Evidence-Based Endocrinology

Evidence-based medicine is the judicious, conscientious, and explicit use of the best available evidence from clinical research in making clinical decisions. This definition recognizes a hierarchy of evidence that arranges study designs by their susceptibility to bias. The top of the hierarchy includes n-of-1 trials, systematic reviews of randomized trials, and single randomized trials reporting patient-important outcomes. The bottom of the hierarchy includes physiologic studies and unsystematic clinical observations. The definition posits that evidence alone is never enough to guide clinical decisions. In addition to evidence from clinical research, decision making requires careful and expert assessment of the patient's circumstances and elicitation of the patient's values and preferences. The latter should drive decisions, particularly when the trade-offs (of benefit and risk) are close or unclear. The evidence-based medicine process involves: (i) asking an answerable question; (ii) acquiring the best available evidence; (iii) appraising the evidence to judge the strength of inference of its results; and (iv) applying the results to the individual patient. Evidence-based endocrinology is hindered by limited high-level evidence assessing patient-important outcomes, limited systematic summaries of this evidence, lack of time, and lack of systematic training of endocrinologists in evidence-based medicine. Current endocrine practice may require a redesign to enhance the role of endocrinologists as information brokers for colleagues and patients. In the last 10 years, evidence-based medicine has matured as a philosophy of clinical care and medical education. An appraisal of its role in endocrinology awaits the pervasion of its principles into all of endocrine practice.     

Imaging the penumbra in acute stroke

Imaging continues to have a huge impact on the understanding of the ischemic penumbra and the management of acute stroke. Determinants of penumbral tissue fate, such as age, hyperglycemia, hematocrit, and oxygen concentration, are increasingly being recognized using neuroimaging. The significance of the penumbra in the white matter and in posterior circulation stroke is also becoming clearer. Neuroimaging is also making invaluable contributions to clinical decision making in acute stroke, especially in relation to reperfusion therapies in the 3- to 6-hour time window. Despite ongoing questions over the choice of parameters to identify the penumbra and their respective clinical usefulness, imaging is gaining widespread use in acute stroke management. However, definitive evidence of its benefit is still lacking. This review explores the recent progress and controversies relating to imaging of the penumbra.     

Substituted Judgment: The Limitations of Autonomy in Surrogate Decision Making

Substituted judgment is often invoked as a guide for decision making when a patient lacks decision making capacity and has no advance directive. Using substituted judgment, doctors and family members try to make the decision that the patient would have made if he or she were able to make decisions. However, empirical evidence suggests that the moral basis for substituted judgment is unsound. In spite of this, many physicians and bioethicists continue to rely on the notion of substituted judgment. Given compelling evidence that the use of substituted judgment has insurmountable flaws, other approaches should be considered. One approach provides limits on decision making using a best interest standard based on community norms. A second approach uses narrative techniques and focuses on each patient’s dignity and individuality rather than his or her autonomy.     

Impact of Artificial Intelligence on Interventional Cardiology: From Decision-Making Aid to Advanced Interventional Procedure Assistance

Access to big data analyzed by supercomputers using advanced mathematical algorithms (i.e., deep machine learning) has allowed for enhancement of cognitive output (i.e., visual imaging interpretation) to previously unseen levels and promises to fundamentally change the practice of medicine. This field, known as “artificial intelligence” (AI), is making significant progress in areas such as automated clinical decision making, medical imaging analysis, and interventional procedures, and has the potential to dramatically influence the practice of interventional cardiology. The unique nature of interventional cardiology makes it an ideal target for the development of AI-based technologies designed to improve real-time clinical decision making, streamline workflow in the catheterization laboratory, and standardize catheter-based procedures through advanced robotics. This review provides an introduction to AI by highlighting its scope, potential applications, and limitations in interventional cardiology.     

Importance of Residual Myocardial Ischemia After Intervention in the Genesis of Cardiovascular Events Among Patients with Chronic Coronary Artery Disease

Recent randomized clinical trials support the strategy of ischemia-guided management for patients with stable ischemic heart disease. The application of serial testing to examine the efficacy of therapeutic intervention for ischemia suppression and to document the extent and severity of ischemia provides an important means to guide clinical decision making. This review provides a synopsis of available evidence on serial testing and meaningful thresholds for application of paired rest/stress myocardial perfusion single photon emission computed tomography imaging.     

