Publications by authors named "Nicole Williams"

128 Publications

Clinical presentations of Kingella kingae musculoskeletal infections in South Australian children.

J Paediatr Child Health 2021 Mar 3. Epub 2021 Mar 3.

Department of Orthopaedic Surgery and Paediatric Trauma Service, Women's and Children's Hospital, Adelaide, South Australia, Australia.

Aim: This study aimed to alert clinicians to the spectrum of presentations of Kingella kingae musculoskeletal infections.

Methods: Between August 2010 and March 2018, 55 children presented with positive K. kingae polymerase chain reaction on joint fluid, bone or deep soft tissue collections involving the limbs and subsequently underwent retrospective medical record, radiological and laboratory review. Demographics and clinical information are presented.

Results: Median age at presentation was 15.9 months (range 4.3 months-10.7 years) and 64% were male. Septic arthritis was the most common diagnosis (95%), median duration of symptoms was 4 days, 65% had a preceding infection (e.g. upper respiratory or gastrointestinal) and 22% re-presented to emergency departments after prior discharge. The lower limb was involved in 84%, with the knee being most affected (55%). If the lower limb was involved, 82% of previously weight-bearing children had a limp or were unable to weight bear. On presentation, median temperature was 36.7°C and inflammatory markers were mildly elevated. No blood cultures grew K. kingae. Five synovial fluid cultures were positive for K. kingae. Plain radiography showed effusion, soft tissue swelling or a lesion in 53% of patients. All 41 ultrasounds showed effusion, soft tissue swelling or synovial thickening. One patient with delayed diagnosis later presented with avascular necrosis of the femoral head.

Conclusion: Kingella kingae is difficult to diagnose due to non-specific symptoms, absence of fevers and often unremarkable blood tests. Despite generally having good long-term outcomes, our case of avascular necrosis suggests accurate diagnosis and treatment are important.
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http://dx.doi.org/10.1111/jpc.15422DOI Listing
March 2021

Comprehensive review of molecular mechanisms and clinical features of invasive lobular cancer.

Oncologist 2021 Feb 27. Epub 2021 Feb 27.

Stefanie Spielman Comprehensive Breast Center, The Ohio State University Comprehensive Cancer Center, Columbus, OH, USA.

Invasive lobular carcinoma (ILC) accounts for 10-15% of breast cancers in the United States, 80% of which is estrogen receptor (ER) positive, with an unusual metastatic pattern of spread to sites such as serosa, meninges, and ovaries, among others. Lobular cancer presents significant challenges in detection and clinical management given its multifocality and multicentricity at presentation. Despite the unique features of ILC, it is often lumped with hormone receptor positive invasive ductal cancers (IDC); consequently, ILC screening, treatment and follow up strategies are largely based on data from IDC. Despite both being treated as ER-positive breast cancer, querying the TCGA database show distinctive molecular aberrations in ILC compared to IDC, such as E-cadherin loss (66% vs. 3%), FOXA1 mutations (7% vs. 2%), GATA3 mutations (5% vs. 20%). Moreover, patients with ILC are less likely to undergo breast-conserving surgery, with lower rates of complete response following therapy as these tumors are less chemosensitive, compared to IDC patients. Taken together, this suggests that ILC are biologically distinct which may influence tumorigenesis and therapeutic strategies. Long term survival and clinical outcomes in ILC patients are worse than stage- and grade-matched IDC patients; therefore, nuanced criteria are needed to better define treatment goals and protocols tailored to ILC's unique biology. In this comprehensive review, we highlight the histologic and clinicopathologic features that distinguish ILC from IDC, with an in-depth discussion of ILC's molecular alterations and biomarkers, clinical trials and treatment strategies, and future targets for therapy. IMPLICATIONS FOR PRACTICE: Majority of invasive lobular breast cancers (ILC) are hormone receptor (HR) positive and low grade. Clinically, ILC is treated similar to HR positive invasive ductal cancer (IDC). However, ILC differs distinctly from IDC in its clinicopathologic characteristics and molecular alterations. ILC also differs in response to systemic therapy, with studies showing ILC as less sensitive to chemotherapy. Patients with ILC have worse clinical outcomes with late recurrences. Despite these differences, clinical trials treat HR positive breast cancers as a single disease and there is an unmet need for studies addressing the unique challenges faced by patients diagnosed with ILC.
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http://dx.doi.org/10.1002/onco.13734DOI Listing
February 2021

How far will you go before switching hands? Handedness on the long pegboard across the lifespan.

Dev Psychobiol 2021 Feb 25. Epub 2021 Feb 25.

Departmnt of Kiesniology & Physical Education, Wilfrid Laurier University, Waterloo, ON, Canada.

Handedness is a significant behavioral asymmetry; however, there is debate surrounding the age at which hand preference develops, and little research has been conducted on handedness in older adults. The current study examined performance on the long pegboard, to identify similarities and differences in young children (ages 4-7 years), older children (ages 8-12 years), young adults (ages 18-25 years), and older adults (ages 70+ years). Average time per hole, number of hand switches, and errors were assessed with left- and right-hand starts. A left-right ratio was computed from the long pegboard, along with laterality quotients from the Waterloo Handedness Questionnaire (WHQ). Results revealed faster performance when participants started the task on the right side of the long pegboard with the right-hand, coupled with a later switch to the left-hand. There was a greater number of errors with left-hand starts, and an earlier switch to the right-hand. Age was a significant predictor of the average time per hole and number of errors. Long pegboard ratio and WHQ laterality quotient were only correlated for adults. Together, findings offer insight regarding age-related effects in handedness and support the long pegboard as a useful measure of handedness.
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http://dx.doi.org/10.1002/dev.22112DOI Listing
February 2021

Patient-reported sexual function of breast cancer survivors with genitourinary syndrome of menopause after fractional CO2 laser therapy.

Menopause 2021 Feb 1. Epub 2021 Feb 1.

The Ohio State University Medical Center, Columbus, OH Center for Biostatistics, Department of Biomedical Informatics, The Ohio State University College of Medicine, Columbus, OH Mayo Clinic, Jacksonville, FL Mayo Clinic, Rochester, MN.

