Barsky 2010.
| Study characteristics | ||
| Methods | RCT; 3 arms; assessed pretreatment, post‐treatment, 6‐, and 12‐months | |
| Participants | Post‐treatment n = 133 at 6 months Start of treatment n = 168 Sex: 146 F, 22 M Mean age = 53.4 (SD 12.9) Source = hospital, public advertisements Diagnosis = rheumatoid arthritis Mean years of pain = 13.5 (SD 11.5) |
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| Interventions | CBT ‐ Cognitive behavioural therapy RR ‐ Relaxation response training AE ‐ Arthritis eduction |
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| Outcomes |
Primary pain outcome: Rheumatoid Arthritis Symptom Questionnaire (RASQ) VAS 1‐10 Primary disability outcome: Arthritis Impact Measurement Scale (AIMS‐2) Mobility Primary distress outcome: Rand Mental Health Inventory (Depression) Rheumatoid Arthritis Symptom Questionnaire (RASQ) Arthritis Impact Measurement Scale (AIMS‐2) Erythrocyte sedimentation rate (ESR) Standardised physician ratings of joint swelling to index disease severity and activity Medications Rand Mental Health Inventory |
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| Notes | No data provided Funding statement: Supported by research grant R01 AR 4701401 from the National Institute of Arthritis & Musculoskeletal and Skin Diseases. Conflict of interests: None described. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Once five subjects were accrued, this group was randomly assigned by computer to one of the three treatment modalities" |
| Allocation concealment (selection bias) | High risk | No description of allocation. However, this statement was included in the text suggesting that the latter participants had unequal chance of being randomised to treatment conditions. "However, after accruing 127 patients, unequal numbers of patients across the treatment arms led us to an unbalanced randomization for the remaining 41 patients in order to restore balance." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Data were gathered by research assistants blind to treatment modality, and the therapists had no role in data collection." |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Attrition > 10%. LOCF analyses used. |
| Selective reporting (reporting bias) | Unclear risk | Protocol registered (NCT00056667). Some questionnaires registered in protocol not included in manuscript. |
| Treatment expectations | Unclear risk | Not assessed. |