correspondence 1. De Bruyne B, Fearon WF, Pijls NHJ, et al. Fractional flow
despite their awareness of functionally significant coronary disease. Ensuring that patients and clinicians were unaware of the assigned treatment theoretically could have added methodologic rigor, but this hardly seems feasible. In addition, the largest meta-epidemiologic study to date showed no evidence of relevant bias associated with awareness of study-drug assignments by patients and therapists when objective outcomes were used.1 Rather, outcome assessors should be unaware of study-drug assignments DOI: 10.1056/NEJMc1412894 when they adjudicate these types of outcomes, as was the case in our trial. The Authors Reply: Shah’s point with regard to Bernard De Bruyne, M.D., Ph.D. periprocedural infarctions could be plausible. Cardiovascular Center Aalst However, an analysis of the entire duration of the Aalst, Belgium follow-up period shows that there were 8 peri- [email protected] procedural infarctions (1.8%) in the PCI group William F. Fearon, M.D. versus 5 (1.1%) in the medical-therapy group Stanford University Medical Center (hazard ratio, 1.59; 95% confidence interval [CI], Stanford, CA 0.52 to 4.86). Conversely, there were 18 spontane- Peter Jüni, M.D. ous myocardial infarctions (4.0%) in the PCI University of Bern Bern, Switzerland group versus 25 (5.7%) in the medical-therapy Since publication of their article, the authors report no further group (hazard ratio, 0.70; 95% CI, 0.38 to 1.29); potential conflict of interest. this provides support for our initial conclusions. 1. Savović J, Jones HE, Altman DG, et al. Influence of reported As we acknowledged in our article, the aware- study design characteristics on intervention effect estimates ness of the presence of stenoses may indeed in- from randomized, controlled trials. Ann Intern Med 2012;157: fluence patients’ or physicians’ decisions. Yet, 429-38. registry patients had a low number of events DOI: 10.1056/NEJMc1412894 reserve–guided PCI for stable coronary artery disease. N Engl J Med 2014;371:1208-17. 2. Prasad A, Herrmann J. Myocardial infarction due to percutaneous coronary intervention. N Engl J Med 2011;364:453-64. 3. Rothberg MB, Sivalingam SK, Ashraf J, et al. Patients’ and cardiologists’ perceptions of the benefits of percutaneous coronary intervention for stable coronary disease. Ann Intern Med 2010;153:307-13. 4. Lin GA, Dudley RA, Redberg RF. Cardiologists’ use of percutaneous coronary interventions for stable coronary artery disease. Arch Intern Med 2007;167:1604-9. 5. Schulz KF, Grimes DA. Blinding in randomised trials: hiding who got what. Lancet. 2002;359:696-700.
Health and Health Care in South Africa To the Editor: Mayosi et al. (Oct. 2 issue)1 note that South Africa’s local challenges to improving health are a microcosm of worldwide impediments to better population health. The causal factors of inequality are complex interactions of sociopolitical–economic factors and cultural attitudes. Similarly, it would be simplistic to attribute the origins and perpetuation of legislative discrimination to a moral failing and myopia unique to South Africans. To do so would be to accept the attribution error of apartheid — namely, that groups of people are inherently different. Political oppression and social suffering arising from the failure to recognize common humanity and shared interest are not specific to one people or period. The current global inequalities in health2 re-
flect the darkest history of South African society. International legislative barriers to common access to, and benefit from, education, natural resources, and economic progress are associated with profound differences in health outcomes. As global citizens today, we should recognize and act on the fundamental lesson of apartheid’s local history: We are not that different. Paul G. Firth, M.B., Ch.B. Massachusetts General Hospital Boston, MA [email protected] No potential conflict of interest relevant to this letter was reported. 1. Mayosi BM, Benatar SR. Health and health care in South Af-
rica — 20 years after Mandela. N Engl J Med 2014;371:1344-53. 2. Murray CJL, Lopez AD. Measuring the global burden of disease. N Engl J Med 2013;369:448-57. DOI: 10.1056/NEJMc1413160
n engl j med 372;1 nejm.org january 1, 2015
The New England Journal of Medicine Downloaded from nejm.org at CAMBRIDGE UNIVERSITY LIBRARY on August 11, 2015. For personal use only. No other uses without permission. Copyright © 2015 Massachusetts Medical Society. All rights reserved.
