EDITORIALS procedure that requires diagnosis and staging of lung cancer with puncture of three or four lymph nodes and biopsy of the primary mass may be quite lengthy and greatly facilitated by the administration of general anesthesia. For uncomplicated procedures in experienced centers, it appears that either moderate sedation or general anesthesia may accomplish the same goals for both the operators and patients. Although it is not directly addressed in this study, this study offers a glimpse into the economics of EBUS-TBNA. The new paradigm in health care delivery is to increase the value of care, where value is simply defined as quality of care divided by the cost. Health care organizations and providers are striving to either improve the quality of care at the same cost or, at the least, deliver the same quality of care at a lower cost. Eliminating expensive technical anesthesia fees in appropriate patients undergoing EBUSTBNA may get us closer to a more efficient delivery of care, particularly in the care of the patient with lung cancer. As novel bronchoscopic technologies emerge, the question of optimal sedation will loom large on the minds of bronchoscopists seeking high performance, minimal cost, and comfortable patient experience. Additional randomized multicenter controlled trials are needed to validate the findings of this study and take us to the “comfort zone” in EBUS-TBNA. n Author disclosures are available with the text of this article at www.atsjournals.org. Momen M. Wahidi, M.D., M.B.A. Department of Medicine Duke University School of Medicine Durham, North Carolina
Daniel H. Sterman, M.D. Department of Medicine New York University School of Medicine New York, New York
References 1. Wahidi MM, Yasufuku K. Point: should endobronchial ultrasound guide every transbronchial needle aspiration of lymph nodes? Yes. Chest 2013;144:732–734. 2. Dasgupta A, Mehta AC. Transbronchial needle aspiration: an underused diagnostic technique. Clin Chest Med 1999;20:39–51. 3. Gu P, Zhao YZ, Jiang LY, Zhang W, Xin Y, Han BH. Endobronchial ultrasound-guided transbronchial needle aspiration for staging of lung cancer: a systematic review and meta-analysis. Eur J Cancer 2009;45: 1389–1396. 4. Adams K, Shah PL, Edmonds L, Lim E. Test performance of endobronchial ultrasound and transbronchial needle aspiration biopsy for mediastinal staging in patients with lung cancer: systematic review and meta-analysis. Thorax 2009;64:757–762. 5. Chandra S, Nehra M, Agarwal D, Mohan A. Diagnostic accuracy of endobronchial ultrasound-guided transbronchial needle biopsy in mediastinal lymphadenopathy: a systematic review and metaanalysis. Respir Care 2012;57:384–391. 6. Silvestri GA, Gonzalez AV, Jantz MA, Margolis ML, Gould MK, Tanoue LT, Harris LJ, Detterbeck FC. Methods for staging non-small cell lung cancer. Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest 2013;143:e211S–e250S. 7. Casal RF, Lazarus DR, Kuhl K, Nogueras-Gonzalez ´ G, Perusich S, Green LK, Ost DE, Sarkiss M, Jimenez CA, Eapen GA, et al. Randomized trial of endobronchial ultrasound-guided transbronchial needle aspiration under general anesthesia versus moderate sedation. Am J Respir Crit Care Med 2015;191:796–803.
Copyright © 2015 by the American Thoracic Society
Global Participation in Core Data Sets for Emerging Pathogens The threat to public health from emerging infections seems to have accelerated in the last decade. Research should be considered an integral component of the local and international response to epidemic diseases, but a global research response requires coordinated effort from the international medical community. Countries in West Africa are facing an unprecedented outbreak of Ebola virus disease (1), and health departments and providers in other countries are adjusting to the challenges of patient management and disease containment (2, 3). Although there are pressing daily challenges in respiratory health, and the current Ebola virus disease outbreak is commanding our attention, we must not lose sight of other emerging pathogens that cause severe critical illness and death globally. For example, the Middle East respiratory syndrome coronavirus (MERS-CoV) was discovered in 2012 and has been implicated in clusters of severe respiratory infections, with the largest clusters occurring in Saudi Arabia in April and May 2014 (4). Many
Author Contributions: Conception and design: S.S.C., R.A.F., J.P.C., Y.M.A., and D.H.I. Drafting the manuscript for important intellectual content: S.S.C., R.A.F., J.P.C., Y.M.A., and D.H.I.
