Welcome to the Person-Centred Research Directorate, a specialised unit within the Monash University Eastern Health Clinical School. Our mission is to ensure that the perspectives, experiences and outcomes that matter most to patients – and healthcare consumers more broadly – are embedded in health research, clinical care and policy. We achieve this by advancing the measurement and application of self-reported health outcomes, including health-related quality of life and other person-centred outcomes (PCOs) as well as patients’ experiences with healthcare.
Established in 2024, the Directorate focuses on the development, translation/cross-cultural adaptation, validation and implementation of patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs). We are particularly interested in improving the interpretation and meaningful use of PROM data by advancing methods around score interpretation and identification of measurement bias.
Our methodological expertise spans co-design and consumer engagement approaches, qualitative research, psychometrics and other advanced quantitative methods. Through these approaches, we strive to improve the quality, relevance and impact of person-centred measurement in healthcare.
Beyond research, we offer training programs and workshops in person-centred outcomes research, particularly in psychometric methods, and provide expert advice to various PCO stakeholders, including the not-for-profit sector, industry, and healthcare policy. Examples of our consulting services include the selection, validation, interpretation and implementation of PROMs and PREMs across clinical research, practice and health systems.
Our research
We give a voice to patients – and consumers more broadly – by promoting and advancing research methods around PROMs and PREMs for application in clinical practice and research. Our research methodology includes co-design, qualitative and quantitative/psychometric research methods.
Evidence generation for side effect burden item Q168
Funding: European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group
Lead CIs: A/Prof Sandra Nolte, Claire Piccinin (EORTC Quality of Life Department, Belgium)
Other investigators from PCR: Tamara Jones
EORTC item Q168 and FACIT item GP5 are referenced by the US Food and Drug Administration (FDA) as examples of single-item measures that can be used to assess patients’ overall perceptions of side effect burden from cancer treatment. However, evidence supporting the use of single-item measures to assess patients’ overall treatment-related side effect burden remains limited. This project aims to address this gap.
By applying both qualitative and quantitative research methods, this project aims to generate evidence to support (or potentially refute) the use of single-item measures of self-reported treatment-related side effect burden in cancer clinical trials and other research settings.
Multi-national validation of the ELderly Functional Index (ELFI) as a composite measure of functional status and indicator of frailty in cancer patients
Lead CIs: A/Prof Sandra Nolte, Dr Kheng Soo (Monash University, Eastern Health)
Project Lead: Dr Claire Samanna
Psychometrician: Dr Jonathon Little
People with cancer vary in their physical function, independence, and ability to tolerate treatment. Lower physical function can be a sign of frailty, and frailty is linked with a higher risk of complications and poorer outcomes. Understanding functional status can help guide treatment decisions and identify people who may benefit from additional support. This is especially important for older adults and for people who may be at risk of frailty. The ELderly Functional Index (ELFI) is a short questionnaire that asks about daily activities, mobility, and social roles. It is designed to help identify people who may need extra support during cancer treatment.
This study will recruit approximately 400 adults with cancer who are making treatment decisions. Participants will complete short questionnaires at the start of the study, again a few days later, and again about three months later. This will help us understand whether the ELFI gives stable results and whether it relates to later changes in health, symptoms, and treatment experiences.
The study team will also collect basic clinical and background information. Where possible, medical records may be reviewed for important outcomes such as hospital visits or treatment completion.
The main aim is to find out whether ELFI is a reliable and useful way to assess functional status and frailty‑related risk in people with cancer. If ELFI is validated, it may help identify patients who could benefit from further assessment, monitoring, or supportive care. It is not intended to replace clinical judgement or comprehensive geriatric assessment.
