Program: Live Sessions

Events » 28th Annual Conference » Live Sessions

Live events are only presented at their scheduled times, with the exception of plenary sessions. Plenary sessions will be available on-demand following their live presentation date.

Plenary Sessions

Plenary: Cutting Edge Research Plenary

Tuesday, 12 October | 8:30 am – 9:45 am CDT

Description:

The Cutting Edge Research plenary session features some of the highest-ranked, innovative research from ISOQOL abstract submissions. In particular, these abstracts reflect research that truly “pushes the ISOQOL envelope” in providing new and different ways to look at quality of life.

Plenary : Use of PROs for People-Centred Care

Wednesday, 13 October | 8:30 am – 10:00 am CDT

Description:

Person-centred care is a fundamental shift in the delivery of health care that personalizes it by placing the patient/client at the nucleus of this care. This plenary will incorporate critical perspectives to explore the interconnections of person-centred care and PRO use at individual and aggregated levels, alongside patient engagement with patients as partners in healthcare and their own use of PROs.

 

Speakers:

Joakim Öhlén, RN PhD, Institute of Health and Care Sciences and Centre for Person-Centred Care at the University of Gothenburg, and Palliative Centre Sahlgrenska University Hospital, Gothenburg, Sweden

Joakim Öhlén, PhD, RN, is professor in nursing at the Sahlgrenska Academy, University of Gothenburg in Sweden, and has a clinical appointment to the Palliative Centre at Sahlgrenska University Hospital in Gothenburg. He is the Centre Director at the University of Gothenburg Centre for Person-Centred Care, and leads a research programme on person-centeredness in palliative care. He has contributed with knowledge about how to put person-centeredness in action including a practice model for communication in the context of palliative care, patients’ preparedness for recovery, and support to family members in palliative care. He has extensive teaching experience.

 

Kirstie Haywood, DPhil BSc(Hons), PGCertTLHE, Warwick Research in Nursing, Warwick University, Coventry, United Kingdom

Kirstie’s interest in PRO research has embraced many conditions, with a long-term interest in rheumatology/musculoskeletal and resuscitation research. She has led on the development, use and evaluation of PRO approaches in research and routine practice settings, and in core outcome set development. She is passionate about working collaboratively with patients as partners across these endeavours, co-founding and chairing ISOQOL’s Patient Engagement SIG. She is an invited member of the European Resuscitation Council guidelines and American Heart Association ‘Statement of Survival after Cardiac Arrest’ writing groups, raising the importance of capturing the voice of survivors and their families in resuscitation research.

Plenary: Validation of PROs for decision-making

Thursday, 14 October | 9:30 am – 11:00 am CDT

Description:

Modern perspectives of measurement validity focus on the inferences, actions and decisions based on PROs. This plenary will address diverse evidence-based foundations for using individual and aggregated PRO data at micro-, meso- and macro-levels of healthcare decision-making.

 

Speakers:

Mirjam Sprangers, PhD, Amsterdam University Medical Centers, Amsterdam, Netherlands

Mirjam Sprangers, psychologist by training, is full professor at the Department of Medical Psychology of the Amsterdam University Medical Centers in the Netherlands. She coordinates a research line addressing the methodological, theoretical and clinically applied aspects of quality-of-life research in a range of chronic diseases. She is a long-standing member of the European Organisation for Research and Treatment of Cancer Study Group on Quality of Life. She was a Foreign Adjunct Professor of the Karolinska Institute in Stockholm, Sweden. She served as President of the board of ISOQOL and received the 2014 ISOQOL President’s award.

 

Bruno D. Zumbo, PhD, The University of British Columbia, Vancouver, British Columbia, Canada

 

Plenary: The Importance of Patient-reports in Learning Healthcare Systems

Friday, 15 October | 9:30 am – 11:00 am CDT

Description:

Patient reports on their health outcomes and healthcare experiences, including their narratives, are central to person-centred learning healthcare systems. The presenters will discuss the state of the art in using patient reports to ensure that value-based healthcare is achieved and drives the person-centred learning health systems.

 

Speakers:

Charles P. Friedman, PhD, University of Michigan Medical School, Ann Arbor, MI, United States

Charles Friedman is the Josiah Macy Jr. Professor of Medical Education and Chair of the Department of Learning Health Sciences at the University of Michigan Medical School. In recent years, he has focused his academic interests and activities on the concept of Learning Health Systems, and the socio-technical infrastructure required to sustain them. He is editor-in-chief of the open-access journal Learning Health Systems and co-chair of the movement to Mobilize Computable Biomedical Knowledge.

