Clinical question: Does therapeutic anticoagulation of isolated calf deep vein thrombosis (DVT) decrease risk for proximal DVT or PE?

Background: Optimal management of isolated calf DVT lacks consensus.

Study design: Single-center, retrospective, cohort study.

Setting: Large academic hospital.

Nevertheless, 9.2% of control patients and 3.3% of exposure patients developed a proximal DVT or PE. The anticoagulation group was associated with lower likelihood of proximal DVT or PE (risk ratio 0.36; 95% CI, 0.15-0.84) but an increased risk of bleeding (8.6%), compared with the nonexposure group (2.2%). Sensitivity analysis did not alter the observed association.

Bottom line: Therapeutic anticoagulation for isolated calf DVT may be warranted to decrease the risk for proximal DVT or PE but with an increased risk of bleeding. Randomized trials are needed to clarify the risk versus benefit.

Citation: Utter GH, Dhillon TS, Salcedo ES, et al. Therapeutic anticoagulation for isolated calf deep vein thrombosis. JAMA Surg. 2016;151(9):e161770. doi: 10.1001/jamasurg.2016.1770.


Dr. Zuleta is an assistant professor and associate program director of the Jackson Memorial/University of Miami Internal Medicine residency training program and the site director of the program at University of Miami Hospital.

Clinical question: Does therapeutic anticoagulation of isolated calf deep vein thrombosis (DVT) decrease risk for proximal DVT or PE?

Background: Optimal management of isolated calf DVT lacks consensus.

Study design: Single-center, retrospective, cohort study.

Setting: Large academic hospital.

Nevertheless, 9.2% of control patients and 3.3% of exposure patients developed a proximal DVT or PE. The anticoagulation group was associated with lower likelihood of proximal DVT or PE (risk ratio 0.36; 95% CI, 0.15-0.84) but an increased risk of bleeding (8.6%), compared with the nonexposure group (2.2%). Sensitivity analysis did not alter the observed association.

Bottom line: Therapeutic anticoagulation for isolated calf DVT may be warranted to decrease the risk for proximal DVT or PE but with an increased risk of bleeding. Randomized trials are needed to clarify the risk versus benefit.

Citation: Utter GH, Dhillon TS, Salcedo ES, et al. Therapeutic anticoagulation for isolated calf deep vein thrombosis. JAMA Surg. 2016;151(9):e161770. doi: 10.1001/jamasurg.2016.1770.


Dr. Zuleta is an assistant professor and associate program director of the Jackson Memorial/University of Miami Internal Medicine residency training program and the site director of the program at University of Miami Hospital.

Clinical question: Does therapeutic anticoagulation of isolated calf deep vein thrombosis (DVT) decrease risk for proximal DVT or PE?

Background: Optimal management of isolated calf DVT lacks consensus.

Study design: Single-center, retrospective, cohort study.

Setting: Large academic hospital.

Nevertheless, 9.2% of control patients and 3.3% of exposure patients developed a proximal DVT or PE. The anticoagulation group was associated with lower likelihood of proximal DVT or PE (risk ratio 0.36; 95% CI, 0.15-0.84) but an increased risk of bleeding (8.6%), compared with the nonexposure group (2.2%). Sensitivity analysis did not alter the observed association.

Bottom line: Therapeutic anticoagulation for isolated calf DVT may be warranted to decrease the risk for proximal DVT or PE but with an increased risk of bleeding. Randomized trials are needed to clarify the risk versus benefit.

Citation: Utter GH, Dhillon TS, Salcedo ES, et al. Therapeutic anticoagulation for isolated calf deep vein thrombosis. JAMA Surg. 2016;151(9):e161770. doi: 10.1001/jamasurg.2016.1770.


Dr. Zuleta is an assistant professor and associate program director of the Jackson Memorial/University of Miami Internal Medicine residency training program and the site director of the program at University of Miami Hospital.

Most surgeons today are familiar with professional burnout – in their colleagues, in surgical trainees, and perhaps, in themselves. But the understanding of burnout is evolving.  The discussion is moving away from blaming physicians for their poor coping skills toward identifying the structural and organizational roots of burnout.

Burnout is a syndrome cause by work-related stress that features emotional exhaustion, depersonalization, and a decreased sense of personal accomplishment. A recent study of nearly 7,000 physicians using the Maslach Burnout Inventory found that 54.4% of those surveyed reported at least one symptom of burnout (Mayo Clin Proc. 2015 Dec;90[12]:1600-19). Other studies have found similar rates of burnout in the surgical specialties such as orthopedic, oncologic, cardiothoracic, and plastic surgery (JAMA Surg. 2014 Sep;149:948-53; Ann Surg Oncol 2011 May;18:1229-35; Internat J Cardiol. 2015 Jan 20;179:7-72; Aesthet Surg J. 2016 Sep 27. E-pub ahead of print).

Courtesy Mayo Clinic

A new paradigm of burnout

The paradigm of burnout as a personal issue that can be managed by individual coping strategies is giving way to an understanding that the structural roots of burnout require the shared responsibility of individuals and their work organizations to solve the problem. A revised approach has emerged: Physician burnout as a symptom not of personal failure to cope, but of institutional failure to adapt to new circumstances in the health care milieu. The growing number of physicians employed in large group practices and medical centers has come with a whole array of management problems that are only beginning to be recognized, and burnout may be one of the most challenging.

Tait D. Shanafelt, MD, of the Mayo Foundation for Medical Education and Research, and John H. Noseworthy, MD, president and CEO of the Mayo Clinic, both in Rochester, Minn., have partnered to distill years of study and practice on the issue of burnout to a set of organizational strategies to tackle the problem and describe the Mayo Clinic experience. The study, “Executive Leadership and Physician Well-Being: Nine Organizational Strategies to Promote Engagement and Reduce Burnout” (Mayo Clin Proc. 2016 Nov 18. doi. org/10.1016/j.mayocp.2016.10.004) reverses the conventional “blame the victim” approach and identifies instead institutional responsibility to address burnout.

“Increasing evidence over the last 10 years demonstrating links to quality of care, productivity, and turnover have raised appreciation … by organizations that they have a substantial stake in this issue and that they control many of the factors that contribute to this problem,” said Dr. Shanafelt in an interview.

Unintended consequences of the individual solution

The focus on individual responsibility can have unintended consequences. A physician suffering from burnout can take action by leaving his or her job or cutting back. Staff turnover, a phenomenon closely tied to burnout, is costly and damaging to productivity and patient care (Physician Leadersh J. 2015 May-Jun;2[3]:22-5); Health Care Manage Rev. 2004;29[1]2-7). These personal strategies may help individuals cope but can end up harming the institution and the work life of other staff members. Physicians experiencing burnout in their own lives can trigger the same condition in their colleagues.

The Mayo paper by Dr. Shanafelt and Dr. Noseworthy states, “Mistakenly, most hospitals, medical centers, and practice groups operate under the framework that burnout and professional satisfaction are solely the responsibility of the individual physician. This frequently results in organizations pursuing a narrow list of ‘solutions’ that are unlikely to result in meaningful progress (e.g., stress management workshops and individual training in mindfulness/resilience). Such strategies neglect the organizational factors that are the primary drivers of physician burnout and are correctly viewed with skepticism by physicians as an insincere effort by the organization to address the problem.”

Organizational strategies to reduce burnout

Dr. Shanafelt and Dr. Noseworthy developed a list of nine organizational strategies that have been shown to reduce burnout among doctors. A critical piece of this approach is the accumulated evidence of the financial burden of burnout among physicians in health care institutions. The approach is based on an informed leadership that recognizes the costs of inaction, without which a systemic solution is unlikely to be achieved.

1. Naming the issue and assessing the problem

Acknowledgment of burnout as an institutional problem and meaningful measurement of physician well-being are the initial steps in tackling the problem. This requires a sincere commitment at the highest level of management to listen and to recognize what staff physicians are saying. “At Mayo Clinic, we have incorporated town halls, radio broadcasts, letters, and video interviews along with face-to-face meetings involving clinical divisions, work units, and small groups as formats or [by using] the CEO to reach the staff.” Assessing physician well-being and quality of work life using one or more of the many available tools has to be an ongoing “a barometer of organization health,” and not just a one-off, crisis management activity.

2. Harnessing the power of leadership

Studies have found that management behaviors and strategies of supervisors are key components of physician well-being. The bottom line is that physician supervisors must accept a share of responsibility for burnout in those they manage. Leaders can be chosen on the basis of their ability to listen, engage, develop, and lead, and but they can also be trained to improve. In addition, leaders should be regularly assessed by those whom they lead. Dr. Shanafelt and Dr. Noseworthy argue that a crucial element of successful leadership involves recognizing unique interests and talents of individual physicians whom they manage and facilitating professional development so that each staff member spends about 20% of work time engaged in activities that he or she finds most meaningful.

3. Developing targeted interventions

Just as all politics is local, the study suggests that many sources of burnout are local as well. For example, although a high clerical burden on physicians may be a universal driver of burnout, it manifests differently in each institutional setting. The key here is to dig into the specific structural driver at the unit or ward level, engage physicians in analysis and problem-solving, and implement a plan to address the problem.

Dr. Shanafelt noted, “We organize the drivers of engagement and burnout around seven dimensions: workload, efficiency, flexibility/control, community at work, organizational culture and values, work-life integration, and meaning in work. Each of these dimensions has organizational and individual components. Work units should begin by identifying which one or two dimensions are the biggest challenges for the group and then begin a stepwise process to address them.”
 

4. Cultivating community at work

Peer support, a long-standing source of strength among surgeons and other physicians, unintentionally has been eroded in many modern medical institutions. There is ample evidence that this loss of collegiality is tied to burnout. “These interactions have been an unintended casualty of increasing productivity expectations, documentation requirements, and clerical burden. [Many organizations have eliminated] formal spaces for physicians to interact (e.g., physicians’ lounge or dining room) without recognizing the important role that this dedicated space played in fostering interpersonal connections among physicians.” The Mayo Clinic and other institutions are reversing this trend by creating dedicated physician rooms for breaks, snacks, and a venue for peer interaction and camaraderie.

5. Rethinking rewards and incentives

Compensation is now commonly linked to productivity in many health care organizations, but this approach has some profound drawbacks: It can lead to physician burnout. Incentive structures based on patient satisfaction and quality metrics can have similar unintended consequences. All these incentive structures can combine to drive physicians to overwork. “Physicians may be particularly vulnerable to overwork due to high levels of education debt, their desire to ‘do everything for their patients,’ unhealthy role modeling by colleagues, and normalization of extreme work hours during the training process.” The investigators do not claim to have the ultimate answer to the problem of incentives that create unhealthy work patterns, but they argue that it is critical for leaders to recognize the potential unintended consequences of the productivity reward/incentive model and consider strategies to prevent overwork leading to burnout.

6. Aligning values and strengthening culture

The investigators also describe Mayo’s efforts to pursue self-appraisal of alignment of mission, values, and culture. They also describe the regular use of an all-staff survey, which has on occasion yielded candid feedback that, while not always flattering, has been the basis of a profound institutional rethink. The willingness of leadership to be receptive to hard truths from physicians is the foundation of institutional learning about burnout prevention and encourages engagement of the staff.

7. Promoting flexibility and work-life integration

Allowing employees greater flexibility in how and when they work is a management strategy that is gaining ground in many industries. Increasing part-time positions and expanding options for the work day have both been found to help prevent burnout and also help physicians recover from burnout. In addition, “institutions should also comprehensively examine the structure of their vacation benefits, coverage for life events (e.g., birth of a child, illness/death in family), approach to scheduling, and strategy for coverage of nights and weekends. Compensation practices that disincentivize using vacation time are shortsighted and should be eliminated.”

8. Providing resources to promote resilience and self-care

The solutions to burnout have been aimed at the individual and involve stress-reduction training and other personal management strategies. A metastudy of the interventions mentions psychoeducation, counseling, wellness management, interpersonal communication, and mindfulness meditation (J Nerv Ment Dis. 2014 May;202:353-9). But without concomitant structural reform, these individual solutions can backfire. “When individually focused offerings are not coupled with sincere efforts to address the system-based issues contributing to burnout, this approach is typically met with skepticism and resistance by physicians (‘They are implying I am the problem’). In this context, the response to well-intentioned ‘resilience training’ is frequently a cynical one (‘You only want to make me more resilient so you can further increase my workload’).”

9. Funding organizational research

Organizational science is a well-developed field of study. But cutting-edge management models such as the learning organization, participatory management, and collaborative action planning have been slow in coming to health care institutions. Dr. Shanafelt and Dr. Noseworthy argue that “vanguard institutions” such as the Mayo Clinic (which began its Program on Physician Well-Being in 2008), Stanford (Calif.) University, and other innovative institutions have the responsibility of developing evidence-based strategies to combat burnout that smaller institutions can implement.

