American journal of respiratory and critical care medicine
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Am. J. Respir. Crit. Care Med. · Sep 2017
Comparative StudyA Comparative Analysis of Pulmonary and Critical Care Medicine Guideline Development Methodologies.
The Institute of Medicine (IOM) standards for guideline development have had unintended negative consequences. A more efficient approach is desirable. ⋯ We propose the CORE process as an early step in guideline creation. Questions for which 70% agreement on a recommendation cannot be achieved should go through an IOM-compliant process; however, questions for which 70% agreement on a recommendation can be achieved can be accepted, avoiding a lengthy systematic review.
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Am. J. Respir. Crit. Care Med. · Sep 2017
ReviewApplying Precision Medicine to Trial Design Using Physiology: Extracorporeal CO2 Removal for ARDS.
In clinical trials of therapies for acute respiratory distress syndrome (ARDS), the average treatment effect in the study population may be attenuated because individual patient responses vary widely. This inflates sample size requirements and increases the cost and difficulty of conducting successful clinical trials. One solution is to enrich the study population with patients most likely to benefit, based on predicted patient response to treatment (predictive enrichment). ⋯ To support this claim, we simulated the predicted effect of ECCO2R on driving pressure and mortality in a preexisting cohort of patients with ARDS. Our computations suggest that restricting enrollment to patients in whom ECCO2R allows driving pressure to be decreased by 5 cm H2O or more can reduce sample size requirement by more than 50% without increasing the total number of patients to be screened. We discuss potential implications for trial design based on this framework.
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Am. J. Respir. Crit. Care Med. · Sep 2017
Multicenter StudyCT Measure of Lung At-risk and Lung Function Decline in Chronic Obstructive Pulmonary Disease.
The rate of decline of lung function is greater than age-related change in a substantial proportion of patients with chronic obstructive pulmonary disease, even after smoking cessation. Regions of the lung adjacent to emphysematous areas are subject to abnormal stretch during respiration, and this biomechanical stress likely influences emphysema initiation and progression. ⋯ Areas of normal-appearing lung are mechanically influenced by emphysematous areas and this lung at risk is associated with lung function decline. Clinical trial registered with www.clinicaltrials.gov (NCT00608764).
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Am. J. Respir. Crit. Care Med. · Sep 2017
Comparative StudyAssessing the Generalizability of the National Lung Screening Trial: Comparison of Stage 1 Patients.
The findings of the NLST (National Lung Screening Trial) are the basis for screening high-risk individuals according to age and smoking history. Although screening is covered for eligible Medicare beneficiaries, the generalizability of the NLST in the elderly population has been questioned. ⋯ Elderly patients with minimal comorbid conditions meeting the inclusion criteria of the NLST who underwent surgery had excellent postoperative outcomes and similar lung cancer-specific 5-year survivorship. In those with significant comorbidities or those not undergoing surgery, competing causes of death may diminish the benefit, and there is no evidence to recommend screening in this group.
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Am. J. Respir. Crit. Care Med. · Sep 2017
Letter Randomized Controlled TrialRandomized Double-blind Controlled Trial of Roflumilast at Acute Exacerbations of COPD.