Prior to coming to Michigan, Friedman held executive positions at the Office of the National Coordinator for Health IT (ONC) in the U.S. Department of Health and Human Services. Immediately prior to his work in the government, Dr. Friedman was Associate Vice Chancellor for Biomedical Informatics, and Founding Director of the Center for Biomedical Informatics at the University of Pittsburgh.

 

Verna Yiu, MD FRCPC, Alberta Health Services, Edmonton, Alberta, Canada

An accomplished leader in the academic and healthcare sectors, Dr. Verna Yiu has been involved in public sector governance for over two decades. She is currently the President and CEO of Alberta Health Services (AHS), Canada’s first and largest province-wide health system providing integrated care to more than 4.2 million Albertans. AHS has been recognized as a national and international leader in many clinical and administrative areas including: being named as one of the top 5 most integrated healthcare systems out of 40 countries, having one of the top 3 best health supply chain management systems in the world, and awarded one of Canada’s Top 100 Employers for three consecutive years.

Dr. Yiu previously served as Vice President, Quality and Chief Medical Officer in AHS from 2012-2016. Prior to the role of Interim Dean in 2011, she was Vice-Dean for the Faculty of Medicine/Dentistry from 2008-2011 and Assistant Dean for Student Affairs from 2000-2008. She has won numerous awards for teaching and clinical excellence and also chaired the Specialty of Nephrology for the Royal College of Physicians and Surgeons of Canada for 6 years. Dr. Yiu is a Professor of Pediatrics at the University of Alberta and continues to practice as a pediatric nephrologist.

 

Brenda Hemmelgarn, MD PhD, University of Alberta, Edmonton, Alberta, Canada

Dr. Brenda Hemmelgarn is a nephrologist, health services researcher and Dean, Faculty of Medicine & Dentistry U of Alberta. Her research includes strategies to improve care and outcomes for patients with kidney disease and other chronic conditions. She is a strong advocate for patient-oriented research, patient engagement and integrated knowledge translation. She has more than $20 million in funding and more than 500 peer-reviewed publications. Among her awards Dr. Hemmelgarn received the Alberta Science and Technology Leadership (ASTech) Foundation Award for Outstanding Achievement in Health Innovation and is a fellow of the Canadian Academy of Health Sciences.

Roundtables

Roundtables are informal meetings with limited attendance focused on networking and discussing a specific topic. To accommodate a range of time zones during the virtual conference, there are two roundtables per day – each with a different host – discussing the same topic.

  • Sign-up: Paid ticket
  • Purchase Limits: One roundtable
  • Ticket Distribution: First come, first served
  • View: Live only

*Note: Roundtables presented through Zoom.

18-20 October | 7:00 am & 2:00 pm CDT (Twice Daily)

Roundtable 1A: How can PROMs and PREMs enable the integration of person-centred care practices?

Monday, 18 October | 7:00 am – 8:00 am CDT

Description:

This discussion will focus on how the use of PROMs and PREMs can function as enablers and triggers for the integration of person-centred care in healthcare practice. Possible questions for discussion: What are the features of a person-centred practice? What are the users’ interests as related to using PROMs and PREMs? What are the practice interests that can drive the development?

 

Host:

Joakim Öhlén, RN PhD
Institute of Health and Care Sciences and Centre for Person-Centred Care at the University of Gothenburg, and Palliative Centre Sahlgrenska University Hospital

Roundtable 2A: Studying online symptom monitoring with ePROs combined with patient self-management advice during cancer treatments – engaging patients and clinicians

Monday, 18 October | 7:00 am – 8:00 am CDT

Description:

ePROs-based online interventions are complex, with active components influencing patients, clinicians and clinical pathways. Patient benefit depends on the content and design of the intervention, patients’ and clinicians’ engagement and associated clinical actions or self-management. We will discuss different approaches across oncology contexts to learn how interventions could be designed and delivered to maximise benefit. Bring your questions, examples and experiences.

 

Host:

Galina Velikova, MD PhD FRCP
University of Leeds

Roundtable 2B: Strategies and Overcoming Barriers to Implement PROs into Clinical Practice

Monday, 18 October | 2:00 pm – 3:00 pm CDT

Description:

In this roundtable, we will discuss the challenging process of Implementing patient-reported outcomes (PROs) into clinical practice with a focus on the spectrum of approaches from Volkswagen to Cadillac. We will use the Canadian pediatric landscape as an example. We are looking forward to an interactive discussion.

