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Does nurse-physician rounding matter?
Advancing the Quadruple Aim
Inadequate and fragmented communication between physicians and nurses can lead to unwelcome events for the hospitalized patient and clinicians. Missing orders, medication errors, patient misidentification, and lack of physician awareness of significant changes in patient status are just some examples of how deficits in formal communication can affect health outcomes during acute stays.
A 2000 Institute of Medicine report showed that bad systems, not bad people, account for the majority of errors and injuries caused by complexity, professional fragmentation, and barriers in communication. Their recommendation was to train physicians, nurses, and other professionals in teamwork.1,2 However, as Milisa Manojlovich, PhD, RN, found, there are significant differences in how physicians and nurses perceive collaboration and communication.3
Nurse-physician rounding was historically standard for patient care during hospitalization. When physicians split time between inpatient and outpatient care, nurses had to maximize their time to collaborate and communicate with physicians whenever the physicians left their outpatient offices to come and round on their patients. Today most inpatient care is delivered by hospitalists on a 24-hour basis. This continuous availability of physicians reduces the perceived need to have joint rounds.
However, health care teams in acute care facilities now face higher and sicker patient volumes, different productivity models and demands, new compliance standards, changing work flows, and increased complexity of treatment and management of patients. This has led to gaps in timely communication and partnership.4-6 Erosion of the traditional nurse-physician relationships affects the quality of patient care, the patient’s experience, and patient safety.8-10 Poor communication among health care team members is one of the most common causes of patient care errors.4 Poor nurse-physician communication can also lead to medical errors, poor outcomes caused by lack of coordination within the treatment team, increased use of unnecessary resources with inefficiency, and increases in the complexity of communication among team members, and time wastage.5,7,11 All these lead to poor work flows and directly affect patient safety.7
At Lee Health System in Lee County, Fla., we saw an opportunity in this changing health care environment to promote nurse-physician rounding. We created a structured, standardized process for morning rounding and engaged unit clerks, nursing leadership, and hospitalist service line leaders. We envisioned improvement of the patient experience, nurse-physician relationship, quality of care, the discharge planning process, and efficiency, as well as decreasing length of stay, improving communication, and bringing the patient and the treatment team closer, as demonstrated by Bradley Monash, MD, et al.12
Some data suggest that patient-centered bedside rounds on hospitalized patients have no effect on patient perceptions or their satisfaction with care.13 However, we felt that collaboration among a multidisciplinary team would help us achieve better outcomes. For example, our patients would perceive the care team (MD-RN) as a cohesive unit, and in turn gain trust in the members of the treatment team, as found by Nathalie McIntosh, PhD, et al and by Jason Ramirez, MD.7,16 Our vision was to empower nurses to be advocates for patients and their family members as they navigated their acute care admission. Nurses could also support physicians by communicating the physicians’ care plans to families and patients. After rounding with the physician, the nurse would be part of the decision-making process and care planning.17
Every rounding session had discharge planning and hospital stay expectations that were shared with the patient and nurse, who could then partner with case managers and social workers, which would streamline and reduce length of stay.14 We hoped rounding would also decrease the number of nurse pages to clarify or question orders. This would, in turn, improve daily work flow for the physicians and the nursing team with improvements in employee satisfaction scores.15 A study also has demonstrated a reduction in readmission rates from nurse-physician rounding.19
A disconnect in communication and trust between physicians and the nursing staff was reflected in low patient experience scores and perceived quality of care received during in-hospital stay. Gwendolyn Lancaster, EdD, MSN, RN, CCRN, et al, as well as a Joint Commission report, demonstrated how a lack of communication and poor team dynamics can translate to poor patient experience and be a major cause for sentinel events.6,20 Artificial, forced hierarchies and role perception among health care team members led to frustration, hostility, and distrust, which compromises quality and patient safety.1
One of our biggest challenges when we started this project was explaining the “Why” to the hospitalist group and nursing staff. Physicians were used to being the dominant partner in the team. Partnering with and engaging nurses in shared decision making and care planning was a seismic shift in culture and work flow within the care team. Early gains helped skeptical team members begin to understand the value in nurse-physician rounding. Near universal adoption of the rounding process at Lee Health has caused improvements in the working relationship and trust among the health care professionals. We have seen improvements in utilization management, as well as appropriateness and timeliness of resource use, because of better communication and understanding of care plans by nursing and physicians. Collaboration with specialists and alignment in care planning are other gains. Hospitalists and nurses are both very satisfied with the decrease in the number of pages during the day, and this has lowered stressors on health care teams.
How we did it
Nurse-physician rounding is a proven method to improve collaboration, communication, and relationships among health care team members in acute care facilities. In the complex health care challenges faced today, this improved work flow for taking care of patients can help advance the Quadruple Aim of high quality, low cost, improved patient experience, physician, and staff satisfaction.21
Lee Health System includes four facilities in Lee County, with a total of 1,216 licensed adult acute care beds. The pilot project was started in 2014.
Initially the vice president of nursing and the hospitalist medical director met to create an education plan for nurses and physicians. We chose one adult medicine unit to pilot the project because there already existed a closely knit nursing and hospitalist team. In our facility there is no strict geographical rounding; each hospitalist carries between three and six patients in the unit. As a first step, a nurse floor assignment sheet was faxed in the morning to the hospitalist office with the direct phone numbers of the nurses. The unit clerk, using physician assignments in the EHR, teamed up the physician and nurses for rounding. Once the physician arrived at the unit, he or she checked in with the unit clerk, who alerted nurses that the hospitalist was available on the floor to commence rounding. If the primary nurse was unavailable because of other duties or breaks, the charge nurse rounded with the physician.
Once in the room with the patient, the duo introduced themselves as members of the treatment team and acknowledged the patient’s needs. During the visit, care plans and treatment were reviewed, the patient’s questions were answered, a physical exam was completed, and lab and imaging results were discussed; the nurse also helped raise questions he or she had received from family members so answers could be communicated to the family later. Patients appreciated knowing that their physicians and nurses were working together as a team for their safety and recovery. During the visit, care was taken to focus specially on the course of hospitalization and discharge planning.
We tracked the rounding with a manual paper process maintained by the charge nurse. Our initial rounding rates were 30%-40%, and we continued to promote this initiative to the team, and eventually the importance and value of these rounds caught on with both nurses and physicians, and now our current average rounding rate is 90%. We then decided to scale this to all units in the hospital.
This process was repeated at other hospitals in the system once a standardized work flow was created (See Image 1). This initiative was next presented to the health system board of directors, who agreed that nurse-physician rounding should be the standard of care across our health system. Through partnership and collaboration with the IT department, we developed a tool to track nurse-physician rounding through our EHR system, which gave accountability to both physicians and nurses.
In conclusion, improved communication by timely nurse-physician rounding can lead to better outcomes for patients and also reduce costs and improve patient and staff experience, advancing the Quadruple Aim. Moving forward to build and sustain this work flow, we plan to continue nurse-physician collaboration across the health system consistently and for all areas of acute care operations.
Explaining the “Why,” sharing data on the benefits of the model, and reinforcing documentation of the rounding in our EHR are some steps we have put into action at leadership and staff meetings to sustain the activity. We are soliciting feedback, as well as monitoring and identifying any unaddressed barriers during rounding. Addition of this process measure to our quality improvement bonus opportunity also has helped to sustain performance from our teams.
Dr. Laufer is system medical director of hospital medicine and transitional care at Lee Health in Ft. Myers, Fla. Dr. Prasad is chief medical officer of Lee Physician Group, Ft. Myers, Fla.
References
1. Leape LL et al. Five years after to err is human: What we have learned? JAMA. 2005;293(19):2384-90.
2. Sutcliffe KM et al. Communication failures: An insidious contributor to medical mishaps. Acad Med. 2004;79(2):186-94.
3. Manojlovich M. Reframing communication with physicians as sensemaking. J Nurs Care Qual. 2013 Oct-Dec;28(4):295-303.
4. Siegele P. Enhancing outcomes in a surgical intensive care unit by implementing daily goals. Crit Care Nurse. 2009 Dec;29(6):58-69.
5. Asthon J et al. Qualitative evaluation of regular morning meeting aimed at improving interdisciplinary communication and patient outcomes. Int J Nurs Pract. 2005 Oct;11(5):206-13.
6. Lancaster G et al. Interdisciplinary Communication and collaboration among physicians, nurses, and unlicensed assistive personnel. J Nurs Scholarsh. 2015 May;47(3):275-84.
7. McIntosh N et al. Impact of provider coordination on nurse and physician perception of patient care quality. J Nurs Care Qual. 2014 Jul-Sep;29(3):269-79.
8. Jo M et al. An organizational assessment of disruptive clinical behavior. J Nurs Care Qual. 2013 Apr-Jun;28(2):110-21.
9. World Health Organization. Framework for action on interprofessional education and collaborative practice. Geneva, 2010.
10. O’Connor P et al. A mixed-methods study of the causes and impact of poor teamwork between junior doctors and nurses. Int J Qual Health Care. 2016 Jun;28(3):339-45.
11. Manojlovich M. Nurse/Physician communication through a sense making lens. Med Care. 2010 Nov;48(11):941-6.
12. Monash B et al. Standardized attending rounds to improve the patient experience: A pragmatic cluster randomized controlled trial. J Hosp Med. 2017 Mar;12(3):143-9.
13. O’Leary KJ et al. Effect of patient-centered bedside rounds on hospitalized patients decision control, activation and satisfaction with care. BMJ Qual Saf. 2016 Dec;25(12):921-8.
14. Dutton RP et al. Daily multidisciplinary rounds shorten length of stay for trauma patients. J Trauma. 2003 Nov;55(5):913-9.
15. Manojlovich M et al. Healthy work environments, nurse-physician communication, and patients’ outcomes. Am J Crit Care. 2007 Nov;16(6):536-43.
16. Ramirez J et al. Patient satisfaction with bedside teaching rounds compared with nonbedside rounds. South Med J. 2016 Feb;109(2):112-5.
17. Sollami A et al. Nurse-Physician collaboration: A meta-analytical investigation of survey scores. J Interprof Care. 2015 May;29(3):223-9.
18. House S et al. Nurses and physicians perceptions of nurse-physician collaboration. J Nurs Adm. 2017 Mar;47(3):165-71.
19. Townsend-Gervis M et al. Interdisciplinary rounds and structured communications reduce re-admissions and improve some patients’ outcomes. West J Nurs Res. 2014 Aug;36(7):917-28.
20. The Joint Commission. Sentinel Events. http://www.jointcommission.org/sentinel_event.aspx. Accessed Oct 2017.
21. Bodenheimer T et al. From Triple to Quadruple Aim: Care of the patient requires care of the provider. Ann Fam Med. 2014 Nov-Dec;12(6):573-6.
Advancing the Quadruple Aim
Advancing the Quadruple Aim
Inadequate and fragmented communication between physicians and nurses can lead to unwelcome events for the hospitalized patient and clinicians. Missing orders, medication errors, patient misidentification, and lack of physician awareness of significant changes in patient status are just some examples of how deficits in formal communication can affect health outcomes during acute stays.
A 2000 Institute of Medicine report showed that bad systems, not bad people, account for the majority of errors and injuries caused by complexity, professional fragmentation, and barriers in communication. Their recommendation was to train physicians, nurses, and other professionals in teamwork.1,2 However, as Milisa Manojlovich, PhD, RN, found, there are significant differences in how physicians and nurses perceive collaboration and communication.3
Nurse-physician rounding was historically standard for patient care during hospitalization. When physicians split time between inpatient and outpatient care, nurses had to maximize their time to collaborate and communicate with physicians whenever the physicians left their outpatient offices to come and round on their patients. Today most inpatient care is delivered by hospitalists on a 24-hour basis. This continuous availability of physicians reduces the perceived need to have joint rounds.
