Abstract
Evidence-based medicine and quality improvement are among the most commonly-used terms in healthcare and health systems. Evidence-based medicine is credited as one of the greatest medical advances of the 20th century and has influenced spheres far beyond health, from ‘evidence-based policy’ to ‘evidence-based conservation’. Quality improvement has been variably defined, 1 but was recently championed in Darzi's future vision of the NHS. 2 With increasing interest in the incorporation of quality improvement into daily clinical practice, comparison of quality improvement with evidence-based medicine may provide insights to inform the future progress of the quality improvement movement. By process of literature review and discussion with opinion leaders, the history, definitions, successes and failures of the two movements are analysed.
Definitions
Sackett's 1996 definition of evidence-based medicine is probably the most widely used: ‘the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients’. 3 One-quarter of a century earlier, Archie Cochrane acknowledged the importance of an economic perspective in evidence-based medicine, saying that ‘clinical decisions had to be based “on hard evidence” as to the gain to be expected from the patient's angle and the cost’. 4
Quality improvement has been defined as ‘the combined and unceasing efforts of everyone – healthcare professionals, patients and their families, researchers, payers, planners and educators – to make the changes that will lead to better patient outcomes (health), better system performance (care) and better professional development’. 1
The two concepts of evidence-based medicine and quality improvement are complementary. While evidence-based medicine justifies clinical decisions with evidence, quality improvement is ‘translational’; putting evidence-based medicine into practice in healthcare systems and grappling with incentives in healthcare, whether they are non-financial, reputational or financial. However, quality improvement becomes difficult to justify or measure and arguably does not work without evidence. ‘Evidence-based’, ‘peer review’ and other evidence-based medicine-related terms have often been misused. The lesson is that in accurate definitions may lead to incorrect use of the concept and diminished credibility. Quality improvement is a dynamic, wide-ranging and ongoing process of testing and learning, unlike ‘quality’ which is relatively static and based on professionally driven and professionally owned standards. Token use of the term ‘quality’ in all areas of healthcare without putting core principles into practice will lead to mistrust and reduced uptake of quality improvement.
History of evidence-based medicine
Medical interventions have been tested for efficacy since the 11th century. However, only in the 20th century did this effort evolve to impact almost all fields of healthcare and policy. Archie Cochrane advocated the concepts behind evidence-based medicine since the early 1970s, leading to centres of evidence-based medical research – Cochrane Centres – and an international organization, the Cochrane Collaboration. The term ‘evidence-based’ was first used in 1990 by David Eddy, 5 and ‘evidence-based medicine’ first appeared in 1992. Several evidence-based journals appeared, including the BMJ's ‘Clinical Evidence’, and evidence-based medicine was promoted as an exemplar for all public policy.
Eddy argues that the adoption of evidence-based medicine has been based on two different routes: ‘evidence-based guidelines’ and ‘evidence-based individual decision-making’ (Box 1). 6 Evidence-based guidelines focus on design of evidence-based guidelines to ensure they are followed by practitioners downstream. On the other hand, evidence-based individual decision-making focuses on practitioners to teach evidence-based methods so that they can interpret information coming from upstream. Eddy argues that the current evidence-based medicine definition includes the latter but not the former. 6 At both levels of evidence-based medicine, all health systems must include both assessment of outcomes and opportunity costs since resources are limited.
Routes of uptake of evidence-based medicine 5
Evidence-based guidelines involve ‘multidisciplinary teams to produce guidelines and policies that address the needs of groups of people and that affect individual patients indirectly by influencing the decisions of healthcare decision-makers’.
Evidence-based individual decision-making involves ‘individual physicians, to make decisions about individual patients and directly determine their care’.
Evidence-based medicine has profited from technological advances in computing, databases, Internet, electronic and open-access journals, search tools, and even social networking and updating applications, e.g. TwitterTM. The evidence-based medicine methodology has been continuously updated throughout its history, whether in terms of study design, statistical methods or guidelines for systematic reviews.
