Abstract
We would like to congratulate Dr Miller and colleagues on developing a smartphone application to provide clinical decision support (CDS) for interpreting rotational thromboelastometry (ROTEM®; TEM international GmbH, Munich, Germany), a form of viscoelastic haemostatic assay (VHA) for point-of-care coagulation assessment in the context of massive transfusion (MT). 1 MT is a complex and multifaceted task that can occur unpredictably and require significant resources at a moment’s notice. Cognitive aids and CDS as paper-based or electronic tools are increasingly used in resuscitation scenarios. 2 MTs are also commonly protocol-based, where institutional massive transfusion protocols (MTP) are used to direct staff, determine blood products to be transfused, provide goals of care and provide CDS to clinicians, and therefore lend themselves towards an electronic CDS solution, given their complexity. Despite the adoption of point-of-care coagulation assessment into clinical practice for the management of major haemorrhage, its benefit in MT has not yet been established. A recent trial that compared VHA-based management of major trauma haemorrhage versus use of conventional coagulation testing found no difference in patient outcomes. 3
Smartphones are almost ubiquitous in healthcare, with a recent survey of anaesthetists demonstrating all respondents owned a smartphone and used their device during clinical practice. 4 With each new model, specifications, connectivity and integrations have expanded, to the point where they can even be used for arrhythmia diagnosis. Given their availability and capabilities, it is no wonder that CDS is increasingly being implemented using smartphone-based medical applications. Smartphones are also an attractive option to deploy new tools rapidly in what can otherwise be difficult Electronic Medical Record software environments. The evidence to support widespread adoption of these smartphone applications for decision support, however, is lacking. A recent review of CDS smartphone applications for use across a broad range of areas demonstrated a lack of rigorous clinical trial–based evaluation and instead found that research mainly focused on diagnostic accuracy. 5 Even if smartphone applications show benefit in a research environment, their success will still depend on addressing the real-world organisational, human and technological implementation factors faced by any medical device.
In-house development of these IT solutions and other devices in medicine more generally by motivated clinicians are a great source of ingenuity, but they come with a risk of ‘MacGyver bias’—a term coined by Duggan et al. to describe the tendency to hold improvised devices in ‘high regard despite the relative absence of evidence for their efficacy’. 6 In-house developers also need to consider regulatory requirements of medical devices relevant in their jurisdiction. In Australia, the Therapeutic Goods Administration requires registration of medical devices and CDS software before these tools move from research interventions under investigation to technologies in routine use. 7 It is also important that development of these tools does not prevent rigorous investigation of the original problem, for which there may be a range of technical and non-technical solutions. With a rigorous approach to the development, evaluation and deployment of electronic CDS for MT, the question of their benefit in an otherwise stressful environment can hopefully be answered.
