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Implementing a Sports Ultrasound Curriculum in Undergraduate Medical Education
Schroeder, Allison N. , Amin, Idris, Bowen, Brady J., Callender, Shelley Street, Ferderber, Megan , Kerr, Hamish , Phillips, Shawn, Romero, Joshua , Rudolph, Lauren, Vidlock, Kathryn , Waterbrook, Anna L., Kruse, Ryan C. , Bowen, Brady J.

Current Sports Medicine Reports | September 6, 2023 | Volume: 22 | Issue: 9 | Pages: 328-335

10.1249/jsr.0000000000001099 | PMID 37678352 Get It

Abstract The utilization of sports ultrasound in the clinical practice of sports medicine physicians is growing rapidly. Simultaneously, ultrasound is being increasingly implemented as a teaching tool in undergraduate medical education. However, a sports ultrasound curriculum for medical students has not been previously described. In this article, we describe methods as well as barriers to implementing a sports ultrasound curriculum at the medical school level. Recommended content for the curriculum also is discussed. While educational goals and resources will vary among institutions, this article may serve as a general roadmap for the creation of a successful curriculum.
Decoding the Signals: An Analysis of Preference Signaling in the 2023 Orthopaedic Surgery Residency Match
Deckey, David G. , Lin, Eugenia , Gerhart, Coltin R. B. , Brinkman, Joseph C. , Patel, Karan A. , Bingham, Joshua S. , Patel, Karan , Bingham, Joshua S

JBJS Open Access | September 1, 2023 | Volume: 8 | Issue: 3 | Pages: No page available

10.2106/jbjs.oa.23.00052 | PMID 37662882 Get It

Background: While previously used in other specialties, the preference signaling program (PSP) was implemented in the 2022 to 2023 orthopaedic surgery residency application process for the first time. The PSP allowed for 30 signaling tokens to be sent by applicants to programs of their choice to indicate particular interest in a program. It remains unknown how the PSP affects applicants and programs in the orthopaedic surgery residency match. Thus, this study's purpose was to assess the utility of preference signaling within the orthopaedic surgery residency application process in its inaugural year of use. Methods: An anonymous electronic survey was emailed to all orthopaedic surgery residency applicants who applied to the authors' institution during the 2022 to 2023 application cycle. The survey was sent after match lists were submitted and closed before the release of match results. The survey collected information regarding applicant demographics, preference signaling habits, and attitude toward preference signaling. Results: The survey was completed by 101 applicants. Applicants applied to a mean of 90 programs (range: 10-197) and received an average of 12 interview invitations (range: 0-39). Applicants almost uniformly used all 30 signals, with nearly two-thirds signaling their home programs (65%, 49/76), and nearly all applicants sending signals to programs at which they performed away rotations (95.7%, 88/92). Applicants received a mean of 9 invitations from programs they signaled, compared with 2 invitations from programs they did not signal. Applicants were significantly more likely to receive an interview invite at a program they signaled than one they did not (p < 0.01). Overall, 57% of applicants (57/101) found the PSP to be helpful, whereas 28% (28/101) found it to be unhelpful, and 16% (16/101) had a neutral opinion. Conclusions: This study reports that the PSP in the 2022 to 2023 orthopaedic surgery match was an effective method of expressing interest in a program because applicants were significantly more likely to receive interview invites to signaled programs. More than half of respondents felt PSP to be helpful; however, the effect on application numbers is still unclear. Level of Evidence: III
Life‐Threatening Subglottic Thrombus Formation after Administration of Nebulized Tranexamic Acid
Awadallah, Andrew S. , Armstrong, Michael , Aden, Aisha A. , Weidermann, Joshua, Bayan, Semirra L. , Ekbom, Dale C. , Awadallah, Andrew , Aden, Aisha , Armstrong, Michael F , Bayan, Semirra

The Laryngoscope | August 25, 2023 | Volume: 134 | Issue: 3 | Pages: 1356-1358

10.1002/lary.30973 | PMID 37622726 Get It

Sex Differences in Neurovascular Control: Implications for Obstructive Sleep Apnea
Bock, Joshua M. , Greenlund, Ian M. , Baker, Sarah E. , Baker, Sarah E , Bock, Joshua , Somers, Virend K.