History of quality improvement
In business circles, quality management is considered to have three main components: quality control, quality assurance and quality improvement. The roots of this movement can be traced from 19th-century weapon production through to car manufacturers in the early 20th century, including Henry Ford and Karl Friedrich Benz, and Toyota's pioneering and well-publicized techniques in the 1950s and 1960s. Quality improvement is not a new phenomenon in healthcare either.
Donabedian created a framework for quality evaluation in medicine in his seminal 1966 paper. 7 This framework, ‘Donabedian's Triad’, underpins most quality measurement activities in healthcare (Box 2), although economic evaluation, a crucial part of healthcare evaluation, is omitted.
Donabedian's Triad 7
Structure (how healthcare is organized)
Process (what was done)
Outcome (what happened to the patient)
Throughout the 1970s and 1980s, several American studies showed wide variations in patterns of care that were neither supported by evidence nor justified by outcomes. For example, New Haven residents were twice as likely to receive coronary artery bypass surgery and 50% more likely to undergo hysterectomy than similar patients living in Boston. 8 Wennberg divided such ‘unwarranted variations’ into: (1) variations in effective care and patient safety (including services whose effectiveness is proven by clinical evidence and ‘whose use does not involve substantial trade-offs that depend on patient preferences’); (2) variations in supply-sensitive cares (use of services which is dependent on resources); and (3) variations in preference-sensitive care (situations where two or more medically acceptable options exist and choice should depend on patient preferences). 8 Variations in healthcare are present in all health systems and have been well-characterized in the UK. 9
The unmet need for evidence-based medicine to be translated into practice began to be recognized by other ‘outcomes research’ experts, such as Don Berwick, who founded the Institute for Healthcare Improvement (IHI) in 1991 to pursue quality improvement. So-called ‘outcomes researchers’ began to determine, through rigorous studies, what truly were the best approaches, and to codify this information in the form of ‘practice guidelines’ (Box 3).
IHI's ‘No Needless List’
No needless deaths
No needless pain or suffering
No helplessness in those served or serving
No unwanted waiting
No waste
No-one left out
In the UK, ‘quality was seen as inherent in the system, sustained by the ethos and skills of the health professionals working within it’, since the birth of the NHS in 1948. Lack of local accountability for healthcare delivery led to managerial accountability for output measures since 1982. Until the 1990s, ‘cost containment’ was the major quality driver, a goal separate from improving efficiency. 10 In the 1990s, a series of high profile medical errors and system failures, along with growing agreement that the NHS must make best use of available resources, led to a re-examination of quality, and the birth of ‘clinical governance’. 10 Clinical governance was defined as ‘a framework through which NHS organisations are accountable for continually improving the quality of their services and safeguarding high standards of care by creating an environment in which excellence in clinical care will flourish’. 11 Lord Darzi's Next Stage Review for the NHS represents another system-wide effort to raise awareness and to increase the uptake of quality improvement at all levels of health service provision, 2 in order to optimize use of NHS resources in the face of growing costs.
Comparing the history of evidence-based medicine and quality improvement, it is clear that both are concepts that should inherently appeal to all individuals involved in healthcare in the face of strains that health systems face in all countries. The evidence base for interventions that work in healthcare quality improvement and the validation of methodology in quality improvement are at a ‘younger’ stage than for evidence-based medicine, and these two areas may well need to be developed before quality improvement is widely adopted. Within the NHS, there have been policy statements from successive governments regarding quality assurance and improvement for at least 20 years, whereas the recommendations have largely come from within health professions with regard to evidence-based medicine. Quality improvement will have to gain credibility and support from health professionals who will implement its principles, as top-down government policy alone will not change hearts and minds.
Lessons from social movements
Social movements are defined as ‘collective challenges (to elites, authorities, other groups or cultural codes) by people with common purposes and solidarity in sustained interactions with elites, opponents and authorities’. 12 Social movement theory examines how and why certain ideologies develop into successful movements, whereas others fail. Evidence-based medicine has become a movement in the sense that it permeates medical training and practice, but the same is not yet true for quality improvement, despite its application in healthcare settings over the last 30 years.
