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Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life endpoints

Setting International Standards in Analyzing

Patient-Reported Outcomes and Quality of Life

endpoints

Downloads and Resources

Dorme L, Oliver K (on behalf of the SISAQOL Consortium). Getting the maximum out of patient reported data in clinical trials: an update on the SISAQOL initiative. 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.

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). Presenter: 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.


International standards of Analysis – The SISAQOL initiative (SISAQOL Consortium). Presenter: Madeline Pe. Quality of Life and Cancer Clinical Trials Conference, Brussels, Belgium, April 2017.


The Challenge of Missing Data. What can we, as patient advocates, do to help? (Incorporating the EORTC’s SISAQOL Initiative). Presenters: Jeff Sloan and Madeline Pe. The Third Biennial World Summit of Brain Tumour Patient Advocates, London, United Kingdom, October 2017.

Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data Consortium. 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, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Devlin N, Dorme L, Flechtner HH, Gotay C, Griebsch I, Groenvold M, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Musoro JZ, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Quinten C, Reijneveld JC, Schürmann C, Smith AW, Soltys KM, Taphoorn MJB, Velikova G, Bottomley A.

The Lancet Oncology.


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, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Dirven L, Dueck AC, Devlin N, Flechtner HH, Gotay C, Griebsch I, Groenvold M, King M, Koller M, Malone DC, Martinelli F, Mitchell SA, Musoro J, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Pimentel FL, Quinten C, Reijneveld JC, Schürmann C, Sloan J, Velikova G, Bottomley

(2018) The Lancet Oncology, 19(9), e459-e469.


Moving forward towards standardizing analysis of quality of life data in randomized cancer clinical trials.

Bottomley A, Pe M, Sloan J, Basch E, Bonnetain F, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Dueck AC, Devlin N, Flechtner HH, Gotay C, Greimel E, Griebsch I, Groenvold M, Hamel JF, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Moinpour CM, Musoro J, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Pimentel FL, Quinten C, Reijneveld JC, Schürmann C, Smith AW, Soltys KM, Sridhara R, Taphoorn M, Velikova G, Coens C.

(2018) Clinical Trials, 15(6), 624-630.


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, Bonnetain F, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Dueck AC, Devlin N, Flechtner HH, Gotay C, Greimel E, Griebsch I, Groenvold M, Hamel JF, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Moinpour CM, Musoro J, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Pimentel FL, Quinten C, Reijneveld JC, Schürmann C, Smith AW, Soltys KM, Taphoorn M, Velikova G, Coens C.

(2016). The Lancet Oncology, 17(11), e510-e514.

A new international initiative to Harmonize Analysis of Cancer Patient-Reported Outcomes. The 21st World Congress of Psycho-Oncology, Banff, Canada, September 2019.

Gotay C, Pe M, Corneel C, Basch E, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Devlin N, Dorme L, Dueck AC, Flechtner HH, Griebsch I, Groenvold M, Johnson LL, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Musoro J, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Quinten C, Reijneveld JC, Schürmann C, Sloan J, Wilder Smith A, Soltys K, Sridhara R, Taphoorn MJB, Velikova G, Bottomley A.


Towards standardization of patient-reported (PRO) data analysis in cancer randomized controlled trials: the SISAQOL initiative. PSI Annual conference, QEII Centre, London, UK, June 2019.

Coens C, Pe M, Basch E, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Devlin N, Dorme L, Dueck AC, Flechtner HH, Gotay C, Greimel E, Griebsch I, Groenvold M, Hamel JF, Johnson LL, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Musoro J, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Pimentel FL, Quinten C, Reijneveld JC, Schürmann C, Sloan J, Wilder Smith A, Soltys K, Sridhara R, Taphoorn MJB, Velikova G, Bottomley A.


Developing International Standards and Recommendations for the Analysis of Patient-Reported Outcomes and Quality of Life Data. PROMS Annual Research Conference 2019, Leeds Beckett University, Leeds, UK, June 2019.

