VIDEO: TNF inhibitors don’t boost cancer risk in JIA

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– Tumor necrosis factor inhibitors don’t appear to confer any additional cancer risk upon children with juvenile idiopathic arthritis above the increased incidence of cancer that comes hand in hand with the disease itself.

In 2009, the drugs came under suspicion of boosting the already-known increased cancer risk in these patients, Timothy G. Beukelman, MD, said at the annual meeting of the American College of Rheumatology. But the large database review that he conducted with his colleagues doesn’t validate those fears.

“I feel fairly confident now that I can stand in front of parents and say that we can treat their child effectively without putting that child at an even higher risk of a malignancy,” he said in a video interview.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

Thomas J.A. Lehman, MD, chief of pediatric rheumatology at the Hospital for Special Surgery, New York, and professor of clinical pediatrics at Weill Cornell Medical College in New York, agreed.

“This study again indicates that anti-TNF therapy does not increase the risk of cancer for children with arthritis,” he said in an interview. “Although children with rheumatic diseases have a small increased background risk of malignancies, this is independent of the use of anti-TNF therapies. For physicians who have cared for children in the era when we did not have anti-TNF therapies available, it is clear that any minor risks associated with these medications are far outweighed by their dramatic benefits.”

In the last few years, five large studies have found that children with juvenile idiopathic arthritis (JIA) have a two- to sixfold increased malignancy risk, compared with the general pediatric population. However, only two of those studies included children taking TNF inhibitors, who comprised just 2% and 9% of those study populations.

In 2009, based on voluntary adverse event reporting, the Food and Drug Administration issued a black box warning on TNF inhibitors, citing a possibly increased risk of cancer in children and adolescents who received the drugs for JIA, inflammatory bowel diseases, and other inflammatory diseases.

Shortly thereafter, a report identified a fivefold increase in the risk of childhood lymphoma associated with the medications (Arthritis Rheum. 2010 Aug;62[8]:2517-24). Other studies have not borne this out, but the boxed warning stands.

To further explore the association, Dr. Beukelman of the University of Alabama, Birmingham, and his associates examined billing data from two large national billing databases: the National U.S. Truven MarketScan claims database and Medicaid billing records. Together, the databases contained information on 27,000 children with JIA who received a prescription for a TNF inhibitor any time during 2000-2014. Cancer rates in this population were compared with those seen in a cohort of 2.64 million children with attention-deficit/hyperactivity disorder who were included in the national Surveillance, Epidemiology, and End Results (SEER) database. The investigators chose individuals with ADHD as a control group because of ADHD’s chronicity and lack of any association with cancer risk.

Dr. Beukelman also performed a within-group analysis on the JIA patients, comparing cancer rates among those treated with a TNF inhibitor and with methotrexate. The mean follow-up for patients who took TNF inhibitors was 4 years (median of 1.4 years), but there were a full 14 years of data for some patients.

Among the controls, with more than 4 million person-years of follow-up, there were 727 cases of any malignancy – a standardized incident rate (SIR) of 1.03. Among all children with JIA, with more than 52,000 person-years of follow-up, there were 20 malignancies. The SEER database predicted eight among a sex- and age-matched cohort of healthy children. This translated to an SIR of 2.4. This represents the baseline increased risk of cancer conferred by JIA alone.

Nine malignancies occurred in the subgroup of children with JIA who took no medications. The SEER expectation among this group was 3.8 cancers, also translating to an SIR of 2.4

One malignancy occurred in the group treated with methotrexate only. Among these children, the SEER expected number was 1.9; the SIR in this group was 0.53.

Seven malignancies occurred among children who took TNF inhibitors, translating to an SIR of 2.9. Six occurred in children who took a TNF inhibitor in combination with or without methotrexate – an SIR of 3.0.

A final group consisted of children who took a wide range of other medications used in JIA (abatacept, anakinra, canakinumab, rilonacept, rituximab, tocilizumab, ustekinumab, tofacitinib, azathioprine, cyclosporine, gold, leflunomide, mycophenolate mofetil, tacrolimus, thalidomide, lenalidomide). This group also included patients who may or may not have taken methotrexate or a TNF inhibitor. Among these, there were four cancers when the SEER expected number was 0.7. This translated to an SIR of almost 6 – a surprising finding, Dr. Beukelman said. But since there were only four cancers and the group was exposed to so many different medications, it’s tough to know what that means, if anything, Dr. Beukelman said.

“There’s a lot to unpack here. The treatment paradigm for JIA is methotrexate followed by a TNF inhibitor if that’s ineffective. So these kids were on all of these more uncommon drugs,” suggesting that neither TNF inhibition nor methotrexate worked. “Some of these patients might actually have had systemic arthritis, Still’s disease, which is a completely separate thing, and we don’t know anything about the risk of malignancy in that. They might have an even higher rate of malignancies at baseline due to having worse disease, or uncontrolled inflammation. It is concerning, but I think it probably speaks to the fact that these patients are difficult to treat and probably at higher risk.”

Dr. Beukelman didn’t specifically break out the types and numbers of cancer, except to say that 3 of the 20 were lymphomas. The rest were leukemias and brain cancers – a finding that reflects the general pattern of childhood malignancies.

“Unfortunately, the most common childhood cancers are lymphomas, leukemias, and brain cancers, and that is what we saw in this study as well,” he said.

The study was supported by the U.S. Agency for Healthcare Research and Quality. Dr. Beukelman noted that he has received consulting fees from Novartis, Genetech/Roche, and UCB.

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– Tumor necrosis factor inhibitors don’t appear to confer any additional cancer risk upon children with juvenile idiopathic arthritis above the increased incidence of cancer that comes hand in hand with the disease itself.

In 2009, the drugs came under suspicion of boosting the already-known increased cancer risk in these patients, Timothy G. Beukelman, MD, said at the annual meeting of the American College of Rheumatology. But the large database review that he conducted with his colleagues doesn’t validate those fears.

“I feel fairly confident now that I can stand in front of parents and say that we can treat their child effectively without putting that child at an even higher risk of a malignancy,” he said in a video interview.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

Thomas J.A. Lehman, MD, chief of pediatric rheumatology at the Hospital for Special Surgery, New York, and professor of clinical pediatrics at Weill Cornell Medical College in New York, agreed.

“This study again indicates that anti-TNF therapy does not increase the risk of cancer for children with arthritis,” he said in an interview. “Although children with rheumatic diseases have a small increased background risk of malignancies, this is independent of the use of anti-TNF therapies. For physicians who have cared for children in the era when we did not have anti-TNF therapies available, it is clear that any minor risks associated with these medications are far outweighed by their dramatic benefits.”

In the last few years, five large studies have found that children with juvenile idiopathic arthritis (JIA) have a two- to sixfold increased malignancy risk, compared with the general pediatric population. However, only two of those studies included children taking TNF inhibitors, who comprised just 2% and 9% of those study populations.

In 2009, based on voluntary adverse event reporting, the Food and Drug Administration issued a black box warning on TNF inhibitors, citing a possibly increased risk of cancer in children and adolescents who received the drugs for JIA, inflammatory bowel diseases, and other inflammatory diseases.

Shortly thereafter, a report identified a fivefold increase in the risk of childhood lymphoma associated with the medications (Arthritis Rheum. 2010 Aug;62[8]:2517-24). Other studies have not borne this out, but the boxed warning stands.

To further explore the association, Dr. Beukelman of the University of Alabama, Birmingham, and his associates examined billing data from two large national billing databases: the National U.S. Truven MarketScan claims database and Medicaid billing records. Together, the databases contained information on 27,000 children with JIA who received a prescription for a TNF inhibitor any time during 2000-2014. Cancer rates in this population were compared with those seen in a cohort of 2.64 million children with attention-deficit/hyperactivity disorder who were included in the national Surveillance, Epidemiology, and End Results (SEER) database. The investigators chose individuals with ADHD as a control group because of ADHD’s chronicity and lack of any association with cancer risk.

Dr. Beukelman also performed a within-group analysis on the JIA patients, comparing cancer rates among those treated with a TNF inhibitor and with methotrexate. The mean follow-up for patients who took TNF inhibitors was 4 years (median of 1.4 years), but there were a full 14 years of data for some patients.

Among the controls, with more than 4 million person-years of follow-up, there were 727 cases of any malignancy – a standardized incident rate (SIR) of 1.03. Among all children with JIA, with more than 52,000 person-years of follow-up, there were 20 malignancies. The SEER database predicted eight among a sex- and age-matched cohort of healthy children. This translated to an SIR of 2.4. This represents the baseline increased risk of cancer conferred by JIA alone.

Nine malignancies occurred in the subgroup of children with JIA who took no medications. The SEER expectation among this group was 3.8 cancers, also translating to an SIR of 2.4

One malignancy occurred in the group treated with methotrexate only. Among these children, the SEER expected number was 1.9; the SIR in this group was 0.53.

Seven malignancies occurred among children who took TNF inhibitors, translating to an SIR of 2.9. Six occurred in children who took a TNF inhibitor in combination with or without methotrexate – an SIR of 3.0.

A final group consisted of children who took a wide range of other medications used in JIA (abatacept, anakinra, canakinumab, rilonacept, rituximab, tocilizumab, ustekinumab, tofacitinib, azathioprine, cyclosporine, gold, leflunomide, mycophenolate mofetil, tacrolimus, thalidomide, lenalidomide). This group also included patients who may or may not have taken methotrexate or a TNF inhibitor. Among these, there were four cancers when the SEER expected number was 0.7. This translated to an SIR of almost 6 – a surprising finding, Dr. Beukelman said. But since there were only four cancers and the group was exposed to so many different medications, it’s tough to know what that means, if anything, Dr. Beukelman said.

“There’s a lot to unpack here. The treatment paradigm for JIA is methotrexate followed by a TNF inhibitor if that’s ineffective. So these kids were on all of these more uncommon drugs,” suggesting that neither TNF inhibition nor methotrexate worked. “Some of these patients might actually have had systemic arthritis, Still’s disease, which is a completely separate thing, and we don’t know anything about the risk of malignancy in that. They might have an even higher rate of malignancies at baseline due to having worse disease, or uncontrolled inflammation. It is concerning, but I think it probably speaks to the fact that these patients are difficult to treat and probably at higher risk.”

Dr. Beukelman didn’t specifically break out the types and numbers of cancer, except to say that 3 of the 20 were lymphomas. The rest were leukemias and brain cancers – a finding that reflects the general pattern of childhood malignancies.

“Unfortunately, the most common childhood cancers are lymphomas, leukemias, and brain cancers, and that is what we saw in this study as well,” he said.

The study was supported by the U.S. Agency for Healthcare Research and Quality. Dr. Beukelman noted that he has received consulting fees from Novartis, Genetech/Roche, and UCB.

[email protected]
On Twitter @alz_gal

– Tumor necrosis factor inhibitors don’t appear to confer any additional cancer risk upon children with juvenile idiopathic arthritis above the increased incidence of cancer that comes hand in hand with the disease itself.

In 2009, the drugs came under suspicion of boosting the already-known increased cancer risk in these patients, Timothy G. Beukelman, MD, said at the annual meeting of the American College of Rheumatology. But the large database review that he conducted with his colleagues doesn’t validate those fears.

“I feel fairly confident now that I can stand in front of parents and say that we can treat their child effectively without putting that child at an even higher risk of a malignancy,” he said in a video interview.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

Thomas J.A. Lehman, MD, chief of pediatric rheumatology at the Hospital for Special Surgery, New York, and professor of clinical pediatrics at Weill Cornell Medical College in New York, agreed.

“This study again indicates that anti-TNF therapy does not increase the risk of cancer for children with arthritis,” he said in an interview. “Although children with rheumatic diseases have a small increased background risk of malignancies, this is independent of the use of anti-TNF therapies. For physicians who have cared for children in the era when we did not have anti-TNF therapies available, it is clear that any minor risks associated with these medications are far outweighed by their dramatic benefits.”

In the last few years, five large studies have found that children with juvenile idiopathic arthritis (JIA) have a two- to sixfold increased malignancy risk, compared with the general pediatric population. However, only two of those studies included children taking TNF inhibitors, who comprised just 2% and 9% of those study populations.

In 2009, based on voluntary adverse event reporting, the Food and Drug Administration issued a black box warning on TNF inhibitors, citing a possibly increased risk of cancer in children and adolescents who received the drugs for JIA, inflammatory bowel diseases, and other inflammatory diseases.

Shortly thereafter, a report identified a fivefold increase in the risk of childhood lymphoma associated with the medications (Arthritis Rheum. 2010 Aug;62[8]:2517-24). Other studies have not borne this out, but the boxed warning stands.

To further explore the association, Dr. Beukelman of the University of Alabama, Birmingham, and his associates examined billing data from two large national billing databases: the National U.S. Truven MarketScan claims database and Medicaid billing records. Together, the databases contained information on 27,000 children with JIA who received a prescription for a TNF inhibitor any time during 2000-2014. Cancer rates in this population were compared with those seen in a cohort of 2.64 million children with attention-deficit/hyperactivity disorder who were included in the national Surveillance, Epidemiology, and End Results (SEER) database. The investigators chose individuals with ADHD as a control group because of ADHD’s chronicity and lack of any association with cancer risk.

Dr. Beukelman also performed a within-group analysis on the JIA patients, comparing cancer rates among those treated with a TNF inhibitor and with methotrexate. The mean follow-up for patients who took TNF inhibitors was 4 years (median of 1.4 years), but there were a full 14 years of data for some patients.

Among the controls, with more than 4 million person-years of follow-up, there were 727 cases of any malignancy – a standardized incident rate (SIR) of 1.03. Among all children with JIA, with more than 52,000 person-years of follow-up, there were 20 malignancies. The SEER database predicted eight among a sex- and age-matched cohort of healthy children. This translated to an SIR of 2.4. This represents the baseline increased risk of cancer conferred by JIA alone.

Nine malignancies occurred in the subgroup of children with JIA who took no medications. The SEER expectation among this group was 3.8 cancers, also translating to an SIR of 2.4

One malignancy occurred in the group treated with methotrexate only. Among these children, the SEER expected number was 1.9; the SIR in this group was 0.53.

