ACMS Bulletin October 2022

Cancer surgery expertise for your patients.

On the cover

City of Bridges

Elias Hilal, MD

Bulletin

Medical Editor

Deval (Reshma) Paranjpe (reshma_paranjpe@hotmail.com)

Associate Editors

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Fall Nourishment

Deval (Reshma) PaRanjPe, mD, mBa, FaCs

Autumn: the season of glorious color, pumpkin spice everything, football, bonfires, and cuisine that warms your body and soul. The outdoor heaters are re-emerging at your favorite restaurants, and it’s time for a roundup of the places to sate your cravings for warming, nurturing and festive food.

Fig and Ash

514 East Ohio Street, North Side. 412-321-2222

A hidden gem with an unexpected large public city parking lot immediately behind it (access from Emlin Street off James Street). The autumn menu features signature meatloaf (worth it), lamb ragu tagliatelle, short rib, as well as a pumpkin risotto that is a star attraction. The roasted carrots are a fine appetizer as are the spicy mussels; try the Pecan or Pecan’t (There is No Try) cocktail, a pecan infused riff on an Old Fashioned. Sit at the beautiful bar or in the dining room, or better yet, sit by the fire in the covered outdoor space for an intimate dinner by firelight and heavenly aromas wafting about from the smoker.

Apteka

4606 Penn Avenue, Bloomfield. 412-251-0189

Finally recognized nationally, Apteka made the New York Times 50 Best Restaurants List this year. These truths intersect for most visitors to Apteka: 1) you will love it 2) it is vegan 3) your mind will be blown and your world shaken because of this juxtaposition. Apteka still features exquisite authentic pierogis—light, flavorful, and filled with traditional ingredients that you won’t find at your local church hall or grocery store. It has also branched out into more adventurous but equally delicious dishes which still promise unexpected thrills. Eastern European liquors and cocktails which you won’t find anywhere else are also offered.

Spork 5433 Penn Avenue, Bloomfield/Garfield. 412-441-1700

All around perfection. If you have a special event to celebrate or a sweetheart to impress, this is the place to go. The menu is rife with old school classics including Veal Osso Bucco, Stuffed Quail, Forest Mushroom Ravioli, Tagliatelle Bolognese, Prawns, Octopus, Lobster Roll, Scallops, Duck Confit and two separate Wagyu beef dishes. And yet the chef manages to

add unexpectedly playful and luxurious touches like a lobster corn dog in the Wagyu Surf and Turf, or duck fat fried potatoes and wine truffle butter sauce in the Poutine. Try the autumn special Berkshire Pork Cheek with Spatzle, cider glace and horseradish crème to get in the seasonal mood. The food is reliably perfect, and the service is wonderful as well. A dining experience rarely gets better than this.

The Parlor Dim Sum 4401 Butler Street, Lawrenceville. 412-586-4796

Chef Roger Li has settled on brick and mortar after a series of wildly successful pop-ups. Focusing on Dim Sum and Cantonese specialties such as barbecue and congee, Li showcases Wok Hei (breath of the wok) and other cooking methods. Here you can find Dim Sum for dinner—a wide range of sweet and savory bite-sized dishes meant to be shared and served with hot tea. Look for Cantonese Roast Duck as well as Har Gow, Cha Siu Bao, Siu Mai and a plethora of others. Dinner only at present time.

Mola

6018 Penn Avenue, East Liberty. 412-365-6688

Easily the best and hottest sushi in town next to the venerable Umi and booked-solid Gi-Jin, yet without the Umi price tag and more accessible than GiJin. Daily Lunch specials 7 days a week from 11 am-3:30 pm include 2 hand rolls/cut rolls/bao OR a rice bowl, and a side of either miso soup or seaweed, spicy crab or mixed green salads. Both food and service are spectacular, and call-ahead omakase may be an option (call ahead to inquire, naturally).

Con Alma

Ellsworth 5884 Ellsworth Avenue, Shadyside 412-932-2387

Downtown 613 Penn Avenue Cultural District 412-363-5316

These are the restaurant/jazz clubs that we had needed for years. The Ellsworth location made Esquire’s 27 Best Bars in America 2021 list. The Downtown location is in the heart of the Cultural District and boasts much more space. Both locations feature jazz every weekend, with weekday jazz at Ellsworth. The food is an eclectic, tasty, spice-filled journey to the Caribbean, Central America and New Orleans with nods to Chinese and Indian cuisine. Ellsworth features a vegan menu (like Apteka, your mind will be blown) while downtown has full-service offerings. Downtown also features a New Orleans style brunch including Shrimp Creole, Beignets, Cajun Steak and Eggs, Bananas Foster French Toast, Jambalaya with eggs, and Champagne and Frites.

Laissez les bon temps rouler!

Point Brugge

401 Hastings Street, Point Breeze 412-441-3334

Park Bruges 5801 Bryant Street, Highland Park 412-661-3334

What is Fall without a giant bowl of moules frites at one of these two Belgian neighborhood gathering spots? Choose from classic white wine, red curry or Dijon cream sauces and two bowl sizes for your mussels. Mezze, charcuterie and cheese boards serve as prelude for heartier dishes such as Steak Frites, Carbonnade Flamande (beef braised in brown ale), Salmon with Risotto, Chicken Milanese and soul-soothing vegetarian Cavatappi. You can also find Poutine, Mac and Cheese, Tarte Flambee (think Alsatian pizza), Croque Monsieur, Point Burger and lovely salads to round out the menu. Enjoy with a fine Belgian Tripel or glass of wine if you wish. Lunch, dinner and brunch; takeout available.

Hyde Park Steakhouse

247 North Shore Drive, North Shore. 412-222-4014

I’m going old-school to finish out this list. Although perhaps less glamorous and well known than the Capital Grille or Ruth’s Chris downtown, Hyde Park is rock solid with excellent service, curbside valet parking and an inviting atmosphere with two fireplaces. Offering a menu of classic steakhouse fare including a variety of dry aged steaks and chops, seafood and vegetarian options made perfectly to order, you are sure to find something you love. Sides are flavorful and rich; desserts are fantastic and luscious. Curbside carryout and delivery. A reliable class act with lovely ambiance that will keep you warm as the weather gets cold.

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KRisten ehRenBeRgeR

Miasmata, citizens fleeing in panic, a plague sent from God, a moral punch line warning of the evil of fear itself—surely these are not imagery one would associate with a modern, industrial, scientificallyadvanced country. And yet, this poem was written not when Europe first encountered cholera in the politically restive early 1830s., nor in 1848 when revolution also broke out (again), nor even during repeat epidemics in 1853-55 or in 1866-75. “Cholera and Fear” appeared in the weekly family magazine Die Gegenwart in 1884. From Calcutta (now Kolkata), Dr. Robert Koch (1843-1910) had just announced that he had identified the

“Cholera and Fear”

cause: Vibrio cholerae. Coming so soon after his identification of Bacillus anthracis in 1896 and Mycobacterium tuberculosis in 1882, it was yet another triumph for himself and the German state that financed his research in Germany, Egypt, and India.

Interestingly, at the dawn of the “bacteriological revolution” (c. 18801930), popular imagery of cholera included both reproductions of drawings of comma-shaped bacteria as seen through a microscope and vivid, medieval imagery like exotic mists and sword-bearing phantoms. Hermann Friedrichs’ (1854-1911) poem drew heavily from motifs of colonialism, orientalism (West vs East, Europe vs

Asia), and militarized nationalism then circulating in Imperial Germany.

I thought a lot about this poem at the beginning of the COVID-19 pandemic. I considered how older means of coping with disease and societal disruption mingled with new discoveries, such as the SARS-CoV-2 genetic sequence and then mRNA vaccines. While hand washing, mask wearing, and quarantine (or “social distancing”) are tried and true, we have had a hard time giving up xenophobia and the kind of isolationist mindset that hoards vaccine until it expires instead of sending it to low-resource countries. I wonder what future historians will think when they look back to this period and its ubiquitous spiky virions.

Schwüle Nacht Am Thor der heil’gen Stadt, Die einst Welt und Geist geknechtet hat, Pocht ein Fremdling mit dem Schwertesknauf: ,,Hollah, Pförtner, schlieβ daβ Thor mir auf!“ Schaurig dröhnt der Ruf durch Nacht und Graun, Und des Wächters helle Augen schaun Forschend in des Pilgers Angesicht: ,,Deiner Stimme, Fremdling, trau‘ ich nicht! Harre drauβen bis der Morgen graut Diese Stadt hat Gott mir anvertraut!“ ,,Gott ja sendet mich!“ ruft Jener wild. ,,Komm und prüfe meinen Wappenschild, Hab‘ vor kurzem erst ihn aufgefrischt, Wo der Nildunst mit dem Smum sich mischt Emsig mäht mein Schwert, wenn ich es schwinge, Fiebergluthen stählen seine Klinge!“ ,,Doch der Pförtner, vor Entsetzen bleich: ,,Dennoch,‘‘ spricht er, ,,wehr‘ ich dir mein Reich, Leistet du mir nicht den heil’gen Schwur, Mir zu nehmen tausend Seelen nur.

