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Investigator(s) |
Min H, Manion FJ, Goralczyk E, Wong YN, Ross E, Beck JR. Integration of Prostate Cancer Clinical Data Using an Ontology. J Biomed Inform. 2009 Jun 1;.
It is increasingly important for investigators to efficiently and effectively access, interpret, and analyze the data from diverse biological, literature, and annotation sources in a unified way. The heterogeneity of biomedical data and the lack of metadata are the primary sources of the difficulty for integration, presenting major challenges to effective search and retrieval of the information. As a proof of concept, the Prostate Cancer Ontology (PCO) is created for the development of the Prostate Cancer Information System (PCIS). PCIS is applied to demonstrate how the ontology is utilized to solve the semantic heterogeneity problem from the integration of two prostate cancer related database systems at the Fox Chase Cancer Center. As the results of the integration process, the semantic query language SPARQL is applied to perform the integrated queries across the two database systems based on PCO.
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Beck
Wong
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Wong YN, Meropol NJ, Speier W, Sargent D, Goldberg RM, Beck JR. Cost implications of new treatments for advanced colorectal cancer. Cancer. 2009 May 15;115(10):2081-91.
BACKGROUND: Since 1996, 6 new drugs have been introduced for the treatment of metastatic colorectal cancer. Although they are promising, these drugs frequently are given in the palliative and are much more expensive than older treatments. The objective of the current study was to measure the cost implications of treatment with sequential regimens that include chemotherapy and/or monoclonal antibodies. METHODS: A Markov model was used to evaluate a hypothetical cohort of 1000 patients with newly diagnosed, metastatic colorectal cancer. Patients supposedly received up to 3 lines of treatment before supportive care and subsequent death. Data were obtained from published, multicenter phase 2 and randomized phase 3 clinical trials. Sensitivity analyses were conducted on the efficacy, toxicity, and cost. RESULTS: Using drug costs alone, treatment that included new chemotherapeutic agents increased survival at an incremental cost-effectiveness ratio (ICER) of $100,000 per discounted life-year (DLY). The addition of monoclonal antibodies improved survival at an ICER of >$170,000 per DLY. The results were most sensitive to changes in the initial regimen. Even with significant improvements in clinical characteristics (efficacy and toxicity), treatment with the most effective regimens still had very high ICERs. CONCLUSIONS: Treatment of metastatic colorectal cancer with the most effective regimens came at very high incremental costs. The authors concluded that cost-effectiveness analyses should be a routine component of the drug-development process, so that physicians and patients are informed appropriately regarding the value of new innovations.
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Meropol
Beck
Wong
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Guo YP, Kock K, Ritter CA, Chen ZS, Grube M, Jedlitschky G, Illmer T, Ayres M, Beck JF, Siegmund W, Ehninger G, Gandhi V, Kroemer HK, Kruh GD, Schaich M. Expression of ABCC-Type Nucleotide Exporters in Blasts of Adult Acute Myeloid Leukemia: Relation to Long-term Survival. Clin Cancer Res. 2009 Mar;15(5):1762-9.
Purpose: Successful treatment of acute myeloid leukemia (AML) remains a therapeutic challenge, with a high percentage of patients suffering from persistent or relapsed disease. Resistance to drug therapy can develop from increased drug export and/or altered intracellular signaling. Both mechanisms are mediated by the efflux transporters ABCC4 (MRP4), ABCC5 (MRP5), and ABCC11 (MRP8), which are involved in cellular efflux of endogenous signaling molecules (e.g., cyclic adenosine 3',5'-monophosphate and cyclic guanosine 3',5'-monophosphate) and nucleoside analogues. The nucleoside analogue cytosine arabinoside (AraC) is administered to all patients with AML. Experimental Design: Expression of ABCC transporters MRP4, MRP5, and MRP8 in blast samples from 50 AML patients was investigated by real-time reverse transcription-PCR analysis and correlated with clinical outcome measures. Accumulation of radiolabeled AraC, transport of AraC metabolites, and AraC cytotoxicity were analyzed in MRP8-transfected LLC-PK1 cells. Results: Regression analysis revealed that high expression of MRP8 is associated with a low probability of overall survival assessed over 4 years (P < 0.03). MRP8-transfected LLC-PK1 cells accumulated reduced intracellular levels of AraC (63% of the parental vector-transfected LLC-PK1 control cells) as well as AraC metabolites. Furthermore, AraC monophosphate was transported by MRP8-enriched membrane vesicles (116 +/- 6 versus 65 +/- 13 pmol/mg/10 minutes by control vesicles), and MRP8-transfected cells were resistant to AraC. Conclusion: These data suggest that MRP8 is differentially expressed in AML blasts, that expression of MRP8 serves as a predictive marker for treatment outcome in AML, and that efflux of AraC metabolites by MRP8 is a mechanism that contributes to resistance of AML blasts.
