PRO Consortium Publications, White Papers and Resources

Publications/White Papers/GBTI* Resources Library

*eCOA: Getting Better Together Initiative (GBTI), which ran from 2019 to 2024

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TitleDescriptionHover DescriptionSource
Publication DateAuthorsGBTI
Link
eCOA LexiconDescriptionWithout a common lexicon among eCOA vendors, sponsors, and regulators, the chance for miscommunication, errors, and inefficiencies increases. The objective of this team is to review the terminology and create an aligned eCOA Lexicon for use by stakeholders across the eCOA ecosystem.C-PathMay 2023GBTI TeamYeshttps://media.c-path.org/wp-content/uploads/20241204203508/GBTI_eCOALexicon_v3.pdf
eCOA: Process, Workflow, Roles, Responsibilities (Abbreviations Table)DescriptionDefine an eCOA process and workflow that aligns expectations for successful eCOA strategy development and deployment and clarifies roles and responsibilities.C-PathDecember, 2020GBTI TeamYeshttps://media.c-path.org/wp-content/uploads/20240427173146/GBTI_AbbreviationsTable_v1.pdf
eCOA: Process, Workflow, Roles, Responsibilities (Roles Table)DescriptionDefine an eCOA process and workflow that aligns expectations for successful eCOA strategy development and deployment and clarifies roles and responsibilities.C-PathDecember, 2020GBTI TeamYeshttps://media.c-path.org/wp-content/uploads/20240427173146/GBTI_Roles_Table_v1.pdf
eCOA: Process, Workflow, Roles, Responsibilities (Process Step Table)DescriptionDefine an eCOA process and workflow that aligns expectations for successful eCOA strategy development and deployment and clarifies roles and responsibilities.C-PathDecember, 2020GBTI TeamYeshttps://media.c-path.org/wp-content/uploads/20240427173145/GBTI_Process_StepTable_v1.0.pdf
eCOA: Process, Workflow, Roles, Responsibilities (Process Workflow)DescriptionDefine an eCOA process and workflow that aligns expectations for successful eCOA strategy development and deployment and clarifies roles and responsibilities.C-PathDecember, 2020GBTI TeamYeshttps://media.c-path.org/wp-content/uploads/20240427173144/GBTI_eCOA_Process_Workflow_v1.pdf
Best Practice Recommendations: User Acceptance Testing for Systems Designed to Collect Clinical Outcome Assessment Data ElectronicallyArticleThis article provides best practice recommendations for user acceptance testing to support a high-quality eCOA system and ensure reliable and more complete data are collected during the study.Therapeutic Innovation & Regulatory ScienceMarch 1, 2022Gordon 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
Yeshttps://link.springer.com/article/10.1007/s43441-021-00363-z
Best Practice Recommendations for Electronic Patient-Reported Outcome (ePRO) Dataset Structure and Standardization to Support Drug DevelopmentArticleThis article discusses best practice recommendations covering the application of CDISC standards for ePRO Datasets, the involvement of key stakeholders, and strategies to manage ePRO dataset content, quality control, and validation.Value in HealthAugust 2023Hudgens S, Kern S, Barsdorf AI, Cassells S, Rowe A, King-Kallimanis BL, Coon C, Low G, Eremenco SYeshttps://www.valueinhealthjournal.com/article/S1098-3015(23)00060-8/fulltext?_returnURL=https://linkinghub.elsevier.com/retrieve/pii/S1098301523000608?showall=true
