Letters
The PEITHO study1 was not published when we wrote our review (although it has been published since), and we chose not to describe in detail data only available from an abstract. Furthermore, given the complexity and cost of thrombolytic therapy, we focused on mortality as the most likely outcome to affect practice. We acknowledge that the study was positive for the primary end point. In the MOPETT trial,2 the primary outcome was not clinically relevant (a reduction in pulmonary artery pressure) and therefore not likely to change practice; hence, we did not refer to it. With respect to thrombolysis for massive pulmonary embolism, there are no clinical trials that can be used as evidence to support it as a therapeutic mode. However, for patients with massive life-threatening pulmonary embolism, thrombolysis and surgery remain the only options available. Inferior vena cava filters are widely used in patients with acute venous thrombosis when anticoagulation is contraindicated, although there are no randomized trials that address this issue. Hence, it is correct that there is no strong evidence to support this practice. However, guidelines such as those from the American College of Chest Physicians 3 recommend this therapy when anticoagulation is contraindicated, but give it a grade 1B recommendation because there are no adequate data. The Prévention du Risque d’Embolie Pulmonaire par Interruption Cave 4 study did not address this issue but instead randomized patients with venous thromboembolism treated with anticoagulants to receive or not receive a filter. With respect to the use of aspirin for extended treatment of venous thromboembolism, we agree that the network meta-analysis5 showed a nonsignificant effect favoring the effectiveness of aspirin. In our opinion, at this time that is not enough to recommend aspirin as a treatment mode. Although it may be a reasonable option for secondary cardiovascular prevention, there are no data to support its use for a combined indication. Furthermore, although patients at high risk of bleeding with anticoagulation may bleed less with aspirin, there are no direct comparisons in patients with venous thromboembolism. In addition, there are currently no bleeding risk prediction tools that have been validated sufficiently in patients with venous thromboembolism. It is difficult to recommend aspirin when a high-risk bleeding group cannot be identified. Philip S. Wells, MD, FRCPC, MSc Melissa A. Forgie, MD, FRCPC, MSc Marc A. Rodger, MD, FRCPC, MSc Author Affiliations: Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada. Corresponding Author: Philip S. Wells, MD, FRCP(C), MSc, 501 Smyth Rd, PO Box 206, Ottawa, ON K1H 8L6, Canada ([email protected]). Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported. 2544
1. Meyer G, Vicaut E, Danays T, et al; PEITHO Investigators. Fibrinolysis for patients with intermediate-risk pulmonary embolism. N Engl J Med. 2014;370 (15):1402-1411. 2. Sharifi M, Bay C, Skrocki L, Rahimi F, Mehdipour M; MOPETT Investigators. Moderate pulmonary embolism treated with thrombolysis (from the “MOPETT” Trial). Am J Cardiol. 2013;111(2):273-277. 3. Kearon C, Akl EA, Comerota AJ, et al. American College of Chest Physicians. Antithrombotic therapy for VTE disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2)(suppl):e419Se494S. 4. Decousus H, Leizorovicz A, Parent F, et al. A clinical trial of vena caval filters in the prevention of pulmonary embolism in patients with proximal deep-vein thrombosis: Prévention du Risque d’Embolie Pulmonaire par Interruption Cave Study Group. N Engl J Med. 1998;338(7):409-415. 5. Castellucci LA, Cameron C, Le Gal G, et al. Efficacy and safety outcomes of oral anticoagulants and antiplatelet drugs in the secondary prevention of venous thromboembolism: systematic review and network meta-analysis. BMJ. 2013;347:f5133.
Legal and Ethical Challenges in Brain Death To the Editor Mr Gostin in his Viewpoint1 argued that “All states have followed the model act, although 2 states—New Jersey and New York—require hospitals to consider the family’s religious or moral views in determining a course of action after brain death.” However, the New Jersey statute and New York regulation require consideration of the individual’s belief, not the family’s. Furthermore, these states require determining death not by neurological criteria (and thus not after brain death) but solely upon the basis of cardiorespiratory criteria.2 Michael A. Grodin, MD Author Affiliation: Department of Health Law, Bioethics, and Human Rights, Boston University School of Public Health, Boston, Massachusetts. Corresponding Author: Michael A. Grodin, MD, Department of Health Law, Bioethics, and Human Rights, Boston University School of Public Health, 715 Albany St, Talbot W, Room 358, Boston, MA 02118 ([email protected]). Conflict of Interest Disclosures: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported. 1. Gostin LO. Legal and ethical responsibilities following brain death: the McMath and Muñoz cases. JAMA. 2014;311(9):903-904. 2. Grodin MA. Religious exemptions: brain death and Jewish law. J Church State. 1994;36(2):357-372.
