New Regents, B/G Executive Committee Members Elected

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Two new members of the American College of Surgeons (ACS) Board of Regents (B/R) were elected at the October 19 Annual Business Meeting of Members: Anthony Atala, MD, FACS, and Fabrizio Michelassi, MD, FACS. Dr. Atala is director, Wake Forest Institute for Regenerative Medicine, and W. Boyce Professor and Chair, department of urology, Wake Forest University, Winston Salem, NC. Dr. Michelassi is the Lewis Atterbury Stimson Professor and Chair, Weill Cornell Medical Center, and surgeon-in-chief, New York-Presbyterian/Weill Cornell Medical Center, NY, and Immediate Past-Chair of the Board of Governors (B/G).

The 2016-2017 Chair of the B/R is Michael J. Zinner, MD, FACS, an ACS Regent since 2010 and founding chief executive officer and executive medical director, Miami Cancer Institute, Baptist Health South Florida, Coral Gables. The Vice-Chair is Leigh A. Neumayer, MD, MS, FACS, a Regent since 2009 and professor and chair, department of surgery, University of Arizona, and Margaret and Fenton Maynard Endowed Chair in Breast Cancer Research, University of Arizona College of Medicine, Tucson.

Replacing Dr. Michelassi as Chair of the B/G Executive Committee is Diana L. Farmer, MD, FACS, a pediatric surgeon, Pearl Stamps Stewart Professor of Surgery, and chair, department of surgery, University of California Davis Health System, Sacramento. Steven C. Stain, MD, FACS, a general surgeon and Henry and Sally Schaffer Chair and Professor, department of surgery, Albany Medical Center, NY, has been elected Vice-Chair; and Susan K. Mosier, MD, MBA, FACS, an ophthalmologist, Secretary, Kansas Department of Health and Environment, and State Health Officer for Kansas, Topeka, has been elected Secretary.

In addition, S. Rob Todd, MD, FACS, FCCM, was elected to serve an initial one-year term on the Executive Committee of the B/G. Dr. Todd is professor and chief, section of acute care surgery, department of surgery, and program director, surgical critical care residency, Baylor College of Medicine; and chief, general surgery, and director, Ginni and Richard Mithoff Trauma Center, Ben Taub Hospital, Houston, TX. Elected to an initial two-year term on the B/G Executive Committee was Nicole S. Gibran, MD, FACS, David and Nancy Auth-Washington Research Foundation Endowed Chair for Restorative Burn Surgery, professor, department of surgery, director, UW Medicine Regional Burn Center at Harborview Medical Center, and adjunct professor, department of medicine, division of dermatology, University of Washington, Seattle.
 

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Two new members of the American College of Surgeons (ACS) Board of Regents (B/R) were elected at the October 19 Annual Business Meeting of Members: Anthony Atala, MD, FACS, and Fabrizio Michelassi, MD, FACS. Dr. Atala is director, Wake Forest Institute for Regenerative Medicine, and W. Boyce Professor and Chair, department of urology, Wake Forest University, Winston Salem, NC. Dr. Michelassi is the Lewis Atterbury Stimson Professor and Chair, Weill Cornell Medical Center, and surgeon-in-chief, New York-Presbyterian/Weill Cornell Medical Center, NY, and Immediate Past-Chair of the Board of Governors (B/G).

The 2016-2017 Chair of the B/R is Michael J. Zinner, MD, FACS, an ACS Regent since 2010 and founding chief executive officer and executive medical director, Miami Cancer Institute, Baptist Health South Florida, Coral Gables. The Vice-Chair is Leigh A. Neumayer, MD, MS, FACS, a Regent since 2009 and professor and chair, department of surgery, University of Arizona, and Margaret and Fenton Maynard Endowed Chair in Breast Cancer Research, University of Arizona College of Medicine, Tucson.

Replacing Dr. Michelassi as Chair of the B/G Executive Committee is Diana L. Farmer, MD, FACS, a pediatric surgeon, Pearl Stamps Stewart Professor of Surgery, and chair, department of surgery, University of California Davis Health System, Sacramento. Steven C. Stain, MD, FACS, a general surgeon and Henry and Sally Schaffer Chair and Professor, department of surgery, Albany Medical Center, NY, has been elected Vice-Chair; and Susan K. Mosier, MD, MBA, FACS, an ophthalmologist, Secretary, Kansas Department of Health and Environment, and State Health Officer for Kansas, Topeka, has been elected Secretary.

In addition, S. Rob Todd, MD, FACS, FCCM, was elected to serve an initial one-year term on the Executive Committee of the B/G. Dr. Todd is professor and chief, section of acute care surgery, department of surgery, and program director, surgical critical care residency, Baylor College of Medicine; and chief, general surgery, and director, Ginni and Richard Mithoff Trauma Center, Ben Taub Hospital, Houston, TX. Elected to an initial two-year term on the B/G Executive Committee was Nicole S. Gibran, MD, FACS, David and Nancy Auth-Washington Research Foundation Endowed Chair for Restorative Burn Surgery, professor, department of surgery, director, UW Medicine Regional Burn Center at Harborview Medical Center, and adjunct professor, department of medicine, division of dermatology, University of Washington, Seattle.
 

 

Two new members of the American College of Surgeons (ACS) Board of Regents (B/R) were elected at the October 19 Annual Business Meeting of Members: Anthony Atala, MD, FACS, and Fabrizio Michelassi, MD, FACS. Dr. Atala is director, Wake Forest Institute for Regenerative Medicine, and W. Boyce Professor and Chair, department of urology, Wake Forest University, Winston Salem, NC. Dr. Michelassi is the Lewis Atterbury Stimson Professor and Chair, Weill Cornell Medical Center, and surgeon-in-chief, New York-Presbyterian/Weill Cornell Medical Center, NY, and Immediate Past-Chair of the Board of Governors (B/G).

The 2016-2017 Chair of the B/R is Michael J. Zinner, MD, FACS, an ACS Regent since 2010 and founding chief executive officer and executive medical director, Miami Cancer Institute, Baptist Health South Florida, Coral Gables. The Vice-Chair is Leigh A. Neumayer, MD, MS, FACS, a Regent since 2009 and professor and chair, department of surgery, University of Arizona, and Margaret and Fenton Maynard Endowed Chair in Breast Cancer Research, University of Arizona College of Medicine, Tucson.

Replacing Dr. Michelassi as Chair of the B/G Executive Committee is Diana L. Farmer, MD, FACS, a pediatric surgeon, Pearl Stamps Stewart Professor of Surgery, and chair, department of surgery, University of California Davis Health System, Sacramento. Steven C. Stain, MD, FACS, a general surgeon and Henry and Sally Schaffer Chair and Professor, department of surgery, Albany Medical Center, NY, has been elected Vice-Chair; and Susan K. Mosier, MD, MBA, FACS, an ophthalmologist, Secretary, Kansas Department of Health and Environment, and State Health Officer for Kansas, Topeka, has been elected Secretary.

In addition, S. Rob Todd, MD, FACS, FCCM, was elected to serve an initial one-year term on the Executive Committee of the B/G. Dr. Todd is professor and chief, section of acute care surgery, department of surgery, and program director, surgical critical care residency, Baylor College of Medicine; and chief, general surgery, and director, Ginni and Richard Mithoff Trauma Center, Ben Taub Hospital, Houston, TX. Elected to an initial two-year term on the B/G Executive Committee was Nicole S. Gibran, MD, FACS, David and Nancy Auth-Washington Research Foundation Endowed Chair for Restorative Burn Surgery, professor, department of surgery, director, UW Medicine Regional Burn Center at Harborview Medical Center, and adjunct professor, department of medicine, division of dermatology, University of Washington, Seattle.
 

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Rheumatology among specialties that continue to see strong Specialty Match Day

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Rheumatology saw nearly 97% of its positions filled during the 2016 Specialty Match Day.

The specialty had 217 open slots and ended the Dec. 7 match day with only 7 positions unfilled. There were 312 applicants that selected rheumatology as their primary specialty, with 206 applicants being matched. Six were matched to different specialties and 100 who selected rheumatology as their primary specialty did not get matched to any program.

However, those seven unfilled slots will likely get matched.

Dr. Anne Bass
“There is something called the ‘scramble’ where any program that has empty slots that they want filled can match with applicants that have not matched,” Anne Bass, MD, chair of the American College of Rheumatology’s Committee on Rheumatology Training and Workforce Issues, said. “Usually most, if not all, of those empty slots end up filling.”

Overall, Dr. Bass, who is the program director of the rheumatology fellowship program at the Hospital for Special Surgery, New York, said the numbers reflect strong interest in rheumatology.

“In 2012, there were 240 applicants to rheumatology, and this year there were 312,” she said. “It’s been a linear trend. ... The number of programs has actually gone up but it has not kept pace with demand. In 2012, 63 applicants didn’t match at any program, and this year, the number was 100.”

Dr. Bass said that this speaks to the attractiveness of rheumatology as a field and that there will be a need to create more fellowship slots.

To that end, the Rheumatology Research Foundation, the grant-giving philanthropic arm of ACR that funds research grants and fellowship training awards, is examining that very issue.

“I am leading a working group to try to figure out how to configure this award so that we try to direct them to fellowship programs that can expand or even [create] new fellowship programs,” Dr. Bass said. “The ACR and RRF will continue to fund fellowship programs because many programs have to scramble to fund the salary to support trainees and in particular to try to direct resources that will actually end up creating a new rheumatology fellow where one would not have existed before.”

The group is also looking at ways to encourage programs that have internal funding to increase their capacity if they are able to do so, she added.

Rheumatology was among a number of specialties that were able to fill at least 90% of their open slots, Other areas included allergy/immunology, cardiovascular disease, gastroenterology, hematology and oncology, pulmonary disease and pulmonary/critical care.

On the flip side, nephrology, infectious disease, and geriatric medicine had more positions available than there were applicants who prefer those specialties.

“The results this year mirror prior-year results, with slight improvement in a few specialties but no significant changes,” Mona Singer, president and CEO of the National Resident Match Program, said.

Overall, across all specialties, there were 4,731 slots, with 4,139 positions filled, accounting for about 75% of the 5,512 enrolled applicants.

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Rheumatology saw nearly 97% of its positions filled during the 2016 Specialty Match Day.

The specialty had 217 open slots and ended the Dec. 7 match day with only 7 positions unfilled. There were 312 applicants that selected rheumatology as their primary specialty, with 206 applicants being matched. Six were matched to different specialties and 100 who selected rheumatology as their primary specialty did not get matched to any program.

However, those seven unfilled slots will likely get matched.

Dr. Anne Bass
“There is something called the ‘scramble’ where any program that has empty slots that they want filled can match with applicants that have not matched,” Anne Bass, MD, chair of the American College of Rheumatology’s Committee on Rheumatology Training and Workforce Issues, said. “Usually most, if not all, of those empty slots end up filling.”

Overall, Dr. Bass, who is the program director of the rheumatology fellowship program at the Hospital for Special Surgery, New York, said the numbers reflect strong interest in rheumatology.

“In 2012, there were 240 applicants to rheumatology, and this year there were 312,” she said. “It’s been a linear trend. ... The number of programs has actually gone up but it has not kept pace with demand. In 2012, 63 applicants didn’t match at any program, and this year, the number was 100.”

Dr. Bass said that this speaks to the attractiveness of rheumatology as a field and that there will be a need to create more fellowship slots.

To that end, the Rheumatology Research Foundation, the grant-giving philanthropic arm of ACR that funds research grants and fellowship training awards, is examining that very issue.

“I am leading a working group to try to figure out how to configure this award so that we try to direct them to fellowship programs that can expand or even [create] new fellowship programs,” Dr. Bass said. “The ACR and RRF will continue to fund fellowship programs because many programs have to scramble to fund the salary to support trainees and in particular to try to direct resources that will actually end up creating a new rheumatology fellow where one would not have existed before.”

The group is also looking at ways to encourage programs that have internal funding to increase their capacity if they are able to do so, she added.

Rheumatology was among a number of specialties that were able to fill at least 90% of their open slots, Other areas included allergy/immunology, cardiovascular disease, gastroenterology, hematology and oncology, pulmonary disease and pulmonary/critical care.

On the flip side, nephrology, infectious disease, and geriatric medicine had more positions available than there were applicants who prefer those specialties.

“The results this year mirror prior-year results, with slight improvement in a few specialties but no significant changes,” Mona Singer, president and CEO of the National Resident Match Program, said.

Overall, across all specialties, there were 4,731 slots, with 4,139 positions filled, accounting for about 75% of the 5,512 enrolled applicants.

Rheumatology saw nearly 97% of its positions filled during the 2016 Specialty Match Day.

The specialty had 217 open slots and ended the Dec. 7 match day with only 7 positions unfilled. There were 312 applicants that selected rheumatology as their primary specialty, with 206 applicants being matched. Six were matched to different specialties and 100 who selected rheumatology as their primary specialty did not get matched to any program.

However, those seven unfilled slots will likely get matched.

Dr. Anne Bass
“There is something called the ‘scramble’ where any program that has empty slots that they want filled can match with applicants that have not matched,” Anne Bass, MD, chair of the American College of Rheumatology’s Committee on Rheumatology Training and Workforce Issues, said. “Usually most, if not all, of those empty slots end up filling.”

Overall, Dr. Bass, who is the program director of the rheumatology fellowship program at the Hospital for Special Surgery, New York, said the numbers reflect strong interest in rheumatology.

“In 2012, there were 240 applicants to rheumatology, and this year there were 312,” she said. “It’s been a linear trend. ... The number of programs has actually gone up but it has not kept pace with demand. In 2012, 63 applicants didn’t match at any program, and this year, the number was 100.”

Dr. Bass said that this speaks to the attractiveness of rheumatology as a field and that there will be a need to create more fellowship slots.

To that end, the Rheumatology Research Foundation, the grant-giving philanthropic arm of ACR that funds research grants and fellowship training awards, is examining that very issue.

“I am leading a working group to try to figure out how to configure this award so that we try to direct them to fellowship programs that can expand or even [create] new fellowship programs,” Dr. Bass said. “The ACR and RRF will continue to fund fellowship programs because many programs have to scramble to fund the salary to support trainees and in particular to try to direct resources that will actually end up creating a new rheumatology fellow where one would not have existed before.”

The group is also looking at ways to encourage programs that have internal funding to increase their capacity if they are able to do so, she added.

Rheumatology was among a number of specialties that were able to fill at least 90% of their open slots, Other areas included allergy/immunology, cardiovascular disease, gastroenterology, hematology and oncology, pulmonary disease and pulmonary/critical care.

On the flip side, nephrology, infectious disease, and geriatric medicine had more positions available than there were applicants who prefer those specialties.

“The results this year mirror prior-year results, with slight improvement in a few specialties but no significant changes,” Mona Singer, president and CEO of the National Resident Match Program, said.

Overall, across all specialties, there were 4,731 slots, with 4,139 positions filled, accounting for about 75% of the 5,512 enrolled applicants.

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MACRA’s near and potential long-term future outlined for rheumatology

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– Now that implementation of the Medicare Access and CHIP Reauthorization Act is on rheumatologists’ doorsteps, figuring out what is required in 2017 is imperative to avoid future penalties and maximize the chance of earning a bonus.

Recent announcements from the Centers for Medicare & Medicaid Services (CMS) on performance thresholds and how to meet them in 2017 give rheumatologists a great shot at not getting penalized when payment adjustments begin in 2019.

Dr. William F. Harvey
Of the two quality reporting pathways that CMS has established for physician participation in 2017 and beyond – the Merit-based Incentive Payment System (MIPS) and Advanced Alternative Payment Models (APMs) – most rheumatology practices will probably choose MIPS because most will not qualify to participate in an APM, William F. Harvey, MD, said at the annual meeting of the American College of Rheumatology.

However, efforts by the ACR to create new rheumatology-focused APMs could play a major role in changing that, said Dr. Harvey, clinical director of the Arthritis Treatment Center at Tufts Medical Center, Boston, and former chair of the ACR’s Committee on Government Affairs.

The MIPS option in MACRA is “a repackaging” of old programs, including Meaningful Use (which is now called Advancing Care Information), value-based modifiers, and the Physician Quality Reporting System (PQRS). “One silver lining to this massive piece of legislation is that it’s actually less downside risk than if you had continued with Meaningful Use, PQRS, and value-based modifier,” Dr. Harvey said.

MIPS is onerous by design, in Dr. Harvey’s opinion. “CMS does not want to continue the fee-for-service arrangement and MIPS is basically fee-for-service with a bit of pay-for-performance bolted on top of it. They’ve already stated that they want to push every provider into alternative payment model–type reimbursements going forward.”

Rheumatologists aren’t eligible for MIPS if they see fewer than 100 Medicare patients per year or if they bill less than $30,000 in Medicare fees. For MIPS-eligible physicians, adjustments to Medicare payments begin in 2019 based on 2017 quality reporting data. Physicians will still receive yearly 0.5% increases in Medicare pay in 2017-2019 and 0% each year through 2025 before any adjustments are made based on the MIPS score. Participation in the MIPS pathway gives the potential for payment adjustments starting at plus or minus 4% in 2019, plus or minus 5% in 2020, plus or minus 7% in 2021, and plus or minus 9% in 2022 and beyond, based on how rheumatologists compare against their peers.

Targets for 2017 and adjustments beyond 2017

Each year in November, CMS will announce the base performance threshold goal that physicians will need to reach in the following year in order to avoid negative Medicare payment adjustments 2 years later.

Each year’s threshold will be based on the data collected from the prior year. For the year starting Jan. 1, 2017, in order to avoid a 4% cut in their Medicare Part B base rate payment in 2019, rheumatologists will need to meet a base performance threshold score of just 3 out of 100.

“Basically, if you participate in a program in any way whatsoever, you can hit this target,” Dr. Harvey said.

In 2017, getting a score of 70 or more out of 100 puts rheumatologists into a high performance category that makes them eligible for a piece of the $500 million pool of positive payment adjustments that will be available in each of the first 6 years of MIPS.

Providers who score less than 3 out of 100 will get the maximum penalty – a 4% cut in their 2019 Medicare payment rate. Further, in 2017, only 90 days of reporting is required to qualify for positive adjustments in 2019.

The base performance threshold will certainly go up for 2018 to “probably 30, 40, 50; something like that,” Dr. Harvey said.

Knowing the threshold in advance should help rheumatologists to predict by the middle of each year whether they are going to make it, but how much of any increase (or decrease) in payment adjustment they will have 2 years hence will be very difficult to know, he said, because each year the adjustment must be budget neutral and is dependent on how many physicians are above and below the threshold.

The MIPS score is based on four categories that total up to 100 points:

Quality (60% of 2017 score)

The quality category is determined by six measures that are worth 10 points each. All of the quality domains from PQRS are gone, and out of those six measures providers must have one cross-cutting measure and one outcome measure, or just one high-priority measure. Since rheumatology does not yet have any designated outcome measures, rheumatologists will need to report other designated measures. For each of these six required measures, a provider would earn 3 points for reaching the benchmark, and then the score could be increased to 4-10 points per measure based on a decile system that determines the provider’s performance against others who have met the benchmark for that measure.

 

 

Of the 13 quality metrics that are in the rheumatology quality measure set, 7 are not specific to rheumatology (advanced directive documentation, body mass index screening and follow-up, taking a comprehensive medication list, tobacco screening in adolescents, tobacco screening in adults, hypertension screening and follow-up, and sending consult note to referring doctor), whereas 6 are (TB screening within 6 months of starting a biologic, yearly TB screening on biologics, measuring rheumatoid arthritis [RA] disease activity, measuring RA functional assessment, documenting RA prognosis, and RA steroid management).

The quality category will account for 50% of the MIPS score in 2018.

Resource use (0% of 2017 score)

“The fact that the resource use part of the equation has been set to 0% for the 2017 performance year is a really good thing for rheumatologists because we use some of the most expensive drugs around,” Dr. Harvey said. “Part of the reason that CMS did this is that they are having trouble accounting for the fact that they have easy access to Part B cost data – infusion cost data – but they don’t have very good access to Part D self-injectable drug cost data.”

“We are going to make it a key advocacy point that they appropriately take into account cost in future years,” he added.

While the resource use category of MIPS contributes nothing to the 2017 MIPS score, it will increase to 10% in 2018 and by 2021 it’s anticipated to be 30% of the MIPS score, while the quality category is anticipated to drop to 30%.

Clinical practice improvement activities (15% of 2017 score)

This part includes more than 90 proposed activities to count toward the category’s score, including patient engagement activities, care coordination, extended office hours, and participation in a qualified clinical data registry (QCDR), such as the ACR’s RISE Registry, which is already a certified QCDR. A total of 40 points in this category gives full credit for the 15 percentage point value given to it for 2017.

All of the proposed activities for 2017 are weighted as medium (10 points) or high weight (20 points). For example, 40 points could be earned by meeting two medium-weight measures and one high-weight measure.

The clinical practice improvement activities category will stay at 15% of the MIPS score in 2018.

