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Complex interventions and service innovations: development and application of the COMPLETE framework for patient-centered and justice-oriented design
Bradley, Cory , May, Christine, Smyth, Rachel , Stevenson, Fiona , May, Carl , Hillis, Alyson , Gravenhorst, Katja C , Geng, Elvin Hsing , Gallacher, Katie , Chew-Graham, Carolyn Anne , Lippiett, Kate Alice , Richardson, Alison Mead , Mair, Frances S , MacFarlane, Anne E. , Montori, Víctor M.

Mayo Clinic

No container title available | July 10, 2023 | Volume: No volume available | Issue: No issue available | Pages: No page available

10.21203/rs.3.rs-3059427/v1 Get It

AbstractBackground. The field of implementation research has recently seen considerable, and long overdue, interest in equity, with a strong emphasis on recognizing and responding to disparities in care. The COMPLETE (COMPLEx inTErventions and service innovation)framework is intended to support inclusive intervention and service design. The aim is the development of a patient-centered and justice-informed framework for the design of complex healthcare interventions and innovations in service design.Methods. We undertook three studies. (1) We operationalized constructs from sociological theories of inequality, implementation processes, social roles and expectations, to build a Matrix Model of mechanisms that drive the embedding of disparities in complex healthcare interventions and service innovations. (2) We developed patient-centered and justice-informed principles for design that form a Theory of Change that can be applied in intervention and service design. (3) We then linked the Matrix Model and the Theory of Change together with core elements of theories of prefigurative design and research justice, to build a Transformational Design Cycle for complex interventions and service innovations around a set of critical questions about the implications.Results. The COMPLETE framework focuses on the ways health inequalities and inequities are brought into being by systemic mechanisms within health services; are then propagated and normalized through implementation mechanisms; and are then realized and normalized in practice through institutionalized expectations of patients and caregivers. The framework provides tools to resist the naturalization of inequities and inequalities.Conclusion. We developed a framework for intervention and service design that consists of three components: a conceptual model of the translation of social determinants of health through organizational mechanisms that shape patient and caregivers’ lived experience of disparities in health and healthcare; a transformational theory of change; and a set of principles for design that seeks to place restitution for disparities at its center.
Intravenous tranexamic acid is associated with an increased risk of pulmonary embolism following sarcoma resection
Sebro, Ronnie , Spaulding, Aaron , Goulding, Krista , Houdek, Matthew T. , Wilke, Benjamin K. , Foster, Devon, Garner, Hillary, Stanborough, Rupert, Spaulding, Aaron , Goulding, Krista , Houdek, Matthew T , Wilke, B K , Foster, Devon T. , Garner, Hillary W. , Stanborough, Rupert O.

Mayo Clinic

Journal of Surgical Oncology | July 10, 2023 | Volume: 128 | Issue: 5 | Pages: 869-876

