5. Evidence-based practice: focus on quality and safety

are costly, and have long latency periods. This may have important implications during study design, especially when establishing appropriate inclusion criteria or standardizing experimental interventions [3, 4, 18, 38]. Limitations and challenges associated with RCTs have forced physicians to look into alternate study designs that are easier to conduct, take less time

Perhaps the most commonly employed tool that allows researchers quickly and effectively leverage the wealth of existing evidence from various RCTs is meta-analysis [88, 92, 93]. Having said that, systematic reviews including meta-analyses can generate secondary evidence that is only as good as the cumulative evidence provided by primary source studies [15, 52]. Therefore, the validity of evidence from systematic reviews is largely based on the RCTs included, and meta-analyses cannot ameliorate any biases present in source studies [15]. Moreover, systematic reviews and meta-analyses rely solely on published data and evidence, some of which may be published in obscure journals and not easily accessible. In addition, some of the reported data may be limited in scope, with heterogeneous reporting of outcome parameters. This phenomenon is called publication bias, and in order to minimize such a bias, researchers are advised to search literature thoroughly and methodically as well as maintain

Observational studies, including case-control and cohort designs, come with their own set of limitations and biases [94, 95]. Case-control studies draw a comparison between individuals with a condition or disease (cases) and those individuals in whom the condition or disease is absent (controls), optimally in a fixed ratio of cases and controls (e.g., 1:2, 1:3, or 1:4) [14]. Since both groups are compared with respect to their past and present exposures, most of the information provided relies on recall and may end up being incomplete or even untrue [47]. In addition, validation of the collected information may be extremely difficult or not feasible, and a detailed study on the mechanism of the researched disease is rarely possible. On the other hand, cohort studies select a group of individuals with certain characteristics and follow them over a long period of time for the development of a particular disease or outcome of choice [96]. Since cohort studies are usually conducted over extended periods, key challenges include high study costs and ensuring adequate follow-up over a long period of time. Moreover, a sizable group of subjects is required to adequately investigate a rare disease and control of peripheral variables may be incomplete, resulting in increased bias [4, 37, 44, 45]. Finally, it is difficult to accurately account for changes in medical treatment over time, resulting in the emergence of "temporal bias".

Unsystematic personal observations, prior to the introduction of EBM, have carried great weight in shaping both medical education and practice [15]. We now have a much better appreciation of how these observations may be inherently biased and how much progress was forfeited by perpetuating a system of subjective opinions in our current era of less biased, objective scientific investigation [4]. Although the different limitations of various LSEs discussed above may seem considerable, one must remember that they are dwarfed by the potential harm resulting from unrestricted, non-evidenced practice of yesterday. As long as practitioners and champions of healthcare quality and safety use a healthy degree of informed caution when interpreting published evidence and clinical data, continued progress can be

made toward a better and safer, evidence-based medicine of tomorrow [2, 8].

to complete, are less expensive, and yield similar results to RCTs [2].

62 Vignettes in Patient Safety - Volume 3

contact with both study authors/investigators and other experts in the field [15].

The practice of EBM is essential for making safe and effective clinical decisions and is also crucial to promoting quality improvement and ensuring continuous focus on patient safety in healthcare organizations [10, 25, 97]. Research is the foundation of the practice of EBM. It helps drive enhanced health outcomes, promotes standardized approaches to care, and facilitates cost reduction in a resource-limited healthcare system [98–101]. Evidence for beneficial effects of EBM continues to accumulate in a diverse number of allied health and medical areas of specialty, including surgery, critical care, primary care and preventive medicine, internal medicine and subspecialties, obstetrics and gynecology, as well as nursing, hospital administration, health information technology, quality, and patient safety [102–106]. EBM can also be formulated from patient-reported outcomes using established clinical processes such as The Joint Commission Core Measures [107]. In addition, the Agency for Healthcare Research and Quality (AHRQ) developed a series of quality indicators designed to standardize evidencebased care medicine for preventing in-hospital complications that may result in penalties under the auspices of value-based purchasing program [108]. Often, performance in standardized quality indicators can be used to benchmark quality and safety performance in various patient populations [108]. Preoperative prophylactic antibiotics, bowel preparation, and deep vein thrombosis prophylaxis are examples of evidence-based best practices that have been defined and protocolized by organizations and initiatives like Centers for Medicare & Medicaid Services (CMS) and the Surgical Care Improvement Project (SCIP) [109]. Similarly, checklists have revolutionized healthcare across increasing number of settings, as documented by multiple studies demonstrating lower mortality, postoperative complication rates, and enhanced adherence to patient safety procedures [110–115].

