Background: Routine use of next-generation sequencing (NGS) gene panel testing is now widely adopted for therapeutic decision-making in patients with advanced solid malignancies. The VA National Precision Oncology Program was launched in 2016 to standardize and facilitate the adoption of NGS testing within VHA. As part of the 2016 Cancer Moonshot initiative, VHA began using IBM Watson for Genomics (WfG) to assist with annotation of NGS results.
Purpose/Rationale: The primary objective of this program evaluation is to investigate the impact of NGS testing and WfG annotation on therapeutic decision-making by VA providers. Secondary objectives will include assessing the efficiency and efficacy of precision oncology, the attitudes of patients and providers towards the process, and the cost-effectiveness of these techniques.
Methods: Evaluation will be performed as a mixed-methods study using a combination of provider survey and retrospective analysis of veterans who received their oncologic care through VHA and underwent NGS testing. We will review health records from approximately 150 patients who underwent NGS testing and review via expert “precision oncology consultation,” as well as a sampling of 150 patients who underwent NGS testing alone. We will query the medical record to identify the timing of testing and reporting of results to the ordering providers. Changes in provider decision-making based on NGS results/consultation will be directly assessed by reviewing the medical record for proposed therapy prior to testing/consultation in addition to pharmacy data for choice of therapeutic agent following formal reporting of NGS results. Survey data will be used to evaluate physician attitudes towards NGS testing, reasons for seeking expert consultation, as well as satisfaction with the overall process. We will identify and implement prospective methods of data collection for future NGS testing and “precision oncology consultation”, including common criteria for consultation and proposed decision-making before and after testing/consultation. Further outcome assessments will convey the financial toxicity of the treatment changes and the impact on patient outcomes.
