bluuebunny/crossref_metadata_2025 huggingface dataset:
Setting up a quantitative SPECT imaging network for a European multi-centre dosimetry study of radioiodine treatment for thyroid cancer as part of the MEDIRAD project
Authors: Taprogge Jan , Leek Francesca , Schurrat Tino , Tran-Gia Johannes , Vallot Delphine , Bardiès Manuel , Eberlein Uta , Lassmann Michael , Schlögl Susanne , Vergara Gil Alex ,   the MEDIRAD WP3 Investigator Team, Buck Andreas , Clayton Naomi , Courbon Frédéric , Lapa Constantin , Luster Markus , Mora-Ramirez Erick , Newbold Kate , Schumann Sarah , Verburg Frederik , Vija Lavinia , Zerdoud Slimane , Flux Glenn D.
Published: October 2020

Background

Differentiated thyroid cancer has been treated with radioiodine for almost 80 years, although controversial questions regarding radiation-related risks and the optimisation of treatment regimens remain unresolved. Multi-centre clinical studies are required to ensure recruitment of sufficient patients to achieve the statistical significance required to address these issues. Optimisation and standardisation of data acquisition and processing are necessary to ensure quantitative imaging and patient-specific dosimetry.

Material and methods

A European network of centres able to perform standardised quantitative imaging of radioiodine therapy of thyroid cancer patients was set-up within the EU consortium MEDIRAD. This network will support a concurrent series of clinical studies to determine accurately absorbed doses for thyroid cancer patients treated with radioiodine. Five SPECT(/CT) systems at four European centres were characterised with respect to their system volume sensitivity, recovery coefficients and dead time.

Results

System volume sensitivities of the Siemens Intevo systems (crystal thickness 3/8″) ranged from 62.1 to 73.5 cps/MBq. For a GE Discovery 670 (crystal thickness 5/8″) a system volume sensitivity of 92.2 cps/MBq was measured. Recovery coefficients measured on three Siemens Intevo systems show good agreement. For volumes larger than 10 ml, the maximum observed difference between recovery coefficients was found to be ± 0.02. Furthermore, dead-time coefficients measured on two Siemens Intevo systems agreed well with previously published dead-time values.

Conclusions

Results presented here provide additional support for the proposal to use global calibration parameters for cameras of the same make and model. This could potentially facilitate the extension of the imaging network for further dosimetry-based studies.
The outcome of COVID-19 among the geriatric age group in African countries: protocol for a systematic review and meta-analysis
Authors: Tadesse Degena Bahrey , Wahdey Shishay , Negash Melaku , Ayele Ebud , Haile Teklehaimanot Gereziher , Kiros Kbrom Gemechu , Tesfamichael Yohannes Ashebir , Gebrekidan Kiros Belay
Published: October 2020

Background

According to the World Health Organization (WHO), the outbreak of coronavirus disease in 2019 (COVID-19) has been declared as a pandemic and public health emergency that infected more than 5 million people worldwide at the time of writing this protocol. Strong evidence for the outcome of COVID-19 among the geriatric age group has not been published in Africa. Therefore, this protocol will be served as a guideline to conduct a systematic review and meta-analysis of the outcome of COVID-19 among the geriatric age group in Africa.

Methods

Published and unpublished studies on the outcome of COVID-19 among the geriatric age group in Africa and written in any language will be included. Databases (PubMed / MEDLINE, Google Scholar, Google, EMBASE, Web of Science, Microsoft Academic, WHO COVID-19 database, Cochran Library, Africa Wide Knowledge, and Africa Index Medicus) from March to August 2020 will be searched. Two independent reviewers will select, screen, extract data, and assess the risk of bias. The proportion will be measured using a random-effects model. Subgroup analysis will be conducted to manage heterogeneity. The presence of publication bias will be assessed using Egger’s test and visual inspection of the funnel plots. This systematic and meta-analysis review protocol will be reported per the PRISMA-P guidelines.

Conclusion

This systematic review and meta-analysis protocol will be expected to quantify the outcome of COVID-19 among the geriatric age group in Africa.

Systematic review registration

This protocol was submitted for registration with the International Prospective Register of Systematic Reviews (PROSPERO) in April 2020 and accepted with the registration number: (https://www.crd.york.ac.uk/PROSPERO). CRD42020180600.
Implementation of a trauma-informed, evidence-informed intervention for Latinx families experiencing interpersonal violence and child maltreatment: protocol for a pilot randomized control trial of SafeCare+®
Authors: Fettes Danielle L. , Aarons Gregory A. , Brew Valerie , Ledesma Karla , Silovsky Jane
Published: October 2020

Background

A consistently demonstrated overlap exists between the occurrence of domestic violence and child maltreatment, yet these issues are historically addressed by distinct systems and programming. The randomized control trial pilot study presented in this article adapts, implements, and tests a new approach for addressing family violence for Latinx families with co-occurring risk for domestic violence and child maltreatment. In doing so, this pilot study addresses the clear need for collaboration between the two fields and focuses on Latinx families, who often face specific challenges regarding seeking and receiving needed services. The primary aim of the current study is a pilot implementation of SafeCare+®, an evidence-based parenting curriculum (SafeCare®) augmented with a healthy relationships curriculum (SafeCare+®). The objectives are a reduction of family violence, improved communication, and a healthy home environment for children in Latinx families with co-occurring domestic violence and child maltreatment.

