| Methods |
Patients were allocated at random to experimental (n = 29) or control group (n = 31). The randomization was carried out block‐wise per rheumatologist. No statement concerning concealment of allocation. Outcome assessors were blinded for allocation |
| Participants |
Patients suffering from rheumatoid arthritis (RA), based on ACR criteria, for less than 3 years. Active disease defined by an erythrocyte sedimentation rate (ESR) greater than 28 mm 1st hour, the presence of 6 or more painful joints, and the presence of 3 or more swollen joints. Disease‐modifying anti‐rheumatic drug (DMARD) therapy with sulphasalazine had to be indicated by the attending rheumatologist and agreed for by the patients. Patients who had used any DMARD other than hydroxychloroquine were excluded |
| Interventions |
The experimental group attended 6 patient education meetings. The education program focused on compliance with sulphasalazine therapy, physical exercises, endurance activities (walking, swimming, bicycling), advice on energy conservation, and joint protection. 4 (2‐hour) meetings were offered during the first months. Reinforcement meetings were given after 4 and 8 months. The program was implemented in groups and partners were invited to attend the meetings. 1 instructor (HB) provided information on RA, attendant problems, and basic treatment. The related beliefs of the patients were discussed and, when necessary, corrected. If patients anticipated problems with the applications of any of the treatments, these were discussed, including possible solutions. A training was given in proper execution of physical exercise. Patients were encouraged to plan their treatment regimens. Their intentions were discussed and help was given in recasting unrealistic ones. Patients made contracts with themselves regarding their intentions. Feedback on the eventual implementation of therapeutic advice was included in each meeting. The control group received a brochure on RA, as provided by the Dutch League against Rheumatism. This brochure gives comprehensive information on medication, physical, and occupational therapy. Sulphasalazine in the form of 500 mg enteric coated tablets was prescribed to all patients. The daily dose was increased in 4 weeks by steps of 1 tablet, until a daily dose of 4 tablets was reached. In individual cases, this could be increased to 6 tablets a day, reduced as deemed necessary, or stopped in case of inefficacy or toxicity, at the description of the attending rheumatologist. All patients obtained the sulphasalazine tablets from the pharmacists according to the local Health Care System |
| Outcomes |
Compliance with sulphasalazine therapy was evaluated at 3, 6, and 12 months. Medical records and pharmacy records were the source of data on the number of tablets prescribed and the number of tablets obtained. At each evaluation, the number of remaining tablets were counted. Compliance was defined as the number of tablets that had been taken during the preceding period divided by the number of tablets prescribed. Disease activity was measured by the disease activity score (DAS). This is a function of ESR, Ritchie score (0 to 78), and number of swollen joints (0 to 52). The DAS ranges from 0 to 10, where 0 represents the lowest level of disease activity possible, and 10 the highest. Physical function was measured by a Dutch version of the M‐HAQ. The Dutch‐AIMS questionnaire was used to assess physical function, psychological function, pain, and social activities. Compliance rates with prescriptions for physical exercise and with endurance activity regiments (walking, swimming, bicycling) were measured by questionnaire. Compliance with prescriptions for energy conservation was measured by questioning whether patients spread their activities over the day to prevent fatigue. A test for joint protection performance was used as an indication for the level of compliance with the prescription of joint protection. Patients were asked to perform actions, representing relevant ergonomic principles. The test score ranges from 0 to 10, where 0 represents a poor performance and a 10 good performance |
| Notes |
― |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
No details provided in the article. (pg 147) Patients were allocated at random to the experimental or control group. The randomization was carried out block‐wise per rheumatologist |
| Allocation concealment (selection bias) |
Unclear risk |
Allocation concealment not detailed. (pg 147) "randomised, controlled, assessor blinded, clinical trial. It was intended to follow up all patients for one year. Patients were allocated at random to the experimental or control group. The randomisation was carried out blockwise per rheumatologist." |
| Selective reporting (reporting bias) |
Unclear risk |
Reasons for missing data unclear. (pg 148) "Sixty five patients were selected. Thirty two were randomised to the experimental condition. Three patients in the experimental group and two in the control group refused informed consent. Sixty patients entered the study: 29 in the experimental condition and 31 in the control. Ten groups of patients received the education programme. Eleven partners attended the meetings. From each group one patient refused the evaluation at six months. Another three patients refused the final evaluation. The results presented here concern the available data on the remaining 25 experimental and 30 control subjects." |
| Other bias |
High risk |
Inappropriate co‐intervention. (pg 148) "Three patients of these 10 received another DMARD together with a low dose prednisone, four another DMARD alone, and three used neither of these. (...) One of these seven patients was using another DMARD in combination with a low dose prednisone, one was using only prednisone, and five were using neither of these." Inclusion/Exclusion criteria were not systematically applied. p.149 "According to the described randomisation procedure the attending rheumatologists selected the patients. Therefore, at inclusion, the data on disease activity as scored by the independent measurement technician, did not always fulfill the selection criteria, but according to the protocol patients were included because they were selected previously." |
| Blinding of outcome assessment (detection bias)
Adherence measure |
Low risk |
(PRIMARY) PILL COUNT ‐ (pg 147) "Evaluations were made by the same assessor, a measurement technician. He was blinded for the allocation". Blinding was done for assessor who collected data |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Low risk |
(PRIMARY) DISEASE ACTIVITY SCORES ‐ Blinding done for outcome assessor. (pg 147) "Evaluations were made by the same assessor, a measurement technician. He was blinded for the allocation." |
| Blinding of participants (performance bias)
Adherence measure |
High risk |
(PRIMARY) PILL COUNT ‐ No blinding and could have influenced pill count over long periods of time (3, 6, 12 months) |
| Blinding of participants (performance bias)
Patient outcome |
High risk |
(PRIMARY) DISEASE ACTIVITY SCORES ‐ No blinding of patient |
| Blinding of personnel (performance bias)
Adherence measure |
Unclear risk |
(PRIMARY) PILL COUNT ‐ No information on whether the rest of the study group was blinded |
| Blinding of personnel (performance bias)
Patient outcome |
Unclear risk |
(PRIMARY) DISEASE ACTIVITY SCORES ‐ No information provided |
| Incomplete outcome data (attrition bias)
Adherence measure |
Unclear risk |
(PRIMARY) PILL COUNT ‐ see 1.5. Uneven attrition, with more dropouts in the intervention group, among a small numbers, but insufficient information provided to make a judgment |
| Incomplete outcome data (attrition bias)
Patient outcome |
Unclear risk |
(PRIMARY) DISEASE ACTIVITY SCORES ‐ Balanced loss to follow‐up but reasons for loss to follow‐up not clear |