Dorme L, Pe M, Coens C, Basch E, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Devlin N, Dueck AC, Flechtner HH, Gotay C, Griebsch I, Groenvold M, Johnson LL, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Musoro J, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Quinten C, Reijneveld JC, Schürmann C, Sloan J, Wilder Smith A, Soltys K, Sridhara R, Taphoorn MJB, Velikova G, Bottomley


Setting standards in patient-reported outcomes analysis for cancer randomized controlled trials – a SISAQOL initiative update. 40th Annual Conference of the International Society for Clinical Biostatisticians, O&N Gasthuisberg, Leuven, BE, July 2019.

Coens C, Pe M, Basch E, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Devlin N, Dorme L, Dueck AC, Flechtner HH, Gotay C, Griebsch I, Groenvold M, Johnson LL, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Musoro J, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Pimentel FL, Quinten C, Reijneveld JC, Schürmann C, Sloan J, Wilder Smith A, Soltys K, Sridhara R, Taphoorn MJB, Velikova G, Bottomley A.


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. PROMS Research Conference, University of Birmingham, Birmingham, UK, June 2018.

Pe M, Dorme L, Coens C, Hamel JF, Basch E, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Dirven L, Dueck AC, Devlin N, Flechtner HH, Gotay C, Griebsch I, Groenvold M, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Musoro J, Oliver K, Piault-Louis E, Piccart M, Pimentel FL, Quinten C, Reijneveld JC, Sloan J, Velikova G, Bottomley A.

Journal of Patient Reported outcomes 2 (Suppl 2), ab04, p:3-4


Setting Standards for Analysis of Patient Reported Outcomes and Quality of Life Data for International Cancer Clinical Trials (SISAQOL consortium): Progress update. 25th Annual Conference of the International Society for Quality of Life Research, Dublin, Ireland October 2018.

Bottomley A, Pe M, Dorme L, Hamel JF, Basch E, Bonnetain F, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Dueck AC, Devlin N, Flechtner HH, Gotay C, Greimel E, Griebsch I, Groenvold M, Johnson LL, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Musoro J, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Pimentel FL, Quinten C, Reijneveld JC, Schürmann C, Sloan J, Wilder Smith A, Soltys K, Sridhara R, Taphoorn MJB, Velikova G, Coens C.

Qual Life Res 27, 1, abS1, p:4-5.


Improving standards of patient reported outcomes analysis: developing a consensus taxonomy of key research objectives – a SISAQOL initiative. 25th Annual Conference of the International Society for Quality of Life Research, Dublin, Ireland, October 2018.

Pe M, Dorme L, Coens C, Hamel JF, Basch E, Bonnetain F, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Dueck AC, Devlin N, Flechtner HH, Gotay C, Greimel E, Griebsch I, Groenvold M, Johnson LL, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Musoro J, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Pimentel FL, Quinten C, Reijneveld JC, Schürmann C, Sloan J, Wilder Smith A, Soltys K, Sridhara R, Taphoorn MJB, Velikova G, Bottomley A.

Qual Life Res 27, 1, ab203.4, p:35-36.


How Much Missing Data is Too Much? Monte Carlo Simulations to Develop SISAQOL Guidelines for Missing Data Handling. 25th Annual Conference of the International Society for Quality of Life Research, Dublin, Ireland October 2018.

Mazza G, Pe M, Dorme L, Coens C, Oliver K, Bottomley A, Sloan JA, Dueck AC.

Qual Life Res 27, 1, ab208.1, p:43.


Setting Standards for Analysis of Quality of Life Data for International Cancer Clinical Trials (SISAQOL Consortium). Annual Conference of the European Cancer Organisation, Amsterdam, the Netherlands 2017.

Bottomley A, Pe M, Sloan J, Basch E, Bonnetain F, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Dueck AC, Devlin N, Flechtner HH, Gotay C, Greimel E, Griebsch I, Groenvold M, Hamel JF, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Moinpour CM, Musoro J, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Pimentel FL, Quinten C, Reijneveld JC, Schürmann C, Wilder Smith A, Soltys K, Taphoorn MJB, Velikova G, Coens C.