Schwüle Nacht Am Thor der heil’gen Stadt, Die einst Welt und Geist geknechtet hat, Pocht ein Fremdling mit dem Schwertesknauf: ,,Hollah, Pförtner, schlieβ daβ Thor mir auf!“ Schaurig dröhnt der Ruf durch Nacht und Graun, Und des Wächters helle Augen schaun Forschend in des Pilgers Angesicht: ,,Deiner Stimme, Fremdling, trau‘ ich nicht! Harre drauβen bis der Morgen graut Diese Stadt hat Gott mir anvertraut!“ ,,Gott ja sendet mich!“ ruft Jener wild. ,,Komm und prüfe meinen Wappenschild, Hab‘ vor kurzem erst ihn aufgefrischt, Wo der Nildunst mit dem Smum sich mischt Emsig mäht mein Schwert, wenn ich es schwinge, Fiebergluthen stählen seine Klinge!“

On a humid night that oppressed matter and spirit, a stranger banged on the door of the holy city with the pommel of his sword. “Hollah, porter, unbar the gate for me!”

On a humid night that oppressed matter and spirit, a stranger banged on the door of the holy city with the pommel of his sword. “Hollah, porter, unbar the gate for me!”

The shout boomed gruesomely through the night, and the guard’s bright eyes looked searchingly at the pilgrim’s countenance: “I do not trust your voice, stranger! Wait outside until the morning dawns God has entrusted me with this city!”

The shout boomed gruesomely through the night, and the guard’s bright eyes looked searchingly at the pilgrim’s countenance: “I do not trust your voice, stranger! Wait outside until the morning dawns God has entrusted me with this city!”

“It is God who sends me!” replied the other roughly “Come and examine my escutcheon [crest] I’ve just cleaned it where the Nile miasma and desert sandstorm mingle. My sword reaps assiduously when I swing it, [for] the heat of fever hardens its blade.”

“It is God who sends me!” replied the other roughly “Come and examine my escutcheon [crest] I’ve just cleaned it where the Nile miasma and desert sandstorm mingle. My sword reaps assiduously when I swing it, [for] the heat of fever hardens its blade.”

Denn ich weiβ, du bist ein Nimmersatt, Schafft gern mehr, als Gott geboten hat.“

,,Doch der Pförtner, vor Entsetzen bleich: ,,Dennoch,‘‘ spricht er, ,,wehr‘ ich dir mein Reich, Leistet du mir nicht den heil’gen Schwur, Mir zu nehmen tausend Seelen nur. Denn ich weiβ, du bist ein Nimmersatt, Schafft gern mehr, als Gott geboten hat.“

Jener schwört Der Pförtner läβt ihn ein. Düster schleicht ein Schatten hinterdrein Eine Alte, bleich und abgezehrt, Mit des Allgewalt’gen Schild beschwert.

Jener schwört Der Pförtner läβt ihn ein. Düster schleicht ein Schatten hinterdrein Eine Alte, bleich und abgezehrt, Mit des Allgewalt’gen Schild beschwert.

Fragend miβt der Pförtner die Gestalt, Doch ihr Blick durchzuckt ihn meh und kalt ,,Gott, erbarme dich der tausend Seelen!“ Spricht er schauernd, ,,laβ sie dir empfehlen!“

Fragend miβt der Pförtner die Gestalt, Doch ihr Blick durchzuckt ihn meh und kalt ,,Gott, erbarme dich der tausend Seelen!“ Spricht er schauernd, ,,laβ sie dir empfehlen!“

Wochen flohn Die Stadt füllt Schreckt und Graus.

Wochen flohn Die Stadt füllt Schreckt und Graus.

Wild, verzweifelnd schaut der Pförtner aus Nach den Bahren, die vorüberziehn, Nach den Bürgern, die der Stadt entfliehen. Heiβ durchwühlt die Adern ihm der Zorn, Ihn verwundert bangen Zweifels Dorn. Immer neue Bahren ziehn vorbei, Immer lauter hallt das Wehgeschrei. Ach! schon fünfmal tausend liegen todt, Und noch immer mehrt sich Leid und Noth.

Wild, verzweifelnd schaut der Pförtner aus Nach den Bahren, die vorüberziehn, Nach den Bürgern, die der Stadt entfliehen. Heiβ durchwühlt die Adern ihm der Zorn, Ihn verwundert bangen Zweifels Dorn. Immer neue Bahren ziehn vorbei, Immer lauter hallt das Wehgeschrei. Ach! schon fünfmal tausend liegen todt, Und noch immer mehrt sich Leid und Noth.

Endlich kehrt der Gottgesandte wieder, Läβt zur Rast sich mit der Alten nieder; Doch der Pförtner fährt ihn grimmig an: ,,Tausend, schwurst du, ungefüger Mann! Und du brachst den Eid?“

Endlich kehrt der Gottgesandte wieder, Läβt zur Rast sich mit der Alten nieder; Doch der Pförtner fährt ihn grimmig an: ,,Tausend, schwurst du, ungefüger Mann! Und du brachst den Eid?“

Der Andre spricht: ,,Nein! Denn mehr als tausend schlug ich nicht! Was darüber, nahm dir diese da, Stets, auf Schritt und Tritt, war sie mir nah ” ,,Und wer ist dies Scheufel?“

Der Andre spricht: ,,Nein! Denn mehr als tausend schlug ich nicht! Was darüber, nahm dir diese da, Stets, auf Schritt und Tritt, war sie mir nah ” ,,Und wer ist dies Scheufel?“

,,Blicke hin, ‘s ist die Furcht, die schlimmste Würgerin!“

,,Blicke hin, ‘s ist die Furcht, die schlimmste Würgerin!“

The porter blanched at the horror: “Nevertheless,” he said, “I will defend my territory against you, if you do not render me the holy oath, that you will only take a thousand souls Because I know that you are a glutton who likes to do more than God has allowed.”

The porter blanched at the horror: “Nevertheless,” he said, “I will defend my territory against you, if you do not render me the holy oath, that you will only take a thousand souls Because I know that you are a glutton who likes to do more than God has allowed.”

The other swore The porter let him in Grimly skulked a shadow behind him an old woman, pale and emaciated, burdened with the shield of the omnipotent one.

The other swore The porter let him in Grimly skulked a shadow behind him an old woman, pale and emaciated, burdened with the shield of the omnipotent one.

Questioningly the porter eyed the figure, but her stare seared through him, painful and cold. “God, embrace the thousand souls!” he shuddered, “May they be commended to your care!”

Questioningly the porter eyed the figure, but her stare seared through him, painful and cold. “God, embrace the thousand souls!” he shuddered, “May they be commended to your care!”

Weeks flew by, and the city filled with terror and dread The porter watched with fury and despair as the stretchers passed by and as citizens fled the city Hot anger coursed through his veins, as the thorn of doubt deeply wounded him Always new stretchers went by, always louder rang the painful cries Ach! Already five times a thousand lay dead, and the suffering and need continued to increase.

Weeks flew by, and the city filled with terror and dread The porter watched with fury and despair as the stretchers passed by and as citizens fled the city Hot anger coursed through his veins, as the thorn of doubt deeply wounded him Always new stretchers went by, always louder rang the painful cries Ach! Already five times a thousand lay dead, and the suffering and need continued to increase.

Finally, the One sent by God returned with the old woman and sat down to rest; grimly the porter rounded on them: “A thousand, you promised, reckless man! Didn’t you break your oath?” And other replied: “No! Because I felled no more than a thousand! What is more, you must understand, she was always close on my heels ” “Who is this monster?” “Look over there, ‘tis Fear, the most terrible destroyer!”

Finally, the One sent by God returned with the old woman and sat down to rest; grimly the porter rounded on them: “A thousand, you promised, reckless man! Didn’t you break your oath?” And other replied: “No! Because I felled no more than a thousand! What is more, you must understand, she was always close on my heels ” “Who is this monster?” “Look over there, ‘tis Fear, the most terrible destroyer!”

Citation: Hermann Friedrichs, “Die Cholera und die Furcht,” Die Gegenwart 26 (1884): 86.

Citation: Hermann Friedrichs, “Die Cholera und die Furcht,” Die Gegenwart 26 (1884): 86.

Translation: Kristen Ann Ehrenberger

Translation: Kristen Ann Ehrenberger

„Die Cholera und die Furcht.“ Von Hermann Friedrichs. “Cholera and Fear.” By Hermann Friedrichs.

„Die Cholera und die Furcht.“ Von Hermann Friedrichs. “Cholera and Fear.” By Hermann Friedrichs.

Paper Chase

RiChaRD h. DaFFneR, mD, FaCR

Academic advancement, no matter what the discipline, is predicated on the “Publish or Perish” principle. Having one’s work published in peer-reviewed literature is a mark of academic productivity, sometimes regardless of the quality of the research. My entire fifty-year medical career in radiology was spent in academic programs. During that time, I was productive, being fortunate enough to have 170 papers accepted in the peer-reviewed literature, nine medical textbooks1, and 19 book chapters. Over the years I, like all authors, experienced the joys and disappointments of having my papers accepted or rejected, respectively. In the process, however, I learned a lot about the dynamics and the politics of medical publishing in my roles as an author, manuscript reviewer, and member of editorial boards for two radiology journals. What follows are my unapologetic observations on this important industry.

