Excel with Evidera

Outcomes Research

Evidera scientists are leading single-sponsor and consortium efforts to develop patient-reported outcome (PRO) instruments for use in clinical trials, including the first EMA and FDA-qualified PRO measure, the EXACT. Read More

Services & Products

  • Publications

    Publication

    A New Approach for Identifying Patients with Undiagnosed Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2017 Mar 15;195(6):748-756. doi: 10.1164/rccm.201603-0622OC. ABSTRACT

    Publication

    Evaluation of COPD Treatments: A Multicriteria Decision Analysis of Aclidinium and Tiotropium in the United States. Value Health. 2017 Jan;20(1):132-140. doi: 10.1016/j.jval.2016.08.724. Epub 2016 Oct 5. ABSTRACT

    Publication

    Psychometric Properties of the St George's Respiratory Questionnaire in Patients with Idiopathic Pulmonary Fibrosis. Eur Respir J. 2017 Jan 18;49(1). pii: 1601788. doi: 10.1183/13993003.01788-2016. Print 2017 Jan. ABSTRACT
    See More
  • Webinars

    Webinar

    Medication Adherence and Outcomes Research: 21st Century Insights

    Presenters: Colleen A. McHorney, PhD, Senior Research Leader, Outcomes Research, Evidera

    Additional Info
    Contact us for slides
    Recording

    Webinar

    How are Patient Preferences Used to Support Decisions? Examples from Industry

    Presenters: Heather Gelhorn, PhD, Senior Research Scientist, Outcomes Research, Evidera; Jiat-Ling Poon, PhD, Senior Research Associate, Outcomes Research, Evidera; Sumitra Sri Bhashyam, PhD, Research Associate III, Modeling & Simulation, Evidera

    THIRD OF 3-PART SERIES ON PATIENT PREFERENCE

    Additional Info
    Contact us for slides
    Recording

    Webinar

    Which Method to Use for Capturing Patient Preferences in Benefit-Risk Assessment

    Presenters: Heather Gelhorn, PhD, Senior Research Scientist, Outcomes Research, Evidera; Katharine Gries, PharmD, PhD, formerly with Evidera; Tommi Tervonen, PhD, Senior Research Associate, Modeling & Simulation, Evidera

    SECOND OF 3-PART SERIES ON PATIENT PREFERENCE

    Additional Info
    Contact us for slides
    Recording
    See More
  • White Papers

    Whitepaper

    Oncology Treatments, HRQL and Value Assessments

    Authors: Dennis A. Revicki, PhD, Evidera

    Year: 2016

    View

    Whitepaper

    Advancing Patient-Centered Outcomes Research: An Interview with Dr. Bryan Luce and Dr. Lori Frank of PCORI

    Authors: Dr. Bryan Luce and Dr. Lori Frank, PCORI

    Year: 2015

    View

    Whitepaper

    FDA Qualification of Plasma Fibrinogen as a Biomarker for Clinical Trials of COPD

    Authors: Jason Simeone, PhD, Research Scientist, Real-World Evidence, Evidera; Nancy Kline Leidy, PhD, Senior Vice President, Scientific Affairs, Senior Research Leader, Outcomes Research, Evidera; David M. Mannino, MD, Prof. & Chair, Preventive Medicine & Environmental Health, Univ. of Kentucky; Deborah Merrill, MBA, Senior Director of the COPD Biomarkers Qualification Consortium, COPD Foundation; Bruce Miller, PhD, Clinical Development Director, GlaxoSmithKline

    Year: 2015

    View
    See More
  • Presentations

    Oral Presentation

    Determination of Minimal Important Difference Thresholds for Parkinson’s Disease Questionnaire-39 in Advanced Parkinson’s Disease Patients

    XXI World Congress on Parkinson’s Disease and Related Disorders:

    Milan, Italy
    06-Dec-2015

    Authors/Presenters: Antonini A, Bacci ED, Sail K, Jalundhwala YJ, Kandukuri PL, Marshall T, Chatamra K, Wiklund I, Revicki D

    Year: 2015

    Poster

    Challenges and Opportunities for PROs and Big Data: Applications for the Pharmaceutical Industry

    ISOQOL 22nd Annual Conference – 2015:

    Vancouver, BC, Canada
    21-Oct-2015

    Authors/Presenters: Lenderking WR

    Year: 2015

    Poster

    What Type of Response Scale is the Most Responsive? A Comprehensive Review of Response Scale Options for Patient-reported Outcome Measures

