title: The implausibility of 'usual care' in an open system: sedation and weaning practices in Paediatric Intensive Care Units (PICUs) in the United Kingdom (UK).
abstract: BACKGROUND
  The power of the randomised controlled trial depends upon its capacity to operate in a closed system whereby the intervention is the only causal force acting upon the experimental group and absent in the control group, permitting a valid assessment of intervention efficacy. Conversely, clinical arenas are open systems where factors relating to context, resources, interpretation and actions of individuals will affect implementation and effectiveness of interventions. Consequently, the comparator (usual care) can be difficult to define and variable in multi-centre trials. Hence outcomes cannot be understood without considering usual care and factors that may affect implementation and impact on the intervention.
  
  
  METHODS
  Using a fieldwork approach, we describe PICU context, 'usual' practice in sedation and weaning from mechanical ventilation, and factors affecting implementation prior to designing a trial involving a sedation and ventilation weaning intervention. We collected data from 23 UK PICUs between June and November 2014 using observation, individual and multi-disciplinary group interviews with staff.
  
  
  RESULTS
  Pain and sedation practices were broadly similar in terms of drug usage and assessment tools. Sedation protocols linking assessment to appropriate titration of sedatives and sedation holds were rarely used (9% and 4% of PICUs respectively). Ventilator weaning was primarily a medical-led process with 39% of PICUs engaging senior nurses in the process: weaning protocols were rarely used (9% of PICUs). Weaning methods were variably based on clinician preference. No formal criteria or use of spontaneous breathing trials were used to test weaning readiness. Seventeen PICUs (74%) had prior engagement in multi-centre trials, but limited research nurse availability. Barriers to previous trial implementation were intervention complexity, lack of belief in the evidence and inadequate training. Facilitating factors were senior staff buy-in and dedicated research nurse provision.
  
  
  CONCLUSIONS
  We examined and identified contextual and organisational factors that may impact on the implementation of our intervention. We found usual practice relating to sedation, analgesia and ventilator weaning broadly similar, yet distinctively different from our proposed intervention, providing assurance in our ability to evaluate intervention effects. The data will enable us to develop an implementation plan; considering these factors we can more fully understand their impact on study outcomes.
authors.affiliation: School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, University Road, Belfast, BT7 1NN, Northern Ireland, UK. b.blackwood@qub.ac.uk.
authors.forename: Bronagh
authors.initials: B
authors.lastname: Blackwood
authors.affiliation: School of Health, PICU, Alder Hey Hospital, Eaton Road, Liverpool, Merseyside, L12 2AP, UK. Lyvonne.tume@alderhey.nhs.uk.|University of Central Lancashire, Fylde Road, Preston, Lancashire, PR1 2HE, UK. Lyvonne.tume@alderhey.nhs.uk.
authors.forename: Lyvonne
authors.initials: L
authors.lastname: Tume
mesh_terms: D002648:Child; D002675:Child, Preschool; D020445:Hospitalists / Q000639:trends; D006801:Humans; D006993:Hypnotics and Sedatives / Q000627:therapeutic use*; D007223:Infant; D015278:Intensive Care Units, Pediatric / Q000639:trends*; D009741:Nursing Staff, Hospital / Q000639:trends; D059408:Pain Management / Q000639:trends*; D010561:Personnel Staffing and Scheduling / Q000639:trends; D010818:Practice Patterns, Physicians' / Q000639:trends*; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D012108:Research Personnel / Q000639:trends; D006113:United Kingdom; D015300:Ventilator Weaning / Q000639:trends*
chemical_list: D006993:Hypnotics and Sedatives