 

Hosts:

Robert Klaassen, MD FRCP(c)
Children’s Hospital of Eastern Ontario

 

 

 

Samantha J. Anthony, PhD MSW RSW
SickKids

Roundtable 3A: Using Implementation Science: from theory to practice

Tuesday, 19 October | 7:00 am – 8:00 am CDT

Description:

Who does the ‘work’ of implementing patient-reported measures in routine care settings, and how? In this roundtable we will discuss common barriers to implementing PROMs and PREMs in clinical practice, and explore practical strategies for overcoming them informed by implementation science theory. Bring your experiences to share!

 

Host:

Caroline Potter, DPhil
University of Oxford

Roundtable 3B: PROM Implementation 2.0: Can implementation science help us advance PROM implementation initiatives in routine care settings?

Tuesday, 19 October | 2:00 pm – 3:00 pm CDT

Description:

In this roundtable, we will discuss the process, barriers, and enablers of implementing patient-reported outcome measures (PROMs) in routine care settings. This will be an interactive session covering broad principles such as what implementation science can do for PROMs, theories that may be helpful, and how to evaluate PROM implementation initiatives. Please bring your questions!

 

Host:

Angela Stover, PhD
University of North Carolina – Chapel Hill

Roundtable 4A: PROs for Real-World Evidence/Regulatory Decisions

Tuesday, 19 October | 7:00 am – 8:00 am CDT

Description:

This roundtable will discuss the ability of PROMs, as a Clinical Outcome Assessment (COA), to provide real-world evidence (RWE) for making regulatory decision. This will be a discussion for those who have implemented PROMs at a registry or health system level and are interested in how PROMs may be used to support post-marketing surveillance.

 

Host:

Richard Skolasky, ScD
Johns Hopkins Univeristy

Roundtable 4B: Implementing PROMs to Improve Value in Clinical Care

Tuesday, 19 October | 2:00 pm – 3:00 pm CDT

Description:

This roundtable will discuss the clinical implementation of PROMs from a health economic framework. This is a discussion for those who have implemented and those who are wanting to implement; addressing both how to design implementations with this framework in mind and once implemented how PROMs can be used to improve quality and decrease cost.

 

Host:

Amy Cizik, PhD MPH
University of Utah

 

Roundtable 5A: Engaging with patients and the public as research partners - how well are we doing?

Wednesday, 20 October | 7:00 am – 8:00 am CDT

Description:

Effective engagement with patients and members of the public as research partners can have a profound impact on the conceptualisation and conduct of research. Seven years since the ‘values’ for patient engagement in health-related quality of life research were proposed, how well are we doing? This is an opportunity to explore the barriers, opportunities and advances in patient engagement. Please bring your experiences and questions for an interactive session!

 

Host:

Kirstie Haywood, DPHiL BSc (Hons)
University of Warwick
Warwick Medical School
Warwick Research in Nursing

Roundtable 5B: Co-designing PRO interventions in clinical practice

Wednesday, 20 October | 2:00 pm – 3:00 pm CDT

Description:

In this roundtable, we will explore co-design of interventions using patient-reported outcome (PROs) in clinical practice. We will cover the broad principles of patient engagement. Case studies will present design factors that can impact PRO measurement. This is an interactive discussion, we would like to hear your experiences.

 

Host:

Natasha Roberts, BN(Hons)
Royal Brisbane and Women’s Hospital

Roundtable 6A: Validity of the instrument that collects the data or validity of the data collected by the instrument? (quantitative focus)

Wednesday, 20 October | 7:00 am – 8:00 am CDT

Description:

Historically, validity has been seen as a static property of an instrument, established during its development, whereas modern validity theory holds that validity is a property of the inferences drawn from data for a particular context. This Roundtable will discuss the five sources of validity evidence (generated mainly, but not only, by quantitative research methods) from the Standards for Educational and Psychological Testing in contrast to types of validity.

 

Host:

Richard Osbourne, PhD
Swinburne University of Technology

Roundtable 6B: Validity of the instrument that collects the data or validity of the data collected by the instrument? (qualitative focus)

Wednesday, 20 October | 2:00 pm – 3:00 pm CDT

Description:

Historically, validity has been seen as a static property of an instrument, established during its development, whereas modern validity theory holds that validity is a property of the inferences drawn from data for a particular context. This Roundtable will discuss the five sources of validity evidence (generated mainly, but not only, by qualitative research methods) from the Standards for Educational and Psychological Testing in contrast to types of validity.

 

Host:

Melanie Hawkins, PhD
Swinburne University of Technology

Educational Workshops

  • Sign-up: Paid ticket
  • Purchase Limits: One workshop
  • Ticket Distribution: First come, first served
  • View: Live only

*Note: Workshops presented through Zoom.

