International Society for Quality of Life Research
International Society for Quality of Life Research

Archived Webinars


2018

Webinar Series: Debating 'Hot Topics' in HRQOL Research

December 2017-February 2018

The ISOQOL Webinar Committee hosted a series of three webinars discussing important topics in HRQOL research. Each webinar explores a topic from different perspectives to facilitate an open discourse among researchers. The aim of these webinars is to provide a forum where the ISOQOL community can learn about key issues and hear differing approaches and perspectives from experts in the field.

Hot Topics Webinar #1
Psychometric Versus Preference-Based Health-Related Quality of Life Summary Measures

Hot Topics Webinar #2
'The Times They are a Changing': Exploring Meaningful Change in Health Outcomes Measurement

Hot Topics Webinar #3
Different perspectives on meaningful interpretation of change in patient-reported outcomes: Meaningful (Clinically) Important Differences

Evaluating the Benefits of Mobile Health Devices in Clinical Trials

 


2017

Training Clinicians in How to Use Patient-Reported Outcome Measures in Routine Clinical Care

How to Write a Good Peer Review for an Academic Journal


2016

Standardized Evaluations of Patient Reported Outcomes (PRO): the EMPRO Methodology

Statistical Methods for Response Shift Detection

Evaluaciones estandarizadas de Resultados Percibidos por los Pacientes (PRO): método EMPRO

Response Shift: A Review of the Literature


2015

Clinical Outcomes Assessment in a Multi-Cultural Context: Measurement Challenges and Recommendations

Applying the FDA Patient-reported Outcome (PRO) Guidance to Performance Outcome (PerfO) Measures

Doc, how bad is it? Setting standards for severity of patient reported outcomes data using item banks from PROMS and Neuro-QOL

Group Concept Mapping: A patient-centric, mixed-methods, approach to understand the patients' experiences and support outcomes strategy


2014

Lessons Learned from the EQ-5D-3L Valuation in Brazil

Webinar Series: Best Practices for Integrating Patient-Reported Outcomes in Oncology Clinical Trials
A Collaboration project between NCI and ISOQOL

The series includes 6 videos which can be viewed independently, or in sequence to meet an individual's learning needs. Experts in PRO research present on topics including: selecting PRO measures, designing high quality studies with PRO endpoints, statistical considerations, ensuring data quality, and reporting outcomes.

August-September 2014

How to report PRO study findings from clinical trials

How to develop the statistical plan and sample size calculation for the PRO component of a clinical study

How to design a high quality study with PRO endpoints

How to select the appropriate PRO measure

How to identify the PRO context for clinical trials and identify the relevant PRO domains

How to assure data quality for PROs in oncology clinical trials


2013

Symptom Management & Quality of Life Concept Design
A Collaboration project between NCI and ISOQOL

Lessons Learned from PROs in FDA and EMA Label Claims

 


2012

Incorporating Patient-Reported Outcomes into Comparative Effectiveness Research

Using Patient-Reported Outcome Measures to Improve Clinical Practice  

 

 


Descriptions

 

Lessons Learned from PROs in FDA and EMA Label Claims

May 2013
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This webinar includes presentations from industry sponsors that have interacted with the FDA or EMA to support labeling of their products. The webinar includes a review of PRO measures and determination of how to move them forward and/or revise them as appropriate to support labeling claims. Specifically, the webinar addresses how to conduct a gap analysis and how to adapt or modify existing measures to assess and/or confirm the validity of the measure. FDA and EMA considerations of PRO measures are addressed through the use of case studies.

Presenters:

  • Kathy Beusterien, MPH, Senior Director, Oxford Outcomes
  • Thomas Hare, Vice President, Development Operations, Incyte
  • William Lenderking, PhD, Senior Research Leader, United BioSource
  • Linda Abetz-Webb, EU Practice Lead, PRO Adelphi Values

Sponsored by:

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Symptom Management & Quality of Life Concept Design
A Collaboration project between NCI and ISOQOL

December 2013
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This video covers a variety of practical considerations for developing a symptom management concept for clinical research. Experts in the field present on topics including: required elements, statistics, and the community physician perspective.