    ISPOR 20th Annual International Meeting – 2015:

    Philadelphia, PA, USA
    16-May-2015

    Authors/Presenters: Rudell K, Vernon MK, Gries K, Safikhani S, DeLozier A, McQuarrie K, Norquist J, Coons SJ

    Year: 2015

    See More
  • Fact Sheets

    Fact Sheet

    Outcomes Research
    Download

    Fact Sheet

    Patient-Centered Outcomes Research at Evidera
    Download

    Fact Sheet

    Pharmaceutical Products Approved by FDA with PRO Label Information; Updated Through Q4 2016
    Download

    Fact Sheet

    Pharmaceutical Products Authorised by EMA with PRO Label Information; Updated Through Q4 2016
    Download

Evidera’s outcomes researchers represent a unique combination of scientific disciplines, including psychometrics, epidemiology, biostatistics, psychology and public health. We develop and evaluate clinical outcome assessments to support labeling and promotional claims. We are your partner for evaluating patient, clinician, caregiver and performance outcomes, utilities and preferences, adherence and other customized prospective observational study needs.

Evidera designs and implements strategies for outcome evaluation, including clinician-reported outcomes (ClinRO), patient-reported outcomes (PRO), observer/caregiver-reported outcomes (ObsRO) and/or performance outcomes/tests (PerfO) that meet regulatory and stakeholder demands. We take an evidence-based approach to instrument development, driven by extensive experience measuring health outcomes across a variety of conditions and diseases. We help you understand the issues and design your program from concept identification and development through platform selection, instrument design and psychometric testing, and we provide ongoing support during implementation and analyses.

With Evidera as your partner, you get a team of leading scientists who have developed innovative methods and instruments that are rapidly adopted by the field. For example, Evidera:

  • Created one of the few PRO instruments recommended for clinical use in an international clinical guidance document: COPD Assessment Test (CAT)
  • Developed the first multisponsor PRO consortium: The EXACT-PRO Initiative
  • Developed the first PRO instrument to achieve FDA PRO qualification: The EXACT
  • Designed two of the first condition-specific utility indexes: asthma symptom utility index (ASU) and rhinitis symptom utility index (RSUI)
  • Partnered with the American Neurogastroenterology and Motility Society (ANMS) to develop the ANMS gastroparesis cardinal symptom daily diary, now an endpoint for clinical trials in diabetic and idiopathic gastroparesis

Offerings

Instrument Development and Psychometric Evaluation

Develop strategies to enhance ClinRO, PRO, ObsRO and PerfO from concept identification through psychometric evaluation and dissemination.

Outcomes Strategy

Discuss the strengths and limitations of your product or portfolio, identify outcomes with measurable value, establish research goals, prepare a plan for goal achievement and guide the plan to a successful conclusion. Develop focused and customizable training programs, which can be a valuable component in achieving these goals.

Outcomes Evidence Dossier

Enhance your regulatory positioning with a carefully compiled dossier of evidence delineating the precision of your product’s key outcome measures.

Health Utilities Studies

Obtain health state utility valuations (time trade-off and standard gamble), consultation on inputs for cost-utility modeling, the development of condition-specific preference-based measures, and mapping to generic preference-based measures.

Clinical Trials Support

Support trial design, Clinical Outcomes Assessment (COA) strategies, patient engagement, statistical analysis plans, results interpretation and reports.

Electronic Clinical Outcomes Assessment (eCOA)

Evaluate mode selection and conduct cognitive interview/usability and equivalence studies for electronic instrument development.

Advanced Psychometric and Statistical Modeling Services

Conduct in-depth statistical analyses, including Rasch and item response theory (IRT) methods and advanced psychometric methods as well as advanced statistical modeling such as latent growth curve analysis, mixture models and structural equation models.

Regulatory Support

Inform your outcomes research strategy from trial design to communication with regulatory agencies.

Scientific Dissemination

Plan and execute outcomes research dissemination strategies from inception to completion.