Best Practice Recommendations for Electronic Clinical Outcome Assessment Data ChangesArticleThis article presents key best practices that are aligned to the latest health authority guidance. From 2018 to 2022, 45 representatives of C-Path’s Patient-Reported Outcome Consortium, eCOA Consortium, and the eClinical Forum collaborated to develop guidelines on changes to eCOA data. The resulting core principles can become the foundation upon which sponsors, investigators, and eCOA providers can evaluate and manage data change requests.Journal of the Society for Clinical Data ManagementDecember 14, 2023Delong 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 SYeshttps://www.jscdm.org/article/id/249/
Best Practice Recommendations for Electronic Clinical Outcome Assessment Data ChangesWebinarThis webinar provides key best practices of electronic clinical outcome assessment data changes that are aligned to the latest health authority guidance. It is based on the article published on December 14, 2023, in the Journal of the Society for Clinical Data Management.C-PathFebruary 6, 2024Delong P, Humler D, Yeomans AYes
Best Practice Recommendations for Electronic Clinical Outcome Assessment Data ChangesPost-Webinar Q&AProvides answers to questions that were received during the Q&A portion of the webinar but not answered due to time limitations. The webinar provided best practices of electronic clinical outcome assessment data changes that are aligned to the latest health authority guidance. It is based on the article published on December 14, 2023, in the Journal of the Society for Clinical Data Management.C-PathFebruary 6, 2024GBTI TeamYeshttps://media.c-path.org/wp-content/uploads/20240510123257/eCOADataChanges-PostWebinarQA.pdf
Best Practice Recommendations for Electronic Clinical Outcome Assessment Data ChangesSlidesThe slide deck presented during the webinar on February 6, 2024. The webinar provided best practices of electronic clinical outcome assessment data changes that are aligned to the latest health authority guidance. It is based on the article published on December 14, 2023, in the Journal of the Society for Clinical Data Management.C-PathFebruary 6, 2024GBTI TeamYeshttps://media.c-path.org/wp-content/uploads/20240427170529/eCOADataChanges_FINAL-2.pdf
Flexible approaches to eCOA administration in clinical trials: The site perspectiveArticleThis article presents the results of a survey of eCOA-experienced clinical trial sites to understand their challenges and gather suggestions for simplification that may result in a more flexible, participant- and site-centric approach to ePRO implementation in clinical trials.Contemporary Clinical Trials CommunicationsDecember 7, 2023Haenel E, Elash C, Garner K, Turner M, Kern S on behalf of the Electronic Clinical Outcome (eCOA) Consortium and the Patient-Reported Outcome (PRO) ConsortiumYeshttps://www.sciencedirect.com/science/article/pii/S2451865423001874?via=ihub
Bring Your Own Device (BYOD)PodcastThis podcast provides an exploration of the conceptual challenges around BYOD adoption.C-PathApril, 2022Steele S, Kern SYeshttps://www.youtube.com/watch?v=OHu6XbKTo9o
Bring Your Own Device (BYOD)WebinarThis webinar highlights the key recommendations to enable successful BYOD implementation.C-PathJuly 18, 2024Dumais K, McEvoy K, Romero H, Barden CYeshttps://www.youtube.com/watch?v=DILxBKJSJvI
Bring Your Own Device (BYOD)Guide SlidesThese guide slides provide a more detailed version of the webinar slides with more granular recommendations.C-PathJuly 18, 2024GBTI TeamYeshttps://media.c-path.org/wp-content/uploads/20240726132856/GBTI-BYOD-Webinar-GuideSlides.pdf
Approaches to the Assessment of Clinical Benefit of Treatments for Conditions That Have Heterogeneous Symptoms and Impacts: Potential Applications in Rare DiseaseValue in Health2023Murray LT, Howell TA, Matza LS, Eremenco S, Adams HR, Trundell D, Coons SJNohttps://doi.org/10.1016/j.jval.2022.11.012
