Conflicting Terminology in Digital Health Space: A Call for Consensus | Applied Clinical Trials | February 15, 2023 | eCOA Consortium | https://www.appliedclinicaltrialsonline.com/view/conflicting-terminology-in-digital-health-space-a-call-for-consensus |
First-hand Perspectives on Achieving True Digital Health Engagement | Applied Clinical Trials | December 2, 2022 | eCOA Consortium | https://www.appliedclinicaltrialsonline.com/view/first-hand-perspectives-on-achieving-true-digital-health-engagement |
Comparability of a provisioned device versus bring your own device for completion of patient-reported outcome measures by participants with chronic obstructive pulmonary disease: quantitative study findings | Journal of Patient-Reported Outcomes | November 26, 2022 | Stacie Hudgens, Louise Newton, Sonya Eremenco, Mabel Crescioni, Tara Symonds, Philip C. G. Griffiths, David S. Reasner, Bill Byrom, Paul O’Donohoe, Susan Vallow on behalf of the Patient-Reported Outcome (PRO) Consortium and Electronic Clinical Outcome Assessment (eCOA) Consortium | https://jpro.springeropen.com/articles/10.1186/s41687-022-00521-3 |
Implementing Numeric Rating and Visual Analog Scales in an eCOA Solution | Applied Clinical Trials | November 10, 2022 | eCOA Consortium | https://www.appliedclinicaltrialsonline.com/view/implementing-numeric-rating-and-visual-analog-scales-in-an-ecoa-solution |
Survey Investigates Backup Solution Adoption for ePRO Systems | Applied Clinical Trials | October 14, 2022 | eCOA Consortium | https://www.appliedclinicaltrialsonline.com/view/survey-investigates-backup-solution-adoption-for-epro-systems |
Evaluating the Use of Backup Solutions for ePRO Systems | Applied Clinical Trials | September 7, 2022 | eCOA Consortium | https://www.appliedclinicaltrialsonline.com/view/evaluating-the-use-of-backup-solutions-for-epro-systems |
Measurement Comparability of Electronic and Paper Administration of Visual Analogue Scales: A Review of Published Studies | Therapeutic Innovation & Regulatory Science | February 10, 2022 | Byrom B, Elash CA, Eremenco S, Bodart S, Muehlhausen W, Platko JV, Watson C, Howry C | https://doi.org/10.1007/s43441-022-00376-2 |
Comparability of a Provisioned Device Versus Bring Your Own Device for Completion of Patient-Reported Outcome Measures by Participants with Chronic Obstructive Pulmonary Disease: Qualitative Interview Findings | Journal of Patient-Reported Outcomes | April 4, 2022 | Newton L, Knight-West O, Eremenco S, Hudgens S, Crescioni M, Symonds T, Reasner DS, Byrom B, O’Donohoe P, Vallow S on behalf of the Patient-Reported Outcome Consortium and the Electronic Clinical Outcome Assessment Consortium | https://doi.org/10.1186/s41687-022-00492-5 |
Progressing BYOD Adoption | Applied Clinical Trials | June 4, 2022 | eCOA Consortium | https://www.appliedclinicaltrialsonline.com/view/progressing-byod-adoption |
Administering Complex Cognitive Tests Remotely in The Cognitively-Impaired | Applied Clinical Trials | June 7, 2022 | eCOA Consortium | https://www.appliedclinicaltrialsonline.com/view/administering-complex-cognitive-tests-remotely-in-the-cognitively-impaired |
The Power of Collaboration: Introducing the eCOA Consortium | Applied Clinical Trials | May 12, 2022 | eCOA Consortium | https://www.appliedclinicaltrialsonline.com/view/the-power-of-collaboration-introducing-the-ecoa-consortium |
Best Practice Recommendations: User Acceptance Testing for Systems Designed to Collect Clinical Outcome Assessment Data Electronically | Therapeutic Innovation & Regulatory Science | March 1, 2022 | Gordon S, Crager J, Howry C, Barsdorf AI, Cohen J, Crescioni M, Dahya B, Delong P, Knaus C, Reasner DS, Vallow S, Zarzar K, Eremenco S | https://doi.org/10.1007/s43441-021-00363-z |
Recommendations for the Electronic Migration and Implementation of Clinician-reported Outcome Assessments in Clinical Trials | Value in Health | April 1, 2022 | Romero H, DeBonis D, O’Donohoe P, Wyrwich K, Arnera V, Platko J, Willgoss T, Harris K, Crescioni M, Steele S, Eremenco S, on behalf of the Electronic Patient-Reported Outcome Consortium and the Patient-Reported Outcome Consortium | https://doi.org/10.1016/j.jval.2022.02.012 |
