Improved efficiency of daratumumab treatment of multiple myeloma adopting the subcutaneous route: A micro-costing analysis in three Italian hematology centers.

BACKGROUND: Daratumumab is a humanized monoclonal antibody approved for the treatment of adult patients with newly diagnosed or relapsed/refractory multiple myeloma (RRMM). Subcutaneous (SC) formulation proved to be non-inferior in comparison with intravenous (IV) administration route. This study aimed at assessing the economic and time impact associated with the use of SC versus IV daratumumab in patients with RRMM from the perspective of the hematology center. METHODS: This was a 5-month multicenter time-and-motion cross-sectional micro-costing study conducted in three Italian hematology centers among adult patients diagnosed with RRMM with ongoing treatment with IV or SC daratumumab. Measurements were performed by an ad hoc App. RESULTS: Nineteen (20%) IV and 76 (80%) SC administration procedures were measured. Patients spent a mean of 4.85 ± 0.91 or 1.08 ± 0.56 h in the hematology center to receive IV or SC daratumumab, respectively. Healthcare professionals (HCPs) spent a mean of 49.38 ± 16.13 and 20.37 ± 7.88 min of active working time to manage IV and SC administrations, respectively. The infusion chair was occupied for a mean of 4.85 ± 0.91 and 0.99 ± 0.55 h during IV or SC administration, respectively. On average, considering the costs due to HCP and chair time, materials, and overhead costs, every IV and SC administration costed €80.33 and 34.90, respectively. CONCLUSIONS: In conclusion, as compared with IV administration, SC daratumumab was associated with 78%, 59%, 80% savings in terms of patient time, HCP active working time, and infusion chair, respectively, and 56.6% budget savings.

Comparison of the Results of Proficiency Testing in Seven Medical Laboratories - a Benchmark Project to Define a Uniform Key Performance Indicator.

BACKGROUND: In medical laboratories, it is mandatory to ensure the analytical quality of the measurement procedures by proficiency testing (PT). The aim of this study was to evaluate whether the PT results of seven medical laboratories in South Tyrol - as a measure of the analytical performance - were different. METHODS: As a measure for the analytical performance of the individual laboratories, we used the PT results (RIQAS, Randox international quality assessment scheme) of one year for 34 analytes. We calculated annual 'total scores' of each analyte for all participating laboratories and compared them statistically. RESULTS: In 2018, there was a highly significant difference between the seven laboratories in the 'total scores' for the 34 analytes (p < 0.001). The laboratories had a 'cumulative, annual total score' of 75 - 91% of the maximum achievable values. Essentially, two groups could be distinguished. Laboratories 1 - 3 achieved better results (90 - 91%) than laboratories 4 - 7 (77 - 82%). In particular, the non-participation of the laboratories 4 - 7 in several PT cycles in 2018 and the registration in the wrong homogeneous group for some analytes in the laboratories 4 and 5 seem to be responsible for the worse results. CONCLUSIONS: The analytical performance as assessed by the PT results was different across the seven participating laboratories of the South Tyrolean Medical Service. Based on our study results, we defined a uniform key performance indicator for the seven laboratories with a limit value for the 'cumulative, annual total score' of > 80%.

Evaluation of the Impact of Changing Quality Control Rules and Frequency on the Risk Management Index: Results from the Clinical Routine of a Medical Laboratory.

OBJECTIVE: The consideration of the principles of risk management in the analytical process is a current trend. The aim of this study was to evaluate whether the risk management index (RMI) for various laboratory parameters can be influenced by interventions that change the internal quality control (IQC) strategy. METHODS: We selected 10 laboratory parameters associated with cardiovascular disease for the study (myoglobin, N-terminal fragment of the pro B-type natriuretic polypeptide, cardiac troponin T, creatinine kinase, lactate dehydrogenase, glucose, triglycerides, total cholesterol, and low-density lipoprotein and high-density lipoprotein cholesterol). The study-specific interventions included changing the IQC rules and changing the IQC schedule. This was a one-armed intervention study in which changes in the RMI, a measure of patient harm risk, was recorded over time. RESULTS: Before the intervention, the mean RMI was 1.022 (95% confidence interval [CI], 0.269-1.776). After the intervention, the mean RMI was 0.934 (95% CI, 0.088-1.956). The RMI values before and after the intervention were not significantly different (P =.89). CONCLUSION: The study-specific interventions did not lead to an improvement of the RMI in the clinical routines of a medical laboratory. There is a great need to further explore this subject area with interventional studies to clarify how the risk of unintended patient harm can be measurably improved.