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1.
Ann Am Thorac Soc ; 21(1): 136-150, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37027538

RESUMO

Rationale: The American Thoracic Society convened an international, multidisciplinary panel to develop clinical practice guidelines for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD). Objective: To conduct a systematic review and evaluate the literature to determine whether patients with SSc-ILD should be treated with mycophenolate. Methods: A literature search was conducted across the MEDLINE, EMBASE, and CENTRAL databases through June 2022 for studies using mycophenolate to treat patients with SSc-ILD. Mortality, disease progression, quality of life, and adverse event data were extracted, and meta-analyses were performed when possible. The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) Working Group method was used to assess the quality of evidence. Results: The literature review resulted in seven studies fitting the inclusion criteria. The systematic review and meta-analyses revealed changes in forced vital capacity % predicted (mean difference [MD], 5.4%; 95% confidence interval [95% CI]: 3.3%, 7.5%), diffusing capacity of the lung for carbon monoxide % predicted (MD, 4.64%; 95% CI: 0.54%, 8.74%), and breathlessness score (MD, 1.99; 95% CI: 0.36, 3.62) favored mycophenolate over placebo. The risk of anemia (relative risk [RR], 2.3; 95% CI: 1.2, 71.4) was higher with mycophenolate. There were no significant differences between mycophenolate and cyclophosphamide, except risk of premature discontinuation (RR, 0.6; 95% CI: 0.4, 0.9), and leukopenia (RR, 0.1; 95% CI: 0.05, 0.4) favored mycophenolate. The quality of evidence was moderate to very low per GRADE. Conclusions: Mycophenolate use in patients with SSc-ILD is associated with statistically significant improvements in disease progression and quality-of-life measures compared with placebo. There were no differences in mortality, disease progression, or quality of life compared with cyclophosphamide, but there were fewer adverse events. The quality of evidence is very low.


Assuntos
Doenças Pulmonares Intersticiais , Escleroderma Sistêmico , Humanos , Qualidade de Vida , Doenças Pulmonares Intersticiais/etiologia , Doenças Pulmonares Intersticiais/complicações , Ácido Micofenólico/uso terapêutico , Imunossupressores/uso terapêutico , Ciclofosfamida/uso terapêutico , Pulmão , Progressão da Doença
3.
Ann Am Thorac Soc ; 21(1): 122-135, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37772975

RESUMO

Background: The American Thoracic Society convened an international, multidisciplinary panel to develop clinical practice guidelines for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD). Objective: To conduct a systematic review and evaluate the literature to determine whether patients with SSc-ILD should be treated with cyclophosphamide. Data Sources: A literature search was conducted across the MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials databases through June 2022 for studies using cyclophosphamide to treat patients with SSc-ILD. Data Extraction: Mortality, disease progression, quality of life, and adverse event data were extracted, and meta-analyses were performed when possible. The Grading of Recommendations, Assessment, Development and Evaluation Working Group method was used to assess the quality of evidence. Synthesis: Five studies were included; two randomized controlled trials compared cyclophosphamide versus placebo, and one randomized controlled trial and two retrospective case-control studies compared cyclophosphamide versus mycophenolate. Compared with placebo, there was a 2.83% reduction in the decline at 12 months for forced vital capacity (FVC) % predicted using cyclophosphamide (95% confidence interval [CI], 0.80-4.87; low evidence). There were improvements in breathlessness (Transition Dyspnea Index mean difference [MD], 2.90; 95% CI, 1.94-3.86; minimum clinically important difference, 1; moderate evidence) and disability (Health Assessment Questionnaire-Disability Index MD, -0.16; 95% CI, -0.28 to -0.04; minimum clinically important difference, -0.14; moderate evidence). There were increased risks of leukopenia and constitutional symptoms using cyclophosphamide, but no difference in mortality. When cyclophosphamide was compared with mycophenolate, there were differences in diffusing capacity of the lung for carbon monoxide % predicted favoring mycophenolate at 6 months (MD, -3.67%; 95% CI, -6.3% to -1.1% unadjusted; MD, -4.88%; 95% CI, -7.3% to -2.5% adjusted for alveolar volume; moderate evidence), 12 months (MD, -5.90%; 95% CI, -8.4% to -3.4% adjusted for alveolar volume; moderate evidence), and 18 months (MD, -3.26%; 95% CI, -6.1% to -0.4%; moderate evidence), but not at 24 months. There were no differences in FVC % predicted, mortality, or quality-of-life outcomes, but participants were more likely to prematurely discontinue cyclophosphamide compared with mycophenolate (relative risk, 1.70; 95% CI, 1.10-2.63; high-certainty evidence). Conclusions: A review of the published evidence shows that cyclophosphamide is effective in SSc-ILD compared with placebo, with an increased risk of side effects. However, mycophenolate may be equivocal or better than cyclophosphamide. Clinicians and patients should weigh the potential benefits and risks with respect to individual patient circumstances and preferences.