International Journal of Molecular Sciences | August 23, 2023 | Volume: 24 | Issue: 17 | Pages: 13094

10.3390/ijms241713094 | PMID 37685900 Get It

Patients with obstructive sleep apnea (OSA) have a heightened risk of developing cardiovascular diseases, namely hypertension. While seminal evidence indicates a causal role for sympathetic nerve activity in the hypertensive phenotype commonly observed in patients with OSA, no studies have investigated potential sex differences in the sympathetic regulation of blood pressure in this population. Supporting this exploration are large-scale observational data, as well as controlled interventional studies in healthy adults, indicating that sleep disruption increases blood pressure to a greater extent in females relative to males. Furthermore, females with severe OSA demonstrate a more pronounced hypoxic burden (i.e., disease severity) during rapid eye movement sleep when sympathetic nerve activity is greatest. These findings would suggest that females are at greater risk for the hemodynamic consequences of OSA and related sleep disruption. Accordingly, the purpose of this review is three-fold: (1) to review the literature linking sympathetic nerve activity to hypertension in OSA, (2) to highlight recent experimental data supporting the hypothesis of sex differences in the regulation of sympathetic nerve activity in OSA, and (3) to discuss the potential sex differences in peripheral adrenergic signaling that may contribute to, or offset, cardiovascular risk in patients with OSA.
Efficacy of Rubella Vaccination after Co-Inoculation with Rhogam
Brunton, Joshua , Theiler, Regan N. , Mehta, Ramila A. , Enninga, Elizabeth Ann L. , Torbenson, Vanessa E. , Brunton, Joshua S , Mehta, Ramila, Branda, Megan E. , Enninga, Elizabeth Ann L , Theiler, Regan

Viruses | August 22, 2023 | Volume: 15 | Issue: 9 | Pages: 1782

10.3390/v15091782 | PMID 37766189 Get It

Congenital rubella syndrome is a constellation of birth defects that can have devastating consequences, impacting approximately 100,000 births worldwide each year. The incidence is much lower in countries that routinely vaccinate their population. In the US, postnatal immunization of susceptible women is an important epidemiological strategy for the prevention of rubella as the Center for Disease Control (CDC) does not recommend administering this vaccine during pregnancy due to its nature as a live attenuated virus vaccine. However, concerns that the co-administration of rubella vaccine with other immunoglobins (i.e., Rhogam) could compromise vaccine efficacy has produced warnings that can delay the administration of rubella vaccination postpartum, leaving women susceptible to the disease in subsequent pregnancies. We aimed to address whether the co-administration of the measles, mumps, and rubella (MMR) vaccine and Rhogam decreased antibody responses compared to those receiving only MMR vaccination. This retrospective cohort study utilized clinical data from 78 subjects who received the MMR vaccine and Rhogam after delivery and 45 subjects who received the MMR vaccine alone. Maternal demographics, pregnancy complications and rubella status at the start of a subsequent pregnancy were recorded for analysis. Overall, the two cohorts had similar baseline characteristics; however, lower parity was noted in the participants that received both MMR vaccination and Rhogam. Making assessments based on maternal antibody IgG index for rubella during the next pregnancy, we observed that 88% of the Rhogam + MMR vaccine group had positive serology scores, which was not significantly different from the 80% rate in the MMR-vaccine-only cohort (p = 0.2). In conclusion, no differences were observed in rubella immunity status in subsequent pregnancies in those mothers given both the MMR vaccine and Rhogam concurrently. Given these findings, warnings against co-administration of vaccines in combination with Rhogam appear unwarranted.
Does Preoperative Pharmacogenomic Testing of Patients Undergoing TKA Improve Postoperative Pain? A Randomized Trial
Kekić, Adrijana, Erickson, Colby , Grilli, Christopher, Seamans, David P. , Upjohn, David P., Hentz, Joseph G. , Kraus, Molly B , Grilli, Christopher B, Clarke, Henry D. , Spangehl, Mark J. , Kraus, Molly B. , Bingham, Joshua S.

Clinical Orthopaedics & Related Research | August 18, 2023 | Volume: 482 | Issue: 2 | Pages: 291-300