Burnout among physicians is now on the radar of leadership in many health care institutions. Evidence on the cost and consequences is accumulating, and it becoming increasingly difficult to ignore what is happening to many physicians. Dr. Shanafelt projected an increasing need for operational solutions at the organizational level to address the problem. He said, “We need evidence to guide organizations to implement changes that truly make a difference, not well-intentioned but ineffective programs. Now that organizations recognize the strong business case, they are ready to invest resources to address this issue but they need to know it is money well spent and that there is an evidence-base to justify the investment.”
 

[email protected]

Most surgeons today are familiar with professional burnout – in their colleagues, in surgical trainees, and perhaps, in themselves. But the understanding of burnout is evolving.  The discussion is moving away from blaming physicians for their poor coping skills toward identifying the structural and organizational roots of burnout.

Burnout is a syndrome cause by work-related stress that features emotional exhaustion, depersonalization, and a decreased sense of personal accomplishment. A recent study of nearly 7,000 physicians using the Maslach Burnout Inventory found that 54.4% of those surveyed reported at least one symptom of burnout (Mayo Clin Proc. 2015 Dec;90[12]:1600-19). Other studies have found similar rates of burnout in the surgical specialties such as orthopedic, oncologic, cardiothoracic, and plastic surgery (JAMA Surg. 2014 Sep;149:948-53; Ann Surg Oncol 2011 May;18:1229-35; Internat J Cardiol. 2015 Jan 20;179:7-72; Aesthet Surg J. 2016 Sep 27. E-pub ahead of print).

Courtesy Mayo Clinic

A new paradigm of burnout

The paradigm of burnout as a personal issue that can be managed by individual coping strategies is giving way to an understanding that the structural roots of burnout require the shared responsibility of individuals and their work organizations to solve the problem. A revised approach has emerged: Physician burnout as a symptom not of personal failure to cope, but of institutional failure to adapt to new circumstances in the health care milieu. The growing number of physicians employed in large group practices and medical centers has come with a whole array of management problems that are only beginning to be recognized, and burnout may be one of the most challenging.

Tait D. Shanafelt, MD, of the Mayo Foundation for Medical Education and Research, and John H. Noseworthy, MD, president and CEO of the Mayo Clinic, both in Rochester, Minn., have partnered to distill years of study and practice on the issue of burnout to a set of organizational strategies to tackle the problem and describe the Mayo Clinic experience. The study, “Executive Leadership and Physician Well-Being: Nine Organizational Strategies to Promote Engagement and Reduce Burnout” (Mayo Clin Proc. 2016 Nov 18. doi. org/10.1016/j.mayocp.2016.10.004) reverses the conventional “blame the victim” approach and identifies instead institutional responsibility to address burnout.

“Increasing evidence over the last 10 years demonstrating links to quality of care, productivity, and turnover have raised appreciation … by organizations that they have a substantial stake in this issue and that they control many of the factors that contribute to this problem,” said Dr. Shanafelt in an interview.

Unintended consequences of the individual solution

The focus on individual responsibility can have unintended consequences. A physician suffering from burnout can take action by leaving his or her job or cutting back. Staff turnover, a phenomenon closely tied to burnout, is costly and damaging to productivity and patient care (Physician Leadersh J. 2015 May-Jun;2[3]:22-5); Health Care Manage Rev. 2004;29[1]2-7). These personal strategies may help individuals cope but can end up harming the institution and the work life of other staff members. Physicians experiencing burnout in their own lives can trigger the same condition in their colleagues.

The Mayo paper by Dr. Shanafelt and Dr. Noseworthy states, “Mistakenly, most hospitals, medical centers, and practice groups operate under the framework that burnout and professional satisfaction are solely the responsibility of the individual physician. This frequently results in organizations pursuing a narrow list of ‘solutions’ that are unlikely to result in meaningful progress (e.g., stress management workshops and individual training in mindfulness/resilience). Such strategies neglect the organizational factors that are the primary drivers of physician burnout and are correctly viewed with skepticism by physicians as an insincere effort by the organization to address the problem.”

Organizational strategies to reduce burnout

Dr. Shanafelt and Dr. Noseworthy developed a list of nine organizational strategies that have been shown to reduce burnout among doctors. A critical piece of this approach is the accumulated evidence of the financial burden of burnout among physicians in health care institutions. The approach is based on an informed leadership that recognizes the costs of inaction, without which a systemic solution is unlikely to be achieved.

1. Naming the issue and assessing the problem

Acknowledgment of burnout as an institutional problem and meaningful measurement of physician well-being are the initial steps in tackling the problem. This requires a sincere commitment at the highest level of management to listen and to recognize what staff physicians are saying. “At Mayo Clinic, we have incorporated town halls, radio broadcasts, letters, and video interviews along with face-to-face meetings involving clinical divisions, work units, and small groups as formats or [by using] the CEO to reach the staff.” Assessing physician well-being and quality of work life using one or more of the many available tools has to be an ongoing “a barometer of organization health,” and not just a one-off, crisis management activity.

2. Harnessing the power of leadership

Studies have found that management behaviors and strategies of supervisors are key components of physician well-being. The bottom line is that physician supervisors must accept a share of responsibility for burnout in those they manage. Leaders can be chosen on the basis of their ability to listen, engage, develop, and lead, and but they can also be trained to improve. In addition, leaders should be regularly assessed by those whom they lead. Dr. Shanafelt and Dr. Noseworthy argue that a crucial element of successful leadership involves recognizing unique interests and talents of individual physicians whom they manage and facilitating professional development so that each staff member spends about 20% of work time engaged in activities that he or she finds most meaningful.

3. Developing targeted interventions

Just as all politics is local, the study suggests that many sources of burnout are local as well. For example, although a high clerical burden on physicians may be a universal driver of burnout, it manifests differently in each institutional setting. The key here is to dig into the specific structural driver at the unit or ward level, engage physicians in analysis and problem-solving, and implement a plan to address the problem.

Dr. Shanafelt noted, “We organize the drivers of engagement and burnout around seven dimensions: workload, efficiency, flexibility/control, community at work, organizational culture and values, work-life integration, and meaning in work. Each of these dimensions has organizational and individual components. Work units should begin by identifying which one or two dimensions are the biggest challenges for the group and then begin a stepwise process to address them.”
 

4. Cultivating community at work

Peer support, a long-standing source of strength among surgeons and other physicians, unintentionally has been eroded in many modern medical institutions. There is ample evidence that this loss of collegiality is tied to burnout. “These interactions have been an unintended casualty of increasing productivity expectations, documentation requirements, and clerical burden. [Many organizations have eliminated] formal spaces for physicians to interact (e.g., physicians’ lounge or dining room) without recognizing the important role that this dedicated space played in fostering interpersonal connections among physicians.” The Mayo Clinic and other institutions are reversing this trend by creating dedicated physician rooms for breaks, snacks, and a venue for peer interaction and camaraderie.

5. Rethinking rewards and incentives

Compensation is now commonly linked to productivity in many health care organizations, but this approach has some profound drawbacks: It can lead to physician burnout. Incentive structures based on patient satisfaction and quality metrics can have similar unintended consequences. All these incentive structures can combine to drive physicians to overwork. “Physicians may be particularly vulnerable to overwork due to high levels of education debt, their desire to ‘do everything for their patients,’ unhealthy role modeling by colleagues, and normalization of extreme work hours during the training process.” The investigators do not claim to have the ultimate answer to the problem of incentives that create unhealthy work patterns, but they argue that it is critical for leaders to recognize the potential unintended consequences of the productivity reward/incentive model and consider strategies to prevent overwork leading to burnout.

6. Aligning values and strengthening culture

The investigators also describe Mayo’s efforts to pursue self-appraisal of alignment of mission, values, and culture. They also describe the regular use of an all-staff survey, which has on occasion yielded candid feedback that, while not always flattering, has been the basis of a profound institutional rethink. The willingness of leadership to be receptive to hard truths from physicians is the foundation of institutional learning about burnout prevention and encourages engagement of the staff.

7. Promoting flexibility and work-life integration

Allowing employees greater flexibility in how and when they work is a management strategy that is gaining ground in many industries. Increasing part-time positions and expanding options for the work day have both been found to help prevent burnout and also help physicians recover from burnout. In addition, “institutions should also comprehensively examine the structure of their vacation benefits, coverage for life events (e.g., birth of a child, illness/death in family), approach to scheduling, and strategy for coverage of nights and weekends. Compensation practices that disincentivize using vacation time are shortsighted and should be eliminated.”

8. Providing resources to promote resilience and self-care

The solutions to burnout have been aimed at the individual and involve stress-reduction training and other personal management strategies. A metastudy of the interventions mentions psychoeducation, counseling, wellness management, interpersonal communication, and mindfulness meditation (J Nerv Ment Dis. 2014 May;202:353-9). But without concomitant structural reform, these individual solutions can backfire. “When individually focused offerings are not coupled with sincere efforts to address the system-based issues contributing to burnout, this approach is typically met with skepticism and resistance by physicians (‘They are implying I am the problem’). In this context, the response to well-intentioned ‘resilience training’ is frequently a cynical one (‘You only want to make me more resilient so you can further increase my workload’).”

9. Funding organizational research

Organizational science is a well-developed field of study. But cutting-edge management models such as the learning organization, participatory management, and collaborative action planning have been slow in coming to health care institutions. Dr. Shanafelt and Dr. Noseworthy argue that “vanguard institutions” such as the Mayo Clinic (which began its Program on Physician Well-Being in 2008), Stanford (Calif.) University, and other innovative institutions have the responsibility of developing evidence-based strategies to combat burnout that smaller institutions can implement.

Burnout among physicians is now on the radar of leadership in many health care institutions. Evidence on the cost and consequences is accumulating, and it becoming increasingly difficult to ignore what is happening to many physicians. Dr. Shanafelt projected an increasing need for operational solutions at the organizational level to address the problem. He said, “We need evidence to guide organizations to implement changes that truly make a difference, not well-intentioned but ineffective programs. Now that organizations recognize the strong business case, they are ready to invest resources to address this issue but they need to know it is money well spent and that there is an evidence-base to justify the investment.”
 

[email protected]

Most surgeons today are familiar with professional burnout – in their colleagues, in surgical trainees, and perhaps, in themselves. But the understanding of burnout is evolving.  The discussion is moving away from blaming physicians for their poor coping skills toward identifying the structural and organizational roots of burnout.

Burnout is a syndrome cause by work-related stress that features emotional exhaustion, depersonalization, and a decreased sense of personal accomplishment. A recent study of nearly 7,000 physicians using the Maslach Burnout Inventory found that 54.4% of those surveyed reported at least one symptom of burnout (Mayo Clin Proc. 2015 Dec;90[12]:1600-19). Other studies have found similar rates of burnout in the surgical specialties such as orthopedic, oncologic, cardiothoracic, and plastic surgery (JAMA Surg. 2014 Sep;149:948-53; Ann Surg Oncol 2011 May;18:1229-35; Internat J Cardiol. 2015 Jan 20;179:7-72; Aesthet Surg J. 2016 Sep 27. E-pub ahead of print).

Courtesy Mayo Clinic

A new paradigm of burnout

The paradigm of burnout as a personal issue that can be managed by individual coping strategies is giving way to an understanding that the structural roots of burnout require the shared responsibility of individuals and their work organizations to solve the problem. A revised approach has emerged: Physician burnout as a symptom not of personal failure to cope, but of institutional failure to adapt to new circumstances in the health care milieu. The growing number of physicians employed in large group practices and medical centers has come with a whole array of management problems that are only beginning to be recognized, and burnout may be one of the most challenging.

Tait D. Shanafelt, MD, of the Mayo Foundation for Medical Education and Research, and John H. Noseworthy, MD, president and CEO of the Mayo Clinic, both in Rochester, Minn., have partnered to distill years of study and practice on the issue of burnout to a set of organizational strategies to tackle the problem and describe the Mayo Clinic experience. The study, “Executive Leadership and Physician Well-Being: Nine Organizational Strategies to Promote Engagement and Reduce Burnout” (Mayo Clin Proc. 2016 Nov 18. doi. org/10.1016/j.mayocp.2016.10.004) reverses the conventional “blame the victim” approach and identifies instead institutional responsibility to address burnout.

“Increasing evidence over the last 10 years demonstrating links to quality of care, productivity, and turnover have raised appreciation … by organizations that they have a substantial stake in this issue and that they control many of the factors that contribute to this problem,” said Dr. Shanafelt in an interview.