Demystifying Submissions of eCOA Documentation for Ethics Review: Are We Making Submissions More Difficult than Necessary? | Applied Clinical Trials | August 14, 2020 | Gertel A, Raymond S, Vallow S, Arnera V, Crescioni M, Chassany O, Bodart S, Eremenco S | https://www.appliedclinicaltrialsonline.com/view/demystifying-submissions-of-ecoa-documentation-for-ethics-review-are-we-making-submissions-more |
Agreement Among Paper and Electronic Modes of the EQ-5D-5L | The Patient – Patient-Centered Outcomes Research | April 28, 2020 | Lundy JJ, Coons SJ, Flood E, Patel MJ on behalf of the ePRO Consortium | https://doi.org/10.1007/s40271-020-00419-6 |
Perceived Burden of Completion of Patient-Reported Outcome Measures in Clinical Trials: Results of a Preliminary Study | Therapeutic Innovation & Regulatory Science | December 23, 2019 | Bodart S, Byrom B, Crescioni M, Eremenco S, Flood E, on behalf of the ePRO Consortium | https://doi.org/10.1177%2F2168479018788053 |
Best Practices for Avoiding Paper Backup When Implementing Electronic Approaches to Patient-Reported Outcome Data Collection in Clinical Trials | Therapeutic Innovation & Regulatory Science | December 23, 2019 | Howry C, Elash C, Crescioni M, Eremenco S, O’Donohoe P, Rothrock T, on behalf of the ePRO Consortium | https://doi.org/10.1177%2F2168479018785160 |
Training on the Use of Technology to Collect Patient-Reported Outcome Data Electronically in Clinical Trials: Best Practice Recommendations from the ePRO Consortium | Therapeutic Innovation & Regulatory Science | December 23, 2019 | Ly J, Crescioni M, Eremenco S, Bodart S, Donoso M, Butler A, Dallabrida S, on behalf of the ePRO Consortium | https://link.springer.com/article/10.1177/2168479018796206 |
Selection of and Evidententiary Considerations for Wearable Devices and Their Measurements for Use in Regulatory Decision Making: Recommendations from the ePRO Consortium | Value in Health | November 7, 2017 | Byrom B, Watson C, Doll H, Coons SJ, Eremenco S, Ballinger R, McCarthy M, Crescioni M, O’Donohoe P, Howry C | https://doi.org/10.1016/j.jval.2017.09.012 |
Optimizing Electronic Capture of Clinical Outcome Assessment Data in Clinical Trials: The Case of Patient-Reported Endpoints | Therapeutic Innovation & Regulatory Science | December 30, 2015 | Fleming S, Barsdorf AI, Howry C, O’Gorman H, Coons SJ | https://doi.org/10.1177/2168479015609102 |
“Bring Your Own Device” (BYOD): The Future of Field-Based Patient-Reported Outcome Data Collection in Clinical Trials | Therapeutic Innovation & Regulatory Science | December 30, 2015 | Gwaltney C, Coons SJ, O’Donohoe P, O’Gorman H, Denomey M, Howry C, Ross J | https://doi.org/10.1177/2168479015609104 |
Considerations for Requiring Subjects to Provide a Response to Electronic Patient-reported Outcome Instruments | Therapeutic Innovation & Regulatory Science | October 13, 2015 | Paul O’Donohoe P, Lundy JJ, Gnanasakthy A, Greene A | http://dij.sagepub.com/content/49/6/792.short |
Capturing Patient-Reported Outcome (PRO) Data Electronically: The Past, Present, and Promise of ePRO Measurement in Clinical Trials | The Patient – Patient-Centered Outcomes Research | October 10, 2014 | Coons SJ, Eremenco S, Lundy JJ, O’Donohoe P, O’Gorman H, Malizia W | https://doi.org/10.1007/s40271-014-0090-z |
ePRO Systems Validation: Clearly Defining the Roles of Clinical Trials Teams and ePRO System Providers | Value in Health | June, 2013 | Coons, SJ | https://doi.org/10.1016/j.jval.2013.04.006 |
Best Practices for Participant Registration in Clinical Trials Using Bring Your Own Device (BYOD) Technology for Data Collection | White Paper | April, 2021 | eCOA Consortium | https://c-path.org/wp-content/uploads/2022/02/BestPractices5_upd.pdf |
