Effects of preoperative enoxaparin versus unfractionated heparin on bleeding indices in patients undergoing coronary artery bypass grafting.

BACKGROUND: We examined the effects of preoperative administration of enoxaparin (ENOX), a low-molecular-weight heparin, on bleeding indices and transfusion rates in patients undergoing coronary artery bypass grafting (CABG). METHODS: Patients undergoing isolated CABG between 1997 and 2002 who received preoperative ENOX or a continuous infusion of unfractionated heparin (UFH) were randomly divided into three groups: continuous UFH, ENOX last administered more than 12 hours before surgery (ENOX > 12), and ENOX administered less than 12 hours before surgery (ENOX < 12). Perioperative hemoglobin values, transfusion rates, and bleeding complications were compared. RESULTS: A total of 69, 58, and 34 patients comprised the UFH, ENOX > 12, and ENOX < 12 groups, respectively. Preoperative demographics and hematologic data were similar among the groups. Compared with the UFH group, the ENOX < 12 group had significantly lower postoperative hemoglobin values (9.6 +/- 1.3 g/dL versus 10.4 +/- 1.2 g/dL, p < 0.05), higher transfusion rates (73.5% versus 50.7%, p < 0.05), and required more total packed red cells per patient (882 +/- 809 mL versus 472 +/- 626 mL, p < 0.05). A nonsignificant increase was noted in the risk of returning to the operating room for bleeding in patients who had received ENOX compared with patients receiving UFH (6.5% versus 2.9%). CONCLUSIONS: The preoperative use of ENOX less than 12 hours before CABG is associated with lower postoperative hemoglobin values and higher rates of transfusion than continuous UFH.

Medication-related predictors of health-related quality of life in glaucoma patients enrolled in a medicare health maintenance organization.

BACKGROUND: Glaucoma is an important public health concern in the United States, particularly among older adults (aged >or=65 years). Pharmacologic therapy for glaucoma consists mainly of topical eye drops containing beta-blockers or prostaglandin analogs. OBJECTIVE: The goal of this study was to assess the associations between factors of topical medication use (self reported medication compliance, belief in benefit of medication use, usage difficulty, usage assistance, and complexity of medication regimen) and health-related quality of life (HRQOL) in a cross-sectional population of older patients with glaucoma. METHODS: A self-administered, 48-question survey soliciting information on medication-taking behaviors, treatmen-trelated factors, and HRQOL was mailed to members of a Medicare health maintenance organization who were aged >or=65 years and had primary open-angle glaucoma. Two mailings were conducted 4 months apart; the second was sent to members whose responses to the first mailing had not yet been received. The 12-Item Short-Form Health Survey (SF-12) and the 25-Item National Eye Institute Visual Function Questionnaire (VFQ-25) were used to assess HRQOL. Other questions addressed perceptions of eye drop use in these patients. Multiple regression techniques were used to analyze associations between medication-related factors and HRQOL in this population. RESULTS: The questionnaire was mailed to 589 patients; 375 responded (218 in the first mailing and 157 in the second mailing). A total of 358 responses were complete and analyzable (effective response rate, 62%). After controlling for the effects of other confounders, we found that self reported difficulty in using eye drops was strongly associated with decreased HRQOL (11.5% in VFQ-25 total score and 8.4% in SF-12 mental health score, P<0.05). Other medication-related factors that were examined were not significantly associated with changes in HRQOL. CONCLUSION: Based on our findings, patients aged >or=65 years with glaucoma were likely to have significant comorbidity, which affected both visual and general health and well-being perception. Additionally, a significant proportion of these patients reported difficulty with use of topical medication, which was independently associated with a significant decrease in HRQOL. Care of older patients with glaucoma should incorporate strategies to minimize the difficulty associated with medication use.

Working with the institutional review board.

PURPOSE: Working with an institutional review board (IRB) to ensure compliance and ethical conduct of research involving human subjects is discussed. SUMMARY: The Department of Health and Human Services (DHHS) and Food and Drug Administration regulations for the conduct of human research are grounded in the principles of the Belmont Report. By establishing the requirements for the function and operation of the IRB, the criteria needed for the review and approval of research, and the requirements for obtaining and documenting informed consent, the federal regulations help ensure the safety, rights and welfare of subjects. In developing research protocols and submissions to the IRB, the investigator should include clear, detailed information that addresses the regulatory requirements for the review and approval of research. Before starting a research study, review and approval by the IRB is required unless the study is determined to be minimal risk and fits one of the defined categories. Some research projects involving observation of public behavior, collection of anonymous surveys of nonvulnerable individuals in which the information is not considered sensitive, and evaluation of standard education practices may be exempt from DHHS regulations. Informed consent is central to the protection of human subjects and is required unless the IRB allows a waiver or alteration of informed consent. Once the study is approved, the investigator must conduct the study as approved by the IRB and continue to meet the regulatory requirements related to modifications, reporting unanticipated events, and continuing review. CONCLUSION: IRB review is integral to ensuring regulatory compliance and ethical conduct of research involving human subjects. Working closely with the IRB or colleagues who have had experience with the IRB will help junior investigators better understand the IRB submission and review process.