Unintended consequences of the individual solution

The focus on individual responsibility can have unintended consequences. A physician suffering from burnout can take action by leaving his or her job or cutting back. Staff turnover, a phenomenon closely tied to burnout, is costly and damaging to productivity and patient care (Physician Leadersh J. 2015 May-Jun;2[3]:22-5); Health Care Manage Rev. 2004;29[1]2-7). These personal strategies may help individuals cope but can end up harming the institution and the work life of other staff members. Physicians experiencing burnout in their own lives can trigger the same condition in their colleagues.

The Mayo paper by Dr. Shanafelt and Dr. Noseworthy states, “Mistakenly, most hospitals, medical centers, and practice groups operate under the framework that burnout and professional satisfaction are solely the responsibility of the individual physician. This frequently results in organizations pursuing a narrow list of ‘solutions’ that are unlikely to result in meaningful progress (e.g., stress management workshops and individual training in mindfulness/resilience). Such strategies neglect the organizational factors that are the primary drivers of physician burnout and are correctly viewed with skepticism by physicians as an insincere effort by the organization to address the problem.”

Organizational strategies to reduce burnout

Dr. Shanafelt and Dr. Noseworthy developed a list of nine organizational strategies that have been shown to reduce burnout among doctors. A critical piece of this approach is the accumulated evidence of the financial burden of burnout among physicians in health care institutions. The approach is based on an informed leadership that recognizes the costs of inaction, without which a systemic solution is unlikely to be achieved.

1. Naming the issue and assessing the problem

Acknowledgment of burnout as an institutional problem and meaningful measurement of physician well-being are the initial steps in tackling the problem. This requires a sincere commitment at the highest level of management to listen and to recognize what staff physicians are saying. “At Mayo Clinic, we have incorporated town halls, radio broadcasts, letters, and video interviews along with face-to-face meetings involving clinical divisions, work units, and small groups as formats or [by using] the CEO to reach the staff.” Assessing physician well-being and quality of work life using one or more of the many available tools has to be an ongoing “a barometer of organization health,” and not just a one-off, crisis management activity.

2. Harnessing the power of leadership

Studies have found that management behaviors and strategies of supervisors are key components of physician well-being. The bottom line is that physician supervisors must accept a share of responsibility for burnout in those they manage. Leaders can be chosen on the basis of their ability to listen, engage, develop, and lead, and but they can also be trained to improve. In addition, leaders should be regularly assessed by those whom they lead. Dr. Shanafelt and Dr. Noseworthy argue that a crucial element of successful leadership involves recognizing unique interests and talents of individual physicians whom they manage and facilitating professional development so that each staff member spends about 20% of work time engaged in activities that he or she finds most meaningful.

3. Developing targeted interventions

Just as all politics is local, the study suggests that many sources of burnout are local as well. For example, although a high clerical burden on physicians may be a universal driver of burnout, it manifests differently in each institutional setting. The key here is to dig into the specific structural driver at the unit or ward level, engage physicians in analysis and problem-solving, and implement a plan to address the problem.

Dr. Shanafelt noted, “We organize the drivers of engagement and burnout around seven dimensions: workload, efficiency, flexibility/control, community at work, organizational culture and values, work-life integration, and meaning in work. Each of these dimensions has organizational and individual components. Work units should begin by identifying which one or two dimensions are the biggest challenges for the group and then begin a stepwise process to address them.”
 

4. Cultivating community at work

Peer support, a long-standing source of strength among surgeons and other physicians, unintentionally has been eroded in many modern medical institutions. There is ample evidence that this loss of collegiality is tied to burnout. “These interactions have been an unintended casualty of increasing productivity expectations, documentation requirements, and clerical burden. [Many organizations have eliminated] formal spaces for physicians to interact (e.g., physicians’ lounge or dining room) without recognizing the important role that this dedicated space played in fostering interpersonal connections among physicians.” The Mayo Clinic and other institutions are reversing this trend by creating dedicated physician rooms for breaks, snacks, and a venue for peer interaction and camaraderie.

5. Rethinking rewards and incentives

Compensation is now commonly linked to productivity in many health care organizations, but this approach has some profound drawbacks: It can lead to physician burnout. Incentive structures based on patient satisfaction and quality metrics can have similar unintended consequences. All these incentive structures can combine to drive physicians to overwork. “Physicians may be particularly vulnerable to overwork due to high levels of education debt, their desire to ‘do everything for their patients,’ unhealthy role modeling by colleagues, and normalization of extreme work hours during the training process.” The investigators do not claim to have the ultimate answer to the problem of incentives that create unhealthy work patterns, but they argue that it is critical for leaders to recognize the potential unintended consequences of the productivity reward/incentive model and consider strategies to prevent overwork leading to burnout.

6. Aligning values and strengthening culture

The investigators also describe Mayo’s efforts to pursue self-appraisal of alignment of mission, values, and culture. They also describe the regular use of an all-staff survey, which has on occasion yielded candid feedback that, while not always flattering, has been the basis of a profound institutional rethink. The willingness of leadership to be receptive to hard truths from physicians is the foundation of institutional learning about burnout prevention and encourages engagement of the staff.

7. Promoting flexibility and work-life integration

Allowing employees greater flexibility in how and when they work is a management strategy that is gaining ground in many industries. Increasing part-time positions and expanding options for the work day have both been found to help prevent burnout and also help physicians recover from burnout. In addition, “institutions should also comprehensively examine the structure of their vacation benefits, coverage for life events (e.g., birth of a child, illness/death in family), approach to scheduling, and strategy for coverage of nights and weekends. Compensation practices that disincentivize using vacation time are shortsighted and should be eliminated.”

8. Providing resources to promote resilience and self-care

The solutions to burnout have been aimed at the individual and involve stress-reduction training and other personal management strategies. A metastudy of the interventions mentions psychoeducation, counseling, wellness management, interpersonal communication, and mindfulness meditation (J Nerv Ment Dis. 2014 May;202:353-9). But without concomitant structural reform, these individual solutions can backfire. “When individually focused offerings are not coupled with sincere efforts to address the system-based issues contributing to burnout, this approach is typically met with skepticism and resistance by physicians (‘They are implying I am the problem’). In this context, the response to well-intentioned ‘resilience training’ is frequently a cynical one (‘You only want to make me more resilient so you can further increase my workload’).”

9. Funding organizational research

Organizational science is a well-developed field of study. But cutting-edge management models such as the learning organization, participatory management, and collaborative action planning have been slow in coming to health care institutions. Dr. Shanafelt and Dr. Noseworthy argue that “vanguard institutions” such as the Mayo Clinic (which began its Program on Physician Well-Being in 2008), Stanford (Calif.) University, and other innovative institutions have the responsibility of developing evidence-based strategies to combat burnout that smaller institutions can implement.

Burnout among physicians is now on the radar of leadership in many health care institutions. Evidence on the cost and consequences is accumulating, and it becoming increasingly difficult to ignore what is happening to many physicians. Dr. Shanafelt projected an increasing need for operational solutions at the organizational level to address the problem. He said, “We need evidence to guide organizations to implement changes that truly make a difference, not well-intentioned but ineffective programs. Now that organizations recognize the strong business case, they are ready to invest resources to address this issue but they need to know it is money well spent and that there is an evidence-base to justify the investment.”
 

[email protected]

As third-party payers become stingier and stingier with their payments, it becomes more and more important to hold them accountable for decisions that impact patient care – and your revenue. Physicians have the right to a full and fair appeal review of all rejected and underpaid claims; yet surprisingly, less than 5% of denied dermatology claims are appealed, according to one study.

Many practitioners seem to feel that appeals are simply not worth the time and effort, particularly in a high-volume field such as dermatology; but since the chance that appealing will increase your reimbursement is more than 50%, it is usually well worth the effort – particularly in the current climate of steadily decreasing reimbursements. Furthermore, once insurers become aware that you are scrutinizing your payment statements and challenging all unwarranted rejections, they will be less cavalier in denying legitimate claims.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

As third-party payers become stingier and stingier with their payments, it becomes more and more important to hold them accountable for decisions that impact patient care – and your revenue. Physicians have the right to a full and fair appeal review of all rejected and underpaid claims; yet surprisingly, less than 5% of denied dermatology claims are appealed, according to one study.

Many practitioners seem to feel that appeals are simply not worth the time and effort, particularly in a high-volume field such as dermatology; but since the chance that appealing will increase your reimbursement is more than 50%, it is usually well worth the effort – particularly in the current climate of steadily decreasing reimbursements. Furthermore, once insurers become aware that you are scrutinizing your payment statements and challenging all unwarranted rejections, they will be less cavalier in denying legitimate claims.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

As third-party payers become stingier and stingier with their payments, it becomes more and more important to hold them accountable for decisions that impact patient care – and your revenue. Physicians have the right to a full and fair appeal review of all rejected and underpaid claims; yet surprisingly, less than 5% of denied dermatology claims are appealed, according to one study.

Many practitioners seem to feel that appeals are simply not worth the time and effort, particularly in a high-volume field such as dermatology; but since the chance that appealing will increase your reimbursement is more than 50%, it is usually well worth the effort – particularly in the current climate of steadily decreasing reimbursements. Furthermore, once insurers become aware that you are scrutinizing your payment statements and challenging all unwarranted rejections, they will be less cavalier in denying legitimate claims.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

In a global survey, 88% of respondents knew that unprotected sun exposure leads to skin cancer, but less than 60% “always” or “often” applied sunscreen to their faces, arms, and legs, researchers said.

Many respondents also reported ignoring whole categories of sun-protective behaviors – such as wearing long sleeves and seeking shade – and lacked knowledge about individual risk factors for skin cancer, such as skin type and size of moles, Sophie Seite, PhD, and her coauthors reported in the Journal of the European Academy of Dermatology and Venereology. These data suggest “that messaging needs to be specifically targeted for at-risk demographics (especially by age, gender, skin type, and country),” they added.

karenfoleyphotography/Thinkstock

In a global survey, 88% of respondents knew that unprotected sun exposure leads to skin cancer, but less than 60% “always” or “often” applied sunscreen to their faces, arms, and legs, researchers said.

Many respondents also reported ignoring whole categories of sun-protective behaviors – such as wearing long sleeves and seeking shade – and lacked knowledge about individual risk factors for skin cancer, such as skin type and size of moles, Sophie Seite, PhD, and her coauthors reported in the Journal of the European Academy of Dermatology and Venereology. These data suggest “that messaging needs to be specifically targeted for at-risk demographics (especially by age, gender, skin type, and country),” they added.

karenfoleyphotography/Thinkstock

In a global survey, 88% of respondents knew that unprotected sun exposure leads to skin cancer, but less than 60% “always” or “often” applied sunscreen to their faces, arms, and legs, researchers said.

Many respondents also reported ignoring whole categories of sun-protective behaviors – such as wearing long sleeves and seeking shade – and lacked knowledge about individual risk factors for skin cancer, such as skin type and size of moles, Sophie Seite, PhD, and her coauthors reported in the Journal of the European Academy of Dermatology and Venereology. These data suggest “that messaging needs to be specifically targeted for at-risk demographics (especially by age, gender, skin type, and country),” they added.

karenfoleyphotography/Thinkstock

Poliovirus vaccinations for children in the United States who may have been vaccinated elsewhere must meet Advisory Committee on Immunization Practices recommendations to ensure protection against all three poliovirus types, according to guidance published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

Although the United States continues to use an inactivated polio vaccine (IPV) that contains all three types, other countries using an oral polio vaccine (OPV) switched from a trivalent oral poliovirus vaccine (tOPV) to a bivalent version (bOPV) after the World Health Organization declared type 2 polio virus eradicated in September 2015.

designer491/Thinkstock

Poliovirus vaccinations for children in the United States who may have been vaccinated elsewhere must meet Advisory Committee on Immunization Practices recommendations to ensure protection against all three poliovirus types, according to guidance published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

Although the United States continues to use an inactivated polio vaccine (IPV) that contains all three types, other countries using an oral polio vaccine (OPV) switched from a trivalent oral poliovirus vaccine (tOPV) to a bivalent version (bOPV) after the World Health Organization declared type 2 polio virus eradicated in September 2015.

designer491/Thinkstock

Poliovirus vaccinations for children in the United States who may have been vaccinated elsewhere must meet Advisory Committee on Immunization Practices recommendations to ensure protection against all three poliovirus types, according to guidance published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

Although the United States continues to use an inactivated polio vaccine (IPV) that contains all three types, other countries using an oral polio vaccine (OPV) switched from a trivalent oral poliovirus vaccine (tOPV) to a bivalent version (bOPV) after the World Health Organization declared type 2 polio virus eradicated in September 2015.

designer491/Thinkstock

VIENNA – Several different tests for PD-L1 levels in tumor cells of patients with metastatic non–small cell lung cancer showed high concordance when run at seven French centers, boosting confidence in the clinical utility of this testing to guide first-line pembrolizumab treatment of patients with this cancer.

