Identification of Cutpoints for Acceptable Health Status and Important Improvement in Patient-Reported Outcomes, in Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis

2009 ◽  
Vol 37 (1) ◽  
pp. 26-31 ◽  
Author(s):  
MARIA KNOPH KVAMME ◽  
IVAR SØNBØ KRISTIANSEN ◽  
ELISABETH LIE ◽  
TORE KRISTIAN KVIEN

Objective.To identify cutpoints reflecting Patient Acceptable Symptom State (PASS) and Minimal Clinically Important Improvement (MCII) in patient-reported multi-attribute health status classification systems and health status measurements among patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS), and psoriatic arthritis (PsA).Methods.We identified patients with RA, AS, and PsA from the Norwegian disease-modifying antirheumatic drug (DMARD) register (NOR-DMARD). The patients (n = 4225) had started with DMARD and responded to the PASS and MCII anchoring questions at the 3-month followup examination. Receiver operating characteristics (ROC) curves with 80% specificity and the 75th percentile approach were used to identify PASS and MCII cutpoints in the EuroQol-5 Dimensions (EQ-5D) and the Short-Form-6 Dimensions (SF-6D) indexes, but also in other patient-reported outcomes (joint pain and patient global visual analog scale and Modified Health Assessment Questionnaire).Results.The PASS cutpoints estimated with 80% specificity were around 0.70 in EQ-5D in all diseases and around 0.65 in SF-6D. The cutpoints were around 0.65 and 0.60, respectively, when the 75th percentile approach was used. The MCII cutpoints assessed by 80% specificity varied from 0.10 to 0.19 in EQ-5D and from 0.07 to 0.10 in SF-6D.Conclusion.The cutpoints for PASS in EQ-5D and SF-6D indicate that PASS corresponds to a health-related quality of life that is far from perfect health. Somewhat different cutpoints were identified for both PASS and MCII with 80% specificity versus the 75th percentile method.

2010 ◽  
Vol 37 (5) ◽  
pp. 1024-1028 ◽  
Author(s):  
TIFFANY KWOK ◽  
JANET E. POPE

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.


2011 ◽  
Vol 38 (8) ◽  
pp. 1728-1734 ◽  
Author(s):  
JOHN R. KIRWAN ◽  
ANNELIES BOONEN ◽  
MARK J. HARRISON ◽  
SARAH E. HEWLETT ◽  
GEORGE A. WELLS ◽  
...  

This workshop reviewed progress in a number of areas related to patient perspective outcomes that were not specifically included within other areas of the program. A substantial review of the work of the valuing health outcomes group (the “QALY” working group) with participation and feedback from the plenary audience resulted in guidance to refocus on the use of patient preferences in the elaboration of more robust outcome measures for patient-reported outcomes and life impact measures. Progress and developments in the areas of fatigue and sleep in rheumatoid arthritis, outcome measures in hip and knee arthroplasty clinical trials, and scleroderma were outlined, and the challenge of truly understanding the nature of clinically important improvement was reviewed.


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