Stuifbergen 2003.
Methods | RCT. | |
Participants | USA N = 121 (8 dropouts) treatment = 61 (5 drop outs), control = 60 (3 drop outs) | |
Interventions | Treatment group ‐ 2‐phased MD wellness programme consisting of a lifestyle change phase, followed by telephone calls post completion of programme. Control group ‐ monthly phone call. | |
Outcomes | ISS, SF36, SRAHP, HPLP‐II, BHPADPS, PRQ85 (part 2), employment | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation performed by random number table method. |
Allocation concealment (selection bias) | High risk | Allocation concealment not stated. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding of participants and treating personnel. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding of outcome assessors. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Overall 75 dropout. |
Selective reporting (reporting bias) | Low risk | All pre‐specified primary and secondary outcomes reported. |
Other bias | Unclear risk | ITT was specified but figures were not provided. |
ITT = Intention to Treat IVMP = intravenous methylprednisolone MD = Multidisciplinary MS = Multiple sclerosis N = Number OT = Occupational therapy PT = Physiotherapy RCT = Randomised Controlled Trial
CCT Clinical Controlled Trial UK = United Kingdom USA = United States of America