Finalisation and validation of the rheumatoid arthritis impact of disease score, a patient-derived composite measure of impact of rheumatoid arthritis: a EULAR initiative.

OBJECTIVE: A patient-derived composite measure of the impact of rheumatoid arthritis (RA), the rheumatoid arthritis impact of disease (RAID) score, takes into account pain, functional capacity, fatigue, physical and emotional wellbeing, quality of sleep and coping. The objectives were to finalise the RAID and examine its psychometric properties. METHODS: An international multicentre cross-sectional and longitudinal study of consecutive RA patients from 12 European countries was conducted to examine the psychometric properties of the different combinations of instruments that might be included within the RAID combinations scale (numeric rating scales (NRS) or various questionnaires). Construct validity was assessed cross-sectionally by Spearman correlation, reliability by intraclass correlation coefficient (ICC) in 50 stable patients, and sensitivity to change by standardised response means (SRM) in 88 patients whose treatment was intensified. RESULTS: 570 patients (79% women, mean ± SD age 56 ± 13 years, disease duration 12.5 ± 10.3 years, disease activity score (DAS28) 4.1 ± 1.6) participated in the validation study. NRS questions performed as well as longer combinations of questionnaires: the final RAID score is composed of seven NRS questions. The final RAID correlated strongly with patient global (R=0.76) and significantly also with other outcomes (DAS28 R=0.69, short form 36 physical -0.59 and mental -0.55, p<0.0001 for all). Reliability was high (ICC 0.90; 95% CI 0.84 to 0.94) and sensitivity to change was good (SRM 0.98 (0.96 to 1.00) compared with DAS28 SRM 1.06 (1.01 to 1.11)). CONCLUSION: The RAID score is a patient-derived composite score assessing the seven most important domains of impact of RA. This score is now validated; sensitivity to change should be further examined in larger studies.

Elaboration of the preliminary Rheumatoid Arthritis Impact of Disease (RAID) score: a EULAR initiative.

BACKGROUND: Current response criteria in rheumatoid arthritis (RA) usually assess only three patient-reported outcomes (PROs): pain, functional disability and patient global assessment. Other important PROs such as fatigue are not included. OBJECTIVE: To elaborate a patient-derived composite response index for use in clinical trials in RA, the RA Impact of Disease (RAID) score. METHODS: Ten patients identified 17 domains or areas of health relevant for inclusion in the score, then 96 patients (10 per country in 10 European countries) ranked these domains in order of decreasing importance. The seven most important domains were selected. Instruments were chosen for each domain after extensive literature research of psychometric properties and expert opinion. The relative weight of each of the domains was obtained from 505 patients who were asked to "distribute 100 points" among the seven domains. The average ranks of importance of these domains were then computed. RESULTS: The RAID score includes seven domains with the following relative weights: pain (21%), functional disability (16%), fatigue (15%), emotional well-being (12%), sleep (12%), coping (12%) and physical well-being (12%). Weights were similar across countries and across patient and disease characteristics. Proposed instruments include the Health Assessment Questionnaire and numerical ratings scales. CONCLUSION: The preliminary RAID score is a patient-derived weighted score to assess the impact of RA. An ongoing study will allow the final choice of questionnaires and assessment of validity. This score can be used in clinical trials as a new composite index that captures information relevant to patients.

Rheumatoid arthritis is milder in the new millennium: health status in patients with rheumatoid arthritis 1994-2004.

OBJECTIVES: During the last decades major advances have occurred in the treatment of patients with rheumatoid arthritis (RA), and improvements in the burden of the disease have been suggested. We examined whether there was a secular change towards less severe disease from 1994 to 2004 among patients within the representative setting of the Oslo Rheumatoid Arthritis Register (ORAR). METHODS: All living patients in the ORAR received a postal questionnaire in 1994, 1996, 2001 and 2004, including the Modified Health Assessment Questionnaire (MHAQ), SF-36, Arthritis Impact Measurement Scales 2 (AIMS2) and visual analogue scales for the patient global assessment of disease severity, pain and fatigue. A mixed model approach was used for longitudinal analysis adjusting for sex, age, co-morbidity, and for disease duration and DMARD if indicated. RESULTS: The numbers of respondents aged between 20 and 79 years in 1994, 1996, 2001 and 2004 were 931, 1025, 829 and 914 patients with similar demographic characteristics (mean age in 1994 was 60.6 years, mean disease duration 12.6 years, 78% females). Health status in the population with RA was consistently improved in all dimensions of health, and this improvement was statistically significant for the physical dimension, global health and pain over the 10-year period until 2004. Both year of examination and year of disease onset had an effect on measures of longitudinal health status outcome. CONCLUSIONS: Health status in RA improved from 1994 to 2004, probably due to access to better and more aggressive treatments.

Identification of disease activity and health status cut-off points for the symptom state acceptable to patients with rheumatoid arthritis.

