title: Development of Process Control Methodology for Tracking the Quality and Safety of Pain, Agitation, and Sedation Management in Critical Care Units.
abstract: OBJECTIVE
  To develop sedation, pain, and agitation quality measures using process control methodology and evaluate their properties in clinical practice.
  
  
  METHODS
  A Sedation Quality Assessment Tool was developed and validated to capture data for 12-hour periods of nursing care. Domains included pain/discomfort and sedation-agitation behaviors; sedative, analgesic, and neuromuscular blocking drug administration; ventilation status; and conditions potentially justifying deep sedation. Predefined sedation-related adverse events were recorded daily. Using an iterative process, algorithms were developed to describe the proportion of care periods with poor limb relaxation, poor ventilator synchronization, unnecessary deep sedation, agitation, and an overall optimum sedation metric. Proportion charts described processes over time (2 monthly intervals) for each ICU. The numbers of patients treated between sedation-related adverse events were described with G charts. Automated algorithms generated charts for 12 months of sequential data. Mean values for each process were calculated, and variation within and between ICUs explored qualitatively.
  
  
  METHODS
  Eight Scottish ICUs over a 12-month period.
  
  
  METHODS
  Mechanically ventilated patients.
  
  
  METHODS
  None.
  
  
  RESULTS
  The Sedation Quality Assessment Tool agitation-sedation domains correlated with the Richmond Sedation Agitation Scale score (Spearman ρ = 0.75) and were reliable in clinician-clinician (weighted kappa; κ = 0.66) and clinician-researcher (κ = 0.82) comparisons. The limb movement domain had fair correlation with Behavioral Pain Scale (ρ = 0.24) and was reliable in clinician-clinician (κ = 0.58) and clinician-researcher (κ = 0.45) comparisons. Ventilator synchronization correlated with Behavioral Pain Scale (ρ = 0.54), and reliability in clinician-clinician (κ = 0.29) and clinician-researcher (κ = 0.42) comparisons was fair-moderate. Eight hundred twenty-five patients were enrolled (range, 59-235 across ICUs), providing 12,385 care periods for evaluation (range 655-3,481 across ICUs). The mean proportion of care periods with each quality metric varied between ICUs: excessive sedation 12-38%; agitation 4-17%; poor relaxation 13-21%; poor ventilator synchronization 8-17%; and overall optimum sedation 45-70%. Mean adverse event intervals ranged from 1.5 to 10.3 patients treated. The quality measures appeared relatively stable during the observation period.
  
  
  CONCLUSIONS
  Process control methodology can be used to simultaneously monitor multiple aspects of pain-sedation-agitation management within ICUs. Variation within and between ICUs could be used as triggers to explore practice variation, improve quality, and monitor this over time.
authors.affiliation: 1Anaesthetics, Critical Care and Pain Medicine, University of Edinburgh, Edinburgh, United Kingdom.2Centre for Population Health Sciences, University of Edinburgh, Edinburgh, United Kingdom.3Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, United Kingdom.4Department of Anaesthetics, Ninewells Hospital, National Health Service Tayside, Dundee, United Kingdom.5University Department of Anaesthetics, Glasgow University, Glasgow Royal Infirmary, Glasgow, United Kingdom.6Department of Anaesthetics, Monklands Hospital, National Health Service Lanarkshire, United Kingdom.7Department of Anaesthetics, Kirkcaldy Hospital, National Health Service Fife, United Kingdom.8Department of Anaesthetics, Victoria Infirmary, National Health Service GGC, Glasgow, United Kingdom.9Department of Anaesthetics, Dumfries Hospital, National Health Service Dumfries and Galloway, United Kingdom.10Department of Anaesthetics, Forth Valley Royal Hospital, National Health Service Forth Valley, United Kingdom.11Edinburgh Health Services Research Unit, Edinburgh University, Edinburgh, United Kingdom.
authors.forename: Timothy S
authors.initials: TS
authors.lastname: Walsh
authors.forename: Kalliopi
authors.initials: K
authors.lastname: Kydonaki
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Lee
authors.forename: Kirsty
authors.initials: K
authors.lastname: Everingham
authors.forename: Jean
authors.initials: J
authors.lastname: Antonelli
authors.forename: Ronald T
authors.initials: RT
authors.lastname: Harkness
authors.forename: Stephen
authors.initials: S
authors.lastname: Cole
authors.forename: Tara
authors.initials: T
authors.lastname: Quasim
authors.forename: James
authors.initials: J
authors.lastname: Ruddy
authors.forename: Marcia
authors.initials: M
authors.lastname: McDougall
authors.forename: Alan
authors.initials: A
authors.lastname: Davidson
authors.forename: John
authors.initials: J
authors.lastname: Rutherford
authors.forename: Jonathan
authors.initials: J
authors.lastname: Richards
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Weir
mesh_terms: D000368:Aged; D000700:Analgesics / Q000008:administration & dosage; D016292:Procedural Sedation / Q000592:standards*; D003422:Critical Care / Q000592:standards; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage; D007362:Intensive Care Units / Q000592:standards; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000592:standards; D059408:Pain Management; D017064:Process Assessment, Health Care / Q000379:methods; D011446:Prospective Studies; D011595:Psychomotor Agitation / Q000517:prevention & control*; D058996:Quality Improvement; D015203:Reproducibility of Results; D012121:Respiration, Artificial; D012606:Scotland
chemical_list: D000700:Analgesics; D006993:Hypnotics and Sedatives