Letters
3. The Antiarrhythmics versus Implantable Defibrillators (AVID) Investigators. A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. N Engl J Med. 1997;337(22):1576-1583. 4. Grimm W, Flores BT, Marchlinski FE. Shock occurrence and survival in 241 patients with implantable cardioverter-defibrillator therapy. Circulation. 1993;87(6):1880-1888. 5. Pelicano N, Oliveira M, Da Silva N, et al. Long-term clinical outcome in patients with severe left ventricular dysfunction and an implantable cardioverter-defibrillator after ventricular tachyarrhythmias. Rev Port Cardiol. 2005;24(4):487-498.
In Reply We appreciate Rathod and colleagues’ comments regarding the health outcomes after implantable cardioverterdefibrillator (ICD) shocks among patients receiving an ICD for secondary prevention of sudden death. They emphasize important differences in health outcomes among primary prevention and secondary prevention patients. While patients receiving primary prevention ICDs represent the majority of records in the National Cardiovascular Data Registry (NCDR) for ICDs (80%),1 substantial numbers of patients receive an ICD because they have survived sudden cardiac death or other life-threatening ventricular tachyarrhythmias. In addition, as Rathod and colleagues describe, the patient population undergoing primary prevention ICD implantation in the randomized clinical trials had lower ejection fractions and were on average older compared with those undergoing secondary prevention implantation in the Antiarrhythmics vs Implantable Defibrillators (AVID) trial.2-4 Patients receiving an ICD for secondary prevention are much more likely to receive ICD therapies, including high-energy shocks and/or antitachycardia pacing in the context of the randomized clinical trial. The cumulative percentage of patients in AVID with either antitachycardia pacing or shock was 85% at 3 years, much higher than the 31% rate of ICD shocks at the mean follow-up of nearly 3.5 years among the primary prevention patients in the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT).2,3 Rates of device therapies in contemporary populations of patients receiving secondary prevention ICDs is not well described. As Rathod and colleagues discuss, ICD programming is an evolving science that has not been emphasized in the secondary prevention ICD population. Among the published trials using more liberal programming settings, only the Avoid Delivering Therapies for Nonsustained Arrhythmias in ICD Patients III (ADVANCE III)5 and Pacing Fast Ventricular Tachycardia Reduces Shock Therapies (PainFREE Rx II) 6 trials used secondary prevention patients (25% and 50% of the study group, respectively). Unfortunately, no subgroup analyses were performed to detect differences in therapies or outcomes specifically in the secondary prevention population. Admittedly, specific strategies to minimize device therapies among the secondary prevention population where the likelihood of mortality benefits are high and the ratio of inappropriate therapies vs appropriate therapies is low may differ from those used in the primary prevention population. It is reasonable to assume that health outcomes among primary and secondary prevention populations will differ, 2094
given the multitude of differences between the 2 populations. We agree that a “one size fits all” approach to ICD programming is counterintuitive. Regardless of the patient’s indication for ICD implantation, physicians should carefully consider the present trial evidence in the context of the individual patient’s clinical characteristics to provide therapy with the greatest likelihood of treating life-threatening arrhythmias and the lowest likelihood of delivering inappropriate therapies. Ryan T. Borne, MD Paul D. Varosy, MD Frederick A. Masoudi, MD, MSPH Author Affiliations: Division of Cardiology, University of Colorado Anschutz Medical Campus, Aurora, Colorado (Borne, Varosy, Masoudi); VA Eastern Colorado Healthcare System, Denver (Varosy). Corresponding Author: Ryan T. Borne, MD, Division of Cardiology, University of Colorado Anschutz Medical Campus, 12631 E 17th Ave, Campus Box B130, Aurora, CO 80045 ([email protected]). Conflict of Interest Disclosures: None reported. 1. Hammill SC, Kremers MS, Stevenson LW, et al. Review of the registry’s fourth year, incorporating lead data and pediatric ICD procedures, and use as a national performance measure. Heart Rhythm. 2010;7(9):1340-1345. 2. The Antiarrhythmics versus Implantable Defibrillators (AVID) Investigators. A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. N Engl J Med. 1997;337(22):1576-1583. 