(Encore abstract)


Setting Standards for Analysis of Quality of Life Data for International Cancer Clinical Trials (SISAQOL Consortium). 23rd Annual Conference of the International Society for Quality of Life Research, Copenhagen, Denmark, October 2016.

Coens C , Pe M, Sloan J, Basch E, Cleeland C, Cocks K, Collingridge D, Griebsch I, Koller M, Malone D, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Pimentel F, Reijneveld JC, Schuermann C, Smith A, Velikova G, Bottomley A.

Qual Life Res 25, 1, ab101.5, p:23, 2016.


A Systematic Review on the Choice and Implementation of Statistical Methods in Health-Related Quality of Life Data Analyses in Locally Advanced and Metastatic Breast Cancer Randomized Controlled Trials (SISAQOL Consortium). 23rd Annual Conference of the International Society for Quality of Life Research, Copenhagen, Denmark, October 2016.

Pe M , Bottomley A, Bonnetain F, Campbell A, Collette L, Dueck A, Devlin N, Gotay C, Greimel E, Groenvold M, Hamel JF, King M, Martinelli F, Mitchell S, Moinpour C, Jammbe Musoro, Chantal Quinten, Melanie Calvert, Henning Flechtner, Martin Taphoorn, Coens C.

Qual Life Res 25, 1, ab101.4, p:22-23, 2016. (Preliminary results)

The SISAQOL initiative: Establishing International Standards and Recommendations for the Analysis of Patient-Reported Outcomes and Quality of Life Data in Oncology Randomized Clinical Trials. ISPOR Europe 2019, Copenhagen, Denmark, November 2019.

Dorme L, Pe M, Coens C, Basch E, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Devlin N, Dueck AC, Flechtner HH, Gotay C, Griebsch I, Groenvold M, Johnson LL, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Musoro J, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Quinten C, Reijneveld JC, Schürmann C, Sloan J, Wilder Smith A, Soltys K, Sridhara R, Taphoorn MJB, Velikova G, Bottomley A.

Abstract 96614. PCN457. Electronic poster available here.


Setting International Standards in Analysing patient-reported outcomes and quality of life endpoints data for cancer clinical trials – SISAQOL Consortium. ECCO2017: European Cancer Congress, Amsterdam, The Netherlands, January 2017.

Bottomley A, Pe M, Sloan J, Basch E, Bonnetain F, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Dueck AC, Devlin N, Flechtner HH, Gotay C, Greimel E, Griebsch I, Groenvold M, Hamel JF, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Moinpour CM, Musoro J, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Pimentel FL, Quinten C, Reijneveld JC, Schürmann C, A, Soltys K, Taphoorn MJB, Velikova G, Coens C.

Abstract 1333. Poster 226.

Downloads and Resources

Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data Consortium. 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, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Devlin N, Dorme L, Flechtner HH, Gotay C, Griebsch I, Groenvold M, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Musoro JZ, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Quinten C, Reijneveld JC, Schürmann C, Smith AW, Soltys KM, Taphoorn MJB, Velikova G, Bottomley A.

The Lancet Oncology.


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, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Dirven L, Dueck AC, Devlin N, Flechtner HH, Gotay C, Griebsch I, Groenvold M, King M, Koller M, Malone DC, Martinelli F, Mitchell SA, Musoro J, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Pimentel FL, Quinten C, Reijneveld JC, Schürmann C, Sloan J, Velikova G, Bottomley

(2018) The Lancet Oncology, 19(9), e459-e469.


Moving forward towards standardizing analysis of quality of life data in randomized cancer clinical trials.

Bottomley A, Pe M, Sloan J, Basch E, Bonnetain F, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Dueck AC, Devlin N, Flechtner HH, Gotay C, Greimel E, Griebsch I, Groenvold M, Hamel JF, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Moinpour CM, Musoro J, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Pimentel FL, Quinten C, Reijneveld JC, Schürmann C, Smith AW, Soltys KM, Sridhara R, Taphoorn M, Velikova G, Coens C.

