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

Abstract

This paper is written in response to a publication in the Journal of Wound Care by Guest et al. The publication and subsequent analysis of the Guest 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 supplement technologies. It also raises a further important issues regarding whether the outcomes from a single randomised control 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 healthcare it is common that smaller commercial companies present small scale observational trials as evidence for the efficacy of the product they are promoting. This practice is commonly followed because these trials are relatively cheap in comparison to research involving more complex methodologies, have significantly shorter durations and commonly patients are selected by clinicians to produce a likely or desired outcome. Therefore, we question whether this level of data promoted as evidence for clinical efficacy should be dismissed?Guest et al reported that in 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 current clinical practice does it mean that any results produced could not be transferred to the current clinical environment? We discuss the conundrum.