In 2011, the UK Department of Health published ‘A Framework for Technology Enhanced Learning’, which states that health professionals ‘should learn skills in a simulation environment … before undertaking them in supervised clinical practice’.1 In the context of a global attempt to move from time-based to competence-based medical training,2 this poses an important challenge to those with responsibility for the performance of medical procedures. It could also offer an opportunity to decrease the incidence of procedure-related patient harm by examining the ‘procedure’ as a system, which should place the patient at its centre.3,4 Today, those stakeholders who might lessen the incidence of such harm view ‘the medical procedure’ differently. Medical trainees, doctors, the medical device industry, medical educators, licensing bodies, health facility architects and health service managers do not share a common view of medical procedures. We propose that every medical procedure should have an associated ‘pathway’ based on detailed definitions of what it is, its intended outcome, its associated risks and standards for its training and performance. Acquisition and maintenance of proficiency, standards of practice, design of medical and training devices, curricula and clinical trials should be based on these definitions. The medical procedure pathway (MPP) should become a global standard methodology (Fig. 1).
Medical procedures are fundamental effectors of modern healthcare. They are performed for diagnostic, therapeutic or prophylactic purposes; all are associated with a risk of patient harm and failure. One half of adverse events are the result of an invasive procedure4 and (at least in the USA) the number of such events has not decreased since the publication of the Institute of Medicine's ‘To err is human’ in 2000.4 Longstanding models that separate performance of doctors in the simulated from that in clinical environments, medical devices from training devices and licensing of doctors from that of devices, should now be re-examined.
For cultural and legislative reasons, the number of clinical learning opportunities available to trainee doctors is much less than previously. To date, the challenges that these changes pose are not being addressed or are addressed in a disparate way by different stakeholder groups (e.g. trainee, medical device manufacturer, medical licensing body) or by procedure type (surgical, anaesthetic). This heterogeneity of approach is itself an obstacle to both the optimisation of the patient benefit available through well tolerated, effective procedural care and to comparing studies of effectiveness. Currently, there is no standard form of answer to such fundamental questions as ‘what is the procedure?’, ‘what is it for?’ and ‘how proficient must one be to perform the procedure on a patient or on this specific patient?’. The answers to such questions should influence how training, assessment and maintenance of proficiency, design of medical devices and even design of healthcare delivery and healthcare facilities are undertaken. This has some similarity to the approach of the Global Harmonisation Task Force for regulation of medical devices (http://www.ghtf.org).
We suggest that a framework (or model) is required on which these questions can be answered in a manner that is comprehensible and relevant to all stakeholders; derives from best scientific principles; takes advantage of current technical, pedagogical and clinical innovation; and maximises patient safety and benefit. This framework would minimise the deleterious effects of a trainee's transition from a virtual (or simulated) environment to the clinical environment. It could take advantage of the technical advances in navigation systems and robotics to make new medical devices that serve as excellent training tools. The same information used to monitor progress towards a clinical endpoint in a real patient is exactly that required to provide detailed formative feedback based on predefined errors or ‘near miss’ events. This forms the basis of proficiency-based progression to a globally accepted level of performance. For new, complex or high-risk procedures, rehearsal (using patient-specific datasets) and preprocedural ‘warm up’ should become the norm.5
What is the medical procedure pathway?
It is possible to imagine a new definition of individual medical procedures upon which other steps of a ‘pathway’ for its performance are based. First, the desired patient outcomes are defined and the procedure constructed in a detailed and quantified manner using task analysis, resulting in specific metrics linked to patient outcomes. This would enable learners and educators to construct a model (curriculum) that represents one practitioner's performance of the procedure at one specific time point. This in turn permits the learner or a supervisor to chart a course through proficiency-based progression. Clear definitions of the elements (or subtasks) as well as the common errors of the procedure that alone or in combination lead to good or bad patient outcome are the raw material for design and manufacture of clinical devices and training devices (using a design-based approach that intimately involves regulatory and clinical experts in an iterative process). For complicated or novel procedures (involving navigation systems or robotics for instance), these clinical and training devices may be one and the same. Certainly, there will be a need to render these subtasks and acquire data suitable for detailed formative feedback, not just using new simulators but also haptic-enabled platforms for distributed learning (e.g. Savoir platform: http://http://www.cim.mcgill.ca/sre/projects/hsvo/). This is to ensure that dissemination of newly acquired expertise is efficient. The learning environment will possess the capability to layer the procedural challenge rendered with all those human factors that contribute to real-world error (fatigue, stress and so on). Training bodies will make high stakes decisions on the basis of assessment tools using valid criteria derived from the task definition. One might conceive that licensing of devices and licensing of doctors might be linked by the regulatory authorities; namely, a time-limited licence is awarded to an individual doctor for a specific procedure using a specific device. Proficiency could also be regarded as a function of time (to take account of skill attrition). A personalised and time-specific assessment might be based on predefined standards to be achieved at warm up or (using patient specific data) rehearsal for a specific procedure. Thus, self-evaluation could become ‘micro-adaptive’.
