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Reliability and validity of the Veterans Administration Mobility Screening and Solutions Tool

ObjectivesThe Veterans Administration (VA) Mobility Screening and Solutions Tool (VA MSST) was developed to screen a patient’s safe mobility level ‘in the moment’ and provide clinical decision support related to the use of safe patient handling and mobility (SPHM) equipment. This evidence-based flowchart tool is a common language tool that enables any healthcare worker at any time to accurately measure and communicate patient mobility and transfer equipment needs across disciplines and settings.MethodsThe VA MSST has four levels and differentiates between the need for powered and non-powered equipment depending on the patient’s independence. Subject matter experts wrote scenarios for interrater reliability and validity testing. The initial VA MSST draft iteration was reviewed by 163 VA staff (mostly physical therapists and occupational therapists) amongst simulation scenarios and provided content validity, and additional insight and suggestions. Revisions were made to create the final VA MSST which was evaluated by over 200 healthcare workers from varied disciplines (including medical doctors, advanced practice registered nurses, registered nurses, licensed practical nurses, certified nursing assistants, occupational therapists, physical therapists, speech therapists, radiology and ultrasound technicians, etc.). An instruction video and eighteen scenario videos were embedded in an online survey. The survey intended to demonstrate the interrater reliability and validity (concurrent and construct) of the VA MSST. Over 500 VA staff (raters) received a survey invitation via email.ResultsRaters (N = 230) from multiple disciplines and healthcare settings independently screened patient mobility status for each of 18 scenarios using the VA MSST. The raters were diverse in their age and years of experience. The estimated interrater reliability (IRR) for VA MSST was excellent and statistically significant with an estimated Krippendorff’s alpha (ICC (C, k)) of 0.998 [95% CI: 0.996–0.999]. Eighty-two percent of raters reported that overall VA MSST instructions were clear or very clear and understandable. VA MSST ratings made by technicians and nursing assistants group correlated strongly (r = 0.99, p < 0.001) with the ‘gold standard’ (experienced physical therapists), suggesting a high concurrent validity of the tool. The VA MSST significantly discriminated between the different levels of patient mobility required for safe mobilization as intended (each difference, p < 0.0001); this suggests a good construct validity.ConclusionsThe VA MSST is an evidence-based flowchart screening and decision support tool that demonstrates excellent interrater reliability across disciplines and settings. VA MSST has strong face and content validity, as well as good concurrent and construct validity.

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Clinical utility of widespread germline testing of cancer patients in a diverse community cancer clinic.

e18537 Background: Identification of germline mutations can determine prognosis, inform targeted therapies, allow risk-reducing interventions, and suggest additional cancer screenings in patients and their biological relatives. Large prospective cohort studies have been historically skewed towards wealthier socioeconomic populations that lack ethnic diversity and vastly underrepresent African Americans. Recently, small studies outside of standard clinical guidelines reveal detection of pathogenic variants in germline testing with significant clinical ramifications. We present our single center experience of prospective germline testing in a small community clinic in suburban and rural South Carolina with understudied real-world populations. Methods: We performed germline testing, outside of guidelines, in patients presenting at earlier age or with either rare tumors, or recurrent/multiple malignancies. This prospective, observational cohort included a suburban and rural underserved population where approximately 30% identify as African American. Patients were counselled about testing that performed outside of guidelines. Results: We identified 67 individuals outside the guidelines concordance, compromising of 45 male and 22 female patients, within the first 6 months of this prospective, observational cohort. Patients reported race as African American (14), White (50), or Asian American (3). Rare germline findings included Li Fraumeni syndrome, Fanconi’s syndrome, Perelman’s disease, and Von Hippel Lindau’s disease. We summarize our findings in the attached table. Conclusions: There are limited studies that report prevalence of germline findings in cancer patients who are unselected by clinical practice guidelines. Studies also lack representation of ethnic minorities. Recently published data on the clinical utility of broad-based germline testing of all incoming patients suggest current practice of guidelines and genetic counselor recommended testing should be re-examined for broader testing for all incoming cancer patients in a more inclusive manner.[Table: see text]

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Addressing cancer health disparities (CHD) in an independent community cancer clinic: All solutions are local.

