Minimally Important Difference of Health Assessment Questionnaire in Psoriatic Arthritis: Relating Thresholds of Improvement in Functional Ability to Patient-rated Importance and Satisfaction

Objective.To evaluate changes in function as measured by Health Assessment Questionnaire Disability Index (HAQ-DI) and the meaningfulness of the changes, in importance and satisfaction, in patients with psoriatic arthritis (PsA).Methods.HAQ-DI was assessed at baseline and at Weeks 4, 12, and 24 in a randomized double-blind study of 205 patients with active PsA receiving etanercept 25 mg twice weekly or placebo. Concurrently, patients rated the importance of and satisfaction with their change in function on a 7-point scale (1 = not at all important/satisfied; 7 = extremely important/satisfied). Mean HAQ-DI improvement corresponding to ratings of minimally (2–3) or very (6–7) important or satisfied was determined using a posthoc linear mixed-model analysis. Patient importance ratings were used as an anchor to estimate minimally important difference (MID) for HAQ-DI; distribution-based estimates were also calculated.Results.A total of 161 patients (69 placebo; 92 etanercept) had ≥ 1 HAQ-DI scores showing improvement from baseline and a corresponding importance or satisfaction rating. HAQ-DI improvements corresponding to importance scale ratings of 2 or 3 were 0.335 (95% CI 0.214, 0.455) and 0.360 (95% CI 0.263, 0.456), respectively, suggesting an MID of about 0.35. HAQ-DI improvements corresponding to satisfaction scale ratings of 2 and 3 were 0.293 (95% CI 0.230, 0.357) and 0.360 (95% CI 0.307, 0.413). For a given change in HAQ-DI, nearly two-thirds of patients indicated a lower rating for satisfaction than for importance. This trial was registered in the ClinicalTrials.gov registry (NCT00317499).Conclusion.Our study suggests the MID for HAQ-DI in PsA is about 0.35. The results may also provide insight into patient satisfaction with changes in function and expectations for therapy.

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Minimally Important Difference for Patient-reported Outcomes in Psoriatic Arthritis: Health Assessment Questionnaire and Pain, Fatigue, and Global Visual Analog Scales

The Journal of Rheumatology ◽

10.3899/jrheum.090832 ◽

2010 ◽

Vol 37 (5) ◽

pp. 1024-1028 ◽

Cited By ~ 34

Author(s):

TIFFANY KWOK ◽

JANET E. POPE

Keyword(s):

Psoriatic Arthritis ◽

Health Status ◽

Health Assessment Questionnaire ◽

Patient Reported Outcomes ◽

Health Assessment ◽

Disease Status ◽

Minimally Important Difference ◽

Patient Reported ◽

Assessment Questionnaire ◽

Overall Health Status

Objective.To determine the minimally important difference (MID) for the Health Assessment Questionnaire-Disability Index (HAQ-DI), pain, fatigue, sleep, and global visual analog scale (VAS; 0–100 mm) in patients with psoriatic arthritis (PsA) using a patient-reported overall health status anchor. Patient-reported outcomes are often used to gauge the effect of PsA in clinical trials. There is currently no knowledge about the MID for patient-reported outcomes in PsA.Methods.Patients with a diagnosis of PsA who had answered questions about outcomes at 2 consecutive visits and an overall health status question (“How would you describe your overall status since your last visit: much better, better, the same, worse, much worse?”) were included. MID was calculated as the mean change between visits for those who rated their disease as “better” or “worse.”Results.Two hundred patients met inclusion criteria, of whom 17.5% rated their status as “better” and 25.0% rated their status as “worse” than the previous visit. MID estimates for improvement/worsening (SD) respectively were −0.131 (0.411)/0.131 (0.309) for HAQ-DI, −9.37 (24.37)/13.96 (22.05) for pain VAS, −8.15 (23.52)/3.63 (27.62) for fatigue VAS, −10.97 (29.74)/13.81 (27.32) for sleep VAS, and −8.41 (21.17)/11.53 (21.03) for global VAS. Spearman’s r correlation coefficients between the anchor and mean change were 0.374 (HAQ-DI), 0.448 (pain VAS), 0.239 (fatigue VAS), 0.326 (sleep VAS), 0.490 (global VAS); p < 0.01.Conclusion.This is the first study investigating MID of patient-reported outcomes in PsA. MID for HAQ-DI, pain, and global VAS were shown to be the best predictors for a patient’s perception of overall changes in disease status.