(2018) Clinical Trials, 15(6), 624-630.


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, Bonnetain F, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Dueck AC, Devlin N, Flechtner HH, Gotay C, Greimel E, Griebsch I, Groenvold M, Hamel JF, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Moinpour CM, Musoro J, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Pimentel FL, Quinten C, Reijneveld JC, Schürmann C, Smith AW, Soltys KM, Taphoorn M, Velikova G, Coens C.

(2016). The Lancet Oncology, 17(11), e510-e514.

A new international initiative to Harmonize Analysis of Cancer Patient-Reported Outcomes. The 21st World Congress of Psycho-Oncology, Banff, Canada, September 2019.

Gotay C, Pe M, Corneel C, Basch E, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Devlin N, Dorme L, Dueck AC, Flechtner HH, Griebsch I, Groenvold M, Johnson LL, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Musoro J, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Quinten C, Reijneveld JC, Schürmann C, Sloan J, Wilder Smith A, Soltys K, Sridhara R, Taphoorn MJB, Velikova G, Bottomley A.


Towards standardization of patient-reported (PRO) data analysis in cancer randomized controlled trials: the SISAQOL initiative. PSI Annual conference, QEII Centre, London, UK, June 2019.

Coens C, Pe M, Basch E, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Devlin N, Dorme L, Dueck AC, Flechtner HH, Gotay C, Greimel E, Griebsch I, Groenvold M, Hamel JF, Johnson LL, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Musoro J, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Pimentel FL, Quinten C, Reijneveld JC, Schürmann C, Sloan J, Wilder Smith A, Soltys K, Sridhara R, Taphoorn MJB, Velikova G, Bottomley A.


Developing International Standards and Recommendations for the Analysis of Patient-Reported Outcomes and Quality of Life Data. PROMS Annual Research Conference 2019, Leeds Beckett University, Leeds, UK, June 2019.

Dorme L, Pe M, Coens C, Basch E, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Devlin N, Dueck AC, Flechtner HH, Gotay C, Griebsch I, Groenvold M, Johnson LL, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Musoro J, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Quinten C, Reijneveld JC, Schürmann C, Sloan J, Wilder Smith A, Soltys K, Sridhara R, Taphoorn MJB, Velikova G, Bottomley


Setting standards in patient-reported outcomes analysis for cancer randomized controlled trials – a SISAQOL initiative update. 40th Annual Conference of the International Society for Clinical Biostatisticians, O&N Gasthuisberg, Leuven, BE, July 2019.

Coens C, Pe M, Basch E, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Devlin N, Dorme L, Dueck AC, Flechtner HH, Gotay C, Griebsch I, Groenvold M, Johnson LL, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Musoro J, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Pimentel FL, Quinten C, Reijneveld JC, Schürmann C, Sloan J, Wilder Smith A, Soltys K, Sridhara R, Taphoorn MJB, Velikova G, Bottomley A.


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. PROMS Research Conference, University of Birmingham, Birmingham, UK, June 2018.

Pe M, Dorme L, Coens C, Hamel JF, Basch E, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Dirven L, Dueck AC, Devlin N, Flechtner HH, Gotay C, Griebsch I, Groenvold M, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Musoro J, Oliver K, Piault-Louis E, Piccart M, Pimentel FL, Quinten C, Reijneveld JC, Sloan J, Velikova G, Bottomley A.

Journal of Patient Reported outcomes 2 (Suppl 2), ab04, p:3-4


Setting Standards for Analysis of Patient Reported Outcomes and Quality of Life Data for International Cancer Clinical Trials (SISAQOL consortium): Progress update. 25th Annual Conference of the International Society for Quality of Life Research, Dublin, Ireland October 2018.

Bottomley A, Pe M, Dorme L, Hamel JF, Basch E, Bonnetain F, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Dueck AC, Devlin N, Flechtner HH, Gotay C, Greimel E, Griebsch I, Groenvold M, Johnson LL, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Musoro J, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Pimentel FL, Quinten C, Reijneveld JC, Schürmann C, Sloan J, Wilder Smith A, Soltys K, Sridhara R, Taphoorn MJB, Velikova G, Coens C.

