Thursday, 19 October | 8:30 am – 10:00 am

Description:

With the recent emphasis on equity, diversity and inclusion, it is more important than ever to capture the perspectives of all members of a given population. It is no longer acceptable to simply include the easily accessible majority while ignoring important under-represented groups. This plenary session will focus on strategies to engage populations who, for a variety of reasons, traditionally are resistant to complete PROMs and/or enroll in research. In addition, it will highlight cultural differences in the way that questions should be asked and how the results should be used and interpreted.

Speakers:

Nancy Young, BScPT MSc PhD, CHEO Research Institute, Ottawa, Ontario, Canada

Dr. Young is a Senior Scientist at the CHEO Research Institute and specializes in child health measurement science. She leverages research to elevate the voices of children in health assessments. She has collaborated with many different populations, including children with complex disabilities and bleeding disorders. Her current research focuses on innovative methods to measure quality of life among children with rare disorders and on creating culturally-relevant approaches to health measurement with and for Indigenous children and youth. Through collaboration, she has improved access to high-quality local data that inform health services planning within rural and remote Indigenous communities.

Jennifer Stinson, RN-EC PhD CPNP FAAN, The Hospital for Sick Children, Toronto, Ontario, Canada

Dr. Jennifer Stinson is the Mary Jo Haddad Nursing Chair, Nurse Practitioner, and Co-Director of the Pain Centre at the Hospital for Sick Children. She is a Professor at the Lawrence S. Bloomberg Faculty of Nursing and Institute of Health Policy, Management and Evaluation at the University of Toronto. Her research program focuses on co-design and evaluation of digital therapeutics for youth with painful chronic conditions as well as patient reported outcome measures. She also focuses on interprofessional pain education such as Pediatric Project ECHO that provides virtual mentorship to community healthcare providers on management of complex pediatric pain patients.

Mitchell Lunn, MD, Stanford University School of Medicine, Palo Alto, California, United States

Dr. Mitchell R. Lunn (he/him) is an Associate Professor of Medicine (Nephrology) and of Epidemiology and Population Health at Stanford University School of Medicine. He studies sexual and gender minority (SGM) health and utilizes existing and emerging technologies to characterize the health and well-being of underrepresented and vulnerable populations that face numerous health and healthcare disparities. He focuses on improving understanding of the factors that positively and negatively influence SGM health including research on SGM health disparities, SGM societal experiences, provider education about SGM health, and institutional climate towards SGM people.

Moderator:

Ligia M. Chavez, PhD, University of Puerto Rico, San Juan, Puerto Rico

Thursday, 19 October | 10:50 am – 12:00 pm

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.

Friday, 20 October | 8:00 am – 9:30 am

Description:

In recent years, there has been a proliferation of quality of life measures. These may be novel tools to address new clinical areas, or ones which were developed to improve upon existing legacy tools. In this panel debate/discussion, presenters will highlight the good, bad, and ugly of legacy tools. Using examples, they will also explore the pros and cons of moving from legacy tools to more modern ones. Regardless of which camp you may align with, all attendees will be treated to a lively discussion and question and answer period.

Speakers:

Andrew Finlay, FRCP, Cardiff University, Cardiff, United Kingdom

Professor Andrew Finlay has led the development of quality of life measures in dermatology, creating the most widely used outcome measures in dermatology worldwide, including the Dermatology Life Quality Index. His current research focuses on measuring the impact of disease on patients’ family members. Professor Finlay was Head of Dermatology, Cardiff University and was President of the British Association of Dermatologists (BAD). Author of >450 publications, he co-authored the undergraduate textbook “Dermatology at a Glance” and co-edited in 2022 “Dermatology Training: the Essentials”. He was appointed CBE in 2010 and awarded the 2020 Sir Archibald Gray medal by the BAD.

John E. Ware, Jr., PhD, John Ware Research Group, Portsmouth, Rhode Island, United States

Dr. Ware is a research psychologist specializing in psychometrics who’s career began developing patient-reported outcome (PRO) measures in the 5-year randomized RAND Health Insurance Experiment and 4-year quasi-experimental Medical Outcomes Study (MOS), leading to development the MOS 36-item Health Survey (SF-36), and industry-sponsored International Quality of Life Assessment (IQOLA) Project translations of SF-36 used in multinational population surveys and clinical trials worldwide. He is an elected member of the US National Academy of Medicine and one of the most frequently cited scientists. His current emphasis is on more practical and more useful integrations of disease-specific and generic PRO results.

Moderator:

Caroline B. Terwee, PhD, Amsterdam UMC, Amsterdam, Netherlands

Saturday, 21 October | 1:50 pm – 3:20 pm

Description:

Despite the recognized importance, need, and value of patient-reported outcome measures, their implementation within health services remains challenging. This plenary session will feature examples of successful implementation of PROs at the micro (patient), meso (health system), and macro (policy) levels. In addition to presenting how PROs are used, panelists will highlight the strategies that researchers, clinicians, and administrators have utilized to address barriers they encountered, as well as lessons learned along the way.

Speakers:

Judith Baumhauer, MD MPH, University of Rochester Medical Center, Rochester, New York, United States

Dr. Baumhauer is a tenured Professor and serves as the Dean of Academic Affairs for the University of Rochester School of Medicine and Dentistry. She is a clinically active orthopaedic surgeon. She is the Director of the Clinical Health Informatics Core for the UR Health Care System. Dr. Baumhauer is the past president of the ABOS, AOFAS, EOA and PROMIS Health Organization. Her research focuses on patient reported outcomes (PROs) in clinical decision-making. She has studied how collecting and sharing PROs affect patient engagement, patient satisfaction and clinical efficiency.

Stirling Bryan, PhD, Health Research BC / UBC, Vancouver, British Columbia, Canada

Stirling Bryan is a health economist with extensive experience of engagement with health policy and decision-making worlds. He is Chief Scientific Officer at Michael Smith Health Research BC, professor in UBC’s School of Population & Public Health, and senior scientist at Vancouver Coastal Health Research Institute. Before emigrating to Canada in 2008, Stirling held academic positions in the U.K. at St Thomas’ Hospital, Brunel University, and the University of Birmingham. He was a Commonwealth Fund Harkness Fellow in 2005/06, spending a year at Stanford University. In 2020 he was elected as a Fellow of the Canadian Academy of Health Sciences.

Moderator:

Angela Wolff, PhD RN, Associate Professor, School of Nursing, Trinity Western University, Langley, British Columbia, Canada

Description:

PROMs are widely used in mental health contexts, and they have proven to be an effective vehicle for innovative translational research and care concepts. Participants are encouraged to share experience and questions, (i) to explore successes and challenges within this area; (ii) but also to explore the innovation potential that developments in other health and service contexts could bring.

Host:

Jan R. Boehnke, PhD
University of Dundee,
Dundee, United Kingdom

Description:

Data-driven methods, such as machine learning methods and unsupervised latent variable models, are advantageous for the analysis of patient-reported outcomes (PROs) in diverse population. At this roundtable, we invite participants to discuss the potential opportunities and challenges to apply machine learning algorithms to evaluate response shift in the context of longitudinal analysis of patient-reported outcomes.

Hosts:

Tolulope Sajobi, PhD
Department of Community Health Sciences, University of Calgary,
Calgary, Alberta, Canada

Lisa Lix
University of Manitoba,
Winnipeg, Manitoba, Canada

Description:

The use PROs in clinical practice might support more flexible and individualized follow-up activities. In remote care, PRO can be used to support clinical decisions based on PRO-based algorithms and/or assessment by a clinician. In this roundtable session, we will discuss use of PRO-based algorithms to support clinical decisions, how threshold can be defined and evaluated, and benefits and challenges by using PROs in remote care. Roundtable participants are also invited to provide their perspectives on this topic.