Objective: The objective of this pilot study was to evaluate the change in sexual function following treatment with fractional CO2 laser therapy in breast cancer (BC) survivors with genitourinary syndrome of menopause (GSM).

Methods: A single-arm feasibility study of BC survivors with symptoms of GSM, including dyspareunia and/or vaginal dryness, was conducted. Participants who received three treatments with fractional CO2 laser and 4-week follow-up were contacted for patient-reported outcomes and adverse events at 12 months. Sexual function was measured using the Female Sexual Function Index (FSFI) and Female Sexual Distress Scale Revised (FSDS-R). Descriptive statistics were calculated for patient demographics and disease characteristics for the set of participants who agreed to long-term follow-up and those who were lost to follow-up. FSFI and FSDS-R scores were summarized at baseline, 4 weeks and 12 months, as well as the change from baseline, and were compared using a Wilcoxon signed rank test.

Results: A total of 67 BC survivors enrolled, 59 completed treatments and 4-week follow-up; 39 participated in the 12 month follow-up. The overall FSFI score improved from baseline to 4-week follow-up (median Δ 8.8 [Q1, Q3] (QS) (2.2, 16.7)], P < 0.001). There were improvements at 4 weeks in all domains of the FSFI (P < 0.001 for each) including desire (median Δ 1.2; QS [0.6, 1.8]), arousal (median Δ 1.2; QS [0.3, 2.7]), lubrication (median Δ 1.8 (0, 3.3), orgasm (median Δ 1.2; QS [0, 3.6]), satisfaction (median Δ 1.6 (0.4, 3.2)), and pain (median Δ 1.6 (0, 3.6). The FSDS-R score also improved from baseline to 4-week follow-up (median Δ -10.0; QS [-16, -5] P < 0.001) indicating less sexually related distress. The scores of the FSFI and FSDS-R remained improved at 12 months and there were no serious adverse events reported.

Conclusions: In BC survivors with GSM, the total and individual domain scores of the FSFI and the FSDS-R improved after fractional CO2 laser therapy.

Video Summary:http://links.lww.com/MENO/A711.
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http://dx.doi.org/10.1097/GME.0000000000001738DOI Listing
February 2021

Clinical impact of interruption in adjuvant Trastuzumab therapy in patients with operable HER-2 positive breast cancer.

Cardiooncology 2020 Nov 5;6(1):26. Epub 2020 Nov 5.

Stefanie Spielman Comprehensive Breast Cancer, The Ohio State University, Columbus, OH, 43210, USA.

Background: Trastuzumab-induced cardiotoxicity (TIC) can lead to early discontinuation of adjuvant therapy, however there is limited evidence on long-term survival outcomes in patients with operable human epidermal growth factor receptor 2 (HER2)-positive breast cancer (BC) experiencing treatment interruption or discontinuation.

Methods: The primary objective of the study was to evaluate disease-free survival (DFS) in non-metastatic, HER2-positive, female BC patients who experienced treatment interruption or early discontinuation of trastuzumab therapy. Clinical and histopathological data were collected on 400 patients at The Ohio State University, an NCI-designated comprehensive cancer center between January 2005 and December 2015. Treatment interruption was defined as any delay of ≥2 weeks during trastuzumab therapy, including permanent cessation prior to completing planned therapy. TIC was defined as LVEF < 50% or > 15 points decline from baseline as evaluated by 2D echocardiogram after initiation of (neo) adjuvant therapy. DFS was defined as the time from diagnosis to first recurrence (loco-regional or distant recurrence) including second primary BC or death. Overall survival (OS) was defined as the time from diagnosis to death or last known follow up. OS/DFS estimates were generated using Kaplan-Meier methods and compared using Log-rank tests. Cox proportional hazard models were used to calculate adjusted hazard ratios (aHR) for OS/DFS.

Results: A total of 369 patients received trastuzumab therapy; 106 (29%) patients experienced treatment interruption at least once and 42 (11%) permanently discontinued trastuzumab prior to completing planned therapy. TIC was the most common reason for interruption (66 patients, 62%). The median duration of trastuzumab in patients with treatment interruption was 11.3 months (range: 0.5-16.9) with 24 (23%) patients receiving ≤6 months of therapy. This duration includes the time delay related to treatment interruption. Patients with any treatment interruption had worse DFS (aHR: 4.4, p = 0.001) and OS (aHR: 4.8, p < 0.001) after adjusting for age, stage, grade, ER, node status and TIC.

Conclusions: Treatment interruption or early discontinuation of trastuzumab therapy in early HER2-positive BC, most often from TIC, is an independent prognostic marker for worse DFS and OS in operable HER2-positive BC. Future prospective studies should consider targeting at-risk populations and optimizing cardiac function to avoid interruption in trastuzumab therapy.
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http://dx.doi.org/10.1186/s40959-020-00081-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7643282PMC
November 2020

Secukinumab Provides Sustained Reduction in Fatigue in Patients with Ankylosing Spondylitis: Long-term Results of Two Phase III Randomized Controlled Trials.

Arthritis Care Res (Hoboken) 2020 Nov 23. Epub 2020 Nov 23.

Oregon Health & Science University, Portland, OR, United States.

Objective: To investigate the longer-term effects of secukinumab 150 mg on fatigue in patients with ankylosing spondylitis (AS) in MEASURE 1 (up to 3 years) and MEASURE 2 (up to 2 years).

Methods: Patients with active AS were randomized to secukinumab or placebo in MEASURE 1 (10 mg/kg intravenous [IV] followed by 150 mg subcutaneous [SC]) and MEASURE 2 (150 mg SC). Patients were naive to or had an inadequate response/intolerance to tumor necrosis factor inhibitors (anti-TNF-naive/ anti-TNF-IR). Fatigue was measured using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale. Relationships between fatigue response and baseline characteristics and clinical/laboratory variables were explored.