However, health care teams in acute care facilities now face higher and sicker patient volumes, different productivity models and demands, new compliance standards, changing work flows, and increased complexity of treatment and management of patients. This has led to gaps in timely communication and partnership.4-6 Erosion of the traditional nurse-physician relationships affects the quality of patient care, the patient’s experience, and patient safety.8-10 Poor communication among health care team members is one of the most common causes of patient care errors.4 Poor nurse-physician communication can also lead to medical errors, poor outcomes caused by lack of coordination within the treatment team, increased use of unnecessary resources with inefficiency, and increases in the complexity of communication among team members, and time wastage.5,7,11 All these lead to poor work flows and directly affect patient safety.7
At Lee Health System in Lee County, Fla., we saw an opportunity in this changing health care environment to promote nurse-physician rounding. We created a structured, standardized process for morning rounding and engaged unit clerks, nursing leadership, and hospitalist service line leaders. We envisioned improvement of the patient experience, nurse-physician relationship, quality of care, the discharge planning process, and efficiency, as well as decreasing length of stay, improving communication, and bringing the patient and the treatment team closer, as demonstrated by Bradley Monash, MD, et al.12
Some data suggest that patient-centered bedside rounds on hospitalized patients have no effect on patient perceptions or their satisfaction with care.13 However, we felt that collaboration among a multidisciplinary team would help us achieve better outcomes. For example, our patients would perceive the care team (MD-RN) as a cohesive unit, and in turn gain trust in the members of the treatment team, as found by Nathalie McIntosh, PhD, et al and by Jason Ramirez, MD.7,16 Our vision was to empower nurses to be advocates for patients and their family members as they navigated their acute care admission. Nurses could also support physicians by communicating the physicians’ care plans to families and patients. After rounding with the physician, the nurse would be part of the decision-making process and care planning.17
Every rounding session had discharge planning and hospital stay expectations that were shared with the patient and nurse, who could then partner with case managers and social workers, which would streamline and reduce length of stay.14 We hoped rounding would also decrease the number of nurse pages to clarify or question orders. This would, in turn, improve daily work flow for the physicians and the nursing team with improvements in employee satisfaction scores.15 A study also has demonstrated a reduction in readmission rates from nurse-physician rounding.19
A disconnect in communication and trust between physicians and the nursing staff was reflected in low patient experience scores and perceived quality of care received during in-hospital stay. Gwendolyn Lancaster, EdD, MSN, RN, CCRN, et al, as well as a Joint Commission report, demonstrated how a lack of communication and poor team dynamics can translate to poor patient experience and be a major cause for sentinel events.6,20 Artificial, forced hierarchies and role perception among health care team members led to frustration, hostility, and distrust, which compromises quality and patient safety.1
One of our biggest challenges when we started this project was explaining the “Why” to the hospitalist group and nursing staff. Physicians were used to being the dominant partner in the team. Partnering with and engaging nurses in shared decision making and care planning was a seismic shift in culture and work flow within the care team. Early gains helped skeptical team members begin to understand the value in nurse-physician rounding. Near universal adoption of the rounding process at Lee Health has caused improvements in the working relationship and trust among the health care professionals. We have seen improvements in utilization management, as well as appropriateness and timeliness of resource use, because of better communication and understanding of care plans by nursing and physicians. Collaboration with specialists and alignment in care planning are other gains. Hospitalists and nurses are both very satisfied with the decrease in the number of pages during the day, and this has lowered stressors on health care teams.
How we did it
Nurse-physician rounding is a proven method to improve collaboration, communication, and relationships among health care team members in acute care facilities. In the complex health care challenges faced today, this improved work flow for taking care of patients can help advance the Quadruple Aim of high quality, low cost, improved patient experience, physician, and staff satisfaction.21
Lee Health System includes four facilities in Lee County, with a total of 1,216 licensed adult acute care beds. The pilot project was started in 2014.
Initially the vice president of nursing and the hospitalist medical director met to create an education plan for nurses and physicians. We chose one adult medicine unit to pilot the project because there already existed a closely knit nursing and hospitalist team. In our facility there is no strict geographical rounding; each hospitalist carries between three and six patients in the unit. As a first step, a nurse floor assignment sheet was faxed in the morning to the hospitalist office with the direct phone numbers of the nurses. The unit clerk, using physician assignments in the EHR, teamed up the physician and nurses for rounding. Once the physician arrived at the unit, he or she checked in with the unit clerk, who alerted nurses that the hospitalist was available on the floor to commence rounding. If the primary nurse was unavailable because of other duties or breaks, the charge nurse rounded with the physician.
Once in the room with the patient, the duo introduced themselves as members of the treatment team and acknowledged the patient’s needs. During the visit, care plans and treatment were reviewed, the patient’s questions were answered, a physical exam was completed, and lab and imaging results were discussed; the nurse also helped raise questions he or she had received from family members so answers could be communicated to the family later. Patients appreciated knowing that their physicians and nurses were working together as a team for their safety and recovery. During the visit, care was taken to focus specially on the course of hospitalization and discharge planning.
We tracked the rounding with a manual paper process maintained by the charge nurse. Our initial rounding rates were 30%-40%, and we continued to promote this initiative to the team, and eventually the importance and value of these rounds caught on with both nurses and physicians, and now our current average rounding rate is 90%. We then decided to scale this to all units in the hospital.
This process was repeated at other hospitals in the system once a standardized work flow was created (See Image 1). This initiative was next presented to the health system board of directors, who agreed that nurse-physician rounding should be the standard of care across our health system. Through partnership and collaboration with the IT department, we developed a tool to track nurse-physician rounding through our EHR system, which gave accountability to both physicians and nurses.
In conclusion, improved communication by timely nurse-physician rounding can lead to better outcomes for patients and also reduce costs and improve patient and staff experience, advancing the Quadruple Aim. Moving forward to build and sustain this work flow, we plan to continue nurse-physician collaboration across the health system consistently and for all areas of acute care operations.
Explaining the “Why,” sharing data on the benefits of the model, and reinforcing documentation of the rounding in our EHR are some steps we have put into action at leadership and staff meetings to sustain the activity. We are soliciting feedback, as well as monitoring and identifying any unaddressed barriers during rounding. Addition of this process measure to our quality improvement bonus opportunity also has helped to sustain performance from our teams.
Dr. Laufer is system medical director of hospital medicine and transitional care at Lee Health in Ft. Myers, Fla. Dr. Prasad is chief medical officer of Lee Physician Group, Ft. Myers, Fla.
References
1. Leape LL et al. Five years after to err is human: What we have learned? JAMA. 2005;293(19):2384-90.
2. Sutcliffe KM et al. Communication failures: An insidious contributor to medical mishaps. Acad Med. 2004;79(2):186-94.
3. Manojlovich M. Reframing communication with physicians as sensemaking. J Nurs Care Qual. 2013 Oct-Dec;28(4):295-303.
4. Siegele P. Enhancing outcomes in a surgical intensive care unit by implementing daily goals. Crit Care Nurse. 2009 Dec;29(6):58-69.
5. Asthon J et al. Qualitative evaluation of regular morning meeting aimed at improving interdisciplinary communication and patient outcomes. Int J Nurs Pract. 2005 Oct;11(5):206-13.
6. Lancaster G et al. Interdisciplinary Communication and collaboration among physicians, nurses, and unlicensed assistive personnel. J Nurs Scholarsh. 2015 May;47(3):275-84.
7. McIntosh N et al. Impact of provider coordination on nurse and physician perception of patient care quality. J Nurs Care Qual. 2014 Jul-Sep;29(3):269-79.
8. Jo M et al. An organizational assessment of disruptive clinical behavior. J Nurs Care Qual. 2013 Apr-Jun;28(2):110-21.
9. World Health Organization. Framework for action on interprofessional education and collaborative practice. Geneva, 2010.
10. O’Connor P et al. A mixed-methods study of the causes and impact of poor teamwork between junior doctors and nurses. Int J Qual Health Care. 2016 Jun;28(3):339-45.
11. Manojlovich M. Nurse/Physician communication through a sense making lens. Med Care. 2010 Nov;48(11):941-6.
12. Monash B et al. Standardized attending rounds to improve the patient experience: A pragmatic cluster randomized controlled trial. J Hosp Med. 2017 Mar;12(3):143-9.
13. O’Leary KJ et al. Effect of patient-centered bedside rounds on hospitalized patients decision control, activation and satisfaction with care. BMJ Qual Saf. 2016 Dec;25(12):921-8.
14. Dutton RP et al. Daily multidisciplinary rounds shorten length of stay for trauma patients. J Trauma. 2003 Nov;55(5):913-9.
15. Manojlovich M et al. Healthy work environments, nurse-physician communication, and patients’ outcomes. Am J Crit Care. 2007 Nov;16(6):536-43.
16. Ramirez J et al. Patient satisfaction with bedside teaching rounds compared with nonbedside rounds. South Med J. 2016 Feb;109(2):112-5.
17. Sollami A et al. Nurse-Physician collaboration: A meta-analytical investigation of survey scores. J Interprof Care. 2015 May;29(3):223-9.
18. House S et al. Nurses and physicians perceptions of nurse-physician collaboration. J Nurs Adm. 2017 Mar;47(3):165-71.
19. Townsend-Gervis M et al. Interdisciplinary rounds and structured communications reduce re-admissions and improve some patients’ outcomes. West J Nurs Res. 2014 Aug;36(7):917-28.
20. The Joint Commission. Sentinel Events. http://www.jointcommission.org/sentinel_event.aspx. Accessed Oct 2017.
21. Bodenheimer T et al. From Triple to Quadruple Aim: Care of the patient requires care of the provider. Ann Fam Med. 2014 Nov-Dec;12(6):573-6.
Inadequate and fragmented communication between physicians and nurses can lead to unwelcome events for the hospitalized patient and clinicians. Missing orders, medication errors, patient misidentification, and lack of physician awareness of significant changes in patient status are just some examples of how deficits in formal communication can affect health outcomes during acute stays.
A 2000 Institute of Medicine report showed that bad systems, not bad people, account for the majority of errors and injuries caused by complexity, professional fragmentation, and barriers in communication. Their recommendation was to train physicians, nurses, and other professionals in teamwork.1,2 However, as Milisa Manojlovich, PhD, RN, found, there are significant differences in how physicians and nurses perceive collaboration and communication.3
Nurse-physician rounding was historically standard for patient care during hospitalization. When physicians split time between inpatient and outpatient care, nurses had to maximize their time to collaborate and communicate with physicians whenever the physicians left their outpatient offices to come and round on their patients. Today most inpatient care is delivered by hospitalists on a 24-hour basis. This continuous availability of physicians reduces the perceived need to have joint rounds.
However, health care teams in acute care facilities now face higher and sicker patient volumes, different productivity models and demands, new compliance standards, changing work flows, and increased complexity of treatment and management of patients. This has led to gaps in timely communication and partnership.4-6 Erosion of the traditional nurse-physician relationships affects the quality of patient care, the patient’s experience, and patient safety.8-10 Poor communication among health care team members is one of the most common causes of patient care errors.4 Poor nurse-physician communication can also lead to medical errors, poor outcomes caused by lack of coordination within the treatment team, increased use of unnecessary resources with inefficiency, and increases in the complexity of communication among team members, and time wastage.5,7,11 All these lead to poor work flows and directly affect patient safety.7
At Lee Health System in Lee County, Fla., we saw an opportunity in this changing health care environment to promote nurse-physician rounding. We created a structured, standardized process for morning rounding and engaged unit clerks, nursing leadership, and hospitalist service line leaders. We envisioned improvement of the patient experience, nurse-physician relationship, quality of care, the discharge planning process, and efficiency, as well as decreasing length of stay, improving communication, and bringing the patient and the treatment team closer, as demonstrated by Bradley Monash, MD, et al.12
Some data suggest that patient-centered bedside rounds on hospitalized patients have no effect on patient perceptions or their satisfaction with care.13 However, we felt that collaboration among a multidisciplinary team would help us achieve better outcomes. For example, our patients would perceive the care team (MD-RN) as a cohesive unit, and in turn gain trust in the members of the treatment team, as found by Nathalie McIntosh, PhD, et al and by Jason Ramirez, MD.7,16 Our vision was to empower nurses to be advocates for patients and their family members as they navigated their acute care admission. Nurses could also support physicians by communicating the physicians’ care plans to families and patients. After rounding with the physician, the nurse would be part of the decision-making process and care planning.17
Every rounding session had discharge planning and hospital stay expectations that were shared with the patient and nurse, who could then partner with case managers and social workers, which would streamline and reduce length of stay.14 We hoped rounding would also decrease the number of nurse pages to clarify or question orders. This would, in turn, improve daily work flow for the physicians and the nursing team with improvements in employee satisfaction scores.15 A study also has demonstrated a reduction in readmission rates from nurse-physician rounding.19
A disconnect in communication and trust between physicians and the nursing staff was reflected in low patient experience scores and perceived quality of care received during in-hospital stay. Gwendolyn Lancaster, EdD, MSN, RN, CCRN, et al, as well as a Joint Commission report, demonstrated how a lack of communication and poor team dynamics can translate to poor patient experience and be a major cause for sentinel events.6,20 Artificial, forced hierarchies and role perception among health care team members led to frustration, hostility, and distrust, which compromises quality and patient safety.1
One of our biggest challenges when we started this project was explaining the “Why” to the hospitalist group and nursing staff. Physicians were used to being the dominant partner in the team. Partnering with and engaging nurses in shared decision making and care planning was a seismic shift in culture and work flow within the care team. Early gains helped skeptical team members begin to understand the value in nurse-physician rounding. Near universal adoption of the rounding process at Lee Health has caused improvements in the working relationship and trust among the health care professionals. We have seen improvements in utilization management, as well as appropriateness and timeliness of resource use, because of better communication and understanding of care plans by nursing and physicians. Collaboration with specialists and alignment in care planning are other gains. Hospitalists and nurses are both very satisfied with the decrease in the number of pages during the day, and this has lowered stressors on health care teams.