95
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n e w e ng l a n d j o u r na l
The authors reply: We welcome Firth’s support for our contention that South Africa’s problems reflect forces that are causally implicated in creating worldwide disparities in wealth and health.1 Acknowledgment that these deeper causal forces lie behind such seemingly disparate challenges as climate change, HIV–AIDS, and the Ebola epidemic and their global implications could encourage realization of the extent of north–south interdependence in the 21st century.2 The complex notion of an ecologic and systems conception of global health3 requires insight into the power of global political economic structures either to continue to perpetuate disparities and the extreme poverty conducive to the emergence, rapid spread, and intractable establishment of new infectious diseases and multidrug-resistant organisms or to reverse such trends. Understanding global health in this way, and the interconnectedness of all life and human well-being on a planet that is ecologically threatened by human
of
m e dic i n e
activities,4 could allow us to begin to ameliorate disparities and reduce threats to the state of health of individuals and whole populations globally.5 To paraphrase John Donne: No nation is an island. Solomon R. Benatar, M.B., Ch.B., D.Sc. (Med.) Bongani M. Mayosi, M.B., Ch.B., D.Phil. University of Cape Town Cape Town, South Africa Since publication of their article, the authors report no further potential conflict of interest. 1. Alexander T. Unravelling global apartheid: an overview of
world politics. Oxford, England: Polity Press, 1996.
2. Garrett L. The coming plague: newly emerging diseases in a
world out of balance. New York: Farrar, Straus and Giroux, 1994.
3. Benatar S, Upshur R. What is global health? In: Benatar S,
Brock G, eds. Global health and global health ethics. Cambridge, England: Cambridge University Press, 2011:13-23. 4. Rockström J, Steffen W, Noone K, et al. A safe operating space for humanity. Nature 2009;461:472-5. 5. Gill S, ed. Global crises and the crisis of global leadership. Cambridge, England: Cambridge University Press, 2011. DOI: 10.1056/NEJMc1413160
Airway Fistula Closure after Stem-Cell Infusion
A
C
96
To the Editor: Large-airway defects and tracheo- effective methods of treatment.1 Bronchopleural bronchial dehiscence after lung resection present fistula is a pathologic connection between the a problem for clinicians because there are few airway and the pleural space that may develop after lung resection. For many patients with emB pyema, the presence or absence of a fistula makes the difference between recovery, chronic illness, and death.2,3 In our previous preclinical experiments, we Figure 1. Repair of an Airway Fistula after Stem-Cell Infusion. Panel A shows a flexible bronchoscopic view before bone marrow–derived mesenchymal stem-cell transplantation for the treatment of patency in the central part of the right bronchial stump (arrow), with a 3-mm orifice. Panel B shows a subtle bronchopleural fistula (circle) at the end of the right main bronchus, communicating with a distal small cavity. Panel C shows the flexible bronchoscopy view 60 days after the infusion of mesenchymal stem cells, with visible healing of the central bronchial dehiscence and no evidence of the titanium staple on the external aspect of the suture (arrow). Panel D shows post-treatment volume rendering of the airway, with interruption of the fistula at its orifice from the right bronchus (circle) where the cells were injected.