When I began my radiology career in 1970 there were two authoritative monthly radiology journals, the American Journal of Roentgenology (AJR, “Yellow Journal”) and Radiology (“Gray Journal”). Both earned their nicknames because of the color of their covers. AJR, first issued in 1906, was the official publication of the American

Roentgen Ray Society (ARRS), founded in 1900. Radiology, first issued in 1923, was the official publication of the Radiological Society of North America (RSNA), founded in 1915. At that time there were several quarterly journals as well. With the explosion of new imaging technology (CT, ultrasound, and MRI) that began in the 1970’s, radiologists became superspecialized and new professional societies (such as the International Skeletal Society [ISS], formed in 1972) dedicated to those disciplines were formed. Each of these societies soon began publishing a journal (ISS began publishing Skeletal Radiology in 1974). Interestingly the tally of my papers published, by journal was: AJR – 48, Skeletal Radiology – 33, Emergency Radiology – 10, Radiology – 4 (the remaining 75 articles were in miscellaneous journals).

Evolution

As new technology developed there was an interesting pattern to the articles being published. CT was one of the first of the new technologies to emerge. Those practitioners who were fortunate enough to have the early CT units – almost exclusively academic teaching hospitals – began publishing their initial experiences of CT images of

different diseases. Sometimes, these initial observations were erroneous. Once enough case material had been obtained, the same authors published follow-up reports on the topics they had initially reported, either validating their initial observations or explaining their mistakes. As ultrasound and MRI developed, the pattern of publication was repeated. MRI was ripe for publications because of the unlimited number of scanning protocols that are available. Hardly a month goes by today without a new scanning protocol for knee or shoulder MRI. The Paper Chase was made for this kind of technology.

Playing favorites?

The review process for all journals is supposed to be performed in an anonymous fashion, where the reviewer does not know the author or the institution at which (s)he is working. In my many years of reviewing manuscripts I encountered only two instances where I was aware of the authors’ identities, having been in attendance when they delivered the paper at a society meeting. In both cases, I returned the manuscripts with a note of explanation to the Editor-inChief, even though I knew I could give an objective review of the papers.

Loyal readers of the many medical journals will often recognize the same names of authors, or the same institutions of the published papers. In most of cases, this is justified. My colleague Dr. Donald Resnick at UCSD, a world-class researcher and author on musculoskeletal (MSK) disorders is a prime example. Some editors, however, have “favorite sons or daughters” or favored institutions and will accept any paper they write, regardless of its merit. An example from many years ago was a paper in the New England Journal of Medicine on the prospect of patients developing radiation-induced cancer from repeated diagnostic x-rays. This paper, which in my opinion was bad science (extrapolating radiation exposure data from the Hiroshima atom bomb), was published because it came from the Harvard School of Public Health and a prestigious main author.

The review process used to take weeks to months from the time a paper was submitted until a decision was made regarding its acceptability in the journal. The old system relied on “snail mail” via the USPS at every step. Since the mid-1990’s, the process has been significantly shortened. Submissions are electronic, Editors now ask reviewers to submit their assessments within ten days to two weeks, and authors are notified whether their work has been accepted (pending a revision according to the reviewers’ comments) or rejected within a month of the submission. Even if a paper is rejected, today, the author is sent a detailed explanation for the editorial decision. It was not always so.

Years ago, I presented a paper on the use of CT for diagnosing facial fractures, at the annual meeting of the RSNA. When authors present at these society meetings, they are required to submit a manuscript of that work to the official organ of that society. I duly submitted our paper which, to my knowledge was the first on the subject, to the “Gray Journal”. After six months had elapsed, and I had not heard from the editors, I made a phone call to the editorial office to inquire about the delay. I was told the paper was “still under review”. Three months later the paper was returned with a cover letter telling me that “the paper was reviewed and deemed unsuitable for publication” with no other comments. Coincidentally, that month’s issue of the journal had a similar article on CT for facial fractures, written by one of the “golden boys” the journal favored. Interestingly, our paper had more case material and better examples than those in the published article. I submitted our paper to another journal, where it was accepted with minor changes. I never submitted another paper to that society’s journal.

The “Publication Mafia”

Several journal editors-in-chief relied on their own faculty members for initial review of submitted papers. This has the advantage of saving time in the review process. However, this can also have a downside. One Editor relied heavily on this process, and his faculty reviewers applied their own interpretation of the findings reported in the papers submitted to them. I called this group the “Publication Mafia”

because of some of their methods. We had submitted a paper on the use of T-1 MRI images of the pelvis and spine for the detection of metastatic bone lesions2. On T-1 sequences such lesions are uniformly dark and indicate areas where a bone biopsy should be performed to confirm the diagnosis. The paper underwent requests for six revisions before it was finally accepted for publication. The final revision request asked us to add material that earlier reviews had told us to delete! The reviewer’s comments demonstrated that the reviewers did not understand what we were trying to say. The published paper was subsequently listed among the top 100 the journal named in its centennial year for number of citations in the medical literature.

As another example, I wrote the editor of that same journal after receiving a very unprofessional review after a paper I sent to them was rejected. The second reviewer gave a different assessment with concrete suggestions to improve the paper. The editor asked me to resubmit the paper and he would send it to a different reviewer. I made the suggested changes of the second reviewer and sent the revised paper to another journal, where it was accepted as is.

Today, at least in the world of radiology journals, when authors submit their work electronically, they are often asked by the journal if they had any suggestions for who they would like to review their paper. This allows for true peer review. For example, in MSK we are even more specialized, with experts in trauma, arthritis, infection, sports medicine, and

Editorial

even modality (CT, MRI, ultrasound). In addition, the authors are asked if there any reviewers they do not want for reviewers (to prevent professional jealousy).

Times have changed

The last decade has seen the emergence of many commercial journals that will publish anything submitted to them, provided the author pays a fee for publication. Most are not listed in Pub Med. Hardly a day goes by where I don’t find an invitation in my Spam file to submit a paper. My

simply bad science. When I reviewed manuscripts that were sent to me, the first area I looked at was the “Materials and Methods” section, where I could quickly determine whether proper scientific methodology had been used or whether the paper reported bad science. Fortunately, in the “Publish or Perish” realm of academe, where the size of ones resumés are used for promotions, samples of the candidates’ works are submitted to outside reviewers to validate the quality of the research. It is a good system of checks and balances.

References:

1. Daffner RH. Making a book. ACMS Bulletin July 2022, pp 9-11.

2. Daffner RH, Lupetin AR, Dash N, Deeb ZL, Sefczek RJ, Schapiro RL: MRI in the Detection of Malignant Infiltration of Bone Marrow. Am J Roentgenol, 1986; 146:353-358.

Dr.Daffner is a retired radiologist, who practiced at Allegheny General Hospital for over 30 years. He is Emeritus Clinical Professor of Radiology at Temple University School of Medicine.

The opinion expressed in this column is that of the writer and does not necessarily reflect the opinion of the Editorial Board, the Bulletin, or the Allegheny County Medical Society.

Personalization by Design: Just Do It

The current health care landscape is rapidly changing – patients increasingly care about personalization and convenience in their care. The 2019 NRC Healthcare Consumer Trends Report shared that over 50% of patients make health care related decisions based on convenient, easy access and 80% would switch providers for convenience alone (NRC Health, 2019). These metrics will only continue to increase following the COVID-19 pandemic. Few patients make health care decisions based on factors such as expertise or quality alone. Providers are now challenged to redesign how they provide high quality, expert care in a way that is convenient and meets the preferences of patients.

Knowing Patient Preferences

Patients’ wants and needs must be understood to meet patient preferences. Nine times out of ten, what care team members think a patient prefers, differs significantly from their actual wants and needs. This requires the care team (all roles in the health care delivery team) to ask

and listen to patients, what services interest them, and how they want to receive care. Once these preferences are known, providing highly customized and personalized services can be co-produced. Asking patients to share their preferences is not difficult. The Bone and Joint Center at UPMC Magee-Womens Hospital has utilized the “What Matters to You?” tool, patient shadowing, and workflow analysis to identify and meet patient needs, while delivering leading clinical outcomes. Patient engagement tools like these actively involve patients in their care and are proven to make substantial improvement on outcomes for any intervention. These tools, paired with conversation-oriented questions, are applicable in any care setting and meant to engage the patient real-time and deliver human-centered care.

The Bone and Joint Centered deployed this tool in 2020 and 2021 to partner with patients and re-design their patient education pathway so that patients were better prepared and could go home sooner. Simple questions included:

● What types of exercise would you like to learn how to do? What do you enjoy doing now?

● Describe the type of information that you would like to know about hip and knee arthritis, prevention, non-operative treatment, and a total joint replacement if needed.

● Rank how you would prefer to be presented information, 1 being most preferred and 5 being least preferred.

Data revealed that patients desired comprehensive and highly coordinated care, mobility-increasing and cardiovascular exercises they could do at home, and written stepwise education delivered verbally and electronically (that could be shared with their coach). Not surprisingly, patients had specific interest in services related to weight loss, pain management, exercise, and smoking cessation.

