PRO Consortium Publications, White Papers and Resources

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TitleJournalPublication DateAuthorsLink
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 SJhttps://doi.org/10.1016/j.jval.2022.11.012
Best Practice Recommendations for Electronic Patient-Reported Outcome (ePRO) Dataset Structure and Standardization to Support Drug DevelopmentValue in Health2023Hudgens S, Kern S, Barsdorf AI, Cassells S, Rowe A, King-Kallimanis BL, Coon C, Low G, Eremenco Shttps://doi.org/10.1016/j.jval.2023.02.011
Best practice recommendations: user acceptance testing for systems designed to collect clinical outcome assessment data electronicallyTherapeutic Innovation & Regulatory Science2022Gordon S, Crager J, Howry C, Barsdorf A, Cohen J, Crescioni M, Dahya B, Delong P, Knaus C, Reasner D, Vallow S, Zarzar K, Eremenco S, on behalf of the Patient-Reported Outcome (PRO) Consortium and eCOA Consortium at the Critical Path Institutehttps://doi.org/10.1007/s43441-021-00363-z
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 Consortiumhttps://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 Subcommitteehttps://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 SJhttps://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 Consortiumhttps://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 SJhttps://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 SJhttps://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 Mhttps://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 Dhttps://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 SJhttps://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 SJhttps://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 Grouphttps://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 Nhttps://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 SJhttps://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 Mhttps://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 Mhttps://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 Subcommitteehttps://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 Mhttps://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 Grouphttps://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 SJhttps://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 Grouphttps://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 Grouphttps://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 Grouphttps://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 DGhttps://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 SJhttps://link.springer.com/article/10.1007%2Fs11136-016-1333-3
Interpreting change in scores on patient-reported outcome instrumentsTherapeutic Innovation & Regulatory Science2016Coon CD, Cappelleri JChttps://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 Grouphttps://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 Jhttps://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 Grouphttps://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 Whttps://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 Ahttps://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 Institutehttps://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 SJhttps://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 Mhttps://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 LBhttps://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) Consortiumhttps://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 SJhttps://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 SJhttps://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 Consortiumhttps://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 Grouphttps://jpro.springeropen.com/articles/10.1186/s41687-023-00639-y
Flexible approaches to eCOA Administration in clinical trials: The site perspectiveContemporary Clinical Trials Communications2023Haenel E, Elash C, Garner K, Turner M, Kern S on behalf of the Electronic Clinical Outcome Assessment (eCOA) Consortium and the Patient-Reported Outcome (PRO) Consortiumhttps://doi.org/10.1016/j.conctc.2023.101241
Best Practice Recommendations for Electronic Clinical Outcome Assessment Data ChangesJournal of the Society for Clinical Data Management2023Delong 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 PerspectiveContemporary 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) Consortiumhttps://doi.org/10.1016/j.conctc.2023.101241
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 Grouphttps://doi.org/10.1016/j.jval.2024.01.013
eCOA: Getting Better Together Initiative FAQ Icon

eCOA: Getting Better Together Initiative This initiative is a pre-competitive collaboration among Critical Path Institute, clinical trial sponsors from the Patient-Reported Outcome (PRO) Consortium, providers of electronic data collection technologies and services from the Electronic Clinical Outcome Assessment (eCOA) Consortium, contract research organizations, and regulators. The initiative was launched in 2019 to identify and address the root cause of challenges with the implementation of clinical outcome assessments collected electronically in clinical trials, elevate eCOA improvement efforts to the clinical trial industry level, and drive positive and lasting change in the eCOA ecosystem.

Quarterly Update

Please click here to view the most recent quarterly update, which includes the status of current and future areas of focus.

eCOA: Getting Better Together Initiative

Resources

Name Description Links
eCOA Lexicon Without 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. eCOA Lexicon
eCOA: Process/Workflow and Roles/Responsibilities Define an eCOA process and workflow that aligns expectations for successful eCOA strategy development and deployment and clarifies roles and responsibilities. Abbreviations Table

Roles Table

Process Step Table

Process Workflow

Best Practice Recommendations: User Acceptance Testing for Systems Designed to Collect Clinical Outcome Assessment Data Electronically This 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 Science
Best Practice Recommendations for Electronic Patient-Reported Outcome (ePRO) Dataset Structure and Standardization to Support Drug Development This article discusses best practice recommendations covering the application of CDISC standards for ePRO Datasets, involvement of key stakeholders, and strategies to manage ePRO dataset content, quality control, and validation. Value in Health
Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes This 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. Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes

Webinar

Post-Webinar Q&A

Slides

Flexible approaches to eCOA administration in clinical trials: The site perspective This article presents 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 Communications
Bring Your Own Device (BYOD) This podcast discusses the use of BYOD approaches for the collection of eCOA data in clinical trials. The podcast offers a review of lessons learned from a year-long initiative that is investigating both what is needed to implement BYOD approaches as well as what can be done to accelerate the adoption of BYOD approaches in clinical trials. Bring Your Own Device (BYOD)