Annals of the American Thoracic Society
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Observational studies and pragmatic trials can complement classical randomized controlled trials (RCTs) by providing data more relevant to the circumstances under which medicine is routinely practiced, thereby providing practical guidance for clinicians. The bearing of RCT findings on day-to-day practice can be weighted and the data more meaningfully interpreted by practicing clinicians if evidence is integrated from a variety of different study designs and methodologies. ⋯ This article discusses where observational studies and pragmatic trials have utility, namely: in addressing clinical questions that are unanswered and/or unanswerable by RCTs; in testing new hypotheses and possible license extensions; and in helping to differentiate between available therapies for a given indication. Moreover, it seeks to highlight how the different approaches fit within a conceptual framework of evidence relevant to clinical practice, a step-change in the traditional view of medical evidence.
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Little is known about adults who frequently visit the emergency department (ED) for acute asthma, or the economic impact of this ED use. ⋯ In this population-based cohort, 26% of patients had multiple asthma-related ED visits within 1 year. These patients were more likely to be black, Hispanic, and of lower socioeconomic status; they accounted for 57% of asthma-related hospital charges in Florida. To improve population health and to control asthma-related health care spending, we believe it is imperative to identify and assist adults with frequent asthma-related ED visits.
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Clinical practice guidelines are usually developed by a group of experts coming together to review the evidence in a field to make evidence-based recommendations on how to integrate new evidence into practice. The development process often draws on strict methodological rules to assess and assign quality grades to the evidence used to underpin the recommendations. Yet the goal of clinical practice guidelines--to help guide clinicians to understand, translate, and apply new evidence into everyday practice--can be thwarted by a lack of diversity and plurality of committee members, by limitations in the published evidence base, and by the design of the randomized controlled trials (RCTs) that largely underpin their pronouncements. ⋯ Although RCTs can adequately demonstrate efficacy of a specific treatment, pragmatic trials and postmarketing observational studies are usually required to evaluate the long-term safety of therapeutic interventions. The practical usefulness of clinical practice guidelines may be enhanced by ensuring representation of a broad stakeholder group within guideline committees (e.g., patients, primary and secondary care clinicians, policy makers, and health insurers) and by integrating effectiveness as well as efficacy data. Only in this way can clinical practice guidelines achieve their goal of guiding the meaningful implementation of new research into practice, for the benefit of all stakeholders.
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Observational Study
An index of daily step count and systemic inflammation predicts clinical outcomes in chronic obstructive pulmonary disease.
Identification of persons with chronic obstructive pulmonary disease (COPD) at risk for acute exacerbations (AEs) targets them for close monitoring. ⋯ An index combining daily step count and systemic inflammation can predict AEs and COPD-related hospitalizations. A validation study in a separate cohort is needed to confirm the utility of the proposed index as a clinical tool to risk stratify persons with COPD.
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There are no published data regarding use of the STOP-BANG sleep apnea questionnaire in populations referred to Veterans Affairs (VA) sleep facilities. If a particular STOP-BANG score cutpoint had high positive predictive value in this referral population, it could reduce the need for diagnostic sleep studies. ⋯ The STOP-BANG questionnaire alone is insufficient to confirm the presence of significant sleep apnea. A maximal score of 8 did not have a high enough positive predictive value to forego confirmatory sleep testing.