Methods

This protocol outlines a feasibility, randomized control trial to examine the potential efficacy of SafeCare+. The pilot study is divided into two phases. Components of phase one involve developing a detailed implementation and evaluation plan, including a community needs assessment, determining screening and outcome measures, and assuring all components are culturally appropriate for the target population. Phase two implements the randomization of parents, who are involved in the child welfare system and referred for in-home parenting services, into SafeCare+ or SafeCare as usual. Participants complete assessments regarding mental health, provider-parent relationship, interpersonal violence experiences, and fidelity to the intervention. Analyses will focus on improvement on target outcomes for the intervention group, as well as comparison to the control group.

Discussion

This study will provide evidence on the feasibility and potential effectiveness of an early intervention program aimed at improving communication skills and mental health and reducing incidents of violence for Latinx parents who are involved with the child welfare service system. The findings of the study will inform the decision to progress to a full scale, definitive randomized control trial to test the effectiveness of an intervention, delivered as part of home visitation, for improving outcomes for families with histories of domestic violence.

Trial registration

ClinicalTrials.gov, NCT03041558; registered 2 February, 2017—retrospectively registered.
Fecal carriage and factors associated with extended-spectrum β-lactamase-producing Enterobacteriaceae among pregnant women at the tertiary referral hospital, Tanzania
Authors: Mwandigha Ambele M. , Kamori Doreen , Kibwana Upendo O. , Masoud Salim , Manyahi Joel , Majigo Mtebe
Published: October 2020

Background

Infections due to extended-spectrum β-lactamase-producing Enterobacteriaceae (ESBL-E) are increasing worldwide. Evidence indicates that fecal carriage of ESBL-E in pregnancy predisposes women to potential life-threatening urinary tract infections and subsequently increasing the risk of neonatal infections. There is limited data regarding fecal carriage of ESBL-E and associated factors among pregnant women in Tanzania. We aimed to address the gap by determining the proportion of pregnant women with ESBL-E fecal carriage and identify the related factors.

Methodology

A hospital-based cross-sectional study was conducted at Muhimbili National Hospital in Dar es Salaam, Tanzania. A total of 182 pregnant women at the gestational age of 37 weeks and above were enrolled. Participants’ socio-demographic, clinical, and hygienic information were collected by using a well-structured questionnaire. Rectal swabs were collected and processed for isolation of ESBL-E. The extended-spectrum β-lactamase production and antibiotic susceptibility test (AST) were performed using a double-disc synergy test and Kirby-Bauer disc diffusion method, respectively.

Results

A total of 117 (64.3%) pregnant women were found to carry ESBL-E. Factors such as self-prescription of antibiotic medication during pregnancy, low education level, and toilet sharing were independently associated with ESBL-E fecal carriage. Five ESBL-E species that were isolated include Escherichia coli (84.6%), Klebsiella pneumoniae (8.9%), Klebsiella oxytoca (3.3%), Citrobacter spp. (1.6%), and Enterobacter spp. (1.6%). ESBL-E isolates demonstrated high resistance to aztreonam and sulphamethoxazole-trimethoprim.

Conclusion

This study has revealed a relatively high fecal carriage of ESBL-E among pregnant women, suggesting that there is a need for routine screening among that population. We recommend further studies to explore comprehensively the factors associated with high fecal carriage of ESBL-E in pregnancy and the potential transmission kinetics to their newborn babies.
Chemical composition and in vitro digestibility of some selected under-utilized tropical seeds as protein sources in ruminants’ diet
Authors: Omotoso Oluwatosin Bode , Adeduntan Mary Oluwafunmilayo , Fajemisin Adebowale Noah
Published: October 2020

Background

The study highlighted the potential of three common and under-utilized tropical leguminous seeds (Tomentosa nilotica, Dioclea reflexa and Monodora myristica) to be used as supplementary feed to ruminant livestock. These seeds (their plants inclusive) are valuable sources of food and medicine for the prevention of illness and maintenance of human health. The medicinal properties of these seeds include antimicrobial, anti-inflammatory, anti-oxidant and immuno-stimulant. Trypsin inhibitors, which are common anti-nutritional factors in legumes and for monogastric animals, do not exert adverse effects in ruminants because they are degraded in the rumen. Hence, the crux of this study is to examine the effect of processing methods on the nutritional composition (proximate, fibre fractions, minerals, anti-nutrients) and in vitro digestibility of Tomentosa nilotica, Dioclea reflexa and Monodora myristica seeds and their suitability as feedstuff (protein sources) in small ruminant feed, particularly during off-season.

Results

From the results, raw Tomentosa nilotica and Monodora myristica have the highest crude protein (30.35% CP) and fat (22.40% EE), respectively. It is noteworthy that roasting best improve the mineral and significantly reduce the anti-nutrients observed in this study better compared to boiling and soaking methods. The highest organic matter digestibility, short-chain fatty acids, metabolizable energy and in vitro dry matter digestibility values were obtained in Dioclea reflexa compared to other test seeds. Roasting best improved the nutritive values, while Dioclea reflexa seed was rated highest for all the nutritional attributes and in vitro digestibility.

