PA 509-Quality Control in Healthcare Second Semester 1439/ 1440 Mohammed S. Alnaif, Ph.D.

1. King Saud UniversityCollege of Business AdministrationDepartment of Health Administration - Masters` Program PA 509-Quality Control in Healthcare Second Semester 1439/ 1440 Mohammed S. Alnaif, Ph.D. E-mail: alnaif@ksu.edu.sa Mohammed S Alnaif

2. Variation in Medical Practice Learning Objectives • Why is understanding variation important? • Understand the principle of “understanding & managing variation” • Differentiate between types and causes of variation in medical practice. • Understand the scope and use of variation in healthcare . Mohammed S Alnaif

3. Variation in Medical Practice Knowledge about variation • « Life is variation. Variation there will always be, between people, in output, in service, in product… No two people are alike. Arrival of a train or of an airplane varies from day to day. Time in route to work varies day to day, no matter what be the mode of transport…» (Deming, 1993) Mohammed S Alnaif

4. Variation in Medical Practice Why Is Understanding Variation Important? • Knowledge about variation and how to manage variability is one of the core concepts that Dr. Deming introduced to the world. • Variationexists in people, processes, and systems, and in the outputs produced by systems. • Without an understanding of variation, people are likely to tamper with systems and processes and thereby make matters worse. Mohammed S Alnaif

5. Variation in Medical Practice Why Is Understanding Variation Important? • The consequences of not understanding and managing variation include: management adding waste into the system, increased variation in outputs, increased frustration throughout the organization, and disrespect for individuals. • The problem occurs in management’s reaction to figures and measures, but also in reaction to events and behaviors (when there are no figures). Mohammed S Alnaif

6. Variation in Medical Practice Why Is Understanding Variation Important? • Deming believed that excessive variations were most of the time, sources of problems and, therefore, it is preferable, all things being equal, reduce variation, or at least understand them. • Reducing variation is to avoid irregularity when possible. « Most people prefer certainty to uncertainty, prefer predictability to unpredictability, and prefer to receive services or information when expected rather than too early or too late, and prefer not to be surprised or hassled. Mohammed S Alnaif

7. Variation in Medical Practice Why Is Understanding Variation Important? • The main message is not so much to reduce variation but to know what variation is trying to tell us about systems and the people that work in Deming‘s ideas about variation were based on the work of Shewhart (1931), who suggested it was important to distinguish between twofundamental causes of variation of any system (or process): common (random) causes and special causes: Mohammed S Alnaif

8. Variation in Medical Practice Random Versus Assignable Variation • Variationcan be either random or assignable. • A random variation is a physical attribute of an event or process, adheres to the laws of probability, and cannot be traced to a root cause. • These are numerous causes whose presence is systematic/ chronic and, separately, have little impact on results. • Traditionally, it is considered “background noise,” or “expected” or “common-cause” variation, and it is usually not worth studying in detail. • They will remain unless the system is altered. Mohammed S Alnaif

9. Variation in Medical Practice Random Versus Assignable Variation • Researchers trained in statistics (or collaborating with statisticians) generally can measure assignable variation easily because of the breadth of tests and criteria available for determining whether variation is assignable or random and because of the increasing sensitivity and power of numerical analysis. • Statistical expertise is, however, essential in the measurement of assignable variation because the complexity of study design and the difficulty of distinguishing true variation from artifacts or statistical errors raise the risk of misinterpretation. Mohammed S Alnaif

10. Variation in Medical Practice Random Versus Assignable Variation • Given the distinction between random and special causes, Deming (1986) observed, ―in my experience most troubles and most possibilities for improvement add up to proportions something like this: 94% belong to the system (responsibility of management) 6%special causes. • The vast majority of problems in organizations therefore come not from employees but from management. • This is a primary task for management, as they are the ones who manage and can improve the systems. Mohammed S Alnaif

