Soundings Newsletter Spring 2020 PAO-HNS

Soundings SPRING 2020

PUBLISHED IN THE INTEREST OF OUR MEMBERS AND THEIR PATIENTS

President’s Message outpouring of information and knowledge sharing I have witnessed between otolaryngologists, as well as organizations during this dark time. Initially we knew so little, but understood we should have special concerns about the types of procedures we do and how COVID-19 affected our patients, but uniquely our staff and ourselves. Much remains unanswered, but new information continues to arise almost daily. I encourage everyone to continue those collaborate efforts, and to review websites like ours, the CDC, PAMED, AAOHNS, and the PA Department of Health for information.

Johnathan D. McGinn, MD, FACS PAO-HNS President This message, as well as the majority of this newsletter, Soundings, was written in February. Related to various minor delays and the COVID-19 pandemic, publication was delayed beyond our typical date.

As we were looking at proofs, I came to realize how surreal this time has become.

My original message focused on enjoying the spring weather, the advocacy work we had been doing, and looking forward to a great summer and our Annual Scientific Meeting at Nemacolin Resort. Obviously, much has changed for all of us, our patients, and our nation in that interval, so a re-write was in order.

I know many questions still exist regarding COVID-19 and the impact it has had, and will continue to have, on our practices.

While we are starting to see some light at the end of the proverbial tunnel, I hope that light is not the light of an oncoming new train. I expect we will see some resumption of in-person outpatient visits, operative cases, and “normalcy” in the coming weeks. As we transition to the next phase of the COVID-19 pandemic, what our true new “normal” will be, however, is far from clear. I am proud of the

Much remains unanswered, but new information continues to arise almost daily.

While so much of our lives has been focused on COVID-19, it still remains important to highlight other issues going on in our profession and state.This winter has provided us with several opportunities in advocating for our patients and colleagues, and we have coordinated with state and national groups in those efforts.

On the national level, we partnered with the American Academy of Otolaryngology—Head and Neck Surgery to oppose bills introduced in to both the House and Senate (HR4056 and S2446) which would allow audiologists unfettered direct access to Medicare patients and amend the Social Security Act to label audiologists as practitioners.

Similar efforts have been made in previous Congressional sessions, which we likewise opposed. On a state level, we have advocated for HB1220 supporting CMV education and newborn screening and the bill has passed the House and is being considered in the Senate. We also collaborated with PAMED and several

specialty organizations opposing HB1862, which addresses Surprise Medical Bills.

While all groups support the concept of taking patients out of the middle of insurerprovider out-of-network billing disputes, the rates established for reimbursement jeopardize access to care in the state.

We supported two amendments to the bill which would adjust the reimbursement to more reasonable rates and streamline the arbitration process. No recent motion has occurred on this bill. PAOHNS was also involved in a letter of concern on the proposed procedural rules change on medical liability venue change. We have signed on to a recent letter to the PA Supreme Court opposing the trial lawyers’ efforts to continue pre-trial proceedings against healthcare professionals during the pandemic, and have supported other efforts to seek civil suit immunity for healthcare workers battling the pandemic.

We also have been advocating for our membership via letters requesting the state’s main insurers reconsider their policies on reimbursement for drug-eluting stents for office and operative room placement. Committee members have also participated in discussions on proposed coverage determinations for hypoglossal nerve stimulators. PAOHNS has been in communication with Aetna over their Sinus Surgery policy and have been able to guide them to some upcoming revisions.

When these types of issues arise and impact your practice and your patients, please engage us in efforts to support your concerns.

My original message spoke of two upcoming events to anticipate. The first was the annual AAOHNS/F Leadership Forum and Board of Governor’s Spring Meeting May 1-3, 2020. While the event has been canceled this year, there are BOG meetings September 12, 2020, Continued on page 2

President’s Message Continued from page 1

at the national meeting, as well as next April 16-18, 2021. Our state will continue to be well represented by Dr. Rizzo, the BOG Secretary and PA Governor, but also others in leadership of this organization and specialty societies. The second event is our Annual Scientific Meeting, which has been expectedly altered from its original state.

You should have received save the date emails for our annual PAOHNS Annual Scientific Meeting and its virtual format this year. Planning has gone well under the leadership and innovation of Colin Huntley, MD and Pam Roehm, MD. Kudos to them for the heroic effort to re-organize the whole meeting format in a very short time. We have transitioned the meeting to an all-day Saturday CME webinar event as opposed to the traditional Friday and Saturday mornings. Sessions on the state of the art in thyroid nodule management, advances in hearing loss and assistance devices, and cutting-edge therapies and frontiers in our specialty are still included, as are the usual scientific abstract presentations. The ever-popular Resident Jeopardy Bowl has been modified this year based on logistics to a “Pub Trivia” format Friday evening. Dr. Angela Powell will be our guest for the Women in Otolaryngology event Saturday evening after the main session. We will have virtual exhibitors to visit and ask you to encourage your local corporate representatives to support this novel event format. We hope you all will register ASAP and join us for this great event.

Lastly, I want to welcome Ariel Jones, our new Executive Director for PAOHNS, to our leadership team. She joined us in December 2019, and is already working hard to support our efforts in the specialty society.

Additionally, I want to thank all of those on our leadership team, both physician members and our administrative staff, for their efforts in keeping this organization vibrant and meaningful in this challenging time.

Be safe and stay well.