3. Bardy GH, Lee KL, Mark DB, et al; Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators. Amiodarone or an implantable cardioverterdefibrillator for congestive heart failure. N Engl J Med. 2005;352(3):225-237. 4. Moss AJ, Zareba W, Hall WJ, et al; Multicenter Automatic Defibrillator Implantation Trial II Investigators. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2004;350(21):2151-2158. 5. Gasparini M, Proclemer A, Klersy C, et al. Effect of long-detection interval vs standard-detection interval for implantable cardioverter-defibrillators on antitachycardia pacing and shock delivery: the ADVANCE III randomized clinical trial. JAMA. 2013;309(18):1903-1911. 6. Wathen MS, DeGroot PJ, Sweeney MO, et al; Pain-FREE Rx II Investigators. Prospective randomized multicenter trial of empirical antitachycardia pacing vs shocks for spontaneous rapid ventricular tachycardia in patients with implantable cardioverter-defibrillators: Pacing Fast Ventricular Tachycardia Reduces Shock Therapies (Pain-FREE Rx II) trial results. Circulation. 2004;110(17):2591-2596.
The Challenge of Definition and Moving Creative Arts Therapy Research Forward To the Editor Bradt and Goodill1 rightfully raise the issue of a definition of creative arts therapy (CAT). The definition continues to be disputed in the CAT community.2-4 Although the purpose of our study5 was not to define CAT, the issue of definition was addressed by our group in consort with CAT therapists during review preparation. The terms “expressive” and “creative” arts therapies frequently are used interchangeably. 2,3 However, each addresses a different concept. Expressive arts therapy is a multimodal approach combining different art modalities into the therapeutic process. It is not grounded in any particular media.2,3 Creative arts therapy is a collective approach in which the specialized arts therapy disciplines work together collaboratively but within their respective medias.3,4 While this chal-
JAMA Internal Medicine December 9/23, 2013 Volume 173, Number 22
Copyright 2013 American Medical Association. All rights reserved.
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lenged the systematic review process, it did not detract from the methodological rigor. Our group systematically collected literature in the widely recognized categories of CAT and both aggregated (main review) and decomposed (supplementary material) the CAT modality data to provide an “expressive” and “creative” arts approach, respectively. In the commentary by Bradt and Goodill, 1 we are troubled by their confusion related to the moderator analyses and distraught by implications of lack of transparency. Many articles included in the analyses lacked adequate information regarding intervention features especially related to intervention implementation by a certified CAT therapist. However, the articles still could be theoretically and practically divided into 2 categories: intervention sessions directly led and monitored by a CAT therapist or interventions developed by a CAT therapist but not directly led or monitored by a CAT therapist. These definitions were labeled “creative arts therapist” and “no creative arts therapist,” respectively, and were referenced in the review and presented in eTable 1 of our article.5 These definitions were used throughout the analyses and guided interpretation of results. It is unclear how these definitions contradict the meta-regression results or decomposition of the 2 therapeutic monitoring categories found in eTable 3.5 It is difficult to publish all data from a meta-analysis. We applaud JAMA Internal Medicine for allowing us to produce as much supporting data as they did through the published review and online supplements. However, journal space limitations and feasibility in presenting data on 10 separate analyses (5 outcomes × 2 time points) demanded being selective in how best to present those data to the readership. We apologize if we were not able to address a specific concern with the data presented in the main review but welcome the opportunity to share data with any and all researchers. Timothy W. Puetz, PhD, MPH Christopher A. Morley, MPH Matthew P. Herring, PhD Author Affiliations: Office of the Director, National Institutes of Health, Bethesda, Maryland (Puetz); The ArtReach Foundation Inc, Atlanta, Georgia (Morley); Department of Epidemiology, University of Alabama at Birmingham (Herring). Corresponding Author: Timothy W. Puetz, PhD, MPH, Office of the Director, National Institutes of Health, 9000 Rockville Pike, Bethesda, MD 20802 ([email protected]).