10.1002/jso.27391 | PMID 37428014 Get It

AbstractIntroductionTranexamic acid (TXA) is an antifibrinolytic drug that has been shown to reduce blood loss following surgery. The use of TXA during orthopedic procedures has gained widespread acceptance, with multiple clinical studies demonstrating no increase in thrombotic complications. While TXA has been shown to be safe and effective for several orthopedic procedures, its use in orthopedic sarcoma surgery is not well established. Cancer‐associated thrombosis remains a significant cause of morbidity and mortality in patients with sarcoma. It is unknown if intraoperative TXA use will increase the risk of developing a postoperative thrombotic complication in this population. This study aimed to compare the risk of postoperative thrombotic complications in patients who received TXA during sarcoma resection to patients who did not receive TXA.MethodsA retrospective review was performed of 1099 patients who underwent resection of a soft tissue or bone sarcoma at our institution between 2010 and 2021. Baseline demographics and postoperative outcomes were compared between patients who did and did not receive intraoperative TXA. We evaluated 90‐day complication rates, including: deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction (MI), cerebrovascular accident (CVA), and mortality.ResultsTXA was used more commonly for bone tumors (p < 0.001), tumors located in the pelvis (p = 0.004), and larger tumors (p < 0.001). Patients who received intraoperative TXA were associated with a significant increase in developing a postoperative DVT (odds ratio [OR]: 2.22, p = 0.036) and PE (OR: 4.62, p < 0.001), but had no increase in CVA, MI, or mortality (all p > 0.05) within 90 days of surgery, following univariate analysis. Multivariable analysis confirmed that TXA was independently associated with developing a postoperative PE (OR: 10.64, 95% confidence interval: 2.23–50.86, p = 0.003). We found no association with DVT, MI, CVA, or mortality within 90 days postoperatively, following intraoperative TXA use.ConclusionOur results demonstrate a higher associated risk of PE following TXA use in sarcoma surgery and caution is warranted with TXA use in this patient population.
Whole Exome Sequencing Reveals Novel Variants in Unexplained Erythrocytosis
Khurana, Harshit , Muthusamy, Babylakshmi , Yanamandra, Uday, Garapati, Kishore , Premdeep, Harikrishnan, Shankar, Subramanian , Pandey, Akhilesh , Pandey, Akhilesh , Garapati, Kishore

Mayo Clinic

OMICS: A Journal of Integrative Biology | July 10, 2023 | Volume: 27 | Issue: 7 | Pages: 299-304

10.1089/omi.2023.0059 | PMID 37428608 Get It

Erythrocytosis is characterized by an increase in red cells in peripheral blood. Polycythemia vera, the commonest primary erythrocytosis, results from pathogenic variants in JAK2 in ∼98% of cases. Although some variants have been reported in JAK2 -negative polycythemia, the causal genetic variants remain unidentified in ∼80% of cases. To discover genetic variants in unexplained erythrocytosis, we performed whole exome sequencing in 27 patients with JAK2 -negative polycythemia after excluding the presence of any mutations in genes previously associated with erythrocytosis ( EPOR , VHL , PHD2 , EPAS1 , HBA , and HBB ). We found that the majority of patients (25/27) had variants in genes involved in epigenetic processes, including TET2 and ASXL1 or in genes related to hematopoietic signaling such as MPL and GFIB . Based on computational analysis, we believe that variants identified in 11 patients in this study could be pathogenic although functional studies will be required for confirmation. To our knowledge, this is the largest study reporting novel variants in individuals with unexplained erythrocytosis. Our results suggest that genes involved in epigenetic processes and hematopoietic signaling pathways are likely associated with unexplained erythrocytosis in individuals lacking JAK2 mutations. With very few previous studies targeting JAK2 -negative polycythemia patients to identify underlying variants, this study opens a new avenue in evaluating and managing JAK2 -negative polycythemia.
Does Vitamin D Supplementation Reduce Relapse of Graves' Disease?: The RCT We Needed
Kawkgi, Omar El

Mayo Clinic

Clinical Thyroidology® | July 10, 2023 | Volume: 35 | Issue: 7 | Pages: 268-271

10.1089/ct.2023;35.268-271 Get It

Simulation study of comparative dosimetric analysis of coplanar horizontal-port scanned carbon-ion beam therapy in the head and neck
Ebner, Daniel K. , Koto, Masashi , Furuichi, Wataru, Mori, Shinichiro

Mayo Clinic

The British Journal of Radiology | July 10, 2023 | Volume: 96 | Issue: 1149 | Pages: No page available

