Chapter 15 Skin Integrity

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TABLE 15.2 National Pressure Ulcer Advisory Panel Levels of Evidence, Strengths of Evidence, and Strengths of Recommendations

Levels of Evidence

Level 1 Intervention Studies

Randomized trial(s) with clear-cut results and low risk of error OR systematic literature review or meta- analysis according to the Cochrane methodology or meeting at least 9 out of 11 quality criteria according to AMSTAR appraisal tool.

Level 2

Randomized trial(s) with uncertain results and moderate to high risk of error.

Level 3

Nonrandomized trial(s) with concurrent or

contemporaneous controls. Level 4

Nonrandomized trial(s) with historical controls

Level 5

Case series with no controls. Specify number of subjects.

Strengths of Evidence

A—The recommendation is supported by direct scientific evidence from properly designed and implemented con- trolled trials on pressure ulcers in humans (or humans at risk for pressure ulcers), providing statistical results that consistently support the recommendation (Level 1 studies required).

B—The recommendation is supported by direct scientific evidence from properly designed and implemented clinical series on pressure ulcers in humans (or humans at risk for pressure ulcers), providing statistical results that consist- ently support the recommendation (Level 2–5 studies).

C—The recommendation is supported by indirect evidence (eg, studies in healthy humans, humans with other types of chronic wounds, or animal models) and/or expert opinion.

Strengths of Recommendations

: Strong positive recommendation—definitely do it : Weak positive recommendation—probably do it : No specific recommendation : Weak negative recommendation—probably probably don’t do it : Strong negative recommendation—definitely don’t do it

Source: Used with permission of the National Pressure Ulcer Advisory Panel, 2010. Diagnostic Studies

Systematic review of high-quality (cross-sectional) studies according to the quality

assessment tools with consistently applied reference standard and blinding.

Prognostic Studies

Systematic review of high- quality (longitudinal) prospective cohort studies according to the quality assessment tools.

Individual high-quality (cross sectional) studies according to the quality assessment tools with consistently applied reference standard and blinding among consecutive persons.

Nonconsecutive studies, or studies without consistently applied reference standards.

Case-control studies, or poor/non- independent reference standard.

Mechanism-based reasoning, study of diagnostic yield (no reference standard).

A prospective cohort study.

Analysis of prognostic factors among persons in a single arm of a randomized controlled trial.

Case-series or case-control studies, or poor quality prognostic cohort study, retrospective cohort study.

Not applicable.