Treatment of Nonmelanoma Skin Cancer To the Editor This letter is in response to the recent article by Linos et al.1 As a dermatologic surgeon whose practice is limited to the treatment of nonmelanoma skin cancer (NMSC), a question comes up almost daily from care providers of elderly patients: “My mom is 87, do we really need to treat this?” As the authors mention, although most NMSCs are not life threatening, those of us who manage these diseases are witness to the deep destruction and profound impact on quality of life that they can cause if left untreated. Suspected lesions should always be biopsied because more serious diagnoses such as melanoma or Merkel cell carcinoma are real possibilities, and patients, no matter how old, should be made aware of these conditions. The study does an excellent job of solidifying the safety and efficacy of existing treatments for NMSC. With respect to complications, only 15% of patients responded. These “complications” included minor, temporary symptoms such as numbness and itching, and were not evaluated by the treating physician. There is no reference to complications such as bleeding or infection, presumably because the incidence of these events was low as has been demonstrated previously.2 Statistics are only statistics, and it is impossible for anyone to predict which of our limited–life expectancy patients will be among the 23% who are still alive at 10 years. In that period, a basal cell carcinoma will continue to grow, destroy vital structures, bleed, become infected and ruin the last years of a person’s life. A squamous cell carcinoma can metastasize and become fatal. As dermatologists, we have several options to treat NMSC. Mohs micrographic surgery is a proven approach, particularly for tumors located on the head and neck, with cure rates approaching 100%. While the authors state that this procedure can take 3 hours, the majority of this time is spent with the patient sleeping or sitting in a chair. Lastly, no mention was made as to the fate of those patients who did not undergo treatment. How many of them are regretting their decision? In my office, and those of my colleagues, discussion frequently revolves around the best treatment for a given patient; however, with the safety and efficacy of existing approaches and potential morbitity of these tumors if left untreated, the decision is rarely made to leave a tumor untreated—for cancers only get bigger. Sherrif F. Ibrahim, MD, PhD
Conflict of Interest Disclosures: None reported. Disclaimer: The opinions expressed in this letter are those of the authors and do not necessarily represent the views of the National Institutes of Health.
Author Affiliation: Division of Dermatologic Surgery, University of Rochester Medical Center, Rochester, New York.
1. Bradt J, Goodill S. Creative arts therapies defined. JAMA Intern Med. 2013;173(11):969-970.
Corresponding Author: Sherrif F. Ibrahim, MD, PhD, Division of Dermatologic Surgery, University of Rochester Medical Center, 400 Red Creek Dr, Ste 200, Rochester, NY 14623 ([email protected]).
2. Malchiodi CA. Expressive Therapies. New York, NY: Guilford Press; 2005. 3. McNiff S. Integrating the Arts in Therapy: History, Theory, and Practice. Springfield, IL: Charles C. Thomas Publisher, LTD; 2009.
Conflict of Interest Disclosures: None reported.
4. Rubin JA. Introduction to Art Therapy: Sources & Resources. New York, NY: Taylor & Francis; 2010.
1. Linos E, Parvataneni R, Stuart SE, Boscardin WJ, Landefeld CS, Chren MM. Treatment of nonfatal conditions at the end of life: nonmelanoma skin cancer. JAMA Intern Med. 2013;173(11):1006-1012.
5. Puetz TW, Morley CA, Herring MP. Effects of creative arts therapies on psychological symptoms and quality of life in patients with cancer. JAMA Intern Med. 2013;173(11):960-969.
2. Merritt BG, Lee NY, Brodland DG, Zitelli JA, Cook J. The safety of Mohs surgery: a prospective multicenter cohort study. J Am Acad Dermatol. 2012;67(6):1302-1309.
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JAMA Internal Medicine December 9/23, 2013 Volume 173, Number 22
Copyright 2013 American Medical Association. All rights reserved.
