Letters
enrolled participants as young as 40 to 50 years as trials of elderly patients.6 Nonetheless, most of the outcome studies are of low quality and have been with atenolol. There have been no outcome studies involving vasodilating β-blockers (eg, nebivolol). Although Cruickshank is correct in stating that the benefit of β-blockers vs placebo may be reduced by smoking, α-blockers (eg, carvedilol) seem to maintain antihypertensive efficacy in smokers. However, there are no outcome studies involving α-blockers. Much work remains to be done to provide high-quality decisive data on the role of sympathetic inhibition in hypertension therapy. We must emphasize, however, that while the use of global evidence from up-to-date systematic reviews of randomized clinical trials is indispensable in hypertension therapy, the choice of initial and add-on drugs for any given patient with hypertension should also take the patient’s clinical characteristics, circumstances, values, and preferences into consideration. Lionel H. Opie, MD, DPhil Charles S. Wiysonge, MD, PhD Author Affiliations: Hatter Institute for Cardiovascular Research in Africa, University of Cape Town Medical School, Cape Town, South Africa (Opie); Centre for Evidence-Based Health Care, Stellenbosch University, Cape Town, South Africa (Wiysonge). Corresponding Author: Charles S. Wiysonge, MD, PhD, Centre for Evidence-Based Health Care, Stellenbosch University, Cape Town 7505, South Africa ([email protected]). Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Drs Opie and Wiysonge reported receiving grant funding from the National Research Foundation of South Africa. 1. Smithwick RH. An evaluation of the surgical treatment of hypertension. Bull N Y Acad Med. 1949;25(11):698-716. 2. Dahlöf B, Sever PS, Poulter NR, et al; ASCOT Investigators. Prevention of cardiovascular events with an antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bendroflumethiazide as required, in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA): a multicentre randomised controlled trial. Lancet. 2005;366(9489):895-906. 3. Jennings GL. Recent clinical trials of hypertension management. Hypertension. 2013;62(1):3-7. 4. ESH/ESC Task Force for the Management of Arterial Hypertension. 2013 practice guidelines for the management of arterial hypertension of the European Society of Hypertension (ESH) and the European Society of Cardiology (ESC): ESH/ESC Task Force for the Management of Arterial Hypertension. J Hypertens. 2013;31(10):1925-1938.
decision making on medical costs and use is inadequate. In their review of a randomized trial of shared decision making by 2 of us,2,3 they suggested that the large observed decreases in medical and surgical admissions and the associated reduction in costs in the intervention group were a result of cliniciandirected decisions rather than patient involvement. However, the unit of randomization was the patient. In a randomized trial of more than 170 000 individuals, patients in the intervention group were unlikely to have systematically interacted with clinicians who were practicing better ambulatory care. The trial measured differences resulting from supporting patient involvement in discussions with physicians and demonstrated significant differences in rates of patient support. Physicians were participants, but differences in the 2 study groups could only come from influencing patients. Furthermore, quality of care did not drive the differences: no differences were found between the 2 groups in typical quality of care measures, including medication adherence. More broadly, a fundamental tenet of shared decision making is that physicians and patients share in the decision. Focusing on who influences the decision more misses the point; when shared decision making is incorporated into clinical encounters, rates of treatments are systematically affected.4 We support additional research into how best to incorporate shared decision making into practitioner workflow and how preferences may vary over time (among other research needs). However, physicians cannot wait until shared decision making is more completely understood to incorporate the value set of including patients. In addition, Katz and Hawley’s example of breast cancer (“up to 20% of patients may ultimately have a clinical contraindication to breast-conserving surgery … ”) might suggest that the preferences of the other 80% do not need to be understood. However, part of any well-designed shared decision making effort is to consider only the options that are reasonable for patients in their specific situations. David R. Veroff, MPP John D. Birkmeyer, MD David E. Wennberg, MD, MPH Author Affiliations: Health Dialog, Boston, Massachusetts (Veroff); University of Michigan Health System, Ann Arbor (Birkmeyer); Northern New England Accountable Care Collaborative, Portland, Maine (Wennberg). Corresponding Author: David R. Veroff, MPP, Health Dialog, 60 State St, Ste 1000, Boston, MA 02109 ([email protected]).
