Chest
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Randomized Controlled Trial Multicenter Study
The Idiopathic Pulmonary Fibrosis Clinical Research Network (IPFnet): Diagnostic and Adjudication Processes.
The National Heart, Lung, and Blood Institute-sponsored IPF Clinical Research Network (IPFnet) studies enrolled subjects with idiopathic pulmonary fibrosis (IPF) to evaluate drug therapies in treatment trials. An adjudication committee (AC) provided a structured review of cases in which there was uncertainty or disagreement regarding diagnosis or clinical event classification. This article describes the diagnosis and adjudication processes. ⋯ The IPFnet diagnostic process was generally efficient, but a multidisciplinary adjudication committee was critical to assure correct phenotype for study enrollment. The AC was key in adjudicating all adverse outcomes in two IPFnet studies terminated early because of safety issues. Future clinical trials in IPF should consider logistical and cost issues as they incorporate AExs and hospitalizations as outcome measures.
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Review Meta Analysis
The Impact of Visceral Pleural Invasion In Node-negative Non-small-cell Lung cancer: A Systematic Review and Meta-analysis.
Visceral pleural invasion (VPI) is considered an aggressive and invasive factor in non-small cell lung cancer (NSCLC). Recent studies found that depending on tumor size, VPI influences T stage, but there is no consensus on whether VPI is important in node-negative NSCLC. In addition, its role in stage IB NSCLC is still uncertain. In this meta-analysis, we assessed the role of VPI in node-negative NSCLC according to various tumor sizes and especially in stage IB disease. ⋯ VPI together with tumor size has a synergistic effect on survival in node-negative NSCLC. Patients with stage IB NSCLC and larger tumor size with VPI might be considered for adjuvant chemotherapy after surgical resection and need careful preoperative evaluation and postoperative follow-up. Further randomized clinical trials to determine the impact of adjuvant chemotherapy in patients with stage IB NSCLC with VPI are warranted.
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Multicenter Study Clinical Trial Observational Study
Five-year Outcomes of Patients Enrolled in the Registry to Evaluate Early and Long-term Pulmonary Arterial Hypertension (PAH) Disease Management (REVEAL).
Pulmonary arterial hypertension (PAH) is a rare, severe disease characterized by worsening right-sided heart failure, decreasing functional status, and poor survival. The present study characterizes the 5-year survival in the United States of a new and previous diagnosis of PAH in patients stratified by baseline functional class (FC). The Registry to Evaluate Early and Long-term PAH Disease Management (REVEAL Registry) is a 55-center observational US registry of the demographics, disease course, and management of patients with World Health Organization (WHO) group 1 PAH. ⋯ Patient survival of advanced PAH remains poor at 5 years despite treatment advances. New York Heart Association FC remains one of the most important predictors of future survival. These observations reinforce the importance of continuous monitoring of FC in patients with PAH.
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Case Reports
A 60-Year-Old Woman With Cough, Dyspnea, and Atelectasis 19 Years After Liver Transplant.
A 60-year-old black woman presented with nonproductive cough of 1-month duration. She had also experienced rapidly progressive dyspnea for 1 week and one bout of vomiting a day before presentation. ⋯ Her medical history was significant for diabetes mellitus and liver transplant 19 years earlier for hepatitis C cirrhosis, for which she was receiving tacrolimus and mycophenolate. She was a current smoker with 40 pack-years of smoking history.
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Idiopathic pulmonary fibrosis (IPF) is a progressive, fatal disease. Until recently, the standard therapy for this disease has been essentially supportive, with the exception of a minority of patients who were eligible for lung transplantation. The development pathway for novel medications for IPF has been complicated. ⋯ In October 2014, these two drugs became the first agents to be approved by the US Food and Drug Administration for the treatment of IPF. (Pirfenidone had already been approved in several countries outside the United States.) In November 2014, the European Medicines Agency approved the use of nintedanib for IPF. The landscape for management of IPF has markedly changed with the advent of approved therapeutic options for IPF. In this article, we review the strategies that are being used to increase the likelihood of success in clinical development programs of novel disease-modifying agents in IPF.