10.1097/corr.0000000000002767 | PMID 37594401 Get It

Abstract Background Pharmacogenomics is an emerging and affordable tool that may improve postoperative pain control. One challenge to successful pain control is the large interindividual variability among analgesics in their efficacy and adverse drug events. Whether preoperative pharmacogenomic testing is worthwhile for patients undergoing TKA is unclear. Questions/purposes (1) Are the results of preoperative pharmacogenetic testing associated with lower postoperative pain scores as measured by the Overall Benefit of Analgesic Score (OBAS)? (2) Do the results of preoperative pharmacogenomic testing lead to less total opioids given? (3) Do the results of preoperative pharmacogenomic testing lead to changes in opioid prescribing patterns? Methods Participants of this randomized trial were enrolled from September 2018 through December 2021 if they were aged 18 to 80 years and were undergoing primary TKA under general anesthesia. Patients were excluded if they had chronic kidney disease, a history of chronic pain or narcotic use before surgery, or if they were undergoing robotic surgery. Preoperatively, patients completed pharmacogenomic testing (RightMed, OneOME) and a questionnaire and were randomly assigned to the experimental group or control group. Of 99 patients screened, 23 were excluded, one before randomization; 11 allocated patients in each group did not receive their allocated interventions for reasons such as surgery canceled, patients ultimately undergoing spinal anesthesia, and change in surgery plan. Another four patients in each group were excluded from the analysis because they were missing an OBAS report. This left 30 patients for analysis in the control group and 38 patients in the experimental group. The control and experimental groups were similar in age, gender, and race. Pharmacogenomic test results for patients in the experimental group were reviewed before surgery by a pharmacist, who recommended perioperative medications to the clinical team. A pharmacist also assessed for clinically relevant drug-gene interactions and recommended drug and dose selection according to guidelines from the Clinical Pharmacogenomics Implementation Consortium for each patient enrolled in the study. Patients were unaware of their pharmacogenomic results. Pharmacogenomic test results for patients in the control group were not reviewed before surgery; instead, standard perioperative medications were administered in adherence to our institutional care pathways. The OBAS (maximum 28 points) was the primary outcome measure, recorded 24 hours postoperatively. A two-sample t-test was used to compare the mean OBAS between groups. Secondary measures were the mean 24-hour pain score, total morphine milligram equivalent, and frequency of opioid use. Postoperatively, patients were assessed for pain with a VAS (range 0 to 10). Opioid use was recorded preoperatively, intraoperatively, in the postanesthesia care unit, and 24 hours after discharge from the postanesthesia care unit. Changes in perioperative opioid use based on pharmacogenomic testing were recorded, as were changes in prescription patterns for postoperative pain control. Preoperative characteristics were also compared between patients with and without various phenotypes ascertained from pharmacogenomic test results. Results The mean OBAS did not differ between groups (mean ± SD 4.7 ± 3.7 in the control group versus 4.2 ± 2.8 in the experimental group, mean difference 0.5 [95% CI -1.1 to 2.1]; p = 0.55). Total opioids given did not differ between groups or at any single perioperative timepoint (preoperative, intraoperative, or postoperative). We found no difference in opioid prescribing pattern. After adjusting for multiple comparisons, no difference was observed between the treatment and control groups in tramadol use (41% versus 71%, proportion difference 0.29 [95% CI 0.05 to 0.53]; nominal p = 0.02; adjusted p > 0.99). Conclusion Routine use of pharmacogenomic testing for patients undergoing TKA did not lead to better pain control or decreased opioid consumption. Future studies might focus on at-risk populations, such as patients with chronic pain or those undergoing complex, painful surgical procedures, to test whether pharmacogenomic results might be beneficial in certain circumstances. Level of Evidence Level I, therapeutic study.
Minimum 10-Year Clinical Outcomes and Survivorship of Meniscal Allograft Transplantation With Fresh-Frozen Allografts Using the Bridge-in-Slot Technique
Cotter, Eric J. , Gilat, Ron , Meeker, Zachary D. , Frazier, Landon P., Yanke, Adam B. , Cole, Brian J. , Wagner, Kyle R. , Kaiser, Joshua T. , Hevesi, Mario , Frazier, Landon P.

The American Journal of Sports Medicine | August 18, 2023 | Volume: 51 | Issue: 11 | Pages: 2954-2963