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Patients also indicated that they still prefer a traditional physical paper copy for education materials, but are also interested in education delivered through a website or app. These preferences, when paired with the additional services that interested patients, served as an opportunity for the care team to redesign an education and care pathway that reflected patient preferences. Interestingly, the care team was asked for their perception of how patients would respond; they were surprised that patients’ preferences and responses differed so greatly from theirs.

Honoring Patient Preference

Using high-impact, low-effort coproduction tools has led to innovation, development of customized services, and pathways that honor preference. The Bone and Joint Center has used “What Matters to You?” data to ideate and implement four programs in the recent years– showing that it is possible to deepen person-centered care and innovation during a pandemic.

Move to Mobility

The AMD3 Foundation developed the Move to Mobility education series to provide web-based video demonstrations of pre- and postsurgical rehabilitation exercises. Not only does this program provide education in a dynamic way, it meets patient requests to impact weight loss and exercise for people with varying levels of osteoarthritis - two topics in which patients were most interested. The stepwise video series serves as a platform for patients to do safe and effective exercises at home prior to their total joint replacement. Patients can move through each video with the guidance of a physical therapist, right in their home for free. This platform also allows patients to absorb information at their own pace and includes questions, tips, and tricks from actual patients.

Center for Bone and Joint Health

The Center emerged as a direct result of asking “What Matters to You?” as it became evident that patients desired preventative approaches to maintain bone and joint wellness, not just curative treatments. The Center is based out of the Bone and Joint Center at UPMC Magee-Women’s Hospital and serves highly complex patients in a personalized way. The first cohort of patients at the Center had an average of 10 comorbidities each, most likely a result of the siloed health care system and worsening medical conditions due to the delay of treatment during the COVID-19 pandemic.

The Center has served as a connector of services for its patients, using motivational interviewing and

questions that embody the ethos of “What Matters to You?” to keep patients’ preferences, goals, and voices at the center of care for any provider. The Center has quickly become central to patients needing to navigate the health care system, leading to partnerships with clinical programs such as the Midlife Center, the Osteoporosis Center, pain management services, and Western Wellness.

Screening Tools for Osteoporosis and Literacy in Musculoskeletal Problems (LiMP)

The Center has also led to the emergence of two new screening tools to align patients’ desire for early intervention and clinical services.

Through iterative use of questions like “What matters to you?” in the Center for Bone and Joint Health, patients identified the need for osteoporosis care, specifically a screening tool. This resulted in the implementation of a screening and treatment pathway for patients identified as having or at high-risk for osteopenia or osteoporosis. While new, the screening tools and pathway will help to avoid fragility fractures among high-risk patients.

Additionally, both the Center for Bone and Joint Health and the Bone and Joint Center recognized a need to measure health literacy among their patients. Musculoskeletal patients with lower proficiencies in health literacy experience worse outcomes and have decreased satisfaction than their counterparts following a total knee arthroplasty (Narayanan et al., 2021). Both practices began screening

patients for LiMP and found that 63% of all patients had a normal score but 37% had a low score. This confirmed that the care team needed to deliver information that patients want (weight loss, pain management, weight loss, smoking cessation) in the way they want, (print and digital) in a way that is easy to comprehend, and in plain terms. The team now evaluates their education and other patient-facing materials to make sure they meet adult learning principles and are written with health literacy in mind to ensure equitable care (and outcomes) are being delivered.

Meeting the Needs of Patients in the New Normal Health care providers and systems must work to ensure that they are aware of patient preference and do what they can to honor those preferences. Using “What Matters to You?” and other similarly inquisitive questions as the primary patient engagement tools to amplify patient voices have been instrumental to meet patient needs at the Bone and Joint Center and, in general, for middleaged patients wanting to maximize their bone and joint wellness and overall health.

References:

Barry MJ, Edgman-Levitan S. Shared decision making–pinnacle of patient-centered care. N Engl J Med. (2012 Mar 1);366(9):780-1. https://www.ncbi.nlm.nih.gov/ pub med/?term=22375967

NRC Health. (2019). 2019 Healthcare Consumer Trends Report. https:// nrchealth.com/wp-content/ uploads/2018/12/2019-HealthcareConsumer-Trends-Report.pdf

Narayanan, A. S., Stoll, K. E., Pratson, L. F., Lin, F. C., Olcott, C. W., & Del Gaizo, D. J. (2021). Musculoskeletal Health Literacy is Associated With Outcome and Satisfaction of Total Knee Arthroplasty. The Journal of arthroplasty, 36(7S), S192–S197. https://doi.org/10.1016/j. arth.2021.02.075

Ms. Hamlin is a Project Consultant at goShadow and a 2023 MHA candidate at The Ohio State University.

Angela Devanney is a founding member of goShadow, a technology startup focused on person-centered care, process mapping, and improvement. Angela is an expert advisor and speaker in safety and reliability, improvement science, valuebased care, customer experience, employee engagement, and retention. Her background combines extensive clinical and operations experience alongside consulting and service delivery for clients in the public and private sector of all sizes domestic and abroad. Angela provides practical, relationship-focused expertise to process improvement and implementation support for leaders and teams using experiential learning techniques and human-centered tools.

Dr. DiGioia is medical director of the Bone and Joint Center at UPMC Magee-Womens Hospital and comedical director of the Center for Bone and Joint Health.

Nominating Committee Report for Officers and Delegates September 2022

The Nominating Committee met on August 31, 2022 and is pleased to recommend the following candidates for election to office in 2023 Election will take place the first week of November

President elect Raymond E. Pontzer, MD (Automatically becomes president 2024)

Secretary Keith T. Kanel, MD

Treasurer William F. Coppula, MD

Directors (Five to be elected)

Anuradha Anand, MD Micah A. Jacobs, MD Michael M. Aziz, MD Ezz Eldin Moukamal, MD

Amber R. Elway, MD Elizabeth Ungerman, MD Stephen N. Fisher, MD G. Alan Yeasted, MD Mark A. Goodman, MD Alexander Yu, MD

Other Directors currently serving but not up for election this year:

Term Expires in 2023

Term Expires in 2024

Peter G. Ellis, MD, will Chair 2023 Steven Evans, MD Douglas F. Clough, MD Matthew B. Straka, MD, President 2023 Bruce A. MacLeod, MD Kirsten D. Lin, MD Amelia A. Paré, MD Jan B. Madison, MD Adele L. Towers, MD Raymond J. Pan, MD OPEN OPEN

Delegate Alternate Delegates

Two Year Term

Eight to be Elected

One Year Term

Michael M. Aziz, MD Douglas F. Clough, MD Vint R. Blackburn, MD Marilyn S. Daroski, MD William F. Coppula, MD Stephen N. Fisher, MD Patricia L. Dalby, MD Michael Hu, MD Amber R. Elway, MD Alexandra Johnston, MD Richard A. Fortunato, DO Jasbir S. Kang, MD Deborah A. Gentile, MD Anthony L. Kovatch, MD Lawrence R. John, MD James T. McCormick, MD Michael M. McDowell, MD Stacie M. McKnight, DO Abigail A. Palmer, DO Devon Ramaeker, MD Joseph C. Paviglianiti, MD Rajiv R. Varma, MD Angela M. Stupi, MD Alexander Yu, MD

Other members currently serving but not up for election: Niravkumar Barot, MBBS, MPH Richard B. Hoffmaster, MD Jan W. Madison, MD Weston F. Bettner, MD Micah A. Jacobs, MD Raymond J. Pan, MD Coleen A. Carignan, MD Keith T. Kanel, MD

Nadia K. Sundlass, MD David J. Deitrick, DO Bruce A. MacLeod, MD Adele L. Towers, MD Mark A. Goodman, MD Matthew A. Vasil, MD

Respectfully submitted, Raymond E. Pontzer, MD

Adele L. Towers, MD Chair, Nominating Committee 2022 Amber L. Elway, MD Matthew A. Vasil, DO Jan W. Madison, MD G. Alan Yeasted, MD

James W. Boyle, MD

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Dr. Mallory Ciukszato & Dr. Natalie Gentile

What inspired you to choose medicine for your career path?

My experience with medicine in my early life was very personal. My mother was a hospice nurse, and when I was 9 years old, my 2-year-old sister was di agnosed with a glioblastoma. She went through surgery, chemo, and radiation and subsequently developed leukemia. I had the opportunity to be her bone marrow donor prior to her death a few weeks before I started college, which was a defining experience in my life.

Anyone who has experienced the dayto-day trauma of having and loved one with cancer understands how much you want to help and how helpless you often feel. Being my sister’s bone mar row donor was a real, tangible thing I could do, and after experiencing that kind of meaning and purpose, I wanted to spend my life helping.

What project/program/passion most excites you currently in you work?

As all of us in medicine know that the social determinants of health matter more than our care much of the time.

With the help of a dedicated commit tee, I run the Food Assistance Match program through the Bellevue Farmers Market. Our program addresses local food insecurity by matching SNAP, WIC, and other food assistance dollars to help our neighbors afford fresh,

locally grown foods and support our farmers. I help fundraise to make sure that if marketgoers bring food assistance dollars to our market, $1 spends like $3. Last year, we secured a community development block grant for $37,000. This year, we are actively seeking fundraising not only for our market but hopefully to expand our program in the upcoming years.