Co-sponsored by:

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Lessons Learned from the EQ-5D-3L Valuation in Brazil

December 2014
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The purpose of this webinar is to share the Brazilian experience on health preference measurement, through methods and results discussion. In this session the panel of speakers will describe the study design, exploring the alternative methodological options and discussing its impact on value estimation and to states selection. This webinar includes lessons for all researchers interested in valuation studies in developing countries as well as methodological issues with traditional valuation tasks (e.g., TTO).

Presenters:

  • Marisa Santos, MD, PhD, Instituto Nacional de Cardiologia, Brazil
  • Monica Akissue Cintra, MD, PhD, Instituto Nacional de Cardiologia, Brazil
  • Andréa Libório, MSc, Instituto Nacional de Cardiologia, Brazil
  • Claudia Pereira, PhD, ENSP- FIOCRUZ, Brazil
  • Marcelo Correa, MSc, Instituto Nacional de Cardiologia, Brazil

Presented by:
Health Preference Research (HPR) SIG & Ibero America SIG

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Group Concept Mapping: A patient-centric, mixed-methods, approach to understand the patients' experiences and support outcomes strategy

January 2015
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The audience will benefit and get an understanding of the history and application of mixed methods approaches to outcomes research and learn how to apply an innovative, mixed methods approach with a strong patient-centric focus, to answer different outcomes research questions.

Learning Objectives are:

  • Understand a brief history of mixed methods research
  • Understand a brief history of Group Concept Mapping approach
  • Understand the 4 steps involved in Group Concept Mapping and how the methodology can be applied to different research questions

Presenters:

  • Louise Humphrey, MSc, Director of Clinical Outcomes Assessment, Abacus International, UK
  • Thomas Willgoss, PhD, Project Manager, Abacus International, UK
  • Tara Symonds, PhD, Partner and Strategic Lead, Clinical Outcomes Solutions, UK
  • Joseph C Cappelleri, PhD, Senior Director - Biostatistics , Pfizer Inc., US

Moderated by: 

  • Josephine M. Norquist, MS, ISOQOL Industry Advisory Committee (IAC) Chair

Sponsored by:

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Doc, how bad is it? Setting standards for severity of patient reported outcomes data using item banks from PROMS and Neuro-QOL

June 2015
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The goal of the workshop is to teach health outcomes researchers how to develop and conduct a standard-setting protocol in order to identify cut scores for clinical levels of PRO domains.

Learning Objectives are:

  • Participants will be able to identify at least three benefits of having clinical classification systems for PRO scores.
  • Participants will identify methods for validating cut-scores based on empirical data.
  • Participants will be able to identify areas for future research on the generalizability of Bookmarking results.

Presenters:

  • Karon F. Cook, PhD, Research Professor, Feinberg School of Medicine, Northwestern University
  • Deborah M. Miller, PhD, Associate Professor, Mellen Center, Cleveland Clinic
  • David E. Victorson, PhD, Associate Professor Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University

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Applying the FDA Patient-reported Outcome (PRO) Guidance to Performance Outcome (PerfO) Measures

November 2015
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The FDA PRO Guidance of 2009 provides a gold standard against which the appropriateness of PRO measures for use in clinical trials are assessed. The principles that apply to PROs broadly apply to other types of assessments such as PerfOs. This session provides examples of PerfOs, including cognitive and physical functioning assessments and highlights the importance of establishing conceptual relevance and ecological validity. Included is an overview of innovative technologies such as preference-based studies, cognitive task analysis and video diaries.

Learning Objectives are:

  • Understand the importance of conceptual relevance and ecological validity of PerfOs
  • Learn how innovative methods (e.g. cognitive task analysis) provide insights into decision making when administering and completing these tasks

Presenters:

  • Fiona McDougall, PhD ClinPsyD, Roche Products Limited
  • Louise Humphrey, MSc
  • Lee Scott Ehrhart, PhD, MITRE Corporation
  • Helen A. Doll, MSc DPhil, ICON Patient Reported Outcomes

Moderated by: 

  • Diana Rofail, CPsychol, Roche Products Limited

Presented by:
The Industry Special Interest Group (Formerly the Industry Advisory Committee - IAC)

 

Sponsored by:

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Clinical Outcomes Assessment in a Multi-Cultural Context: Measurement Challenges and Recommendations

December 2015
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Clinical Outcome Assessment (COA) in an international study requires particular caution due to the differences in language, culture, education, and differing standards of care.  These differences are likely to be sources of variability in measurement outcomes. If not adequately managed, this variability can potentially jeopardize the accurate capture of the targeted concepts, and make the demonstration of treatment benefit more difficult. Cross-cultural equivalence of COAs used in international studies is, therefore, of particular importance. The webinar will present the challenges and discuss possible solutions related to this question.