10.1177/03635465231188657 | PMID 37594374 Get It

Background: Meniscal allograft transplantation (MAT) has been shown to provide clinical benefits in patients with symptomatic meniscal deficiency in the short term and midterm. There is, however, a paucity of data regarding long-term outcomes after MAT using fresh-frozen allografts and the bridge-in-slot technique. Purpose: To report clinical outcomes and revision rates after primary MAT with fresh-frozen allografts and the bridge-in-slot technique in a large case series of patients at a 10-year minimum follow-up. Study Design: Case series; Level of evidence, 4. Methods: A retrospective review of prospectively collected data was performed on patients undergoing primary MAT between 2001 and 2012. Lysholm, International Knee Documentation Committee subjective form, and Knee injury and Osteoarthritis Outcome Score subscales were collected preoperatively and at 1-, 2-, 5-, and minimum 10-year follow-ups. Cox proportional hazards modeling was used to identify variables associated with reoperation and failure, defined as revision MAT or conversion to arthroplasty. Reoperation was defined as a subsequent surgical intervention on the transplanted meniscus, including partial or total meniscectomy, meniscal repair, or failure as defined in the previous sentence. Results: A total of 174 patients undergoing MAT met the inclusion criteria and were followed for a mean of 12.7 ± 2.7 years (range, 10.0-21.0 years). The mean age at surgery was 28.3 ± 10.1 years. The patients were predominantly female (n = 92; 53%), and medial MAT was the most commonly performed procedure (n = 91; 52%). Concomitant procedures were performed in 115 patients (66%), with the most common procedure being osteochondral allograft transplantation (n = 59; 34%). Patients demonstrated statistically significant postoperative improvements at all time points for all patient-reported outcome measures ( P ≤ .0001). A total of 65 patients (37%) underwent a meniscal reoperation at a mean time of 6.6 ± 5.5 years (range, 0.3-16.7 years) postoperatively. A total of 40 patients (23%) met the criteria for failure at a mean time of 7.3 ± 5.0 years (range, 1.0-17.4 years) after MAT, with 22 of these patients having undergone a previous meniscal reoperation. At the final follow-up, 13 patients (7%) had undergone revision MAT and 27 (15%) had converted to arthroplasty. The MAT survival rates free of meniscal reoperation and failure were 73% and 85% at 10 years and 60% and 72% at 15 years, respectively. At the time of the final follow-up, 86% of patients reported that they were satisfied with their overall postoperative condition. Conclusion: Primary MAT demonstrates efficacy and durability with high rates of patient satisfaction at a minimum 10-year follow-up. Patients should be counseled that although reoperation rates may approach 40% at 15 years, rates of overall revision MAT and conversion to arthroplasty remain low at long-term follow-up.
Systemic Anticancer Therapy and Thromboembolic Outcomes in Hospitalized Patients With Cancer and COVID-19
Hsu, Chih–Yuan , Shah, Surbhi, Zon, Rebecca L. , Alsamarai, Susan, El-Bakouny, Ziad, Beeghly, Alicia, Doroshow, Deborah B. , Flora, Daniel , Fromowitz, Ariel, Jani, Chinmay , Khan, Hina, Klein, Elizabeth J. , Heater, Natalie Knox , Koshkin, Vadim S. , Kwon, Daniel H. , McKay, Rana R. , Nonato, Taylor K., Polimera, Hyma , Puc, Matthew , Shastri, Aditi , Singh, Sunny , Weissmann, Lisa B., Wilkins, Cy R. , Yoon, James J., Mishra, Sanjay , Grivas, Petros , Connors, Jean M. , Gandhi, Rikin, Gartrell, Benjamin A. , Makower, Della , Sullivan, Darciann O', Ohri, Nitin , Verma, Amit , Butt, Omar H. , Fiala, Mark A. , Monahan, Ryan, Bitran, Jacob D. , Hallmeyer, Sigrun , Mundt, Daniel , Pandravada, Sasirekha, Papaioannou, Philip V., Patel, Mauli, Streckfuss, Mitrianna, Tadesse, Eyob, Lammers, Philip E. , Bindal, Poorva , Lam, Barbara