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3. The Antiarrhythmics versus Implantable Defibrillators (AVID) Investigators. A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. N Engl J Med. 1997;337(22):1576-1583. 4. Grimm W, Flores BT, Marchlinski FE. Shock occurrence and survival in 241 patients with implantable cardioverter-defibrillator therapy. Circulation. 1993;87(6):1880-1888. 5. Pelicano N, Oliveira M, Da Silva N, et al. Long-term clinical outcome in patients with severe left ventricular dysfunction and an implantable cardioverter-defibrillator after ventricular tachyarrhythmias. Rev Port Cardiol. 2005;24(4):487-498.
In Reply We appreciate Rathod and colleagues’ comments regarding the health outcomes after implantable cardioverterdefibrillator (ICD) shocks among patients receiving an ICD for secondary prevention of sudden death. They emphasize important differences in health outcomes among primary prevention and secondary prevention patients. While patients receiving primary prevention ICDs represent the majority of records in the National Cardiovascular Data Registry (NCDR) for ICDs (80%),1 substantial numbers of patients receive an ICD because they have survived sudden cardiac death or other life-threatening ventricular tachyarrhythmias. In addition, as Rathod and colleagues describe, the patient population undergoing primary prevention ICD implantation in the randomized clinical trials had lower ejection fractions and were on average older compared with those undergoing secondary prevention implantation in the Antiarrhythmics vs Implantable Defibrillators (AVID) trial.2-4 Patients receiving an ICD for secondary prevention are much more likely to receive ICD therapies, including high-energy shocks and/or antitachycardia pacing in the context of the randomized clinical trial. The cumulative percentage of patients in AVID with either antitachycardia pacing or shock was 85% at 3 years, much higher than the 31% rate of ICD shocks at the mean follow-up of nearly 3.5 years among the primary prevention patients in the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT).2,3 Rates of device therapies in contemporary populations of patients receiving secondary prevention ICDs is not well described. As Rathod and colleagues discuss, ICD programming is an evolving science that has not been emphasized in the secondary prevention ICD population. Among the published trials using more liberal programming settings, only the Avoid Delivering Therapies for Nonsustained Arrhythmias in ICD Patients III (ADVANCE III)5 and Pacing Fast Ventricular Tachycardia Reduces Shock Therapies (PainFREE Rx II) 6 trials used secondary prevention patients (25% and 50% of the study group, respectively). Unfortunately, no subgroup analyses were performed to detect differences in therapies or outcomes specifically in the secondary prevention population. Admittedly, specific strategies to minimize device therapies among the secondary prevention population where the likelihood of mortality benefits are high and the ratio of inappropriate therapies vs appropriate therapies is low may differ from those used in the primary prevention population. It is reasonable to assume that health outcomes among primary and secondary prevention populations will differ, 2094
given the multitude of differences between the 2 populations. We agree that a “one size fits all” approach to ICD programming is counterintuitive. Regardless of the patient’s indication for ICD implantation, physicians should carefully consider the present trial evidence in the context of the individual patient’s clinical characteristics to provide therapy with the greatest likelihood of treating life-threatening arrhythmias and the lowest likelihood of delivering inappropriate therapies. Ryan T. Borne, MD Paul D. Varosy, MD Frederick A. Masoudi, MD, MSPH Author Affiliations: Division of Cardiology, University of Colorado Anschutz Medical Campus, Aurora, Colorado (Borne, Varosy, Masoudi); VA Eastern Colorado Healthcare System, Denver (Varosy). Corresponding Author: Ryan T. Borne, MD, Division of Cardiology, University of Colorado Anschutz Medical Campus, 12631 E 17th Ave, Campus Box B130, Aurora, CO 80045 ([email protected]). Conflict of Interest Disclosures: None reported. 1. Hammill SC, Kremers MS, Stevenson LW, et al. Review of the registry’s fourth year, incorporating lead data and pediatric ICD procedures, and use as a national performance measure. Heart Rhythm. 2010;7(9):1340-1345. 2. The Antiarrhythmics versus Implantable Defibrillators (AVID) Investigators. A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. N Engl J Med. 1997;337(22):1576-1583. 3. Bardy GH, Lee KL, Mark DB, et al; Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators. Amiodarone or an implantable cardioverterdefibrillator for congestive heart failure. N Engl J Med. 2005;352(3):225-237. 4. Moss AJ, Zareba W, Hall WJ, et al; Multicenter Automatic Defibrillator Implantation Trial II Investigators. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2004;350(21):2151-2158. 5. Gasparini M, Proclemer A, Klersy C, et al. Effect of long-detection interval vs standard-detection interval for implantable cardioverter-defibrillators on antitachycardia pacing and shock delivery: the ADVANCE III randomized clinical trial. JAMA. 2013;309(18):1903-1911. 6. Wathen MS, DeGroot PJ, Sweeney MO, et al; Pain-FREE Rx II Investigators. Prospective randomized multicenter trial of empirical antitachycardia pacing vs shocks for spontaneous rapid ventricular tachycardia in patients with implantable cardioverter-defibrillators: Pacing Fast Ventricular Tachycardia Reduces Shock Therapies (Pain-FREE Rx II) trial results. Circulation. 2004;110(17):2591-2596.