Assuntos
Doenças Pulmonares Intersticiais , Escleroderma Sistêmico , Humanos , Estudos Retrospectivos , Qualidade de Vida , Ciclofosfamida/uso terapêutico , Imunossupressores/uso terapêutico , Doenças Pulmonares Intersticiais/etiologia , Doenças Pulmonares Intersticiais/complicações , Dispneia/tratamento farmacológico , Escleroderma Sistêmico/complicações , Escleroderma Sistêmico/tratamento farmacológico
4.
Am J Respir Crit Care Med ; 209(2): 137-152, 2024 Jan 15.
Artigo em Inglês | MEDLINE | ID: mdl-37772985

RESUMO

Background: Interstitial lung disease (ILD) is a significant cause of morbidity and mortality in patients with systemic sclerosis (SSc). To date, clinical practice guidelines regarding treatment for patients with SSc-ILD are primarily consensus based. Methods: An international expert guideline committee composed of 24 individuals with expertise in rheumatology, SSc, pulmonology, ILD, or methodology, and with personal experience with SSc-ILD, discussed systematic reviews of the published evidence assessed using the Grading of Recommendations, Assessment, Development, and Evaluation approach. Predetermined conflict-of-interest management strategies were applied, and recommendations were made for or against specific treatment interventions exclusively by the nonconflicted panelists. The confidence in effect estimates, importance of outcomes studied, balance of desirable and undesirable consequences of treatment, cost, feasibility, acceptability of the intervention, and implications for health equity were all considered in making the recommendations. This was in accordance with the American Thoracic Society guideline development process, which is in compliance with the Institute of Medicine standards for trustworthy guidelines. Results: For treatment of patients with SSc-ILD, the committee: 1) recommends the use of mycophenolate; 2) recommends further research into the safety and efficacy of (a) pirfenidone and (b) the combination of pirfenidone plus mycophenolate; and 3) suggests the use of (a) cyclophosphamide, (b) rituximab, (c) tocilizumab, (d) nintedanib, and (e) the combination of nintedanib plus mycophenolate. Conclusions: The recommendations herein provide an evidence-based clinical practice guideline for the treatment of patients with SSc-ILD and are intended to serve as the basis for informed and shared decision making by clinicians and patients.


Assuntos
Doenças Pulmonares Intersticiais , Escleroderma Sistêmico , Humanos , Estados Unidos , Imunossupressores/uso terapêutico , Doenças Pulmonares Intersticiais/tratamento farmacológico , Doenças Pulmonares Intersticiais/etiologia , Ciclofosfamida/uso terapêutico , Rituximab/uso terapêutico , Escleroderma Sistêmico/complicações , Pulmão
5.
Ann Am Thorac Soc ; 21(2): 317-327, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-37772987

RESUMO

Background: The American Thoracic Society convened an international, multidisciplinary panel to develop clinical practice guidelines for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD). Objective: To conduct a systematic review and evaluate the literature to determine whether patients with SSc-ILD should be treated with rituximab. Data Sources: A literature search was conducted across MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL) databases through June 2022 for studies using rituximab to treat patients with SSc-ILD. Data Extraction: Disease progression, quality of life, mortality, and adverse event data were extracted. The intervention was rituximab. The standard-of-care comparator group was decided a priori by consensus of the panel as either placebo or mycophenolate. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) Working Group approach was used to assess the quality of evidence. Synthesis: Three relevant studies were selected. Rituximab significantly improved the forced vital capacity % predicted (mean difference, 3.13; 95% confidence interval [CI], 0.37 to 5.90) and the modified Rodnan Skin Score (mean difference, -7.01; 95% CI, 11.46 to -2.56) at 24-48 weeks. Conclusions: Rituximab use in patients with SSc-ILD is associated with stabilization of lung function. The quality of evidence for study outcomes was considered to be very low, as defined by the GRADE approach. Additional research on treatment with rituximab is imperative.


Assuntos
Doenças Pulmonares Intersticiais , Escleroderma Sistêmico , Humanos , Rituximab/uso terapêutico , Rituximab/efeitos adversos , Doenças Pulmonares Intersticiais/etiologia , Doenças Pulmonares Intersticiais/complicações , Qualidade de Vida , Imunossupressores/uso terapêutico , Escleroderma Sistêmico/tratamento farmacológico , Pulmão
6.
Ann Am Thorac Soc ; 21(3): 474-485, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-37773000

RESUMO

Background: The American Thoracic Society convened an international multidisciplinary panel to develop clinical practice guidelines for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD). Objective: To conduct a systematic review and evaluate the literature to determine whether patients with SSc-ILD should be treated with nintedanib alone or with the combination of nintedanib plus mycophenolate. Data Sources: Literature searches were conducted across MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials databases through June 2022 for studies using nintedanib or nintedanib plus mycophenolate to treat patients with SSc-ILD. Data Extraction: Mortality, disease progression, quality of life, and adverse event data were extracted, and meta-analysis was performed when possible. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) Working Group method was used to assess the quality of evidence. Synthesis: For nintedanib therapy alone, the systematic review included three total studies and revealed that disease progression was less in the nintedanib arm (the annual rate of decline in forced vital capacity [FVC] was 44.5 ml less, the absolute change from baseline was 46.4 ml less, and FVC% predicted was 1.2% less in the nintedanib arm) compared with placebo. However, gastrointestinal side effects and treatment discontinuation were double in the nintedanib arm compared with placebo. For combination therapy, the systematic review also included three total studies and revealed that changes in the annual rate of decline in FVC favored combination therapy over placebo (mean difference, 79.1 ml). Combination therapy was, however, associated with increased gastrointestinal adverse effects compared with placebo. The quality of evidence for all outcomes was very low as per GRADE. Conclusions: The use of nintedanib alone and in combination with mycophenolate in patients with SSc-ILD is associated with a significant reduction in disease progression compared with placebo but at the cost of increased gastrointestinal side effects and treatment discontinuation. The quality of evidence is very low.