18-22 October | 8:00 am – 11:00 am CDT (Daily)

Workshop 1: Using Patient-reported Outcome Measures for Screening

Monday, 18 October | 8:00 am – 11:00 am CDT

Workshop level: Basic

 

Workshop Goals:

Our goal is to provide an overview of the development, evaluation, and implementation of PROMs for screening in clinical practice and research. We will emphasize key skills with workshop activities. Background: Patient-reported outcome measures (PROMs) used for screening purposes have score thresholds (cut-scores) that can be used to categorize patients into clinically-meaningful groups, which facilitates identifying patients who might benefit from additional intervention or supportive care. Score thresholds can also enhance the interpretability and actionability of PROMs in clinical practice and research.

Intended Audience

Individuals interested in developing and/or using PROMs for screening purposes in clinical practice or research. This workshop is designed to be applicable to any patient population and to learners of all levels with prior knowledge/experience with PROMs.

Overview/Outline

  1. Introduction and workshop objectives (10 minutes) All presenters
  2. Methods lecture (45 minutes) 3 presenters
    • Methods for establishing score thresholds for a PROM when a “gold standard” is available
    • Methods for establishing score thresholds for PROMs in the absence of a gold-standard,
  3. Methods Activity (25 minutes) All presenters: break out groups moderated by presenters will apply the methods learned in the didactic lecture to example data.
    Break (5 minutes)
  4. Clinical/research applications (45 minutes)
    • Example 1 – Successes and learnings from integrating a screening PROM in otolaryngology practices – 1 presenter
    • Example 2 – Consideration of the Needs of Clinicians to Successfully Implement PROMs Used for Screening Purposes – 1 presenter
    • Example 3 – Using self-reported cognitive concerns and cognitive test performance to screen for cognitive impairment in primary care – 1 presenter
  5. Panel discussion – Workshop presenters will discuss lessons learned from the Clinical Examples in a Q&A format (10 minutes)
    Break (5 minutes)
  6. Evaluation/Implementation Activity (25 minutes) All presenters: Break out groups will elicit and discuss desirable properties of PROMs when used for screening and key considerations for successful implementation based on pre-defined contextual scenarios
  7. Discuss resources for further learning (10 minutes) – 1 presenter
    Closing Total time = 180 minutes (max = 180)

 

Learning Objectives

  1. Describe the methods for developing or adapting PROMs for screening purposes in clinical practice and research. Through didactic presentations, participants will learn the methods for developing new or adapting existing PROMs for screening purposes when a gold standard is available (sensitivity, specificity, negative and positive predictive value, etc.) versus when a gold standard is not available (standard setting by a panel of stakeholders, use of normative data, etc.), including the strengths and limitations of various approaches. Moderated break-out groups will provide participants with the opportunity to apply the methods discussed.
  2. Identify the properties of a useful patient-reported screener. Presenters will describe approaches for critically evaluating PROMs used for screening purposes. In a second break-out session, participants will be presented with example PROMs for screening and clinical and/or research vignettes. For example, one important property for clinicians working directly with patients is the clinical relevance and integration of results into their clinical reasoning processes. Attendees will apply their knowledge in discussions of selecting and evaluating the properties of PROMs for screening for specific applications.
  3. Recognize opportunities to use PROMs as screening tools in clinical practice and research. Didactic presentations will instruct attendees on how to identify situations where PROMs can be informative as well as situations where their use is to be avoided. Practical applications of PROMs for screening purposes will be illustrated through a series of three case studies. Additionally, consideration of the needs and individual factors that impact clinicians’ behaviors to support the use of PROMs as screeners will be illustrated. In the second moderated break-out session, participants will use research vignettes to elicit and discuss attributes needed for successful implementation of PROM screening tools in clinical practice or research.

Organizers:

  • Kathleen Yost, PhD, Mayo Clinic, Rochester, United States
  • Theresa Coles, PhD, Duke University School of Medicine, Durham, United States
  • Minji Lee, PhD, Mayo Clinic, Rochester, United States
  • Angela Wolff, RN PhD, Trinity Western University, Langley, British Columbia, Canada
  • Cindy Nowinski, MD PhD, Northwestern University, Chicago, United States
  • Natasha Roberts, Royal Brisbane and Women’s Hospital, Herston, Australia

Workshop 2: The Estimand Framework, Sensitivity Analyses, and Applications in Patient-reported Outcomes

Monday, 18 October | 8:00 am – 11:00 am CDT

Workshop level: Advanced

 

Workshop Goals:

  1. Illustrate the importance of the estimand framework for patient-reported endpoints
  2. Demonstrate the link from the PRO objective to the interpretation through the estimand framework
  3. Provide a clear and accessible demonstration of PRO estimands that can be applied in the regulatory setting

Intended Audience

The workshop is intended for academics, trialists and outcomes researchers who design clinical trials and plan and analyze patient-reported endpoints.

