title: Study protocol of an economic evaluation of an extended implementation strategy for the treatment of low back pain in general practice: a cluster randomised controlled trial.
abstract: BACKGROUND
  In Denmark, guidelines on low back pain management are currently being implemented; in association with this, a clinical trial is conducted. A health economic evaluation is carried out alongside the clinical trial to assess the cost-effectiveness of an extended implementation strategy to increase the general practitioners' adherence to the guidelines. In addition to usual dissemination, the extended implementation strategy is composed of visits from a guideline facilitator, stratification tools, and feedback on guideline adherence. The aim of this paper is to provide the considerations on the design of the health economic evaluation.
  
  
  METHODS
  The economic evaluation is carried out alongside a cluster randomised controlled trial consisting of 60 general practices in the North Denmark Region. An expected 1,200 patients between the age of 18 and 65 years with a low back pain diagnosis will be enrolled. The economic evaluation comprises both a cost-effectiveness analyses and a cost-utility analysis. Effectiveness measures include referral to secondary care, health-related quality of life measured by EQ-5D-5L, and disability measured by the Roland Morris disability questionnaire. Cost measures include all relevant additional costs of the extended implementation strategy compared to usual implementation. The economic evaluation will be performed from both a societal perspective and a health sector perspective with a 12-month time horizon.
  
  
  CONCLUSIONS
  It is expected that the extended implementation strategy will reduce the number of patients referred to secondary care. It is hypothesised that the additional upfront cost of extended implementation will be counterbalanced by improvements in clinical practice and patient-related outcomes, thereby rendering the extended implementation strategy cost-effective.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01699256.
authors.affiliation: Danish Center for Healthcare Improvements, Faculty of Social Sciences and Faculty of Health Sciences, Aalborg University, Aalborg, Denmark. celga@business.aau.dk.
authors.forename: Cathrine Elgaard
authors.initials: CE
authors.lastname: Jensen
authors.forename: Allan
authors.initials: A
authors.lastname: Riis
authors.forename: Kjeld Møller
authors.initials: KM
authors.lastname: Pedersen
authors.forename: Martin Bach
authors.initials: MB
authors.lastname: Jensen
authors.forename: Karin Dam
authors.initials: KD
authors.lastname: Petersen
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D003362:Cost-Benefit Analysis; D005260:Female; D058006:General Practice / Q000191:economics / Q000379:methods*; D019983:Guideline Adherence / Q000191:economics; D006801:Humans; D017116:Low Back Pain / Q000191:economics / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D016730:Program Development; D011788:Quality of Life; D055815:Young Adult