Seven malignancies occurred among children who took TNF inhibitors, translating to an SIR of 2.9. Six occurred in children who took a TNF inhibitor in combination with or without methotrexate – an SIR of 3.0.

A final group consisted of children who took a wide range of other medications used in JIA (abatacept, anakinra, canakinumab, rilonacept, rituximab, tocilizumab, ustekinumab, tofacitinib, azathioprine, cyclosporine, gold, leflunomide, mycophenolate mofetil, tacrolimus, thalidomide, lenalidomide). This group also included patients who may or may not have taken methotrexate or a TNF inhibitor. Among these, there were four cancers when the SEER expected number was 0.7. This translated to an SIR of almost 6 – a surprising finding, Dr. Beukelman said. But since there were only four cancers and the group was exposed to so many different medications, it’s tough to know what that means, if anything, Dr. Beukelman said.

“There’s a lot to unpack here. The treatment paradigm for JIA is methotrexate followed by a TNF inhibitor if that’s ineffective. So these kids were on all of these more uncommon drugs,” suggesting that neither TNF inhibition nor methotrexate worked. “Some of these patients might actually have had systemic arthritis, Still’s disease, which is a completely separate thing, and we don’t know anything about the risk of malignancy in that. They might have an even higher rate of malignancies at baseline due to having worse disease, or uncontrolled inflammation. It is concerning, but I think it probably speaks to the fact that these patients are difficult to treat and probably at higher risk.”

Dr. Beukelman didn’t specifically break out the types and numbers of cancer, except to say that 3 of the 20 were lymphomas. The rest were leukemias and brain cancers – a finding that reflects the general pattern of childhood malignancies.

“Unfortunately, the most common childhood cancers are lymphomas, leukemias, and brain cancers, and that is what we saw in this study as well,” he said.

The study was supported by the U.S. Agency for Healthcare Research and Quality. Dr. Beukelman noted that he has received consulting fees from Novartis, Genetech/Roche, and UCB.

[email protected]
On Twitter @alz_gal
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Key clinical point: TNF inhibitors didn’t raise the cancer risk in children with juvenile idiopathic arthritis above the disease-associated elevation.

Major finding: Children with JIA were about twice as likely to get cancer as the general population, regardless of whether they took a TNF inhibitor.

Data source: A database review comprising 27,000 patients and 2.5 million controls.

Disclosures: The study was supported by the U.S. Agency for Healthcare Research and Quality. Dr. Beukelman noted that he has received consulting fees from Novartis, Genetech/Roche, and UCB.

Surgical Simulation in Orthopedic Surgery Residency

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Surgical Simulation in Orthopedic Surgery Residency

The training model for orthopedic resident education has been transformed. Surgeon factors, patient expectations, financial and legal concerns, associated costs, and work hour restrictions have put pressure on resident autonomy in the operating room.1,2 At the end of resident training, the expectation is that board-eligible surgeons will have the surgical skills necessary to perform a wide range of surgical procedures.3,4 Helping residents become proficient for independent practice requires a multidisciplinary approach.5 This approach, regardless of its details, requires investment in time, resources, expertise, and funding.

Many residency programs are trying to bridge the gap between observation and autonomy with surgical simulation. According to one study, 76% of residency programs have a surgical skills laboratory, and 46% have a structured surgical skills curriculum.6Surgical skills preparation is available in different modalities. Synthetic bones, virtual reality, and arthroscopic simulators represent potential opportunities for practice. Through these modalities, residents become more comfortable with the tools used in orthopedic procedures. Cadaveric dissection allows them to practice surgical approaches in the setting of real anatomy.1 Independent dissection helps them appreciate the planes, layers, and proximity of crucial body structures and understand important surgical anatomy.4Surgical simulation can be expensive, and funding comes in many forms. Cadaver laboratories require investment in specimens, facilities, and time away from clinical obligations.4 Cadaver availability varies with regional resources, and the cost of a cadaver ranges from $1000 to $2000.7,8 Arthroscopic simulators and virtual reality programs are expensive as well. These modalities range from a less expensive video box (with standard arthroscopic equipment) to a virtual reality haptic simulation costing a residency program as much as $80,000.9 Synthetic bone simulations are less expensive but require investment in faculty time and outside implants and instrumentation.10 The cost of simulation raises the question of funding sources.

Funding surgical simulation is a challenge. In a national survey of program directors, conducted by Karam and colleagues,6 87.3% of residencies cited lack of funding as the most significant barrier to a formal surgical skills program. Simulation can be residency-sponsored, industry-sponsored, or specialty-sponsored. Karam and colleagues6 found that department, hospital, and industry funding were the 3 main sponsors of surgical simulation. Each funding mechanism brings its own set of challenges and opportunities. Industry-sponsored simulation provides a cost-effective outlet for residency programs. However, this type of funding is under scrutiny, as industry funding for education becomes more transparent. In addition, industry funding typically limits the technology that can be used during the simulation to the sponsor’s technology. Courses offered by the American Academy of Orthopaedic Surgeons (AAOS) and a number of subspecialty societies provide less conflicted simulation at reasonable cost.

If residents, residency programs, hospitals, industry, subspecialty societies, and the AAOS are going to invest in resident education through simulation, then the effect of simulation on resident education must be understood. Intuitively, simulation as a modality for improving resident skills makes sense. For residency programs to invest in simulation and surgical skills, different modalities must be objectively evaluated and their utility validated. If simulation is to become valuable, first it must be done correctly.

Kneebone11 proposed a framework for evaluating simulation. In this framework, simulation should allow for sustained, deliberate practice in a safe environment. It should provide access to expert tutors when appropriate. It should map onto real-life clinical experience. Last, it should provide a supportive, motivational, learner-centered milieu. Residents and program directors should consider this framework when deciding which simulation exercises to engage in and which resources to supply for exercises. Having supportive supervision during simulation can lead to a positive outcome. Likewise, learning incorrect techniques or bad habits or having inexperienced teachers can have the opposite effect.

Several authors have reviewed the evidence and found simulation to be an important part of orthopedic resident education.1,2,4,9,12,13 They have evaluated cadaveric simulation, synthetic bone simulation, arthroscopic simulation, and virtual reality simulation. Their studies demonstrated that simulation is an effective tool and provided objective criteria for evaluating residents on a larger scale. In a blinded, randomized study by Howells and colleagues,14 junior residents were either trained on a knee simulator or received no training before evaluation. Those who received the training scored significantly better than their peers on validated assessment measures.

The literature on different modalities shows simulation is an effective teaching tool for general orthopedic surgical skills5; knee, shoulder, and ankle arthroscopy14-21; spine surgery22; and orthopedic trauma surgery.23-26 Investigators in several other surgical specialties have studied the utility of simulation, and many are incorporating simulation into their resident curricula.

More effective simulation seems correlated with a yearlong structured curriculum rather than with intermittent, isolated experiences.3 Dunn and colleagues27 evaluated arthroscopic shoulder simulation 1 year after a training exercise. The group that received formal training did better than the control group on an initial arthroscopic surgery skill evaluation tool. At 1 year, however, the gains made through training were lost.

Simulation is a new paradigm for resident education. It offers multiple opportunities and challenges for residents, residency programs, industry partners, specialty and subspecialty societies, and medical examiners. The Accreditation Council for Graduate Medical Education’s ACGME Program Requirements for Graduate Medical Education in Orthopaedic Surgery requires of residency programs a didactic curriculum dedicated to basic motor skills in addition to a dedicated space for facilitating basic surgical skills training.28 Residency programs must demonstrate to ACGME their commitment to surgical skills training and simulation. Implementation of simulation for resident education has many variables, including funding, type of simulation, demonstrated efficacy, provision of supervision, resident time, and establishment of a formal curriculum. Residents and residency programs should embrace this changing paradigm to bridge the gap between observation and autonomy in orthopedic surgical and arthroscopic technique.

Am J Orthop. 2016;45(7):E426-E428. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

References

1. Atesok K, Mabrey JD, Jazrawi LM, Egol KA. Surgical simulation in orthopaedic skills training. J Am Acad Orthop Surg. 2012;20(7):410-422.

2. Thomas GW, Johns BD, Marsh JL, Anderson DD. A review of the role of simulation in developing and assessing orthopaedic surgical skills. Iowa Orthop J. 2014;34:181-189.

3. Reznick RK, MacRae H. Teaching surgical skills—changes in the wind. N Engl J Med. 2006;355(25):2664-2669.

4. Holland JP, Waugh L, Horgan A, Paleri V, Deehan DJ. Cadaveric hands-on training for surgical specialties: is this back to the future for surgical skills development? J Surg Educ. 2011;68(2):110-116.

5. Sonnadara RR, Van Vliet A, Safir O, et al. Orthopedic boot camp: examining the effectiveness of an intensive surgical skills course. Surgery. 2011;149(6):745-749.

6. Karam MD, Pedowitz RA, Natividad H, Murray J, Marsh JL. Current and future use of surgical skills training laboratories in orthopaedic resident education: a national survey. J Bone Joint Surg Am. 2013;95(1):e4.

7. Bushey C. Cadaver supply: the last industry to face big changes. Crain’s Chicago Business. February 23, 2013.

8. Human K. Cadaver shortage hits medical schools. Denver Post. April 29, 2008.

9. Michelson JD. Simulation in orthopaedic education: an overview of theory and practice. J Bone Joint Surg Am. 2006;88(6):1405-1411.

10. Elfar J, Menorca RM, Reed JD, Stanbury S. Composite bone models in orthopaedic surgery research and education. J Am Acad Orthop Surg. 2014;22(2):111-120.

11. Kneebone R. Evaluating clinical simulations for learning procedural skills: a theory-based approach. Acad Med. 2005;80(6):549-553.

12. Stirling ER, Lewis TL, Ferran NA. Surgical skills simulation in trauma and orthopaedic training. J Orthop Surg Res. 2014;9:126.

13. Mabrey JD, Reinig KD, Cannon WD. Virtual reality in orthopaedics: is it a reality? Clin Orthop Relat Res. 2010;468(10):2586-2591.

14. Howells NR, Gill HS, Carr AJ, Price AJ, Rees JL. Transferring simulated arthroscopic skills to the operating theatre: a randomised blinded study. J Bone Joint Surg Br. 2008;90(4):494-499.

15. Gomoll AH, O’Toole RV, Czarnecki J, Warner JJ. Surgical experience correlates with performance on a virtual reality simulator for shoulder arthroscopy. Am J Sports Med. 2007;35(6):883-888.

16. Gomoll AH, Pappas G, Forsythe B, Warner JJ. Individual skill progression on a virtual reality simulator for shoulder arthroscopy: a 3-year follow-up study. Am J Sports Med. 2008;36(6):1139-1142.

17. Pedowitz RA, Esch J, Snyder S. Evaluation of a virtual reality simulator for arthroscopy skills development. Arthroscopy. 2002;18(6):E29.

18. Martin KD, Belmont PJ, Schoenfeld AJ, Todd M, Cameron KL, Owens BD. Arthroscopic basic task performance in shoulder simulator model correlates with similar task performance in cadavers. J Bone Joint Surg Am. 2011;93(21):e1271-e1275.

19. Martin KD, Cameron K, Belmont PJ, Schoenfeld A, Owens BD. Shoulder arthroscopy simulator performance correlates with resident and shoulder arthroscopy experience. J Bone Joint Surg Am. 2012;94(21):e160.

20. Martin KD, Patterson D, Phisitkul P, Cameron KL, Femino J, Amendola A. Ankle arthroscopy simulation improves basic skills, anatomic recognition, and proficiency during diagnostic examination of residents in training. Foot Ankle Int. 2015;36(7):827-835.

21. Frank RM, Erickson B, Frank JM, et al. Utility of modern arthroscopic simulator training models. Arthroscopy. 2014;30(1):121-133.

22. Rambani R, Ward J, Viant W. Desktop-based computer-assisted orthopedic training system for spinal surgery. J Surg Educ. 2014;71(6):805-809.

23. Leong JJ, Leff DR, Das A, et al. Validation of orthopaedic bench models for trauma surgery. J Bone Joint Surg Br. 2008;90(7):958-965.

24. Rambani R, Viant W, Ward J, Mohsen A. Computer-assisted orthopedic training system for fracture fixation. J Surg Educ. 2013;70(3):304-308.

25. Blyth P, Stott NS, Anderson IA. A simulation-based training system for hip fracture fixation for use within the hospital environment. Injury. 2007;38(10):1197-1203.

26. Egol KA, Phillips D, Vongbandith T, Szyld D, Strauss EJ. Do orthopaedic fracture skills courses improve resident performance? Injury. 2015;46(4):547-551.

27. Dunn JC, Belmont PJ, Lanzi J, et al. Arthroscopic shoulder surgical simulation training curriculum: transfer reliability and maintenance of skill over time. J Surg Educ. 2015;72(6):1118-1123.

28. Accreditation Council for Graduate Medical Education. ACGME Program Requirements for Graduate Medical Education in Orthopaedic Surgery. https://www.acgme.org/Portals/0/PFAssets/ProgramRequirements/260_orthopaedic_surgery_2016.pdf. Published July 1, 2012. Accessed September 30, 2016.

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The training model for orthopedic resident education has been transformed. Surgeon factors, patient expectations, financial and legal concerns, associated costs, and work hour restrictions have put pressure on resident autonomy in the operating room.1,2 At the end of resident training, the expectation is that board-eligible surgeons will have the surgical skills necessary to perform a wide range of surgical procedures.3,4 Helping residents become proficient for independent practice requires a multidisciplinary approach.5 This approach, regardless of its details, requires investment in time, resources, expertise, and funding.

