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Introduction: The American Urological Association Quality Improvement Summit occurs regularly to provide education and promote dialogue around the issues of quality improvement and patient ...

Objective: To construct a clinical prediction rule for coronary artery disease (CAD) presenting with chest pain in primary care. Study Design and Setting: Meta-Analysis using 3,099 patients from five studies. To identify candidate predictors, we used random forest trees, multiple imputation of missing values, and logistic regression within individual studies. To generate a prediction rule on the pooled data, we applied a regression model that took account of the differing standard data sets collected by the five studies. Results: The most parsimonious rule included six equally weighted predictors: age >= 55 (males) or >= 65 (females) (+1); attending physician suspected a serious diagnosis (+1); history of CAD (+1); pain brought on by exertion (+1); pain feels like "pressure" (+1); pain reproducible by palpation (-1). CAD was considered absent if the prediction score is = 2, it was 43.0% (95% CI: 35.8-50.4%). Conclusions: Clinical prediction rules are a key strategy for individualizing care. Large data sets based on electronic health records from diverse sites create opportunities for improving their internal and external validity. Our patient-level meta-analysis from five primary care sites should improve external validity. Our strategy for addressing site-to-site systematic variation in missing data should improve internal validity. Using principles derived from decision theory, we also discuss the problem of setting the cutoff prediction score for taking action. (C) 2016 Elsevier Inc. All rights reserved. This study was funded by Federal Ministry of Education and Research, Germany (BMBF grant no. FKZ 01GK0920).

Objective To determine the presence of a set of pre-specified traditional and non-traditional criteria used to assess scientists for promotion and tenure in faculties of biomedical sciences among universities worldwide. Design Cross sectional study. Setting International sample of universities. Participants 170 randomly selected universities from the Leiden ranking of world universities list. Main outcome measure Presence of five traditional (for example, number of publications) and seven non-traditional (for example, data sharing) criteria in guidelines for assessing assistant professors, associate professors, and professors and the granting of tenure in institutions with biomedical faculties. Results A total of 146 institutions had faculties of biomedical sciences, and 92 had eligible guidelines available for review. Traditional criteria of peer reviewed publications, authorship order, journal impact factor, grant funding, and national or international reputation were mentioned in 95% (n=87), 37% (34), 28% (26), 67% (62), and 48% (44) of the guidelines, respectively. Conversely, among non-traditional criteria, only citations (any mention in 26%; n=24) and accommodations for employment leave (37%; 34) were relatively commonly mentioned. Mention of alternative metrics for sharing research (3%; n=3) and data sharing (1%; 1) was rare, and three criteria (publishing in open access mediums, registering research, and adhering to reporting guidelines) were not found in any guidelines reviewed. Among guidelines for assessing promotion to full professor, traditional criteria were more commonly reported than non-traditional criteria (traditional criteria 54.2%, non-traditional items 9.5%; mean difference 44.8%, 95% confidence interval 39.6% to 50.0%; P=0.001). Notable differences were observed across continents in whether guidelines were accessible (Australia 100% (6/6), North America 97% (28/29), Europe 50% (27/54), Asia 58% (29/50), South America 17% (1/6)), with more subtle differences in the use of specific criteria. Conclusions This study shows that the evaluation of scientists emphasises traditional criteria as opposed to non-traditional criteria. This may reinforce research practices that are known to be problematic while insufficiently supporting the conduct of better quality research and open science. Institutions should consider incentivising non-traditional criteria. Study registration Open Science Framework (https://osf.io/26ucp/?view_only=b80d2bc7416543639f577c1b8f756e44).

AB Purpose: Comparative effectiveness research (CER) is designed to support informed decision making at both the individual, population, and policy levels. The American College of Sports Medicine and partners convened a conference with the focus of building an agenda for CER within the context of physical activity and nonpharmacological lifestyle approaches in the prevention and treatment of chronic disease. This report summarizes the conference content and consensus recommendations that culminated in a CER roadmap for physical activity and lifestyle approaches to reducing the risk of chronic disease. Methods: This conference focused on presentations and discussion around the following topic areas: 1) defining CER, 2) identifying the current funding climate to support CER, 3) summarizing methods for conducting CER, and 4) identifying CER opportunities for physical activity. Results: This conference resulted in consensus recommendations to adopt a CER roadmap for physical activity and lifestyle approaches to reducing the risk of chronic disease. In general, this roadmap provides a systematic framework by which CER for physical activity can move from a planning phase to a phase of engagement in CER related to lifestyle factors with particular emphasis on physical activity to a societal change phase that results in changes in policy, practice, and health. Conclusions: It is recommended that physical activity researchers and health care providers use the roadmap developed from this conference as a method to systematically engage in and apply CER to the promotion of physical activity as a key lifestyle behavior that can be effective at making an impact on a variety of health-related outcomes. (C) 2015 American College of Sports Medicine