A certain amount of cross-cultural variation can be prevented using qualitative methods during the development and translation of a COA.  Content can be considered from a cross-cultural perspective using multi-cultural patient interviews and techniques such as Translatability Assessment. Evaluation of cross-cultural equivalence of a measure has traditionally been accomplished using quantitative methods. These methods include investigation of differential item functioning and measurement invariance. Once data have been collected and evaluated quantitatively, further investigation can be conducted qualitatively to focus on specific areas of variability that raise questions about equivalency or comparability. Once the cross-cultural equivalence of a COA used in a multicultural study has been tested and variability addressed using both qualitative and quantitative methods, a more clear demonstration of a treatment benefit can be ascertained with confidence in the results.

These topics and methods for early qualitative and quantitative evaluation will be described, using examples, during the webinar by speakers from both the Translation and Cultural Adaptation and Psychometrics Special Interest Groups of ISOQOL. The presentation will be followed by an interactive Q&A session during which the speakers will address questions from the audience.

Learning Objectives are:

  • To anticipate potential measurement issues related to cultural differences in the context of a multi-cultural study
  • To outline a strategy to investigate cross-cultural equivalence of COAs using appropriate quantitative and qualitative methods

Presenters:

  • Stacie Hudgens, MA (AbD) Managing Partner, Strategic Lead for Clinical Outcome Solutions
  • Antoine Regnault, PhD Research Director for Mapi
  • Lori McLeod, PhD Head, Psychometrics for RTI Health Solutions
  • Mona Martin, RN MPA Executive Director for Health Research Associates Inc.
  • Sonya Eremenco, MA Director, ePRO New Products for Evidera, Inc.

Presented by:
The Psychometric and Translation & Cultural Adaptation Special Interest Groups

 

Sponsored by:


 

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Response Shift: A Review of the Literature

January 2016
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Response shift (RS) refers to changes in an individual’s self-evaluation of his/her health status and quality of life because of changes in internal standards, values, or concepts. According to Sprangers and Schwartz (1999), there are three types of RS, including (a) recalibration (change in internal
standards of measurements), (b) reprioritization (change in prioritization of component domains constituting the target construct), and (c) reconceptualization (redefinition of the target construct). RS has been investigated in a number of medical conditions where the diagnosis, or treatment, or other factors may act as catalysts that induce change in an individual’s self-perceptions of health status and quality of life. It has been shown that response shift could influence assessments of treatment effects and changes in patients’ health status and quality of life over time.

A number of methods for measuring and detecting response shift have been developed and tested. Our research team conducted a scoping review on the literature on response shift. In this webinar, based on the results of our scoping review, participants will learn about the literature on response shift, the different types of response shift, the different statistical methods for detecting response shift, and future directions of research in the field.

Learning Objectives are:

  • Participants will learn about the results of our scoping review of the response shift literature
  • Participants will be able to explain the potential influence that response shift has on the assessment of treatment effects, as well as assessment of changes in patients’ health status and quality of life over time
  • Participants will be able to critically evaluate and consider the different commonly used statistical methods of response shift
  • Participants will be able to describe the role of response shift in measurement validation (with an emphasis on the modern theories of measurement validity).

Presenters:

  • Rick Sawatzky, PhD, RN, Associate Professor and Canada Research Chair, School of Nursing, Trinity Western University
  • Tolu Sajobi, PhD, Assistant Professor, Department of Community Health Sciences, University of Calgary
  • Ronak Brahmbhatt, MBBS, MPH

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Evaluaciones estandarizadas de Resultados Percibidos por los Pacientes (PRO): método EMPRO

June 2016
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SPANISH VERSION

Antecedentes:

Los investigadores y profesionales de la salud se enfrentan al problema de seleccionar el instrumento de Resultados Percibidos por los Pacientes (PRO, en inglés) más apropiada para cada ocasión, de entre los diversos instrumentos existentes. Este seminario se centrará en cómo apoyar la toma de decisiones a través de una evaluación estandarizada y validada de las propiedades métricas y las cuestiones relacionadas con la administración de resultados reportados por los pacientes mediante el sistema de “Evaluación de  Medidas de Resultados Percibidos por los Pacientes” (EMPRO).