Sincerely, Johnathan D. McGinn, MD

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Contents | Spring 2020 1 President’s Message 3 Specialty Leadership Cabinet 4 Legislative Update 5 BOG Update 9 The Role of Biologics in Chronic Rhinosinusitis 11 That Pesky Human Factor

President Johnathan D. McGinn, MD, FACS Penn State Hershey Otolaryngology-Head & Neck Surgery 500 University Dr., Ste. 400 UPC, H091 Hershey, PA 17033-2360 President-Elect David M. Cognetti, MD, FACS Otolaryngology-Head & Neck Surgery 925 Chestnut St Fl 6 Philadelphia PA 19107-4204 Secretary-Treasurer Jessyka G. Lighthall, MD Penn State Hershey Otolaryngology-Head & Neck Surgery 500 University Dr., Ste. 400 UPC, H091 Hershey, PA 17033-2360 Administrative Office 777 East Park Drive, PO Box 8820 Harrisburg, PA 17105-8820 717-558-7750 ext. 1519 717-558-7841 (fax) Visit our website at www.otopa.org

Soundings accepts classified advertisements; however, there is no guarantee that they will be published. All submissions are subject to review. The advertisement should be of interest/pertain to otolaryngologists, their practice, and health care in Pennsylvania. Submissions that are selfpromotional or commercial in nature will not be accepted. Publication of advertising does not imply endorsement of the products advertised or the statements contained in such advertising by Soundings or the PAO-HNS. The opinions expressed in this newsletter do not necessarily reflect the opinion of PAO-HNS.

Specialty Leadership Cabinet The SLC will likely be undergoing some changes this year. PAMED has decided to engage a new web platform to create virtual SLC “meetings” to discuss any specialty’s concerns, and engage these concerns more often than three times a year. This new format will not alleviate all of the in-person meetings, but PAMED feels it will create a venue to more rapidly assess issues, while still providing opportunity for online discussions, question and answers, and voting. The new system will be demonstrated at the SLC meeting, May 5, 2020.

Johnathan D. McGinn, MD, FACS PAO-HNS President The PAMED Specialty Leadership Cabinet (SLC) is an advisory group consisting of the leadership of state specialty societies, and serves as a conduit for discussion of relevant specialty issues that can then be brought to the PAMED Board. Traditionally this group meets in the PAMED offices three times per year.

Our most recent meeting was held on February 4, 2020.

This new format will not alleviate all of the in-person meetings, but PAMED feels it will create a venue to more rapidly assess issues.

An update on the Hahnemann closure and the impact to residents and physician, specifically in the area of medical liability insurance. Hahnemann had a claims made

policy, but the tail policy was not provided by the institution. PAMED, the AMA, the Philadelphia County Medical Society, and Drexel University have all been engaged to remedy this problem and have called on the state to intervene. While extensions have been made for the deadline to secure a tail policy, those deadline extensions may expire at some point, leaving many residents and physicians without insurance, and jeopardizing their licenses. PAMED maintains a website with updates on the issue: https://www. pamedsoc.org/list/articles/hahnemannuniversity-hospital-closure.

Senator Kristin Phillips-Hill (R-York County) met with the SLC to review advocacy efforts she is making on behalf of physicians in the state, including fighting current preauthorization policies, medical liability venue change, and CRNP scope of practice.

Legislative updates are available in the section from Milliron and Goodman.

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Legislative Update

Overview While lawmakers are in the middle of their usual spring session, things are far from business as usual in Harrisburg.

The novel coronavirus, COVID-19, has closed the capitol building to everyone except legislators, key staff, and certain credentialed press. Both the House and Senate are operating under special rules that allow swift consideration of bills and shorter timeline for those bills to be amended.

The legislature has been focusing a bulk of their work on relief efforts for those impacted by COVID-19 including such things as changes to unemployment compensation rules, providing guidance for school districts amid building closures and requiring the Pennsylvania Health Care Cost Containment Council to study the impact of COVID-19 on hospitals and health systems.

At the time of this writing, the legislature has sent SB857, a telemedicine bill, to the Governor. However, Governor Wolf has vetoed the measure because the bill contains language that prohibits telemedicine on those drugs that have a Risk Evaluation and Mitigation Strategy enforced by the FDA. The Governor sees this provision as anti-choice and the debate on the telemedicine bill focused solely on abortion.

In addition to legislative initiatives, the Governor has issued myriad executive orders pertaining to COVID-19 including waiving licensing requirements to allow retired health care professionals to practice during the Coronavirus emergency.

The Session Schedule at the time of this writing is as follows:

2020 PA SENATE SESSION SCHEDULE April May June

6, 7, 8 (cancelled), 15, 20, 21 4, 5, 6, 18, 19, 20 1, 2, 3, 8, 9, 10, 15, 16, 17, 22, 23, 24, 25, 26, 29, 30

2020 PA HOUSE SESSION SCHEDULE April May

June September October November

6, 7, 13 (non-voting), 14, 16 (non-voting), 20, 21, 27, 28, 29 4, 5, 6, 11, 12, 13, 18 (non-voting), 19 (cancelled), 20 (cancelled) 1, 2, 3, 8, 9, 10, 15, 16, 17, 22, 23, 24, 25, 26, 29, 30 15, 16, 17, 29, 30 1, 5, 6, 7, 19, 20, 21 10

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Hospital Regulations At the time of this writing, the hospital regulations have not been made public and we anticipate further delay due to the COVID-19 crisis.

The proposed draft regulations will be made public once they are published in the Pennsylvania Bulletin. At that time, the clock starts on a 30-day public comment period.

The proposed draft regulations are over 500 pages, including preamble, proposed changes, and analysis. Once released, we will be reviewing these regulations and PAO-HNS will be commenting on any proposed changes that would negatively impact your practice and the care you provide to your patients.

Opioids Milliron Goodman is still monitoring opioid legislation in the general assembly, however, nearly all of those bills have been put on hold for now while the legislature deals with matters pertaining to COVID-19.