What area of medicine do you hope to dive deeper into as your career moves forward?

St. Clair is expanding education opportunities and I am hoping to take on more teaching in the new few years.

What would be one thing people would be surprised to know about you?

I love to cook and host friends and family for dinner parties in my home regularly.

Is there any advice for the next generation of physicians rising?

Medicine is a big space and there are many ways you can serve and be useful. Figure out what you care about and make time for it.

Dr. Mallory Ciuksza

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Dr Natalie Gentile

What inspired you to choose medicine for your career path?

I always knew I would become a physician. For as long as I can remem ber, I’ve wanted to practice medicine and focus on wellness and mental health for my patients. What I didn’t realize is that I would also find a passion for being an entrepreneur. Being able to practice medicine in my own space in the way that serves my patients best has been an incredible gift.

What project/program/passion most excites you currently in your work?

My newest business, Rebel Wellness, gets me up every morning. This endeavor is innovative and exciting. We are building a space where the community can learn the tenets of lifestyle medicine through a teaching kitchen, group fitness space, yoga/mindfulness work and group workshops.

What area of medicine do you hope to dive deeper into as your career moves forward?

A weight neutral, health at every size approach to care. As a lifestyle medicine trained physician, I have the privilege to work with patients at all stages, ages, and sizes, and aim to help them feel safe with me and heard.

What would be one thing people would be surprised to know about you?

I have no business training! I learned how to start and grow businesses on my own, with the help of many mentors and encouraging family members along the way.

Is there any advice for the next generation of physicians rising?

Yes! Don’t settle for anything less than what fuels your inner fire. You put in so much time, passion, money, and emotional stress to become a physician. So the job you choose after all of that training should ideally fuel your inner fire. If the job itself can’t do that, then make sure to prioritize your interests and self-care outside of work so you never lose sight of “you”.

Pittsburgh Ophthalmology Society announces November and December Presenters and meeting date

The Pittsburgh Ophthalmology Society (POS) is pleased to announce the following upcoming monthly meeting dates and guest faculty.

On November 3*, the POS welcomes Ann Shue, MD, Clinical Assistant Professor, Ophthalmology; Clinical Assistant Professor (by courtesy), Pediatrics; Stanford Health Care, Stanford Medicine Children’s Health, Stanford, CA. Thank you to Ian Conner, MD, PhD for inviting Dr. Shue and to the following co-sponsors: PNC Bank, Sight Sciences, and Sun Ophthalmics.

Dr. Shue specializes in glaucoma, pediatric ophthalmology, and adult strabismus, a unique combination of sub specializations practiced by few surgeons worldwide. She is a board-certified ophthalmologist who completed fellowships in glaucoma at Yale University and pediatric ophthalmology and adult strabismus at Duke University. She practices at the Stanford Byers Eye Institute and the Lucile Packard Children’s Hospital.

The POS returns to the Rivers Casino ballroom on December 1st and welcomes Sunil Srivastava, MD, Fellowship Director, Vitreo-Retinal Fellowships, Cleveland Clinic Cole Eye Institute, Cleveland, OH. Thank you to Jared Knickelbein, MD, PhD for inviting Dr. Srivastava and to the following co-sponsors of the program: BioTissue, DORC, and Genentech.

He is both a Senior Achievement Award recipient from the American Academy of Ophthalmology and a Senior Honor Award from American Society of Retinal Specialists.

He has received multiple Cleveland Clinic Innovations Awards for his work in novel imaging analysis. Dr. Srivastava has co-authored over 140 publications in peer-reviewed journals and has delivered over 200 lectures at national and international conferences. His current interest includes the use of novel imaging in uveitis and retinal diseases, the development imaging outcome measures in uveitis and intraoperative imaging in vitreo-retinal surgery.

*The November 3 meeting will be held in the Ballroom of the Babb Bldg (850 Ridge Ave, Pittsburgh, PA 15212).

Members are asked to visit the POS website for directions and details on the venue.

Contact Nadine Popovich, administrator to confirm the status of your membership, registration, or to inquire about upcoming programs. She can be reached by email: npopovich@acms.org or by phone: 412.321.5030 x 110.

Legal Summary

After The Public Health Emergency

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On January 31, 2020, while most of us were only vaguely aware of a new virus being reported overseas (and only seven cases had been confirmed within the U.S.) Secretary Alex Azar of the Department of Health and Human Services formally declared a nationwide Public Health Emergency (PHE) to confront the 2019 Novel Coronavirus. This PHE has been extended nine times by Secretary Azar and his successor, Xavier Becarra, most recently through January 11, 2023. After nearly three years of battling the COVID-19 pandemic, the PHE may be allowed to expire sometime next year. The Department has promised to provide a 60-day notice of termination or expiration of the PHE, but health care providers should begin to prepare for special COVID-related rules and exceptions to revert to pre-2020 status when that happens.

In anticipation, the Centers for Medicare and Medicaid Services (CMS) published guidance on August 18, 2022, on its website entitled “Creating a Roadmap for the End of the COVID-19 Public Health Emergency”. As CMS notes, a number of emergency authority waivers, regulations, enforcement discretion and guidance have been issued since January 31, 2022, to ensure

access to care and give health care providers the flexibilities needed to respond to COVID-19. However, some of these changes were designed to be temporary and to expire when the PHE ends. Other new rules, such as telemedicine flexibility, have been implemented in a manner that will extend beyond the PHE, at least for some additional period of time. Other temporary measures have already been rescinded, such as waivers of training standards for long term care staff, which CMS believes may have led to increases in such facilities’ residents’ weight-loss, depression, and incidence of pressure ulcers. Similarly, waivers of physician visit requirements in skilled nursing facilities and waivers relating to delegation of tasks by physicians in SNFs were terminated on May 7, 2022.

CMS has published a list of COVID-related waivers here: https:// www.cms.gov/coronavirus-waivers Unless otherwise specified, these waivers will end with the PHE. They include:

Flexibility for Medicare Telehealth Services—This waiver expands the types of health care professionals who can furnish distant site telehealth services to include all those who are eligible to bill Medicare for their

professional services. This allows health care professionals who were previously ineligible to furnish and bill for Medicare telehealth services, including physical therapists, occupational therapists, speech language pathologists, and others, to receive payment for Medicare telehealth services. This waiver will end 151 days after the conclusion of the PHE. However, a separate waiver, making it easier for telemedicine services to be furnished to a hospital’s patients through an agreement with an off-site hospital, will end at the conclusion of the PHE.

Audio-Only Telehealth for Certain Services—This waiver allows the use of audio-only equipment to furnish evaluation and management services and behavioral health counseling and educational services. This waiver will also end 151 days after the conclusion of the PHE.

EMTALA Screening—This waiver allowed hospitals, psychiatric hospitals, and critical access hospitals to screen patients at a location offsite from the hospital’s campus to prevent the spread of COVID-19, as long as it is consistent with a state’s emergency preparedness or pandemic plan.

Legal Summary

Verbal Orders—Requirements for authentication of certain verbal orders in hospitals were relaxed to address “surge” situations.

Medical Staff and Credentialing—

This waiver allowed physicians whose privileges will expire to continue practicing at the hospital and for new physicians to be able to practice before full medical staff/governing body review and approval. A similar waiver applied to Ambulatory Surgery Facilities.

Physical Environment in Hospitals—

This waiver allowed hospitals to utilize facility and non-facility space that is not normally used for patient care to be utilized for patient care or quarantine, provided the location is approved by the state and is consistent with the state’s emergency preparedness or pandemic plan to handle surges and quarantine needs.

Hospital Physician Services—This provision waived the requirement that Medicare patients be under the care of a physician if consistent with a state’s emergency preparedness or pandemic plan, to allow for expanded use of extenders during physician shortages.

Anesthesia Services—CMS waived the requirement that a certified registered nurse anesthetist (CRNA) must be under the supervision of a physician as long as the arrangements for anesthesia are consistent with state law and a state’s emergency preparedness or pandemic plan.

Responsibilities of Physicians in Critical Access Hospitals (CAHs) CMS waived the requirement that a M.D. or D.O. must be present at all times in a CAH to provide medical direction, consultation, and supervision for the services provided.

Physician Supervision of NPs in Certain Clinics—CMS waived the requirement that physicians must provide medical direction to nurse practitioners in Rural Health Clinics and Federally Qualified Health Centers, so long as they are in contact via telehealth or other remote communications. The pre-PHE rules will be restored at the end of the calendar year that the PHE ends, but CMS is exploring options to make this flexibility permanent.

Practitioner Locations and Licensure—CMS waived the rule that required out-of-state practitioners be licensed in the state where they are providing services in certain situations so long as they are licensed in another state. Many states implemented similar waivers to allow physicians to travel across state lines to assist with acute physician shortages early in the pandemic. When the PHE ends, current regulations will continue to defer to state law (including state waivers), so practitioners should check applicable state rules.

Expedited Enrollment—CMS expedited any pending or new applications from practitioners, providers and suppliers beginning March 1, 2020. When the PHE ends, CMS will resume normal application processing times.