Advancing care information (25% of 2017 score)

“This is another one that gets complicated, but there’s one key take-home message: This is way easier than Meaningful Use has ever been,” Dr. Harvey said. There are 100 points needed in the advancing care information category in order to get the full 25 percentage points that it accounts for in the 2017 MIPS score.

For reporting on five required measures (electronic health record [EHR] security analysis, e-prescribing, patient access to an EHR, and being able to send and accept summary of care documents), a provider will earn 50 points.

Another 90 performance points are available for reporting certain information, and this is based on a decile system just like the quality category in which a rheumatologist’s performance is measured against other rheumatologists who have met the benchmark for each particular measure. These optional measures include providing patient-specific educational information; patients being able to view, download, and transmit their own medical records; secure messaging; acceptance of patient-generated health data; medication reconciliation; and submitting data to a state immunization registry.

Another 15 bonus points are available for additional public health reporting and reporting to CMS using a certified EHR or QCDR.

All these measures together give providers the potential to earn 155 points toward the 100-point threshold.

“If you’re already doing Meaningful Use, chances are you’re going to do really well in this area,” he said.

The advancing care information category will stay at 25% of the MIPS score in 2018.

Problems with current APMs

Under MACRA, participation in an APM means that the physician is exempt from MIPS and will receive a 5% lump sum bonus per year in 2019-2024, a higher annual increase in fee-for-service revenues, and the general benefits of participating in an APM. However, few rheumatologists will qualify for the APM pathway, and there are no rheumatology-specific APMs in existence.

Harold D. Miller
APMs arose because of barriers in the fee-for-service system that prevent physicians from delivering higher-quality care at lower costs, and these barriers are not always appreciated, said Harold D. Miller, president and CEO of the Center for Healthcare Quality and Payment Reform. He is also a member of the Physician-Focused Payment Model Technical Advisory Committee. These include no payment or inadequate payment for high-value services and the loss of revenue that occurs when patients can be treated with low-cost services.

Most current APMs are “shared savings” programs where if the physician or health system can reduce spending below the expected levels, then the provider receives a share of the payer’s savings. However, these shared-savings APMs all still use a fee-for-service structure, which makes them just a different form of pay for performance, according to Mr. Miller.

Physicians still don’t get paid for unfunded or underfunded services, and physicians who are already efficient receive little or no additional revenue and may be forced out of business, while physicians who have been practicing inefficiently or inappropriately are paid more than conservative physicians. There’s also the potential for rewarding the denial of needed care. Physicians in shared-savings APMs are also placed at risk for costs they cannot control and for random variations in spending. And most of all, the shared savings bonuses are temporary and when there are no more savings to be generated, physicians are underpaid, Mr. Miller said.

During 2013-2015, 46%-48% of Medicare shared-savings accountable care organizations (ACOs) increased their Medicare spending rather than reduced it, and only 24%-30% of the ACOs received shared-savings payments. In each year, Medicare spent more than it saved, with net losses ranging from $50 million to $216 million. This happened because physicians in the programs still got paid with fee-for-service payments, Mr. Miller said.

 

 

Creating rheumatology-focused APMs

MACRA designated the development of the Physician-Focused Payment Model Technical Advisory Committee, of which Mr. Miller is a member, to solicit and review physician-focused payment models and make recommendations to CMS about which ones to implement.

Physician-focused payment models got their start through pioneering work by physicians who obtained data from insurers to find ways to reach out proactively to patients to address problems before patients are hospitalized. Through these efforts, they have reduced cost and increased patient satisfaction while also increasing payment to physicians by supporting “medical home” services, according to Dr. Miller.

These efforts to create APMs that support high-quality, physician-directed care begin by identifying avoidable spending that varies from specialty to specialty and from condition to condition. Then they address barriers in the current fee-for-service system – such as no payment for many high-value services and insufficient revenue to cover costs when using fewer or low-cost services – by providing flexible, adequate payment while requiring physicians to take responsibility for the things they said could be avoidable when paid in that way. However, this responsibility must be focused on what a particular physician can influence, Mr. Miller noted.

Rheumatologists could be helped by these physician-focused payment models because they receive less than 10% of the total Medicare health care spending per patient whose care was directed by a rheumatologist. In that case, finding ways to drop total spending per patient by 5% could at the same time give rheumatologists a 25% increase in payment while also saving Medicare 3% overall, he said.

Rheumatologists are best set up to take condition-based payments that are geared to keep patients out of the hospital, rather than the hospital episode–based payments that have dominated APMs in existence so far. Central to this condition-based model is getting the right diagnosis at the start, so payment for getting the correct diagnosis would be critical.

APMs designed for rheumatologists could take into account the diseases often seen by a rheumatologist, such as RA, and then identify opportunities to improve care and reduce costs while identifying barriers in the current payment system for achieving those goals, Mr. Miller said. These opportunities and barriers would vary from condition to condition. In some cases, particularly for low-frequency conditions, there may not need to be a new payment model established and it could be done through fee-for-service.

Ideally, these condition-based payment models for specialists such as rheumatologists would exist within the “medical neighborhood” of primary care physicians who could refer to them when necessary. Specialists would be accountable for the aspects of care that they can control, such as avoiding unnecessary tests and procedures and avoiding infections and complications.

“That’s building the ACO from the bottom up, rather than what Medicare is trying to do, which is to create it from the top down,” Mr. Miller said.

Mr. Miller noted that it will be important for specialties such as rheumatology to define the cost data it needs in order to develop condition-based payment models.

Dr. Harvey had no relevant disclosures. Mr. Miller has no financial relationships with any commercial interests.

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– Now that implementation of the Medicare Access and CHIP Reauthorization Act is on rheumatologists’ doorsteps, figuring out what is required in 2017 is imperative to avoid future penalties and maximize the chance of earning a bonus.

Recent announcements from the Centers for Medicare & Medicaid Services (CMS) on performance thresholds and how to meet them in 2017 give rheumatologists a great shot at not getting penalized when payment adjustments begin in 2019.

Dr. William F. Harvey
Of the two quality reporting pathways that CMS has established for physician participation in 2017 and beyond – the Merit-based Incentive Payment System (MIPS) and Advanced Alternative Payment Models (APMs) – most rheumatology practices will probably choose MIPS because most will not qualify to participate in an APM, William F. Harvey, MD, said at the annual meeting of the American College of Rheumatology.

However, efforts by the ACR to create new rheumatology-focused APMs could play a major role in changing that, said Dr. Harvey, clinical director of the Arthritis Treatment Center at Tufts Medical Center, Boston, and former chair of the ACR’s Committee on Government Affairs.

The MIPS option in MACRA is “a repackaging” of old programs, including Meaningful Use (which is now called Advancing Care Information), value-based modifiers, and the Physician Quality Reporting System (PQRS). “One silver lining to this massive piece of legislation is that it’s actually less downside risk than if you had continued with Meaningful Use, PQRS, and value-based modifier,” Dr. Harvey said.

MIPS is onerous by design, in Dr. Harvey’s opinion. “CMS does not want to continue the fee-for-service arrangement and MIPS is basically fee-for-service with a bit of pay-for-performance bolted on top of it. They’ve already stated that they want to push every provider into alternative payment model–type reimbursements going forward.”

Rheumatologists aren’t eligible for MIPS if they see fewer than 100 Medicare patients per year or if they bill less than $30,000 in Medicare fees. For MIPS-eligible physicians, adjustments to Medicare payments begin in 2019 based on 2017 quality reporting data. Physicians will still receive yearly 0.5% increases in Medicare pay in 2017-2019 and 0% each year through 2025 before any adjustments are made based on the MIPS score. Participation in the MIPS pathway gives the potential for payment adjustments starting at plus or minus 4% in 2019, plus or minus 5% in 2020, plus or minus 7% in 2021, and plus or minus 9% in 2022 and beyond, based on how rheumatologists compare against their peers.

Targets for 2017 and adjustments beyond 2017

Each year in November, CMS will announce the base performance threshold goal that physicians will need to reach in the following year in order to avoid negative Medicare payment adjustments 2 years later.

Each year’s threshold will be based on the data collected from the prior year. For the year starting Jan. 1, 2017, in order to avoid a 4% cut in their Medicare Part B base rate payment in 2019, rheumatologists will need to meet a base performance threshold score of just 3 out of 100.

“Basically, if you participate in a program in any way whatsoever, you can hit this target,” Dr. Harvey said.

In 2017, getting a score of 70 or more out of 100 puts rheumatologists into a high performance category that makes them eligible for a piece of the $500 million pool of positive payment adjustments that will be available in each of the first 6 years of MIPS.

Providers who score less than 3 out of 100 will get the maximum penalty – a 4% cut in their 2019 Medicare payment rate. Further, in 2017, only 90 days of reporting is required to qualify for positive adjustments in 2019.

The base performance threshold will certainly go up for 2018 to “probably 30, 40, 50; something like that,” Dr. Harvey said.

Knowing the threshold in advance should help rheumatologists to predict by the middle of each year whether they are going to make it, but how much of any increase (or decrease) in payment adjustment they will have 2 years hence will be very difficult to know, he said, because each year the adjustment must be budget neutral and is dependent on how many physicians are above and below the threshold.

The MIPS score is based on four categories that total up to 100 points:

Quality (60% of 2017 score)

The quality category is determined by six measures that are worth 10 points each. All of the quality domains from PQRS are gone, and out of those six measures providers must have one cross-cutting measure and one outcome measure, or just one high-priority measure. Since rheumatology does not yet have any designated outcome measures, rheumatologists will need to report other designated measures. For each of these six required measures, a provider would earn 3 points for reaching the benchmark, and then the score could be increased to 4-10 points per measure based on a decile system that determines the provider’s performance against others who have met the benchmark for that measure.

 

 

Of the 13 quality metrics that are in the rheumatology quality measure set, 7 are not specific to rheumatology (advanced directive documentation, body mass index screening and follow-up, taking a comprehensive medication list, tobacco screening in adolescents, tobacco screening in adults, hypertension screening and follow-up, and sending consult note to referring doctor), whereas 6 are (TB screening within 6 months of starting a biologic, yearly TB screening on biologics, measuring rheumatoid arthritis [RA] disease activity, measuring RA functional assessment, documenting RA prognosis, and RA steroid management).

The quality category will account for 50% of the MIPS score in 2018.

Resource use (0% of 2017 score)

“The fact that the resource use part of the equation has been set to 0% for the 2017 performance year is a really good thing for rheumatologists because we use some of the most expensive drugs around,” Dr. Harvey said. “Part of the reason that CMS did this is that they are having trouble accounting for the fact that they have easy access to Part B cost data – infusion cost data – but they don’t have very good access to Part D self-injectable drug cost data.”

“We are going to make it a key advocacy point that they appropriately take into account cost in future years,” he added.

While the resource use category of MIPS contributes nothing to the 2017 MIPS score, it will increase to 10% in 2018 and by 2021 it’s anticipated to be 30% of the MIPS score, while the quality category is anticipated to drop to 30%.

Clinical practice improvement activities (15% of 2017 score)

This part includes more than 90 proposed activities to count toward the category’s score, including patient engagement activities, care coordination, extended office hours, and participation in a qualified clinical data registry (QCDR), such as the ACR’s RISE Registry, which is already a certified QCDR. A total of 40 points in this category gives full credit for the 15 percentage point value given to it for 2017.

All of the proposed activities for 2017 are weighted as medium (10 points) or high weight (20 points). For example, 40 points could be earned by meeting two medium-weight measures and one high-weight measure.

The clinical practice improvement activities category will stay at 15% of the MIPS score in 2018.

Advancing care information (25% of 2017 score)

“This is another one that gets complicated, but there’s one key take-home message: This is way easier than Meaningful Use has ever been,” Dr. Harvey said. There are 100 points needed in the advancing care information category in order to get the full 25 percentage points that it accounts for in the 2017 MIPS score.

For reporting on five required measures (electronic health record [EHR] security analysis, e-prescribing, patient access to an EHR, and being able to send and accept summary of care documents), a provider will earn 50 points.

Another 90 performance points are available for reporting certain information, and this is based on a decile system just like the quality category in which a rheumatologist’s performance is measured against other rheumatologists who have met the benchmark for each particular measure. These optional measures include providing patient-specific educational information; patients being able to view, download, and transmit their own medical records; secure messaging; acceptance of patient-generated health data; medication reconciliation; and submitting data to a state immunization registry.

Another 15 bonus points are available for additional public health reporting and reporting to CMS using a certified EHR or QCDR.

All these measures together give providers the potential to earn 155 points toward the 100-point threshold.

“If you’re already doing Meaningful Use, chances are you’re going to do really well in this area,” he said.

The advancing care information category will stay at 25% of the MIPS score in 2018.

Problems with current APMs

Under MACRA, participation in an APM means that the physician is exempt from MIPS and will receive a 5% lump sum bonus per year in 2019-2024, a higher annual increase in fee-for-service revenues, and the general benefits of participating in an APM. However, few rheumatologists will qualify for the APM pathway, and there are no rheumatology-specific APMs in existence.

Harold D. Miller
APMs arose because of barriers in the fee-for-service system that prevent physicians from delivering higher-quality care at lower costs, and these barriers are not always appreciated, said Harold D. Miller, president and CEO of the Center for Healthcare Quality and Payment Reform. He is also a member of the Physician-Focused Payment Model Technical Advisory Committee. These include no payment or inadequate payment for high-value services and the loss of revenue that occurs when patients can be treated with low-cost services.

Most current APMs are “shared savings” programs where if the physician or health system can reduce spending below the expected levels, then the provider receives a share of the payer’s savings. However, these shared-savings APMs all still use a fee-for-service structure, which makes them just a different form of pay for performance, according to Mr. Miller.

Physicians still don’t get paid for unfunded or underfunded services, and physicians who are already efficient receive little or no additional revenue and may be forced out of business, while physicians who have been practicing inefficiently or inappropriately are paid more than conservative physicians. There’s also the potential for rewarding the denial of needed care. Physicians in shared-savings APMs are also placed at risk for costs they cannot control and for random variations in spending. And most of all, the shared savings bonuses are temporary and when there are no more savings to be generated, physicians are underpaid, Mr. Miller said.

During 2013-2015, 46%-48% of Medicare shared-savings accountable care organizations (ACOs) increased their Medicare spending rather than reduced it, and only 24%-30% of the ACOs received shared-savings payments. In each year, Medicare spent more than it saved, with net losses ranging from $50 million to $216 million. This happened because physicians in the programs still got paid with fee-for-service payments, Mr. Miller said.

 

 

Creating rheumatology-focused APMs

MACRA designated the development of the Physician-Focused Payment Model Technical Advisory Committee, of which Mr. Miller is a member, to solicit and review physician-focused payment models and make recommendations to CMS about which ones to implement.

Physician-focused payment models got their start through pioneering work by physicians who obtained data from insurers to find ways to reach out proactively to patients to address problems before patients are hospitalized. Through these efforts, they have reduced cost and increased patient satisfaction while also increasing payment to physicians by supporting “medical home” services, according to Dr. Miller.

These efforts to create APMs that support high-quality, physician-directed care begin by identifying avoidable spending that varies from specialty to specialty and from condition to condition. Then they address barriers in the current fee-for-service system – such as no payment for many high-value services and insufficient revenue to cover costs when using fewer or low-cost services – by providing flexible, adequate payment while requiring physicians to take responsibility for the things they said could be avoidable when paid in that way. However, this responsibility must be focused on what a particular physician can influence, Mr. Miller noted.

Rheumatologists could be helped by these physician-focused payment models because they receive less than 10% of the total Medicare health care spending per patient whose care was directed by a rheumatologist. In that case, finding ways to drop total spending per patient by 5% could at the same time give rheumatologists a 25% increase in payment while also saving Medicare 3% overall, he said.

Rheumatologists are best set up to take condition-based payments that are geared to keep patients out of the hospital, rather than the hospital episode–based payments that have dominated APMs in existence so far. Central to this condition-based model is getting the right diagnosis at the start, so payment for getting the correct diagnosis would be critical.

APMs designed for rheumatologists could take into account the diseases often seen by a rheumatologist, such as RA, and then identify opportunities to improve care and reduce costs while identifying barriers in the current payment system for achieving those goals, Mr. Miller said. These opportunities and barriers would vary from condition to condition. In some cases, particularly for low-frequency conditions, there may not need to be a new payment model established and it could be done through fee-for-service.

Ideally, these condition-based payment models for specialists such as rheumatologists would exist within the “medical neighborhood” of primary care physicians who could refer to them when necessary. Specialists would be accountable for the aspects of care that they can control, such as avoiding unnecessary tests and procedures and avoiding infections and complications.

“That’s building the ACO from the bottom up, rather than what Medicare is trying to do, which is to create it from the top down,” Mr. Miller said.

Mr. Miller noted that it will be important for specialties such as rheumatology to define the cost data it needs in order to develop condition-based payment models.

Dr. Harvey had no relevant disclosures. Mr. Miller has no financial relationships with any commercial interests.

 

– Now that implementation of the Medicare Access and CHIP Reauthorization Act is on rheumatologists’ doorsteps, figuring out what is required in 2017 is imperative to avoid future penalties and maximize the chance of earning a bonus.

Recent announcements from the Centers for Medicare & Medicaid Services (CMS) on performance thresholds and how to meet them in 2017 give rheumatologists a great shot at not getting penalized when payment adjustments begin in 2019.

Dr. William F. Harvey
Of the two quality reporting pathways that CMS has established for physician participation in 2017 and beyond – the Merit-based Incentive Payment System (MIPS) and Advanced Alternative Payment Models (APMs) – most rheumatology practices will probably choose MIPS because most will not qualify to participate in an APM, William F. Harvey, MD, said at the annual meeting of the American College of Rheumatology.

However, efforts by the ACR to create new rheumatology-focused APMs could play a major role in changing that, said Dr. Harvey, clinical director of the Arthritis Treatment Center at Tufts Medical Center, Boston, and former chair of the ACR’s Committee on Government Affairs.

The MIPS option in MACRA is “a repackaging” of old programs, including Meaningful Use (which is now called Advancing Care Information), value-based modifiers, and the Physician Quality Reporting System (PQRS). “One silver lining to this massive piece of legislation is that it’s actually less downside risk than if you had continued with Meaningful Use, PQRS, and value-based modifier,” Dr. Harvey said.

MIPS is onerous by design, in Dr. Harvey’s opinion. “CMS does not want to continue the fee-for-service arrangement and MIPS is basically fee-for-service with a bit of pay-for-performance bolted on top of it. They’ve already stated that they want to push every provider into alternative payment model–type reimbursements going forward.”

Rheumatologists aren’t eligible for MIPS if they see fewer than 100 Medicare patients per year or if they bill less than $30,000 in Medicare fees. For MIPS-eligible physicians, adjustments to Medicare payments begin in 2019 based on 2017 quality reporting data. Physicians will still receive yearly 0.5% increases in Medicare pay in 2017-2019 and 0% each year through 2025 before any adjustments are made based on the MIPS score. Participation in the MIPS pathway gives the potential for payment adjustments starting at plus or minus 4% in 2019, plus or minus 5% in 2020, plus or minus 7% in 2021, and plus or minus 9% in 2022 and beyond, based on how rheumatologists compare against their peers.

Targets for 2017 and adjustments beyond 2017

Each year in November, CMS will announce the base performance threshold goal that physicians will need to reach in the following year in order to avoid negative Medicare payment adjustments 2 years later.

Each year’s threshold will be based on the data collected from the prior year. For the year starting Jan. 1, 2017, in order to avoid a 4% cut in their Medicare Part B base rate payment in 2019, rheumatologists will need to meet a base performance threshold score of just 3 out of 100.

“Basically, if you participate in a program in any way whatsoever, you can hit this target,” Dr. Harvey said.

In 2017, getting a score of 70 or more out of 100 puts rheumatologists into a high performance category that makes them eligible for a piece of the $500 million pool of positive payment adjustments that will be available in each of the first 6 years of MIPS.

Providers who score less than 3 out of 100 will get the maximum penalty – a 4% cut in their 2019 Medicare payment rate. Further, in 2017, only 90 days of reporting is required to qualify for positive adjustments in 2019.

The base performance threshold will certainly go up for 2018 to “probably 30, 40, 50; something like that,” Dr. Harvey said.

Knowing the threshold in advance should help rheumatologists to predict by the middle of each year whether they are going to make it, but how much of any increase (or decrease) in payment adjustment they will have 2 years hence will be very difficult to know, he said, because each year the adjustment must be budget neutral and is dependent on how many physicians are above and below the threshold.

The MIPS score is based on four categories that total up to 100 points:

Quality (60% of 2017 score)

The quality category is determined by six measures that are worth 10 points each. All of the quality domains from PQRS are gone, and out of those six measures providers must have one cross-cutting measure and one outcome measure, or just one high-priority measure. Since rheumatology does not yet have any designated outcome measures, rheumatologists will need to report other designated measures. For each of these six required measures, a provider would earn 3 points for reaching the benchmark, and then the score could be increased to 4-10 points per measure based on a decile system that determines the provider’s performance against others who have met the benchmark for that measure.