Overview/Outline

1. Background
a. Regulatory and reimbursement authorities increasingly require that patient experience is captured in clinical trials
b. PRO objectives are often vaguely defined, leading to interpretation challenges and exclusion of results from the drug label
c. The estimand framework provides a clear process for defining and interpreting PRO endpoints
d. Regulatory agencies are adopting the estimand framework and it is expected to be increasingly used in trials
2. Definitions of estimands, per ICH E9 addendum
a. 5 components
b. Strategies for evaluating estimands:
• Treatment policy
• Composite
• Hypothetical
• Principal Stratum
1. When might this be helpful?
2. Advantages and disadvantages
3. User-friendly and more technical resources and examples
• While on treatment
3. Sensitivity analyses for PRO endpoints
4. Demonstration of estimands on PRO endpoints
a. The ACCENT trial evaluated the efficacy of N-acetylcysteine (NAC) in adults with cannabis use disorder;
b. The Marijuana Cravings Questionnaire4 evaluated patient-reported marijuana cravings;
c. Estimand 1: assessment of efficacy for NAC relative to placebo on patient-reported cravings
i. Definition of intercurrent events
ii. Strategies used:
• a composite strategy for discontinuation
• a treatment policy strategy for non-adherence
iii. Sensitivity analyses
iv. Communicating the findings
d. Estimand 2: assessment of efficacy for NAC relative to placebo on patient-reported cravings while participants were medically adherent
i. Definition of intercurrent events
ii. Strategies used:
1. a hypothetical strategy for discontinuation and for non-adherence
iii. Sensitivity analyses
iv. Communicating the findings
e. Estimand 3: assessment of efficacy for NAC relative to placebo on patient-reported cravings while participants were receiving treatment
i. Definition of intercurrent events
ii. Strategies used:
1. a while on treatment strategy for discontinuation
2. a treatment policy strategy for non-adherence
iii. Sensitivity analyses
iv. Communicating the findings
5. Final remarks
a. The goal of this workshop is to demonstrate a link from the PRO objective to the interpretation through the estimand framework

 

Learning Objectives

  1. Understand how using the International Council for Harmonisation (ICH) addendum on estimands and sensitivity analysis in clinical trials provides a framework connecting the PRO objective, with the analytic approach, and interpretation.
  2. Describe the 5 components of estimands for PROs and evaluate the strengths and limitations of different estimand strategies for clinical trials.
  3. Given a PRO measure, design 3 evaluable estimands for a clinical trial and given a PRO estimand, define a corresponding sensitivity analysis and successfully communicate the interpretation.

Organizers:

  • Libby Floden, PhD MPH, Clinical Outcomes Solutions, Tucson, United States
  • Melanie Bell, PhD, University of Arizona, Tucson, United States
  • Bellinda King-Kallimanis, PhD, LUNGevity, Washington, United States
  • Jessica Roydhouse, PhD, University of Tasmania, Hobart, Australia

Workshop 3: Methods for Estimating Individual Change on Patient-Reported Outcome Measures

Tuesday, 19 October | 8:00 am – 11:00 am CDT

Workshop level: Basic

 

Workshop Goals:

There is a critical need to understand whether individual patients have changed on patient-reported outcome measures (PROs). The United States Food and Drug Administration (FDA) requires that PROs qualified as clinical outcome assessments have established thresholds for meaningful within person change and for determining when individual patients have benefited from treatment (responder definition). Clinicians need to be able to determine if their patients improve after a treatment modification. To date, group-based methods have often been inappropriately used to define individual change. In addition, there is confusion about what counts as important change at the individual level. This workshop will clarify the conceptual basis for defining individual change on PROs, detail the most appropriate methods for estimating individual level change, and provide a hands-on, demonstration-based instructional session on estimation of individual change in common statistical software.

Intended Audience

The intended audience is PRO researchers, clinical trialists focusing on PROs, practitioners interested in determining whether individual patients have changed, and researchers involved in regulatory applications of PROs.

