Grades of recommendation (A-D) and levels of evidence 1a-1c, 2a-2c, 3a, 3b, 4, 5) are defined at the end of the "Major Recommendations" field.
Recommendation 1 – Level of Evidence C
Institutions and practitioners should strive to create the least restrictive but safest environment for patients in regard to restraint use. This is in keeping with the goals of maintaining the dignity and comfort of our patients while providing excellence in medical care.
Recommendation 2 – Level of Evidence C
Restraining therapies should be used only in clinically appropriate situations and not as a routine component of therapy. When restraints are used, the risk of untoward treatment interference events must outweigh the physical, psychological, and ethical risks of their use.
Recommendation 3 – Level of Evidence C
Patients must always be evaluated to determine whether treatment of an existing problem would obviate the need for restraint use. Alternatives to restraining therapies should be considered to minimize the need for and extent of their use.
Recommendation 4 – Level of Evidence C
The choice of restraining therapy should be the least invasive option capable of optimizing patient safety, comfort, and dignity.
Recommendation 5 – Level of Evidence C
The rationale for restraint use must be documented in the medical record. Orders for restraining therapy should be limited in duration to a 24-hr period. New orders should be written after 24 hrs if restraining therapies are to be continued. The potential to discontinue or reduce restraining therapy should be considered at least every 8 hrs.
Recommendation 6 – Level of Evidence C
Patients should be monitored for the development of complications from restraining therapies at least every 4 hrs, more frequently if the patient is agitated or if otherwise clinically indicated. Each assessment for complications should be documented in the medical record.
Recommendation 7 – Level of Evidence C
Patients and their significant others should receive ongoing education as to the need for and nature of restraining therapies.
Recommendation 8 – Level of Evidence C
Analgesics, sedatives, and neuroleptics used for the treatment of pain, anxiety, or psychiatric disturbance of the intensive care unit patient should be used as agents to mitigate the need for restraining therapies and not overused as a method of chemical restraint.
Recommendation 9 – Level of Evidence C
Patients who receive neuromuscular blocking agents must have adequate sedation, amnesia, and analgesia. The use of neuromuscular blocking agents necessitates frequent neuromuscular blockade assessment to minimize the serious sequelae associated with long-term paralysis. Neuromuscular blocking agents should not be used as chemical restraints when not otherwise indicated by the patient’s condition.
Definitions:
Grades of Recommendation
- Levels of evidence 1a, 1b, 1c
- Levels of evidence 2a, 2b, 2c, 3a, 3b
- Levels of evidence 4
- Levels of evidence 5
Levels of Evidence
1a
- Therapy/Prevention, Etiology/Harm: Systems research (SR) (with homogeneity*) of randomized, controlled trial (RCT)
- Prognosis: SR (with homogeneity) of inception cohort studies or a clinical prediction guide (CPG) validated on a test set
- Diagnosis: SR (with homogeneity) of level 1 diagnostic studies or a CPG validated on a test set
1b
- Therapy/Prevention, Etiology/Harm: Individual RCT (with narrow confidence interval*)
- Prognosis: Individual inception cohort study with >80% follow-up
- Diagnosis: Independent blind comparison of an appropriate spectrum of consecutive patients, all of whom have undergone both the diagnostic test and the reference standard
1c
- Therapy/Prevention, Etiology/Harm: All or none*
- Prognosis: All or none case-series*
- Diagnosis: absolute SpPins and SnNouts*
2a
- Therapy/Prevention, Etiology/Harm: SR (with homogeneity) of cohort studies
- Prognosis: SR (with homogeneity) of either retrospective cohort studies or untreated control groups in RCTs
- Diagnosis: SR (with homogeneity) of level >2 diagnostic studies
2b
- Therapy/Prevention, Etiology/Harm: Individual cohort study (including low-quality RCT; e.g., <80% follow-up)
- Prognosis: Retrospective cohort study or follow-up of untreated control patients in an RCT or CPG not validated in a test set
- Diagnosis: Any of:
- Independent blind or objective comparison
- Study performed in a set of nonconsecutive patients or confined to a narrow spectrum of study individuals (or both), all of whom have undergone both the diagnostic test and the reference standard
- A diagnostic CPG not validated in a test set
2c
- Therapy/Prevention, Etiology/Harm: "Outcomes" research
- Prognosis: "Outcomes" research
3a
- Therapy/Prevention, Etiology/Harm: SR (with homogeneity) of case-control studies
3b
- Therapy/Prevention, Etiology/Harm: Individual case-control study
- Diagnosis: Independent blind comparison of an appropriate spectrum, but the reference standard was not applied to all study patients
4
- Therapy/Prevention, Etiology/Harm: Case-series (and poor quality cohort and case-control studies*)
- Prognosis: Case-series (and poor quality prognostic cohort studies*)
- Diagnosis: Any of:
- Reference standard was not objective, unblended, or not independent
- Positive and negative tests were verified using separate reference standards
- Study was performed in an inappropriate spectrum of patients
5
- Therapy/Prevention, Etiology/Harm: Expert opinion without explicit critical appraisal, or based on physiology, bench research, or "first principles"
- Prognosis: Expert opinion without explicit critical appraisal, or based on physiology, bench research, or "first principles"
- Diagnosis: Expert opinion without explicit critical appraisal, or based on physiology, bench research, or "first principles"
* Refer to Table 1 "Cochrane methodology: Levels of evidence and grades of recommendations" in the original guideline document for further explanation.
