bluuebunny/crossref_metadata_2025_split huggingface dataset:
Treatment evaluation of acute stroke for using in regenerative cell elements (TREASURE) trial: Rationale and design
Authors: Osanai Toshiya , Houkin Kiyohiro , Uchiyama Shinichiro , Minematsu Kazuo , Taguchi Akihiko , Terasaka Shunsuke 
Published: November 2017

Rationale MultiStem® (HLM051) is one of the promising allogenic cell products for acute ischemic stroke with strong evidence. A previous phase 2 randomized, double-blind, placebo-controlled, multicenter dose-escalation trial showed the safety of MultiStem® for acute ischemic stroke, with a time window beyond that of rt-PA and endovascular thrombectomy. We aim to obtain stronger evidence and to show the efficacy of the MultiStem® for treatment of ischemic stroke. Sample size Estimated sample size is 220 (110 patients per group), which has 90% power at 5% significance level. Methods and design TREASURE is a randomized, double-blind, placebo-controlled, multicenter phase 2/3 trial. The trial will be done at 31 medical centers in Japan. Patients with acute ischemic stroke including motor or speech deficit defined by a National Institution of Health Stroke Scale (NIHSS) score of 8–20 at baseline will be randomized 1:1 to receive a single intravenous infusion of MultiStem® or placebo within 18–36 h of stroke onset. Study outcomes Primary outcome in this study is the proportion of patients with an excellent outcome at day 90 defined by the functional assessment. Trial registration ClinicalTrials.gov (NCT02961504). Conclusion The TREASURE trial will provide a novel treatment option and expand the therapeutic window for patients with stroke if the results are positive.
Pediatric sleep and autonomic complaints
Authors: Gundrum Kaitlyn , Chelimsky Thomas C , Norins Nan A , Simpson Pippa , Nugent Melodee , Chelimsky Gisela 
Published: November 2017

Objectives: Little is known about the relationship between autonomic dysfunction and sleep disturbances. This study aimed to identify patterns of sleep disturbances and autonomic dysfunction in children. Methods: A retrospective chart review of 14 children who underwent sleep and autonomic testing was performed. Subjects were divided into three groups based on sudomotor Composite Autonomic Severity Score Scale score and postural tachycardia syndrome criteria. Sleep quality, sleep architecture, and number of comorbidities were analyzed. Results: There were no statistically significant differences between groups in measures of sleep quality, sleep architecture, and number of comorbidities. Conclusion: Patients with postural tachycardia syndrome and autonomic dysfunction experience multiple sleep-related complaints. The low power of our study did not allow firm conclusions, but there is no pattern to these abnormalities.
Juvenile Osteochondritis Dissecans of the Knee: Does Magnetic Resonance Imaging Instability Correlate With the Need for Surgical Intervention?
Authors: Haeri Hendy Simon , de SA Darren , Ainsworth Kelly , Ayeni Olufemi R. , Simunovic Nicole , Peterson Devin 
Published: November 2017

Background: Several magnetic resonance imaging (MRI) classification systems have been developed to determine the degree of instability of juvenile osteochondritis dissecans (JOCD) lesions. Our current practice involves correlating the patients’ symptoms with their MRI findings, but there are many cases in which this correlation is poor and results in incorrect classification of the stability of a JOCD lesion. Purpose: To determine whether certain MRI findings of JOCD instability are associated with the necessity for arthroscopic intervention to assess lesion stability. A secondary objective was to determine the interobserver agreement of the Kijowski et al (2008) MRI criteria for osteochondritis dissecans (OCD) instability. Study Design: Case series; Level of evidence, 4. Methods: A retrospective review was performed of patients who had documented femoral condyle OCD lesions, had open growth plates, and had been evaluated with serial MRI examinations. Each OCD lesion on MRI was classified according to the Kijowski classification as either stable or likely unstable. Results: The study included 16 patients (17 knees) with 49 MRI examinations. The initial MRI lesion was graded as stable in 59% (10/17), and 7 of these remained stable throughout the study period, with only 1 requiring operative intervention. Two became unstable on MRI, with 1 requiring surgery and 1 reverting back to stable with nonoperative management. The initial MRI lesion was graded as unstable in 41% (7/17) of the knees, with 2 of these becoming stable on MRI during the follow-up period with nonoperative management. The other 5 lesions remained unstable, with 3 eventually requiring surgery. The most important finding in this study was that MRI instability is a poor predictor of the necessity for surgery for JOCD lesions. The correlation between a nonradiologist and a trained musculoskeletal radiologist in the interpretation of the MRI criteria by Kijowski et al showed only substantial agreement for multiple cysts. Conclusion: MRI criteria for OCD instability in the pediatric knee do not always correlate with the necessity for surgery. They are, at times, a helpful adjunct to the management of these patients; however, care must be taken to interpret all available clinical and radiographic information in surgical decision making.
Need for nutritional support in advanced cancer patients with cachexia: A survey in palliative care settings.
Authors: Amano Koji , Morita Tatsuya , Miyamoto Jiro , Uno Teruaki , Katayama Hirofumi , Tatara Ryohei 
Published: November 2017