Qual Life Res 27, 1, abS1, p:4-5.


Improving standards of patient reported outcomes analysis: developing a consensus taxonomy of key research objectives – a SISAQOL initiative. 25th Annual Conference of the International Society for Quality of Life Research, Dublin, Ireland, October 2018.

Pe M, Dorme L, Coens C, Hamel JF, Basch E, Bonnetain F, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Dueck AC, Devlin N, Flechtner HH, Gotay C, Greimel E, Griebsch I, Groenvold M, Johnson LL, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Musoro J, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Pimentel FL, Quinten C, Reijneveld JC, Schürmann C, Sloan J, Wilder Smith A, Soltys K, Sridhara R, Taphoorn MJB, Velikova G, Bottomley A.

Qual Life Res 27, 1, ab203.4, p:35-36.


How Much Missing Data is Too Much? Monte Carlo Simulations to Develop SISAQOL Guidelines for Missing Data Handling. 25th Annual Conference of the International Society for Quality of Life Research, Dublin, Ireland October 2018.

Mazza G, Pe M, Dorme L, Coens C, Oliver K, Bottomley A, Sloan JA, Dueck AC.

Qual Life Res 27, 1, ab208.1, p:43.


Setting Standards for Analysis of Quality of Life Data for International Cancer Clinical Trials (SISAQOL Consortium). Annual Conference of the European Cancer Organisation, Amsterdam, the Netherlands 2017.

Bottomley A, Pe M, Sloan J, Basch E, Bonnetain F, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Dueck AC, Devlin N, Flechtner HH, Gotay C, Greimel E, Griebsch I, Groenvold M, Hamel JF, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Moinpour CM, Musoro J, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Pimentel FL, Quinten C, Reijneveld JC, Schürmann C, Wilder Smith A, Soltys K, Taphoorn MJB, Velikova G, Coens C.

(Encore abstract)


Setting Standards for Analysis of Quality of Life Data for International Cancer Clinical Trials (SISAQOL Consortium). 23rd Annual Conference of the International Society for Quality of Life Research, Copenhagen, Denmark, October 2016.

Coens C , Pe M, Sloan J, Basch E, Cleeland C, Cocks K, Collingridge D, Griebsch I, Koller M, Malone D, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Pimentel F, Reijneveld JC, Schuermann C, Smith A, Velikova G, Bottomley A.

Qual Life Res 25, 1, ab101.5, p:23, 2016.


A Systematic Review on the Choice and Implementation of Statistical Methods in Health-Related Quality of Life Data Analyses in Locally Advanced and Metastatic Breast Cancer Randomized Controlled Trials (SISAQOL Consortium). 23rd Annual Conference of the International Society for Quality of Life Research, Copenhagen, Denmark, October 2016.

Pe M , Bottomley A, Bonnetain F, Campbell A, Collette L, Dueck A, Devlin N, Gotay C, Greimel E, Groenvold M, Hamel JF, King M, Martinelli F, Mitchell S, Moinpour C, Jammbe Musoro, Chantal Quinten, Melanie Calvert, Henning Flechtner, Martin Taphoorn, Coens C.

Qual Life Res 25, 1, ab101.4, p:22-23, 2016. (Preliminary results)

The SISAQOL initiative: Establishing International Standards and Recommendations for the Analysis of Patient-Reported Outcomes and Quality of Life Data in Oncology Randomized Clinical Trials. ISPOR Europe 2019, Copenhagen, Denmark, November 2019.

Dorme L, Pe M, Coens C, Basch E, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Devlin N, Dueck AC, Flechtner HH, Gotay C, Griebsch I, Groenvold M, Johnson LL, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Musoro J, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Quinten C, Reijneveld JC, Schürmann C, Sloan J, Wilder Smith A, Soltys K, Sridhara R, Taphoorn MJB, Velikova G, Bottomley A.

Abstract 96614. PCN457. Electronic poster available here.


