Rehabilitation following lumbar fusion surgery (REFS) a randomised controlled feasibility study.

PURPOSE: Following lumbar fusion surgery (LFS), 40% of patients are unsure/dissatisfied with their outcome. A prospective, single-centre, randomised, controlled trial was conducted to evaluate the feasibility (including clinical and economic impact) of a theoretically informed rehabilitation programme following LFS (REFS). METHODS: REFS was informed by an explicit theoretical framework and consisted of 10 consecutive weekly group rehabilitation sessions (education, low-tech cardiovascular, limb and spine strengthening exercises, and peer support). Participants were randomised to REFS or 'usual care.' Primary feasibility outcomes included recruitment and engagement. Secondary outcomes, collected preoperatively and 3, 6, and 12  months postoperatively, comprised the Oswestry disability index, European Quality of Life 5 dimensions score, pain self-efficacy questionnaire, hospital anxiety and depression scale and the aggregated functional performance time. Economic impact was evaluated with the Client Services Receipt Inventory. RESULTS: Fifty-two of 58 eligible participants were recruited, and engagement with REFS was > 95%. REFS participants achieved a clinically meaningful reduction in unadjusted mean short-term disability (- 13.27 ± 13.46), which was not observed in the 'usual care' group (- 2.42 ± 12.33). This was maintained in the longer term (- 14.72% ± 13.34 vs - 7.57 ± 13.91). Multilevel regression analyses, adjusted for body mass index, baseline depression, and smoking status reported a statistically significant short-term improvement in disability (p = 0.014) and pain self-efficacy (p = 0.007). REFS costs £275 per participant. CONCLUSIONS: Results suggest that REFS is feasible and potentially affordable for delivery in the National Health Service. It is associated with a clinically meaningful impact. A multicentre randomised controlled study to further elucidate these results is warranted. These slides can be retrieved under Electronic Supplementary Material.

Biotechnology: delivering on the promise.

The research and development of innovative new therapies are expensive and risky processes, and companies require substantial resources if they are to translate basic science into modern biomedical products. When resources are limited, as in the current economic climate, biotechnology start-up companies are often among the first casualties in the fight for assets. Policy-makers can play an important role in bolstering these important innovators.