BACKGROUND: Established thresholds for low levels of disease activity need to be examined from a patients' perspective. OBJECTIVE: To identify new cut-off points for patients' perception of satisfactory condition (patient acceptable symptom state (PASS)) in composite indices and patient-reported outcomes, and to examine the agreement between the new PASS cut-off points for composite indices and existing thresholds for remission, low and moderate disease activity. METHODS: Patients with rheumatoid arthritis from a treatment register (n = 1496, 72.1% women, mean (SD) age 53.9 (13.5) years, disease duration 7.6 (9.1) years, 28-joint Disease Activity Score (DAS28) 4.98 (1.36)) responded during follow-up (12, 24 and 52 weeks) to a global dichotomised question on satisfactory condition (PASS). New PASS cut-off points were identified with the 75th centile estimation and receiver operating characteristic analyses for a variety of outcome measures, and cut-off points for composite indices were examined for agreement with the low disease activity threshold (1.625) of the Patient Activity Scale (PAS) and thresholds for remission, low and moderate disease activity in DAS28, Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI). RESULTS: New PASS cut-off points for DAS28, SDAI and CDAI were in the moderate range of disease activity, and the cut-off point was 3.56 for PAS. Agreement between thresholds for disease activity levels and the PASS cut-off points was best for low disease activity (accuracy 64.5-74.6), and better for moderate disease activity (accuracy 61.3-67.2) than for remission (accuracy 30.7-45.8). CONCLUSION: The current PASS concept seems to be in the range of moderate disease activity.

Performance of health status measures with a pen based personal digital assistant.

BACKGROUND: Increasing use of self reported health status in clinical practice and research, as well as patient appreciation of monitoring fluctuations of health over time, suggest a need for more frequent collection of data. Electronic use of health status measures in the follow up of patients is a possible way to achieve this. OBJECTIVE: To compare self reported health status measures in a personal digital assistant (PDA) version and a paper/pencil version for test-retest reliability, agreement between scores, and feasibility. METHODS: 30 patients with stable rheumatoid arthritis (mean age 61.6 years, range 49.8 to 70.0; mean disease duration, 16.7 years; 63% female; 67% rheumatoid factor positive; 46.6% on disease modifying antirheumatic drugs) completed self reported health status measures (pain, fatigue, and global health on visual analogue scales (VAS), rheumatoid arthritis disease activity index, modified health assessment questionnaire, SF-36) in a conventional paper based questionnaire version and on a PDA (HP iPAQ, model h5450). Completion was repeated after five to seven days. RESULTS: Test-retest reliability was similar, as evaluated by the Bland-Altman approach, the coefficient of variation, and intraclass correlation coefficients. The scores showed acceptable agreement, but with a slight tendency to higher scores on VAS with the PDA than the paper/pencil version. No significant differences were seen for measures of feasibility (time to complete, satisfaction score), but 65.5% preferred PDA, 20.7% preferred paper, and 13.8% had no preference. CONCLUSIONS: The clinimetric performance of paper/pencil versions of self reported health status measures was similar to an electronic version, using an inexpensive PDA.

Seven year changes in health status and priorities for improvement of health in patients with rheumatoid arthritis.

OBJECTIVES: To examine possible changes in priorities for improvement in health and health status from 1994 to 2001 within the setting of the Oslo Rheumatoid Arthritis (RA) Register, which provides representative data for the entire RA population in the county. METHODS: All living patients in the Oslo RA Register area received a postal questionnaire in 1994 and 2001, including the Arthritis Impact Measurement Scales 2 (AIMS2), Short Form-36, the modified Health Assessment Questionnaire, and pain and fatigue visual analogue scales (VAS). Priorities for improvement in health were examined through question 60 in AIMS2, where patients are asked to indicate three of 12 areas of health where they would most like to see improvement. RESULTS: The number of respondents aged 20-79 years in 1994/2001 was 932/830, with similar demographic characteristics (78.8/78.3% were female, mean age 60.6/60.8, and disease duration 12.6/13.9 years). Health status was improved in all dimensions, with statistical improvement for the physical dimension, global health and pain, from 1994 to 2001. The profile of priorities remained mostly unchanged. Improvement in pain had the highest priority in both cohorts. Both symptom modifying and disease modifying drugs were more extensively used in 2001. CONCLUSIONS: Health status had improved from 1994 to 2001, probably because of access to better and more aggressive treatments. Pain remained the area of highest priority for improvement among patients with RA-despite an improved level of pain in 2001.

Peptide-containing fractions in depression.

A mixture of peptides and glycoproteins has been found in benzoic acid-precipitable material from urines of psychomotorically agitated and retarded endogenous depressive patients. This complex mixture of compounds is fractionated on a Sephadex G-25 gel, from which the different peaks are further separated on Biogel P2. The G-25 elution profiles ultraviolet absorbance, 280 nm) from depressive patients deviated from the normal pattern. The increase in hydrolyzable ninhydrin-colorable material of the P2 fractionation step encountered in psychotic depression was several-fold that of the normal population. Neurochemically active peptide-containing fractions were found. As explanation of these findings, it is probable that a genetically determined peptidase insufficiency is present, causing a peptide overflow when the secretion outstrips the breakdown. This model could easily combine more psychodynamic models with the genetic-biological models. The variability of the peptide patterns could possibly reflect the considerable clinical variability of the syndrome. Furthermore, the presence of a group of active compounds with different neuropharmacological activities might reflect the composite nature of the depressive syndrome.