Overview/Outline

  1. Introduction (5 minutes)
  2. Background on Key Concepts (60 minutes)
    • Change scores
    • Brief history of minimally important differences and change
    • Group change: Anchor methods vs. distribution methods
    • Group methods should not be used for individual change
    • Methods for individuals
      • Reliable change index and related statistics
      • Applications in Item Response Theory
      • Meaningful change at the individual level
  3. Guided Group Discussion (15 minutes)
    Break (15 minutes)
  4. Demonstration and Practice Estimating Individual Change in Common Statistical Software (60 min)
    • Set-up cloud-based access to practice data for all participants
    • Ensure each participant has appropriate software installed
    • Walk-through multiple examples
  5. Guided Group Discussion (20 minutes)
  6. Wrap-up (5 minutes)

 

Learning Objectives

  1. Distinguish between appropriate methods for estimating group and individual change on PRO measures.
  2. Be familiar with methods to identify statistically significant and meaningful change on PROs, and the advantages and limitations of applying different thresholds.
  3. Estimate statistically significant individual change using common statistical software (e.g., SAS, R) and interpret the results.

Organizers:

  • John Peipert, PhD, Northwestern University, Chicago, United States
  • Ron Hays, PhD, UCLA Department of Medicine, Los Angeles, United States

Workshop 5: Successfully Selecting, Developing, and Deploying Digital Clinical Measures of Health

Wednesday, 20 October | 8:00 am – 11:00 am CDT

Workshop level: Basic

 

Workshop Goals:

To support the adoption of high-quality, evidence-based, fit for purpose digital clinical measures in clinical trials, patient care, and public health.

Intended Audience

Professionals dedicated to the development and deployment of digital clinical measures using wearable sensor technology.
We are skilled at communicating with diverse audiences, and will provide invaluable insights to everyone passionate about advancing remote patient monitoring.

Overview/Outline

The global COVID-19 pandemic driven a new urgency for devising a common framework for the development and deployment of high quality, patient centric, digital clinical measures. Multiple digital technologies for symptom tracking and contact tracing are currently in use and/or development, and clinical researchers are now designing new decentralized clinical trial strategies using telemedicine and remote patient monitoring to minimize pandemic-related disruption of the clinical research enterprise. Adoption of a comprehensive “how-to” roadmap to synthesize best practices in the digital health field is essential for guiding these efforts and safeguarding public health.

The Playbook synthesizes best practices from the digital health field into one comprehensive “how-to” document. A first draft, built by collaborators from the Digital Medicine Society, Elektra Labs, Genentech, Koneksa, Myokardia, Sage Bionetworks, Scripps Research, and the FDA. The Playbook is now being advanced for broad adoption by these organizations and new collaborators from ActiGraph; Activinsights; American Pharmacists Association; BlackThorne Rx; Center for Digital Health at Brown University; Covance; Digital.Health; Duke University; Eli Lilly and Company; the European Medicines Agency; Evidation Health; Merck.; Open mHealth; Pfizer; physIQ; Savvy Coop; Takeda; VivoSense; and Winterlight Labs.

This session will be delivered as an interactive workshop, providing participants with the foundational elements of selecting, developing, and deploying high quality digital clinical measures that cut across use cases. Speakers are co-creators of The Playbook with extensive experience and expertise in measurement science, HEOR, the science of patient engagement, regulatory science, and — perhaps most importantly — education. This speaker panel demonstrates disciplinary diversity as well as effective pre-competitive collaboration. To support the audience in selecting, developing, and deploying fit-for-purpose, meaningful digital clinical measures across clinical research, patient care, and public health.

 

Learning Objectives

  1. To support the audience in selecting, developing, and deploying fit-for-purpose, meaningful digital clinical measures across clinical research, patient care, and public health.
  2. To support the audience in identifying ethical considerations associated with the introduction of digital clinical measures to clinical trials, patient care, and public health.
  3. To support the audience in selecting the right partners for co-creating and implementing high quality, patient centric, digital measures of health.

Organizers:

  • Jennifer Goldsak, MChem MA MBA, Digital Medicine Society (DiMe), Boston, United States
  • Betsy Tschosik, Genentech, Chicago, United States
  • Elizabeth Nicki Bush, Eli Lily and Company, Indianapolis, United States

Workshop 6: Why is it so complex? How to integrate PROs in routine care using Complexity Theory

Wednesday, 20 October | 8:00 am – 11:00 am CDT

Workshop level: Basic

 

Workshop Goals:

Integrating PRO measures into clinical practice requires a considered approach to ensure effectiveness and sustainability. There is much to take into account, including impacts from the health service, from staff, and from patients and their families.
The goal is of this to workshop is to explore the application of complexity theory to the use of PROs routine clinical care.

Intended Audience

This workshop is intended for individuals who have a basic knowledge of PROs in research and/or clinical practice.

