Vishakha Sharma1, Allan Fong1, Robert A Beckman1, Shruti Rao1, Simina M Boca1, Peter B McGarvey1, Raj M Ratwani1, Subha Madhavan1. 1. 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.
Abstract
PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.
PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.
Authors: A Lawrence Gould; Robert K Campbell; John W Loewy; Robert A Beckman; Jyotirmoy Dey; Anja Schiel; Carl-Fredrik Burman; Joey Zhou; Zoran Antonijevic; Eva R Miller; Rui Tang Journal: PLoS One Date: 2022-06-24 Impact factor: 3.752
Authors: Joaquin Mateo; Lotte Steuten; Philippe Aftimos; Fabrice André; Mark Davies; Elena Garralda; Jan Geissler; Don Husereau; Iciar Martinez-Lopez; Nicola Normanno; Jorge S Reis-Filho; Stephen Stefani; David M Thomas; C Benedikt Westphalen; Emile Voest Journal: Nat Med Date: 2022-04-19 Impact factor: 87.241
Authors: J Thouvenin; C Van Marcke; L Decoster; G Raicevic; K Punie; M Vandenbulcke; R Salgado; E Van Valckenborgh; B Maes; S Joris; D Vander Steichel; K Vranken; S Jacobs; F Dedeurwaerdere; G Martens; H Devos; F P Duhoux; M Rasschaert; P Pauwels; K Geboes; J Collignon; S Tejpar; J-L Canon; M Peeters; A Rutten; T Van de Mooter; J Vermeij; D Schrijvers; W Demey; W Lybaert; J Van Huysse; J Mebis; A Awada; K B M Claes; A Hebrant; J Van der Meulen; B Delafontaine; I Vanden Bempt; J Maetens; M de Hemptinne; S Rottey; P Aftimos; J De Grève Journal: ESMO Open Date: 2022-08-12