Among 27 laboratory-developed tests for PD-L1 (programmed death–ligand 1) levels in tumor cells that used any one of three prespecified testing platforms (made by Dako, Ventana, or Leica), 14 (52%) had “similar” concordance when compared with reference assays, Julien Adam, MD, said at the World Conference on Lung Cancer, sponsored by the International Association for the Study of Lung Cancer. “These results will provide the basis for making national recommendations for PD-L1 testing in patients with non–small cell lung cancer [NSCLC]” in France, added Dr. Adam, a pathologist at Gustave Roussy Cancer Center in Paris. “We expect to produce recommendations by the second half of 2017.”

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

[email protected]

On Twitter @mitchelzoler

VIENNA – Several different tests for PD-L1 levels in tumor cells of patients with metastatic non–small cell lung cancer showed high concordance when run at seven French centers, boosting confidence in the clinical utility of this testing to guide first-line pembrolizumab treatment of patients with this cancer.

Among 27 laboratory-developed tests for PD-L1 (programmed death–ligand 1) levels in tumor cells that used any one of three prespecified testing platforms (made by Dako, Ventana, or Leica), 14 (52%) had “similar” concordance when compared with reference assays, Julien Adam, MD, said at the World Conference on Lung Cancer, sponsored by the International Association for the Study of Lung Cancer. “These results will provide the basis for making national recommendations for PD-L1 testing in patients with non–small cell lung cancer [NSCLC]” in France, added Dr. Adam, a pathologist at Gustave Roussy Cancer Center in Paris. “We expect to produce recommendations by the second half of 2017.”

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

[email protected]

On Twitter @mitchelzoler

VIENNA – Several different tests for PD-L1 levels in tumor cells of patients with metastatic non–small cell lung cancer showed high concordance when run at seven French centers, boosting confidence in the clinical utility of this testing to guide first-line pembrolizumab treatment of patients with this cancer.

Among 27 laboratory-developed tests for PD-L1 (programmed death–ligand 1) levels in tumor cells that used any one of three prespecified testing platforms (made by Dako, Ventana, or Leica), 14 (52%) had “similar” concordance when compared with reference assays, Julien Adam, MD, said at the World Conference on Lung Cancer, sponsored by the International Association for the Study of Lung Cancer. “These results will provide the basis for making national recommendations for PD-L1 testing in patients with non–small cell lung cancer [NSCLC]” in France, added Dr. Adam, a pathologist at Gustave Roussy Cancer Center in Paris. “We expect to produce recommendations by the second half of 2017.”

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

[email protected]

On Twitter @mitchelzoler

SAN DIEGO – Patients with chronic lymphocytic leukemia at risk for early relapse were about 85% less likely to progress on lenalidomide maintenance therapy compared with placebo, based on an interim analysis of the randomized phase III CLLM1 study.

After a typical follow-up time of 17.5 months, median durations of progression-free survival were not reached with lenalidomide and were 13 months with placebo, for a hazard ratio of 0.15 (95% confidence interval, 0.06-0.35). These results were “statistically significant, robust, and reliable in favor of lenalidomide,” Anna Fink, MD, said at the 2016 meeting of the American Society of Hematology. Several patients in the lenalidomide arm also converted to minimal residual disease (MRD) negativity, added Dr. Fink of University Hospital Cologne (Germany).

The study included patients whose CLL responded at least partially to front-line chemoimmunotherapy, but who were at high risk of progression – minimal residual disease levels were at least 10^–2, or were between 10^–4 and 10^–2 in patients who also had an unmutated IGHV gene status or del(17p) or TP53 mutations at baseline. Among 89 patients who met these criteria, 60 received lenalidomide maintenance and 20 received placebo.

The initial lenalidomide cycle consisted of 5 mg daily for 28 days. To achieve MRD negativity, clinicians increased this dose during subsequent cycles to a maximum of 15 mg daily for patients who were MRD negative after cycle 12, 20 mg for patients who were MRD negative after cycle 18, and 25 mg for patients who remained MRD positive. Median age was 64 years, more than 80% of patients were male, and the median cumulative illness rating was relatively low at 2, ranging between 0 and 8.

A total of 37% of patients had a high MRD level and 63% had an intermediate level. For both cohorts, lenalidomide maintenance significantly prolonged progression-free survival, compared with placebo, with hazard ratios of 0.17 and 0.13, respectively. Patients received a median of 11 and up to 40 cycles of lenalidomide, but a median of only 8 cycles of placebo.

In all, 43% of lenalidomide patients and 72% of placebo patients stopped maintenance. Nearly a third of those who discontinued lenalidomide did so because of adverse events, but 45% of patients who stopped placebo did so because of progressive disease, Dr. Fink said. Lenalidomide was associated with more neutropenia, gastrointestinal disorders, nervous system disorders, and respiratory and skin disorders than was placebo, but the events were usually mild to moderate in severity, she added.

The three deaths in this study yielded no treatment-based difference in rates of overall survival. Causes of death included acute lymphoblastic leukemia (lenalidomide arm), progressive multifocal leukoencephalopathy (placebo), and Richter’s syndrome (placebo). Venous thromboembolic events were uncommon because patients were given low-dose aspirin or anticoagulant therapy, Dr. Fink noted.

“Lenalidomide is a feasible and efficacious maintenance option for high-risk CLL after chemoimmunotherapy,” she concluded. The low duration of progression-free survival in the placebo group confirms the prognostic utility of assessing risk based on MRD, which might be useful in future studies, she added.

The German CLL Study Group sponsored the trial. Dr. Fink disclosed ties to Mundipharma, Roche, Celgene, and AbbVie.

SAN DIEGO – Patients with chronic lymphocytic leukemia at risk for early relapse were about 85% less likely to progress on lenalidomide maintenance therapy compared with placebo, based on an interim analysis of the randomized phase III CLLM1 study.

After a typical follow-up time of 17.5 months, median durations of progression-free survival were not reached with lenalidomide and were 13 months with placebo, for a hazard ratio of 0.15 (95% confidence interval, 0.06-0.35). These results were “statistically significant, robust, and reliable in favor of lenalidomide,” Anna Fink, MD, said at the 2016 meeting of the American Society of Hematology. Several patients in the lenalidomide arm also converted to minimal residual disease (MRD) negativity, added Dr. Fink of University Hospital Cologne (Germany).

The study included patients whose CLL responded at least partially to front-line chemoimmunotherapy, but who were at high risk of progression – minimal residual disease levels were at least 10^–2, or were between 10^–4 and 10^–2 in patients who also had an unmutated IGHV gene status or del(17p) or TP53 mutations at baseline. Among 89 patients who met these criteria, 60 received lenalidomide maintenance and 20 received placebo.

The initial lenalidomide cycle consisted of 5 mg daily for 28 days. To achieve MRD negativity, clinicians increased this dose during subsequent cycles to a maximum of 15 mg daily for patients who were MRD negative after cycle 12, 20 mg for patients who were MRD negative after cycle 18, and 25 mg for patients who remained MRD positive. Median age was 64 years, more than 80% of patients were male, and the median cumulative illness rating was relatively low at 2, ranging between 0 and 8.

A total of 37% of patients had a high MRD level and 63% had an intermediate level. For both cohorts, lenalidomide maintenance significantly prolonged progression-free survival, compared with placebo, with hazard ratios of 0.17 and 0.13, respectively. Patients received a median of 11 and up to 40 cycles of lenalidomide, but a median of only 8 cycles of placebo.

In all, 43% of lenalidomide patients and 72% of placebo patients stopped maintenance. Nearly a third of those who discontinued lenalidomide did so because of adverse events, but 45% of patients who stopped placebo did so because of progressive disease, Dr. Fink said. Lenalidomide was associated with more neutropenia, gastrointestinal disorders, nervous system disorders, and respiratory and skin disorders than was placebo, but the events were usually mild to moderate in severity, she added.

The three deaths in this study yielded no treatment-based difference in rates of overall survival. Causes of death included acute lymphoblastic leukemia (lenalidomide arm), progressive multifocal leukoencephalopathy (placebo), and Richter’s syndrome (placebo). Venous thromboembolic events were uncommon because patients were given low-dose aspirin or anticoagulant therapy, Dr. Fink noted.

“Lenalidomide is a feasible and efficacious maintenance option for high-risk CLL after chemoimmunotherapy,” she concluded. The low duration of progression-free survival in the placebo group confirms the prognostic utility of assessing risk based on MRD, which might be useful in future studies, she added.

The German CLL Study Group sponsored the trial. Dr. Fink disclosed ties to Mundipharma, Roche, Celgene, and AbbVie.

SAN DIEGO – Patients with chronic lymphocytic leukemia at risk for early relapse were about 85% less likely to progress on lenalidomide maintenance therapy compared with placebo, based on an interim analysis of the randomized phase III CLLM1 study.

After a typical follow-up time of 17.5 months, median durations of progression-free survival were not reached with lenalidomide and were 13 months with placebo, for a hazard ratio of 0.15 (95% confidence interval, 0.06-0.35). These results were “statistically significant, robust, and reliable in favor of lenalidomide,” Anna Fink, MD, said at the 2016 meeting of the American Society of Hematology. Several patients in the lenalidomide arm also converted to minimal residual disease (MRD) negativity, added Dr. Fink of University Hospital Cologne (Germany).

The study included patients whose CLL responded at least partially to front-line chemoimmunotherapy, but who were at high risk of progression – minimal residual disease levels were at least 10^–2, or were between 10^–4 and 10^–2 in patients who also had an unmutated IGHV gene status or del(17p) or TP53 mutations at baseline. Among 89 patients who met these criteria, 60 received lenalidomide maintenance and 20 received placebo.

The initial lenalidomide cycle consisted of 5 mg daily for 28 days. To achieve MRD negativity, clinicians increased this dose during subsequent cycles to a maximum of 15 mg daily for patients who were MRD negative after cycle 12, 20 mg for patients who were MRD negative after cycle 18, and 25 mg for patients who remained MRD positive. Median age was 64 years, more than 80% of patients were male, and the median cumulative illness rating was relatively low at 2, ranging between 0 and 8.

A total of 37% of patients had a high MRD level and 63% had an intermediate level. For both cohorts, lenalidomide maintenance significantly prolonged progression-free survival, compared with placebo, with hazard ratios of 0.17 and 0.13, respectively. Patients received a median of 11 and up to 40 cycles of lenalidomide, but a median of only 8 cycles of placebo.

In all, 43% of lenalidomide patients and 72% of placebo patients stopped maintenance. Nearly a third of those who discontinued lenalidomide did so because of adverse events, but 45% of patients who stopped placebo did so because of progressive disease, Dr. Fink said. Lenalidomide was associated with more neutropenia, gastrointestinal disorders, nervous system disorders, and respiratory and skin disorders than was placebo, but the events were usually mild to moderate in severity, she added.

The three deaths in this study yielded no treatment-based difference in rates of overall survival. Causes of death included acute lymphoblastic leukemia (lenalidomide arm), progressive multifocal leukoencephalopathy (placebo), and Richter’s syndrome (placebo). Venous thromboembolic events were uncommon because patients were given low-dose aspirin or anticoagulant therapy, Dr. Fink noted.

“Lenalidomide is a feasible and efficacious maintenance option for high-risk CLL after chemoimmunotherapy,” she concluded. The low duration of progression-free survival in the placebo group confirms the prognostic utility of assessing risk based on MRD, which might be useful in future studies, she added.

The German CLL Study Group sponsored the trial. Dr. Fink disclosed ties to Mundipharma, Roche, Celgene, and AbbVie.

Two recent clinical practice guidelines – one for cholesterol management and another for treatment of chronic hepatitis C – did not meet the Institute of Medicine’s standards for limiting commercial conflicts of interest, according to results of a new analysis.

In research published online Jan. 17, Akilah A. Jefferson, MD, and Steven D. Pearson, MD, both of the National Institutes of Health in Bethesda, Md., re-examined conflict of interest disclosures for the 2013 American College of Cardiology and American Heart Association cholesterol management guideline, as well as for the American Association for the Study of Liver Diseases and Infectious Diseases Society of America’s joint 2014 guideline related to novel drug treatments for chronic hepatitis C virus (HCV) infection.

The IOM standards for conflicts of interest in guidelines, introduced in 2011, require that less than half the members of any guideline writing committee have a commercial conflict, which can include consultancies, board memberships, and stock in manufacturers of devices or treatments. Guideline writing committee chairs and cochairs should have no commercial conflicts of interest, according to the IOM.

For the cholesterol guidelines, the investigators found that while the committee members fell below the threshold with only 44% reporting commercial conflicts, one writing chair had multiple conflicts until about 1 year before guideline development began, an analysis of concurrent publications suggested. For the HCV guidelines, meanwhile, 72% of the committee members reported commercial conflicts, along with four out of six committee cochairs. An analysis of concurrent publications revealed incomplete disclosure of conflicts among authors of both guidelines (JAMA Intern Med. 2017 Jan 17. doi: 10.1001/jamainternmed.2016.8439).

