Publications
Single-arm studies involving patient-reported outcome data in oncology: a literature review on current practiceLiu L, Choi J, Musoro JZ, Sauerbrei W, et al. |
International standards for the analysis of quality-of-life and patient-reported outcome endpoints in cancer randomised controlled trials: recommendations of the SISAQOL Consortium.Coens C, Pe M, Dueck AC, Sloan J, Basch E et al. The Lancet Oncology. 2020 Statistical analysis of patient-reported outcome data in randomized controlled trials of locally advanced and metastatic breast cancer: a systematic review.Pe M, Dorme L, Coens C, Basch E et al. The Lancet Oncology. 2018 Moving forward towards standardizing analysis of quality of life data in randomized cancer clinical trials.Bottomley A, Pe M, Sloan J, Basch E et al. Clinical Trials. 2018 Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards.Bottomley A, Pe M, Sloan J, Basch E et al. The Lancet Oncology. 2018 |
An Emerging Trend in Oncology: Global Initiatives Incorporating Patient-Reported Outcomes.PE M. |
The use of PRO data in cancer randomised controlled trials (RCTs): Literature reviews on current practices and guidelines.Cocks K, Catalan C, Machingura A, Coens C, et al. |
An Emerging Trend in Oncology: Global Initiatives Incorporating Patient-Reported Outcomes.Mulkey F, Chen T, Pe M, Cappelleri J, Bhatnagar V, Fiero M. |
Generating recommendations for design, analysis and interpretation of patient-reported outcomes for cancer clinical trials: Progress from SISAQOL-IMI.Cocks K, PE M, Coens C, Schlichting M, et al. |
Developing recommendations to handle patient reported outcome data in oncology cancer trials: SISAQOL-IMI.Le Cessie S, Goetghebeur E, Thomassen D. |
Imputation of longitudinal patient reported outcomes in the presence of death and other intercurrent events.Thomassen D, Roychoudhury S, Delphin CA, Liu L, et al. |
Imputation of longitudinal patient reported outcomes in the presence of death and other intercurrent events.Goetghebeur E, Reynerds D, Thomassen D, Le Cessie S. |
What do we know about visualisation of group-level PRO data from cancer clinical trials for healthcare professionals and other stakeholders? Results from a systematic literature review.Wintner L, Gross F, Peacock R, Boele F, et al. |
Developing international standards in the analysis of patient reported outcomes in cancer clinical trials: methodological issues and STRATOS engagement in the European IMI-SISAQOL project.Le Cessie S, Goetghebeur E, Liu L, Thomassen D. |
A new international initiative to Harmonize Analysis of Cancer Patient-Reported Outcomes.
Gotay C, Pe M, Corneel C, Basch E et al. The 21st World Congress of Psycho-Oncology, Banff, Canada, September 2019.
Towards standardization of patient-reported (PRO) data analysis in cancer randomized controlled trials:
the SISAQOL initiative.
Coens C, Pe M, Basch E, Calvert M et al. PSI Annual conference, QEII Centre, London, UK, June 2019.
Developing International Standards and Recommendations for the Analysis of Patient-Reported Outcomes
and Quality of Life Data.
Dorme L, Pe M, Coens C, Basch E et al. PROMS Annual Research Conference 2019, Leeds Beckett University, Leeds, UK, June 2019.
Conference website
Setting standards in patient-reported outcomes analysis for cancer randomized controlled trials –
a SISAQOL initiative update.
Coens C, Pe M, Basch E, Calvert M et al. 40th Annual Conference of the International Society for Clinical
Biostatisticians, O&N Gasthuisberg, Leuven, BE, July 2019.
Current State of Statistical Analysis of Patient Reported Outcomes Data in Cancer Randomized Controlled
Trials on Locally Advanced and Metastatic Breast Cancer – A Systematic Review.
Pe M, Dorme L, Coens C, Hamel JF et al. PROMS Research Conference, University of Birmingham, Birmingham, UK, June 2018.
Setting Standards for Analysis of Patient Reported Outcomes and Quality of Life Data for International
Cancer Clinical Trials (SISAQOL consortium): Progress update.
Bottomley A, Pe M, Dorme L, Hamel JF et al. 25th Annual Conference of the International Society for Quality
of Life Research, Dublin, Ireland October 2018.
Improving standards of patient reported outcomes analysis: developing a consensus taxonomy of key
research objectives – a SISAQOL initiative.
Pe M, Dorme L, Coens C, Hamel JF et al. 25th Annual Conference of the International Society for Quality
of Life Research, Dublin, Ireland, October 2018.
How Much Missing Data is Too Much? Monte Carlo Simulations to Develop SISAQOL Guidelines for
Missing Data Handling.
Mazza G, Pe M, Dorme L, Coens C et al. 25th Annual Conference of the International Society for Quality
of Life Research, Dublin, Ireland October 2018.
Setting Standards for Analysis of Quality of Life Data for International Cancer Clinical Trials
(SISAQOL Consortium).
Bottomley A, Pe M, Sloan J, Basch E et al. ECCO2017: European Cancer Congress, Amsterdam, The Netherlands, January 2017.
What do we know about visualisation of group-level PRO data from cancer clinical trials for patients? Results from a systematic literature review.Gross F, Wintner L, Peacock R, Boele F, et al. |
SISAQOL-IMI: Evaluating treatment effects on quality of life in oncology.Goetghebeur E, Liu L, Thomassen D, Le Cessie S. Conference website | Poster PDF The SISAQOL initiative: Establishing International Standards and Recommendations for the Analysis of
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Analysis of PRO data: SISAQOL recommendations and practical examples.
Presenter: Kim Cocks. PSI One day Scientific Meeting: The analysis and reporting of PROs in Clinical Trials,
Roche, Welwyn Garden City, UK, July 2019.
International standards of Analysis – The SISAQOL initiative (SISAQOL Consortium).
Madeline Pe. 5th EORTC Quality of Life and Cancer Clinical Trials Conference, Brussels, Belgium, May 2019.
Efforts to Standardize PRO Analysis Methods.
Chair: Laura Lee Johnson. Presenters: Andrew Bottomley, Kathy Soltys, Amylou Dueck, Rajeshwari Sridhara.
ASCO FDA Core Outcome Assessments in Cancer Clinical Trials (COA-CCT) Workshop, Silver Spring, USA, June 2018.
Getting the maximum out of patient reported data in clinical trials: an update on the SISAQOL initiative.
Dorme L, Oliver K (on behalf of the SISAQOL Consortium). Brain Tumour Magazine: World Edition 2019, p: 26-28.
PROs and HRQOL: Are we talking about the same things? Challenges in interpreting PRO and HRQOL findings
across trials.
Presenter: Madeline Pe. WECAN Academy 2019, Frankfurt, Germany, July 2019.
- Appendix 1 – Harmonised statements between RCTs and SATs
- Appendix 2 – Original statements for each PRO variable of interest presented as condensed summary statements
- Appendix 3 – Allocation of graph types to PRO endpoints
- Appendix 4 – List of participating organisations in SISAQOL-IMI by stakeholder group
- Appendix 5 – Development of statements in the scientific work packages
- Appendix 6 – SISAQOL-IMI priority of objectives for statements development
- Appendix 7 – Divergent views table
- Appendix 8 – Table of diverging views
- Appendix 9 – Hierarchical list of references/sources used to define the SISAQOL-IMI glossary terms
- Appendix 11 – Members of the Independent Ethics and Scientific Advisory Boards