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Efficacy and safety of a single switch from etanercept originator to etanercept biosimilar in a cohort of inflammatory arthritis

Scientific Reports ◽

10.1038/s41598-020-73183-0 ◽

2020 ◽

Vol 10 (1) ◽

Author(s):

Maria Chiara Ditto ◽

Simone Parisi ◽

Marta Priora ◽

Silvia Sanna ◽

Clara Lisa Peroni ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Ankylosing Spondylitis ◽

Disease Activity ◽

Inflammatory Arthritis ◽

Health Assessment Questionnaire ◽

Activity Index ◽

Health Assessment ◽

Disease Activity Index ◽

Clinical State ◽

Assessment Questionnaire

Abstract AntiTNF-α biosimilars are broadly available for the treatment of inflammatory arthritis. There are a lot of data concerning the maintenance of clinical efficacy after switching from originators to biosimilars; therefore, such a transition is increasingly encouraged both in the US and Europe. However, there are reports about flares and adverse events (AE) as a non-medical switch remains controversial due to ethical and clinical implications (efficacy, safety, tolerability). The aim of our work was to evaluate the disease activity trend after switching from etanercept originator (oETA-Enbrel) to its biosimilar (bETA-SP4/Benepali) in a cohort of patients in Turin, Piedmont, Italy. In this area, the switch to biosimilars is stalwartly encouraged. We switched 87 patients who were in a clinical state of stability from oETA to bETA: 48 patients were affected by Rheumatoid Arthritis (RA),26 by Psoriatic Arthritis (PsA) and 13 by Ankylosing Spondylitis (AS).We evaluated VAS-pain, Global-Health, CRP, number of swollen and tender joints, Disease Activity Score on 28 joints (DAS28) for RA, Disease Activity in Psoriatic Arthritis (DAPSA) for PsA, Health Assessment Questionnaire (HAQ) and Health Assessment Questionnaire for the spondyloarthropathies (HAQ-S),Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for AS patients. 11/85 patients (12.6%) stopped treatment after switching to biosimilar etanercept. No difference was found between oETA and bETA in terms of efficacy. However, some arthritis flare and AE were reported. Our data regarding maintenance of efficacy and percentage of discontinuation were in line with the existing literature.

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Measuring physical function in psoriatic arthritis: comparing the Multi-Dimensional Health Assessment Questionnaire to the Health Assessment Questionnaire Disability Index

The Journal of Rheumatology ◽

10.3899/jrheum.200927 ◽

2021 ◽

pp. jrheum.200927

Author(s):

Weiyu Ye ◽

Simon Hackett ◽

Claire Vandevelde ◽

Sarah Twigg ◽

Philip S. Helliwell ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Physical Function ◽

Health Assessment Questionnaire ◽

Health Assessment ◽

Clinic Visit ◽

Retest Reliability ◽

Floor Effects ◽

Test Retest Reliability ◽

Assessment Questionnaire ◽

Questionnaire Disability

Objective To compare physical function scales of the Multi-Dimensional Health Assessment Questionnaire (MDHAQ) to the Health Assessment Questionnaire Disability Index (HAQDI) in patients with psoriatic arthritis (PsA), and examine whether either questionnaire is less prone to ‘floor effects’. Methods Data were collected prospectively from 2018 to 2019 across three UK hospitals. All patients completed physical function scales within the MDHAQ and HAQDI in a single clinic visit. Agreement was assessed using medians and the Bland-Altman method. Intraclass correlation coefficients (ICCs) were used to assess test-retest reliability. Results 210 patients completed the clinic visit; one withdrew consent thus 209 were analysed. 60.0% were male, with mean age of 51.7 years and median disease duration of 7 years. In clinic, median MDHAQ and HAQDI including/excluding aids scores were 0.30, 0.50 and 0.50 respectively. Although the median score for HAQDI is higher than MDHAQ, the difference between the two mostly lies within 1.96 standard deviations from the mean suggesting good agreement. The ICCs demonstrated excellent test-retest reliability for both HAQ questionnaires.Similar numbers of patients scored ‘0’ on the MDHAQ and HAQDI including/excluding aids (48, 47, and 49 respectively). Using a score of ≤0.5 as a cut-off for minor functional impairment, 23 patients had a MDHAQ ≤0.5 when their HAQDI including aids >0.5. Conversely, 4 patients had a MDHAQ > 0.5 when the HAQDI including aids ≤0.5. ConclusionBoth HAQ questionnaires appear to be similar in detecting floor effects in patients with PsA.

