Stability of fatigue, pain, patient global assessment and the Bath Ankylosing Spondylitis Functional Index (BASFI) in spondyloarthropathy patients with stable disease according to the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

Ole Rintek Madsen

doi:10.1007/s00296-017-3920-1

Stability of fatigue, pain, patient global assessment and the Bath Ankylosing Spondylitis Functional Index (BASFI) in spondyloarthropathy patients with stable disease according to the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

Ole Rintek Madsen

Department of Clinical Medicine

5 Citations (Scopus)

Abstract

The study objective was to examine natural variation of the patient-reported outcome measures fatigue, pain, patient global assessment (PaGl) and the Bath Ankylosing Spondylitis Functional Index (BASFI) in patients with stable axial spondyloarthropathy (ax-SpA) defined on the basis of the Bath Spondylitis Ankylosing Disease Activity Index (BASDAI). 107 TNF-inhibitor treated stable ax-SpA patients were identified in the Danish rheumatology registry (DANBIO). According to the Assessment of SpondyloArthritis international Society (ASAS) response criteria, stable disease was defined as a change in BASDAI < 20 between two consecutive visits. Data on BASDAI, fatigue, pain, PaGl and BASFI (0-100) from such two visits were extracted for each patient. Lower and upper 95% limits of agreement (LLoA;ULoA) and the mean of intra-individual differences (the bias) were computed for each measure. Associations were described by linear correlations and standard errors of estimation. Mean BASDAI was 35.6 ± 23.8, mean BASDAI change 0.0 ± 9.7 (range - 19 to 19) and mean inter-visit time duration 16 ± 13 weeks. LLoA;ULoA [bias] for fatigue was - 37.4;36.2 [- 0.6], for pain - 34.1;32.5 [- 0.8], for PaGl - 35.7;32.9 [- 1.4] and for BASFI - 23.2;22.6 [- 0.3]. Intra-individual differences in fatigue, pain, BASFI and PaGl were not correlated with the inter-visit time duration, were poorly inter-correlated and were poorly correlated with baseline values and with changes in BASDAI. In conclusion, natural variation of patient-reported outcome measures was substantial and unpredictable in individual ax-SpA patients in steady state defined on the basis of BASDAI. Consequently, observed changes in the daily clinic should be interpreted with caution.

Original language	English
Journal	Rheumatology International
Volume	38
Issue number	3
Pages (from-to)	425-432
ISSN	0172-8172
DOIs	https://doi.org/10.1007/s00296-017-3920-1
Publication status	Published - 1 Mar 2018

Keywords

Adult
Biological Products/therapeutic use
Denmark
Fatigue/diagnosis
Female
Health Status
Humans
Linear Models
Male
Middle Aged
Observer Variation
Pain/diagnosis
Pain Measurement
Patient Reported Outcome Measures
Predictive Value of Tests
Prognosis
Registries
Reproducibility of Results
Retrospective Studies
Severity of Illness Index
Spondylarthropathies/diagnosis
Spondylitis, Ankylosing/diagnosis

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Stability of fatigue, pain, patient global assessment and the Bath Ankylosing Spondylitis Functional Index (BASFI) in spondyloarthropathy patients with stable disease according to the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). / Madsen, Ole Rintek.

In: Rheumatology International, Vol. 38, No. 3, 01.03.2018, p. 425-432.

Research output: Contribution to journal › Journal article › Research › peer-review

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title = "Stability of fatigue, pain, patient global assessment and the Bath Ankylosing Spondylitis Functional Index (BASFI) in spondyloarthropathy patients with stable disease according to the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)",

abstract = "The study objective was to examine natural variation of the patient-reported outcome measures fatigue, pain, patient global assessment (PaGl) and the Bath Ankylosing Spondylitis Functional Index (BASFI) in patients with stable axial spondyloarthropathy (ax-SpA) defined on the basis of the Bath Spondylitis Ankylosing Disease Activity Index (BASDAI). 107 TNF-inhibitor treated stable ax-SpA patients were identified in the Danish rheumatology registry (DANBIO). According to the Assessment of SpondyloArthritis international Society (ASAS) response criteria, stable disease was defined as a change in BASDAI < 20 between two consecutive visits. Data on BASDAI, fatigue, pain, PaGl and BASFI (0-100) from such two visits were extracted for each patient. Lower and upper 95% limits of agreement (LLoA;ULoA) and the mean of intra-individual differences (the bias) were computed for each measure. Associations were described by linear correlations and standard errors of estimation. Mean BASDAI was 35.6 ± 23.8, mean BASDAI change 0.0 ± 9.7 (range - 19 to 19) and mean inter-visit time duration 16 ± 13 weeks. LLoA;ULoA [bias] for fatigue was - 37.4;36.2 [- 0.6], for pain - 34.1;32.5 [- 0.8], for PaGl - 35.7;32.9 [- 1.4] and for BASFI - 23.2;22.6 [- 0.3]. Intra-individual differences in fatigue, pain, BASFI and PaGl were not correlated with the inter-visit time duration, were poorly inter-correlated and were poorly correlated with baseline values and with changes in BASDAI. In conclusion, natural variation of patient-reported outcome measures was substantial and unpredictable in individual ax-SpA patients in steady state defined on the basis of BASDAI. Consequently, observed changes in the daily clinic should be interpreted with caution.",