Conclusions

Dioclea reflexa could be incorporated in ruminants’ diet as protein source, particularly during the off-season, for improved ruminant production in Nigeria. However, in vivo study is therefore recommended to validate this report.
Dural tear from diagnostic lumbar puncture followed by long-term morbidity: a case report
Authors: Haugstvedt Aleksander Fjeld , Havsteen Inger Birgitte , Christensen Hanne
Published: October 2020

Background

Lumbar punctures are performed in different medical settings and are a key procedure in the diagnosis of several neurological conditions. Complications are rare and generally self-limiting. There are no reports of symptomatic accumulation of fluid in the epidural space after lumbar puncture in adults and there are no studies on long-term outcome after post dural puncture headache (PDPH).

Case

A lumbar puncture was performed in a 29 y.o. slender woman with unspecific symptoms to rule out neuro-infection. Next day MRI showed substantial accumulation of CSF in the epidural space from C2 to the sacrum dislocating the spinal chord in the spinal canal. The condition was ameliorated by epidural blood-patching. At 5 months she was still impaired by severe orthostatic headache.

Conclusions

The only plausible explanation for the massive CSF leak was a dural tear occurring during multiple attempts of lumbar puncture. Anterior dislocation of the spinal chord due to CSF leak is not a recognised complication to lumbar puncture. This complication was followed by long-term disability in our case. The diagnosis can be made by MRI. A difficult procedure with several attempts and use of traumatic technique may increase risk of this complication.
Optimization of inulin production process parameters using response surface methodology
Authors: Akram Wasim , Garud Navneet
Published: October 2020

Background

Chicory is one of the major source of inulin. In our study, Box–Behnken model/response surface analysis (RSM) was used for the optimization of spray drying process variables to get the maximum inulin yield from chicory (Cichorium intybus L.). For this investigation, the investigational plan utilized three process variables drying temperature (115–125 °C), creep speed (20–24 rpm), and pressure (0.02–0.04 MPa).

Result

The optimal variables established by applying the Box–Behnken model were as follows: drying temperature 119.20 °C, creep speed 21.64 rpm, and pressure 0.03 MPa. The obtained powdered inulin by spray drying was investigated for the yield value, identification, size, and surface morphology of the particle. The inulin obtained from the spray drying process consists of a fine molecule-sized white powder. Instead, the drying methods shows a significant effect on the morphology and internal configuration of the powdered inulin, as the inulin obtained from spray drying was of a widespread and uniform size and shape, with a rough surface on increase in temperature and smoother surface while increasing the creep speed. The findings indicate that the spray drying with optimum parameters resulted in maximum product yield.

Conclusion

The outcomes of the study concluded that the product yield through spray drying technique under optimized condition is optimal as compared to other drying technique. Hence, this technique may be applied at commercial scale for the production of inulin.
Characterizing participants in the North Carolina Breast and Cervical Cancer Control Program (NC BCCCP): A review of 90,000 women.
Authors: Tait Sarah D , Ren Yi , Horton Cushanta C. , Oshima Sachiko M. , Thomas Samantha M. , Wright Sherry , Caesar Awanya , Plichta Jennifer Kay , Hwang Eun-Sil Shelley , Greenup Rachel Adams , Rosenberger Laura Horst , DiLalla Gayle , Menendez Carolyn S. , Tolnitch Lisa , Hyslop Terry , Nelson Debi , Fayanju Oluwadamilola Motunrayo
Published: October 2020

101

Background: Overall breast cancer mortality in the US has declined since 1990, but racial/ethnic disparities have worsened. Since 1992, NC BCCCP has provided free/low-cost breast cancer screening to underserved women as part of a national effort by the Centers for Disease Control and Prevention (CDC) to mitigate these disparities. We sought to characterize and evaluate benchmarks for this previously unstudied, state-level cohort. Methods: We identified women ≥18y who underwent their first breast cancer screening via NC BCCCP from 2009-2018. Univariate analysis was used to compare differences in timeline of care and rates of breast pathology (i.e., cancer or atypia) by race/ethnicity and age. Logistic and negative binomial regression were used to identify factors associated with cancer diagnosis and time from enrollment to diagnosis (TTD) and treatment (TTT), respectively. Results: 88,893 women with complete records were identified (median age 50y, IQR 44-56): 45.5% were Non-Hispanic (NH) white, 30.9% NH black, 19.5% Hispanic, 1.7% American Indian (AI), and 1.1% Asian. Overall participation peaked in 2012 but steadily increased among Hispanic women over time (p < 0.001). Breast pathology was diagnosed in 2,016 (2.3%) women, with rates ranging from 1% in Hispanic women to 2.7% in NH whites. After adjustment, Hispanic women were least likely (vs NH white women: OR 0.40; 95% CI 0.34-0.47) to be diagnosed with breast cancer. Median TTD was 19d and TTT was 33d, both within the CDC’s 60d standard. In univariate analyses, women < 50 had shorter TTD (median 18d vs 21d) and TTT (median 30d vs 35d) vs women ≥50 (both p < 0.01), and there were no significant differences by race/ethnicity or between women with atypia vs cancer. In multivariate models, however, older age and NH black race were associated with longer TTD and TTT. Conclusions: NC BCCCP meets national quality benchmarks for TTD and TTT. These data also highlight broader opportunities to achieve racial/ethnic parity and improve equity for breast cancer prevention. [Table: see text]
An Optimal Care Coordination Model (OCCM) for Medicaid patients with lung cancer: Results from the beta model testing phase of a multisite initiative in the United States.
Authors: Smeltzer Matthew , Boehmer Leigh , Kramar Amanda , Asfeldt Thomas , Faris Nicholas , Amorosi Christine Fay , Ray Meredith , Nolan Vikki G. , Oyer Randall A. , Lathan Christopher S. , Osarogiagbon Raymond U.
Published: October 2020