5. James PA, Oparil S, Carter BL, et al. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. doi:10.1001/jama.2013.284427.
Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Wennberg reported receiving royalty payments from Health Dialog. No other disclosures were reported.
6. Wiysonge CS, Bradley HA, Volmink J, Mayosi BM, Mbewu A, Opie LH. Beta-blockers for hypertension. Cochrane Database Syst Rev. 2012;11:CD002003.
1. Katz SJ, Hawley S. The value of sharing treatment decision making with patients: expecting too much? JAMA. 2013;310(15):1559-1560.
Patient-Physician Shared Decision Making To the Editor We believe that the Viewpoint by Drs Katz and Hawley1 on shared decision making inaccurately states its premise and misrepresents the evidence about its effects. Katz and Hawley’s position is that the evidence for the effect of shared
2. Wennberg DE, Marr A, Lang L, O’Malley S, Bennett G. A randomized trial of a telephone care-management strategy. N Engl J Med. 2010;363(13):1245-1255. 3. Veroff D, Marr A, Wennberg DE. Enhanced support for shared decision making reduced costs of care for patients with preference-sensitive conditions. Health Aff (Millwood). 2013;32(2):285-293. 4. 2013 International Shared Decision Making Conference. Cochrane review of patient decision aids for treatment or screening decisions: update in 2012 reveals 24 new trials for 110 total [abstract]. http://isdm2013.org/files/2012/05 /ABSTRACT_GUIDE1.pdf. Accessed September 29, 2013.
jama.com
JAMA February 26, 2014 Volume 311, Number 8
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a Western Oregon University User on 05/29/2015
863
Letters
In Reply Similar to Mr Veroff and colleagues, we are strong proponents of shared decision making between clinicians and their patients, including incorporating values and preferences into treatment decisions. We lead a research program funded by the National Cancer Institute to address better ways to do this, including developing and evaluating new patient-centered deliberation tools.1 However, in our Viewpoint we concluded that the literature does not support the role of shared decision making in reducing overtreatment and medical cost inflation. We established that there were important flaws in a frequently cited Cochrane meta-analysis that suggested that patient decision aids were associated with less extensive surgical treatment. The letter from Veroff and colleagues further highlights the challenges of disentangling patient vs clinician influences on utilization in studies assessing the effect of shared decision making on cost and treatment patterns. The study by Wennberg et al2 was a randomized clinical trial of a telephone-based case management program led by clinical nurses, pharmacists, and other allied health practitioners. The intervention was associated with lower costs through reductions in hospital admissions. Whether the effect was the result of clinician team–directed decisions (eg, better medication management or more effective outpatient management) vs patient and family influences on decision making could not be addressed because no measures of communication or decision making were reported in the study. Despite the statement by Veroff and colleagues, no patient medication adherence measures were reported in either of the cited studies.2,3 This underscores the need to incorporate more granular measures of treatment communication and decision making into studies aimed at evaluating strategies to reduce overtreatment and costs. The fact that the unit of randomization in the study was the patient does not address the mechanism by which the case management program worked to reduce hospitalizations. This would have required measuring key mediators of the association of the intervention with the outcome. Our evidence-based example of surgical treatment decision making for breast cancer illustrates that more patient influence on decision making may yield more extensive surgery.4,5 Ironically, surgical treatment for breast cancer has been frequently cited as an example of a preference-sensitive condition in which more shared decision making could reduce overtreatment. This highlights the need to avoid blanket assumptions about the consequences of increasing shared decision making on treatment decisions.6 We agree with Veroff and colleagues that there are compelling reasons to act now to increase shared decision making in clinical encounters. There is strong evidence that increasing shared decision making can improve the patient