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Beck
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Wong YN, Meropol NJ, Speier W, Sargent D, Goldberg RM, Beck JR. Cost Implications of New Treatments for Advanced Colorectal Cancer. Cancer. 2009 May;115(10):2081-91.
BACKGROUND: Since 1996, 6 new drugs have been introduced for the treatment of metastatic colorectal cancer. Although they are promising, these drugs frequently are given in the palliative and are much more expensive than older treatments. The objective of the current study was to measure the cost implications of treatment with sequential regimens that include chemotherapy and/or monoclonal antibodies. METHODS: A Markov model was used to evaluate a hypothetical cohort of 1000 patients with newly diagnosed, metastatic colorectal cancer. Patients supposedly received up to 3 lines of treatment before supportive care and subsequent death. Data were obtained from published, multicenter phase 2 and randomized phase 3 clinical trials. Sensitivity analyses were conducted on the efficacy, toxicity, and cost. RESULTS: Using drug costs alone, treatment that included new chemotherapeutic agents increased survival at an incremental cost-effectiveness ratio (ICER) of $100,000 per discounted life-year (DLY). The addition of monoclonal antibodies improved survival at an ICER of >$170,000 per DLY. The results were most sensitive to changes in the initial regimen. Even with significant improvements in clinical characteristics (efficacy and toxicity), treatment with the most effective regimens still had very high ICERs. CONCLUSIONS: Treatment of metastatic colorectal cancer with the most effective regimens came at very high incremental costs. The authors concluded that cost-effectiveness analyses should be a routine component of the drug-development process, so that physicians and patients are informed appropriately regarding the value of new innovations, Cancer 2009;115:2081-91. (C) 2009 American Cancer Society.
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Meropol
Beck
Wong
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Cantor SB, Cardenas-Turanzas M, Cox DD, Atkinson EN, Nogueras-Gonzalez GM, Beck JR, Follen M, Benedet JL. Accuracy of colposcopy in the diagnostic setting compared with the screening setting. Obstet Gynecol. 2008 Jan;111(1):7-14.
OBJECTIVE: To estimate the accuracy of colposcopy to identify cervical precancer in screening and diagnostic settings. METHODS: As part of a larger clinical trial to evaluate the diagnostic accuracy of optical spectroscopy, we recruited 1,850 patients into a diagnostic or a screening group depending on their history of abnormal findings on Papanicolaou tests. Colposcopic examinations were performed and biopsies specimens obtained from abnormal and normal colposcopic sites for all patients. The criterion standard of test accuracy was the histologic report of biopsies. We calculated sensitivities, specificities, likelihood ratios, receiver operating characteristic curves, and areas under the receiver operating characteristic curves. RESULTS: The prevalence of high-grade squamous intraepithelial lesions (HSIL) or cancer was 29.0% for the diagnostic group and 2.2% for the screening group. Using a disease threshold of HSIL, colposcopy had a sensitivity of 0.983 and a specifici!
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Beck
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Cardenas-Turanzas M, Nogueras-Gonzalez GM, Scheurer ME, Adler-Storthz K, Benedet JL, Beck JR, Follen M, Cantor SB. The performance of human papillomavirus high-risk DNA testing in the screening and diagnostic settings. Cancer Epidemiology Biomarkers & Prevention. 2008 Oct;17(10):2865-71.