 

 

Of the 13 quality metrics that are in the rheumatology quality measure set, 7 are not specific to rheumatology (advanced directive documentation, body mass index screening and follow-up, taking a comprehensive medication list, tobacco screening in adolescents, tobacco screening in adults, hypertension screening and follow-up, and sending consult note to referring doctor), whereas 6 are (TB screening within 6 months of starting a biologic, yearly TB screening on biologics, measuring rheumatoid arthritis [RA] disease activity, measuring RA functional assessment, documenting RA prognosis, and RA steroid management).

The quality category will account for 50% of the MIPS score in 2018.

Resource use (0% of 2017 score)

“The fact that the resource use part of the equation has been set to 0% for the 2017 performance year is a really good thing for rheumatologists because we use some of the most expensive drugs around,” Dr. Harvey said. “Part of the reason that CMS did this is that they are having trouble accounting for the fact that they have easy access to Part B cost data – infusion cost data – but they don’t have very good access to Part D self-injectable drug cost data.”

“We are going to make it a key advocacy point that they appropriately take into account cost in future years,” he added.

While the resource use category of MIPS contributes nothing to the 2017 MIPS score, it will increase to 10% in 2018 and by 2021 it’s anticipated to be 30% of the MIPS score, while the quality category is anticipated to drop to 30%.

Clinical practice improvement activities (15% of 2017 score)

This part includes more than 90 proposed activities to count toward the category’s score, including patient engagement activities, care coordination, extended office hours, and participation in a qualified clinical data registry (QCDR), such as the ACR’s RISE Registry, which is already a certified QCDR. A total of 40 points in this category gives full credit for the 15 percentage point value given to it for 2017.

All of the proposed activities for 2017 are weighted as medium (10 points) or high weight (20 points). For example, 40 points could be earned by meeting two medium-weight measures and one high-weight measure.

The clinical practice improvement activities category will stay at 15% of the MIPS score in 2018.

Advancing care information (25% of 2017 score)

“This is another one that gets complicated, but there’s one key take-home message: This is way easier than Meaningful Use has ever been,” Dr. Harvey said. There are 100 points needed in the advancing care information category in order to get the full 25 percentage points that it accounts for in the 2017 MIPS score.

For reporting on five required measures (electronic health record [EHR] security analysis, e-prescribing, patient access to an EHR, and being able to send and accept summary of care documents), a provider will earn 50 points.

Another 90 performance points are available for reporting certain information, and this is based on a decile system just like the quality category in which a rheumatologist’s performance is measured against other rheumatologists who have met the benchmark for each particular measure. These optional measures include providing patient-specific educational information; patients being able to view, download, and transmit their own medical records; secure messaging; acceptance of patient-generated health data; medication reconciliation; and submitting data to a state immunization registry.

Another 15 bonus points are available for additional public health reporting and reporting to CMS using a certified EHR or QCDR.

All these measures together give providers the potential to earn 155 points toward the 100-point threshold.

“If you’re already doing Meaningful Use, chances are you’re going to do really well in this area,” he said.

The advancing care information category will stay at 25% of the MIPS score in 2018.

Problems with current APMs

Under MACRA, participation in an APM means that the physician is exempt from MIPS and will receive a 5% lump sum bonus per year in 2019-2024, a higher annual increase in fee-for-service revenues, and the general benefits of participating in an APM. However, few rheumatologists will qualify for the APM pathway, and there are no rheumatology-specific APMs in existence.

Harold D. Miller
APMs arose because of barriers in the fee-for-service system that prevent physicians from delivering higher-quality care at lower costs, and these barriers are not always appreciated, said Harold D. Miller, president and CEO of the Center for Healthcare Quality and Payment Reform. He is also a member of the Physician-Focused Payment Model Technical Advisory Committee. These include no payment or inadequate payment for high-value services and the loss of revenue that occurs when patients can be treated with low-cost services.

Most current APMs are “shared savings” programs where if the physician or health system can reduce spending below the expected levels, then the provider receives a share of the payer’s savings. However, these shared-savings APMs all still use a fee-for-service structure, which makes them just a different form of pay for performance, according to Mr. Miller.

Physicians still don’t get paid for unfunded or underfunded services, and physicians who are already efficient receive little or no additional revenue and may be forced out of business, while physicians who have been practicing inefficiently or inappropriately are paid more than conservative physicians. There’s also the potential for rewarding the denial of needed care. Physicians in shared-savings APMs are also placed at risk for costs they cannot control and for random variations in spending. And most of all, the shared savings bonuses are temporary and when there are no more savings to be generated, physicians are underpaid, Mr. Miller said.

During 2013-2015, 46%-48% of Medicare shared-savings accountable care organizations (ACOs) increased their Medicare spending rather than reduced it, and only 24%-30% of the ACOs received shared-savings payments. In each year, Medicare spent more than it saved, with net losses ranging from $50 million to $216 million. This happened because physicians in the programs still got paid with fee-for-service payments, Mr. Miller said.

 

 

Creating rheumatology-focused APMs

MACRA designated the development of the Physician-Focused Payment Model Technical Advisory Committee, of which Mr. Miller is a member, to solicit and review physician-focused payment models and make recommendations to CMS about which ones to implement.

Physician-focused payment models got their start through pioneering work by physicians who obtained data from insurers to find ways to reach out proactively to patients to address problems before patients are hospitalized. Through these efforts, they have reduced cost and increased patient satisfaction while also increasing payment to physicians by supporting “medical home” services, according to Dr. Miller.

These efforts to create APMs that support high-quality, physician-directed care begin by identifying avoidable spending that varies from specialty to specialty and from condition to condition. Then they address barriers in the current fee-for-service system – such as no payment for many high-value services and insufficient revenue to cover costs when using fewer or low-cost services – by providing flexible, adequate payment while requiring physicians to take responsibility for the things they said could be avoidable when paid in that way. However, this responsibility must be focused on what a particular physician can influence, Mr. Miller noted.

Rheumatologists could be helped by these physician-focused payment models because they receive less than 10% of the total Medicare health care spending per patient whose care was directed by a rheumatologist. In that case, finding ways to drop total spending per patient by 5% could at the same time give rheumatologists a 25% increase in payment while also saving Medicare 3% overall, he said.

Rheumatologists are best set up to take condition-based payments that are geared to keep patients out of the hospital, rather than the hospital episode–based payments that have dominated APMs in existence so far. Central to this condition-based model is getting the right diagnosis at the start, so payment for getting the correct diagnosis would be critical.

APMs designed for rheumatologists could take into account the diseases often seen by a rheumatologist, such as RA, and then identify opportunities to improve care and reduce costs while identifying barriers in the current payment system for achieving those goals, Mr. Miller said. These opportunities and barriers would vary from condition to condition. In some cases, particularly for low-frequency conditions, there may not need to be a new payment model established and it could be done through fee-for-service.

Ideally, these condition-based payment models for specialists such as rheumatologists would exist within the “medical neighborhood” of primary care physicians who could refer to them when necessary. Specialists would be accountable for the aspects of care that they can control, such as avoiding unnecessary tests and procedures and avoiding infections and complications.

“That’s building the ACO from the bottom up, rather than what Medicare is trying to do, which is to create it from the top down,” Mr. Miller said.

Mr. Miller noted that it will be important for specialties such as rheumatology to define the cost data it needs in order to develop condition-based payment models.

Dr. Harvey had no relevant disclosures. Mr. Miller has no financial relationships with any commercial interests.

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EXPERT ANALYSIS FROM THE ACR ANNUAL MEETING

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FDA bans powdered gloves

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The Food and Drug Administration has banned powdered gloves for use in health care settings, citing “numerous risks to patients and health care workers.” The ban extends to gloves currently in commercial distribution and in the hands of the ultimate user, meaning powdered gloves will have to be pulled from examination rooms and operating theaters.

“A thorough review of all currently available information supports FDA’s conclusion that powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove should be banned,” according to a FDA final rule available now online and scheduled for publication in the Federal Register on Dec. 19, 2016. The ban will become effective 30 days after the document’s publication in the Federal Register.

Specific risks of powdered gloves cited by the FDA in support of the ban include health care worker and patient sensitization to latex, the risk of peritoneal adhesions if the powder comes in contact with exposed tissue during surgery, and other adverse events related to the inflammatory response that glove powder can provoke. Severe airway inflammation, asthma, conjunctivitis, and dyspnea have all been associated with powdered glove use.

Notes the final document, “The benefits of powdered gloves appear to only include greater ease of donning and doffing, decreased tackiness, and a degree of added comfort, which FDA believes are nominal when compared to the risks posed by these devices.”
 

 

Since viable nonpowdered alternatives exist, the FDA believes that the ban would not have significant economic impact and that shortages should not affect care delivery.

Many nonpowdered gloves, said the FDA, now “have the same level of protection, dexterity, and performance” as powdered gloves.

Powder may still be used in the glove manufacturing process, but the FDA continues to recommend that no more than 2 mg of residual powder per glove remains after the manufacturing process.

Though the final document banning powdered gloves notes that the FDA received many comments asking for a ban of all natural rubber latex (NRL) gloves, the ban applied only to powdered gloves. The FDA noted that NRL gloves already must carry a statement alerting users to the risks of allergic reaction, and also noted that eliminating powder from NRL gloves reduces the risk of latex sensitization.

In explaining its analysis of the costs and benefits of the powdered glove ban, the FDA estimated that the annual net benefits would range between $26.8 million and $31.8 million.

When this ban comes into force, it will be only the second such ban; the first was the 1983 ban of prosthetic hair fibers, which were found to provide no public health benefit.

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The Food and Drug Administration has banned powdered gloves for use in health care settings, citing “numerous risks to patients and health care workers.” The ban extends to gloves currently in commercial distribution and in the hands of the ultimate user, meaning powdered gloves will have to be pulled from examination rooms and operating theaters.

“A thorough review of all currently available information supports FDA’s conclusion that powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove should be banned,” according to a FDA final rule available now online and scheduled for publication in the Federal Register on Dec. 19, 2016. The ban will become effective 30 days after the document’s publication in the Federal Register.

Specific risks of powdered gloves cited by the FDA in support of the ban include health care worker and patient sensitization to latex, the risk of peritoneal adhesions if the powder comes in contact with exposed tissue during surgery, and other adverse events related to the inflammatory response that glove powder can provoke. Severe airway inflammation, asthma, conjunctivitis, and dyspnea have all been associated with powdered glove use.

Notes the final document, “The benefits of powdered gloves appear to only include greater ease of donning and doffing, decreased tackiness, and a degree of added comfort, which FDA believes are nominal when compared to the risks posed by these devices.”
 

 

Since viable nonpowdered alternatives exist, the FDA believes that the ban would not have significant economic impact and that shortages should not affect care delivery.

Many nonpowdered gloves, said the FDA, now “have the same level of protection, dexterity, and performance” as powdered gloves.

Powder may still be used in the glove manufacturing process, but the FDA continues to recommend that no more than 2 mg of residual powder per glove remains after the manufacturing process.

Though the final document banning powdered gloves notes that the FDA received many comments asking for a ban of all natural rubber latex (NRL) gloves, the ban applied only to powdered gloves. The FDA noted that NRL gloves already must carry a statement alerting users to the risks of allergic reaction, and also noted that eliminating powder from NRL gloves reduces the risk of latex sensitization.

In explaining its analysis of the costs and benefits of the powdered glove ban, the FDA estimated that the annual net benefits would range between $26.8 million and $31.8 million.

When this ban comes into force, it will be only the second such ban; the first was the 1983 ban of prosthetic hair fibers, which were found to provide no public health benefit.

The Food and Drug Administration has banned powdered gloves for use in health care settings, citing “numerous risks to patients and health care workers.” The ban extends to gloves currently in commercial distribution and in the hands of the ultimate user, meaning powdered gloves will have to be pulled from examination rooms and operating theaters.

“A thorough review of all currently available information supports FDA’s conclusion that powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove should be banned,” according to a FDA final rule available now online and scheduled for publication in the Federal Register on Dec. 19, 2016. The ban will become effective 30 days after the document’s publication in the Federal Register.

Specific risks of powdered gloves cited by the FDA in support of the ban include health care worker and patient sensitization to latex, the risk of peritoneal adhesions if the powder comes in contact with exposed tissue during surgery, and other adverse events related to the inflammatory response that glove powder can provoke. Severe airway inflammation, asthma, conjunctivitis, and dyspnea have all been associated with powdered glove use.

Notes the final document, “The benefits of powdered gloves appear to only include greater ease of donning and doffing, decreased tackiness, and a degree of added comfort, which FDA believes are nominal when compared to the risks posed by these devices.”
 

 

Since viable nonpowdered alternatives exist, the FDA believes that the ban would not have significant economic impact and that shortages should not affect care delivery.

Many nonpowdered gloves, said the FDA, now “have the same level of protection, dexterity, and performance” as powdered gloves.

Powder may still be used in the glove manufacturing process, but the FDA continues to recommend that no more than 2 mg of residual powder per glove remains after the manufacturing process.

Though the final document banning powdered gloves notes that the FDA received many comments asking for a ban of all natural rubber latex (NRL) gloves, the ban applied only to powdered gloves. The FDA noted that NRL gloves already must carry a statement alerting users to the risks of allergic reaction, and also noted that eliminating powder from NRL gloves reduces the risk of latex sensitization.

In explaining its analysis of the costs and benefits of the powdered glove ban, the FDA estimated that the annual net benefits would range between $26.8 million and $31.8 million.

When this ban comes into force, it will be only the second such ban; the first was the 1983 ban of prosthetic hair fibers, which were found to provide no public health benefit.

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Effective hospitalist roles for NPs, PAs

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Single-site study offers success story, isn’t one-size-fits-all solution.

I’m often asked about effective roles for nurse practitioners (NPs) and physician assistants (PAs), collectively known as advanced practice clinicians (APCs). My first response is always the same: They have much to contribute and can be effective members of hospitalist groups. Most hospital medicine groups (HMGs) should think about having them in their staffing mix if they don’t already.

Dr. John Nelson

Yet despite all that NPs/PAs can offer, my experience is that many (even most) hospitalist groups fail to develop roles that optimize their APCs’ skills.

An October 2016 study in the Journal of Clinical Outcomes Management adds additional data to help think about this issue. You may have seen the study mentioned in several news articles and blogs. Most summarized the study along the lines of “using high levels of PA staffing results in lower hospital costs per case.” Framing it this way is awfully misleading, so I’ll go a little deeper here.

Study context

The study, “A Comparison of Conventional and Expanded Physician Assistant Hospitalist Staffing Models at a Community Hospital,” is a retrospective analysis of performance measures from two hospitalist groups at Anne Arundel Medical Center (AAMC) in Annapolis, Md.1 One HMG is employed by the hospital. The other, called MDICS, is a private company that contracts with AAMC as well as approximately 13 other hospitals and 40 rehabilitation facilities. Tim Capstack, MD, is the AAMC medical director for MDICS and lead author of the study (representing a potential conflict of interest acknowledged in the article). Barry Meisenberg, MD, is a coauthor, a hospitalist in the AAMC-employed group, and chair for quality improvement and health care systems research at AAMC.

Tim told me by phone that both groups have practiced at AAMC for more than 10 years and enjoy a collegial relationship. Both groups employ PAs and pair them with a single physician in a dyad arrangement each day. Tim’s MDICS group, the “expanded PA” group, staffs each day shift with three physicians and three PAs, compared with the nine physicians and two PAs in the hospital-employed “conventional” group. The MDICS PAs are responsible for more patients each day than their conventional-group counterparts and, during the January 2012 to July 2013 study period, averaged 14.2 patients versus 8.3, respectively.

Over the course of the study, PAs in the expanded PA group saw and billed 36% of patient visits independently, compared with 5.9% for the conventional group.
 

Notable study findings

I think the main value of this study is in showing that the expanded PA group had rates of readmission, inpatient mortality, length of stay, and consultant use that weren’t statistically different from the conventional group.

The workloads and years of experience of doctors and PAs in each group were similar. And while there were some differences in the patients each group cared for, they seem unlikely to have a significant influence on outcomes. Clearly, there are many unmeasured variables (e.g., culture, morale, and leadership) in each group that could have influenced the outcomes, so this one study at one hospital doesn’t provide a definitive answer about appropriate APC staffing levels. However, it didn’t uncover big differences in the measured outcomes.

And this study did show that higher levels of PA staffing were associated with lower hospital charges per case. Although the difference was a modest 3%, it was statistically significant (P less than .001). I’m skeptical there is causation here; this more likely is just correlation.

It would be great to see a larger study of this.

Information applications

So does this study support the idea that HMGs can or should increase APC staffing and workload significantly to realize lower hospital cost per case and not harm patient outcomes? Not so fast!

This study only compared two hospitalist groups at one hospital. It’s probably not very generalizable.

And as described in the paper, and stressed by Tim talking with me by phone, the outcomes of their expanded PA model likely have a lot to do with their very careful recruiting and screening of experienced PAs before hiring them, not to mention a lengthy and deliberate on-boarding process (summarized in the article) to support their ability to perform well. Groups that are not as thoughtful and deliberate in how they hire and position APCs to contribute to the practice may not perform as well.
 

 

Why study only PAs? What about NPs? Tim told me that his group is agnostic regarding the training background of the APCs they hire; he suspects an identical study with NPs rather than PAs in each hospitalist group would probably yield very similar results. I see this the same way. Although there are differences in background and training between NPs and PAs, I think personal traits like years of experience in various health care settings and the ability to work efficiently are more important than training background.
 

 

 

A practical approach

Any group who thinks this study is evidence that adding more APCs and having them manage a higher number of patients relatively independently will go well in any setting is mistaken. But it does offer a story of one place where, with careful planning and execution, it went OK.

In my view, the real take-home message is to think carefully to ensure any APCs in your group have professionally satisfying roles that position them to contribute effectively. While common, I think configuring APCs and physicians as rounding dyads often ends up underperforming and not working out well because of inefficiency. When well executed, as is apparently the case in this study, it can be fine. But my experience is that positioning APCs to assume primary responsibility for some clinical activities, such as covering the observation unit or serving as an evening admitter/cross-cover provider (all with appropriate physician collaboration and backup), more reliably turns out well.
 

Reference

Capstack TM, Seguija C, Vollono LM, Moser JD, Meisenberg BR, Michtalik HJ. A comparison of conventional and expanded physician assistant hospitalist staffing models at a community hospital. J Clin Outcomes Manag. 2016;23(10):455-61.
 

Dr. Nelson has been a practicing hospitalist since 1988. He is co-founder and past president of SHM and principal in Nelson Flores Hospital Medicine Consultants. He is co-director for SHM’s “Best Practices in Managing a Hospital Medicine Program” course. Write to him at [email protected].

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Single-site study offers success story, isn’t one-size-fits-all solution.
Single-site study offers success story, isn’t one-size-fits-all solution.

I’m often asked about effective roles for nurse practitioners (NPs) and physician assistants (PAs), collectively known as advanced practice clinicians (APCs). My first response is always the same: They have much to contribute and can be effective members of hospitalist groups. Most hospital medicine groups (HMGs) should think about having them in their staffing mix if they don’t already.

Dr. John Nelson

Yet despite all that NPs/PAs can offer, my experience is that many (even most) hospitalist groups fail to develop roles that optimize their APCs’ skills.

An October 2016 study in the Journal of Clinical Outcomes Management adds additional data to help think about this issue. You may have seen the study mentioned in several news articles and blogs. Most summarized the study along the lines of “using high levels of PA staffing results in lower hospital costs per case.” Framing it this way is awfully misleading, so I’ll go a little deeper here.

Study context

The study, “A Comparison of Conventional and Expanded Physician Assistant Hospitalist Staffing Models at a Community Hospital,” is a retrospective analysis of performance measures from two hospitalist groups at Anne Arundel Medical Center (AAMC) in Annapolis, Md.1 One HMG is employed by the hospital. The other, called MDICS, is a private company that contracts with AAMC as well as approximately 13 other hospitals and 40 rehabilitation facilities. Tim Capstack, MD, is the AAMC medical director for MDICS and lead author of the study (representing a potential conflict of interest acknowledged in the article). Barry Meisenberg, MD, is a coauthor, a hospitalist in the AAMC-employed group, and chair for quality improvement and health care systems research at AAMC.

Tim told me by phone that both groups have practiced at AAMC for more than 10 years and enjoy a collegial relationship. Both groups employ PAs and pair them with a single physician in a dyad arrangement each day. Tim’s MDICS group, the “expanded PA” group, staffs each day shift with three physicians and three PAs, compared with the nine physicians and two PAs in the hospital-employed “conventional” group. The MDICS PAs are responsible for more patients each day than their conventional-group counterparts and, during the January 2012 to July 2013 study period, averaged 14.2 patients versus 8.3, respectively.

Over the course of the study, PAs in the expanded PA group saw and billed 36% of patient visits independently, compared with 5.9% for the conventional group.
 

Notable study findings

I think the main value of this study is in showing that the expanded PA group had rates of readmission, inpatient mortality, length of stay, and consultant use that weren’t statistically different from the conventional group.