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 findingsJournal of Patient-Reported Outcomes2022Newton L, Knight-West O, Eremenco S, Hudgins 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 ConsortiumNohttps://doi.org/10.1186/s41687-022-00492-5
Comparing patient global impression of severity and patient global impression of change to evaluate test–retest reliability of depression, non-small cell lung cancer, and asthma measuresQuality of Life Research2022Eremenco S, Chen WH, Blum SI, Bush EN, Bushnell DM, DeBusk K, Gater A, Nelsen L, Coons SJ, on behalf of the PRO Consortium’s Communication SubcommitteeNohttps://doi.org/10.1007/s11136-022-03180-5
Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ): measurement properties and estimated clinically meaningful thresholds from a phase 3 studyJTO Clinical and Research Reports2022Williams P, Burke T, Norquist J, Daskalopoulou C, Speck R, Samkari A, Eremenco S, Coons SJNohttps://doi.org/10.1016/j.jtocrr.2022.100298
Recommendations for the electronic migration and implementation of clinician-reported outcome assessments in clinical trialsValue in Health2022Romero 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 ConsortiumNohttps://doi.org/10.1016/j.jval.2022.02.012
Asthma Daytime Symptom Diary (ADSD) and Asthma Nighttime Symptom Diary (ANSD): measurement properties of novel patient-reported symptom measuresThe Journal of Allergy Clinical Immunology: In Practice 2021Gater A, Nelsen L, Coon C, Eremenco S, O’Quinn S, Khan A, Eckert L, Staunton H, Bonner N, Hall R, Krishnan J, Stoloff S, Schatz M, Haughney J, Coons SJNohttps://doi.org/10.1016/j.jaip.2021.11.026
Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ): psychometric performance and regulatory qualification of a novel patient-reported symptom measureCurrent Therapuetic Research2021Bushnell DM, Atkinson T, McCarrier K, Liepa A, DeBusk K, Coons SJNohttps://doi.org/10.1016/j.curtheres.2021.100642
Considerations for development of an evidence dossier to support the use of mobile sensor technology for clinical outcome assessments in clinical trialsContemporary Clinical Trials2020Walton MK, Cappelleri JC, Byrom B, Goldsack JC, Eremenco S, Harris D, Potero E, Patel N, Flood E, Daumer MNohttps://doi.org/10.1016/j.cct.2020.105962
Good practices for the translation, cultural adaptation, and linguistic validation of clinician-reported outcome, observer-reported outcome, and performance outcome measuresJournal of Patient-Reported Outcomes2020McKown S, Acquadro C, Anfray C, Arnold B, Eremenco S, Giroudet C, Martin M, Weiss DNohttps://doi.org/10.1186/s41687-020-00248-z
Why reinvent the wheel?  Use or modification of existing clinical outcome assessment tools in medical product developmentValue in Health2020Papadopoulos E, Bush EN, Eremenco S, Coons SJNohttps://doi.org/10.1016/j.jval.2019.09.2745
Assessing test-retest reliability of patient-reported outcome measures using intraclass correlation coefficients: recommendations for selecting and documenting the analytical formulaQuality of Life Research2019Qin S, Nelson L, McLeod L, Eremenco S, Coons SJNohttps://doi.org/10.1007/s11136-018-2076-0
Symptoms of Major Depressive Disorder Scale (SMDDS): performance of a novel patient-reported symptom measureValue in Health2019Bushnell DM, McCarrier KP, Bush EN, Abraham L, Jamieson C, McDougall F, Trivedi M, Thase M, Carpenter L, Coons SJ, on behalf of the Patient-Reported Outcome Consortium’s Depression Working GroupNohttps://doi.org/10.1016/j.jval.2019.02.010