11. Variation in Medical Practice Random Versus Assignable Variation • When the variation appears to be primarily due to common cause (random) variation, the appropriate action is to study and improve the system that is causing the variation. • This includes testing ideas for improvement using the PDSA cycle. • When a process shows common cause variation only, it has a defined capability (for the near future). • Just because the common causes are the primary source of variation does not mean that “doing nothing” is appropriate. • A process that is influenced primarily by common cause variation may be producing output that is undesirable. Mohammed S Alnaif

12. Variation in Medical Practice Process Variation • Process variation is one category of variation in medical practice. It refers to different usage of a therapeutic or diagnostic procedure in an organization, geographic area, or other grouping of healthcare providers. • In addition to variation in use versus nonuse of a particular procedure, variation may arise when multiple procedures can be used to achieve approximately the same ends. Mohammed S Alnaif

13. Variation in Medical Practice Process Variation • For example, in the case of screening for colorectal cancer, the same purpose (screening) may be served by fecal occult blood testing, sigmoidoscopy, colonoscopy, or some combination of these options. • Process variation should not be confused with technique, which refers to the multitude of ways in which a particular procedure can be performed within the realm of acceptable medical practice . Mohammed S Alnaif

14. Variation in Medical Practice Outcome Variation • Another category is outcome variation, which occurs when different results follow from a single process. Healthcare quality researchers and medical practitioners often focus on this measure and seek to identify the process that yields optimal results. • When the results of a particular process can be observed in relatively short order or when procedural changes can be made in a timely fashion, the optimal process is easily determined. • Unfortunately, genuine outcome studies often require extensive follow-up periods—often years or decades—making it difficult to determine in real- time whether the process being applied is, in fact, yielding optimal results. Mohammed S Alnaif

15. Variation in Medical Practice Performance Variation • Performance variation—the difference between any given result and the optimal result is arguably the most important category of variation applicable to healthcare quality improvement. • Logically, it may relate to both choice of process and application of that process to achieve the optimal result. • This best practice is the standard against which other practices are compared to determine the variation although some key analytical tools, such as statistical process control, do not directly address performance relative to a standard. Mohammed S Alnaif

16. Variation in Medical Practice Performance Variation • With respect to quality of care, “the variation that is the greatest cause for concern is that between actual practice and evidence-based ‘best practice.’” • The measurement of performance variation and its application to quality improvement work assume, however, that a best practice has been identified. • In such a scenario, performance variation tells us where we are and how far we are from where we want to be and suggests ways to achieve the desired goal. Mohammed S Alnaif

17. Variation in Medical Practice Variation in Medical Practice • Variation in medical practice has excited interest since 1938, when Dr. J. Allison Glover (1938) published his classic study on the incidence of tonsillectomy in school children in England and Wales, uncovering geographic variation that defied any explanation other than variation in medical opinion on the indications for surgery. • Subsequent studies have revealed similar variationinternationally and across a variety of medical conditions and procedures, including prostatectomy, knee replacement, arteriovenous fistula dialysis, and invasive cardiac procedures. Mohammed S Alnaif

18. Variation in Medical Practice Variation in Medical Practice • The degree of variation seen in utilization of a particular procedure (although not the absolute rate of use) is more related to the characteristics of that procedure than to the country or healthcare system in which it is being performed—although there are some exceptions. • For example, Canadian government health insurance restricts coverage for endovascular abdominal aortic aneurysm repair (EVAR) to high-surgical-risk patients. Mohammed S Alnaif

19. Variation in Medical Practice Variation in Medical Practice • Important procedural characteristics include the degree of professional uncertainty about the diagnosis and treatment of the condition the procedure addresses, the availability of alternative treatments, and controversy versus consensus regarding the appropriate use of the procedure. • Differences among physicians in diagnosis style and in belief in the efficacy of a treatment contribute substantially to variation. Mohammed S Alnaif

20. Variation in Medical Practice Variation in Medical Practice • The first important distinction to make when considering variation in medical practice is the difference between warranted variation, which is based on differences in patient preferences, disease prevalence, or other patient-related factors, and unwarranted variation, which cannot be explained by patient preference or condition or evidence-based medicine. • While the former is a necessary part of providing appropriate and personalized evidence-based patient care, the latter is typically regarded as a quality-of-care concern by hospitals and healthcare systems. Mohammed S Alnaif