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Prophylactic oral glutamine for docetaxel or paclitaxel associated taste alterations in cancer patients: A randomised, parallel, placebo-controlled, double-blind study

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.9104 ◽

2007 ◽

Vol 25 (18_suppl) ◽

pp. 9104-9104

Author(s):

F. Strasser ◽

R. Demmer ◽

C. Boehme ◽

S. Schmitz ◽

B. Thuerlimann ◽

...

Keyword(s):

Mixed Model ◽

Linear Mixed Model ◽

Linear Time ◽

Group Analysis ◽

Estimating Equation ◽

Taste Perception ◽

Double Blind Study ◽

Double Blind ◽

Baseline Effect ◽

First Time

9104 Background: Taste alterations (TA) can occur as side-effects of taxane-based chemotherapy (T-Ch) and studies suggest that glutamin can reduce neurotoxicity. We compared in patients (pts) with a first time T-Ch oral glutamin (G) with placebo (P) for occurrence and severity of TA. Methods: Pts were randomised for 30g per day G or P (maltodextrin) (Baxter, Switzerland) from the first day of T-Ch. Subjective TA (dysgeusia) was measured daily by VAS, at baseline 3 times. On each cycle of T-Ch, objective (sour, sweet, salty, bitter) and subjective (4-categorical scale of 4 tastes) TA, and toxicity (NCI CTC V.3) were assessed. Stomatitis and zinc deficiency were screened for and treated. Of 47 pts receiving at least one day G or P, three (2 G, 1 P) died to tumor progression and three (2 G, 1 P) withdraw consent in the first cycle of T-Ch. For primary outcomes, repeated dysgeusia scores were analyzed by linear mixed model and repeated binary values of each objective taste item by generalized estimating equation using logit link function. Results: G (n=21) and P (n=20) pts groups were comparable for demographics (f:m 5:16, median age 67 [49,83], 9 prostate, 3 lung, 3 breast, 6 other cancer; 8:12, 63 [40,73], 2, 6, 6, 6), and T-Ch drug (docetaxel 11/paclitaxel 10; 7/13), schedule (weekly 18/3-weekly 3; 14/6), or goal (adjuvant 1/palliative 20; 5/15). At baseline, average median dysgeusia was 11 in both groups (0,90; SD 23. 0,99; 22), 4 tastes were recognized by 12, 16, 13, and 15 pts in G (n=16) and 16, 19, 17, 19 in P (n=20). Study duration was 73 days for G (median; 4, 385) and 74 for P (7, 187). 19 of 39 pts (11 G, 8 P) developed peripheral neuropathy G1 or G2, none G3. Maximal (mean) dysgeusia was 31 (1, 100) in G and 33 (4, 74) in P; increase from baseline was 20 (1, 100) and 22 (1, 63). No effect of G or P on dysgeusia was detected (p=ns), linear time effect was p=0.46. Baseline dysgeusia effect was significant (p<0.0001), two group analysis (dysgeusia =11) did not alter results. Objective taste tests (no baseline effect) or subjective TA were not different, as were adverse events. Conclusions: Oral glutamin at the dose given did not decrease subjective taste disturbances or altered taste perception associated with T-Ch compared to placebo. No significant financial relationships to disclose.