How we did it
Nurse-physician rounding is a proven method to improve collaboration, communication, and relationships among health care team members in acute care facilities. In the complex health care challenges faced today, this improved work flow for taking care of patients can help advance the Quadruple Aim of high quality, low cost, improved patient experience, physician, and staff satisfaction.21
Lee Health System includes four facilities in Lee County, with a total of 1,216 licensed adult acute care beds. The pilot project was started in 2014.
Initially the vice president of nursing and the hospitalist medical director met to create an education plan for nurses and physicians. We chose one adult medicine unit to pilot the project because there already existed a closely knit nursing and hospitalist team. In our facility there is no strict geographical rounding; each hospitalist carries between three and six patients in the unit. As a first step, a nurse floor assignment sheet was faxed in the morning to the hospitalist office with the direct phone numbers of the nurses. The unit clerk, using physician assignments in the EHR, teamed up the physician and nurses for rounding. Once the physician arrived at the unit, he or she checked in with the unit clerk, who alerted nurses that the hospitalist was available on the floor to commence rounding. If the primary nurse was unavailable because of other duties or breaks, the charge nurse rounded with the physician.
Once in the room with the patient, the duo introduced themselves as members of the treatment team and acknowledged the patient’s needs. During the visit, care plans and treatment were reviewed, the patient’s questions were answered, a physical exam was completed, and lab and imaging results were discussed; the nurse also helped raise questions he or she had received from family members so answers could be communicated to the family later. Patients appreciated knowing that their physicians and nurses were working together as a team for their safety and recovery. During the visit, care was taken to focus specially on the course of hospitalization and discharge planning.
We tracked the rounding with a manual paper process maintained by the charge nurse. Our initial rounding rates were 30%-40%, and we continued to promote this initiative to the team, and eventually the importance and value of these rounds caught on with both nurses and physicians, and now our current average rounding rate is 90%. We then decided to scale this to all units in the hospital.
This process was repeated at other hospitals in the system once a standardized work flow was created (See Image 1). This initiative was next presented to the health system board of directors, who agreed that nurse-physician rounding should be the standard of care across our health system. Through partnership and collaboration with the IT department, we developed a tool to track nurse-physician rounding through our EHR system, which gave accountability to both physicians and nurses.
In conclusion, improved communication by timely nurse-physician rounding can lead to better outcomes for patients and also reduce costs and improve patient and staff experience, advancing the Quadruple Aim. Moving forward to build and sustain this work flow, we plan to continue nurse-physician collaboration across the health system consistently and for all areas of acute care operations.
Explaining the “Why,” sharing data on the benefits of the model, and reinforcing documentation of the rounding in our EHR are some steps we have put into action at leadership and staff meetings to sustain the activity. We are soliciting feedback, as well as monitoring and identifying any unaddressed barriers during rounding. Addition of this process measure to our quality improvement bonus opportunity also has helped to sustain performance from our teams.
Dr. Laufer is system medical director of hospital medicine and transitional care at Lee Health in Ft. Myers, Fla. Dr. Prasad is chief medical officer of Lee Physician Group, Ft. Myers, Fla.
References
1. Leape LL et al. Five years after to err is human: What we have learned? JAMA. 2005;293(19):2384-90.
2. Sutcliffe KM et al. Communication failures: An insidious contributor to medical mishaps. Acad Med. 2004;79(2):186-94.
3. Manojlovich M. Reframing communication with physicians as sensemaking. J Nurs Care Qual. 2013 Oct-Dec;28(4):295-303.
4. Siegele P. Enhancing outcomes in a surgical intensive care unit by implementing daily goals. Crit Care Nurse. 2009 Dec;29(6):58-69.
5. Asthon J et al. Qualitative evaluation of regular morning meeting aimed at improving interdisciplinary communication and patient outcomes. Int J Nurs Pract. 2005 Oct;11(5):206-13.
6. Lancaster G et al. Interdisciplinary Communication and collaboration among physicians, nurses, and unlicensed assistive personnel. J Nurs Scholarsh. 2015 May;47(3):275-84.
7. McIntosh N et al. Impact of provider coordination on nurse and physician perception of patient care quality. J Nurs Care Qual. 2014 Jul-Sep;29(3):269-79.
8. Jo M et al. An organizational assessment of disruptive clinical behavior. J Nurs Care Qual. 2013 Apr-Jun;28(2):110-21.
9. World Health Organization. Framework for action on interprofessional education and collaborative practice. Geneva, 2010.
10. O’Connor P et al. A mixed-methods study of the causes and impact of poor teamwork between junior doctors and nurses. Int J Qual Health Care. 2016 Jun;28(3):339-45.
11. Manojlovich M. Nurse/Physician communication through a sense making lens. Med Care. 2010 Nov;48(11):941-6.
12. Monash B et al. Standardized attending rounds to improve the patient experience: A pragmatic cluster randomized controlled trial. J Hosp Med. 2017 Mar;12(3):143-9.
13. O’Leary KJ et al. Effect of patient-centered bedside rounds on hospitalized patients decision control, activation and satisfaction with care. BMJ Qual Saf. 2016 Dec;25(12):921-8.
14. Dutton RP et al. Daily multidisciplinary rounds shorten length of stay for trauma patients. J Trauma. 2003 Nov;55(5):913-9.
15. Manojlovich M et al. Healthy work environments, nurse-physician communication, and patients’ outcomes. Am J Crit Care. 2007 Nov;16(6):536-43.
16. Ramirez J et al. Patient satisfaction with bedside teaching rounds compared with nonbedside rounds. South Med J. 2016 Feb;109(2):112-5.
17. Sollami A et al. Nurse-Physician collaboration: A meta-analytical investigation of survey scores. J Interprof Care. 2015 May;29(3):223-9.
18. House S et al. Nurses and physicians perceptions of nurse-physician collaboration. J Nurs Adm. 2017 Mar;47(3):165-71.
19. Townsend-Gervis M et al. Interdisciplinary rounds and structured communications reduce re-admissions and improve some patients’ outcomes. West J Nurs Res. 2014 Aug;36(7):917-28.
20. The Joint Commission. Sentinel Events. http://www.jointcommission.org/sentinel_event.aspx. Accessed Oct 2017.
21. Bodenheimer T et al. From Triple to Quadruple Aim: Care of the patient requires care of the provider. Ann Fam Med. 2014 Nov-Dec;12(6):573-6.
Skin signs may be good omens during cancer therapy
Signs of efficacy of anti-cancer therapies may be only skin deep, results of a retrospective review indicate.
Cutaneous toxicities such as vitiligo, rash, alopecia, and nail toxicities may be early signs of efficacy of targeted therapies, immunotherapy, or cytotoxic chemotherapy, according to Alexandra K. Rzepecki, of the University of Michigan, and her coauthors from Albert Einstein Medical College in the Bronx, New York.
“Because cutaneous toxicities are a clinically visible parameter, they may alert clinicians to the possibility of treatment success or failure in a rapid, cost-effective, and noninvasive manner,” they wrote. The report is in the Journal of the American Academy of Dermatology.
The investigators reviewed the medical literature for clinical studies of three major classes of anti-cancer therapies that included data on associations between cutaneous toxicities and clinical outcomes such progression-free survival (PFS) overall survival (OS).
The drug classes and their associations with cutaneous toxicities and clinical outcomes were as follows:
- Targeted therapies, including tyrosine kinase inhibitors targeting the epidermal growth factor receptor (EGFR) such as cetuximab (Erbitux) and erlotinib (Tarceva), and multikinase targeted agents such as sorafenib (Nexavar) and sunitinib (Sutent). Toxicities associated with clinical benefit from EGFR inhibitors include rash, xerosis, leukocytoclastic vasculitis, paronychia, and pruritus, whereas skin toxicities associated with the multikinase inhibitors trended toward the hand-foot syndrome and hand-foot skin reaction.
- Immunotherapies included blockers of cytotoxic T-lymphocyte associated protein 4 (CTLA4) such as ipilimumab (Yervoy) and inhibitors of programmed death 1 protein (PD-1) and its ligand 1 (PD-L1) such as nivolumab (Opdivo), pembrolizumab (Keytruda), and atezolizumab (Tecentriq). In studies of pembrolizumab for various malignancies, rash or vitiligo was an independent prognostic factor for longer OS, a higher proportion of objective responses, and longer PFS. Similar associations were seen with nivolumab, with the additional association of hair repigmentation among patients with non–small-cell lung cancer being associated with stable disease responses or better. Among patients with melanoma treated with ipilimumab, hair depigmentation correlated with durable responses.
- Cytotoxic chemotherapy agents included the anthracycline doxorubicin, taxanes such as paclitaxel and docetaxel, platinum agents (cisplatin and carboplatin), and fluoropyrimidines such as capecitabine. Patients treated for various cancers with doxorubicin who had alopecia were significantly more likely to have clinical remissions than were patients who did not lose their hair, and patients treated with this agent who developed hand-foot syndrome had significantly longer PFS. For patients treated with docetaxel, severity of nail changes and/or development of nail alterations were associated with both improved OS and PFS. Patients treated with the combination of paclitaxel and a platinum agent who developed grade 2 or greater alopecia up to cycle 3 had significantly longer OS than did patients who had hair loss later in the course of therapy. Patients treated with capecitabine who developed had hand-foot skin reactions had improved progression-free and disease-free survival.
“Although further studies are needed to better evaluate these promising associations, vigilant monitoring of cutaneous toxicities should be a priority, as their development may indicate a favorable response to treatment. Dermatologists have a unique opportunity to collaborate with oncologists to help identify and manage these toxicities, thereby allowing patients to receive life-prolonging anticancer therapy while minimizing dose reduction or interruption of their treatment,” the authors wrote.
They reported no study funding source and no conflicts of interest.
SOURCE: Rzepecki A, et al. J Am Acad Dermatol. 2018;79:545-555.
Signs of efficacy of anti-cancer therapies may be only skin deep, results of a retrospective review indicate.
Cutaneous toxicities such as vitiligo, rash, alopecia, and nail toxicities may be early signs of efficacy of targeted therapies, immunotherapy, or cytotoxic chemotherapy, according to Alexandra K. Rzepecki, of the University of Michigan, and her coauthors from Albert Einstein Medical College in the Bronx, New York.
“Because cutaneous toxicities are a clinically visible parameter, they may alert clinicians to the possibility of treatment success or failure in a rapid, cost-effective, and noninvasive manner,” they wrote. The report is in the Journal of the American Academy of Dermatology.
The investigators reviewed the medical literature for clinical studies of three major classes of anti-cancer therapies that included data on associations between cutaneous toxicities and clinical outcomes such progression-free survival (PFS) overall survival (OS).
The drug classes and their associations with cutaneous toxicities and clinical outcomes were as follows:
- Targeted therapies, including tyrosine kinase inhibitors targeting the epidermal growth factor receptor (EGFR) such as cetuximab (Erbitux) and erlotinib (Tarceva), and multikinase targeted agents such as sorafenib (Nexavar) and sunitinib (Sutent). Toxicities associated with clinical benefit from EGFR inhibitors include rash, xerosis, leukocytoclastic vasculitis, paronychia, and pruritus, whereas skin toxicities associated with the multikinase inhibitors trended toward the hand-foot syndrome and hand-foot skin reaction.
- Immunotherapies included blockers of cytotoxic T-lymphocyte associated protein 4 (CTLA4) such as ipilimumab (Yervoy) and inhibitors of programmed death 1 protein (PD-1) and its ligand 1 (PD-L1) such as nivolumab (Opdivo), pembrolizumab (Keytruda), and atezolizumab (Tecentriq). In studies of pembrolizumab for various malignancies, rash or vitiligo was an independent prognostic factor for longer OS, a higher proportion of objective responses, and longer PFS. Similar associations were seen with nivolumab, with the additional association of hair repigmentation among patients with non–small-cell lung cancer being associated with stable disease responses or better. Among patients with melanoma treated with ipilimumab, hair depigmentation correlated with durable responses.
