In European patients treated with sorafenib, the HAP was the most discriminant prognostic score and may facilitate stratification in trials and inform clinical decision making.

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Background Decision impact studies have become increasingly prevalent in cancer prognostic research in recent years. These studies aim to evaluate the impact of a genomic test on decision-making and appear to be a new form of evidence of clinical utility. The objectives of this review were to identify and characterize decision impact studies in genomic medicine in cancer care and categorize the types of clinical utility outcomes reported. Methods We conducted a search of four databases, Medline, Embase, Scopus and Web of Science, from inception to June 2022. Empirical studies that reported a “decision impact” assessment of a genomic assay on treatment decisions or recommendations for cancer patients were included. We followed scoping review methodology and adapted the Fryback and Thornbury Model to collect and analyze data on clinical utility. The database searches identified 1803 unique articles for title/abstract screening; 269 articles moved to full-text review. Results 87 studies met inclusion criteria. All studies were published in the last 12 years with the majority for breast cancer (72%); followed by other cancers (28%) (lung, prostate, colon). Studies reported on the impact of 19 different proprietary (18) and generic (1) assays. Across all four levels of clinical utility, outcomes were reported for 22 discrete measures, including the impact on provider/team decision-making (100%), provider confidence (31%); change in treatment received (46%); patient psychological impacts (17%); and costing or savings impacts (21%). Based on the data synthesis, we created a comprehensive table of outcomes reported for clinical utility. Conclusions This scoping review is a first step in understanding the evolution and uses of decision impact studies and their influence on the integration of emerging genomic technologies in cancer care. The results imply that DIS are positioned to provide evidence of clinical utility and impact clinical practice and reimbursement decision-making in cancer care. Systematic review registration: Open Science Framework osf.io/hm3jr.

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Peripheral blood stem cell (PBSC) collection from donors through apheresis has become the main source of stem cells for hematopoietic stem cell transplantation. This procedure requires a high blood flow venous access. A peripheral venous catheter (PVC), compared to a central venous catheter (CVC), is considered to provide safer venous access. However, initially at our institution, King Abdul-Aziz Medical City - Riyadh, a CVC was frequently used (72%). A quality improvement multidisciplinary team has been formed to conduct a systematic quality performance analysis to evaluate the current process of collecting donor PBSCs with the aim to reduce CVC use to less than the international benchmark (20%). A quality improvement methodology, rapid cycles of plan-do-study-act (PDSA), was used to test a set of initiatives. An Intravenous (IV) team assessed the donor's venous access and inserted an appropriate PVC when feasible. This project ran over 16 months with 42 adult donors undergoing PBSC collection. During the first PDSA cycle, 1 CVC was inserted for every 4 donors. In the second PDSA cycle, 1 CVC was inserted for every 8 apheresis donations. In the third PDSA cycle, no CVC was used for 30 apheresis donations. The targeted stem cell dose was collected successfully in one apheresis session in all donors assigned for PVC access with no complications. A significant reduction of CVC use from 72% to 0% was achieved. This quality improvement project demonstrated that a successful apheresis procedure can be achieved easily and safely in the majority of PBSC donors preventing the potential adverse events associated with CVCs. The interdisciplinary collaboration between the IV team, apheresis and clinical hematology teams was paramount to optimize the safe care of donors.