bluuebunny/crossref_metadata_2025_split huggingface dataset:
Multiple uses for a clinical research database
Authors: Greco A. O. , Licavoli C. M. , White L. A. , Eckardt J. R. , Easley K. O. , Sjak-Shie N. N. 
Published: March 2020

17037 Background: In Sept 2000, the research staff at The Center for Cancer Care and Research (TCCCR) developed an excel data base to track new consults referred to the practice. It is used to identify pts for participation in Cooperative Group Clinical Trials and to identify gaps in the active protocol list. Several additional uses for the data base have evolved. Methods: Medical records provided by referring physicians for each new consult are evaluated by a Research Coordinator. Information including the pt's name, date of visit, physician, referring physician, diagnosis, protocol for which the pt is evaluated, and eligibility information is entered in the data base. Results: The data base provides a method by which we can follow pts through the protocol selection and informed consent process. Early on, the data base identified a site need for trials in metastatic breast cancer prompting us to search other sources such as the CTSU and industry. Additionally, the percentage of new consults actually enrolled on a clinical trial can be determined as well as tracking eligibility/ineligibility trends. The Pharmaceutical Research Dept can use the information to complete feasibility studies prior to participating in industry trials. The data base can be used to evaluate trends in referral patterns and has helped identify referring physicians who support our research efforts. In 2006, TCCCR had a protocol available for 45% of new consults with a cancer dx. Of those pts, 16% enrolled on a Cooperative Group Clinical Trial. According to published evaluations, 16% is well above the national average of pts who participate in oncology clinical trials. It is our assessment that TCCCR's success is due in part to the data base. Conclusions: It is well known that in order to improve treatment outcomes and diminish treatment toxicity, oncology practices and pts must participate in clinical research. It is also well known that the numbers of pts who participate in oncology clinical trials is dismal. This data base has become a valuable tool providing a method to identify and evaluate some of the reasons why pts do not enroll in clinical trials and given our practice guidance to increase pt participation. Our next goal is to evaluate the differences between the rural and urban population at TCCCR's two sites to identify additional trends in clinical trial participation. No significant financial relationships to disclose.
Average length of stay in hospice for five types of cancer
Authors: Tanis D. , Kinzbrunner B. 
Published: March 2020

17038 Background: Factors which influence average length of stay (ALOS) for cancer patients who choose hospice include patient and family preferences, availability of hospice services, demographics, specialty and experience of referring physician, advances in treatment options, and type of cancer. In this paper, we examine trends in ALOS for the top five cancers in patients who utilized a large, national hospice provider between 2000 and 2006. Methods: We examined 61,457 patients with prostate, colorectal, breast, lung, or pancreatic cancer who were admitted to one of 40 hospice programs and died on service between 1/1/2000 and 11/30/2006. The top five cancers accounted for 58% of all cancer deaths in the Vitas programs. The effect of Type of Cancer and Year on ALOS was evaluated using analysis of variance. Pair-wise differences were compared using the Bonferroni correction. Results: Overall ALOS was 40.6 days. ALOS for prostate, colorectal, breast, lung and pancreas was 47.9, 45.6, 45.5, 37.8 and 31.7 days, respectively. Prostate, colorectal and breast ALOS were not significantly different from one other; lung ALOS was significantly less than the top three (p < .001); and pancreas ALOS was significantly lower than all others (p < .001). There was no evidence of yearly trends in ALOS for different cancers during the study period. Conclusions: ALOS for patients with one of the five leading cancers who elected hospice services prior to death has remained remarkably stable over the last seven years. This stability, combined with an overall ALOS of less than six weeks, suggests that much still needs to be done to maximize cancer patient utilization of hospice services. The somewhat longer ALOS for patients with prostate, colorectal and breast cancer may be related to differences in natural history and effectiveness of anti-neoplastic therapies when compared to cancers of the lung and pancreas. No significant financial relationships to disclose.
The relation between health systems coverage and clinical outcomes among women with newly diagnosed breast cancer in a region of southeast Brazil
Authors: Guerra M. R. , Bustamante-Teixeira M. T. , Cintra J. R. Duarte , Domenge C. , Mendonça G. A. , Passman L. J. 
Published: March 2020

