You can measure opportunity with the same yardstick that measures the risk involved. They go together.
Introduction
From 1999 onwards, after the publication of the report To Err is Human (Kohn et al. 1999), patient safety has become a priority at an international level because “the gulf between a rapidly advancing medical knowledge base and its application to patient care is growing” (Yih 2011).
Adverse events (AEs) are relevant phenomena worldwide; the median overall incidence of in-hospital AEs has been estimated as 9.2% (de Vries 2010), with a median percentage of preventability of 43.5%. More than half (56.3%) of patients experience no or minor disability, while 7.4% of these events lead to the death of the patient. Surgical- (39.6%) and medication-related (15.1%) events represent the majority of adverse events.
Compared to the adult population, elderly patients (Thomas and Brennan 2000) have a higher incidence of preventable events related to medical procedures (such as thoracentesis, cardiac catheterization) (0.69% vs. 0.13%), adverse drug events (0.63% vs. 0.17%), and preventable falls (0.10% vs. 0.01%). Drug adverse events and patient falls are recognized to be more common in older adults, independent of whether they live in a community, in long-term care facilities or are hospitalized. Concerning surgical procedures, mortality associated with anesthesia and surgery in the general population remains at 1.2%, compared with 2.2% in patients aged 60–69 years, 2.9% in those 70–79 years and 5.8–6.2% in patients over 80 years. Major surgery is also associated with increased mortality among elderly patients.
Despite these findings, very seldom are systemic, coordinated and integrated measures aimed to keep clinical risk under control implemented in the field of geriatric surgery found, and this area of clinical risk management still remains neglected in the majority of general hospitals.
Clinical Risk Topics in Geriatric Surgery
Despite a general awareness that older surgical patients are a group at higher risk of perioperative complications, systematic studies investigating AEs in this population are few and the majority of empirical studies have focused on patients receiving a single diagnosis or undergoing the same surgical procedure. No studies approaching the matter in systemic terms has been found in the literature. However, it is well-known that some postoperative complications that are frequent in this patient group are widely preventable, such as postoperative delirium (see Chapter 14), decubitus ulcers and falls (see Chapter 35), postoperative pulmonary embolism or deep vein thrombosis (see Chapter 37) and postoperative respiratory failure (see Chapter 39).
AEs have been found to be more likely to occur among oldest old patients, those with higher comorbidities or receiving low-quality medical assistance (Cho et al. 2003). A potential link has been found between adverse events and work environment or organizational factors (Zhan and Miller 2003), whereas pressure ulcers have been shown to be associated with the nurse skill mix and staffing (Kovner and Gergen 1998). Reduction in adverse events occurrence have been reported to be causally related with the implementation of organizational changes (Provonost et al. 2006).
The implementation of policies aimed to promote risk prevention in geriatric surgical care, at both governmental and single-hospital level, is highly recommended. The best results can be obtained when risk prevention strategies are embodied in the quality system itself and the results are periodically analyzed (see Chapter 48). The introduction of pay-for-performance policies (DoBias 2009) has shown to contribute in improving risk management and consequently reducing the rate of preventable complications (Kim et al. 2010).
Concept of Risk and Insights into its Control
Risks
Many definitions are given for risk, in different fields (safety, security, finance, industry), some even with positive indications. Two are assumed here:
descriptive: “effect of uncertainty on objectives” in ISO 31000 (ISO 2009),
mathematical: probability (likelihood) of an AE happening, multiplied by the magnitude (impact, consequence, damage).
A few related terms, sometimes overlapping, will be defined later:
danger
risk factor
damage
frequency
resilience
vulnerability
level of risk.
Risk factors in elderly care are quite well known (e.g., risks of falls and delirium), and also risk factors for complications and adverse outcomes in geriatric surgery have been identified, but no evidence-based definition is available for systemic risk management, nor have strategies been found to address both patient safety and the containment of possible litigation, which is expected to increase.
Reasonably, total risk is assumed to be the sum of general risks associated with surgery and specific risks in elderly care (medication errors, falls, delirium), further aggravated because they occur in the challenging critical environment of elderly surgery (e.g., increase in probability and magnitude).