Locum Tenens Billing—CMS waived the 60-day limit under which a substitute physician’s services could be billed to Medicare under the absent physician’s provider number. This waiver will expire 61 days after the end of the PHE.

Stark Self-Referral Law—Certain “blanket” waivers were implemented which loosened the requirements for written agreements under the Stark law, permitted amendment of arrangements that qualified for exceptions, expanded the exception for indirect compensation arrangements, and modified the requirements for loans and income guarantees with physicians. These waivers will expire with the end of the PHE.

Be Prepared

If you are utilizing any of the waivers that are set to expire either upon the end of the PHE or within certain defined periods, now is the time to prepare for going back to the way things were done during the “before times.” Expect significant pressure on regulators to preserve some of these flexibilities, particularly those regarding telemedicine. The announcement of the impending end of the PHE will likely be a major news item, and will give you at least 60 days to get ready. Take advantage of this lead time to implement the necessary changes and consult your health care attorney for further guidance.

William H. Maruca is a health care partner with the Pittsburgh office of the national law firm of Fox Rothschild LLP. He can be reached at wmaruca@ foxrothschild.com or 412.394.5575

Tirzepatide (Mounjaro®): the first “twincretin” for type 2 diabetes

Diabetes mellitus is a metabolic disorder that is caused by either defective insulin secretion by pancreatic β-cells or the inability of insulin-sensitive tissues to respond to insulin.1 Diabetes mellitus type 2, or T2DM, occurs when the body has insulin resistance and blood sugars subsequently rise.2 T2DM affects approximately 90-95% of the more than 37 million Americans who have diabetes, and usually develops in adults age 45 years and older. Typical patient characteristics of T2DM include having a higher body fat percentage, or being obese, often in the abdominal region.1 Persistently high blood glucose levels can lead to complications such as heart disease, vision loss, and kidney disease. Nerve disease associated with potential amputations in the extremities and oral health issues such as inflammation of the gums are also complications which make proper treatment important in patients with T2DM.2,3

Medications for T2DM

Initial treatment of T2DM includes increased amounts of exercise and dietary modifications.1 However, many patients with T2DM require intervention beyond proper diet and exercise to achieve long-term blood glucose control. There are many pharmacological options in

this situation, which are available in both oral and injectable forms. The oral classes include meglitinides, sulfonylureas, dipeptidyl-peptidase 4 (DPP-4) inhibitors, biguanides, thiazolidinediones, alpha-glucosidase inhibitors, sodium-glucose cotransporter 2 (SGLT2) inhibitors, and bile acid sequestrants. Injectable options include conventional insulin, amylin mimetics, and incretin mimetics (also known as glucagon-like peptide 1 receptor antagonists or GLP-1 analogs).4 Metformin, which is a part of the biguanide class, has been the preferred first-line treatment for T2DM for many years. However, it is important to note that less than 50% of individuals with T2DM will reach a target hemoglobin A1c (HbA1c) of < 7%, even after the initiation of medications.5 Therefore, more effective treatments are still needed.

GLP-1 Receptor Antagonists

Glucagon-like peptide 1 (GLP-1) receptor agonists are an established treatment option for T2DM. This class of drugs includes dulaglutide (Trulicity®), exenatide (Byetta® and Bydureon BCise®), liraglutide (Victoza®), lixisenatide (Adlyxin®), and semaglutide (Ozempic® and Rybelsus®). The GLP-1 analogs improve desired effects of the body’s natural response to food as well as

reduce glucose levels after eating to assist in achieving glycemic control. GLP-1 receptor agonists should be considered if there is an intolerance or contraindication to metformin, in patients who have a HbA1c that is greater than 1.5% over target, or in patients who do not reach their HbA1c goal in three months on other medications.6,7

GLP-1 receptor agonists are frequently prescribed due to their efficacy in glycemic control as well as weight reduction, reduction of progression to diabetic renal disease, and favorable cardiac outcomes.8,9 GLP-1 receptor agonists target many of the underlying pathophysiologies of T2DM, including enhanced appropriate pancreatic β-cell insulin secretion, decreased liver glucose production, delayed gastric emptying time, and increased insulin uptake in peripheral tissues.6 Short-acting GLP-1 receptor agonists mainly affect gastric emptying time, while the long-acting agents lower post-meal glucose levels by increasing insulin secretion and suppressing glucagon.10 In clinical studies, long-acting GLP-1 receptor agonists had greater effects on lowering fasting blood glucose, HbA1c, and body weight compared to the short-acting agents.

The addition of GLP-1 receptor agonists to other anti-diabetes

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medications is endorsed by the American Diabetes Association and the Endocrine Society, among others.11,12

The First “Twincretin”

The United States Food and Drug Administration (FDA) recently approved a new T2DM agent called tirzepatide (Mounjaro®). It is unique because it not only has the effects of GLP-1 receptor agonists, but it is also a glucose-dependent insulinotropic polypeptide (GIP). GIP stimulates glucose-dependent insulin secretion and affects after-meal fat metabolism.13 Until recently, GIP was not considered to have potential as a glucose-lowering agent. However, recent data has shown that co-administration of GLP-1 and GIP has a synergistic effect, which ultimately results in a significantly increased insulin and glucagonostatic responses compared to individual administration of each agent.9 This finding has led to the development of dual GLP-1/GIP receptor agonists, now known as a “twincretins.”9

Tirzepatide the first dual GLP-1/ GIP receptor agonist approved by the FDA as an adjunct to diet and exercise to improve glycemic control in adults with T2DM after promising results from several phase III trials.

Tirzepatide (LY3298176, Mounjaro®)

Tirzepatide is formulated as a synthetic linear peptide that is based on the body’s native GIP sequence. It is attached to a fatty diacid moiety, which ultimately prolongs its half-life to five days. Therefore, tirzepatide is administered once weekly as a subcutaneous injection.14

In phase II trials, tirzepatide demonstrated greater HbA1c reduction

from baseline (—2.4% with 15 mg weekly) with similar adverse effects as compared to the GLP-1 receptor agonist dulaglutide with or without metformin.8,15 The success of these phase II trials led to the completion of a series of phase III trials known as the SURPASS program.

The SURPASS Trials

The SURPASS clinical trial program aims to assess the efficacy and safety of tirzepatide as a treatment to improve glycemic control in patients with T2DM in multiple head-to-head comparison studies.9 In a series of global registration phase III trials, tirzepatide is being studied in patients who are naïve to anti-hyperglycemic therapy, as well as in patients on various oral anti-hyperglycemic agents such as metformin, sulfonylurea, GLP-1 receptor agonists, pioglitazone, sodium-glucose cotransporter 2 (SGLT2) inhibitors and/or insulin.8,9,16 Some of the trials are placebocontrolled, while others have active comparators. The primary endpoint for the majority of the trials is the change in HbA1c from baseline.9 A summary of the SURPASS trials can be found in Table 1.

SURPASS-1 was a double-blind, randomized phase III trial of 478 patients with T2DM who were naïve to injectable diabetes treatment, had not been using oral hypoglycemic agents for at least 3 months, and were inadequately controlled by diet and exercise alone.15 Participants were randomized to tirzepatide 5, 10 or 15 mg or placebo once weekly. The primary endpoint was the mean change in HbA1c from baseline at 40 weeks. At the conclusion of the trial, all doses of tirzepatide were superior to placebo for changes from baseline

in HbA1c, fasting serum glucose, body weight, and HbA1c targets of <7.0% and <5.7%. Mean HbA1c decreased from baseline by 1.87% with tirzepatide 5 mg, 1.89% with tirzepatide 10 mg, and 2.07% with tirzepatide 15 mg compared to +0.04% with placebo; this resulted in estimated treatment differences of —1.91% with tirzepatide 5 mg, —1.93% with tirzepatide 10 mg, and —2.11% with tirzepatide 15 mg (all p < 0.001).15 More patients who received tirzepatide met HbA1c targets of <7.0% compared to placebo (8792% vs 20%); similarly, more patients who received tirzepatide met HbA1c targets of <5.7% compared to placebo (31-52% vs 1%).15

In SURPASS-2, the safety and efficacy of tirzepatide were compared to semaglutide in 1,879 patients with T2DM that was inadequately controlled with metformin at a dose of at least 1500 mg daily. The primary endpoint of this open-label, phase III trial was the change in HbA1c level from baseline at 40 weeks.17 At the conclusion of the study, tirzepatide at all doses was both non-inferior and superior to semaglutide. The estimated mean change from baseline in the HbA1c level was −2.01%, −2.24%, and −2.30% with 5 mg, 10 mg, and 15 mg of tirzepatide, respectively, and −1.86% with semaglutide.17

SURPASS-3 assessed the efficacy and safety of tirzepatide compared to titrated insulin degludec in patients with T2DM inadequately controlled by metformin with or without SGLT2 inhibitors.18 This open-label, parallelgroup, phase III study included 1,444 patients with T2DM with baseline HbA1c of 7.0-10.5%, body mass index of ≥25 kg/m2, stable weight,