Objective: We sought to evaluate the performance of the human papillomavirus high-risk DNA test in patients 30 years and older. Materials and Methods: Screening (n = 835) and diagnosis (n = 518) groups were defined based on prior Papanicolaou smear results as part of a clinical trial for cervical cancer detection. We compared the Hybrid Capture 11 (HCII) test result with the worst histologic report. We used cervical intraepithelial neoplasia (CIN) 2/3 or worse as the reference of disease. We calculated sensitivities, specificities, positive and negative likelihood ratios (LR+ and LR-), receiver operating characteristic (ROC) curves, and areas under the ROC curves for the HCII test. We also considered alternative strategies, including Papanicolaou smear, a combination of Papanicolaou smear and the HCII test, a sequence of Paparticolaou smear followed by the HCII test, and a sequence of the HCII test followed by Papanicolaou smear. Results: For the screening group, the sensitivity was 0.69 and the specificity was 0.93; the area under the ROC curve was 0.81. The LR+ and LR- were 10.24 and 0.34, respectively. For the diagnosis group, the sensitivity was 0.88 and the specificity was 0.78; the area under the ROC curve was 0.83. The LR+ and LR- were 4.06 and 0.14, respectively. Sequential testing showed little or no improvement over the combination testing. Conclusions: The HCII test in the screening group had a greater LR+ for the detection of CIN 2/3 or worse. HCII testing may be an additional screening tool for cervical cancer in women 30 years and older.
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Beck
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Huang Y, Collins MA, Ross EA, Beck JR. Usability test of a family health history web tool. AMIA Annu Symp Proc. 2008;:981.
We developed a web application prototype to collect cancer-related family health history data from clinical study participants and patients of Fox Chase Cancer Center. We conducted an initial round of usability testing by observing participants using the tool and recorded their experiences via a short survey. This process identified several issues with the current design using limited resources.
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Beck
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Cardenas-Turanzas M, Follen M, Nogueras-Gonzalez GM, Benedet JL, Beck JR, Cantor SB. The Accuracy of the Papanicolaou Smear in the Screening and Diagnostic Settings. Journal of Lower Genital Tract Disease. 2008 Oct;12(4):269-75.
Objective. We evaluated the performance of the Papanicolaou smear in screening and diagnostic settings. Study Design. We analyzed Papanicolaou smear results of 1,850 women recruited into a clinical trial to evaluate an emerging technology for the detection of cervical cancer. Screening and diagnosis groups were based on the history of previous Papanicolaou smear results. We calculated sensitivities, specificities, positive and negative likelihood ratios (LR+ and LR-), receiver operating characteristic curves, and areas under the receiver operating characteristic curve (AUC). Results. In the screening group, by defining disease as cervical intraepithelial neoplasia (CIN) 2,3/cancer or worse and using high-grade squamous intraepithelial lesion (HSIL) as the test cutpoint, the AUC was 0.689, and the LR+ and LR- were 39.25 and 0.67, respectively. in the diagnosis group, the AUC was 0.764, and the LR+ and LR-were 3.79 and 0.56, respectively. By defining disease as human papillomavirus/CIN 1 or worse and HSIL as the test cutpoint, the AUC was 0.586, and the LR+ and LR- were 17.01 and 0.92 in the screening group; in the diagnosis group, the AUC was 0.686, and the LR+ and LR- were 2.77 and 0.75, respectively. Conclusions. In a screening setting, a Papanicolaou smear result of HSIL or worse is 39 times more likely in a patient with CIN 2,3/cancer than in a patient without it. This compares to 4 times more likely in the diagnostic setting. The magnitude of the positive likelihood ratio observed in the screening group indicated that abnormal Papanicolaou smear results obtained in the screening setting should have more impact on clinical decision making than those from results obtained in the diagnostic setting.
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Beck
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Konski A, Speier W, Hanlon A, Beck JR, Pollack A. Is proton beam therapy cost effective in the treatment of adenocarcinoma of the prostate?. J Clin Oncol. 2007 Aug 20;25(24):3603-8.
