood and urine, MRI scans, radiographs of knees and hands, CT scan of the knee, low radiation whole-body CT, HandScan, motion analysis and performance-based tests.After two years, data will show whether those patients with the highest probabilities for progression experienced disease progression as compared to those wit lower probabilities (model validation) and whether phenotypes/endotypes can be identified and predicted to facilitate targeted drug therapy.TRIAL REGISTRATION NUMBER: NCT03883568.
AB - PURPOSE: The Applied Public-Private Research enabling OsteoArthritis Clinical Headway (APPROACH) consortium intends to prospectively describe in detail, preselected patients with knee osteoarthritis (OA), using conventional and novel clinical, imaging, and biochemical markers, to support OA drug development.PARTICIPANTS: APPROACH is a prospective cohort study including 297 patients with tibiofemoral OA, according to the American College of Rheumatology classification criteria. Patients were (pre)selected from existing cohorts using machine learning models, developed on data from the CHECK cohort, to display a high likelihood of radiographic joint space width (JSW) loss and/or knee pain progression.FINDINGS TO DATE: Selection appeared logistically feasible and baseline characteristics of the cohort demonstrated an OA population with more severe disease: age 66.5 (SD 7.1) vs 68.1 (7.7) years, min-JSW 2.5 (1.3) vs 2.1 (1.0) mm and Knee injury and Osteoarthritis Outcome Score pain 31.3 (19.7) vs 17.7 (14.6), except for age, all: p<0.001, for selected versus excluded patients, respectively. Based on the selection model, this cohort has a predicted higher chance of progression.FUTURE PLANS: Patients will visit the hospital again at 6, 12 and 24 months for physical examination, pain and general health questionnaires, collection of blood and urine, MRI scans, radiographs of knees and hands, CT scan of the knee, low radiation whole-body CT, HandScan, motion analysis and performance-based tests.After two years, data will show whether those patients with the highest probabilities for progression experienced disease progression as compared to those wit lower probabilities (model validation) and whether phenotypes/endotypes can be identified and predicted to facilitate targeted drug therapy.TRIAL REGISTRATION NUMBER: NCT03883568.
KW - protocols & guidelines
KW - qualitative research
KW - rheumatology
UR - http://www.scopus.com/inward/record.url?scp=85088881484&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2019-035101
DO - 10.1136/bmjopen-2019-035101
M3 - Article
C2 - 32723735
AN - SCOPUS:85088881484
SN - 2044-6055
VL - 10
JO - BMJ Open
JF - BMJ Open
IS - 7
M1 - e035101
ER -