The workloads and years of experience of doctors and PAs in each group were similar. And while there were some differences in the patients each group cared for, they seem unlikely to have a significant influence on outcomes. Clearly, there are many unmeasured variables (e.g., culture, morale, and leadership) in each group that could have influenced the outcomes, so this one study at one hospital doesn’t provide a definitive answer about appropriate APC staffing levels. However, it didn’t uncover big differences in the measured outcomes.

And this study did show that higher levels of PA staffing were associated with lower hospital charges per case. Although the difference was a modest 3%, it was statistically significant (P less than .001). I’m skeptical there is causation here; this more likely is just correlation.

It would be great to see a larger study of this.

Information applications

So does this study support the idea that HMGs can or should increase APC staffing and workload significantly to realize lower hospital cost per case and not harm patient outcomes? Not so fast!

This study only compared two hospitalist groups at one hospital. It’s probably not very generalizable.

And as described in the paper, and stressed by Tim talking with me by phone, the outcomes of their expanded PA model likely have a lot to do with their very careful recruiting and screening of experienced PAs before hiring them, not to mention a lengthy and deliberate on-boarding process (summarized in the article) to support their ability to perform well. Groups that are not as thoughtful and deliberate in how they hire and position APCs to contribute to the practice may not perform as well.
 

 

Why study only PAs? What about NPs? Tim told me that his group is agnostic regarding the training background of the APCs they hire; he suspects an identical study with NPs rather than PAs in each hospitalist group would probably yield very similar results. I see this the same way. Although there are differences in background and training between NPs and PAs, I think personal traits like years of experience in various health care settings and the ability to work efficiently are more important than training background.
 

 

 

A practical approach

Any group who thinks this study is evidence that adding more APCs and having them manage a higher number of patients relatively independently will go well in any setting is mistaken. But it does offer a story of one place where, with careful planning and execution, it went OK.

In my view, the real take-home message is to think carefully to ensure any APCs in your group have professionally satisfying roles that position them to contribute effectively. While common, I think configuring APCs and physicians as rounding dyads often ends up underperforming and not working out well because of inefficiency. When well executed, as is apparently the case in this study, it can be fine. But my experience is that positioning APCs to assume primary responsibility for some clinical activities, such as covering the observation unit or serving as an evening admitter/cross-cover provider (all with appropriate physician collaboration and backup), more reliably turns out well.
 

Reference

Capstack TM, Seguija C, Vollono LM, Moser JD, Meisenberg BR, Michtalik HJ. A comparison of conventional and expanded physician assistant hospitalist staffing models at a community hospital. J Clin Outcomes Manag. 2016;23(10):455-61.
 

Dr. Nelson has been a practicing hospitalist since 1988. He is co-founder and past president of SHM and principal in Nelson Flores Hospital Medicine Consultants. He is co-director for SHM’s “Best Practices in Managing a Hospital Medicine Program” course. Write to him at [email protected].

I’m often asked about effective roles for nurse practitioners (NPs) and physician assistants (PAs), collectively known as advanced practice clinicians (APCs). My first response is always the same: They have much to contribute and can be effective members of hospitalist groups. Most hospital medicine groups (HMGs) should think about having them in their staffing mix if they don’t already.

Dr. John Nelson

Yet despite all that NPs/PAs can offer, my experience is that many (even most) hospitalist groups fail to develop roles that optimize their APCs’ skills.

An October 2016 study in the Journal of Clinical Outcomes Management adds additional data to help think about this issue. You may have seen the study mentioned in several news articles and blogs. Most summarized the study along the lines of “using high levels of PA staffing results in lower hospital costs per case.” Framing it this way is awfully misleading, so I’ll go a little deeper here.

Study context

The study, “A Comparison of Conventional and Expanded Physician Assistant Hospitalist Staffing Models at a Community Hospital,” is a retrospective analysis of performance measures from two hospitalist groups at Anne Arundel Medical Center (AAMC) in Annapolis, Md.1 One HMG is employed by the hospital. The other, called MDICS, is a private company that contracts with AAMC as well as approximately 13 other hospitals and 40 rehabilitation facilities. Tim Capstack, MD, is the AAMC medical director for MDICS and lead author of the study (representing a potential conflict of interest acknowledged in the article). Barry Meisenberg, MD, is a coauthor, a hospitalist in the AAMC-employed group, and chair for quality improvement and health care systems research at AAMC.

Tim told me by phone that both groups have practiced at AAMC for more than 10 years and enjoy a collegial relationship. Both groups employ PAs and pair them with a single physician in a dyad arrangement each day. Tim’s MDICS group, the “expanded PA” group, staffs each day shift with three physicians and three PAs, compared with the nine physicians and two PAs in the hospital-employed “conventional” group. The MDICS PAs are responsible for more patients each day than their conventional-group counterparts and, during the January 2012 to July 2013 study period, averaged 14.2 patients versus 8.3, respectively.

Over the course of the study, PAs in the expanded PA group saw and billed 36% of patient visits independently, compared with 5.9% for the conventional group.
 

Notable study findings

I think the main value of this study is in showing that the expanded PA group had rates of readmission, inpatient mortality, length of stay, and consultant use that weren’t statistically different from the conventional group.

The workloads and years of experience of doctors and PAs in each group were similar. And while there were some differences in the patients each group cared for, they seem unlikely to have a significant influence on outcomes. Clearly, there are many unmeasured variables (e.g., culture, morale, and leadership) in each group that could have influenced the outcomes, so this one study at one hospital doesn’t provide a definitive answer about appropriate APC staffing levels. However, it didn’t uncover big differences in the measured outcomes.

And this study did show that higher levels of PA staffing were associated with lower hospital charges per case. Although the difference was a modest 3%, it was statistically significant (P less than .001). I’m skeptical there is causation here; this more likely is just correlation.

It would be great to see a larger study of this.

Information applications

So does this study support the idea that HMGs can or should increase APC staffing and workload significantly to realize lower hospital cost per case and not harm patient outcomes? Not so fast!

This study only compared two hospitalist groups at one hospital. It’s probably not very generalizable.

And as described in the paper, and stressed by Tim talking with me by phone, the outcomes of their expanded PA model likely have a lot to do with their very careful recruiting and screening of experienced PAs before hiring them, not to mention a lengthy and deliberate on-boarding process (summarized in the article) to support their ability to perform well. Groups that are not as thoughtful and deliberate in how they hire and position APCs to contribute to the practice may not perform as well.
 

 

Why study only PAs? What about NPs? Tim told me that his group is agnostic regarding the training background of the APCs they hire; he suspects an identical study with NPs rather than PAs in each hospitalist group would probably yield very similar results. I see this the same way. Although there are differences in background and training between NPs and PAs, I think personal traits like years of experience in various health care settings and the ability to work efficiently are more important than training background.
 

 

 

A practical approach

Any group who thinks this study is evidence that adding more APCs and having them manage a higher number of patients relatively independently will go well in any setting is mistaken. But it does offer a story of one place where, with careful planning and execution, it went OK.

In my view, the real take-home message is to think carefully to ensure any APCs in your group have professionally satisfying roles that position them to contribute effectively. While common, I think configuring APCs and physicians as rounding dyads often ends up underperforming and not working out well because of inefficiency. When well executed, as is apparently the case in this study, it can be fine. But my experience is that positioning APCs to assume primary responsibility for some clinical activities, such as covering the observation unit or serving as an evening admitter/cross-cover provider (all with appropriate physician collaboration and backup), more reliably turns out well.
 

Reference

Capstack TM, Seguija C, Vollono LM, Moser JD, Meisenberg BR, Michtalik HJ. A comparison of conventional and expanded physician assistant hospitalist staffing models at a community hospital. J Clin Outcomes Manag. 2016;23(10):455-61.
 

Dr. Nelson has been a practicing hospitalist since 1988. He is co-founder and past president of SHM and principal in Nelson Flores Hospital Medicine Consultants. He is co-director for SHM’s “Best Practices in Managing a Hospital Medicine Program” course. Write to him at [email protected].

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Pediatric Dermatology Consult - December 2016

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Urticaria pigmentosa

BY CATALINA MATIZ, MD, AND JEREMY UDKOFF

Frontline Medical News

Maculopapular cutaneous mastocytosis (MPCM), colloquially known as urticaria pigmentosa, typically presents as multiple brown lesions on the skin and accounts for the majority of pediatric cutaneous mastocytosis.1 The category of cutaneous mastocytosis also includes diffuse cutaneous mastocytosis (characterized by generalized erythema and thickened skin), solitary mastocytoma (present as a solitary brown or red lesion), and telangiectasia macularis eruptiva perstans (diffuse telangiectatic macules on the skin, usually in adult patients).

Cutaneous manifestations of mastocytosis are caused by collections of mast cells and the local release of their mediators into the skin. Some of these patients can present with pruritus and flushing, and rarely with diarrhea, abdominal pain, or heart palpitations. Alternatively, systemic mastocytosis, where mast cells invade extracutaneous organs such as the bone marrow or the gastrointestinal tract, may present with or without associated skin lesions. These patients usually have more severe systemic symptoms such as fever, weight loss, epigastric pain, neuropsychiatric symptoms, or bone pain.2,3

One of the lesions reddened and wheeled after we stroked it.
One of the lesions reddened and wheeled after we stroked it.
More than 80% of patients with cutaneous mastocytosis exhibit characteristic brown, red or orange macules, papules, and rarely nodules, that demonstrate a positive Darier’s sign (wheeling and reddening of lesions with stroking or rubbing).4 MPCM in particular is characterized by small to large, polymorphic macules and papules on the trunk, head, and extremities and may blister in more severe cases.4 Lesions on the forehead are characteristic for MPCM, and it should be noted that pediatric MPCM lesions on the head are particularly prone to blistering.4 Despite the potential uncomfortable symptoms, the prognosis of childhood MPCM is usually good as most cases are self-limited and may resolve by adolescence.1 However, a minority of pediatric patients have recalcitrant disease that is typically associated with small monomorphic round lesions like the ones observed in adults.5

The pathogenesis of mastocytosis revolves around abnormal mast cell proliferation. These mast cells then accumulate in organs such as the skin. Mechanical stimulations result in a release of cell mediators, such as histamine, eicosanoids, and cytokines, that causes the associated symptoms. Recent studies have shown c-KIT mutations to be present in the majority of mastocytosis cases, and these mutations are thought to contribute to disease progression.6

Differential diagnosis

Because of its varied presentation, the differential diagnosis for MPCM includes café au lait macules, lentigines, nevi, lichen planus, pseudolymphoma, diffuse juvenile xanthogranuloma, and Langerhans cell histiocytosis. Although these diseases may include macules and papules that look similar to MPCM, the Darier’s sign is an extremely powerful tool in differentiating these diseases as it is almost always present in mastocytosis. When there is a history of blistering lesions, the differential diagnosis should include epidermolysis bullosa, herpes simplex, bullous arthropod bites, bullous impetigo, linear IgA dermatosis, and rarely autoimmune bullous conditions. Equivocal cases should be referred to a pediatric dermatologist for evaluation, as conditions such as Langerhans cell histiocytosis and epidermolysis bullosa are usually associated with poor outcomes.

Work-up and treatment

In cases where the lesions are not classic or there is not a clear Darier’s sign, a skin biopsy with special staining, such as Giemsa or toluidine blue, is recommended to help clarify the diagnosis and rule out other worrisome conditions as mentioned above. If the child presents with systemic symptoms, performing a complete blood count with differential, tryptase level, and organ-specific testing based on the symptoms is recommended.

Serum tryptase is a biomarker for mast cell degranulation. It is typically normal in pediatric patients with MPCM but may be positive if there are symptoms of systemic disease such as fever, weight loss, bone pain, epigastric pain, headaches, or anaphylaxis. Similarly, the risk of anaphylactic reactions correlates with the serum tryptase level.4,7 If the tryptase level is elevated, a bone marrow biopsy should be performed to rule out more severe forms of systemic disease.

Potent topical corticosteroids, such as fluocinonide, are typically used to the treat cutaneous lesions when they are inflamed. Other supportive treatments used in MPCM usually revolve around controlling the cutaneous symptoms as there is no cure for the disease. H1 and H2 antihistamines may be used alone or together to control itching and are thought to decrease flushing and blistering associated with MPCM. Other possible treatments include topical cromolyn sodium and leukotriene antagonists. Mastocytoma lesions that are increasing in size or are very symptomatic despite the treatments listed above may benefit from local immunosuppressants, ultraviolet radiation and psoralen application, or excision.8

Lifestyle modifications also are recommended for patients with mastocytosis. They are advised to avoid foods, medications, and environmental triggers that can cause mast cell degranulation. These triggers include aspirin, nonsteroidal anti-inflammatory agents and narcotics, topical polymyxin B sulfate, heat, friction, and certain systemic anesthetic agents.9

References

1. Br J Dermatol. 2015;172(3):642-51.

2. Clin Pediatr. (Phila) 2008;47(8):757-61.

3. “Mastocytosis,” in Dermatology, 3rd ed. (China: Elsevier, 2012).

4. J Allergy Clin Immunol. 2016;137(1):35-45.

5.  J Allergy Clin Immunol. 2015 Dec;136(6):1581-90.e1-e3.

6. J Invest Dermatol. 2010;130(3):804-15.

7. Pediatr Dermatol. 2014;31(3):271-5.

8. Eur J Clin Invest. 2007;37(6):435-53.

9.  “Histiocytosis and Malignant Skin Diseases,” in Hurwitz Clinical Pediatric Dermatology: A Textbook of Skin Disorders of Childhood and Adolescence, 5th ed. (China: Elsevier, 2016).

 

Dr. Matiz is assistant professor of dermatology at Rady Children’s Hospital San Diego–University of California, San Diego, and Jeremy Udkoff is a medical student at the university.

 

 

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Urticaria pigmentosa

BY CATALINA MATIZ, MD, AND JEREMY UDKOFF

Frontline Medical News

Maculopapular cutaneous mastocytosis (MPCM), colloquially known as urticaria pigmentosa, typically presents as multiple brown lesions on the skin and accounts for the majority of pediatric cutaneous mastocytosis.1 The category of cutaneous mastocytosis also includes diffuse cutaneous mastocytosis (characterized by generalized erythema and thickened skin), solitary mastocytoma (present as a solitary brown or red lesion), and telangiectasia macularis eruptiva perstans (diffuse telangiectatic macules on the skin, usually in adult patients).

Cutaneous manifestations of mastocytosis are caused by collections of mast cells and the local release of their mediators into the skin. Some of these patients can present with pruritus and flushing, and rarely with diarrhea, abdominal pain, or heart palpitations. Alternatively, systemic mastocytosis, where mast cells invade extracutaneous organs such as the bone marrow or the gastrointestinal tract, may present with or without associated skin lesions. These patients usually have more severe systemic symptoms such as fever, weight loss, epigastric pain, neuropsychiatric symptoms, or bone pain.2,3

One of the lesions reddened and wheeled after we stroked it.
One of the lesions reddened and wheeled after we stroked it.
More than 80% of patients with cutaneous mastocytosis exhibit characteristic brown, red or orange macules, papules, and rarely nodules, that demonstrate a positive Darier’s sign (wheeling and reddening of lesions with stroking or rubbing).4 MPCM in particular is characterized by small to large, polymorphic macules and papules on the trunk, head, and extremities and may blister in more severe cases.4 Lesions on the forehead are characteristic for MPCM, and it should be noted that pediatric MPCM lesions on the head are particularly prone to blistering.4 Despite the potential uncomfortable symptoms, the prognosis of childhood MPCM is usually good as most cases are self-limited and may resolve by adolescence.1 However, a minority of pediatric patients have recalcitrant disease that is typically associated with small monomorphic round lesions like the ones observed in adults.5

The pathogenesis of mastocytosis revolves around abnormal mast cell proliferation. These mast cells then accumulate in organs such as the skin. Mechanical stimulations result in a release of cell mediators, such as histamine, eicosanoids, and cytokines, that causes the associated symptoms. Recent studies have shown c-KIT mutations to be present in the majority of mastocytosis cases, and these mutations are thought to contribute to disease progression.6

Differential diagnosis

Because of its varied presentation, the differential diagnosis for MPCM includes café au lait macules, lentigines, nevi, lichen planus, pseudolymphoma, diffuse juvenile xanthogranuloma, and Langerhans cell histiocytosis. Although these diseases may include macules and papules that look similar to MPCM, the Darier’s sign is an extremely powerful tool in differentiating these diseases as it is almost always present in mastocytosis. When there is a history of blistering lesions, the differential diagnosis should include epidermolysis bullosa, herpes simplex, bullous arthropod bites, bullous impetigo, linear IgA dermatosis, and rarely autoimmune bullous conditions. Equivocal cases should be referred to a pediatric dermatologist for evaluation, as conditions such as Langerhans cell histiocytosis and epidermolysis bullosa are usually associated with poor outcomes.

Work-up and treatment

In cases where the lesions are not classic or there is not a clear Darier’s sign, a skin biopsy with special staining, such as Giemsa or toluidine blue, is recommended to help clarify the diagnosis and rule out other worrisome conditions as mentioned above. If the child presents with systemic symptoms, performing a complete blood count with differential, tryptase level, and organ-specific testing based on the symptoms is recommended.

Serum tryptase is a biomarker for mast cell degranulation. It is typically normal in pediatric patients with MPCM but may be positive if there are symptoms of systemic disease such as fever, weight loss, bone pain, epigastric pain, headaches, or anaphylaxis. Similarly, the risk of anaphylactic reactions correlates with the serum tryptase level.4,7 If the tryptase level is elevated, a bone marrow biopsy should be performed to rule out more severe forms of systemic disease.

Potent topical corticosteroids, such as fluocinonide, are typically used to the treat cutaneous lesions when they are inflamed. Other supportive treatments used in MPCM usually revolve around controlling the cutaneous symptoms as there is no cure for the disease. H1 and H2 antihistamines may be used alone or together to control itching and are thought to decrease flushing and blistering associated with MPCM. Other possible treatments include topical cromolyn sodium and leukotriene antagonists. Mastocytoma lesions that are increasing in size or are very symptomatic despite the treatments listed above may benefit from local immunosuppressants, ultraviolet radiation and psoralen application, or excision.8

Lifestyle modifications also are recommended for patients with mastocytosis. They are advised to avoid foods, medications, and environmental triggers that can cause mast cell degranulation. These triggers include aspirin, nonsteroidal anti-inflammatory agents and narcotics, topical polymyxin B sulfate, heat, friction, and certain systemic anesthetic agents.9

References

1. Br J Dermatol. 2015;172(3):642-51.

2. Clin Pediatr. (Phila) 2008;47(8):757-61.

3. “Mastocytosis,” in Dermatology, 3rd ed. (China: Elsevier, 2012).

4. J Allergy Clin Immunol. 2016;137(1):35-45.

5.  J Allergy Clin Immunol. 2015 Dec;136(6):1581-90.e1-e3.

6. J Invest Dermatol. 2010;130(3):804-15.

7. Pediatr Dermatol. 2014;31(3):271-5.

8. Eur J Clin Invest. 2007;37(6):435-53.

9.  “Histiocytosis and Malignant Skin Diseases,” in Hurwitz Clinical Pediatric Dermatology: A Textbook of Skin Disorders of Childhood and Adolescence, 5th ed. (China: Elsevier, 2016).

 

Dr. Matiz is assistant professor of dermatology at Rady Children’s Hospital San Diego–University of California, San Diego, and Jeremy Udkoff is a medical student at the university.

 

 

Urticaria pigmentosa

BY CATALINA MATIZ, MD, AND JEREMY UDKOFF

Frontline Medical News

Maculopapular cutaneous mastocytosis (MPCM), colloquially known as urticaria pigmentosa, typically presents as multiple brown lesions on the skin and accounts for the majority of pediatric cutaneous mastocytosis.1 The category of cutaneous mastocytosis also includes diffuse cutaneous mastocytosis (characterized by generalized erythema and thickened skin), solitary mastocytoma (present as a solitary brown or red lesion), and telangiectasia macularis eruptiva perstans (diffuse telangiectatic macules on the skin, usually in adult patients).