Materia Medica

and insulin-naïve. The primary efficacy endpoint was non-inferiority of tirzepatide 10 mg, 15 mg, or both compared to insulin degludec in mean change from baseline HbA1c after 52 weeks. The authors concluded that the mean change from baseline in HbA1c level was −1.93% for tirzepatide 5 mg, −2.2% for tirzepatide 10 mg, −2.37% for tirzepatide 15 mg, and −1.34% for insulin degludec.18 With these results, the non-inferiority margin of the study was met. Likewise, the proportion of participants who achieved HbA1c <7% at week 52 was statistically significantly greater in all three tirzepatide groups compared to insulin deglutec (82-93% vs 61%).18

The SURPASS-4 trial assessed the efficacy and safety of tirzepatide compared to insulin glargine in 2,002 patients with T2DM and high cardiovascular risk who were inadequately controlled on oral anti-diabetic agents. The primary endpoint of this open-label, phase III study was non-inferiority of tirzepatide 10 mg, 15 mg, or both compared to insulin glargine in HbA1c change from baseline at 52 weeks; however, treatment was continued for a maximum of 104 weeks to collect and assess major adverse cardiovascular events (MACE).19 At 52 weeks, mean HbAc1 changes were −2.43% with tirzepatide 10 mg, −2.58% with tirzepatide 15 mg, and −1.44% with insulin glargine. When assessing cardiovascular events, 109 patients experienced a MACE-4 event (cardiovascular death, myocardial infarction, stroke, or hospitalization for unstable angina); the number of MACE-4 events was not increased

in patients who received tirzepatide compared to those who received insulin glargine. The authors concluded that treatment with tirzepatide was not associated with excess cardiovascular risk.19

Finally, the SURPASS-5 trial assessed the efficacy and safety of tirzepatide added to insulin glargine in patients with T2DM with inadequate glycemic control while treated with once-daily insulin glargine with or without metformin.20 This was a randomized, phase 3 trial in 475 adults, with a primary endpoint of mean change from baseline in HbA1c at week 40. At the conclusion of the study, mean HbA1c change from baseline was −2.11% with tirzepatide 5 mg, −2.40% with tirzepatide 10 mg and −2.34% with tirzepatide 15 mg compared to −0.86% with placebo (p < 0.001 for all tirzepatide doses compared with placebo).20

The investigators of the SURPASS-6 trial are expected to publish results in November 2022. Two SURPASS-J trials and the SURPASSAP trial are being conducted entirely in Japan; published results are expected in September 2022 for the SURPASS-J trials, and although the SURPASS-AP trial has concluded, the timeline for publication is unknown.9,16

The SURPASS-CVOT trial is ongoing. It is a randomized, doubleblind controlled trial that compares tirzepatide with dulaglutide for clinically relevant cardiovascular outcomes. The trial will include 12,500 patients with T2DM and established atherosclerotic cardiovascular disease from 30 countries and will assess both noninferiority and superiority of tirzepatide against dulaglutide.9 Results are expected in 2024.8,16

Adverse Reactions

Similar to the GLP-1 receptor agonists, the most frequently reported adverse effects of tirzepatide are related to the gastrointestinal system. The most commonly reported adverse effects include nausea (up to 18%), diarrhea (up to 17%), decreased appetite (up to 11%), and vomiting (up to 9%). Other reported gastrointestinal effects include constipation, dyspepsia and abdominal pain.14 These adverse effects were noted to be dosedependent.9,21 Likewise, the majority of reports of nausea, vomiting, and/ or diarrhea occurred during dose escalation and decreased over time.14

The incidence of hypoglycemia in the reported SURPASS trials is low, occurring in <10% of patients.21 Other rarely reported adverse events include pancreatitis, injection site reactions, and hypersensitivity reactions, all of which occurred in <10% of patients. In a meta-analysis of 7 trials of tirzepatide, use of the agent was not associated with a higher incidence of serious adverse events or all-cause mortality.21

In preclinical animal studies, rats treated with tirzepatide developed thyroid C-cell tumors.14 The development of these tumors occurred in dose-dependent and treatmentduration-dependent manner. It is currently unknown whether tirzepatide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the relevance of rodent thyroid C-cell tumors to human tumor development has not been determined. Therefore, tirzepatide is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).14

Materia Medica

Information for Patients

Tirzepatide is available as a pre-filled single-dose pen. The recommended initial dose is 2.5 mg injected subcutaneously once weekly. After 4 weeks, the dose may be increased to 5 mg injected subcutaneously once weekly. If additional glycemic control is needed, the dosage can be increased in 2.5 mg increments after at least 4 weeks on the current dose. The maximum dosage is 15 mg subcutaneously once weekly.14

Tirzepatide can be administered at any time of day, with or without meals. The pre-filled pen should be injected subcutaneously in the abdomen, thigh, or upper arm. The injections sites should be rotated with each dose. Other injectable diabetes medications, including insulin, should not be mixed into the same injection as tirzepatide.14

Concomitant use of tirzepatide with insulin or an insulin secretagogue, such as a sulfonylurea, may increase the risk of hypoglycemia. The risk of hypoglycemia may be lowered by reducing the dose of insulin or the other concomitantly administered insulin secretagogue. Patients using these concomitant medications should be counseled about the risk of hypoglycemia and educated regarding the signs and symptoms of hypoglycemia.14

The gastrointestinal effects noted with tirzepatide are most applicable to patients with pre-existing risk factors, such as a history of gastrointestinal disorders or concurrent treatment with metformin.21 Similarly, tirzepatide delays gastric emptying, and therefore it has the potential to impact

the absorption of concomitantly administered oral medications.14 Consultation with a pharmacist is recommended for a thorough medication list review.

Patients should be counseled regarding the potential risk for MTC with tirzepatide. Patients should also be informed of symptoms of thyroid tumors, including a mass in the neck, dysphagia, dyspnea, and/or persistent hoarseness. The value of routine thyroid ultrasound or monitoring of serum calcitonin for early detection of MTC in patients receiving tirzepatide is uncertain, and therefore not currently recommended.14

Future Directions

Tirzepatide represents an advancement over the currently available GLP-1 receptor agonists, providing enhanced glycemic control in a shorter period of time without an associated increase in gastrointestinal adverse effects.5 Tirzepatide may also enhance weight reduction in patients with T2DM. However, the potential long-term effects of tirzepatide, particularly in terms of cardiovascular events and mortality as well as adverse effects, remain unknown at the present time.

Tirzepatide’s effects on reduction in body weight is also of great interest. The phase III SURMOUNT-1 trial compared three doses of tirzepatide to placebo in 2,539 adults with obesity. All three doses of tirzepatide provided substantial and sustained reductions in body weight at 72 weeks, with average weight reductions of approximately 20% in the 10 mg and 15 mg dose arms.22 These weight reductions were accompanied by improvements in

all cardiovascular and metabolic risk factors measured during the study period. These improvements may translate into reduced risk of T2DM, cardiovascular disease, chronic kidney disease, and other chronic health conditions, but longer-term follow-up is needed and tirzepatide is not currently indicated for weight loss.20,22,23

Reductions in ALT and AST have been observed during tirzepatide therapy, which may support a potential role of this agent in fatty liver disease.15 The safety and efficacy of tirzepatide in patients with non-alcoholic steatohepatitis is being assessed in the randomized, double-blind, placebo-controlled phase II SYNERGY-NASH study.8

The landscape of treatment options for T2DM continues to evolve as we learn how to best tailor individual treatment recommendations. The SURPASS trial data supports the incorporation of tirzepatide, either alone or in combination with other agents. However, the exact place in therapy of this agent remains undefined, and long-term outcomes are yet to be reported. Further information and extended follow-up data are eagerly awaited.

Ms. Metro is a Doctor of Pharmacy candidate at Duquesne University School of Pharmacy. Dr. Fancher is an associate professor of pharmacy practice at Duquesne University School of Pharmacy. She also serves as a clinical pharmacy specialist in oncology at the University of Pittsburgh Medical Center at Passavant Hospital. She can be reached at fancherk@duq.edu or (412) 396-5485.

Materia Medica

From Page 27

Table 1. Summary of the SURPASS trials9,15 20

Trial Comparator group Enrollment Concomitant therapy Primary outcome Results

SURPASS 1 Placebo 478 None Change from baseline in HbA1c Published June 2021

SURPASS 2 Semaglutide 1,879 Metformin

SURPASS 3 Insulin deglutec 1,444

SURPASS 4 Insulin glargine 2,002

Metformin +/ SGLT2 inhibitor

Metformin and/or SGLT2 inhibitor and/or sulfonylurea

Change from baseline in HbA1c Published June 2021

Change from baseline in HbA1c Published August 2021

Change from baseline in HbA1c

SURPASS 5 Placebo 472*

Insulin glargine +/ metformin

SURPASS 6 Insulin lispro 1,182*

Insulin glargine +/ metformin

SURPASS J mono Dulatglutide 636*

None or one oral anti hyperglycemic medication

SURPASS J combo None 441*

One oral anti hyperglycemic medication

SURPASS AP combo Insulin glargine 956* Metformin +/ sulfonylurea

SURPASS CVOT Dulaglutide 12,500*

*Estimated enrollment.