864
experience in clinical encounters and increase decision effectiveness. But there is no compelling evidence that shared decision making should be promoted as a strategy for reducing overtreatment and medical cost inflation. Steven J. Katz, MD, MPH Sarah Hawley, PhD Author Affiliations: Department of Medicine, University of Michigan, Ann Arbor. Corresponding Author: Steven J. Katz, MD, MPH, University of Michigan, 2800 Plymouth Rd, North Campus Research Complex, Bldg 16, Room 430W, Ann Arbor, MI 48109 ([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. 1. Katz SJ, Morrow M. The challenge of individualizing treatments for patients with breast cancer. JAMA. 2012;307(13):1379-1380. 2. Wennberg DE, Marr A, Lang L, O’Malley S, Bennett G. A randomized trial of a telephone care-management strategy. N Engl J Med. 2010;363(13):1245-1255. 3. Veroff D, Marr A, Wennberg DE. Enhanced support for shared decision making reduced costs of care for patients with preference-sensitive conditions. Health Aff (Millwood). 2013;32(2):285-293. 4. Hawley ST, Griggs JJ, Hamilton AS, et al. Decision involvement and receipt of mastectomy among racially and ethnically diverse breast cancer patients. J Natl Cancer Inst. 2009;101(19):1337-1347. 5. Katz SJ, Lantz PM, Janz NK, et al. Patient involvement in surgery treatment decisions for breast cancer. J Clin Oncol. 2005;23(24):5526-5533. 6. Katz SJ, Hawley ST. From policy to patients and back: surgical treatment decision making for patients with breast cancer. Health Aff (Millwood). 2007;26(3):761-769.
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]. Section Editor: Jody W. Zylke, MD, Senior Editor.
JAMA February 26, 2014 Volume 311, Number 8
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a Western Oregon University User on 05/29/2015
jama.com
enrolled participants as young as 40 to 50 years as trials of elderly patients.6 Nonetheless, most of the outcome studies are of low quality and have been with atenolol. There have been no outcome studies involving vasodilating β-blockers (eg, nebivolol). Although Cruickshank is correct in stating that the benefit of β-blockers vs placebo may be reduced by smoking, α-blockers (eg, carvedilol) seem to maintain antihypertensive efficacy in smokers. However, there are no outcome studies involving α-blockers. Much work remains to be done to provide high-quality decisive data on the role of sympathetic inhibition in hypertension therapy. We must emphasize, however, that while the use of global evidence from up-to-date systematic reviews of randomized clinical trials is indispensable in hypertension therapy, the choice of initial and add-on drugs for any given patient with hypertension should also take the patient’s clinical characteristics, circumstances, values, and preferences into consideration. Lionel H. Opie, MD, DPhil Charles S. Wiysonge, MD, PhD Author Affiliations: Hatter Institute for Cardiovascular Research in Africa, University of Cape Town Medical School, Cape Town, South Africa (Opie); Centre for Evidence-Based Health Care, Stellenbosch University, Cape Town, South Africa (Wiysonge). Corresponding Author: Charles S. Wiysonge, MD, PhD, Centre for Evidence-Based Health Care, Stellenbosch University, Cape Town 7505, South Africa ([email protected]). Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Drs Opie and Wiysonge reported receiving grant funding from the National Research Foundation of South Africa. 1. Smithwick RH. An evaluation of the surgical treatment of hypertension. Bull N Y Acad Med. 1949;25(11):698-716. 2. Dahlöf B, Sever PS, Poulter NR, et al; ASCOT Investigators. Prevention of cardiovascular events with an antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bendroflumethiazide as required, in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA): a multicentre randomised controlled trial. Lancet. 2005;366(9489):895-906. 3. Jennings GL. Recent clinical trials of hypertension management. Hypertension. 2013;62(1):3-7. 4. ESH/ESC Task Force for the Management of Arterial Hypertension. 2013 practice guidelines for the management of arterial hypertension of the European Society of Hypertension (ESH) and the European Society of Cardiology (ESC): ESH/ESC Task Force for the Management of Arterial Hypertension. J Hypertens. 2013;31(10):1925-1938.
