Ostelo 2003.
| Methods | Randomised by a priori prepared, opaque and sealed envelopes | |
| Participants | 105 patients still suffering complaints six weeks post‐surgery | |
| Interventions | (I: N = 52) Behavioral graded activity (operant therapy) using graded activity and positive reinforcement, time‐contingency management. Based on baseline measurements, an individually graded exercise training programme was established, using quota setting. In total, 18 sessions (30 minutes a session) over a three‐month period (R: N = 53) Physiotherapiy programme: ADL instructions, exercise trunk muscles (increase strength and stability). Mobilisation exercises. Number of sessions (of 30 minutes each) at the discretion of therapists (max 18 sessions) |
|
| Outcomes | Global perceived effect: I: 48% recovered versus R: 67% (three short‐term) and 75% (I) versus 73% on one‐year follow‐up Functional status (24‐item RDQ): I: mean improvement (–5.2, SD: 5.9) versus (5.6, SD: 5.3) for R on the short term, long term: I: (7.0, SD: 5.5) versus R: (7.0, SD: 5.3) Pain back (VAS): mean improvement: I: (9.3, SD: 27.8) versus R: (16.0, SD: 25.3) short term; one‐year follow‐up: I: (17.6, SD: 32.5) versus R: (22.4, SD: 33.0) Cost‐effectiveness analysis: Total direct costs in behavioural graded activity are EUR 639 (95% CI 91 to 1368) higher than physiotherapy costs | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation |
| Allocation concealment (selection bias) | Low risk | A priori prepared opaque and sealed envelopes |
| Blinding (performance bias and detection bias) All outcomes ‐ patients? | High risk | BGA versus UC PT |
| Blinding (performance bias and detection bias) All outcomes ‐ care providers? | High risk | BGA versus UC PT |
| Blinding (performance bias and detection bias) All outcomes ‐ outcome assessors? | High risk | Patient reported |
| Incomplete outcome data (attrition bias) All outcomes ‐ drop‐outs? | High risk | Number of dropouts not similar in the two groups: 1/53 = 2% and 7/52 = 14% short term, 2/53 = 4% and 10/52 = 19% |
| Incomplete outcome data (attrition bias) All outcomes ‐ ITT analysis? | Low risk | Figure 1 |
| Selective reporting (reporting bias) | Low risk | VAS for pain and RDQ in outcome measurements and reported in results |
| Similarity of baseline characteristics? | Low risk | Table 1 |
| Co‐interventions avoided or similar? | High risk | Number of visits to allied health professionals higher in BGA (economic evaluation article, results) |
| Compliance acceptable? | Low risk | UC on average 15.5 treatments, BGA 14.8 |
| Timing outcome assessments similar? | Low risk | 3,6,12 months |