Cutaneous manifestations of mastocytosis are caused by collections of mast cells and the local release of their mediators into the skin. Some of these patients can present with pruritus and flushing, and rarely with diarrhea, abdominal pain, or heart palpitations. Alternatively, systemic mastocytosis, where mast cells invade extracutaneous organs such as the bone marrow or the gastrointestinal tract, may present with or without associated skin lesions. These patients usually have more severe systemic symptoms such as fever, weight loss, epigastric pain, neuropsychiatric symptoms, or bone pain.2,3

One of the lesions reddened and wheeled after we stroked it.
One of the lesions reddened and wheeled after we stroked it.
More than 80% of patients with cutaneous mastocytosis exhibit characteristic brown, red or orange macules, papules, and rarely nodules, that demonstrate a positive Darier’s sign (wheeling and reddening of lesions with stroking or rubbing).4 MPCM in particular is characterized by small to large, polymorphic macules and papules on the trunk, head, and extremities and may blister in more severe cases.4 Lesions on the forehead are characteristic for MPCM, and it should be noted that pediatric MPCM lesions on the head are particularly prone to blistering.4 Despite the potential uncomfortable symptoms, the prognosis of childhood MPCM is usually good as most cases are self-limited and may resolve by adolescence.1 However, a minority of pediatric patients have recalcitrant disease that is typically associated with small monomorphic round lesions like the ones observed in adults.5

The pathogenesis of mastocytosis revolves around abnormal mast cell proliferation. These mast cells then accumulate in organs such as the skin. Mechanical stimulations result in a release of cell mediators, such as histamine, eicosanoids, and cytokines, that causes the associated symptoms. Recent studies have shown c-KIT mutations to be present in the majority of mastocytosis cases, and these mutations are thought to contribute to disease progression.6

Differential diagnosis

Because of its varied presentation, the differential diagnosis for MPCM includes café au lait macules, lentigines, nevi, lichen planus, pseudolymphoma, diffuse juvenile xanthogranuloma, and Langerhans cell histiocytosis. Although these diseases may include macules and papules that look similar to MPCM, the Darier’s sign is an extremely powerful tool in differentiating these diseases as it is almost always present in mastocytosis. When there is a history of blistering lesions, the differential diagnosis should include epidermolysis bullosa, herpes simplex, bullous arthropod bites, bullous impetigo, linear IgA dermatosis, and rarely autoimmune bullous conditions. Equivocal cases should be referred to a pediatric dermatologist for evaluation, as conditions such as Langerhans cell histiocytosis and epidermolysis bullosa are usually associated with poor outcomes.

Work-up and treatment

In cases where the lesions are not classic or there is not a clear Darier’s sign, a skin biopsy with special staining, such as Giemsa or toluidine blue, is recommended to help clarify the diagnosis and rule out other worrisome conditions as mentioned above. If the child presents with systemic symptoms, performing a complete blood count with differential, tryptase level, and organ-specific testing based on the symptoms is recommended.

Serum tryptase is a biomarker for mast cell degranulation. It is typically normal in pediatric patients with MPCM but may be positive if there are symptoms of systemic disease such as fever, weight loss, bone pain, epigastric pain, headaches, or anaphylaxis. Similarly, the risk of anaphylactic reactions correlates with the serum tryptase level.4,7 If the tryptase level is elevated, a bone marrow biopsy should be performed to rule out more severe forms of systemic disease.

Potent topical corticosteroids, such as fluocinonide, are typically used to the treat cutaneous lesions when they are inflamed. Other supportive treatments used in MPCM usually revolve around controlling the cutaneous symptoms as there is no cure for the disease. H1 and H2 antihistamines may be used alone or together to control itching and are thought to decrease flushing and blistering associated with MPCM. Other possible treatments include topical cromolyn sodium and leukotriene antagonists. Mastocytoma lesions that are increasing in size or are very symptomatic despite the treatments listed above may benefit from local immunosuppressants, ultraviolet radiation and psoralen application, or excision.8

Lifestyle modifications also are recommended for patients with mastocytosis. They are advised to avoid foods, medications, and environmental triggers that can cause mast cell degranulation. These triggers include aspirin, nonsteroidal anti-inflammatory agents and narcotics, topical polymyxin B sulfate, heat, friction, and certain systemic anesthetic agents.9

References

1. Br J Dermatol. 2015;172(3):642-51.

2. Clin Pediatr. (Phila) 2008;47(8):757-61.

3. “Mastocytosis,” in Dermatology, 3rd ed. (China: Elsevier, 2012).

4. J Allergy Clin Immunol. 2016;137(1):35-45.

5.  J Allergy Clin Immunol. 2015 Dec;136(6):1581-90.e1-e3.

6. J Invest Dermatol. 2010;130(3):804-15.

7. Pediatr Dermatol. 2014;31(3):271-5.

8. Eur J Clin Invest. 2007;37(6):435-53.

9.  “Histiocytosis and Malignant Skin Diseases,” in Hurwitz Clinical Pediatric Dermatology: A Textbook of Skin Disorders of Childhood and Adolescence, 5th ed. (China: Elsevier, 2016).

 

Dr. Matiz is assistant professor of dermatology at Rady Children’s Hospital San Diego–University of California, San Diego, and Jeremy Udkoff is a medical student at the university.

 

 

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Physical exam was notable for many scattered, 3 to 5 mm, polymorphic, light brown to orange macules and papules.
Physical exam was notable for many scattered, 3 to 5 mm, polymorphic, light brown to orange macules and papules.

 

An 18-month-old girl was referred to our pediatric dermatology clinic for an evaluation of multiple brown macules all over her body. The lesions had been present for about 1 year and were not increasing in size, but she was getting new lesions on her face and scalp. They were not symptomatic and did not seem to bother the patient. The mother noted that some lesions may become red with changes in the weather. She denied symptoms such as wheezing, flushing, or diarrhea. No other family members were affected, and the patient was not taking any medications. She had no family history of neurofibromatosis or other genetic conditions. The physical exam was notable for many scattered, 3- to 5-mm, polymorphic, light brown to orange macules and papules. One of the lesions reddened and wheeled after we stroked it. The patient had no lymphadenopathy or hepatosplenomegaly.

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Thu, 03/28/2019 - 14:59
Read the chart, elevate your patients’ confidence.

Editor’s note: “Everything We Say and Do” is an informational series developed by SHM’s Patient Experience Committee to provide readers with thoughtful and actionable communication tactics that have great potential to positively impact patients’ experience of care. Each article will focus on how the contributor applies one or more of the “key communication” tactics in practice to maintain provider accountability for “everything we say and do that affects our patients’ thoughts, feelings, and well-being.”

Thomas Northcut/Thinkstock

What I say and do

I inform my patients that I have reviewed their chart and that I am familiar with their diagnosis.

Why I do it

In the hospital setting, in particular, patients are concerned about communication between their various healthcare professionals. Many times, the patient’s primary-care provider works strictly in the outpatient setting, so the hospitalist is the person who assumes total care of the patient throughout hospitalization. This understandably creates anxiety for patients and families because they wonder if the hospitalist really knows their medical history. One way to alleviate this anxiety is to review your patients’ charts prior to speaking with them and to verbally let your patients know you are familiar with their diagnoses.

How I do it

Step 1: Before entering the room, I review my patient’s chart. If I am taking over the service from my colleague, I review all notes from the current hospitalization to ensure I understand everything that has happened. I also review tests, procedures, and radiographic studies. To gain a better understanding of my patient, I read the most recent discharge summary and outpatient clinic note. Likewise, if I am admitting a new patient to the hospital, before entering the room to do the history and physical examination, I review recent hospitalizations, clinic notes, and emergency department visits.

I also like to review the chart to see if I have taken care of the patient before. Patients often remember me even though I may not remember them, so reviewing my prior notes may be helpful. Thankfully, my electronic health record (EHR) has a search function where I can enter my name or any other keyword and it searches for patient records based on this keyword.

Step 2: Even though reading the chart and being informed about my patient is important, it is only the first step. The next step is to let my patient and family know that I have read the chart and that I am up-to-date on my patient’s diagnosis. I feel it is very important for me to verbalize that I have read the chart because without doing this, my patients never really know that I took the time prior to entering the room to learn about them.

I might say:

  • “I was reviewing your chart before I came in, and I saw that your daughter brought you to the hospital for chest pain.”
  • “I read your chart and saw that you have been to the emergency room twice in the last week.”
  • “I read your primary-care doctor’s note, and I saw that she recently treated you for pneumonia.”
  • “I read your chart, and I wanted to confirm a few things I read to ensure we are on the same page.”

There are many different ways you can phrase this, but the important point is to make sure your patients know you read the chart by specifically referencing something you learned. This helps your patients feel more confident that you know their medical history.

I know some of the doctors reading this column see patients in the outpatient setting. One way to help yourself remember pertinent facts about a patient’s medical history is to include these facts in a specific place in your clinic note. That way, prior to seeing the patient, you can always review your last note and know the important information about your patient’s medical history will always be in the same place in each note. Another tip is to use your EHR’s note function. My EHR has “sticky notes,” and they provide a place for the PCP to store information about the patient without it becoming part of the permanent medical record.
 

 

These notes allow the PCP to record important events that happen between one clinic visit and the next. Thus, when the patient returns to the clinic, the PCP opens the chart, reviews the sticky note, and enters the exam room prepared to discuss significant events in the patient’s recent medical history.

In the end, it does not matter which technique you use. It simply matters that you take time to review your patient’s chart prior to entering the room and that you verbalize what you have learned. In patients, this inspires confidence and trust and helps alleviate concerns that the physician does not know important information in their medical history. 

 

 

Dr. Dorrah is regional medical director for quality and the patient experience at Baylor Scott & White Health in Round Rock, Tex. She is a member of SHM’s Patient Experience Committee.

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Read the chart, elevate your patients’ confidence.
Read the chart, elevate your patients’ confidence.

Editor’s note: “Everything We Say and Do” is an informational series developed by SHM’s Patient Experience Committee to provide readers with thoughtful and actionable communication tactics that have great potential to positively impact patients’ experience of care. Each article will focus on how the contributor applies one or more of the “key communication” tactics in practice to maintain provider accountability for “everything we say and do that affects our patients’ thoughts, feelings, and well-being.”

Thomas Northcut/Thinkstock

What I say and do

I inform my patients that I have reviewed their chart and that I am familiar with their diagnosis.

Why I do it

In the hospital setting, in particular, patients are concerned about communication between their various healthcare professionals. Many times, the patient’s primary-care provider works strictly in the outpatient setting, so the hospitalist is the person who assumes total care of the patient throughout hospitalization. This understandably creates anxiety for patients and families because they wonder if the hospitalist really knows their medical history. One way to alleviate this anxiety is to review your patients’ charts prior to speaking with them and to verbally let your patients know you are familiar with their diagnoses.

How I do it

Step 1: Before entering the room, I review my patient’s chart. If I am taking over the service from my colleague, I review all notes from the current hospitalization to ensure I understand everything that has happened. I also review tests, procedures, and radiographic studies. To gain a better understanding of my patient, I read the most recent discharge summary and outpatient clinic note. Likewise, if I am admitting a new patient to the hospital, before entering the room to do the history and physical examination, I review recent hospitalizations, clinic notes, and emergency department visits.

I also like to review the chart to see if I have taken care of the patient before. Patients often remember me even though I may not remember them, so reviewing my prior notes may be helpful. Thankfully, my electronic health record (EHR) has a search function where I can enter my name or any other keyword and it searches for patient records based on this keyword.

Step 2: Even though reading the chart and being informed about my patient is important, it is only the first step. The next step is to let my patient and family know that I have read the chart and that I am up-to-date on my patient’s diagnosis. I feel it is very important for me to verbalize that I have read the chart because without doing this, my patients never really know that I took the time prior to entering the room to learn about them.

I might say:

  • “I was reviewing your chart before I came in, and I saw that your daughter brought you to the hospital for chest pain.”
  • “I read your chart and saw that you have been to the emergency room twice in the last week.”
  • “I read your primary-care doctor’s note, and I saw that she recently treated you for pneumonia.”
  • “I read your chart, and I wanted to confirm a few things I read to ensure we are on the same page.”

There are many different ways you can phrase this, but the important point is to make sure your patients know you read the chart by specifically referencing something you learned. This helps your patients feel more confident that you know their medical history.

I know some of the doctors reading this column see patients in the outpatient setting. One way to help yourself remember pertinent facts about a patient’s medical history is to include these facts in a specific place in your clinic note. That way, prior to seeing the patient, you can always review your last note and know the important information about your patient’s medical history will always be in the same place in each note. Another tip is to use your EHR’s note function. My EHR has “sticky notes,” and they provide a place for the PCP to store information about the patient without it becoming part of the permanent medical record.
 

 

These notes allow the PCP to record important events that happen between one clinic visit and the next. Thus, when the patient returns to the clinic, the PCP opens the chart, reviews the sticky note, and enters the exam room prepared to discuss significant events in the patient’s recent medical history.

In the end, it does not matter which technique you use. It simply matters that you take time to review your patient’s chart prior to entering the room and that you verbalize what you have learned. In patients, this inspires confidence and trust and helps alleviate concerns that the physician does not know important information in their medical history. 

 

 

Dr. Dorrah is regional medical director for quality and the patient experience at Baylor Scott & White Health in Round Rock, Tex. She is a member of SHM’s Patient Experience Committee.

Editor’s note: “Everything We Say and Do” is an informational series developed by SHM’s Patient Experience Committee to provide readers with thoughtful and actionable communication tactics that have great potential to positively impact patients’ experience of care. Each article will focus on how the contributor applies one or more of the “key communication” tactics in practice to maintain provider accountability for “everything we say and do that affects our patients’ thoughts, feelings, and well-being.”

Thomas Northcut/Thinkstock

What I say and do

I inform my patients that I have reviewed their chart and that I am familiar with their diagnosis.

Why I do it

In the hospital setting, in particular, patients are concerned about communication between their various healthcare professionals. Many times, the patient’s primary-care provider works strictly in the outpatient setting, so the hospitalist is the person who assumes total care of the patient throughout hospitalization. This understandably creates anxiety for patients and families because they wonder if the hospitalist really knows their medical history. One way to alleviate this anxiety is to review your patients’ charts prior to speaking with them and to verbally let your patients know you are familiar with their diagnoses.

How I do it

Step 1: Before entering the room, I review my patient’s chart. If I am taking over the service from my colleague, I review all notes from the current hospitalization to ensure I understand everything that has happened. I also review tests, procedures, and radiographic studies. To gain a better understanding of my patient, I read the most recent discharge summary and outpatient clinic note. Likewise, if I am admitting a new patient to the hospital, before entering the room to do the history and physical examination, I review recent hospitalizations, clinic notes, and emergency department visits.

I also like to review the chart to see if I have taken care of the patient before. Patients often remember me even though I may not remember them, so reviewing my prior notes may be helpful. Thankfully, my electronic health record (EHR) has a search function where I can enter my name or any other keyword and it searches for patient records based on this keyword.

Step 2: Even though reading the chart and being informed about my patient is important, it is only the first step. The next step is to let my patient and family know that I have read the chart and that I am up-to-date on my patient’s diagnosis. I feel it is very important for me to verbalize that I have read the chart because without doing this, my patients never really know that I took the time prior to entering the room to learn about them.

I might say:

  • “I was reviewing your chart before I came in, and I saw that your daughter brought you to the hospital for chest pain.”
  • “I read your chart and saw that you have been to the emergency room twice in the last week.”
  • “I read your primary-care doctor’s note, and I saw that she recently treated you for pneumonia.”
  • “I read your chart, and I wanted to confirm a few things I read to ensure we are on the same page.”

There are many different ways you can phrase this, but the important point is to make sure your patients know you read the chart by specifically referencing something you learned. This helps your patients feel more confident that you know their medical history.

I know some of the doctors reading this column see patients in the outpatient setting. One way to help yourself remember pertinent facts about a patient’s medical history is to include these facts in a specific place in your clinic note. That way, prior to seeing the patient, you can always review your last note and know the important information about your patient’s medical history will always be in the same place in each note. Another tip is to use your EHR’s note function. My EHR has “sticky notes,” and they provide a place for the PCP to store information about the patient without it becoming part of the permanent medical record.
 

 

These notes allow the PCP to record important events that happen between one clinic visit and the next. Thus, when the patient returns to the clinic, the PCP opens the chart, reviews the sticky note, and enters the exam room prepared to discuss significant events in the patient’s recent medical history.

In the end, it does not matter which technique you use. It simply matters that you take time to review your patient’s chart prior to entering the room and that you verbalize what you have learned. In patients, this inspires confidence and trust and helps alleviate concerns that the physician does not know important information in their medical history. 

 

 

Dr. Dorrah is regional medical director for quality and the patient experience at Baylor Scott & White Health in Round Rock, Tex. She is a member of SHM’s Patient Experience Committee.

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What referring physicians need to know about bariatric surgery success rates

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– About one-third of bariatric surgery patients achieve a body mass index below 30 kg/m2 at 1 year of follow-up, and the strongest predictor of success is having a BMI of 40 kg/m2 or less at the time of surgery, Oliver A. Varban, MD, reported at Obesity Week 2016.

Indeed, patients with a baseline BMI of 40 kg/m2 or less were fully 13.3-fold more likely to have a BMI of less than 30 kg/m2 1 year post surgery in a study of 19,764 patients in the Michigan Bariatric Surgery Collaborative database, according to Dr. Varban, surgical director of the adult bariatric surgery program at the University of Michigan, Ann Arbor.

 


“In order to optimize outcomes of bariatric surgery, patients should be encouraged to consider it when their BMI is less than 40 kg/m2. And policies that obstruct or delay surgery can actually result in inferior outcomes,” he said at the meeting, which was presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

Dr. Oliver A. Varban
Dr. Varban said this was a study conducted primarily to inform and, hopefully, influence the behavior of referring physicians.

“These patients are being referred to us. We don’t seek them out. The biggest impetus for this study was to be able to show referring physicians that outcomes are better when treatment is sought earlier. Every patient who shows up at our clinics with a BMI of 65 must have had a BMI of 35 at some point in time. I think we miss the boat on a lot of those patients,” the surgeon said. “Society at large should recognize that bariatric surgery is the most effective treatment for obesity, but it’s also the most underutilized one.”

The Michigan Bariatric Surgery Collaborative is a unique statewide, payer-funded consortium focused on quality improvement. Dr. Varban presented an analysis of 19,764 patients who underwent a primary bariatric procedure in Michigan during 2006-2015 for whom complete 1-year follow-up data were available. The mean preoperative BMI for the overall group was 48 kg/m2, and the mean postoperative BMI at 1 year was 33 kg/m2.

Thirty-eight percent of patients achieved a BMI below 30 kg/m2 at 1 year; their mean BMI at that time was 26.7 kg/m2. The mean BMI 1 year post surgery in the 62% of patients who didn’t reach the goal was 36.7 kg/m2.
 

 

Only 6.2% of patients who didn’t get to a BMI of less than 30 kg/m2 1 year post surgery had a preoperative BMI of 40 kg/m2 or below, whereas 31.7% of patients who achieved the goal did have a baseline BMI of 40 kg/m2 or below.

Among patients with a preoperative BMI of 50-59 kg/m2, only 7.6% reached the target. And among those with a preoperative BMI of 60 kg/m2, only 0.4% had a BMI of less than 30 kg/m2 at 1 year.

“Patients with a BMI of 50 kg/m2 or more should be given realistic expectations about the type of weight loss they’ll have after bariatric surgery,” Dr. Varban said.

Why is a postsurgical BMI below 30 kg/m2 such an important benchmark? Abundant evidence indicates that having a BMI of 30 kg/m2 or higher is associated with a 50%-100% increase in the risk of premature death compared to that of normal-weight individuals. Successful bariatric surgery reduces that risk by 30%-40%.

In the Michigan study, patients who reached the BMI target had a significantly higher rate of resolution of common comorbid conditions associated with morbid obesity, including type 2 diabetes, hypertension, dyslipidemia, and sleep apnea. They also scored higher on a patient satisfaction survey.

The mean percent preoperative weight loss was 2.3% in patients who didn’t achieve the target BMI and similar at 2.5% in those who did. Thus, preoperative weight loss is not a major contributor to postoperative success, Dr. Varban continued.

Failure to reach the postoperative BMI goal was significantly more common among patients who were black or Hispanic, had an annual income below $25,000, or didn’t have private insurance.

Thirty-day perioperative complication rates didn’t differ between patients who attained a BMI below 30 kg/m2 at 1 year and those who did not.
 

 

Dr. Varban said it will come to no surprise to bariatric surgeons that the likelihood of attaining the target 1-year BMI varied according to the type of bariatric surgery: Compared to patients who underwent adjustable laparoscopic banding, the success rate was 19-fold higher with Roux-en-Y gastric bypass, 7.2-fold higher with sleeve gastrectomy, and a whopping 72-fold higher in patients who had a duodenal switch procedure.

Neither the mean preoperative nor 1-year postoperative BMI figures changed much over the study period, even though sleeve gastrectomy became much more common after 2010. For example, the mean preoperative BMI was 48.3 kg/m2 in 2006 and 46.9 kg/m2 in 2015, while the mean postoperative BMIs were 32.7 and 32.6 kg/m2, respectively, in those years.

Dr. Varban said that as he ran the numbers, he was surprised to see that the baseline BMI was so high – far higher than he would have guessed. But since then as he has discussed the study findings with referring physicians throughout Michigan, he’s come to understand the explanation: Many of them are content to wait until their morbidly obese patients grow to a BMI above 50 kg/m2 before making the referral because they consider the alternate criterion for bariatric surgery referral – that is, failure to achieve significant weight loss after 1 year of medically supervised attempts – to be too much for them to take on.

Amir A. Ghaferi, MD, a University of Michigan bariatric surgeon and coinvestigator in the study, rose from the audience to urge his colleagues to focus on the health policy implications of the findings.