We will continue to monitor and ensure that any changes to laws or policy around opioids will have the input of PAO-HNS Balance Billing Legislation addressing out-of-network balance billing is gaining momentum nationally and on the state level. Most recently, Governor Wolf proposed this as part of Pennsylvania’s COVID-19 Recovery Plan for Health Care Systems and Providers. Specifically, the plan calls for “making sure that patients who seek out in-network care aren’t surprised with a bill for treatment by an out-of-network provider at an in-network facility.”

Clinical and Surgical reopening Our firm will continue to have dialogue with the Administration on how to safely reopen healthcare services in the Commonwealth.

At this point, we expect the rollout of reopening to be regional and a data driven reopening. It seems, at this point, the reopening will the reverse of the state’s regional closure in March.

AAO/HNS Board of Governors The Academy continues to support legislation that takes patients out of the middle of billing disputes and includes a mediation process with no qualifying threshold. The House Ways and Means Committee recently advanced HR5826 the “Consumer Protections Against Surprise Medical Bills Act” created to protect patients from unanticipated medical bills.

The Academy supports any legislation that would protect patients by including Independent Dispute Resolution without payment benchmarks.

Karen A. Rizzo, MD, FACS Governor The American Academy of Otolaryngology/Head and Neck Surgery has been busy advocating and supporting issues of importance to its membership.

The AAO/HNS leads efforts to oppose audiology direct access legislation. The Academy recently sent letters strongly opposing federal legislation HR4056/ S2446 that grants unlimited direct access of Medicare patients to audiologists without a physician referral. The letters which were sent to House and Senate leadership were signed by 120 national, state, and local medical societies.

Promoting patient safety and physician oversight in treating patient’s hearing loss continues to be a top priority for the AAO.

The AAO/HNS recently responded to requests from Medicare on Scope of Practice concerns which directly impact our specialty. It reinforced the importance in education and training of physicians and nonphysicians and highlighted the vast differences that exist, stressing the importance of maintaining physician leadership of the healthcare team and requiring physician supervision of nonphysician professionals.

The AAO continues its advocacy efforts addressing the Youth E-Cigarette Epidemic.

It expressed strong support for HR2339, the “Reversing Youth Tobacco Epidemic Act of 2019”, which would ban all flavored tobacco products including menthol cigarettes and prohibit all online sales of e-cigarettes.

Following an extensive review process involving several AAO/HNS committees and the Physician Payment Policy (3P) Workgroup, the AAO submitted responses to 7 new Blue Cross Blue Shield reviews: Implantable Bone-Conduction and Bone Anchored Hearing Aids, Cochlear Implant, Eustachian Tube Balloon Dilation, FESS for Chronic Rhinosinusitis, Middle Ear Implantable Hearing Aids, Steroid Eluting Sinus Stents, and Treatment of Tinnitus.

These 2020 summaries will be used by the Blues to determine coverage policies.

The AAO recently sent comments to the Blues Federal Employee program opposing their policy designating balloon ostial dilation as experimental or investigational.

The Academy highlighted their Position Statement and Clinical Consensus Statement on this procedure and provided extensive literature supporting this procedure as the standard of care.

Karen A. Rizzo, MD FACS / BOG Governor and Secretary Lancaster Ear, Nose, & Throat

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Updates in Congenital Cytomegalovirus Rachel L. Whelan, MD, Dennis J. Kitsko, DO and Jeffrey P. Simons, MD Accounting for approximately 20% of all congenital hearing loss, congenital cytomegalovirus (c-CMV) infection remains the leading non-genetic cause of sensorineural hearing loss to date. While the majority of children with congenital CMV infection remain asymptomatic, 10% of children have manifestations of disease at birth. Signs and symptoms of disease span a wide spectrum of severity ranging from rash or jaundice to more severe retinitis, microcephaly, and/or central nervous system involvement. Approximately 5% of c-CMV infants are found to have some degree of sensorineural hearing loss at birth, increasing to 15% by 5 years of age1. Due to the potential for later onset and/or progression of hearing loss over time, recommendations for early and continued audiometric testing remain important.

While CMV is most commonly transmitted through direct contact with bodily fluids including saliva, urine, or breastmilk, congenital CMV is acquired via a transplacental route. Akin to other members of the herpesvirus family, a hallmark of CMV infection is the propensity to remain latent following seroconversion. This characteristic allows congenital infection to occur as a result of either primary maternal infection or reactivation of latent disease. Diagnosis of congenital CMV requires positive testing less than 3 weeks post-partum, with salivary PCR for CMV IgM via cheek swab largely replacing traditional tissue culture testing in recent years. False positive testing can occur in the setting of seropositive breast-feeding mothers, in which case urine PCR is used as confirmatory testing2.

Given the nearly 100% prevalence of CMV in the general population, combined with the lack of effective vaccination and lack of data to support treatment for CMV during pregnancy, the Centers for Disease Control and Prevention (CDC) currently recommends against universal screening in both pregnant women and asymptomatic neonates1. Pregnant women

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are encouraged to observe frequent handwashing and limit exposure to potentially infected secretions of younger children (i.e. sharing drinks or changing diapers) as able.

For children born with sequelae suggestive of possible infection, recent years have seen significant expansion in state-based initiatives with respect to CMV screening guidelines. Enacted in April 2019, the state of Pennsylvania currently mandates CMV testing in all neonates who fail newborn hearing screening or upon specific parental request3.