PURPOSE: New treatments are introduced routinely into clinical practice without rigorous economic analysis. The specific aim of this study was to examine the cost effectiveness of proton beam radiation compared with current state-of-the art therapy in the treatment of patients with prostate cancer. Materials and METHODS: A Markov model was informed with cost, freedom from biochemical failure (FFBF), and utility data obtained from the literature and from patient interviews to compare the cost effectiveness of 91.8 cobalt gray equivalent (CGE) delivered with proton beam versus 81 CGE delivered with intensity-modulated radiation therapy (IMRT). The length of how many years the model was run, patient's age, probability of FFBF after treatment with proton beam therapy and IMRT, utility of patients treated with salvage hormone therapy, and treatment cost were tested in sensitivity analyses. RESULTS: Analysis at 15 years resulted in an expected mean cost of proton beam therapy and IMRT of $63,511 and $36,808, and $64,989 and $39,355 for a 70-year-old and 60-year-old man respectively, with quality-adjusted survival of 8.54 and 8.12 and 9.91 and 9.45 quality-adjusted life-years (QALY), respectively. The incremental cost effectiveness ratio was calculated to be $63,578/QALY for a 70-year-old man and $55,726/QALY for a 60-year-old man. CONCLUSION: Even when based on the unproven assumption that protons will permit a 10-Gy escalation of prostate dose compared with IMRT photons, proton beam therapy is not cost effective for most patients with prostate cancer using the commonly accepted standard of $50,000/QALY. Consideration should be given to limiting the number of proton facilities to allow comprehensive evaluation of this modality.
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Pollack
Beck
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Bane AL, Beck JC, Bleiweiss I, Buys SS, Catalano E, Daly MB, Giles G, Godwin AK, Hibshoosh H, Hopper JL, John EM, Layfield L, Longacre T, Miron A, Senie R, Southey MC, West DW, Whittemore AS, Wu H, Andrulis IL, O'Malley FP. BRCA2 mutation-associated breast cancers exhibit a distinguishing phenotype based on morphology and molecular profiles from tissue microarrays. Am J Surg Pathol. 2007 Jan;31(1):121-8.
A distinct morphologic and molecular phenotype has been reported for BRCA1-associated breast cancers; however, the phenotype of BRCA2-associated breast cancers is less certain. To comprehensively characterize BRCA2-associated breast cancers we performed a retrospective case control study using tumors accrued through the Breast Cancer Family Registry. We examined the tumor morphology and hormone receptor status in 157 hereditary breast cancers with germline mutations in BRCA2 and 314 control tumors negative for BRCA1 and BRCA2 mutations that were matched for age and ethnicity. Tissue microarrays were constructed from 64 BRCA2-associated and 185 control tumors. Tissue microarray sections were examined for FIER2/neu protein overexpression, p53 status and the expression of basal markers, luminal markers, cyclin D I, bcl2, and MIB1 by immunohistochemistry. The majority of BRCA2-associated tumors and control tumors were invasive ductal, no special-type tumors. In contrast to control tumors
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Godwin
Daly
Beck
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Cantor SB, Levy LB, Cardenas-Turanzas M, Basen-Engquist K, Le T, Beck JR, Follen M. Collecting direct non-health care and time cost data: Application to screening and diagnosis of cervical cancer. Med Decis Making. 2006 May-Jun;26(3):265-72.
Background. Data on direct non-health care and time costs are rarely collected, though the incorporation of such data is essential for performing cost-effectiveness analyses according to established guidelines. Objectives. To explore the challenges involved in collecting and analyzing these data from patients enrolled in a clinical trial. Methods. Through the use of a pilot study, the authors designed a questionnaire to collect these costs. They used this questionnaire in a clinical trial conducted at a coinprehensive cancer center and a public community Unity hospital. Patients in the trial were undergoing screening or diagnostic procedures through a clinical protocol designed to measure the effectiveness of fluorescence and reflectance spectroscopy for detecting cervical precancers. Direct non-health care costs were adjusted to 2003 constant dollars. Results. The authors successfully collected direct non-health core and time cost data, thus demonstrating the feasibility of! acquiring such data. Compared to patients receiving diagnostic services for cervical cancer, for those receiving no screening services for the same condition in both settings incurred lower direct non-health core costs and time costs, as defined in the questionnaire. Compared to patients receiving either service at the comprehensive cancer center, those seeking either service (it the public community hospital incurred lower direct non-health core costs and time costs. When outliers were removed, total direct non-health care costs (and time costs substantially decreased for diagnostic patients in the comprehensive cancer center; total direct non-health core costs and time costs for other subgroups remained essentially unchanged. Conclusions. Direct non-health core and time cost data can be collected within a large-scale clinical trial. The setting (community specialty hospital) and population (patients receiving screening v. diagnostic examination) makes a difference regard! ing the cost totals. The order of magnitude of the final resul! t depend s on the context in which the non-health core and time cost data will be used.
