A multicentred study to validate a consensus bleeding assessment tool developed by the biomedical excellence for safer transfusion collaborative for use in patients with haematological malignancy.

BACKGROUND: There continues to be uncertainty about the optimal approach to documenting bleeding data in platelet transfusion trials, with a desire to apply a common assessment tool across all trials. With this in mind, a consensus bleeding assessment tool (BAT) has been developed by the Biomedical Excellence for Safer Transfusion (BEST) collaborative, based on review of data collection forms used in published randomized trials and following content validation with a range of healthcare professionals at seven haematology centres through BEST members. This study aimed to evaluate reliability and reproducibility of the consensus BAT. METHODS: Replicated clinical assessments of bleeding were undertaken by participants with haematological malignancies recruited at four haematology centres in an international, multicentred, observational study. Concordance of repeat assessments was calculated for agreement in site and grade of bleeding observed. RESULTS: Forty patients consented to participate, and 13 trained bleeding assessors collected these data. Bleeding assessments were carried out on 113 separate days. Of all 225 bleeding assessments, 204 were compared for grade concordance, and 160 were compared for site concordance. There was very good grade concordance (83%, 95% confidence interval 74-93%) and good bleeding site concordance (69%, 95% confidence interval 57-79%) in observations of bleeding. Discordance was primarily in relation to assessing skin bleeding. CONCLUSIONS: Alongside a structured training programme, levels of concordance for a consensus BAT were high. Researchers using assessment tools for bleeding need to balance comprehensive data collection against potential loss of accuracy for some types of bleeding, such as skin findings.

The first-year costs of establishing an unrelated bone marrow donor registry.

The cost of therapies like bone marrow transplantation has been an important consideration for several decades. Bone marrow transplantation is becoming increasingly accepted as an effective treatment for hematologic disorders, including acute nonlymphocytic leukemia. To find suitable donors, bone marrow donor registries are being developed. The first-year costs of establishing an unrelated bone marrow donor registry are reported here. First-year costs are largely due to personnel costs and HLA typing charges. The cost per registrant decreases over time, but further decreases due to economies of scale are limited by the continued fixed requirement for HLA typing. Data are presented by separating costs into six unique categories, thereby allowing other blood centers to estimate start-up costs based on our experience.

Cost-benefit analysis of a plateletapheresis program.

We determined costs and benefits of a community donor plateletapheresis program (CDPP) designed to provide HLA-matched platelet transfusions for patients who were refractory to random-donor platelets (RDPs). Costs of establishing and maintaining the CDPP were $127,520 for the first year (1982). Benefits were expressed as cost savings attributed to the CDPP. After the program began, the use of RDP in the community was 17,458 units less than projected. Estimates of net cost savings during the first year ranged from $177,570 to $272,253 (1982 dollars; cost-to-benefit ratios were 1:1.39 to 1:2.14.) In a matched cohort study of marrow transplant patients, CDPP platelet transfusions were as effective as those from family donors while total platelet and red cell use was unchanged. In patients with acute leukemia treated with chemotherapy, significant reduction in both platelet and red cell use was seen after institution of CDPP support. We conclude that the CDPP is a cost-effective approach to platelet support.

Plateletapheresis program. II. Computer selection of HLA compatible donors.

A rapid, cost-effective data entry and computerized matching system was developed for selection of HLA compatible cytapheresis donors for platelet-alloimmunized patients. The system was user-orientated with a computer-generated prompting system that facilitated program operation. Expansion of the number of compatible donors was achieved by treating splits and crossreactive HLA antigens as identical. By this mechanism, a 500-member donor pool easily supported the needs of a large patient population for single-donor cytapheresis platelets. An average of 3.4 compatible donors per patient was identified. For only two of the 48 (4%) thrombocytopenic recipients was transfusion support from the available donors inadequate to provide a posttransfusion platelet increment. At the end of 7 months, donation frequency for the 441 donors then in the pool averaged 2.0 +/- 2.4. This figure increased to 2.8 +/- 2.4 donations for the 176 panel members who actually underwent cytapheresis. Thus, the impact on donors participating in this program was not excessive.