C.C., Piper‐Vallillo, Andrew J., Arvanitis, Panos , Vieira, Kendra, Angevine, Anne H., Bär, Michael, Prete, Salvatore A. Del , Fiebach, Maryann Z., Gulati, Anthony P., Hatton, Edward H., Houston, Kaly, Lo, K. M. Steve, Stratton, Jamie , Weinstein, Paul L., García, Jorge A. , Routy, Bertrand , Hoyo-Ulloa, Irma , Gupta, Shilpa , Sharifi, Nima , Hoppenot, Claire , Demetri, George D., Zarif, Talal El , Freeman, Dory , Nohria, Anju, Tolaney, Sara M. , Zhang, Tian , Dzimitrowicz, Hannah, Leighton, John, Lynch, Ryan C. , Portuguese, Andrew J. , Schweizer, Michael T. , Vinayak, Shaveta , Wagner, Michael J. , Dansoa, Yvonne , Manikowski, Jesse J. , Vadakara, Joseph , Yossef, Kristena, Beckerman, Jennifer, Goyal, Sharad , Messing, Ian , Provenzano, Destie , Steffes, Dawn R., Clément, Jessica , Cosin, Jonathan A. , Daher, Ahmad , Dailey, Mark E., Hosmer, Wylie, Hsu, Emily , Jayaraj, Asha, Mather, Jeff, Menendez, Alvaro G. , Nadkarni, Rajani, Serrano, Oscar K. , Tejwani, Sheela , Accordino, Melissa , Bodin, Brianne E, Khan, Shaheer , Masson, Cynthia, Alexander, Mariam , Matar, Sara , Bernicker, Eric , Deeken, John F. , Jeffords, Kelly J., Shafer, Danielle , Cárdenas‐Delgado, Ana I., Campos, Rogelio Cuervo, Ramirez, Ana, Valdez-Reyes, Nadia Melissa, Gill, David , Lewis, Mark A. , Low, Clarke A., Rhodes, Terence D., Jones, Michelle, Mansoor, Abdul-Hai, Mashru, Sandeep H., Werner, Mica A., Cohen, Aaron , Hayes‐Lattin, Brandon , Nemecek, Eneida R. , Williamson, Staci, Lewis, Grant C., Smith, Stephanie J., Akhtari, Mojtaba, Castillo, Dan R., Cortez, Kimberly, Park, Kyu, Reeves, Mark E. , O’Connor, Timothy E. , Altman, Jessica K. , Gurley, Michael, Mulcahy, Mary F. , Kulkarni, Amit , Ramesh, Vidhyalakshmi , Wilson, Grace L. , Bardia, Aditya , Gainor, Justin F. , Peppercorn, Jeffrey , Reynolds, Kerry L. , Zubiri, Leyre , Campian, Jian , Riaz, Irbaz B, Williams, Colt , Bonnen, Mark , Mahadevan, Daruka , Salazar, Mary, Wang, Chen‐Pin , Bouganim, Nathaniel , Elkrief, Arielle , Moria, Feras, Panasci, Justin , Nanchal, Rahul , Bahadur, Nadia , Nambiar, Puja H. , Papadopoulos, Esperanza B. , Riely, Gregory J. , Rosenberg, Jonathan E., Cerrone, Kim, Dill, Jennifer A. , Faller, Bryan A. , Ajmera, Archana , Brouha, Sharon S. , Choi, Sharon , Bhatt, Padmanabh , Mariano, Melissa G., Thomson, Carey C. , Glace, Mary Grace, Knoble, Jeanna, Zacks, Rosemary, Blau, Sibel , Brown, CarrieAnn, Namburi, Swathi, Pomerantz, Lauren , Rovito, Marc A., Advani, Pragati E., Cronin, Tara, Fleissner, Bridget, Goel, Shipra , Gopalakrishnan, Dharmesh , Hernandez‐Ilizaliturri, Francisco J. , Kariapper, Ariffa, Levine, Ellis , Wicher, Camille P., Misdary, Christian, Shah, Mansi , Batist, Gerald , Cook, Erin , Esfahani, Khashayar , Ferrario, Cristiano , Lau, Susie , Ma, Kim, Rudski, Lawrence , Dutra, Míriam Santos , Mahmood, Sana , Mico, Vasil, Rivera, Andrea Verghese, Dixon, Becky, Heilman, Hannah, Logan, Barbara, Mandapakala, Chaitanya, Cabebe, Elwyn C., Glover, Michael , Jha, Alokkumar , Schapira, Lidia , Shah, Sumit , Subbiah, Suki , Lopes, Gilberto , Cardenas, Karen de, Russell, Karen , Stith, Brittany, Taylor, Sharona, Klamerus, Justin F., Revankar, Sanjay G. , Addison, Daniel , Chen, James L. , Pillainayagam, Clement, Wall, Sarah , Williams, Nicole , Abbasi, Saqib Hussen, Annis, Sandy, Greenland, Steven, Jones, Regina, Kasi, Anup , Rock, Crosby D. , Wulff‐Burchfield, Elizabeth , Smits, Melissa, Weiß, Matthias , Chism, David D. , Owenby, Susie, Ang, Celina , Galsky, Matthew D. , Metzger, Megan , Uyehara, Catherine, Lashley, Latoya N., Sueyoshi, Mark, Patel, Kanishka G. , Riess, Jonathan W. , Borno, Hala T. , Rubinstein, Samuel M. , Ahmad, Syed A. , Grover, Punita , Jandarov, Roman , Kharofa, Jordan , Marcum, Michelle, Sohal, Davendra , Zamulko, Olga , Balmaceda, Nicole , Geiger, Christopher L., Russ, Atlantis Dawn, Saker, Haneen , Choi, Horyun, Feldman, Lawrence , Gantt, Gerald, Hoskins, Kent , Khan, Mahir, Liu, Li , Nguyen, Ryan