- Cytotoxic chemotherapy agents included the anthracycline doxorubicin, taxanes such as paclitaxel and docetaxel, platinum agents (cisplatin and carboplatin), and fluoropyrimidines such as capecitabine. Patients treated for various cancers with doxorubicin who had alopecia were significantly more likely to have clinical remissions than were patients who did not lose their hair, and patients treated with this agent who developed hand-foot syndrome had significantly longer PFS. For patients treated with docetaxel, severity of nail changes and/or development of nail alterations were associated with both improved OS and PFS. Patients treated with the combination of paclitaxel and a platinum agent who developed grade 2 or greater alopecia up to cycle 3 had significantly longer OS than did patients who had hair loss later in the course of therapy. Patients treated with capecitabine who developed had hand-foot skin reactions had improved progression-free and disease-free survival.
“Although further studies are needed to better evaluate these promising associations, vigilant monitoring of cutaneous toxicities should be a priority, as their development may indicate a favorable response to treatment. Dermatologists have a unique opportunity to collaborate with oncologists to help identify and manage these toxicities, thereby allowing patients to receive life-prolonging anticancer therapy while minimizing dose reduction or interruption of their treatment,” the authors wrote.
They reported no study funding source and no conflicts of interest.
SOURCE: Rzepecki A, et al. J Am Acad Dermatol. 2018;79:545-555.
Signs of efficacy of anti-cancer therapies may be only skin deep, results of a retrospective review indicate.
Cutaneous toxicities such as vitiligo, rash, alopecia, and nail toxicities may be early signs of efficacy of targeted therapies, immunotherapy, or cytotoxic chemotherapy, according to Alexandra K. Rzepecki, of the University of Michigan, and her coauthors from Albert Einstein Medical College in the Bronx, New York.
“Because cutaneous toxicities are a clinically visible parameter, they may alert clinicians to the possibility of treatment success or failure in a rapid, cost-effective, and noninvasive manner,” they wrote. The report is in the Journal of the American Academy of Dermatology.
The investigators reviewed the medical literature for clinical studies of three major classes of anti-cancer therapies that included data on associations between cutaneous toxicities and clinical outcomes such progression-free survival (PFS) overall survival (OS).
The drug classes and their associations with cutaneous toxicities and clinical outcomes were as follows:
- Targeted therapies, including tyrosine kinase inhibitors targeting the epidermal growth factor receptor (EGFR) such as cetuximab (Erbitux) and erlotinib (Tarceva), and multikinase targeted agents such as sorafenib (Nexavar) and sunitinib (Sutent). Toxicities associated with clinical benefit from EGFR inhibitors include rash, xerosis, leukocytoclastic vasculitis, paronychia, and pruritus, whereas skin toxicities associated with the multikinase inhibitors trended toward the hand-foot syndrome and hand-foot skin reaction.
- Immunotherapies included blockers of cytotoxic T-lymphocyte associated protein 4 (CTLA4) such as ipilimumab (Yervoy) and inhibitors of programmed death 1 protein (PD-1) and its ligand 1 (PD-L1) such as nivolumab (Opdivo), pembrolizumab (Keytruda), and atezolizumab (Tecentriq). In studies of pembrolizumab for various malignancies, rash or vitiligo was an independent prognostic factor for longer OS, a higher proportion of objective responses, and longer PFS. Similar associations were seen with nivolumab, with the additional association of hair repigmentation among patients with non–small-cell lung cancer being associated with stable disease responses or better. Among patients with melanoma treated with ipilimumab, hair depigmentation correlated with durable responses.
- Cytotoxic chemotherapy agents included the anthracycline doxorubicin, taxanes such as paclitaxel and docetaxel, platinum agents (cisplatin and carboplatin), and fluoropyrimidines such as capecitabine. Patients treated for various cancers with doxorubicin who had alopecia were significantly more likely to have clinical remissions than were patients who did not lose their hair, and patients treated with this agent who developed hand-foot syndrome had significantly longer PFS. For patients treated with docetaxel, severity of nail changes and/or development of nail alterations were associated with both improved OS and PFS. Patients treated with the combination of paclitaxel and a platinum agent who developed grade 2 or greater alopecia up to cycle 3 had significantly longer OS than did patients who had hair loss later in the course of therapy. Patients treated with capecitabine who developed had hand-foot skin reactions had improved progression-free and disease-free survival.
“Although further studies are needed to better evaluate these promising associations, vigilant monitoring of cutaneous toxicities should be a priority, as their development may indicate a favorable response to treatment. Dermatologists have a unique opportunity to collaborate with oncologists to help identify and manage these toxicities, thereby allowing patients to receive life-prolonging anticancer therapy while minimizing dose reduction or interruption of their treatment,” the authors wrote.
They reported no study funding source and no conflicts of interest.
SOURCE: Rzepecki A, et al. J Am Acad Dermatol. 2018;79:545-555.
FROM JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
Key clinical point: Cutaneous adverse events may be early signs of drug efficacy in patients treated for various cancers.
Major finding: Cutaneous toxicities with targeted therapies, immunotherapy, and cytotoxic drugs were associated in multiple studies with improved outcomes, including progression-free and overall survival.
Study details: Retrospective review of medical literature for clinical studies reporting associations between cutaneous toxicities and clinical outcomes of cancer therapy.
Disclosures: The authors reported no study funding source and no conflicts of interest.
Source: Rzepecki A et al. J Am Acad Dermatol. 2018 Sep;79[3]:545-55.
Dr. Hal C. Lawrence III retires from ACOG
The American College of Obstetricians and Gynecologists has announced that, after 11 years with ACOG, Hal C. Lawrence III, MD, is retiring from his positions as executive vice president and chief executive officer.
“It has been an honor to lead the association and our dedicated team of employees to support members and advance women’s health,” Dr. Lawrence said in a statement from ACOG. “I am proud of all that we have achieved together.”
Under his leadership, ACOG has seen the creation of the Council on Patient Safety in Women’s Health Care and the Alliance for Innovation on Maternal Health, development of ACOG’s Global Operations Advisory Group and immunization expert work group, and creation of the Women’s Preventive Services Initiative. He also helped to restructure and revitalize the ACOG annual meeting, which has been credited for increased member attendance and improved attendee satisfaction.
His retirement becomes effective Oct. 31, 2018.
Prior to his leadership roles at ACOG, Dr. Lawrence was a practicing ob.gyn. in Asheville, N.C., from 1979 to 2007 and was a member of the Ob.Gyn. News editorial advisory board.
The American College of Obstetricians and Gynecologists has announced that, after 11 years with ACOG, Hal C. Lawrence III, MD, is retiring from his positions as executive vice president and chief executive officer.
“It has been an honor to lead the association and our dedicated team of employees to support members and advance women’s health,” Dr. Lawrence said in a statement from ACOG. “I am proud of all that we have achieved together.”
Under his leadership, ACOG has seen the creation of the Council on Patient Safety in Women’s Health Care and the Alliance for Innovation on Maternal Health, development of ACOG’s Global Operations Advisory Group and immunization expert work group, and creation of the Women’s Preventive Services Initiative. He also helped to restructure and revitalize the ACOG annual meeting, which has been credited for increased member attendance and improved attendee satisfaction.
His retirement becomes effective Oct. 31, 2018.
Prior to his leadership roles at ACOG, Dr. Lawrence was a practicing ob.gyn. in Asheville, N.C., from 1979 to 2007 and was a member of the Ob.Gyn. News editorial advisory board.
The American College of Obstetricians and Gynecologists has announced that, after 11 years with ACOG, Hal C. Lawrence III, MD, is retiring from his positions as executive vice president and chief executive officer.
“It has been an honor to lead the association and our dedicated team of employees to support members and advance women’s health,” Dr. Lawrence said in a statement from ACOG. “I am proud of all that we have achieved together.”
Under his leadership, ACOG has seen the creation of the Council on Patient Safety in Women’s Health Care and the Alliance for Innovation on Maternal Health, development of ACOG’s Global Operations Advisory Group and immunization expert work group, and creation of the Women’s Preventive Services Initiative. He also helped to restructure and revitalize the ACOG annual meeting, which has been credited for increased member attendance and improved attendee satisfaction.
His retirement becomes effective Oct. 31, 2018.
Prior to his leadership roles at ACOG, Dr. Lawrence was a practicing ob.gyn. in Asheville, N.C., from 1979 to 2007 and was a member of the Ob.Gyn. News editorial advisory board.
Slowing down
This past Labor Day weekend, I did something radical. I slowed down. Way down. My wife slowed down with me, which helped. We spent the weekend close to home walking, talking, reading, contemplating, planning, assessing, doing puzzles and crosswords, and imbibing a craft beer or two, slowly, of course. Why? Because of Adam Grant, PhD, the organizational psychologist at the University of Pennsylvania’s Wharton School of Business, Philadelphia. I had recently reread his 2016 book I’m a big fan; he’s one of those professors who makes you fervently wish you were a student again, someone who will provoke you and challenge your way of thinking.
Dr. Grant’s basic premise, which he has proved through research, is that procrastination boosts productivity. Here’s how: Let’s say you’re facing a challenge or difficult task. He says to start working on it immediately, then take some time away for reflection. This “quick to start and slow to finish” method allows your brain to continually percolate on the problem. An incomplete task stays partially active in your brain. When you come back to it you often see it with fresh eyes. You will experience your highest productivity when you are toggling between these two modes.
This makes sense, and Dr. Grant cites numerous examples from Leonardo da Vinci to the founders of Warby-Parker, as examples of success. But how can it benefit physicians? Many of us are “precrastinators,” people who tend to complete or at least begin tasks as soon as possible, even when it’s unnecessary or not urgent. Unlike some jobs in which it’s easier to take a break from a project and return to it with more creative solutions, we often are racing against a clock to see more patients, read more slides, answer more emails, and make more phone calls. We are perpetually frenetic, which is not conducive to original thinking.
If this sounds like you, then you are likely to benefit from deliberate procrastination. Here are a few ways to slow down:
- Put it on your calendar. Yes, I see the irony, but it works. Start by scheduling one hour a week where you are to accomplish nothing. You can fill this time with whatever your mind wants to do at that moment.
- When faced with a diagnostic dilemma or treatment failure, resist the urge to solve that problem in that moment. Save that note for later, tell the patient you will call him back or bring him back for a visit later. Even if you’re not actively working on it, it will incubate somewhere in your brain, allowing more divergent thought processes to take over. It’s a little like trying to solve a crossword that seems impossible in the moment and then answers suddenly appear without effort.
- Take up a hobby: Play the guitar, learn to make pasta, climb a big rock. When you are fully engaged in such pursuits it requires complete mental focus. When you revisit the difficult problem you’re working on, you will likely see it from different perspectives.
- Meditate: Meditation requires our brains and bodies to slow down. It can help reduce self-doubt and criticism which stifle problem solving.
- Watch Slow TV. Slow TV is a Scandinavian phenomenon where you sit and watch meditative video such as a 7-hour train cam from Bergen, Norway, to Oslo. There’s no dialogue, no plot, no commercials. It’s just 7 hours of track and train and is weirdly comforting.
If you want to learn more, then when you get a chance, Google “slow living” and explore. Of course, some of you precrastinators probably have already started before finishing this column.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].
This past Labor Day weekend, I did something radical. I slowed down. Way down. My wife slowed down with me, which helped. We spent the weekend close to home walking, talking, reading, contemplating, planning, assessing, doing puzzles and crosswords, and imbibing a craft beer or two, slowly, of course. Why? Because of Adam Grant, PhD, the organizational psychologist at the University of Pennsylvania’s Wharton School of Business, Philadelphia. I had recently reread his 2016 book I’m a big fan; he’s one of those professors who makes you fervently wish you were a student again, someone who will provoke you and challenge your way of thinking.
Dr. Grant’s basic premise, which he has proved through research, is that procrastination boosts productivity. Here’s how: Let’s say you’re facing a challenge or difficult task. He says to start working on it immediately, then take some time away for reflection. This “quick to start and slow to finish” method allows your brain to continually percolate on the problem. An incomplete task stays partially active in your brain. When you come back to it you often see it with fresh eyes. You will experience your highest productivity when you are toggling between these two modes.
This makes sense, and Dr. Grant cites numerous examples from Leonardo da Vinci to the founders of Warby-Parker, as examples of success. But how can it benefit physicians? Many of us are “precrastinators,” people who tend to complete or at least begin tasks as soon as possible, even when it’s unnecessary or not urgent. Unlike some jobs in which it’s easier to take a break from a project and return to it with more creative solutions, we often are racing against a clock to see more patients, read more slides, answer more emails, and make more phone calls. We are perpetually frenetic, which is not conducive to original thinking.
If this sounds like you, then you are likely to benefit from deliberate procrastination. Here are a few ways to slow down:
- Put it on your calendar. Yes, I see the irony, but it works. Start by scheduling one hour a week where you are to accomplish nothing. You can fill this time with whatever your mind wants to do at that moment.