Host:

Liv Marit Valen Schougaard
AmbuFlex – Centre for Patient-reported Outcomes, Gødstrup Hospital, Herning, and Department of Public Health, Aarhus University,
Aarhus, Denmark

Description:

This interactive roundtable will invite participants to discuss ways to improve the quality of PRO utilization in clinical trials, from protocol development and PRO selection through analysis, reporting and dissemination. Existing documents that guide and support quality PROs will be discussed, as will resources from the PROTEUS Consortium that are designed to facilitate using these guides.

Host:

Michael Brundage, MD MSc
Queen’s University,
Kingston, Ontario, Canada

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Moderator and Discussant:

Leah Mcclimans, University of South Carolina, Columbia, South Carolina, United States

Symposium Synopsis:

To be impactful, HRQoL measurement must be relevant and meaningful, as this year’s conference theme suggests. But relevant to whom? And for what? Even when limited to the considerations of day-to-day patient care, tensions emerge. Most agree that HRQoL measures should be relevant to patients. But they also need to be relevant to the service providers who use them and the clinical and research contexts where they are applied. In this panel we explore these tensions, which often present as barriers to relevance, and offer some practical solutions for research, practice and policy.

HRQoL research is full of philosophical questions and relevance is one of them. This panel brings together three philosophers and two HRQoL researchers to present an interdisciplinary dialogue addressing conceptual questions using quantitative, qualitative, philosophical and historical approaches. Many HRQoL researchers have philosophical questions, but don’t know how or where to ask them. The papers in this panel provide a rare opportunity where ISOQoL members can think about conceptual questions of relevance, for example, how can clinicians ascertain the clinical relevance of measures for their practice? How do questions of relevance intersect with questions of validity? What should be done about the often idiosyncratic relevance judgments of patients? The four presentations in this panel address these questions.

The first presentation draws on a philosopher’s observations during the development of a HRQoL measure of older adults living actively in the community (OPAL). It explores the iterative development of this measure as experts strive to make it relevant to the measurement population and context of use. The second presentation specifically addresses the meaning of scores to patients. It suggests a tension between patients’ meanings and administrators standardized interpretation and inferences. Our third presentation focuses on the relevance of HRQoL measures to the clinicians who use them. It presents a training program designed for clinicians who seek to measure youth mental health. Finally, our fourth presentation addresses the relevance of reconceptualizing HRQoL measures in terms of clinimetrics or psychometrics.

Individual Presentations:

Embedded philosophy in the design of an HRQoL instrument: What is ‘Fitness for Purpose’?

Sebastian Rodriguez Duque, PhD Candidate, McGill University, Montreal, Quebec, Canada

“I feel 4 out of 5 depressed” – Meaningful measurement of mental health

Femke Truijens, Dr, Erasmus University Rotterdam, Rotterdam, Netherlands

Addressing barriers to effective measurement of youth mental health in clinical settings

Eran Tal, PhD, McGill University, Montreal, Quebec, Canada
Skye Barbic, PhD, University of British Columbia, Vancouver, British Columbia, Canada

“Clinimetrics” or “Clinical Psychometrics”?: Reexamining disciplinary boundaries and methodological commitments

Rebecca Jackson, MA, Indiana University – Bloomington, Bloomington, Indiana, United States

Moderator:

Walter “Buzz” Stewart, PhD MPH, Medcurio, Inc., Portsmouth, New Hampshire, United States

Discussant:

M. Chris, Runken, PharmD, Grifols Inc., Durham, North Carolina, United States

Symposium Synopsis:

Alzheimer’s Disease (AD) is a neurodegenerative disorder progressing from mild cognitive impairment (MCI) to mild, moderate, and severe AD. Each stage is characterized by differential cognitive impairments and functional consequences. Notably, in the past decade every Phase 3 AD trial has “failed.” Explanations for “failure” include COA endpoints being insufficiently sensitive to detect change in early AD stages (where Phase 3 trials increasingly focus); and efficacy analyses not accounting for inter- and intra-individual heterogeneity in cognitive and functional performance. These factors directly influence the probability of detecting treatment benefit when one exists and the valuation of an efficacious therapy.

The recent divide between industry expectations and CMMS adjudicated reimbursement for Aducanumab reveals the need for valuation methods that use objective and empirical parameters. Valuation differences may be reconciled by linking AD therapy value to avoided costs that would otherwise occur in the absence of therapy from more rapid disease progression.

This symposium will address measurement and modelling theory specific to AD progression with supporting evidence relevant to detection of treatment efficacy (presentation 1 and 2) and valuation of effective therapies (presentation 3).

Presentation 1 will examine heterogeneity in sensitivity to detecting change in primary outcomes for progression between and within AD stages that can impact detection of treatment efficacy.

1. Variation in sensitivity of stage-specific COA endpoints will be examined with methods to mitigate this effect in a power-preserving paradigm.
2. Impact: Change in cognitive and functional outcomes from non-significant to significant.

Presentation 2 will address impact of unobserved heterogeneity in COA outcomes on estimated treatment efficacy, demonstrating:

1. Evidence for inter- and intra-individual AD heterogeneity, grounded in the literature, and use of mixture models to mitigate the effect of unobserved heterogeneity in AD.
2. Impact: Change in cognitive and functional outcomes from non-significant to significant.

Presentation 3 will present a paradigm for empirical valuation of efficacious AD therapies, focusing on:

1. COA-based time-to-event evaluation of the time to cognitive and functional endpoint thresholds associated with substantial home care needs and care facility admission.
2. Impact: Change in cognitive but not functional outcomes from non-significant to significant.

Individual Presentations:

The application of a novel endpoint staging framework to demonstrate plasma exchange with albumin (PE-A) treatment efficacy in Alzheimer’s Disease: a post-hoc evaluation

Lauren Podger, MSc, OPEN Health Group, London, United Kingdom

The use of latent growth mixture models to demonstrate plasma exchange with albumin (PE-A) treatment efficacy in Alzheimer’s Disease

Daniel Serrano, PhD, OPEN Health Group, Bethesda, Maryland, United States

A time-to-event analysis to highlight potential cost-saving benefits of plasma exchange with albumin replacement (PE-A) treatment in Alzheimer’s Disease

Shauna McManus, OPEN Health Group, Parsippany, New Jersey, United States

Moderator:

Felix Fischer, PhD, Charite – Universitätsmedizin Berlin, Berlin, Germany

Symposium Synopsis:

In the past decade, Bayesian methods have been increasingly utilized to analyze patient reported outcome data. The reasons for this trend include: 1) Bayesian modeling is extremely flexible and versatile (e.g., one can fit models not supported by standard statistics software); 2) available evidence can be updated with new data in a straightforward way; and 3) it can accommodate complex data structures (e.g., patients nested within doctors); and 4) Bayesian inference is less prone to problems in conventional statistical inference.

The goal of this symposium is to highlight the aforementioned advantages of Bayesian methods for applications in quality of life research. Following a short introduction to the Bayesian framework, we present recent works using Bayesian approaches to overcome limitations of classical statistical approaches, with an emphasis on their relevance in quality of life research.

The symposium will start with a short introduction highlighting the key concepts of Bayesian data analysis provided by the discussant (Andrew Trigg). The first presentation (Aaron Kaat) will cover strategies to model multidimensional, correlated outcomes in a random effects model. In the second talk we will present a Bayesian approach to assess meaningful change over time (Yuelin Li). In the third talk, we will discuss approaches to estimate prevalence accounting for imperfect diagnostic accuracy of questionnaires often used in population-based studies (Felix Fischer). We will conclude the session with an open Q&A with all three symposium presenters and the discussant, where we aim to specifically discuss the relevance of the proposed methods for quality of life research and analysis of patient reported outcomes.