In Reply Dr Grodin is correct in his assertion that the laws of both New York1 and New Jersey2 refer to the religious beliefs of the individual rather than to those of the family. Both states, however, call upon the family or other close person to determine the individual’s beliefs when they are unknown.2,3 In the absence of an advance directive, it will thus often fall to the family to interpret and communicate the patient’s wishes. He also argues that, where an accommodation is granted, legal determination of death depends upon the cessation of cardiac and respiratory activity rather than upon measurement of neurological function. Such an accommodation could lead to an unfortunate situation in which a patient is medically brain dead but arguably not legally so.
JAMA June 25, 2014 Volume 311, Number 24
Copyright 2014 American Medical Association. All rights reserved.
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Letters
Grodin is correct in asserting that New Jersey requires the use of cardiorespiratory criteria in cases of religious exemption; however, New York’s law is more nuanced, requiring only “reasonable accommodation.” The state’s official guidance suggests that even where an accommodation has been granted, a hospital may “limit the duration of the accommodation,” after which a hospital would be free to declare death based on neurological criteria.3 Grodin’s letter reflects an important challenge inherent in legal accommodations for moral or religious beliefs. Where an individual’s preferences are unknown, it often falls to hospital staff to interpret—and even to mediate between— distraught family members’ interpretations of a patient’s final wishes. Advance directives are often encouraged for elderly or terminally ill patients, but Marlise Muñoz and Jahi McMath were neither. The wider use of advance directives could help alleviate the burden on medical staff and grieving families, leading to more compassionate end-of-life decisions. Lawrence O. Gostin, JD Author Affiliation: O’Neill Institute for National and Global Health Law, Georgetown University Law Center, Washington, DC. Corresponding Author: Lawrence O. Gostin, JD, O’Neill Institute for National and Global Health Law, Georgetown University Law Center, 600 New Jersey Ave NW, Washington, DC 20001 ([email protected]). Conflict of Interest Disclosures: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.
3. New York State Department of Health; New York State Task Force on Life and the Law. Guideline for determining brain death. http://www.health.ny.gov /professionals/hospital_administrator/letters/2011/brain_death_guidelines.pdf. Accessibility verified May 13, 2014.
CORRECTION Misplaced Heading and Wording Error: In the Review article entitled “Treatment of Venous Thromboembolism” published in the February 19, 2014, issue of JAMA (2014;311[7]:717-728. doi:10.1001/jama.2014.65), a heading was misplaced. The heading “Vena Cava Filters” should have appeared above the paragraph that begins “Retrievable or permanent inferior vena cava filters may be used ….” Additionally, in the seventh line of the third paragraph on page 721, the word “proximal” should have been “distal” so as to read “… distal DVT patients rarely develop proximal DVT ….” This article was corrected online.
Guidelines for Letters Letters discussing a recent JAMA article should be submitted within 4 weeks of the article's publication in print.Letters received after 4 weeks will rarely be considered. Letters should not exceed 400 words of text and 5 references and may have no more than 3 authors. Letters reporting original research should not exceed 600 words of text and 6 references and may have no more than 7 authors. They may include up to 2 tables or figures but online supplementary material is not allowed. All letters should include a word count. Letters must not duplicate other material published or submitted for publication. Letters not meeting these specifications are generally not considered. Letters being considered for publication ordinarily will be sent to the authors of the JAMA article, who will be given the opportunity to reply. Letters will be published at the discretion of the editors and are subject to abridgement and editing. Further instructions can be found at http: //jama.com/public/InstructionsForAuthors.aspx. A signed statement for authorship criteria and responsibility, financial disclosure, copyright transfer, and acknowledgment and the ICMJE Form for Disclosure of Potential Conflicts of Interest are required before publication. Letters should be submitted via the JAMA online submission and review system at http://manuscripts.jama.com. For technical assistance, please contact [email protected].
1. NY Comp Codes R & Regs ch 10, §400.16. 2. NJ Admin Code §13:35-6A.6.
Section Editor: Jody W. Zylke, MD, Senior Editor.
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JAMA June 25, 2014 Volume 311, Number 24
Copyright 2014 American Medical Association. All rights reserved.