Risk Mitigation/Reduction
Risk mitigation is the term used for any activity aimed at increasing safety and reduce AEs in general; zero risk is impossible, unless it coincides with zero activity. The definition above covers ways to cope with risks, synthetized in ISO 31000 in seven general ways as follows, integrated with examples in geriatric surgery:
avoiding the risk by deciding not to start or continue with the activity that gives rise to the risk (meaning to avoid surgery: a typical example of ageism)
changing the probability (increasing patients’ functional reserves by prehabilitation: a good example of patient-focused strategy)
changing the magnitude (considering different surgical options, i.e., more or less radical approaches: a good example of personalized care)
accepting or increasing the risk in order to pursue an opportunity (a challenging surgery expected to significantly improve quality of life: a good choice when coinciding with a patient’s wishes)
removing the risk source (perioperative elimination of anticholinergic drugs: a good example of prevention of postoperative delirium)
retaining the risk by informed decision (the patient wants to be operated on at any risk: a good example of respecting patient’s wishes)
sharing the risk with another party (not adaptable to medicine, except perhaps when seeking a second opinion).
Interactions Among Risks
A thorny problem is encountered when risks relate to opposing requirements. Regretfully, no decision algorithm can solve such matters; only a proper frame of mind, mental associations and creativity can find balanced solutions case by case. A simple example involves fall and delirium risks in geriatric surgery:
injuries from bed falls are severe, while the probability tends to zero using bedrails
the risk of delirium is severe, while probability and magnitude are reduced by avoiding any form of containment.
As true as the statements are, the respective solutions cancel each other out: the trade-off is a height-adjustable bed (hi–low bed, recommended by the American FDA), with safe, convenient heights when the patient:
is ready to lie down, sitting on the edge, both feet planted (55–65 cm)
receives nursing care/consultations (75–80 cm)
rests/sleeps safely near the floor (20 cm or less) with lowered bedrails, or fixed/mobile quarter- or half-rails: assistive devices (enablers) – not restraints – whose scope is:
to give a minimal, unperceived fall-check
to support safe bed transfers (within rooms, between spaces)
to provide confidence.
Last but not least:
high–low beds prevent the patient getting out of bed unassisted
no bed-rails avoids problems related to the use of restraints.
In any trade-off, costs (purchase, maintenance) are important; no study was found on the cost/benefit of electrically operated high–low beds in hospitals, let alone geriatric surgeries. However, 1 in 40 over-65s sustains a fall fracture in healthcare institutions, with an estimated cost of 30,000 euros in the case of hip fracture, so the ratio seems highly favorable. High–low beds are hence part of a multifaceted approach to reduce the risk of fall injuries (see Chapter 46).
Reliability
Reliability is the level of trust that can be accorded to a person, organization, system or solution to give a consistently good performance. Interestingly, Beyea (2016) has looked at whether surgical departments are highly reliable organizations. The author’s answer is based on the level of teamwork and communication, and on how team-members learn together. A number of attitudes emerge, which will be reported as a conclusion in the last paragraph.
Resilience
In accordance with BS6500 (BSI 2014), resilience is the “ability of an organization to anticipate, prepare for, and respond to incremental change and sudden disruption in order to survive and prosper.” One measure of resilience is therefore the ability of foresight – to anticipate the changing shape of risk, before failure and harm occur (Woods 2005).
The relevance of CRM for healthcare organizations is striking; compared to reliability, it is an even more suitable concept to grasp the complexity of “care supply,” encompassing its potential to absorb changes in its important components (patients, technology, knowledge, research advancements, economics, resources).
The concept of resilience is strictly related to – even integrated into – ergonomics, and human factors are of paramount importance in discovering errors, while promoting the capability of facing and fixing them.
Incremental Collapse: A Curious Parallel with Frailty
Reliability, resilience, robustness and frailty (see Chapter 1) are interlinked concepts, often connected in engineering with the notion of incremental collapse. And frailty, together with complexity, is the reason why systems engineering (see Chapter 49) and risk analysis assume paramount importance in the perioperative care of the elderly.
For risk managers and engineers, it is interesting to observe a constitutional kinship between health-status deterioration/decline, and the collapse of facilities, structures and organizations (electro-medical equipment, buildings, machines, systems in general). Indeed, in both cases events seem to follow the same pattern. Beyond a certain level of stress on an organ/part, failure ensues, and failure of the first organ/part determines escalation and spiralling of stress in other organs, speeding up multiple failures, towards a global collapse; this is defined in engineering incremental collapse. Hence, frailty is – as in mechanical structures – an endemic loss of resistance in single organs/functions due to the insult of internal/external agents, with consequent loss of robustness (the capacity to avoid disproportionate global damage, even after heavy damage to single organs) of the whole body. The concept of resilience is also connected, resilience in engineering being the property that enables materials to resume their original shape or position after stress.