In this issue, Farias and colleagues describe how to develop a clinical care pathway by using a structured, continuous learning process embedded within the day-to-day delivery of care. Their method is called Standardized Clinical Assessment and Management Plans (SCAMPs). A care pathway, such as a SCAMP, includes multiple decision points and related recommendations. The SCAMP process can test the validity of each decision point if clinicians document patient data and record their reasoning when they deviate from the recommended action at a decision point. The unique feature of SCAMPs is that they encourage dissent, unlike clinical practice guidelines (CPGs), algorithms, and bundled electronic health record protocols, which are designed to be followed. If a clinician deviates from the recommended action at a decision point, an explanation is required. This feedback, which should explain why a patient does not precisely "fit" the logic of the care pathway, may lead the SCAMP developers to modify the decision point. The authors of this Commentary argue that SCAMPs and CPGs, two approaches to developing clinical standards of care, are fundamentally equivalent. The key link between them is the recently described process of deconstructing a CPG into the many steps that are necessary to consistently apply it to clinical practice. The SCAMP process puts these steps to the test of daily practice. The Commentary ends with a list of foundational principles for developing standards of clinical care. These principles should apply to care pathways, algorithms, practice guidelines, or SCAMPs.

Available online 12 September 2017. The Publisher regrets that this article is an accidental duplication of an article that has already been published, http://dx.doi.org/10.1016/j.jval.2017.08.3019. The duplicate article has therefore been withdrawn. The full Elsevier Policy on Article Withdrawal can be found at https://www.elsevier.com/about/our-business/policies/article-withdrawal.

Comparative effectiveness research (CER) in genomic medicine (GM) measures the clinical utility of using genomic information to guide clinical care in comparison to appropriate alternatives. We summarized findings of high-quality systematic reviews that compared the analytic and clinical validity and clinical utility of GM tests. We focused on clinical utility findings to summarize CER-derived evidence about GM and identify evidence gaps and future research needs. We abstracted key elements of study design, GM interventions, results, and study quality ratings from 21 systematic reviews published in 2010 through 2015. More than half (N = 13) of the reviews were of cancer-related tests. All reviews identified potentially important clinical applications of the GM interventions, but most had significant methodological weaknesses that largely precluded any conclusions about clinical utility. Twelve reviews discussed the importance of patient-centered outcomes, although few described evidence about the impact of genomic medicine on these outcomes. In summary, we found a very limited body of evidence about the effect of using genomic tests on health outcomes and many evidence gaps for CER to address.Genet Med advance online publication 13 April 2017.

© 2017 Elsevier Inc. Background Well-written and transparent case reports (1) reveal early signals of potential benefits, harms, and information on the use of resources; (2) provide information for clinical research and clinical practice guidelines, and (3) inform medical education. High-quality case reports are more likely when authors follow reporting guidelines. During 2011–2012, a group of clinicians, researchers, and journal editors developed recommendations for the accurate reporting of information in case reports that resulted in the CARE (CAse REport) Statement and Checklist. They were presented at the 2013 International Congress on Peer Review and Biomedical Publication, have been endorsed by multiple medical journals, and translated into nine languages. Objectives This explanation and elaboration document has the objective to increase the use and dissemination of the CARE Checklist in writing and publishing case reports. Article Design and Setting Each item from the CARE Checklist is explained and accompanied by published examples. The explanations and examples in this document are designed to support the writing of high-quality case reports by authors and their critical appraisal by editors, peer reviewers, and readers. Results and Conclusion This article and the 2013 CARE Statement and Checklist, available from the CARE website [www.care-statement.org] and the EQUATOR Network [www.equator-network.org], are resources for improving the completeness and transparency of case reports.

Background A case report is a narrative that describes, for medical, scientific, or educational purposes, a medical problem experienced by one or more patients. Case reports written without guidance from reporting standards are insufficiently rigorous to guide clinical practice or to inform clinical study design. Primary Objective Develop, disseminate, and implement systematic reporting guidelines for case reports. Methods We used a three-phase consensus process consisting of (1) pre-meeting literature review and interviews to generate items for the reporting guidelines, (2) a face-to-face consensus meeting to draft the reporting guidelines, and (3) post-meeting feedback, review, and pilot testing, followed by finalization of the case report guidelines. Results This consensus process involved 27 participants and resulted in a 13-item checklist - a reporting guideline for case reports. The primary items of the checklist are title, key words, abstract, introduction, patient information, clinical findings, timeline, diagnostic assessment, therapeutic interventions, follow-up and outcomes, discussion, patient perspective, and informed consent. Conclusions We believe the implementation of the CARE (CAse REport) guidelines by medical journals will improve the completeness and transparency of published case reports and that the systematic aggregation of information from case reports will inform clinical study design, provide early signals of effectiveness and harms, and improve healthcare delivery. © 2014 Elsevier Inc. All rights reserved.