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Beck
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Spurdle AB, Antoniou AC, Kelemen L, Holland H, Peock S, Cook MR, Smith PL, Greene MH, Simard J, Plourde M, Southey MC, Godwin AK, Beck J, Miron A, Daly MB, Santella RM, Hopper JL, John EM, Andrulis IL, Durocher F, Struewing JP, Easton DF, Chenevix-Trench G. The AIB1 polyglutamine repeat does not modify breast cancer risk in BRCA1 and BRCA2 mutation carriers. Cancer Epidemiology Biomarkers & Prevention. 2006 Jan;15(1):76-9.
This is by far the largest study of its kind to date, and further suggests that AIB1 does not play a substantial role in modifying the phenotype of BRCA1 and BRCA2 carriers. The AIB1 gene encodes the AIB1/SRC-3 steroid hormone receptor coactivator, and amplification of the gene and/or protein occurs in breast and ovarian tumors. A CAG/CAA repeat length polymorphism encodes a stretch of 17 to 29 glutamines in the HR-interacting carboxyl-terminal region of the protein which is somatically unstable in tumor tissues and cell lines. There is conflicting evidence regarding the role of this polymorphism as a modifier of breast cancer risk in BRCA1 and BRCA2 carriers. To further evaluate the evidence for an association between AM glutamine repeat length and breast cancer risk in BRCA1 and BRCA2 mutation carriers, we have genotyped this polymorphism in 1,090 BRCA1 and 661 BRCA2 mutation carriers from Australia, Europe, and North America. There was no evidence for an increased risk as sociated with AIB1 glutamine repeat length. Given the large sample size, with more than adequate power to detect previously reported effects, we conclude that the AM glutamine repeat does not substantially modify risk of breast cancer in BRCA1 and BRCA2 mutation carriers.
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Godwin
Daly
Beck
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Meropol
Beck
Wong
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Konski A, Watkins-Bruner D, Feigenberg S, Hanlon A, Kulkarni S, Beck JR, Horwitz EM, Pollack A. Using decision analysis to determine the cost-effectiveness of intensity-modulated radiation therapy in the treatment of intermediate risk prostate cancer. Int J Radiat Oncol Biol Phys. 2006 Aug 1;66(2):408-15.
BACKGROUND: The specific aim of this study is to evaluate the cost-effectiveness of intensity-modulated radiation therapy (IMRT) compared with three-dimensional conformal radiation therapy (3D-CRT) in the treatment of a 70-year-old with intermediate-risk prostate cancer. METHODS: A Markov model was designed with the following states; posttreatment, hormone therapy, chemotherapy, and death. Transition probabilities from one state to another were calculated from rates derived from the literature for IMRT and 3D-CRT. Utility values for each health state were obtained from preliminary studies of preferences conducted at Fox Chase Cancer Center. The analysis took a payer's perspective. Expected mean costs, cost-effectiveness scatterplots, and cost acceptability curves were calculated with commercially available software. RESULTS: The expected mean cost of patients undergoing IMRT was $47,931 with a survival of 6.27 quality-adjusted life years (QALYs). The expected mean cost of patients having 3D-CRT was $21,865 with a survival of 5.62 QALYs. The incremental cost-effectiveness comparing IMRT with CRT was $40,101/QALYs. Cost-effectiveness acceptability curve analysis revealed a 55.1% probability of IMRT being cost-effective at a $50,000/QALY willingness to pay. CONCLUSION: Intensity-modulated radiation therapy was found to be cost-effective, however, at the upper limits of acceptability. The results, however, are dependent on the assumptions of improved biochemical disease-free survival with fewer patients undergoing subsequent salvage therapy and improved quality of life after the treatment. In the absence of prospective randomized trials, decision analysis can help inform physicians and health policy experts on the cost-effectiveness of emerging technologies.