Outcomes Research Experts

Services & Products

  • Publications

    Publication

    A New Approach for Identifying Patients with Undiagnosed Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2017 Mar 15;195(6):748-756. doi: 10.1164/rccm.201603-0622OC. ABSTRACT

    Publication

    Evaluation of COPD Treatments: A Multicriteria Decision Analysis of Aclidinium and Tiotropium in the United States. Value Health. 2017 Jan;20(1):132-140. doi: 10.1016/j.jval.2016.08.724. Epub 2016 Oct 5. ABSTRACT

    Publication

    Psychometric Properties of the St George's Respiratory Questionnaire in Patients with Idiopathic Pulmonary Fibrosis. Eur Respir J. 2017 Jan 18;49(1). pii: 1601788. doi: 10.1183/13993003.01788-2016. Print 2017 Jan. ABSTRACT
    See More
  • Webinars

    Webinar

    Medication Adherence and Outcomes Research: 21st Century Insights

    Presenters: Colleen A. McHorney, PhD, Senior Research Leader, Outcomes Research, Evidera

    Additional Info
    Contact us for slides
    Recording

    Webinar

    How are Patient Preferences Used to Support Decisions? Examples from Industry

    Presenters: Heather Gelhorn, PhD, Senior Research Scientist, Outcomes Research, Evidera; Jiat-Ling Poon, PhD, Senior Research Associate, Outcomes Research, Evidera; Sumitra Sri Bhashyam, PhD, Research Associate III, Modeling & Simulation, Evidera

    THIRD OF 3-PART SERIES ON PATIENT PREFERENCE

    Additional Info
    Contact us for slides
    Recording

    Webinar

    Which Method to Use for Capturing Patient Preferences in Benefit-Risk Assessment

    Presenters: Heather Gelhorn, PhD, Senior Research Scientist, Outcomes Research, Evidera; Katharine Gries, PharmD, PhD, formerly with Evidera; Tommi Tervonen, PhD, Senior Research Associate, Modeling & Simulation, Evidera

    SECOND OF 3-PART SERIES ON PATIENT PREFERENCE

    Additional Info
    Contact us for slides
    Recording
    See More
  • White Papers

    Whitepaper

    Oncology Treatments, HRQL and Value Assessments

    Authors: Dennis A. Revicki, PhD, Evidera

    Year: 2016

    View

    Whitepaper

    Advancing Patient-Centered Outcomes Research: An Interview with Dr. Bryan Luce and Dr. Lori Frank of PCORI

    Authors: Dr. Bryan Luce and Dr. Lori Frank, PCORI

    Year: 2015

    View

    Whitepaper

    FDA Qualification of Plasma Fibrinogen as a Biomarker for Clinical Trials of COPD

    Authors: Jason Simeone, PhD, Research Scientist, Real-World Evidence, Evidera; Nancy Kline Leidy, PhD, Senior Vice President, Scientific Affairs, Senior Research Leader, Outcomes Research, Evidera; David M. Mannino, MD, Prof. & Chair, Preventive Medicine & Environmental Health, Univ. of Kentucky; Deborah Merrill, MBA, Senior Director of the COPD Biomarkers Qualification Consortium, COPD Foundation; Bruce Miller, PhD, Clinical Development Director, GlaxoSmithKline

    Year: 2015

    View
    See More
  • Presentations

    Oral Presentation

    Determination of Minimal Important Difference Thresholds for Parkinson’s Disease Questionnaire-39 in Advanced Parkinson’s Disease Patients

    XXI World Congress on Parkinson’s Disease and Related Disorders:

    Milan, Italy
    06-Dec-2015

    Authors/Presenters: Antonini A, Bacci ED, Sail K, Jalundhwala YJ, Kandukuri PL, Marshall T, Chatamra K, Wiklund I, Revicki D

    Year: 2015

    Poster

    Challenges and Opportunities for PROs and Big Data: Applications for the Pharmaceutical Industry

    ISOQOL 22nd Annual Conference – 2015:

    Vancouver, BC, Canada
    21-Oct-2015

    Authors/Presenters: Lenderking WR

    Year: 2015

    Poster

    What Type of Response Scale is the Most Responsive? A Comprehensive Review of Response Scale Options for Patient-reported Outcome Measures

    ISPOR 20th Annual International Meeting – 2015:

    Philadelphia, PA, USA
    16-May-2015

    Authors/Presenters: Rudell K, Vernon MK, Gries K, Safikhani S, DeLozier A, McQuarrie K, Norquist J, Coons SJ

    Year: 2015

    See More
  • Fact Sheets

    Fact Sheet

    Outcomes Research
    Download

    Fact Sheet

    Patient-Centered Outcomes Research at Evidera
    Download

    Fact Sheet

    Pharmaceutical Products Approved by FDA with PRO Label Information; Updated Through Q4 2016
    Download

    Fact Sheet

    Pharmaceutical Products Authorised by EMA with PRO Label Information; Updated Through Q4 2016
    Download
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