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol. The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

This review describes methods used in comparative effectiveness research (CER). The aim of CER is to improve decisions that affect medical care at the levels of both policy and the individual. The key elements of CER are (a) head-to-head comparisons of active treatments, (b) study populations typical of day-to-day clinical practice, and (c) a focus on evidence to inform care tailored to the characteristics of individual patients. These requirements will stress the principal methods of CER: observational research, randomized trials, and decision analysis. Observational studies are especially vulnerable because they use data that directly reflect the decisions made in usual practice. CER will challenge researchers and policy makers to think deeply about how to extract more actionable information from the vast enterprise of the daily practice of medicine. Fortunately, the methods are largely applicable to research in the public health system, which should therefore benefit from the intense interest in CER.

The complex agenda for comparative-effectiveness research outlined by the Institute of Medicine and the Federal Coordinating Council will require sustained, mission-focused leadership. Jordan VanLare and colleagues propose a five-step process.

The purpose of this article is to trace the development of medical professionalism in medicine from its origins to the present. Codes of professional conduct are the tangible expressions of professionalism. I use them as a window into contemporary circumstances of medical practice. The medieval guilds are my framework for examining the relationship of the medical profession in relation to society. The craft guilds of postmedieval Europe wielded considerable power. They controlled entry into a craft, training, and standards of quality. By controlling the volume of production, they controlled price. The craft guilds flourished until their monopoly powers began to hinder the forces of capitalism, which influenced the state to limit the powers of the guild. The professions are the offspring of the medieval craft guilds. Since the early 19th century, the medical profession in the United States has sought guild powers. The triangular relationship between state, capitalism, and the medical profession explains the rise of the profession during the 19th century and its decline since the mid-20th century. I argue that the codes of conduct of the profession reflect what it needs to maintain its guild powers against the forces of capitalism and the state. The Charter on Medical Professionalism calls on physicians to take into account both the individual patient's needs and those of society. I believe this important clause reflects the conflict of the profession with the state and capitalism over the aggregate costs of medical care.

In this issue of the Journal, a study by Heijnsdijk et al.1 shows the way to a resolution of the long-standing controversy about screening for prostate cancer. This is welcome news, since the 2009 reports of the long-awaited European and North American randomized trials of prostate-specific antigen (PSA) screening did not settle the matter.2,3 In the American trial, screening did not reduce prostate-cancer mortality, but the results were confounded by frequent PSA screening in the control group (e.g., 52% in the sixth year).3 In the European Randomized Study of Screening for Prostate Cancer, the screening of men between the . . .

Practice guidelines are an important innovation in patient care. According to the 2011 Institute of Medicine (IOM) definition, practice guidelines are “statements that include recommendations, intended to optimize patient care, that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options.”1 In the United States, guideline programs began in the early 1980s. As guidelines have been used for decisions about insurance coverage and standards for measuring quality of care, they have become increasingly influential, and conflict of interest (COI) in developing guidelines has become an important concern.

In October 2010, the National Cancer Institute (NCI) announced that patients who were randomly assigned to screening with low-dose computed tomography (CT) had fewer deaths from lung cancer than did patients randomly assigned to screening with chest radiography. The first report of the NCI-sponsored National Lung Screening Trial (NLST) in a peer-reviewed medical journal appears in this issue of the Journal.1 Eligible participants were between 55 and 74 years of age and had a history of heavy smoking. They were screened once a year for 3 years and were then followed for 3.5 additional years with no screening. At . . .

Wayne Gretzky once explained how he became a hockey player of genius: “I skate to where the puck is going to be, not where it has been.” Since the Affordable Care Act (ACA) enacted the Hospital Readmissions Reduction Program, hospitals have been ever more focused on playing to the puck to avoid financial penalties for high rates of early readmission. This Viewpoint examines the Hospital Readmissions Reduction Program as an example of similar initiatives by the Centers for Medicare & Medicaid Services (CMS) and discusses the increasing use of financial penalties for changing the behavior of hospitals.