H., Schwartz, Candice, Venepalli, Neeta K. , Boldt, Anne, Fecher, Leslie A. , Su, Chris, Bijjula, Ragneel R., Mavromatis, Blanche H., Seletyn, Mildred E., Wood, Barbara R., Kaklamani, Virginia , Charles, Lawrence J., Cheng, Alex , Ding, Tan , Enriquez, Kyle T. , French, Benjamin , Gillaspie, Erin A. , Hennessy, Cassandra , Johnson, Douglas B. , Lewis, Judy T., Reid, Sonya , Saif, Sara, Slosky, David, Solórzano, Carmen C. , Sun, Tianyi , Yang, Yuanchu James , Carducci, Theresa M., Goldsmith, Karen J., Loon, Susan Van, Topaloĝlu, Ümit , Moore, Joan K., Cabalona, Wilhelmina D., Shisler, Elizabeth, McCollough, Briana Barrow, Peddi, Prakash , Rosen, L, Bilen, Mehmet Asım , Castellano, Cecilia A. , Ravindranathan, Deepak , LoRusso, Patricia , Lustberg, Maryam B. , Masters, Tyler, Mishra, Sanjay , Zubiri, Leyre , Fiala, Mark A , Bilen, Mehmet A , Portuguese, Andrew J , Lustberg, Maryam , Gulati, Shuchi , Shah, Pankil , Awosika, Joy A. , Bashir, Babar , Berg, Stephanie , De‐la‐Rosa‐Martinez, Daniel , Egan, Pamela , Fein, Joshua Alexander , Friese, Christopher R. , Griffiths, Elizabeth A. , Hwang, Clara , Joshi, Monika , Labaki, Chris , Latif, Tahir , Nagaraj, Gayathri , Nakasone, Elizabeth S. , Razavi, Pedram , Ruíz‐García, Erika , Saliby, Renée Maria , Tagalakis, Vicky , Vilar‐Compte, Diana , Wise-Draper, Trisha Michel , Wotman, Michael T. , Shyr, Yu , Warner, Jeremy L. , Shah, Dimpy P. , Rosovsky, Rachel , Goel, Sanjay , Halmos, Balázs , Sica, Roberto Alejandro , Henderson, Jeffrey P. , Stockerl‐Goldstein, Keith , Zhou, Alice Y. , Tadesse, Eyob, Thompson, Michael A. , Loree, Jonathan M. , Lam, Barbara, Peters, Mary Linton B , Farmakiotis, Dimitrios , Olszewski, Adam J. , Hatton, Edward, Rose, Suzanne J. , Nizam, Amanda , Pennell, Nathan A , Li, Ang , Bitterman, Danielle S. , Choueiri, Toni K. , Florez, Narjust , Giordano, Antonio , Morgans, Alicia K. , Nohria, Anju , Van Allen, Eliezer M , Xu, Wenxin Vincent , Halabi, Susan , Graber, Jerome J. , Hawley, Jessica E. , Loggers, Elizabeth T , Lyman, Gary H , Su, Christopher , Tachiki, Lisa , Yeh, Albert C. , Gatson, Na Tosha , Makary, Mina S. , Rao, Yuan James , Rosenstein, Lori J. , Elias, Rawad , Eton, Omar , Yu, Peter Paul , Gadgeel, Shirish M. , Bhutani, Divaya , Hershman, Dawn L. , Ingham, Matthew , Schwartz, Gary K. , Reuben, Daniel Y. , McWeeney, Shannon K. , Wehbe, Firas , Durbin, Eric B. , Nelson, Heather H. , Sachs, Zohar , Wilson, Grace, Boland, Genevieve M. , Smith, Katherine E. , Bekaii‐Saab, Tanios , Desai, Aakash , Hálfdánarson, Þorvarður R. , Joyner, Michael J. , Senefeld, Jonathon W. , Ramirez, Amelie G , Mesa, Ruben A. , Papenburg, Jesse , Vinh, Donald Cuong , Singh, Harpreet , Bao, Ting , O'Cearbhaill, Roisin E , Philip, John, Robson, Mark E. , Rosenberg, Jonathan E., Schoenfeld, Adam Jacob , Tamimi, Rulla M. , Dill, Jennifer, Hsiao, Albert , Reid, Erin G , Rink, Cameron L. , Jain, Prantesh , Moffitt, Melissa , O’Connor, Tracey L. , Puzanov, Igor , Smith, Laurie J., Zsíros, Emese , Jabbour, Salma K , Cook, Erin, Miller, Wilson H. , Wilchesky, Machelle , McNair, Christopher M. , Khaki, Ali Raza , Nagpal, Seema , Wu, Julie , Whaley, David, Gatti-Mays, Margaret Elena , Jhawar, Sachin R. , Palmer, Joshua D. , Stover, Daniel G. , Weiss, Matthias, Berenberg, Jeffrey L. , Fazio, Alyson, Huber, Kathryn E. , Small, Eric J. , Zhang, Sylvia , Andermann, Tessa M. , Jensen, Christopher Edward , Wood, William A. , Li, Ningjing , Abidi, Maheen Z. , Bowles, Daniel W. , Markham, Merry Jennifer , Acoba, Jared David , Rho, Young Soo, Nguyen, Ryan H., Pasquinelli, Mary M. , Vikas, Praveen , Zakharia, Yousef , Zaman, Qamar U., Brown, Alaina J. , Crispens, Marta Ann , Croessmann, Sarah , Davis, Elizabeth J. , Ding, Tan, Duda, Stephany N. , Hausrath, Daniel J. , Li, Xuanyi , Prescott, Lauren Shore , Wang, Lucy Lu , Aboulafia, David M. , Hafez, Navid , Herbst, Roy S. , Stratton, Catherine , Painter, Corrie , Peters, Solange

