Annals of the American Thoracic Society
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Use of electronic cigarettes, devices that deliver a nicotine-containing vapor, has increased rapidly across the country and globally. Perceived and marketed as a "healthier alternative" to conventional cigarettes, few data exist regarding the safety of these devices and their efficacy in harm reduction and treatment of tobacco dependence; even less is known about their overall impact on population health. This review highlights the recent data regarding electronic cigarette toxicity, impact on lung function, and efficacy in smoking reduction and cessation. ⋯ The long-term carcinogenic and lung function effects of electronic cigarettes are not known. Although some data demonstrate that electronic cigarettes may be effective in reducing conventional cigarette consumption, there are no data demonstrating the efficacy of electronic cigarettes as a tool to achieve cessation. Until robust longitudinal evaluations demonstrate the safety of electronic cigarettes and efficacy in treatment of tobacco dependence, their role as a harm reduction tool is unclear.
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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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Observational Study
Development and preliminary evaluation of a telephone-based mindfulness training intervention for survivors of critical illness.
Persistent symptoms of psychological distress represent an unmet need among intensive care unit (ICU) survivors. ⋯ A new ICU survivor-specific mindfulness training intervention delivered by telephone was acceptable and feasible. Changes in symptoms of distress were correlated with changes in skills that were targeted by the mindfulness program. Controlled trials are needed to further evaluate this promising intervention.
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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.