title: A mixed-methods systematic review protocol to examine the use of physical restraint with critically ill adults and strategies for minimizing their use.
abstract: Critically ill patients frequently experience severe agitation placing them at risk of harm. Physical restraint is common in intensive care units (ICUs) for clinician concerns about safety. However, physical restraint may not prevent medical device removal and has been associated with negative physical and psychological consequences. While professional society guidelines, legislation, and accreditation standards recommend physical restraint minimization, guidelines for critically ill patients are over a decade old, with recommendations that are non-specific. Our systematic review will synthesize evidence on physical restraint in critically ill adults with the primary objective of identifying effective minimization strategies.
  
  
  
  Two authors will independently search from inception to July 2016 the following: Ovid MEDLINE, CINAHL, Embase, Web of Science, Cochrane Library, PROSPERO, Joanna Briggs Institute, grey literature, professional society websites, and the International Clinical Trials Registry Platform. We will include quantitative and qualitative study designs, clinical practice guidelines, policy documents, and professional society recommendations relevant to physical restraint of critically ill adults. Authors will independently perform data extraction in duplicate and complete risk of bias and quality assessment using recommended tools. We will assess evidence quality for quantitative studies using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach and for qualitative studies using the Confidence in the Evidence from Reviews of Qualitative Research (CERQual) guidelines. Outcomes of interest include (1) efficacy/effectiveness of physical restraint minimization strategies; (2) adverse events (unintentional device removal, psychological impact, physical injury) and associated benefits including harm prevention; (3) ICU outcomes (ventilation duration, length of stay, and mortality); (4) prevalence, incidence, patterns of use including patient and treatment characteristics and chemical restraint; (5) barriers and facilitators to minimization; (6) patient, family, and healthcare professional perspectives; (7) professional society-endorsed recommendations; and (8) evidence gaps and research priorities.
  
  
  
  We will use our systematic review findings to produce updated guidelines on physical restraint use for critically ill adults and to develop a professional society-endorsed position statement. This will foster patient and clinician safety by providing clinicians, administrators, and policy makers with a tool to promote minimal and safe use of physical restraint for critically ill adults.
  
  
  
  PROSPERO CRD42015027860.
authors.affiliation: Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, 2075 Bayview Ave, Toronto, M4N 3M5, Canada. louise.rose@utoronto.ca.|Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, 155 College St., Toronto, M5T 1P8, Canada. louise.rose@utoronto.ca.|Institute for Clinical Evaluative Sciences, Veterans Hill Trail, 2075 Bayview Avenue G1 06, Toronto, M4N 3M5, Canada. louise.rose@utoronto.ca.|Provincial Centre of Weaning Excellence, Michael Garron Hospital, 825 Coxwell Ave, East York, M4C 3E7, Canada. louise.rose@utoronto.ca.
authors.forename: Louise
authors.initials: L
authors.lastname: Rose
authors.affiliation: Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, 155 College St., Toronto, M5T 1P8, Canada.
authors.forename: Craig
authors.initials: C
authors.lastname: Dale
authors.affiliation: Department of Critical Care, Nursing/Clinical Research, Li Ka Shing Knowledge Institute, St. Michael's Hospital, 30 Bond St, Toronto, ON, M5B 1W8, Canada.
authors.forename: Orla M
authors.initials: OM
authors.lastname: Smith
authors.affiliation: Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College St, Toronto, M5S 3M2, Canada.|Mount Sinai Hospital, 600 University Ave, Toronto, M5G 1X5, Canada.
authors.forename: Lisa
authors.initials: L
authors.lastname: Burry
authors.affiliation: Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, 155 College St., Toronto, M5T 1P8, Canada.
authors.forename: Glenn
authors.initials: G
authors.lastname: Enright
authors.affiliation: Clinical Epidemiology Program, Ottawa Hospital Research Institute, 500 Smyth Road, Ottawa, ON, K1H 8L6, Canada.|Faculty of Medicine, University of Ottawa, 451 Smyth Rd, Ottawa, K1H 8M5, Canada.
authors.forename: Dean
authors.initials: D
authors.lastname: Fergusson
authors.affiliation: Mount Sinai Hospital, 600 University Ave, Toronto, M5G 1X5, Canada.|Faculty of Medicine, University of Toronto Medical Sciences Building, 1 King's College Cir #3172, Toronto, M5S 1A8, Canada.|Department of Family and Community Medicine, 500 University Ave, Toronto, M5G 1V7, Canada.|Institute of Health Policy, Management and Evaluation, University of Toronto, 155 College St, Toronto, ON, M5T 3M6, Canada.
authors.forename: Samir
authors.initials: S
authors.lastname: Sinha
authors.affiliation: Mount Sinai Hospital, 600 University Ave, Toronto, M5G 1X5, Canada.
authors.forename: Lesley
authors.initials: L
authors.lastname: Wiesenfeld
authors.affiliation: Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, 2075 Bayview Ave, Toronto, M4N 3M5, Canada.|Faculty of Medicine, University of Toronto Medical Sciences Building, 1 King's College Cir #3172, Toronto, M5S 1A8, Canada.
authors.forename: Tasnim
authors.initials: T
authors.lastname: Sinuff
authors.affiliation: Mount Sinai Hospital, 600 University Ave, Toronto, M5G 1X5, Canada.|Faculty of Medicine, University of Toronto Medical Sciences Building, 1 King's College Cir #3172, Toronto, M5S 1A8, Canada.
authors.forename: Sangeeta
authors.initials: S
authors.lastname: Mehta
mesh_terms: D016638:Critical Illness; D006801:Humans; D007362:Intensive Care Units; D007902:Length of Stay; D063868:Patient Outcome Assessment; D036301:Qualitative Research; D012121:Respiration, Artificial; D012149:Restraint, Physical / Q000009:adverse effects* / Q000706:statistics & numerical data*; D000078202:Systematic Reviews as Topic; D013997:Time Factors
keywords: Intensive care; Mechanical ventilation; Patient safety; Physical restraint; Systematic review