Overview/Outline

Workshop outline [180 minutes]:
1. Overview of complex interventions [40 minutes]

  • Welcome and agenda overview
  • Introduction to complex interventions:
  • What does it mean for an intervention to be “complex”?
  • What tools and resources are available? What makes using PROs complex?
  • Small group activity reflecting their experiences of complexity
  • Facilitated discussion of what each group identified from their settings/contexts

2. Theoretical approaches to complexity [30 minutes]

  • Overview of implementation science and PROs
  • Complexity science theory
  • PCORI proposed method standards for studies of complex interventions
  • Process Measurement for the implementation of complex interventions

Break [15 minutes]

3. Case Study 1 [25 minutes]: Developing a strategy for introducing PROs using Complexity Theory: Using PROs to overcome the fragmentation in clinical care of individual patients

  • Facilitated discussion and questions

4. Case Study 2 [25 minutes]: Development of a PRO intervention in clinical practice: How using phases of development can be used to build a robust complex intervention

  • Facilitated discussion and questions

5. Case Study 3 [25 minutes]: Using a complexity lens to guide the design and implementation of PROs in clinical practice: A complexity-informed approach across multiple use cases and workflows within a health system

  • Facilitated discussion on sustaining complex intervention and questions

6. Interactive Group Activity with Facilitators – Apply complexity theory to your context [15 minutes]
7. Share results and wrap up [5 minutes]

 

Learning Objectives

  1. Describe the fundamentals of complexity theory and complex interventions in relation to healthcare
    Participants will be able to classify theoretical approaches, understand what complexity is, and why a theoretical approach is needed. They will be able to recognize the complexities of PRO use in individual patients, clinicians, specific subgroups, local institutions and broader health system and assist incorporation of PROs into the workflow. Through facilitated reflection and group discussion about complex interventions, participants’ will be able to draw on their experiences. Participants will be able to access tools and resources available to manage complexity in research and practice and know where to find further information.
  2. Describe PRO use in clinical practice as a complex intervention
    Participants will be able to identify why PROs are complex interventions. They will be able to compare and contrast complexity theory in order to recognize complex interventions in their respective settings. This learning objective will be achieved through presented content of both theory and applied international case studies, through facilitated reflection, and group discussion. As a result, participants will be able to explore the value and potential for using PROs in clinical practice.
  3. Apply understanding of complexity theory and complex intervention frameworks based on international case studies
    Participants will be able to understand how to apply complexity theory to PROs in clinical practice. They will be able to plan the design of a clinical implementation that integrates complex PRO interventions into clinical care. Participants will be able to understand the complexities of using PROs at an individual patient and clinician level, complexities at the local level, and at a broader health service level. Additionally, real world examples will enable the application of complexity theory across a variety of disease types, patient and clinician groups and international health services.

Organizers:

  • Natasha Roberts, PhD, University of Queensland, Herston, Australia
  • Elizabeth Austin, MPH, University of Washington, Seattle, WA, United States
  • Liv Marit Valen Schougaard, PhD, Regional Hospital West Jutland, Herning, Denmark
  • Bernice Gulek, MS, University of Washington, Seattle, United States
  • Angela Wolff, PhD, Trinity Western University, Langley, British Columbia, Canada

Workshop 7: Digital Storytelling in Health Research

Thursday, 21 October | 8:00 am – 11:00 am CDT

Workshop level: Basic

 

Workshop Goals:

  1. Introduction to the method and practice of Digital Storytelling (DST)
  2. Take part in viewing and discussion of digital stories
  3. Discuss how stories can be used and shared in health-related quality-of-life research
  4. Discuss the ethical considerations of DST

Intended Audience

Researchers, clinicians, patient-partners, and other stakeholders interested in learning about the methodology, process, and practice of storytelling in health research, and how digital stories complement patient-reported outcomes research.

Overview/Outline

Stories and storytelling help us to make sense of our thoughts, feelings, and experiences. They help us to better understand our environment, interactions with others and to formulate and convey our values, beliefs, and insights for ourselves and others.

DST is an innovative Community-Based Participatory Research (CBPR) method that increases the participation of people with lived experience in health research. Digital stories are short (3-5 minutes), first-person video narratives created with the combination of images, video, narration, and music. DST has been used by academics across disciplines, including health research for the past two decades.
In this workshop, we will focus on DST methods, how DST works in practice as well as its benefits and challenges. This workshop will introduce you to a 7-step methodology developed by Story Center, US (Lambert, J., 2020, Berkeley, CA., USA). The 7-steps include owning your insights, owning your emotions, finding the moment, seeing your story, hearing your story, assembling your story, and sharing your story. As a CBPR method, DST can help to reach and elevate the voices of underrepresented populations and can be used as a tool to meaningfully engage populations who value storytelling as a way of knowing and understanding. It could also be used as a tool to understand what matters most to patients, to inform and personalize quantitative data, and as a powerful knowledge translation tool.