Individual Presentations:

Fundamentals of Bayesian analysis

Contributor: Andrew Trigg, MSc, Bayer Plc, Reading, United Kingdom

Multilevel Multivariate Bayesian Regression

Aaron Kaat, PhD, Northwestern University, Chicago, Illinois, United States

Estimating prevalence with depression screening tools

Felix Fischer, PhD, Charite – Universitätsmedizin Berlin, Berlin, Germany

Meaningful Change in Quality Of Life using Bayesian Posterior Predictive Distribution

Yuelin Li, PhD, Department of Psychiatry & Behavioral Sciences; Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York, United States

Moderators:

Jeanette Jackson, Health Quality Council of Alberta, Calgary, Alberta, Canada
Chyloe Healy, Blackfoot Confederacy Tribal Council, Calgary, Alberta, Canada
Kristina Watkins, Health Quality Council of Alberta, Calgary, Alberta, Canada
Rhonda Pouliot, MA BSc MLT, Health Quality Council of Alberta, Calgary, Alberta, Canada
Richard Sawatzky, PhD, Trinity Western University, Langley, British Columbia, Canada

Symposium Synopsis:

Ongoing colonialism continues to impact the wellness of Indigenous Peoples and constructs barriers to accessing traditional health practices. Further, the lack of diverse Indigenous voices and methodologies in mainstream measurement contribute to health inequities. This symposium aims to share four distinct Nation and place-based perspectives and approaches to measuring the unique health and wellbeing needs of Indigenous Peoples. The symposium will expose gaps in measurement and measurement methodologies that challenge the assumptions of the dominant systems perspectives. Recent calls for eradicating Indigenous-specific racism and discrimination in the health system have created space for Indigenous people to join the conversation on providing culturally safe measurement. Indigenous led and lens measurement highlights measures and indicators relevant to Indigenous Peoples’ wellness providing contextual strengths-based solutions.

The four invited presenters will share their perspective (15 minutes each):

1. Wise Practices – from Indigenous lens to Indigenous led
2. Co-endeavour, building Māori Health Equity Report of New Zealand Health System Quality Dashboard
3. Decolonizing Birth Research: Indigenous-led research centering lived expertise and equity in perinatal services)
4. Supporting the Trajectory of our Spirit: Living the Cree Pimatisiwin and Blackfoot Kipaitaipiiwahsinnooni – “Our Spiritual Way of Life”

The symposium moderators will then guide a robust discussion to inspire ongoing conversations about thinking and doing measurement differently. It is paramount to self-reflect and keep in mind, who is telling the story to initiate more responsive changes for those who have been historically excluded from the dominant systems perspectives. Both, Indigenous led and Indigenous lens measurement approaches offer a more wholistic story that is currently missed.

At a critical time in our Reconciliation journey with our Indigenous people here in Canada, we see this as a unique opportunity to welcome our international peers in a good way to this topic and create a safer space for conversation. To enable a fulsome experience for everyone joining the symposium and increased appreciation for the context of this topic, we would like to bring in ceremony, as well as allocate more time for discussion.

Individual Presentations:

Wise Practices – Moving Patient-Centred Measurement from Indigenous-lens to Indigenous-led

Mark Matthew, BBA, British Columbia Patient Safety & Quality Council, Kamloops, British Columbia, Canada

Co-endeavour, building Māori Health Equity Report of New Zealand Health System Quality Dashboard

Ying Li, MSc. major in Applied Statistics, Health Quality & Safety Commission New Zealand, Wellington, New Zealand
Patricia Keelan, BA Public Policy, Te Pinakitanga ki te ao Kairangi, Executive MBA, Current PhD Student – Indigenous Futures, Ngāti Porou, Te Aupouri, Tūranga/Gisborne, New Zealand

Decolonizing Birth Research: Indigenous-led research centering lived expertise and equity in peri-natal services

Wanda Phillips-Beck, PhD, First Nation Health and Social Secretariat of Manitoba, Winnipeg, Manitoba, Canada

Supporting the Trajectory of our Spirit: Living the Cree Pimatisiwin and Blackfoot Kipaitaipiiwahsinnooni – “Our Spiritual Way of Life”

Chyloe Healy, Blackfoot Confederacy Tribal Council, Calgary, Alberta, Canada

Moderator:

Elizabeth Unni, Touro College of Pharmacy, New York, New York, United States

Symposium Synopsis:

Patient reported outcome measures (PROMs) assess a patient’s health-related quality of life. It is now clear that PROMs can improve the effectiveness of therapeutic interventions and the efficiency of the healthcare system. As a result of these research advances, the use of PROMs in clinical settings has proliferated. Central to the optimal use of PROMs is the completion of the PROMs by the patients. Many healthcare institutions offer training programs to clinicians to understand the use and meaning of PROMs. Less attention has been given to educating patients and their caregivers about PROMs, which can jeopardize optimal co-production of better health-related quality of life. Literature review demonstrates that more work is needed to educate patients about PROMs. Compared to the few patients who are involved in the PROM development, a much larger number will be asked to complete the PROMs on a regular basis. Educating patients in the use of PROMs in clinical care is the key to ensure that their use is relevant to patients. Training and education materials should be co-designed with them.

This symposium aims to explore solutions and answers to the following questions:

1. What evidence exists regarding educating patients on PROMs?
2. How have patients been educated in PROMs completion?
3. How can we engage patients in creating education programs for patients regarding PROMs
4. How can patients be educated in using these outcomes in their discussions with the healthcare providers?
5. What are patient’s experiences using PROMs in clinical care?

Each presenter will discuss these questions in a case study format from three countries, both adults and pediatrics. The symposium will start with a short overview of the evidence, followed by case studies, and end with presentations by patients and families describing their personal experiences in understanding the PROMs’ use in their routine clinical care. The symposium will provide an opportunity for attendees to consider and discuss the best approaches in educating patients about PROMs in routine clinical care.

Individual Presentations:

Engaging Patient and Caregivers in Using Patient-reported Outcomes Measures in Paediatric Clinical Care

Maria Jose Santana, PhD MPharm, Associate Professor, Patient and Family-centred care Scientist, Departments of Paediatrics and Community Health Sciences, Cumming School of Medicine, University of Calgary and Provincial Lead, Patient Engagement, Alberta Strategy for Patient Oriented Research Unit
Calgary, Calgary, Alberta, Canada

Engaging and educating patients about PROMs in clinical practice: experiences from the Netherlands

Maud van Muilekom, PhD, Emma Children’s Hospital, Amsterdam UMC, University of Amsterdam, Department of Child and Adolescent Psychiatry & Psychosocial Care, Amsterdam, Netherlands

Educating patients in the use of PROMs in clinical practice: Experiences from the adult cancer setting

Kate Absolom, PhD, University Academic Fellow, Leeds Institute of Medical Research/Leeds Institute of Health Services Research, University of Leeds, Leeds, United Kingdom

Moderator:

Tom Willgoss, Roche, Welwyn Garden City, United Kingdom

Symposium Synopsis:

The past 10 years has seen a booming interest in the inclusion of qualitative methods within clinical trials. During this period our application of methods has evolved and improved, and the research questions and insights have broadened in scope. Today, in-trial interviews have become commonplace in interventional clinical trials and their value is of interest to a broad range of stakeholders.

Despite the growing interest, in-trial interviews are not without challenges. These include choosing inappropriate methods for the research question, practical barriers at clinical trial sites, and compliance hurdles. This symposium will discuss the state-of-the-art of in-trial qualitative methods based on a decade of learning. In addition to showcasing innovative approaches and use cases from real-world examples, we will also critically evaluate the value of in-trial methods in a range of settings.

Each presenter will share and reflect on their experiences of designing and implementing in-trial interviews, and share recommendations on how to optimize this approach. We will conclude the symposium with a panel discussion and Q&A to ensure maximum audience participation.

Individual Presentations:

When are in-trial interviews needed and not (only) exit interviews?