D
n engl j med 372;1
nejm.org
january 1, 2015
The New England Journal of Medicine Downloaded from nejm.org at CAMBRIDGE UNIVERSITY LIBRARY on August 11, 2015. For personal use only. No other uses without permission. Copyright © 2015 Massachusetts Medical Society. All rights reserved.
despite their awareness of functionally significant coronary disease. Ensuring that patients and clinicians were unaware of the assigned treatment theoretically could have added methodologic rigor, but this hardly seems feasible. In addition, the largest meta-epidemiologic study to date showed no evidence of relevant bias associated with awareness of study-drug assignments by patients and therapists when objective outcomes were used.1 Rather, outcome assessors should be unaware of study-drug assignments DOI: 10.1056/NEJMc1412894 when they adjudicate these types of outcomes, as was the case in our trial. The Authors Reply: Shah’s point with regard to Bernard De Bruyne, M.D., Ph.D. periprocedural infarctions could be plausible. Cardiovascular Center Aalst However, an analysis of the entire duration of the Aalst, Belgium follow-up period shows that there were 8 peri- [email protected] procedural infarctions (1.8%) in the PCI group William F. Fearon, M.D. versus 5 (1.1%) in the medical-therapy group Stanford University Medical Center (hazard ratio, 1.59; 95% confidence interval [CI], Stanford, CA 0.52 to 4.86). Conversely, there were 18 spontane- Peter Jüni, M.D. ous myocardial infarctions (4.0%) in the PCI University of Bern Bern, Switzerland group versus 25 (5.7%) in the medical-therapy Since publication of their article, the authors report no further group (hazard ratio, 0.70; 95% CI, 0.38 to 1.29); potential conflict of interest. this provides support for our initial conclusions. 1. Savović J, Jones HE, Altman DG, et al. Influence of reported As we acknowledged in our article, the aware- study design characteristics on intervention effect estimates ness of the presence of stenoses may indeed in- from randomized, controlled trials. Ann Intern Med 2012;157: fluence patients’ or physicians’ decisions. Yet, 429-38. registry patients had a low number of events DOI: 10.1056/NEJMc1412894 reserve–guided PCI for stable coronary artery disease. N Engl J Med 2014;371:1208-17. 2. Prasad A, Herrmann J. Myocardial infarction due to percutaneous coronary intervention. N Engl J Med 2011;364:453-64. 3. Rothberg MB, Sivalingam SK, Ashraf J, et al. Patients’ and cardiologists’ perceptions of the benefits of percutaneous coronary intervention for stable coronary disease. Ann Intern Med 2010;153:307-13. 4. Lin GA, Dudley RA, Redberg RF. Cardiologists’ use of percutaneous coronary interventions for stable coronary artery disease. Arch Intern Med 2007;167:1604-9. 5. Schulz KF, Grimes DA. Blinding in randomised trials: hiding who got what. Lancet. 2002;359:696-700.
Health and Health Care in South Africa To the Editor: Mayosi et al. (Oct. 2 issue)1 note that South Africa’s local challenges to improving health are a microcosm of worldwide impediments to better population health. The causal factors of inequality are complex interactions of sociopolitical–economic factors and cultural attitudes. Similarly, it would be simplistic to attribute the origins and perpetuation of legislative discrimination to a moral failing and myopia unique to South Africans. To do so would be to accept the attribution error of apartheid — namely, that groups of people are inherently different. Political oppression and social suffering arising from the failure to recognize common humanity and shared interest are not specific to one people or period. The current global inequalities in health2 re-
flect the darkest history of South African society. International legislative barriers to common access to, and benefit from, education, natural resources, and economic progress are associated with profound differences in health outcomes. As global citizens today, we should recognize and act on the fundamental lesson of apartheid’s local history: We are not that different. Paul G. Firth, M.B., Ch.B. Massachusetts General Hospital Boston, MA [email protected] No potential conflict of interest relevant to this letter was reported. 1. Mayosi BM, Benatar SR. Health and health care in South Af-
rica — 20 years after Mandela. N Engl J Med 2014;371:1344-53. 2. Murray CJL, Lopez AD. Measuring the global burden of disease. N Engl J Med 2013;369:448-57. DOI: 10.1056/NEJMc1413160
n engl j med 372;1 nejm.org january 1, 2015
The New England Journal of Medicine Downloaded from nejm.org at CAMBRIDGE UNIVERSITY LIBRARY on August 11, 2015. For personal use only. No other uses without permission. Copyright © 2015 Massachusetts Medical Society. All rights reserved.