- When faced with a diagnostic dilemma or treatment failure, resist the urge to solve that problem in that moment. Save that note for later, tell the patient you will call him back or bring him back for a visit later. Even if you’re not actively working on it, it will incubate somewhere in your brain, allowing more divergent thought processes to take over. It’s a little like trying to solve a crossword that seems impossible in the moment and then answers suddenly appear without effort.
- Take up a hobby: Play the guitar, learn to make pasta, climb a big rock. When you are fully engaged in such pursuits it requires complete mental focus. When you revisit the difficult problem you’re working on, you will likely see it from different perspectives.
- Meditate: Meditation requires our brains and bodies to slow down. It can help reduce self-doubt and criticism which stifle problem solving.
- Watch Slow TV. Slow TV is a Scandinavian phenomenon where you sit and watch meditative video such as a 7-hour train cam from Bergen, Norway, to Oslo. There’s no dialogue, no plot, no commercials. It’s just 7 hours of track and train and is weirdly comforting.
If you want to learn more, then when you get a chance, Google “slow living” and explore. Of course, some of you precrastinators probably have already started before finishing this column.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].
This past Labor Day weekend, I did something radical. I slowed down. Way down. My wife slowed down with me, which helped. We spent the weekend close to home walking, talking, reading, contemplating, planning, assessing, doing puzzles and crosswords, and imbibing a craft beer or two, slowly, of course. Why? Because of Adam Grant, PhD, the organizational psychologist at the University of Pennsylvania’s Wharton School of Business, Philadelphia. I had recently reread his 2016 book I’m a big fan; he’s one of those professors who makes you fervently wish you were a student again, someone who will provoke you and challenge your way of thinking.
Dr. Grant’s basic premise, which he has proved through research, is that procrastination boosts productivity. Here’s how: Let’s say you’re facing a challenge or difficult task. He says to start working on it immediately, then take some time away for reflection. This “quick to start and slow to finish” method allows your brain to continually percolate on the problem. An incomplete task stays partially active in your brain. When you come back to it you often see it with fresh eyes. You will experience your highest productivity when you are toggling between these two modes.
This makes sense, and Dr. Grant cites numerous examples from Leonardo da Vinci to the founders of Warby-Parker, as examples of success. But how can it benefit physicians? Many of us are “precrastinators,” people who tend to complete or at least begin tasks as soon as possible, even when it’s unnecessary or not urgent. Unlike some jobs in which it’s easier to take a break from a project and return to it with more creative solutions, we often are racing against a clock to see more patients, read more slides, answer more emails, and make more phone calls. We are perpetually frenetic, which is not conducive to original thinking.
If this sounds like you, then you are likely to benefit from deliberate procrastination. Here are a few ways to slow down:
- Put it on your calendar. Yes, I see the irony, but it works. Start by scheduling one hour a week where you are to accomplish nothing. You can fill this time with whatever your mind wants to do at that moment.
- When faced with a diagnostic dilemma or treatment failure, resist the urge to solve that problem in that moment. Save that note for later, tell the patient you will call him back or bring him back for a visit later. Even if you’re not actively working on it, it will incubate somewhere in your brain, allowing more divergent thought processes to take over. It’s a little like trying to solve a crossword that seems impossible in the moment and then answers suddenly appear without effort.
- Take up a hobby: Play the guitar, learn to make pasta, climb a big rock. When you are fully engaged in such pursuits it requires complete mental focus. When you revisit the difficult problem you’re working on, you will likely see it from different perspectives.
- Meditate: Meditation requires our brains and bodies to slow down. It can help reduce self-doubt and criticism which stifle problem solving.
- Watch Slow TV. Slow TV is a Scandinavian phenomenon where you sit and watch meditative video such as a 7-hour train cam from Bergen, Norway, to Oslo. There’s no dialogue, no plot, no commercials. It’s just 7 hours of track and train and is weirdly comforting.
If you want to learn more, then when you get a chance, Google “slow living” and explore. Of course, some of you precrastinators probably have already started before finishing this column.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].
How to screen for, manage FASD in a medical home
providing early intervention and accessing community resources, according to a clinical report from the American Academy of Pediatrics.
After the AAP released its guidelines on fetal alcohol spectrum disorder (FASD) in 2015, some pediatricians asked for further guidance on how to care for patients with FASD within the medical home, as many had a knowledge gap on how to best manage these patients.
“For some pediatricians, it can seem like a daunting task to care for an individual with an FASD, but there are aspects of integrated care and providing a medical home that can be instituted as with all children with complex medical diagnoses,” wrote Renee M. Turchi, MD, MPH, of the department of pediatrics at St. Christopher’s Hospital for Children and Drexel Dornsife School of Public Health in Philadelphia, and her colleagues on the AAP Committee on Substance Abuse and the Council on Children with Disabilities. Their report is in Pediatrics. “In addition, not recognizing an FASD can lead to inadequate treatment and less-than-optimal outcomes for the patient and family.”
Dr. Turchi and her colleagues released the FASD clinical report with “strategies to support families who are interacting with early intervention services, the educational system, the behavioral and/or mental health system, other community resources, and the transition to adult-oriented heath care systems when appropriate.” They noted the prevalence of FASD is increasing, with 1 in 10 pregnant women using alcohol within the past 30 days and 1 in 33 pregnant women reporting binge drinking in the past 30 days. They reaffirmed the AAP’s endorsement from the 2015 clinical report on FASD regarding abstinence of alcohol for pregnant women, emphasizing that there is no amount or kind of alcohol that is risk free during pregnancy, nor is there a time in pregnancy when drinking alcohol is risk free.
Providers in a medical home should communicate any prenatal alcohol exposure (PAE) to obstetric providers so they can review risk factors, optimize screening, and monitor children, Dr. Turchi and her colleagues said. They also should understand the diagnostic criteria and classifications for FASDs, including physical features such as low weight, short palpebral features, smooth philtrum, a thin upper lip, abnormalities in the central nervous system, and any alcohol use during pregnancy. Any child – regardless of age – is a candidate for universal PAE screening at initial visits or when “additional cognitive and behavioral concerns arise.”
The federal Child Abuse Prevention and Treatment Act “does not require clinicians to report to child protective services if a child has been exposed prenatally to alcohol (i.e., for a positive PAE screening result). Referral to child protective services is required if the child has been diagnosed with an FASD in the period between birth and 3 years. The intent of this referral is to develop safe care and possible treatment plans for the infant and caregiver if needed, not to initiate punitive actions,” according to the report. States have their own definitions about child abuse and neglect, so the report encourages providers to know the mandates and reporting laws in the states where they practice.
Monitoring children in a medical home for the signs and symptoms of FASD is important, the authors said, because research has shown an increased chance at reducing adverse life outcomes if a child is diagnosed before age 6 and is in a stable home with access to support services.
Management of children with FASD is individual, as symptoms for each child will uniquely present not just in terms of physical issues such as growth or congenital defects affecting the heart, eyes, kidneys, or bones, but also as developmental, cognitive, and behavioral problems. Children with FASD also may receive a concomitant diagnosis when evaluated, such as ADHD or depression, that will require additional accommodation. The use of evidence-based diagnostic and standard screening approaches and referring when necessary will help reevaluate whether a child has a condition such as ADHD, oppositional defiant disorder, or another diagnosis, or is displaying symptoms of FASD such as a receptive or expressive language disorder.
Pediatricians must work together with the families, educational professionals, the mental health community, and therapists to help manage FASD in children. In cases where a child is in foster care, partnering with the foster care partners and child welfare agencies to gain access to the medical information of the biological parents is important to determine whether there is parental history of substance abuse and to provide appropriate treatment and interventions.
“Given the complex array of systems and services requiring navigation and coordination for children with an FASD and their families, a high-quality primary care medical home with partnerships with families, specialists, therapists, mental and/or behavioral health professionals, and community partners is critical, as it is for all children with special health care needs,” Dr. Turchi and her colleagues said.
The authors reported no relevant conflicts of interest.
SOURCE: Turchi RM et al. Pediatrics. 2018 Sept 10. doi:10.1542/peds.2018-2333.
providing early intervention and accessing community resources, according to a clinical report from the American Academy of Pediatrics.
After the AAP released its guidelines on fetal alcohol spectrum disorder (FASD) in 2015, some pediatricians asked for further guidance on how to care for patients with FASD within the medical home, as many had a knowledge gap on how to best manage these patients.
“For some pediatricians, it can seem like a daunting task to care for an individual with an FASD, but there are aspects of integrated care and providing a medical home that can be instituted as with all children with complex medical diagnoses,” wrote Renee M. Turchi, MD, MPH, of the department of pediatrics at St. Christopher’s Hospital for Children and Drexel Dornsife School of Public Health in Philadelphia, and her colleagues on the AAP Committee on Substance Abuse and the Council on Children with Disabilities. Their report is in Pediatrics. “In addition, not recognizing an FASD can lead to inadequate treatment and less-than-optimal outcomes for the patient and family.”
Dr. Turchi and her colleagues released the FASD clinical report with “strategies to support families who are interacting with early intervention services, the educational system, the behavioral and/or mental health system, other community resources, and the transition to adult-oriented heath care systems when appropriate.” They noted the prevalence of FASD is increasing, with 1 in 10 pregnant women using alcohol within the past 30 days and 1 in 33 pregnant women reporting binge drinking in the past 30 days. They reaffirmed the AAP’s endorsement from the 2015 clinical report on FASD regarding abstinence of alcohol for pregnant women, emphasizing that there is no amount or kind of alcohol that is risk free during pregnancy, nor is there a time in pregnancy when drinking alcohol is risk free.
Providers in a medical home should communicate any prenatal alcohol exposure (PAE) to obstetric providers so they can review risk factors, optimize screening, and monitor children, Dr. Turchi and her colleagues said. They also should understand the diagnostic criteria and classifications for FASDs, including physical features such as low weight, short palpebral features, smooth philtrum, a thin upper lip, abnormalities in the central nervous system, and any alcohol use during pregnancy. Any child – regardless of age – is a candidate for universal PAE screening at initial visits or when “additional cognitive and behavioral concerns arise.”
The federal Child Abuse Prevention and Treatment Act “does not require clinicians to report to child protective services if a child has been exposed prenatally to alcohol (i.e., for a positive PAE screening result). Referral to child protective services is required if the child has been diagnosed with an FASD in the period between birth and 3 years. The intent of this referral is to develop safe care and possible treatment plans for the infant and caregiver if needed, not to initiate punitive actions,” according to the report. States have their own definitions about child abuse and neglect, so the report encourages providers to know the mandates and reporting laws in the states where they practice.
Monitoring children in a medical home for the signs and symptoms of FASD is important, the authors said, because research has shown an increased chance at reducing adverse life outcomes if a child is diagnosed before age 6 and is in a stable home with access to support services.
Management of children with FASD is individual, as symptoms for each child will uniquely present not just in terms of physical issues such as growth or congenital defects affecting the heart, eyes, kidneys, or bones, but also as developmental, cognitive, and behavioral problems. Children with FASD also may receive a concomitant diagnosis when evaluated, such as ADHD or depression, that will require additional accommodation. The use of evidence-based diagnostic and standard screening approaches and referring when necessary will help reevaluate whether a child has a condition such as ADHD, oppositional defiant disorder, or another diagnosis, or is displaying symptoms of FASD such as a receptive or expressive language disorder.
Pediatricians must work together with the families, educational professionals, the mental health community, and therapists to help manage FASD in children. In cases where a child is in foster care, partnering with the foster care partners and child welfare agencies to gain access to the medical information of the biological parents is important to determine whether there is parental history of substance abuse and to provide appropriate treatment and interventions.
“Given the complex array of systems and services requiring navigation and coordination for children with an FASD and their families, a high-quality primary care medical home with partnerships with families, specialists, therapists, mental and/or behavioral health professionals, and community partners is critical, as it is for all children with special health care needs,” Dr. Turchi and her colleagues said.
The authors reported no relevant conflicts of interest.
SOURCE: Turchi RM et al. Pediatrics. 2018 Sept 10. doi:10.1542/peds.2018-2333.
providing early intervention and accessing community resources, according to a clinical report from the American Academy of Pediatrics.
After the AAP released its guidelines on fetal alcohol spectrum disorder (FASD) in 2015, some pediatricians asked for further guidance on how to care for patients with FASD within the medical home, as many had a knowledge gap on how to best manage these patients.