Many residency programs are trying to bridge the gap between observation and autonomy with surgical simulation. According to one study, 76% of residency programs have a surgical skills laboratory, and 46% have a structured surgical skills curriculum.6Surgical skills preparation is available in different modalities. Synthetic bones, virtual reality, and arthroscopic simulators represent potential opportunities for practice. Through these modalities, residents become more comfortable with the tools used in orthopedic procedures. Cadaveric dissection allows them to practice surgical approaches in the setting of real anatomy.1 Independent dissection helps them appreciate the planes, layers, and proximity of crucial body structures and understand important surgical anatomy.4Surgical simulation can be expensive, and funding comes in many forms. Cadaver laboratories require investment in specimens, facilities, and time away from clinical obligations.4 Cadaver availability varies with regional resources, and the cost of a cadaver ranges from $1000 to $2000.7,8 Arthroscopic simulators and virtual reality programs are expensive as well. These modalities range from a less expensive video box (with standard arthroscopic equipment) to a virtual reality haptic simulation costing a residency program as much as $80,000.9 Synthetic bone simulations are less expensive but require investment in faculty time and outside implants and instrumentation.10 The cost of simulation raises the question of funding sources.

Funding surgical simulation is a challenge. In a national survey of program directors, conducted by Karam and colleagues,6 87.3% of residencies cited lack of funding as the most significant barrier to a formal surgical skills program. Simulation can be residency-sponsored, industry-sponsored, or specialty-sponsored. Karam and colleagues6 found that department, hospital, and industry funding were the 3 main sponsors of surgical simulation. Each funding mechanism brings its own set of challenges and opportunities. Industry-sponsored simulation provides a cost-effective outlet for residency programs. However, this type of funding is under scrutiny, as industry funding for education becomes more transparent. In addition, industry funding typically limits the technology that can be used during the simulation to the sponsor’s technology. Courses offered by the American Academy of Orthopaedic Surgeons (AAOS) and a number of subspecialty societies provide less conflicted simulation at reasonable cost.

If residents, residency programs, hospitals, industry, subspecialty societies, and the AAOS are going to invest in resident education through simulation, then the effect of simulation on resident education must be understood. Intuitively, simulation as a modality for improving resident skills makes sense. For residency programs to invest in simulation and surgical skills, different modalities must be objectively evaluated and their utility validated. If simulation is to become valuable, first it must be done correctly.

Kneebone11 proposed a framework for evaluating simulation. In this framework, simulation should allow for sustained, deliberate practice in a safe environment. It should provide access to expert tutors when appropriate. It should map onto real-life clinical experience. Last, it should provide a supportive, motivational, learner-centered milieu. Residents and program directors should consider this framework when deciding which simulation exercises to engage in and which resources to supply for exercises. Having supportive supervision during simulation can lead to a positive outcome. Likewise, learning incorrect techniques or bad habits or having inexperienced teachers can have the opposite effect.

Several authors have reviewed the evidence and found simulation to be an important part of orthopedic resident education.1,2,4,9,12,13 They have evaluated cadaveric simulation, synthetic bone simulation, arthroscopic simulation, and virtual reality simulation. Their studies demonstrated that simulation is an effective tool and provided objective criteria for evaluating residents on a larger scale. In a blinded, randomized study by Howells and colleagues,14 junior residents were either trained on a knee simulator or received no training before evaluation. Those who received the training scored significantly better than their peers on validated assessment measures.

The literature on different modalities shows simulation is an effective teaching tool for general orthopedic surgical skills5; knee, shoulder, and ankle arthroscopy14-21; spine surgery22; and orthopedic trauma surgery.23-26 Investigators in several other surgical specialties have studied the utility of simulation, and many are incorporating simulation into their resident curricula.

More effective simulation seems correlated with a yearlong structured curriculum rather than with intermittent, isolated experiences.3 Dunn and colleagues27 evaluated arthroscopic shoulder simulation 1 year after a training exercise. The group that received formal training did better than the control group on an initial arthroscopic surgery skill evaluation tool. At 1 year, however, the gains made through training were lost.

Simulation is a new paradigm for resident education. It offers multiple opportunities and challenges for residents, residency programs, industry partners, specialty and subspecialty societies, and medical examiners. The Accreditation Council for Graduate Medical Education’s ACGME Program Requirements for Graduate Medical Education in Orthopaedic Surgery requires of residency programs a didactic curriculum dedicated to basic motor skills in addition to a dedicated space for facilitating basic surgical skills training.28 Residency programs must demonstrate to ACGME their commitment to surgical skills training and simulation. Implementation of simulation for resident education has many variables, including funding, type of simulation, demonstrated efficacy, provision of supervision, resident time, and establishment of a formal curriculum. Residents and residency programs should embrace this changing paradigm to bridge the gap between observation and autonomy in orthopedic surgical and arthroscopic technique.

Am J Orthop. 2016;45(7):E426-E428. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

The training model for orthopedic resident education has been transformed. Surgeon factors, patient expectations, financial and legal concerns, associated costs, and work hour restrictions have put pressure on resident autonomy in the operating room.1,2 At the end of resident training, the expectation is that board-eligible surgeons will have the surgical skills necessary to perform a wide range of surgical procedures.3,4 Helping residents become proficient for independent practice requires a multidisciplinary approach.5 This approach, regardless of its details, requires investment in time, resources, expertise, and funding.

Many residency programs are trying to bridge the gap between observation and autonomy with surgical simulation. According to one study, 76% of residency programs have a surgical skills laboratory, and 46% have a structured surgical skills curriculum.6Surgical skills preparation is available in different modalities. Synthetic bones, virtual reality, and arthroscopic simulators represent potential opportunities for practice. Through these modalities, residents become more comfortable with the tools used in orthopedic procedures. Cadaveric dissection allows them to practice surgical approaches in the setting of real anatomy.1 Independent dissection helps them appreciate the planes, layers, and proximity of crucial body structures and understand important surgical anatomy.4Surgical simulation can be expensive, and funding comes in many forms. Cadaver laboratories require investment in specimens, facilities, and time away from clinical obligations.4 Cadaver availability varies with regional resources, and the cost of a cadaver ranges from $1000 to $2000.7,8 Arthroscopic simulators and virtual reality programs are expensive as well. These modalities range from a less expensive video box (with standard arthroscopic equipment) to a virtual reality haptic simulation costing a residency program as much as $80,000.9 Synthetic bone simulations are less expensive but require investment in faculty time and outside implants and instrumentation.10 The cost of simulation raises the question of funding sources.

Funding surgical simulation is a challenge. In a national survey of program directors, conducted by Karam and colleagues,6 87.3% of residencies cited lack of funding as the most significant barrier to a formal surgical skills program. Simulation can be residency-sponsored, industry-sponsored, or specialty-sponsored. Karam and colleagues6 found that department, hospital, and industry funding were the 3 main sponsors of surgical simulation. Each funding mechanism brings its own set of challenges and opportunities. Industry-sponsored simulation provides a cost-effective outlet for residency programs. However, this type of funding is under scrutiny, as industry funding for education becomes more transparent. In addition, industry funding typically limits the technology that can be used during the simulation to the sponsor’s technology. Courses offered by the American Academy of Orthopaedic Surgeons (AAOS) and a number of subspecialty societies provide less conflicted simulation at reasonable cost.

If residents, residency programs, hospitals, industry, subspecialty societies, and the AAOS are going to invest in resident education through simulation, then the effect of simulation on resident education must be understood. Intuitively, simulation as a modality for improving resident skills makes sense. For residency programs to invest in simulation and surgical skills, different modalities must be objectively evaluated and their utility validated. If simulation is to become valuable, first it must be done correctly.

Kneebone11 proposed a framework for evaluating simulation. In this framework, simulation should allow for sustained, deliberate practice in a safe environment. It should provide access to expert tutors when appropriate. It should map onto real-life clinical experience. Last, it should provide a supportive, motivational, learner-centered milieu. Residents and program directors should consider this framework when deciding which simulation exercises to engage in and which resources to supply for exercises. Having supportive supervision during simulation can lead to a positive outcome. Likewise, learning incorrect techniques or bad habits or having inexperienced teachers can have the opposite effect.

Several authors have reviewed the evidence and found simulation to be an important part of orthopedic resident education.1,2,4,9,12,13 They have evaluated cadaveric simulation, synthetic bone simulation, arthroscopic simulation, and virtual reality simulation. Their studies demonstrated that simulation is an effective tool and provided objective criteria for evaluating residents on a larger scale. In a blinded, randomized study by Howells and colleagues,14 junior residents were either trained on a knee simulator or received no training before evaluation. Those who received the training scored significantly better than their peers on validated assessment measures.

The literature on different modalities shows simulation is an effective teaching tool for general orthopedic surgical skills5; knee, shoulder, and ankle arthroscopy14-21; spine surgery22; and orthopedic trauma surgery.23-26 Investigators in several other surgical specialties have studied the utility of simulation, and many are incorporating simulation into their resident curricula.

More effective simulation seems correlated with a yearlong structured curriculum rather than with intermittent, isolated experiences.3 Dunn and colleagues27 evaluated arthroscopic shoulder simulation 1 year after a training exercise. The group that received formal training did better than the control group on an initial arthroscopic surgery skill evaluation tool. At 1 year, however, the gains made through training were lost.

Simulation is a new paradigm for resident education. It offers multiple opportunities and challenges for residents, residency programs, industry partners, specialty and subspecialty societies, and medical examiners. The Accreditation Council for Graduate Medical Education’s ACGME Program Requirements for Graduate Medical Education in Orthopaedic Surgery requires of residency programs a didactic curriculum dedicated to basic motor skills in addition to a dedicated space for facilitating basic surgical skills training.28 Residency programs must demonstrate to ACGME their commitment to surgical skills training and simulation. Implementation of simulation for resident education has many variables, including funding, type of simulation, demonstrated efficacy, provision of supervision, resident time, and establishment of a formal curriculum. Residents and residency programs should embrace this changing paradigm to bridge the gap between observation and autonomy in orthopedic surgical and arthroscopic technique.

Am J Orthop. 2016;45(7):E426-E428. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

References

1. Atesok K, Mabrey JD, Jazrawi LM, Egol KA. Surgical simulation in orthopaedic skills training. J Am Acad Orthop Surg. 2012;20(7):410-422.

2. Thomas GW, Johns BD, Marsh JL, Anderson DD. A review of the role of simulation in developing and assessing orthopaedic surgical skills. Iowa Orthop J. 2014;34:181-189.

3. Reznick RK, MacRae H. Teaching surgical skills—changes in the wind. N Engl J Med. 2006;355(25):2664-2669.

4. Holland JP, Waugh L, Horgan A, Paleri V, Deehan DJ. Cadaveric hands-on training for surgical specialties: is this back to the future for surgical skills development? J Surg Educ. 2011;68(2):110-116.

5. Sonnadara RR, Van Vliet A, Safir O, et al. Orthopedic boot camp: examining the effectiveness of an intensive surgical skills course. Surgery. 2011;149(6):745-749.

6. Karam MD, Pedowitz RA, Natividad H, Murray J, Marsh JL. Current and future use of surgical skills training laboratories in orthopaedic resident education: a national survey. J Bone Joint Surg Am. 2013;95(1):e4.

7. Bushey C. Cadaver supply: the last industry to face big changes. Crain’s Chicago Business. February 23, 2013.

8. Human K. Cadaver shortage hits medical schools. Denver Post. April 29, 2008.

9. Michelson JD. Simulation in orthopaedic education: an overview of theory and practice. J Bone Joint Surg Am. 2006;88(6):1405-1411.

10. Elfar J, Menorca RM, Reed JD, Stanbury S. Composite bone models in orthopaedic surgery research and education. J Am Acad Orthop Surg. 2014;22(2):111-120.

11. Kneebone R. Evaluating clinical simulations for learning procedural skills: a theory-based approach. Acad Med. 2005;80(6):549-553.

12. Stirling ER, Lewis TL, Ferran NA. Surgical skills simulation in trauma and orthopaedic training. J Orthop Surg Res. 2014;9:126.

13. Mabrey JD, Reinig KD, Cannon WD. Virtual reality in orthopaedics: is it a reality? Clin Orthop Relat Res. 2010;468(10):2586-2591.

14. Howells NR, Gill HS, Carr AJ, Price AJ, Rees JL. Transferring simulated arthroscopic skills to the operating theatre: a randomised blinded study. J Bone Joint Surg Br. 2008;90(4):494-499.

15. Gomoll AH, O’Toole RV, Czarnecki J, Warner JJ. Surgical experience correlates with performance on a virtual reality simulator for shoulder arthroscopy. Am J Sports Med. 2007;35(6):883-888.

16. Gomoll AH, Pappas G, Forsythe B, Warner JJ. Individual skill progression on a virtual reality simulator for shoulder arthroscopy: a 3-year follow-up study. Am J Sports Med. 2008;36(6):1139-1142.

17. Pedowitz RA, Esch J, Snyder S. Evaluation of a virtual reality simulator for arthroscopy skills development. Arthroscopy. 2002;18(6):E29.

18. Martin KD, Belmont PJ, Schoenfeld AJ, Todd M, Cameron KL, Owens BD. Arthroscopic basic task performance in shoulder simulator model correlates with similar task performance in cadavers. J Bone Joint Surg Am. 2011;93(21):e1271-e1275.

19. Martin KD, Cameron K, Belmont PJ, Schoenfeld A, Owens BD. Shoulder arthroscopy simulator performance correlates with resident and shoulder arthroscopy experience. J Bone Joint Surg Am. 2012;94(21):e160.

20. Martin KD, Patterson D, Phisitkul P, Cameron KL, Femino J, Amendola A. Ankle arthroscopy simulation improves basic skills, anatomic recognition, and proficiency during diagnostic examination of residents in training. Foot Ankle Int. 2015;36(7):827-835.

21. Frank RM, Erickson B, Frank JM, et al. Utility of modern arthroscopic simulator training models. Arthroscopy. 2014;30(1):121-133.

22. Rambani R, Ward J, Viant W. Desktop-based computer-assisted orthopedic training system for spinal surgery. J Surg Educ. 2014;71(6):805-809.

23. Leong JJ, Leff DR, Das A, et al. Validation of orthopaedic bench models for trauma surgery. J Bone Joint Surg Br. 2008;90(7):958-965.

24. Rambani R, Viant W, Ward J, Mohsen A. Computer-assisted orthopedic training system for fracture fixation. J Surg Educ. 2013;70(3):304-308.

