OBJECTIVES: The aim of this study was to assess the measurement equivalence of individual response scale types by using a patient reported outcome measure (PROM) collected on paper and migrated into electronic format for use on the subject's own mobile device (BYOD) and on a provisioned device (site device). METHODS:Subjects suffering from chronic health conditions causing daily pain or discomfort were invited to participate in this single-site, single visit, three-way crossover study. Association between individual item and instrument subscale scores was assessed by using the intraclass correlation coefficient (ICC) and its CI. Participant attitudes toward the use of BYOD in a clinical trial were assessed through use of a questionnaire. RESULTS: In this study, 155 subjects (females 83 [54%]; males 72 [46%]) ages 19 to 69 years (mean ±SD: 48.6 ± 13.1) were recruited. High association between the modes of administration (paper, BYOD, site device) was shown with analysis of ICCs (0.79-0.98) for each response scale type, including visual analogue scale, numeric rating scale, verbal response scale, and Likert scale. Of the subjects, 94% (146 of 155) stated that they would definitely or probably be willing to download an app onto their own mobile device for a forthcoming clinical trial. Forty-five percent of subjects felt BYOD would be more convenient compared with 15% preferring a provisioned device (40% had no preference). CONCLUSIONS: This study provides strong evidence supporting the use of BYOD for PROM collection in terms of the conservation of instrument measurement equivalence across the most widely used response scale types, and high patient acceptance of the approach.
RCT Entities:
OBJECTIVES: The aim of this study was to assess the measurement equivalence of individual response scale types by using a patient reported outcome measure (PROM) collected on paper and migrated into electronic format for use on the subject's own mobile device (BYOD) and on a provisioned device (site device). METHODS: Subjects suffering from chronic health conditions causing daily pain or discomfort were invited to participate in this single-site, single visit, three-way crossover study. Association between individual item and instrument subscale scores was assessed by using the intraclass correlation coefficient (ICC) and its CI. Participant attitudes toward the use of BYOD in a clinical trial were assessed through use of a questionnaire. RESULTS: In this study, 155 subjects (females 83 [54%]; males 72 [46%]) ages 19 to 69 years (mean ± SD: 48.6 ± 13.1) were recruited. High association between the modes of administration (paper, BYOD, site device) was shown with analysis of ICCs (0.79-0.98) for each response scale type, including visual analogue scale, numeric rating scale, verbal response scale, and Likert scale. Of the subjects, 94% (146 of 155) stated that they would definitely or probably be willing to download an app onto their own mobile device for a forthcoming clinical trial. Forty-five percent of subjects felt BYOD would be more convenient compared with 15% preferring a provisioned device (40% had no preference). CONCLUSIONS: This study provides strong evidence supporting the use of BYOD for PROM collection in terms of the conservation of instrument measurement equivalence across the most widely used response scale types, and high patient acceptance of the approach.
Authors: Mariana H G Monje; Rebecca L M Fuller; Esther Cubo; Tiago A Mestre; Ai Huey Tan; Julie C Stout; Shazia Ali; Lana Chahine; Kathy Dujardin; Cheryl J Fitzer-Attas; Jinyoung Youn; Bastiaan R Bloem; Fay B Horak; Aristide Merola; Ralf Reilmann; Serene S Paul; Earl Ray Dorsey; Walter Maetzler; Alberto J Espay; Pablo Martinez-Martin; Glenn T Stebbins; Álvaro Sánchez-Ferro Journal: Mov Disord Clin Pract Date: 2020-12-28
Authors: Lindsay A Jibb; James S Khan; Puneet Seth; Chitra Lalloo; Lauren Mulrooney; Kathryn Nicholson; Dominik A Nowak; Harneel Kaur; Alyssandra Chee-A-Tow; Joel Foster; Jennifer N Stinson Journal: J Med Internet Res Date: 2020-06-16 Impact factor: 5.428
Authors: Saeid Shahraz; Tan P Pham; Marc Gibson; Marie De La Cruz; Munther Baara; Sachin Karnik; Christopher Dell; Sheryl Pease; Suyash Nigam; Joseph C Cappelleri; Craig Lipset; Patrick Zornow; Jeff Lee; Bill Byrom Journal: J Patient Rep Outcomes Date: 2021-02-27