“Management of levels of commercial [conflict of interest] among guideline committees remains an important problem 5 years after the IOM standards were published,” the investigators wrote. They recommended “broader and more explicit adoption” of the IOM’s framework for conflict of interest.

The study notes that the HCV guideline met all nine of the additional IOM guideline development and evidence standards, while the cholesterol guideline met five of those standards.

The study was funded by an NIH grant. Dr. Pearson reported receiving research funding from foundations and membership dues paid by insurance and pharmaceutical companies. No other disclosures were reported.

Two recent clinical practice guidelines – one for cholesterol management and another for treatment of chronic hepatitis C – did not meet the Institute of Medicine’s standards for limiting commercial conflicts of interest, according to results of a new analysis.

In research published online Jan. 17, Akilah A. Jefferson, MD, and Steven D. Pearson, MD, both of the National Institutes of Health in Bethesda, Md., re-examined conflict of interest disclosures for the 2013 American College of Cardiology and American Heart Association cholesterol management guideline, as well as for the American Association for the Study of Liver Diseases and Infectious Diseases Society of America’s joint 2014 guideline related to novel drug treatments for chronic hepatitis C virus (HCV) infection.

The IOM standards for conflicts of interest in guidelines, introduced in 2011, require that less than half the members of any guideline writing committee have a commercial conflict, which can include consultancies, board memberships, and stock in manufacturers of devices or treatments. Guideline writing committee chairs and cochairs should have no commercial conflicts of interest, according to the IOM.

For the cholesterol guidelines, the investigators found that while the committee members fell below the threshold with only 44% reporting commercial conflicts, one writing chair had multiple conflicts until about 1 year before guideline development began, an analysis of concurrent publications suggested. For the HCV guidelines, meanwhile, 72% of the committee members reported commercial conflicts, along with four out of six committee cochairs. An analysis of concurrent publications revealed incomplete disclosure of conflicts among authors of both guidelines (JAMA Intern Med. 2017 Jan 17. doi: 10.1001/jamainternmed.2016.8439).

“Management of levels of commercial [conflict of interest] among guideline committees remains an important problem 5 years after the IOM standards were published,” the investigators wrote. They recommended “broader and more explicit adoption” of the IOM’s framework for conflict of interest.

The study notes that the HCV guideline met all nine of the additional IOM guideline development and evidence standards, while the cholesterol guideline met five of those standards.

The study was funded by an NIH grant. Dr. Pearson reported receiving research funding from foundations and membership dues paid by insurance and pharmaceutical companies. No other disclosures were reported.

Two recent clinical practice guidelines – one for cholesterol management and another for treatment of chronic hepatitis C – did not meet the Institute of Medicine’s standards for limiting commercial conflicts of interest, according to results of a new analysis.

In research published online Jan. 17, Akilah A. Jefferson, MD, and Steven D. Pearson, MD, both of the National Institutes of Health in Bethesda, Md., re-examined conflict of interest disclosures for the 2013 American College of Cardiology and American Heart Association cholesterol management guideline, as well as for the American Association for the Study of Liver Diseases and Infectious Diseases Society of America’s joint 2014 guideline related to novel drug treatments for chronic hepatitis C virus (HCV) infection.

The IOM standards for conflicts of interest in guidelines, introduced in 2011, require that less than half the members of any guideline writing committee have a commercial conflict, which can include consultancies, board memberships, and stock in manufacturers of devices or treatments. Guideline writing committee chairs and cochairs should have no commercial conflicts of interest, according to the IOM.

For the cholesterol guidelines, the investigators found that while the committee members fell below the threshold with only 44% reporting commercial conflicts, one writing chair had multiple conflicts until about 1 year before guideline development began, an analysis of concurrent publications suggested. For the HCV guidelines, meanwhile, 72% of the committee members reported commercial conflicts, along with four out of six committee cochairs. An analysis of concurrent publications revealed incomplete disclosure of conflicts among authors of both guidelines (JAMA Intern Med. 2017 Jan 17. doi: 10.1001/jamainternmed.2016.8439).

“Management of levels of commercial [conflict of interest] among guideline committees remains an important problem 5 years after the IOM standards were published,” the investigators wrote. They recommended “broader and more explicit adoption” of the IOM’s framework for conflict of interest.

The study notes that the HCV guideline met all nine of the additional IOM guideline development and evidence standards, while the cholesterol guideline met five of those standards.

The study was funded by an NIH grant. Dr. Pearson reported receiving research funding from foundations and membership dues paid by insurance and pharmaceutical companies. No other disclosures were reported.

Take-Home Points

• Music therapists use patient-preferred live music, increasing neurologic cues that enhance movement—a seminal recovery function in postoperative spine patients.
• Music therapy is an evidence-based, integrative treatment addressing body, mind, and spirit.
• Tension release through music therapy can serve as a critical mechanism for building resilience related to pain management.
• Music therapy and music medicine are distinct forms of clinical practice that focus on mind-body integration in the healing process.
• Music therapists, board-certified and licensed by the state as recognized healthcare professionals, address pain management, which is an increasing subspecialty in postoperative care.

About 70% of people in the United States experience at least 1 episode of back pain in their lifetime,¹ and more than 5 million are temporarily or permanently disabled by spinal disorders.^2-4 Some require surgery, which may rectify injury, but pain during recovery is often inevitable, and the road to recovery is not guaranteed to be smooth.^5-20

Postoperative spine patients are at major risk for pain management challenges.^14,15,18,20 Treatment is primarily pharmacologic and based on the surgical team’s pain management orders. Nursing care consists of monitoring the airway, vital signs, and neurovascular status and having patients rate their pain on a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable). Nurses have the challenge of monitoring and continually assessing to make sure patients are achieving the optimal outcomes, particularly during the immediate postoperative period, when pain and anxiety are prominently increased.

Variability in spine surgery outcomes can be explained at least partly on the basis of prognostic psychological factors, including hypochondriasis, hysteria, depression, and poor pain coping strategies (eg, catastrophizing).²¹ In spine surgery patients, kinesiophobia (fear of moving) is a common component of distress that can impede recuperation.^21-23Psychological interventions that assist with the secondary stressors associated with pain and loss during physical recuperation are recommended, with increased attention given to the importance of treating the whole person: body, mind, and spirit.^24-29 Conventional pain-alleviating medical interventions can be enhanced with integrative therapies that empower patients to marshal their inner resources during recovery.^25-28Music therapy may be particularly suited to this effort, as it is adaptable to the patient’s individual and culturally specific needs.^29-33

Rationale for Live Music

Pain is subjective and personal, and warrants an individualized approach to care. There is a body of music medicine research on the use of recorded music in modulating psychological and physiological factors in pain perception.^30,32,34-54 This research supports the unique relationship of music to well-being, and the understanding that controlling any of these factors affects the duration, intensity, and quality of that experience.^41,43,52

These findings provide incentive for breathing-entrained music therapy interventions, which enhance the relaxation response and release of pain-related tension;^32,55-58 empower patients to unlock physical and emotional tension;^32,57,58 provide a channel for expression and body movement; and enhance blood flow and/or alleviate pain by activating neurologic areas involved in the experience of pain.^59-62Studies have found that physical endurance may be enhanced when movement is rhythmically coordinated with a musical stimulus.^63-66 Music may prolong physical endurance by inhibiting psychological feedback associated with physical exertion related to fatigue, which may translate into accelerated recovery periods. When we listen to a rhythmic sound, our brains tend to automatically synchronize, or entrain, to external rhythmic cues that can stimulate increased motor control and coordination.⁶³ Sound can arouse and raise the excitability of spinal motor neurons mediated by auditory-motor neuronal connections on the brain stem and spinal cord level.^64-66 Rhythmically organized sounds serve as a neurological function in our capacity to organize predictable timing cues that are apparent in music, and may result in an effective treatment intervention in recovery.^63,64

Music Therapy in Recovery From Spine Surgery

In music therapy, music is used within a therapeutic relationship to support or affect change in the patient and the treatment regimen.^32,33,56-58 Research on music therapy with patients who are recovering from spine surgery is scant.^67-69 Kleiber and Adamek⁶⁷ studied perceptions of music therapy in 8 adolescents after spinal fusion surgery. In their study, a music therapist provided patients with a postoperative music therapy session focusing on the use of patient-preferred live music for relaxation and expression. Although their qualitative query was based on a therapeutic approach similar to that used in the present study, only 1 session was offered during the recovery period, and follow-up was conducted by survey invitation and telephone. In addition, the number of participants was small, and there was no quantitative measure of pain or other symptoms.

Another study focused on the effects of listening to music on pain intensity and distress after spine surgery.⁶⁸ Patients in the study’s music group made their selections from prerecorded classical music and domestic and international popular songs from various genres and listened to their chosen recordings 30 minutes a day. Although the study was not a music therapy study per se, it showed a positive impact of listening to music on anxiety and pain perception in 60 adults who were randomly assigned to the music group or to a non-music control group (n = 30 in each). Differences between the music and control groups’ VAS ratings of anxiety (Ps = .018-.001) and pain (P = .001) were statistically significant.

Different from our study, the aforementioned studies did not include tension release–focused live music offered within a therapeutic relationship. Our 1.5-year pilot study, conducted prior to the present study indicated that music therapy led to increased resilience and recovery mechanisms.⁵⁸

Methods

Our mixed-methods study design combined standard medical treatment with integrative music therapy interventions based on pain assessments to better understand the effects of music therapy on the recovery of patients after spine surgery.

The Spine Institute of New York within the Department of Orthopedic Surgery at Mount Sinai Beth Israel provides surgical treatment of common spinal cord conditions. Prioritizing patient satisfaction and positive outcomes,^27,28 the institute integrates music therapy through the Louis Armstrong Center for Music and Medicine to enhance treatment of pain symptoms.

Patients were recruited by the research team as per the daily surgical schedule, or through referral by the medical team or patient care navigator. Sixty patients (35 female, 25 male) ranging in age from 40 to 55 years underwent anterior, posterior, or anterior-posterior spinal fusion and were enrolled in the study after signing a participation consent form. Minorities, women, and patients with Medicaid and Medicare were included. Patients who received a diagnosis of clinical psychosis or depression prior to spine injury were excluded.

The experimental group received music therapy plus standard care (medical and nursing care with scheduled pharmacologic pain intervention), and a wait-listed control group received standard care only. A randomization chart created by a blinded statistician who did not have access to the patient census determined the intervention–nonintervention schedule. Patients in the music therapy group received one 30-minute music therapy session during an 8-hour period within 72 hours after surgery.

For both groups, measurements were completed before and after the study window. Control patients were offered music therapy after completion of the post-intervention surveys in order to minimize the ethical dilemma of denying potentially helpful pain intervention. For this same reason, both groups were given the option of receiving follow-up music therapy sessions for the duration of their hospitalization.

The research team consisted of 2 licensed, board-certified music therapists. In addition, Master’s-level music therapy interns completing clinical hours as part of the trajectory for board certification served on the research team over the 5-year period 2009 to 2014, and 13 blinded research assistants helped with enrolling and collecting data on patients.

Intervention

Each music therapy session included a warm-up phase of verbal or musical discourse. Next was the treatment phase, which was based on patient need as assessed during warm-up. Treatment options included use of patient-preferred live music that supported tension release/relaxation through incentive-based clinical improvisation, singing, and/or rhythmic drumming or through breathwork and visualization. Psychoeducation about mind–body awareness through the use of breath and imagery was introduced and explained by the therapist at this time.

The improvised music intervention was focused on making salient the natural harmonic tension-resolution cycles that occur in music and that were entrained to the patient’s presentation (respiratory rate, verbal report, clinical presentation). When patient-preferred precomposed songs were used, tension resolution was achieved by sustaining cadence and resolution, also entrained to the patient’s respiratory cycles.^32,57,58

After the music therapy intervention, a period of closure or integration was facilitated by the therapist contingent on the patient’s degree of alertness. If awake, the patient was supported in a reflexive process of thoughts, impressions, or issues that may have contributed to the overall experience. If the patient was asleep, the researcher returned within 30 minutes for post-intervention interviewing. Interview information was recorded in a qualitative post-participation survey. To prevent bias, researchers who were not the treating clinicians conducted the surveys.

Outcome Measures

Both primary and secondary outcome measures were collected before and after the intervention. The primary outcome measure was VAS pain ratings, and the secondary outcome measures were scores on the Hospital Anxiety and Depression Scale (HADS), the Tampa Scale for Kinesiophobia (TSK), and the Color Analysis Scale (CAS).