COVID-19: Risk Assessment and Mitigation Strategies for the Collection of Patient-Reported Outcome Data through Clinical Sites | White Paper | June 5, 2020 | eCOA Consortium | https://c-path.org/wp-content/uploads/2022/02/COVID-19_CPath_v3.0_2020JUN5.pdf%22 |
Best Practices for Electronic Implementation of Response Scales for Patient-Reported Outcome Measures | White Paper | September, 2018 | eCOA Consortium | https://c-path.org/wp-content/uploads/2022/02/BestPractices2_Response_Scales.pdf |
Best Practices for Maximizing Electronic Data Capture Options during the Development of New Patient-Reported Outcome Measures | White Paper | September, 2018 | eCOA Consortium | https://c-path.org/wp-content/uploads/2022/02/BestPractices_Maximizing_Data_Capture.pdf |
Best Practices for Migrating Existing Patient-Reported Outcome Measures to a New Data Collection Model | White Paper | September, 2018 | eCOA Consortium | https://c-path.org/wp-content/uploads/2022/02/BestPractices3_Migrating.pdf |
eCOA Systems and CE Certification | White Paper | March, 2023 | eCOA Consortium | https://c-path.org/wp-content/uploads/2023/03/eCOA-Systems-and-CE-Certification.pdf |
eCOA Systems and the CE Mark: Navigating the Regulations | Applied Clinical Trials | March 2, 2023 | eCOA Consortium | https://www.appliedclinicaltrialsonline.com/view/ecoa-systems-and-the-ce-mark-navigating-the-regulations |
Best Practice Recommendations for Electronic Patient-Reported Outcome (ePRO) Dataset Structure and Standardization to Support Drug Development | Value in Health | August, 2023 | Hudgens S, Kern S, Barsdorf AI, Cassells S, Rowe A, King-Kallimanis BL, Coon C, Low G, Eremenco S | https://doi.org/10.1016/j.jval.2023.02.011 |
Data Standards and ePRO Systems: A Road Less Travelled? | Applied Clinical Trials | April 14, 2023 | eCOA Consortium | https://www.appliedclinicaltrialsonline.com/view/data-standards-and-epro-systems-a-road-les-travelled |
An eCOA Lexicon: The Quest for Single, Trusted Source of Terminology | Applied Clinical Trials | June 7, 2023 | eCOA Consortium | https://www.appliedclinicaltrialsonline.com/view/an-ecoa-lexicon-the-quest-for-single-trusted-source-of-terminology |
eCOA Systems and Intended Use: Key Considerations | Applied Clinical Trials | September 7, 2023 | eCOA Consortium | https://www.appliedclinicaltrialsonline.com/view/ecoa-systems-and-intended-use-key-considerations |
Training the Raters: An Important Factor in Clinical Trial Success | Applied Clinical Trials | October 13, 2023 | eCOA Consortium | https://www.appliedclinicaltrialsonline.com/view/training-the-raters-an-important-factor-in-clinical-trial-success |
The First eCOA Forum Examines BYOD and Item Skipping | Applied Clinical Trials | August 11, 2023 | eCOA Consortium | https://www.appliedclinicaltrialsonline.com/view/the-first-ecoa-forum-examines-byod-and-item-skipping |
A New and Comprehensive Guide to ePRO Migration and Implementation | Applied Clinical Trials | November 14, 2023 | eCOA Consortium | https://www.appliedclinicaltrialsonline.com/view/a-new-and-comprehensive-guide-and-epro-migration-and-implementation |
Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes | Journal of the Society for Clinical Data Management | December 14, 2023 | Delong P, Humler D, Haag T, Yeomans A, Andrus J, Eremenco S, Finan A, Gable J, Gilfillan D, Howry C, Kern S, Lesniewski S, Simpliciano K, Staunton H, Turnbull J, Workman C, Raymond S. | https://doi.org/10.47912/jscdm.249 |
Flexible Approaches to eCOA Administration in Clinical Trials: The Site Perspective | Contemporary Clinical Trials Communications | December 7, 2023 | Haenel E, Elash C, Garner K, Turner M, Kern S on behalf of the Electronic Clinical Outcome (eCOA) Consortium and the Patient-Reported Outcome (PRO) Consortium | https://doi.org/10.1016/j.conctc.2023.101241 |
Best Practices for the Electronic Implementation and Migration of Patient-Reported Outcome Measures | Value in Health | October 23, 2023 | Mowlem F, Elash CA, Dumais KM, Newara MC, Kern S on behalf of the Electronic Clinical Outcome Assessment Consortium | https://doi.org/10.1016/j.jval.2023.10.007 |