title: Lean Participative Process Improvement: Outcomes and Obstacles in Trauma Orthopaedics.
abstract: To examine the effectiveness of a "systems" approach using Lean methodology to improve surgical care, as part of a programme of studies investigating possible synergy between improvement approaches.
  
  
  
  A controlled before-after study using the orthopaedic trauma theatre of a UK Trust hospital as the active site and an elective orthopaedic theatre in the same Trust as control.
  
  
  
  All staff involved in surgical procedures in both theatres.
  
  
  
  A one-day "lean" training course delivered by an experienced specialist team was followed by support and assistance in developing a 6 month improvement project. Clinical staff selected the subjects for improvement and designed the improvements.
  
  
  
  We compared technical and non-technical team performance in theatre using WHO checklist compliance evaluation, "glitch count" and Oxford NOTECHS II in a sample of directly observed operations, and patient outcome (length of stay, complications and readmissions) for all patients. We collected observational data for 3 months and clinical data for 6 months before and after the intervention period. We compared changes in measures using 2-way analysis of variance.
  
  
  
  We studied 576 cases before and 465 after intervention, observing the operation in 38 and 41 cases respectively. We found no significant changes in team performance or patient outcome measures. The intervention theatre staff focused their efforts on improving first patient arrival time, which improved by 20 minutes after intervention.
  
  
  
  This version of "lean" system improvement did not improve measured safety processes or outcomes. The study highlighted an important tension between promoting staff ownership and providing direction, which needs to be managed in "lean" projects. Space and time for staff to conduct improvement activities are important for success.
authors.affiliation: Saïd Business School, University of Oxford, Oxford, United Kingdom.
authors.forename: Steve
authors.initials: S
authors.lastname: New
authors.affiliation: Warwick Medical School, University of Coventry and Warwick, Warwick, United Kingdom.
authors.forename: Mohammed
authors.initials: M
authors.lastname: Hadi
authors.affiliation: Warwick Medical School, University of Coventry and Warwick, Warwick, United Kingdom.
authors.forename: Sharon
authors.initials: S
authors.lastname: Pickering
authors.affiliation: Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom.
authors.forename: Eleanor
authors.initials: E
authors.lastname: Robertson
authors.affiliation: Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom.
authors.forename: Lauren
authors.initials: L
authors.lastname: Morgan
authors.affiliation: Warwick Medical School, University of Coventry and Warwick, Warwick, United Kingdom.
authors.forename: Damian
authors.initials: D
authors.lastname: Griffin
authors.affiliation: Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom.
authors.forename: Gary
authors.initials: G
authors.lastname: Collins
authors.affiliation: Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.
authors.forename: Oliver
authors.initials: O
authors.lastname: Rivero-Arias
authors.affiliation: Cedars-Sinai Medical Centre, Los Angeles, United States of America.
authors.forename: Ken
authors.initials: K
authors.lastname: Catchpole
authors.affiliation: Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom.
authors.forename: Peter
authors.initials: P
authors.lastname: McCulloch
mesh_terms: D057189:Checklist; D002983:Clinical Competence; D065187:Controlled Before-After Studies / Q000379:methods; D017558:Elective Surgical Procedures / Q000379:methods; D006801:Humans; D007902:Length of Stay; D009873:Operating Rooms / Q000379:methods; D009985:Orthopedics / Q000379:methods*; D017063:Outcome Assessment, Health Care / Q000379:methods; D010348:Patient Care Team; D014947:Wounds and Injuries / Q000601:surgery*