Oral or injectable anti hyperglycemic medications

Published October 2021

Change from baseline in HbA1c Published February 2022

Change from baseline in HbA1c

Change from baseline in HbA1c

Number of participants with ≥1 serious adverse event

Change from baseline in HbA1c

Time to first occurrence of a component of MACE 3 event

Estimated publication in November 2022

Will be published in September 2022

Will be published in September 2022

Completed, publication date unknown

Estimated October 2024

HbA1c = glycated hemoglobin; MACE = major adverse cardiovascular event; SGLT2 = sodium glucose cotransporter 2.

Materia Medica

REFERENCES

1. Galicia-Garcia U, Benito-Vicente A, Jebari S, et al. Pathophysiology of type 2 diabetes mellitus. Int J Mol Sci. 2020;21(17). DOI: 10.3390/ijms21176275.

2.Type 2 diabetes. Centers for Disease Control and Prevention. Available at https:// www.cdc.gov/diabetes/basics/type2.html. Published December 16, 2021. Accessed September 4, 2022.

3. International Diabetes FederationHome. Available at https://www.idf.org/ aboutdiabetes/complications.html. Accessed September 5, 2022. .

4. Diabetes treatment: Medications for type 2 diabetes. Mayo Clinic. Available at https:// www.mayoclinic.org/diseases-conditions/ type-2-diabetes/in-depth/diabetes-treatment/ art-20051004.

Accessed September 4, 2022.

5. New type 2 diabetes drug to regulate blood sugar levels, aid weight loss. Mint. Avail able at https://www.livemint.com/news/world/ new-type-2-diabetes-drug-to-regulate-bloodsugar-levels-aid-weight-loss-check-detailshere-11663512904734.html . Accessed September 26, 2022.

6. Cornell S. A review of GLP-1 receptor agonists in type 2 diabetes: A focus on the mechanism of action of once-weekly agents. J Clin Pharm Ther. 2020;45 Suppl 1:17-27. DOI: 10.1111/jcpt.13230.

7. Collins L, Costello RA. Glucagon-like peptide-1 receptor agonists. [Updated 2022 May 29]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan. Available from: https://www.ncbi.nlm.nih.gov/ books/NBK551568/ .

Accessed September 4, 2022.

8. Tan TM, Khoo B. Tirzepatide and the new era of twincretins for diabetes. Lancet. 2021;398(10295):95-97. DOI: 10.1016/ S0140-6736(21)01390-8.

9. Min T, Bain SC. The role of tirzepatide, dual GIP and GLP-1 receptor agonist, in the man agement of type 2 diabetes: the SURPASS clinical trials. Diabetes Ther. 2021;12(1):143157. DOI: 10.1007/s13300-020-00981-0.

10. Nauck MA, Quast DR, Wefers J, Meier JJ. GLP-1 receptor agonists in the treatment of type 2 diabetes - state-of-the-art. Mol Metab. 2021;46:101102. DOI: 10.1016/j. molmet.2020.101102.

11. American Diabetes A. 9. Pharmacologic ap proaches to glycemic treatment: Standards of medical care in diabetes-2021. Diabetes Care. 2021;44(Suppl 1):S111-S124. DOI: 10.2337/dc21-S009.

12. LeRoith D, Biessels GJ, Braithwaite SS, et al. Treatment of diabetes in older adults: an Endocrine Society* Clinical Practice Guideline. J Clin Endocrinol Metab. 2019;104(5):1520-1574. DOI: 10.1210/ jc.2019-00198.

13. Urva S, Coskun T, Loghin C, et al. The novel dual glucose-dependent insuli notropic polypeptide and glucagon-like peptide-1 (GLP-1) receptor agonist tirze patide transiently delays gastric emptying similarly to selective long-acting GLP-1 receptor agonists. Diabetes Obes Metab. 2020;22(10):1886-1891. DOI: 10.1111/ dom.14110.

14. Mounjaro [prescribing information]. India napolis, IN; Eli Lilly and Company, 2022. .

15. Rosenstock J, Wysham C, Frias JP, et al. Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in pa tients with type 2 diabetes (SURPASS-1): a double-blind, randomised, phase 3 trial. Lancet. 2021;398(10295):143-155. DOI: 10.1016/S0140-6736(21)01324-6.

16. Medicine Matters Diabetes. A quick guide to the SURPASS and SURMOUNT trials. Available at https://diabetes.medicinemat ters.com/tirzepatide/type-2-diabetes/aquick-guide-to-the-surpass-and-surmounttrials/18478154 .

Accessed September 1, 2022.

17. Frias JP, Davies MJ, Rosenstock J, et al. Tirzepatide versus semaglutide once week ly in patients with type 2 diabetes. N Engl J Med. 2021;385(6):503-515. DOI: 10.1056/ NEJMoa2107519.

18. Ludvik B, Giorgino F, Jodar E, et al. Once-weekly tirzepatide versus once-daily insulin degludec as add-on to metformin with or without SGLT2 inhibitors in patients with type 2 diabetes (SURPASS-3): a ran domised, open-label, parallel-group, phase 3 trial. Lancet. 2021;398(10300):583-598. DOI: 10.1016/S0140-6736(21)01443-4.

19. Del Prato S, Kahn SE, Pavo I, et al. Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, phase 3 trial. Lancet. 2021;398(10313):1811-1824. DOI: 10.1016/S0140-6736(21)02188-7.

20. Dahl D, Onishi Y, Norwood P, et al. Effect of subcutaneous tirzepatide vs placebo added to titrated insulin glargine on glycemic control in patients with type 2 diabetes: the SURPASS-5 randomized clinical trial. JAMA. 2022;327(6):534-545. DOI: 10.1001/jama.2022.0078.

21. Karagiannis T, Avgerinos I, Liakos A, et al. Management of type 2 diabetes with the dual GIP/GLP-1 receptor agonist tirzepati de: a systematic review and meta-analysis. Diabetologia. 2022;65(8):1251-1261. DOI: 10.1007/s00125-022-05715-4.

22. Jastreboff AM, Aronne LJ, Ahmad NN, et al. Tirzepatide once weekly for the treatment of obesity. N Engl J Med. 2022;387(3):205216. DOI: 10.1056/NEJMoa2206038.

23. Mounjaro (tirzepatide) injection. Available at https://www.mounjaro.com/. Accessed September 1, 2022

Editorial Editorial

adjacent lumbar vertebra, explaining her pain. My resident, from Georgia, upon seeing the findings said, in his deep southern drawl, “Fellahs, there’s a lesson here. Crocks daah (die), too.” Unfortunately for the patient, CT scanning and ultrasound exams had not been developed. The important lesson is that for most patients with a diagnosis of psychosomatic illness, the symptoms are real, and in fact a small number of these patients indeed have real abnormalities accounting for their symptoms.

Sigmund Freud’s view of humor was that it was a conscious expression of thoughts that society usually suppressed or was forbidden.2 As long as the humor, in this case name-

calling, is meant in a benign fashion, it is considered harmless.

However, in today’s politically divisive atmosphere, it is best to use humor only when you truly know your audience. As a good example, I remember the not so “good old days,” when it was expected that a speaker at a conference or a refresher course would tell jokes. Many of the “old timers” were very colorful characters. Today, fortunately, speakers are business-like and jokes are tacitly forbidden, since they are bound to offend someone. Finally, we should always remember that no matter how unpleasant some of our patients are to us, they are still our fellow human beings.

Dr. Daffner, associate editor of the ACMS Bulletin, is a retired radiologist who practiced at Allegheny General Hospital for more than 30 years. He is emeritus clinical professor of Radiology at Temple University School of Medicine and is the author of nine textbooks. He can be reached at bulletin@acms.org.

The opinion expressed in this column is that of the writer and does not necessarily reflect the opinion of the Editorial Board, the Bulletin, or the Allegheny County Medical Society.

References

1. Shem S. The House of God. Richard Marek Publishers 1978.

2. Freud S, (Strachey J, Trans.). Jokes and their relation to the unconscious New York: W. W. Norton, 1960 (Original work published 1905).

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NOVEMBER 16

MPHC 2022, a premier educational event for medical practice administrators and their office personnel, provides a robust engagement opportunity to discuss the challenges facing medicine and to leave with innovative strategies to improve practices!

KEYNOTE SPEAKER

Conference Highlights include:

Conference Kickoff and Closing Keynote: by Jordan Corcoran, CEO & Creator: ListenLucy.orgDon’t miss this timely presentation on mental health in the workplace. Jordan candidly discusses her battle with mental illness in a relatable, honest, and informal way. Attendees will come away with self care and coping techniques to share with staff.

Legislative and Regulatory Update: presented by a Pennsylvania Medical Society Advocacy team staff member, you’ll receive exclusive insight following the 2022 mid term elections.

Idea Exchange! Connect with your colleagues to share professional experiences and solutions to your most challenging professional issues.

Coding Session: *AAPC CEUs available: 1.0 CEU available for session. This session will help you to understand the high level changes for EM code sets in 2023, split/shared visits with mid levels documentation rules for 2023, and current landscape of telehealth.

Payor Help Support Desk: an exclusive opportunity to meet with insurance payors to discuss your practice's pain points. Time slots must be reserved and open only to MPHC 2022 attendees