Using health information technology to improve hypertension management

High-quality medical care requires implementing evidence-based best practices, with continued monitoring to improve performance. Implementation science is beginning to identify approaches to developing, implementing, and evaluating quality improvement strategies across health care systems that lead to good outcomes for patients. Health information technology has much to contribute to quality improvement for hypertension, particularly as part of multidimensional strategies for improved care. Clinical reminders closely aligned with organizational commitment to quality improvement may be one component of a successful strategy for improving blood pressure control. The ATHENA-Hypertension (Assessment and Treatment of Hypertension: Evidence-based Automation) system is an example of more complex clinical decision support. It is feasible to implement and deploy innovative health information technologies for clinical decision support with features such as clinical data visualizations and evidence to support specific recommendations. Further study is needed to determine the optimal contexts for such systems and their impact on patient outcomes.     

Multidisciplinary evidence-based medicine journal clubs: curriculum design and participants' reactions

BACKGROUND: Evidence-based medicine (EBM) is becoming an accepted educational paradigm in medical education at a variety of levels. It focuses on identifying the best evidence for medical decision making and applying that evidence to patient care. METHODS: Three EBM journal clubs were developed at the West Virginia University School of Medicine. One was for senior medical students, another for residents, and the third for primary care faculty members. In each, the sessions stressed answering clinical questions arising from actual patient-care issues. The curricular structure and development of the journal clubs are described. Participants anonymously evaluated aspects of the journal clubs regarding their educational value with Likert scale questions. RESULTS: Faculty members and residents generally gave high evaluations to all aspects of the EBM journal clubs. Student evaluations were more mixed. For each of the evaluation questions, the student means were lower than those of faculty and residents. However the differences reached statistical significance only in the responses to the usefulness of the sessions in understanding the medical literature (P < 0.01). Residents and faculty rated the EBM sessions more favorably than grand rounds or the resident lecture series. CONCLUSIONS: The establishment of evidence-based medicine journal clubs is feasible, and learners seem to value the sessions. More developed learners may gain more from the experience than those earlier in their medical education.     

A typology of shared decision making, informed consent, and simple consent

Enhancing patient choice is a central theme of medical ethics and law. Informed consent is the legal process used to promote patient autonomy; shared decision making is a widely promoted ethical approach. These processes may most usefully be seen as distinct in clinically and ethically important respects. The approach outlined in this article uses a model that arrays all medical decisions along 2 axes: risk and certainty. At the extremes of these continua, 4 decision types are produced, each of which constrains the principal actors in predictable ways. Shared decision making is most appropriate in situations of uncertainty, in which 2 or more clinically reasonable alternatives exist. When there is only 1 realistic choice, patient and physician may gather and exchange information; however, the patient cannot be empowered to make choices that do not exist. In contrast, informed consent does not require the presence of clinical choice; it is appropriate for all decisions of significant risk, even if there is only one option. When a clinical decision contains both risk and uncertainty, shared decision making and informed consent are both appropriate. For decisions of lower risk, consent should still be present, but it can be simple rather than informed. Clinicians may use this analysis as a guide to their own interactions with patients. In the continuing effort to provide patients with appropriate decisional authority over their own medical choices, shared decision making, informed consent, and simple consent each has a distinct role to play.     

Contextualizing medical decisions to individualize care

Clinical decision making can be described as answering one question: “What is the best next thing for this patient at this time?” In addition to incorporating clinical information, research evidence, and patient preferences, the process requires considering contextual factors that are unique to each patient and relevant to their care. The failure to do so, thereby compromising that care, can be called a “contextual error.” Although proponents of evidence-based clinical decision making and many scholars of the medical interview emphasize the importance of individualizing care, no operational definition is provided for the concept, nor is any methodology proposed for the interpretation of clinically relevant patient-specific variables. By conceptualizing the physician-patient encounter as a participant-observer case study with an N of 1, this essay describes how existing approaches to studying social systems can provide clinicians with a systematic approach to individualizing their clinical decision making.     

Beyond Stage C: Considerations in the Management of Patients With Heart Failure Progression and Gaps in Evidence

Despite treatment with contemporary medical therapies for chronic heart failure (HF), there has been an increase in the prevalence of patients progressing to more advanced disease. Patients progressing to and living at the interface of severe stage C and stage D HF are underrepresented in clinical trials, and there is a lack of high-quality evidence to guide clinical decision making. For patients with severe HF phenotypes, the medical therapies used for patients with less advanced stages of illness are often no longer tolerated or provide inadequate clinical stability. The limited data on these patients highlights the need to increase formal research characterizing this high-risk population. This review summarizes existing clinical trial data and incorporates our considerations for approaches to the medical management of patients advanced “beyond stage C” HF.     

