Decision impact studies, evidence of clinical utility for genomic assays in cancer: A scoping review

• Published in: PloS one 2023-03, Vol.18 (3), p.e0280582
• Main Authors: Parker, Gillian, Hunter, Sarah, Ghazi, Samer, Hayeems, Robin Z, Rousseau, Francois, Miller, Fiona A
• Format: Article
• Language: English
• Subjects: Assaying; Biology and Life Sciences; Breast cancer; Breast Neoplasms; Cancer; Cancer therapies; Chemotherapy; Clinical decision making; Clinical outcomes; Decision making; Empirical analysis; Genetic aspects; Genetic screening; Genomics; Humans; Male; Medical research; Medicine and Health Sciences; Methods; Patients; People and Places; Prognosis; Proprietary; Prostate; Prostate cancer; Reimbursement; Research and Analysis Methods; Social Sciences; Validity
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0280582

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. 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. 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. 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.