Evidence for the treatment of congenital CMV centers largely upon hearing outcomes. A randomized controlled trial

by Kimberlin et al. in 2003 demonstrated significant hearing benefit in c-CMV infants with symptomatic disease treated with IV ganciclovir when compared to controls, with 0% compared to 41% showing respective hearing deterioration over a 6-month period (p<0.01), a difference that persisted on 12-month follow up ABR testing4. Further data suggested similar bioavailability to the oral antiviral agent valganciclovir, which remains the standard treatment to date5. Rates of neutropenia vary between 20-60% in the literature and must be discussed prior to initiation of therapy. Should hearing loss progress despite medical treatment, children with severe to profound hearing loss have shown comparable outcomes to age-matched peers following cochlear implantation with respect to hearing outcomes, language production, and perception skills6.

As the diagnosis of congenital CMV must be made within 3 weeks post-partum, investigation in recent years has questioned the utility of retrospective diagnosis via archived newborn dried blood spot (DBS) testing. In one study, PCR testing of archived DBS in children with unexplained sensorineural hearing loss identified CMV DNA in 15 of 57 patients, suggesting the potential to identify hearing loss etiology that otherwise would remain unknown7.

However, retrospective DBS analysis in children with known c-CMV positively identified only 11/26 with hearing loss and 72/270 without hearing loss, concluding poor sensitivity and specificity with an

inability for DBS testing to reliably identify those with c-CMV nor predict associated hearing loss.8 Further studies regarding the utility of DBS testing for c-CMV are ongoing.

Congenital CMV confers a wide spectrum of disease manifestations and remains a common cause of congenital hearing loss. While the severity and progression of associated hearing loss varies greatly, prompt testing and initiation of antiviral treatment remain paramount. Future research efforts geared towards vaccination development as well as identification of a reliable biomarker to prognosticate disease course and severity are needed.

References 1. Marsico C, Kimberlin DW. Congenital Cytomegalovirus infection: Advances and challenges in diagnosis, prevention and treatment. Ital J Pediatr. 2017;43(1):38. doi:10.1186/s13052-017-0358-8 2. Dobbie AM. Evaluation and management of cytomegalovirus-associated congenital hearing loss. Curr Opin Otolaryngol Head Neck Surg. 2017;25(5):390395. doi:10.1097/MOO.0000000000000401 3. THE GENERAL ASSEMBLY OF PENNSYLVANIA. https://www.legis.state.pa.us/cfdocs/legis/PN/Public/ btCheck.

4. Kimberlin DW, Lin CY, Sรกnchez PJ, et al. Effect of ganciclovir therapy on hearing in symptomatic congenital cytomegalovirus disease involving the central nervous system: A randomized, controlled trial.

J Pediatr. 2003;143(1):16-25. doi:10.1016/S00223476(03)00192-6 5. Kimberlin DW, Jester PM, Sรกnchez PJ, et al. Valganciclovir for symptomatic congenital cytomegalovirus disease.

N Engl J Med. 2015;372(10):933-943. doi:10.1056/ NEJMoa1404599 6. Yoshida H, Takahashi H, Kanda Y, Kitaoka K, Hara M. Long-term outcomes of cochlear implantation in children with congenital cytomegalovirus infection.

Otol Neurotol. 2017;38(7):e190-e194. doi:10.1097/ MAO.0000000000001483 7. Meyer L, Sharon B, Huang TC, et al. Analysis of archived newborn dried blood spots (DBS) identifies congenital cytomegalovirus as a major cause of unexplained pediatric sensorineural hearing loss. Am J Otolaryngol - Head Neck Med Surg. 2017;38(5):565-570. doi:10.1016/j.amjoto.2017.06.002 8. Ross SA, Ahmed A, Palmer AL, et al. Newborn Dried Blood Spot Polymerase Chain Reaction to Identify Infants with Congenital Cytomegalovirus-Associated Sensorineural Hearing Loss. J Pediatr. 2017;184:57-61. e1. doi:10.1016/j.jpeds.2017.01.047

Contemporary Management of CSF Otorrhea Philip L. Perez M.D., Barry E. Hirsch M.D., Andrew A. McCall M.D. Department of Otolaryngology, University of Pittsburgh Medical Center A CSF (cerebrospinal fluid) leak of the lateral skull base occurs when there is a connection between the intradural compartment and the pneumatized temporal bone. While CSF otorrhea may result from trauma, infection, cholesteatoma, or surgery, it most commonly arises spontaneously (idiopathic CSF otorrhea), with no inciting event or cause identified. The precipitating event of otorrhea is often a myringotomy (with or without a myringotomy tube) done to drain an effusion from the middle ear. The incidence of spontaneous CSF leakage and encephalocele of the lateral skull base has risen sharply commensurate with the rise in obesity rates.1 This positive correlation has been attributed to the hypothesized underlying pathophysiology, in which chronically increased intracranial pressure leads to erosion of the temporal bone.2 Diagnosing spontaneous CSF leaks of the lateral skull base can be challenging due to the nonspecific signs and symptoms associated with this process. Patients most commonly present with aural fullness, hearing loss, a clear effusion of the middle ear, or persistent otorrhea following placement of a myringotomy tube. On rare occasion, a patient may present with sudden clear fluid rhinorrhea. Making the diagnosis requires a high index of suspicion to distinguish this entity from more common diseases, such as acute or chronic serous otitis media. The traits most commonly associated with spontaneous CSF otorrhea include obesity, female gender, middle age, obstructive sleep apnea, and benign intracranial hypertension, which may help point the clinician toward the correct diagnosis.