Helen Kitchen, MSc, Clarivate, London, United Kingdom

Qualitative estimates of within-person meaningful change on novel Clinical Outcome Assessment (COA) measures from exit interviews – is it really useful?

Robert Krupnick, PhD, IQVIA, Boston, Massachusetts, United States

Looking beyond exploring change in interviews alongside late phase clinical trials

Claire Burbridge, MSc, Clinical Outcomes Solutions, Folkestone, United Kingdom

Design Considerations for Successful In-Trial Interviews: The Who, What, When, Where, and How

Dana B. DiBenedetti, PhD, RTI Health Solutions, Research Triangle Park, North Carolina, United States

Moderator:

Arto Ohinmaa, University of Alberta, Edmonton, Alberta, Canada

Symposium Synopsis:

There is a considerable body of evidence and relative consensus on measuring and valuing health in adult population for various purposes including economic evaluation and applications in health technology assessment. However, such evidence and consensus are lacking in younger populations including children and adolescents. Measuring and valuing health in these population groups poses various challenges, starting with the conceptualization of health and health-related quality of life, to methods used to measure these constructs, as well as methods used to value health states. Children go through different developmental stages from newborns and infants up to adolescents and young adults and these changes need to be considered both in the development of the instrument questions, how the data is collected (proxy and self responses), and what valuation methodologies are used.

The EuroQol Group has led a significant amount of research for over a decade to examine methods of measuring and valuing health, which started with the launch of the EQ-5D-Y-3L in 2010. The group continues to develop and test new measures for pediatric use, including the EQ-5D-Y-5L, and a new tool aimed at measuring and valuing health in infants and toddlers, EQ-TIPs.  The group has also explored ways of valuing health in children: a valuation protocol for the EQ-5D-Y-3L published in 2020 has successfully been used to produce value sets around the world. Important methods issues remain e.g. how to interpret different characteristics of values for child and adult EQ-5D instruments? And how/whether to value HRQoL for very young children? That is how to incorporate pediatric HRQoL measurement and valuation in the lifespan measurement of EQ-5D.

In this symposium, the speakers will provide the current state of play in measuring and valuing health using EuroQol instruments, discuss key challenges and opportunities in advancing the measurement and valuation of health and validation of these instruments in children across a range of diseases, and share examples from large projects being conducted around the world. All the speakers have been extensively involved in the development and testing of methods to measure and value health in children and are currently leading international projects in this area.

Individual Presentations:

Measuring health in younger populations: EQ-5D-Y and beyond

Michael Herdman, MSc, Insight Consulting & Research, Mataró, Spain

Methods for valuing child HRQoL: value sets for EQ-5D-Y-3L and related methods challenges

Nancy Devlin, BA(Hons) PhD, University of Melbourne, Melbourne, Australia

Validating the EQ-5D-Y-5L in childhood arthritis: the UCAN precision health study

Deborah Marshall, PhD, University of Calgary, Calgary, Alberta, Canada

Entering the child’s mind: qualitative and quantitative evidence in valuing youth health in Canada

Feng Xie, PhD, McMaster University, Hamilton, Ontario, Canada

Moderator:

Amylou Dueck, PhD, Mayo Clinic, Scottsdale, Arizona, United States

Contributor:

Madeline Pe, PhD, EORTC Quality of Life Department, Brussels, Belgium

Discussant:

Michael Brundage, Queen’s Cancer Research Institute, Kingston, Ontario, Canada

Symposium Synopsis:

The availability of reliable and valid HRQOL instruments marked a critical milestone in the cancer clinical trial field. These measures were developed with a strategy of having a core questionnaire that can be supplemented with disease-specific and/or treatment-specific modules. Although this approach advanced the use of HRQOL instruments in clinical trials, there were limitations to this approach. Because of their “static” nature, patients are asked the same set of questions regardless of their disease stage, therapies used or relevance of the items to their current state. The inability to tailor these “static” HRQOL questionnaires to the needs of specific cancer clinical trials and/or individual patients led to the development of PRO item libraries that allows investigators the flexibility of selecting the HRQOL domains of interest and the type of form to administer to assess treatment impact in terms of benefit of safety.  Item banks and computerized-adaptive testing (CAT) methods are considered part of the broader PRO Item Libraries.

This symposium will provide an overview on how the development of HRQOL instruments in the oncology field evolved over time. We will contrast the traditional versus PRO item library when implementing HRQOL measures in cancer clinical trials. A practical example of a modern, balanced, approach to selecting HRQOL instruments in cancer clinical trials will be provided.

Individual Presentations:

The development of HRQOL instruments in oncology: the static approach

Claire, Piccinin, MSc, Quality of Life Department, European Organisation for Research and Treatment of Cancer, Brussels, Belgium

Best Practices for Selection of HRQOL Item Libraries in Oncology Trials

Bryce Reeve, PhD, Duke University School of Medicine, Durham, North Carolina, United States

Real-world Example Demonstrating the Use of HRQOL Item Libraries in an Oncology Trial

Amylou Dueck, PhD, Mayo Clinic, Scottsdale, Arizona, United States

Moderators:

Sandra Zelinsky, University of Calgary, Canada
Sadia Ahmed, Master of Science, University of Calgary, Canada
Natasha Roberts, The University of Queensland, Australia

Speakers:

Natasha Roberts, University of Queensland, Australia
Maria J. Santana, University of Calgary, Canada
Leonie Young, Australia & New Zealand Urogenital & Prostate Cancer Trials Group, Australia (Patient Research Partner)
Jessica Caron, MS, Chronically-Jess.com, United States, (Patient Research Partner)
John J. Librett, Survivor Healthcare, United States
Jessica Gentile, PharmD MPA, RPh PA-C, Survivor Healthcare, United States

The aim of this educational session is to explore patient engagement in quality of life research internationally. Presenters include clinicians, researchers, and patient research partners who will share their projects and perspectives on how patient engagement is carried out in quality of life research.

Moderator:

Prof. Wenjie DUAN, Phd, East China University of Science and Technology, China

Speakers:

Assoc. Prof. Guannan Bai, The Children’s Hospital, Zhejiang University School of Medicine, China.
Prof. Wenjie Duan, PhD, East China University of Science and Technology, China
Assoc. Prof. Daniel Yee Tak Fong, School of Nursing, The University of Hong Kong, Hong Kong
Prof. Xuejing Jin, Beijing University of Chinese Medicine, China
Assoc. Prof. Zhihao Yang, PhD, Guizhou Medical University, China

The importance of quality of life (QoL) has been increasingly recognized in Chinese communities. Many health professionals have begun to incorporate the assessment of QoL in their clinical research and practice. A good understanding of the challenges, opportunities, and implications of using QoL for Chinese would be essential for health professionals using QoL in research or practice. The topics cover applied studies in QoL assessment and interventional strategies across three life stages. The proposed speakers have been trained in different areas covering social work, public health, epidemiology, and psychology, but they are all native Chinese who are experienced in QoL research. They will present research experience on measuring and promoting QoL in China. The highlights will focus on the challenges, opportunities, and implications of applying QoL theories, measures, and intervention programs for the Chinese.

Moderator:

Donna Rowen, University of Sheffield, United Kingdom

Speakers:

Ava Mehdipour, McMaster University, Canada
Ana Moga, PT MSc PhD-c, McGill University, Canada
Philip Powell, PhD, University of Sheffield, United Kingdom
Julie Campbell, BEc (Hons) PhD, University of Tasmania, Australia
Heather Gelhorn, PhD, Evidera, United States
Jiat Ling Poon, PhD, Eli Lilly and Company, United States
Mehmet Inceer, PhD, IQVIA, Canada
Sarah Knight, MSc, Clarivate, United Kingdom

The role of health preference research (HPR) in PROM development, validation and refinement is emerging, and the use of HPR to enable PROMs to inform healthcare decision-making and clinical practice is rapidly expanding globally. This symposium will provide case studies covering HPR in Quality of Life PROM development and testing and the use of HPR to enable PROMs to inform decision-making and clinical practice. The session is intended for anyone interested in HPR or curious to learn how HPR use can leverage and enhance the use of PROMs. The session will combine presentations (8-9 minutes per speaker) from 8 speakers with audience discussion, and will share the international work of HPR SIG members from academia and industry.