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N2 - The study objective was to examine natural variation of the patient-reported outcome measures fatigue, pain, patient global assessment (PaGl) and the Bath Ankylosing Spondylitis Functional Index (BASFI) in patients with stable axial spondyloarthropathy (ax-SpA) defined on the basis of the Bath Spondylitis Ankylosing Disease Activity Index (BASDAI). 107 TNF-inhibitor treated stable ax-SpA patients were identified in the Danish rheumatology registry (DANBIO). According to the Assessment of SpondyloArthritis international Society (ASAS) response criteria, stable disease was defined as a change in BASDAI < 20 between two consecutive visits. Data on BASDAI, fatigue, pain, PaGl and BASFI (0-100) from such two visits were extracted for each patient. Lower and upper 95% limits of agreement (LLoA;ULoA) and the mean of intra-individual differences (the bias) were computed for each measure. Associations were described by linear correlations and standard errors of estimation. Mean BASDAI was 35.6 ± 23.8, mean BASDAI change 0.0 ± 9.7 (range - 19 to 19) and mean inter-visit time duration 16 ± 13 weeks. LLoA;ULoA [bias] for fatigue was - 37.4;36.2 [- 0.6], for pain - 34.1;32.5 [- 0.8], for PaGl - 35.7;32.9 [- 1.4] and for BASFI - 23.2;22.6 [- 0.3]. Intra-individual differences in fatigue, pain, BASFI and PaGl were not correlated with the inter-visit time duration, were poorly inter-correlated and were poorly correlated with baseline values and with changes in BASDAI. In conclusion, natural variation of patient-reported outcome measures was substantial and unpredictable in individual ax-SpA patients in steady state defined on the basis of BASDAI. Consequently, observed changes in the daily clinic should be interpreted with caution.

AB - The study objective was to examine natural variation of the patient-reported outcome measures fatigue, pain, patient global assessment (PaGl) and the Bath Ankylosing Spondylitis Functional Index (BASFI) in patients with stable axial spondyloarthropathy (ax-SpA) defined on the basis of the Bath Spondylitis Ankylosing Disease Activity Index (BASDAI). 107 TNF-inhibitor treated stable ax-SpA patients were identified in the Danish rheumatology registry (DANBIO). According to the Assessment of SpondyloArthritis international Society (ASAS) response criteria, stable disease was defined as a change in BASDAI < 20 between two consecutive visits. Data on BASDAI, fatigue, pain, PaGl and BASFI (0-100) from such two visits were extracted for each patient. Lower and upper 95% limits of agreement (LLoA;ULoA) and the mean of intra-individual differences (the bias) were computed for each measure. Associations were described by linear correlations and standard errors of estimation. Mean BASDAI was 35.6 ± 23.8, mean BASDAI change 0.0 ± 9.7 (range - 19 to 19) and mean inter-visit time duration 16 ± 13 weeks. LLoA;ULoA [bias] for fatigue was - 37.4;36.2 [- 0.6], for pain - 34.1;32.5 [- 0.8], for PaGl - 35.7;32.9 [- 1.4] and for BASFI - 23.2;22.6 [- 0.3]. Intra-individual differences in fatigue, pain, BASFI and PaGl were not correlated with the inter-visit time duration, were poorly inter-correlated and were poorly correlated with baseline values and with changes in BASDAI. In conclusion, natural variation of patient-reported outcome measures was substantial and unpredictable in individual ax-SpA patients in steady state defined on the basis of BASDAI. Consequently, observed changes in the daily clinic should be interpreted with caution.

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KW - Female

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KW - Linear Models

KW - Male

KW - Middle Aged

KW - Observer Variation

KW - Pain/diagnosis

KW - Pain Measurement

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KW - Registries

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KW - Retrospective Studies

KW - Severity of Illness Index

KW - Spondylarthropathies/diagnosis

KW - Spondylitis, Ankylosing/diagnosis

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JO - Rheumatology International

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