105

Background: Medicaid patients with lung cancer have poorer outcomes than non-Medicaid patients, partly because of suboptimal care quality. The Association of Community Cancer Centers (ACCC) launched a project to develop, test, and refine an OCCM. Methods: The OCCM comprised 13 areas, spanning care access to supportive care/survivorship. Using the OCCM, 7 cancer programs in 6 US states conducted self-assessments of care delivery systems and implemented quality improvement projects. Sites worked with ACCC to conduct data benchmarked projects. Data collection and analysis were centralized. Statistical analyses used Kruskal−Wallis and chi-squared tests. Results: There were 926 patients (257 Medicaid/dual eligible; 669 non-Medicaid) across 7 sites. Medicaid/dual eligible patients were 52% male, 69% Caucasian, 48% active smokers, and 45% clinical stage III/IV. Prospective multidisciplinary case planning (PMCP), patient care access, and tobacco cessation were commonly selected for projects. PMCP evaluation used fortnightly tumor board (FTB), virtual tumor board (VTB), and multidisciplinary team huddle (MTH). Presentation of eligible patients was higher for VTB and MTH (FTB: 23%, VTB: 100%, MTH: 100%, p < 0.0001). While FTB and MTH discussed all cases prospectively, VTB achieved 80%. Median days (d) from diagnosis to presentation were 18 (FTB), 14 (VTB), and 9 (MTH, p = 0.14). Patient care access was evaluated with timeliness metrics at 2 sites. Site 1: Medicaid patients had a median of 13 d from lesion discovery to diagnosis and 21 d from diagnosis to treatment (not different from non-Medicaid; p = 0.96 and 0.38). 94% met the goal of treatment initiation within 45 d. Site 2: Medicaid patients had a median of 16 d from discovery to diagnosis and 27 d from diagnosis to treatment (not different from non-Medicaid; p = 0.68 and 0.83). Similar benchmarks were collected and compared for other assessment areas. Sites identified enhanced collaboration and improved programming (e.g., patient navigation) as successes. Challenges at project start included inadequate staffing and lack of centralized data collection and benchmarking. Importance of lung cancer–dedicated navigation, PMCP, and Medicaid patient needs were key transferable lessons. Conclusions: The OCCM is useful for cancer programs’ self-assessment of care delivery to Medicaid patients across 13 high-impact areas. Dissemination can advance multidisciplinary coordinated care delivery, but sites may need additional resources to evaluate outcomes.
Disparities in utilization of oral anticancer agents and related costs in elderly patients with metastatic renal cell carcinoma in the United States.
Authors: Wilson Lauren E , Spees Lisa , Pritchard Jessica , Greiner Melissa A. , Scales Charles D. , Baggett Chris , Kaye Deborah , George Daniel J. , Zhang Tian , Wheeler Stephanie B. , Dinan Michaela Ann
Published: October 2020

106

Background: Although survival among patients with metastatic renal cell carcinoma (mRCC) has improved with the introduction of targeted therapies, substantial disparities in mRCC survival persist. The purpose of this study was to identify patient characteristics associated with differential adoption of emerging oral anticancer agents (OAAs) and related costs in the management of mRCC. Methods: SEER-Medicare patients diagnosed with mRCC aged 65 years or older from 2007-2015 continuously enrolled in Medicare Part D benefits for at least 1 year after diagnosis or until death were included. Associations between patient-level characteristics and OAA receipt were analyzed using univariable and multivariable log-binomal regression; associations between patient characteristics, OAA receipt, and total, cancer-specific, and OAA-specific costs in the 12 months following diagnosis were modeled as relative cost ratios using generalized linear regression with a gamma link. Reported costs were adjusted to 2015 dollars. Results: 2,792 patients with mRCC met inclusion criteria; 32.4% received an OAA in the 12 months following diagnosis. The majority of patients receiving an OAA used either sunitinib or pazopanib. Receipt increased slightly over the study period from 2007 (31% of patients) to 2015 (37%). In multivariable-adjusted models, patients of advanced age ( > 80 years RR 0.50; 95% CI 0.42-0.60) or residing in the Southern US (RR 0.83 95% CI 0.70-0.98) were less likely to receive OAAs. Married patients were 20% more likely (RR 1.19; 95% CI 1.04-1.37) to receive OAAs. After multivariable adjustment, receipt of OAAs was associated with higher total and cancer-specific costs, as was Hispanic ethnicity. Among patients receiving an OAA, the cost of OAAs to Medicare increased approximately 7% per year (95% CI 4%-9%), while patient out-of-pocket spending for OAAs decreased approximately 10% per year (95% CI 7%-14%). Out-of-pocket OAA costs were consistently lower for Black, Hispanic, and Other patient race/ethnicity categories compared to the White Non-Hispanic category. Conclusions: Patient characteristics including age at metastatic diagnosis, marital status, geographic region, and certain comorbidities are related to the likelihood of receiving OAAs. Future research is warranted to investigate if such differences in OAA use lead to differences in survival.
Effect of rurality and neighborhood disadvantage on clinical trial interest and decision-making style in patients with cancer living in the Deep South.
Authors: Caston Nicole , Williams Courtney , Ye Star , Pywell Cameron , Ingram Stacey A. , Yu Elaine , Aswani Monica S. , Azuero Andres , Rocque Gabrielle Betty
Published: October 2020

