title: Effectiveness of facilitated introduction of a standard operating procedure into routine processes in the operating theatre: a controlled interrupted time series.
abstract: BACKGROUND
  Standard operating procedures (SOPs) should improve safety in the operating theatre, but controlled studies evaluating the effect of staff-led implementation are needed.
  
  
  METHODS
  In a controlled interrupted time series, we evaluated three team process measures (compliance with WHO surgical safety checklist, non-technical skills and technical performance) and three clinical outcome measures (length of hospital stay, complications and readmissions) before and after a 3-month staff-led development of SOPs. Process measures were evaluated by direct observation, using Oxford Non-Technical Skills II for non-technical skills and the 'glitch count' for technical performance. All staff in two orthopaedic operating theatres were trained in the principles of SOPs and then assisted to develop standardised procedures. Staff in a control operating theatre underwent the same observations but received no training. The change in difference between active and control groups was compared before and after the intervention using repeated measures analysis of variance.
  
  
  RESULTS
  We observed 50 operations before and 55 after the intervention and analysed clinical data on 1022 and 861 operations, respectively. The staff chose to structure their efforts around revising the 'whiteboard' which documented and prompted tasks, rather than directly addressing specific task problems. Although staff preferred and sustained the new system, we found no significant differences in process or outcome measures before/after intervention in the active versus the control group. There was a secular trend towards worse outcomes in the postintervention period, seen in both active and control theatres.
  
  
  CONCLUSIONS
  SOPs when developed and introduced by frontline staff do not necessarily improve operative processes or outcomes. The inherent tension in improvement work between giving staff ownership of improvement and maintaining control of direction needs to be managed, to ensure staff are engaged but invest energy in appropriate change.
authors.affiliation: Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.
authors.forename: Lauren
authors.initials: L
authors.lastname: Morgan
authors.affiliation: Saïd Business School, University of Oxford, Oxford, UK.
authors.forename: Steve
authors.initials: S
authors.lastname: New
authors.affiliation: Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.
authors.forename: Eleanor
authors.initials: E
authors.lastname: Robertson
authors.affiliation: Centre for Statistics in Medicine, University of Oxford, Oxford, UK.
authors.forename: Gary
authors.initials: G
authors.lastname: Collins
authors.affiliation: Nuffield Department of Population Health, University of Oxford, Oxford, UK Red de Investigación de Servicios Sanitarios en Cronicidad (REDISSEC), Spain.
authors.forename: Oliver
authors.initials: O
authors.lastname: Rivero-Arias
authors.affiliation: Cedars-Sinai Medical Centre, Los Angeles, USA.
authors.forename: Ken
authors.initials: K
authors.lastname: Catchpole
authors.affiliation: Warwick Medical School, University of Coventry and Warwick, Warwick, UK.
authors.forename: Sharon P
authors.initials: SP
authors.lastname: Pickering
authors.affiliation: Warwick Medical School, University of Coventry and Warwick, Warwick, UK.
authors.forename: Mohammed
authors.initials: M
authors.lastname: Hadi
authors.affiliation: Warwick Medical School, University of Coventry and Warwick, Warwick, UK.
authors.forename: Damian
authors.initials: D
authors.lastname: Griffin
authors.affiliation: Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.
authors.forename: Peter
authors.initials: P
authors.lastname: McCulloch
mesh_terms: D057189:Checklist / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D065186:Interrupted Time Series Analysis; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D009873:Operating Rooms / Q000458:organization & administration* / Q000592:standards; D010359:Patient Readmission / Q000706:statistics & numerical data; D061214:Patient Safety; D015397:Program Evaluation; D013514:Surgical Procedures, Operative / Q000009:adverse effects / Q000379:methods* / Q000592:standards
keywords: Patient safety; Quality improvement; Surgery