Results: Significant improvements in FACIT-F scores from baseline were observed with secukinumab across both studies versus placebo at week 16 (P < 0.05). Improvements were sustained through week 156 (MEASURE 1)/week 104 (MEASURE 2). Significantly more patients reported fatigue responses (FACIT-F increase ≥4; observed data) with secukinumab 150 mg than placebo at week 16 in both MEASURE 1 (P < 0.05) and MEASURE 2 (P < 0.01). Fatigue responses were achieved by 75.6% of patients receiving secukinumab at week 156 (MEASURE 1) and 81.4% at week 104 (MEASURE 2); these results were consistent in both anti-TNF-naive (74.3% and 84.6%) and anti-TNF-IR (81.3% and 75.0%) patients. Baseline characteristics did not predict improvement in fatigue consistently. Fatigue responses were moderately to strongly correlated with responses in several clinical measures, including Assessment of SpondyloArthritis international Society (ASAS)20/40, ASAS5/6 responses, Ankylosing Spondylitis Disease Activity Score-C reactive protein (ASDAS-CRP), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and Short-form (SF)-36 scores.

Conclusion: Secukinumab provided rapid and sustained improvements in fatigue for up to 3 years, regardless of prior anti-TNF exposure.
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http://dx.doi.org/10.1002/acr.24517DOI Listing
November 2020

Psychometric evaluation of the Nocturia Sleep Quality Scale based on data from a prospective observational study.

J Clin Sleep Med 2020 Nov 18. Epub 2020 Nov 18.

Ferring Pharmaceuticals A/S, Copenhagen, Denmark.

Study Objectives: The Nocturia Sleep Quality Scale (NSQS), a novel patient-reported outcomes measure, was developed to assess the impact of sleep disturbance from nocturia. The objective of this study was to assess the psychometric properties of the NSQS, including its structure, reliability, and validity.

Methods: Data were collected in the context of a web-based, prospective, longitudinal, observational study. Participants with nocturia were randomized 1:1 to either a group that received sleep hygiene instructions, including instructions to limit liquids at nighttime and empty bladder prior to bedtime, or one that did not receive sleep instructions. All participants were asked to provide responses to the web-based questionnaires from day 1 to day 10. Psychometric analyses, aligned with current regulatory guidance, were conducted to evaluate the daily scores and 3-day average scores of NSQS items and potential composites. Item-level analyses were conducted first, followed by composite-level analyses.

Results: The NSQS items and supporting measures demonstrated very slight improvement in patient-perceived sleep disturbance from nocturia over the course of the study. NSQS test-retest reliabilities were generally satisfactory. Correlations between NSQS items and related patient-reported measures tended to support the construct validity of the NSQS, and the known-groups analyses supplied evidence of its discriminating ability. NSQS responsiveness statistics were small.

Conclusions: The NSQS is a reliable and valid measure of the impact of nocturia on patients' sleep. The present analyses lay the psychometric groundwork for the use of the NSQS in future clinical trials to support product approval and labeling claims.
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http://dx.doi.org/10.5664/jcsm.9010DOI Listing
November 2020

Triple-negative breast cancer: promising prognostic biomarkers currently in development.

Expert Rev Anticancer Ther 2021 Feb;21(2):135-148

Division of Medical Oncology, The Ohio State University Wexner Medical Center, James Cancer Hospital and Solove Research Institute, Columbus, OH, USA.

: Triple-negative breast cancer (TNBC) is an aggressive type of breast cancer associated with poor prognosis and limited treatment options. Validated prognostic and predictive biomarkers are needed to guide treatment decisions and prognostication.: In this review, we discuss established and developing prognostic and predictive biomarkers in TNBC and associated emerging and approved therapies. Biomarkers reviewed include epidermal growth factor receptor (EGFR), vascular endothelial growth factors (VEGF), fibroblast growth factor receptor (FGFR), human epidermal growth factor receptor 2 (HER2), androgen receptor, NOTCH signaling, oxidative stress/redox signaling, microRNAs, mutation, breast cancer susceptibility gene 1 or 2 () mutation/homologous recombination deficiency (HRD), NTRK gene fusion, PI3K/AKT/mTOR, immune biomarkers (programmed death-ligand 1 (PDL1), tumor-infiltrating lymphocytes (TILs), tumor mutational burden (TMB), neoantigens, defects in DNA mismatch repair proteins (dMMR)/microsatellite instability-high (MSI-H)), circulating tumor cells/cell-free DNA, novel targets of antibody-drug conjugates, and residual disease.: Biomarker-driven care in the management of TNBC is increasing and has helped expand options for patients diagnosed with this subtype of breast cancer. Research efforts are ongoing to identify additional biomarkers and targeted treatment options with the ultimate goal of improving clinical outcomes and survivorship.
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http://dx.doi.org/10.1080/14737140.2021.1840984DOI Listing
February 2021

Estrogen Receptor Beta (ERβ): A Ligand Activated Tumor Suppressor.

Front Oncol 2020 23;10:587386. Epub 2020 Oct 23.

Comprehensive Cancer Center, The Ohio State University, Columbus, OH, United States.

Estrogen receptor alpha (ERα) and estrogen receptor beta (ERβ) belong to a superfamily of nuclear receptors called steroid hormone receptors, which, upon binding ligand, dimerize and translocate to the nucleus where they activate or repress the transcription of a large number of genes, thus modulating critical physiologic processes. ERβ has multiple isoforms that show differing association with prognosis. Expression levels of the full length ERβ1 isoform are often lower in aggressive cancers as compared to normal tissue. High ERβ1 expression is associated with improved overall survival in women with breast cancer. The promise of ERβ activation, as a potential targeted therapy, is based on concurrent activation of multiple tumor suppressor pathways with few side effects compared to chemotherapy. Thus, ERβ is a nuclear receptor with broad-spectrum tumor suppressor activity, which could serve as a potential treatment target in a variety of human cancers including breast cancer. Further development of highly selective agonists that lack ERα agonist activity, will be necessary to fully harness the potential of ERβ.
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http://dx.doi.org/10.3389/fonc.2020.587386DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7645238PMC
October 2020

Worry and rumination in breast cancer patients: perseveration worsens self-rated health.

J Behav Med 2020 Nov 1. Epub 2020 Nov 1.

Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, 460 Medical Center Drive, Columbus, OH, 43210, USA.