110

Background: Patients living in rural or disadvantaged settings are historically underrepresented in clinical trials. This study sought to understand associations between neighborhood characteristics and both interest in clinical trial participation and decision-making style preference. Methods: This cross-sectional study used patient-reported outcome data from patients with cancer treated at the University of Alabama at Birmingham from January 2017 to May 2019. Rural-Urban Commuting Area Codes (RUCA) scores were used to determine rurality of patient residence. Area Deprivation Index (ADI) values (range 0-100) were used to identify patients living in the most disadvantaged (top 15%) census block groups. The Control Preferences Scale captured decision-making preference. Likelihood of interest in clinical trial participation by rurality and neighborhood disadvantage was estimated using risk ratios (RR) and 95% confidence intervals (CI) from modified Poisson regression models. Multinomial regression was used to calculate RRs and 95% CIs estimating likelihood of preferred decision-making style by rurality and neighborhood disadvantage. Models were adjusted for age, sex, race, cancer type, cancer stage, ECOG performance status, and phase of care. Results: Of 1005 patients with cancer, mean age was 67 (SD 11), 68% were female, and 74% white. Gynecologic cancer (32%) was the most prevalent diagnosis, followed by hematologic (20%) and breast (15%) cancer. Of this sample, 16% of patients lived in a rural setting and 18% lived in a disadvantaged neighborhood. Interest in clinical trial participation was no different for patients living in rural vs. urban (RR 0.93, 95% CI 0.73-1.17) or disadvantaged vs. non-disadvantaged neighborhoods (RR 0.88, 95% CI 0.69-1.13). Patients living in rural vs. urban settings trended toward increased likelihood of preferring physician- to patient-driven decision-making (RR 1.67, 95% CI 0.95-2.94). Patients living in disadvantaged vs. non-disadvantaged neighborhoods trended toward increased likelihood of preferring physician- to patient-driven decision-making (RR 1.39, 95% CI 0.82-2.35). Conclusions: Though clinical trial participation interest was similar, patients with cancer living in rural vs. urban settings trended toward increased likelihood of preferring physician- vs. patient-driven decision-making. Opportunities exist for providers to engage historically underrepresented patients for trial participation.
Effect of hospital volume on outcome of stage IV pancreatic cancer.
Authors: Goksu Suleyman Yasin , Ozer Muhammet , Bacik Goksu Busra N , Kazmi Syed Mohammad Ali , Sanford Nina Niu , Hsieh David , Sanjeevaiah Aravind , Khosama Leticia , Aguilera Todd Anthony , Beg Muhammad Shaalan
Published: October 2020

123

Background: The effect of hospital volume on the outcome of stage 4 pancreatic cancer is not well known. We evaluated the effect of hospital volume on time to treatment and survival in patients with stage 4 pancreatic adenocarcinoma (PDAC). Methods: We used the National Cancer Database, including 1,319 hospitals to identify the study population. Adult (≥ 18 years) patients with stage 4 PDAC were included. We excluded the patients who had other histologies, unknown follow-up, and survival of less than 30 days. We categorized the hospital volume as three groups: low- (<25th centile), medium- (25th–75th centile), and high-volume hospitals (HVH) (>75th centile). Time from diagnosis to chemotherapy initiation was classified as early (≤ 6 weeks) or late (> 6 weeks). Kaplan-Meier and Cox regression methods were used to evaluate the overall survival (OS) between HVH and low-volume hospital (LVH) groups. Results: Among 72,531 patients with stage 4 PDAC; 65% received chemotherapy. Patients treated at HVH had higher rates of chemotherapy ( 73% vs. 60%, p<.001), and late chemotherapy initiation ( 27% vs. 20%, p<.001) compared to LVH. Patients at HVH were more likely to be younger, have less comorbidity score, private insurance, treated at the academic center, and need to travel more than 50 miles (all p<.001). Patients treated at HVH had better OS than LVH (6 vs. 4 months, p<.001). In multivariable analysis, HVH was independently associated with better OS versus LVH ( HR 0.79 [0.72-0.87]). In addition, HVH was associated with better OS in patients who received chemotherapy ( HR 0.78 [0.69-0.88]), while early treatment initiation, age, black race, uninsured status was not. Conclusions: Treatment at an HVH is independently associated with improved survival among patients with stage 4 PDAC. Patients seen at HVH had a higher rate of chemotherapy administration but a longer time to treatment initiation. [Table: see text]
Early-onset colorectal cancer in younger patients: A population-based study.
Authors: Huang Hu , Wang Suwei , Scheufele Elisabeth , Dankwa-Mullan Irene , Jackson Gretchen Purcell , Arriaga Yull Edwin
Published: October 2020