“Maybe our bariatric surgery criteria aren’t right. We’ve been talking a lot amongst ourselves about pushing the BMI threshold lower and reducing some of the insurance barriers. I think what this study demonstrates from a policy perspective is we need to get these patients sooner, without so many barriers ahead of us and in front of the patients, in order to achieve the best possible outcomes,” Dr. Ghaferi said.

Dr. Varban reported receiving research funding from Blue Cross Blue Shield of Michigan.
 

 

 

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– About one-third of bariatric surgery patients achieve a body mass index below 30 kg/m2 at 1 year of follow-up, and the strongest predictor of success is having a BMI of 40 kg/m2 or less at the time of surgery, Oliver A. Varban, MD, reported at Obesity Week 2016.

Indeed, patients with a baseline BMI of 40 kg/m2 or less were fully 13.3-fold more likely to have a BMI of less than 30 kg/m2 1 year post surgery in a study of 19,764 patients in the Michigan Bariatric Surgery Collaborative database, according to Dr. Varban, surgical director of the adult bariatric surgery program at the University of Michigan, Ann Arbor.

 


“In order to optimize outcomes of bariatric surgery, patients should be encouraged to consider it when their BMI is less than 40 kg/m2. And policies that obstruct or delay surgery can actually result in inferior outcomes,” he said at the meeting, which was presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

Dr. Oliver A. Varban
Dr. Varban said this was a study conducted primarily to inform and, hopefully, influence the behavior of referring physicians.

“These patients are being referred to us. We don’t seek them out. The biggest impetus for this study was to be able to show referring physicians that outcomes are better when treatment is sought earlier. Every patient who shows up at our clinics with a BMI of 65 must have had a BMI of 35 at some point in time. I think we miss the boat on a lot of those patients,” the surgeon said. “Society at large should recognize that bariatric surgery is the most effective treatment for obesity, but it’s also the most underutilized one.”

The Michigan Bariatric Surgery Collaborative is a unique statewide, payer-funded consortium focused on quality improvement. Dr. Varban presented an analysis of 19,764 patients who underwent a primary bariatric procedure in Michigan during 2006-2015 for whom complete 1-year follow-up data were available. The mean preoperative BMI for the overall group was 48 kg/m2, and the mean postoperative BMI at 1 year was 33 kg/m2.

Thirty-eight percent of patients achieved a BMI below 30 kg/m2 at 1 year; their mean BMI at that time was 26.7 kg/m2. The mean BMI 1 year post surgery in the 62% of patients who didn’t reach the goal was 36.7 kg/m2.
 

 

Only 6.2% of patients who didn’t get to a BMI of less than 30 kg/m2 1 year post surgery had a preoperative BMI of 40 kg/m2 or below, whereas 31.7% of patients who achieved the goal did have a baseline BMI of 40 kg/m2 or below.

Among patients with a preoperative BMI of 50-59 kg/m2, only 7.6% reached the target. And among those with a preoperative BMI of 60 kg/m2, only 0.4% had a BMI of less than 30 kg/m2 at 1 year.

“Patients with a BMI of 50 kg/m2 or more should be given realistic expectations about the type of weight loss they’ll have after bariatric surgery,” Dr. Varban said.

Why is a postsurgical BMI below 30 kg/m2 such an important benchmark? Abundant evidence indicates that having a BMI of 30 kg/m2 or higher is associated with a 50%-100% increase in the risk of premature death compared to that of normal-weight individuals. Successful bariatric surgery reduces that risk by 30%-40%.

In the Michigan study, patients who reached the BMI target had a significantly higher rate of resolution of common comorbid conditions associated with morbid obesity, including type 2 diabetes, hypertension, dyslipidemia, and sleep apnea. They also scored higher on a patient satisfaction survey.

The mean percent preoperative weight loss was 2.3% in patients who didn’t achieve the target BMI and similar at 2.5% in those who did. Thus, preoperative weight loss is not a major contributor to postoperative success, Dr. Varban continued.

Failure to reach the postoperative BMI goal was significantly more common among patients who were black or Hispanic, had an annual income below $25,000, or didn’t have private insurance.

Thirty-day perioperative complication rates didn’t differ between patients who attained a BMI below 30 kg/m2 at 1 year and those who did not.
 

 

Dr. Varban said it will come to no surprise to bariatric surgeons that the likelihood of attaining the target 1-year BMI varied according to the type of bariatric surgery: Compared to patients who underwent adjustable laparoscopic banding, the success rate was 19-fold higher with Roux-en-Y gastric bypass, 7.2-fold higher with sleeve gastrectomy, and a whopping 72-fold higher in patients who had a duodenal switch procedure.

Neither the mean preoperative nor 1-year postoperative BMI figures changed much over the study period, even though sleeve gastrectomy became much more common after 2010. For example, the mean preoperative BMI was 48.3 kg/m2 in 2006 and 46.9 kg/m2 in 2015, while the mean postoperative BMIs were 32.7 and 32.6 kg/m2, respectively, in those years.

Dr. Varban said that as he ran the numbers, he was surprised to see that the baseline BMI was so high – far higher than he would have guessed. But since then as he has discussed the study findings with referring physicians throughout Michigan, he’s come to understand the explanation: Many of them are content to wait until their morbidly obese patients grow to a BMI above 50 kg/m2 before making the referral because they consider the alternate criterion for bariatric surgery referral – that is, failure to achieve significant weight loss after 1 year of medically supervised attempts – to be too much for them to take on.

Amir A. Ghaferi, MD, a University of Michigan bariatric surgeon and coinvestigator in the study, rose from the audience to urge his colleagues to focus on the health policy implications of the findings.

“Maybe our bariatric surgery criteria aren’t right. We’ve been talking a lot amongst ourselves about pushing the BMI threshold lower and reducing some of the insurance barriers. I think what this study demonstrates from a policy perspective is we need to get these patients sooner, without so many barriers ahead of us and in front of the patients, in order to achieve the best possible outcomes,” Dr. Ghaferi said.

Dr. Varban reported receiving research funding from Blue Cross Blue Shield of Michigan.
 

 

 

– About one-third of bariatric surgery patients achieve a body mass index below 30 kg/m2 at 1 year of follow-up, and the strongest predictor of success is having a BMI of 40 kg/m2 or less at the time of surgery, Oliver A. Varban, MD, reported at Obesity Week 2016.

Indeed, patients with a baseline BMI of 40 kg/m2 or less were fully 13.3-fold more likely to have a BMI of less than 30 kg/m2 1 year post surgery in a study of 19,764 patients in the Michigan Bariatric Surgery Collaborative database, according to Dr. Varban, surgical director of the adult bariatric surgery program at the University of Michigan, Ann Arbor.

 


“In order to optimize outcomes of bariatric surgery, patients should be encouraged to consider it when their BMI is less than 40 kg/m2. And policies that obstruct or delay surgery can actually result in inferior outcomes,” he said at the meeting, which was presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

Dr. Oliver A. Varban
Dr. Varban said this was a study conducted primarily to inform and, hopefully, influence the behavior of referring physicians.

“These patients are being referred to us. We don’t seek them out. The biggest impetus for this study was to be able to show referring physicians that outcomes are better when treatment is sought earlier. Every patient who shows up at our clinics with a BMI of 65 must have had a BMI of 35 at some point in time. I think we miss the boat on a lot of those patients,” the surgeon said. “Society at large should recognize that bariatric surgery is the most effective treatment for obesity, but it’s also the most underutilized one.”

The Michigan Bariatric Surgery Collaborative is a unique statewide, payer-funded consortium focused on quality improvement. Dr. Varban presented an analysis of 19,764 patients who underwent a primary bariatric procedure in Michigan during 2006-2015 for whom complete 1-year follow-up data were available. The mean preoperative BMI for the overall group was 48 kg/m2, and the mean postoperative BMI at 1 year was 33 kg/m2.

Thirty-eight percent of patients achieved a BMI below 30 kg/m2 at 1 year; their mean BMI at that time was 26.7 kg/m2. The mean BMI 1 year post surgery in the 62% of patients who didn’t reach the goal was 36.7 kg/m2.
 

 

Only 6.2% of patients who didn’t get to a BMI of less than 30 kg/m2 1 year post surgery had a preoperative BMI of 40 kg/m2 or below, whereas 31.7% of patients who achieved the goal did have a baseline BMI of 40 kg/m2 or below.

Among patients with a preoperative BMI of 50-59 kg/m2, only 7.6% reached the target. And among those with a preoperative BMI of 60 kg/m2, only 0.4% had a BMI of less than 30 kg/m2 at 1 year.

“Patients with a BMI of 50 kg/m2 or more should be given realistic expectations about the type of weight loss they’ll have after bariatric surgery,” Dr. Varban said.

Why is a postsurgical BMI below 30 kg/m2 such an important benchmark? Abundant evidence indicates that having a BMI of 30 kg/m2 or higher is associated with a 50%-100% increase in the risk of premature death compared to that of normal-weight individuals. Successful bariatric surgery reduces that risk by 30%-40%.

In the Michigan study, patients who reached the BMI target had a significantly higher rate of resolution of common comorbid conditions associated with morbid obesity, including type 2 diabetes, hypertension, dyslipidemia, and sleep apnea. They also scored higher on a patient satisfaction survey.

The mean percent preoperative weight loss was 2.3% in patients who didn’t achieve the target BMI and similar at 2.5% in those who did. Thus, preoperative weight loss is not a major contributor to postoperative success, Dr. Varban continued.

Failure to reach the postoperative BMI goal was significantly more common among patients who were black or Hispanic, had an annual income below $25,000, or didn’t have private insurance.

Thirty-day perioperative complication rates didn’t differ between patients who attained a BMI below 30 kg/m2 at 1 year and those who did not.
 

 

Dr. Varban said it will come to no surprise to bariatric surgeons that the likelihood of attaining the target 1-year BMI varied according to the type of bariatric surgery: Compared to patients who underwent adjustable laparoscopic banding, the success rate was 19-fold higher with Roux-en-Y gastric bypass, 7.2-fold higher with sleeve gastrectomy, and a whopping 72-fold higher in patients who had a duodenal switch procedure.

Neither the mean preoperative nor 1-year postoperative BMI figures changed much over the study period, even though sleeve gastrectomy became much more common after 2010. For example, the mean preoperative BMI was 48.3 kg/m2 in 2006 and 46.9 kg/m2 in 2015, while the mean postoperative BMIs were 32.7 and 32.6 kg/m2, respectively, in those years.

Dr. Varban said that as he ran the numbers, he was surprised to see that the baseline BMI was so high – far higher than he would have guessed. But since then as he has discussed the study findings with referring physicians throughout Michigan, he’s come to understand the explanation: Many of them are content to wait until their morbidly obese patients grow to a BMI above 50 kg/m2 before making the referral because they consider the alternate criterion for bariatric surgery referral – that is, failure to achieve significant weight loss after 1 year of medically supervised attempts – to be too much for them to take on.

Amir A. Ghaferi, MD, a University of Michigan bariatric surgeon and coinvestigator in the study, rose from the audience to urge his colleagues to focus on the health policy implications of the findings.

“Maybe our bariatric surgery criteria aren’t right. We’ve been talking a lot amongst ourselves about pushing the BMI threshold lower and reducing some of the insurance barriers. I think what this study demonstrates from a policy perspective is we need to get these patients sooner, without so many barriers ahead of us and in front of the patients, in order to achieve the best possible outcomes,” Dr. Ghaferi said.

Dr. Varban reported receiving research funding from Blue Cross Blue Shield of Michigan.
 

 

 

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OBESITY WEEK 2016

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Key clinical point: Don’t wait until a patient’s BMI gets above 40 kg/m2 to make the referral.

Major finding: Patients who underwent bariatric surgery when their BMI was 40 kg/m2 or below were 13.3-fold more likely to have a BMI below 30 kg/m2 1 year later.

Data source: A study of 1-year outcomes in nearly 20,000 patients in the Michigan Bariatric Surgery Collaborative database.

Disclosures: The study presenter reported receiving research funding from Blue Cross Blue Shield of Michigan.

How to sustain a quality improvement effort

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In the final of a three-part series about developing and implementing a quality improvement initiative, Dr. Bernstein and his colleagues outline how such a program can be sustained and cemented into a gastroenterology practice. This mini-series has focused on community practices and presented a road map for quality improvement through descriptions of clinical vignettes – specifically focused on improving adenoma detection rates. In multiple other articles within the Toolbox series, we have described how gastroenterologists can measure and improve one of our most important outcome measures – the adenoma detection rate for screening colonoscopy. We all are aware of the Hawthorne effect (that is, observer effect) in which people modify their behavior in response to being measured or observed. The key to sustained quality improvement is to change fundamental practices once the flush of initial success fades.
 

John I. Allen, MD, MBA, AGAF

Editor in Chief

Series review

In this series, you are a community-based urban general gastroenterologist asked by hospital administration to improve your current group adenoma detection rate (ADR) of 19% to the established target of 25% among each individual endoscopist within the group during a 12-month period.

The team has implemented standardized endoscopist report cards during the past 9 months. At present, ADR has been more than 25% for all practitioners for 4 consecutive months. The quality improvement team meets to determine how to sustain the gains long term.

Sustainability of improved outcomes has been defined as: “When new ways of working and improved outcomes become the norm.”1 This incorporates a number of important concepts. “New ways of working” means that a change has been made in the way care has been provided. This includes interventions such as a new policy, implementation of a checklist, or a new clinical pathway. “Improved outcomes” implies that the result of the intervention has been measured and has demonstrated an improvement. “Become the norm” means that this change has now become a part of standard work and does not need ongoing support to continue.

Although a great deal of literature currently exists that focuses on initiation and implementation of quality improvement (QI) activities, much less has been written on sustaining efforts once the goal has been achieved. A number of reasons have been proposed for this, including stability being typically regarded as less interesting, as well as the research requiring much longer time frames for study.2 However, there is important evidence that suggests that up to 70% of long-term changes in health care organizations ultimately fail.3 This indicates a pressing need for effective strategies to sustain improved outcomes.

Challenges

A number of challenges face the sustainability phase of an intervention.2 First, the initial enthusiasm for a novel intervention wanes after time, often limiting long-term compliance if it has not become part of standard work. Second, the local or national support for a project may have changed as strategic priorities shift. This can result in a loss of leadership support and/or resources. Third, most institutions value novel ideas over a steady state, and focusing on the next initiative offers more career value for managers as compared with maintaining current practices. Finally, it is common for groups to declare victory too soon. This is defined as celebrating the first performance improvement as the final goal instead of it being the first step to long-term success.

Determining readiness for sustainability

The first step in determining readiness for sustaining an improvement is to determine whether there has been an actual improvement to sustain. This means both completing the plan-do-study-act cycles and establishing a true steady state. In addition, it needs to be demonstrated that a sustained change has occurred. The second article in this series addresses these steps in detail.4

The National Health Service (United Kingdom) Improvement Leaders’ Guide to Sustainability and Spread identifies four sets of questions to ask when determining whether a project can enter the sustainability phase.3

1. Is the (intervention) near the final stage of development? If there were room for further changes, would these completely alter the way the solution has been introduced?

2. Are the measurements demonstrating real improvement?

3. Who cares about this improvement? Is the solution representative of the wider views of those involved?

4. What policy or technological changes may render this solution redundant? When might this happen?

Once the answers to these questions have been determined and it is believed that a steady state has been achieved, it is time to move on to sustaining the intervention. Article no. 2 in our series outlines how to know whether an improvement has occurred. Although there is no single metric that can determine a project is in a steady state, it is generally believed that four or five cycles with consistent improvement and without special cause variation, along with an intervention that has been fully established, typically represent a steady state.

ACTION PLAN: For the ADR example, the answers to the questions are as follows:

 

 

1. The intervention was developed and finalized through iterative design among the QI team.

2. Performance has been consistently above target among all endoscopists for 4 consecutive months.

3. ADR is an important quality metric to individual endoscopists as well as hospital leadership. Moreover, because there are increasing models tying reimbursement to funding that are based on adherence to quality indicators, ADR will become more important.

4. If hospitals become mandated to provide scorecard data, the intervention may become redundant. However, the measurement and implications of the data still may be relevant to ongoing QI activities.

Interventions supporting sustainability

Sustainability planning is ideally started at the initiation phase of the project. When choosing a target for change, consideration of organizational factors such as strategic priorities, staff engagement, and leadership support are integral to long-term success. Factors influencing the type of intervention developed should include available funding (both long term and short term), existing information technology (IT) resources, and the ability to incorporate into existing workflow. Considering these factors from the outset will help improve a project’s long-term viability.

A number of toolkits have been produced to guide QI teams through the sustainability process. The National Health Service Institute for Innovation and Improvement has produced a comprehensive guide to sustainability.4 The guide provides advice on how to identify opportunities to increase the likelihood of sustainability for your initiative. It is accompanied by a model that can be used to predict success by dividing the factors influencing sustainability into three groups: staff, process, and organization. Each of these has a number of subcategories, and relative significance is attributed to each, with staff factors (clinical leadership engagement, senior leadership engagement, staff involvement in the change, and staff attitudes toward the change) holding the highest weighting. On the basis of the results of the model, the QI team can identify both the likelihood of success as well as opportunities for improvement.

Visual aids are another intervention that promotes sustainability. Visual cues such as posters, buttons, and magnets act as easy reminders for front-line staff. Creating a storyboard at the beginning of the project allows stakeholders to have a broad perspective on both the intervention and sustainability phases.5 Ongoing auditing and reporting of results also encourage long-term compliance. This can take the form of posting results of the intervention in the department on a regular basis as well as reports to senior administration. Regular check-ins with all stakeholders are also encouraged. This can be at a monthly staff meeting or a brief “improvement huddle” on a standing basis.

Factors influencing success

Any discussion of QI work must consider context. An understanding of the system one is working within will allow for optimization of system strengths and avoidance of pitfalls because of weaknesses. A lack of attention to context can lead to an unsuccessful project. This could be due to choosing a focus that is not in line with hospital priorities, a project that is asking staff to take on additional tasks without removing others, or developing a solution that requires funding or IT infrastructure that is not readily available.

Any organization has a number of different settings that need to be considered simultaneously. This is most simply divided into microsystem, mesosystem, and macrosystem. Microsystem is defined as the combination of a small team of people who work together on a regular basis. The mesosystem focuses on the integrated care needs of a particular group or population with the same diseases or conditions and provides support for individual microsystems. The macrosystem forms the infrastructure of the larger organization, providing the systems and governance that define the system.6 In our example, the microsystem is the endoscopy unit, including physicians, nurses, administrative support, and managers. The mesosystem is composed of the endoscopy unit in addition to the Departments of Gastroenterology and Surgery, the hospital IT team, and the Pathology Department. The macrosystem is the hospital, including senior leadership and administration. Another way of thinking about this is the microsystem is the environment most easily influenced by the individual provider, whereas the macrosystem includes the organizational-level factors that need to be taken into consideration when designing an intervention.

A great number of factors have been proposed to influence sustainability. National Health Service Scotland performed a literature review and met with subject matter experts to determine key factors that require consideration when engaging in activities to sustain and spread QI activities. They produced a guide that focused on 10 factors thought to have the greatest influence.6 Although a review of all 10 factors is beyond the scope of this review, we will highlight key ones to consider.

 

 

Innovation

The nature of the change greatly influences its likelihood of being sustained. In addition, one must consider the process of the intervention as well as those who will be impacted by the change. Core qualities that predispose to success include the following:7

1. Clear advantage compared with current ways

2. Compatibility/integration with current systems and values

3. Simplicity of the change and its implementation

4. Ease of testing

5. Observability of the change and its impact

This list highlights the point that the plan to sustain an intervention needs to start at the design phase and not once the change has been proven successful. Support among users also influences long-term success. Early adopters are those who embrace the intervention or change. Identifying the early adopters and using their support for positive publicity and momentum are integral in any sustainability effort.

ACTION PLAN: In our example, components of the intervention that would predispose to sustainability include choosing an outcome that is aligned with the hospital’s strategic focus (for example, cancer screening and prevention). ADR is already a measurable outcome at the hospital, which facilitates dissemination of results. Alternatively, some of the resistance to change may be due to the increased work to compile and distribute the scorecards monthly.

Organizational culture

Culture has been most simply defined as “the way we do things around here”.7 The approach of an organization toward QI will clearly impact its long-term viability. On a macrosystem level, interventions should ideally fit within strategic goals and priorities of organizations to garner maximum support. When promoting the intervention, it may be appropriate to focus on the benefits to the individual group (that is, cost savings to senior administration, time saved to front-line staff). Studies have shown that teams that demonstrate a strong teamwork ethic, have a positive attitude toward the intervention, and where all members know and understand their role on the team were more likely to have sustained success.8 In addition, engagement of all key stakeholders early in the process has been correlated with improved long-term outcomes. In a microsystem level, providers can choose to implement the intervention among a well-established team that works well together, ideally where there is a history or prior QI work.

