Evidence Generation for Wound Care Dressing Selection: reviewing the issues
Abstract
In the UK, dressings are categorised as medical devices and manufacturers only have to provide limited evidence of effectiveness before dressings are used in clinical practice. Therefore, evidence based on clinical trial methods is scant. As a direct result, governing bodies in the UK are now recommending that decisions to select one dressing over another could mainly be made on price. Placed within the movement critiquing evidence-based practice (EBP), this paper summarises the main issues surrounding the generation of evidence in selecting dressings for wound care, which is immersed in a context that lacks resources, legislative clarity and freedom to choose methodological alternatives. Dressings are therapeutic medical devices rather than consumables and any rationalisation based on costs may have far-reaching implications for wound care clinicians through purchasing decisions and thus may limit their ability to manage wounds effectively.
The incidence of wounds in the UK population is considerable. Guest et al.1 reported that the NHS managed an estimated 2.2 million patients with a wound during 2012/2013, equivalent to 4.5% of the adult population, estimated to cost the NHS £5.3 billion, amounting to 4% of the total expenditure on UK public health in 2013. In a later paper,2 they recommend faster adoption of advanced dressings with ‘proven clinical effectiveness’; proving the clinical effectiveness of dressings is however, not as straightforward as it may seem.
Madden3 reported that wound care clinicians expressed an antagonistic relationship toward evidence-based practice (EBP), positioning it in opposition to clinical knowledge. She adds that wound care clinicians see EBP as an obstacle to innovation and as a remover of solutions. While she correctly points out that dressings used in wound care are medical devices, it is not the only reasons why there is limited empirical evidence to support clinical practice. The challenges faced in generating evidence for dressing selection in wound care are multi-factorial: from a legal viewpoint dressings are listed as medical devices limiting the need for evidence generation; from a methodological point of view, generating evidence using trial methodologies has proven challenging for a number of technical reasons4 which are well recognised in clinical practice.
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