VAS. With the VAS, images are used to rate pain. The scale has points labeled 0 to 10 and corresponding faces representing progression in pain intensity. The scale is quickly rendered and can be interpreted according to the patient’s recovery phase at time of rendering.

HADS. The HADS⁷⁰ provides a specific baseline for anxiety and depression as an indicator of how the patient might fare during hospitalization (admission through recovery and discharge).

TSK. The TSK⁷¹ provides insight into the patient’s perception of fear-related movement, which is an important factor in this study because of the movement required for rehabilitation. We used a shortened version of the TSK to accommodate the sensitive threshold for pain tolerance and pharmacologic side effects commonly experienced by spine patients.

CAS. The CAS was developed at the Louis Armstrong Center for Music and Medicine to assess comorbidities and dynamic aspects of pain. Through a coloring exercise, patients illustrate their pain experience, which gives tangible form to the abstract experience of pain.

Coding

We collected patients’ demographic data, including age, sex, and diagnoses. Clinical indicators of the preoperative baseline included lifestyle, surgical history, and prior experience with music or other mind–body strategies for self-regulation.

As fundamental to qualitative methodology,^72,73 the reported responses to questions were grouped into themes that were peer-tested with members of the research team before and during the coding process.

Statistical Methods

Means and standard deviations were used for continuous variables, and frequencies (percentages) for categorical variables. All outcomes were analyzed on an intent-to-treat basis. Repeated-measures analysis of variance was used to compare changes in outcomes from before to after intervention for the music and control groups. In particular, a statistically significant Group (music vs control) × Time (before vs after intervention) interaction would support the hypothesis that there would be more benefit (less pain) in the music group as a result of the music therapy. For all tests, significance was set at P < .05. SPSS Version 20 (IBM) was used for all statistical analyses. Based on previously found differences in heart rate and mobility,³¹ we assumed an effect size of 0.71 for the difference between music and control (no music), which would require 32 patients per group to achieve a power of 0.8 with an α of 0.05.

Results

Of the 136 patients who were asked to participate in the study, 76 were not enrolled; the other 60 were equally assigned to either the control group or the music therapy group (n = 30 in each) according to randomization indicated by a blinded statistician (Figure 1).

Table 2 lists the pre-intervention and post-intervention comparisons of the main outcomes between groups.

Relationship with music was coded for significance and included reports of music as a resource accessed for stimulation and/or relaxation through listening; direct involvement with instrument playing; and history of music training. 

Perceptions of surgical outcome in patients’ responses were coded across 3 themes: (1) optimistic (belief and hope in returning to original baseline of functionality), (2) indifferent (neither hopeful nor cynical about results of surgery), and (3) pessimistic (belief that nothing will restore the quality of life that existed before the spinal condition).

The CAS helped us better understand the diversity and complexity of the pain experience.

Discussion

Our hospital has the unique capability of providing music therapy to postoperative and other hospitalized patients. In this study, we compared the impact of a structured postoperative music therapy program on spine patients relative to control patients who did not receive music therapy after spine surgery.

We found a significant benefit in VAS pain levels (>1 point) but no statistically significant differences in HADS Anxiety, HADS Depression, or TSK scores. Although a 2-point difference is usually considered clinically significant, the degree of change in the music group is notable for having been achieved by nonpharmacologic means with scant chance of adverse effects. We suspect the lack of significant change in HADS Anxiety, HADS Depression, and TSK scores is attributable to the narrow study window. Given the observational data from our pilot study⁵⁸ and ongoing results with spine patients,³² it seems clear that both mood state and resilience in coping are enhanced through an ongoing relationship with music therapy.

The study of a population as vulnerable as patients recovering from spine surgery raises many issues for providers and researchers. Although it is worthwhile to determine the efficacy of integrative modalities in serving these patients, the request for participation in a protocol at such a vulnerable time was often resisted. During our pilot work, it became clear that the ability of potential subjects to comprehend and complete protocol surveys was impacted by adverse effects, including sedation drowsiness; respiratory depression; nausea and vomiting; pruritus; and urinary retention caused by the medications used for postoperative pain management. Consequently, after piloting 5 cases before the main study, we extended the enrollment window to 72 hours.

Other unforeseen intrinsic or external obstacles were identified: Patient-related issues—including availability, level of interest in participation, and inability to participate because of the medication adverse effects mentioned.

Staff investment/education—addressed over the first 3 study years with several in-services, starting with the surgical team and continuing with nursing and support staff in various combinations. These meetings led to the creation of an Institutional Review Board (IRB) approved educational sheet for inclusion in the information packet given to surgical patients on registration.

Programming interruptions—caused by the convergence of several unanticipated factors, including a delay in expedited review of the IRB renewal during the year of Hurricane Sandy and an interruption in the spine team’s service for administrative and program modification.

Conclusion

Music therapy interventions (eg, use of patient-preferred live music) offered within a therapeutic relationship favorably affected pain perceptions in patients recovering from spine surgery. This effect was achieved through several therapeutic entry points, including support of expression and opportunities for emotional catharsis.

At the core of music therapy’s efficacy is individualized treatment, through which patients are supported in their recovery of “self.” Measurable benefits—including increased comfort; reduced pain; improved gait; increased range of motion, endurance, and ability to relax; and empowerment to actively participate in one’s own care through daily activities imbued with an enhanced sense of agency—are of cardinal importance, as they may lead to quicker recovery perceptions and enhanced quality of life.

Am J Orthop. 2017;46(1):E13-E22. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.

Take-Home Points

• Music therapists use patient-preferred live music, increasing neurologic cues that enhance movement—a seminal recovery function in postoperative spine patients.
• Music therapy is an evidence-based, integrative treatment addressing body, mind, and spirit.
• Tension release through music therapy can serve as a critical mechanism for building resilience related to pain management.
• Music therapy and music medicine are distinct forms of clinical practice that focus on mind-body integration in the healing process.
• Music therapists, board-certified and licensed by the state as recognized healthcare professionals, address pain management, which is an increasing subspecialty in postoperative care.

About 70% of people in the United States experience at least 1 episode of back pain in their lifetime,¹ and more than 5 million are temporarily or permanently disabled by spinal disorders.^2-4 Some require surgery, which may rectify injury, but pain during recovery is often inevitable, and the road to recovery is not guaranteed to be smooth.^5-20

Postoperative spine patients are at major risk for pain management challenges.^14,15,18,20 Treatment is primarily pharmacologic and based on the surgical team’s pain management orders. Nursing care consists of monitoring the airway, vital signs, and neurovascular status and having patients rate their pain on a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable). Nurses have the challenge of monitoring and continually assessing to make sure patients are achieving the optimal outcomes, particularly during the immediate postoperative period, when pain and anxiety are prominently increased.

Variability in spine surgery outcomes can be explained at least partly on the basis of prognostic psychological factors, including hypochondriasis, hysteria, depression, and poor pain coping strategies (eg, catastrophizing).²¹ In spine surgery patients, kinesiophobia (fear of moving) is a common component of distress that can impede recuperation.^21-23Psychological interventions that assist with the secondary stressors associated with pain and loss during physical recuperation are recommended, with increased attention given to the importance of treating the whole person: body, mind, and spirit.^24-29 Conventional pain-alleviating medical interventions can be enhanced with integrative therapies that empower patients to marshal their inner resources during recovery.^25-28Music therapy may be particularly suited to this effort, as it is adaptable to the patient’s individual and culturally specific needs.^29-33

Rationale for Live Music

Pain is subjective and personal, and warrants an individualized approach to care. There is a body of music medicine research on the use of recorded music in modulating psychological and physiological factors in pain perception.^30,32,34-54 This research supports the unique relationship of music to well-being, and the understanding that controlling any of these factors affects the duration, intensity, and quality of that experience.^41,43,52

These findings provide incentive for breathing-entrained music therapy interventions, which enhance the relaxation response and release of pain-related tension;^32,55-58 empower patients to unlock physical and emotional tension;^32,57,58 provide a channel for expression and body movement; and enhance blood flow and/or alleviate pain by activating neurologic areas involved in the experience of pain.^59-62Studies have found that physical endurance may be enhanced when movement is rhythmically coordinated with a musical stimulus.^63-66 Music may prolong physical endurance by inhibiting psychological feedback associated with physical exertion related to fatigue, which may translate into accelerated recovery periods. When we listen to a rhythmic sound, our brains tend to automatically synchronize, or entrain, to external rhythmic cues that can stimulate increased motor control and coordination.⁶³ Sound can arouse and raise the excitability of spinal motor neurons mediated by auditory-motor neuronal connections on the brain stem and spinal cord level.^64-66 Rhythmically organized sounds serve as a neurological function in our capacity to organize predictable timing cues that are apparent in music, and may result in an effective treatment intervention in recovery.^63,64

Music Therapy in Recovery From Spine Surgery

In music therapy, music is used within a therapeutic relationship to support or affect change in the patient and the treatment regimen.^32,33,56-58 Research on music therapy with patients who are recovering from spine surgery is scant.^67-69 Kleiber and Adamek⁶⁷ studied perceptions of music therapy in 8 adolescents after spinal fusion surgery. In their study, a music therapist provided patients with a postoperative music therapy session focusing on the use of patient-preferred live music for relaxation and expression. Although their qualitative query was based on a therapeutic approach similar to that used in the present study, only 1 session was offered during the recovery period, and follow-up was conducted by survey invitation and telephone. In addition, the number of participants was small, and there was no quantitative measure of pain or other symptoms.

Another study focused on the effects of listening to music on pain intensity and distress after spine surgery.⁶⁸ Patients in the study’s music group made their selections from prerecorded classical music and domestic and international popular songs from various genres and listened to their chosen recordings 30 minutes a day. Although the study was not a music therapy study per se, it showed a positive impact of listening to music on anxiety and pain perception in 60 adults who were randomly assigned to the music group or to a non-music control group (n = 30 in each). Differences between the music and control groups’ VAS ratings of anxiety (Ps = .018-.001) and pain (P = .001) were statistically significant.

Different from our study, the aforementioned studies did not include tension release–focused live music offered within a therapeutic relationship. Our 1.5-year pilot study, conducted prior to the present study indicated that music therapy led to increased resilience and recovery mechanisms.⁵⁸

Methods

Our mixed-methods study design combined standard medical treatment with integrative music therapy interventions based on pain assessments to better understand the effects of music therapy on the recovery of patients after spine surgery.

The Spine Institute of New York within the Department of Orthopedic Surgery at Mount Sinai Beth Israel provides surgical treatment of common spinal cord conditions. Prioritizing patient satisfaction and positive outcomes,^27,28 the institute integrates music therapy through the Louis Armstrong Center for Music and Medicine to enhance treatment of pain symptoms.

Patients were recruited by the research team as per the daily surgical schedule, or through referral by the medical team or patient care navigator. Sixty patients (35 female, 25 male) ranging in age from 40 to 55 years underwent anterior, posterior, or anterior-posterior spinal fusion and were enrolled in the study after signing a participation consent form. Minorities, women, and patients with Medicaid and Medicare were included. Patients who received a diagnosis of clinical psychosis or depression prior to spine injury were excluded.

The experimental group received music therapy plus standard care (medical and nursing care with scheduled pharmacologic pain intervention), and a wait-listed control group received standard care only. A randomization chart created by a blinded statistician who did not have access to the patient census determined the intervention–nonintervention schedule. Patients in the music therapy group received one 30-minute music therapy session during an 8-hour period within 72 hours after surgery.

For both groups, measurements were completed before and after the study window. Control patients were offered music therapy after completion of the post-intervention surveys in order to minimize the ethical dilemma of denying potentially helpful pain intervention. For this same reason, both groups were given the option of receiving follow-up music therapy sessions for the duration of their hospitalization.

The research team consisted of 2 licensed, board-certified music therapists. In addition, Master’s-level music therapy interns completing clinical hours as part of the trajectory for board certification served on the research team over the 5-year period 2009 to 2014, and 13 blinded research assistants helped with enrolling and collecting data on patients.

Intervention

Each music therapy session included a warm-up phase of verbal or musical discourse. Next was the treatment phase, which was based on patient need as assessed during warm-up. Treatment options included use of patient-preferred live music that supported tension release/relaxation through incentive-based clinical improvisation, singing, and/or rhythmic drumming or through breathwork and visualization. Psychoeducation about mind–body awareness through the use of breath and imagery was introduced and explained by the therapist at this time.