Assuntos
Indóis , Doenças Pulmonares Intersticiais , Escleroderma Sistêmico , Humanos , Qualidade de Vida , Imunossupressores/uso terapêutico , Progressão da Doença , Doenças Pulmonares Intersticiais/tratamento farmacológico , Doenças Pulmonares Intersticiais/etiologia , Escleroderma Sistêmico/complicações
7.
Ann Am Thorac Soc ; 21(2): 328-337, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-37773003

RESUMO

Background: The American Thoracic Society (ATS) convened an international, multidisciplinary panel to develop clinical practice guidelines for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD). Objective: To conduct a systematic review and evaluate the literature to determine the impact of treating patients with SSc-ILD with tocilizumab on prespecified critical and important outcomes determined by the ATS guideline panel. Data Sources: A literature search was conducted across MEDLINE, EMBASE, and Cochrane databases through June 2022 for studies using tocilizumab to treat patients with SSc-ILD. Data Extraction: Mortality and disease progression were determined to be critical outcomes of focus, with quality of life and adverse events important outcomes. Data on these outcomes were extracted and meta-analyses performed using the generic inverse variance method when possible. The Grading of Recommendations, Assessment, Development, and Evaluation Working Group method was used to assess the quality of evidence. Synthesis: The literature review resulted in five studies for inclusion. The absolute decrease from baseline in forced vital capacity (FVC) for the tocilizumab arm was 118 ml, 241 ml, and 129 ml less than the placebo arm at 24, 48, and 96 weeks, respectively, favoring tocilizumab. The mean decrease in FVC% predicted at 48 weeks was 6.50% less and the risk of decrease >10% was 66% less in the tocilizumab arm, whereas patients were 1.97 times more likely to have any increase in FVC% predicted if they received tocilizumab in place of placebo. When the placebo arm was given tocilizumab from 48 to 96 weeks, the mean change in absolute FVC was 54.90 ml less and the mean change in FVC% predicted was 1.30% less. For diffusing capacity of the lung for carbon monoxide (DlCO)% predicted, at 48 weeks there was 1.50% less change and from 48 to 96 weeks there was 5.40% less change in the tocilizumab arm. Quantitative Interstitial Lung Disease scores and Quantitative Lung Fibrosis scores at 48 weeks and modified Rodnan skin scores at 72 weeks all favored the tocilizumab arm, as did several adverse event parameters, including serious adverse events (mean difference, -27.40; 95% confidence interval, -30.10 to -24.70). The quality of evidence was very low grade. Conclusions: Tocilizumab use in patients with SSc-ILD is associated with less disease progression and a better toxicity profile than placebo. However, the quality of evidence is very low, and large prospective studies dedicated to assessing tocilizumab specifically for SSc-ILD are needed.


Assuntos
Anticorpos Monoclonais Humanizados , Doenças Pulmonares Intersticiais , Escleroderma Sistêmico , Humanos , Estudos Prospectivos , Qualidade de Vida , Escleroderma Sistêmico/complicações , Escleroderma Sistêmico/tratamento farmacológico , Pulmão , Doenças Pulmonares Intersticiais/etiologia , Doenças Pulmonares Intersticiais/complicações , Capacidade Vital , Progressão da Doença
8.
Chest ; 164(1): 124-136, 2023 07.
Artigo em Inglês | MEDLINE | ID: mdl-36907373

RESUMO

BACKGROUND: The COVID-19 pandemic has led to unprecedented mental health disturbances, burnout, and moral distress among health care workers, affecting their ability to care for themselves and their patients. RESEARCH QUESTION: In health care workers, what are key systemic factors and interventions impacting mental health and burnout? STUDY DESIGN AND METHODS: The Workforce Sustainment subcommittee of the Task Force for Mass Critical Care (TFMCC) utilized a consensus development process, incorporating evidence from literature review with expert opinion through a modified Delphi approach to determine factors affecting mental health, burnout, and moral distress in health care workers, to propose necessary actions to help prevent these issues and enhance workforce resilience, sustainment, and retention. RESULTS: Consolidation of evidence gathered from literature review and expert opinion resulted in 197 total statements that were synthesized into 14 major suggestions. These suggestions were organized into three categories: (1) mental health and well-being for staff in medical settings; (2) system-level support and leadership; and (3) research priorities and gaps. Suggestions include both general and specific occupational interventions to support health care worker basic physical needs, lower psychological distress, reduce moral distress and burnout, and foster mental health and resilience. INTERPRETATION: The Workforce Sustainment subcommittee of the TFMCC offers evidence-informed operational strategies to assist health care workers and hospitals plan, prevent, and treat the factors affecting health care worker mental health, burnout, and moral distress to improve resilience and retention following the COVID-19 pandemic.