95
The
n e w e ng l a n d j o u r na l
The authors reply: We welcome Firth’s support for our contention that South Africa’s problems reflect forces that are causally implicated in creating worldwide disparities in wealth and health.1 Acknowledgment that these deeper causal forces lie behind such seemingly disparate challenges as climate change, HIV–AIDS, and the Ebola epidemic and their global implications could encourage realization of the extent of north–south interdependence in the 21st century.2 The complex notion of an ecologic and systems conception of global health3 requires insight into the power of global political economic structures either to continue to perpetuate disparities and the extreme poverty conducive to the emergence, rapid spread, and intractable establishment of new infectious diseases and multidrug-resistant organisms or to reverse such trends. Understanding global health in this way, and the interconnectedness of all life and human well-being on a planet that is ecologically threatened by human
of
m e dic i n e
activities,4 could allow us to begin to ameliorate disparities and reduce threats to the state of health of individuals and whole populations globally.5 To paraphrase John Donne: No nation is an island. Solomon R. Benatar, M.B., Ch.B., D.Sc. (Med.) Bongani M. Mayosi, M.B., Ch.B., D.Phil. University of Cape Town Cape Town, South Africa Since publication of their article, the authors report no further potential conflict of interest. 1. Alexander T. Unravelling global apartheid: an overview of
world politics. Oxford, England: Polity Press, 1996.
2. Garrett L. The coming plague: newly emerging diseases in a
world out of balance. New York: Farrar, Straus and Giroux, 1994.
3. Benatar S, Upshur R. What is global health? In: Benatar S,
Brock G, eds. Global health and global health ethics. Cambridge, England: Cambridge University Press, 2011:13-23. 4. Rockström J, Steffen W, Noone K, et al. A safe operating space for humanity. Nature 2009;461:472-5. 5. Gill S, ed. Global crises and the crisis of global leadership. Cambridge, England: Cambridge University Press, 2011. DOI: 10.1056/NEJMc1413160
Airway Fistula Closure after Stem-Cell Infusion
A
C
96
To the Editor: Large-airway defects and tracheo- effective methods of treatment.1 Bronchopleural bronchial dehiscence after lung resection present fistula is a pathologic connection between the a problem for clinicians because there are few airway and the pleural space that may develop after lung resection. For many patients with emB pyema, the presence or absence of a fistula makes the difference between recovery, chronic illness, and death.2,3 In our previous preclinical experiments, we Figure 1. Repair of an Airway Fistula after Stem-Cell Infusion. Panel A shows a flexible bronchoscopic view before bone marrow–derived mesenchymal stem-cell transplantation for the treatment of patency in the central part of the right bronchial stump (arrow), with a 3-mm orifice. Panel B shows a subtle bronchopleural fistula (circle) at the end of the right main bronchus, communicating with a distal small cavity. Panel C shows the flexible bronchoscopy view 60 days after the infusion of mesenchymal stem cells, with visible healing of the central bronchial dehiscence and no evidence of the titanium staple on the external aspect of the suture (arrow). Panel D shows post-treatment volume rendering of the airway, with interruption of the fistula at its orifice from the right bronchus (circle) where the cells were injected.
D
n engl j med 372;1
nejm.org
january 1, 2015
The New England Journal of Medicine Downloaded from nejm.org at CAMBRIDGE UNIVERSITY LIBRARY on August 11, 2015. For personal use only. No other uses without permission. Copyright © 2015 Massachusetts Medical Society. All rights reserved.