17045 Background: Brazil is a continental size country with a population of 186 million. Breast cancer is the leading cause of death among Brazilian women. There are two principal forms of health systems coverage: a universal government system, Sistema Único de Saúde (SUS), and private health insurance (PHI). We investigated whether clinical outcomes among women with newly diagnosed breast cancer differed according to health system used. Methods: We studied breast cancer patients in the Juiz de Fora metropolitan area of the state of Minas Gerais, where the educational attainment, income and racial composition of the population of approximately 1 million roughly mirror that of the nation. We studied all breast cancer patients newly diagnosed from 1998 to 2000 who were treated with standard consensus guidelines regimens, to compare outcomes in the two Brazilian health systems. Kaplan-Meier method and Cox proportional hazard model were used to calculate overall survival (OS) and to determine the prognostic importance of health systems after adjusting for factors as age, stage, and race. Results: 869 patients were studied with a follow-up of at least 5 years; median 5.3 years. SUS patients presented with more advanced disease than PHI patients (P<0.001). At 5 years, OS was 69% for SUS patients versus 79% for PHI patients (p=0.003); however, when adjusted for age, stage, and race this effect disappeared (p=0.13). The adjusted relative risk of death for SUS compared to PHI patients was 1.3 (95%CI: 0.9 to 1.8). Conclusions: In the two Brazilian health systems, women with breast cancer treated with guideline protocols have similar stage-adjusted clinical outcomes. However, women in the public system are diagnosed at more advanced stages, and thus have significantly poorer outcomes. This suggests that such women would benefit from improved access to screening and referral for evaluation that promotes earlier diagnosis and treatment. [Table: see text] No significant financial relationships to disclose.
Nitric oxide and asymmetric dimethylarginine and CD 40 ligand levels in malignancy associated thrombosis and their modulation by anticoagulants
Authors: Hoppensteadt D. , Fareed D. , Iqbal O. , Lale A. , Fareed J. 
Published: March 2020

17049 Background: Cancer associated thrombotic complications are primarily due to endothelial dysfunction and upregulation of inflammatory processes. Nitric oxide (NO) represents one of the major endothelial derived vasoactive mediators. Asymmetric dimethylarginine (ADMA) is an endogenous competitive inhibitor of NO synthase which inhibits NO production at pathophysiologic levels. CD 40 ligand (CD 40L) is also upregulated in cancer. Methods: To test the hypothesis that endothelial dysfunction in cancer patients may result in increased ADMA levels, plasma samples were retrospectively analyzed from an open label, multidose, active comparator designed study in which all patients (n=110) were initially treated with low molecular weight heparin, enoxaparin (E) at 1–1.5 mg/kg sc for 5 days and further subdivided into group E which continued to receive E and warfarin (W) group which was given oral anticoagulants for a period of up to 12 weeks. Baseline blood samples (BL), 5 days post E (IPE) and 4–6 week samples from the E and W were analyzed for ADMA and CD 40L levels by ELISA methods. NO levels were measured using a chromogenic method. Results: The baseline levels of NO, ADMA and CD 40L levels were markedly elevated in cancer patients. The E treated group showed a marked decrease in the ADMA and CD 40L levels which persisted throughout the treatment period. However, in the W converted group the ADMA and CD 40L levels rebounded to an increased level indicating that E differentially regulated ADMA in these patients. The down regulation pattern of NO was similar for both E and W. Conclusions: These results suggest that patients with cancer and thrombosis exhibit simultaneous upregulation of ADMA, CD 40L and NO. While E and W show a differential regulation of ADMA and CD 40L, both result in a downregulation of NO. The fact that E regulates ADMA is highly suggestive of its role in iNOS regulation which may be involved in the inflammatory response in cancer patients. [Table: see text] No significant financial relationships to disclose.
Evaluation of outcomes before and after electronic medical record (EMR) and computerized physician order entry (CPOE) system implementation in an outpatient oncology setting
Authors: Harshberger C. A. , Brockstein B. , Carro G. , Jiang W. , Spath W. , Lawton J. 
Published: March 2020