The EORTC Norm Data Study 2.0: A 10-year update and expansion of general population normative data for the EORTC CAT Core and the EORTC QLQ-C30
Lead CIs: A/Prof Sandra Nolte, Prof Mogens Groenvold (University of Copenhagen, Denmark)
Project Lead: TBD
This project, recently funded by the EORTC Quality of Life Group, is an update and expansion of the European norm data project led by A/Prof Sandra Nolte from 2015–2019. The original Norm Data Study 1.0 collected quality-of-life data from the general population in spring 2017 and included a total of 15 countries (i.e., Austria, Canada, Denmark, France, Germany, Hungary, Italy, the Netherlands, Poland, Russia, Spain, Sweden, Türkiye, United Kingdom, United States), with 11 EU countries forming the “European Norm” for two key EORTC instruments: the EORTC QLQ-C30 and the EORTC CAT Core. The study resulted in two core and nine national QLQ-C30 norm data articles.
As the European Norms for the EORTC QLQ-C30 and EORTC CAT Core instruments are becoming outdated and important research questions remain, our team was recently funded to update and expand the general population norm dataset, enabling us to answer research questions about temporal stability of norm data across countries and exploring general population norms in additional countries across all continents. We are currently in the process of recruiting for the project lead position. Stay tuned!
The Australian Real World Cancer Evidence Network: Development of a Core Outcomes Set (COS) for PROMs and PREMs, and mapping of instruments to the COS domains
Funding: Movember, Cancer Australia
Lead CIs: A/Prof Sandra Nolte, Dr Tamara Jones
The Pan Cancer Initiative aims to optimise cancer care delivery and improve outcomes for all Australians by integrating patient-reported measures (PRMs), subsuming PROMs and PREMs, across the cancer care sector. Incorporating PRMs into cancer care settings will help ensure the best care possible for people with cancer, by prioritising their actual experiences and needs. This initiative aligns with the Australian Cancer Plan’s five-year strategic goal of placing patient experiences and outcomes at the centre of cancer care.
One of our key contributions to the Pan Cancer Initiative was being part of the Pan Cancer Advisory Board and developing a Core Outcomes Set (COS) of patient-reported outcome and patient-reported experience domains. As part of this, our group was contracted to map actual measures, i.e., a range of established PROMs and PREMs, to the Pan Cancer COS domains.
Development of an Interpretation Guideline for the EORTC PRO Measures
Funding: European Organisation for Research and Treatment of Cancer (EORTC)
Lead CIs: Dr Monika Sztankay (Medical University of Innsbruck, Austria), Prof Susanne Singer (University of Rostock, Germany)
Investigators from PCR: A/Prof Sandra Nolte (co-author of several chapters)
The assessment of PRO data in oncological practice and research has proved beneficial for patient outcomes. By offering guidance on interpretation, the EORTC Quality of Life Group aims to support the use of PRO data assessed with its measures. To meet the need for practical guidance on differentiating and using the various ways of interpreting EORTC PRO data, this project is aimed at the development of an EORTC Interpretation Guideline that will include best-practice recommendations on interpreting PROs assessed with EORTC PRO measures for both scientific and clinical use. The recommendations will be based on existing evidence and consensus among PRO experts in the field, including buy-in from relevant stakeholders (i.e., patient representatives, clinicians, researchers, representatives of the pharmaceutical industry). Guideline development will follow the procedure established by the National Institute for Health and Care Excellence (NICE) and the GIN-McMaster Guideline Development Checklist.
Development of a Guideline for the EORTC Item Library and Using the Item Library to Assess Symptomatic Patient-Reported Adverse Events
Funding: European Organisation for Research and Treatment of Cancer (EORTC)
Lead CIs: A/Prof Alexandra Gilbert (University of Leeds), Claire Piccinin (Belgium), Drs Hayat Hamzeh, Christopher Bedding, Rosemary Peacock (all University of Leeds)
Investigators from PCR: A/Prof Sandra Nolte, Dr Tamara Jones
The aim of the EORTC-PRO-AE project is to develop a comprehensive inventory of patient-reported symptomatic adverse events using items from the EORTC Item Library. The project aims to establish the face and content validity of newly developed items, and subsequently evaluate the psychometric performance of all EORTC-PRO-AE items to support broader implementation in cancer research and clinical care.