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2545
The PEITHO study1 was not published when we wrote our review (although it has been published since), and we chose not to describe in detail data only available from an abstract. Furthermore, given the complexity and cost of thrombolytic therapy, we focused on mortality as the most likely outcome to affect practice. We acknowledge that the study was positive for the primary end point. In the MOPETT trial,2 the primary outcome was not clinically relevant (a reduction in pulmonary artery pressure) and therefore not likely to change practice; hence, we did not refer to it. With respect to thrombolysis for massive pulmonary embolism, there are no clinical trials that can be used as evidence to support it as a therapeutic mode. However, for patients with massive life-threatening pulmonary embolism, thrombolysis and surgery remain the only options available. Inferior vena cava filters are widely used in patients with acute venous thrombosis when anticoagulation is contraindicated, although there are no randomized trials that address this issue. Hence, it is correct that there is no strong evidence to support this practice. However, guidelines such as those from the American College of Chest Physicians 3 recommend this therapy when anticoagulation is contraindicated, but give it a grade 1B recommendation because there are no adequate data. The Prévention du Risque d’Embolie Pulmonaire par Interruption Cave 4 study did not address this issue but instead randomized patients with venous thromboembolism treated with anticoagulants to receive or not receive a filter. With respect to the use of aspirin for extended treatment of venous thromboembolism, we agree that the network meta-analysis5 showed a nonsignificant effect favoring the effectiveness of aspirin. In our opinion, at this time that is not enough to recommend aspirin as a treatment mode. Although it may be a reasonable option for secondary cardiovascular prevention, there are no data to support its use for a combined indication. Furthermore, although patients at high risk of bleeding with anticoagulation may bleed less with aspirin, there are no direct comparisons in patients with venous thromboembolism. In addition, there are currently no bleeding risk prediction tools that have been validated sufficiently in patients with venous thromboembolism. It is difficult to recommend aspirin when a high-risk bleeding group cannot be identified. Philip S. Wells, MD, FRCPC, MSc Melissa A. Forgie, MD, FRCPC, MSc Marc A. Rodger, MD, FRCPC, MSc Author Affiliations: Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada. Corresponding Author: Philip S. Wells, MD, FRCP(C), MSc, 501 Smyth Rd, PO Box 206, Ottawa, ON K1H 8L6, Canada ([email protected]). Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported. 2544
1. Meyer G, Vicaut E, Danays T, et al; PEITHO Investigators. Fibrinolysis for patients with intermediate-risk pulmonary embolism. N Engl J Med. 2014;370 (15):1402-1411. 2. Sharifi M, Bay C, Skrocki L, Rahimi F, Mehdipour M; MOPETT Investigators. Moderate pulmonary embolism treated with thrombolysis (from the “MOPETT” Trial). Am J Cardiol. 2013;111(2):273-277. 3. Kearon C, Akl EA, Comerota AJ, et al. American College of Chest Physicians. Antithrombotic therapy for VTE disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2)(suppl):e419Se494S. 4. Decousus H, Leizorovicz A, Parent F, et al. A clinical trial of vena caval filters in the prevention of pulmonary embolism in patients with proximal deep-vein thrombosis: Prévention du Risque d’Embolie Pulmonaire par Interruption Cave Study Group. N Engl J Med. 1998;338(7):409-415. 5. Castellucci LA, Cameron C, Le Gal G, et al. Efficacy and safety outcomes of oral anticoagulants and antiplatelet drugs in the secondary prevention of venous thromboembolism: systematic review and network meta-analysis. BMJ. 2013;347:f5133.
Legal and Ethical Challenges in Brain Death To the Editor Mr Gostin in his Viewpoint1 argued that “All states have followed the model act, although 2 states—New Jersey and New York—require hospitals to consider the family’s religious or moral views in determining a course of action after brain death.” However, the New Jersey statute and New York regulation require consideration of the individual’s belief, not the family’s. Furthermore, these states require determining death not by neurological criteria (and thus not after brain death) but solely upon the basis of cardiorespiratory criteria.2 Michael A. Grodin, MD Author Affiliation: Department of Health Law, Bioethics, and Human Rights, Boston University School of Public Health, Boston, Massachusetts. Corresponding Author: Michael A. Grodin, MD, Department of Health Law, Bioethics, and Human Rights, Boston University School of Public Health, 715 Albany St, Talbot W, Room 358, Boston, MA 02118 ([email protected]). Conflict of Interest Disclosures: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported. 1. Gostin LO. Legal and ethical responsibilities following brain death: the McMath and Muñoz cases. JAMA. 2014;311(9):903-904. 2. Grodin MA. Religious exemptions: brain death and Jewish law. J Church State. 1994;36(2):357-372.