17058 Background: Computerized physician order entry (CPOE) in electronic medical records (EMR) has been recognized as an important tool in optimal health care provision that can reduce errors and improve safety. The objective of this study is to describe documentation completeness and user satisfaction of medical charts before and after outpatient oncology EMR/CPOE system implementation in a hospital based outpatient cancer center within three treatment sites and with sixteen physicians. Methods: A retrospective chart review was conducted on 32 randomly selected patients to date, who received one of the following regimens: FOLFOX, carboplatin-paclitaxel, CHOP-rituximab, or AC between 1999 and 2006. Charts were case matched with physician and regimen to compare documentation completeness. Completeness scores were assigned to each chart based on the number of documented data points found out of the 33 data points assessed. A user satisfaction survey of the paper chart and EMR/CPOE system was conducted among the physicians (n=16), nurses (n=43), and pharmacists (n=8) who worked with both systems. Results: The mean percentage of identified data points successfully found in the EMR/CPOE charts was 94% vs. 68% in the paper charts (p<0.001). Regimen complexity did not alter the number of data points found. The survey response rate was 64% and the results showed that satisfaction was statistically significant in favor of the EMR/CPOE system. The time required to find the data points will be assessed by having a physician, nurse, and pharmacist review the same charts. Data on 112 charts will be presented. Conclusions: Using EMR/CPOE systems improves completeness of medical record and chemotherapy order documentation and improves user satisfaction with the medical record system. No significant financial relationships to disclose.
Compliance to National Comprehensive Cancer Network guidelines in patients with newly diagnosed small cell lung cancer at a community cancer center
Authors: Oettel K. R. , Joseph R. , George B. , Lee J. , Mathiason M. , Meyer L. , Go R. 
Published: March 2020

17064 Background: The National Comprehensive Cancer Network (NCCN) provides yearly updated guidelines for the management of patients diagnosed with small cell lung cancer (SCLC). Compliance to clinical guidelines may improve patient care and outcome, but this may vary among institutions. In this study, we determined the compliance of our community cancer center to the NCCN guidelines in patients with SCLC. Methods: We identified patients with newly diagnosed SCLC in 2004 and 2005 using our cancer registry database. Using the NCCN guideline for the corresponding years, we determined the compliance rate for the following phases of cancer care: initial evaluation (pathology review, imaging, smoking cessation counseling, mediastinal staging for T1-T2 limited disease), and treatment (chemotherapy, radiation). Results: There were 39 new patients with SCLC, 14 (35.9%) of which had limited stage disease. The overall compliance rates for initial evaluation and treatment were 33.3%, and 92.3%, respectively. A total of 32 deviations were identified: 21 (65.6%) for neglecting smoking cessation counseling, 7 (21.9%) for not performing recommended imaging, 3 (9.4%) for not giving recommended chemotherapy and/or radiation and 1 (3.1%) for not reviewing outside pathology. In all of the imaging and treatment deviations, there were medically appropriate reasons for doing so: 7 patients with limited disease had PET/CT scan instead of CT/bone scan (PET/CT scan now incorporated into the 2006 guidelines); 2 patients with limited disease did not receive concurrent chemoradiotherapy due to poor performance status and co-morbidity; 1 patient with extensive disease refused chemotherapy. Conclusion: Our compliance with NCCN guidelines for SCLC was poor for initial evaluation, but better for treatment. The primary reasons for this outcome were the lack of a perceived benefit in smoking cessation counseling and the use of PET/CT scanning as the initial imaging modality of choice. No significant financial relationships to disclose.
Development of a novel information technology (IT) system using the electronic medical record (EMR) in daily clinical practice
Authors: Matsumoto S. , Nishimura T. , Kanai M. , Ishiguro H. , Yasuda H. , Yoshikawa K. , Misawa A. , Kitano T. , Yanagihara K. , Fukushima M. 
Published: March 2020

