title: Primum non nocere: shared informed decision making in low back pain--a pilot cluster randomised trial.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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).
  
  
  RESULTS
  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%.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN46035546 registered on 11/02/10.
authors.affiliation: Division of Health Sciences, Warwick Medical School, University of Warwick, CV4 7AL Coventry, UK. shilpa.patel@warwick.ac.uk.
authors.forename: Shilpa
authors.initials: S
authors.lastname: Patel
authors.forename: Anne
authors.initials: A
authors.lastname: Ngunjiri
authors.forename: Siew Wan
authors.initials: SW
authors.lastname: Hee
authors.forename: Yaling
authors.initials: Y
authors.lastname: Yang
authors.forename: Sally
authors.initials: S
authors.lastname: Brown
authors.forename: Tim
authors.initials: T
authors.lastname: Friede
authors.forename: Frances
authors.initials: F
authors.lastname: Griffiths
authors.forename: Joanne
authors.initials: J
authors.lastname: Lord
authors.forename: Harbinder
authors.initials: H
authors.lastname: Sandhu
authors.forename: Jill
authors.initials: J
authors.lastname: Thistlethwaite
authors.forename: Colin
authors.initials: C
authors.lastname: Tysall
authors.forename: Martin
authors.initials: M
authors.lastname: Underwood
mesh_terms: D000328:Adult; D016000:Cluster Analysis; D003657:Decision Making; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000175:diagnosis* / Q000523:psychology / Q000628:therapy*; D008297:Male; D057240:Patient Preference / Q000523:psychology; D017060:Patient Satisfaction; D010865:Pilot Projects