728
of the clusters have been nosocomial in nature, highlighting the potential vulnerability of healthcare workers and the importance of infection prevention and control. Often resulting in severe adult respiratory distress syndrome, the reported mortality rate of MERS-CoV infections ranges from 32% to 60% (5, 6). In the past, MERS-CoV infections occurred primarily in the springtime, but this fall, new cases and nosocomial transmission already are being reported, raising the possibility of an accelerating cycle of infection. In August, pediatric centers in the United States were surprised by an unusual number of cases of acute respiratory failure resulting from enterovirus D68 with some associated deaths (7). New strains of influenza such as avian influenza A (H7N9) and other respiratory pathogens remain a constant threat. In response to the recent outbreaks of emerging pathogens associated with critical illness and high case fatality rates, the American Thoracic Society endorses and recommends the following: 1. There is a major need for high-quality ongoing epidemiologic, clinical, and biological research designed to characterize the clinical syndromes of different emerging pathogens. The syndrome qualities will likely evolve as the full spectrum of
American Journal of Respiratory and Critical Care Medicine Volume 191 Number 7 | April 1 2015
EDITORIALS
2.
3.
4.
5.
disease is appreciated, and there also is potential for change with mutations or changing strains. In addition, interventional research is needed to plan and test the efficacy of potential treatments. There should be a common international clinical and biological data-reporting standard, ideally based on a “tiered” approach facilitating data collection. The common reporting forms should foster investigations in settings that vary with respect to their research capabilities and be readily used in studies that vary in research design. Reporting forms should support a minimum core data set and an expanded data set specific for each emerging respiratory and systemic pathogen. The data-reporting standard recently released by the World Health Organization in collaboration with the International Severe Acute Respiratory and Emerging Infection Consortium (http://www.cliresdms.org) provides these capabilities and is supported by international research collaborations such as the International Forum of Acute Care Trialists, regional professional organizations such as the American Thoracic Society, and national clinical trials groups such as the U.S. Critical Illness and Injury Trials Group (USCIIT Group). As this standard is used, periodic consensus modifications will need to occur to ensure it is feasible across a wide variety of settings and studies and as more information is available about specific components needed in each expanded data set. Health authorities and hospitals in countries with cases of Ebola virus disease, MERS-CoV, or other emerging pathogens should foster reporting of de-identified data from affected patients, in accordance with all local and national regulatory processes. This is essential to inform the responses of clinicians, researchers, and those conducting systems and operational evaluations. These data sets should be housed and controlled locally but should contain all the elements in common reporting standards, described in the second point presented here, and should be shared in very timely fashion with the World Health Organization. This ensures maximal potential for international collaboration and progress in understanding and responding to emerging health threats. Funding to ensure collection and reporting of de-identified data is essential. The health authorities, health ministries, and research funding agencies of countries with emerging infections and international agencies should prioritize funding to support capture of relevant data and entry into the common reporting form, preservation of relevant biologic samples, and research on effective treatments to improve outcomes and decrease the spread of the illness. This includes prevention of transmission to healthcare workers who are disproportionally exposed to infection. Funding also should be prioritized to support collaborative, multicenter research, particularly encouraging collaboration across countries. The relevant international and national professional societies should work jointly to facilitate and aid these efforts, making available expertise and support from their constituents to meet the evolving needs of the patients, families, and health care systems in the affected countries.
The broadly endorsed World Health Organization reporting forms described in the second recommendation presented Editorials
here, supporting minimum and extended core data sets for emerging infections, can serve as an example for responses to other epidemics. Amid the urgency to respond to clinical care needs, data entry from multiple care sites will allow epidemiologists and clinical scientists to evaluate disease trends and responses to medical care in a systematic way. This will then inform implementation plans and research as well as inform clinical trials of new interventions. Timely and accurate collection of information in the midst of outbreaks, epidemics and pandemics can be very difficult, particularly when the disease is severe and the affected population is expanding rapidly. However, it is only by having up-to-date, shared, and accurate information available that appropriate public health and intervention efforts can be designed to have the maximum potential benefit and chance to interrupt transmission and treat patients. n Author disclosures are available with the text of this article at www.atsjournals.org. Acknowledgment: This editorial was reviewed and supported by the Critical Care Society Collaborative members, constituting leadership of the American Thoracic Society, American College of Chest Physicians, and the Society of Critical Care Medicine. Shannon S. Carson, M.D. University of North Carolina Chapel Hill, North Carolina Robert A. Fowler, M.D., M.D.C.M., M.Sc. University of Toronto Toronto, Ontario, Canada J. Perren Cobb, M.D. Massachusetts General Hospital Boston, Massachusetts Yaseen M. Arabi, M.D. King Saud bin Abdulaziz University for Health Sciences Riyadh, Saudi Arabia David H. Ingbar, M.D. University of Minnesota Minneapolis, Minnesota for the ATS Taskforce on Emerging Pathogens American Thoracic Society Taskforce on Emerging Pathogens Members: Yaseen Arabi, Charles Bennett, Satish Bhagwanjee, Charles Cairns, Shannon S. Carson, J. Perren Cobb, William A. Fischer, Robert Fowler, Michelle Gong, David Ingbar, Anthony Martinez, Jonathon Sevransky, and Satish Bhagwanjee.
