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Item Barriers and Facilitators to Implementing Patient-Reported Outcome Monitoring in Gastrointestinal Surgery(Elsevier, 2023) Iroz, Cassandra B.; Johnson, Julie K.; Ager, Meagan S.; Joung, Rachel Hae-Soo; Brajcich, Brian C.; Cella, David; Franklin, Patricia D.; Holl, Jane L.; Bilimoria, Karl Y.; Merkow, Ryan P.; Surgery, School of MedicineIntroduction: More than 30% of patients experience complications after major gastrointestinal (GI) surgery, many of which occur after discharge when patients and families must assume responsibility for monitoring. Patient-reported outcomes (PROs) have been proposed as a tool for remote monitoring to identify deviations in recovery, and recognize and manage complications earlier. This study's objective was to characterize barriers and facilitators to the use of PROs as a patient monitoring tool following GI surgery. Methods: We conducted semistructured interviews with GI surgery patients and clinicians (surgeons, nurses, and advanced practitioners). Patients and clinicians were asked to describe their experience using a PRO monitoring system in three surgical oncology clinics. Using a phenomenological approach, research team dyads independently coded the transcripts using an inductively developed codebook and the constant comparative approach with differences reconciled by consensus. Results: Ten patients and five clinicians participated in the interviews. We identified four overarching themes related to functionality, workflow, meaningfulness, and actionability. Functionality refers to barriers faced by clinicians and patients in using the PRO technology. Workflow represents problematic integration of PROs into the clinical workflow and need for setting expectations with patients. Meaningfulness refers to lack of patient and clinician understanding of the impact of PROs on patient care. Finally, actionability reflects barriers to follow-up and practical use of PRO data. Conclusions: While use of PRO systems for postoperative patient monitoring have expanded, significant barriers persist for both patients and clinicians. Implementation enhancements are needed to optimize functionality, workflow, meaningfulness, and actionability.Item Barriers to Post-Discharge Monitoring and Patient-Clinician Communication: A Qualitative Study(Elsevier, 2021) Brajcich, Brian C.; Shallcross, Meagan L.; Johnson, Julie K.; Joung, Rachel Hae-Soo; Iroz, Cassandra B.; Holl, Jane L.; Bilimoria, Karl Y.; Merkow, Ryan P.; Surgery, School of MedicineIntroduction: As postoperative length of stay has decreased for many operations, the proportion of complications occurring post-discharge is increasing. Early identification and management of these complications requires overcoming barriers to effective post-discharge monitoring and communication. The aim of this study was to identify barriers to post-discharge monitoring and patient-clinician communication through a qualitative study of surgical patients and clinicians. Materials and methods: Semi-structured interviews and focus groups were held with gastrointestinal surgery patients and clinicians. Participants were asked about barriers to post-discharge monitoring and communication. Each transcript was coded by 2 of 4 researchers, and recurring themes related to communication and care barriers were identified. Results: A total of 15 patients and 17 clinicians participated in interviews and focus groups. Four themes which encompassed barriers to post-discharge monitoring and communication were identified from patient interviews, and 4 barriers were identified from clinician interviews and focus groups. Patient-identified barriers included education and expectation setting, technology access and literacy, availability of resources and support, and misalignment of communication preferences, while clinician-identified barriers included health education, access to clinical team, healthcare practitioner time constraints, and care team experience and consistency. Conclusions: Multiple barriers exist to effective post-discharge monitoring and patient-clinician communication among surgical patients. These barriers must be addressed to develop an effective system for post-discharge care after surgery.Item Establishment