Chest
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Mortality has long been used as a primary end point for randomized controlled trials in critical care. Recently, a plurality of trials targeting mortality end points as their primary outcome has failed to detect a difference between study arms. ⋯ We explore some of the reasons why such trials may be biased toward a neutral result, as well as reasons to consider alternative end points that are better coupled to the expected therapeutic effect. We also discuss to what extent mortality as a binary outcome is patient-important in the ICU.
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Providing guideline-concordant management of pulmonary nodules can present challenges when a patient's anxiety about cancer or fear of invasive procedures colors judgment. The way in which providers discuss and make decisions about how to evaluate a pulmonary nodule can affect patient satisfaction, distress, and adherence to evaluation. This article discusses the complexity of tailoring patient-provider communication, decision-making, and implementation of guidelines for pulmonary nodule evaluation to the individual patient, emphasizing the importance of how information is conveyed and the value of listening to and addressing patients' concerns. We summarize the relevant guideline recommendations and literature, and provide two case scenarios to illustrate a patient-centered approach to discussing and managing pulmonary nodules from our perspectives as a pulmonologist and thoracic surgeon.
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Randomized controlled trials (RCTs) are considered the highest level of evidence to establish causal associations in clinical research. There are many RCT designs and features that can be selected to address a research hypothesis. Designs of RCTs have become increasingly diverse as new methods have been proposed to evaluate increasingly complex scientific hypotheses. ⋯ To illustrate their diversity, examples of RCTs from the literature are provided. Statistical considerations, such as power and type I error rates, are discussed with the intention of providing practical guidance about how to specify study hypotheses that address the scientific question while being statistically appropriate. Finally, the freely available Consolidated Standards of Reporting Trials guidelines and US Food and Drug Administration guidance documents are introduced, along with a set of guidelines one should consider when planning an RCT or reviewing RCTs submitted for publication in peer-reviewed academic journals.
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COPD is a heterogeneous disease demonstrating inter-individual variation. A high COPD prevalence in Chinese populations is described, but little is known about disease clusters and prognostic outcomes in the Chinese population across Southeast Asia. We aim to determine if clusters of Chinese patients with COPD exist and their association with systemic inflammation and clinical outcomes. ⋯ We describe clusters of Chinese patients with COPD, two of which represent high-risk clusters. The cardiovascular and ex-TB patient clusters exhibit high mortality, significant inflammation, and complex cytokine networks. Clinical and inflammatory risk stratification of Chinese patients with COPD should be considered for targeted intervention to improve disease outcomes.
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Guidelines for clinical documentation of evaluation and management face-to-face services were developed > 20 years ago. Recently, the Centers for Medicare & Medicaid Services (CMS) have addressed office and other outpatient services and the corresponding reimbursement, intending to reduce the amount of required documentation and to alleviate clerical burden. A CMS final rule for 2021 will eliminate the history and physical examination as criteria for level of service, allow time or medical decision-making to be used as coding criteria, and will recognize a code for prolonged service. The net effect of these changes may be some decrease in documentation burden, a change in the composition of clinical notes, and greater recognition by CMS of primary care and those who see highly complex patients requiring prolonged services.