25. Blyth P, Stott NS, Anderson IA. A simulation-based training system for hip fracture fixation for use within the hospital environment. Injury. 2007;38(10):1197-1203.

26. Egol KA, Phillips D, Vongbandith T, Szyld D, Strauss EJ. Do orthopaedic fracture skills courses improve resident performance? Injury. 2015;46(4):547-551.

27. Dunn JC, Belmont PJ, Lanzi J, et al. Arthroscopic shoulder surgical simulation training curriculum: transfer reliability and maintenance of skill over time. J Surg Educ. 2015;72(6):1118-1123.

28. Accreditation Council for Graduate Medical Education. ACGME Program Requirements for Graduate Medical Education in Orthopaedic Surgery. https://www.acgme.org/Portals/0/PFAssets/ProgramRequirements/260_orthopaedic_surgery_2016.pdf. Published July 1, 2012. Accessed September 30, 2016.

References

1. Atesok K, Mabrey JD, Jazrawi LM, Egol KA. Surgical simulation in orthopaedic skills training. J Am Acad Orthop Surg. 2012;20(7):410-422.

2. Thomas GW, Johns BD, Marsh JL, Anderson DD. A review of the role of simulation in developing and assessing orthopaedic surgical skills. Iowa Orthop J. 2014;34:181-189.

3. Reznick RK, MacRae H. Teaching surgical skills—changes in the wind. N Engl J Med. 2006;355(25):2664-2669.

4. Holland JP, Waugh L, Horgan A, Paleri V, Deehan DJ. Cadaveric hands-on training for surgical specialties: is this back to the future for surgical skills development? J Surg Educ. 2011;68(2):110-116.

5. Sonnadara RR, Van Vliet A, Safir O, et al. Orthopedic boot camp: examining the effectiveness of an intensive surgical skills course. Surgery. 2011;149(6):745-749.

6. Karam MD, Pedowitz RA, Natividad H, Murray J, Marsh JL. Current and future use of surgical skills training laboratories in orthopaedic resident education: a national survey. J Bone Joint Surg Am. 2013;95(1):e4.

7. Bushey C. Cadaver supply: the last industry to face big changes. Crain’s Chicago Business. February 23, 2013.

8. Human K. Cadaver shortage hits medical schools. Denver Post. April 29, 2008.

9. Michelson JD. Simulation in orthopaedic education: an overview of theory and practice. J Bone Joint Surg Am. 2006;88(6):1405-1411.

10. Elfar J, Menorca RM, Reed JD, Stanbury S. Composite bone models in orthopaedic surgery research and education. J Am Acad Orthop Surg. 2014;22(2):111-120.

11. Kneebone R. Evaluating clinical simulations for learning procedural skills: a theory-based approach. Acad Med. 2005;80(6):549-553.

12. Stirling ER, Lewis TL, Ferran NA. Surgical skills simulation in trauma and orthopaedic training. J Orthop Surg Res. 2014;9:126.

13. Mabrey JD, Reinig KD, Cannon WD. Virtual reality in orthopaedics: is it a reality? Clin Orthop Relat Res. 2010;468(10):2586-2591.

14. Howells NR, Gill HS, Carr AJ, Price AJ, Rees JL. Transferring simulated arthroscopic skills to the operating theatre: a randomised blinded study. J Bone Joint Surg Br. 2008;90(4):494-499.

15. Gomoll AH, O’Toole RV, Czarnecki J, Warner JJ. Surgical experience correlates with performance on a virtual reality simulator for shoulder arthroscopy. Am J Sports Med. 2007;35(6):883-888.

16. Gomoll AH, Pappas G, Forsythe B, Warner JJ. Individual skill progression on a virtual reality simulator for shoulder arthroscopy: a 3-year follow-up study. Am J Sports Med. 2008;36(6):1139-1142.

17. Pedowitz RA, Esch J, Snyder S. Evaluation of a virtual reality simulator for arthroscopy skills development. Arthroscopy. 2002;18(6):E29.

18. Martin KD, Belmont PJ, Schoenfeld AJ, Todd M, Cameron KL, Owens BD. Arthroscopic basic task performance in shoulder simulator model correlates with similar task performance in cadavers. J Bone Joint Surg Am. 2011;93(21):e1271-e1275.

19. Martin KD, Cameron K, Belmont PJ, Schoenfeld A, Owens BD. Shoulder arthroscopy simulator performance correlates with resident and shoulder arthroscopy experience. J Bone Joint Surg Am. 2012;94(21):e160.

20. Martin KD, Patterson D, Phisitkul P, Cameron KL, Femino J, Amendola A. Ankle arthroscopy simulation improves basic skills, anatomic recognition, and proficiency during diagnostic examination of residents in training. Foot Ankle Int. 2015;36(7):827-835.

21. Frank RM, Erickson B, Frank JM, et al. Utility of modern arthroscopic simulator training models. Arthroscopy. 2014;30(1):121-133.

22. Rambani R, Ward J, Viant W. Desktop-based computer-assisted orthopedic training system for spinal surgery. J Surg Educ. 2014;71(6):805-809.

23. Leong JJ, Leff DR, Das A, et al. Validation of orthopaedic bench models for trauma surgery. J Bone Joint Surg Br. 2008;90(7):958-965.

24. Rambani R, Viant W, Ward J, Mohsen A. Computer-assisted orthopedic training system for fracture fixation. J Surg Educ. 2013;70(3):304-308.

25. Blyth P, Stott NS, Anderson IA. A simulation-based training system for hip fracture fixation for use within the hospital environment. Injury. 2007;38(10):1197-1203.

26. Egol KA, Phillips D, Vongbandith T, Szyld D, Strauss EJ. Do orthopaedic fracture skills courses improve resident performance? Injury. 2015;46(4):547-551.

27. Dunn JC, Belmont PJ, Lanzi J, et al. Arthroscopic shoulder surgical simulation training curriculum: transfer reliability and maintenance of skill over time. J Surg Educ. 2015;72(6):1118-1123.

28. Accreditation Council for Graduate Medical Education. ACGME Program Requirements for Graduate Medical Education in Orthopaedic Surgery. https://www.acgme.org/Portals/0/PFAssets/ProgramRequirements/260_orthopaedic_surgery_2016.pdf. Published July 1, 2012. Accessed September 30, 2016.

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Brian Harte, MD, SFHM, Discusses Path from Hospitalist to Transformational Healthcare Leader

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Brian Harte, MD, SFHM, Discusses Path from Hospitalist to Transformational Healthcare Leader

Brian Harte, MD, SFHM, longtime member of the Society of Hospital Medicine (SHM) and now president of its Board of Directors, was recently named president of Cleveland Clinic Akron General and the Southern Region. He previously served as president of Cleveland Clinic Hillcrest Hospital, the 500-bed flagship for the Cleveland Clinic Health System.

 

 

Dr. Harte

 

The Hospitalist spoke with Dr. Harte about SHM’s impact on his career and how he sees hospitalists’ roles growing in an evolving health system.

 

Question: In your speech at Hospital Medicine 2016 in San Diego, you referenced the critical need for hospitalists to explore opportunities to grow both personally and professionally, with SHM as a means of support. How has SHM been that support for you throughout your career from hospitalist to hospitalist leader?

 

Answer: Hospital medicine is a fantastic career because there are so many opportunities available to us. SHM supports our members in finding their own career paths in a number of ways. For example, Leadership Academy is a valuable resource to develop leadership skills from basic to advanced. More generally, SHM provides many role models and networking opportunities to allow others to learn from hospital medicine professionals and healthcare leaders and help them advance their careers.

 

Q: Tell us a bit about your expanded role at Cleveland Clinic Health System and how you can leverage SHM as a way to accomplish your goals in this new position.

 

A: I’ve been at Cleveland Clinic for 12 years, both as a hospitalist and in a number of leadership positions. After having served as president of Cleveland Clinic Hillcrest Hospital, I have a new role now as president of one of their newly acquired hospitals in Akron, Cleveland Clinic Akron General Hospital. Both are community hospitals within the Cleveland Clinic’s integrated healthcare network.

 

In my new role, I will be overseeing and facilitating the process of integration, and I’m really looking forward to it as a new challenge. I am particularly interested in how other health system and hospital executives who are hospitalists within SHM can help guide me and provide advice on how they have taken on challenges, built bridges, and overseen integration within other organizations.

 

Q: How does the career path of a hospitalist lend itself to leadership opportunities in a way that some other specialties may not?

 

A: Being a hospitalist lends itself to an almost limitless set of very interesting and rewarding career paths, both within and outside of pure clinical medicine. Hospitalists tend to have a very close relationship with administration, not just around clinical issues but around performance measurement and management. Because of this, we learn on the job about what leadership really consists of and that effective hospitalists are, by definition, effective leaders. What we do every day, functioning within and ultimately leading high-performing teams, epitomizes experiential leadership development.

 

SHM is positioned to help guide our members both in identifying their career paths and continuing to follow that path through events like Leadership Academy, Annual Meeting, and other networking opportunities that allow them to meet other hospitalists who have already walked down similar paths. We can help guide each other in terms of avoiding some of the pitfalls we have experienced but also by discovering opportunities and how to take advantage of them.

 

Q: Moving forward, how can hospitalists demonstrate the value that they add to the healthcare landscape both in practice and from a leadership perspective?

 

A: Since hospital medicine’s inception, hospitalists have had to show the value that they add to patient care, to hospitals, and to the healthcare system. As we move into an era of alternative payment models (APMs) and healthcare reform, the need to do that for all physicians will only be greater. Hospitalists are extremely well positioned to demonstrate value partly because we have been doing that all along in terms of improving patient care, quality outcomes, or performance measurements that the hospital is keeping track of.

 

 

 

We’re going to have to be stronger advocates for the value we provide to the healthcare system in terms of outcomes for patients as well as cost and efficiency. I know SHM will continue to help our members and the leaders within our membership develop the skills needed to do that.

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Brian Harte, MD, SFHM, longtime member of the Society of Hospital Medicine (SHM) and now president of its Board of Directors, was recently named president of Cleveland Clinic Akron General and the Southern Region. He previously served as president of Cleveland Clinic Hillcrest Hospital, the 500-bed flagship for the Cleveland Clinic Health System.

 

 

Dr. Harte

 

The Hospitalist spoke with Dr. Harte about SHM’s impact on his career and how he sees hospitalists’ roles growing in an evolving health system.

 

Question: In your speech at Hospital Medicine 2016 in San Diego, you referenced the critical need for hospitalists to explore opportunities to grow both personally and professionally, with SHM as a means of support. How has SHM been that support for you throughout your career from hospitalist to hospitalist leader?

 

Answer: Hospital medicine is a fantastic career because there are so many opportunities available to us. SHM supports our members in finding their own career paths in a number of ways. For example, Leadership Academy is a valuable resource to develop leadership skills from basic to advanced. More generally, SHM provides many role models and networking opportunities to allow others to learn from hospital medicine professionals and healthcare leaders and help them advance their careers.

 

Q: Tell us a bit about your expanded role at Cleveland Clinic Health System and how you can leverage SHM as a way to accomplish your goals in this new position.

 

A: I’ve been at Cleveland Clinic for 12 years, both as a hospitalist and in a number of leadership positions. After having served as president of Cleveland Clinic Hillcrest Hospital, I have a new role now as president of one of their newly acquired hospitals in Akron, Cleveland Clinic Akron General Hospital. Both are community hospitals within the Cleveland Clinic’s integrated healthcare network.

 

In my new role, I will be overseeing and facilitating the process of integration, and I’m really looking forward to it as a new challenge. I am particularly interested in how other health system and hospital executives who are hospitalists within SHM can help guide me and provide advice on how they have taken on challenges, built bridges, and overseen integration within other organizations.

 

Q: How does the career path of a hospitalist lend itself to leadership opportunities in a way that some other specialties may not?

 

A: Being a hospitalist lends itself to an almost limitless set of very interesting and rewarding career paths, both within and outside of pure clinical medicine. Hospitalists tend to have a very close relationship with administration, not just around clinical issues but around performance measurement and management. Because of this, we learn on the job about what leadership really consists of and that effective hospitalists are, by definition, effective leaders. What we do every day, functioning within and ultimately leading high-performing teams, epitomizes experiential leadership development.

 

SHM is positioned to help guide our members both in identifying their career paths and continuing to follow that path through events like Leadership Academy, Annual Meeting, and other networking opportunities that allow them to meet other hospitalists who have already walked down similar paths. We can help guide each other in terms of avoiding some of the pitfalls we have experienced but also by discovering opportunities and how to take advantage of them.

 

Q: Moving forward, how can hospitalists demonstrate the value that they add to the healthcare landscape both in practice and from a leadership perspective?

 

A: Since hospital medicine’s inception, hospitalists have had to show the value that they add to patient care, to hospitals, and to the healthcare system. As we move into an era of alternative payment models (APMs) and healthcare reform, the need to do that for all physicians will only be greater. Hospitalists are extremely well positioned to demonstrate value partly because we have been doing that all along in terms of improving patient care, quality outcomes, or performance measurements that the hospital is keeping track of.

 

 

 

We’re going to have to be stronger advocates for the value we provide to the healthcare system in terms of outcomes for patients as well as cost and efficiency. I know SHM will continue to help our members and the leaders within our membership develop the skills needed to do that.

Brian Harte, MD, SFHM, longtime member of the Society of Hospital Medicine (SHM) and now president of its Board of Directors, was recently named president of Cleveland Clinic Akron General and the Southern Region. He previously served as president of Cleveland Clinic Hillcrest Hospital, the 500-bed flagship for the Cleveland Clinic Health System.

 

 

Dr. Harte

 

The Hospitalist spoke with Dr. Harte about SHM’s impact on his career and how he sees hospitalists’ roles growing in an evolving health system.

 

Question: In your speech at Hospital Medicine 2016 in San Diego, you referenced the critical need for hospitalists to explore opportunities to grow both personally and professionally, with SHM as a means of support. How has SHM been that support for you throughout your career from hospitalist to hospitalist leader?