21. Variation in Medical Practice Variation in Medical Practice • The effects of unwarranted variation include inefficient care (i.e., underutilization of effective procedures and/or overutilization of procedures with limited or no benefit) and related cost implications as well as disparities in care between geographic regions or healthcare providers. Mohammed S Alnaif

22. Variation in Medical Practice Variation in Medical Practice JohnWennberg, defines three categories of care in which unwarranted variation indicates different possible problems: • Effective care (15 percent of healthcare) is care for which the evidence has established that its benefits outweigh its risks and the “right rate” of use is 100 percent of the patients defined by evidence-based guidelines as needing such care. In this category, variation in the rate of use within a defined patient population indicates areas of underuse. Mohammed S Alnaif

23. Variation in Medical Practice Variation in Medical Practice JohnWennberg, defines three categories of care in which unwarranted variation indicates different possible problems: • Preference-sensitive care (25 percent of healthcare) includes areas of care in which there is more than one generally accepted treatment available for the condition being addressed, so the “right rate” should depend on patient preference. A challenge posed by this type of care is the uncertainty of whether patient preferences can be accurately measured using current methods—and if they can, whether measurement methods are so resource intensive that inclusion of patient preference is impracticable in large population- based studies. Mohammed S Alnaif

24. Variation in Medical Practice Variation in Medical Practice JohnWennberg, defines three categories of care in which unwarranted variation indicates different possible problems: • Supply-sensitive care (60 percent of healthcare) is care whose frequency of use relates to the capacity of the local healthcare system. Studies have repeatedly shown that regions with high use of supply-sensitive care do not perform better on mortality or quality-of-life indicators than do regions with low use, so variation in this area of healthcare services can provide evidence of overuse. Mohammed S Alnaif

25. Variation in Medical Practice Variation in Medical Practice • The objective for quality improvement researchers is not simply to identify variation but also to determine its value. • If variation reveals a suboptimal process, the task is to identify how the variation can be reduced or eliminated. • If the variation is good or desirable, understanding how it can be applied across an organization to improve quality broadly is essential. Mohammed S Alnaif

26. Variation in Medical Practice Variation in Medical Practice • The quality improvement goals in each of Wennberg’s categories of care are different. For effective care, the goal is to achieve 100 percent utilization in the relevant patient population; as such, variation can indicate areas of underuse. • For preference-sensitive care, the goal is a rate of utilization of each alternative that is consistent with patient preference; this goal can be achieved through active engagement of patients in decision making. • Use of decision aids to increase patient involvement appears to decrease the demand for invasive treatments. Mohammed S Alnaif

27. Variation in Medical Practice Variation in Medical Practice • For supply-sensitive care, the goal is twofold: • to acquire the evidence (through comparative effectiveness research) necessary to move procedures currently in the supply sensitive care category to either the effective care or preference-sensitive care category and • to adopt a pattern of use that achieves the best value. Mohammed S Alnaif

28. Variation in Medical Practice Sources of Unwarranted Variation in Medical Practice A critical aspect of achieving the quality-of-care improvements indicated by observations of unwarranted variation is to understand the factors contributing to the variation. Frameworks for investigating unwarranted variation should provide: • A scientific basis for including or excluding each influencing factor and for determining when the factor is applicable and not applicable; Mohammed S Alnaif

29. Variation in Medical Practice Sources of Unwarranted Variation in Medical Practice • A clear definition and explanation of each factor suggested as a cause; and • An explanation of how the factor is operationalized, measured, and integrated with other factors. Mohammed S Alnaif

30. Variation in Medical Practice Sources of Unwarranted Variation in Medical Practice • Existing frameworks’ definitions of unwarranted variation vary, ranging from variation that is unexplained by type or severity of illness or patient preference, • to variationnot explained by population difference, • to differences in care that exist despite evidence of agreement on what constitutes evidence-based best practice, • to variation that—as a matter of judgment—is unacceptable. Mohammed S Alnaif

