Primum non nocere: shared informed decision making in low back pain

Low back pain is a widespread and disabling condition leading to large health service and societal costs. While there are several treatment options for back pain not much is known about how to improve patient choice in treatment selection. The goal of this study was to pilot a decision support package to help people choose between low back pain treatments. This was a single-centred pilot cluster randomised controlled trial conducted in a community physiotherapy service. Adults with non-specific low back pain referred for physiotherapy were included. Intervention participants were sent an information booklet prior to their first consultation. Intervention physiotherapists were trained to enhance their skills in shared informed decision making. Those in the control group were given care as usual. The primary outcome was satisfaction with the treatment received at four months using a five-point Likert Scale dichotomised into “satisfaction” (very satisfied or somewhat satisfied) and “non-satisfaction” (neither satisfied nor dissatisfied, somewhat dissatisfied or very dissatisfied). 148 participants participated in the study. In the control group 67% of participants were satisfied with their treatment and in the intervention group 53%. The adjusted relative risk of being satisfied was 1.28 (95% confidence interval 0.79 to 2.09). For most secondary outcomes the trend was towards worse outcomes in the intervention group. For one measure; the Roland Morris Disability Questionnaire, this difference was clinically significant (2.27, 95% confidence interval 0.08 to 4.47). Mean healthcare costs were slightly lower (£38 saving per patient) within the intervention arm but health outcomes were also less favourable (0.02 fewer QALYs); the estimated probability that the intervention would be cost-effective at an incremental threshold of £20,000 per QALY was 16%.

This study failed to find that this decision support package improved satisfaction with treatment; it may have had a significant detrimental effect on clinical outcome, and is very unlikely to prove cost-effective. That a decision support package might have a clinically important detrimental effect is of concern. Decision support packages should be formally tested for clinical and cost-effectiveness, and safety before implementation.