and characterization of patient-derived xenograft of a rare pediatric anaplastic pleomorphic xanthoastrocytoma (PXA) bearing a CDC42SE2-BRAF fusion(Springer Nature, 2023-06-06) Damayanti, Nur P.; Saadatzadeh, M. Reza; Dobrota, Erika; Ordaz, Josue D.; Bailey, Barbara J.; Pandya, Pankita H.; Bijangi-Vishehsaraei, Khadijeh; Shannon, Harlan E.; Alfonso, Anthony; Coy, Kathy; Trowbridge, Melissa; Sinn, Anthony L.; Zhang, Zhong-Yin; Gallagher, Rosa I.; Wulfkuhle, Julia; Petricoin, Emanuel; Richardson, Angela M.; Marshall, Mark S.; Lion, Alex; Ferguson, Michael J.; Balsara, Karl E.; Pollok, Karen E.; Neurological Surgery, School of MedicinePleomorphic xanthoastrocytoma (PXA) is a rare subset of primary pediatric glioma with 70% 5-year disease free survival. However, up to 20% of cases present with local recurrence and malignant transformation into more aggressive type anaplastic PXA (AXPA) or glioblastoma. The understanding of disease etiology and mechanisms driving PXA and APXA are limited, and there is no standard of care. Therefore, development of relevant preclinical models to investigate molecular underpinnings of disease and to guide novel therapeutic approaches are of interest. Here, for the first time we established, and characterized a patient-derived xenograft (PDX) from a leptomeningeal spread of a patient with recurrent APXA bearing a novel CDC42SE2-BRAF fusion. An integrated -omics analysis was conducted to assess model fidelity of the genomic, transcriptomic, and proteomic/phosphoproteomic landscapes. A stable xenoline was derived directly from the patient recurrent tumor and maintained in 2D and 3D culture systems. Conserved histology features between the PDX and matched APXA specimen were maintained through serial passages. Whole exome sequencing (WES) demonstrated a high degree of conservation in the genomic landscape between PDX and matched human tumor, including small variants (Pearson's r = 0.794-0.839) and tumor mutational burden (~ 3 mutations/MB). Large chromosomal variations including chromosomal gains and losses were preserved in PDX. Notably, chromosomal gain in chromosomes 4-9, 17 and 18 and loss in the short arm of chromosome 9 associated with homozygous 9p21.3 deletion involving CDKN2A/B locus were identified in both patient tumor and PDX sample. Moreover, chromosomal rearrangement involving 7q34 fusion; CDC42SE-BRAF t (5;7) (q31.1, q34) (5:130,721,239, 7:140,482,820) was identified in the PDX tumor, xenoline and matched human tumor. Transcriptomic profile of the patient's tumor was retained in PDX (Pearson r = 0.88) and in xenoline (Pearson r = 0.63) as well as preservation of enriched signaling pathways (FDR Adjusted P < 0.05) including MAPK, EGFR and PI3K/AKT pathways. The multi-omics data of (WES, transcriptome, and reverse phase protein array (RPPA) was integrated to deduce potential actionable pathways for treatment (FDR < 0.05) including KEGG01521, KEGG05202, and KEGG05200. Both xenoline and PDX were resistant to the MEK inhibitors trametinib or mirdametinib at clinically relevant doses, recapitulating the patient's resistance to such treatment in the clinic. This set of APXA models will serve as a preclinical resource for developing novel therapeutic regimens for rare anaplastic PXAs and pediatric high-grade gliomas bearing BRAF fusions.Item Evaluation of Emergency Department Treat-and-Release Encounters After Major Gastrointestinal Surgery(Wiley, 2023) Brajcich, Brian C.; Johnson, Julie K.; Holl, Jane L.; Bilimoria, Karl Y.; Shallcross, Meagan L.; Chung, Jeanette; Joung, Rachel Hae Soo; Iroz, Cassandra B.; Odell, David D.; Bentrem, David J.; Yang, Anthony D.; Franklin, Patricia D.; Slota, Jennifer M.; Silver, Casey M.; Skolarus, Ted; Merkow, Ryan P.; Surgery, School of MedicineBackground and objectives: Emergency department (ED) utilization after gastrointestinal cancer operations is poorly characterized. Our study objectives were to determine the incidence of, reasons for, and predictors of ED treat-and-release encounters after gastrointestinal cancer operations. Methods: Patients who underwent elective esophageal, hepatobiliary, gastric, pancreatic, small intestinal, or colorectal operations for cancer were identified in the 2015-2017 Healthcare Cost and Utilization Project State