Setting International Standards in Analysing patient-reported outcomes and quality of life endpoints data for cancer clinical trials – SISAQOL Consortium. ECCO2017: European Cancer Congress, Amsterdam, The Netherlands, January 2017.

Bottomley A, Pe M, Sloan J, Basch E, Bonnetain F, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Dueck AC, Devlin N, Flechtner HH, Gotay C, Greimel E, Griebsch I, Groenvold M, Hamel JF, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Moinpour CM, Musoro J, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Pimentel FL, Quinten C, Reijneveld JC, Schürmann C, A, Soltys K, Taphoorn MJB, Velikova G, Coens C.

Abstract 1333. Poster 226.

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). Presenter: 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.


International standards of Analysis – The SISAQOL initiative (SISAQOL Consortium). Presenter: Madeline Pe. Quality of Life and Cancer Clinical Trials Conference, Brussels, Belgium, April 2017.


The Challenge of Missing Data. What can we, as patient advocates, do to help? (Incorporating the EORTC’s SISAQOL Initiative). Presenters: Jeff Sloan and Madeline Pe. The Third Biennial World Summit of Brain Tumour Patient Advocates, London, United Kingdom, October 2017.

Dorme L, Oliver K (on behalf of the SISAQOL Consortium). Getting the maximum out of patient reported data in clinical trials: an update on the SISAQOL initiative. 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.

Downloads and Resources

Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data Consortium. 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, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Devlin N, Dorme L, Flechtner HH, Gotay C, Griebsch I, Groenvold M, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Musoro JZ, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Quinten C, Reijneveld JC, Schürmann C, Smith AW, Soltys KM, Taphoorn MJB, Velikova G, Bottomley A.

The Lancet Oncology.

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, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Dirven L, Dueck AC, Devlin N, Flechtner HH, Gotay C, Griebsch I, Groenvold M, King M, Koller M, Malone DC, Martinelli F, Mitchell SA, Musoro J, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Pimentel FL, Quinten C, Reijneveld JC, Schürmann C, Sloan J, Velikova G, Bottomley

(2018) The Lancet Oncology, 19(9), e459-e469.

Moving forward towards standardizing analysis of quality of life data in randomized cancer clinical trials.

Bottomley A, Pe M, Sloan J, Basch E, Bonnetain F, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Dueck AC, Devlin N, Flechtner HH, Gotay C, Greimel E, Griebsch I, Groenvold M, Hamel JF, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Moinpour CM, Musoro J, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Pimentel FL, Quinten C, Reijneveld JC, Schürmann C, Smith AW, Soltys KM, Sridhara R, Taphoorn M, Velikova G, Coens C.

(2018) Clinical Trials, 15(6), 624-630.

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, Bonnetain F, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Dueck AC, Devlin N, Flechtner HH, Gotay C, Greimel E, Griebsch I, Groenvold M, Hamel JF, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Moinpour CM, Musoro J, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Pimentel FL, Quinten C, Reijneveld JC, Schürmann C, Smith AW, Soltys KM, Taphoorn M, Velikova G, Coens C.

(2016). The Lancet Oncology, 17(11), e510-e514.

A new international initiative to Harmonize Analysis of Cancer Patient-Reported Outcomes. The 21st World Congress of Psycho-Oncology, Banff, Canada, September 2019.

Gotay C, Pe M, Corneel C, Basch E, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Devlin N, Dorme L, Dueck AC, Flechtner HH, Griebsch I, Groenvold M, Johnson LL, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Musoro J, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Quinten C, Reijneveld JC, Schürmann C, Sloan J, Wilder Smith A, Soltys K, Sridhara R, Taphoorn MJB, Velikova G, Bottomley A.

Towards standardization of patient-reported (PRO) data analysis in cancer randomized controlled trials: the SISAQOL initiative. PSI Annual conference, QEII Centre, London, UK, June 2019.