Patient safety research focuses on the identification of safety issues (e.g., patient safety gaps) and their subsequent remediation through the study and implementation of new practices and policies [113, 116]. Despite ample descriptive evidence, the implementation of safety practices remains an underresearched subject, with much work remaining before achieving "zero incidence" goals across many adverse event types [9, 117]. Perhaps more troubling is the observation that the gap between research findings and implementation across various clinical settings may indeed be widening [102]. There is an estimated lag time of approximately 17 years from research to implementation in clinical practice [118, 119]. It stands to reason that a better process is required for this much needed translational process to occur more efficiently. For example, since the mid-1800s, the importance of hand hygiene has been a widely accepted fact, as numerous studies have confirmed the significant benefit of this practice. Despite the presence of widespread awareness and institutional guidelines, compliance among healthcare workers and doctors in particular remains low [120, 121]. Dissemination and application of evidence-based safety practices is often met with multiple obstacles and/or outright resistance, both at the individual and organizational levels [8, 106]. In one systematic review of 23 studies of stand-alone teaching of EBM principles in a postgraduate education setting, it was noted that although knowledge increased, behaviors, attitudes, and skills did not change; and a system of interactive teaching strategies was recommended [122]. Development of effective policies based on carefully vetted research evidence constitutes another major barrier to the actual implementation of evidence into practice, especially within organizations where expert opinion and hierarchical decision-making impose "glass ceilings" toward evidence-based approaches. Moreover, numerous methodological and ethical complexities make research in clinical safety particularly challenging, as patients cannot be subjected to blinding or randomization [102].

It is important to reiterate that EBM is not purely about conducting RCTs and implementing their context-appropriate results into clinical practice. Evidence-based medicine extends to critical decision-making regarding treatment and practices that stem from carefully and thoughtfully considering and weighing "best evidence" [123–125]. Well-designed case-control and cohort studies can prove to be equally effective tools and should be considered for areas where RCTs are simply not feasible or impractical. Lastly, it is every practitioner's obligation to provide the best available care for their patients and that will continue to be driven by the increasing wealth of available literature [126], hopefully characterized by better LSEs and overall quality of both methodology and data. Practitioners and champions of patient safety must therefore be encouraged to thoroughly search and evaluate published research and thoughtfully consider "best evidence" in an unbiased, holistic manner before committing to any clinical decisions or programmatic implementations.

subjective components of both the available evidence and its corresponding interpretation. It is important to note that different other GOR paradigms have been devised, with the topic being so vast as to warrant its own dedicated chapter and/or book [124]. Finally, another matter that is beyond the scope of the current discussion is the advent of various reporting requirements for different types of studies. The reader is referred to external resources for additional infor-

approximate the estimate of the effect, but non-trivial possibility exists of a "substantial difference" Low There is low overall confidence that the effect estimate reflects the true effect. In other words, the true (actual)

Fact versus Conjecture: Exploring Levels of Evidence in the Context of Patient Safety and Care Quality

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Very low There is very little confidence that the effect estimate reflects the true effect. In other words, the true effect is

High High level of confidence regarding the true effect being close to that of the estimate of the effect Moderate Moderate level of confidence regarding the effect estimate. In other words, the true effect is likely to

Another important development in the area of translating evidence into practice was the introduction of the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach [135, 136]. In the GRADE paradigm, evidence is assessed in terms of both its certainty (e.g., quality) and strength of the corresponding clinical recommendation(s) [135, 137]. In terms of practical applicability of the GRADE system, quality of evidence and the corresponding definitions are provided in Table 3 [138]. A multi-tiered system, examining specific evidence-related factors and criteria in the context of their influence on the direction and strength of the recommendation, is then employed to help with clinical implementations and translations of research data [139]. Since its introduction, the GRADE paradigm provides a well-organized and objectivized framework for evaluating the relative importance of research outcomes and alternative clinical approaches, and summarizing evidence for systematic

7. Synthesis: putting evidence to work, one improvement cycle at a time

The entirety of our previous discussion revolved around the levels of scientific evidence, various aspects of their interpretation and implementation, as well as grades of recommendations outlined in the overall context of EBM-based discussion. At this point, it will be important for the reader to become familiar with some of the methodologies employed in healthcare quality and patient safety improvement efforts. It is critical to emphasize that these approaches not only rely on EBM for planning and assessment but also help modify our existing EBM patterns through a continuous process improvement cycle. While evidence-based medicine has focused on providing the most recent evidence-based care for patients, quality improvement has focused more on the way we provide that care [140]. The evidence must be reviewed to ensure that it is indeed the right care while there also needs to be a clinical improvement

mation on this important and increasingly complex subject [131–134].

effect may be substantially different from the estimated effect

likely to be substantially different from the estimated effect

Table 3. Quality of evidence assessment definitions, as utilized in the GRADE approach [138].

reviews and clinical practice guidelines [139].

Clinical pathways and guidelines are used by practitioners to provide a framework of care for specific patient populations to improve outcomes [107]. Clinical guidelines are evidence-based care recommendations for defined populations and assist the clinician in decision-making regarding the patient care plan. Clinical pathways are used to implement the guidelines into practice and represent what has been determined to be the best evidence-based care for most patients [127]. They are typically a written tool and may be facility specific with an overarching goal of minimizing variability and optimizing outcomes. Rotter et al. [128] reviewed 27 studies involving 11,398 participants. Twenty of those studies compared clinical pathways with usual care. Their review identified a reduction in complications and improved documentation. Most studies also reported significant reductions in patient length of stay and thus a favorable impact on associated costs [128].