Development of a symptom-focused patient-reported outcome measure for functional dyspepsia: the Functional Dyspepsia Symptom Diary (FDSD)American Journal of Gastroenterology2018Taylor F, Higgins S, Carson R, Eremenco S, Foley C, Lacy B, Parkman H, Reasner D, Shields A, Tack J, Talley NNohttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5770596/
Informing the tolerability of cancer treatments using patient-reported outcome (PRO) measures: summary of an FDA and Critical Path Institute workshopValue in Health2018Kluetz PG, Kanapuru B, Lemery S, Johnson LL, Fiero M, Arscott K, Barbachano Y, Basch E, Campbell M, Cappelleri JC, Cella D, Cleeland C, Coens C, Daniels S, Denlinger CS, Fairclough DL, Hillard JR, Minasian L, Mitchell SA, O’Connor D, Patel S, Rubin EH, Ryden A, Soltys K, Sridhara R, Thanarajasingam G, Velikova G, Coons SJNohttps://doi.org/10.1016/j.jval.2017.09.009
Literature review to assemble the evidence for response scales used in patient-reported outcome measuresJournal of Patient-Reported Outcomes2018Gries K, Berry P, Harrington M, Crescioni M, Patel M, Rudell K, Safikhani S, Pease S, Vernon MNohttps://doi.org/10.1186/s41687-018-0056-3
Literature review to characterize the empirical basis for response scale selection in pediatric populationsJournal of Patient-Reported Outcomes2018Naegeli AN, Hanlon J, Gries KS, Safikhani S, Ryden A, Patel M, Crescioni M, Vernon MNohttps://doi.org/10.1186/s41687-018-0051-8
Patient-Reported Outcome (PRO) Consortium translation process: consensus development of updated best practicesJournal of Patient-Reported Outcomes2018Eremenco S, Pease S, Mann S, Berry P, on behalf of the PRO Consortium’s Process SubcommitteeNohttps://doi.org/10.1186/s41687-018-0037-6
Response scale selection in adult pain measures: results from a literature reviewJournal of Patient-Reported Outcomes2018Safikhani S, Gries KS, Trudeau JJ, Reasner D, Rudell K, Coons SJ, Bush EN, Hanlon J, Abraham L, Vernon MNohttps://doi.org/10.1186/s41687-018-0053-6
Clinically meaningful outcomes in early Alzheimer disease: a consortia-driven approach to identifying what matters to patientsTherapeutic Innovation & Regulatory Science 2017Ropacki MT, Hannesdottir K, Hendrix S, Gordon MF, Stephenson D, Coons SJ, Stern RA, on behalf of the Critical Path Institute’s Coalition Against Major Diseases and Patient-Reported Outcome Consortium Cognition Working GroupNohttps://doi.org/10.1177/2168479016689712
Development of a harmonized patient-reported outcome questionnaire to assess myelofibrosis symptoms in clinical trialsLeukemia Research2017Gwaltney C, Paty J, Kwitkowski VE, Mesa RA, Dueck AC, Papadopoulos EJ, Wang L, Feliciano J, Coons SJNohttps://doi.org/10.1016/j.leukres.2017.05.012
Development of the Diary for Irritable Bowel Syndrome Symptoms (DIBSS) to assess treatment benefit in clinical trials: foundational qualitative researchValue in Health2017Fehnel SE, Ervin CM, Carson RT, Rigoni G, Lackner JM, Coons SJ, on behalf of the Critical Path Institute Patient-Reported Outcome Consortium’s Irritable Bowel Syndrome Working GroupNohttps://doi.org/10.1016/j.jval.2016.11.001
Assessing asthma symptoms in adolescents and adults: qualitative research supporting development of the Asthma Daily Symptom DiaryValue in Health2016Gater A, Nelsen L, Fleming S, Lundy JJ, Bonner N, Hall R, Marshall C, Staunton H, Krishnan JA, Stoloff S, Schatz M, Haughney J, on behalf of the Patient-Reported Outcome Consortium’s Asthma Working GroupNohttps://doi.org/10.1016/j.jval.2016.01.007