Assuntos
Esgotamento Profissional , COVID-19 , Desastres , Humanos , COVID-19/epidemiologia , Pandemias , Consenso , Pessoal de Saúde/psicologia , Cuidados Críticos , Recursos Humanos , Esgotamento Profissional/epidemiologia , Esgotamento Profissional/prevenção & controle , Esgotamento Profissional/psicologia , Atenção à Saúde
9.
ATS Sch ; 3(3): 379-389, 2022 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-36312803

RESUMO

A new era in guideline creation began in 2011 with publication of the Institute of Medicine (now the National Academy of Medicine) Standards for Developing Trustworthy Clinical Practice Guidelines. The American Thoracic Society (ATS) was committed to developing guidelines in accordance with the new standards and decided that an experienced guideline methodologist would be required on ATS guideline projects to ensure correct implementation of the standards. The ATS Guideline Methodology Training Program was launched to increase the pool of trained methodologists. Each year, accepted trainees (methodology scholars) attend a workshop that introduces them to the terminology and process of guideline development and are given the option of participating in a guideline project. Scholars work with the mentorship of a lead methodologist to conduct and then present a systematic review to the guideline committee, discuss the evidence, and participate in the development of evidence-based graded recommendations. Scholars have participated in 22 ATS guidelines over the past 9 years, and most remain engaged in guideline development. For the past 2 years, the methodological aspects of all ATS guideline projects were led by graduates of the training program, and several scholars have accepted positions to lead guidelines for other professional societies. Guideline methodology is particularly suitable for clinician educators because the work is clinically oriented, and guidelines confer high academic capital. Those who elect not to continue in guideline development still acquire the skills to perform and publish systematic reviews, as well as to educate trainees in reading and reviewing literature.

10.
Ann Am Thorac Soc ; 19(6): 1030-1039, 2022 06.
Artigo em Inglês | MEDLINE | ID: mdl-35499847

RESUMO

Background: The American Thoracic Society, European Respiratory Society, Japanese Respiratory Society, and Asociación Latinoamericana del Tórax convened to update clinical practice guidelines for interstitial lung disease (ILD). Objective: To conduct a systematic review to evaluate existing ILD literature to determine whether patients with progressive pulmonary fibrosis (PPF) should be treated with the antifibrotic pirfenidone. Data Sources: A literature search was conducted across MEDLINE, EMBASE, and Cochrane databases through December 2020 for studies using pirfenidone to treat patients with PPF. Data Extraction: Mortality, disease progression, lung function, and adverse event data were extracted. Meta-analyses were performed when possible. The Grading of Recommendations, Assessment, Development and Evaluation Working Group approach was used to assess the quality of evidence. Synthesis: Two studies met inclusion criteria. Meta-analyses revealed that changes in forced vital capacity (FVC) percent predicted (mean difference [MD], 2.3%; 95% confidence interval [CI], 0.5-4.1%), the FVC in milliliters (MD, 100.0 ml; 95% CI, 98.1-101.9 ml), and the 6-minute-walk distance in meters (MD, 25.2 m; 95% CI, 8.3-42.1 m) all favored pirfenidone over placebo. The changes in the diffusing capacity of the lung for carbon monoxide (DLCO) in millimoles per kilopascal per minute (MD, 0.40 mmol/kPa/min; 95%, CI 0.10-0.70 mmol/kPa/min) and risk of DLCO declining more than 15% (relative risk [RR], 0.27; 95% CI, 0.08-0.95) also favored pirfenidone. The risks of gastrointestinal discomfort (RR, 1.83; 95% CI, 1.29-2.60) and photosensitivity (RR, 4.88; 95% CI, 1.09-21.83) were higher with pirfenidone. The quality of the evidence was low or very low according to the Grading of Recommendations, Assessment, Development and Evaluation criteria, depending on the outcome. Conclusions: Pirfenidone use in patients with PPF is associated with a statistically significant decrease in disease progression and with protection of lung function. However, there is very low certainty in the estimated effects because of limitations in the available evidence. Primary Source of Funding: Funded by the American Thoracic Society, European Respiratory Society, Japanese Respiratory Society, and Asociación Latinoamericana del Tórax.


Assuntos
Doenças Pulmonares Intersticiais , Fibrose Pulmonar , Progressão da Doença , Humanos , Fibrose Pulmonar/tratamento farmacológico , Piridonas/uso terapêutico
11.
Ann Am Thorac Soc ; 19(6): 1040-1049, 2022 06.
Artigo em Inglês | MEDLINE | ID: mdl-35499854