e18522 Background: The COVID-19–associated global pandemic has brought many public and population health issues to light. A glaring issue is the disparities among and differences in susceptibility of diverse ethnicities. Viral infection is not the only area of healthcare facing this issue: disparities in prevalence, biology, prognosis, and outcomes of cancer exist, often based on socioeconomics and social determinants of health (SDoH). CHD have been debated and discussed at several levels, from local counties to the congress to the Centers for Medicare and Medicaid Services. Amid the debates and recommendations, it has been difficult to carve out a clear path forward. The complex factors involved include access to care because of financial challenges, biological and genetic factors, impact of SDoH, and access to screening, NGS testing, and clinical trials. CHD may contribute to almost 34% of deaths among adult cancer patients and additional spending of $230 billion. Addressing CHD could result in an indirect savings of as much as $1 trillion over 3 years (AACR, CDR, 2020). A comprehensive approach is needed to generate a groundswell of resources. This should include support for public policies aimed at improving understanding of the issue by all parts of the ecosystem (pharma, researchers, government agencies, physicians), adequate funding for federal and local initiatives, considerations of health in community planning and development, and collection of real-world data and evidence. At Carolina Blood and Cancer Care (CBCCA), the team decided to study this issue and initiate solutions one step at a time. Methods: CBCCA prioritized solutions in 5 categories. The top priority was to address issues impacting patients: access to care, NGS testing, cancer screening, SDoH, and clinical trial access. To address access to care issue (financial constraints), 2.5 FTEs (full-time equivalents) were allocated to carry out needs assessments and identify resources, including Medicaid eligibility, dual eligibility, other foundations, and sources for free drugs. A not-for-profit entity, No One Left Alone, was started to address CHD. Results: During 2021 CBCCA physicians saw 1787 unique cancer patients (both established and new). Of these, 319 needed IV anticancer treatment and an additional 104 needed oral oncolytics. Fifty-three could not pay for their cancer treatment. Another 101 patients needed assistance for out-of-pocket costs. Financial counselors procured free drugs worth $1,633,588 and an additional $135,931 in cash assistance for high out-of-pocket costs. The pharmacy team raised $253,218 for 64 patients (374 transactions) for out-of-pocket costs. As a result, not a single patient was left without treatment. Conclusions: Financial toxicity was addressed by allocating 0.5 FTE per oncologist to ensure access to care. In the next phase, CBCCA will address access to NGS testing.

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The role of real-world evidence (RWE) registries using NGS testing to address cancer health disparities (CHD) in small community oncology practices.

e18519 Background: CHD may result from multiple factors, including access to care, screening, and clinical trials; limited uptake of biomarker and next-generation sequencing (NGS) testing; and unfavorable social determinants of health. CHD may contribute to almost 34% of deaths among adult cancer patients and additional spending of $230 billion. Addressing CHD could result in an indirect savings of as much as $1 trillion over 3 years (AACR, CDR, 2020). Biomarker testing enables the option of targeted treatment, providing better outcomes and reduced toxicity. The NGS testing rate is very low in some regions and among minority populations, and underuse worsens disparities. Carolina Blood and Cancer Care Associates (CBCCA) has created best practices to improve biomarker testing and provide standard-of-care treatment in advanced cancer. Methods: As a part of a pledge to decrease CHD, CBCCA partnered with 2 national NGS testing vendors to create a RWE registry to identify appropriate patients and provide access to NGS biomarker tests for somatic mutations, including whole exome sequencing (WES). Liquid biopsy was made available when tissue was unavailable. Results: CBCCA has 1 suburban and 1 rural location, with an ethnically diverse population. Regular care was provided for 1466 of the 1786 unique cancer patients seen in 2021, and 442 participated in a RWE registry. Nonparticipants were survivors having routine follow-up care (n = 512), patients with early-stage or noninvasive disease (510), or patients who refused testing because they were responding to ongoing treatment or had reservations. NGS testing was obtained for 354 patients, 31% of whom were members of ethnic minority groups. Liquid biopsy was used for 133 samples, and the remaining 221 were analyzed with somatic NGS panels or WES. Of the liquid biopsies, 24 patients had actionable mutations; an additional 52 had findings of germline implications. Actionable mutations that could be treated with an FDA-approved drug were identified using tissue-based NGS testing in 38 pt. In tissue-based testing, WES detected more results with germline implications, compared to somatic testing alone. Another 64 tests found mutations treatable with an approved drug in another tumor type. The NGS and biomarker testing rate (either tissue or liquid biopsy) was 84% of eligible pt. Of the patients tested with NGS, clinically actionable variants that could be treated with an approved agent were found in 23% (same tumor type) and 28% (another tumor type). Another 40% of patients had results with germline implications, of which P53 deletion was the most common finding. Conclusions: It is feasible to increase the NGS testing rate in appropriate situations. In this study, actionable mutations impacting treatment selection were found in up to 25% of patients where targeted therapy could be offered.