JAMA Oncology | August 17, 2023 | Volume: 9 | Issue: 10 | Pages: 1390

10.1001/jamaoncol.2023.2934 | PMID 37589970 Get It

ImportanceSystematic data on the association between anticancer therapies and thromboembolic events (TEEs) in patients with COVID-19 are lacking.ObjectiveTo assess the association between anticancer therapy exposure within 3 months prior to COVID-19 and TEEs following COVID-19 diagnosis in patients with cancer.Design, Setting, and ParticipantsThis registry-based retrospective cohort study included patients who were hospitalized and had active cancer and laboratory-confirmed SARS-CoV-2 infection. Data were accrued from March 2020 to December 2021 and analyzed from December 2021 to October 2022.ExposureTreatments of interest (TOIs) (endocrine therapy, vascular endothelial growth factor inhibitors/tyrosine kinase inhibitors [VEGFis/TKIs], immunomodulators [IMiDs], immune checkpoint inhibitors [ICIs], chemotherapy) vs reference (no systemic therapy) in 3 months prior to COVID-19.Main Outcomes and MeasuresMain outcomes were (1) venous thromboembolism (VTE) and (2) arterial thromboembolism (ATE). Secondary outcome was severity of COVID-19 (rates of intensive care unit admission, mechanical ventilation, 30-day all-cause mortality following TEEs in TOI vs reference group) at 30-day follow-up.ResultsOf 4988 hospitalized patients with cancer (median [IQR] age, 69 [59-78] years; 2608 [52%] male), 1869 had received 1 or more TOIs. Incidence of VTE was higher in all TOI groups: endocrine therapy, 7%; VEGFis/TKIs, 10%; IMiDs, 8%; ICIs, 12%; and chemotherapy, 10%, compared with patients not receiving systemic therapies (6%). In multivariable log-binomial regression analyses, relative risk of VTE (adjusted risk ratio [aRR], 1.33; 95% CI, 1.04-1.69) but not ATE (aRR, 0.81; 95% CI, 0.56-1.16) was significantly higher in those exposed to all TOIs pooled together vs those with no exposure. Among individual drugs, ICIs were significantly associated with VTE (aRR, 1.45; 95% CI, 1.01-2.07). Also noted were significant associations between VTE and active and progressing cancer (aRR, 1.43; 95% CI, 1.01-2.03), history of VTE (aRR, 3.10; 95% CI, 2.38-4.04), and high-risk site of cancer (aRR, 1.42; 95% CI, 1.14-1.75). Black patients had a higher risk of TEEs (aRR, 1.24; 95% CI, 1.03-1.50) than White patients. Patients with TEEs had high intensive care unit admission (46%) and mechanical ventilation (31%) rates. Relative risk of death in patients with TEEs was higher in those exposed to TOIs vs not (aRR, 1.12; 95% CI, 0.91-1.38) and was significantly associated with poor performance status (aRR, 1.77; 95% CI, 1.30-2.40) and active/progressing cancer (aRR, 1.55; 95% CI, 1.13-2.13).Conclusions and RelevanceIn this cohort study, relative risk of developing VTE was high among patients receiving TOIs and varied by the type of therapy, underlying risk factors, and demographics, such as race and ethnicity. These findings highlight the need for close monitoring and perhaps personalized thromboprophylaxis to prevent morbidity and mortality associated with COVID-19–related thromboembolism in patients with cancer.
Assessing the use of observational methods and real-world data to emulate ongoing randomized controlled trials
Wallach, Joshua D. , Deng, Yihong , Dhruva, Sanket S. , Quinto, Kenneth , Gandotra, Charu , Ross, Joseph S , Wallach, Joshua D , Deng, Yihong , Polley, Eric C. , Herrin, Jeph , Crown, William H. , Noseworthy, Peter A. , Yao, Xiaoxi , Jeffery, Molly Moore , Lyon, Timothy D. , Ross, Joseph S. , McCoy, Rozalina G.