17066 Background: The information generated in daily practices is critical to assure safety and efficacy of therapeutic interventions. Clinical investigators are faced with enormous amounts of data and a greater need to organize it in a meaningful and coherent manner than ever before. Computerization could offer many advantages that clinical data systematically accumulated in the course of routine medical care can provide researchers with the clues to resolve many medical questions. Methods: We developed a novel clinical database system, named CyberOncology, integrated in EMR of Kyoto University Hospital. It contained summarized treatment history, national cancer registry and consecutive clinical database. All adverse events according CTCAE ver.3, response to the treatment based on RECIST criteria and survival data were collected. The medical staffs have routinely used the CyberOncology since its starting on October 2003. The CyberOncology directly collected all data concerning oncology management of inpatient and outpatient care from EMR, and simultaneously analyzed clinical outcomes. Results: For three years since October 2003, consecutive 1,516 new cancer patients including 590 GI, 435 lung, 234 breast cancer, and 140 lymphoma with 19,767 chemotherapeutic administrations were registered in the CyberOncology. Main benefits are improvement of the quality of patient care and safety, practice standardization, and the quickness and the reliability of collecting the data. Moreover, it had the capability to serve a cross-sectional approach of cancer and drug-orientated analysis. For example, this system can easily provided with a review of clinical practice in a real time manner. Conclusions: The CyberOncology form integrated EMR successfully meets requirements of electronic case report. It has been useful in monitoring outcomes of care, effectiveness, efficiency and adherence to clinical trial. No significant financial relationships to disclose.
Economic impact of mortality risk reduction with first-line imatinib (IM) versus interferon-α (IFN) in patients newly diagnosed with chronic phase (CP) chronic myeloid leukemia (CML) under the Brazilian public healthcare system perspective over a 5-year period
Authors: Mataveli F. D. , Calabró A. , Mendes W. , Vianna D. , Dorlhiac-Llacer P. , Bigni R. , Hungria V. 
Published: March 2020

17068 Background: Patients receiving imatinib had a significant survival advantage compared with patients receiving IFN therapy (Roy et al. Blood 2006; Kantarjian et al. Blood 2006). Although reimbursed as second line therapy for CP CML patients who did not respond to INF-a, IM was not considered for public reimbursement as first line treatment in Brazil based on drug costs. An economic evaluation considering the mortality risk reduction with first line IM versus INF was performed under the Brazilian Public Healthcare System perspective, comparing the costs to avoid one death of a chronic phase CML patient over a 5-year period. Methods: Risk of death in 5 years was defined by survival rates in the 60 month follow-up of IRIS for IM (Rim= 10%) (Druker et al. JCO 2006), MD Anderson cohort of CML patients treated with INF-a for INF-a (RINF-a= 38%) (Cortes et al. American J. Med 1996) and a population based-survey in Norway for the natural course of the disease (Rnon-treatment= 67%). IRIS INF group survival rate was not used due to high crossover to IM in the trial. Risk of death in the natural course of the disease was the basis for the absolute risk reduction (ARR) calculation (ARRim= 57%; ARRINF-a= 29%). Number need to treat (NNT) was obtained by the inverse of ARR value for each first line treatment (NNT =1/ARR). Costs were estimated based on the Brazilian public healthcare reimbursement payment (APAC-SUS) for chronic phase CML treatment. A base case economic model of 100 patients for each treatment option was constructed focused on drug costs and adverse events (AE) from the IRIS study for both groups. Clinical guidelines from two public hematology centers were used to estimate AE treatment costs. Costs were discounted at a 6% annual rate. Results: The treatment costs and NNTs for a 5-year period are US$ 62,135 and 3.45 for INF-a, and US$ 93,397 and 1.75 for IM, respectively. The costs to avoid one death over a 5-year period are US$ 214,368 for INF-a and US$ 163,445 for IM. Conclusions: The costs for avoiding one death of a chronic phase CML patient over a 5-year period is US$ 50,923 higher with first line INF-a than it would be with first line imatinib. [Table: see text]
The impact of Australia Asia Pacific Clinical Oncology Research Development (ACORD) on research productivity of participants according to region of origin
Authors: Koczwara B. , Ackland S. , Esterman A. , Marine F. , Stockler M. , Olver I. 
Published: March 2020