 

Answer: Hospital medicine is a fantastic career because there are so many opportunities available to us. SHM supports our members in finding their own career paths in a number of ways. For example, Leadership Academy is a valuable resource to develop leadership skills from basic to advanced. More generally, SHM provides many role models and networking opportunities to allow others to learn from hospital medicine professionals and healthcare leaders and help them advance their careers.

 

Q: Tell us a bit about your expanded role at Cleveland Clinic Health System and how you can leverage SHM as a way to accomplish your goals in this new position.

 

A: I’ve been at Cleveland Clinic for 12 years, both as a hospitalist and in a number of leadership positions. After having served as president of Cleveland Clinic Hillcrest Hospital, I have a new role now as president of one of their newly acquired hospitals in Akron, Cleveland Clinic Akron General Hospital. Both are community hospitals within the Cleveland Clinic’s integrated healthcare network.

 

In my new role, I will be overseeing and facilitating the process of integration, and I’m really looking forward to it as a new challenge. I am particularly interested in how other health system and hospital executives who are hospitalists within SHM can help guide me and provide advice on how they have taken on challenges, built bridges, and overseen integration within other organizations.

 

Q: How does the career path of a hospitalist lend itself to leadership opportunities in a way that some other specialties may not?

 

A: Being a hospitalist lends itself to an almost limitless set of very interesting and rewarding career paths, both within and outside of pure clinical medicine. Hospitalists tend to have a very close relationship with administration, not just around clinical issues but around performance measurement and management. Because of this, we learn on the job about what leadership really consists of and that effective hospitalists are, by definition, effective leaders. What we do every day, functioning within and ultimately leading high-performing teams, epitomizes experiential leadership development.

 

SHM is positioned to help guide our members both in identifying their career paths and continuing to follow that path through events like Leadership Academy, Annual Meeting, and other networking opportunities that allow them to meet other hospitalists who have already walked down similar paths. We can help guide each other in terms of avoiding some of the pitfalls we have experienced but also by discovering opportunities and how to take advantage of them.

 

Q: Moving forward, how can hospitalists demonstrate the value that they add to the healthcare landscape both in practice and from a leadership perspective?

 

A: Since hospital medicine’s inception, hospitalists have had to show the value that they add to patient care, to hospitals, and to the healthcare system. As we move into an era of alternative payment models (APMs) and healthcare reform, the need to do that for all physicians will only be greater. Hospitalists are extremely well positioned to demonstrate value partly because we have been doing that all along in terms of improving patient care, quality outcomes, or performance measurements that the hospital is keeping track of.

 

 

 

We’re going to have to be stronger advocates for the value we provide to the healthcare system in terms of outcomes for patients as well as cost and efficiency. I know SHM will continue to help our members and the leaders within our membership develop the skills needed to do that.

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Brian Harte, MD, SFHM, Discusses Path from Hospitalist to Transformational Healthcare Leader
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Hashimoto’s Thyroiditis and Lymphoma

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From a recent case study, researchers find best practices for diagnosing and treating patients with Hashimoto’s thyroiditis.

A “heightened index of suspicion” is called for when a patient with Hashimoto’s thyroiditis (HT)  presents with an enlarging neck mass, say researchers from Tan Tock Seng Hospital, Singapore, in a case report. According to the researchers, because the complication of thyroid lymphoma is rare, physicians commonly forgotten it. But primary thyroid lymphomas (PTLs) have a 60-fold risk in patients with HT.

Related: Study Points to Risk Factors for Lymphoma

Hashimoto’s thyroiditis typically is treated successfully with thyroxine. The study patient, however, began to lose weight and developed a mass in her neck that was diagnosed as diffuse large B-cell lymphoma. Previously, research suggested that having HT for ≥ 20 years increased the risk of thyroid lymphoma, but small studies have found that the interval between diagnosis of HT and diagnosis of thyroid lymphoma might be shorter—4 to 9 years, the researchers note. They cite another study that found the median interval was 18 months, as with their patient. Symptoms usually last from a few days to 36 months before diagnosis; in the study patient, symptoms of compression occurred over 2 to 3 weeks.

That shorter time frame may indicate that ultrasonography surveillance should be started early and done periodically, the researchers say, to detect lymphoma development as soon as possible. Radiologic imaging is helpful but “only serves as an adjunct to the diagnosis.” Histologic diagnosis is still needed for definitive diagnosis.

Related: Use of Fluorodeoxyglucose-Positron Emission Tomography in the Diagnosis of Intravascular Diffuse Large B-Cell Lymphoma

Timely diagnosis and early treatment mean the prognosis can be good for PTL, with relatively high survival rates after chemotherapy and radiotherapy. In this case, the patient underwent 6 cycles of chemotherapy with adjuvant radiotherapy. She then was maintained on thyroxine 75 µg daily. She remains euthyroid and disease free 1 year after completing her cancer treatment.

Source:
Chiang B, Cheng S, Seow CJ. BMJ Case Rep. 2016;pii:bcr2016217568.
doi: 10.1136/bcr-2016-217568.

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From a recent case study, researchers find best practices for diagnosing and treating patients with Hashimoto’s thyroiditis.
From a recent case study, researchers find best practices for diagnosing and treating patients with Hashimoto’s thyroiditis.

A “heightened index of suspicion” is called for when a patient with Hashimoto’s thyroiditis (HT)  presents with an enlarging neck mass, say researchers from Tan Tock Seng Hospital, Singapore, in a case report. According to the researchers, because the complication of thyroid lymphoma is rare, physicians commonly forgotten it. But primary thyroid lymphomas (PTLs) have a 60-fold risk in patients with HT.

Related: Study Points to Risk Factors for Lymphoma

Hashimoto’s thyroiditis typically is treated successfully with thyroxine. The study patient, however, began to lose weight and developed a mass in her neck that was diagnosed as diffuse large B-cell lymphoma. Previously, research suggested that having HT for ≥ 20 years increased the risk of thyroid lymphoma, but small studies have found that the interval between diagnosis of HT and diagnosis of thyroid lymphoma might be shorter—4 to 9 years, the researchers note. They cite another study that found the median interval was 18 months, as with their patient. Symptoms usually last from a few days to 36 months before diagnosis; in the study patient, symptoms of compression occurred over 2 to 3 weeks.

That shorter time frame may indicate that ultrasonography surveillance should be started early and done periodically, the researchers say, to detect lymphoma development as soon as possible. Radiologic imaging is helpful but “only serves as an adjunct to the diagnosis.” Histologic diagnosis is still needed for definitive diagnosis.

Related: Use of Fluorodeoxyglucose-Positron Emission Tomography in the Diagnosis of Intravascular Diffuse Large B-Cell Lymphoma

Timely diagnosis and early treatment mean the prognosis can be good for PTL, with relatively high survival rates after chemotherapy and radiotherapy. In this case, the patient underwent 6 cycles of chemotherapy with adjuvant radiotherapy. She then was maintained on thyroxine 75 µg daily. She remains euthyroid and disease free 1 year after completing her cancer treatment.

Source:
Chiang B, Cheng S, Seow CJ. BMJ Case Rep. 2016;pii:bcr2016217568.
doi: 10.1136/bcr-2016-217568.

A “heightened index of suspicion” is called for when a patient with Hashimoto’s thyroiditis (HT)  presents with an enlarging neck mass, say researchers from Tan Tock Seng Hospital, Singapore, in a case report. According to the researchers, because the complication of thyroid lymphoma is rare, physicians commonly forgotten it. But primary thyroid lymphomas (PTLs) have a 60-fold risk in patients with HT.

Related: Study Points to Risk Factors for Lymphoma

Hashimoto’s thyroiditis typically is treated successfully with thyroxine. The study patient, however, began to lose weight and developed a mass in her neck that was diagnosed as diffuse large B-cell lymphoma. Previously, research suggested that having HT for ≥ 20 years increased the risk of thyroid lymphoma, but small studies have found that the interval between diagnosis of HT and diagnosis of thyroid lymphoma might be shorter—4 to 9 years, the researchers note. They cite another study that found the median interval was 18 months, as with their patient. Symptoms usually last from a few days to 36 months before diagnosis; in the study patient, symptoms of compression occurred over 2 to 3 weeks.

That shorter time frame may indicate that ultrasonography surveillance should be started early and done periodically, the researchers say, to detect lymphoma development as soon as possible. Radiologic imaging is helpful but “only serves as an adjunct to the diagnosis.” Histologic diagnosis is still needed for definitive diagnosis.

Related: Use of Fluorodeoxyglucose-Positron Emission Tomography in the Diagnosis of Intravascular Diffuse Large B-Cell Lymphoma

Timely diagnosis and early treatment mean the prognosis can be good for PTL, with relatively high survival rates after chemotherapy and radiotherapy. In this case, the patient underwent 6 cycles of chemotherapy with adjuvant radiotherapy. She then was maintained on thyroxine 75 µg daily. She remains euthyroid and disease free 1 year after completing her cancer treatment.

Source:
Chiang B, Cheng S, Seow CJ. BMJ Case Rep. 2016;pii:bcr2016217568.
doi: 10.1136/bcr-2016-217568.

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Biomaterial stops bleeding, doesn’t rely on thrombosis

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Thu, 11/17/2016 - 06:00
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Biomaterial stops bleeding, doesn’t rely on thrombosis

Piglet

Photo courtesy of USDA

Bioengineers have developed an injectable material that may provide a better way to stop bleeding in injured patients, even those taking anticoagulants and individuals with coagulopathy.

The so-called shear-thinning biomaterial (STB) is composed of gelatin and silicate nanoplatelet hydrogel.

It can be injected through a catheter or needle to occlude blood vessels.

The STB demonstrated efficacy in vitro and in experiments with mice and pigs.

“This work is an example of how bioengineering can help address the challenges that clinicians and patients face,” said Ali Khademhosseini, PhD, of Brigham and Women’s Hospital in Boston, Massachusetts.

“Our work thus far has been in the lab, but we are on a translational path to bring this new biomaterial for embolization to the clinic to improve patient care.”

Dr Khademhosseini and his colleagues described their work with STB in Science Translational Medicine.

The researchers noted that trauma or injury often leads to excessive bleeding that can result in death.

Embolic materials, such as metallic coils or liquid embolic agents, are commonly used to block injured blood vessels and stem bleeding, but these materials can cause complications such as coil migration or breakthrough bleeding.

Because these materials rely on intrinsic thrombosis, they are often ineffective in patients with severe bleeding disorders or those on anticoagulation therapy.

In search of a safer and more effective alternative, Dr Khademhosseini and his colleagues developed their STB.

The STB can be flowed into a blood vessel using a catheter, but the material is able to maintain its shape once inside the vessel, obstructing the vessel without relying on the formation of a blood clot.

In vitro, the STB performed just as well as metallic coils and was able to withstand high pressures without fragmenting or being dislodged in explant vessels.

The STB was even effective in stemming anticoagulated blood flow in vitro, suggesting that it could potentially be used in patients with bleeding disorders or those on anticoagulants.

The STB successfully blocked arteries and veins in mice and pigs, forming an impenetrable cast of the vessels that remained in place for up to 24 days.

The researchers said some of the beneficial properties of the STB include its ability to withstand pressure within the blood vessel, remain at the site of injection, and naturally degrade over time.

In addition, the STB attracted cells to migrate and deposit themselves at the site of the STB, helping to block the vessel.

The researchers noted that the individual component materials that make up the STB have been previously used in humans, which may mean a quicker path to regulatory approval.

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Piglet

Photo courtesy of USDA

Bioengineers have developed an injectable material that may provide a better way to stop bleeding in injured patients, even those taking anticoagulants and individuals with coagulopathy.

The so-called shear-thinning biomaterial (STB) is composed of gelatin and silicate nanoplatelet hydrogel.

It can be injected through a catheter or needle to occlude blood vessels.

The STB demonstrated efficacy in vitro and in experiments with mice and pigs.

“This work is an example of how bioengineering can help address the challenges that clinicians and patients face,” said Ali Khademhosseini, PhD, of Brigham and Women’s Hospital in Boston, Massachusetts.

“Our work thus far has been in the lab, but we are on a translational path to bring this new biomaterial for embolization to the clinic to improve patient care.”

Dr Khademhosseini and his colleagues described their work with STB in Science Translational Medicine.

The researchers noted that trauma or injury often leads to excessive bleeding that can result in death.

Embolic materials, such as metallic coils or liquid embolic agents, are commonly used to block injured blood vessels and stem bleeding, but these materials can cause complications such as coil migration or breakthrough bleeding.

Because these materials rely on intrinsic thrombosis, they are often ineffective in patients with severe bleeding disorders or those on anticoagulation therapy.

In search of a safer and more effective alternative, Dr Khademhosseini and his colleagues developed their STB.

The STB can be flowed into a blood vessel using a catheter, but the material is able to maintain its shape once inside the vessel, obstructing the vessel without relying on the formation of a blood clot.

In vitro, the STB performed just as well as metallic coils and was able to withstand high pressures without fragmenting or being dislodged in explant vessels.

The STB was even effective in stemming anticoagulated blood flow in vitro, suggesting that it could potentially be used in patients with bleeding disorders or those on anticoagulants.

The STB successfully blocked arteries and veins in mice and pigs, forming an impenetrable cast of the vessels that remained in place for up to 24 days.

The researchers said some of the beneficial properties of the STB include its ability to withstand pressure within the blood vessel, remain at the site of injection, and naturally degrade over time.

In addition, the STB attracted cells to migrate and deposit themselves at the site of the STB, helping to block the vessel.

The researchers noted that the individual component materials that make up the STB have been previously used in humans, which may mean a quicker path to regulatory approval.

Piglet

Photo courtesy of USDA

Bioengineers have developed an injectable material that may provide a better way to stop bleeding in injured patients, even those taking anticoagulants and individuals with coagulopathy.

The so-called shear-thinning biomaterial (STB) is composed of gelatin and silicate nanoplatelet hydrogel.

It can be injected through a catheter or needle to occlude blood vessels.

The STB demonstrated efficacy in vitro and in experiments with mice and pigs.