10.1259/bjr.20221138 | PMID 37427708 Get It

Objective: Carbon-ion radiotherapy (CIRT) has demonstrated success in treating radioresistant disease within the head and neck, owing to its unique physical and radiobiological properties. Construction cost remains prohibitive; a center offering only a horizontal port may bridge this difficulty, but removal of the vertical port may prohibit treatment of disease near critical organs-at-risk. Building a center only containing a horizontal treatment port has been proposed as one method for cost savings. Methods: 20 complex cases of head and neck cancer previously treated with conventional CIRT were retrospectively planned using horizontal-port-only treatment incorporating non-coplanar treatment angles to achieve greater degrees of freedom. These were dosimetrically compared with the previous plans. Results: Comparable D95 coverage of both planning target volume and gross tumor volume with ability to meet organ-at-risk constraints were feasible with horizontal-port-only treatment. Collectively differences were noted in PTV D95, brain stem Dmax, contralateral eye Dmax and V10 Gy (RBE); further qualitative differences were noted on a plan-by-plan basis dependent on disease location. Conclusion: Horizontal-port-only treatment employing non-coplanar angles was feasible for complicated head and neck disease typically treated with CIRT, though careful consideration is necessary on a plan-by-plan basis. Advances in knowledge: It is worth noting that non-coplanar approaches are not typically used with the current treatment gantry and may extend further the difference between horizontal port planning and a gantry-based gold-standard.
Role of individual factor X concentrate pharmacokinetic studies in perioperative management of AL amyloidosis‐associated acquired factor X deficiency
Lewis, Akeem R. , Peffley, Nathan, Klompas, Allan M. , Ashrani, Aneel A.

Mayo Clinic

Transfusion | July 10, 2023 | Volume: 63 | Issue: 9 | Pages: 1773-1777

10.1111/trf.17477 | PMID 37427705 Get It

AbstractBackgroundAL amyloidosis is associated with acquired factor X (FX) deficiency. Experience related to its management is limited to case reports and series using prothrombin complex concentrate, fresh frozen plasma, plasma exchange, recombinant activated factor seven, and desmopressin with limited and variable efficacy. FX concentrate has not been widely used in its management.Study Design and MethodsWe report our experience with the perioperative use of FX concentrate (Coagadex) in two patients with AL amyloidosis‐associated acquired FX deficiency requiring surgery, using their individual pharmacokinetic studies to manage perioperative hemostasis. Pharmacokinetic studies involved obtaining post‐infusion FX activity at 10 min, 2, and 4 h following the administration of FX concentrate to calculate the FX half‐life.ResultsBoth patients' plasma FX activity was successfully increased to provide perioperative hemostatic support. Monitoring FX activity post‐surgery was also utilized to maintain FX activity levels to prevent post‐operative bleeding.ConclusionPharmacokinetic studies have a useful role in tailoring preoperative FX repletion in patients with AL amyloidosis associated with acquired FX deficiency.
Iohexol-Measured Glomerular Filtration Rate and Urinary Biomarker Changes between Vancomycin and Vancomycin Plus Piperacillin-Tazobactam in a Translational Rat Model
Chang, Jack , Pais, Gwendolyn, Marianski, Sylwia, Valdez, Kimberly, Lesnicki, Emily, Frazee, Erin N. , Scheetz, Marc H. , Pais, Gwendolyn M , Frazee, Erin N , Scheetz, Marc H

Mayo Clinic

Antimicrobial Agents and Chemotherapy | July 10, 2023 | Volume: 67 | Issue: 8 | Pages: No page available

10.1128/aac.00304-23 | PMID 37428202 Get It

Recent clinical studies have reported additive nephrotoxicity with the combination of vancomycin and piperacillin-tazobactam. However, preclinical models have failed to replicate this finding.
Novel treatment of bronchopleural fistula in a lung transplant recipient with endobronchial sealant and endobronchial valve placement via robotic-assisted bronchoscopy
Wadiwala, Ishaq , Fernández-Bussy, Sebastián , Garg, Pankaj , Ali, Mostafa, Feinglass, Neil G., Thomas, Mathew , Thomas, Mathew , Wadiwala, Ishaq J , Pham, Si M. , Thomas, Mathew , Garg, Pankaj

Mayo Clinic

Journal of Surgical Case Reports | July 10, 2023 | Volume: 2023 | Issue: 7 | Pages: No page available