decision making on medical costs and use is inadequate. In their review of a randomized trial of shared decision making by 2 of us,2,3 they suggested that the large observed decreases in medical and surgical admissions and the associated reduction in costs in the intervention group were a result of cliniciandirected decisions rather than patient involvement. However, the unit of randomization was the patient. In a randomized trial of more than 170 000 individuals, patients in the intervention group were unlikely to have systematically interacted with clinicians who were practicing better ambulatory care. The trial measured differences resulting from supporting patient involvement in discussions with physicians and demonstrated significant differences in rates of patient support. Physicians were participants, but differences in the 2 study groups could only come from influencing patients. Furthermore, quality of care did not drive the differences: no differences were found between the 2 groups in typical quality of care measures, including medication adherence. More broadly, a fundamental tenet of shared decision making is that physicians and patients share in the decision. Focusing on who influences the decision more misses the point; when shared decision making is incorporated into clinical encounters, rates of treatments are systematically affected.4 We support additional research into how best to incorporate shared decision making into practitioner workflow and how preferences may vary over time (among other research needs). However, physicians cannot wait until shared decision making is more completely understood to incorporate the value set of including patients. In addition, Katz and Hawley’s example of breast cancer (“up to 20% of patients may ultimately have a clinical contraindication to breast-conserving surgery … ”) might suggest that the preferences of the other 80% do not need to be understood. However, part of any well-designed shared decision making effort is to consider only the options that are reasonable for patients in their specific situations. David R. Veroff, MPP John D. Birkmeyer, MD David E. Wennberg, MD, MPH Author Affiliations: Health Dialog, Boston, Massachusetts (Veroff); University of Michigan Health System, Ann Arbor (Birkmeyer); Northern New England Accountable Care Collaborative, Portland, Maine (Wennberg). Corresponding Author: David R. Veroff, MPP, Health Dialog, 60 State St, Ste 1000, Boston, MA 02109 ([email protected]).
5. James PA, Oparil S, Carter BL, et al. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. doi:10.1001/jama.2013.284427.
Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Wennberg reported receiving royalty payments from Health Dialog. No other disclosures were reported.
6. Wiysonge CS, Bradley HA, Volmink J, Mayosi BM, Mbewu A, Opie LH. Beta-blockers for hypertension. Cochrane Database Syst Rev. 2012;11:CD002003.
1. Katz SJ, Hawley S. The value of sharing treatment decision making with patients: expecting too much? JAMA. 2013;310(15):1559-1560.
Patient-Physician Shared Decision Making To the Editor We believe that the Viewpoint by Drs Katz and Hawley1 on shared decision making inaccurately states its premise and misrepresents the evidence about its effects. Katz and Hawley’s position is that the evidence for the effect of shared
2. Wennberg DE, Marr A, Lang L, O’Malley S, Bennett G. A randomized trial of a telephone care-management strategy. N Engl J Med. 2010;363(13):1245-1255. 3. Veroff D, Marr A, Wennberg DE. Enhanced support for shared decision making reduced costs of care for patients with preference-sensitive conditions. Health Aff (Millwood). 2013;32(2):285-293. 4. 2013 International Shared Decision Making Conference. Cochrane review of patient decision aids for treatment or screening decisions: update in 2012 reveals 24 new trials for 110 total [abstract]. http://isdm2013.org/files/2012/05 /ABSTRACT_GUIDE1.pdf. Accessed September 29, 2013.