Descripción:

EMPRO fue desarrollado para evaluar la calidad de un instrumento, teniendo en cuenta toda la información disponible. Se incluyen evaluaciones estandarizadas de expertos de los 8 atributos principales para la medición de cada PRO, dando lugar a puntuaciones que permitan comparaciones directas entre instrumentos. Estos atributos fueron propuestos originalmente por la Medical Outcomes Trust: Modelo conceptual y de medición; Fiabilidad; Validez; Sensibilidad al cambio; Interpretabilidad; Carga de administración; Modos de administración alternativos, y Adaptación cultural.

El propósito de este seminario es definir cada atributo evaluado por esta herramienta, y explicar cómo aplicarlos a los PROs genéricos y específicos. Se describirá el algoritmo de puntuación y su razón de ser. También se abordarán otras herramientas de evaluación complementarias, como la lista de verificación COSMIN para evaluar la calidad metodológica de los estudios de propiedades métricas. Este seminario incluye temas que pueden ser de interés para todos los investigadores que trabajen en la evaluación de las propiedades métricas.

Objetivos De Aprendizaje:

  • Reconocer y aplicar los criterios necesarios para la evaluación de los ocho atributos evaluados con el sistema EMPRO: Modelo conceptual y de medición; Fiabilidad; Validez; Sensibilidad al cambio; Interpretabilidad; Carga de administración; Modos de administración alternativos, y Adaptación cultural.

Presenters /Presentadores:

  • Jordi Alonso, MD PhD, Institut Hospital del Mar d'Investigacions Médiques, Health Services Research Group
  • Montse Ferrer, MD MPH PhD, Institut Hospital del Mar d'Investigacions Médiques. Health Services Research Group
  • Gemma Vilagut, MSc, Institut Hospital del Mar d'Investigacions Médiques, Health Services Research Group
  • Carlos Garcia Forero, PhD, Institut Hospital del Mar d'Investigacions Médiques, Health Services Research Group
  • Olatz Garin, PhD, Institut Hospital del Mar d'Investigacions Médiques, Health Services Research Group
  • Jose M. Valderas, MD MPH PhD, University of Exeter Medical School, PenCLAHRC, Institute of Health Services Research

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Statistical Methods for Response Shift Detection

June 2016
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Description:

Response shift (RS) refers to a change in an individual’s perceptions of his/her quality of life (QOL) or health status over time. According to Sprangers and Schwartz (1999), RS can result from three different processes: recalibration (changes in the individual’s internal standards of measurements), reprioritization (changes in the individual’s values and in the relative importance given to the questions or dimensions constituting the target construct), and reconceptualization (changes in the individual’s definition of the target construct). A literature review of RS presented at a previous ISOQOL webinar revealed that RS can occur for many different acute and chronic medical conditions and procedures, including surgeries and stroke. RS can impact the ability to detect change in QOL over time, which could ultimately impact on patient care.

The current webinar will focus specifically on important and cutting-edge statistical methods for RS detection and adjustment for true change estimation, including latent variable modelling and relative importance analysis. Specifically, leading RS researchers will discuss the use of structural equation modelling (SEM), Item Response/Rasch Measurement Theory (IRT/RMT), and importance measures based on logistic regression and discriminant analysis. The strengths, limitations, and assumptions of the methods will be reviewed, as will the types of RS that can be detected with each method. An overview of available software to implement these methods will be provided. Future directions of research in the field will be discussed.