100 Background: Few studies have investigated the need for nutritional support in advanced cancer patients in palliative care settings.The aim of this survey is to examine the relationship between the need for nutritional support and cancer cachexia, specific needs, perceptions, and beliefs. Methods: We conducted a questionnaire in outpatient service/palliative care teams/palliative care units. Patients were classified into two groups: 1) Non-cachexia/Pre-cachexia and 2) Cachexia/Refractory cachexia. Results: A total of 117 out of 121 patients responded (96.7%). A significant difference was observed in the need for nutritional support between the groups: Non-cachexia/Pre-cachexia (32.7%) and Cachexia/Refractory cachexia (53.6%) (p = 0.031). The specific needs of patients requiring nutritional support were nutritional counseling (93.8%), ideas to improve food intake (87.5%), oral nutritional supplements (83.0%), parenteral nutrition and hydration (77.1%), and tube feeding (22.9%). The top perceptions regarding the best time to receive nutritional support and the best medical staff to provide nutritional support were “when anorexia, weight loss, and muscle weakness become apparent” (48.6%) and “nutritional support team” (67.3%), respectively. The top three beliefs of nutritional treatments were “I do not wish to receive tube feeding” (78.6%), “parenteral nutrition and hydration are essential” (60.7%), and “parenteral hydration is essential” (59.6%). Conclusions: Patients with cancer cachexia had a greater need for nutritional support. Advanced cancer patients wished to receive nutritional support from medical staff with specific knowledge when they become unable to take sufficient nourishment orally and the negative impact of cachexia becomes apparent. Additionally, most patients wished to receive parenteral nutrition and hydration.
Disparity in use of supportive resources in elderly patients on chemotherapy for gastrointestinal malignancies: A single institution analysis.
Authors: Joshi Prashant J. , Matin Khalid , Sima Adam 
Published: November 2017

102 Background: Chemotherapy has clinical benefit for elderly patients with careful selection. Selection is based on ECOG Performance Status determination. Patients with ECOG PS of 0-2 are considered chemotherapy candidates whereas patients with PS > 3 are considered unlikely to benefit from it. Recommended tools such as a Comprehensive Geriatric Assessment (CGA) to help stratify patients further are not widely adopted. This study looks at disparity in use of supportive resources in patients > 65 years of age undergoing chemotherapy at the Virginia Commonwealth University (VCU) Hospital. Methods: We conducted a retrospective analysis for all patients 65 and above with gastrointestinal malignancies (gastroesophageal, colorectal, and pancreatic) treated between January 2005 and July 2016 that received chemotherapy in any setting. ECOG performance status at initiation of therapy was required. Data collected on receipt of supportive resources such as Physical Therapy (PT), Occupational Therapy (OT), Nutrition, Mental Health, Geriatrics and Palliative Care. Exact Pearson’s chi-square tests were used for comparison of services and ECOG PS, race, etc. Results: 226 patients met criteria. Majority of patients were male (56%), white (63%) and had advanced malignancies (80% Stage III/IV disease). Mean age was 72.2 (SD = 5.6). ECOG PS was ≤1 in 88% and ≥2 in the remainder. 61% of patients utilized at least one resource (Palliative care: 46%, Nutrition: 21%, Mental Health: 15%, PT: 13%). Patients with an ECOG PS 0 or 1 tended to use more services; nutrition statistically significant (p = 0.037). Racial disparities observed in receipt of PT (P = 0.002), mental health (P = 0.012), palliative care (P = 0.039) with white patients more likely to receive the service in each case. More white than non-white patients received services (66% vs. 55%, P = 0.067). Conclusions: ECOG PS 0 or 1 correlated with increased utilization as compared to less robust ECOG 2 patients; tools such as CGA for appropriate service allocation are needed. We identified racial disparity in the utilization of certain services and these need further exploration, including patters for referral of these services as a factor.
African American perceptions of early palliative care in oncology.
Authors: Pirl William F. , Saez-Flores Estefany , Arana Neysari , Greer Joseph , El-Jawahri Areej , Temel Jennifer S. , Erin Kobetz 
Published: November 2017