jama.com
JAMA February 26, 2014 Volume 311, Number 8
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a Western Oregon University User on 05/29/2015
863
Letters
In Reply Similar to Mr Veroff and colleagues, we are strong proponents of shared decision making between clinicians and their patients, including incorporating values and preferences into treatment decisions. We lead a research program funded by the National Cancer Institute to address better ways to do this, including developing and evaluating new patient-centered deliberation tools.1 However, in our Viewpoint we concluded that the literature does not support the role of shared decision making in reducing overtreatment and medical cost inflation. We established that there were important flaws in a frequently cited Cochrane meta-analysis that suggested that patient decision aids were associated with less extensive surgical treatment. The letter from Veroff and colleagues further highlights the challenges of disentangling patient vs clinician influences on utilization in studies assessing the effect of shared decision making on cost and treatment patterns. The study by Wennberg et al2 was a randomized clinical trial of a telephone-based case management program led by clinical nurses, pharmacists, and other allied health practitioners. The intervention was associated with lower costs through reductions in hospital admissions. Whether the effect was the result of clinician team–directed decisions (eg, better medication management or more effective outpatient management) vs patient and family influences on decision making could not be addressed because no measures of communication or decision making were reported in the study. Despite the statement by Veroff and colleagues, no patient medication adherence measures were reported in either of the cited studies.2,3 This underscores the need to incorporate more granular measures of treatment communication and decision making into studies aimed at evaluating strategies to reduce overtreatment and costs. The fact that the unit of randomization in the study was the patient does not address the mechanism by which the case management program worked to reduce hospitalizations. This would have required measuring key mediators of the association of the intervention with the outcome. Our evidence-based example of surgical treatment decision making for breast cancer illustrates that more patient influence on decision making may yield more extensive surgery.4,5 Ironically, surgical treatment for breast cancer has been frequently cited as an example of a preference-sensitive condition in which more shared decision making could reduce overtreatment. This highlights the need to avoid blanket assumptions about the consequences of increasing shared decision making on treatment decisions.6 We agree with Veroff and colleagues that there are compelling reasons to act now to increase shared decision making in clinical encounters. There is strong evidence that increasing shared decision making can improve the patient
864
experience in clinical encounters and increase decision effectiveness. But there is no compelling evidence that shared decision making should be promoted as a strategy for reducing overtreatment and medical cost inflation. Steven J. Katz, MD, MPH Sarah Hawley, PhD Author Affiliations: Department of Medicine, University of Michigan, Ann Arbor. Corresponding Author: Steven J. Katz, MD, MPH, University of Michigan, 2800 Plymouth Rd, North Campus Research Complex, Bldg 16, Room 430W, Ann Arbor, MI 48109 ([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. 1. Katz SJ, Morrow M. The challenge of individualizing treatments for patients with breast cancer. JAMA. 2012;307(13):1379-1380. 2. Wennberg DE, Marr A, Lang L, O’Malley S, Bennett G. A randomized trial of a telephone care-management strategy. N Engl J Med. 2010;363(13):1245-1255. 3. Veroff D, Marr A, Wennberg DE. Enhanced support for shared decision making reduced costs of care for patients with preference-sensitive conditions. Health Aff (Millwood). 2013;32(2):285-293. 4. Hawley ST, Griggs JJ, Hamilton AS, et al. Decision involvement and receipt of mastectomy among racially and ethnically diverse breast cancer patients. J Natl Cancer Inst. 2009;101(19):1337-1347. 5. Katz SJ, Lantz PM, Janz NK, et al. Patient involvement in surgery treatment decisions for breast cancer. J Clin Oncol. 2005;23(24):5526-5533. 6. Katz SJ, Hawley ST. From policy to patients and back: surgical treatment decision making for patients with breast cancer. Health Aff (Millwood). 2007;26(3):761-769.
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]. Section Editor: Jody W. Zylke, MD, Senior Editor.
JAMA February 26, 2014 Volume 311, Number 8
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a Western Oregon University User on 05/29/2015
jama.com