Factors that may make sustaining a QI effort more challenging include interventions that increase time or costs to the organization. Many healthcare organizations may have specific targets set out from their regulatory body. If the intervention lowers the result of one of the targeted outcomes (or does not address those targets at all), it may be met with increased resistance within a system. In cases like this it is integral to use data to demonstrate to senior leadership why this still has tangible benefit to the organization.

ACTION PLAN: In our example, culture can promote sustainability on a microsystem level through reinforcing local success stories. This can be through posting of visual aids in the unit such as posters that display performance or progress boards that chart the status of the intervention. In addition, QI projects can be a regular agenda item at unit meetings, reinforcing their importance to team members.

Leadership

One key component of organizational culture is the influence of leadership. An effective leader will have both technical QI skills and strong interpersonal skills.7 Teams where all members feel comfortable making suggestions or voicing concerns are far more likely to succeed, and it is incumbent on leadership to create this environment. This concept is often termed psychological safety and has been directly linked to the inclusiveness of the leader. Team members with psychological safety are more likely to feel like active participants in the process, and this improves their long-term engagement.7,8 In addition, effective leaders create accountability systems to ensure gains are maintained. These may include regular performance reviews, reminders about the intervention, and assigning responsibility to senior level team members. Finally, celebration of accomplishments reinforces the positive impact of the time and energy invested by members of the team.9 The concept of distributed leadership is another key concept. This acknowledges that for any one intervention, there are a number of formal and informal leadership roles, and these can be filled by a number of different individuals.7

ACTION PLAN: For our ADR example, sustainability can be promoted through effective leadership. On a microsystem level, one option is the implementation of a weekly Improvement Huddle. This is a 10- to 15-minute meeting within the microsystem that is designed to review current performance and anticipate problems. All team members are encouraged to voice any concerns. On the macrosystem level, quarterly reports to senior administration and presentation of process and results at Grand Rounds may contribute to this goal.

 

 

Change management

Change management looks at how an organization approaches the new ways of working. This can be on both a social level and a technical level (often termed Organizational Infrastructure). Creating interventions that integrate with existing systems (data collection, workflow) is ideal for sustainability because it can serve to reinforce the change as standard work. In instances where the change does not immediately integrate, organizations can support change by demonstrating flexibility. This includes modification of existing technology to measure the desired outcome, development of new protocols to integrate the modified workflow, or changing job definitions of team members to demonstrate that the intervention is now considered part of daily responsibilities. Ongoing feedback also reinforces maintenance of performance. This can be through performance reviews for staff members as well as providing data to the appropriate audiences to demonstrate sustained gains.7,9

ACTION PLAN: For the ADR example, change management can contribute to sustainability through creation of a sustainable data reporting system that integrates current workflow. This will allow ongoing measurement of key metrics and is integral for long-term viability.

Summary

In this final article of a three-part series directed toward gastroenterologists interested in local QI endeavors, we selectively reviewed concepts surrounding sustainability of QI endeavors. This included determining readiness and understanding the factors that influence long-term success on both a macrosystem and microsystem level. Factors under the direct control of the individual practitioner were highlighted to give examples of specific strategies for successful sustainability.

References

1. Thomas, S., Zahn, D. Sustaining improved outcomes: a toolkit. Available at: http://nyshealthfoundation.org/resources-and-reports/resource/sustaining-improved-outcomes-a-toolkit.

2. Buchanan, D., Fitzgerald, L., Ketley, D., et al. No going back: a review of the literature on sustaining organizational change. Int. J Manag Rev. 2005;7:189-205.

3. Sustainability: model and guide. National Health Service Institute for Innovation and Improvement, Leeds, U.K.; 2007.

4. Improvement leaders’ guide to sustainability and spread. NHS Modernisation Agency. Ipswich, England: Ancient House Printing Group; 2002.

5. Nelson, E.C., Batalden, P.B., Godfrey, M.M. Quality by design: a clinical microsystems approach. Jossey-Bass, San Francisco, Calif; 2007.

6. Available at: http://www.ashpfoundation.org/lean.

7. NHS Scotland Quality Improvement Hub. The spread and sustainability of quality improvement in healthcare. 2014. Available at: http://www.qihub.scot.nhs.uk/knowledge-centre/quality-improvement-topics/spread-and-sustainability.aspx.

8. Healthcare Improvement Scotland. Quality improvement: sustainable in any organizational culture? 2013. Available at: http://www.healthcareimprovementscotland.org/previous_resources/benchmarking_report/quality_improvement_report.aspx.

9. 5 Million Lives Campaign. Getting started kit: rapid response teams. Institute for Healthcare Improvement, Cambridge, MA; 2008 (Available at:) www.ihi.org.
 

Dr. Bernstein is in the division of gastroenterology, department of medicine, Sunnybrook Health Sciences Centre; Dr. Weizman is at the Mount Sinai Hospital Centre for Inflammatory Bowel Disease, department of medicine, and Institute of Health Policy, Management and Evaluation; Dr. Mosko is in the division of gastroenterology, department of medicine, St. Michael’s Hospital, and the Institute of Health Policy, Management, and Evaluation; Dr. Bollegala is in the division of gastroenterology, department of medicine, Women’s College Hospital; Dr. Brahmania is in the Toronto Center for Liver Diseases, division of gastroenterology, department of medicine, University Health Network; Dr. Liu is in the division of gastroenterology, department of medicine, University Health Network; Dr. Steinhart is at Mount Sinai Hospital Centre for Inflammatory Bowel Disease, department of medicine and Institute of Health Policy, Management, and Evaluation; Dr. Silver is in the division of nephrology, St. Michael’s Hospital; Dr. Nguyen is at Mount Sinai Hospital Centre for Inflammatory Bowel Disease, department of medicine; and Dr. Bell is in the division of internal medicine, department of medicine, Mount Sinai Hospital. All are at the University of Toronto except Dr. Hou, who is at the Houston VA Health Services Research and Development Center of Excellence, Michael DeBakey Veterans Affairs Medical Center, and the section of gastroenterology and hepatology, Baylor College of Medicine, Houston. The authors disclose no conflicts.

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In the final of a three-part series about developing and implementing a quality improvement initiative, Dr. Bernstein and his colleagues outline how such a program can be sustained and cemented into a gastroenterology practice. This mini-series has focused on community practices and presented a road map for quality improvement through descriptions of clinical vignettes – specifically focused on improving adenoma detection rates. In multiple other articles within the Toolbox series, we have described how gastroenterologists can measure and improve one of our most important outcome measures – the adenoma detection rate for screening colonoscopy. We all are aware of the Hawthorne effect (that is, observer effect) in which people modify their behavior in response to being measured or observed. The key to sustained quality improvement is to change fundamental practices once the flush of initial success fades.
 

John I. Allen, MD, MBA, AGAF

Editor in Chief

Series review

In this series, you are a community-based urban general gastroenterologist asked by hospital administration to improve your current group adenoma detection rate (ADR) of 19% to the established target of 25% among each individual endoscopist within the group during a 12-month period.

The team has implemented standardized endoscopist report cards during the past 9 months. At present, ADR has been more than 25% for all practitioners for 4 consecutive months. The quality improvement team meets to determine how to sustain the gains long term.

Sustainability of improved outcomes has been defined as: “When new ways of working and improved outcomes become the norm.”1 This incorporates a number of important concepts. “New ways of working” means that a change has been made in the way care has been provided. This includes interventions such as a new policy, implementation of a checklist, or a new clinical pathway. “Improved outcomes” implies that the result of the intervention has been measured and has demonstrated an improvement. “Become the norm” means that this change has now become a part of standard work and does not need ongoing support to continue.

Although a great deal of literature currently exists that focuses on initiation and implementation of quality improvement (QI) activities, much less has been written on sustaining efforts once the goal has been achieved. A number of reasons have been proposed for this, including stability being typically regarded as less interesting, as well as the research requiring much longer time frames for study.2 However, there is important evidence that suggests that up to 70% of long-term changes in health care organizations ultimately fail.3 This indicates a pressing need for effective strategies to sustain improved outcomes.

Challenges

A number of challenges face the sustainability phase of an intervention.2 First, the initial enthusiasm for a novel intervention wanes after time, often limiting long-term compliance if it has not become part of standard work. Second, the local or national support for a project may have changed as strategic priorities shift. This can result in a loss of leadership support and/or resources. Third, most institutions value novel ideas over a steady state, and focusing on the next initiative offers more career value for managers as compared with maintaining current practices. Finally, it is common for groups to declare victory too soon. This is defined as celebrating the first performance improvement as the final goal instead of it being the first step to long-term success.

Determining readiness for sustainability

The first step in determining readiness for sustaining an improvement is to determine whether there has been an actual improvement to sustain. This means both completing the plan-do-study-act cycles and establishing a true steady state. In addition, it needs to be demonstrated that a sustained change has occurred. The second article in this series addresses these steps in detail.4

The National Health Service (United Kingdom) Improvement Leaders’ Guide to Sustainability and Spread identifies four sets of questions to ask when determining whether a project can enter the sustainability phase.3

1. Is the (intervention) near the final stage of development? If there were room for further changes, would these completely alter the way the solution has been introduced?

2. Are the measurements demonstrating real improvement?

3. Who cares about this improvement? Is the solution representative of the wider views of those involved?

4. What policy or technological changes may render this solution redundant? When might this happen?

Once the answers to these questions have been determined and it is believed that a steady state has been achieved, it is time to move on to sustaining the intervention. Article no. 2 in our series outlines how to know whether an improvement has occurred. Although there is no single metric that can determine a project is in a steady state, it is generally believed that four or five cycles with consistent improvement and without special cause variation, along with an intervention that has been fully established, typically represent a steady state.

ACTION PLAN: For the ADR example, the answers to the questions are as follows:

 

 

1. The intervention was developed and finalized through iterative design among the QI team.

2. Performance has been consistently above target among all endoscopists for 4 consecutive months.

3. ADR is an important quality metric to individual endoscopists as well as hospital leadership. Moreover, because there are increasing models tying reimbursement to funding that are based on adherence to quality indicators, ADR will become more important.

4. If hospitals become mandated to provide scorecard data, the intervention may become redundant. However, the measurement and implications of the data still may be relevant to ongoing QI activities.

Interventions supporting sustainability

Sustainability planning is ideally started at the initiation phase of the project. When choosing a target for change, consideration of organizational factors such as strategic priorities, staff engagement, and leadership support are integral to long-term success. Factors influencing the type of intervention developed should include available funding (both long term and short term), existing information technology (IT) resources, and the ability to incorporate into existing workflow. Considering these factors from the outset will help improve a project’s long-term viability.

A number of toolkits have been produced to guide QI teams through the sustainability process. The National Health Service Institute for Innovation and Improvement has produced a comprehensive guide to sustainability.4 The guide provides advice on how to identify opportunities to increase the likelihood of sustainability for your initiative. It is accompanied by a model that can be used to predict success by dividing the factors influencing sustainability into three groups: staff, process, and organization. Each of these has a number of subcategories, and relative significance is attributed to each, with staff factors (clinical leadership engagement, senior leadership engagement, staff involvement in the change, and staff attitudes toward the change) holding the highest weighting. On the basis of the results of the model, the QI team can identify both the likelihood of success as well as opportunities for improvement.

Visual aids are another intervention that promotes sustainability. Visual cues such as posters, buttons, and magnets act as easy reminders for front-line staff. Creating a storyboard at the beginning of the project allows stakeholders to have a broad perspective on both the intervention and sustainability phases.5 Ongoing auditing and reporting of results also encourage long-term compliance. This can take the form of posting results of the intervention in the department on a regular basis as well as reports to senior administration. Regular check-ins with all stakeholders are also encouraged. This can be at a monthly staff meeting or a brief “improvement huddle” on a standing basis.

Factors influencing success

Any discussion of QI work must consider context. An understanding of the system one is working within will allow for optimization of system strengths and avoidance of pitfalls because of weaknesses. A lack of attention to context can lead to an unsuccessful project. This could be due to choosing a focus that is not in line with hospital priorities, a project that is asking staff to take on additional tasks without removing others, or developing a solution that requires funding or IT infrastructure that is not readily available.

Any organization has a number of different settings that need to be considered simultaneously. This is most simply divided into microsystem, mesosystem, and macrosystem. Microsystem is defined as the combination of a small team of people who work together on a regular basis. The mesosystem focuses on the integrated care needs of a particular group or population with the same diseases or conditions and provides support for individual microsystems. The macrosystem forms the infrastructure of the larger organization, providing the systems and governance that define the system.6 In our example, the microsystem is the endoscopy unit, including physicians, nurses, administrative support, and managers. The mesosystem is composed of the endoscopy unit in addition to the Departments of Gastroenterology and Surgery, the hospital IT team, and the Pathology Department. The macrosystem is the hospital, including senior leadership and administration. Another way of thinking about this is the microsystem is the environment most easily influenced by the individual provider, whereas the macrosystem includes the organizational-level factors that need to be taken into consideration when designing an intervention.

A great number of factors have been proposed to influence sustainability. National Health Service Scotland performed a literature review and met with subject matter experts to determine key factors that require consideration when engaging in activities to sustain and spread QI activities. They produced a guide that focused on 10 factors thought to have the greatest influence.6 Although a review of all 10 factors is beyond the scope of this review, we will highlight key ones to consider.

 

 

Innovation

The nature of the change greatly influences its likelihood of being sustained. In addition, one must consider the process of the intervention as well as those who will be impacted by the change. Core qualities that predispose to success include the following:7

1. Clear advantage compared with current ways

2. Compatibility/integration with current systems and values

3. Simplicity of the change and its implementation

4. Ease of testing

5. Observability of the change and its impact

This list highlights the point that the plan to sustain an intervention needs to start at the design phase and not once the change has been proven successful. Support among users also influences long-term success. Early adopters are those who embrace the intervention or change. Identifying the early adopters and using their support for positive publicity and momentum are integral in any sustainability effort.

ACTION PLAN: In our example, components of the intervention that would predispose to sustainability include choosing an outcome that is aligned with the hospital’s strategic focus (for example, cancer screening and prevention). ADR is already a measurable outcome at the hospital, which facilitates dissemination of results. Alternatively, some of the resistance to change may be due to the increased work to compile and distribute the scorecards monthly.

Organizational culture

Culture has been most simply defined as “the way we do things around here”.7 The approach of an organization toward QI will clearly impact its long-term viability. On a macrosystem level, interventions should ideally fit within strategic goals and priorities of organizations to garner maximum support. When promoting the intervention, it may be appropriate to focus on the benefits to the individual group (that is, cost savings to senior administration, time saved to front-line staff). Studies have shown that teams that demonstrate a strong teamwork ethic, have a positive attitude toward the intervention, and where all members know and understand their role on the team were more likely to have sustained success.8 In addition, engagement of all key stakeholders early in the process has been correlated with improved long-term outcomes. In a microsystem level, providers can choose to implement the intervention among a well-established team that works well together, ideally where there is a history or prior QI work.

Factors that may make sustaining a QI effort more challenging include interventions that increase time or costs to the organization. Many healthcare organizations may have specific targets set out from their regulatory body. If the intervention lowers the result of one of the targeted outcomes (or does not address those targets at all), it may be met with increased resistance within a system. In cases like this it is integral to use data to demonstrate to senior leadership why this still has tangible benefit to the organization.

ACTION PLAN: In our example, culture can promote sustainability on a microsystem level through reinforcing local success stories. This can be through posting of visual aids in the unit such as posters that display performance or progress boards that chart the status of the intervention. In addition, QI projects can be a regular agenda item at unit meetings, reinforcing their importance to team members.

Leadership

One key component of organizational culture is the influence of leadership. An effective leader will have both technical QI skills and strong interpersonal skills.7 Teams where all members feel comfortable making suggestions or voicing concerns are far more likely to succeed, and it is incumbent on leadership to create this environment. This concept is often termed psychological safety and has been directly linked to the inclusiveness of the leader. Team members with psychological safety are more likely to feel like active participants in the process, and this improves their long-term engagement.7,8 In addition, effective leaders create accountability systems to ensure gains are maintained. These may include regular performance reviews, reminders about the intervention, and assigning responsibility to senior level team members. Finally, celebration of accomplishments reinforces the positive impact of the time and energy invested by members of the team.9 The concept of distributed leadership is another key concept. This acknowledges that for any one intervention, there are a number of formal and informal leadership roles, and these can be filled by a number of different individuals.7

ACTION PLAN: For our ADR example, sustainability can be promoted through effective leadership. On a microsystem level, one option is the implementation of a weekly Improvement Huddle. This is a 10- to 15-minute meeting within the microsystem that is designed to review current performance and anticipate problems. All team members are encouraged to voice any concerns. On the macrosystem level, quarterly reports to senior administration and presentation of process and results at Grand Rounds may contribute to this goal.

 

 

Change management

Change management looks at how an organization approaches the new ways of working. This can be on both a social level and a technical level (often termed Organizational Infrastructure). Creating interventions that integrate with existing systems (data collection, workflow) is ideal for sustainability because it can serve to reinforce the change as standard work. In instances where the change does not immediately integrate, organizations can support change by demonstrating flexibility. This includes modification of existing technology to measure the desired outcome, development of new protocols to integrate the modified workflow, or changing job definitions of team members to demonstrate that the intervention is now considered part of daily responsibilities. Ongoing feedback also reinforces maintenance of performance. This can be through performance reviews for staff members as well as providing data to the appropriate audiences to demonstrate sustained gains.7,9

ACTION PLAN: For the ADR example, change management can contribute to sustainability through creation of a sustainable data reporting system that integrates current workflow. This will allow ongoing measurement of key metrics and is integral for long-term viability.

Summary

In this final article of a three-part series directed toward gastroenterologists interested in local QI endeavors, we selectively reviewed concepts surrounding sustainability of QI endeavors. This included determining readiness and understanding the factors that influence long-term success on both a macrosystem and microsystem level. Factors under the direct control of the individual practitioner were highlighted to give examples of specific strategies for successful sustainability.

References

1. Thomas, S., Zahn, D. Sustaining improved outcomes: a toolkit. Available at: http://nyshealthfoundation.org/resources-and-reports/resource/sustaining-improved-outcomes-a-toolkit.

2. Buchanan, D., Fitzgerald, L., Ketley, D., et al. No going back: a review of the literature on sustaining organizational change. Int. J Manag Rev. 2005;7:189-205.

3. Sustainability: model and guide. National Health Service Institute for Innovation and Improvement, Leeds, U.K.; 2007.

4. Improvement leaders’ guide to sustainability and spread. NHS Modernisation Agency. Ipswich, England: Ancient House Printing Group; 2002.

5. Nelson, E.C., Batalden, P.B., Godfrey, M.M. Quality by design: a clinical microsystems approach. Jossey-Bass, San Francisco, Calif; 2007.

6. Available at: http://www.ashpfoundation.org/lean.

7. NHS Scotland Quality Improvement Hub. The spread and sustainability of quality improvement in healthcare. 2014. Available at: http://www.qihub.scot.nhs.uk/knowledge-centre/quality-improvement-topics/spread-and-sustainability.aspx.

8. Healthcare Improvement Scotland. Quality improvement: sustainable in any organizational culture? 2013. Available at: http://www.healthcareimprovementscotland.org/previous_resources/benchmarking_report/quality_improvement_report.aspx.

9. 5 Million Lives Campaign. Getting started kit: rapid response teams. Institute for Healthcare Improvement, Cambridge, MA; 2008 (Available at:) www.ihi.org.
 

Dr. Bernstein is in the division of gastroenterology, department of medicine, Sunnybrook Health Sciences Centre; Dr. Weizman is at the Mount Sinai Hospital Centre for Inflammatory Bowel Disease, department of medicine, and Institute of Health Policy, Management and Evaluation; Dr. Mosko is in the division of gastroenterology, department of medicine, St. Michael’s Hospital, and the Institute of Health Policy, Management, and Evaluation; Dr. Bollegala is in the division of gastroenterology, department of medicine, Women’s College Hospital; Dr. Brahmania is in the Toronto Center for Liver Diseases, division of gastroenterology, department of medicine, University Health Network; Dr. Liu is in the division of gastroenterology, department of medicine, University Health Network; Dr. Steinhart is at Mount Sinai Hospital Centre for Inflammatory Bowel Disease, department of medicine and Institute of Health Policy, Management, and Evaluation; Dr. Silver is in the division of nephrology, St. Michael’s Hospital; Dr. Nguyen is at Mount Sinai Hospital Centre for Inflammatory Bowel Disease, department of medicine; and Dr. Bell is in the division of internal medicine, department of medicine, Mount Sinai Hospital. All are at the University of Toronto except Dr. Hou, who is at the Houston VA Health Services Research and Development Center of Excellence, Michael DeBakey Veterans Affairs Medical Center, and the section of gastroenterology and hepatology, Baylor College of Medicine, Houston. The authors disclose no conflicts.

 

In the final of a three-part series about developing and implementing a quality improvement initiative, Dr. Bernstein and his colleagues outline how such a program can be sustained and cemented into a gastroenterology practice. This mini-series has focused on community practices and presented a road map for quality improvement through descriptions of clinical vignettes – specifically focused on improving adenoma detection rates. In multiple other articles within the Toolbox series, we have described how gastroenterologists can measure and improve one of our most important outcome measures – the adenoma detection rate for screening colonoscopy. We all are aware of the Hawthorne effect (that is, observer effect) in which people modify their behavior in response to being measured or observed. The key to sustained quality improvement is to change fundamental practices once the flush of initial success fades.
 

