Research Spotlight

Nguyen, A.D. (2021). “Impact of bariatric surgery on gastroesophageal reflux disease and esophageal motility.” Curr Opin Gastroenterol 37(4): 364-371.

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PURPOSE OF REVIEW: Obesity is rapidly increasing in prevalence, and bariatric surgery has become a popular treatment option that can improve all-cause mortality in obese individuals. Gastroesophageal reflux disease (GERD) and esophageal motility disorders are common in the obese population, and the effects of bariatric surgery on these conditions differ depending on the type of bariatric surgery performed. RECENT FINDINGS: Laparoscopic adjustable gastric banding has declined in popularity due to its contributions to worsening GERD symptoms and the development of esophageal dysmotility. Although laparoscopic sleeve gastrectomy (LSG) is the most popular type of bariatric surgery, a comprehensive assessment for acid reflux should be performed as LSG has been linked with worsening GERD. Novel methods to address GERD due to LSG include magnetic sphincter augmentation and concomitant fundoplication. Due to the decreased incidence of postoperative GERD and dysmotility compared to other types of bariatric surgeries, Roux-en-Y gastric bypass should be considered for obese patients with GERD and esophageal dysmotility. SUMMARY: Bariatric surgery can affect esophageal motility and contribute to worsening or development of GERD. A thorough workup of gastrointestinal symptoms before bariatric surgery should be performed with consideration for formal testing with high-resolution manometry and pH testing. Based on these results, the choice of bariatric surgery technique should be tailored accordingly to improve clinical outcomes.

Kitzman, H., DaGraca, B., Mamun, A., Collinsworth, A., Halloran, K. and Masica, A. (2021). “Embedded Health Systems Science as a driver of care improvement within an integrated delivery organization.” Healthc (Amst) 8 Suppl 1: 100497.

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BACKGROUND: Embedded Health Systems Science (HSS) has the potential to reduce gaps between research and delivery of evidence-based medicine. Models are needed to guide the development of embedded HSS in health care delivery organizations particularly with the rise of value-based care. METHODS: The development of HSS infrastructure at a large nonprofit health care delivery organization is described, along with an embedded HSS diabetes study to illustrate the integration of program specific data, electronic health records, and health care system data infrastructure. To compare diabetes outcomes across four evidenced-based programs, a control group was developed from EHR data using propensity score matching. Mixed effect adjusted models were used to estimate reductions in hemoglobin A1c (HbA1c) and body weight. RESULTS: Adjusted analyses using an EHR derived comparison group demonstrated significantly different findings than unadjusted pre to post analyses. The embedded HSS study indicates that appropriate statistical methods, staff with required expertise, and integration with health system data infrastructure are needed to develop timely and rigorous HSS outcomes that effectively improve patient care. CONCLUSIONS: Embedded HSS has the potential to inform value-based care models and contribute to evidence-based medicine approaches that improve patient care. Although developing system wide integrated data structures and staff with the appropriate skills requires substantial effort, the outcome is more reliable evaluations that lead to higher quality and higher value care. IMPLICATIONS: Health care delivery organizations can improve patient care by dedicating resources to embed HSS into its routine operations.

Johnston, S., O’Shaughnessy, J., Martin, M., Huober, J., Toi, M., Sohn, J., André, V.A.M., Martin, H.R., Hardebeck, M.C. and Goetz, M.P. (2021). “Abemaciclib as initial therapy for advanced breast cancer: MONARCH 3 updated results in prognostic subgroups.” NPJ Breast Cancer 7(1): 80.