Inpatient and State Emergency Department Databases for New York, Maryland, and Florida. The primary outcomes were the incidence of ED treat-and-release encounters and readmissions within 30 days of discharge. Results: Among 51 527 patients at 406 hospitals, 4047 (7.9%) had an ED treat-and-release encounter, and 5573 (10.8%) had an ED encounter with readmission. In total, 40.7% of ED encounters were treat-and-release encounters. ED treat-and-release encounters were most frequently for pain (12.0%), device/ostomy complaints (11.7%), or wound complaints (11.4%). ED treat-and-release encounters predictors included non-Hispanic Black race/ethnicity (odds ratio [OR] 1.24, 95% confidence interval [CI] 1.12-1.37) and Medicare (OR 1.27, 95% CI 1.16-1.40) or Medicaid (OR 1.82, 95% CI 1.62-2.40) coverage. Conclusions: ED treat-and-release encounters are common after major gastrointestinal operations, making up nearly half of postdischarge ED encounters. The reasons for ED treat-and-release encounters differ from those for ED encounters with readmissions.Item Prevalence, trends, and characteristics of trials investigating local therapy in contemporary phase 3 clinical cancer research(Wiley, 2023) Sherry, Alexander D.; Corrigan, Kelsey L.; Kouzy, Ramez; Jaoude, Joseph Abi; Yang, Yumeng; Patel, Roshal R.; Totten, Douglas J.; Newman, Neil B.; Das, Prajnan; Taniguchi, Cullen; Minsky, Bruce; Snyder, Rebecca A.; Fuller, C. David; Ludmir, Ethan; Otolaryngology -- Head and Neck Surgery, School of MedicineBackground: Although most patients with cancer are treated with local therapy (LT), the proportion of late-phase clinical trials investigating local therapeutic interventions is unknown. The purpose of this study was to determine the proportion, characteristics, and trends of phase 3 cancer clinical trials assessing the therapeutic value of LT over time. Methods: This was a cross-sectional analysis of interventional randomized controlled trials in oncology published from 2002 through 2020 and registered on ClinicalTrials.gov. Trends and characteristics of LT trials were compared to all other trials. Results: Of 1877 trials screened, 794 trials enrolling 584,347 patients met inclusion criteria. A total of 27 trials (3%) included a primary randomization assessing LT compared with 767 trials (97%) investigating systemic therapy or supportive care. Annual increase in the number of LT trials (slope [m] = 0.28; 95% confidence interval [CI], 0.15-0.39; p < .001) was outpaced by the increase of trials testing systemic therapy or supportive care (m = 7.57; 95% CI, 6.03-9.11; p < .001). LT trials were more often sponsored by cooperative groups (22 of 27 [81%] vs. 211 of 767 [28%]; p < .001) and less often sponsored by industry (5 of 27 [19%] vs. 609 of 767 [79%]; p < .001). LT trials were more likely to use overall survival as primary end point compared to other trials (13 of 27 [48%] vs. 199 of 767 [26%]; p = .01). Conclusions: In contemporary late-phase oncology research, LT trials are increasingly under-represented, under-funded, and evaluate more challenging end points compared to other modalities. These findings strongly argue for greater resource allocation and funding mechanisms for LT clinical trials. Plain language summary: Most people who have cancer receive treatments directed at the site of their cancer, such as surgery or radiation. We do not know, however, how many trials test surgery or radiation compared to drug treatments (that go all over the body). We reviewed trials testing the most researched strategies (phase 3) completed between 2002 and 2020. Only 27 trials tested local treatments like surgery or radiation compared to 767 trials testing other treatments. Our study has important implications for funding research and understanding cancer research priorities.Item Regenerative tissue filler for breast conserving surgery and other soft tissue restoration and reconstruction needs(Springer Nature, 2021-02-01) Puls, Theodore J.; Fisher, Carla S.; Cox, Abigail; Plantenga, Jeannie M.; McBride, Emma L.; Anderson, Jennifer L.; Goergen, Craig J.; Bible, Melissa; Moller, Tracy; Voytik‑Harbin, Sherry L.; Surgery, School of MedicineComplete removal of cancerous tissue and preservation of breast cosmesis with a single breast conserving