“This work is an example of how bioengineering can help address the challenges that clinicians and patients face,” said Ali Khademhosseini, PhD, of Brigham and Women’s Hospital in Boston, Massachusetts.

“Our work thus far has been in the lab, but we are on a translational path to bring this new biomaterial for embolization to the clinic to improve patient care.”

Dr Khademhosseini and his colleagues described their work with STB in Science Translational Medicine.

The researchers noted that trauma or injury often leads to excessive bleeding that can result in death.

Embolic materials, such as metallic coils or liquid embolic agents, are commonly used to block injured blood vessels and stem bleeding, but these materials can cause complications such as coil migration or breakthrough bleeding.

Because these materials rely on intrinsic thrombosis, they are often ineffective in patients with severe bleeding disorders or those on anticoagulation therapy.

In search of a safer and more effective alternative, Dr Khademhosseini and his colleagues developed their STB.

The STB can be flowed into a blood vessel using a catheter, but the material is able to maintain its shape once inside the vessel, obstructing the vessel without relying on the formation of a blood clot.

In vitro, the STB performed just as well as metallic coils and was able to withstand high pressures without fragmenting or being dislodged in explant vessels.

The STB was even effective in stemming anticoagulated blood flow in vitro, suggesting that it could potentially be used in patients with bleeding disorders or those on anticoagulants.

The STB successfully blocked arteries and veins in mice and pigs, forming an impenetrable cast of the vessels that remained in place for up to 24 days.

The researchers said some of the beneficial properties of the STB include its ability to withstand pressure within the blood vessel, remain at the site of injection, and naturally degrade over time.

In addition, the STB attracted cells to migrate and deposit themselves at the site of the STB, helping to block the vessel.

The researchers noted that the individual component materials that make up the STB have been previously used in humans, which may mean a quicker path to regulatory approval.

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Device provides long-lasting drug delivery

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Device provides long-lasting drug delivery

The team designed a structure

with 6 arms that can be folded

and encased in a capsule.

Photo by Melanie Gonick/MIT

A new device can provide long-term, controlled drug release, according to research published in Science Translational Medicine.

Researchers tested this device—a 6-armed structure encased in a capsule—by loading it with ivermectin, an antiparasitic drug that disrupts malaria transmission by killing infected mosquitoes.

When administered to pigs, the device safely stayed in the stomach, slowly releasing ivermectin for up to 14 days.

Researchers believe this type of lasting drug delivery could help bolster the success of malaria elimination campaigns, which rely on treatment adherence and cost-effective approaches that reach large, rural populations.

The team also believes this device could be used to treat a range of other diseases, particularly those in which treatment adherence may be an issue.

“We want to make it as easy as possible for people to take their medications over a sustained period of time,” said study author C. Giovanni Traverso, MB, BChir, PhD, of the Massachusetts Institute of Technology (MIT) in Cambridge.

“When patients have to remember to take a drug every day or multiple times a day, we start to see less and less adherence to the regimen. Being able to swallow a capsule once a week or once a month could change the way we think about delivering medications.”

This research has led to the launch of Lyndra, a company that is developing this technology with a focus on diseases for which patients would benefit the most from sustained drug delivery. This includes neuropsychiatric disorders, HIV, diabetes, and epilepsy.

Designing, testing the device

To provide long-term drug delivery, the researchers designed a star-shaped device with 6 arms that can be folded inward and encased in a smooth capsule.

Drug molecules are loaded into the arms, which are made of a rigid polymer called polycaprolactone. Each arm is attached to a rubber-like core by a linker that is designed to eventually break down.

After the capsule is swallowed, stomach acid dissolves the outer layer, allowing the 6-armed device to unfold.

Once the device expands, it is large enough to stay in the stomach and resist the forces that would normally push an object further down the digestive tract. However, it is not large enough to cause any harmful blockage of the digestive tract.

The drug is gradually released over a period of several days. After that, the linkers that join the arms to the core of the device dissolve, allowing the arms to break off. The pieces are small enough that they can pass harmlessly through the digestive tract.

In pigs, the device slowly released ivermectin for up to 14 days without causing injury to the stomach or obstructing the passage of food, before breaking apart and passing safely out of the body.

Modeling the impact

The researchers used mathematical modeling to predict the potential impact of this drug delivery method.

The data suggested that if the device were used to deliver ivermectin, it could increase the efficacy of mass drug administration campaigns designed to fight malaria.

“What we showed is that we stand to significantly amplify the effect of those campaigns,” Dr Traverso said. “The introduction of this kind of system could have a substantial impact on the fight against malaria and transform clinical care in general by ensuring patients receive their medication.”

Potential applications

“Until now, oral drugs would almost never last for more than a day,” said study author Robert Langer, ScD, of MIT.

 

 

“This really opens the door to ultra-long-lasting oral systems, which could have an effect on all kinds of diseases, such as Alzheimer’s or mental health disorders. There are a lot of exciting things this could someday enable.”

“This is a platform into which you can incorporate any drug,” added Mousa Jafari, PhD, of MIT. “This can be used with any drug that requires frequent dosing. We can replace that dosing with a single administration.”

This type of delivery could also help researchers run better clinical trials by making it easier for patients to take the drugs, said Shiyi Zhang, PhD, of MIT.

“It may help doctors and the pharma industry to better evaluate the efficacy of certain drugs because, currently, a lot of patients in clinical trials have serious medication adherence problems that will mislead the clinical studies,” he said.

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The team designed a structure

with 6 arms that can be folded

and encased in a capsule.

Photo by Melanie Gonick/MIT

A new device can provide long-term, controlled drug release, according to research published in Science Translational Medicine.

Researchers tested this device—a 6-armed structure encased in a capsule—by loading it with ivermectin, an antiparasitic drug that disrupts malaria transmission by killing infected mosquitoes.

When administered to pigs, the device safely stayed in the stomach, slowly releasing ivermectin for up to 14 days.

Researchers believe this type of lasting drug delivery could help bolster the success of malaria elimination campaigns, which rely on treatment adherence and cost-effective approaches that reach large, rural populations.

The team also believes this device could be used to treat a range of other diseases, particularly those in which treatment adherence may be an issue.

“We want to make it as easy as possible for people to take their medications over a sustained period of time,” said study author C. Giovanni Traverso, MB, BChir, PhD, of the Massachusetts Institute of Technology (MIT) in Cambridge.

“When patients have to remember to take a drug every day or multiple times a day, we start to see less and less adherence to the regimen. Being able to swallow a capsule once a week or once a month could change the way we think about delivering medications.”

This research has led to the launch of Lyndra, a company that is developing this technology with a focus on diseases for which patients would benefit the most from sustained drug delivery. This includes neuropsychiatric disorders, HIV, diabetes, and epilepsy.

Designing, testing the device

To provide long-term drug delivery, the researchers designed a star-shaped device with 6 arms that can be folded inward and encased in a smooth capsule.

Drug molecules are loaded into the arms, which are made of a rigid polymer called polycaprolactone. Each arm is attached to a rubber-like core by a linker that is designed to eventually break down.

After the capsule is swallowed, stomach acid dissolves the outer layer, allowing the 6-armed device to unfold.

Once the device expands, it is large enough to stay in the stomach and resist the forces that would normally push an object further down the digestive tract. However, it is not large enough to cause any harmful blockage of the digestive tract.

The drug is gradually released over a period of several days. After that, the linkers that join the arms to the core of the device dissolve, allowing the arms to break off. The pieces are small enough that they can pass harmlessly through the digestive tract.

In pigs, the device slowly released ivermectin for up to 14 days without causing injury to the stomach or obstructing the passage of food, before breaking apart and passing safely out of the body.

Modeling the impact

The researchers used mathematical modeling to predict the potential impact of this drug delivery method.

The data suggested that if the device were used to deliver ivermectin, it could increase the efficacy of mass drug administration campaigns designed to fight malaria.

“What we showed is that we stand to significantly amplify the effect of those campaigns,” Dr Traverso said. “The introduction of this kind of system could have a substantial impact on the fight against malaria and transform clinical care in general by ensuring patients receive their medication.”

Potential applications

“Until now, oral drugs would almost never last for more than a day,” said study author Robert Langer, ScD, of MIT.

 

 

“This really opens the door to ultra-long-lasting oral systems, which could have an effect on all kinds of diseases, such as Alzheimer’s or mental health disorders. There are a lot of exciting things this could someday enable.”

“This is a platform into which you can incorporate any drug,” added Mousa Jafari, PhD, of MIT. “This can be used with any drug that requires frequent dosing. We can replace that dosing with a single administration.”

This type of delivery could also help researchers run better clinical trials by making it easier for patients to take the drugs, said Shiyi Zhang, PhD, of MIT.

“It may help doctors and the pharma industry to better evaluate the efficacy of certain drugs because, currently, a lot of patients in clinical trials have serious medication adherence problems that will mislead the clinical studies,” he said.

The team designed a structure

with 6 arms that can be folded

and encased in a capsule.

Photo by Melanie Gonick/MIT

A new device can provide long-term, controlled drug release, according to research published in Science Translational Medicine.

Researchers tested this device—a 6-armed structure encased in a capsule—by loading it with ivermectin, an antiparasitic drug that disrupts malaria transmission by killing infected mosquitoes.

When administered to pigs, the device safely stayed in the stomach, slowly releasing ivermectin for up to 14 days.

Researchers believe this type of lasting drug delivery could help bolster the success of malaria elimination campaigns, which rely on treatment adherence and cost-effective approaches that reach large, rural populations.

The team also believes this device could be used to treat a range of other diseases, particularly those in which treatment adherence may be an issue.

“We want to make it as easy as possible for people to take their medications over a sustained period of time,” said study author C. Giovanni Traverso, MB, BChir, PhD, of the Massachusetts Institute of Technology (MIT) in Cambridge.

“When patients have to remember to take a drug every day or multiple times a day, we start to see less and less adherence to the regimen. Being able to swallow a capsule once a week or once a month could change the way we think about delivering medications.”

This research has led to the launch of Lyndra, a company that is developing this technology with a focus on diseases for which patients would benefit the most from sustained drug delivery. This includes neuropsychiatric disorders, HIV, diabetes, and epilepsy.

Designing, testing the device

To provide long-term drug delivery, the researchers designed a star-shaped device with 6 arms that can be folded inward and encased in a smooth capsule.

Drug molecules are loaded into the arms, which are made of a rigid polymer called polycaprolactone. Each arm is attached to a rubber-like core by a linker that is designed to eventually break down.

After the capsule is swallowed, stomach acid dissolves the outer layer, allowing the 6-armed device to unfold.

Once the device expands, it is large enough to stay in the stomach and resist the forces that would normally push an object further down the digestive tract. However, it is not large enough to cause any harmful blockage of the digestive tract.

The drug is gradually released over a period of several days. After that, the linkers that join the arms to the core of the device dissolve, allowing the arms to break off. The pieces are small enough that they can pass harmlessly through the digestive tract.

In pigs, the device slowly released ivermectin for up to 14 days without causing injury to the stomach or obstructing the passage of food, before breaking apart and passing safely out of the body.

Modeling the impact

The researchers used mathematical modeling to predict the potential impact of this drug delivery method.

The data suggested that if the device were used to deliver ivermectin, it could increase the efficacy of mass drug administration campaigns designed to fight malaria.

“What we showed is that we stand to significantly amplify the effect of those campaigns,” Dr Traverso said. “The introduction of this kind of system could have a substantial impact on the fight against malaria and transform clinical care in general by ensuring patients receive their medication.”

Potential applications

“Until now, oral drugs would almost never last for more than a day,” said study author Robert Langer, ScD, of MIT.

 

 

“This really opens the door to ultra-long-lasting oral systems, which could have an effect on all kinds of diseases, such as Alzheimer’s or mental health disorders. There are a lot of exciting things this could someday enable.”

“This is a platform into which you can incorporate any drug,” added Mousa Jafari, PhD, of MIT. “This can be used with any drug that requires frequent dosing. We can replace that dosing with a single administration.”

This type of delivery could also help researchers run better clinical trials by making it easier for patients to take the drugs, said Shiyi Zhang, PhD, of MIT.

“It may help doctors and the pharma industry to better evaluate the efficacy of certain drugs because, currently, a lot of patients in clinical trials have serious medication adherence problems that will mislead the clinical studies,” he said.

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Compound could treat leukemia, other cancers

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Compound could treat leukemia, other cancers

Study authors Hui Ding

and Patrick Harran with

a model of DZ-2384

Photo courtesy of

Reed Hutchinson/UCLA

A new compound holds promise for treating leukemia and other cancers, according to researchers.

The compound, DZ-2384, is a synthetic version of diazonamide A, a toxin isolated from a marine animal.

DZ-2384 is a microtubule-targeting agent (MTA). It binds to and alters the stability of microtubules, disrupting the normal function of the mitotic spindle and arresting cell-cycle progression at mitosis, ultimately leading to cell death.

However, researchers found that DZ-2384 behaves somewhat differently from other MTAs.

They reported these findings in Science Translational Medicine. The research was supported, in part, by Diazon Pharmaceuticals Inc.

The researchers tested DZ-2384 in mouse models of various cancers, including adult Philadelphia chromosome–negative acute lymphocytic leukemia.

In animals receiving DZ-2384, tumors shrank as much as or more than when a conventional MTA was used, but with much less toxicity at effective doses.

In particular, animals receiving DZ-2384 had markedly less peripheral neuropathy than those that received docetaxel, a conventional MTA. Peripheral neuropathy is one of the chief side effects of MTAs and can prompt treatment discontinuation.

“We have good reason to expect that human clinical trials of DZ-2384 will show that, at doses effective for treating a person’s cancer, there will be much less risk of the peripheral neuropathy that can force clinicians to stop treatment,” said study author Patrick Harran, PhD, of the University of California, Los Angeles.

Dr Harran believes clinical trials of DZ-2384 could begin within 2 years.

How this study began

Dr Harran began his work with diazonamides as a fundamental chemistry research problem.

In 1991, a group of researchers described diazonamides A and B, which they had isolated from the marine animal Diazona chinensis.