In Reply Dr Grodin is correct in his assertion that the laws of both New York1 and New Jersey2 refer to the religious beliefs of the individual rather than to those of the family. Both states, however, call upon the family or other close person to determine the individual’s beliefs when they are unknown.2,3 In the absence of an advance directive, it will thus often fall to the family to interpret and communicate the patient’s wishes. He also argues that, where an accommodation is granted, legal determination of death depends upon the cessation of cardiac and respiratory activity rather than upon measurement of neurological function. Such an accommodation could lead to an unfortunate situation in which a patient is medically brain dead but arguably not legally so.
JAMA June 25, 2014 Volume 311, Number 24
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a J H Quillen College User on 05/27/2015
jama.com
Letters
Grodin is correct in asserting that New Jersey requires the use of cardiorespiratory criteria in cases of religious exemption; however, New York’s law is more nuanced, requiring only “reasonable accommodation.” The state’s official guidance suggests that even where an accommodation has been granted, a hospital may “limit the duration of the accommodation,” after which a hospital would be free to declare death based on neurological criteria.3 Grodin’s letter reflects an important challenge inherent in legal accommodations for moral or religious beliefs. Where an individual’s preferences are unknown, it often falls to hospital staff to interpret—and even to mediate between— distraught family members’ interpretations of a patient’s final wishes. Advance directives are often encouraged for elderly or terminally ill patients, but Marlise Muñoz and Jahi McMath were neither. The wider use of advance directives could help alleviate the burden on medical staff and grieving families, leading to more compassionate end-of-life decisions. Lawrence O. Gostin, JD Author Affiliation: O’Neill Institute for National and Global Health Law, Georgetown University Law Center, Washington, DC. Corresponding Author: Lawrence O. Gostin, JD, O’Neill Institute for National and Global Health Law, Georgetown University Law Center, 600 New Jersey Ave NW, Washington, DC 20001 ([email protected]). Conflict of Interest Disclosures: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.
3. New York State Department of Health; New York State Task Force on Life and the Law. Guideline for determining brain death. http://www.health.ny.gov /professionals/hospital_administrator/letters/2011/brain_death_guidelines.pdf. Accessibility verified May 13, 2014.
CORRECTION Misplaced Heading and Wording Error: In the Review article entitled “Treatment of Venous Thromboembolism” published in the February 19, 2014, issue of JAMA (2014;311[7]:717-728. doi:10.1001/jama.2014.65), a heading was misplaced. The heading “Vena Cava Filters” should have appeared above the paragraph that begins “Retrievable or permanent inferior vena cava filters may be used ….” Additionally, in the seventh line of the third paragraph on page 721, the word “proximal” should have been “distal” so as to read “… distal DVT patients rarely develop proximal DVT ….” This article was corrected online.
Guidelines for Letters Letters discussing a recent JAMA article should be submitted within 4 weeks of the article's publication in print.Letters received after 4 weeks will rarely be considered. Letters should not exceed 400 words of text and 5 references and may have no more than 3 authors. Letters reporting original research should not exceed 600 words of text and 6 references and may have no more than 7 authors. They may include up to 2 tables or figures but online supplementary material is not allowed. All letters should include a word count. Letters must not duplicate other material published or submitted for publication. Letters not meeting these specifications are generally not considered. Letters being considered for publication ordinarily will be sent to the authors of the JAMA article, who will be given the opportunity to reply. Letters will be published at the discretion of the editors and are subject to abridgement and editing. Further instructions can be found at http: //jama.com/public/InstructionsForAuthors.aspx. A signed statement for authorship criteria and responsibility, financial disclosure, copyright transfer, and acknowledgment and the ICMJE Form for Disclosure of Potential Conflicts of Interest are required before publication. Letters should be submitted via the JAMA online submission and review system at http://manuscripts.jama.com. For technical assistance, please contact [email protected].
1. NY Comp Codes R & Regs ch 10, §400.16. 2. NJ Admin Code §13:35-6A.6.
Section Editor: Jody W. Zylke, MD, Senior Editor.
jama.com
JAMA June 25, 2014 Volume 311, Number 24
Copyright 2014 American Medical Association. All rights reserved.
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