Less commonly, CSF otorrhea will be discovered after a patient develops bacterial meningitis. The risk of meningitis is a major driving factor for addressing

CSF otorrhea surgically. Unlike traumatic causes of CSF leak, spontaneous CSF leak of the lateral temporal bone has a low rate of spontaneous healing.3 When a lateral skull base CSF leak is suspected, high resolution CT, including both axial and coronal formats, is sensitive for identification of dehiscence of the temporal bone, which occurs much more commonly in the tegmen mastoideum and tegmen tympani than the petrous apex or posterior fossa plate, and which may occur in multiple sites.4 Nonspecific opacification of the air cells of the temporal bone is commonly seen. MRI with T2 weighted coronal sequences (FIESTA or CISS) can identify the presence of an encephalocele and CSF fistula in many cases, and may also demonstrate findings associated with benign intracranial hypertension, such as empty sella syndrome. These two imaging modalities are complimentary and are recommended in most cases. In-clinic or at-home collection of otorrhea may be sent for beta-2 transferrin, which has a sensitivity of 99% but which may be falsely negative in the presence of infection.5 Intermittent drainage does not rule out this diagnosis, as a ball-valve effect can occur with small encephaloceles.

Surgical repair can be performed via middle cranial fossa (MCF), transmastoid, or combined approaches. Our technique for the most common bony defect associated with CSF otorrhea â&#x20AC;&#x201C; tegmen defect(s) â&#x20AC;&#x201C;typically involves a MCF approach performed as team surgery with our Neurosurgery colleagues, which enables visualization and repair of defects of the entire tegmen. We perform a multilayered closure that routinely includes temporalis fascia, a split calvarial bone graft, vascularized deep temporalis fascia-periosteal flap, and addressing the dural defect. Other groups describe successful use of hydroxyapatite bone cement to repair these defects.6 Titanium mesh has been associated with increased risk of postoperative infection.7 Because elevated ICP is believed to underlie this diagnosis, our group treats benign

intracranial hypertension aggressively in the postoperative period to reduce the risk of development of recurrent CSF otorrhea or CSF leaks from other sites. A preoperative spinal tap and drain are placed at the beginning of the procedure. A normal pressure measurement may be seen due to the patient having their pressure lowered from spontaneous fistula drainage. For patients with elevated ICP, medical therapy with acetazolamide (Diamox) is the first line of therapy; our group has a relatively low threshold for progressing on to placement of a ventriculoperitoneal shunt when medical management is insufficient.8 Successful surgical repair of spontaneous CSF leaks is quoted in the literature to range from 72-100%, with higher rates associated with multilayer closures.2,9 Complication rates following MCF are <5%, with seizure, temporary neurological defect, and hematoma being most common.9 Long-term follow up of these patients is advised, given the potential for ongoing underlying pathophysiology and remote recurrence.

Although relatively uncommon, spontaneous CSF leak of the lateral skull base will likely continue to increase in incidence. Its nonspecific presentation requires thoughtful diagnostic consideration, aided by multimodal imaging and beta-2 transferrin testing.

Surgical repair in the hands of an experienced team is recommended to prevent the life-threatening complication of meningitis. Postoperative long-term management of benign intracranial hypertension is necessary.

References 1. Nelson RF, Gantz BJ, Hansen MR. The rising incidence of spontaneous cerebrospinal fluid leaks in the United States and the association with obesity and obstructive sleep apnea. Otol Neurotol 2015; 36:476-480.

2. Kutz JW, Jr., Tolisano AM. Diagnosis and management of spontaneous cerebrospinal fluid fistula and encephaloceles. Curr Opin Otolaryngol Head Neck Surg 2019; 27:369-375.

Continued on page 8

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Contemporary Management of CSF Otorrhea Continued from page 7

3. S avva A, Taylor MJ, Beatty CW. Management of cerebrospinal fluid leaks involving the temporal bone: report on 92 patients. Laryngoscope 2003; 113:50-56.

4. Cooper T, Choy MH, Gardner PA, Hirsch BE, McCall AA. Comparison of Spontaneous Temporal Bone Cerebrospinal Fluid Leaks From the Middle and Posterior Fossa. Otol Neurotol 2020; 41:e232-e237.

5. Korem M, Ovadia H, Paldor Iet al. False negative beta-2 transferrin in the diagnosis of cerebrospinal fluid leak in the presence of Streptococcus pneumoniae. Laryngoscope 2015; 125:556-560.

6. Kutz JW, Jr., Johnson AK, Wick CC. Surgical management of spontaneous cerebrospinal fistulas and encephaloceles of the temporal bone.

Laryngoscope 2018; 128:2170-2177.

7. Carlson ML, Copeland WR, 3rd, Driscoll CLet al.

Temporal bone encephalocele and cerebrospinal fluid fistula repair utilizing the middle cranial fossa or combined mastoid-middle cranial fossa approach. J Neurosurg 2013; 119:1314-1322.

8. Vivas EX, McCall A, Raz Y, Fernandez-Miranda JC, Gardner P, Hirsch BE. ICP, BMI, surgical repair, and CSF diversion in patients presenting with spontaneous CSF otorrhea. Otol Neurotol 2014; 35:344-347.

9. Gonen L, Handzel O, Shimony N, Fliss DM, Margalit N. Surgical management of spontaneous cerebrospinal fluid leakage through temporal bone defects--case series and review of the literature.

Neurosurg Rev 2016; 39:141-150; discussion 150.

New Members Catherine Weng, MD

ENT Associates

Jaqueline Tucker, MD Student

Penn State Hershey Medical Center

Rebecca Chiffer, MD

Assistant Professor

Mark Fadel, MD, JD Linda Magana, MD, PhD

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Eye and Ear Institute

The Role of Biologics in Chronic Rhinosinusitis Heather N. Ungerer, BA, Jasmine Miravitlles, BS, Ishita Srivastava, BS, George R. Gardner, BS, John V. Bosso, MD, Nithin D. Adappa, MD—Hospital of the University of Pennsylvania There has been recent interest from the Otolaryngology community regarding the promise of biological therapy in the management of chronic rhinosinusitis with nasal polyps (CRSwNP). Due to the target-specific nature of biologics and their ability to act on the immune system and inflammatory pathways, this form of treatment has evolved into a growing field of biomedical interest, research, and clinical applications.