“For some pediatricians, it can seem like a daunting task to care for an individual with an FASD, but there are aspects of integrated care and providing a medical home that can be instituted as with all children with complex medical diagnoses,” wrote Renee M. Turchi, MD, MPH, of the department of pediatrics at St. Christopher’s Hospital for Children and Drexel Dornsife School of Public Health in Philadelphia, and her colleagues on the AAP Committee on Substance Abuse and the Council on Children with Disabilities. Their report is in Pediatrics. “In addition, not recognizing an FASD can lead to inadequate treatment and less-than-optimal outcomes for the patient and family.”
Dr. Turchi and her colleagues released the FASD clinical report with “strategies to support families who are interacting with early intervention services, the educational system, the behavioral and/or mental health system, other community resources, and the transition to adult-oriented heath care systems when appropriate.” They noted the prevalence of FASD is increasing, with 1 in 10 pregnant women using alcohol within the past 30 days and 1 in 33 pregnant women reporting binge drinking in the past 30 days. They reaffirmed the AAP’s endorsement from the 2015 clinical report on FASD regarding abstinence of alcohol for pregnant women, emphasizing that there is no amount or kind of alcohol that is risk free during pregnancy, nor is there a time in pregnancy when drinking alcohol is risk free.
Providers in a medical home should communicate any prenatal alcohol exposure (PAE) to obstetric providers so they can review risk factors, optimize screening, and monitor children, Dr. Turchi and her colleagues said. They also should understand the diagnostic criteria and classifications for FASDs, including physical features such as low weight, short palpebral features, smooth philtrum, a thin upper lip, abnormalities in the central nervous system, and any alcohol use during pregnancy. Any child – regardless of age – is a candidate for universal PAE screening at initial visits or when “additional cognitive and behavioral concerns arise.”
The federal Child Abuse Prevention and Treatment Act “does not require clinicians to report to child protective services if a child has been exposed prenatally to alcohol (i.e., for a positive PAE screening result). Referral to child protective services is required if the child has been diagnosed with an FASD in the period between birth and 3 years. The intent of this referral is to develop safe care and possible treatment plans for the infant and caregiver if needed, not to initiate punitive actions,” according to the report. States have their own definitions about child abuse and neglect, so the report encourages providers to know the mandates and reporting laws in the states where they practice.
Monitoring children in a medical home for the signs and symptoms of FASD is important, the authors said, because research has shown an increased chance at reducing adverse life outcomes if a child is diagnosed before age 6 and is in a stable home with access to support services.
Management of children with FASD is individual, as symptoms for each child will uniquely present not just in terms of physical issues such as growth or congenital defects affecting the heart, eyes, kidneys, or bones, but also as developmental, cognitive, and behavioral problems. Children with FASD also may receive a concomitant diagnosis when evaluated, such as ADHD or depression, that will require additional accommodation. The use of evidence-based diagnostic and standard screening approaches and referring when necessary will help reevaluate whether a child has a condition such as ADHD, oppositional defiant disorder, or another diagnosis, or is displaying symptoms of FASD such as a receptive or expressive language disorder.
Pediatricians must work together with the families, educational professionals, the mental health community, and therapists to help manage FASD in children. In cases where a child is in foster care, partnering with the foster care partners and child welfare agencies to gain access to the medical information of the biological parents is important to determine whether there is parental history of substance abuse and to provide appropriate treatment and interventions.
“Given the complex array of systems and services requiring navigation and coordination for children with an FASD and their families, a high-quality primary care medical home with partnerships with families, specialists, therapists, mental and/or behavioral health professionals, and community partners is critical, as it is for all children with special health care needs,” Dr. Turchi and her colleagues said.
The authors reported no relevant conflicts of interest.
SOURCE: Turchi RM et al. Pediatrics. 2018 Sept 10. doi:10.1542/peds.2018-2333.
FROM PEDIATRICS
Women, older patients at greater risk of more aggressive PBC
A large, real-world study of primary biliary cholangitis has revealed that patients who are female, older, or have other autoimmune diseases are likely to have a more progressed and aggressive disease profile.
In the Journal of Clinical Gastroenterology, researchers reported the findings of a medical records database study involving 15,875 patients with primary biliary cholangitis (PBC) – previously known as primary biliary cirrhosis – a chronic, autoimmune form of liver disease.
Overall, more than one-third of patients (38.3%) had high levels of alkaline phosphatase – a marker for treatment nonresponse, defined as at least 1.5 times the upper limit of the normal range, which is also an indicator of adverse outcomes and of progression to high-risk liver disease.
These patients were more likely to be female, less likely to be insured by Medicaid, and more likely to have been diagnosed more than 1 year ago than patients whose alkaline phosphatase levels were not high. They were also more likely to be older, from the Midwest or Southern regions of the United States, have cirrhosis, or have other autoimmune diseases such as Sjögren’s syndrome and RA.
Patients with high alkaline phosphatase also showed higher aminotransferase and bilirubin, more cirrhosis, pruritus, and jaundice, but lower albumin.
Conversely, male patients had a higher incidence of cirrhosis, the study found. Other factors independently associated with cirrhosis included older age, having Medicaid insurance, having high alkaline phosphatase, and certain autoimmune conditions including type 1 diabetes, autoimmune hepatitis, and ulcerative colitis.
In patients with cirrhosis, the authors saw higher serum levels of AST and bilirubin, but lower albumin and platelets.
Zobair M. Younossi, MD, from the Center for Liver Diseases at Inova Fairfax Hospital, Falls Church, Virginia, and his coauthors said the results suggest many patients with PBC have progressed further in their condition than previously thought.
“This implies that a heightened focus on these patients with a goal toward treating more optimally should be considered to reduce their probability of disease progression,” they wrote. “Once cirrhosis develops, adverse patient outcomes such as increased mortality and adverse health care system outcomes such as excessive resource utilization increases substantially.”
The authors noted that most patients were female and white – consistent with previous reports of PBC – but the mean age of 60 years was older than expected.
“Our data suggest that PBC patients may be getting older and this could have major implications for Medicare,” they wrote. The study also examined how patients used health care resources, and found those with alkaline phosphatase levels more than 1.5 times the upper range of normal had significantly higher use. For example, they had significantly more all-cause and disease-related visits to the doctor and more use of outpatient resources for all causes.
They also had significantly more cumulative days of treatment with ursodeoxycholic acid – the standard treatment for PBC – at 528.4 days, compared with 41.6 days in individuals without high alkaline phosphatase levels. However they were no more likely to undergo imaging procedures.
Patients with cirrhosis were also more likely to have higher levels of health care utilization, compared with patients without cirrhosis, particularly use of outpatient services, inpatient stays, and ED visits. The authors also noted that patients with Medicaid but not Medicare had a higher rate of abdominal procedures.
Given that more advanced disease and presence of cirrhosis were both major drivers of increased health care use, the authors called for better identification and treatment of these patients. “This should not only potentially improve patients’ long-term outcomes but also aid in the reduction or delay of conceivably costly health resource utilization,” they wrote.
Two authors declared research funding or consulting fees from the pharmaceutical industry, and one author was an employee of Intercept Pharmaceuticals. No other conflicts of interest were declared.
SOURCE: Younossi ZM et al. J Clin Gastroenterol. 2018 Aug 24. doi: 10.1097/MCG.0000000000001120.
A large, real-world study of primary biliary cholangitis has revealed that patients who are female, older, or have other autoimmune diseases are likely to have a more progressed and aggressive disease profile.
In the Journal of Clinical Gastroenterology, researchers reported the findings of a medical records database study involving 15,875 patients with primary biliary cholangitis (PBC) – previously known as primary biliary cirrhosis – a chronic, autoimmune form of liver disease.
Overall, more than one-third of patients (38.3%) had high levels of alkaline phosphatase – a marker for treatment nonresponse, defined as at least 1.5 times the upper limit of the normal range, which is also an indicator of adverse outcomes and of progression to high-risk liver disease.
These patients were more likely to be female, less likely to be insured by Medicaid, and more likely to have been diagnosed more than 1 year ago than patients whose alkaline phosphatase levels were not high. They were also more likely to be older, from the Midwest or Southern regions of the United States, have cirrhosis, or have other autoimmune diseases such as Sjögren’s syndrome and RA.
Patients with high alkaline phosphatase also showed higher aminotransferase and bilirubin, more cirrhosis, pruritus, and jaundice, but lower albumin.
Conversely, male patients had a higher incidence of cirrhosis, the study found. Other factors independently associated with cirrhosis included older age, having Medicaid insurance, having high alkaline phosphatase, and certain autoimmune conditions including type 1 diabetes, autoimmune hepatitis, and ulcerative colitis.
In patients with cirrhosis, the authors saw higher serum levels of AST and bilirubin, but lower albumin and platelets.
Zobair M. Younossi, MD, from the Center for Liver Diseases at Inova Fairfax Hospital, Falls Church, Virginia, and his coauthors said the results suggest many patients with PBC have progressed further in their condition than previously thought.
“This implies that a heightened focus on these patients with a goal toward treating more optimally should be considered to reduce their probability of disease progression,” they wrote. “Once cirrhosis develops, adverse patient outcomes such as increased mortality and adverse health care system outcomes such as excessive resource utilization increases substantially.”
The authors noted that most patients were female and white – consistent with previous reports of PBC – but the mean age of 60 years was older than expected.
“Our data suggest that PBC patients may be getting older and this could have major implications for Medicare,” they wrote. The study also examined how patients used health care resources, and found those with alkaline phosphatase levels more than 1.5 times the upper range of normal had significantly higher use. For example, they had significantly more all-cause and disease-related visits to the doctor and more use of outpatient resources for all causes.
They also had significantly more cumulative days of treatment with ursodeoxycholic acid – the standard treatment for PBC – at 528.4 days, compared with 41.6 days in individuals without high alkaline phosphatase levels. However they were no more likely to undergo imaging procedures.
Patients with cirrhosis were also more likely to have higher levels of health care utilization, compared with patients without cirrhosis, particularly use of outpatient services, inpatient stays, and ED visits. The authors also noted that patients with Medicaid but not Medicare had a higher rate of abdominal procedures.
Given that more advanced disease and presence of cirrhosis were both major drivers of increased health care use, the authors called for better identification and treatment of these patients. “This should not only potentially improve patients’ long-term outcomes but also aid in the reduction or delay of conceivably costly health resource utilization,” they wrote.
Two authors declared research funding or consulting fees from the pharmaceutical industry, and one author was an employee of Intercept Pharmaceuticals. No other conflicts of interest were declared.
SOURCE: Younossi ZM et al. J Clin Gastroenterol. 2018 Aug 24. doi: 10.1097/MCG.0000000000001120.
A large, real-world study of primary biliary cholangitis has revealed that patients who are female, older, or have other autoimmune diseases are likely to have a more progressed and aggressive disease profile.
In the Journal of Clinical Gastroenterology, researchers reported the findings of a medical records database study involving 15,875 patients with primary biliary cholangitis (PBC) – previously known as primary biliary cirrhosis – a chronic, autoimmune form of liver disease.
Overall, more than one-third of patients (38.3%) had high levels of alkaline phosphatase – a marker for treatment nonresponse, defined as at least 1.5 times the upper limit of the normal range, which is also an indicator of adverse outcomes and of progression to high-risk liver disease.
These patients were more likely to be female, less likely to be insured by Medicaid, and more likely to have been diagnosed more than 1 year ago than patients whose alkaline phosphatase levels were not high. They were also more likely to be older, from the Midwest or Southern regions of the United States, have cirrhosis, or have other autoimmune diseases such as Sjögren’s syndrome and RA.
Patients with high alkaline phosphatase also showed higher aminotransferase and bilirubin, more cirrhosis, pruritus, and jaundice, but lower albumin.
Conversely, male patients had a higher incidence of cirrhosis, the study found. Other factors independently associated with cirrhosis included older age, having Medicaid insurance, having high alkaline phosphatase, and certain autoimmune conditions including type 1 diabetes, autoimmune hepatitis, and ulcerative colitis.
In patients with cirrhosis, the authors saw higher serum levels of AST and bilirubin, but lower albumin and platelets.
Zobair M. Younossi, MD, from the Center for Liver Diseases at Inova Fairfax Hospital, Falls Church, Virginia, and his coauthors said the results suggest many patients with PBC have progressed further in their condition than previously thought.
“This implies that a heightened focus on these patients with a goal toward treating more optimally should be considered to reduce their probability of disease progression,” they wrote. “Once cirrhosis develops, adverse patient outcomes such as increased mortality and adverse health care system outcomes such as excessive resource utilization increases substantially.”
The authors noted that most patients were female and white – consistent with previous reports of PBC – but the mean age of 60 years was older than expected.
“Our data suggest that PBC patients may be getting older and this could have major implications for Medicare,” they wrote. The study also examined how patients used health care resources, and found those with alkaline phosphatase levels more than 1.5 times the upper range of normal had significantly higher use. For example, they had significantly more all-cause and disease-related visits to the doctor and more use of outpatient resources for all causes.