Learning Objectives:

  • Participants will learn about different statistical methods that can be used for RS detection and adjustment for true change estimation
  • Participants will be able to critically compare the leading statistical methods for RS analysis and interpretation based on latent variable modelling and relative importance analysis
  • Participants will be able to assess the potential influence that RS has on the assessment of changes in patients’ health status and quality of life over time in longitudinal studies

Presenters:

  • Lisa Lix, Professor & Manitoba Research Chair, BSHEc, MSc, PhD, P.Stat, University of Manitoba
  • Bellinda King-Kallimanis, Sr Scientist, Psychometrics & Biostatistics, BSc, MSc, PhD, Pharmerit International
  • Myriam Blanchin, Research Engineer in Biostatistics, BSc, MSc, PhD, EA 4275 SPHERE "methodS in Patient-centered outcomes and HEalth ResEarch", University of Nantes

Moderated by: 

  • Véronique Sébille , Professor of Biostatistics, BSc, MSc, PhD, ScD, EA 4275 SPHERE "methodS in Patient-centered outcomes and HEalth ResEarch", University of Nantes

Presented by:
The Response Shift SIG

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Standardized Evaluations of Patient Reported Outcomes (PRO): the EMPRO Methodology

July 2016
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Background:

Researchers and health professionals face the problem of selecting the most appropriate PRO tool for a given purpose among competing instruments. This webinar will focus on how to support decision making through validated standardized assessment of metric properties and issues related to administration of PROs with the ‘Evaluating Measures of Patient Reported Outcomes’ (EMPRO) system.

Description:

EMPRO was developed to assess an instrument’s quality, considering all available information. It consists of standardized expert evaluations of 8 key measurement attributes for each PRO, resulting in scores that allow direct comparisons among instruments. These attributes were originally proposed by the Medical Outcomes Trust: Concept and measurement model; Reliability; Validity; Sensitivity to change; Interpretation; Burden; Alternative modes of administration, and Cultural adaptation.

The purposes of this webinar are to define each attribute assessed by this tool, and to explain how to apply them to generic and specific PROs. The scoring algorithm and its rationale will be described. Other complementary evaluative tools, such as the COSMIN checklist to appraise the methodological quality of metric properties’ studies, will be addressed. This webinar includes lessons for all researchers interested in valuation of metric properties.

Learning Objectives:

To recognize and apply the criteria required for the evaluation of the eight attributes assessed with EMPRO system: Reliability; Validity; Sensitivity to change; Interpretation; Burden; Alternative modes of administration, and Cultural adaptation.

Presenters:

  • Jordi Alonso, MD PhD, Institut Hospital del Mar d'Investigacions Médiques, Health Services Research Group
  • Montse Ferrer, MD MPH PhD, Institut Hospital del Mar d'Investigacions Médiques, Health Services Research Group
  • Gemma Vilagut, MSc, Institut Hospital del Mar d'Investigacions Médiques, Health Services Research Group
  • Olatz Garin, PhD, Institut Hospital del Mar d'Investigacions Médiques, Health Services Research Group
  • Jose M. Valderas, MD MPH PhD, University of Exeter Medical School, PenCLAHRC, Institute of Health Services Research

Moderated by: 

  • Carlos Garcia Forero, PhD, Institut Hospital del Mar d'Investigacions Médiques, Health Services Research Group

Presented by:
The Ibero SIG

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How to Write a Good Peer Review for an Academic Journal

May 2017
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Background:

Learn the Do's and Don'ts of writing a constructive peer-review. At the end of the webinar you'll have a better understanding of what is peer-review, why you should engage in peer-review, and what to consider before agreeing to review an article.

Description:

This webinar will focus on the peer review process with a special focus on PROMs and QOL. New and experienced researchers will discuss importance of a sound review and establish a structured approach and criteria to facilitate the peer-review process.

Learning Objectives:

  • Participants will learn important aspects of a reviewing a manuscript for a scientific journal
  • Participants will be able to write a sound and structured peer-review

Presenters:

  • William R. Lenderking, PhD, Vice President, Outcomes Research, Evidera
  • Jan. R. Boehnke, PhD, Senior Research Fellow in Evaluation Design and Research Methods, Dundee Centre for Health and Related Research School of Nursing and Health Sciences, University of Dundee

Moderated by: 

  • Kathryn Fischer, Charite Universitatsmedizin Berlin

Presented By:
New Investigator SIG

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Training Clinicians in How to Use Patient-Reported Outcome Measures in Routine Clinical Care

September 2017
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Using patient-reported outcome (PRO) measures in routine clinical care identifies problems, enhances patient-clinician communication as well communication with and among family members, improves clinical management, and promotes shared decision making. But clinicians need to be trained to interpret PRO data and make it actionable. The webinar describes three programs training clinicians to use PROs in routine clinical practice of chronically ill patients, illustrating both successes and obstacles.