The improvised music intervention was focused on making salient the natural harmonic tension-resolution cycles that occur in music and that were entrained to the patient’s presentation (respiratory rate, verbal report, clinical presentation). When patient-preferred precomposed songs were used, tension resolution was achieved by sustaining cadence and resolution, also entrained to the patient’s respiratory cycles.^32,57,58

After the music therapy intervention, a period of closure or integration was facilitated by the therapist contingent on the patient’s degree of alertness. If awake, the patient was supported in a reflexive process of thoughts, impressions, or issues that may have contributed to the overall experience. If the patient was asleep, the researcher returned within 30 minutes for post-intervention interviewing. Interview information was recorded in a qualitative post-participation survey. To prevent bias, researchers who were not the treating clinicians conducted the surveys.

Outcome Measures

Both primary and secondary outcome measures were collected before and after the intervention. The primary outcome measure was VAS pain ratings, and the secondary outcome measures were scores on the Hospital Anxiety and Depression Scale (HADS), the Tampa Scale for Kinesiophobia (TSK), and the Color Analysis Scale (CAS).

VAS. With the VAS, images are used to rate pain. The scale has points labeled 0 to 10 and corresponding faces representing progression in pain intensity. The scale is quickly rendered and can be interpreted according to the patient’s recovery phase at time of rendering.

HADS. The HADS⁷⁰ provides a specific baseline for anxiety and depression as an indicator of how the patient might fare during hospitalization (admission through recovery and discharge).

TSK. The TSK⁷¹ provides insight into the patient’s perception of fear-related movement, which is an important factor in this study because of the movement required for rehabilitation. We used a shortened version of the TSK to accommodate the sensitive threshold for pain tolerance and pharmacologic side effects commonly experienced by spine patients.

CAS. The CAS was developed at the Louis Armstrong Center for Music and Medicine to assess comorbidities and dynamic aspects of pain. Through a coloring exercise, patients illustrate their pain experience, which gives tangible form to the abstract experience of pain.

Coding

We collected patients’ demographic data, including age, sex, and diagnoses. Clinical indicators of the preoperative baseline included lifestyle, surgical history, and prior experience with music or other mind–body strategies for self-regulation.

As fundamental to qualitative methodology,^72,73 the reported responses to questions were grouped into themes that were peer-tested with members of the research team before and during the coding process.

Statistical Methods

Means and standard deviations were used for continuous variables, and frequencies (percentages) for categorical variables. All outcomes were analyzed on an intent-to-treat basis. Repeated-measures analysis of variance was used to compare changes in outcomes from before to after intervention for the music and control groups. In particular, a statistically significant Group (music vs control) × Time (before vs after intervention) interaction would support the hypothesis that there would be more benefit (less pain) in the music group as a result of the music therapy. For all tests, significance was set at P < .05. SPSS Version 20 (IBM) was used for all statistical analyses. Based on previously found differences in heart rate and mobility,³¹ we assumed an effect size of 0.71 for the difference between music and control (no music), which would require 32 patients per group to achieve a power of 0.8 with an α of 0.05.

Results

Of the 136 patients who were asked to participate in the study, 76 were not enrolled; the other 60 were equally assigned to either the control group or the music therapy group (n = 30 in each) according to randomization indicated by a blinded statistician (Figure 1).

Table 2 lists the pre-intervention and post-intervention comparisons of the main outcomes between groups.

Relationship with music was coded for significance and included reports of music as a resource accessed for stimulation and/or relaxation through listening; direct involvement with instrument playing; and history of music training. 

Perceptions of surgical outcome in patients’ responses were coded across 3 themes: (1) optimistic (belief and hope in returning to original baseline of functionality), (2) indifferent (neither hopeful nor cynical about results of surgery), and (3) pessimistic (belief that nothing will restore the quality of life that existed before the spinal condition).

The CAS helped us better understand the diversity and complexity of the pain experience.

Discussion

Our hospital has the unique capability of providing music therapy to postoperative and other hospitalized patients. In this study, we compared the impact of a structured postoperative music therapy program on spine patients relative to control patients who did not receive music therapy after spine surgery.

We found a significant benefit in VAS pain levels (>1 point) but no statistically significant differences in HADS Anxiety, HADS Depression, or TSK scores. Although a 2-point difference is usually considered clinically significant, the degree of change in the music group is notable for having been achieved by nonpharmacologic means with scant chance of adverse effects. We suspect the lack of significant change in HADS Anxiety, HADS Depression, and TSK scores is attributable to the narrow study window. Given the observational data from our pilot study⁵⁸ and ongoing results with spine patients,³² it seems clear that both mood state and resilience in coping are enhanced through an ongoing relationship with music therapy.

The study of a population as vulnerable as patients recovering from spine surgery raises many issues for providers and researchers. Although it is worthwhile to determine the efficacy of integrative modalities in serving these patients, the request for participation in a protocol at such a vulnerable time was often resisted. During our pilot work, it became clear that the ability of potential subjects to comprehend and complete protocol surveys was impacted by adverse effects, including sedation drowsiness; respiratory depression; nausea and vomiting; pruritus; and urinary retention caused by the medications used for postoperative pain management. Consequently, after piloting 5 cases before the main study, we extended the enrollment window to 72 hours.

Other unforeseen intrinsic or external obstacles were identified: Patient-related issues—including availability, level of interest in participation, and inability to participate because of the medication adverse effects mentioned.

Staff investment/education—addressed over the first 3 study years with several in-services, starting with the surgical team and continuing with nursing and support staff in various combinations. These meetings led to the creation of an Institutional Review Board (IRB) approved educational sheet for inclusion in the information packet given to surgical patients on registration.

Programming interruptions—caused by the convergence of several unanticipated factors, including a delay in expedited review of the IRB renewal during the year of Hurricane Sandy and an interruption in the spine team’s service for administrative and program modification.

Conclusion

Music therapy interventions (eg, use of patient-preferred live music) offered within a therapeutic relationship favorably affected pain perceptions in patients recovering from spine surgery. This effect was achieved through several therapeutic entry points, including support of expression and opportunities for emotional catharsis.

At the core of music therapy’s efficacy is individualized treatment, through which patients are supported in their recovery of “self.” Measurable benefits—including increased comfort; reduced pain; improved gait; increased range of motion, endurance, and ability to relax; and empowerment to actively participate in one’s own care through daily activities imbued with an enhanced sense of agency—are of cardinal importance, as they may lead to quicker recovery perceptions and enhanced quality of life.

Am J Orthop. 2017;46(1):E13-E22. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.

Take-Home Points

• Music therapists use patient-preferred live music, increasing neurologic cues that enhance movement—a seminal recovery function in postoperative spine patients.
• Music therapy is an evidence-based, integrative treatment addressing body, mind, and spirit.
• Tension release through music therapy can serve as a critical mechanism for building resilience related to pain management.
• Music therapy and music medicine are distinct forms of clinical practice that focus on mind-body integration in the healing process.
• Music therapists, board-certified and licensed by the state as recognized healthcare professionals, address pain management, which is an increasing subspecialty in postoperative care.

About 70% of people in the United States experience at least 1 episode of back pain in their lifetime,¹ and more than 5 million are temporarily or permanently disabled by spinal disorders.^2-4 Some require surgery, which may rectify injury, but pain during recovery is often inevitable, and the road to recovery is not guaranteed to be smooth.^5-20

Postoperative spine patients are at major risk for pain management challenges.^14,15,18,20 Treatment is primarily pharmacologic and based on the surgical team’s pain management orders. Nursing care consists of monitoring the airway, vital signs, and neurovascular status and having patients rate their pain on a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable). Nurses have the challenge of monitoring and continually assessing to make sure patients are achieving the optimal outcomes, particularly during the immediate postoperative period, when pain and anxiety are prominently increased.

Variability in spine surgery outcomes can be explained at least partly on the basis of prognostic psychological factors, including hypochondriasis, hysteria, depression, and poor pain coping strategies (eg, catastrophizing).²¹ In spine surgery patients, kinesiophobia (fear of moving) is a common component of distress that can impede recuperation.^21-23Psychological interventions that assist with the secondary stressors associated with pain and loss during physical recuperation are recommended, with increased attention given to the importance of treating the whole person: body, mind, and spirit.^24-29 Conventional pain-alleviating medical interventions can be enhanced with integrative therapies that empower patients to marshal their inner resources during recovery.^25-28Music therapy may be particularly suited to this effort, as it is adaptable to the patient’s individual and culturally specific needs.^29-33

Rationale for Live Music

Pain is subjective and personal, and warrants an individualized approach to care. There is a body of music medicine research on the use of recorded music in modulating psychological and physiological factors in pain perception.^30,32,34-54 This research supports the unique relationship of music to well-being, and the understanding that controlling any of these factors affects the duration, intensity, and quality of that experience.^41,43,52

These findings provide incentive for breathing-entrained music therapy interventions, which enhance the relaxation response and release of pain-related tension;^32,55-58 empower patients to unlock physical and emotional tension;^32,57,58 provide a channel for expression and body movement; and enhance blood flow and/or alleviate pain by activating neurologic areas involved in the experience of pain.^59-62Studies have found that physical endurance may be enhanced when movement is rhythmically coordinated with a musical stimulus.^63-66 Music may prolong physical endurance by inhibiting psychological feedback associated with physical exertion related to fatigue, which may translate into accelerated recovery periods. When we listen to a rhythmic sound, our brains tend to automatically synchronize, or entrain, to external rhythmic cues that can stimulate increased motor control and coordination.⁶³ Sound can arouse and raise the excitability of spinal motor neurons mediated by auditory-motor neuronal connections on the brain stem and spinal cord level.^64-66 Rhythmically organized sounds serve as a neurological function in our capacity to organize predictable timing cues that are apparent in music, and may result in an effective treatment intervention in recovery.^63,64

Music Therapy in Recovery From Spine Surgery

In music therapy, music is used within a therapeutic relationship to support or affect change in the patient and the treatment regimen.^32,33,56-58 Research on music therapy with patients who are recovering from spine surgery is scant.^67-69 Kleiber and Adamek⁶⁷ studied perceptions of music therapy in 8 adolescents after spinal fusion surgery. In their study, a music therapist provided patients with a postoperative music therapy session focusing on the use of patient-preferred live music for relaxation and expression. Although their qualitative query was based on a therapeutic approach similar to that used in the present study, only 1 session was offered during the recovery period, and follow-up was conducted by survey invitation and telephone. In addition, the number of participants was small, and there was no quantitative measure of pain or other symptoms.

Another study focused on the effects of listening to music on pain intensity and distress after spine surgery.⁶⁸ Patients in the study’s music group made their selections from prerecorded classical music and domestic and international popular songs from various genres and listened to their chosen recordings 30 minutes a day. Although the study was not a music therapy study per se, it showed a positive impact of listening to music on anxiety and pain perception in 60 adults who were randomly assigned to the music group or to a non-music control group (n = 30 in each). Differences between the music and control groups’ VAS ratings of anxiety (Ps = .018-.001) and pain (P = .001) were statistically significant.

Different from our study, the aforementioned studies did not include tension release–focused live music offered within a therapeutic relationship. Our 1.5-year pilot study, conducted prior to the present study indicated that music therapy led to increased resilience and recovery mechanisms.⁵⁸

Methods

Our mixed-methods study design combined standard medical treatment with integrative music therapy interventions based on pain assessments to better understand the effects of music therapy on the recovery of patients after spine surgery.

The Spine Institute of New York within the Department of Orthopedic Surgery at Mount Sinai Beth Israel provides surgical treatment of common spinal cord conditions. Prioritizing patient satisfaction and positive outcomes,^27,28 the institute integrates music therapy through the Louis Armstrong Center for Music and Medicine to enhance treatment of pain symptoms.

Patients were recruited by the research team as per the daily surgical schedule, or through referral by the medical team or patient care navigator. Sixty patients (35 female, 25 male) ranging in age from 40 to 55 years underwent anterior, posterior, or anterior-posterior spinal fusion and were enrolled in the study after signing a participation consent form. Minorities, women, and patients with Medicaid and Medicare were included. Patients who received a diagnosis of clinical psychosis or depression prior to spine injury were excluded.

The experimental group received music therapy plus standard care (medical and nursing care with scheduled pharmacologic pain intervention), and a wait-listed control group received standard care only. A randomization chart created by a blinded statistician who did not have access to the patient census determined the intervention–nonintervention schedule. Patients in the music therapy group received one 30-minute music therapy session during an 8-hour period within 72 hours after surgery.

For both groups, measurements were completed before and after the study window. Control patients were offered music therapy after completion of the post-intervention surveys in order to minimize the ethical dilemma of denying potentially helpful pain intervention. For this same reason, both groups were given the option of receiving follow-up music therapy sessions for the duration of their hospitalization.

The research team consisted of 2 licensed, board-certified music therapists. In addition, Master’s-level music therapy interns completing clinical hours as part of the trajectory for board certification served on the research team over the 5-year period 2009 to 2014, and 13 blinded research assistants helped with enrolling and collecting data on patients.