124

Background: In the US, the incidence of colorectal cancer (CRC) is increasing in patients younger than 50 years who may present with advanced stage, high grade, left-sided colon or rectal cancers with signet ring cell histopathology, aggressive clinical course, and reduced overall survival. Understanding the characteristics of this population could inform screening, early detection, and optimal treatment. In this study, we describe the attributes of adults who are 50 years and younger with a first diagnosis of CRC and ascertain molecular testing rates and time to surgery by using data from a commercially insured cohort in the U.S. Methods: This retrospective study of patients ages 50 and younger with a first diagnosis of CRC utilizes the IBM MarketScan database, and focuses on claims from January 2013 to December 2018. Included patients had continuous insurance enrollment of 12 months before and 6 months after diagnosis. We determined rates of tumor testing for microsatellite instability (MSI) or immunohistochemistry (IHC) for mismatch repair (MMR) proteins and referral to genetic services in all patients, as well as mutational analysis of KRAS, NRAS, and BRAF in metastatic CRC patients. Time to surgical resection of primary tumor (TTS) in non-metastatic colon cancer patients was measured. Results: During the 5-year period, 10,577 patients ages 18 to 50 years had a first diagnosis of CRC, which was 15.6% of the 67,921 adults of all ages with CRC. Claims for MSI or IHC for MMR proteins within 120 days of initial diagnosis were done in 4,429 (41.9%) patients and referral to genetics services/counseling within 1 year of initial diagnosis were done in 443 (4.1%) patients. Among metastatic CRC patients, KRAS, NRAS, or BRAF tumor mutational analyses within 120 days of initial diagnosis were documented in 323 (31.5%). The median TTS ranged from 7 to 15 days with no statistically significant differences based on geographic region or health insurance plan type. Conclusions: Younger patients with early onset CRC had low rates of referral to genetics services, tumor MSI or IHC for MMR proteins testing, and KRAS, NRAS, and BRAF mutational analysis. There were no geographic or insurance type trends in TTS in non-metastatic colon cancer patients. Although underreporting is possible in our study, the findings of low utilization of genetic services and tumor genomic testing in these younger patients with early onset CRC should alert the oncology community to critical management gaps in the care of this population.
Trends in obesity among patients registered to SWOG cancer clinical treatment trials.
Authors: Vaidya Riha , Till Cathee , Greenlee Heather , Hershman Dawn L. , Unger Joseph M.
Published: October 2020

126

Background: Rising obesity rates have been documented in the United States population since the 1980s. Several studies have shown links between obesity and the incidence of – and the outcomes of – specific cancer types. Few studies have examined the prevalence of obesity among cancer patients at the time of diagnosis or among those who participate in clinical trials. We examined the prevalence of obesity over a 35-year period among patients enrolled in clinical treatment trials conducted by the SWOG Cancer Research Network. Methods: We analyzed body mass index (BMI) at registration among patients enrolled in phase II or III clinical trials conducted by SWOG. Adult patients (age≥18) participating in trials in obesity-related cancers between 1985 and 2020 were included. Obesity was classified as BMI ≥ 30 kg/m2. Multivariable logistic regression was used to examine time trends, adjusting for age, sex, race, and treatment type. Time was defined as year of enrollment and examined in separate models as continuous years and as 5-year intervals. We examined trends among patient subgroups by sex and by treatment type (chemotherapy, immunotherapy, and targeted therapy). Results: 16,374 patients enrolled in SWOG clinical trials conducted between 1985 and 2020 were analyzed. Patients were most commonly enrolled in trials for breast cancer (n = 6,327, 38.6%), colon cancer (n = 2,408, 14.7%), multiple myeloma (n = 2,112, 12.9%), and rectal cancer (n = 1,785, 10.9%). Overall, 32% of patients were obese (n = 5,252). Unadjusted obesity rates among trial participants increased from 18% in 1985-1990 to 42% in 2016-2020, compared to an increase from 23% to 42% among US adults over a similar period. Obesity prevalence rates increased over time for all sex, age, and race subgroups. Overall, there was an increasing linear trend in obesity (OR = 1.36 for each 5-year increase, 95% CI: 1.33-1.39, p < .0001). These trends persisted with adjustments for age, sex, race, and treatment type (OR = 1.35 per 5-year increase, 95% CI: 1.31-1.39, p < .0001). Positive linear trends in obesity prevalence were observed for all subgroups by sex and treatment type. There was no evidence of difference in trends between males and females or between the three treatment types. Conclusions: We observed an increasing trend in obesity among patients participating in clinical trials for obesity-related cancers, mirroring US adult obesity rates. Our findings indicate good representation of obese patients in clinical treatment trials, which has favorable implications for the applicability of trial findings to this group of patients.
Treatment sequence, hospital practice patterns, and completion of multimodality therapy for locally advanced gastric cancer.
Authors: Portuondo Jorge Ignacio , Tran Cao Hop Sanderson , Massarweh Nader Nabile
Published: October 2020

