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131.
The Multicenter Study of Hydroxyurea in Sickle Cell Anemia (MSH) demonstrated the efficacy of hydroxyurea in reducing the rate of painful crises compared to placebo. We used resource utilization data collected in the MSH to determine the cost-effectiveness of hydroxyurea. The MSH was a randomized, placebo-controlled double-blind clinical trial involving 299 patients at 21 sites. The primary outcome, visit to a medical facility, was one of the criteria to define occurrence of painful crisis. Cost estimates were applied to all outpatient and emergency department visits and inpatient hospital stays that were classified as a crisis. Other resources for which cost estimates were applied included hospitalization for chest syndrome, analgesics received, hydroxyurea dosing, laboratory testing, and clinic visits for management of patient care. Annualized differential costs were calculated between hydroxyurea- and placebo-receiving patients. Hospitalization for painful crisis accounted for the majority of costs in both arms of the study, with an annual mean of $12,160 (95% CI: $9,440, $14,880) for hydroxyurea and $17,290 (95% CI: $13,010, $21,570) for placebo. The difference in means was $5,130 (95% CI: $60, $10,200; P = 0.048). Chest syndrome was the next largest cost with a mean difference of $830 (95% CI: $-340, $2,000; P = 0.16). The hydroxyurea arm was also associated with lower costs for emergency department visits, transfusion, and use of opiate analgesics. In total, the annual average cost per patient receiving hydroxyurea was $16,810 (95% CI: $13,350, $20,270) and the annual average costs per patient receiving placebo was $22,020 (95% CI: $17,340, $26,710). The difference in means was $5,210 (95% CI: $-610, $11,030; P = 0.21). The cost of hydroxyurea with the more intensive monitoring required when using this drug appears to be more than offset by decreased costs for medical care of painful crisis and analgesic use. Although the total cost difference was not significant statistically, these results suggest that hydroxyurea therapy is cost-effective compared to placebo in the management of adult patients with sickle cell anemia. If hydroxyurea can prevent development of chronic organ damage, long-term savings may be even greater. 相似文献
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We provide an overview of the individual and combined clinical endpoints and patient-reported outcomes typically used in clinical trials and prospective epidemiological investigations. We discuss the strengths and limitations associated with the utilization of aggregated study endpoints and surrogate measures of important clinical endpoints and patient-centered outcomes. We hope that the points raised in this overview will lead to the collection of clinically rich, relevant, measurable, and cost-efficient study outcomes. 相似文献
136.
Stacey Panozzo Brian Le Anna Collins Jennifer Weil Jan Whyte Michael Barton Maria Coperchini Meri Rametta Jennifer Philip 《Internal medicine journal》2020,50(2):243-246
Following legislative changes in the availability and prescribing of medicinal cannabis in Australia, we sought to understand prospectively the nature of information seeking and requests for medicinal cannabis in consultations between palliative care clinicians and patients with cancer. The 104 discussions were overwhelmingly initiated by patients and carers (93%) and were for a variety of symptoms, reflecting high levels of patient interest in the use of medicinal cannabis in cancer. 相似文献
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Krone N Reisch N Idkowiak J Dhir V Ivison HE Hughes BA Rose IT O'Neil DM Vijzelaar R Smith MJ MacDonald F Cole TR Adolphs N Barton JS Blair EM Braddock SR Collins F Cragun DL Dattani MT Day R Dougan S Feist M Gottschalk ME Gregory JW Haim M Harrison R Olney AH Hauffa BP Hindmarsh PC Hopkin RJ Jira PE Kempers M Kerstens MN Khalifa MM Köhler B Maiter D Nielsen S O'Riordan SM Roth CL Shane KP Silink M Stikkelbroeck NM Sweeney E Szarras-Czapnik M Waterson JR Williamson L Hartmann MF Taylor NF 《The Journal of clinical endocrinology and metabolism》2012,97(2):E257-E267
139.
Hwang KK Chen X Kozink DM Gustilo M Marshall DJ Whitesides JF Liao HX Catera R Chu CC Yan XJ Luftig MA Haynes BF Chiorazzi N 《Blood》2012,119(7):e35-e44
B-cell chronic lymphocytic leukemia (B-CLL) is characterized by the clonal expansion of CD5-expressing B lymphocytes that produce mAbs often reactive with microbial or autoantigens. Long-term culture of B-CLL clones would permit the collection and characterization of B-CLL mAbs to study antigen specificity and of B-CLL DNA to investigate molecular mechanisms promoting the disease. However, the derivation of long-term cell lines (eg, by EBV), has not been efficient. We have improved the efficiency of EBV B-CLL transformation of CpG oligonucleotide-stimulated cells by incubating patient peripheral blood mononuclear cells in the presence of an irradiated mouse macrophage cell line, J774A.1. Using this approach, peripheral blood mononuclear cells isolated from 13 of 21 B-CLL patients were transformed as documented by IGHV-D-J sequencing. Four clones grew and retained CD5 expression in culture for 2 to 4 months. However, despite documentation of EBV infection by expression of EBNA2 and LMP1, B-CLL cells died after removal of macrophage feeder cells. Nevertheless, using electrofusion technology, we generated 6 stable hetero-hybridoma cell lines from EBV-transformed B-CLL cells, and these hetero-hybridomas produced immunoglobulin. Thus, we have established enhanced methods of B-CLL culture that will enable broader interrogation of B-CLL cells at the genetic and protein levels. 相似文献