A number of studies have shown that self-rated health reliably predicts mortality. This study assessed the impact of perseveration on self-rated health, physical functioning, and physical symptoms (pain, fatigue, breast cancer symptoms) among breast cancer patients. We hypothesized that cancer-related distress would serve as an intervening variable between both worry and rumination and self-rated health, physical functioning, and physical symptoms. Women (N = 124) who were approximately 7 weeks post-surgery but pre adjuvant treatment completed the Impact of Events Scale, the Penn State Worry Questionnaire, and the Rumination Scale. They also rated their pain, fatigue, physical functioning, and self-rated health using the RAND-36 and breast cancer symptoms with the Breast Cancer Prevention Trial Symptom Checklist (BCPT). Covariates included body mass index, age, cancer stage, menopause status, and physical comorbidities. Worry was associated with higher cancer-related distress, which in turn predicted greater pain and breast cancer symptoms, poorer physical functioning, and lower self-rated health. Rumination also predicted greater cancer-related distress, which ultimately contributed to greater pain along with poorer physical functioning and self-rated health. Models with fatigue as an outcome were not significant. These findings suggest that perseveration can heighten cancer-related distress and subsequent perceptions of physical symptoms and health among breast cancer patients prior to adjuvant treatment. Perseveration early in the cancer trajectory can adversely increase the impact of a cancer diagnosis and treatment on functioning and quality of life.
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http://dx.doi.org/10.1007/s10865-020-00192-9DOI Listing
November 2020

Buckled, bent or broken? A guide to paediatric forearm fractures.

Aust J Gen Pract 2020 11;49(11):740-744

FRACS, BMed, BMedSc (Hons), Orthopaedic Surgeon, Women@s and Children@s Hospital, SA; Associate Professor, Discipline of Orthopaedics and Trauma, University of Adelaide, SA.

Background: The radius and ulna are the most commonly fractured long bones in the school-aged population, accounting for 40% of all fractures. Management of individual fractures depends on the fracture pattern and age of the child.

Objective: The aim of this article is to provide an overview of the management concepts for specific fracture patterns and support general practitioners to confidently manage these fractures and refer to orthopaedic services when required.

Discussion: Orthopaedic advice and/or referral are recommended for unstable fracture types (greenstick and complete fractures), particularly in older children where remodelling potential is minimal. Early referral for growth plate injuries and suspected Monteggia and Galeazzi injuries is warranted to minimise long term complications.
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http://dx.doi.org/10.31128/AJGP-10-19-5132DOI Listing
November 2020

Prospective Decision Analysis Study of Clinical Genomic Testing in Metastatic Breast Cancer: Impact on Outcomes and Patient Perceptions.

JCO Precis Oncol 2019 18;3. Epub 2019 Nov 18.

The Ohio State University College of Medicine, Columbus, OH.

Purpose: To evaluate the impact of targeted DNA sequencing on selection of cancer therapy for patients with metastatic breast cancer (MBC).

Patients And Methods: In this prospective, single-center, single-arm trial, patients with MBC were enrolled within 10 weeks of starting a new therapy. At enrollment, tumor samples underwent next-generation sequencing for any of 315 cancer-related genes to high depth (> 500×) using FoundationOne CDx. Sequencing results were released to providers at the time of disease progression, and physician treatment recommendations were assessed via questionnaire. We evaluated three prespecified questions to assess patients' perceptions of genomic testing.

Results: In all, 100 patients underwent genomic testing, with a median of five mutations (range, 0 to 13 mutations) detected per patient. Genomic testing revealed one or more potential therapies in 98% of patients (98 of 100), and 60% of patients (60 of 100) had one or more recommended treatments with level I/II evidence for actionability. Among the 94 genomic text reports that were released, there was physician questionnaire data for 87 patients (response rate, 92.6%) and 31.0% of patients (27 of 87) had treatment change recommended by their physician. Of these, 37.0% (10 of 27) received the treatment supported by genomic testing. We did not detect a statistically significant difference in time-to-treatment failure (log-rank = .87) or overall survival ( = .71) among patients who had treatment change supported by genomic testing versus those who had no treatment change. For patients who completed surveys before and after genomic testing, there was a significant decrease in confidence of treatment success, specifically among patients who did not have treatment change supported by genomic testing (McNemar's test of agreement = .001).

Conclusion: In this prospective study, genomic profiling of tumors in patients with MBC frequently identified potential treatments and resulted in treatment change in a minority of patients. Patients whose therapy was not changed on the basis of genomic testing seemed to have a decrease in confidence of treatment success.
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http://dx.doi.org/10.1200/PO.19.00090DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7446448PMC
November 2019

A Homodimeric Aptamer Variant Generated from Ligand-Guided Selection Activates the T Cell Receptor Cluster of Differentiation 3 Complex.

Mol Ther Nucleic Acids 2020 Aug 19;22:167-178. Epub 2020 Aug 19.

Department of Chemistry, Lehman College, The City University of New York, 250 Bedford Park Blvd. West, Bronx, NY 10468, USA; PhD Programs in Chemistry and Biochemistry, CUNY Graduate Center, 365 Fifth Avenue, New York, NY 10016, USA; PhD Program in Molecular, Cellular and Developmental Biology, CUNY Graduate Center, 365 Fifth Avenue, New York, NY 10016, USA. Electronic address:

Recently, immunotherapeutic modalities with engineered cells and monoclonal antibodies have been effective in treating several malignancies. Nucleic acid aptamers can serve as alternative molecules to design immunotherapeutic agents with high functional diversity. Here we report a synthetic prototype consisting of DNA aptamers that can activate the T cell receptor cluster of differentiation 3 (TCR-CD3) complex in cultured T cells. We show that the activation potential is similar to that of a monoclonal antibody (mAb) against TCR-CD3, suggesting potential for aptamers in developing efficacious synthetic immunomodulators. The synthetic prototype of anti-TCR-CD3ε, as described here, was designed using aptamer ZUCH-1 against TCR-CD3ε, generated by ligand-guided selection (LIGS). Aptamer ZUCH-1 was truncated and modified with nuclease-resistant RNA analogs to enhance stability. Several dimeric analogs with truncated and modified variants were designed with variable linker lengths to investigate the activation potential of each construct. Among them, a dimeric aptamer with dimensions approximately similar to those of an antibody showed the highest T cell activation, suggesting the importance of optimizing linker lengths in engineering functional aptamers. The observed activation potential of dimeric aptamers shows the vast potential of aptamers in designing synthetically versatile immunomodulators with tunable pharmacokinetic properties, expanding immunotherapeutic designs by using nucleic acid-based ligands such as aptamers.
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http://dx.doi.org/10.1016/j.omtn.2020.08.016DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7494611PMC
August 2020

Staying home but not out of trouble: no reduction in presentations to the South Australian paediatric major trauma service despite the COVID-19 pandemic.