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Pollack
Beck
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Jibaja-Weiss ML, Volk RJ, Friedman LC, Granchi TS, Neff NE, Spann SJ, Robinson EK, Aoki N, Beck JR. Preliminary testing of a just-in-time, user-defined values clarification exercise to aid lower literate women in making informed breast cancer treatment decisions. HEALTH EXPECTATIONS. 2006 Sep;9(3):218-31.
Objective To report on the initial testing of a values clarification exercise utilizing a jewellery box within a computerized patient decision aid (CPtDA) designed to assist women in making a surgical breast cancer treatment decision. Design Pre-post design, with patients interviewed after diagnosis, and then after completing the CPtDA sometime later at their preoperative visit. Sample Fifty-one female patients, who are low literate and naive computer users, newly diagnosed with early stage breast cancer from two urban public hospitals. Intervention A computerized decision aid that combines entertainment-education (edutainment) with enhanced (factual) content. An interactive jewellery box is featured to assist women in: (1) recording and reflecting over issues of concern with possible treatments, (2) deliberating over surgery decision, and (3) communicating with physician and significant others. Outcomes Patients' use of the jewellery box to store issues during completion of the CPtDA, and perceived clarity of values in making a treatment decision, as measured by a low literacy version of the Decisional Conflict Scale (DCS). Results Over half of the participants utilized the jewellery box to store issues they found concerning about the treatments. On average, users flagged over 13 issues of concern with the treatments. Scores on the DCS Uncertainty and Feeling Unclear about Values subscales were lower after the intervention compared to before the decision was made. Conclusions A values clarification exercise using an interactive jewellery box may be a promising method for promoting informed treatment decision making by low literacy breast cancer patients.
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Beck
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Jibaja-Weiss ML, Volk RJ, Granch TS, Nefe NE, Spann SJ, Aoki N, Robinson EK, Freidman LC, Beck JR. Entertainment education for informed breast cancer treatment decisions in low-literate women: development and initial evaluation of a patient decision aid. J Cancer Educ. 2006 Fall;21(3):133-9.
BACKGROUND: We report on the development and initial evaluation of a novel computerized decision support system (CDSS) that utilizes concepts from entertainment education (edutainment) to assist low-literate, multiethnic women in making initial surgical treatment decisions. METHOD: We randomly assigned 51 patients diagnosed with early stage breast cancer to use the decision aid. RESULTS: Patients who viewed the CDSS improved their knowledge of breast cancer treatment; found the application easy to use and understand, informative, and enjoyable; and were less worried about treatment. CONCLUSION: The system clearly reached its intended objectives to create a usable decision aid for low-literate, novice computer users.
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Beck
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Konski A, Sherman E, Krahn M, Bremner K, Beck JR, Watkins-Bruner D, Pilepich M. Economic analysis of a phase III clinical trial evaluating the addition of total androgen suppression to radiation versus radiation alone for locally advanced prostate cancer (Radiation Therapy Oncology Group protocol 86-10). International Journal of Radiation Oncology Biology Physics. 2005 Nov 1;63(3):788-94.
Purpose: To evaluate the cost-effectiveness of adding hormone therapy to radiation for patients with locally advanced prostate cancer, using a Monte Carlo simulation of a Markov Model. Methods and Materials: Radiation Therapy Oncology Group (RTOG) protocol 86-10 randomized patients to receive radiation therapy (RT) alone or RT plus total androgen suppression (RTHormones) 2 months before and during RT for the treatment of locally advanced prostate cancer. A Markov model was designed with Data Pro (TreeAge Software, Williamstown, MA). The analysis took a payer's perspective. Transition probabilities from one state of health (i.e., with no disease progression or with hormone-responsive metastatic disease) to another were calculated from published rates pertaining to RTOG 86-10. Patients remained in one state of health for 1 year. Utility values for each health state and treatment were obtained from the literature. Distributions were sampled at random from the treatment utilities according to a second-order Monte Carlo simulation technique. Results: The mean expected cost for the RT-only treatments was $29,240 (range, $29,138-$29,403). The mean effectiveness for the RT-only treatment was 5.48 quality-adjusted life years (QALYs) (range, 5.47-5.50). The mean expected cost for RTHormones was $31,286 (range, $31,058-$31,555). The mean effectiveness was 6.43 QALYs (range, 6.42-6.44). Incremental cost-effectiveness analysis showed RTHormones to be within the range of cost-effectiveness at $2,153/QALY. Cost-effectiveness acceptability curve analysis resulted in a > 80% probability that RTHormones is cost-effective. Conclusions: Our analysis shows that adding hormonal treatment to RT improves health outcomes at a cost that is within the acceptable cost-effectiveness range. (c) 2005 Elsevier Inc.