14

Background: Optimal oncologic care for patients with locally advanced gastric cancer includes multimodality therapy (MMT). While both perioperative chemotherapy and postoperative chemoradiotherapy are recommended, it is unclear whether one approach is more effective for ensuring patients complete MMT. Methods: National cohort study of 5,450 patients with locally advanced gastric cancer (i.e.: ≥cT2 and/or cN+) treated at 983 hospitals within the National Cancer Data Base (2006-15). Patients were categorized as having surgery first or chemotherapy first (patients not undergoing resection after chemotherapy or not receiving adjuvant after surgery were included based on intent-to-treat). MMT was defined as surgical resection with either neoadjuvant chemotherapy or adjuvant chemoradiotherapy. Hospitals were categorized into terciles based on utilization of chemotherapy first: 1.) predominantly chemotherapy first; 2.) mixed pattern; 2.) predominantly surgery first. The association between patient-level treatment, hospital practice pattern, and MMT completion was evaluated using multivariable hierarchical regression and the association with overall risk of death using multivariable Cox shared frailty modeling. Results: Overall, 55.5% of surgery first and 64.8% of chemotherapy first patients completed MMT (p<0.001) and five-year survival for those completing MMT was 45.5% and 46.6%, respectively (log-rank, p=0.91). At the patient-level, chemotherapy first was significantly associated with MMT completion (Odds Ratio [OR] 1.61 [1.39– 1.86]). By comparison, relative to mixed hospitals, care at surgery first hospitals was associated with MMT completion (OR 1.32 [1.08 – 1.59]), which was due to differences in case-mix and the proportion of patients not receiving resection after chemotherapy (surgery first hospitals—4.1%; mixed hospitals—19.0%; chemotherapy first hospitals—29.4%, p<0.001). MMT by either approach was associated with lower risk of death (ref—surgery only; chemotherapy first – Hazard Ratio [HR] 0.77 [0.68 – 0.86]; surgery first – HR 0.77 [0.68 – 0.87]) while hospital practice pattern was not. Conclusions: The type of MMT strategy is less important than ensuring patients complete MMT. After accounting for treatment drop-outs (which are substantial with either strategy), chemotherapy first appears more effective in the general community for ensuring patients complete MMT. National guidelines should be modified to emphasize neoadjuvant over surgery first MMT strategies.
The impact of within-visit and pre-visit decision aids for localized prostate cancer on patient knowledge.
Authors: Tilburt Jon Charles , Pacyna Joel E , Cina Kristin , Petereit Daniel G. , Kaur Judith Salmon , Storrrick Elizabeth M. , Zahrieh David , Dueck Amylou C. , Kim Simon P.
Published: October 2020

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Background: Decision aids (DAs) for prostate cancer treatment can improve knowledge and reduce decisional conflict, but the relative effect of pre-visit and within-visit DAs is not known, and effect sizes for minority populations has not been estimated. Methods: We conducted a 3-arm, patient-level-RCT in specialty urology and radiation oncology practices in Ohio, South Dakota, and Alaska, test the effect of pre-consultation and with-in consultation decision aids on patient knowledge immediately after specialty consultation compared to usual care. We used linear regression to estimate effects of each intervention arm, including the respective standard error, two-sided 95% confidence interval, and two-sided P value for testing the study’s hypotheses. Results: 103 patients were recruited and randomized to receive either the pre-visit decision aid, within-visit decision aid, or neither decision aids (usual care). In 2017 and 20018, we accrued similar numbers of men to pre-consultation aid (n = 37), during-consultation aid (n = 33) and usual care arms, respectively (n = 33). The median (range) age in years was 64 [49, 81]; 67.6% were White, 15.7% were Black or African American, 16.7% were American Indian or Alaska Native, and 1% were not reported. 47.6%, 45.6%, and 6.8% had a baseline clinical stage of T1, T2, and T3, respectively. The median [range] prostate specific antigen (PSA) was 8.0 [2.4, 53.7]. There were no clinically notable imbalances. We obtained usable data on 102 of the 103 patient-participants. The pre-visit decision aid arm showed a mean knowledge effect of 0.694 (0.636, 0.753). The within-visit decision arm showed a very similar mean knowledge effect of 0.686 (0.625, 0.748). The usual care arm showed a mean knowledge effect of 0.644 (0.582,0.705). The linear regression model showed, that, compared with usual care, neither intervention effect achieved statistical significance in the primary analysis (p = 0.24, 0.330, for pre-visit and within-visit, respectively). Conclusions: Modest knowledge gains of pre-visit and during-visit decision aids for prostate cancer treatment were not statistically significant. Clinical trial information: NCT03182998 .
Patient-reported outcomes in routine oncology care: Perceptions, execution, and barriers.
Authors: Gajra Ajeet , Jeune-Smith Yolaine , Yeh Ting-Chun , Fortier Stephanie , Feinberg Bruce A.
Published: October 2020