ANZ J Surg 2020 10 21;90(10):1863-1864. Epub 2020 Sep 21.

Paediatric Major Trauma Service, Division of Surgical Services, Women's and Children's Hospital, Adelaide, South Australia, Australia.

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http://dx.doi.org/10.1111/ans.16277DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7461070PMC
October 2020

Disruption of paediatric orthopaedic hospital services due to the COVID-19 pandemic in a region with minimal COVID-19 illness.

J Child Orthop 2020 Aug;14(4):245-251

Department of Orthopaedic Surgery, Women's and Children's Hospital Adelaide, North Adelaide, Australia.

Purpose: This study was designed to evaluate the impact of the COVID-19 pandemic on paediatric orthopaedic services in a paediatric tertiary hospital in South Australia.

Methods: A retrospective audit was conducted of orthopaedic activity at a major paediatric tertiary hospital with a Level 1 paediatric trauma centre, where no patients were admitted with COVID-19 illness. Orthopaedic Emergency Department (ED) presentations, outpatient clinics and hospital admissions for the period between 16 March 2020 to 26 April 2020 were studied and compared with the same period in 2019 (18 March 2019 to 28 April 2019). Chi-square tests were performed with p < 0.05 indicating statistical significance.

Results: In total, 621 patients presented to the ED with orthopaedic complaints during the pandemic (versus 997 in 2019). However, there was minimal change in the number of ED presentations requiring admission (110 in 2020 versus 116 in 2019). Among patients discharged directly from ED, 27.3% received hospital outpatient referral (versus 39.1% in 2019), with the remaining patients referred to community health services or discharged directly.There was a 509.8% increase in telehealth (video and phone) outpatient consultations compared to 2019 and a 60.6% decline in face-to-face appointments. There was a total of 144 orthopaedic admissions (elective and emergency) compared to 184 in 2019. Admissions for children under seven remained unchanged (32.5% reduction in children aged seven and above).

Conclusion: Despite an overall decline in all paediatric orthopaedic hospital activity, the number of emergency admissions for musculoskeletal conditions did not change. Elective surgery numbers for children aged under seven were also unchanged. Appropriate planning and hospital resources allocation are necessary to meet this service requirement in future pandemics.Level of evidence IV.
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http://dx.doi.org/10.1302/1863-2548.14.200140DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7453176PMC
August 2020

Asymmetrically Substituted Quadruplex-Binding Naphthalene Diimide Showing Potent Activity in Pancreatic Cancer Models.

ACS Med Chem Lett 2020 Aug 16;11(8):1634-1644. Epub 2020 Jul 16.

School of Pharmacy, University College London, London WC1N 1AX, United Kingdom.

Targeting of genomic quadruplexes is an approach to treating complex human cancers. We describe a series of tetra-substituted naphthalene diimide (ND) derivatives with a phenyl substituent directly attached to the ND core. The lead compound (SOP1812) has 10 times superior cellular and activity compared with previous ND compounds and nanomolar binding to human quadruplexes. The pharmacological properties of SOP1812 indicate good bioavailability, which is consistent with the activity in xenograft and genetic models for pancreatic cancer. Transcriptome analysis shows that it down-regulates several cancer gene pathways, including Wnt/β-catenin signaling.
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http://dx.doi.org/10.1021/acsmedchemlett.0c00317DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7429975PMC
August 2020

Multidisciplinary patient-centered management of brain metastases and future directions.

Neurooncol Adv 2020 Jan-Dec;2(1):vdaa034. Epub 2020 Mar 16.

Department of Radiation Oncology, Centre Hospitalier de l' Université de Montreal, Montreal, Quebec, Canada.

The incidence of brain metastasis is increasing as improvements in systemic therapy lead to increased survival. This provides new and challenging clinical decisions for patients who are trying to balance the risk of recurrence or progression with treatment-related side effects, and it requires appropriate management strategies from multidisciplinary teams. Improvements in prognostic assessment and systemic therapy with increasing activity in the brain allow for individualized care to better guide the use of local therapies and/or systemic therapy. Here, we review the current landscape of brain-directed therapy for the treatment of brain metastasis in the context of recent improved systemic treatment options. We also discuss emerging treatment strategies including targeted therapies for patients with actionable mutations, immunotherapy, modern whole-brain radiation therapy, radiosurgery, surgery, and clinical trials.
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http://dx.doi.org/10.1093/noajnl/vdaa034DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7415255PMC
March 2020

An integrated multidisciplinary team approach to the management of vascular anomalies: challenges and benefits.

Pediatr Surg Int 2020 Oct 8;36(10):1149-1156. Epub 2020 Aug 8.

Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, Australia.

Background: Vascular anomalies comprise highly variable pathophysiology and commonly pose diagnostic and management dilemmas. Consequently, patients often benefit from input from multiple specialists. This study describes the inception of a multidisciplinary team (MDT) Vascular Anomaly Clinic (VAC) in a tertiary paediatric centre, and the subsequent experience managing this complex patient group.

Methods: This was a retrospective study of paediatric patients (< 18 years old) attending an MDT VAC from its inception in October 2012 until November 2019. Patient demographics, presentation, diagnosis and management were reviewed.

Results: One hundred and thirty-three paediatric patients were seen over 7 years with a median age of 9.8 years. Vascular malformations were the most common diagnosis (88%), with venous malformations predominating (27%). The most common symptoms were pain (46%) and swelling (34%). Patients often required ≥ 2 investigations, with Doppler ultrasound (86%) and magnetic-resonance imaging (61%) being most common. Management included surgery (27%), sclerotherapy (26%), compression garments (23%), analgesia (12%), laser (15%), embolisation (5%) and sirolimus (3%).

Conclusions: The complex nature of vascular anomalies and high proportion of patients requiring multi-specialty management justified the establishment of an MDT VAC in our centre. Our experience demonstrates the success of an efficient one-stop MDT environment in the management of these challenging conditions.