31. Variation in Medical Practice Sources of Unwarranted Variation in Medical Practice • They similarly identify different causes of unwarranted variation, including • inadequatepatient involvement in decision making, • inequitableaccess to resources, • poor communication, role confusion, and • misinterpretationor misapplication of relevant clinical evidence. Mohammed S Alnaif

32. Variation in Medical Practice Sources of Unwarranted Variation in Medical Practice • Other views are that variation is driven by clinician uncertainty (in defining disease, making a diagnosis, selecting a procedure, observing out- comes, assessing probabilities, and assigning preferences) and/or • by physicians’ economic incentives. Mohammed S Alnaif

33. Variation in Medical Practice Sources of Unwarranted Variation in Medical Practice • Under the uncertainty hypothesis, the exercise of clinical judgment produces unwarranted variation because physicians develop individual practice styles, while under the economic incentives or “supply” hypothesis, physicians take advantage of their dual role as seller of a service and agent for the buyer (patient) to influence demand for a service, and marginal/deviant physician behavior is the most important regulatory focus in addressing quality-of-care deficits. Mohammed S Alnaif

34. Variation in Medical Practice Sources of Unwarranted Variation in Medical Practice • The latter hypothesis has strongly influenced public policy in the past but has been criticized as being neither generally in operation nor able to establish a rational medical market because it misinterprets physician behavior by underestimating the market implications of uncertainty in diagnosing and treating disease. • Rather, the variation in demand among communities for specific procedures (“demand shift”) is better characterized as the impact on consumption rates by the different belief sets held by individual physicians. Mohammed S Alnaif

35. Variation in Medical Practice Sources of Unwarranted Variation in Medical Practice • These belief sets are sometimes divided into endogenous (e.g., education and ability) and exogenous (e.g., reimbursement structures, role models, organizational policies, patients’ economic constraints) sources of variation. • Exogenousforces are able to overcome endogenous forces, bringing about conformity with local practice (Long 2002). Mohammed S Alnaif

36. Variation in Medical Practice Sources of Unwarranted Variation in Medical Practice • From this viewpoint, the physician resource demand model suggests that physicians demand resources consistent with patients’ clinical needs but modified by local exogenous influences, including patient–agency constraints (e.g., patients’ financial resources and access to care), organizational constraints (e.g., policies and protocols), and environmental constraints (e.g., surgeons, hospital beds, other facilities per capita) (Long 2002). Mohammed S Alnaif

37. Variation in Medical Practice Sources of Unwarranted Variation in Medical Practice • These exogenous factors might influence physician behavior in multiple ways, and the resulting behavior may contribute to local variation. For example, physicians might choose to practice in a particular area or organization to be able to exercise their aggressive/nonaggressive intervention style, or they might adapt to the style of the community where they settle. Mohammed S Alnaif

38. Variation in Medical Practice Sources of Unwarranted Variation in Medical Practice • Physicians might also adapt their practices to local patient expectations and demands or adapt to local market forces to maintain their income (e.g., shortening patient follow-up intervals when practicing in an area with a large number of physicians per capita to keep a full schedule) (Sirovich et al. 2008). Mohammed S Alnaif

39. Variation in Medical Practice Sources of Unwarranted Variation in Medical Practice • Hospitals and physician practices might similarly be influenced by exogenous factors compelling them to comply with a local standard. • For example, those in high-spending, high-healthcare-density areas might be subject to greater competitive stresses and might pressure physicians to order profitable services, while less availability of such services in low-spending areas could dissuade physicians from ordering them. Mohammed S Alnaif

40. Variation in Medical Practice Sources of Unwarranted Variation in Medical Practice • Certainly, overall practice intensity is strongly correlated with local healthcare spending; physicians in all areas are equally likely to recommend guideline-supported interventions, but those in high-spending areas see patients more frequently, recommend more tests of uncertain benefit, and opt for more resource-intensive interventions without achieving improved patient outcomes. Mohammed S Alnaif