The June 2019 approval by the FDA of dupilumab (Dupixent), for treatment of CRSwNP, has prompted a discussion about the future role of biologics in CRSwNP management. Dupilumab is a monoclonal antibody that binds to the IL-4 receptor, thereby inhibiting the signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two cytokines that play a key role in type 2 (T2) inflammation. Dupilumab is also currently indicated for the treatment of two other inflammatory conditions, atopic dermatitis and asthma. The successful outcomes of biologics in inflammatory conditions such as these have sparked much of the corresponding research for its application in CRSwNP. The approval of dupilumab is based on two multinational, multicenter studies, LIBERTY NP SINUS-24 and LIBERTY NP SINUS-52. These studies evaluated the efficacy and safety of dupilumab in patients with CRSwNP who, at any point in the past two years, failed either systemic or intranasal corticosteroid treatment and/or surgical intervention.

The two studies combined involved a total of 724 patients (438 test patients, 286 placebo patients) and outcomes were based on changes in nasal polyp score (NPS) and in the 22-item Sino-Nasal Outcome Test (SNOT-22) score. Test patients receiving dupilumab showed a statistically significant improvement in NPS

and in SNOT-22 score. These outcomes indicate that dupilumab has the potential to be an important tool for physicians in treating CRSwNP patients. However, it is the very novelty of dupilumab and using biological therapies to treat CRSwNP that necessitates a conversation about the indications for its usage given the breadth of other forms of medical management and surgical options available and the high cost of the drug itself.

The difficulty in determining the proper indications for dupilumab stems from the promising, yet sparse data on how to best combine this drug with other medical treatments, such as oral or topical corticosteroids, immunotherapy, and sinus surgery. Important considerations include: severity of CRSwNP disease, the specific endotype of CRSwNP (e.g. aspirin exacerbated respiratory disease, or AERD) and the presence of comorbidities (especially moderate to severe asthma).

The other confounder is cost. Currently, dupilumab has an average wholesale price of over $40,000 annually. In addition, this may be a lifelong therapy for patients as inhibition of IL-4 and IL-13 ends with cessation of medication. Of additional consideration are patient preferences. Dupilumab is currently available as a self-administered injection every two weeks and comes with inherent associated risks and side effects of such therapy. Adverse events include injection site reactions, conjunctivitis (reported in up to 28% of patients), oral herpes and nonlife-threatening allergic reactions.

out sinus disease by way of endoscopic sinus surgery (ESS), using oral and topical corticosteroids, and in the case of specific endotypes of CRSwNP such as AERD, aspirin desensitization, all remain highly effective approaches to treat this chronic inflammatory condition. Thus, they are unlikely to be completely supplanted by dupilumab. For those cases recalcitrant to pre-existing therapy used at its full potential, dupilumab will serve as an adjunctive treatment. Long term outcomes and all potential long-term adverse events remain to be seen. As with most new therapies, more data, research, and time is needed to determine the ultimate role T2 biologic therapy will play in treating CRSwNP. References 1. Claus Bachert, Joseph K Han, et al., Efficacy and safety of dupilumab in patients with severe chronic rhinosinusitis with nasal polyps (LIBERTY NP SINUS-24 and LIBERTY NP SINUS-52): results from two multicentre, randomised, double-blind, placebo-controlled, parallel-group phase 3 trials, The Lancet, 2019, ISSN 0140-6736, https://doi. org/10.1016/S0140-6736(19)31881-1.

2. Medi-Span 2019 3. U.S. Food and Drug Administration. “FDA approves first treatment for chronic rhinosinusitis with nasal polyps.” U.S. FDA. Press Release, 26 June. 2019.

4. Ou Z, Chen C, Chen A, Yang Y, Zhou W. Adverse events of Dupilumab in adults with moderate-to-severe atopic dermatitis: A meta-analysis. Int Immunopharmacol.

2018;54:303–310. doi:10.1016/j.intimp.2017.11.031 5. D’Ippolito, D., & Pisano, M. Dupilumab (Dupixent): An Interleukin-4 Receptor Antagonist for Atopic Dermatitis.

P & T : a peer-reviewed journal for formulary management, 2018:43(9), 532–535.

While dupliumab is a novel and promising treatment for CRSwNP, care must be taken to evaluate each patient individually with the goal of maximizing the efficacy of their standard treatment. Specific considerations include severity of disease, specific endotype, the presence of comorbidities, patient preferences, and cost-benefit analysis. With the addition of dupilumab to the toolkit of Otolaryngologists, the future of CRSwNP treatment should change only modestly. This is because manually clearing SOUNDINGS | Spring 2020

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The Value of Creating a Multidisciplinary Tracheotomy/Laryngectomy (Neck Airway Team) By: Neerav Goyal MD MPH FACS, Penn State Tracheotomy Team*, Linda Williams, RRT * The Tracheotomy Team members include: Physicians: Jenn Toth, David Goldenberg, Scott Armen, Mike Reed, Will Hazard, Danish Ahmad, John Oh, and Guy Slonimsky, Wound care: Cheryl Bealer. Speech Therapy: Kelly Kaufman and Laura Nairns Since before the days of Chevalier Jackson, otolaryngology â&#x20AC;&#x201C; head and neck surgery has prided itself on its expertise of the cervical airway including the pharynx, larynx, and cervical trachea. Inherent in this was the surgical creation of airways including tracheotomies, tracheostomies, and laryngectomies.

