| Methods |
Design: three group parallel trial
Purpose: examine the effect of stress management on clinical outcomes of rheumatoid arthritis (RA) |
| Participants |
Patients: out‐patients with RA
Baseline comparability: yes |
| Interventions |
Placebo: sessions where a education programme was discussed with each patient
Untreated: no sessions
Experimental: sessions with stress management
(Co‐intervention: standard RA treatment, 74% of patients in placebo and 77% in untreated group continued on stable medication). |
| Outcomes |
Pain (VAS)
McGill Pain Questionnaire
Hassles scale
Daily Stress Inventory
Arthritis Helplessness Index
Center for Epidemiologic Studies Depression Scale
State‐Trait Anxiety inventory
Arthritis Self‐Efficacy Scale
Coping Strategy Questionnaire
Arthritis impact Measurement Scale
Disease Activity |
| Notes |
Relevant outcome data not accessible in trial report but retrieved by contact with authors. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
High risk |
Not described as double‐blind (placebo/stress‐management) |
| Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcome |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Drop‐out <15% |
| Free of selective reporting? |
High risk |
Relevant outcome data not accessible in trial report but retrieved by contact with authors. |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
High risk |
Either variance inequality (F‐test statistically significant) or skewness (1.64 standard deviations exceeds the mean) |
| Trial size > 49? |
Low risk |
N = 94 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Allocation not clearly concealed |