17074 Background: ACORD is a 1-week, intensive educational workshop designed to increase skills of junior cancer clinical researchers from the Asia Pacific region. Participants come from region of diverse cultures, languages and resources. Methods: We surveyed participants 1 year after the workshop to determine its impact on their research output. Participants were grouped into those from: Australia or New Zealand (ANZ), developed Asian countries (Japan, Korea, Taiwan), and developing Asian countries (India, China, Bangladesh, Philippines, Indonesia, Malaysia). Results: The response rate was higher from developed Asia (10/10, 100%), than ANZ (44/59, 75%) and developing Asia (7/12, 58%). The proportion of respondents spending more than half of their time in research was higher in ANZ (21%), than developing Asia (14%) or developed Asia (10%). The workshop was rated very valuable by more respondents from developing Asia (71%) than from ANZ (59%) and developed Asia (60%). More than half of respondents had submitted their ACORD protocol to an IRB. Progress activating protocols was reported more frequently by respondents from developing Asia (86%) than developed Asia (70%) and ANZ (59%). Involvement in other research was also reported more frequently by respondents from developing Asia (100%) than ANZ (82%) or developed Asia (80%). The most frequently reported barriers to progressing research were: other work commitments (71% for developing Asia, 44% for ANZ, 30% for developed Asia) and lack of funding (71% for developing Asia, 39% for ANZ, and 33% for developed Asia). Continuing contact with faculty and participants was reported more frequently by respondents from ANZ (59%), than developed Asia (43%) or developing Asia (30%). Conclusions: Respondents were highly satisfied with the workshop, perceiving positive effects on their research skills and careers. Participants from developing countries were more likely to take their protocols forward, despite reporting greater barriers to progress, and less continuing contact with faculty and participants. Protected time and support for researchers are worth considering for developing countries wanting to improve their research output. [Table: see text]
Healthcare (HC) utilization and costs in patients (pts) with newly diagnosed metastatic thyroid cancer (mTC)
Authors: Berger A. , Edelsberg J. , Chung K. , Ngyuyen A. , Stepan D. , Oster G. 
Published: March 2020

17082 Background: mTC is relatively rare and little is known about treatment patterns or HC costs in patients with newly diagnosed disease. Methods: Retrospective longitudinal cohort study. Using a large (∼14 million covered lives) US health-insurance claims database, we identified a cohort of pts with diagnoses of thyroid cancer (ICD-9-CM diagnosis codes 193.XX) and distant metastatic disease (197.XX-198.XX) between 1/1/2003 and 12/31/2005 (“study period”); the date of first mention of metastatic disease was designated the “index date”. All pts were required to be =18 years of age as of their index date and to have been continuously enrolled in the database for =6 months prior to this date. Pts were followed from their index date until health plan disenrollment (for any reason) or end of the study period, whichever occurred first. Utilization of HC services and costs (total reimbursed amount including pt liability) were then examined during each quarter of follow-up (eg, first 3 months of follow-up=Q1). Results: 183 pts met all study entry criteria. Mean (±SD) age was 51.5 (11.8) years; mean duration of follow-up was 344 days (median=275 days). Most common management/treatment strategies during Q1 included: imaging [eg, US/CT of the neck (49.7%)], thyroglobulin/thyroglobulin antibody testing (25.7%); radiation therapy (23.0%); I131 therapy (19.1%); thyroid surgery (12.6%); chemotherapy (10.9%); lymphadenectomy (8.7%); and bisphosphonate therapy (3.8%). In addition, during Q1, pts averaged 9.5 office visits (95% CI, 8.2, 10.9) and 0.6 hospitalizations (95% CI, 0.5, 0.7); for pts hospitalized during Q1, average length of stay was 6.6 (95% CI, 4.9, 8.4). Costs during the first 2 years of follow-up are presented in the table ; inpt care represented 43% of total HC costs. Conclusions: Many different treatment modalities are used in pts with newly diagnosed mTC; the cost of such care is substantial. [Table: see text] [Table: see text]