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.