surgery (BCS) is essential for surgeons. New and better options would allow them to more consistently achieve this goal and expand the number of women that receive this preferred therapy, while minimizing the need for re-excision and revision procedures or more aggressive surgical approaches (i.e., mastectomy). We have developed and evaluated a regenerative tissue filler that is applied as a liquid to defects during BCS prior to transitioning to a fibrillar collagen scaffold with soft tissue consistency. Using a porcine simulated BCS model, the collagen filler was shown to induce a regenerative healing response, characterized by rapid cellularization, vascularization, and progressive breast tissue neogenesis, including adipose tissue and mammary glands and ducts. Unlike conventional biomaterials, no foreign body response or inflammatory-mediated “active” biodegradation was observed. The collagen filler also did not compromise simulated surgical re-excision, radiography, or ultrasonography procedures, features that are important for clinical translation. When post-BCS radiation was applied, the collagen filler and its associated tissue response were largely similar to non-irradiated conditions; however, as expected, healing was modestly slower. This in situ scaffold-forming collagen is easy to apply, conforms to patient-specific defects, and regenerates complex soft tissues in the absence of inflammation. It has significant translational potential as the first regenerative tissue filler for BCS as well as other soft tissue restoration and reconstruction needs.Item Virtual Tumor Boards for Remote Learning in Head and Neck Surgical Oncology(American Medical Association, 2023) Papazian, Michael R.; Chow, Michael; Weed, Donald; Liu, Jeffrey C.; Bewley, Arnaud F.; Moore, Michael G.; Givi, Babak; Otolaryngology -- Head and Neck Surgery, School of MedicineImportance: In addition to their patient management value, multidisciplinary tumor boards have been recognized as effective learning tools. However, the value of using a virtual tumor board as a learning tool for head and neck surgical oncology fellows has not been studied. Objective: To describe the structure and content of the American Head and Neck Society (AHNS) Virtual Tumor Board and assess its educational value as perceived by attendees. Design, setting, and participants: All sessions of the AHNS Virtual Tumor Board from April 8, 2020, to June 1, 2022, were reviewed. Topics, presenters, participants, and viewership data were collected as of October 15, 2022, from session recordings posted to an online video sharing and social media platform. Additionally, an anonymous, 14-question online survey was designed to elicit feedback from head and neck surgery trainees on virtual tumor board engagement, strengths, and weaknesses. The survey was electronically distributed in June and July 2022 to the 101 fellows enrolled in AHNS-accredited programs between July 1, 2020, and June 30, 2022. Main outcomes and measures: The primary aim was to tabulate online viewership of the sessions. The secondary aim was to qualitatively assess the experience of head and neck trainees with the AHNS Virtual Tumor Board using a survey. Results: Forty-two sessions of the virtual tumor board were held between April 8, 2020, and June 1, 2022. Almost all sessions (41 [98%]) were case based. One hundred and sixteen cases were presented, representing 2 to 3 cases per session, by 75 unique faculty members. Each session was viewed a mean of 217 times (range, 64-2216 views). In the 2021 to 2022 academic year, a mean of 60 viewers (range, 30-92 viewers) attended each live session. In all, 29 survey responses were collected from 101 fellows in AHNS-accredited programs (29% response rate). Most respondents felt the format allowed for excellent teaching (18 of 26 respondents [69%]) and discussion (19 of 26 respondents [73%]). Most respondents (22 of 29 respondents [76%]) believed that practicing head and neck surgeons would benefit from the sessions. Conclusions and relevance: This survey study found that the AHNS Virtual Tumor Board was well-attended and well-reviewed by head and neck surgical oncology trainees. The virtual tumor board format could be used as model of remote learning for other organizations.