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Beck
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John EM, Hopper JL, Beck JC, Knight JA, Neuhausen SL, Senie RT, Ziogas A, Andrulis IL, Anton-Culver H, Boyd N, Buys SS, Daly MB, O'Malley FP, Santella RM, Southey MC, Venne VL, Venter DJ, West DW, Whittemore AS, Seminara DG. The Breast Cancer Family Registry: an infrastructure for cooperative multinational, interdisciplinary and translational studies of the genetic epidemiology of breast cancer. Breast Cancer Research. 2004;6(4):R375-R389.
Introduction The etiology of familial breast cancer is complex and involves genetic and environmental factors such as hormonal and lifestyle factors. Understanding familial aggregation is a key to understanding the causes of breast cancer and to facilitating the development of effective prevention and therapy. To address urgent research questions and to expedite the translation of research results to the clinical setting, the National Cancer Institute ( USA) supported in 1995 the establishment of a novel research infrastructure, the Breast Cancer Family Registry, a collaboration of six academic and research institutions and their medical affiliates in the USA, Canada, and Australia. Methods The sites have developed core family history and epidemiology questionnaires, data dictionaries, and common protocols for biospecimen collection and processing and pathology review. An Informatics Center has been established to collate, manage, and distribute core data. Results As of September 2003, 9116 population-based and 2834 clinic-based families have been enrolled, including 2346 families from minority populations. Epidemiology questionnaire data are available for 6779 affected probands (with a personal history of breast cancer), 4116 unaffected probands, and 16,526 relatives with or without a personal history of breast or ovarian cancer. The biospecimen repository contains blood or mouthwash samples for 6316 affected probands, 2966 unaffected probands, and 10,763 relatives, and tumor tissue samples for 4293 individuals. Conclusion This resource is available to internal and external researchers for collaborative, interdisciplinary, and translational studies of the genetic epidemiology of breast cancer. Detailed information can be found at the URL http://www.cfr.epi.uci.edu/.
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Daly
Beck
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Aoki N, Dunn K, Fukui T, Beck JR, Schull WJ, Li HK. Cost-effectiveness analysis of telemedicine to evaluate diabetic retinopathy in a prison population. Diabetes Care. 2004 May;27(5):1095-101.
OBJECTIVE - A cost-effectiveness analysis was conducted to investigate the clinical and economic impact of teleophthalmology in evaluating diabetic retinopathy in prison inmated with type 2 diabetes. RESEARCH DESIGN AND METHODS - Based on a hypothetical teleophthalmology system to evaluate diabetic retinopathy patients with type 2 diabetes in a prison care setting, a Markov decision model was developed with probability and cost data derived primarily from published epidemiological and outcome studies. A 40-year-old African-American man with type 2 diabetes was used as a reference case subject. The number of quality-adjusted life-years (QALYs) gained was used as the clinical outcome, and the cost in U.S. dollars from the year 2003 was used as the economic outcome. Teleophthalmology and nonteleophthalmology strategies were compared using an expected QALYs calculation and two types of sensitivity analeyses: probabilistic and traditional n-way sensitivity analyses. RESULTS-The teleophthalmology strategy dominates in the cost-effectiveness analysis for the reference case subject: $16,514/18.73 QALYs for teleophthalmology and $17,590/18.58 QALYs for nonteleophthalmology. Ninety percent of the Monte Carlo simulations showed cost effectiveness (annual cost/QALYs less than or equal to $50,000) in the teleophthalmology strategy based on an assumed inmate population. Teleophthalmology is the better strategy if the number of diabetic inmates in the prison community is > 500. CONCLUSIONS- our cost-effectiveness analysis demonstrates that teleophthalmology holds great promise to reduce the cost of inmate care and reduce blindness caused by diabetic retinopathy in type 2 diabetic patients.
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Beck
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Pollack
Beck
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