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BACKGROUND Navigators can facilitate timely access to cancer services, but to the authors' knowledge there are little data available regarding their economic impact. METHODS The authors conducted a cost-consequence analysis of navigation versus usual care among 10,521 individuals with abnormal breast, cervical, colorectal, or prostate cancer screening results who enrolled in the Patient Navigation Research Program study from January 1, 2006 to March 31, 2010. Navigation costs included diagnostic evaluation, patient and staff time, materials, and overhead. Consequences or outcomes were time to diagnostic resolution and probability of resolution. Differences in costs and outcomes were evaluated using multilevel, mixed-effects regression modeling adjusting for age, race/ethnicity, language, marital status, insurance status, cancer, and site clustering. RESULTS The majority of individuals were members of a minority (70.7%) and uninsured or publically insured (72.7%). Diagnostic resolution was higher for navigation versus usual care at 180 days (56.2% vs 53.8%; P = .008) and 270 days (70.0% vs 68.2%; P < .001). Although there were no differences in the average number of days to resolution between the 2 groups (110 days vs 109 days; P = .63), the probability of ever having diagnostic resolution was higher for the navigation group versus the usual-care group (84.5% vs 79.6%; P < .001). The added cost of navigation versus usual care was $275 per patient (95% confidence interval, $260-$290; P < .001). There was no significant difference in stage distribution among the 12.4% of patients in the navigation group vs 11% of the usual-care patients diagnosed with cancer. CONCLUSIONS Navigation adds costs and modestly increases the probability of diagnostic resolution among patients with abnormal screening test results. Navigation is only likely to be cost-effective if improved resolution translates into an earlier cancer stage at the time of diagnosis. Cancer 2014;120:570-578. © 2013 American Cancer Society. [ABSTRACT FROM AUTHOR]

Background Patient navigation (PN) is a method for addressing racial-ethnic and socioeconomically based disparities in cancer-related care. Patient navigators provide logistic and emotional support to underserved patients to facilitate successful completion of diagnostic and treatment care. Yet, little is known about patient satisfaction with the relationship with a navigator due to a dearth of instruments measuring satisfaction. Objective The objective of this study was to validate the Patient Satisfaction with Interpersonal Relationship with Navigator (PSN-I) measure for patients undergoing diagnostic and/or therapeutic cancer care. Methods We administered the PSN-I to 783 participants from the nine different sites of the National Cancer Institute sponsored Patient Navigation Research Program. We evaluated the latent structure and internal consistency of the PSN-I using principal components analysis (PCA) and Cronbach coefficient alpha ( α), respectively. We used correlation analyses to examine divergence and convergence of the PSN-I with the Patient Satisfaction with Cancer-related Care (PSCC), the Rapid Estimate of Adult Literacy in Medicine (REALM) Long Form, and patients' demographics. Results The PCA revealed a coherent set of items that explicates 76.6% of the variance in PSN-I. Reliability assessment revealed high internal consistency ( α ranging from 0.95 to 0.96). The PSN-I had good face validity as well as convergent and divergent validities as indicated by moderate correlations with score on the PSCC (all ps < 0.0001) and non-significant correlations with primary language, marital status, and scores on the REALM Long Form (all ps > 0.05). Conclusion The PSN-I is a valid and suitable measure of satisfaction with a patient navigator for the present sample. Copyright © 2011 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

The article focuses on a conceptual model to evaluate the cost-effectiveness of cancer navigation programs such as the one used by the Patient Navigation Research Program (PNRP), a multicenter study supported by the National Cancer Institute in the U.S. It states that navigation programs improve access to healthcare but their efficiency, efficacy of cancer diagnostic and therapeutic services remain unclear. PNRP examines navigation programs that reduce time to deliver a quality cancer care.

BACKGROUND: Since 1988, millions of patients have received epoetin products intravenously (IV) and subcutaneously. In 1998, epoetin-associated pure red cell aplasia (PRCA) was first reported and causation was attributed to formulations without human serum albumin (HSA), subcutaneous administration, and uncoated rubber stoppers. STUDY DESIGN AND METHODS: Data on erythropoietin (EPO)-associated PRCA were obtained from the Food and Drug Administration (FDA), regulatory authorities in other countries, and the manufacturers of epoetin alfa, epoetin beta, and darbepoetin. The data included information on numbers of PRCA cases and estimated exposure-adjusted incidence rates by EPO product, anemia etiology, administration route, country of PRCA identification, and date reported. RESULTS: In 1999, academicians in Paris identified 12 EPO-treated patients with antibody-mediated PRCA; 11 of these patients were on hemodialysis and had received subcutaneous Eprex (Johnson & Johnson). In 2002, authorities in Europe, Australia, Singapore, and Canada mandated Eprex by IV route to hemodialysis patients, and the relevant manufacturers added Teflon coating to prefilled syringes of Eprex; PRCA cases subsequently decreased by 90 percent. By 2003, 180 Eprex-associated PRCA cases were identified in Europe, Canada, Australia, and Asia, despite improvements in handling. Since 2002, FDA safety databases include information on 59 new cases of antibody-associated PRCA, primarily associated with subcutaneous epoetin alfa and darbepoetin that does not contain HSA. CONCLUSION: Independent actions by regulatory authorities, manufacturers, and academic researchers identified significant numbers of PRCA cases between 1998 and 2003 and characterized the probable etiology. Today, antibody-mediated PRCA is an infrequent class toxicity occurring among some hemodialysis patients on EPOs. [ABSTRACT FROM AUTHOR]

Pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF) and granulocyte colony-stimulating factor (G-CSF) promote haematopoietic progenitor cell maturation. We reviewed the findings for healthy volunteers/donors who developed haematological malignancies following PEG-rHuMGDF or G-CSF administration. Information was reviewed for three of 538 volunteers who received PEG-rHuMGDF in clinical trials and two of 200 donors who underwent G-CSF mobilised stem cell harvesting procedures for sibling stem cell transplants. Mantle cell, diffuse large B-cell lymphoma and chronic lymphocytic leukaemia were diagnosed 1–5 years after PEG-rHuMGDF exposure among three volunteers. For one patient, thrombocytopenia due to autoantibodies to PEG-rHuMGDF developed shortly after PEG-rHuMGDF administration and persisted until chemotherapy was administered. All three achieved complete remission, although one patient relapsed. Acute myeloid leukaemia was diagnosed 4 and 5 years after G-CSF mobilisation in two donors who underwent peripheral blood stem cell donation for sibling allogeneic haematopoietic stem cell transplantation. Following intensive chemotherapy, one died from acute leukaemia and the second is in complete remission. Controversy exists over the appropriateness of administering haematopoietic growth factors to healthy individuals. While a causal relationship with haematological malignancies cannot be demonstrated, long-term follow-up among healthy individuals who receive haematopoietic growth factors is needed. [ABSTRACT FROM AUTHOR]

The article presents a study on the activity of ADAMTS13, a disintegrin and metalloprotease with thrombospondin type 1 motifs 13, activity among ticlopidine-associated thrombotic thrombocytopenic purpura (TTP) patients in Japan. The study mentions that ADAMTS13 is involved in peptide bond cleavage between the amino acids Thymine1605 and Metionine1606 in the A2 domain of the von willebrand factor (VWF). The study reported deficient activity of ADAMTS13 in ticlopidine-associated TTP patients.

A letter to the editor is presented in response to the article related about visual hallucinations in an elderly woman published in a previous issue.

A response by the authors to a letter to the editor about their article related to Charles Bonnet Syndrome is presented.