PMID- 31867564
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220412
IS  - 2520-1026 (Electronic)
IS  - 2520-1026 (Linking)
VI  - 3
DP  - 2019
TI  - Use of a "critical difference" statistical criterion improves the predictive 
      utility of the Health Assessment Questionnaire-Disability Index score in patients 
      with rheumatoid arthritis.
PG  - 51
LID - 10.1186/s41927-019-0095-2 [doi]
LID - 51
AB  - BACKGROUND: The Health Assessment Questionnaire-Disability Index (HAQ-DI) is used 
      to assess functional status in rheumatoid arthritis (RA), but the change required 
      for meaningful improvements remains unclear. A minimum clinically important 
      difference (MCID) of 0.22 is frequently used in RA trials. The aim of this study 
      was to determine a statistically defined critical difference for HAQ-DI 
      (HAQ-DI-d(crit)) and evaluate its association with therapeutic outcomes. METHODS: 
      We retrospectively analyzed data from adult German patients with RA enrolled in a 
      multicenter observational trial in which they received adalimumab therapy at the 
      decision of the treating clinician during routine clinical care. The 
      HAQ-DI-d(crit), defined as the minimum change that can be reliably discriminated 
      from random long-term variations in patients on stable therapy, was determined by 
      evaluating intra-individual variation in patient scores. Other outcomes of 
      interest included Disease Activity Score-28 joints and patient-reported pain and 
      fatigue. RESULTS: The HAQ-DI-d(crit) was calculated as an improvement (decrease) 
      from baseline of 0.68 in a discovery cohort (N = 1645) of RA patients on stable 
      therapy and with moderate disease activity (mean DAS28 [standard deviation] of 
      4.4 [1.6]). In the full patient cohort (N = 2740), 22.1% of patients achieved a 
      HAQ-DI-d(crit) improvement at month 6. Compared with patients with a small 
      improvement in HAQ-DI (decrease of >/=0.22 to < 0.68) or no improvement (< 0.22), 
      patients achieving a HAQ-DI-d(crit) at month 6 had better therapeutic outcomes at 
      months 12 and 24, including stable functional improvements. Change in pain was 
      the most important predictor of HAQ-DI improvement during the first 6 months of 
      therapy. CONCLUSIONS: A HAQ-DI-d(crit) of 0.68 is a reliable measure of 
      functional improvement. This measure may be useful in routine clinical care and 
      clinical trials. TRIAL REGISTRATION: ClinicalTrials.gov NCT01076205. Registered 
      on February 26, 2010 (retrospectively registered).
CI  - (c) The Author(s) 2019.
FAU - Behrens, Frank
AU  - Behrens F
AD  - 1Division of Rheumatology, University Hospital Frankfurt, Goethe University, 
      Frankfurt am Main, Germany. ISNI: 0000 0004 0578 8220. GRID: grid.411088.4
AD  - Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group 
      Translational Medicine & Pharmacology TMP, Frankfurt am Main, Germany.
FAU - Koehm, Michaela
AU  - Koehm M
AD  - 1Division of Rheumatology, University Hospital Frankfurt, Goethe University, 
      Frankfurt am Main, Germany. ISNI: 0000 0004 0578 8220. GRID: grid.411088.4
AD  - Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group 
      Translational Medicine & Pharmacology TMP, Frankfurt am Main, Germany.
FAU - Schwaneck, Eva C
AU  - Schwaneck EC
AD  - 3Schwerpunkt Rheumatologie/Klinische Immunologie Medizinische Klinik und 
      Poliklinik II, Universitat Wurzburg, Wurzburg, Germany. ISNI: 0000 0001 1958 
      8658. GRID: grid.8379.5
FAU - Schmalzing, Marc
AU  - Schmalzing M
AD  - 3Schwerpunkt Rheumatologie/Klinische Immunologie Medizinische Klinik und 
      Poliklinik II, Universitat Wurzburg, Wurzburg, Germany. ISNI: 0000 0001 1958 
      8658. GRID: grid.8379.5
FAU - Gnann, Holger
AU  - Gnann H
AD  - Abteilung Biostatistik, GKM Gesellschaft fur Therapieforschung mbH, Munich, 
      Germany.
FAU - Greger, Gerd
AU  - Greger G
AD  - 5AbbVie Deutschland GmbH & Co. KG, Wiesbaden, Germany. ISNI: 0000 0004 4662 2788. 
      GRID: grid.467162.0
FAU - Tony, Hans-Peter
AU  - Tony HP
AD  - 3Schwerpunkt Rheumatologie/Klinische Immunologie Medizinische Klinik und 
      Poliklinik II, Universitat Wurzburg, Wurzburg, Germany. ISNI: 0000 0001 1958 
      8658. GRID: grid.8379.5
FAU - Burkhardt, Harald
AU  - Burkhardt H
AUID- ORCID: 0000-0002-6261-3131
AD  - 1Division of Rheumatology, University Hospital Frankfurt, Goethe University, 
      Frankfurt am Main, Germany. ISNI: 0000 0004 0578 8220. GRID: grid.411088.4
AD  - Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group 
      Translational Medicine & Pharmacology TMP, Frankfurt am Main, Germany.
LA  - eng
SI  - ClinicalTrials.gov/NCT01076205
PT  - Journal Article
DEP - 20191210
PL  - England
TA  - BMC Rheumatol
JT  - BMC rheumatology
JID - 101738571
PMC - PMC6902502
OTO - NOTNLM
OT  - Adalimumab
OT  - Functional ability
OT  - Health Assessment Questionnaire
OT  - Rheumatoid arthritis
COIS- Competing interestsFB, MK, MS, ECS, HB, and H-PT received speaker's fees or 
      compensation for consultation from AbbVie. HG is a paid consultant for AbbVie and 
      GG is a former employee of AbbVie.
EDAT- 2019/12/24 06:00
MHDA- 2019/12/24 06:01
PMCR- 2019/12/10
CRDT- 2019/12/24 06:00
PHST- 2019/05/01 00:00 [received]
PHST- 2019/10/10 00:00 [accepted]
PHST- 2019/12/24 06:00 [entrez]
PHST- 2019/12/24 06:00 [pubmed]
PHST- 2019/12/24 06:01 [medline]
PHST- 2019/12/10 00:00 [pmc-release]
AID - 95 [pii]
AID - 10.1186/s41927-019-0095-2 [doi]
PST - epublish
SO  - BMC Rheumatol. 2019 Dec 10;3:51. doi: 10.1186/s41927-019-0095-2. eCollection 
      2019.