They also had significantly more cumulative days of treatment with ursodeoxycholic acid – the standard treatment for PBC – at 528.4 days, compared with 41.6 days in individuals without high alkaline phosphatase levels. However they were no more likely to undergo imaging procedures.
Patients with cirrhosis were also more likely to have higher levels of health care utilization, compared with patients without cirrhosis, particularly use of outpatient services, inpatient stays, and ED visits. The authors also noted that patients with Medicaid but not Medicare had a higher rate of abdominal procedures.
Given that more advanced disease and presence of cirrhosis were both major drivers of increased health care use, the authors called for better identification and treatment of these patients. “This should not only potentially improve patients’ long-term outcomes but also aid in the reduction or delay of conceivably costly health resource utilization,” they wrote.
Two authors declared research funding or consulting fees from the pharmaceutical industry, and one author was an employee of Intercept Pharmaceuticals. No other conflicts of interest were declared.
SOURCE: Younossi ZM et al. J Clin Gastroenterol. 2018 Aug 24. doi: 10.1097/MCG.0000000000001120.
FROM THE JOURNAL OF CLINICAL GASTROENTEROLOGY
Key clinical point: Women, older individuals, and patients with other autoimmune diseases are more likely to have worse primary biliary cholangitis (PBC).
Major finding: More than one-third of patients with PBC have high levels of alkaline phosphatase.
Study details: An analysis of medical records for 15,875 patients with PBC.
Disclosures: Two authors declared research funding or consulting fees from the pharmaceutical industry; one author was an employee of Intercept Pharmaceuticals. No other conflicts of interest were declared.
Source: Younossi ZM et al. J Clin Gastroenterol. 2018 August 24. doi: 10.1097/MCG.0000000000001120.
CDC: Obesity affects over 35% in 7 states
Iowa and Oklahoma, the two newest states with prevalences at or exceeding 35%, joined Alabama, Arkansas, Louisiana, Mississippi, and West Virginia, which has the country’s highest rate of adult obesity at 38.1%. Colorado’s 22.6% rate is the lowest prevalence among all states. The District of Columbia and Hawaii also have prevalences under 25%; previously, Massachusetts also was in this group, but its prevalence went up to 25.9% last year, the CDC reported.
Regional disparities in self-reported adult obesity put the South (32.4%) and the Midwest (32.3%) well ahead of the Northeast (27.7%) and the West (26.1%) in 2017. Racial and ethnic disparities also were seen, with large gaps between blacks, who had a prevalence of 39%, and Hispanics (32.4%) and whites (29.3%). Obesity prevalence was 35% or higher among black adults in 31 states and D.C., while this was true among Hispanics in eight states and among whites in one (West Virginia), although the prevalence was at or above 35% for multiple racial groups in some of these states, the CDC reported based on data from the Behavioral Risk Factor Surveillance System.
“Obesity costs the United States health care system over $147 billion a year [and] research has shown that obesity affects work productivity and military readiness,” the CDC said in a written statement. “To protect the health of the next generation, support for healthy behaviors such as healthy eating, better sleep, stress management, and physical activity should start early and expand to reach Americans across the lifespan in the communities where they live, learn, work, and play.”
Iowa and Oklahoma, the two newest states with prevalences at or exceeding 35%, joined Alabama, Arkansas, Louisiana, Mississippi, and West Virginia, which has the country’s highest rate of adult obesity at 38.1%. Colorado’s 22.6% rate is the lowest prevalence among all states. The District of Columbia and Hawaii also have prevalences under 25%; previously, Massachusetts also was in this group, but its prevalence went up to 25.9% last year, the CDC reported.
Regional disparities in self-reported adult obesity put the South (32.4%) and the Midwest (32.3%) well ahead of the Northeast (27.7%) and the West (26.1%) in 2017. Racial and ethnic disparities also were seen, with large gaps between blacks, who had a prevalence of 39%, and Hispanics (32.4%) and whites (29.3%). Obesity prevalence was 35% or higher among black adults in 31 states and D.C., while this was true among Hispanics in eight states and among whites in one (West Virginia), although the prevalence was at or above 35% for multiple racial groups in some of these states, the CDC reported based on data from the Behavioral Risk Factor Surveillance System.
“Obesity costs the United States health care system over $147 billion a year [and] research has shown that obesity affects work productivity and military readiness,” the CDC said in a written statement. “To protect the health of the next generation, support for healthy behaviors such as healthy eating, better sleep, stress management, and physical activity should start early and expand to reach Americans across the lifespan in the communities where they live, learn, work, and play.”
Iowa and Oklahoma, the two newest states with prevalences at or exceeding 35%, joined Alabama, Arkansas, Louisiana, Mississippi, and West Virginia, which has the country’s highest rate of adult obesity at 38.1%. Colorado’s 22.6% rate is the lowest prevalence among all states. The District of Columbia and Hawaii also have prevalences under 25%; previously, Massachusetts also was in this group, but its prevalence went up to 25.9% last year, the CDC reported.
Regional disparities in self-reported adult obesity put the South (32.4%) and the Midwest (32.3%) well ahead of the Northeast (27.7%) and the West (26.1%) in 2017. Racial and ethnic disparities also were seen, with large gaps between blacks, who had a prevalence of 39%, and Hispanics (32.4%) and whites (29.3%). Obesity prevalence was 35% or higher among black adults in 31 states and D.C., while this was true among Hispanics in eight states and among whites in one (West Virginia), although the prevalence was at or above 35% for multiple racial groups in some of these states, the CDC reported based on data from the Behavioral Risk Factor Surveillance System.
“Obesity costs the United States health care system over $147 billion a year [and] research has shown that obesity affects work productivity and military readiness,” the CDC said in a written statement. “To protect the health of the next generation, support for healthy behaviors such as healthy eating, better sleep, stress management, and physical activity should start early and expand to reach Americans across the lifespan in the communities where they live, learn, work, and play.”
Recommendations to Improve Asthma Outcomes: Work Group Call to Action
Click here to read the supplement.
What can be done to address the burden of asthma beyond pharmacotherapy? A panel of experts discuss steps for addressing sensitization to allergens that trigger increased asthma burden.
Topics Include:
- Identifying Patients with Allergic Components of Asthma
- Identifying and Addressing Allergen Exposure in Daily Practice
- The Opportunity for Payers and Health Systems for Supporting Trigger Avoidance Education
Click here to read the supplement.
Click here to read the supplement.
What can be done to address the burden of asthma beyond pharmacotherapy? A panel of experts discuss steps for addressing sensitization to allergens that trigger increased asthma burden.
Topics Include:
- Identifying Patients with Allergic Components of Asthma
- Identifying and Addressing Allergen Exposure in Daily Practice
- The Opportunity for Payers and Health Systems for Supporting Trigger Avoidance Education
Click here to read the supplement.
Click here to read the supplement.
What can be done to address the burden of asthma beyond pharmacotherapy? A panel of experts discuss steps for addressing sensitization to allergens that trigger increased asthma burden.
Topics Include:
- Identifying Patients with Allergic Components of Asthma
- Identifying and Addressing Allergen Exposure in Daily Practice
- The Opportunity for Payers and Health Systems for Supporting Trigger Avoidance Education
Click here to read the supplement.
GERD patients who fail PPI often have functional heartburn or hypersensitivity
Abnormal pH results were similar in patients with gastroesophageal reflux disease (GERD) who improved or failed to improve on a once-daily dose of a proton pump inhibitor (PPI), but 75% of patients who failed treatment demonstrated either functional heartburn or reflux hypersensitivity, based on data from 29 adults.
Previous research on PPI failure in GERD patients has focused on twice-daily doses; “the purpose of the study was to compare impedance-pH parameters between patients who failed versus those who responded to PPI once daily,” wrote Jason Abdallah, MD, of Case Western Reserve University in Cleveland and colleagues.
In a study published in Clinical Gastroenterology and Hepatology, the investigators reviewed data from adults diagnosed with GERD who were treated with PPI therapy. The 16 who reported heartburn and/or regurgitation at least twice a week for 3 months while on a standard, once-daily PPI dose were classified as the failure group. The 13 patients who reported complete symptom resolution for at least 4 weeks while on the same standard dose were classified as the success group.
Most of the patients in the PPI-failure group (75%) were found to have either functional heartburn or reflux hypersensitivity with GERD. Impedance and pH parameters did not differ significantly between the PPI-failure and -success group, the researchers noted. Abnormal pH test results were similar between the groups, occurring in four of the patients who were successfully treated with PPI (31%) and four of the patients who failed PPI treatment (25%).
All patients completed the Short-Form 36 (SF-36) and GERD Health-Related Quality of Life (GERD-HRQL) questionnaires, and all underwent upper endoscopy and combined 24-hour esophageal impedance and pH monitoring within 2-4 weeks of study enrollment and while following their PPI treatment plans. There were no significant differences in demographic characteristics between the success and failure groups; the mean ages were 55 years and 47 years, respectively.
The patients in the success group averaged higher scores on the SF-36 than the failure group, but the difference was not significant. On the GERD-HRQL, treatment-failure patients reported that overall heartburn and either heartburn or bloating while lying down were the symptoms they found most annoying on a daily basis.
Among the treatment-failure patients, 10 (62%) had normal acid exposure and negative symptom-reflux association, 2 patients (13%) had normal acid exposure and positive symptom-reflux association, and 4 patients (25%) had abnormal esophageal acid exposure. Patients in the treatment failure group reported a total of 315 episodes of either heartburn or regurgitation.
Endoscopy findings were normal in most of the patients in both groups; 81% of the treatment-failure patients and 69% of the treatment-success patients had normal upper endoscopy findings. Abnormal findings in the treatment-success group included one case of erosive esophagitis, two cases of Barrett’s esophagus, three cases of nonobstructive Schatzki rings, and five cases of hiatal hernia. Abnormal findings in the treatment-failure group included two cases of Schatzki rings, one case of esophageal stricture, and three cases of hiatal hernia.
The total number of reflux events was similar between the groups; 1,279 in the treatment-failure group and 1,099 in the treatment-success group, with the number of reflux events per patient averaging 80 and 84, respectively.
“Our results support the hypothesis that PPI failure is primarily driven by esophageal hypersensitivity,” the researchers noted. The similarity in impedance and reflux “implies that the shift to nonacidic reflux is a general PPI phenomenon, as opposed to being unique to PPI-failure patients,” they said.
The study was limited by the small patient population, but the results provide some insight into refractory GERD and suggest that patients who fail to respond to once-daily PPI might benefit from a neuromodulator, as well as psychological interventions including cognitive-behavioral therapy, hypnotherapy, relaxation techniques, mindfulness, and biofeedback, the researchers concluded.
Dr. Abdullah had no financial conflicts to disclose; a coauthor disclosed relationships with companies including Ironwood Pharmaceuticals, Mederi Therapeutics, and Ethicon Pharmaceuticals.
SOURCE: Abdallah J et al. Clin Gastroenterol Hepatol. 2018; doi: 10.1016/j.cgh.2018.06.018.
Abnormal pH results were similar in patients with gastroesophageal reflux disease (GERD) who improved or failed to improve on a once-daily dose of a proton pump inhibitor (PPI), but 75% of patients who failed treatment demonstrated either functional heartburn or reflux hypersensitivity, based on data from 29 adults.
Previous research on PPI failure in GERD patients has focused on twice-daily doses; “the purpose of the study was to compare impedance-pH parameters between patients who failed versus those who responded to PPI once daily,” wrote Jason Abdallah, MD, of Case Western Reserve University in Cleveland and colleagues.
In a study published in Clinical Gastroenterology and Hepatology, the investigators reviewed data from adults diagnosed with GERD who were treated with PPI therapy. The 16 who reported heartburn and/or regurgitation at least twice a week for 3 months while on a standard, once-daily PPI dose were classified as the failure group. The 13 patients who reported complete symptom resolution for at least 4 weeks while on the same standard dose were classified as the success group.
Most of the patients in the PPI-failure group (75%) were found to have either functional heartburn or reflux hypersensitivity with GERD. Impedance and pH parameters did not differ significantly between the PPI-failure and -success group, the researchers noted. Abnormal pH test results were similar between the groups, occurring in four of the patients who were successfully treated with PPI (31%) and four of the patients who failed PPI treatment (25%).
All patients completed the Short-Form 36 (SF-36) and GERD Health-Related Quality of Life (GERD-HRQL) questionnaires, and all underwent upper endoscopy and combined 24-hour esophageal impedance and pH monitoring within 2-4 weeks of study enrollment and while following their PPI treatment plans. There were no significant differences in demographic characteristics between the success and failure groups; the mean ages were 55 years and 47 years, respectively.