Level Of Evidence: IV.
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http://dx.doi.org/10.1007/s00383-020-04727-8DOI Listing
October 2020

Response to Ly Pen and Andreu: Response to: "Screening for Carpal Tunnel Syndrome in Patients With Mucopolysaccharidosis".

J Child Neurol 2020 Dec 20;35(14):1019. Epub 2020 Jul 20.

Department of Genetics and Molecular Pathology, Women's and Children's Hospital, Adelaide, Australia.

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http://dx.doi.org/10.1177/0883073820941743DOI Listing
December 2020

Features, Outcomes, and Management Strategies of Male Breast Cancer: A Single Institution Comparison to Well-Matched Female Controls.

Eur J Breast Health 2020 Jul 20;16(3):201-207. Epub 2020 May 20.

Stefanie Spielman Comprehensive Breast Cancer, The Ohio State University, Columbus, OH, USA.

Objective: The primary objective of this study was to delineate differences in management, overall and distant disease-free survival in males diagnosed with breast cancer and treated at The Ohio State University Comprehensive Cancer Center as compared to comprehensively matched female subjects. Secondary objectives included assessment of clinical and histopathologic features and recurrence score, as measured by Oncotype DX and the modified Magee equation #2.

Materials And Methods: This single institution retrospective study compared male and comprehensively matched female patients (1:2) with stage I-III breast cancer between 1994 and 2014. Recurrence risk was estimated using a modified Magee equation. Overall survival and distant disease-free survival were estimated and compared using Kaplan-Meier and Log-rank methods.

Results: Forty-five male breast cancer patients were included (stage I: 26.7%; stage II: 53.3%; stage III: 20.0%; hormone receptor positive: 97.8%; human epidermal growth factor receptor 2 negative: 84.4%) with a median age of 63.8 (43.0-79.4) years at diagnosis. Intermediate and low recurrence scores were most common in male and female patients respectively; mean score was similar between groups (20.3 vs. 19.8). The proportion of male breast cancer patients treated with adjuvant chemotherapy and post-mastectomy radiation was lower compared to female patients (42.2% vs. 65.3%, p=0.013; 22.7% vs. 44.4%, p=0.030, respectively). Overall survival and distant disease-free survival between male and female patients were similar.

Conclusion: Male breast cancer patient outcomes were similar compared to well-matched female patients suggesting that breast cancer specific factors are more prognostic than gender.
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http://dx.doi.org/10.5152/ejbh.2020.5536DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7337913PMC
July 2020

Implementing a multidisciplinary approach for older adults with Cancer: geriatric oncology in practice.

BMC Geriatr 2020 07 6;20(1):231. Epub 2020 Jul 6.

The James Cancer Hospital/Solove Research Institute, Columbus, USA.

Background: Evidence-based practice in geriatric oncology is growing, and national initiatives have focused on expanding cancer care and research to improve health outcomes for older adults. However, there are still gaps between knowledge and practice for older adults with cancer.

Main Text: Here we provide a detailed methodology of geriatric oncology care delivery within a single institution. The Cancer and Aging Resiliency (CARE) clinic is a multidisciplinary approach for implementing geriatric-driven health care for older adults with cancer. The CARE clinic was developed as a direct response to recommendations targeting key multifactorial geriatric health conditions (e.g. falls, nutritional deficits, sensory loss, cognitive impairment, frailty, multiple chronic conditions, and functional status). The multidisciplinary team assesses and delivers a comprehensive set of recommendations, all in one clinic visit, to minimize burden on the patient and the caregiver. The CARE clinic consultative model is a novel approach integrating cancer subspecialties with geriatric oncology healthcare delivery.

Conclusions: Older adults with cancer have unique needs that are independent of routine oncology care. The CARE clinic model provides specific assessments and interventions to improve health outcomes among older adults with cancer.
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http://dx.doi.org/10.1186/s12877-020-01625-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7336473PMC
July 2020

Development and Validation of Caregiver Risk Evaluation (CaRE): A New Algorithm to Screen for Caregiver Burden.

J Appl Gerontol 2020 May 26:733464820920102. Epub 2020 May 26.

University of Waterloo, Ontario, Canada.

The main objective was to develop a decision-support tool to assess the risk of caregiver burden, the Caregiver Risk Evaluation (CaRE) algorithm. Home care clients were assessed using the Resident Assessment Instrument for Home Care (RAI-HC). Their caregiver completed the 12-item Zarit Burden Interview (ZBI), the main dependent measure, which was linked to the RAI-HC. In the sample ( = 344), 48% were aged 85+ years and 61.6% were female. The algorithm can be collapsed into four categories (low, moderate, high, and very high risk). Relative to the low-risk group, clients in the very high-risk group had an odds ratio of 5.16 (95% confidence interval: [2.05, 12.9]) for long-term care admission, after adjusting for client age, sex, and regional health authority. The CaRE algorithm represents a new tool to be used by home care clinicians as they proactively plan for the needs of clients and their caregivers.
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http://dx.doi.org/10.1177/0733464820920102DOI Listing
May 2020

Exploratory analysis of immune checkpoint receptor expression by circulating T cells and tumor specimens in patients receiving neo-adjuvant chemotherapy for operable breast cancer.

BMC Cancer 2020 May 19;20(1):445. Epub 2020 May 19.

The Ohio State University Comprehensive Cancer Center, The Ohio State University, 410 W 12th Avenue, Columbus, OH, 43210, USA.

Background: While combinations of immune checkpoint (ICP) inhibitors and neo-adjuvant chemotherapy (NAC) have begun testing in patients with breast cancer (BC), the effects of chemotherapy on ICP expression in circulating T cells and within the tumor microenvironment are still unclear. This information could help with the design of future clinical trials by permitting the selection of the most appropriate ICP inhibitors for incorporation into NAC.

Methods: Peripheral blood samples and/or tumor specimens before and after NAC were obtained from 24 women with operable BC. The expression of CTLA4, PD-1, Lag3, OX40, and Tim3 on circulating T lymphocytes before and at the end of NAC were measured using flow cytometry. Furthermore, using multi-color immunohistochemistry (IHC), the expression of immune checkpoint molecules by stromal tumor-infiltrating lymphocytes (TILs), CD8+ T cells, and tumor cells was determined before and after NAC. Differences in the percentage of CD4+ and CD8+ T cells expressing various checkpoint receptors were determined by a paired Student's t-test.