10.1093/jscr/rjad383 | PMID 37434719 Get It

Abstract Bronchopleural fistulas (BPFs) are a dreaded complication following pulmonary surgery. Endobronchial valves (EVs), with endobronchial sealant (ES), instilled with robotic bronchoscopy (RB), allow occlusion of BPF, avoiding surgery. The patient was a 71-year-old woman with a history of chronic obstructive pulmonary disease and bronchiectasis who underwent bilateral lung transplantation and wedge resection of the right middle lobe and left lingula. A BPF was discovered on postoperative day (POD) 21. Conservative measures with chest tubes failed, and robotic-assisted bronchoscopy aided in reaching the bronchial segment and instilling ES, and EV was deployed with the conventional bronchoscope. The pneumothorax was cleared 12 days later, and on POD 56, she was discharged. The RB procedure was successful, with no pneumothorax or BPF symptoms after a median follow-up of POD 284. Robotic endobronchial closure of BPF with EV and ES is an effective treatment option avoiding invasive surgeries.
Bibliometric Analysis of the Top 50 Most Influential Studies on Patellar Tendon Injury
Boddu, Sayi P. , Gill, Vikram S., Haglin, Jack M. , Lai, Cara , Brinkman, Joseph C. , Lai, Cara H , Boddu, Sayi , Moore, M. Lane , Chhabra, Anikar

Mayo Clinic

Orthopaedic Journal of Sports Medicine | July 10, 2023 | Volume: 11 | Issue: 7 | Pages: No page available

10.1177/23259671231182694 | PMID 37448652 Get It

Background: There is a wide range of literature on patellar tendon injury, making it increasingly difficult to stay informed on the most influential studies in this field. It is essential to be familiar with the foundational articles of patellar tendon injury research to understand the current state of the literature and deliver high quality care. Purpose: To objectively identify the 50 most influential articles relating to patellar tendon injury and conduct a bibliometric analysis to identify key features of these articles. Study Design: Cross-sectional study. Methods: The Clarivate Analytics Web of Knowledge database was utilized to gather metrics on the 50 most cited articles on patellar tendon injury on June 27, 2022. The information extracted from each article included publication year, number of citations, author information, article type, level of evidence, country of origin, journal name, study focus, and industry influence. Results: The top 50 studies were cited a total of 8543 times and published between 1977 and 2015. The majority of articles were published after 2003, and the majority of citations were accrued after 2011. The most prevalent article types were cohort studies (n = 23), and the majority of studies were of evidence level 2 (n = 14) or 4 (n = 13). Australia and the United States (US) each published the most studies (n = 11). Only 4 (8%) studies focused on patellar tendon rupture, and 12 (24%) of the top 50 studies were associated with industry. Conclusion: The majority of the top 50 most influential articles in patellar tendon injury were published and accumulated citations in the past 10 to 20 years. Non-US countries, institutions, and journals published many of the top 50 studies, reflecting a global interest and commitment to research in this field. Patellar tendon rupture and surgical repair represents a minority of research in the top 50 studies and could be a point of growth in the future.
Subacromial Balloon Implantation for the Treatment of Irreparable Posterosuperior Rotator Cuff Tears
Marigi, Erick M. , Alder, Kareme D. , Morrey, Mark E. , Sánchez‐Sotelo, Joaquín , Morrey, Mark M, Sanchez-Sotelo, J. , Marigi, Erick , Morrey, Mark E

Mayo Clinic

Arthroscopy Techniques | July 10, 2023 | Volume: 12 | Issue: 8 | Pages: No page available

10.1016/j.eats.2023.03.021 | PMID 37654869 Get It

Abstract Despite the development of various therapeutic options, surgical management of irreparable rotator cuff tears (IRCTs) remains controversial. Recently, implantation of a biodegradable subacromial balloon spacer (InSpace, Stryker Corporation; Kalamazoo, MI) has gained considerable interest for the treatment of certain IRCTs. The reported outcome of balloon implantation has not been consistent, likely due to differing indications and technical approaches. The purpose of this article is to present a reproducible arthroscopic technique for implantation of a subacromial balloon and to review the literature published to date, regarding the efficacy and outcomes of this procedure. Technique Video video See video under supplementary data.