The Challenge of Definition and Moving Creative Arts Therapy Research Forward To the Editor Bradt and Goodill1 rightfully raise the issue of a definition of creative arts therapy (CAT). The definition continues to be disputed in the CAT community.2-4 Although the purpose of our study5 was not to define CAT, the issue of definition was addressed by our group in consort with CAT therapists during review preparation. The terms “expressive” and “creative” arts therapies frequently are used interchangeably. 2,3 However, each addresses a different concept. Expressive arts therapy is a multimodal approach combining different art modalities into the therapeutic process. It is not grounded in any particular media.2,3 Creative arts therapy is a collective approach in which the specialized arts therapy disciplines work together collaboratively but within their respective medias.3,4 While this chal-
JAMA Internal Medicine December 9/23, 2013 Volume 173, Number 22
Copyright 2013 American Medical Association. All rights reserved.
Downloaded From: http://archinte.jamanetwork.com/ by a Ndsu Library Periodicals User on 06/02/2015
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Letters
lenged the systematic review process, it did not detract from the methodological rigor. Our group systematically collected literature in the widely recognized categories of CAT and both aggregated (main review) and decomposed (supplementary material) the CAT modality data to provide an “expressive” and “creative” arts approach, respectively. In the commentary by Bradt and Goodill, 1 we are troubled by their confusion related to the moderator analyses and distraught by implications of lack of transparency. Many articles included in the analyses lacked adequate information regarding intervention features especially related to intervention implementation by a certified CAT therapist. However, the articles still could be theoretically and practically divided into 2 categories: intervention sessions directly led and monitored by a CAT therapist or interventions developed by a CAT therapist but not directly led or monitored by a CAT therapist. These definitions were labeled “creative arts therapist” and “no creative arts therapist,” respectively, and were referenced in the review and presented in eTable 1 of our article.5 These definitions were used throughout the analyses and guided interpretation of results. It is unclear how these definitions contradict the meta-regression results or decomposition of the 2 therapeutic monitoring categories found in eTable 3.5 It is difficult to publish all data from a meta-analysis. We applaud JAMA Internal Medicine for allowing us to produce as much supporting data as they did through the published review and online supplements. However, journal space limitations and feasibility in presenting data on 10 separate analyses (5 outcomes × 2 time points) demanded being selective in how best to present those data to the readership. We apologize if we were not able to address a specific concern with the data presented in the main review but welcome the opportunity to share data with any and all researchers. Timothy W. Puetz, PhD, MPH Christopher A. Morley, MPH Matthew P. Herring, PhD Author Affiliations: Office of the Director, National Institutes of Health, Bethesda, Maryland (Puetz); The ArtReach Foundation Inc, Atlanta, Georgia (Morley); Department of Epidemiology, University of Alabama at Birmingham (Herring). Corresponding Author: Timothy W. Puetz, PhD, MPH, Office of the Director, National Institutes of Health, 9000 Rockville Pike, Bethesda, MD 20802 ([email protected]).