But Dr Harran and his colleagues found the described structure of diazonamide A was incorrect. In 2001, the team published a study that corrected the chemical structure of diazonamide A, and, 2 years later, they had synthesized the true structure in their lab.

Next, they began studying what the molecule might be doing to stop cells from dividing. In 2007, they discovered that the synthetic diazonamides they had produced minimized undesirable toxic effects that are commonly associated with chemotherapy.

Specifically, the compounds had an unusually large therapeutic window. In experiment after experiment, Dr Harran said, the researchers found that synthetic diazonamides’ therapeutic window was at least 10 times larger than that of traditional MTAs.

A key finding

In 2015, researchers prepared a form of DZ-2384 that was engineered with a molecular-scale “tracking device” so they could monitor its activity and better understand how it worked.

That helped the team confirm what they had come to suspect: that the compound binds to tubulin, which is a building block of mitotic spindles and a common target of MTAs.

Armed with this information, the researchers used X-ray crystallography to determine the structure of DZ-2384 bound to tubulin.

Their work offers a possible explanation for how DZ-2384 could disrupt dynamic tubulin polymers during cell division but spare those polymers in resting cells like neurons in the peripheral nervous system.

And that is what appears to allow the compound to attack growing cancer cells while minimizing damage to healthy cells.

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Study authors Hui Ding

and Patrick Harran with

a model of DZ-2384

Photo courtesy of

Reed Hutchinson/UCLA

A new compound holds promise for treating leukemia and other cancers, according to researchers.

The compound, DZ-2384, is a synthetic version of diazonamide A, a toxin isolated from a marine animal.

DZ-2384 is a microtubule-targeting agent (MTA). It binds to and alters the stability of microtubules, disrupting the normal function of the mitotic spindle and arresting cell-cycle progression at mitosis, ultimately leading to cell death.

However, researchers found that DZ-2384 behaves somewhat differently from other MTAs.

They reported these findings in Science Translational Medicine. The research was supported, in part, by Diazon Pharmaceuticals Inc.

The researchers tested DZ-2384 in mouse models of various cancers, including adult Philadelphia chromosome–negative acute lymphocytic leukemia.

In animals receiving DZ-2384, tumors shrank as much as or more than when a conventional MTA was used, but with much less toxicity at effective doses.

In particular, animals receiving DZ-2384 had markedly less peripheral neuropathy than those that received docetaxel, a conventional MTA. Peripheral neuropathy is one of the chief side effects of MTAs and can prompt treatment discontinuation.

“We have good reason to expect that human clinical trials of DZ-2384 will show that, at doses effective for treating a person’s cancer, there will be much less risk of the peripheral neuropathy that can force clinicians to stop treatment,” said study author Patrick Harran, PhD, of the University of California, Los Angeles.

Dr Harran believes clinical trials of DZ-2384 could begin within 2 years.

How this study began

Dr Harran began his work with diazonamides as a fundamental chemistry research problem.

In 1991, a group of researchers described diazonamides A and B, which they had isolated from the marine animal Diazona chinensis.

But Dr Harran and his colleagues found the described structure of diazonamide A was incorrect. In 2001, the team published a study that corrected the chemical structure of diazonamide A, and, 2 years later, they had synthesized the true structure in their lab.

Next, they began studying what the molecule might be doing to stop cells from dividing. In 2007, they discovered that the synthetic diazonamides they had produced minimized undesirable toxic effects that are commonly associated with chemotherapy.

Specifically, the compounds had an unusually large therapeutic window. In experiment after experiment, Dr Harran said, the researchers found that synthetic diazonamides’ therapeutic window was at least 10 times larger than that of traditional MTAs.

A key finding

In 2015, researchers prepared a form of DZ-2384 that was engineered with a molecular-scale “tracking device” so they could monitor its activity and better understand how it worked.

That helped the team confirm what they had come to suspect: that the compound binds to tubulin, which is a building block of mitotic spindles and a common target of MTAs.

Armed with this information, the researchers used X-ray crystallography to determine the structure of DZ-2384 bound to tubulin.

Their work offers a possible explanation for how DZ-2384 could disrupt dynamic tubulin polymers during cell division but spare those polymers in resting cells like neurons in the peripheral nervous system.

And that is what appears to allow the compound to attack growing cancer cells while minimizing damage to healthy cells.

Study authors Hui Ding

and Patrick Harran with

a model of DZ-2384

Photo courtesy of

Reed Hutchinson/UCLA

A new compound holds promise for treating leukemia and other cancers, according to researchers.

The compound, DZ-2384, is a synthetic version of diazonamide A, a toxin isolated from a marine animal.

DZ-2384 is a microtubule-targeting agent (MTA). It binds to and alters the stability of microtubules, disrupting the normal function of the mitotic spindle and arresting cell-cycle progression at mitosis, ultimately leading to cell death.

However, researchers found that DZ-2384 behaves somewhat differently from other MTAs.

They reported these findings in Science Translational Medicine. The research was supported, in part, by Diazon Pharmaceuticals Inc.

The researchers tested DZ-2384 in mouse models of various cancers, including adult Philadelphia chromosome–negative acute lymphocytic leukemia.

In animals receiving DZ-2384, tumors shrank as much as or more than when a conventional MTA was used, but with much less toxicity at effective doses.

In particular, animals receiving DZ-2384 had markedly less peripheral neuropathy than those that received docetaxel, a conventional MTA. Peripheral neuropathy is one of the chief side effects of MTAs and can prompt treatment discontinuation.

“We have good reason to expect that human clinical trials of DZ-2384 will show that, at doses effective for treating a person’s cancer, there will be much less risk of the peripheral neuropathy that can force clinicians to stop treatment,” said study author Patrick Harran, PhD, of the University of California, Los Angeles.

Dr Harran believes clinical trials of DZ-2384 could begin within 2 years.

How this study began

Dr Harran began his work with diazonamides as a fundamental chemistry research problem.

In 1991, a group of researchers described diazonamides A and B, which they had isolated from the marine animal Diazona chinensis.

But Dr Harran and his colleagues found the described structure of diazonamide A was incorrect. In 2001, the team published a study that corrected the chemical structure of diazonamide A, and, 2 years later, they had synthesized the true structure in their lab.

Next, they began studying what the molecule might be doing to stop cells from dividing. In 2007, they discovered that the synthetic diazonamides they had produced minimized undesirable toxic effects that are commonly associated with chemotherapy.

Specifically, the compounds had an unusually large therapeutic window. In experiment after experiment, Dr Harran said, the researchers found that synthetic diazonamides’ therapeutic window was at least 10 times larger than that of traditional MTAs.

A key finding

In 2015, researchers prepared a form of DZ-2384 that was engineered with a molecular-scale “tracking device” so they could monitor its activity and better understand how it worked.

That helped the team confirm what they had come to suspect: that the compound binds to tubulin, which is a building block of mitotic spindles and a common target of MTAs.

Armed with this information, the researchers used X-ray crystallography to determine the structure of DZ-2384 bound to tubulin.

Their work offers a possible explanation for how DZ-2384 could disrupt dynamic tubulin polymers during cell division but spare those polymers in resting cells like neurons in the peripheral nervous system.

And that is what appears to allow the compound to attack growing cancer cells while minimizing damage to healthy cells.

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Anticoagulant therapies appear comparable

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Bivalirudin

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NEW ORLEANS—Two types of anticoagulant therapy produce comparable outcomes for patients undergoing percutaneous coronary intervention (PCI), according to a new study.

The study was designed to determine which of 2 treatment methods—heparin combined with a short-term (less than 6 hours) infusion of tirofiban, or short-term periprocedural bivalirudin—was more effective.

Results showed that the 1-year risk of death, myocardial infarction, and urgent target vessel revascularization (UTVR) was not significantly different between the 2 treatment methods.

The incidence of Thrombolysis in Myocardial Infarction (TIMI) major bleeding at 30 days was also similar between the treatment groups.

Results of this study were presented at the American Heart Association Scientific Sessions (abstract 15074). The study was funded by an unrestricted grant from the Medicure Corporation.

“Bivalirudin has been considered the gold standard for reducing bleeding during percutaneous coronary intervention, but our study shows heparin plus short-term tirofiban is just as good and possibly better,” said study investigator J. Brent Muhlestein, MD, of Intermountain Medical Center Heart Institute in Salt Lake City, Utah.

“The results certainly justify a randomized clinical trial to explore identified trends.”

Dr Muhlestein and his colleagues studied data on patients who underwent PCI between January 2013 and December 2015.

Of the 857 patients enrolled in the study, 402 received heparin plus short-term tirofiban treatment, and 455 received bivalirudin. The patients were between the ages of 51 and 78.

Results

At 30 days, the incidence of TIMI major bleeding was 1.2% for patients treated with heparin and tirofiban and 3.1% for bivalirudin-treated patients (P=0.10).

Also at 30 days, the incidence of death was 0.7% in the heparin/tirofiban group and 1.9% in the bivalirudin group (P=0.23). The incidence of myocardial infarction was 0.5% and 0.7%, respectively (P=1.00). And the incidence of UTVR was 0% and 0.7%, respectively (P=0.25).

At 1 year, the incidence of death was 3.4% for patients treated with heparin and tirofiban and 5.5% for bivalirudin-treated patients (P=0.42).

The incidence of myocardial infarction at 1 year was 2.9% and 3.0%, respectively (P=1.00). And the incidence of UTVR was 2.0% and 1.5%, respectively (P=0.67).

In multivariable analysis, the odds ratio (OR) for 30-day TIMI major bleeding (heparin/tirofiban vs bivalirudin) was 0.41 (P=0.11).

The OR for death at 1 year was 0.50 (P=0.33). The OR for non-fatal myocardial infarction at 1 year was 1.09 (P=0.91). And the OR for UTVR at 1 year was 1.23 (P=0.84).

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Bivalirudin

Photo from Business Wire

NEW ORLEANS—Two types of anticoagulant therapy produce comparable outcomes for patients undergoing percutaneous coronary intervention (PCI), according to a new study.

The study was designed to determine which of 2 treatment methods—heparin combined with a short-term (less than 6 hours) infusion of tirofiban, or short-term periprocedural bivalirudin—was more effective.

Results showed that the 1-year risk of death, myocardial infarction, and urgent target vessel revascularization (UTVR) was not significantly different between the 2 treatment methods.

The incidence of Thrombolysis in Myocardial Infarction (TIMI) major bleeding at 30 days was also similar between the treatment groups.

Results of this study were presented at the American Heart Association Scientific Sessions (abstract 15074). The study was funded by an unrestricted grant from the Medicure Corporation.

“Bivalirudin has been considered the gold standard for reducing bleeding during percutaneous coronary intervention, but our study shows heparin plus short-term tirofiban is just as good and possibly better,” said study investigator J. Brent Muhlestein, MD, of Intermountain Medical Center Heart Institute in Salt Lake City, Utah.

“The results certainly justify a randomized clinical trial to explore identified trends.”

Dr Muhlestein and his colleagues studied data on patients who underwent PCI between January 2013 and December 2015.

Of the 857 patients enrolled in the study, 402 received heparin plus short-term tirofiban treatment, and 455 received bivalirudin. The patients were between the ages of 51 and 78.

Results

At 30 days, the incidence of TIMI major bleeding was 1.2% for patients treated with heparin and tirofiban and 3.1% for bivalirudin-treated patients (P=0.10).

Also at 30 days, the incidence of death was 0.7% in the heparin/tirofiban group and 1.9% in the bivalirudin group (P=0.23). The incidence of myocardial infarction was 0.5% and 0.7%, respectively (P=1.00). And the incidence of UTVR was 0% and 0.7%, respectively (P=0.25).

At 1 year, the incidence of death was 3.4% for patients treated with heparin and tirofiban and 5.5% for bivalirudin-treated patients (P=0.42).

The incidence of myocardial infarction at 1 year was 2.9% and 3.0%, respectively (P=1.00). And the incidence of UTVR was 2.0% and 1.5%, respectively (P=0.67).

In multivariable analysis, the odds ratio (OR) for 30-day TIMI major bleeding (heparin/tirofiban vs bivalirudin) was 0.41 (P=0.11).

The OR for death at 1 year was 0.50 (P=0.33). The OR for non-fatal myocardial infarction at 1 year was 1.09 (P=0.91). And the OR for UTVR at 1 year was 1.23 (P=0.84).

Bivalirudin

Photo from Business Wire

NEW ORLEANS—Two types of anticoagulant therapy produce comparable outcomes for patients undergoing percutaneous coronary intervention (PCI), according to a new study.

The study was designed to determine which of 2 treatment methods—heparin combined with a short-term (less than 6 hours) infusion of tirofiban, or short-term periprocedural bivalirudin—was more effective.

Results showed that the 1-year risk of death, myocardial infarction, and urgent target vessel revascularization (UTVR) was not significantly different between the 2 treatment methods.

The incidence of Thrombolysis in Myocardial Infarction (TIMI) major bleeding at 30 days was also similar between the treatment groups.

Results of this study were presented at the American Heart Association Scientific Sessions (abstract 15074). The study was funded by an unrestricted grant from the Medicure Corporation.

“Bivalirudin has been considered the gold standard for reducing bleeding during percutaneous coronary intervention, but our study shows heparin plus short-term tirofiban is just as good and possibly better,” said study investigator J. Brent Muhlestein, MD, of Intermountain Medical Center Heart Institute in Salt Lake City, Utah.

“The results certainly justify a randomized clinical trial to explore identified trends.”

Dr Muhlestein and his colleagues studied data on patients who underwent PCI between January 2013 and December 2015.

Of the 857 patients enrolled in the study, 402 received heparin plus short-term tirofiban treatment, and 455 received bivalirudin. The patients were between the ages of 51 and 78.

Results

At 30 days, the incidence of TIMI major bleeding was 1.2% for patients treated with heparin and tirofiban and 3.1% for bivalirudin-treated patients (P=0.10).

Also at 30 days, the incidence of death was 0.7% in the heparin/tirofiban group and 1.9% in the bivalirudin group (P=0.23). The incidence of myocardial infarction was 0.5% and 0.7%, respectively (P=1.00). And the incidence of UTVR was 0% and 0.7%, respectively (P=0.25).