John I. Allen, MD, MBA, AGAF

Editor in Chief

Series review

In this series, you are a community-based urban general gastroenterologist asked by hospital administration to improve your current group adenoma detection rate (ADR) of 19% to the established target of 25% among each individual endoscopist within the group during a 12-month period.

The team has implemented standardized endoscopist report cards during the past 9 months. At present, ADR has been more than 25% for all practitioners for 4 consecutive months. The quality improvement team meets to determine how to sustain the gains long term.

Sustainability of improved outcomes has been defined as: “When new ways of working and improved outcomes become the norm.”1 This incorporates a number of important concepts. “New ways of working” means that a change has been made in the way care has been provided. This includes interventions such as a new policy, implementation of a checklist, or a new clinical pathway. “Improved outcomes” implies that the result of the intervention has been measured and has demonstrated an improvement. “Become the norm” means that this change has now become a part of standard work and does not need ongoing support to continue.

Although a great deal of literature currently exists that focuses on initiation and implementation of quality improvement (QI) activities, much less has been written on sustaining efforts once the goal has been achieved. A number of reasons have been proposed for this, including stability being typically regarded as less interesting, as well as the research requiring much longer time frames for study.2 However, there is important evidence that suggests that up to 70% of long-term changes in health care organizations ultimately fail.3 This indicates a pressing need for effective strategies to sustain improved outcomes.

Challenges

A number of challenges face the sustainability phase of an intervention.2 First, the initial enthusiasm for a novel intervention wanes after time, often limiting long-term compliance if it has not become part of standard work. Second, the local or national support for a project may have changed as strategic priorities shift. This can result in a loss of leadership support and/or resources. Third, most institutions value novel ideas over a steady state, and focusing on the next initiative offers more career value for managers as compared with maintaining current practices. Finally, it is common for groups to declare victory too soon. This is defined as celebrating the first performance improvement as the final goal instead of it being the first step to long-term success.

Determining readiness for sustainability

The first step in determining readiness for sustaining an improvement is to determine whether there has been an actual improvement to sustain. This means both completing the plan-do-study-act cycles and establishing a true steady state. In addition, it needs to be demonstrated that a sustained change has occurred. The second article in this series addresses these steps in detail.4

The National Health Service (United Kingdom) Improvement Leaders’ Guide to Sustainability and Spread identifies four sets of questions to ask when determining whether a project can enter the sustainability phase.3

1. Is the (intervention) near the final stage of development? If there were room for further changes, would these completely alter the way the solution has been introduced?

2. Are the measurements demonstrating real improvement?

3. Who cares about this improvement? Is the solution representative of the wider views of those involved?

4. What policy or technological changes may render this solution redundant? When might this happen?

Once the answers to these questions have been determined and it is believed that a steady state has been achieved, it is time to move on to sustaining the intervention. Article no. 2 in our series outlines how to know whether an improvement has occurred. Although there is no single metric that can determine a project is in a steady state, it is generally believed that four or five cycles with consistent improvement and without special cause variation, along with an intervention that has been fully established, typically represent a steady state.

ACTION PLAN: For the ADR example, the answers to the questions are as follows:

 

 

1. The intervention was developed and finalized through iterative design among the QI team.

2. Performance has been consistently above target among all endoscopists for 4 consecutive months.

3. ADR is an important quality metric to individual endoscopists as well as hospital leadership. Moreover, because there are increasing models tying reimbursement to funding that are based on adherence to quality indicators, ADR will become more important.

4. If hospitals become mandated to provide scorecard data, the intervention may become redundant. However, the measurement and implications of the data still may be relevant to ongoing QI activities.

Interventions supporting sustainability

Sustainability planning is ideally started at the initiation phase of the project. When choosing a target for change, consideration of organizational factors such as strategic priorities, staff engagement, and leadership support are integral to long-term success. Factors influencing the type of intervention developed should include available funding (both long term and short term), existing information technology (IT) resources, and the ability to incorporate into existing workflow. Considering these factors from the outset will help improve a project’s long-term viability.

A number of toolkits have been produced to guide QI teams through the sustainability process. The National Health Service Institute for Innovation and Improvement has produced a comprehensive guide to sustainability.4 The guide provides advice on how to identify opportunities to increase the likelihood of sustainability for your initiative. It is accompanied by a model that can be used to predict success by dividing the factors influencing sustainability into three groups: staff, process, and organization. Each of these has a number of subcategories, and relative significance is attributed to each, with staff factors (clinical leadership engagement, senior leadership engagement, staff involvement in the change, and staff attitudes toward the change) holding the highest weighting. On the basis of the results of the model, the QI team can identify both the likelihood of success as well as opportunities for improvement.

Visual aids are another intervention that promotes sustainability. Visual cues such as posters, buttons, and magnets act as easy reminders for front-line staff. Creating a storyboard at the beginning of the project allows stakeholders to have a broad perspective on both the intervention and sustainability phases.5 Ongoing auditing and reporting of results also encourage long-term compliance. This can take the form of posting results of the intervention in the department on a regular basis as well as reports to senior administration. Regular check-ins with all stakeholders are also encouraged. This can be at a monthly staff meeting or a brief “improvement huddle” on a standing basis.

Factors influencing success

Any discussion of QI work must consider context. An understanding of the system one is working within will allow for optimization of system strengths and avoidance of pitfalls because of weaknesses. A lack of attention to context can lead to an unsuccessful project. This could be due to choosing a focus that is not in line with hospital priorities, a project that is asking staff to take on additional tasks without removing others, or developing a solution that requires funding or IT infrastructure that is not readily available.

Any organization has a number of different settings that need to be considered simultaneously. This is most simply divided into microsystem, mesosystem, and macrosystem. Microsystem is defined as the combination of a small team of people who work together on a regular basis. The mesosystem focuses on the integrated care needs of a particular group or population with the same diseases or conditions and provides support for individual microsystems. The macrosystem forms the infrastructure of the larger organization, providing the systems and governance that define the system.6 In our example, the microsystem is the endoscopy unit, including physicians, nurses, administrative support, and managers. The mesosystem is composed of the endoscopy unit in addition to the Departments of Gastroenterology and Surgery, the hospital IT team, and the Pathology Department. The macrosystem is the hospital, including senior leadership and administration. Another way of thinking about this is the microsystem is the environment most easily influenced by the individual provider, whereas the macrosystem includes the organizational-level factors that need to be taken into consideration when designing an intervention.

A great number of factors have been proposed to influence sustainability. National Health Service Scotland performed a literature review and met with subject matter experts to determine key factors that require consideration when engaging in activities to sustain and spread QI activities. They produced a guide that focused on 10 factors thought to have the greatest influence.6 Although a review of all 10 factors is beyond the scope of this review, we will highlight key ones to consider.

 

 

Innovation

The nature of the change greatly influences its likelihood of being sustained. In addition, one must consider the process of the intervention as well as those who will be impacted by the change. Core qualities that predispose to success include the following:7

1. Clear advantage compared with current ways

2. Compatibility/integration with current systems and values

3. Simplicity of the change and its implementation

4. Ease of testing

5. Observability of the change and its impact

This list highlights the point that the plan to sustain an intervention needs to start at the design phase and not once the change has been proven successful. Support among users also influences long-term success. Early adopters are those who embrace the intervention or change. Identifying the early adopters and using their support for positive publicity and momentum are integral in any sustainability effort.

ACTION PLAN: In our example, components of the intervention that would predispose to sustainability include choosing an outcome that is aligned with the hospital’s strategic focus (for example, cancer screening and prevention). ADR is already a measurable outcome at the hospital, which facilitates dissemination of results. Alternatively, some of the resistance to change may be due to the increased work to compile and distribute the scorecards monthly.

Organizational culture

Culture has been most simply defined as “the way we do things around here”.7 The approach of an organization toward QI will clearly impact its long-term viability. On a macrosystem level, interventions should ideally fit within strategic goals and priorities of organizations to garner maximum support. When promoting the intervention, it may be appropriate to focus on the benefits to the individual group (that is, cost savings to senior administration, time saved to front-line staff). Studies have shown that teams that demonstrate a strong teamwork ethic, have a positive attitude toward the intervention, and where all members know and understand their role on the team were more likely to have sustained success.8 In addition, engagement of all key stakeholders early in the process has been correlated with improved long-term outcomes. In a microsystem level, providers can choose to implement the intervention among a well-established team that works well together, ideally where there is a history or prior QI work.

Factors that may make sustaining a QI effort more challenging include interventions that increase time or costs to the organization. Many healthcare organizations may have specific targets set out from their regulatory body. If the intervention lowers the result of one of the targeted outcomes (or does not address those targets at all), it may be met with increased resistance within a system. In cases like this it is integral to use data to demonstrate to senior leadership why this still has tangible benefit to the organization.

ACTION PLAN: In our example, culture can promote sustainability on a microsystem level through reinforcing local success stories. This can be through posting of visual aids in the unit such as posters that display performance or progress boards that chart the status of the intervention. In addition, QI projects can be a regular agenda item at unit meetings, reinforcing their importance to team members.

Leadership

One key component of organizational culture is the influence of leadership. An effective leader will have both technical QI skills and strong interpersonal skills.7 Teams where all members feel comfortable making suggestions or voicing concerns are far more likely to succeed, and it is incumbent on leadership to create this environment. This concept is often termed psychological safety and has been directly linked to the inclusiveness of the leader. Team members with psychological safety are more likely to feel like active participants in the process, and this improves their long-term engagement.7,8 In addition, effective leaders create accountability systems to ensure gains are maintained. These may include regular performance reviews, reminders about the intervention, and assigning responsibility to senior level team members. Finally, celebration of accomplishments reinforces the positive impact of the time and energy invested by members of the team.9 The concept of distributed leadership is another key concept. This acknowledges that for any one intervention, there are a number of formal and informal leadership roles, and these can be filled by a number of different individuals.7

ACTION PLAN: For our ADR example, sustainability can be promoted through effective leadership. On a microsystem level, one option is the implementation of a weekly Improvement Huddle. This is a 10- to 15-minute meeting within the microsystem that is designed to review current performance and anticipate problems. All team members are encouraged to voice any concerns. On the macrosystem level, quarterly reports to senior administration and presentation of process and results at Grand Rounds may contribute to this goal.

 

 

Change management

Change management looks at how an organization approaches the new ways of working. This can be on both a social level and a technical level (often termed Organizational Infrastructure). Creating interventions that integrate with existing systems (data collection, workflow) is ideal for sustainability because it can serve to reinforce the change as standard work. In instances where the change does not immediately integrate, organizations can support change by demonstrating flexibility. This includes modification of existing technology to measure the desired outcome, development of new protocols to integrate the modified workflow, or changing job definitions of team members to demonstrate that the intervention is now considered part of daily responsibilities. Ongoing feedback also reinforces maintenance of performance. This can be through performance reviews for staff members as well as providing data to the appropriate audiences to demonstrate sustained gains.7,9

ACTION PLAN: For the ADR example, change management can contribute to sustainability through creation of a sustainable data reporting system that integrates current workflow. This will allow ongoing measurement of key metrics and is integral for long-term viability.

Summary

In this final article of a three-part series directed toward gastroenterologists interested in local QI endeavors, we selectively reviewed concepts surrounding sustainability of QI endeavors. This included determining readiness and understanding the factors that influence long-term success on both a macrosystem and microsystem level. Factors under the direct control of the individual practitioner were highlighted to give examples of specific strategies for successful sustainability.

References

1. Thomas, S., Zahn, D. Sustaining improved outcomes: a toolkit. Available at: http://nyshealthfoundation.org/resources-and-reports/resource/sustaining-improved-outcomes-a-toolkit.

2. Buchanan, D., Fitzgerald, L., Ketley, D., et al. No going back: a review of the literature on sustaining organizational change. Int. J Manag Rev. 2005;7:189-205.

3. Sustainability: model and guide. National Health Service Institute for Innovation and Improvement, Leeds, U.K.; 2007.

4. Improvement leaders’ guide to sustainability and spread. NHS Modernisation Agency. Ipswich, England: Ancient House Printing Group; 2002.

5. Nelson, E.C., Batalden, P.B., Godfrey, M.M. Quality by design: a clinical microsystems approach. Jossey-Bass, San Francisco, Calif; 2007.

6. Available at: http://www.ashpfoundation.org/lean.

7. NHS Scotland Quality Improvement Hub. The spread and sustainability of quality improvement in healthcare. 2014. Available at: http://www.qihub.scot.nhs.uk/knowledge-centre/quality-improvement-topics/spread-and-sustainability.aspx.

8. Healthcare Improvement Scotland. Quality improvement: sustainable in any organizational culture? 2013. Available at: http://www.healthcareimprovementscotland.org/previous_resources/benchmarking_report/quality_improvement_report.aspx.

9. 5 Million Lives Campaign. Getting started kit: rapid response teams. Institute for Healthcare Improvement, Cambridge, MA; 2008 (Available at:) www.ihi.org.
 

Dr. Bernstein is in the division of gastroenterology, department of medicine, Sunnybrook Health Sciences Centre; Dr. Weizman is at the Mount Sinai Hospital Centre for Inflammatory Bowel Disease, department of medicine, and Institute of Health Policy, Management and Evaluation; Dr. Mosko is in the division of gastroenterology, department of medicine, St. Michael’s Hospital, and the Institute of Health Policy, Management, and Evaluation; Dr. Bollegala is in the division of gastroenterology, department of medicine, Women’s College Hospital; Dr. Brahmania is in the Toronto Center for Liver Diseases, division of gastroenterology, department of medicine, University Health Network; Dr. Liu is in the division of gastroenterology, department of medicine, University Health Network; Dr. Steinhart is at Mount Sinai Hospital Centre for Inflammatory Bowel Disease, department of medicine and Institute of Health Policy, Management, and Evaluation; Dr. Silver is in the division of nephrology, St. Michael’s Hospital; Dr. Nguyen is at Mount Sinai Hospital Centre for Inflammatory Bowel Disease, department of medicine; and Dr. Bell is in the division of internal medicine, department of medicine, Mount Sinai Hospital. All are at the University of Toronto except Dr. Hou, who is at the Houston VA Health Services Research and Development Center of Excellence, Michael DeBakey Veterans Affairs Medical Center, and the section of gastroenterology and hepatology, Baylor College of Medicine, Houston. The authors disclose no conflicts.

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First trimester exposure raises risk of Zika-related birth defects

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Birth defects associated with the Zika virus occurred in 11% of completed pregnancies of mothers infected with the virus during the first trimester, based on data from the U.S. Zika Pregnancy Registry. The findings were published online in JAMA.

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“These findings support the importance of screening pregnant women for Zika virus exposure,” Margaret A. Honein, PhD, of the Centers for Disease Control and Prevention in Atlanta, and her colleagues wrote.

The researchers reviewed data from completed pregnancies in the continental U.S. and Hawaii from Jan. 15, 2016, to Sept. 22, 2016. The data were collected from state and local health departments through the U.S. Zika Pregnancy Registry.

Birth defects were reported in 26 cases; 16 of 271 asymptomatic women and 10 of 167 symptomatic women (approximately 6% of each group). The most common birth defects potentially associated with Zika were microcephaly and brain abnormalities (14 cases), 4 brain abnormalities without microcephaly, and 4 cases of microcephaly and no reported neuroimaging. Overall, microcephaly was present in 4% of completed pregnancies.

Other potentially Zika-related complications included intracranial calcifications, corpus callosum abnormalities, abnormal cortical formation, cerebral atrophy, ventriculomegaly, hydrocephaly, and cerebellar abnormalities, the researchers wrote.

The women ranged in age from 15 to 50 years, and the population included 395 live births (21 infants with birth defects) and 47 pregnancy losses (5 fetuses with birth defects).

“No birth defects were reported among the pregnancies with maternal symptoms or exposure only in the second trimester or third trimester,” the researchers noted, “but there are insufficient data to adequately estimate the proportion affected during these trimesters,” they wrote.

Long-term monitoring of infants with possible congenital Zika virus is essential, the researchers wrote, as some normocephalic infants develop adverse effects of the virus not present at birth.

“In addition, future observations can elucidate the possible role of Zika virus infection in other outcomes, including spontaneous abortions and stillbirths as well as other structural birth defects that are not currently part of the inclusion criteria for Zika-associated birth defects surveillance,” they noted.

The researchers reported having no financial disclosures.

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Birth defects associated with the Zika virus occurred in 11% of completed pregnancies of mothers infected with the virus during the first trimester, based on data from the U.S. Zika Pregnancy Registry. The findings were published online in JAMA.

Aunt_Spray/Thinkstock
“These findings support the importance of screening pregnant women for Zika virus exposure,” Margaret A. Honein, PhD, of the Centers for Disease Control and Prevention in Atlanta, and her colleagues wrote.

The researchers reviewed data from completed pregnancies in the continental U.S. and Hawaii from Jan. 15, 2016, to Sept. 22, 2016. The data were collected from state and local health departments through the U.S. Zika Pregnancy Registry.

Birth defects were reported in 26 cases; 16 of 271 asymptomatic women and 10 of 167 symptomatic women (approximately 6% of each group). The most common birth defects potentially associated with Zika were microcephaly and brain abnormalities (14 cases), 4 brain abnormalities without microcephaly, and 4 cases of microcephaly and no reported neuroimaging. Overall, microcephaly was present in 4% of completed pregnancies.

Other potentially Zika-related complications included intracranial calcifications, corpus callosum abnormalities, abnormal cortical formation, cerebral atrophy, ventriculomegaly, hydrocephaly, and cerebellar abnormalities, the researchers wrote.

The women ranged in age from 15 to 50 years, and the population included 395 live births (21 infants with birth defects) and 47 pregnancy losses (5 fetuses with birth defects).

“No birth defects were reported among the pregnancies with maternal symptoms or exposure only in the second trimester or third trimester,” the researchers noted, “but there are insufficient data to adequately estimate the proportion affected during these trimesters,” they wrote.

Long-term monitoring of infants with possible congenital Zika virus is essential, the researchers wrote, as some normocephalic infants develop adverse effects of the virus not present at birth.

“In addition, future observations can elucidate the possible role of Zika virus infection in other outcomes, including spontaneous abortions and stillbirths as well as other structural birth defects that are not currently part of the inclusion criteria for Zika-associated birth defects surveillance,” they noted.

The researchers reported having no financial disclosures.

 

Birth defects associated with the Zika virus occurred in 11% of completed pregnancies of mothers infected with the virus during the first trimester, based on data from the U.S. Zika Pregnancy Registry. The findings were published online in JAMA.

Aunt_Spray/Thinkstock
“These findings support the importance of screening pregnant women for Zika virus exposure,” Margaret A. Honein, PhD, of the Centers for Disease Control and Prevention in Atlanta, and her colleagues wrote.

The researchers reviewed data from completed pregnancies in the continental U.S. and Hawaii from Jan. 15, 2016, to Sept. 22, 2016. The data were collected from state and local health departments through the U.S. Zika Pregnancy Registry.

Birth defects were reported in 26 cases; 16 of 271 asymptomatic women and 10 of 167 symptomatic women (approximately 6% of each group). The most common birth defects potentially associated with Zika were microcephaly and brain abnormalities (14 cases), 4 brain abnormalities without microcephaly, and 4 cases of microcephaly and no reported neuroimaging. Overall, microcephaly was present in 4% of completed pregnancies.

Other potentially Zika-related complications included intracranial calcifications, corpus callosum abnormalities, abnormal cortical formation, cerebral atrophy, ventriculomegaly, hydrocephaly, and cerebellar abnormalities, the researchers wrote.

The women ranged in age from 15 to 50 years, and the population included 395 live births (21 infants with birth defects) and 47 pregnancy losses (5 fetuses with birth defects).

“No birth defects were reported among the pregnancies with maternal symptoms or exposure only in the second trimester or third trimester,” the researchers noted, “but there are insufficient data to adequately estimate the proportion affected during these trimesters,” they wrote.

Long-term monitoring of infants with possible congenital Zika virus is essential, the researchers wrote, as some normocephalic infants develop adverse effects of the virus not present at birth.

“In addition, future observations can elucidate the possible role of Zika virus infection in other outcomes, including spontaneous abortions and stillbirths as well as other structural birth defects that are not currently part of the inclusion criteria for Zika-associated birth defects surveillance,” they noted.

The researchers reported having no financial disclosures.

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Key clinical point: Early screening is important to identify Zika virus in pregnant women.

Major finding: Approximately 6% of fetuses or infants of women with possible Zika virus infections at any point during pregnancy showed signs of Zika-related birth defects, but the number increased to 11% among women with Zika infections during the first trimester.

Data source: A review of data from 442 completed pregnancies collected via the U.S. Zika Pregnancy Registry.

Disclosures: The researchers reported having no financial disclosures.