Moderator:

Ana Maria Rodriguez-Leboeuf, PhD MSc PT, McGill University and IQVIA, Canada

Speakers:

Konrad Maruszczyk, University of Birmingham, United Kingdom
Norah L. Crossnohere, PhD, The Ohio State University College of Medicine, United States
Chris Fidyk, Vinehealth, United Kingdom
Paul Williams, MPH, IQVIA, France
Ana Maria Rodriguez-Leboeuf, PhD MSc PT, McGill University and IQVIA, Canada

As real-world evidence (RWE) is increasingly used to inform decision making, the importance of guidance on the use, analysis, and interpretation of PRO data in RWE is growing. Guidance documents have been in circulation since 2005 to delineate the development, use, and interpretation of PRO data in the context of clinical trials for submission to regulatory authorities, but how this guidance adapts to a RW setting has not been explicated. This symposium will provide case studies and considerations covering RWE uses of PRO, and differences with their use in clinical trials that may require special considerations to be used to inform decision-making and clinical practice. The session is intended for anyone with or without industry experience who may be interested in the transition of PRO evidence from clinical trial to RWE research and practice. The session will combine presentations from 4 speakers with audience discussion.

Wednesday, 18 October | 9:00 am – 4:00 pm

Workshop level: Basic

Workshop Goals:

The recent proliferation of personal mobile technologies allows researchers and practitioners to collect objective patient behavioral and health data at increased granularity. That can be done in real-time and in context, longitudinally, and may also reduce patient burden. Collecting and acting upon these co-called Technology-Reported Outcomes (TechROs) will become a cornerstone of patient-centered care. TechROs can assess individual characteristics, biological and physiological variables, physical, psychological, social/role functioning, and environmental variables. Acquiring the data via the TechROs can be challenging as there are many options, each with advantages and disadvantages, in addition to the many operational and human factors influencing the collected TechROs data quality. The same applies to selecting the right methods for analysis to derive meaningful results from the collected data.

Intended Audience

• Health professionals
• Medical scientists who are not experts in the use of TechROs
• Consultants
• Pharmaceutical and medical device representatives
• New investigators and research students
• Policymakers
• Other associations and individuals who are interested in acquiring familiarity with the TechRO research terms and methodology
• Patients and caregivers

Presentation Format

This full-day, intensive and interactive educational workshop offers a curriculum that will provide a basic level introduction to the why and how of using TechROs in research, which later can pave the way for clinical practice. Initial lectures will present how, when, and with which devices TechROs can be collected in order to empower their research in many domains. Attendees will also be given the opportunity to apply their learning throughout the course (hands-on learning). Specifically, they will first play with real-world collected TechROs data and assess causality using a state-of-the-art method developed for the simulation of a randomized control trial from longitudinal observational data. After, they will be given the opportunity to collect and analyze their own TechRO datasets, by wearing a wearable (provided by the workshops authors) throughout the conference duration (optional).

Overview/Outline

The workshop will present how, when, and with which devices TechROs can be collected to empower research. It will do so by bringing together academic and industry experts to discuss TechROs future. Additionally, attendees will learn how to assess causality from longitudinal observational data collected with those TechROs.

Learning Objectives

1. Participants will learn about the rationale and value of incorporating TechROs into QoL assessment through an understanding of the definition, history, types, and different efficacy of technologies in assessing QoL. Additionally, they will have an understanding of typical human and operational factors influencing the TechRO data quality.
2. Participants will learn about the different quantitative and qualitative methods of analyzing data collected with TechROs, using powerful statistical and machine learning methods.
3. Participants will be guided step-by-step on a hands-on basis on how to implement and interpret results acquired with a novel method for causality estimation of real-life collected longitudinal TechROs data. Furthermore, participants will be given a wearable device for usage during the conference days to analyze their own data with that same method after the event ends.

Organizers:

Katarzyna Wac, Prof. Dr., University of Geneva, QoL Lab, Geneva, Switzerland

Igor Matias, MSc, University of Geneva, QoL Lab, Geneva, Switzerland

Clauirton Siebra, PhD, University of Geneva, QoL Lab, Geneva, Switzerland

Contributors:

• Eric J. Daza, Dr.P.H., Evidation, San Mateo, United States
• Paul De Villèle, PhD, Withings, Paris, France

Wednesday, 18 October | 9:00 am – 4:00 pm

Workshop level: Advanced

Workshop Goals:

The aim of the interactive workshop is to provide participants with foundational knowledge, skills, and resources to prepare and motivate healthcare providers (HCPs) to routinely use PROMs in direct care (i.e., preventive care, chronic care, population-based care). The Consolidated Framework for Implementation Research will guide the workshop to illustrate the intersection between the “user” and “implementation process” domains.

Intended Audience

Are you currently planning the implementing PROMs in patient care areas? Have you implemented PROMs by require sustainability assistance? This workshop is for you! To get the most from this workshop, participants should have an intermediate knowledge level about PROMs in clinical practice and the overall implementation process (e.g., selected PROMs and/or implementation experience). Having an implementation case/project to design implementation supports (e.g., training, practice supports, interpretation tools, and decision-making aids) is beneficial.

Presentation Format

50% lecture; 35% interactive activities; 15% admin (intro, breaks, conclusion).

Overview/Outline

HCPs are often the lynchpin to the successful implementation of PROMs to engage patients in their care. Although using PROMs in practice is becoming more prevalent the preparation of HCPs is not standardized and/or limited. Facilitating HCP adoption of PROMs is a complex behavior change, often necessitating flexible and tailored strategies to suit the local context and current workflow. To facilitate their incorporation into routine clinical care, several questions need to be answered: What knowledge do clinicians need to use PROMs on a regular basis? How can clinicians be motivated and engaged? What evidence-based strategies could be used to assist clinicians? How do the needs of clinicians vary for ongoing and sustained use? How do clinicians visualize PROMs data and interpret scores (e.g., initial scores and meaningful change)? How can clinicians use the PROM score data/feedback into inform patient care (e.g., shared decision making and planning care)? By answering these and many other questions you may have, we explore the multifaceted aspects of HCP behavior change by showcasing theory-informed approaches and best practice from current implementation projects in diverse clinical settings. This workshop will provide participants with the opportunity to apply the theory/knowledge to their own context to address the needs of HPCs and specific barriers to PROMs implementation.

Learning Objectives

To implement patient-reported outcome measures (PROMs) into daily clinical care, this interactive workshop focuses on the needs of healthcare providers (HCPs) for both initial and sustained. Moreover, we focus on the specific details to address that are often overlooked or unforeseen. The objectives are to:

1. Illustrate the knowledge needed to and attitude/beliefs required for optimal application of PROMs to meet the specific needs of clients for preventive care (screening), chronic care (monitory symptoms and functions), and population-based care (interventional care such as oncology and surgery).
2. Demonstrate the skills needed to (a) collect PROMs data (e.g., fill out the PROMs questionnaire), (b) discuss results with patients, (c) score and interpret PROMs, and (d) incorporate PROMs data into clinical reasoning and shared decision making with patients.
3. Evaluate the implementation of PROMs by HCPs (process and outcomes) and identify evidence-based strategies to provide ongoing support for adoption.