References 1. WHO Ebola Response Team. Ebola virus disease in West Africa—the first 9 months of the epidemic and forward projections. N Engl J Med 2014;371:1481–1495. 2. Decker BK, Sevransky JE, Barrett K, Davey RT, Chertow DS. Preparing for critical care services to patients with Ebola. Ann Intern Med 2014; 161:831–832. 3. Fowler RA, Fletcher T, Fischer WA II, Lamontagne F, Jacob S, BrettMajor D, Lawler JV, Jacquerioz FA, Houlihan C, O’Dempsey T, et al. Caring for critically ill patients with Ebola virus disease: perspectives from West Africa. Am J Respir Crit Care Med 2014;190: 733–737. 4. Al-Abdallat MM, Payne DC, Alqasrawi S, Rha B, Tohme RA, Abedi GR, Al Nsour M, Iblan I, Jarour N, Farag NH, et al.; Jordan MERS-CoV Investigation Team. Hospital-associated outbreak of
729
EDITORIALS Middle East respiratory syndrome coronavirus: a serologic, epidemiologic, and clinical description. Clin Infect Dis 2014;59: 1225–1233. 5. Arabi YM, Arifi AA, Balkhy HH, Najm H, Aldawood AS, Ghabashi A, Hawa H, Alothman A, Khaldi A, Al Raiy B. Clinical course and outcomes of critically ill patients with Middle East respiratory syndrome coronavirus infection. Ann Intern Med 2014;160:389–397. 6. Saad M, Omrani AS, Baig K, Bahloul A, Elzein F, Matin MA, Selim MA, Mutairi MA, Nakhli DA, Aidaroos AY, et al. Clinical aspects and outcomes of 70 patients with Middle
730
East respiratory syndrome coronavirus infection: a singlecenter experience in Saudi Arabia. Int J Infect Dis 2014;29: 301–306. 7. Midgley CM, Jackson MA, Selvarangan R, Turabelidze G, Obringer E, Johnson D, Giles L, Patel A, Echols F, Oberste S, et al. Severe respiratory illness associated with Enterovirus D68 - Missouri and Illinois, 2014. MMWR Morb Mortal Wkly Rep 2014;14:798–799.
Copyright © 2015 by the American Thoracic Society
American Journal of Respiratory and Critical Care Medicine Volume 191 Number 7 | April 1 2015
Daniel H. Sterman, M.D. Department of Medicine New York University School of Medicine New York, New York
References 1. Wahidi MM, Yasufuku K. Point: should endobronchial ultrasound guide every transbronchial needle aspiration of lymph nodes? Yes. Chest 2013;144:732–734. 2. Dasgupta A, Mehta AC. Transbronchial needle aspiration: an underused diagnostic technique. Clin Chest Med 1999;20:39–51. 3. Gu P, Zhao YZ, Jiang LY, Zhang W, Xin Y, Han BH. Endobronchial ultrasound-guided transbronchial needle aspiration for staging of lung cancer: a systematic review and meta-analysis. Eur J Cancer 2009;45: 1389–1396. 4. Adams K, Shah PL, Edmonds L, Lim E. Test performance of endobronchial ultrasound and transbronchial needle aspiration biopsy for mediastinal staging in patients with lung cancer: systematic review and meta-analysis. Thorax 2009;64:757–762. 5. Chandra S, Nehra M, Agarwal D, Mohan A. Diagnostic accuracy of endobronchial ultrasound-guided transbronchial needle biopsy in mediastinal lymphadenopathy: a systematic review and metaanalysis. Respir Care 2012;57:384–391. 6. Silvestri GA, Gonzalez AV, Jantz MA, Margolis ML, Gould MK, Tanoue LT, Harris LJ, Detterbeck FC. Methods for staging non-small cell lung cancer. Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest 2013;143:e211S–e250S. 7. Casal RF, Lazarus DR, Kuhl K, Nogueras-Gonzalez ´ G, Perusich S, Green LK, Ost DE, Sarkiss M, Jimenez CA, Eapen GA, et al. Randomized trial of endobronchial ultrasound-guided transbronchial needle aspiration under general anesthesia versus moderate sedation. Am J Respir Crit Care Med 2015;191:796–803.