Development and validation of EORTC quality of life measures for children, adolescents and young adults (AYA) with cancer as well as survivors of childhood cancer
Funding: European Organisation for Research and Treatment of Cancer (EORTC)
Lead CIs: Prof Anne-Sophie Darlington (University of Southampton, UK), Dr Samantha Sodergren (University of Southampton, UK), Dr David Riedl (Medical University of Innsbruck, Austria)
Other investigators from PCR: A/Prof Sandra Nolte
Collaborators in Australia: A/Prof Maria McCarthy, Dr Cinzia De Luca (both Murdoch Children’s Research Institute), Prof Kim Dalziel (The University of Melbourne)
The EORTC is currently developing a range of health-related quality of life instruments for children and AYA. Part of the development process involves testing of the new instruments in various countries, including Australia. In collaboration with the Murdoch Children’s Research Institute/Royal Children’s Hospital, we are interviewing Australian children, AYAs, childhood cancer survivors, parents and healthcare providers to generate evidence regarding the use of these newly developed EORTC measures, including whether children (and their parents) understand the questions, find them relevant to their situation and identify any questions or health domains that are potentially missing from the instruments.
8. PRO-specific SAP for a Clinical Trial in MelanomaView
PRO-specific Statistical Analysis Plan (SAP) for Melanoma Margins Trial (MelMarT-II): A Phase III, multi-centre, multi-national randomised control trial investigating 1 cm versus 2 cm wide excision margins for primary cutaneous melanoma
Funding: Melanoma and Skin Cancer Trials (MASC) Limited
Lead CIs: A/Prof Sandra Nolte, Dr Lucy Busija; project delivered in early 2026
The objective of this project was to develop the PRO-specific statistical analysis plan (SAP) and statistical code for the MelMarT-II Trial. This included delivery of a PRO-specific SAP, development of statistical code, support for the statistical analyses and interpretation of the PRO data. The project was delivered in early 2026.
Validity arguments for patient-reported outcomes (PROs): Validation planning and consideration of the consequences of the intended interpretation and use of PRO data
Funding: no external funding
Lead CIs: A/Prof Melanie Hawkins (La Trobe University), A/Prof Sandra Nolte; project delivered in mid-2026
Contrary to common usage in the health sciences, the term “valid” does not refer to the properties of a measurement instrument but to the extent to which data-derived inferences are appropriate, meaningful, and useful for intended decision making. The aim of this project is to determine how validity testing theory (the Standards for Educational and Psychological Testing) and methodology (Kane’s argument-based approach to validation) from education and psychology can be applied to validation practices for patient-reported outcomes measured by instruments that assess theoretical constructs in health.
Defining Score Interpretation Thresholds for Clinical Outcome Assessment Measures: A Review of Terminology and Reporting Recommendations
Funding: no external funding
Lead CIs: Emuella Flood (AstraZeneca, USA), A/Prof Sandra Nolte; project delivered in the end of 2025
Both the concept of ‘score interpretation threshold’ for understanding score differences of clinical outcome assessments (COAs) and the terminology around this topic have evolved over several decades. However, considerable confusion regarding terminology remains, leading to potentially erroneous interpretation of COA results. This project, instigated as part of a larger initiative through the Drug Information Association (DIA), sought to provide an updated overview of terminology and an assessment of trends to explore opportunities for harmonising the field.
Over the last 20 years, we have built an extensive global network in patient-reported outcomes (PRO) research across academic, not-for-profit and industry sectors. These range from close collaborations and partnerships to consulting to active engagement in various initiatives and learned societies in the PRO field.
1. Self-reported side effect burden
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2. Screening for Frailty in Cancer Patients
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3. EORTC General Population Norm Data
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4. Pan Cancer Initiative
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9. The Validity Framework in PRO Research
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10. Clinical Outcome Assessment (COA) Score Interpretation Threshold
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