RESUMO

Background: The American Thoracic Society, European Respiratory Society, Japanese Respiratory Society, and Asociación Latinoamericana del Tórax convened to update clinical practice guidelines for interstitial lung disease (ILD). Objective: To conduct a systematic review to evaluate existing ILD literature to determine whether patients with progressive pulmonary fibrosis (PPF) should be treated with the antifibrotic nintedanib. Data Sources: A literature search was conducted across MEDLINE, EMBASE, and Cochrane databases through December 2020 for studies using nintedanib to treat patients with PPF. Data Extraction: Mortality, disease progression, and adverse event data were extracted, and meta-analyses performed when possible. The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) Working Group approach was used to assess the quality of evidence. Synthesis: Two relevant studies were selected. The annual decline in forced vital capacity was less in the nintedanib arm in the overall study population (mean difference [MD], 107 ml/yr; 95% confidence interval [CI], 65.4 to 148.5 ml/yr) and in the subgroups with usual interstitial pneumonia (UIP) pattern of pulmonary fibrosis (MD, 128.2 ml/yr; 95% CI, 70.8 to 185.6 ml/yr), non-UIP patterns of pulmonary fibrosis (MD, 75.3 ml/yr; 95% CI, 15.5 to 135.0 ml/yr), fibrotic connective tissue disease-related ILD (MD, 106.2 ml/yr; 95% CI, 10.6 to 201.9 ml/yr), fibrotic idiopathic nonspecific interstitial pneumonia (MD, 141.7 ml/yr; 95% CI, 46.0 to 237.4 ml/yr), and fibrotic occupational ILD (MD, 252.8 ml/yr; 95% CI, 79.2 to 426.5 ml/yr), but not fibrotic hypersensitivity pneumonitis (MD, 72.9 ml/yr; 95% CI, -8.9 to 154.7 ml/yr), fibrotic sarcoidosis (MD, -20.5 ml/yr; 95% CI, -337.1 to 296.1 ml/yr), or unclassified fibrotic ILD (MD, 68.5 ml/yr; 95% CI, -31.3 to 168.4 ml/yr) when compared with placebo. Gastrointestinal side effects were common. Quality of evidence for the outcomes ranged from very low to moderate GRADE. Conclusions: Nintedanib use in patients with PPF is associated with a statistically significant decrease in disease progression but increase in gastrointestinal side effects regardless of the radiographic pattern of pulmonary fibrosis. However, limitations in the available evidence lead to low certainty in these effect estimates and make definitive conclusions about the differential effects by subtype of ILD difficult to determine. Primary Source of Funding: Funded by the American Thoracic Society, European Respiratory Society, Japanese Respiratory Society, and Asociación Latinoamericana del Tórax.


Assuntos
Fibrose Pulmonar Idiopática , Doenças Pulmonares Intersticiais , Progressão da Doença , Humanos , Fibrose Pulmonar Idiopática/tratamento farmacológico , Indóis/efeitos adversos , Doenças Pulmonares Intersticiais/tratamento farmacológico
12.
Ann Am Thorac Soc ; 19(7): 1193-1202, 2022 07.
Artigo em Inglês | MEDLINE | ID: mdl-35499855

RESUMO

Rationale: In 2018, a systematic review evaluating transbronchial lung cryobiopsy (TBLC) in patients with interstitial lung disease (ILD) was performed to inform American Thoracic Society, European Respiratory Society, Japanese Respiratory Society, and Asociación Latinoamericana del Tórax clinical practice guidelines on the diagnosis of idiopathic pulmonary fibrosis. Objectives: To perform a new systematic review to inform updated guidelines. Methods: Medline, Excerpta Medica Database, and the Cochrane Central Register of Controlled Trials (CCTR) were searched through June 2020. Studies that enrolled patients with ILD and reported the diagnostic yield or complication rates of TBLC were selected for inclusion. Data was extracted and then pooled across studies via meta-analysis. The quality of the evidence was appraised using the grading of recommendations, assessment, development, and evaluation approach. Results: Histopathologic diagnostic yield (number of procedures that yielded a histopathologic diagnosis divided by the total number of procedures performed) of TBLC was 80% (95% confidence interval [CI], 76-83%) in patients with ILD. TBLC was complicated by bleeding and pneumothorax in 30% (95% CI, 20-41%) and 8% (95% CI, 6-11%) of patients, respectively. Procedure-related mortality, severe bleeding, prolonged air leak, acute exacerbation, respiratory failure, and respiratory infection were rare. The quality of the evidence was very low owing to the uncontrolled study designs, lack of consecutive enrollment, and inconsistent results. Conclusions: Very low-quality evidence indicated that TBLC has a diagnostic yield of approximately 80% in patients with ILD, with manageable complications.


Assuntos
Fibrose Pulmonar Idiopática , Doenças Pulmonares Intersticiais , Biópsia/efeitos adversos , Biópsia/métodos , Broncoscopia/efeitos adversos , Broncoscopia/métodos , Hemorragia/etiologia , Humanos , Fibrose Pulmonar Idiopática/diagnóstico , Fibrose Pulmonar Idiopática/patologia , Pulmão/patologia , Doenças Pulmonares Intersticiais/patologia
13.
Am J Respir Crit Care Med ; 205(9): e18-e47, 2022 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-35486072