We believe that widespread or global application of this approach would result in:
- doctors who perform a procedure on a patient for the first time being optimally prepared;
- the performance of procedures on patients being safer and more successful;
- training of doctors in procedural skills being more efficient;
- doctors continuing to improve their performance of procedures throughout their working lives;
- the benefits of newly developed procedures reaching more patients more quickly;
- doctors having an opportunity to rehearse difficult procedures in a well tolerated patient-specific simulated environment before approaching the real patient.
What is the procedure and what is it for?
‘The operation was a success but the patient died …’.
The key element in developing a universal pathway for a medical procedure is a definition that is accurate, complete, and both comprehensible and useful to each stakeholder. ‘The procedure’ has different and valid meanings for patient, operator, device manufacturer or the assistant who helps to position the patient. For instance, a patient may regard a particular procedure as a necessary but unpleasant and risky part of his/her care. The operator may visualise the same procedure as a predefined series of actions intended to produce a desired effect or outcome. Both perspectives are valid and truthful. To provide a single definition, it is then necessary to determine the physical steps that make up the procedure, the characteristics of its well tolerated performance and the errors that can occur. These parameters will form the basis for both the design (and building) of new medical devices and the developing of valid assessment tools and effective simulators that will be represented in a training curriculum that specifies both learning objectives and proficiency levels. The answer to the question ‘what is the procedure?’ requires a detailed task deconstruction (e.g. hierarchical task analysis)6 with individual elements (or groups of elements) linked to specific patient risks or outcomes. For the establishment of these links, expert input is essential.
How proficient must one be to perform the procedure on a patient?
The definition of the procedure and its outcomes form the basis of the training programme, assessment tool, device, simulator design and ultimately the performance standard. Currently, trainees are confronted (and sometimes confused) by the variation in procedural approaches used by their trainers, even within the same hospital. What is required is a ’reference’ (generic) approach. The MPP would require a definition of such a ‘reference procedure’ using task analysis. Learning skills involves three distinct processes: the cognitive stage; the associative stage; and the autonomous stage.7 The value of a comprehensively defined reference approach is that an individual learner can track his/her progress through these stages eventually ‘freeing up’ the attentional resources to enable one to focus on the (dynamic) cognitive aspects of the procedure.
At what point is one deemed ‘trained’? The question is flawed. We suggest that the MPP would prompt a practitioner to ask and enable him/her to answer a different question before ‘every procedure’ is undertaken. This is ‘Am I proficient to perform this procedure on this patient now?’ Training bodies, however, generally have a statutory duty to define a point at which a medical trainee should be allowed or licensed to practice independently for the first time. Performance proficiency for a particular procedure will form only one part of their assessment. Until recently, trainees were required to complete a defined number of procedures or practise for a set amount of time, until educators or programme directors deemed them ‘trained’. Most training bodies in the developed world now state that they are adopting a competence-based training approach but are impeded by the lack of valid reliable assessment tools. For instance, The American College of Surgeons (ACS) refers to ‘training to competence’ or ‘training to proficiency’. This is a standard approach used in nonmedical simulation (aviation, military, nuclear industry). The procedure is characterised and then performance benchmarked against that of expert/highly experienced personnel. Using these performance characteristics (or metrics) derived from the original task analysis, the ‘standards’ (e.g. for independent practice) are based on the mean performance of experts. These criterion levels unambiguously define the point at which training has been completed.8 This approach has been used in simulation-based training studies with very clear performance benefits.9–11
The MPP that we propose builds upon the best evidence available regarding the acquisition, maintenance and development of procedural skills for safer patient care. Applied well, it could also focus device design and integration, health facility design and use, and even the model of healthcare delivery, unambiguously on the patient.
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