Results: This analysis showed decreased ICP expression by circulating CD4+ T cells after NAC, including significant decreases in CTLA4, Lag3, OX40, and PD-1 (all p values < 0.01). In comparison, circulating CD8+ T cells showed a significant increase in CTLA4, Lag3, and OX40 (all p values < 0.01). Within tumor samples, TILs, CD8+ T cells, and PD-L1/PD-1 expression decreased after NAC. Additionally, fewer tumor specimens were considered to be PD-L1/PD-1 positive post-NAC as compared to pre-NAC biopsy samples using a cutoff of 1% expression.

Conclusions: This work revealed that NAC treatment can substantially downregulate CD4+ and upregulate CD8+ T cell ICP expression as well as deplete the amount of TILs and CD8+ T cells found in breast tumor samples. These findings provide a starting point to study the biological significance of these changes in BC patients.

Trial Registration: NCT04022616.
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http://dx.doi.org/10.1186/s12885-020-06949-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7236344PMC
May 2020

TTF-1 Positive Primary Small Cell Carcinoma of the Breast: A Case Report and Review of the Literature.

Front Endocrinol (Lausanne) 2020 29;11:228. Epub 2020 Apr 29.

Stefanie Spielman Comprehensive Breast Cancer, The Ohio State University, Columbus, OH, United States.

Primary small cell carcinoma of the breast (SCCB) is a rare tumor subtype comprising <0.1% of all breast carcinomas. Here we present a case of thyroid transcription factor-1 (TTF-1) positive SCCB that recurred within 3 years of diagnosis in the lung and lymph nodes. Given the small number of cases, no clear guidelines exist on the appropriate management of patients with these aggressive tumors. We present a case study and review the current literature to highlight the knowledge gaps and needs of patients with these rare tumors. A 50-year-old premenopausal woman with no family history, presented with a palpable right breast mass. Biopsy was consistent with primary SCCB that was poorly differentiated, positive for synaptophysin and chromogranin and TTF-1 and presence of ductal carcinoma component showing neuroendocrine differentiation. Imaging with PET, CT, and MRI brain excluded any other sites of primary disease. She underwent a right lumpectomy with axillary lymph node dissection and was treated with adjuvant cisplatin-based chemotherapy and concurrent radiation therapy. Thirty-four months later, routine scans showed a new right lower-lobe lung nodule and an enlarged sub-carinal node that was proven to be poorly differentiated neuroendocrine cancer. This case report sheds light on a rarely described disease and provides a comprehensive approach to diagnosis and management. Primary SCCB is an extremely rare, aggressive form of breast cancer that is molecularly and histologically similar to SCLC. However, a review of the literature highlights recent mutational analyses that show important differences between these two cancer types, including an increase in PIK3CA mutations in primary SCCB. Further studies, including genomic analyses are needed to better define this malignancy and to develop a standard treatment.
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http://dx.doi.org/10.3389/fendo.2020.00228DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7201766PMC
April 2020

Metastatic breast cancer patient perceptions of somatic tumor genomic testing.

BMC Cancer 2020 May 6;20(1):389. Epub 2020 May 6.

The Ohio State University Comprehensive Cancer Center, Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, Columbus, OH, USA.

Background: To assess metastatic breast cancer (MBC) patient psychological factors, perceptions, and comprehension of tumor genomic testing.

Methods: In a prospective, single institution, single-arm trial, patients with MBC underwent next-generation sequencing at study entry with sequencing results released at progression. Patients who completed surveys before undergoing sequencing were included in the present secondary analysis (n = 58). We administered four validated psychosocial measures: Center for Epidemiologic Studies Depression Scale, Beck Anxiety Inventory, Trust in Physician Scale, and Communication and Attitudinal Self-Efficacy scale for Cancer. Genetic comprehension was assessed using 7-question objective and 6-question subjective measures. Longitudinal data were assessed (n = 40) using paired Wilcoxon signed rank and McNemar's test of agreement.

Results: There were no significant differences between the beginning and end of study in depression, anxiety, physician trust, or self-efficacy (median time on study: 7.6 months). Depression and anxiety were positively associated with each other and both negatively associated with self-efficacy. Self-efficacy decreased from pre- to post-genomic testing (p = 0.05). Objective genetics comprehension did not significantly change from pre- to post-genomic testing, but patients expressed increased confidence in their ability to teach others about genetics (p = 0.04). Objective comprehension was significantly lower in non-white patients (p = 0.02) and patients with lower income (p = 0.04).

Conclusions: This is the only study, to our knowledge, to longitudinally evaluate multiple psychological metrics in MBC as patients undergo tumor genomic testing. Overall, psychological dimensions remained stable over the duration of tumor genomic testing. Among patients with MBC, depression and anxiety metrics were negatively correlated with patient self-efficacy. Patients undergoing somatic genomic testing had limited genomic knowledge, which varied by demographic groups and may warrant additional educational intervention.

Clinical Trial Information: NCT01987726, registered November 13, 2013.
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http://dx.doi.org/10.1186/s12885-020-06905-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7201768PMC
May 2020

Multiclass, Multiresidue Method for the Quantification and Confirmation of 112 Veterinary Drugs in Game Meat (Bison, Deer, Elk, and Rabbit) by Rapid Polarity Switching Liquid Chromatography-Tandem Mass Spectrometry.

J Agric Food Chem 2021 Feb 14;69(4):1175-1186. Epub 2020 May 14.

Denver Laboratory, U.S. Food and Drug Administration, Denver, Colorado 80225, United States.

