Summary of outcome measures at the different time points of the study
| Time | Outcome measures |
|---|---|
| Baseline, 1-year and 2-year follow-up | ▸ Socio-demographic data (age, gender, marital status, school and educational background, work situation, comorbidities (17 other chronic diseases) and disease duration) ▸ Disease activity: DAS28-CRP based on a blinded 28-tender and swollen joint count, VAS-patient global score and C-reactive protein.17 Joint examinations of ankles and feet. ▸ Physical disability: HAQ21 ▸ VAS-pain anchored by ‘no pain’ and ‘unbearable pain’ ▸ VAS-fatigue anchored by ‘fatigue is not a problem’ and ‘fatigue is a big problem’ ▸ VAS-global health anchored by ‘not at all’ and ‘unbearably much’ ▸ Quality of life: Short form 12 (SF-12) 4-week recall V.2.22–24 Scoring and handling of missing data according to instrument guidelines.24 ▸ Self-efficacy (the patients’ belief in their ability to perform specific tasks or behaviours to cope with their arthritis): The Danish version of the Rheumatoid Arthritis Self-Efficacy questionnaire (RASE-DK) consists of 28 questions answered on a 5-point Likert Scale (1: strongly disagree to 5: strongly agree), 28–140 points in the total score;25 the Danish version of the Arthritis Self-Efficacy Scale (ASES-DK) consists of 20 items in 3 subscales (pain, five items; function, nine items and other symptoms, six items), 10–100 points on each subscale26 ▸ VAS-confidence and satisfaction: The two questions ‘How confident are you that if you have problems, this system of care will be able to support you?’ answered on a 100 mm VAS-scale anchored by ‘not at all confident’ and ‘completely confident’ and ‘How satisfied are you with the system of care provided for your RA?’ anchored by ‘not at all satisfied’ and ‘completely satisfied’.27 The two questions, including anchors, were translated by a professional translator and face-validated in RA-patients before they were used in the study. |
| Three-monthly Patient-related outcomes and safety monitoring | ▸ Side effects over the past 3 months (infections, rash, allergic reactions, cough/ shortness of breath, nausea, vomiting or diarrhoea, jaundice, swollen legs, hypertension, headache or dizziness and ‘others’).· HAQ (in addition to baseline, 1-year and 2-year follow-up) ▸ Patient-reported disease activity: The RA Disease Activity Index (RADAI) (including disease activity, pain and joint stiffness), 0–10 in total score.28 (Prior validation studies of the Danish RADAI (unpublished) found a Cronbach's α of 0.91. Mean difference and standard deviation in RADAI-score between test and retest in 63 outpatients with RA were −0.28(1.3). The Spearman r for the correlation between the DAS28-CRP and the RADAI-score at test was 0.71. |
| Baseline and 2-year follow-up | x-Rays of hands and feet, progression or development of erosions (0/1)33 |
| Journal audit | The patients’ journals were audited to check whether they had had the planned blood-tests taken at the planned intervals, the number of out-of-range blood-tests and whether relevant action was taken on out-of-range blood tests. |
DAS28-CRP, Disease Activity Score; DK, Denmark; HAQ, Health Assessment Questionnaire; VAS, visual analogue scale.