Organizers:

Angela Wolff, PhD RN, Associate Professor, School of Nursing, Trinity Western University, Langley, British Columbia, Canada

Elizabeth Austin, PhD MPH, Sr. Research Scientist, Department of Health Systems and Population Health, School of Public Health, University of Washington, Seattle, Washington, United States

Maria Jose Santana, PhD MPharm, Associate Professor, Patient and Family-centred care Scientist, Departments of Paediatrics and Community Health Sciences, Cumming School of Medicine, University of Calgary and Provincial Lead, Patient Engagement, Alberta Strategy for Patient Oriented Research Unit, Calgary, Alberta, Canada

Kate Absolom, PhD, University Academic Fellow, Leeds Institute of Medical Research/Leeds Institute of Health Services Research, University of Leeds, Leeds, United Kingdom

Sara Ahmed, PhD PT, Professor, McGill University, Faculty of Medicine and Health Sciences, McGill University Health Center, Clinical Epidemiology, Montreal, Quebec, Canada

Susan Bartlett, PhD, Professor, McGill University, Faculty of Medicine and Health Sciences; Senior Scientist McGill University Health Center, Montreal, Quebec, Canada

Wednesday, 18 October | 9:00 am – 12:00 pm

Workshop level: Basic

Workshop Goals:

Health-related quality of life (HRQL) research has developed into a highly interdisciplinary field, embracing a wide variety of methodologies and applied contexts. It has therefore become increasingly difficult for researchers and practitioners to navigate this landscape when planning their own research agendas and projects. This workshop aims to help investigators: (i) understand the core methodological standards for health outcomes research; (ii) outline common researcher pitfalls that delay or prevent their research from being published and their solutions; and iii) know about resources that support the development of such research and publications.

Intended Audience

The intended audience is people working with HRQL and patient reported outcomes (PROs) in evaluation or research contexts, developing their own research (programmes) and wanting to get their HRQL/PRO research published. The workshop is targeted at early to mid-career clinicians and researchers and any investigators new to HRQL/PROs.

Presentation Format

40% lecture, 40% hands-on learning, 20% question and answer.

Overview/Outline

The workshop will provide an overview of key considerations for doing good HRQL/PRO research, exploring theoretical and practical issues such as attention to the objectives, research methods, measures, and statistical analysis during protocol development, considerations during study conduct to ensure quality PRO data, and clearly and effectively presenting results to aid interpretation.

The workshop will rely on practical and interactive group work, utilising existing guidelines and resources developed to help navigate the use of PROs in clinical trials and clinical practice and to support good scientific practice. As an additional pragmatic perspective to help identify avoidable inappropriate conduct and dissemination of research, we will introduce concepts from the “research waste” literature, covering formulating research questions, quality research methods, adequacy of publication practices, and quality of research reports.

The later part of the workshop will be organised as a research clinic, drawing on methods used in research speed dating and for concept development. Participants will each pitch an idea and concern area. Depending on where participants are at in the research process, we will work towards either turning ideas into a research study or answering specific questions.

Learning Objectives

1. Appreciate the value of patient reported outcomes (PROs) as outcome measures and the importance of collecting quality PRO data.
2. Understand key considerations for doing good HRQL/PRO research including accepted community standards and practices and approaches to support the planning, conduct and reporting of HRQL/PRO research.
3. Be aware of common researcher pitfalls that lead to research waste, questionable research practices, and failure to publish HRQL/PRO research and their solutions.

Organizers:

Jan R. Boehnke, PhD, School of Health Sciences, University of Dundee, Dundee, United Kingdom

Claudia Rutherford, PhD, Faculty of Medicine and Health, University of Sydney, Sydney, Australia

Wednesday, 18 October | 9:00 am – 12:00 pm

Workshop level: Basic

Workshop Goals:

This workshop builds on a similar workshop presented at the 2022 ISOQOL conference. The overall workshop goal is to equip participants with information and skills about progress in modern validity testing practice in relation to patient-reported outcomes (PROs). The focus this year is on Kane’s argument-based approach to validation, which requires the development of a clear interpretive argument (a rationale) about the intended interpretation and use of an instrument’s scores, and evaluation of a range of evidence to assess the plausibility of the interpretive argument, specifically, the assumptions underpinning it. The 2014 Standards for Educational and Psychological Testing (the Standards) provides the framework of five sources of validity evidence for structured validation practice. Specific goals are to:

1. Describe Kane’s approach and the Standards’ framework
2. Contrast the notion of validation as a property of an instrument with the validation practice of accumulating evidence about an interpretive argument
3. Outline assumptions that are common to interpretive arguments in health research
4. Demonstrate when and why validity evidence should be included in a validation plan, including framing research questions, identifying relevant qualitative and quantitative methods, and reporting validity evidence

Intended Audience

All professionals involved in developing, choosing, and using PROMs.

Presentation Format

30% presentations, 40% hands-on learning, 30% group discussion and questions.

Overview/Outline

Short presentations will provide background about the argument-based approach to validation and modern validity testing practice and will address the imperative to advance validation practice in PRO measurement.

Descriptions of the five sources of validity evidence and interpretive arguments, including common assumptions, will be provided with examples of research questions and evidence generation methods. Emphasis will be on minimising measurement biases and ensuring accurate, useful (actionable), and equitable PRO measurements in diverse populations.

Based on a provided interpretive argument, small groups will build validation plans by developing research questions for the common set of assumptions and identifying relevant sources of validity evidence, including methods for investigation. Existing case studies will be used as examples.

A plenary group discussion will focus on reporting validity evidence and will consider how evidence synthesis informs the plausibility of interpretive arguments.

Learning Objectives

1. Participants will be able to describe the argument-based approach to validation and the sources of validity evidence.
2. Participants will be able to formulate a validation plan to answer research questions related to the kinds of evidence needed to investigate assumptions underpinning an interpretive argument.
3. Participants will be able to choose appropriate qualitative and quantitative methods to generate evidence to ensure accurate, actionable, and equitable PRO measurements, and craft a reporting format for presenting the five sources of validity evidence.

Organizers:

Melanie Hawkins, PhD, Swinburne University of Technology, Melbourne, Australia

R.J. Wirth, PhD, Vector Psychometric Group, LLC, Chapel Hill, North Carolina, United States

Sandra Nolte, Charité Universitätsmedizin Berlin, Berlin, Germany

Scott Gill, Swinburne University of Technology, Melbourne, Australia

Wednesday, 18 October | 9:00 am – 12:00 pm

Workshop level: Basic

Workshop Goals:

This workshop will provide participants with knowledge on the latest research on ethical and equity, diversity and inclusion (EDI) issues in the context of PRO data collection, clinical research, drug development, and clinical practice and will enable:

1. Insights on ethical and EDI issues in PRO data collection, in clinical research, drug development, and clinical practice based on current evidence;
2. Understanding and discussion of minimal ethical and EDI considerations as well as rationale;
3. Application of best practices and practical case studies for inclusion of ethical and EDI considerations.

Intended Audience

A basic knowledge of PROs is assumed. The workshop is intended to academics, members of ethical review boards, researchers from industry and those stakeholders working in PRO data collection, clinical research, drug development, and clinical practice interested in improving the ethical and equity acceptability of PRO research.

Presentation Format

Initially, the workshop will introduce the PRO ethics guidelines and EDI considerations in PRO data collection, clinical research, drug development, and clinical practice. This will be supported by best practices and practical case studies (50%).

Two activities are planned 1) small group discussions focused on PROs data collection, clinical research, clinical practice and industry will be held to discuss specific PRO ethics and EDI considerations; and 2) a group discussion/exercise based on the Implementation Tool for PRO Researchers and Research Ethics Committess included in the PRO Ethics guidelines and EDI considerations (40%). Participants will have the opportunity to discuss with other delegates and ask questions to the facilitators (10%).