Chapter 2: medical tests guidance (2) developing the topic and structuring systematic reviews of medical tests: utility of PICOTS, analytic frameworks, decision trees, and other frameworks

Topic development and structuring a systematic review of diagnostic tests are complementary processes. The goals of a medical test review are to identify and synthesize evidence to evaluate the impacts alternative testing strategies on health outcomes and to promote informed decision making. A common challenge is that the request for a review may state the claim for the test ambiguously. Due to the indirect impact of medical tests on clinical outcomes, reviewers need to identify which intermediate outcomes link a medical test to improved clinical outcomes. In this paper, we propose the use of five principles to deal with challenges: the PICOTS typology (patient population, intervention, comparator, outcomes, timing, setting), analytic frameworks, simple decision trees, other organizing frameworks and rules for when diagnostic accuracy is sufficient.     

African American patients' perspectives on medical decision making

BACKGROUND: The medical literature offers little information about how older African Americans view the medical decision-making process. We sought to describe the perspectives of older African American patients in a primary care clinic as they consider a medical decision. METHODS: We interviewed 25 African American patients older than 50 years who had discussed flexible sigmoidoscopy with their primary care provider. Interviews were analyzed using qualitative methods. RESULTS: Patients listed concerns about cancer and health, risks and benefits, their own understanding of the test, and the recommendation of the provider as the most important factors in their decision. Most patients wanted information about medical tests and procedures to increase their understanding and to provide reassurance rather than to guide decision making. Most patients explained that they wanted the provider to make medical decisions because of his or her training and experience. Despite this, many expressed a sense of ownership or control over one's own body. Patients thought trust was built by a health care provider's honesty, patience, kindness, interest, and continuity of care. CONCLUSIONS: Although traditional models of informed consent have emphasized providing patients with information to guide autonomous decision making, patients may want this information for other reasons. Fully informing patients about their medical condition increases understanding and provides reassurance. Because many of these patients want their provider to participate in making medical decisions, he or she should not only provide information but should also provide guidance to the patient.     

Titrating guidance: a model to guide physicians in assisting patients and family members who are facing complex decisions

Over the last century, developments in new medical treatments have led to an exponential increase in longevity, but, as a consequence, patients may be left with chronic illness associated with long-term severe functional and cognitive disability. Patients and their families are often forced to make a difficult and complex choice between death and long-term debility, neither of which is an acceptable outcome. Traditional models of medical decision making, however, do not fully address how clinicians should best assist with these decisions. Herein, we present a new paradigm that demonstrates how the role of the physician changes over time in response to the curved relationship between the predictability of a patient's outcome and the chance of returning to an acceptable quality of life. To translate this model into clinical practice, we propose a 5-step model for physicians with which they can (1) determine at which point the patient is on our model; (2) identify the cognitive factors and preferences for outcomes that affect the decision-making process of the patient and his or her family; (3) reflect on their own reaction to the decision at hand; (4) acknowledge how these factors can be addressed in conversation; and (5) guide the patient and his or her family in creating a plan of care. This model can help improve patient-physician communication and decision making so that complex and difficult decisions can be turned into ones that yield to medical expertise, good communication, and personal caring.     

Decision analysis for the practicing gastroenterologist. 1. Reading a decision analysis paper

To emphasize, clinical decision analysis rests on logic structures and data, all of which must be derived clinically. There are three reasons to dispute the conclusions of an exercise. The reader may dispute the logic (the construct of the decision tree), challenge the data that was utilized for the decision tree, or be unjustly stubborn. What is the role of decision analysis? It is a formal exposition of some of the subprocesses of medical reasoning, and it may serve as a check on the consistency of current medical practice, or be an excellent educational tool. By isolating the critical data needed for decisions, it can direct research or study. It is not, however, a full imitation of clinical judgment (it is usually too limited in both scope and data) and is not yet a primary guide to patient care, although it has been used, on a regular basis to examine care (e.g., Reference 2). When data are well justified for each node, and when the individual clinician utilizes sensitivity analysis to adjust for his own locale, then perhaps it can be a usual aid in clinical decision making. Until then, the current applications are too limited in scope and are confounded by the same variably adequate data that we presently deal with.     

