Primum non nocere: shared informed decision making in low back pain – a pilot cluster randomised trial
1 Division of Health Sciences, Warwick Medical School, University of Warwick, CV4 7AL Coventry, UK
2 Department of Primary Care Health Sciences, Radcliffe Observatory Quarter, Oxford University, OX2 6GG Oxford, UK
3 Universities/User Teaching and Research Action Partnership (UNTRAP), University of Warwick, CV4 7AL Coventry, UK
4 Department of Medical Statistics, University Medical Centre Göttingen, Humboldtallee 32, D-37073 Göttingen, Germany
5 Health Economics Research Group, Brunel University, UB8 3PH Uxbridge, UK
6 Health Professions Education Consultant, Sydney, Australia
BMC Musculoskeletal Disorders 2014, 15:282 doi:10.1186/1471-2474-15-282Published: 21 August 2014
Low back pain is a common and disabling condition leading to large health service and societal costs. Although there are several treatment options for back pain little is known about how to improve patient choice in treatment selection. The purpose 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. We included adults with non-specific low back pain referred for physiotherapy. 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 arm received 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).
We recruited 148 participants. In the control arm 67% of participants were satisfied with their treatment and in the intervention arm 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 important (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%.
We did not find that this decision support package improved satisfaction with treatment; it may have had a substantial negative 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. To our knowledge this has not been observed previously. Decision support packages should be formally tested for clinical and cost-effectiveness, and safety before implementation.
Current Controlled Trials ISRCTN46035546 registered on 11/02/10.