Over the decades, many other specialties are actively involved in surgical airways including trauma surgery, general surgery, cardiothoracic surgery, interventional pulmonology, as well as intensivist/critical care subspecialties. In our hospital, these critical care specialists include those with primary board certification in anesthesiology, internal medicine, and neurosurgery. Recent research demonstrated that there is a decline in the number of surgical airways performed by otolaryngology relative to other specialties1. In addition to the physicians, routine care of airway patients involve the services of floor and critical care nursing staff, respiratory therapists, wound care nurses, care coordination and social workers. Given the multiple physician specialties and other hospital staff members managing the routine care of surgical airways, we appreciated that our hospital had a huge variation in the care recommended and delivered to these patients.

These variations in care include variation in when to change the initial tracheotomy tube, protocols for decannulation, and in management of tracheotomy sites and skin breakdown. In reviewing the recent consensus statement by the American Academy of Otolaryngology â&#x20AC;&#x201C; Head and Neck Surgery, it is clear that there is a lack of consensus even within the specialty2.

In our hospital, we identified these variations as leading to delays in disposition and discharge planning with respect to appropriately educating patients and families in a timely fashion as well as ensuring appropriate size supplies delivered to the house. Additionally, the relative rarity of performing laryngectomies as compared to other airways led to an identifiable knowledge gap across the hospital regarding the care of this particular patient.

With the lead of co-author Linda Williams, a multi-disciplinary meeting was established including trauma, otolaryngologyhead and neck surgery, thoracic, pulmonary and anesthesia to standardize care and protocols for neck airway patients and

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to create a Multidisciplinary Neck Airway Team that develops standards and improves the quality of care for this patient population, their families and staff to ensure the highest standards in patient safety and experience. The Multidisciplinary Neck Airway Team consists of an attending physician, respiratory therapist, speech pathologist and a wound care nurse and rounds weekly on all adult neck airway patients in the hospital. Rounds include assessment of the airway device, skin integrity, emergency supplies, and weaning needs such as (initial or routine trach changes, downsizing, speaking valves, swallow studies, capping trials and decannulation). The respiratory therapist (Linda) is also available throughout the week to provide help to associated care staff. This also includes evaluation and consideration for early tracheotomy in coordination with the attending of record on those patients with an endotracheal tube in place greater than 96 hours for possible.

To address education needs, the team works closely with social services, care coordination, clinical staff and the adult rehabilitation team in the implementation of education for patients and family members to encourage independence and knowledge for discharge. Given the concern for a knowledge gap, the team has also provided education for staff at our institution and affiliated institutions. In addition to the implementation of the neck airway team, an adult rehabilitation team and educational pathways were developed. The adult rehabilitation team consists of trained and knowledgeable respiratory therapists that initiate education for the appropriate path of discharge for neck airway patients and their family members, so they may independently take care of their neck airways. In addition, a two-week adult trach/vent to home education program was created consisting of education for patients and family members in airway device needs, home equipment uses, emergency procedures, expectations of caretakers and a 24-hour independent care session and car transfer to assure the family is comfortable with discharge. We have standardized initial trach changes and suture removal time lines. We have created and are creating standardized protocols for cuff deflation, capping, decannulation and early mobility.

In a preliminary evaluation of our patient data, the baseline average length of stay (LOS) for this patient population in the year prior to this team was 36.9 days. After the launch of the multi-disciplinary team in April 2018, the average LOS decreased by 11 days. While the data set is small and the team feels confident in the worthiness of this program. The implementation of this Multidisciplinary Neck Airway Team created institutional awareness and protocol standardization. It brought together many entities of our medical center to work together as a team with each specialty contributing to improving patient safety and quality. This in turn may decrease LOS, cost, tracheotomy related wounds, length of mechanical ventilation and possibly readmissions while most of all increasing patient experience and satisfaction.

That Pesky Human Factor Ellen S Deutsch, MD, MS, FACS, FAAP, CPPS Editor, Pennsylvania Patient Safety Advisory Medical Director, Pennsylvania Patient Safety Authority When I hear the term “human factor” mentioned in a root-cause analysis or in the discussion of an Incident or Serious Event, I cringe and wait, wondering what the speaker means by that term. I have two concerns, and I look forward to the day when both are unfounded.

My first concern is that mention of “the human factor” is sometimes a code for identifying “what the human did wrong,” intended to reference the perception that human fallibility is inevitable. It’s true that humans make mistakes. Despite good intentions, our knowledge, judgment, and skills can be imperfect. We know that “to err is human”1 and are further told that “to err is human – and let’s not forget it.”2 Fortunately, humans have strengths as well as weaknesses. Humans invent.

Humans create and develop healthcare advances and solutions. Humans solve problems. Humans learn and improve themselves, their teams, and the complex systems they work within. Humans offer empathy and compassion. Healthcare providers work to provide ever-improving healthcare. In fact, “people working in health care are among the most educated and dedicated work force in any industry.”1 The Pennsylvania Patient Safety Authority celebrates these attributes in our annual “I Am Patient Safety” campaign.

