Brighton 1993.
| Methods | RCT | |
| Participants | 55 female participants (25 intervention group, 30 control group) with active rheumatoid arthritis for at least 1 year (ESR > 25), aged > 18 years (range 27 to 61 years), housewives or sedentary occupation, RF positive, erosions present in MCPs and/or PIPs, Steinbrocker functional class I, all on either gold injections or D‐penicillamine plus anti‐inflammatories Country: South Africa |
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| Interventions | Intervention group: daily home exercise programme consisting of range of motion and strengthening exercises for 48 months, 6‐monthly checks with reinforcement Control group: no treatment |
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| Outcomes | Grip strength (sphygmomanometer, mmHg, higher score = greater strength) Pincer grip strength (sphygmomanometer, mmHg, higher score = greater strength) MCP and PIP total ROM score (goniometer, degrees, sum of flexion and extension ROM of all fingers, higher score = greater movement) Outcome time points: baseline; 4 years |
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| Notes | Source of funding not declared. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "The patients were divided into two groups by random allocation"; however, details regarding randomisation method unclear |
| Allocation concealment (selection bias) | Unclear risk | No method described. |
| Blinding of participants All outcomes | High risk | Not possible |
| Blinding of personnel All outcomes | High risk | Not possible |
| Blinding of outcome assessment (detection bias) Self‐reported outcomes | Unclear risk | Participants were aware of treatment allocation. No subjective outcome measures used. |
| Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Quote: "All the patients were examined by the same examiner unaware of which patient was in the test or control group" |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No explanation given for withdrawals and how they were treated in analysis. |
| Selective reporting (reporting bias) | High risk | No information on data from interim follow‐up assessments |
| Other bias | Unclear risk | No description of baseline characteristics of 2 groups other than age |