RESUMO

Background: This American Thoracic Society, European Respiratory Society, Japanese Respiratory Society, and Asociación Latinoamericana de Tórax guideline updates prior idiopathic pulmonary fibrosis (IPF) guidelines and addresses the progression of pulmonary fibrosis in patients with interstitial lung diseases (ILDs) other than IPF. Methods: A committee was composed of multidisciplinary experts in ILD, methodologists, and patient representatives. 1) Update of IPF: Radiological and histopathological criteria for IPF were updated by consensus. Questions about transbronchial lung cryobiopsy, genomic classifier testing, antacid medication, and antireflux surgery were informed by systematic reviews and answered with evidence-based recommendations using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. 2) Progressive pulmonary fibrosis (PPF): PPF was defined, and then radiological and physiological criteria for PPF were determined by consensus. Questions about pirfenidone and nintedanib were informed by systematic reviews and answered with evidence-based recommendations using the GRADE approach. Results:1) Update of IPF: A conditional recommendation was made to regard transbronchial lung cryobiopsy as an acceptable alternative to surgical lung biopsy in centers with appropriate expertise. No recommendation was made for or against genomic classifier testing. Conditional recommendations were made against antacid medication and antireflux surgery for the treatment of IPF. 2) PPF: PPF was defined as at least two of three criteria (worsening symptoms, radiological progression, and physiological progression) occurring within the past year with no alternative explanation in a patient with an ILD other than IPF. A conditional recommendation was made for nintedanib, and additional research into pirfenidone was recommended. Conclusions: The conditional recommendations in this guideline are intended to provide the basis for rational, informed decisions by clinicians.


Assuntos
Fibrose Pulmonar Idiopática , Doenças Pulmonares Intersticiais , Antiácidos/uso terapêutico , Biópsia , Humanos , Fibrose Pulmonar Idiopática/tratamento farmacológico , Fibrose Pulmonar Idiopática/terapia , Pulmão/diagnóstico por imagem , Pulmão/patologia , Doenças Pulmonares Intersticiais/patologia , Estados Unidos
14.
Ann Am Thorac Soc ; 19(5): 833-844, 2022 05.
Artigo em Inglês | MEDLINE | ID: mdl-35486080

RESUMO

Rationale: Idiopathic pulmonary fibrosis (IPF) is a fibrosing interstitial pneumonia with impaired survival. Previous guidelines recommend antacid medication to improve respiratory outcomes in patients with IPF. Objectives: This systematic review was undertaken during the development of an American Thoracic Society, European Respiratory Society, Japanese Respiratory Society, and Asociación Latinoamericana del Tórax guideline. The clinical question was, "Should patients with IPF who have documented abnormal gastroesophageal reflux (GER) with or without symptoms of GER disease 1) be treated with antacid medication or 2) undergo antireflux surgery to improve respiratory outcomes?" Methods: Medline, Embase, the Cochrane Central Register of Controlled Trials, and the gray literature were searched through June 30, 2020. Studies that enrolled patients with IPF and 1) compared antacid medication to placebo or no medication or 2) compared antireflux surgery to no surgery were selected. Meta-analyses were performed when possible. Outcomes included disease progression, mortality, exacerbations, hospitalizations, lung function, respiratory symptoms, GER severity, and adverse effects/complications. Results: For antacid medication, when two studies were aggregated, there was no statistically significant effect on disease progression, defined as a 10% or more decline in FVC, more than 50-m decline in 6-minute walking distance, or death (risk ratio [RR], 0.88; 95% confidence interval [CI], 0.76-1.03). A separate study that could not be included in the meta-analysis found no statistically significant effect on disease progression when defined as a 5% or more decline in FVC or death (RR, 1.10; 95% CI, 1.00-1.21) and an increase in disease progression when defined as a 10% or more decline in FVC or death (RR, 1.28; 95% CI, 1.08-1.51). For antireflux surgery, there was also no statistically significant effect on disease progression (RR, 0.29; 95% CI, 0.06-1.26). Neither antacid medications nor antireflux surgery was associated with improvements in the other outcomes. Conclusions: There is insufficient evidence to conclude that antacid medication or antireflux surgery improves respiratory outcomes in patients with IPF, most of whom had not had abnormal GER confirmed. Well-designed and adequately powered prospective studies with objective evaluation for GER are critical to elucidate the role of antacid medication and antireflux surgery for respiratory outcomes in patients with IPF.


Assuntos
Refluxo Gastroesofágico , Fibrose Pulmonar Idiopática , Antiácidos/uso terapêutico , Progressão da Doença , Refluxo Gastroesofágico/complicações , Refluxo Gastroesofágico/tratamento farmacológico , Refluxo Gastroesofágico/cirurgia , Humanos , Fibrose Pulmonar Idiopática/complicações , Fibrose Pulmonar Idiopática/tratamento farmacológico , Fibrose Pulmonar Idiopática/cirurgia , Estudos Prospectivos
15.
Ann Am Thorac Soc ; 19(5): 827-832, 2022 05.
Artigo em Inglês | MEDLINE | ID: mdl-34077697

