1.
A decision aid for autologous pre-donation in cardiac surgery--a randomized trial
Laupacis A, O'Connor AM, Drake ER, Rubens FD, Robblee JA, Grant FC, Wells PS
Patient Education and Counseling. 2006;61((3):):458-66.
Abstract
OBJECTIVES The objective of this randomized, controlled study was to determine the usefulness of a decision aid on pre-donation of autologous blood before elective open heart surgery. METHODS The decision aid (DA) group received a tape and booklet which described the options for peri-operative transfusion in detail. The no decision aid (NDA) group received information usually given to patients about autologous donation. RESULTS A total of 120 patients were randomized. The DA group rated themselves better prepared for decision making and showed significant improvements in knowledge (p = 0. 001) and realistic risk perceptions (p = 0. 001). In both groups there was an increase in the proportion of patients choosing allogeneic blood between baseline and follow-up (p = 0. 001). Patients in the DA group were significantly more satisfied with the amount of information they received, how they were treated and with the decision they made, than patients in the NDA group. CONCLUSION The decision aid is useful in preparing patients for decision making. PRACTICE IMPLICATIONS The next stage is to explore strategies to make it available to all appropriate patients.
2.
Effectiveness of perioperative epoetin alfa in patients scheduled for elective hip surgery
Laupacis A
Seminars in Hematology. 1996;33((2 Suppl 2):):51-3; discussion 54.
Abstract
Several strategies have been investigated as a means of reducing allogeneic blood requirements in patients undergoing surgery, including the perioperative administration of epoetin alfa. In a multicenter, double-blind, placebo-controlled study in 208 patients undergoing elective hip replacement surgery, subcutaneous administration of epoetin alfa (300 IU/kg daily) for 14 or 9 days perioperatively (commencing 10 and 5 days preoperatively, respectively) significantly reduced the incidence of primary outcome events (any allogeneic blood transfusion or a postoperative hemoglobin [Hb] level < 8.0 g/dL) compared with placebo (P = .003). Furthermore, the transfusion requirements of epoetin alfa-treated patients were significantly lower than those of patients treated with placebo (P = .007). Preoperative and postoperative Hb levels and reticulocyte counts were higher in epoetin alfa-treated patients compared with placebo. Epoetin alfa was well tolerated, and the incidence of deep vein thrombosis (DVT) was not different from that observed in placebo recipients. Thus, perioperative administration of epoetin alfa reduces the allogeneic blood requirements of patients undergoing elective hip replacement surgery and is of particular benefit in the subgroup of patients whose baseline Hb levels are less than 13.5 g/dL.
3.
Erythropoietin for anaemia in haemodialysis patients: results of a maintenance study (the Canadian Erythropoietin Study Group)
Muirhead N, Laupacis A, Wong C
Nephrology Dialysis Transplantation. 1992;7((8):):811-6.
Abstract
Most published studies of recombinant human erythropoietin (rHuEpo) have been of limited duration and in small patient populations. The present study examines the long-term effects of rHuEpo in 98 haemodialysis patients treated for up to 18 months. All patients had completed a 6 month placebo-controlled study of rHuEpo. Patients previously on placebo (group 1; n = 31) received rHuEpo at an initial dose of 50 U/kg thrice weekly with subsequent dose adjustments to maintain haemoglobin (Hb) in the range 105-120 g/l. Patients previously on rHuEpo (group 2; n = 67) continued on their usual dose with adjustments made to maintain Hb at 105-120 g/l. Haematological parameters were measured every 2 weeks. Quality of life, assessed by a disease-specific kidney disease questionnaire (KDQ), was measured every 6 months. Mean Hb in group 1 increased from 74.2 +/- 11.4 g/l at baseline to 112.9 +/- 12.6 g/l after 12 months of rHuEpo therapy. After 12 weeks of rHuEpo therapy Hb in groups 1 and 2 was indistinguishable. Hb remained constant in both groups throughout the period of follow-up. Mean rHuEpo dose requirements were similar in both groups. At the end of the study the mean intravenous rHuEpo dose in group 1 patients was 176.6 +/- 154.4 and in group 2 patients was 210.0 +/- 144.0 U/kg per week. Access failure was increased during rHuEpo therapy in patients with synthetic grafts (46% versus 7% failures compared to fistulae; P less than 0.001). Group 1 patients receiving rHuEpo had a significant increase in diastolic but not systolic blood pressure despite a 32% increase in overall antihypertensive prescriptions.(ABSTRACT TRUNCATED AT 250 WORDS)
4.
The use of generic and specific quality-of-life measures in hemodialysis patients treated with erythropoietin. The Canadian Erythropoietin Study Group
Laupacis A, Wong C, Churchill D
Controlled Clinical Trials. 1991;12((4, Suppl):):168S-179S.
Abstract
The effect of recombinant human erythropoietin (EPO) on the quality of life and exercise capacity of 118 hemodialysis patients was assessed in a randomized, double-masked placebo-controlled trial. Patients were randomized into three groups: 1) placebo, 2) EPO to achieve a hemoglobin of 95-110 g/L and 3) EPO to achieve a hemoglobin of 115-130 g/L. Patients were followed for six months. Quality of life was assessed using a disease-specific measure [the Kidney Disease Questionnaire (KDQ)] and two generic measures [Sickness Impact Profile (SIP) and the Time Trade OFF (TTO)]. The KDQ contains five dimensions. Functional capacity was assessed with a Six-Minute Walk test (SMW) and an Exercise Stress Test (EST). The mean hemoglobin at six months was 74, 102, and 117 gm/l in groups one, two and three, respectively. There was a marked improvement in quality of life with EPO therapy, but no difference between groups 2 and 3. The outcome measure that was the most responsive to change was the KDQ (P less than .001 for the fatigue and physical symptoms dimensions). The aggregate global (P less than .02) and physical (P = .005) scores of the SIP improved with EPO therapy, the psychosocial score did not. There was no improvement in the TTO. There was an improvement in the EST (P = .02) but not in the SMW. The reproducibility of the outcome measures in placebo-treated patients varied between 0.80 and 0.98 (intra-class correlation coefficient). The correlation among the outcome measures at six months was statistically significant in most cases, as was the correlation of change scores between baseline and six months.
5.
A randomized double-blind study of recombinant human erythropoietin in anaemic hemodialysis patients. Canadian Erythropoietin Study Group
Laupacis A
Transplantation Proceedings. 1991;23((2):):1825-6.
Abstract
This study suggests that both the quality of life and exercise capacity of anaemic hemodialysis patients is improved with EPO therapy. This was seen most convincingly in the dimensions of fatigue and physical symptoms. There was no difference in improvement in quality of life or exercise capacity between patients with a mean hemoglobin level of 102 g/L and those with a mean hemoglobin level of 117 g/L. There was an increase in diastolic blood pressure in the EPO-treated patients, especially those randomized to the high EPO group.