Foundations of medical decision-making for older adults with cardiovascu-lar disease

In order to help older adults with cardiovascular disease navigate complex decisions, clinicians must know tenets of medical ethics and have good communication skills. The elements of decision making capacity and informed consent are reviewed, using relevant clinical examples to illustrate the basic concepts. The shared decision making model, by which clinician and patient work together to determine the plan of care, is described. Useful communication techniques to implement shared decision making are suggested.     

Cardiologists' use of percutaneous coronary interventions for stable coronary artery disease

BACKGROUND: Percutaneous coronary intervention (PCI) is commonly performed in patients with stable coronary artery disease, despite current evidence suggesting that such patients derive minimal benefit from the procedure. We sought to determine the influences on cardiologists' decision to perform elective PCI in patients with stable coronary artery disease. METHODS: We conducted a qualitative study using 3 focus groups of interventional and noninterventional cardiologists in California. Participants discussed issues surrounding the decision to perform PCI using hypothetical case scenarios. We analyzed the data according to the principles of grounded theory. RESULTS: Despite acknowledging data showing that PCI offers no reduction in the risk of death or myocardial infarction in patients with stable coronary artery disease, cardiologists generally believed that PCI would benefit such patients. Reasons given for performing PCI included belief in the benefits of treating ischemia and the open artery hypothesis, especially with drug-eluting stents; potential regret for not intervening if a cardiac event could be averted; alleviation of patient anxiety; and medicolegal considerations. Participants believed that, in patients undergoing coronary angiography, an "oculostenotic reflex" prevailed and all significant amenable stenoses would receive intervention, even in asymptomatic patients. CONCLUSIONS: The widespread application of PCI in stable coronary artery disease for indications unsupported by evidence may reflect discordance between cardiologists' clinical knowledge and their beliefs about the benefits of PCI. Nonclinical factors appear to have substantial influence on physician decision making. Future studies should focus on the development of methods to help providers more fully incorporate clinical evidence into their medical decision making.     

The Role of Noninvasive Imaging in Coronary Artery Disease Detection,Prognosis, and Clinical Decision Making

A vast array of noninvasive imaging modalities is available for the evaluation of the presence and severity of coronary artery disease (CAD). Choosing the right test can be challenging but is critical for proper patient diagnosis and management. Presently available imaging tests for CAD include: (1) nuclear myocardial perfusion imaging procedures (single-photon emission tomography) and positron emission tomography, (2) stress echocardiography, (3) computed tomography coronary angiography, and (4) cardiac magnetic resonance imaging. Exercise treadmill testing electrocardiography is another alternative that we will discuss briefly. Selection of the most appropriate imaging modality requires knowledge of the clinical question being addressed, patient characteristics (pretest probability and prevalence of disease), the strengths, limitations, risks, costs, and availability of each procedure. To assist with test selection, we review the relevant literature in detail to consider the relative merits of cardiac imaging modalities for: (1) detection of CAD, (2) risk stratification and prognostication, and (3) guiding clinical decision making.     

Personalized Decision Support in Type 2 Diabetes Mellitus: Current Evidence and Future Directions

The management of type 2 diabetes comprises a complex series of medical decisions regarding goals of care, self-care behaviors, and medical treatments. The quality of these medical decisions is critical to determining whether an individual diabetes patient is treated appropriately, overtreated, or undertreated. It is hypothesized that the quality of these medical decisions can be enhanced by personalized decision support tools that summarize patient clinical characteristics, treatment preferences, and ancillary data at the point of care. We describe the current state of personalized diabetes decision support on the basis of 13 recently described tools. Three tools provided support for personalized decisions based on preferences, while the remaining 10 provided support for treatment decisions designed to achieve standard diabetes goals. For the tools that supported personalized decisions, patient participation in medical decisions improved. Future decision support tools must be designed to account for both clinical characteristics and patient preferences.     

Imaging technologies and techniques

Equipment manufacturers provide contrast-specific detection techniques that have excellent sensitivity and excellent agent-to-tissue specificity along with helpful tools that improve workflow efficiency dramatically. Excellent contrast agents have been approved for LV opacification and are available worldwide. Techniques designed for low-MI imaging offer real-time acquisition capabilities and lead to faster examinations. Techniques designed for medium-MI imaging offer better sensitivity than low-MI techniques while maintaining the benefit of rapid image acquisition. Techniques designed for high-MI imaging offer the best sensitivity with longer acquisition times. These techniques are viable means for imaging contrast agents tailored to clinical needs. Progress by contrast agent manufacturers, equipment manufacturers, and physicians will continue to drive improvements in the areas of detection and clinical workflow for improved patient care.