Copyright © 2015 by the American Thoracic Society
Global Participation in Core Data Sets for Emerging Pathogens The threat to public health from emerging infections seems to have accelerated in the last decade. Research should be considered an integral component of the local and international response to epidemic diseases, but a global research response requires coordinated effort from the international medical community. Countries in West Africa are facing an unprecedented outbreak of Ebola virus disease (1), and health departments and providers in other countries are adjusting to the challenges of patient management and disease containment (2, 3). Although there are pressing daily challenges in respiratory health, and the current Ebola virus disease outbreak is commanding our attention, we must not lose sight of other emerging pathogens that cause severe critical illness and death globally. For example, the Middle East respiratory syndrome coronavirus (MERS-CoV) was discovered in 2012 and has been implicated in clusters of severe respiratory infections, with the largest clusters occurring in Saudi Arabia in April and May 2014 (4). Many
Author Contributions: Conception and design: S.S.C., R.A.F., J.P.C., Y.M.A., and D.H.I. Drafting the manuscript for important intellectual content: S.S.C., R.A.F., J.P.C., Y.M.A., and D.H.I.
728
of the clusters have been nosocomial in nature, highlighting the potential vulnerability of healthcare workers and the importance of infection prevention and control. Often resulting in severe adult respiratory distress syndrome, the reported mortality rate of MERS-CoV infections ranges from 32% to 60% (5, 6). In the past, MERS-CoV infections occurred primarily in the springtime, but this fall, new cases and nosocomial transmission already are being reported, raising the possibility of an accelerating cycle of infection. In August, pediatric centers in the United States were surprised by an unusual number of cases of acute respiratory failure resulting from enterovirus D68 with some associated deaths (7). New strains of influenza such as avian influenza A (H7N9) and other respiratory pathogens remain a constant threat. In response to the recent outbreaks of emerging pathogens associated with critical illness and high case fatality rates, the American Thoracic Society endorses and recommends the following: 1. There is a major need for high-quality ongoing epidemiologic, clinical, and biological research designed to characterize the clinical syndromes of different emerging pathogens. The syndrome qualities will likely evolve as the full spectrum of
American Journal of Respiratory and Critical Care Medicine Volume 191 Number 7 | April 1 2015
EDITORIALS
2.
3.
4.
5.
disease is appreciated, and there also is potential for change with mutations or changing strains. In addition, interventional research is needed to plan and test the efficacy of potential treatments. There should be a common international clinical and biological data-reporting standard, ideally based on a “tiered” approach facilitating data collection. The common reporting forms should foster investigations in settings that vary with respect to their research capabilities and be readily used in studies that vary in research design. Reporting forms should support a minimum core data set and an expanded data set specific for each emerging respiratory and systemic pathogen. The data-reporting standard recently released by the World Health Organization in collaboration with the International Severe Acute Respiratory and Emerging Infection Consortium (http://www.cliresdms.org) provides these capabilities and is supported by international research collaborations such as the International Forum of Acute Care Trialists, regional professional organizations such as the American Thoracic Society, and national clinical trials groups such as the U.S. Critical Illness and Injury Trials Group (USCIIT Group). As this standard is used, periodic consensus modifications will need to occur to ensure it is feasible across a wide variety of settings and studies and as more information is available about specific components needed in each expanded data set. Health authorities and hospitals in countries with cases of Ebola virus disease, MERS-CoV, or other emerging pathogens should foster reporting of de-identified data from affected patients, in accordance with all local and national regulatory processes. This is essential to inform the responses of clinicians, researchers, and those conducting systems and operational evaluations. These data sets should be housed and controlled locally but should contain all the elements in common reporting standards, described in the second point presented here, and should be shared in very timely fashion with the World Health Organization. This ensures maximal potential for international collaboration and progress in understanding and responding to emerging health threats. Funding to ensure collection and reporting of de-identified data is essential. The health authorities, health ministries, and research funding agencies of countries with emerging infections and international agencies should prioritize funding to support capture of relevant data and entry into the common reporting form, preservation of relevant biologic samples, and research on effective treatments to improve outcomes and decrease the spread of the illness. This includes prevention of transmission to healthcare workers who are disproportionally exposed to infection. Funding also should be prioritized to support collaborative, multicenter research, particularly encouraging collaboration across countries. The relevant international and national professional societies should work jointly to facilitate and aid these efforts, making available expertise and support from their constituents to meet the evolving needs of the patients, families, and health care systems in the affected countries.