RESUMO

Background: Usual interstitial pneumonia (UIP) is the histopathologic hallmark of idiopathic pulmonary fibrosis (IPF), the prototypical interstitial lung disease (ILD). Diagnosis of IPF requires that a typical UIP pattern be identified by using high-resolution chest computed tomography or lung sampling. A genomic classifier for UIP has been developed to predict histopathologic UIP by using lung samples obtained through bronchoscopy. Objective: To perform a systematic review to evaluate genomic classifier testing in the detection of histopathologic UIP to inform new American Thoracic Society, European Respiratory Society, Japanese Respiratory Society, and Asociación Latinoamericana del Tórax guidelines. Data Sources: Medline, Embase, and the Cochrane Central Register of Controlled Trials were searched through June 2020. Data Extraction: Data were extracted from studies that enrolled patients with ILD and reported the use of genomic classifier testing. Synthesis: Data were aggregated across studies via meta-analysis. The quality of the evidence was appraised by using the Grading of Recommendations, Assessment, Development, and Evaluation approach. Results: Genomic classifier testing had a sensitivity of 68% (95% confidence interval [CI], 55-73%) and a specificity of 92% (95% CI, 81-95%) in predicting the UIP pattern in ILD. Confidence in an IPF diagnosis increased from 43% to 93% in one cohort and from 59% to 89% in another cohort. Agreement levels in categorical IPF and non-IPF diagnoses measured by using a concordance coefficient were 0.75 and 0.64 in the two cohorts. The quality of evidence was moderate for test characteristics and very low for both confidence and agreement. Conclusions: Genomic classifier testing predicts histopathologic UIP in patients with ILD with a specificity of 92% and improves diagnostic confidence; however, sensitivity is only 68%, and testing is not widely available.


Assuntos
Fibrose Pulmonar Idiopática , Doenças Pulmonares Intersticiais , Genômica , Humanos , Fibrose Pulmonar Idiopática/diagnóstico , Fibrose Pulmonar Idiopática/genética , Fibrose Pulmonar Idiopática/patologia , Pulmão/diagnóstico por imagem , Pulmão/patologia , Doenças Pulmonares Intersticiais/diagnóstico , Doenças Pulmonares Intersticiais/genética , Doenças Pulmonares Intersticiais/patologia , Tomografia Computadorizada por Raios X/métodos
16.
Chest ; 161(2): 429-447, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-34499878

RESUMO

BACKGROUND: After the publication of a 2014 consensus statement regarding mass critical care during public health emergencies, much has been learned about surge responses and the care of overwhelming numbers of patients during the COVID-19 pandemic. Gaps in prior pandemic planning were identified and require modification in the midst of severe ongoing surges throughout the world. RESEARCH QUESTION: A subcommittee from The Task Force for Mass Critical Care (TFMCC) investigated the most recent COVID-19 publications coupled with TFMCC members anecdotal experience in order to formulate operational strategies to optimize contingency level care, and prevent crisis care circumstances associated with increased mortality. STUDY DESIGN AND METHODS: TFMCC adopted a modified version of established rapid guideline methodologies from the World Health Organization and the Guidelines International Network-McMaster Guideline Development Checklist. With a consensus development process incorporating expert opinion to define important questions and extract evidence, the TFMCC developed relevant pandemic surge suggestions in a structured manner, incorporating peer-reviewed literature, "gray" evidence from lay media sources, and anecdotal experiential evidence. RESULTS: Ten suggestions were identified regarding staffing, load-balancing, communication, and technology. Staffing models are suggested with resilience strategies to support critical care staff. ICU surge strategies and strain indicators are suggested to enhance ICU prioritization tactics to maintain contingency level care and to avoid crisis triage, with early transfer strategies to further load-balance care. We suggest that intensivists and hospitalists be engaged with the incident command structure to ensure two-way communication, situational awareness, and the use of technology to support critical care delivery and families of patients in ICUs. INTERPRETATION: A subcommittee from the TFMCC offers interim evidence-informed operational strategies to assist hospitals and communities to plan for and respond to surge capacity demands resulting from COVID-19.


Assuntos
Comitês Consultivos , COVID-19 , Cuidados Críticos , Atenção à Saúde/organização & administração , Capacidade de Resposta ante Emergências , Triagem , COVID-19/epidemiologia , COVID-19/terapia , Cuidados Críticos/métodos , Cuidados Críticos/organização & administração , Prática Clínica Baseada em Evidências/métodos , Prática Clínica Baseada em Evidências/organização & administração , Humanos , SARS-CoV-2 , Capacidade de Resposta ante Emergências/organização & administração , Capacidade de Resposta ante Emergências/normas , Triagem/métodos , Triagem/normas , Estados Unidos/epidemiologia
17.
Chest ; 159(2): 634-652, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-32971074

RESUMO

BACKGROUND: Early in the coronavirus disease 2019 (COVID-19) pandemic, there was serious concern that the United States would encounter a shortfall of mechanical ventilators. In response, the US government, using the Defense Production Act, ordered the development of 200,000 ventilators from 11 different manufacturers. These ventilators have different capabilities, and whether all are able to support COVID-19 patients is not evident. RESEARCH QUESTION: Evaluate ventilator requirements for affected COVID-19 patients, assess the clinical performance of current US Strategic National Stockpile (SNS) ventilators employed during the pandemic, and finally, compare ordered ventilators' functionality based on COVID-19 patient needs. STUDY DESIGN AND METHODS: Current published literature, publicly available documents, and lay press articles were reviewed by a diverse team of disaster experts. Data were assembled into tabular format, which formed the basis for analysis and future recommendations. RESULTS: COVID-19 patients often develop severe hypoxemic acute respiratory failure and adult respiratory defense syndrome (ARDS), requiring high levels of ventilator support. Current SNS ventilators were unable to fully support all COVID-19 patients, and only approximately half of newly ordered ventilators have the capacity to support the most severely affected patients; ventilators with less capacity for providing high-level support are still of significant value in caring for many patients. INTERPRETATION: Current SNS ventilators and those on order are capable of supporting most but not all COVID-19 patients. Technologic, logistic, and educational challenges encountered from current SNS ventilators are summarized, with potential next-generation SNS ventilator updates offered.