Barriers to social movements are spread of knowledge and convincing people to join the movement. Evidence-based medicine has a clearly defined role in the minds of clinicians, whereas knowledge of quality improvement among clinicians is still lacking. In addition, many health professionals view quality improvement as a management function, rather than part of their own role in patient care. Such concerns will need to be addressed before quality improvement can be widely adopted throughout health systems. In evidence-based medicine, a ‘tipping point’ was reached due to a combination of factors, including widespread realization by both patients and doctors that clinical decisions were not being made on the basis of scientific literature, leading to variations in practice, and harm to patients; easily accessible principles and methodology; and improvements in information technology. Quality improvement was born from a similar realization that in systems with limited resources and responsibilities to taxpayers, inefficient or wrongful use of resources is unacceptable. In order to reach a similar tipping point, the underlying message of quality improvement and its application to the daily work of health professionals needs to be distilled.
Education and training
One of the foundations of evidence-based medicine's successes involves incorporation of its principles into undergraduate medical training and its application at an early stage in the careers of healthcare professionals. There are a plethora of evidence-based medicine courses, diplomas and degrees which can be pursued by health professionals of all disciplines and all stages of training. For example, students are introduced to the concepts during medical school and by the time they start work as doctors, they know how to form, research and answer clinical questions which affect real decisions about their patients.
‘Teaching the teachers’ has been the mantra of evidence-based medicine and has led to the propagation of evidence-based medicine throughout groups of clinicians. Clinicians are trained as individuals but eventually practise in multidisciplinary teams. Quality improvement is related to this team aspect of healthcare delivery, unlike evidence-based medicine which can be done as an individual. Junior clinicians often offer a ‘view from outside’ with a ‘new set of eyes’ and so are important in any innovation in healthcare delivery. In addition, culture change is more likely to be successful at an early stage in training, since new principles will then be applied at every stage of that person's working life. Therefore, proponents of quality improvement must devise ways of making quality improvement accessible to all clinicians but particularly to those in training by giving them ‘hands-on’ experience. New curricula at undergraduate and postgraduate levels need to recognize the importance of quality improvement and make it relevant to the clinical setting and patient care. Just as newly-qualified doctors are now expected to be able to search and evaluate current medical literature, the future aim is for doctors to be competent to evaluate healthcare settings for quality and efficiency.
Leadership
Charismatic leadership is a feature of any social movement and evidence-based medicine had coordinated and sustained leadership from founders (e.g. David Sackett, Gordon Guyatt and the McMaster University group, Cochrane Collaboration), other opinion leaders and clinicians alike. With this leadership, evidence-based medicine was essentially owned and driven by the health professions. Quality improvement's success relies on convincing a range of very different stakeholders of the value of the new approach and yet empowering practitioners in a similar way to ask questions of their health systems.
Conclusions
Evidence-based medicine and quality improvement are necessary to improve healthcare delivery, while the role of clinical trials and economic evaluation is to inform difficult clinical choices. Though evidence-based medicine has faced and still faces challenges, it has engaged clinicians at all levels and is part of their training programmes. The greatest challenge facing quality improvement's proponents is how to similarly engage clinicians and patients by making the concepts and their applications easier to understand. Training and education are critical levers in creating the environment where quality improvement can be adopted by clinicians. Other barriers to convincing clinicians of quality improvement's value include traditional manager–clinician divides, lack of incentive structure for practice of quality improvement in healthcare settings, and evidence that interventions will work if applied across the NHS. Preventable adverse events could cost the NHS £1 billion a year in terms of additional bed-days. There is growing evidence that quality improvement could improve patient experience and cut costs in a time of financial crisis and so its potential should be realized.
DECLARATIONS
Competing interests
None declared
Funding
This work was commissioned and funded by the Health Foundation
Ethical approval
Not applicable
Guarantor
AB
Contributorship
AB wrote the initial drafts of the manuscripts; all authors contributed to the final manusript
Acknowledgements
AB had discussions regarding quality improvement and evidence-based medicine with the following: Pritpal Tamber, Map of Medicine; Carl Heneghan and Paul Glasziou, Department of Primary Care, University of Oxford; Susan Went, Royal College of Physicians; James Mountford, UCL Partners; Vivek Muthu, Bazian; Richard Smith, United Health Funding