Overview/Outline

PROs can inform clinical research and regulatory decisions, healthcare policy and provide timely care tailored to individual needs. However, the increased use of PROs has uncovered pre-existing ethical issues. For example, uncertainty among patients about why and how PRO data are being collected and used. Furthermore, the increased use of PRO data should match strategies to ensure greater equity, diversity and inclusion (EDI) in their collection and planning to reflect the perspectives of underserved groups and avoid increasing health disparities. Therefore, it is important to understand how to improve EDI in PRO collection, the implications for not doing so; and strategies for evaluating and addressing EDI issues.

Learning Objectives

1. Enable insights on ethical and EDI issues in PRO data collection, in clinical research, drug development, and clinical practice based on current evidence.
2. Understanding and discussion of minimal ethical and EDI considerations as well as rationale in PRO data collection, in clinical research, drug development, and clinical practice.
3. Application of best practices and practical case studies for inclusion of ethical and EDI considerations in PRO data collection, in clinical research, drug development, and clinical practice.

Organizers:

Samantha Cruz Rivera, Dr, Centre for Patient Reported Outcomes Research, University of Birmingham, Birmingham, United Kingdom

Ameeta Retzer, Dr, Centre for Patient Reported Outcomes Research, University of Birmingham, Birmingham, United Kingdom

Angela Stover, PhD, University of North Carolina, Chapel Hill, North Carolina, United States

Paul Kamudoni, Dr, Merck Healthcare KGaA, Darmstadt, Germany 

Wednesday, 18 October | 1:00 pm – 4:00 pm

Workshop level: Basic

Workshop Goals:

Increasingly, including the patient’s voice is essential in HRQOL research and PRO measurement. But how do we do this rigorously? The overarching goal of this workshop is to equip attendees to undertake methodologically sound qualitative research that advances the fields of HRQOL research and PRO measurement.

Intended Audience

Trainees, industry partners, and researchers.

Presentation Format

50% presentation; 35% individual/small group work; 15% large group discussion.

Attendees will be invited to draw upon their proposed/current research project to create a qualitative purpose statement and research question by following established frameworks (in required pre-readings).

Overview/Outline

Presentation

What is qualitative research?

• Philosophical and methodological roots
• History of qualitative work in HRQOL research and PRO measurement

Why do qualitative research?

• Provide examples of qualitative work in HRQOL research and PRO measurement

What are qualitative methodologies?

• Choose of an appropriate methodology
• Introduction to qualitative description, interpretive description, grounded theory, phenomenology, Indigenous methodologies, and types of content analysis

What are qualitative methods?

• Introduce sampling strategies (participant number and type)
• Outline data collection methods: interviews [closed-ended, semi-structured, and open-ended] and focus groups
• Pros and cons of cognitive interviews and think-aloud in PRO measure development
• Approaches to analysis: content and thematic analysis
• Journal requirements for qualitative checklists

What are common pitfalls and misunderstandings?

• Not specifying an appropriate methodology
• Denoting narrative responses from a survey as “qualitative”
• Closing analysis prematurely
• Forgetting ethical considerations or power dynamics

How do you pose qualitative purpose statements and research questions?

• Description of established frameworks

Individual and group work

Attendees will write a qualitative purpose statement and research question by drawing on established frameworks. They will then identify an appropriate methodology and methods. In small groups, attendees will present this work to each other and provide their rationale. One facilitator will be present in each group. Each group will report back on shared learnings and outstanding questions for full group discussion.

Learning Objectives

1. Comprehend key qualitative research methodologies and worldviews, and how these factors have influenced the use of qualitative approaches in the contexts of a) health-related quality of life (HRQOL) research, b) development of patient-reported outcome (PRO) measures, and c) interpretation and use of PRO scores.
2. Critically analyze “tips, tricks, and pitfalls” in qualitative methodologies and methods used in HRQOL research and PRO measurement.
3. Articulate a qualitative purpose statement and research question, and defend an appropriate qualitative research methodology and methods.

Organizers:

Kara Schick-Makaroff, PhD RN, University of Alberta, Edmonton, Alberta, Canada

Richard Sawatzky, PhD, Trinity Western University, Langley, British Columbia, Canada

Antoinette Davey, PhD, University of Exeter, Exeter, United Kingdom

Motolani Ogunsanya, DPh MSc PhD, University Of Oklahoma, Oklahoma City, Oklahoma, United States

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

Wednesday, 18 October | 1:00 pm – 4:00 pm

Workshop level: Basic

Workshop Goals:

To introduce methods that can be used to generate health utilities in complex patient populations such as young children or orphan/ ultra-orphan indications.

Intended Audience

Beginner. No previous knowledge of utility elicitation methods expected.

Presentation Format

A combination of lectures, hands-on exercises, and online polls/surveys.

Overview/Outline

A version of HTA is used in many countries to decide which drugs, devices, public health initiatives (etc.) are reimbursed. A key component of this process is often some form of economic evaluation with patient benefit expressed in terms of quality-adjusted life years (QALYs). However, to generate these QALYs, it is necessary to have health utilities built into the model on which the economic evaluation is based.

Whilst many generic preference-based instruments, such as the EQ-5D or SF-6D, can be used in general populations, these instruments often have difficulty generating meaningful results in certain populations (e.g., particular orphan/ ultra-orphan indications) due to small sample sizes and heterogenous disease presentation. Consequently, generic measures often lack content validity in such populations, failing to capture aspects of the disease that are important to patients. Additionally, data collection using generic instruments may be impractical, for instance, in very young paediatric populations.

This workshop will provide the attendees with a practical overview of alternative methods for eliciting health utilities that can be used in the HTA of interventions targeting such patient groups or indications. The workshop will begin by providing an overview of health utilities before moving on to explain the difference between direct and indirect elicitation methods and the use of vignettes in the elicitation process. We will also cover important aspects to consider when choosing which approach to use and while designing the vignettes.

Case studies based on practical examples will be used throughout the workshop, and attendees will also have the opportunity to undertake several tasks to help deepen their understanding of the learning provided in the taught part of the workshop.

Learning Objectives

1. Attendees will understand why the use of conventional generic PRO instruments such as the EQ-5D-3L or -5L and SF-36 in complex populations, such as young children or orphan/ ultra-orphan indications, is either not possible or highly sub-optimal.
2. Attendees will understand alternative approaches that can be used to elicit health utilities in these populations for use in economic models that will form the basis of HTA submissions. These alternative approaches will include an extension of the general EQ-5D instruments and vignette-based approaches such as standard gamble/ time trade-off and discrete choice experiments.
3. Attendees will understand the strengths and limitations of these alternative approaches in order to be able to identify which would be the preferred option in a given situation.

Organizers:

Stuart Mealing, MSc, York Health Economics Consortium, York, United Kingdom

Adam Smith, PhD, York Health Economics Consortium, York, United Kingdom

Wednesday, 18 October | 1:00 pm – 4:00 pm

Workshop level: Basic

Workshop Goals:

To optimize the impact of research in practice and policy, patient-centered research must involve different stakeholders, including researchers, clinicians, patients, and policymakers. A key role for this stakeholder group is to formulate relevant and researchable questions that can produce timely results that inform practice and policy. It is important that the voices of diverse stakeholders are heard, and they have the skills and framework to ask meaningful and robust research questions that can be operationalized.

A well-conceptualized and clear research question sets out the variables that are meaningful to each stakeholder and describes how the variables are linked together. Properly framed research questions set the stage, a priori, for a discussion on the research design, analysis, data mobilization strategy, and uptake of results in policy and practice. For applied researchers, a framework is needed to support diverse stakeholders to co-design robust research questions.

The goals of this workshop are to provide participants with 1) knowledge about different research question frameworks in the quantitative paradigm; and 2) the skills to co-design research questions with end-user stakeholders and operationalize the implementation of the research in applied clinical settings.

