57 research outputs found

    Patient Expectations of Functional Outcomes After Rectal Cancer Surgery: A Qualitative Study

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    Rectal cancer patients’ expectations of health and function may affect their disease- and treatment-related experience, but how patients form expectations of post-surgery function has received little study

    Safety and Feasibility of Minimally Invasive Inguinal Lymph Node Dissection in Patients With Melanoma (SAFE-MILND): Report of a Prospective Multi-institutional Trial.

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    BACKGROUND: Minimally invasive inguinal lymph node dissection (MILND) is a novel approach to inguinal lymphadenectomy. SAFE-MILND (NCT01500304) is a multicenter, phase I/II clinical trial evaluating the safety and feasibility of MILND for patients with melanoma in a group of surgeons newly adopting the procedure. METHODS: Twelve melanoma surgeons from 10 institutions without any previous MILND experience, enrolled patients into a prospective study after completing specialized training including didactic lectures, participating in a hands-on cadaveric laboratory, and being provided an instructional DVD of the procedure. Complications and adverse postoperative events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version 4.0. RESULTS: Eighty-seven patients underwent a MILND. Seventy-seven cases (88.5%) were completed via a minimally invasive approach. The median total inguinal lymph nodes pathologically examined (SLN + MILND) was 12.0 (interquartile range 8.0, 14.0). Overall, 71% of patients suffered an adverse event (AE); the majority of these were grades 1 and 2, with 26% of patients experiencing a grade 3 AE. No grade 4 or 5 AEs were observed. CONCLUSIONS: After a structured training program, high-volume melanoma surgeons adopted a novel surgical technique with a lymph node retrieval rate that met or exceeded current oncologic guidelines and published benchmarks, and a favorable morbidity profile

    Researching COVID to Enhance Recovery (RECOVER) Adult Study Protocol: Rationale, Objectives, and Design

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    IMPORTANCE: SARS-CoV-2 infection can result in ongoing, relapsing, or new symptoms or other health effects after the acute phase of infection; termed post-acute sequelae of SARS-CoV-2 infection (PASC), or long COVID. The characteristics, prevalence, trajectory and mechanisms of PASC are ill-defined. The objectives of the Researching COVID to Enhance Recovery (RECOVER) Multi-site Observational Study of PASC in Adults (RECOVER-Adult) are to: (1) characterize PASC prevalence; (2) characterize the symptoms, organ dysfunction, natural history, and distinct phenotypes of PASC; (3) identify demographic, social and clinical risk factors for PASC onset and recovery; and (4) define the biological mechanisms underlying PASC pathogenesis. METHODS: RECOVER-Adult is a combined prospective/retrospective cohort currently planned to enroll 14,880 adults aged ≥18 years. Eligible participants either must meet WHO criteria for suspected, probable, or confirmed infection; or must have evidence of no prior infection. Recruitment occurs at 86 sites in 33 U.S. states, Washington, DC and Puerto Rico, via facility- and community-based outreach. Participants complete quarterly questionnaires about symptoms, social determinants, vaccination status, and interim SARS-CoV-2 infections. In addition, participants contribute biospecimens and undergo physical and laboratory examinations at approximately 0, 90 and 180 days from infection or negative test date, and yearly thereafter. Some participants undergo additional testing based on specific criteria or random sampling. Patient representatives provide input on all study processes. The primary study outcome is onset of PASC, measured by signs and symptoms. A paradigm for identifying PASC cases will be defined and updated using supervised and unsupervised learning approaches with cross-validation. Logistic regression and proportional hazards regression will be conducted to investigate associations between risk factors, onset, and resolution of PASC symptoms. DISCUSSION: RECOVER-Adult is the first national, prospective, longitudinal cohort of PASC among US adults. Results of this study are intended to inform public health, spur clinical trials, and expand treatment options

    Optimizing Cancer Care Delivery through Implementation Science

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    The 2013 Institute of Medicine report investigating cancer care concluded that the cancer care delivery system is in crisis due to an increased demand for care, increasing complexity of treatment, decreasing work force and rising costs. Engaging patients and incorporating evidence-based care into routine clinical practice are essential components of a high quality cancer delivery system. However, a gap currently exists between the identification of beneficial research findings and application in clinical practice. Implementation research strives to address this gap. In this review, we discuss key components of high quality implementation research. We then apply these concepts to a current cancer care delivery challenge in women’s health, specifically the implementation of a surgery decision aid for women newly diagnosed with breast cancer

    Surrounded by quality metrics: What do surgeons think of ACS-NSQIP?

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    Background: In an era of proliferating systems of quality assessment, surgeon confidence in metric tools is essential for successful initiatives in quality improvement. We evaluated surgeons\u27 awareness and attitudes about ACS-NSQIP, which is the only national, surgeon-developed, risk-adjusted, system of surgical outcome assessment. Methods: A 33-item survey instrument was constructed and content validity established through content expert review; test-retest reliability was assessed (weighted-kappa = 0.72). Survey administration occurred in three institutions with varying ACS-NSQIP experience. Summary statistics were generated and subgroup analyses performed (Fisher\u27s exact test). Results: One-hundred and eight surgeons participated. Practice experience varied (27% residents, 33% \u3c 10, 12% 10-20, and 28% \u3e 20 years). Seventy-two percent had fellowship training. Surgeons were familiar with ACS-NSQIP structure, including prospective datacollection (70%), case-sampling (63%), and reporting as observed/expected ratios (83%). Surgeons knew some collected data-points but misidentified EKG-findings of MI (67%), surgeon case-experience (41%), and anastomotic dehiscence (79%). Most felt ACS-NSQIP would improve quality of care (79%) and identify areas for improvement (92%). Surgeons were less confident regarding utility at an individual level, with only 46% believing surgeon-specific outcomes should be reported. Few thought ACS-NSQIP data should be available publicly (45%), used for marketing (26%), or direct pay-for-performance (24%). Reservations were most pronounced among surgeons with institutional ACS-NSQIP experience. Conclusion: While surgeons accept ACS-NSQIP at an institutional level, skepticism remains surrounding measurement of individual outcomes and public reporting. Surgeons at institutions with a longer duration of experience with ACS-NSQIP tended to be more cynical about potential data applications. Ongoing education and assessment of surgeons\u27 perceptions of quality improvement initiatives is necessary to ensure surgeons remain engaged actively in determining how quality of care data is measured and utilized. © 2009 Mosby, Inc. All rights reserved
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