An analytical program for multiclass, multiresidue residue analysis to qualitatively and quantitatively determine veterinary drug compounds in game meats by LC-MS/MS has been developed and validated. The method was validated for the analysis of muscle from bison, deer, elk, and rabbit to test for 112 veterinary drug residues from the following drug classes: β-agonists, anthelmintics, anti-inflammatory drugs, corticosteroids, fluoroquinolones, β-lactams, macrolides, nitroimidazoles, phenicols, polypeptides, sulfonamides, tetracyclines, thyreostats, and tranquilizers. Muscle was extracted using a simple and quick procedure based on a solvent extraction with 80% ACN/water and sample cleanup with dispersive solid-phase extraction. The compounds of interest were separated using a Waters HSS T3 column and detected by tandem mass spectrometry with rapid polarity switching to detect both negatively and positively charged ions in a single run. Recoveries were calculated using extracted matrix-matched calibration curves for each type of matrix. The average accuracy of fortified compounds ranged from 95.6 to 101% at the target quantitative validation level in the four matrices. The method was also validated as a qualitative screening method where all sample responses were compared with a single extracted matrix-matched calibrant at the target testing level (5 or 25 ng/g). Samples demonstrating a presumptive positive above the threshold value were re-extracted and analyzed with a five-point matrix-matching extracted calibration curve. Since the beginning of this survey program, 360 samples have been analyzed for veterinary drug residues in game meats. Antibiotic or tranquilizer residues have been identified in deer (chlortetracycline, haloperidol, and tulathromycin) and rabbit (sulfadiazine).
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http://dx.doi.org/10.1021/acs.jafc.0c01422DOI Listing
February 2021

Caregiving work: The experiences and needs of caregivers in Australia.

Health Soc Care Community 2020 09 21;28(5):1764-1771. Epub 2020 Apr 21.

School of Psychology, The University of Adelaide, Adelaide, SA, Australia.

A considerable evidence base exists demonstrating the high prevalence of family caregiving in the community; however, there is a paucity of in-depth research examining the impact of family caregiving on the living and employment needs of those providing this unpaid service. This study employed a qualitative interview design with purposive sampling to examine the experiences of family caregivers, in order to examine how family caregiving decisions are made, the nature and challenges of caregiving work, and living and work supports that may enhance the caregiving experience. A sample of 12 adults providing care and assistance to family members with a range of disabilities, chronic conditions and long-term illnesses were interviewed. The results showed that family caregivers 'fall into' the caregiving role and often continue to provide care indefinitely without pay and with little or no financial support from others. In describing the best aspects of their experience many caregivers talked about helping their care recipient remain in their home and maintain their independence. In describing the worst aspects of their experience, all referred to the living and financial challenges of the caregiving work, and many highlighted the impact of their caregiving work on their employment and career needs. In conclusion, there is a need for public policies, programs and health services in Australia to better respond to the living, financial and support needs of family caregivers as health service providers, as well as their employment, development and career needs which are seriously impacted upon by caregiving work.
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http://dx.doi.org/10.1111/hsc.13001DOI Listing
September 2020

Cross-Sectional Nutrition Profile of Palliative Home Care Clients in Ontario and Performance of the interRAI Palliative Care Nutrition Clinical Assessment Protocol.

JPEN J Parenter Enteral Nutr 2021 Jan 8;45(1):183-192. Epub 2020 Apr 8.

Department of Kinesiology and Physical Education and Department of Health Sciences, Wilfrid Laurier University, Waterloo, Ontario, Canada.

Background: The nutrition profile of palliative home care clients is unknown. This study describes this group and their nutrition issues and evaluates the performance of the interRAI nutrition Clinical Assessment Protocol (CAP).

Methods: This was a cross-sectional secondary analysis using Ontario interRAI Palliative Care (interRAI PC) Assessment data. The sample represents 74,963 unique Ontario home care clients assessed between 2011 and 2018. Frequencies and standardized differences (stdiffs) of nutrition characteristics were presented for cancer (n = 62,394) and noncancer (n = 12,569) diagnostic subgroups. Rates of triggering the nutrition CAP were presented by nutrition issue to evaluate its performance.

Results: Of this sample, 16.7% were ≥85 years of age, 52.6% had a prognosis between 6 weeks and 6 months, and 41.4% required assistance with eating. The prevalence was higher among those with nervous/mental/behavioral disorders (72.6%) compared with those with cancer (37.6%; stdiff = 0.75). However, most nutrition issues experienced were similar (stdiff < 0.20) across diagnostic groups. Of the entire sample, 21% triggered the nutrition CAP, indicating a need for further evaluation or intervention. Yet, 73.4% of those who experienced dry mouth, 71.8% of those who required assistance with eating, and 68.4% of those who received a nutrition consult within the last 3 days did not trigger the nutrition CAP.

Conclusions: Nutrition issues are prevalent in palliative home care clients, regardless of diagnosis; yet the nutrition CAP identified a small fraction of this group. There is a need to focus research and care guidelines toward life-limiting illnesses beyond cancer and address nutrition-related issues in this population.
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http://dx.doi.org/10.1002/jpen.1827DOI Listing
January 2021

Recognizing and responding to women experiencing homelessness with gendered and trauma-informed care.

BMC Public Health 2020 Mar 26;20(1):397. Epub 2020 Mar 26.

School of Public Health at the University of Alberta, 3-300 Edmonton Clinic Health Academy, 11405 - 87 Ave, Edmonton, AB, T6G 1C9, Canada.

Background: The purpose of this study is to highlight the experiences of women who are often hidden in what we know and understand about homelessness, and to make policy and practice recommendations for women-centred services including adaptations to current housing interventions.

Methods: Three hundred survey interviews were conducted with people experiencing homelessness in Calgary, Alberta, Canada. The survey instrument measured socio-demographics, adverse childhood experiences, mental and physical health, and perceived accessibility to resources. Eighty-one women participants were identified as a subsample to be examined in greater depth. Descriptive statistics and logistic regressions were calculated to provide insight into women respondents' characteristics and experiences of homelessness and how they differed from men's experiences.

Results: Women's experiences of homelessness are different from their male counterparts. Women have greater mental health concerns, higher rates of diagnosed mental health issues, suicidal thoughts and attempts, and adverse childhood trauma. The results should not be considered in isolation, as the literature suggests, because they are highly interconnected.

Conclusion: In order to ensure that women who are less visible in their experiences of homelessness are able to access appropriate services, it is important that service provision is both gender specific and trauma-informed. Current Housing First interventions should be adapted to ensure women's safety is protected and their unique needs are addressed.
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http://dx.doi.org/10.1186/s12889-020-8353-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7099814PMC
March 2020