At 1 year, the incidence of death was 3.4% for patients treated with heparin and tirofiban and 5.5% for bivalirudin-treated patients (P=0.42).

The incidence of myocardial infarction at 1 year was 2.9% and 3.0%, respectively (P=1.00). And the incidence of UTVR was 2.0% and 1.5%, respectively (P=0.67).

In multivariable analysis, the odds ratio (OR) for 30-day TIMI major bleeding (heparin/tirofiban vs bivalirudin) was 0.41 (P=0.11).

The OR for death at 1 year was 0.50 (P=0.33). The OR for non-fatal myocardial infarction at 1 year was 1.09 (P=0.91). And the OR for UTVR at 1 year was 1.23 (P=0.84).

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‘I Don’t Know How to Get Exercise’

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Tue, 12/13/2016 - 10:27
Researchers find women in different demographic groups have diverse opinions and methods of executing a regular exercise routine.

Much research has been devoted to the importance of exercise and finding out how to get people to exercise more. Yet > 1 in 4 American adults over the age of 50 do not engage in physical activity, according to a CDC report. Women are more likely to be inactive than men (30% vs 26%), and inactivity is highest in the South (30%) and Midwest (28%), although the Northeast (27%) and West (23%) followed closely.  

Related: Walk the Talk: VA Mental Health Care Professionals’ Role in Promoting Physical Activity

A study of 110 women living in rural southern Illinois may help clarify the reasons for inactivity. The women, divided into 4 age groups, participated in focus groups held in various community settings across 7 counties.

The women talked about engaging in physical activity to relieve chronic pain, manage illness, improve mental health, and feel more energetic. However, they also talked about the barriers to being physically active, such as not knowing how to fit exercise into their lives.

Related: Exercise Lowers Risk of Some Cancers

When the researchers analyzed responses by age, they found that young women did not describe exercise as an activity to do with other women. For them, work, household, and family commitments competed with social activities, including those associated with physical activity. Older women, on the other hand, might be more inclined to spend time in activity-related groups, such as walking groups, to spend time with others. But all of the women over the age of 30 described physical and mental health challenges that interfered with being active.

Younger women and mothers also were more likely to be interested in spaces for outdoor recreation, where they could be active with their children. Older women rarely discussed outdoor resources; perhaps because they had more flexible schedules that allowed for structured groups and more affordable options due to senior discounts, the researchers suggest.

Related: A Call to Action: Intensive Lifestyle Intervention Against Diabesity

By understanding the multifactorial reasons for why women aren’t getting enough exercise, the researchers speculate that it might be possible to develop interventions that reduce the barriers and “capitalize on what motivates women at different times in their lives.”

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Researchers find women in different demographic groups have diverse opinions and methods of executing a regular exercise routine.
Researchers find women in different demographic groups have diverse opinions and methods of executing a regular exercise routine.

Much research has been devoted to the importance of exercise and finding out how to get people to exercise more. Yet > 1 in 4 American adults over the age of 50 do not engage in physical activity, according to a CDC report. Women are more likely to be inactive than men (30% vs 26%), and inactivity is highest in the South (30%) and Midwest (28%), although the Northeast (27%) and West (23%) followed closely.  

Related: Walk the Talk: VA Mental Health Care Professionals’ Role in Promoting Physical Activity

A study of 110 women living in rural southern Illinois may help clarify the reasons for inactivity. The women, divided into 4 age groups, participated in focus groups held in various community settings across 7 counties.

The women talked about engaging in physical activity to relieve chronic pain, manage illness, improve mental health, and feel more energetic. However, they also talked about the barriers to being physically active, such as not knowing how to fit exercise into their lives.

Related: Exercise Lowers Risk of Some Cancers

When the researchers analyzed responses by age, they found that young women did not describe exercise as an activity to do with other women. For them, work, household, and family commitments competed with social activities, including those associated with physical activity. Older women, on the other hand, might be more inclined to spend time in activity-related groups, such as walking groups, to spend time with others. But all of the women over the age of 30 described physical and mental health challenges that interfered with being active.

Younger women and mothers also were more likely to be interested in spaces for outdoor recreation, where they could be active with their children. Older women rarely discussed outdoor resources; perhaps because they had more flexible schedules that allowed for structured groups and more affordable options due to senior discounts, the researchers suggest.

Related: A Call to Action: Intensive Lifestyle Intervention Against Diabesity

By understanding the multifactorial reasons for why women aren’t getting enough exercise, the researchers speculate that it might be possible to develop interventions that reduce the barriers and “capitalize on what motivates women at different times in their lives.”

Much research has been devoted to the importance of exercise and finding out how to get people to exercise more. Yet > 1 in 4 American adults over the age of 50 do not engage in physical activity, according to a CDC report. Women are more likely to be inactive than men (30% vs 26%), and inactivity is highest in the South (30%) and Midwest (28%), although the Northeast (27%) and West (23%) followed closely.  

Related: Walk the Talk: VA Mental Health Care Professionals’ Role in Promoting Physical Activity

A study of 110 women living in rural southern Illinois may help clarify the reasons for inactivity. The women, divided into 4 age groups, participated in focus groups held in various community settings across 7 counties.

The women talked about engaging in physical activity to relieve chronic pain, manage illness, improve mental health, and feel more energetic. However, they also talked about the barriers to being physically active, such as not knowing how to fit exercise into their lives.

Related: Exercise Lowers Risk of Some Cancers

When the researchers analyzed responses by age, they found that young women did not describe exercise as an activity to do with other women. For them, work, household, and family commitments competed with social activities, including those associated with physical activity. Older women, on the other hand, might be more inclined to spend time in activity-related groups, such as walking groups, to spend time with others. But all of the women over the age of 30 described physical and mental health challenges that interfered with being active.

Younger women and mothers also were more likely to be interested in spaces for outdoor recreation, where they could be active with their children. Older women rarely discussed outdoor resources; perhaps because they had more flexible schedules that allowed for structured groups and more affordable options due to senior discounts, the researchers suggest.

Related: A Call to Action: Intensive Lifestyle Intervention Against Diabesity

By understanding the multifactorial reasons for why women aren’t getting enough exercise, the researchers speculate that it might be possible to develop interventions that reduce the barriers and “capitalize on what motivates women at different times in their lives.”

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His & Hers Hair Loss

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His & Hers Hair Loss

A 29-year-old woman and her 40-year-old husband present together for evaluation of similar problems: One month ago, they both experienced sudden hair loss—the wife in two spots on her scalp, the husband in his beard. In both cases, the hair came out suddenly, without any symptoms. Neither has had this problem before. Both patients are otherwise healthy, but they admit to being under a great deal of stress in the weeks prior to onset of the condition.

Before consulting dermatology, they were seen in an urgent care clinic, where they were diagnosed with “ringworm.” Twice-daily application of nystatin cream was prescribed—to no good effect.

EXAMINATION
On each side of the woman’s parietal scalp is a round, completely hairless patch with exceptionally well-defined margins. The sites are otherwise unremarkable, free of redness, edema, or scaling. Each lesion measures about 3.5 cm in diameter. No lymph nodes are palpable in the adjacent neck.

On the man’s left jawline is a solitary, round, 4-cm, hairless patch. It is also free of edema, erythema, or epidermal disturbance of any kind. There are no palpable lymph nodes in the drainage area.

What is the diagnosis?

 

 

DISCUSSION
Sudden, asymptomatic, complete, well-marginated hair loss in any hair-bearing area is likely to be alopecia areata (AA). AA is an autoimmune process in which hair follicles are immobilized and unable to grow new hair until the process stops, which usually happens within weeks to months.

Because stress and AA have a suspected correlation, the patients’ histories of recent stress corroborate the diagnosis. Other features that bolster this impression are the lack of epidermal disturbance (eg, scaling, redness, edema) or palpable nodes in the area. The unusual factor in this case was the simultaneous appearance of the condition in husband and wife—for which I have no good explanation.

There are many items in the differential for localized hair loss, including discoid lupus, lichen planopilaris, and tinea capitis. However, these almost always manifest with frank inflammation characterized by epidermal disturbance.

Treatments such as intralesional steroid injection can promote modest hair growth but are generally ineffective for long-term recovery; unless the procedure is repeated, the hair will continue to fall out. These patients were offered treatment but declined, and they recovered in a short period of time.

TAKE-HOME LEARNING POINTS
• Alopecia areata (AA) typically displays as acute, asymptomatic, complete hair loss in one or more hair-bearing locations, usually in a round, well-defined configuration.
• AA is an autoimmune process that immobilizes hair follicles, causing them to fall out and not be replaced until the process ceases. This can take months, and the condition does not respond well to treatment.
• AA can affect the scalp, beard, brows, or even genital hair.
• The differential for localized hair loss includes tinea capitis, discoid lupus, lichen planopilaris, and lues; however, these all involve disruption of the overlying skin with scaling, redness, or edema.

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A 29-year-old woman and her 40-year-old husband present together for evaluation of similar problems: One month ago, they both experienced sudden hair loss—the wife in two spots on her scalp, the husband in his beard. In both cases, the hair came out suddenly, without any symptoms. Neither has had this problem before. Both patients are otherwise healthy, but they admit to being under a great deal of stress in the weeks prior to onset of the condition.

Before consulting dermatology, they were seen in an urgent care clinic, where they were diagnosed with “ringworm.” Twice-daily application of nystatin cream was prescribed—to no good effect.

EXAMINATION
On each side of the woman’s parietal scalp is a round, completely hairless patch with exceptionally well-defined margins. The sites are otherwise unremarkable, free of redness, edema, or scaling. Each lesion measures about 3.5 cm in diameter. No lymph nodes are palpable in the adjacent neck.

On the man’s left jawline is a solitary, round, 4-cm, hairless patch. It is also free of edema, erythema, or epidermal disturbance of any kind. There are no palpable lymph nodes in the drainage area.

What is the diagnosis?

 

 

DISCUSSION
Sudden, asymptomatic, complete, well-marginated hair loss in any hair-bearing area is likely to be alopecia areata (AA). AA is an autoimmune process in which hair follicles are immobilized and unable to grow new hair until the process stops, which usually happens within weeks to months.

Because stress and AA have a suspected correlation, the patients’ histories of recent stress corroborate the diagnosis. Other features that bolster this impression are the lack of epidermal disturbance (eg, scaling, redness, edema) or palpable nodes in the area. The unusual factor in this case was the simultaneous appearance of the condition in husband and wife—for which I have no good explanation.

There are many items in the differential for localized hair loss, including discoid lupus, lichen planopilaris, and tinea capitis. However, these almost always manifest with frank inflammation characterized by epidermal disturbance.

Treatments such as intralesional steroid injection can promote modest hair growth but are generally ineffective for long-term recovery; unless the procedure is repeated, the hair will continue to fall out. These patients were offered treatment but declined, and they recovered in a short period of time.

TAKE-HOME LEARNING POINTS
• Alopecia areata (AA) typically displays as acute, asymptomatic, complete hair loss in one or more hair-bearing locations, usually in a round, well-defined configuration.
• AA is an autoimmune process that immobilizes hair follicles, causing them to fall out and not be replaced until the process ceases. This can take months, and the condition does not respond well to treatment.
• AA can affect the scalp, beard, brows, or even genital hair.
• The differential for localized hair loss includes tinea capitis, discoid lupus, lichen planopilaris, and lues; however, these all involve disruption of the overlying skin with scaling, redness, or edema.

A 29-year-old woman and her 40-year-old husband present together for evaluation of similar problems: One month ago, they both experienced sudden hair loss—the wife in two spots on her scalp, the husband in his beard. In both cases, the hair came out suddenly, without any symptoms. Neither has had this problem before. Both patients are otherwise healthy, but they admit to being under a great deal of stress in the weeks prior to onset of the condition.

Before consulting dermatology, they were seen in an urgent care clinic, where they were diagnosed with “ringworm.” Twice-daily application of nystatin cream was prescribed—to no good effect.

EXAMINATION
On each side of the woman’s parietal scalp is a round, completely hairless patch with exceptionally well-defined margins. The sites are otherwise unremarkable, free of redness, edema, or scaling. Each lesion measures about 3.5 cm in diameter. No lymph nodes are palpable in the adjacent neck.

On the man’s left jawline is a solitary, round, 4-cm, hairless patch. It is also free of edema, erythema, or epidermal disturbance of any kind. There are no palpable lymph nodes in the drainage area.

What is the diagnosis?

 

 

DISCUSSION
Sudden, asymptomatic, complete, well-marginated hair loss in any hair-bearing area is likely to be alopecia areata (AA). AA is an autoimmune process in which hair follicles are immobilized and unable to grow new hair until the process stops, which usually happens within weeks to months.

Because stress and AA have a suspected correlation, the patients’ histories of recent stress corroborate the diagnosis. Other features that bolster this impression are the lack of epidermal disturbance (eg, scaling, redness, edema) or palpable nodes in the area. The unusual factor in this case was the simultaneous appearance of the condition in husband and wife—for which I have no good explanation.

There are many items in the differential for localized hair loss, including discoid lupus, lichen planopilaris, and tinea capitis. However, these almost always manifest with frank inflammation characterized by epidermal disturbance.

Treatments such as intralesional steroid injection can promote modest hair growth but are generally ineffective for long-term recovery; unless the procedure is repeated, the hair will continue to fall out. These patients were offered treatment but declined, and they recovered in a short period of time.

TAKE-HOME LEARNING POINTS
• Alopecia areata (AA) typically displays as acute, asymptomatic, complete hair loss in one or more hair-bearing locations, usually in a round, well-defined configuration.
• AA is an autoimmune process that immobilizes hair follicles, causing them to fall out and not be replaced until the process ceases. This can take months, and the condition does not respond well to treatment.
• AA can affect the scalp, beard, brows, or even genital hair.
• The differential for localized hair loss includes tinea capitis, discoid lupus, lichen planopilaris, and lues; however, these all involve disruption of the overlying skin with scaling, redness, or edema.

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