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In MONARCH 3, continuous dosing of abemaciclib with an aromatase inhibitor (AI) conferred significant clinical benefit to postmenopausal women with HR+, HER2- advanced breast cancer. We report data for clinically prognostic subgroups: liver metastases, progesterone receptor status, tumor grade, bone-only disease, ECOG performance status, and treatment-free interval (TFI) from an additional 12-month follow-up (after final progression-free survival [PFS] readout). In the intent-to-treat population, after median follow-up of approximately 39 months, the updated PFS was 28.2 versus 14.8 months (hazard ratio [HR], 0.525; 95% confidence interval, 0.415-0.665) in abemaciclib versus placebo arms, respectively. Time to chemotherapy (HR, 0.513), time to second disease progression (HR, 0.637), and duration of response (HR, 0.466) were also statistically significantly prolonged with the addition of abemaciclib to AI. Treatment benefit was observed across all subgroups, as evidenced by objective response rate change from the addition of abemaciclib to AI, with the largest effects observed in patients with liver metastases, progesterone receptor-negative tumors, high-grade tumors, or TFI < 36 months. Extended follow-up in the MONARCH 3 trial further confirmed that the addition of abemaciclib to AI conferred significant treatment benefit to all subgroups, including those with poorer prognosis.

Jacobs, J.P., Shahian, D.M., Grau-Sepulveda, M., O’Brien, S.M., Pruitt, E.Y., Bloom, J.P., Edgerton, J.R., Kurlansky, P.A., Habib, R.H., Antman, M.S., Cleveland, J.C., Jr., Fernandez, F.G., Thourani, V.H. and Badhwar, V. (2021). “Current Penetration, Completeness, and Representativeness of The Society of Thoracic Surgeons Adult Cardiac Surgery Database.” Ann Thorac Surg Jun 18;S0003-4975(21)01039-0. [Epub ahead of print].

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BACKGROUND: The Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database (ACSD) is the largest cardiac surgical database in the world. Linked data from STS ACSD and the CMS Medicare database were used to determine contemporary completeness, penetration, and representativeness of STS ACSD. METHODS: Using variables common to both STS and CMS databases, STS procedures were linked to CMS data for all CMS CABG discharges between 2000 and 2018, inclusive. For each CMS CABG hospitalization, it was determined whether a matching STS record existed. RESULTS: Center-level penetration (number of CMS sites with at least one matched STS participant divided by total number of CMS CABG sites) increased from 45% in 2000 to 95% in 2018. In 2018, 949 of 1,004 CMS CABG sites (95%) were linked to an STS site. Patient-level penetration (number of CMS CABG hospitalizations at STS sites divided by total number of CMS CABG hospitalizations) increased from 51% in 2000 to 97% in 2018. In 2018, 68,584 of 70,818 CMS CABG hospitalizations (97%) occurred at an STS site. Completeness of case inclusion at STS sites (number of CMS CABG cases at STS sites linked to STS records divided by total number of CMS CABG cases at STS sites) increased from 88% in 2000 to 98% in 2018. In 2018, 66,673 of 68,108 CMS CABG hospitalizations at STS sites (98%) were linked to an STS record. CONCLUSIONS: Linkage of STS and CMS databases demonstrates high and increasing penetration and completeness of STS ACSD. STS ACSD now includes 97% of CABG in USA.

Newman, J.G., Hall, M.A., Kurley, S.J., Cook, R.W., Farberg, A.S., Geiger, J.L. and Koyfman, S.A. (2021). “Adjuvant therapy for high-risk cutaneous squamous cell carcinoma: A 10-year review.” Head Neck Jun 7. [Epub ahead of print].

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Standard of care for high-risk cutaneous squamous cell carcinoma (cSCC) is surgical excision of the primary lesion with clear margins when possible, and additional resection of positive margins when feasible. Even with negative margins, certain high-risk factors warrant consideration of adjuvant therapy. However, which patients might benefit from adjuvant therapy is unclear, and supporting evidence is conflicting and limited to mostly small retrospective cohorts. Here, we review literature from the last decade regarding adjuvant radiation therapy and systemic therapy in high-risk cSCC, including recent and current trials and the role of immune checkpoint inhibitors. We demonstrate evidence gaps in adjuvant therapy for high-risk cSCC and the need for prognostic tools, such as gene expression profiling, to guide patient selection. More large-cohort clinical studies are needed for collecting high-quality, evidence-based data for determining which patients with high-risk cSCC may benefit from adjuvant therapy and which therapy is most appropriate for patient management.