Possible implications and clinical value of commercially sponsored evaluations: discussion on research methodology.

This paper is written in response to a publication in the Journal of Wound Care in 2018 by Guest et al., 'Cost-effectiveness of an electroceutical device in treating non-healing venous leg ulcers: results of an RCT'. The publication and subsequent analysis of the paper provides a vehicle for a wider debate about the care of people with wounds, including who manages the wound, how resources are allocated and the use of supplemental technologies. It also raises a further important issue regarding whether the outcomes from a single randomised controlled trial (RCT) provides a more reliable level of evidence than the findings of previous investigations involving observational trials. This article analyses the results from the cited study, comparing clinical outcomes from previous published studies, and evaluates whether a conclusion may be reached as to the most appropriate and reliable method to assess the efficacy of such medical devices used in wound care. It discusses why the assessment of clinical evidence can be a problem when there is variance of outcomes in studies which use different research methodologies. The hierarchy of evidence lies at the heart of the appraisal process; and within health-care it is common that smaller commercial companies present small-scale observational trials as evidence for the efficacy of the product they are promoting. We question whether this level of data promoted as evidence for clinical efficacy should be dismissed. Guest et al. reported that, in the UK within wound care, clinical practice is inconsistent with significant regional variations; therefore, unless clinical practice guidelines are strictly enforced in a study, which then may be unrepresentative of clinical practice, does it mean that any results produced could not be transferred to the clinical environment? We discuss the conundrum.

Changes in S100 Proteins Identified in Healthy Skin following Electrical Stimulation: Relevance for Wound Healing.

OBJECTIVE: Targeted electrical energy applied to wounds has been shown to improve wound-healing rates. However, the mechanisms are poorly understood. The aim of this study was to identify genes that are responsive to electrical stimulation (ES) in healthy subjects with undamaged skin. METHODS: To achieve this objective, study authors used a small, noninvasive ES medical device to deliver a continuous, specific, set sequence of electrical energy impulses over a 48-hour period to the skin of healthy volunteers and compared resultant gene expression by microarray analysis. MAIN RESULTS: Application of this specific ES resulted in differential expression of 105 genes, the majority of which were down-regulated. Postmicroarray analyses revealed there was commonality with a small number of genes that have previously been shown to be up-regulated in skin wounds, including venous leg ulcers. CONCLUSIONS: The specific sequence of ES applied continuously for 48 hours to the skin of healthy patients has the effect of modifying expression in a number of identified genes. The identification of the differential expression in this subset of genes in healthy subjects provides new potential lines of scientific inquiry for identifying similar responses in subjects with slow or poorly healing wounds.