Clinical Trials | August 17, 2023 | Volume: 20 | Issue: 6 | Pages: 689-698

10.1177/17407745231193137 | PMID 37589143 Get It

Background/aims There has been growing interest in better understanding the potential of observational research methods in medical product evaluation and regulatory decision-making. Previously, we used linked claims and electronic health record data to emulate two ongoing randomized controlled trials, characterizing the populations and results of each randomized controlled trial prior to publication of its results. Here, our objective was to compare the populations and results from the emulated trials with those of the now-published randomized controlled trials. Methods This study compared participants’ demographic and clinical characteristics and study results between the emulated trials, which used structured data from OptumLabs Data Warehouse, and the published PRONOUNCE and GRADE trials. First, we examined the feasibility of implementing the baseline participant characteristics included in the published PRONOUNCE and GRADE trials’ using real-world data and classified each variable as ascertainable, partially ascertainable, or not ascertainable. Second, we compared the emulated trials and published randomized controlled trials for baseline patient characteristics (concordance determined using standardized mean differences <0.20) and results of the primary and secondary endpoints (concordance determined by direction of effect estimates and statistical significance). Results The PRONOUNCE trial enrolled 544 participants, and the emulated trial included 2226 propensity score-matched participants. In the PRONOUNCE trial publication, one of the 32 baseline participant characteristics was listed as an exclusion criterion on ClinicalTrials.gov but was ultimately not used. Among the remaining 31 characteristics, 9 (29.0%) were ascertainable, 11 (35.5%) were partially ascertainable, and 10 (32.2%) were not ascertainable using structured data from OptumLabs. For one additional variable, the PRONOUNCE trial did not provide sufficient detail to allow its ascertainment. Of the nine variables that were ascertainable, values in the emulated trial and published randomized controlled trial were discordant for 6 (66.7%). The primary endpoint of time from randomization to the first major adverse cardiovascular event and secondary endpoints of nonfatal myocardial infarction and stroke were concordant between the emulated trial and published randomized controlled trial. The GRADE trial enrolled 5047 participants, and the emulated trial included 7540 participants. In the GRADE trial publication, 8 of 34 (23.5%) baseline participant characteristics were ascertainable, 14 (41.2%) were partially ascertainable, and 11 (32.4%) were not ascertainable using structured data from OptumLabs. For one variable, the GRADE trial did not provide sufficient detail to allow for ascertainment. Of the eight variables that were ascertainable, values in the emulated trial and published randomized controlled trial were discordant for 4 (50.0%). The primary endpoint of time to hemoglobin A1c ≥7.0% was mostly concordant between the emulated trial and the published randomized controlled trial. Conclusion Despite challenges, observational methods and real-world data can be leveraged in certain important situations for a more timely evaluation of drug effectiveness and safety in more diverse and representative patient populations.
Magnetic Resonance Imaging Artifact Associated With Transcutaneous Bone Conduction Implants: Cholesteatoma and Vestibular Schwannoma Surveillance
Nassiri, Ashley M. , Lane, John I. , McGee, Kiaran P. , Trzasko, Joshua D. , Carlson, Matthew L. , Messina, Steven A. , Benson, John C.

Otolaryngology–Head and Neck Surgery | August 16, 2023 | Volume: 170 | Issue: 1 | Pages: 187-194

10.1002/ohn.474 | PMID 37582349 Get It

AbstractObjectiveTo evaluate the magnetic resonance (MR) image artifact and image distortion associated with the two transcutaneous bone conduction implants currently available in the United States.Study DesignCadaveric study.MethodsTwo cadaveric head specimens (1 male, 1 female) were unilaterally implanted according to manufacturer guidelines and underwent MR imaging (General Electric and Siemens 1.5 T scanners) under the following device conditions: (1) no device, (2) Cochlear Osia with magnet and headwrap, (3) Cochlear Osia without magnet, and (4) MED‐EL Bonebridge with magnet. Maximum metal mitigation techniques were employed in all conditions, and identical sequences were obtained. Blinded image scoring (diagnostic vs nondiagnostic image) was performed by experienced neuroradiologists according to anatomical subsites.ResultsAll device conditions produced artifact and image distortion. The Osia with magnet produced diagnostic T1‐ and T2‐weighted images of the ipsilateral temporal bone, however, non‐echo planar imaging diffusion‐weighted imaging (DWI) was nondiagnostic. The Osia without magnet scanned on the Siemens MR imaging demonstrated the least amount of artifact and was the only condition that allowed for diagnostic imaging of the ipsilateral temporal bone on DWI. The Bonebridge produced a large area of artifact and distortion with the involvement of the ipsilateral and contralateral temporal bones.ConclusionIn summary, of the three device conditions (Osia with magnet, Osia without magnet, and Bonebridge), Osia without magnet offered the least amount of artifact and distortion and was the only condition in which diagnostic DWI was available for the middle ear and mastoid regions on the Siemens MR imaging scanner.