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Background: There has been an increased emphasis on patient-reported outcomes (PROs) in recent oncology trials, and the benefits of incorporating PRO assessments during routine care have been established. The aim of the present study was to assess the perceptions, adoption and barriers to implementation of PROs in community practices during routine care. Methods: A live meeting in September 2019 surveyed US-based community oncology health care providers (HCPs), including medical oncologists/hematologists and advanced practice providers (APPs; defined as nurse practitioners and physician assistants) regarding their perceptions of PROs and their adoption of PROs during routine patient care. Participants completed both a web-based premeeting survey and live queries captured via audience response system. Data were summarized using descriptive statistics. Results: 71 HCPs (51 medical oncologists/hematologists and 20 APPs) participated. HCPs described their practices as: urban 50%, suburban 37%, and rural 13%. Over 80% reported having collected PRO data from their patients. Over 90% indicated that PROs are important to guide their treatment of patients, irrespective of the data sources (clinical studies or in real-world). Commonly collected PRO data included disease symptoms (66%), activities of daily living (62%), physical function (61%) and adverse events (59%). The NCCN Distress Thermometer (41%) was reported as the most common PRO instrument used during routine oncology care (Table). Despite understanding the importance of implementing PROs, 54% indicated that more resources (software and incentive systems) are needed, and 53% said that discussing PRO results with each patient is critical to facilitate the collection and utilization of PRO data. 84% were unaware of results of a seminal study which demonstrated that PROs improve quality of life and survival (Basch et al 2016, 2017). Conclusions: Most of the community oncology providers surveyed collected PRO data and acknowledged its value. However, more resources are needed to increase collection and use of PROs during routine care. Education directed towards community oncology providers is needed to highlight the value that PROs can add in cancer care. [Table: see text]
Stakeholder feedback at four ePRO-naïve healthcare institutions about the need, effectiveness, and barriers to usage of a fully EHR-integrated ePRO tool.
Authors: Schrag Deborah , Osarogiagbon Raymond U. , Wong Sandra L. , Hazard Hannah , Bian Jessica J , Dizon Don S. , Cronin Christine , Hassett Michael J. ,   eSyM Project Managers
Published: October 2020

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Background: Collecting patient-reported outcomes (PROs) is a proven method to enhance doctor-patient communication and care. With the influx of technology and usage of telehealth services, electronic PROs (ePROS) have become the mainstay for ascertaining how a patient is doing at home. Collection of ePROs is particularly valuable for providers caring for rural and vulnerable populations with limited access to high quality care. A fully EHR-integrated ePRO collection system could help bridge the gap. Methods: To inform the design, function, and deployment of a new EHR-integrated ePRO symptom management system, focus groups with stakeholders were conducted at four institutions caring for largely rural-based populations (Baptist Cancer Center, West Virginia University Cancer Institute, Dartmouth-Hitchcock Medical Center, Maine Medical Center). Sessions were conducted 2 to 3 months prior to the launch of a new ePRO platform and included oncologists, surgeons, practice nurses, tech analysts, operations staff, and institutional leadership. Each group included a 30-minute overview of the new tool followed by a 30-minute discussion with qualitative open-ended questions and clicker-enabled multiple-choice questions. Developed questions utilized the CFIR and RE-AIM implementation frameworks. Results: In total, 134 stakeholders participated from the four institutions. RNs made up nearly half of respondents (47%). 97% of participants felt a new ePRO system would complement existing healthcare initiatives and 64% felt it would be extremely effective/very effective in improving symptom management. Each group was asked to rate the barriers to patient usage of an ePRO system in the home-care setting. Computer literacy (51%) and access to an internet-enabled device (48%) ranked as the highest barriers. Other barriers perceived to be of less significance included privacy, distrust, and limited English-language proficiency. Consequently, two-thirds of respondents felt patients would only be somewhat likely/not so likely to use an ePRO system; one-third felt patients would be likely/extremely likely to utilize the system. Conclusions: From the perspective of stakeholders at four engaged institutions, an integrated ePRO tool is considered a widely acceptable symptom management solution, but uncertainty remains around patient acceptance and uptake. Future research will include post-implementation discussions with stakeholders and evaluation of patient utilization and clinical outcomes.
Results of a pilot study to increase adherence to ASCO G-CSF recommendations at community clinics.
Authors: Kreizenbeck Karma L. , Egan Kathryn , Wong Tracy , Jagels Barbara , Jensen Barbara , Smith Julie C. , Irwin Blair Billings , Noble Heather , Ramsey Scott David
Published: October 2020

19

Background: An ASCO 2012 Choosing Wisely recommendation cautions against the use of primary prophylactic colony stimulating factors (PP-CSF) for chemotherapy regimens with <20% risk of febrile neutropenia (FN). Our pilot aimed to test the feasibility and impact of using academic detailing and an automated CSF ordering system on CSF prescribing at 6 regional community oncology clinics in Washington State. Methods: The intervention was 1) academic detailing for oncologists during a regular staff meeting and 2) reconfiguring ordering systems to show FN risk and PP-CSF recommendation in a passive alert and include or exclude PP-CSF standing orders with >20% or ≤20% FN risk regimens, respectively. Clinic tumor registries were queried for patients with stage II-IV breast, non-small cell lung, or colorectal cancer starting first-line chemotherapy pre- or post-intervention. PP-CSF use, FN risk factors, and chemotherapy regimens matching the study protocol were manually abstracted. A regimen order was coded as adherent if it is low (<10%) FN risk without PP-CSF use; intermediate (10-20%) FN risk without PP-CSF use or FN risk factors are present; or high (>20%) FN risk with PP-CSF use. Results: The intervention was successfully implemented at 4 out of 6 participating clinics. The remaining 2 clinics were transitioning from paper to electronic orders in 1-2 years or using a system managed by a non-participating hospital. Adherence across the four implementing clinics increased after the intervention. *=p<0.05 Implementation of the CSF order-entry intervention was successful across a variety of ordering systems, including paper-based systems. Overall, while adherence prior to the intervention was high for these clinics, the order entry systems significantly improved adherence. Population characteristics and data availability may account for variation in adherence. Conclusions: An intervention with both academic detailing and ordering system presets may help increase adherence to Choosing Wisely recommendations. [Table: see text]