41. Variation in Medical Practice Applying Evidence of Unwarranted Variation to Quality Improvement • Unlike patient safety and “appropriate use” studies, practice variation studies compare utilizationrates in a given setting or by a given provider to an average utilization rate rather than impose a rate based on expert opinion of best practices. • Policymakers and managers can use these data-driven studies to pinpoint areas of care in which best practices may need to be identified or—if they have already been identified—implemented. Mohammed S Alnaif

42. Variation in Medical Practice Applying Evidence of Unwarranted Variation to Quality Improvement • Appropriate use and patient safety studies constitute the next level of analysis once best practices have been established and serve as ongoing performance management tools. • Where best practices have been identified (i.e., effective care), a common approach to decreasing unwarranted variation/increasing the quality of care is the development of clinical guidelines. Mohammed S Alnaif

43. Variation in Medical Practice Applying Evidence of Unwarranted Variation to Quality Improvement • However, the development and availability of clinical guidelines are often insufficient to align practice with scientific standards due to numerous factors, including physician inertia, uncertainty regarding the knowledge base for the guidelines, the perception that guidelines “deskill” physicians through the introduction of “cookbook medicine,” and physicians’ common perception that their practice is already consistent with best practices. Mohammed S Alnaif

44. Variation in Medical Practice Applying Evidence of Unwarranted Variation to Quality Improvement • However, the development and availability of clinical guidelines are often insufficient to align practice with scientific standards due to numerous factors, including physician inertia, uncertainty regarding the knowledge base for the guidelines, the perception that guidelines “deskill” physicians through the introduction of “cookbook medicine,” and physicians’ common perception that their practice is already consistent with best practices. Mohammed S Alnaif

45. Variation in Medical Practice Applying Evidence of Unwarranted Variation to Quality Improvement • Moreover, the “evidence-based bandwagon” has become so popular and so many guidelines have been produced by individuals, organizations, and insurers that the benefits of consistency may disappear under the confusion of overlapping, poorly constructed practice standards. Mohammed S Alnaif

46. Variation in Medical Practice Applying Evidence of Unwarranted Variation to Quality Improvement • Other strategies hospitals have used to reduce unwarranted variation in effective care include benchmarking and report cards, academic detailing, and pay-for-performance programs. • Additional recommendations for tackling underuse include establishing the necessary infrastructure for systemic implementation of evidence-based clinical guidelines and regionalization of care for procedures for which higher use by hospitals and physicians is associated with better outcomes (e.g., complex cardiovascular or thoracic surgeries such as esophagostomy). Mohammed S Alnaif

47. Variation in Medical Practice Applying Evidence of Unwarranted Variation to Quality Improvement • However, the ability to monitor variation patterns and relate them to outcomes is limited to those hospital systems that have the infrastructure (e.g., electronic health records [EHRs] and data analysts) necessary to collect and analyze these data on an ongoing basis. Mohammed S Alnaif

48. Variation in Medical Practice Applying Evidence of Unwarranted Variation to Quality Improvement • Where unwarranted variation is identified in preference-sensitive care, improvement calls for comparative effectiveness research to elucidate differences between available treatment options and thus enable selection of the option that best addresses the patient’s concerns and priorities; this research needs to be complemented by increased involvement of patients in treatment choices. Mohammed S Alnaif

49. Variation in Medical Practice Applying Evidence of Unwarranted Variation to Quality Improvement • To date, much of the research related to unwarranted variation has focused on physician/hospital/healthcare system behavior, treating the patient as inert; however, hospitals report including initiatives to increase patient engagement and education in their quality improvement strategies focused on unwarranted variation. Mohammed S Alnaif

50. Variation in Medical Practice Applying Evidence of Unwarranted Variation to Quality Improvement • Ironically, while informed patient involvement decreases unwarranted variation in preference-sensitive care (bringing utilization rates into line with patient preferences), it might increase total variation because the preferences of patients coming from varied backgrounds and contexts might be more diverse than those of their physicians, who generally have similar educational backgrounds and training. Mohammed S Alnaif