As discussed many times in this column, one of the primary benefits of standardization – be it in process or in products - is the ability to reduce “uncontrolled” variation that can impact quality. When it comes to patient care, there is an added dimension in the pursuit of quality – the reduction of “unwarranted” variation. In this month’s column, we explore a program in the UK that is demonstrating the value of this approach, from both a clinical and financial perspective.
First, let’s explore the differences between uncontrolled and unwarranted variation. Those trained in the Six Sigma methodology seek near perfection in the form of no more than 3.4 defects per million opportunities (which translates to six standard deviations between the mean and the nearest specification limit). Anything outside those specification limits is considered uncontrolled variation. Within those limits, there will always be some degree of controlled variation, the result of normal causes that will always exist in nature. In the pursuit of quality, the key is to determine if the variation is uncontrolled (the result of special causes) and can and should be addressed. Failure to recognize the difference and misdirected improvement efforts can result in actions that can worsen, not improve, quality.
When it comes to patient care, there is a further consideration: whether variation is warranted or unwarranted. Let me explain. In contrast to building a product to certain specifications, such as a car, patients are unique. There is still tremendous value in standardizing clinical protocols based on evidence of what works best for specific patient populations. But individual patients also present with their own unique anatomical characteristics, genetics, lifestyles, even personal opinions as to what they consider to be favorable outcomes. As a result, as we seek to standardize care on what works best, we should also create mechanisms for clinicians to vary care – including the choice of devices or drugs – to meet the unique needs of their patients.
A program in the UK – Getting it Right the First Time (GIRFT) – is performing groundbreaking work in this area at the system level, seeking to reduce variation in how care is delivered across the National Health Service (NHS). The program was started by orthopedic surgeon and professor Tim Briggs, who was provoked by the case of a 73-year-old woman who, after undergoing spine surgery, was unable to raise her head to look forward. He wants to ensure that no patient, let alone someone at her age, has to undergo corrective surgery because it wasn’t done right the first time.
GIRFT’s first workstream was in orthopedics, laying the foundation for a methodology now being deployed across 40 medical and surgical specialties in the NHS. By identifying the practices that lead to the best outcomes, GIRFT clinical leaders seek to standardize those practices in their respective areas of expertise across the NHS.
Some of GIRFT’s early groundbreaking work focused on the appropriate use of cemented vs. uncemented orthopedic implants in patients over and above the age of 55. Despite evidence of better outcomes (from a patient satisfaction and clinical perspective) for total hip arthroplasty (THR) patients over 55 with less expensive cemented implants, and no evidence of a difference between cemented and uncemented implants in younger patients, GIRFT identified a substantial increase in the use of uncemented implants for patients of all ages. With an aging population, rising rates of obesity, and nearly 20 percent annual increases in referrals for THR, GIRFT warned of a substantial financial drain on the NHS and recommended standardizing care based on clinical evidence and cost considerations.
In its research, GIRFT identified significant variation in practice and outcomes in terms of device and procedure selection, clinical costs, infection rates, readmission rates, and litigation rates. With predictions of lower revision rates with cemented implants (especially for patients over 65), studies estimated the NHS could save £18.5 million within five years, and likely more, if it were to standardize care more on cemented implants. Even taking into account faster surgery times with uncemented implants, research found trusts would not be more profitable even if they doubled the number of procedures with uncemented devices due to their higher costs.
GIRFT research across numerous medical specialties is generating important research on the value of standardization of care to reduce unwarranted variation. At the same time, researchers also recognize the continued need for warranted variation based on specific patient needs. As one study noted: “The use of cemented components in routine primary THR in the NHS as a whole can be justified on a financial level but we recognize individual patient factors must be considered when deciding which components to use.”