Coens C, Pe M, Basch E, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Devlin N, Dorme L, Dueck AC, Flechtner HH, Gotay C, Greimel E, Griebsch I, Groenvold M, Hamel JF, Johnson LL, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Musoro J, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Pimentel FL, Quinten C, Reijneveld JC, Schürmann C, Sloan J, Wilder Smith A, Soltys K, Sridhara R, Taphoorn MJB, Velikova G, Bottomley A.

Developing International Standards and Recommendations for the Analysis of Patient-Reported Outcomes and Quality of Life Data. PROMS Annual Research Conference 2019, Leeds Beckett University, Leeds, UK, June 2019.

Dorme L, Pe M, Coens C, Basch E, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Devlin N, Dueck AC, Flechtner HH, Gotay C, Griebsch I, Groenvold M, Johnson LL, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Musoro J, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Quinten C, Reijneveld JC, Schürmann C, Sloan J, Wilder Smith A, Soltys K, Sridhara R, Taphoorn MJB, Velikova G, Bottomley

Setting standards in patient-reported outcomes analysis for cancer randomized controlled trials – a SISAQOL initiative update. 40th Annual Conference of the International Society for Clinical Biostatisticians, O&N Gasthuisberg, Leuven, BE, July 2019.

Coens C, Pe M, Basch E, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Devlin N, Dorme L, Dueck AC, Flechtner HH, Gotay C, Griebsch I, Groenvold M, Johnson LL, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Musoro J, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Pimentel FL, Quinten C, Reijneveld JC, Schürmann C, Sloan J, Wilder Smith A, Soltys K, Sridhara R, Taphoorn MJB, Velikova G, Bottomley A.

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. PROMS Research Conference, University of Birmingham, Birmingham, UK, June 2018.

Pe M, Dorme L, Coens C, Hamel JF, Basch E, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Dirven L, Dueck AC, Devlin N, Flechtner HH, Gotay C, Griebsch I, Groenvold M, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Musoro J, Oliver K, Piault-Louis E, Piccart M, Pimentel FL, Quinten C, Reijneveld JC, Sloan J, Velikova G, Bottomley A.

Journal of Patient Reported outcomes 2 (Suppl 2), ab04, p:3-4

Setting Standards for Analysis of Patient Reported Outcomes and Quality of Life Data for International Cancer Clinical Trials (SISAQOL consortium): Progress update. 25th Annual Conference of the International Society for Quality of Life Research, Dublin, Ireland October 2018.

Bottomley A, Pe M, Dorme L, Hamel JF, Basch E, Bonnetain F, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Dueck AC, Devlin N, Flechtner HH, Gotay C, Greimel E, Griebsch I, Groenvold M, Johnson LL, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Musoro J, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Pimentel FL, Quinten C, Reijneveld JC, Schürmann C, Sloan J, Wilder Smith A, Soltys K, Sridhara R, Taphoorn MJB, Velikova G, Coens C.

Qual Life Res 27, 1, abS1, p:4-5.

Improving standards of patient reported outcomes analysis: developing a consensus taxonomy of key research objectives – a SISAQOL initiative. 25th Annual Conference of the International Society for Quality of Life Research, Dublin, Ireland, October 2018.

Pe M, Dorme L, Coens C, Hamel JF, Basch E, Bonnetain F, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Dueck AC, Devlin N, Flechtner HH, Gotay C, Greimel E, Griebsch I, Groenvold M, Johnson LL, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Musoro J, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Pimentel FL, Quinten C, Reijneveld JC, Schürmann C, Sloan J, Wilder Smith A, Soltys K, Sridhara R, Taphoorn MJB, Velikova G, Bottomley A.

Qual Life Res 27, 1, ab203.4, p:35-36.

How Much Missing Data is Too Much? Monte Carlo Simulations to Develop SISAQOL Guidelines for Missing Data Handling. 25th Annual Conference of the International Society for Quality of Life Research, Dublin, Ireland October 2018.

Mazza G, Pe M, Dorme L, Coens C, Oliver K, Bottomley A, Sloan JA, Dueck AC.

Qual Life Res 27, 1, ab208.1, p:43.

