Bethge 2011.
| Methods | cluster RCT | |
| Participants | 236 patients with MSDs resulting in severe restriction of work ability and who requested rehabilitation. Inclusion criteria were at least 12 weeks of sick leave in the year before rehabilitation OR subjective expectation of long‐term restrictions affecting occupational duties OR health‐related unemployment | |
| Interventions | Multimodal work hardening: a three week inpatient group programme for 6‐10 patients with 6 modules: work and health; occupational competence; exercise; aquatic exercise; functional capacity training; relaxation. Conventional musculoskeletal rehabilitation: 3 weeks inpatients therapy including exercises, patient education, and psychosocial interventions. |
|
| Outcomes | Work status at 6 and 12 months defined as positive if the patient was working and had <6 or <12 (after 12 months) weeks of sick leave. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | computer‐generated random numbers blocked to two sequences of 16 numbers |
| Allocation concealment (selection bias) | Low risk | Performed externally by the method centre of the Rehabilitation Research Association of Berlin‐Brandenburg‐Saxony |
| Blinding (performance bias and detection bias) All outcomes ‐ outcome assessors? | Unclear risk | no report |
| Blinding (performance bias and detection bias) All outcomes ‐ patients? | High risk | patients were aware of their treatment |
| Blinding (performance bias and detection bias) All outcomes ‐ care provider? | High risk | care providers were not blinded |
| Incomplete outcome data (attrition bias) All outcomes ‐ drop‐outs? | High risk | questionnaires after 6 and 12 months follow‐up were completed and returned by 169 (71.6%) and 146 (61.9%) patients, respectively |
| Incomplete outcome data (attrition bias) All outcomes ‐ ITT analysis? | Low risk | intention‐to‐treat analysis regardless of premature dropout |
| Selective reporting (reporting bias) | Low risk | No suggestion found |
| Similarity of baseline characteristics? | Low risk | two differences in parameters at baseline were considered as covariates in the analyses |
| Co‐interventions avoided or similar? | Unclear risk | no report |
| Compliance acceptable? | Low risk | treatment was completed according to protocol in 5 out of 6 modules for 91.5% of the MWH participants |
| Timing of the outcome assessment similar? | Low risk | at 6 and 12 months follow‐up |