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Clinical Pathology Selected Abstracts, 2/13

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Clinical pathology abstracts editor: Deborah Sesok-Pizzini, MD, MBA, associate professor, Department of Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, and medical director, Blood Bank and Transfusion Medicine, Children’s Hospital of Philadelphia.

Outcome of patients who refuse transfusion after cardiac surgery

Jehovah’s Witness patients may refuse blood transfusion, due to religious beliefs, following cardiac surgery. Strategies to conserve blood for such patients may include the preoperative use of erythropoietin, iron, and B-complex vitamins, as well as hemoconcentration; intraoperative use of antifibrinolytics and cell-saver and smaller cardiopulmonary bypass circuits; and tolerance of low hematocrit levels postoperatively. There is concern, however, that these practices may impact short- and long-term morbidity and survival. To address this issue, the authors used propensity methods and parametric multiphase hazard statistical analysis to study postoperative morbidity, in-hospital mortality, and long-term survival in Jehovah’s Witness patients, hereafter referred to as Witnesses, versus a similarly matched group of patients who received transfusions. A total of 322 Witnesses and 87,453 non-Witnesses who underwent cardiac surgery at the Cleveland Clinic from Jan. 1, 1983 to Jan. 1, 2011 were included in the study. The study results showed that after propensity matching, Witnesses and non-Witnesses who received transfusions had similar risks of in-hospital mortality, stroke, atrial fibrillation, and renal failure. However, statistical differences were found, with Witnesses having lower occurrences of postoperative myocardial infarction, prolonged ventilation, and additional operations for bleeding, as well as shorter intensive care and postoperative lengths of stay. The study concluded that Witnesses had similar late survival outcomes but better early survival outcomes compared to the matched controls who received transfusions. Although there are many limitations to this study, including variability in treatment of Witnesses over the study period, the study suggests that unique blood conservation strategies do not appear to place patients at heightened risk for reduced long-term survival.

Pattakos G, Koch CG, Brizzio ME, et al. Outcome of patients who refuse transfusion after cardiac surgery. Arch Intern Med. 2012;172(15):1154–1160.

Correspondence: Dr. Colleen G. Koch at kochc@ccf.org

 

A framework for prioritizing cancer genomics research

Genomics research is progressing at an explosive rate, and translating the research findings into new tests is a goal of many genetics laboratories. Many factors influence how laboratories prioritize the development and implementation of new tests. Furthermore, there is a lack of prospective trial evidence that compares the outcomes of genomic testing strategies with standardized approaches to clinical care. Using comparative effectiveness research (CER), researchers and clinicians can systematically evaluate and compare different interventions and strategies to determine the most effective approach for patients. Further, CER trial designs may help compare genomic versus standard clinical care strategies. In this setting, involving other stakeholders in the decisionmaking group may result in a better decision. The authors evaluated six candidate cancer genomics technologies and priority ranked them in a prospective CER trial. The goal of the study was to identify criteria that a diverse group of stakeholders may use to evaluate and prioritize cancer genomics projects. An external advisory group consisting of patients/consumers, payers, clinicians, and test developers was convened. The group used a modified Delphi approach to prioritize projects during a one-day meeting. At first, nine qualitative priority-setting criteria were used. But the stakeholders primarily discussed six of the nine criteria: clinical benefits, population health impacts, economic impacts, analytical and clinical validity, clinical trial implementation and feasibility, and market factors. Additional criteria, including patient-reported outcomes, clinical trial ethics, and trial recruitment, were also identified during the process and incorporated into the criteria. The authors concluded that this modified Delphi approach may be used to effectively prioritize genomics projects for evaluation in a CER trial. Although the study was limited by the number of stakeholders included in the process, the diverse group was able to provide perspectives to assure that the research that was prioritized was relevant to its end users. The authors noted that their findings may be used as a guide for others electing to use priority-setting frameworks to shape investments in genomics technology.

Esmail LC, Roth J, Rangarao S, et al. Getting our priorities straight: a novel framework for stakeholder-informed prioritization of cancer genomics research [published ahead of print October 4, 2012]. Genet Med. doi:10.1038/gim.2012.103.

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