Jensen 2011.
| Methods | RCT | |
| Participants | 351 patients between 16 to 60 years, partly or fully sick‐listed from work for 4 to 12 weeks because of LBP | |
| Interventions | Intervention 1: brief clinical intervention: standard clinical LBP examination by a physician, relevant imaging and examinations were ordered and treatment options were discussed. Patients were informed about cause, prognosis and treatment options. Furthermore, they were informed about exercise being beneficial, medical pain management, and they were advised to resume work when possible. Physiotherapy examination, with advise about exercise, and general advise about increasing physical activity and exercise. Coordination between stakeholders was ensured. Follow‐up visit at physiotherapist after 2 weeks, and physician if necessary. Intervention 2: brief clinical intervention and case management. This included an interview with a case‐manager within 2‐3 days; with questions about work history, private life, pain and disability perception. The case manager and the participant made a tailored rehabilitaion plan aiming at full or partial RTW. Each case was discussed several times by the entire multidisciplinary team including the rehabilitation physician, a specialist in clinical social medicine, a physiotherapist, a social worker, and a occupational therapist. |
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| Outcomes | return to work defined as the first 4 week period within the first year after inclusion, during which the participant received no social transfer payments. Follow‐up was 1 year. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer generated block randomization |
| Allocation concealment (selection bias) | Low risk | Performed by a secretary |
| Blinding (performance bias and detection bias) All outcomes ‐ outcome assessors? | Low risk | data analyses were carried out by researchers outside the hospital |
| Blinding (performance bias and detection bias) All outcomes ‐ patients? | High risk | patients were aware of the result of the randomization |
| Blinding (performance bias and detection bias) All outcomes ‐ care provider? | High risk | at the follow‐up consultation caregivers were aware of the result of the randomization |
| Incomplete outcome data (attrition bias) All outcomes ‐ drop‐outs? | Low risk | For primary outcome no dropouts |
| Incomplete outcome data (attrition bias) All outcomes ‐ ITT analysis? | Low risk | 100% follow‐up |
| Selective reporting (reporting bias) | Low risk | no suggestions found |
| Similarity of baseline characteristics? | Low risk | Adequate correction for any differences at baseline |
| Co‐interventions avoided or similar? | Unclear risk | not described |
| Compliance acceptable? | Unclear risk | no information |
| Timing of the outcome assessment similar? | Low risk | yes |