Development of a patient-reported outcome instrument to assess complex activities of daily living and interpersonal functioning in persons with mild cognitive impairment: The qualitative research phaseAlzheimer's & Dementia2016Gordon MF, Lenderking WR, Duhig A, Chandler J, Lundy JJ, Miller DS, Piault-Louis E, Doody RS, Galasko D, Gauthier S, Frank L, on behalf of the Patient-Reported Outcome Consortium’s Cognition Working GroupNohttps://doi.org/10.1016/j.jalz.2015.04.008
Development of a symptom-based patient-reported outcome instrument for functional dyspepsia: a preliminary conceptual model and an evaluation of the adequacy of existing instrumentsThe Patient—Patient-Centered Outcomes Research 2016Taylor F, Reasner DS, Carson RT, Deal LS, Foley C, Iovin R, Lundy JJ, Pompilus F, Shields AL, Silberg DGNohttps://link.springer.com/article/10.1007%2Fs40271-016-0164-1
Interpretation of verbal descriptors for response options commonly used in verbal rating scales in patient-reported outcome instrumentsQuality of Life Research2016Mutebi A, Slack M, Warholak TL, Hudgens S, Coons SJNohttps://link.springer.com/article/10.1007%2Fs11136-016-1333-3
Interpreting change in scores on patient-reported outcome instrumentsTherapeutic Innovation & Regulatory Science2016Coon CD, Cappelleri JCNohttps://doi.org/10.1177/2168479015622667
Patient-centered research to support the development of the Symptoms of Major Depressive Disorder Scale (SMDDS): initial qualitative researchThe Patient—Patient-Centered Outcomes Research 2016McCarrier KP, Deal LS, Abraham L, Blum SI, Bush EN, Martin M, Thase ME, Coons SJ, on behalf of the PRO Consortium’s Depression Working GroupNohttps://link.springer.com/article/10.1007%2Fs40271-015-0132-1
Practical considerations for the use of clinical outcome assessments (COAs) in pediatric clinical research: examples from pediatric gastroenterologyTherapeutic Innovation & Regulatory Science2016Kovacs SM, Turner-Bowker DM, Calarco G, Mulberg AE, Paty JNohttps://doi.org/10.1177/2168479015621601
Qualitative development and content validity of the Non–Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ), a patient-reported outcome instrumentClinical Therapeutics2016McCarrier KP, Atkinson T, DeBusk K, Liepa A, Scanlon M, Coons SJ, on behalf of the Patient-Reported Outcome Consortium’s NSCLC Working GroupNohttps://doi.org/10.1016/j.clinthera.2016.03.012
Capturing patient-reported outcome (PRO) data electronically: the past, present, and promise of ePRO measurement in clinical trialsThe Patient—Patient-Centered Outcomes Research 2015Coons SJ, Eremenco S, Lundy JJ, O’Donohoe P, O’Gorman H, Malizia WNohttps://link.springer.com/article/10.1007%2Fs40271-014-0090-z
Considerations for requiring subjects to provide a response to electronic patient-reported outcome instrumentsTherapeutic Innovation & Regulatory Science2015O’Donohoe P, Lundy JJ, Gnanasakthy A, Greene ANohttps://doi.org/10.1177/2168479015609647
Optimizing electronic capture of clinical outcome assessment data in clinical trials: the case of patient-reported endpointsTherapeutic Innovation & Regulatory Science2015Fleming S, Barsdorf AI, Howry C, O’Gorman H, Coons SJ, on behalf of the Patient-Reported Outcome (PRO) Consortium and ePRO Consortium at the Critical Path InstituteNohttps://doi.org/10.1177/2168479015609102
The Patient-Reported Outcome (PRO) Consortium: lessons learned along the path to PRO instrument qualificationTherapeutic Innovation & Regulatory Science2015Hayes RP, Blum SI, Gordon MF, Piault E, Burke LB, Slagle AF, Coons SJNohttps://doi.org/10.1177/2168479014549858
Patient self-report for evaluating mild cognitive impairment and prodromal Alzheimer's diseaseAlzheimer Research and Therapy2011Frank L, Lenderking WR, Howard K, Cantillon MNohttps://doi.org/10.1186/alzrt97