The workshop outline:

  1. Introduction to DST: including the 7-steps involved to develop a digital story (60 minutes)
  2. View and discuss the use of digital stories in health research (60 minutes)
  3. Group discussion: digital stories and patient-reported outcomes research (30 minutes)
  4. Group discussion: ethical considerations when using DST as a research method (30 minutes)

 

Learning Objectives

  1. Describe how Digital Storytelling supports efforts to capture patient experiences including those from under-represented populations.
  2. List and describe the 7 steps involved in the Digital Storytelling method.
  3. Describe how Digital Storytelling can be applied in person-centered outcomes research.

Organizers:

  • Sandra Zelinsky, University of Calgary, Calgary, Alberta, Canada
  • Maria Santana, PhD, University of Calgary, Calgary, Alberta, Canada
  • Danielle Lavallee, PhD, British Columbia Academic Health Science Network, Vancouver, British Columbia, Canada
  • Sadia Ahmed, Masters, University of Calgary, Calgary, Alberta, Canada

Workshop 8: PROM data visualization in the clinical setting: what do clinicians need to see?

Friday, 22 October | 8:00 am – 11:00 am CDT

Workshop level: Basic

 

Workshop Goals:

Regardless of whether patient-reported outcome measure (PROM) data is collected via app or integrated into the electronic health record, the numeric results must be transformed into a format that is easy to read and interpret for busy clinicians and their patients. The workshop goals are to present and discuss examples and best practices for visualizing PROM data in the context of clinical care.

Intended Audience

Clinicians, clinical informaticists, clinical researchers, implementation scientists

Overview/Outline

Session 1: Data visualization for clinical PROM interpretation: an overview – 30 min
Abi Williams, Adelphi Values, Boston, United States

  • This session highlights the data visualization research and applications that have been developed to help clinicians interpret results.

Session 2: Real-world application in Orthopedic Surgery- 30 min
Judy Baumhauer, University of Rochester, Rochester, United States

  • The presenter will provide examples of how clinicians use data visualization to interpret patient-reported outcomes in a setting where there is routine collection of PROMs allowing for visualization of symptom trends over time and aggregate data assessment.

Session 3: Recommendations for PRO data visualization – 30 min
Claire Snyder, PhD, Johns Hopkins University, Baltimore, United States

  • Dr. Snyder will review research findings regarding differences in accuracy of interpretation and ratings of clarity across different PROM data display formats. She will then describe how this evidence base informed development of recommendations for PROM data display and how these recommendations meet stakeholders’ needs.

Sessions 1-3 Q&A – 15 min
Session 4: Interactive computer demonstration- 30 min
Alejandro Moreno-Koehler, Adelphi Values, Boston, United States; Ethan Arenson, MA, MS, Adelphi Values, Boston, United States

  • Using a demo computer application, participants can enter responses from a hypothetical patient to one of the PROMIS assessments, and can view a dashboard with different visual interpretations of results.

Session 5: What works for clinicians? A discussion panel – 45 min
Panel: Angela Wolff, PhD RN, Trinity Western University, Langley, BC, Canada; Saied Shahraz, ICON PLC, Dublin, Ireland
Moderator: Emily Henkle, PhD MPH, OHSU-PSU SPH, Portland, United States

  • This panel facilitated by researchers focusing on implementation, end-user needs, and clinical informatics will invite participants to discuss data visualization methods that have helped with the interpretation of PROM results and enabled their use to meaningfully guide patient care.

 

Learning Objectives

  1. To learn about different approaches for visualizing patient-reported outcome measure (PROM) results for clinical interpretations.
  2. To understand evidence-based recommendations for presenting PROM data.
  3. To discuss ways data visualization can improve the interpretation of PROMs in the clinical setting.

Organizers:

  • Emily Henkle, PhD MPH, OHSU-PSU School of Public Health, Portland, United States
  • Ethan Arenson, MA MS, Adelphi Values, Boston, United States

Additional Workshop Speakers:

  • Abi Williams, Adelphi Values, Boston, United States
  • Judy Baumhauer, University of Rochester, Rochester, United States
  • Claire Snyder, PhD, Johns Hopkins University, Baltimore, United States
  • Alejandro Moreno-Koehler, Adelphi Values, Boston, United States
  • Angela Wolff, PhD RN, Trinity Western University, Langley, BC, Canada
  • Saied Shahraz, ICON PLC, Dublin, Ireland

Our Sponsors

The International Society for Quality of Life Research (ISOQOL) is a global community of researchers, clinicians, health care professionals, industry professionals, consultants, and patient research partners advancing health related quality of life research (HRQL).

Together, we are creating a future in which patient perspective is integral to health research, care and policy.