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The Minimally Important Difference for the Health Assessment Questionnaire in Rheumatoid Arthritis Clinical Practice Is Smaller Than in Randomized Controlled Trials

The Journal of Rheumatology ◽

10.3899/jrheum.080479 ◽

2009 ◽

Vol 36 (2) ◽

pp. 254-259 ◽

Cited By ~ 83

Author(s):

JANET E. POPE ◽

DINESH KHANNA ◽

DEBORAH NORRIE ◽

JANINE M. OUIMET

Keyword(s):

Rheumatoid Arthritis ◽

Clinical Practice ◽

Health Assessment Questionnaire ◽

Clinical Care ◽

Damage Index ◽

Health Assessment ◽

Change Score ◽

Minimally Important Difference ◽

Patient Reported ◽

Assessment Questionnaire

Objective.Patient-reported outcomes are used in clinical practice and trials. We studied a large clinical practice to determine the minimally important difference (MID) estimates for (1) the Health Assessment Questionnaire–Damage Index (HAQ-DI): improvement and worsening using patient global assessment anchor; and (2) pain using a patient-reported pain anchor.Methods.Patients with rheumatoid arthritis (RA; N = 225) had clinic visits at 2 timepoints within 1 year, completed the HAQ-DI and pain visual analog scale (VAS; 0–100 mm), and answered the question, “How would you describe your overall status/overall pain since the last visit?”, as much worsened, somewhat worsened, the same, somewhat improved, or much improved. If rated as somewhat improved or worsened, they were defined as the minimally changed subgroups.Results.Eighty-three percent were women, mean age 60 years, with disease duration 11.7 ± 10.7 years. The baseline HAQ-DI was 0.97 ± SD 0.76, and at followup 1.0 ± 0.77 (mean change +0.03 ± 0.40). The baseline pain VAS was 42.3 ± 28.8, and at followup 38.5 ± 27.9 (mean change −2.8 ± 25.9). The mean (SD) HAQ-DI change score was −0.09 (0.42) for somewhat improved and 0.15 (0.33) for somewhat worsened. The HAQ-DI change for somewhat/much better was −0.20 ± 0.52, and for somewhat/much worse +0.21 ± 0.33. For pain, somewhat improved changed by −11.9 mm on the VAS, and somewhat worsened by 6.8 mm. Estimates for HAQ-DI and pain were larger than the for no-change group, 0.03 (0.32) and −3.2 (20.9).Conclusion.The MID for HAQ-DI in clinical practice is smaller than it is in trials. This may have implications for observational studies and clinical care.

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Transition phase towards psoriatic arthritis: clinical and ultrasonographic characterisation of psoriatic arthralgia

RMD Open ◽

10.1136/rmdopen-2019-001067 ◽

2019 ◽

Vol 5 (2) ◽

pp. e001067 ◽

Cited By ~ 9

Author(s):

Alen Zabotti ◽

Dennis G McGonagle ◽

Ivan Giovannini ◽

Enzo Errichetti ◽

Francesca Zuliani ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Health Assessment Questionnaire ◽

Health Assessment ◽

Visual Analogue Scale Pain ◽

Cross Sectional ◽

Anatomical Basis ◽

Joint Tenderness ◽

Analogue Scale Pain ◽

Assessment Questionnaire

ObjectiveNon-specific musculoskeletal pain is common in subjects destined to develop psoriatic arthritis (PsA). We evaluated psoriatic patients with arthralgia (PsOAr) compared with psoriasis alone (PsO) and healthy controls (HCs) using ultrasonography (US) to investigate the anatomical basis for joint symptoms in PsOAr and the link between these imaging findings and subsequent PsA transition.MethodsA cross-sectional prevalence analysis of clinical and US abnormalities (including inflammatory and structural lesions) in PsOAr (n=61), PsO (n=57) and HCs (n=57) was performed, with subsequent prospective follow-up for PsA development.ResultsTenosynovitis was the only significant sonographic feature that differed between PsOAr and PsO (29.5% vs 5.3%, p<0.001), although synovitis and enthesitis were numerically more frequent in PsOAr. Five patients in PsOAr and one in PsO group developed PsA, with an incidence rate of 109.2/1000 person-years in PsOAr vs 13.4/1000 person-years in PsO (p=0.03). Visual Analogue Scale pain, Health Assessment Questionnaire, joint tenderness and US active enthesitis were baseline variables associated with PsA development.ConclusionTenosynovitis was associated with arthralgia in subjects with psoriasis. Baseline US evidence of enthesitis was associated with clinical PsA development in the longitudinal analysis. These findings are relevant for enriching for subjects at risk of imminent PsA development.