The Patient-Reported Outcome (PRO) Consortium: filling measurement gaps for PRO endpoints to support labeling claimsClinical Pharmacology & Therapeutics2011Coons SJ, Kothari S, Monz BU, Burke LBNohttps://doi.org/10.1038/clpt.2011.203
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 findingsJournal of Patient-Reported Outcomes2022Stacie 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) ConsortiumNohttps://jpro.springeropen.com/articles/10.1186/s41687-022-00521-3
Updated Recommendations on Evidence Needed to Support Measurement Comparability Among Modes of Data Collection for Patient-Reported Outcome Measures: A Good Practices Report of an ISPOR Task ForceValue in Health2023O’Donohoe P, Reasner, DS, Kovacs SM, Byrom B, Eremenco S, Barsdorf AI, Arnera V, Coons SJNohttps://doi.org/10.1016/j.jval.2023.01.001
Recommendations on the Selection, Development, and Modification of Performance Outcome Assessments: A Good Practices Report of an ISPOR Task ForceValue in Health2023Edgar CJ, Bush E, Adams HR, Ballinger R, Byrom B, Campbell M, Eremenco S, McDougall F, Papadopoulos E, Slagle AF, Coons SJNohttps://doi.org/10.1016/j.jval.2023.05.003
Setting international standards in analyzing patient-reported outcomes and quality of life endpoints in cancer clinical trials-innovative medicines initiative (SISAQOL-IMI): stakeholder views, objectives, and proceduresThe Lancet Oncology2023Pe M, Alanya A, Falk RS, Amdal CD, Bjordal K, Chang J, Cislo P, Coens C, Dirven L, Speck RM, Fitzgerald K, Galinsky J, Giesinger JM, Holzner B, Le Cessie S, O’Connor D, Oliver K, Pawar V, Quinten C, Schlichting M, Ren J, Roychoudhury S, Taphoorn MJB, Velikova G, Wintner LM, Griebsch I, Bottomley A, on behalf of the SISAQOL-IMI ConsortiumNohttps://doi.org/10.1016/S1470-2045(23)00157-2
Assessing asthma symptoms in children: qualitative research supporting the development of the Pediatric Asthma Diary-Child (PAD-C) and Pediatric Asthma Diary-Observer (PAD-O)Journal of Patient-Reported Outcomes2023Bradley H, Trennery C, Jones AM, Lydon A, White F, Williams-Hall R, Arbuckle R, Tomaszewski E, Shih VH, Haughney J, Eisen A, Winders T, Coons SJ, Eremenco S. on behalf of the Patient-Reported Outcome Consortium’s Pediatric Asthma Working GroupNohttps://jpro.springeropen.com/articles/10.1186/s41687-023-00639-y
Psychometric Evaluation of the Diary for Irritable Bowel Syndrome Symptoms-Constipation in a Prospective Observational Study.Value in HealthMay 2024McLeod L, Ervin C, Fehnel SE, Eremenco S, Carson RT, Hanlon J, Coons SJ, on behalf of the Patient-Reported Outcome Consortium’s Irritable Bowel Syndrome Working GroupNohttps://doi.org/10.1016/j.jval.2024.01.013
Conceptualizing meaningful between-group difference in change over time: a demonstration of possible viewpointsQuality of Life ResearchOctober 2024Trigg A, Ayasse ND, Coon CDNohttps://link.springer.com/article/10.1007/s11136-024-03798-7
COVID-19: Risk Assessment and Mitigation Strategies for the Collection of Patient-Reported Outcome Data through Clinical SitesWhite PaperJune 5, 2020eCOA Consortium, PRO ConsortiumNohttps://c-path.org/wp-content/uploads/COVID-19_CPath_v3.0_2020JUN5-1.pdf
Patient-reported outcomes in non-small cell lung cancer: psychometric evaluation of the PROMIS PF-SF 8c and NSCLC-SAQ in two phase 3 clinical trialsQuality of Life ResearchDecember, 2024Houts CR, Savord A, Gardner MJ, Mattera M, Peipert JD, Agrawal T, Baig M, Barala P, Baumi J, Diorio B, Girvin A, Sermon J, Shah S, Withelder M, Wortman-Vayn H, Schuchard J. Nohttps://link.springer.com/article/10.1007/s11136-024-03846-2