Sharma Vishakha, Fong Allan, Beckman Robert A, Rao Shruti, Boca Simina M, McGarvey Peter B, Ratwani Raj M, Madhavan Subha
Vishakha Sharma, Robert A. Beckman, Shruti Rao, Simina M. Boca, Peter B. McGarvey, and Subha Madhavan, Georgetown University; Vishakha Sharma, Robert A. Beckman, Simina M. Boca, and Subha Madhavan, Georgetown University Medical Center; Allan Fong and Raj M. Ratwani, National Center for Human Factors in Healthcare, MedStar Health; and Raj M. Ratwani, Georgetown University School of Medicine, Washington, DC.
JCO Precis Oncol. 2018 Nov;2:1-11. doi: 10.1200/PO.17.00296.
We conducted usability studies on commercially available molecular diagnostic (MDX) test reports to identify strengths and weaknesses in content and form that drive clinical decision making. Given routine genomic testing in cancer medicine, oncologists must interpret MDX reports as well as evidence concerning clinical utility of biomarkers accurately for treatment or trial selection. This work aims to evaluate effectiveness of MDX reports in facilitating cancer treatment planning.
Fourteen clinicians at an academic tertiary care medical facility, with a wide range of experience in oncology and in the use of molecular testing, participated in this study. Three commercially available, widely used, Clinical Laboratory Improvement Amendments (CLIA)-certified, College of American Pathologists (CAP)-accredited test reports (labeled Laboratories A, B, and C) were used. Eye tracking, surveys, and think-aloud protocols were used to collect usability data for these MDX reports focusing on ease of comprehension and actionability.
Clinicians found two primary areas in molecular diagnostic reports most useful for patient care: therapy options with benefit or lack of benefit to patients, including enrolling clinical trials; and pathogenic tumor molecular anomalies detected. Therapeutic implications and therapy classes such as US Food and Drug Administration-approved off-label, on-label, clinical trials were critical for decision making. However, all reports had usability and comprehension issues in these areas and could be improved.
Focused usability studies can help drive our understanding of the clinical workflow for use of molecular diagnostic tests in cancer care. This in turn can have major effects on quality of care, outcomes, costs, and patient satisfaction. This study demonstrates the use of specific usability techniques (eye tracking and think-aloud protocols) to help clinical laboratories improve MDX report design in a precision oncology treatment setting.
我们对市售的分子诊断(MDX)测试报告进行了可用性研究,以确定在内容和形式上推动临床决策的优势和劣势。鉴于癌症医学中的常规基因组检测,肿瘤学家必须准确解读MDX报告以及有关生物标志物临床效用的证据,以便进行治疗或试验选择。这项工作旨在评估MDX报告在促进癌症治疗规划方面的有效性。
一家学术三级医疗设施的14名临床医生参与了本研究,他们在肿瘤学和分子检测使用方面拥有广泛经验。使用了三份市售的、广泛使用的、经临床实验室改进修正案(CLIA)认证、美国病理学家协会(CAP)认可的测试报告(分别标记为实验室A、B和C)。使用眼动追踪、调查和出声思考协议来收集这些MDX报告的可用性数据,重点关注易理解性和可操作性。
临床医生发现分子诊断报告中有两个主要领域对患者护理最有用:对患者有益或无益的治疗选择,包括参加临床试验;以及检测到的致病性肿瘤分子异常。治疗意义和治疗类别,如美国食品药品监督管理局批准的超说明书用药、说明书用药、临床试验,对决策至关重要。然而,所有报告在这些领域都存在可用性和理解问题,有待改进。
有针对性的可用性研究有助于推动我们对癌症护理中分子诊断测试临床工作流程的理解。这反过来可能对护理质量、结果、成本和患者满意度产生重大影响。本研究展示了使用特定的可用性技术(眼动追踪和出声思考协议)来帮助临床实验室在精准肿瘤治疗环境中改进MDX报告设计。