Treatment of Nonmelanoma Skin Cancer To the Editor This letter is in response to the recent article by Linos et al.1 As a dermatologic surgeon whose practice is limited to the treatment of nonmelanoma skin cancer (NMSC), a question comes up almost daily from care providers of elderly patients: “My mom is 87, do we really need to treat this?” As the authors mention, although most NMSCs are not life threatening, those of us who manage these diseases are witness to the deep destruction and profound impact on quality of life that they can cause if left untreated. Suspected lesions should always be biopsied because more serious diagnoses such as melanoma or Merkel cell carcinoma are real possibilities, and patients, no matter how old, should be made aware of these conditions. The study does an excellent job of solidifying the safety and efficacy of existing treatments for NMSC. With respect to complications, only 15% of patients responded. These “complications” included minor, temporary symptoms such as numbness and itching, and were not evaluated by the treating physician. There is no reference to complications such as bleeding or infection, presumably because the incidence of these events was low as has been demonstrated previously.2 Statistics are only statistics, and it is impossible for anyone to predict which of our limited–life expectancy patients will be among the 23% who are still alive at 10 years. In that period, a basal cell carcinoma will continue to grow, destroy vital structures, bleed, become infected and ruin the last years of a person’s life. A squamous cell carcinoma can metastasize and become fatal. As dermatologists, we have several options to treat NMSC. Mohs micrographic surgery is a proven approach, particularly for tumors located on the head and neck, with cure rates approaching 100%. While the authors state that this procedure can take 3 hours, the majority of this time is spent with the patient sleeping or sitting in a chair. Lastly, no mention was made as to the fate of those patients who did not undergo treatment. How many of them are regretting their decision? In my office, and those of my colleagues, discussion frequently revolves around the best treatment for a given patient; however, with the safety and efficacy of existing approaches and potential morbitity of these tumors if left untreated, the decision is rarely made to leave a tumor untreated—for cancers only get bigger. Sherrif F. Ibrahim, MD, PhD
Conflict of Interest Disclosures: None reported. Disclaimer: The opinions expressed in this letter are those of the authors and do not necessarily represent the views of the National Institutes of Health.
Author Affiliation: Division of Dermatologic Surgery, University of Rochester Medical Center, Rochester, New York.
1. Bradt J, Goodill S. Creative arts therapies defined. JAMA Intern Med. 2013;173(11):969-970.
Corresponding Author: Sherrif F. Ibrahim, MD, PhD, Division of Dermatologic Surgery, University of Rochester Medical Center, 400 Red Creek Dr, Ste 200, Rochester, NY 14623 ([email protected]).
2. Malchiodi CA. Expressive Therapies. New York, NY: Guilford Press; 2005. 3. McNiff S. Integrating the Arts in Therapy: History, Theory, and Practice. Springfield, IL: Charles C. Thomas Publisher, LTD; 2009.
Conflict of Interest Disclosures: None reported.
4. Rubin JA. Introduction to Art Therapy: Sources & Resources. New York, NY: Taylor & Francis; 2010.
1. Linos E, Parvataneni R, Stuart SE, Boscardin WJ, Landefeld CS, Chren MM. Treatment of nonfatal conditions at the end of life: nonmelanoma skin cancer. JAMA Intern Med. 2013;173(11):1006-1012.
5. Puetz TW, Morley CA, Herring MP. Effects of creative arts therapies on psychological symptoms and quality of life in patients with cancer. JAMA Intern Med. 2013;173(11):960-969.
2. Merritt BG, Lee NY, Brodland DG, Zitelli JA, Cook J. The safety of Mohs surgery: a prospective multicenter cohort study. J Am Acad Dermatol. 2012;67(6):1302-1309.
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JAMA Internal Medicine December 9/23, 2013 Volume 173, Number 22
Copyright 2013 American Medical Association. All rights reserved.
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2095