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Mortality trends in a Cohort of Canadian Psoriatic Arthritis Patients

McGill Journal of Medicine ◽

10.26443/mjm.v14i2.205 ◽

2020 ◽

Vol 14 (2) ◽

Author(s):

Boluwaji Ogunyemi

Keyword(s):

Psoriatic Arthritis ◽

Health Assessment Questionnaire ◽

Small Sample Size ◽

Laboratory Data ◽

Health Assessment ◽

Small Sample ◽

Mortality Trends ◽

Nail Changes ◽

Assessment Questionnaire ◽

Dystrophic Nail

Methods: We reviewed retrospectively the charts of psoriatic arthritis patients who died from 1995-2010.We included 13 deceased patients with a psoriatic arthritis di-agnosis and compared them with 140 patients living with psoriatic arthritis that at-tend the same clinic. The population was derived from a single academic rheumatol-ogist’s practice in St. John’s, Newfoundland, Canada. Patients are seen at six-month intervals with a history and physical exam performed at each visit. Laboratory data was collected at each visit. Diagnosis of psoriatic arthritis is based on the CASPAR Classifcation and Diagnostic Criteria for Psoriatic Arthritis. Results: The mean age of the 13 deceased patients was 62.9 years. Of these, 38.5% were female and 85.7% had an erythrocyte sedimentation rate greater than 15 mm/hour vs. 36.4% of patients living with psoriatic arthritis. Of deceased patients, 16%had dystrophic nail changes of vs. 59.6% of living patients. Health Assessment Questionnaire was found to show a signifcantly greater loss in function in deceasedpatients. (1.39 vs. 0.70, p= 0.002). Almost half of the deceased patients had used Prednisone (46.2%) as opposed to 11.2% of living patients. Conclusions: We realize that this study employs a small sample size. Increased ESR and Health Assessment Questionnaire score were found to be associated with mor-tality in psoriatic arthritis patients. Dystrophic nail changes were found to be pro-tective for psoriatic arthritis patients.

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Sex-associated Treatment Differences and Their Outcomes in Rheumatoid Arthritis: Results from the METEOR Register

The Journal of Rheumatology ◽

10.3899/jrheum.171176 ◽

2018 ◽

Vol 45 (10) ◽

pp. 1361-1366 ◽

Cited By ~ 5

Author(s):

Sytske Anne Bergstra ◽

Cornelia F. Allaart ◽

Sofia Ramiro ◽

Arvind Chopra ◽

Nimmisha Govind ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Mixed Model ◽

Linear Mixed Model ◽

Cox Regression ◽

Health Assessment ◽

Daily Practice ◽

Response To Treatment ◽

Men And Women ◽

Assessment Questionnaire ◽

Over Time

Objective.To assess differences in initial treatment and treatment response in male and female patients with rheumatoid arthritis (RA) in daily clinical practice.Methods.The proportion of patients with RA starting different antirheumatic treatments (disease-modifying antirheumatic drugs; DMARD) and the response to treatment were compared in the international, observational METEOR register. All visits from start of the first DMARD until the first DMARD switch or the end of followup were selected. The effect of sex on time to switch from first to second treatment was calculated using Cox regression. Linear mixed model analyses were performed to assess whether men and women responded differently to treatments, as measured by Disease Activity Score (DAS) or Health Assessment Questionnaire.Results.Women (n = 4393) more often started treatment with hydroxychloroquine, as monotherapy or in combination with methotrexate (MTX) or a glucocorticoid, and men (n = 1142) more often started treatment with MTX and/or sulfasalazine. Time to switch DMARD was shorter for women than for men. Women had a statistically significantly higher DAS over time than men (DAS improvement per year β −0.69, 95% CI −0.75 to −0.62 for men and −0.58, 95% CI −0.62 to −0.55 for women). Subanalyses per DMARD group showed for the conventional synthetic DMARD combination therapy a slightly greater decrease in DAS over time in men (−0.89, 95% CI −1.07 to −0.71) compared to women (−0.59, 95% CI −0.67 to −0.51), but these difference between the sexes were clinically negligible.Conclusion.This worldwide observational study suggests that in daily practice, men and women with RA are prescribed different initial treatments, but there were no differences in response to treatment between the sexes.

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