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

Abstract

Evidence-based medicine (EBM) can be defined as the integration of optimized clinical judgment, patient values, and available evidence. It is a philosophical approach to making the best possible clinical decisions for individual patients. Based on objective evaluation and categorization of methodological design and data quality, all existing literature can be organized according to a hierarchy of "evidence quality" that helps determine the applicability and value of scientific findings in terms of clinical implementation and the potential to change existing patterns of practice. In terms of general categorization of scientific impact, randomized controlled trials (RCTs) are placed on top of the hierarchy, followed by systematic reviews of randomized controlled trials (RCTs), quasi-randomized designs, observational studies including retrospective case series, and finally case reports and expert opinion. Each study design is susceptible to certain limitations and biases, highlighting the importance of both clinical and scientific acumen of the interpreting provider. Such approach is critical to determining the value and the applicability of study recommendations in everyday practice. Evidence-based practice (EBP) has become one of the fundamental components of modern medicine and plays an indispensible role in the development (and improvement) of patient care and safety worldwide. Furthermore, organizations that create guidelines and policies for the management of specific conditions, often base the content and strength of their recommendations on the quality of evidence available to expert decision-makers. Therefore, understanding the "state of the science" upon which those recommendations are based will help guide the medical practitioner on "if, when and how" to apply evidence-based guidelines in his or her everyday medical or surgical practice. This chapter focuses on clinically relevant application of levels of scientific evidence (LSE) and the corresponding levels of clinical recommendation (LCR) in the context of care quality and safety.

Introductory Chapter: International Health Security Expanded and Re-Defined

“…Starting with a summative assessment by the IHS Working Group of the American College of Academic International Medicine, the discussion then moves on to incorporate a variety of contemporary topics such as refugee crises, cyber security, social media, big data analytics, scientist training, and point-of-care diagnostics. Also important to the overall IHS discussion, the authors touch upon the importance and impact of organized systems of care on health security, focusing on the tremendous value of such systems to human wellness and the continuous focus on care quality and improving clinical outcomes [24][25][26][27][28].…”

Introductory Chapter: Teams in Healthcare - A Voyage from ‘Nice to Have’ to ‘the Way to Go’

“…This, in turn, helps facilitate the application of evidence-base practice, which appears to be both safer and relatively free of personal biases and/or opinions [8,26]. Moreover, 'team healthcare' environment also provides an excellent substrate for determining that a given protocol or clinical pathway does not work, thus prompting constructive changes that tend to be evidence-based and systematic in nature [10]. Again, success is based upon the participation of champions, leadership support at all levels, and the recognition that such paradigm shifts within a 'culture of behaviors' are better for all aspects of the patient care, including both experiences and outcomes -and not just for individuals who continue to advocate that "the old ways," which might have worked to some degree in the past, are still acceptable across modern healthcare delivery platforms [7,14,24,27].…”

“…Through a series of incremental changes and reforms, significant improvements have been made over time, but the healthcare industry is still far from the safety, quality, and performance records achieved by our counterparts in financial and air transportation sectors [9]. Currently, a significant portion of the overall effort in this area revolves around reinforcing team-based approaches, including the incorporation of continuous quality and performance improvement initiatives into existing, multidisciplinary paradigms across a broad range of care delivery settings [7,10,11].…”

Introductory Chapter: Patient Safety is the Cornerstone of Modern Health-Care Delivery Systems

“…Using specialized processes, such as the plan-do-check-act (PDCA) quality improvement cycle, modern PS protocols and approaches continue to evolve and become increasingly more optimized [29]. Organizations must continue to transform PS systems into more horizontal, cross-disciplinary platforms that function in a nonpunitive, fair, respectful, and inclusive fashion [30,31].…”

“…Of importance, continuous real-time review of patient safety and quality processes must be performed to ensure that all active implementations are being monitored for proper functioning, as well as any unintended consequences or down-stream problems, for either the patient or the health-care system [29,36,37]. This can be accomplished through conducting regular performance improvement initiatives, hiring dedicated staff to track and report on different quality measures, and building robust systems to ensure not only that safety and quality are being upheld but also to resolve any issues as they arise [7,38].…”