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. 2018 Dec 6;2018(12):CD009362. doi: 10.1002/14651858.CD009362.pub3

Summary of findings for the main comparison. Fatty acid versus other topical intervention or standard care for preventing pressure ulcers.

Fatty acid versus other topical intervention or standard care for preventing pressure ulcers
Patient or population: individuals at risk of pressure ulcer development
 Settings: nursing homes (3 trials); orthopaedic unit (1 trial); high‐dependency unit (1 trial)
 Intervention: fatty acid
Comparison: other topical intervention or standard care
Outcomes Illustrative comparative risks* (95% CI) Relative effect
 (95% CI) No of participants
 (trials) Quality of the evidence
 (GRADE) Comments
Assumed risk Corresponding risk
Other topical intervention or standard care Fatty acid
Pressure ulcer incidence: fatty acid vs olive oil Assessed with observation
Follow‐up: range unknown, 16 weeks
Study population RR 1.28 
 (0.76 to 2.17) 1060
 (2 RCTs) ⊕⊕⊝⊝
 Low1 There was no clear difference in pressure ulcer incidence (29/511 (6%) fatty acid, vs 24/549 (4%) olive oil; low‐certainty evidence)
44 per 1000 56 per 1000
 (33 to 95)
Pressure ulcer incidence: fatty acid vs control compound
Assessed
 with observation
Follow‐up: 30 days
Study population RR 0.42 
 (0.22 to 0.80) 331
 (1 RCT) ⊕⊕⊝⊝
 Low2 Fatty acid may reduce pressure ulcer incidence (12/164 (7.3%) fatty acid, vs 29/167 (17.4%) control; low‐certainty evidence)
174 per 1000 73 per 1000
 (38 to 139)
Pressure ulcer incidence: fatty acid vs standard care
Assessed with observation
Follow‐up: range unknown, 30 days
Study population RR 0.70 
 (0.41 to 1.18) 187
 (2 RCTs) ⊕⊕⊝⊝
 Low3 There was no clear difference in pressure ulcer incidence (18/93 (19%) fatty acid, vs 26/94 (28%) standard care; low‐certainty evidence)
277 per 1000 194 per 1000
 (113 to 326)
Pressure ulcer incidence: fatty acid vs olive oil
(high‐quality trials)
Study population RR 1.46 
 (0.77 to 2.75) 831
 (1 RCT) ⊕⊕⊝⊝
 Low4 There was no clear difference in pressure ulcer incidence (fatty acid: 21/394 (5.3%) fatty acid, vs 16/437 (3.7%) olive oil; low‐certainty evidence)
37 per 1000 53 per 1000
 (28 to 101)
Adverse event: fatty acid vs olive oil Study population RR 2.22 
 (0.20 to 24.37) 831
 (1 RCT) ⊕⊕⊝⊝
 Low5 There was no clear difference in adverse events (itching or redness); (fatty acid 2/294 (0.007%), vs 1/437 (0.002%) olive oil; low‐certainty evidence)
2 per 1000 5 per 1000
 (0 to 56)
*The basis for the assumed risk (e.g. the median control group risk across trials) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
 CI: confidence interval; RCT: randomised controlled trial; RR: risk ratio
GRADE Working Group grades of evidenceHigh certainty: we are very confident that the true effect lies close to that of the estimate of the effect.
 Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
 Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.
 Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

1Downgraded twice for imprecision due to the small number of events and the wide confidence interval.
 2Downgraded once for high risk for attrition bias and downgraded once for serious imprecision due to the small number of events.
 3Downgraded once for high risk of performance bias and downgraded once for serious imprecision due to a wide confidence interval.
 4Downgraded twice for imprecision due small number of events leading to a wide confidence interval.
 5Downgraded twice for very serious imprecision due to a very wide confidence interval and very small number of events.