Purpose Measuring the effect of cancer interventions must take into account rising cancer incidence now that people live longer because of declines in mortality from cardiovascular disease (CVD). Cancer mortality rates in the population do not accomplish this objective. We sought a measure that would reveal the effects of changing mortality rates from other diseases. Methods We obtained annual breast, colorectal, lung, and prostate cancer mortality rates from the Surveillance, Epidemiology, and End Results registries; we obtained noncancer mortality rates from national death certificates, 1975 to 2005. We used life-table methods to calculate the burden of cancer mortality as the average person-years of life lost (PYLL) as a result of cancer (cancer-specific PYLL) and quantify individual—and perhaps offsetting—contributions of the two factors that affect cancer-specific PYLL: mortality rates as a result of cancer and other-cause mortality. Results Falling cancer mortality rates reduced the burden of mortality from leading cancers, but increasing cancer incidence as a result of decreasing other-cause mortality rates partially offset this progress. Between 1985 and 1989 and between 2000 and 2004, the burden of lung cancer in males declined by 0.1 year of life lost. This decline reflects the sum of two effects: decreasing lung cancer mortality rates that reduced the average burden of lung cancer mortality by 0.33 years of life lost and declining other-cause mortality rates that raised it by 0.23 years. Other common cancers showed similar patterns. Conclusion By using a measure that accounts for increased cancer incidence as a result of improvements in CVD mortality, we find that prior assessments have underestimated the impact of cancer interventions.

In response to a mail survey, 225 leading general internists provided their opinions of the relative importance to patients of thirty medical innovations. They also provided information about themselves and their practices. Their responses yielded a mean score and a variability score for each innovation. Mean scores were significantly higher for innovations in procedures than in medications and for innovations to treat cardiovascular disease than for those to treat other diseases. The rankings were similar across subgroups of respondents, but the evaluations of a few innovations were significantly related to physicians' age. The greatest variability in response was usually related to the physician's patient mix.

The use of the hospitalist is a means to increase the efficiency of hospitals by achieving equal or better outcomes of care while reducing the cost of care. I comment on David Meltzer's controlled study of the costs and outcomes of hospitalist care, which showed increased cost savings and no change in patients' satisfaction with their care. Relative to full-time community practice, Meltzer's findings probably exaggerate the effect of hospitalists on costs. The physicians in charge of the control group of patients were full-time academic faculty, who typically spend 1 or 2 months per year doing inpatient care, in contrast to the hospitalists, who spent most of their time caring for hospitalized patients. His findings probably minimize differences in satisfaction with care. Resident physicians did most of the bedside care for the hospitalist patients and the control group patients, an arrangement that would reduce any intrinsic differences. Copyright 2001 by the University of Chicago.

Abstract: As medical technology continues to expand and the cost of using all effective clinical services exceeds available resources, decisions about health care delivery may increasingly rely on assessing the cost-effectiveness of medical services. Cost-effectiveness is particularly relevant for decisions about how to implement preventive services, because these decisions typically represent major investments in the future health of large populations. As such, decisions regarding the implementation of preventive services frequently involve, implicitly if not explicitly, consideration of costs. Cost-effectiveness analysis summarizes the expected benefits, harms, and costs of alternative strategies to improve health and has become an important tool for explicitly incorporating economic considerations into clinical decision making. Acknowledging the usefulness of this tool, the third U.S. Preventive Services Task Force (USPSTF) has initiated a process for systematically reviewing cost-effectiveness analyses as an aid in making recommendations about clinical preventive services. In this paper, we provide an overview and examples of roles for using cost-effectiveness analyses to inform preventive services recommendations, discuss limitations of cost-effectiveness data in shaping evidence-based preventive health care policies, outline the USPSTF approach to using cost-effectiveness analyses, and discuss the methods the USPSTF is developing to assess the quality and results of cost-effectiveness studies. While this paper focuses on clinical preventive services (i.e., screening, counseling, immunizations, and chemoprevention), the framework we have developed should be broadly portable to other health care services.

Data on the benefits of screening that have been obtained from studies of middle-aged adults cannot be extrapolated to the elderly; indeed, benefits decline appreciably with age. In addition, recom...

Stage An 80-year-old man with degenerative arthritis of the hip and spine began to have midthoracic back pain and worsening pain in his left hip. The pain began suddenly, was not preceded by trauma, did not radiate, and was not relieved in any position. The back pain persisted for two weeks despite rest and treatment with ibuprofen. The patient took no other medications. Response In an 80-year-old with back pain, I would worry about osteoporosis, either primary or secondary. The midthoracic area is a common site of compression fractures. Although osteoporosis is more common in women than men, at this . . .