The webinar includes presentations on:

  • Using PROs in routine chronic care in pediatrics
  • Training lung transplant specialists to use PRO measures in routine clinical practice
  • Development of a facilitator to train oncologists

Key Lessons Include:

  • Engage Clinicians in Planning States: early and often
  • Stakeholder Involvement in Selection of HRQL measures; graphical presentation of data; support aids
  • Training Sessions Must Be Brief and Flexible
  • Provide Behavioural Feedback, especially early in the dissemination process
  • Integrate data into:
    • Patient Records
    • Clinic Workflow
  • Role of Opinion Leaders
  • Change as an Iterative Process
  • One Size Does Not Fit All; Has to Fit into the existing Delivery System

Learning Objectives:

  • Understand the importance of training clinicians in using PROs
  • How to engage Multi-disciplinary Teams
  • How to organize training sessions
  • What the content of training session could be

Presenters:

  • Lotte Haverman, PhD, Psychosocial Department of the Emma Children’s Hospital, Amsterdam, the Netherlands
  • Maria Jose Santana, PhD, University of Calgary, Calgary, Canada
  • Galina Velikova, PhD, MD, University of Leeds, Leeds, United Kingdom

Presented By:
QOL in Clinical Practice SIG

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Evaluating the Benefits of Mobile Health Devices in Clinical Trials

January 2018
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There has been an increasing interest in using mobile health devices, including wearable devices, to collect patient health data remotely in clinical trials.  This webinar will discuss the emergence and use of mobile health technologies in clinical trials and will provide information on U.S. regulatory considerations when including assessments from these devices to support endpoints in clinical trials as well as other use cases.  This webinar will also provide specific examples of the use of mobile health devices for evaluating treatment benefit.

Learning Objectives:

  • Have an understanding of the types of mobile health devices being used in clinical trials today, and the benefits and challenges associated with the use of these devices.
  • Look at how you can maximize the value of the data from the devices and sensors.
  • Learn through specific examples how mobile health devices could be useful when evaluating treatment benefit in clinical trials.
  • Have a better understanding of U.S. regulatory considerations related to use of mobile health devices in clinical trials.

Presenters:

  • Marie McCarthy, Product Innovation, ICON plc
  • Wen-Hung Chen, Clinical Outcomes Assessment Staff, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
  • Daragh Ryan, mHealth Program, Actelion Pharmaceuticals
  • Ken Skodacek, Clinical Trials Program & Payer Communications Task Force, Center for Devices and Radiological Health, U.S. Food and Drug Administration

Presented By: 
Industry SIG

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Hot Topics Webinar #1
Psychometric Versus Preference-Based Health-Related Quality of Life Summary Measures

December 2017
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This webinar addresses the distinction between psychometric and preference-based summary measures of health-related quality of life (HRQOL).

Description:

This webinar addresses the distinction between psychometric and preference-based summary measures of health-related quality of life (HRQOL). Psychometric methods are used to obtain scales for multiple domains or aspects of HRQOL (profiles). Some domains are correlated strongly enough to support aggregation into higher-order dimensions (e.g., physical and mental health). Summary measures can provide parsimonious information with greater reliability than the scales from which they are derived. Their interpretation depends on the content of the corresponding measurement items or questions. In health preference research, a meaningful change in HRQOL is defined by its influence on choice (i.e., choice defines value), not a scale. Decisions typically require an understanding of a wide variety of outcomes and their trade-offs. Preference-based summary measures weigh these outcomes based on their “value” to inform benefit-risk analyses (Should the treatment be approved?), economic evaluations (Should the treatment be covered?), clinical recommendations (Which patients should be treated?), and decision support tools (How should you be treated?). Their interpretation depends on the decision makers’ perspective (e.g., patient, caregiver, societal). The webinar will conclude with a moderated discussion of strengths and limitations of psychometric versus preference-based summary measures in relation to patient-reported outcomes research, health care decision making and clinical practice.

Audience Benefits:

To learn about approaches to constructing HRQOL summary measures and their uses in patient-reported outcomes research, health care decision making, and clinical practice.