Setting Standards for Analysis of Quality of Life Data for International Cancer Clinical Trials (SISAQOL Consortium). Annual Conference of the European Cancer Organisation, Amsterdam, the Netherlands 2017.

Bottomley A, Pe M, Sloan J, Basch E, Bonnetain F, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Dueck AC, Devlin N, Flechtner HH, Gotay C, Greimel E, Griebsch I, Groenvold M, Hamel JF, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Moinpour CM, Musoro J, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Pimentel FL, Quinten C, Reijneveld JC, Schürmann C, Wilder Smith A, Soltys K, Taphoorn MJB, Velikova G, Coens C.

(Encore abstract)

Setting Standards for Analysis of Quality of Life Data for International Cancer Clinical Trials (SISAQOL Consortium). 23rd Annual Conference of the International Society for Quality of Life Research, Copenhagen, Denmark, October 2016.

Coens C , Pe M, Sloan J, Basch E, Cleeland C, Cocks K, Collingridge D, Griebsch I, Koller M, Malone D, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Pimentel F, Reijneveld JC, Schuermann C, Smith A, Velikova G, Bottomley A.

Qual Life Res 25, 1, ab101.5, p:23, 2016.

A Systematic Review on the Choice and Implementation of Statistical Methods in Health-Related Quality of Life Data Analyses in Locally Advanced and Metastatic Breast Cancer Randomized Controlled Trials (SISAQOL Consortium). 23rd Annual Conference of the International Society for Quality of Life Research, Copenhagen, Denmark, October 2016.

Pe M , Bottomley A, Bonnetain F, Campbell A, Collette L, Dueck A, Devlin N, Gotay C, Greimel E, Groenvold M, Hamel JF, King M, Martinelli F, Mitchell S, Moinpour C, Jammbe Musoro, Chantal Quinten, Melanie Calvert, Henning Flechtner, Martin Taphoorn, Coens C.

Qual Life Res 25, 1, ab101.4, p:22-23, 2016. (Preliminary results)

The SISAQOL initiative: Establishing International Standards and Recommendations for the Analysis of Patient-Reported Outcomes and Quality of Life Data in Oncology Randomized Clinical Trials. ISPOR Europe 2019, Copenhagen, Denmark, November 2019.

Dorme L, Pe M, Coens C, Basch E, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Devlin N, Dueck AC, Flechtner HH, Gotay C, Griebsch I, Groenvold M, Johnson LL, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Musoro J, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Quinten C, Reijneveld JC, Schürmann C, Sloan J, Wilder Smith A, Soltys K, Sridhara R, Taphoorn MJB, Velikova G, Bottomley A.

Abstract 96614. PCN457. Electronic poster available here.


Setting International Standards in Analysing patient-reported outcomes and quality of life endpoints data for cancer clinical trials – SISAQOL Consortium. ECCO2017: European Cancer Congress, Amsterdam, The Netherlands, January 2017.

Bottomley A, Pe M, Sloan J, Basch E, Bonnetain F, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Dueck AC, Devlin N, Flechtner HH, Gotay C, Greimel E, Griebsch I, Groenvold M, Hamel JF, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Moinpour CM, Musoro J, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Pimentel FL, Quinten C, Reijneveld JC, Schürmann C, A, Soltys K, Taphoorn MJB, Velikova G, Coens C.

Abstract 1333. Poster 226.

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). Presenter: 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.


International standards of Analysis – The SISAQOL initiative (SISAQOL Consortium). Presenter: Madeline Pe. Quality of Life and Cancer Clinical Trials Conference, Brussels, Belgium, April 2017.


The Challenge of Missing Data. What can we, as patient advocates, do to help? (Incorporating the EORTC’s SISAQOL Initiative). Presenters: Jeff Sloan and Madeline Pe. The Third Biennial World Summit of Brain Tumour Patient Advocates, London, United Kingdom, October 2017.

Dorme L, Oliver K (on behalf of the SISAQOL Consortium). Getting the maximum out of patient reported data in clinical trials: an update on the SISAQOL initiative. 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.

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