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Social determinants of health in a prospective study of whole-exome sequencing in advanced cancer patients from underserved communities.

e18539 Background: Social determinants of health (SDOH) influence outcomes of oncologic care and more data are needed to understand these factors in underserved communities. At the same time, disparities in access to genomic tests and genomic databases that overrepresent European ancestry may contribute to disparities in precision oncology. We established a prospective study incorporating SDOH assessments and whole exome sequencing for advanced cancer patients in underserved communities. Methods: In this ongoing multi-center, prospective, observational study involving community oncology practices in underserved communities, patients with advanced cancers received whole exome/whole transcriptome sequencing and hereditary cancer testing (Sema4, Stamford, CT). Patients also completed an enrollment questionnaire focused on SDOH. The study began enrollment in July 2021 at a community practice in South Carolina and has expanded to a second practice in North Carolina as of February 2022. This report describes demographic and SDOH characteristics of patients enrolled at the first site between 7/2021-2/2022. Results: A total of 161 enrolled patients have completed baseline demographics. SDOH data are available for 148 (91.9%) patients. The cohort was predominantly female (N = 99, 61.5%), with 34 (21.1%) patients reporting Black race, and a mean age of 65.5 years (s.d. 14.2). Three patients (0.02%) reported Hispanic ethnicity. The most common cancer types in the cohort were breast (N = 37, 23.0%), chronic lymphocytic leukemia (N = 18, 11.2%), colorectal (N = 13, 8.1%), myelodysplastic syndrome (N = 12, 7.5%), and non-small cell lung cancer (N = 11, 6.8%). In terms of SDOH factors, 64 (43.2%) patients reported household incomes &lt; $25,000 and the majority reported household incomes &lt; $50,000 (N = 93, 57.8%). A minority of patients had 4-year college degrees or higher (N = 36, 24.3%); the highest educational attainment was high school graduate for most (N = 70, 47.3%). Household income &lt; $50,000 was associated with financial and food insecurity: patients from lower-income households were more likely to report being worried about being able to pay bills often/always (19.4% vs. 0%, Fisher’s exact p = 0.03) and were more likely to have either worried about running out of food (18.3% vs. 0%, Fisher’s exact p = 0.02) or to have run of out of food (15.1% vs. 0%, Fisher’s exact p = 0.02) in the past 12 months. Conclusions: Among advanced cancer patients in an underserved community, lower household income was associated with both financial and food insecurity. This ongoing observational study will integrate SDOH, genomic characteristics, and clinical outcomes from a diverse cohort of patients seen in community oncology practices.

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Considering Quality Measures for the Care of Transgender Patients: Preliminary Findings from a Technical Expert Panel.

Purpose: Transgender (TG) individuals are a historically understudied and underserved patient population. Although clinical guidelines for the care of TG patients exist, quality measures (QMs) specific to this population are lacking. The goal of this study was to obtain expert input on aspects of care for which quality measurement may be appropriate and describe feedback on candidate QMs. Methods: We convened a virtual technical expert panel in September 2020 with six experts in TG medical care. Experts participated in a guided discussion and provided numeric ratings on dimensions of measure suitability (importance, validity/reliability, feasibility, and ease of understanding) for eight candidate QMs spanning multiple care domains (e.g., laboratory testing/monitoring, cancer screening, and sexually transmitted infection screening). Results: Panelists acknowledged high importance and potential to improve care for some candidate QMs, particularly those related to laboratory testing before initiating and during hormone therapy. Numeric ratings of QMs varied but tended to be higher for testing-focused QMs. Experts raised concerns about overly prescriptive language for some QMs and emphasized the importance of considering more flexible specifications to accommodate diverse care scenarios-including care provided to nonbinary individuals-and align with the individualized nature of gender-affirming care. Conclusion: These preliminary findings support a potential role for QMs in improving quality of care for TG patients. Measures related to laboratory testing/monitoring for patients who receive or plan to initiate hormone therapy may be feasible and promising to explore in the future. Additional larger-scale efforts are needed to develop and test QMs for the care of TG individuals.

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Exercise in the Aquatic Environment for People With Primary Hip Osteoarthritis: A Systematic Review and Meta-analyses