Intervention

Each music therapy session included a warm-up phase of verbal or musical discourse. Next was the treatment phase, which was based on patient need as assessed during warm-up. Treatment options included use of patient-preferred live music that supported tension release/relaxation through incentive-based clinical improvisation, singing, and/or rhythmic drumming or through breathwork and visualization. Psychoeducation about mind–body awareness through the use of breath and imagery was introduced and explained by the therapist at this time.

The improvised music intervention was focused on making salient the natural harmonic tension-resolution cycles that occur in music and that were entrained to the patient’s presentation (respiratory rate, verbal report, clinical presentation). When patient-preferred precomposed songs were used, tension resolution was achieved by sustaining cadence and resolution, also entrained to the patient’s respiratory cycles.^32,57,58

After the music therapy intervention, a period of closure or integration was facilitated by the therapist contingent on the patient’s degree of alertness. If awake, the patient was supported in a reflexive process of thoughts, impressions, or issues that may have contributed to the overall experience. If the patient was asleep, the researcher returned within 30 minutes for post-intervention interviewing. Interview information was recorded in a qualitative post-participation survey. To prevent bias, researchers who were not the treating clinicians conducted the surveys.

Outcome Measures

Both primary and secondary outcome measures were collected before and after the intervention. The primary outcome measure was VAS pain ratings, and the secondary outcome measures were scores on the Hospital Anxiety and Depression Scale (HADS), the Tampa Scale for Kinesiophobia (TSK), and the Color Analysis Scale (CAS).

VAS. With the VAS, images are used to rate pain. The scale has points labeled 0 to 10 and corresponding faces representing progression in pain intensity. The scale is quickly rendered and can be interpreted according to the patient’s recovery phase at time of rendering.

HADS. The HADS⁷⁰ provides a specific baseline for anxiety and depression as an indicator of how the patient might fare during hospitalization (admission through recovery and discharge).

TSK. The TSK⁷¹ provides insight into the patient’s perception of fear-related movement, which is an important factor in this study because of the movement required for rehabilitation. We used a shortened version of the TSK to accommodate the sensitive threshold for pain tolerance and pharmacologic side effects commonly experienced by spine patients.

CAS. The CAS was developed at the Louis Armstrong Center for Music and Medicine to assess comorbidities and dynamic aspects of pain. Through a coloring exercise, patients illustrate their pain experience, which gives tangible form to the abstract experience of pain.

Coding

We collected patients’ demographic data, including age, sex, and diagnoses. Clinical indicators of the preoperative baseline included lifestyle, surgical history, and prior experience with music or other mind–body strategies for self-regulation.

As fundamental to qualitative methodology,^72,73 the reported responses to questions were grouped into themes that were peer-tested with members of the research team before and during the coding process.

Statistical Methods

Means and standard deviations were used for continuous variables, and frequencies (percentages) for categorical variables. All outcomes were analyzed on an intent-to-treat basis. Repeated-measures analysis of variance was used to compare changes in outcomes from before to after intervention for the music and control groups. In particular, a statistically significant Group (music vs control) × Time (before vs after intervention) interaction would support the hypothesis that there would be more benefit (less pain) in the music group as a result of the music therapy. For all tests, significance was set at P < .05. SPSS Version 20 (IBM) was used for all statistical analyses. Based on previously found differences in heart rate and mobility,³¹ we assumed an effect size of 0.71 for the difference between music and control (no music), which would require 32 patients per group to achieve a power of 0.8 with an α of 0.05.

Results

Of the 136 patients who were asked to participate in the study, 76 were not enrolled; the other 60 were equally assigned to either the control group or the music therapy group (n = 30 in each) according to randomization indicated by a blinded statistician (Figure 1).

Table 2 lists the pre-intervention and post-intervention comparisons of the main outcomes between groups.

Relationship with music was coded for significance and included reports of music as a resource accessed for stimulation and/or relaxation through listening; direct involvement with instrument playing; and history of music training. 

Perceptions of surgical outcome in patients’ responses were coded across 3 themes: (1) optimistic (belief and hope in returning to original baseline of functionality), (2) indifferent (neither hopeful nor cynical about results of surgery), and (3) pessimistic (belief that nothing will restore the quality of life that existed before the spinal condition).

The CAS helped us better understand the diversity and complexity of the pain experience.

Discussion

Our hospital has the unique capability of providing music therapy to postoperative and other hospitalized patients. In this study, we compared the impact of a structured postoperative music therapy program on spine patients relative to control patients who did not receive music therapy after spine surgery.

We found a significant benefit in VAS pain levels (>1 point) but no statistically significant differences in HADS Anxiety, HADS Depression, or TSK scores. Although a 2-point difference is usually considered clinically significant, the degree of change in the music group is notable for having been achieved by nonpharmacologic means with scant chance of adverse effects. We suspect the lack of significant change in HADS Anxiety, HADS Depression, and TSK scores is attributable to the narrow study window. Given the observational data from our pilot study⁵⁸ and ongoing results with spine patients,³² it seems clear that both mood state and resilience in coping are enhanced through an ongoing relationship with music therapy.

The study of a population as vulnerable as patients recovering from spine surgery raises many issues for providers and researchers. Although it is worthwhile to determine the efficacy of integrative modalities in serving these patients, the request for participation in a protocol at such a vulnerable time was often resisted. During our pilot work, it became clear that the ability of potential subjects to comprehend and complete protocol surveys was impacted by adverse effects, including sedation drowsiness; respiratory depression; nausea and vomiting; pruritus; and urinary retention caused by the medications used for postoperative pain management. Consequently, after piloting 5 cases before the main study, we extended the enrollment window to 72 hours.

Other unforeseen intrinsic or external obstacles were identified: Patient-related issues—including availability, level of interest in participation, and inability to participate because of the medication adverse effects mentioned.

Staff investment/education—addressed over the first 3 study years with several in-services, starting with the surgical team and continuing with nursing and support staff in various combinations. These meetings led to the creation of an Institutional Review Board (IRB) approved educational sheet for inclusion in the information packet given to surgical patients on registration.

Programming interruptions—caused by the convergence of several unanticipated factors, including a delay in expedited review of the IRB renewal during the year of Hurricane Sandy and an interruption in the spine team’s service for administrative and program modification.

Conclusion

Music therapy interventions (eg, use of patient-preferred live music) offered within a therapeutic relationship favorably affected pain perceptions in patients recovering from spine surgery. This effect was achieved through several therapeutic entry points, including support of expression and opportunities for emotional catharsis.

At the core of music therapy’s efficacy is individualized treatment, through which patients are supported in their recovery of “self.” Measurable benefits—including increased comfort; reduced pain; improved gait; increased range of motion, endurance, and ability to relax; and empowerment to actively participate in one’s own care through daily activities imbued with an enhanced sense of agency—are of cardinal importance, as they may lead to quicker recovery perceptions and enhanced quality of life.

Am J Orthop. 2017;46(1):E13-E22. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.

Pneumococcal conjugate vaccines (PCV) in immunized children show effectiveness against head and neck infections (HNIs), especially against pneumococcal HNIs (pHNIs) that require hospitalization, according to Tal Marom, MD, of Tel Aviv University, Zerifin, Israel, and associates.

In a retrospective study, researchers identified children aged 0-16 years who were hospitalized with HNIs between Jan. 1, 2007 and Dec. 31, 2014. HNIs accounted for 2.5%-4.7% of admissions to the pediatric department, and there was a downward trend in the incidence in the post-PCV years, compared with previous years. Of the 820 children admitted with HNIs, 11% children were identified with pHNIs, 5% with acute otitis media, 4% with acute mastoiditis, and 2% with meningitis; there were no cases of pneumococcal acute bacterial sinusitis or pneumococcal head and neck abscesses. In 2009-2010 (considered as the “transition years,” in which both PCV7 and PCV13 were implemented in Israel), pHNIs incidence sharply decreased, from 7/1,000 to 1.74/1,000 hospitalized children per year, because of a 55% reduction of pneumococcal acute otitis media episodes. There also was an additional decrease observed in the post-PCV years of 2012-2014 (1.62/1,000 hospitalized children per year).

It was noted that unimmunized children were more likely to suffer from pneumococcal infections than immunized children (P = .001). There were no significant differences in the clinical presentation of these two groups, except for the need for surgery, which was significantly greater in immunized children (P = .042).

“The findings of the current study provide further evidence of PCV effectiveness against HNIs in PCV immunized children, and particularly against pHNI which required hospitalization,” Dr. Marom and associates concluded. “A substantial reduction in the all-cause HNIs incidence, and more specifically in pHNIs, in PCV immunized children who required hospitalization, was evident in the present study. This was also followed by a significant reduction in [acute otitis media] rates and to a much lesser extent, in [acute mastoiditis] and meningitis rates.”

Find the full study in the Pediatric Infectious Disease Journal (2016. doi: 10.1097/INF.0000000000001425).

[email protected]

Pneumococcal conjugate vaccines (PCV) in immunized children show effectiveness against head and neck infections (HNIs), especially against pneumococcal HNIs (pHNIs) that require hospitalization, according to Tal Marom, MD, of Tel Aviv University, Zerifin, Israel, and associates.

In a retrospective study, researchers identified children aged 0-16 years who were hospitalized with HNIs between Jan. 1, 2007 and Dec. 31, 2014. HNIs accounted for 2.5%-4.7% of admissions to the pediatric department, and there was a downward trend in the incidence in the post-PCV years, compared with previous years. Of the 820 children admitted with HNIs, 11% children were identified with pHNIs, 5% with acute otitis media, 4% with acute mastoiditis, and 2% with meningitis; there were no cases of pneumococcal acute bacterial sinusitis or pneumococcal head and neck abscesses. In 2009-2010 (considered as the “transition years,” in which both PCV7 and PCV13 were implemented in Israel), pHNIs incidence sharply decreased, from 7/1,000 to 1.74/1,000 hospitalized children per year, because of a 55% reduction of pneumococcal acute otitis media episodes. There also was an additional decrease observed in the post-PCV years of 2012-2014 (1.62/1,000 hospitalized children per year).

It was noted that unimmunized children were more likely to suffer from pneumococcal infections than immunized children (P = .001). There were no significant differences in the clinical presentation of these two groups, except for the need for surgery, which was significantly greater in immunized children (P = .042).

“The findings of the current study provide further evidence of PCV effectiveness against HNIs in PCV immunized children, and particularly against pHNI which required hospitalization,” Dr. Marom and associates concluded. “A substantial reduction in the all-cause HNIs incidence, and more specifically in pHNIs, in PCV immunized children who required hospitalization, was evident in the present study. This was also followed by a significant reduction in [acute otitis media] rates and to a much lesser extent, in [acute mastoiditis] and meningitis rates.”

Find the full study in the Pediatric Infectious Disease Journal (2016. doi: 10.1097/INF.0000000000001425).

[email protected]

Pneumococcal conjugate vaccines (PCV) in immunized children show effectiveness against head and neck infections (HNIs), especially against pneumococcal HNIs (pHNIs) that require hospitalization, according to Tal Marom, MD, of Tel Aviv University, Zerifin, Israel, and associates.

In a retrospective study, researchers identified children aged 0-16 years who were hospitalized with HNIs between Jan. 1, 2007 and Dec. 31, 2014. HNIs accounted for 2.5%-4.7% of admissions to the pediatric department, and there was a downward trend in the incidence in the post-PCV years, compared with previous years. Of the 820 children admitted with HNIs, 11% children were identified with pHNIs, 5% with acute otitis media, 4% with acute mastoiditis, and 2% with meningitis; there were no cases of pneumococcal acute bacterial sinusitis or pneumococcal head and neck abscesses. In 2009-2010 (considered as the “transition years,” in which both PCV7 and PCV13 were implemented in Israel), pHNIs incidence sharply decreased, from 7/1,000 to 1.74/1,000 hospitalized children per year, because of a 55% reduction of pneumococcal acute otitis media episodes. There also was an additional decrease observed in the post-PCV years of 2012-2014 (1.62/1,000 hospitalized children per year).

It was noted that unimmunized children were more likely to suffer from pneumococcal infections than immunized children (P = .001). There were no significant differences in the clinical presentation of these two groups, except for the need for surgery, which was significantly greater in immunized children (P = .042).

“The findings of the current study provide further evidence of PCV effectiveness against HNIs in PCV immunized children, and particularly against pHNI which required hospitalization,” Dr. Marom and associates concluded. “A substantial reduction in the all-cause HNIs incidence, and more specifically in pHNIs, in PCV immunized children who required hospitalization, was evident in the present study. This was also followed by a significant reduction in [acute otitis media] rates and to a much lesser extent, in [acute mastoiditis] and meningitis rates.”

Find the full study in the Pediatric Infectious Disease Journal (2016. doi: 10.1097/INF.0000000000001425).

[email protected]