No case studies and no deterministic implementations have been found on incremental-collapse modeling in humans, only in sub-systems, e.g., numerical analysis of blood flow in vessels with mechanical properties varying due to pathological states (Müller 2014) or venous hemodynamic modeling (Casulli et al. 2012, Toro et al. 2015). However, such views seem to suggest promising research fields to be followed in the future. They stand for a way of thinking of and regarding the surgical geriatric patient as one of the most complex systems on Earth, to be dealt with from a holistic perspective, and the recognition that healing tools can also stress one or more organs of the system, which may lead to an incremental collapse of the whole structure.
Ergonomics and Human Factors
In order to improve the performance of healthcare organizations towards the safety of patients, many studies have focused on ergonomics and human factors, aiming to create systems that are adjustable to the environment and to the limits of human cognitive abilities. Since 2000, case studies, experience and evidence in the literature have increased, showing that the ergonomic approach can help to create safer processes and outcomes for healthcare systems, and CRM has been recognized as the primary, fundamental catalyst of patient safety, centered on:
risk analysis and control
measurement of adverse events
monitoring of risk conditions.
In such a paradigm, ergonomics has allowed researchers and practitioners to analyze and understand the safety issues of all aspects of healthcare systems interacting in highly complex patterns:
environment
technology
organization
communication, both internal and society-related.
The main components are:
adopted arrangements and management
supporting technologies
physical, social, institutional and political environment.
People are the Focus
In promoting patient safety programs, in order to understand AEs and to develop strategies for their prevention, attention should be moved from seeking visible, active errors to detection of hidden, dormant errors, i.e., shifting attention from the failure of the frontline staff (e.g. administering the wrong drug to the wrong patient), to organization and regulation conditions enabling, if not inducing, the wrong action.
In this view, human error is not the prime driver of adverse events; it is rather an unavoidable consequence of anomalies “wired-up” in the system as a result of wrong choices and organizational decisions.
In other words, professionals fail less because of personal shortcomings than lack of planning and orchestration in the structure they work in; the limited rationality of any human worker should lead to design systems with proper ergonomic features accounting for interactions among people, machines, environment and procedures.
Following the systemic approach (see Chapters 48 and 49), errors leading to AEs should not be investigated as out-of-context human or mechanical failures, but rather from a global perspective, where interactions among technical, human and organizational factors favor – or hinder – the occurrence of AEs.
A Systemic Approach to Promoting Patient Safety
The Swiss cheese model (Reason 2000) offers an excellent paradigm for understanding how an AE occurs. Although effective in providing an explanation, it does not offer practical solutions for risk prevention.
A more recent model was developed in the engineering field with specific reference to healthcare settings, the SEIPS (Systems Engineering Initiative for Patient Safety) model (Carayon et al. 2006), which gives a framework for understanding the roles played by structures, processes and outcomes, and the reciprocal links. In this model, training in CRM is considered indispensable to protect team members, the organization itself and service recipients from harm; to be effective, this training should be substantially implemented, even “woven into staff training.” Even though no studies have been found investigating relationships between CRM education and clinical outcome in geriatric surgery, a first tenet could be that of investing in CRM education as a basic preventive measure; knowing the principles and practice of CRM should be considered an important, substantial skill for geriatric surgical unit staff.
Again, no evidence could be found in literature supporting the importance of a systemic approach to CRM in geriatric surgery. Nevertheless, all the concepts mentioned above and studies conducted in different clinical fields or in some specific healthcare contexts (see, for example, Pronovost et al. 2006) support that principle. It is not without reason that both the concept and the practice of CRM are defined as “systemic, coordinated, integrated policies and methods, implemented in order to deploy resources in any activity, process, function, project, product, service or asset, for risk identification, assessment, ranking, mitigation and monitoring.”
So the second tenet, in addition to CRM education, is to approach CRM in a systemic, inclusive and comprehensive way.
High-reliability Organizations (HROs)
HROs are defined (Reason 2000) as:
complex, internally dynamic and, intermittently, intensely interactive
performing exacting tasks under considerable time pressure
carrying out demanding activities with low incident rates and an almost complete absence of catastrophic failures over several years.
Weick and Sutcliffe (2006) measured – in HROs with “mindful” interactions – a higher ability to detect and manage risks, “mindful” meaning:
individuals aware of what happens in their department/unit/workspace/workflow
higher levels of attention within the team
higher capacity to manage unexpected situations and emergencies.
The first condition in fact does not pertain to individuals, but rather lies in the nature and quality of relationships established within the team. The healthcare microsystem relies on complex interactions to cope with uncertainty and ensure safe performance. Examples of organizational ergonomics (applied to safety in healthcare) are:
teamwork
safety culture
large-scale change
shared vision oriented to workflow redesign
readmission decrease, through:
improvement of coordination among care process steps,
accurate discharge planning
impact analysis of information technology on:
workflows
processes
outcomes.
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