The Australian medical sheepskin prevents pressure ulcers: a combined multilevel analysis of three RCTs.

Mistiaen, P., Jolley, D., McGowan, S., Hickey, M., Spreeuwenberg, P., Francke, A. The Australian medical sheepskin prevents pressure ulcers: a combined multilevel analysis of three RCTs. Journal of Clinical Nursing: 2010, 19(suppl. 1) 20. Abstract. 4th European Nursing Congress 'Older Persons. The Future of Care', 4-5 oktober 2010, Rotterdam.
Introduction: Pressure ulcers can to a large extent be prevented by implementing best practice care. For many of the devices to help in the prevention of pressure ulcers there is lack of evidence-based knowledge about their effectiveness. In this study we performed an individual patient data meta-analysis on one such ulcer preventing device, the Australian Medical Sheepskin (AMS), to assess the effect of it for the prevention of sacral pressure ulcers based on the combined existing trials. Methods and Materials: The effectiveness of the AMS has been studied in three RCTs [two in Australian hospital patients (1;2) and one in Dutch nursing home patients (3)]. All patients received an AMS under the buttocks when lying in bed and in all three trials the incidence of sacral pressure ulcers was used as (one of) the outcome measure. The individual data of the three RCTs were combined into one dataset. Results: The total population consisted of 1281 patients (mean age 72) and covers more than 20 000 observation days. The sacral pressure ulcer incidence was significantly lower in the intervention group in two of the three studies. A conventional meta-analysis with the effect sizes of the three trials showed an odds ratio of 0•37 with a 95% confidence interval between 0•17 and 0•77. The multilevel logistic regression across the three studies and controlled for age, gender, pressure ulcer risk and observation length showed an odds ratio of 0•35 with a 95% confidence interval between 0•23 and 0•55. Conclusion: The multilevel analysis on the combined individual patient data of three RCTs confirms and corroborates the conclusions of the separate RCTs that the AMS is an effective aid to prevent and delay sacral PU. The confidence interval is narrowed almost by half, giving a much more precise estimate of the effect of the intervention. Therefore individual patient data meta-analysis is to be preferred above conventional meta-analysis. (aut. ref.)