Learning Objectives:

  • To understand differences between psychometric and preference-based summary score.
  • To learn about the different purposes for using psychometric and preference-based summary scores.
  • To meaningfully interpret psychometric and preference-based summary scores in relation to the various purposes for which they are used.

Presenters:

  • Ron D. Hays, Professor, UCLA Department of Medicine, Los Angeles, California, United States
  • Benjamin Craig, Associate Professor, Department of Economics, Tampa, Florida, United States

Moderator:

  • Richard Sawatzky, Professor and Canada Research Chair, Trinity Western University and Providence Health Care, Langley, British Colombia, Canada

Presented by:
Psychometrics, Health Preferences Research, QOL in Clinical Practice, and Industry SIGs

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Hot Topics Webinar #2
'The Times They are a Changing': Exploring Meaningful Change in Health Outcomes Measurement

January 2018
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This webinar will discuss the complementary role of qualitative and quantitative methods for exploring meaningful change in health outcomes measurement including patient-reported outcomes (PRO) and clinician-reported outcomes (ClinRO). Recent advances in the field has seen the use of qualitative methodology to explore the score changes that represent meaningful changes for patients and clinicians.

Description:

This webinar will present the advantages and disadvantages of mixed methods approaches, present methods for qualitative exploration, and investigate how qualitative data can be amalgamated with quantitative data to aid interpretation of score changes in clinical trials. An industry perspective will be presented to show how qualitative and quantitative data have been successfully combined to identify responder definitions for clinical trial endpoints.

Learning Objectives:

  • Understand the benefits of exploring meaningful score change through qualitative and quantitative methods
  • Identify methods for qualitative exploration of meaningful change
  • Consider how to use qualitative and quantitative data to set responder thresholds for clinical trials

Presenters:

  • Helen Kitchen, Senior Consultant & Specialist Team Lead, Clinical Outcomes Assessment, DRG Abacus, Manchester, United Kingdom
  • Cheryl Coon, Principal, Outcometrix, Boston, MA, United States
  • Allison Martin Nguyen, Principal Scientist, CORE- Patient Reported Outcomes & Study Endpoints, Merck, North Wales, Pennsylvania, United States

Presented by: 
Psychometrics, Health Preferences Research, QOL in Clinical Practice, and Industry SIGs

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Hot Topics Webinar #3
Different perspectives on meaningful interpretation of change in patient-reported outcomes: Meaningful (Clinically) Important Differences

February 2018
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This workshop will provide the audience with an understanding of the history of interpretation thresholds as well as an appreciation for how the adoption of a “one-size-fits-all” perspective may impair the ability to understanding relevant change over time in HRQoL and PRO measures at the individual patient level.

Description:

The development and increasing utilization of health-related quality of life (HRQoL) and patient-reported outcomes (PRO) measures to better understand the important aspects of health and disease from the patient’s perspective has created the need to better understand the magnitude of important HRQoL change. The corresponding development of interpretation thresholds has been influenced, in part, by large population-based research and clinical trials focused on evaluating the magnitude of change over time in HRQoL and PROs.

This workshop will provide a didactic introduction on the motivation, need, and the resulting methodological approaches for deriving interpretation thresholds of change, such as minimal clinically important differences (MCIDs), minimal important differences (MIDs) and responder definitions (RDs). With these understandings established, the limitations and critiques of these interpretation thresholds will be discussed. These limitations include: 1) the resulting restrictions on interpretation, and 2) the potential for distortion of the individual patient’s voice, a key element deserving continued respect in HRQoL research and the use of HRQoL clinical practice.

Learning Objectives:

  • To describe the history, motivation, need for interpretation thresholds of change over time
  • To compare different interpretation thresholds, including minimal clinically important differences (MCIDs), minimal important differences (MIDs) and responder definitions (RDs)
  • To critically consider the strengths and limitations of using interpretation thresholds in evaluating individual differences of change

Presenters:

  • Kathleen W. Wyrwich, Senior Research Advisor, Patient-Focused Outcomes Center of Expertise, Eli Lilly and Company, Lily Corporate Center, Indianapolis, Indiana, United States
  • Jose M. Valderas, Professor of Health Services and Policy, University of Exeter, Essex, United Kingdom

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