104 Background: While ASCO guidelines recommend early palliative care (PC) for patients with metastatic cancer, few African Americans (AA) have participated in PC trials and little data exist on the acceptability and effect of early PC in this population. Using the ADAPT-ITT framework for culturally tailoring evidence-based interventions, we assessed perceptions of PC and its early introduction in oncology in AAs. Methods: We conducted four focus groups with AAs from community centers in Miami. We enrolled adults without a history of cancer to approximate the knowledge and beliefs of someone with newly diagnosed cancer. Focus groups explored knowledge of PC, value of different components of early PC, and perceptions about introducing PC early after cancer diagnosis. We recorded and transcribed the focus groups, performing thematic analysis with NVivo. Results: Thirty-seven AAs participated. Over half were female (24/37), and median age was 54 years old (range 35-71). Participants had little to no knowledge of PC. Lack of familiarity was attributed to AAs receiving sub-standard care and the belief that PC has been kept from AAs. Rather than being concerned that it might result in less cancer treatment, they reported that PC was actually part of doing everything possible for cancer, and it is the “best care.” PC was viewed as a solution to a major theme of doctors not providing adequate information for patients and families to prepare for negative outcomes such as death. However, some objected to discussing specific survival estimates for fear of speaking them into existence. Distinctions were drawn between what doctors manage (treatments) and what God manages (life/death). Participants could not understand why PC would be reserved for later in the course of illness instead of immediately after cancer diagnosis (“Don’t wait until I’m dying; give it to me now!”). PC was described as “supervising your needs and making sure they are addressed.” Conclusions: AAs were enthusiastic about early PC in oncology, but did not support providing specific estimates of survival. End-of-life planning was considered by some to be spiritual and not medical.
Implementation of group visits to improve outpatient oncology advance care planning.
Authors: Lowry Sarah , Lum Hillary , Izumi Seiko , Fromme Erik K 
Published: November 2017

11 Background: Oncology patients that participate in advance care planning (ACP) and complete advance directives (AD) are more likely to receive goal-concordant end of life care. The AD documentation rate within our academically-affiliated community outpatient oncology clinic is below national and institutional averages. A group medical visit effectively facilitated ACP in a geriatric primary care setting. This quality improvement project implemented a similar ACP conversation group (ACPCG) in an outpatient oncology setting. Methods: Adult patients in a community oncology clinic were contacted and invited to participate in ACPCG by a nurse practitioner who works in the clinic. Using a facilitation guide, the 2-session intervention included sharing past ACP experiences, identifying surrogate decision makers, starting conversations, and discussing surrogate flexibility. Recruitment, retention, and patient ACP outcomes were measured. Results: Seventy-six patients were successfully contacted and seventeen signed up (22% recruitment rate). Twelve patients participated in the first session, and five attended the second session (42% retention). Recruitment was time intensive, and several patients responded that ACP was not relevant to their situation. Six participants completed an AD prior to attending the first session (50%) but only one had an AD in their medical record. Two had surrogate decision makers documented prior to the intervention (16%). Participants reported the ACPCG as helpful in making the process less overwhelming. There was no increase in AD documentation rates within the medical record four weeks after the intervention, but the rate of surrogate documentation increased to seven (58%). Conclusions: Participants had higher than average rates of AD completion prior to the intervention but had not shared the document with their providers. While the ACPCG was well received by patients, implementation faced multiple challenges. More efficient recruitment methods and strategies to facilitate better patient understanding of ACP are needed.
Preliminary results of a randomized controlled trial of early integration of specialist palliative care within a tertiary cancer center in the Czech Republic.
Authors: Slama Ondrej , Pochop Lukas , Svetlakova Lucie , Bilek Ondrej , Sedo Jiri , Horova Renata , Demlova Regina , Vyzula Rostislav 
Published: November 2017

113 Background: Clinical trials in the U.S. and Canada have shown the benefit for patients and the health care system of early integration of palliative care into oncological practice. Nevertheless the practical realisation and the timing of this integration may be controversial. The optimal model of specialist palliative care (SPC) involvement may depend on the quality of standard cancer care in the given country. Methods: We present preliminary results of a randomised controlled trial of early integration of SPC conducted in the largest tertiary cancer center in Czech Republic. The trial compares standard oncology care with integrated SPC to standard oncology care alone in patients with advanced solid tumors treated with palliative antineoplastic therapy. The design of the study is inspired by the study of early PC for patients with advanced NSCLC byTemel et al. (2010). The SPC intervention consists of consultations with palliative care team every 6 weeks. Outcomes assessed at baseline and at 3 and 6 months after enrollment are quality of life (EORTC-QoL-Q30), anxiety and depression (HADS) and structure and cost of end of life care. Results: 100 patients have been randomisd between September 2015 and January 2017 (integrated PC 51 pts, conotrole 49pts). There were differences at 3 and 6 months in QoL (66% vs. 55%, p > 0,05; 63% vs. 49% p > 0,05), prevalence of anxiety (37% vs. 43%, p > 0,05; 32% vs. 54%, p > 0,05) and depression (19% vs. 29% p = 0,02; 20% vs. 27% p > 0,05) in intergated and control arm respectively. The mean time from the last chemotherapy to death was 66 days vs.52 days (p = 0,04) and the enrollment rate to hospice programme was 63% vs. 43% (p = 0,02) at the end of life in favour of integrated palliative care. Conclusions: There seem to be a trend for better results in patient reported outcomes and reasonable resource utilisation in favour of integrated care model in the context of advanced cancer care in Czech Republic. But differences between study arms did not reach statistical significance in patient reported outcomes, probably due to small number of patients. We hope to enrol enough patients within next 6 months to overcome this limitation.
Relevance of rapid geriatric assessment for elderly patients with newly diagnosed malignancy.
Authors: Mehta Hina Niranjan , Farhat Rania , Ravulapati Sravanthi , Tu Yifan 
Published: November 2017