The broadly endorsed World Health Organization reporting forms described in the second recommendation presented Editorials
here, supporting minimum and extended core data sets for emerging infections, can serve as an example for responses to other epidemics. Amid the urgency to respond to clinical care needs, data entry from multiple care sites will allow epidemiologists and clinical scientists to evaluate disease trends and responses to medical care in a systematic way. This will then inform implementation plans and research as well as inform clinical trials of new interventions. Timely and accurate collection of information in the midst of outbreaks, epidemics and pandemics can be very difficult, particularly when the disease is severe and the affected population is expanding rapidly. However, it is only by having up-to-date, shared, and accurate information available that appropriate public health and intervention efforts can be designed to have the maximum potential benefit and chance to interrupt transmission and treat patients. n Author disclosures are available with the text of this article at www.atsjournals.org. Acknowledgment: This editorial was reviewed and supported by the Critical Care Society Collaborative members, constituting leadership of the American Thoracic Society, American College of Chest Physicians, and the Society of Critical Care Medicine. Shannon S. Carson, M.D. University of North Carolina Chapel Hill, North Carolina Robert A. Fowler, M.D., M.D.C.M., M.Sc. University of Toronto Toronto, Ontario, Canada J. Perren Cobb, M.D. Massachusetts General Hospital Boston, Massachusetts Yaseen M. Arabi, M.D. King Saud bin Abdulaziz University for Health Sciences Riyadh, Saudi Arabia David H. Ingbar, M.D. University of Minnesota Minneapolis, Minnesota for the ATS Taskforce on Emerging Pathogens American Thoracic Society Taskforce on Emerging Pathogens Members: Yaseen Arabi, Charles Bennett, Satish Bhagwanjee, Charles Cairns, Shannon S. Carson, J. Perren Cobb, William A. Fischer, Robert Fowler, Michelle Gong, David Ingbar, Anthony Martinez, Jonathon Sevransky, and Satish Bhagwanjee.
References 1. WHO Ebola Response Team. Ebola virus disease in West Africa—the first 9 months of the epidemic and forward projections. N Engl J Med 2014;371:1481–1495. 2. Decker BK, Sevransky JE, Barrett K, Davey RT, Chertow DS. Preparing for critical care services to patients with Ebola. Ann Intern Med 2014; 161:831–832. 3. Fowler RA, Fletcher T, Fischer WA II, Lamontagne F, Jacob S, BrettMajor D, Lawler JV, Jacquerioz FA, Houlihan C, O’Dempsey T, et al. Caring for critically ill patients with Ebola virus disease: perspectives from West Africa. Am J Respir Crit Care Med 2014;190: 733–737. 4. Al-Abdallat MM, Payne DC, Alqasrawi S, Rha B, Tohme RA, Abedi GR, Al Nsour M, Iblan I, Jarour N, Farag NH, et al.; Jordan MERS-CoV Investigation Team. Hospital-associated outbreak of
729
EDITORIALS Middle East respiratory syndrome coronavirus: a serologic, epidemiologic, and clinical description. Clin Infect Dis 2014;59: 1225–1233. 5. Arabi YM, Arifi AA, Balkhy HH, Najm H, Aldawood AS, Ghabashi A, Hawa H, Alothman A, Khaldi A, Al Raiy B. Clinical course and outcomes of critically ill patients with Middle East respiratory syndrome coronavirus infection. Ann Intern Med 2014;160:389–397. 6. Saad M, Omrani AS, Baig K, Bahloul A, Elzein F, Matin MA, Selim MA, Mutairi MA, Nakhli DA, Aidaroos AY, et al. Clinical aspects and outcomes of 70 patients with Middle
730
East respiratory syndrome coronavirus infection: a singlecenter experience in Saudi Arabia. Int J Infect Dis 2014;29: 301–306. 7. Midgley CM, Jackson MA, Selvarangan R, Turabelidze G, Obringer E, Johnson D, Giles L, Patel A, Echols F, Oberste S, et al. Severe respiratory illness associated with Enterovirus D68 - Missouri and Illinois, 2014. MMWR Morb Mortal Wkly Rep 2014;14:798–799.
Copyright © 2015 by the American Thoracic Society
American Journal of Respiratory and Critical Care Medicine Volume 191 Number 7 | April 1 2015
