Abstract
BackgroundCritically 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.MethodsTwo 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.DiscussionWe 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.Systematic review registrationPROSPERO CRD42015027860 Electronic supplementary materialThe online version of this article (doi:10.1186/s13643-016-0372-8) contains supplementary material, which is available to authorized users.
Highlights
Ill patients frequently experience severe agitation placing them at risk of harm
While acknowledging variation in international physical restraint practice [5], some reports indicate the prevalence of physical restraint is greater than 70% of mechanically ventilated critically ill patients [6] who are in turn at risk of associated adverse physical and psychological consequences annually
Assessment of heterogeneity If we identify sufficient studies evaluating interventions to minimize physical restraint, we will assess clinical and methodological heterogeneity with forest plots and chisquare tests (P < 0.05 represents significant heterogeneity) and using the I2 statistic, which represents the percentage of variability across studies attributable to heterogeneity rather than chance [36]
Summary
Protocol (PRISMA-P) guidelines [27]. We completed the PRISMA-P checklist (Additional file 1). Measurement of treatment effect If we identify sufficient studies evaluating interventions to minimize physical restraint, we will perform metaanalyses for the following outcomes: proportion of patients physically restrained, duration of mechanical ventilation, ICU length of stay, mortality, and adverse events. Subgroup and sensitivity analysis If we identify sufficient studies of interventions to minimize physical restraint, we will perform subgroup analyses considering intervention type and patient characteristics such as age and admission category (medical, surgical, cardiac, neurological, trauma). Assessing confidence in evidence We will use the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach [48] to assess the confidence in the evidence of effectiveness arising from studies evaluating interventions to minimize physical restraint for the following outcomes: proportion of patients physically restrained, duration of mechanical ventilation, ICU length of stay, mortality, and adverse events. Quality of evidence, and confidence in evidence assessment findings will be provided to an interprofessional and international guideline development group to develop recommendations for inclusion in an updated practice guideline on physical restraint for critically ill adults
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