Assuntos
COVID-19/terapia , Respiração Artificial/métodos , Síndrome do Desconforto Respiratório/terapia , Insuficiência Respiratória/terapia , Estoque Estratégico , Ventiladores Mecânicos/estatística & dados numéricos , Humanos , Unidades de Terapia Intensiva , Respiração Artificial/instrumentação , SARS-CoV-2 , Estados Unidos , Ventiladores Mecânicos/normas , Ventiladores Mecânicos/provisão & distribuição
18.
Am J Respir Crit Care Med ; 202(10): e121-e141, 2020 11 15.
Artigo em Inglês | MEDLINE | ID: mdl-33185464

RESUMO

Background: Evidence-based guidelines are needed for effective delivery of home oxygen therapy to appropriate patients with chronic obstructive pulmonary disease (COPD) and interstitial lung disease (ILD).Methods: The multidisciplinary panel created six research questions using a modified Delphi approach. A systematic review of the literature was completed, and the Grading of Recommendations Assessment, Development and Evaluation approach was used to formulate clinical recommendations.Recommendations: The panel found varying quality and availability of evidence and made the following judgments: 1) strong recommendations for long-term oxygen use in patients with COPD (moderate-quality evidence) or ILD (low-quality evidence) with severe chronic resting hypoxemia, 2) a conditional recommendation against long-term oxygen use in patients with COPD with moderate chronic resting hypoxemia, 3) conditional recommendations for ambulatory oxygen use in patients with COPD (moderate-quality evidence) or ILD (low-quality evidence) with severe exertional hypoxemia, 4) a conditional recommendation for ambulatory liquid-oxygen use in patients who are mobile outside the home and require >3 L/min of continuous-flow oxygen during exertion (very-low-quality evidence), and 5) a recommendation that patients and their caregivers receive education on oxygen equipment and safety (best-practice statement).Conclusions: These guidelines provide the basis for evidence-based use of home oxygen therapy in adults with COPD or ILD but also highlight the need for additional research to guide clinical practice.


Assuntos
Medicina Baseada em Evidências/normas , Serviços de Assistência Domiciliar/normas , Doenças Pulmonares Intersticiais/terapia , Oxigenoterapia/métodos , Oxigenoterapia/normas , Guias de Prática Clínica como Assunto , Doença Pulmonar Obstrutiva Crônica/terapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Sociedades Médicas , Estados Unidos
19.
J Grad Med Educ ; 11(4): 389-401, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31440332

RESUMO

BACKGROUND: Management of mechanical ventilation (MV) is an important and complex aspect of caring for critically ill patients. Management strategies and technical operation of the ventilator are key skills for physicians in training, as lack of expertise can lead to substantial patient harm. OBJECTIVE: We performed a narrative review of the literature describing MV education in graduate medical education (GME) and identified best practices for training and assessment methods. METHODS: We searched MEDLINE, PubMed, and Google Scholar for English-language, peer-reviewed articles describing MV education and assessment. We included articles from 2000 through July 2018 pertaining to MV education or training in GME. RESULTS: Fifteen articles met inclusion criteria. Studies related to MV training in anesthesiology, emergency medicine, general surgery, and internal medicine residency programs, as well as subspecialty training in critical care medicine, pediatric critical care medicine, and pulmonary and critical care medicine. Nearly half of trainees assessed were dissatisfied with their MV education. Six studies evaluated educational interventions, all employing simulation as an educational strategy, although there was considerable heterogeneity in content. Most outcomes were assessed with multiple-choice knowledge testing; only 2 studies evaluated the care of actual patients after an educational intervention. CONCLUSIONS: There is a paucity of information describing MV education in GME. The available literature demonstrates that trainees are generally dissatisfied with MV training. Best practices include establishing MV-specific learning objectives and incorporating simulation. Next research steps include developing competency standards and validity evidence for assessment tools that can be utilized across MV educational curricula.


Assuntos
Competência Clínica/normas , Internato e Residência , Aprendizagem , Respiração Artificial/normas , Treinamento por Simulação/normas , Educação de Pós-Graduação em Medicina , Medicina de Emergência/educação , Humanos , Medicina Interna/educação , Médicos
20.
Crit Care Clin ; 35(4): 535-550, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31445603

RESUMO

The "daily disasters" within the ebb and flow of routine critical care provide a foundation of preparedness for the less-frequent, larger events that affect most health care organizations at some time. Although large disasters can overwhelm, those who strengthen processes and habits through daily practice will be the best prepared to manage them.


Assuntos
Cuidados Críticos , Planejamento em Desastres , Serviço Hospitalar de Emergência , Unidades de Terapia Intensiva , Cuidados Críticos/organização & administração , Planejamento em Desastres/organização & administração , Desastres , Serviço Hospitalar de Emergência/organização & administração , Humanos , Unidades de Terapia Intensiva/organização & administração , Incidentes com Feridos em Massa , Capacidade de Resposta ante Emergências/organização & administração , Triagem
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