Table.
GRADE Evaluation of interventions for Pressure ulcers.
| Important outcomes | Healing rates, Prevention of pressure ulcers | ||||||||
| Studies (Participants) | Outcome | Comparison | Type of evidence | Quality | Consistency | Directness | Effect size | GRADE | Comment |
| What are the effects of preventive interventions in people at risk of developing pressure ulcers? | |||||||||
| 6 (2117) | Prevention of pressure ulcers | Foam alternatives versus standard hospital mattress | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 5 (795) | Prevention of pressure ulcers | Different foam alternatives versus each other | 4 | –1 | 0 | –2 | 0 | Very low | Quality point deducted for incomplete reporting of results. Directness points deducted for underpowered RCTs and small number of comparators |
| 5 (1402) | Prevention of pressure ulcers | Pressure-relieving overlays on operating tables versus standard table alone | 4 | −1 | −1 | −1 | 0 | Very low | Quality point deducted for weak methods. Consistency point deducted for conflicting results between RCTs. Directness point deducted for early termination of 1 RCT |
| 3 (283) | Prevention of pressure ulcers | Low-air-loss beds versus standard intensive-care beds/alternating-pressure mattresses | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for incomplete reporting of intervention and weak methods |
| 2 (730) | Prevention of pressure ulcers | Medical sheep skin overlays versus standard care | 4 | 0 | 0 | –2 | +1 | Moderate | Directness points deducted for selective exclusion of high-risk participants and no intention-to-treat analysis. Effect size point added for RR <0.5 |
| 2 (409) | Prevention of pressure ulcers | Alternating-pressure surfaces versus standard foam mattress | 4 | −3 | 0 | −1 | +1 | Very low | Quality points deducted for unclear allocation concealment, blinding, and incomplete reporting of results. Directness point deducted for no intention-to-treat analysis. Effect size point added for RR <0.5 |
| 10 (1606) | Prevention of pressure ulcers | Alternating-pressure surfaces versus constant-low-pressure supports | 4 | −1 | 0 | −1 | 0 | Low | Quality point deducted for weak methods. Directness point deducted for unclear clinical relevance (heterogeneity in comparators, and wide confidence intervals not excluding clinically important effect) |
| 4 (2153) | Prevention of pressure ulcers | Alternating-pressure surfaces versus each other | 4 | −1 | 0 | −1 | 0 | Low | Quality point deducted for weak methods. Directness point deducted for 3 underpowered RCTs |
| 4 (473) | Prevention of pressure ulcers | Seat cushions versus each other | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for weak methods. Directness point deducted for underpowered individual trials |
| 1 (70) | Prevention of pressure ulcers | Electric profiling beds to prevent pressure ulcers versus standard hospital beds | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for small number of events (no events in either group) |
| 5 (1475) | Prevention of pressure ulcers | Nutritional supplements versus control | 4 | –3 | 0 | –2 | 0 | Very low | Quality points deducted for unclear randomisation, lack of blinding, and high withdrawal rates. Directness points deducted for no intention-to-treat analysis and no between-group analysis in 1 RCT |
| 4 (1055) | Prevention of pressure ulcers | Repositioning versus control, usually standard care | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for weak methods and incomplete reporting of results. Directness point deducted for co-intervention in 1 RCT (change of mattress as well as frequency of repositioning) |
| 1 (46) | Prevention of pressure ulcers | Repositioning at 30 degree tilt versus a 90 degree lateral and supine position | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for sparse data and incomplete reporting of results. Directness point deducted for short follow-up (24 hours) |
| 3 (618) | Prevention of pressure ulcers | Topical lotions and dressings versus placebo or other lotions and dressings | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for incomplete reporting of results and poor follow-up. Directness point deducted for no intention-to-treat analysis |
| 1 (52) | Prevention of pressure ulcers | Air-filled vinyl boot versus hospital pillow | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting of results |
| 1 (111) | Prevention of pressure ulcers | Hydrocellular heel supports versus orthopaedic wool padding/standard care | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and no intention-to-treat analysis |
| 1 (98) | Prevention of pressure ulcers | Low-air-loss hydrotherapy beds versus other specialised support surfaces | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and weak methods |
| What are the effects of treatments in people with pressure ulcers? | |||||||||
| 3 (202) | Healing rates | Air-fluidised supports versus standard care | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for incomplete reporting of results. Directness point deducted for no intention-to-treat analysis |
| 5 (372) | Healing rates | Alternating-pressure surfaces versus standard/other care | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for incomplete reporting of results and poor study completion rate |
| at least 32 (at least 208) | Healing rates | Debridement versus no debridement or different debriding agents versus each other | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for incomplete reporting of results, weak methods, and poor trial completion |
| 7 (at least 396) | Healing rates | Hydrocolloid dressings versus gauze soaked in saline, hypochlorite, or povidone iodine | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for weak methods. Directness point deducted for significance of meta-analysis result being sensitive to the method of calculation |
| 15 (unclear) | Healing rates | Hydrocolloid dressings versus non-hydrocolloid dressings other than gauze soaked in saline, hypochlorite, or povidone iodine | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for weak methods and incomplete reporting of results |
| 6 (154) | Healing rates | Electrotherapy versus sham electrotherapy or standard treatment | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for weak methods and incomplete reporting of results |
| 4 (360) | Healing rates | Low-air-loss beds versus standard beds or standard care | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for incomplete reporting of results. Directness point deducted for no statistical analysis between groups for 2 analyses |
| 2 (104) | Healing rates | Low-level laser treatment versus standard care or sham treatment | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting of results |
| 1 (120) | Healing rates | Low-tech constant-low-pressure supports versus each other | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting of results |
| 9 (400) | Healing rates | Nutritional supplements versus control | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for weak methods and incomplete reporting of results. Directness point deducted for no intention-to-treat analysis in some trials |
| 2 (235) | Healing rates | Seat cushions versus each other or standard care | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for incomplete reporting of results and weak methods. Directness point deducted for no intention-to-treat analysis (selective exclusion of participants from analysis) |
| 2 (128) | Healing rates | Ultrasound versus sham ultrasound | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data, weak methods, and incomplete reporting of results |
| 1 (18) | Healing rates | Ultrasound plus ultraviolet light versus standard care or versus laser treatment | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data, weak methods, and small number of events (3 failures in total in trial) |
| 2 (57) | Healing rates | Topical negative pressure versus control | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data, weak methods, and differences between groups at baseline |
| 3 (159) | Healing rates | Topical phenytoin versus control/standard treatment | 4 | –2 | –1 | –1 | 0 | Very low | Quality points deducted for sparse data and weak methods. Consistency point deducted for conflicting results. Directness point deducted for baseline differences |
We initially allocate 4 points to evidence from RCTs, and 2 points to evidence from observational studies. To attain the final GRADE score for a given comparison, points are deducted or added from this initial score based on preset criteria relating to the categories of quality, directness, consistency, and effect size. Quality: based on issues affecting methodological rigour (e.g., incomplete reporting of results, quasi-randomisation, sparse data [<200 people in the analysis]). Consistency: based on similarity of results across studies. Directness: based on generalisability of population or outcomes. Effect size: based on magnitude of effect as measured by statistics such as relative risk, odds ratio, or hazard ratio.