The patients in the success group averaged higher scores on the SF-36 than the failure group, but the difference was not significant. On the GERD-HRQL, treatment-failure patients reported that overall heartburn and either heartburn or bloating while lying down were the symptoms they found most annoying on a daily basis.
Among the treatment-failure patients, 10 (62%) had normal acid exposure and negative symptom-reflux association, 2 patients (13%) had normal acid exposure and positive symptom-reflux association, and 4 patients (25%) had abnormal esophageal acid exposure. Patients in the treatment failure group reported a total of 315 episodes of either heartburn or regurgitation.
Endoscopy findings were normal in most of the patients in both groups; 81% of the treatment-failure patients and 69% of the treatment-success patients had normal upper endoscopy findings. Abnormal findings in the treatment-success group included one case of erosive esophagitis, two cases of Barrett’s esophagus, three cases of nonobstructive Schatzki rings, and five cases of hiatal hernia. Abnormal findings in the treatment-failure group included two cases of Schatzki rings, one case of esophageal stricture, and three cases of hiatal hernia.
The total number of reflux events was similar between the groups; 1,279 in the treatment-failure group and 1,099 in the treatment-success group, with the number of reflux events per patient averaging 80 and 84, respectively.
“Our results support the hypothesis that PPI failure is primarily driven by esophageal hypersensitivity,” the researchers noted. The similarity in impedance and reflux “implies that the shift to nonacidic reflux is a general PPI phenomenon, as opposed to being unique to PPI-failure patients,” they said.
The study was limited by the small patient population, but the results provide some insight into refractory GERD and suggest that patients who fail to respond to once-daily PPI might benefit from a neuromodulator, as well as psychological interventions including cognitive-behavioral therapy, hypnotherapy, relaxation techniques, mindfulness, and biofeedback, the researchers concluded.
Dr. Abdullah had no financial conflicts to disclose; a coauthor disclosed relationships with companies including Ironwood Pharmaceuticals, Mederi Therapeutics, and Ethicon Pharmaceuticals.
SOURCE: Abdallah J et al. Clin Gastroenterol Hepatol. 2018; doi: 10.1016/j.cgh.2018.06.018.
Abnormal pH results were similar in patients with gastroesophageal reflux disease (GERD) who improved or failed to improve on a once-daily dose of a proton pump inhibitor (PPI), but 75% of patients who failed treatment demonstrated either functional heartburn or reflux hypersensitivity, based on data from 29 adults.
Previous research on PPI failure in GERD patients has focused on twice-daily doses; “the purpose of the study was to compare impedance-pH parameters between patients who failed versus those who responded to PPI once daily,” wrote Jason Abdallah, MD, of Case Western Reserve University in Cleveland and colleagues.
In a study published in Clinical Gastroenterology and Hepatology, the investigators reviewed data from adults diagnosed with GERD who were treated with PPI therapy. The 16 who reported heartburn and/or regurgitation at least twice a week for 3 months while on a standard, once-daily PPI dose were classified as the failure group. The 13 patients who reported complete symptom resolution for at least 4 weeks while on the same standard dose were classified as the success group.
Most of the patients in the PPI-failure group (75%) were found to have either functional heartburn or reflux hypersensitivity with GERD. Impedance and pH parameters did not differ significantly between the PPI-failure and -success group, the researchers noted. Abnormal pH test results were similar between the groups, occurring in four of the patients who were successfully treated with PPI (31%) and four of the patients who failed PPI treatment (25%).
All patients completed the Short-Form 36 (SF-36) and GERD Health-Related Quality of Life (GERD-HRQL) questionnaires, and all underwent upper endoscopy and combined 24-hour esophageal impedance and pH monitoring within 2-4 weeks of study enrollment and while following their PPI treatment plans. There were no significant differences in demographic characteristics between the success and failure groups; the mean ages were 55 years and 47 years, respectively.
The patients in the success group averaged higher scores on the SF-36 than the failure group, but the difference was not significant. On the GERD-HRQL, treatment-failure patients reported that overall heartburn and either heartburn or bloating while lying down were the symptoms they found most annoying on a daily basis.
Among the treatment-failure patients, 10 (62%) had normal acid exposure and negative symptom-reflux association, 2 patients (13%) had normal acid exposure and positive symptom-reflux association, and 4 patients (25%) had abnormal esophageal acid exposure. Patients in the treatment failure group reported a total of 315 episodes of either heartburn or regurgitation.
Endoscopy findings were normal in most of the patients in both groups; 81% of the treatment-failure patients and 69% of the treatment-success patients had normal upper endoscopy findings. Abnormal findings in the treatment-success group included one case of erosive esophagitis, two cases of Barrett’s esophagus, three cases of nonobstructive Schatzki rings, and five cases of hiatal hernia. Abnormal findings in the treatment-failure group included two cases of Schatzki rings, one case of esophageal stricture, and three cases of hiatal hernia.
The total number of reflux events was similar between the groups; 1,279 in the treatment-failure group and 1,099 in the treatment-success group, with the number of reflux events per patient averaging 80 and 84, respectively.
“Our results support the hypothesis that PPI failure is primarily driven by esophageal hypersensitivity,” the researchers noted. The similarity in impedance and reflux “implies that the shift to nonacidic reflux is a general PPI phenomenon, as opposed to being unique to PPI-failure patients,” they said.
The study was limited by the small patient population, but the results provide some insight into refractory GERD and suggest that patients who fail to respond to once-daily PPI might benefit from a neuromodulator, as well as psychological interventions including cognitive-behavioral therapy, hypnotherapy, relaxation techniques, mindfulness, and biofeedback, the researchers concluded.
Dr. Abdullah had no financial conflicts to disclose; a coauthor disclosed relationships with companies including Ironwood Pharmaceuticals, Mederi Therapeutics, and Ethicon Pharmaceuticals.
SOURCE: Abdallah J et al. Clin Gastroenterol Hepatol. 2018; doi: 10.1016/j.cgh.2018.06.018.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Key clinical point: PPI failure in GERD patients appears to be driven by esophageal hypersensitivity, not significantly associated with reflux.
Major finding: Most (75%) of the patients who failed PPI treatment had heartburn or reflux hypersensitivity with GERD.
Study details: The data come from a prospective cohort study of 29 adults with GERD.
Disclosures: Dr. Abdullah had no financial conflicts to disclose; a coauthor disclosed relationships with companies including Ironwood Pharmaceuticals, Mederi Therapeutics, and Ethicon Pharmaceuticals.
Source: Abdullah J et al. Clin Gastroenterol Hepatol. 2018; doi: 10.1016/j.cgh.2018.06.018.
Spurring innovation in digital health
Owing to digital advances, we’re experiencing a reimagination of health care delivery. Consumers are now empowered to take more control of their own health information to make better informed decisions about their medical care and healthy living. These advances enable better health outcomes for patients.
This opportunity is supported by a new technological paradigm of digital health tools, like apps, that enable consumers to have more active engagement and access to real-time information about their health and activities. These tools allow consumers and providers to supersede the traditional, physical constraints of health care delivery and make the most of the opportunities offered by mobile technology.
With these advances has come a new swath of companies that are investing in these new opportunities. These firms may be new to health care products and may not be accustomed to navigating the regulatory landscape that has traditionally surrounded these areas. A great example is the announcement of two mobile medical apps designed by Apple to work on the Apple Watch. One app creates an electrocardiogram, similar to traditional electrocardiograms, to detect the presence of atrial fibrillation and regular heart rhythm, while the other app analyzes pulse rate data to identify irregular heart rhythms suggestive of atrial fibrillation and notify the user. The FDA [Food and Drug Administration] worked closely with the company as they developed and tested these software products, which may help millions of users identify health concerns more quickly. Health care products on ubiquitous devices, like smartwatches, may help users seek treatment earlier and will truly empower them with more information about their health.
In the last few years, the FDA has been taking steps to encourage more development and greater innovation in the digital health space. With the launch of our Digital Health Innovation Action Plan last summer, we committed to implementing policies, adding expertise, and exploring a software precertification pilot program to bring clarity and efficiency to how we regulate digital health products.
This commitment is not only reflected in actions like approving or clearing new apps and launching our Digital Health Innovation Action Plan but also in what we hope to do in the future. That’s why in the FDA’s Fiscal Year 2019 Budget, we proposed to create a Center of Excellence for Digital Health that would advance modernizing our regulatory approach to help this industry grow and reach its full potential, while protecting patients.
Dr. Gottlieb is commissioner of the FDA and Dr. Shuren in director of the FDA Center for Devices and Radiological Health. Their comments are excerpted from an FDA statement released Sept. 12, 2018.
Owing to digital advances, we’re experiencing a reimagination of health care delivery. Consumers are now empowered to take more control of their own health information to make better informed decisions about their medical care and healthy living. These advances enable better health outcomes for patients.
This opportunity is supported by a new technological paradigm of digital health tools, like apps, that enable consumers to have more active engagement and access to real-time information about their health and activities. These tools allow consumers and providers to supersede the traditional, physical constraints of health care delivery and make the most of the opportunities offered by mobile technology.
With these advances has come a new swath of companies that are investing in these new opportunities. These firms may be new to health care products and may not be accustomed to navigating the regulatory landscape that has traditionally surrounded these areas. A great example is the announcement of two mobile medical apps designed by Apple to work on the Apple Watch. One app creates an electrocardiogram, similar to traditional electrocardiograms, to detect the presence of atrial fibrillation and regular heart rhythm, while the other app analyzes pulse rate data to identify irregular heart rhythms suggestive of atrial fibrillation and notify the user. The FDA [Food and Drug Administration] worked closely with the company as they developed and tested these software products, which may help millions of users identify health concerns more quickly. Health care products on ubiquitous devices, like smartwatches, may help users seek treatment earlier and will truly empower them with more information about their health.
In the last few years, the FDA has been taking steps to encourage more development and greater innovation in the digital health space. With the launch of our Digital Health Innovation Action Plan last summer, we committed to implementing policies, adding expertise, and exploring a software precertification pilot program to bring clarity and efficiency to how we regulate digital health products.
This commitment is not only reflected in actions like approving or clearing new apps and launching our Digital Health Innovation Action Plan but also in what we hope to do in the future. That’s why in the FDA’s Fiscal Year 2019 Budget, we proposed to create a Center of Excellence for Digital Health that would advance modernizing our regulatory approach to help this industry grow and reach its full potential, while protecting patients.
Dr. Gottlieb is commissioner of the FDA and Dr. Shuren in director of the FDA Center for Devices and Radiological Health. Their comments are excerpted from an FDA statement released Sept. 12, 2018.
Owing to digital advances, we’re experiencing a reimagination of health care delivery. Consumers are now empowered to take more control of their own health information to make better informed decisions about their medical care and healthy living. These advances enable better health outcomes for patients.
This opportunity is supported by a new technological paradigm of digital health tools, like apps, that enable consumers to have more active engagement and access to real-time information about their health and activities. These tools allow consumers and providers to supersede the traditional, physical constraints of health care delivery and make the most of the opportunities offered by mobile technology.
With these advances has come a new swath of companies that are investing in these new opportunities. These firms may be new to health care products and may not be accustomed to navigating the regulatory landscape that has traditionally surrounded these areas. A great example is the announcement of two mobile medical apps designed by Apple to work on the Apple Watch. One app creates an electrocardiogram, similar to traditional electrocardiograms, to detect the presence of atrial fibrillation and regular heart rhythm, while the other app analyzes pulse rate data to identify irregular heart rhythms suggestive of atrial fibrillation and notify the user. The FDA [Food and Drug Administration] worked closely with the company as they developed and tested these software products, which may help millions of users identify health concerns more quickly. Health care products on ubiquitous devices, like smartwatches, may help users seek treatment earlier and will truly empower them with more information about their health.
In the last few years, the FDA has been taking steps to encourage more development and greater innovation in the digital health space. With the launch of our Digital Health Innovation Action Plan last summer, we committed to implementing policies, adding expertise, and exploring a software precertification pilot program to bring clarity and efficiency to how we regulate digital health products.
This commitment is not only reflected in actions like approving or clearing new apps and launching our Digital Health Innovation Action Plan but also in what we hope to do in the future. That’s why in the FDA’s Fiscal Year 2019 Budget, we proposed to create a Center of Excellence for Digital Health that would advance modernizing our regulatory approach to help this industry grow and reach its full potential, while protecting patients.
Dr. Gottlieb is commissioner of the FDA and Dr. Shuren in director of the FDA Center for Devices and Radiological Health. Their comments are excerpted from an FDA statement released Sept. 12, 2018.