Chest
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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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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.
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Portable monitoring is a convenient means for diagnosing sleep apnea. However, data on whether one night of monitoring is sufficiently precise for the diagnosis of sleep apnea are limited. ⋯ In patients with mild to moderate sleep apnea, one night of portable testing can lead to misclassification of disease severity given the substantial night-to-night variability in the AHI.
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We have entered the era of "big data" and with that the explosion of interest in prediction modeling. With this explosion comes the challenge of evaluating statistical prediction models, both from the standpoint of an author as well as a reviewer. This article provides guidance for the evaluation and critique of a statistical prediction model. Hopefully, this will improve the quality of statistical prediction modeling studies and facilitate their review.
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Mucous exudates occluding the lumen of small airways are associated with reduced lung function and mortality in subjects with COPD; however, luminal plugs in large airways have not been widely studied. We aimed to examine the associations of chest CT scan-identified luminal plugging with lung function, health-related quality of life, and COPD phenotypes. ⋯ In subjects with COPD, CT-identified luminal plugging is associated with airflow obstruction, worse health-related quality of life, and emphysema phenotype. This imaging feature may supplement the current clinical assessment of chronic mucus hypersecretion in COPD.