Background and Purpose: More than 31 million Americans experience activity limitations related to hip osteoarthritis (OA), and aquatic exercise is one management option. To guide aquatic-based exercise practice, the available evidence-based data (quantity and quality) of aquatic environment exercise for people with primary hip OA was evaluated. Methods: A systematic search was conducted from 2004 to 2020 using 8 databases: PubMed, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Library, EMBASE, Allied and Complementary Medicine Database (AMED), Science Citation Index Expanded, ISI Proceedings (Web of Science), and REHABDATA. The extracted data included information related to authors, study design, participant characteristics (demographics, time since diagnosis, comorbidity), intervention details (setting, type, water temperature and depth, and dosage parameters such as frequency, intensity, duration and length), outcome measures, and adverse events. Results: There were 196 studies identified, with 136 studies screened at the abstract level with 48 resultant studies, reviewed at the full-text level with 9 resultant publications included in this quantitative analyses (7 randomized controlled trials [RCTs] and 2 non-RCTs). Individuals with hip OA who participated in prescribed aquatic exercise experienced improved overall lower extremity function including range of motion, strength, balance, gait, function performance (p = .00; standardized mean difference [SMD] = 0.30; SE = 0.07; I 2 = 0), and pain (p = .00; SMD = 0.34; SE = 0.12; I 2 = 45) but no change in quality of life (p = .07; SMD = 0.15; SE = 0.08; I 2 = 0). Discussion and Conclusion: For individuals with primary hip OA, prescribed exercise in an aquatic environment improved lower extremity function, balance, and pain outcomes. To improve consistent, evidence-driven aquatic intervention for individuals experiencing limitations secondary to hip OA, these researchers recommend that schedule individual or staff time to review these systematic review results, establish a user-friendly dosage rubric including these minimum intensity and aquatic environment parameters, and discuss the evidence-driven suggested outcomes and include other specific standardized outcomes for their facility, as well as a means to efficiently document these outcomes.

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Age and comorbidity association with survival outcomes in metastatic colorectal cancer: CALGB 80405 analysis

BackgroundLittle is known about the interaction of comorbidities and age on survival outcomes in colorectal cancer (mCRC), nor how comorbidities impact treatment tolerance. MethodsWe utilized a cohort of 1345 mCRC patients enrolled in CALGB/SWOG 80405, a multicenter phase III trial of fluorouracil/leucovorin + oxaliplatin (FOLFOX) or irinotecan (FOLFIRI) plus bevacizumab, cetuximab or both. Endpoints were overall survival (OS), progression-free survival (PFS), and grade ≥ 3 toxicities assessed using NCI CTCAE v.3.0. Participants completed a questionnaire, including a modified Charlson Comorbidity Index. Adjusted Cox and logistic regression models tested associations of comorbidities and age on the endpoints. ResultsIn CALGB/SWOG 80405, 1095 (81%) subjects were < 70 years and >70 250 (19%). Presence of ≥1 comorbidity was not significantly associated with either OS (HR 1.10, 95% CI 0.96–1.25) or PFS (HR 1.03, 95% CI 0.91–1.16). Compared to subjects <70 with no comorbidities, OS was non-significantly inferior for ≥70 with no comorbidities (HR 1.21, 95% CI 0.98–1.49) and significantly inferior for ≥70 with at least one comorbidity (HR 1.51, 95% CI 1.22–1.86). There were no significant associations or interactions between age or comorbidity with PFS. Comorbidities were not associated with treatment-related toxicities. Age ≥ 70 was associated with greater risk of grade ≥ 3 toxicities (OR 2.15, 95% CI 1.50–3.09, p < 0.001). ConclusionsAmong participants in a clinical trial of combination chemotherapy for mCRC, presence of older age with comorbidities was associated with worse OS but not PFS. The association of age with toxicity suggests additional factors of care should be measured in clinical trials.

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Effect of Immersive Virtual Reality on Pain and Anxiety at a Veterans Affairs Health Care Facility

Objectives: The primary objective of this evaluation is to determine the impact of virtual reality (VR) distraction on acute and chronic pain in Veterans within the Veterans Affairs Health Care System (VA). A secondary objective is to determine the impact of VR on the experience of stress and anxiety in Veterans utilizing VR for the indication of pain. A third objective is to develop an understanding of the Veteran experience of using VR in a healthcare setting.Methods: This prospective, pretest-posttest mixed methods assessment was performed at a VA medical center from August 30, 2019 to November 23, 2020. VR experiences lasted between 10 and 30 min utilizing an immersive head-mounted display with multiple, autonomously chosen virtual environments. Qualitative data was collected concurrently to provide context to quantitative measures which included pain scores and stress/anxiety levels. Data from 79 participants was included in this analysis. Data included pre- and post-VR session Defense and Veterans Pain Rating Scale and stress/anxiety levels.Results: Results for the cohort demonstrated a statistically significant decrease in pain intensity (p &amp;lt;0 .001) with an average 12% decrease in pain levels and an 92% reduction in anxiety for those in concurrent pain.Conclusion: VR as a non-pharmacological adjunct or alternative modality, appears to be a viable option for improving pain management and reducing anxiety in Veteran populations across various age ranges, and levels of acuity and chronicity. VR was found to be an effective distraction from pain, a pleasurable experience for the majority, and opened the door to other non-pharmacological modalities in a Veteran population.

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