Every March, we provide recognition for individuals and groups within Pennsylvania’s healthcare facilities who have demonstrated exceptional activities in support of patient safety, at the Board of Directors meeting and in the Pennsylvania Patient Safety Advisory. We can adopt the refreshing perspective that “to better is human.”3 My second concern is that too few people are aware that Human Factors (HF) is a field of science that can provide insights and techniques to help

us better understand our capabilities and improve our relationships with the complex systems that are integral to providing safe healthcare. HF is “the scientific discipline concerned with the understanding of interactions among humans and other elements of a system.”4 HF professionals apply “theory, principles, data, and methods to design in order to optimize human well-being and overall system performance.”4 Harnessing HF principles can help us augment human capabilities that are weak, such as providing convenient, timely decision support information rather than relying on memorizing long lists of medication dosages. Conversely, employing HF principles can help us leverage human capabilities that are unique and powerful, such as the ability to synthesize complex information from a patient’s history and physical examination to develop an accurate diagnosis.

The range of HF applications in healthcare is quite broad, including both physical and cognitive capabilities and processes.

The Human Factors and Ergonomics Society’s website lists the varied interests of HF experts and provides insight into HF applications that can be useful in healthcare.5 HF experts may address: • The design of a tool or piece of equipment, so that information about correct use is provided within the design of the equipment and the risk of incorrect use is minimized; using ergonomic data and principles to improve the safety, productivity, and quality of work.5 • The design and impact of computer systems and other technologies, including hardware, software, applications, documentation, work activities, and work environment.5 HF recommendations can improve the usability of electronic health records (EHRs), and contribute to improving patient safety by providing guidance about preparing and conveying information so that it can be used by human beings efficiently and effectively.6, 7

• Abstract concepts, such as situational awareness; teamwork; the effects of stress, fatigue, interruptions, and workload on performance; and human cognition and decision making, alone or in conjunction with other individuals or intelligent systems.5,8-10 While it is important for individual healthcare providers and healthcare teams to optimize their own knowledge and skills, their capabilities can be enhanced or constrained by the systems they interact with and work within. Diverse tools, equipment, technologies, protocols and care delivery processes, and systems are indivisibly integrated into the application of knowledge and skill in healthcare.

Healthcare organizations are increasingly integrating HF expertise in patient care and research activities. Applying sound HF principles can help optimize the relationships between healthcare providers and healthcare delivery tools, technologies, and systems, for the benefit of our patients.

I look forward to the day when widespread knowledge of HF principles allows us to support, utilize, and celebrate human capabilities.

Notes 1. Institute of Medicine Committee on Quality of Health Care in America. Kohn LT, Corrigan JM, Donaldson MS, eds. To err is human: building a safer health system.

Washington (DC): National Academy Press; 1999 Nov 1. 223 p.

2. Croskerry P. To err is human--and let’s not forget it. CMAJ 2010 Mar 23;182(5):524. Also available: http://dx.doi. org/10.1503/cmaj.100270. PMID: 20231338.

3. MedStar Health National Center for Human Factors in Healthcare [website]. Washington (DC): MedStar Health; [accessed 2014 Nov 02]. Available: http:// www.medicalhumanfactors.net/ 4. What is ergonomics? Definition and domains of ergonomics [online]. International Ergonomics Association (IEA); 2016 [accessed 2016 Mar 27].

Available: http://www.iea.cc/whats/ 5. Descriptions of all technical groups [online]. Santa Monica (CA): Human Factors and Ergonomics Society (HFES); [accessed 2016 Mar 27]. Available: https:// www.hfes.org/web/TechnicalGroups/descriptions.html

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PRSRT STD US POSTAGE PAID HARRISBURG PA PERMIT NO 922 777 East Park Drive PO Box 8820 Harrisburg, PA 17105

That Pesky Human Factor Continued from page 11 6. Armijo D, McDonnell C, Werner K. Electronic health record usability: Interface design considerations. AHRQ Publication No. 09(10)-0091-2-EF. Rockville (MD): Agency for Healthcare Research and Quality (AHRQ); 2009 Oct. 21 p. Also available:

10. S alas E, Cooke NJ, Rosen MA. On teams, teamwork, and team performance: discoveries and developments.

Hum Factors 2008 Jun;50(3):540-7. PMID: 18689065.

https://healthit.ahrq.gov/sites/default/files/docs/ citation/09-10-0091-2-EF.pdf

Supplemental Material

7. Lowry SZ, Quinn MT, Ramaiah M, et al. A human factors guide to enhance EHR usability of critical user interactions when supporting pediatric patient care.

Gaithersburg (MD): National Insitute of Standards and Technology (NIST); 2012 Jun. 44 p. Also available: http://dx.doi.org/10.6028/NIST.IR.7865 8. IOM (Institute of Medicine). Resident duty hours: enhancing sleep, supervision, and safety. Washington (DC): The National Academies Press; 2009. 400 p.

Also available: http://www.nationalacademies.org/ hmd/Reports/2008/Resident-Duty-Hours-EnhancingSleep-Supervision-and-Safety.aspx 9. Weller J, Boyd M, Cumin D. Teams, tribes and patient safety: overcoming barriers to effective teamwork in healthcare. Postgrad Med J 2014 Mar;90(1061):14954. Also available: http://dx.doi.org/10.1136/ postgradmedj-2012-131168. PMID: 24398594.

Selected Resources for Additional Information Carayon P, Wood KE. Patient Safety: the role of human factors and systems engineering. Stud Health Technol Inform 2010;153:2346. http://www.ncbi.nlm.nih. gov/pmc/articles/PMC3057365/pdf/ nihms274759.pdf [online; accessed 2016 May 18] Topic 2: What is human factors and why is it important to patient safety? [online; accessed 2016 May 18]. http://www. who.int/patientsafety/education/ curriculum/who_mc_topic-2.pdf

The Pennsylvania Patient Safety Advisory may be reprinted and distributed without restriction, provided it is printed or distributed in its entirety and without alteration. Individual articles may be reprinted in their entirety and without alteration, provided the source is clearly attributed.

Current and previous issues are available online at http://patientsafety.pa.gov.

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