PURPOSE: In the United States, there are currently 1,000 to 2,000 physicians who specialize in inpatient hospital care. The number of such hospitalists appears to be growing rapidly, but the ultimate size of the hospitalist workforce is not known. METHODS: We obtained workload data from 365 practicing hospitalists who completed a survey by the National Association of Inpatient Physicians. We then estimated the number of potential hospitalists, based on published national hospital census data. We assumed that hospitalists would care for all medical inpatients, but only at hospitals large enough to require ≥3 hospitalists. We also made estimates based on the primary care physician referral base and international benchmarks. We estimated hospitalists' primary care referral base from telephone interviews with key informants. Official sources in England and Germany provided international workforce data. RESULTS: Hospitalists reported an average workload of 13 inpatients. To cover all adult medical inpatients in the United States, we estimate a potential workforce of 19,000 hospitalists. Sensitivity analysis yielded 10,000 to 30,000 hospitalists. Our alternative models yielded estimates within this same range. CONCLUSIONS: The future hospitalist workforce is potentially quite large. This finding highlights the need to evaluate the economic and clinical outcomes of hospitalist systems.

The consequences of medical decisions are inherently uncertain at the decisive moment. Using clinical examples related to the diagnosis and management of low back pain, the authors review some principles that can help physicians deal with this uncertainty. This article addresses the following: the use of probability as a useful representation of uncertainty, the use of Bayes' theorem to update probability estimates when new information is obtained, the measurement of a diagnostic test's accuracy, the use of the threshold model for choosing a diagnostic test, the principles of expected-value decision making, the use of utility assessment as a way of attaching value to outcomes, and the use of quality-adjusted life years as a measure of value. These principles can aid physicians in approaching complex and uncertain decisions with their patients. As the use of computers becomes more integrated into the process of care, the opportunity exists to move formal decision models from the policy level to the patient care level.

Stage A 48-year-old man who had received three cadaveric renal transplants had a 10-day history of painless edema of the legs. He was not short of breath at rest but had had moderate dyspnea on exertion for a week. Response The edema may be hydrostatic in origin, from either heart failure or other causes, or oncotic in origin, from hypoalbuminemia; bilateral deep venous thromboses would be unusual. The patient's shortness of breath may be caused by heart failure or fluid overload, but it could indicate lung infection. He is immunocompromised, so we need a broad differential diagnosis that includes opportunistic . . .

Physicians often obtain the same test over and over again. This article first considers screening tests, such as mammographic screening for breast cancer, and describes several proposals for finding the interval that best balances cost, harms, and benefits. The same principles apply to monitoring a patient for recurrence of a disease, such as bladder cancer. The article closes with a theoretical consideration of the circumstances for repeating a test once to check a surprising value.

Health care in the United States is far costlier than in any other country, yet its outcomes, while improving, are worsening relative to other countries in the Organisation for Economic Co-operation and Development (OECD). 1 Perhaps the de facto organizing principle for US health care—approaching each patient strictly as an individual—is obsolete. The population health approach is an alternative. It aims to improve and maintain health across a defined population. 2,3 A “defined population” can mean a clinician’s patients or a health plan’s enrollees, but the defined population for the population health approach includes everyone in the community. This Viewpoint addresses 3 related questions. First, can the population health approach improve the outcomes of US health care? Second, for the population health approach to succeed, must it reconcile the needs of the individual and the community? Third, how might

Public interest in disease and injury prevention is very high, driven by a steady accumulation of high-quality evidence that preventive interventions do reduce cause-specific death rates. The purpose of these interventions is to eliminate the root causes of diseases that precede death (e.g., heart disease, cancer, and stroke). This chapter presents a review of health risks posed by substance abuse (tobacco, alcohol, and drugs), accidents (e.g., from motor vehicles, accidental poisoning, falling, fire, drowning, and firearms), and domestic violence. The physician’s role in prevention is to identify risk factors for disease and injury and counsel patients about modifying potentially harmful behaviors. Figures illustrate the life expectancy of men and women, and years of potential life lost from various causes, in the United States. Tables list recommendations of the United States Preventive Services Task Force (USPSTF), years of smoking abstinence needed to reduce the risk of disease, elements of a successful smoking cessation strategy, stages of readiness for smoking cessation, the test performance of screening questionnaires for alcohol abuse, the CAGE questionnaire, unintentional and undetermined poisoning deaths in 11 states, and risk factors for falls among the elderly. A sidebar provides links to domestic violence information on the Internet. This review contains 3 highly rendered figures, 9 tables, and 87 references.