115 Background: The elderly population is the fastest growing segment of the US population, and it is widely affected by cancer and its related sequelae. At St. Louis University (SLU), a simple Rapid Geriatric Assessment (RGA) was developed based on the SLU Mental Status Exam (SLUMS). The RGA includes screening for frailty, sarcopenia, nutrition, and cognition. In this pilot study, we used RGA to assess geriatric patients with newly diagnosed malignancy prior to cancer therapy and its ability to improve outcomes in oncology patients. Methods: Elderly patients (aged 65 and above) with newly diagnosed malignancy completed the RGA either inpatient or outpatient at SLU. A retrospective chart review was done to collect patient's demographics, type of malignancy, number of hospitalizations since diagnosis and referral to palliative care over a 6 month period. Relationship between tolerability and RGA subscores were assessed using general linear models, Kaplan-Meier survival analysis and Chi-square testing. Results: Twenty six patients (mean age 76 [65-90]) were included from December 2015 to 2016 of which 9 were male (n = 35) and 17 female (n = 65). 19 patients (73%) were inpatient, 7 (27%) were outpatient and 13 patients (50%) received chemotherapy. Using the Mann-Whitney U test, no significant difference was seen between RGA subscores (FRAIL p = 1; SNAQ p = 0.69; SARC-F p = 0.71; RCS p = 1) in patients receiving versus not receiving chemotherapy. There was no significant difference in overall survival (OS) over a 20 month period based on chemotherapy status (p = 0.39). In our study, 62% of patients (n = 16) were referred to palliative care and noted to have a significant better OS (p = 0.04). Conclusions: The RGA is a self-explanatory tool that can be used in geriatric oncology patients and it can bedone in 10 minutes. In this pilot study, we used this tool in a small number of patients. We plan to perform a prospective study to evaluate the RGA comparing to ECOG-performance status in geriatric patients prior to standard cancer therapies. Improvement of overall survival with incorporation of palliative care in oncology patients is reaffirmed in our study.
Barriers between providers and families regarding palliative care integration in a multidisciplinary pediatric oncology practice.
Authors: Draper Lauren , Pannier Samantha , Mann Karely , Fair Douglas Beaty , Perlman Holly , Moore Dominic , Kirchhoff Anne C. 
Published: November 2017

121 Background: Pediatric oncology patients are known to have high symptom burden. The pediatric oncology population is a natural fit for early integration of palliative care (PC), yet there are often systemic and communication barriers. We assessed oncologists and supportive care providers’ beliefs about PC and described how well prognosis is currently communicated between clinical team members and families. Methods: Primary Children’s Hospital (PCH) is the only pediatric tertiary care hospital serving the Mountain West region. We conducted surveys and semi-structured interviews with all pediatric oncologists at PCH (N = 12) and supportive care providers such as nurses and social workers (N = 13). Surveys were also administered to caregivers of patients (N = 23). Descriptive statistics were generated. Results: Oncologists and and supportive care providers differ even in their beliefs about who should receive PC and when it should begin. 41.7% (N = 5) of attending pediatric oncologists strongly agreed that their patients could benefit from a comprehensive PC consultation and that this should happen around the time of diagnosis. Of the supportive care providers only 15% (N = 2) strongly agree that their patients could benefit from a PC consultation, but 38% strongly agree it should begin at the time of diagnosis. Of the physicians, 33% (N = 4) believe the system currently in place is “adequate,” while only 8% (N = 1) of supportive care providers agree. Physicians report 100% of the time that they “often or always” discuss prognosis with a family, but only 44% (N = 10) of caregivers strongly agree that prognosis was clearly explained. 57% (N = 4) of patients report additional emotional support would have been helpful. Conclusions: Less than half of providers feel their patients could benefit from a PC consultation, despite the majority feeling the current system is inadequate. Also, providers and caregivers perceive discussions about prognosis, a key part of comprehensive PC, in different ways. Our findings demonstrate that a major barrier to the integration of a comprehensive PC program may be a lack of agreement among providers on the team and ineffective communication with families.