Intended Audience

Health outcomes researchers including early career investigators, decision-makers, graduate students, patient partners, and policy-oriented researchers.

Presentation Format

The workshop format will be small group activities, lectures, and discussions

• Small group activities (60%) – to appraise existing research questions and craft strong research questions based on the lessons learned from the workshop. In small group activities, members will play different stakeholder roles.
• Lectures (20%) – to introduce frameworks for different types of questions and a case presentation on how to co-design relevant and researchable questions
• Discussion and Q&A (20%)

Overview/Outline

1. Presentation of a patient engagement example identifying researchable questions from the perspective of the relevant stakeholders.
2. The research cycle: Event/outcome estimation, identification of causes, elucidation of mechanisms, and evaluation of deliberate interventions or programs
3. Introduction to different frameworks for formulating research questions according to the intent (e.g., PICOT, PECO).
4. Architecture and vocabulary for strong research questions
5. Going from the question to the research design, analysis, and data mobilization strategy.
6. Crafting tables to show the answer to the question

Learning Objectives

1. To recognize the principles and benefits of patient engagement in applied research topic selection and formulation of research objectives and describe potential strategies to improve or support continued patient involvement in research. To optimize the impact of research in practice and policy, patient-centred research must involve different stakeholders, including researchers, clinicians, patients, and policymakers. A key role for this stakeholder group is to formulate relevant and researchable questions that can produce timely results that inform practice and policy.
2. To identify the appropriate research question framework for different types of applied clinical research. A well-conceptualized and clear research question sets out the variables that are meaningful to each stakeholder and describes how the variables are linked together. Properly framed research questions set the stage, a priori, for a discussion on the research design, analysis, data mobilization strategy, and uptake of results in policy and practice.
3. To design a relevant client- or community-centred research objective using appropriate frameworks. For applied researchers, a framework is needed to support diverse stakeholders to co-design robust research questions.

Organizers:

Nikki Ow, PhD, The University of British Columbia, Vancouver, British Columbia, Canada

Maryam Mozafarinia, PhD, McGill University Health Center, Montreal, Quebec, Canada

Dan Nixon, Foundry Central Office, Vancouver, British Columbia, Canada

Skye Barbic, PhD, The University of British Columbia, Vancouver, British Columbia, Canada

Nancy Mayo, PhD, McGill University, Montreal, British Columbia, Canada

Wednesday, 18 October | 9:00 am – 12:00 pm

Introduction to Quality of Life and Patient Reported Outcomes (IPRO)

Theory, Measurement, and Applications

For those who have taken the IPRO educational course or are familiar with the course content, ISOQOL offers a session at the Annual Conference providing further opportunities for engagement and advancement of skills. Connect with different instructors from the course, discuss changes in the field, and network with other individuals interested in PROs at this new event.

Please note: Taking the IPRO e-learning course is a recommended prerequisite for this session. The e-learning course is not included in the ticket price for this event, and a separate purchase would need to be completed on the ISOQOL e-learning platform. Learn more about the course here.

*Tickets can be purchased with conference registration, but are also available for individual purchase. Individual purchase is still done through conference registration, where you will select the “Wednesday only attendee” member type to attend only the education course and not pay for access to the entire conference.

Since this is a half-day event, lunch is not included in the session ticket. Attendees participating in the session may choose to purchase a boxed lunch at an additional cost.

Wednesday, 18 October | 1:00 pm – 4:00 pm

Introduction to Patient-Centered Outcomes Research for the Pharma/Biotech Industry (IPCOR)

Informed Decision Making for Regulators, Payers, Prescribers and Patients

For those who have taken the IPCOR Pharma educational course or are familiar with the course content, ISOQOL offers a session at the Annual Conference providing further opportunities for engagement and advancement of skills. Connect with different instructors from the course, discuss changes in the field, and network with other individuals interested in PCOs at this new event.

Please note: Taking the IPCOR Pharma e-learning course is a recommended prerequisite for this session. The e-learning course is not included in the ticket price for this event, and a separate purchase would need to be completed on the ISOQOL e-learning platform. Learn more about the course here.

*Tickets can be purchased with conference registration, but are also available for individual purchase. Individual purchase is still done through conference registration, where you will select the “Wednesday only attendee” member type to attend only the education course and not pay for access to the entire conference.

Since this is a half-day event, lunch is not included in the session ticket. Attendees participating in the session may choose to purchase a boxed lunch at an additional cost.

Wednesday, 18 October | 6:00 pm – 7:30 pm

Begin your time at the conference by visiting with old friends and networking with new friends and colleagues in the Imperial Ballroom 5 at the Hyatt Regency Calgary. Savor local flavors with provided light hors d’oeuvres or sip on a beverage from the cash bar while getting to know your peers.

Thursday, 19 October | 5:40 pm – 6:20 pm

Organized by the New Investigator SIG

More information about the Tricks of the Trade presentation will be added soon.

Thursday, 19 October | 6:30 pm – 7:30 pm

The ISOQOL mentoring program promotes career development and provides in-person networking opportunities for students and new investigators within the Society during the Annual Conference. Individuals interested in serving as a mentor will be paired up with students and new investigators that have signed up for the program. This reception provides a forum for conversation and professional networking the exchange of knowledge in a relaxed atmosphere. Refreshments will be provided.

You can sign up to be a mentor or mentee by selecting your preference during conference registration. This event is free to attend but requires pre-registration to aid in the pairing process. The deadline to sign up for this year’s Mentor/Mentee Reception is 1 September. 

Friday, 20 October | 7:00 pm – 10:00 pm

The Experience Calgary Social Event at the 30th Annual Conference is an exciting way to socialize with your colleagues and build new connections. The ticket price includes light hors d’oeuvres, two drink tickets, musical entertainment, and dancing. This is a truly unique way to toast another successful year of quality of life research, so don’t miss it!

More information about the Experience Calgary Social Event will be added soon. 

*Ticketed Event – Attendees and guests should purchase tickets through the conference registration form to attend this event. Tickets will be available soon!

Each Special Interest Group (SIGs) has 60 minutes scheduled for a business meeting during the Annual Conference. Room assignments will be listed in the conference mobile app.

Thursday, 19 October | 7:00 am – 8:00 am

• Australia and New Zealand SIG
• Developing Nation SIG
• Ibero America SIG
• Japan SIG

Thursday, 19 October | 12:05 pm – 1:05 pm

• Canada PRO SIG
• Chinese PRO SIG
• German Speaking Countries SIG
• Psychometrics SIG Meeting
• United Kingdom and Ireland SIG

Friday, 20 October | 7:00 am – 8:00 am

• New Investigator SIG

Friday, 20 October | 11:40 am – 12:40 pm

• QOL in Clinical Practice SIG
• Response Shift SIG
• Regulatory and Health Technology Assessment Engagement SIG
• Statistics SIG
• Translation and Cultural Adaptation SIG

Saturday, 21 October | 7:00 am – 8:00 am

• Child Health SIG
• Health Preference Research SIG
• Industry SIG
• Mixed Methods SIG
• Patient Engagement SIG

Wednesday, 18 October | 7:15 pm

The ISOQOL Dine-Around event is a great opportunity to visit with fellow conference attendees while experiencing Calgary’s culture! Individuals who participate in the ISOQOL Dine-Arounds will be placed in a group of six to eight people. A table is reserved for all groups at unique restaurants around Calgary.

All Dine-Around participants are responsible for paying for their own meal and arranging their own transportation. ISOQOL will coordinate a meeting location in the hotel lobby for Dine-Around groups to gather before the reservation.

Saturday, 21 October | 12:05 pm – 1:35 pm

The Awards and Member Business Meeting on Saturday includes presentation of annual awards, leadership transition, and official ISOQOL business. Since membership dues are included in the conference registration, all Annual Conference attendees are members and are encouraged to attend this session.

Lunch will be served during this meeting.