About PROBE

About the PROBE study

Haemophilia Foundation Australia is participating in the PROBE (Patient Reported Outcomes Burdens and Experiences) Study.

The PROBE study is a multi-national, patient-focused research study.

The PROBE study allows people with haemophilia to report their haemophilia severity, treatment history and the impact of haemophilia on their daily life. This data is used to analyse the perspectives of people with haemophilia on outcomes that affect their own life and care. The research supports efforts to improve treatment and comprehensive care programs in Australia and other countries around the world. All data is kept confidential.

More details about the PROBE international study, including publications, are available on the PROBE study website.

PHASE 1

Phase 1 (2014-2015) was the very first stage of developing the questionnaire:

• Test understanding of questionnaire content and clarity (haemophilia impact only at this stage)
• Assess methodology and in-country implementation feasibility
• Establish core analytics​

A small number of Australian community members with haemophilia or parents of children with haemophilia were invited to test the draft questionnaire and give feedback on the questions and instructions.

Read more about Phase 1 here.

PHASE 2

Phase 2 (2016) was the next stage to assess the questionnaire's feasibility through a pilot study:

• Validate proof of concept
• Pilot web platform
• Assess reproducibility
• Establish analytic controls/population comparators

More than 100 Australian community members with haemophilia or who carry the gene and people who do not have a bleeding disorder tested the online and print questionnaire.

Read more about Phase 2 here.

PHASE 3/REAL WORLD

Phase 3/Real World (2019 onwards) is the next stage to extend the study and is now underway in Australia:

• Real world roll-out – inviting the wider haemophilia community to participate in the study
• Maintaining the capacity to continue collecting the data
• Modifying the study infrastructure to allow for longitudinal collection of PROBE data (repeating the study on the same individuals and linking their data over a number of years)
• Complementing and enhancing the utility of national registries or WFH Global Survey data
• Measuring impact of country development initiatives.

Read more about Phase 3/Real World here.

Who is Probe?

PROBE is a multi-national patient-focused investigator driven research project. It is led by a global team of patient and academic investigators with diverse professional credentials:

INTERNATIONAL INVESTIGATION TEAM:

PRINCIPAL INVESTIGATOR

Mark Skinner, JD, Institute for Policy Advancement Ltd [former WFH President] (US)

CO-INVESTIGATORS

Chatree Chai-Adisaksopha MD, Division of Hematology, Department of Internal Medicine Chiang Mai University (Thailand)
Randall Curtis MBA, Factor VIII Computing (USA)
Neil Frick MS, National Hemophilia Foundation (USA)
Alfonso Iorio MD PhD FRCPC, McMaster University, Dept of Clinical Epidemiology and Biostatistics (Canada)
Michael Nichol PhD, University of Southern California, School of Policy and Planning Development (USA)
Declan Noone, European Haemophilia Consortium (Belgium)
Brian O’Mahony, Irish Haemophilia Society (Ireland)
David Page, Canadian Hemophilia Society (Canada)
Jeff Stonebraker PhD, North Carolina State University, Poole College of Management (US)

AUSTRALIAN INVESTIGATION TEAM:

Haemophilia Foundation Australia

Suzanne O’Callaghan, Policy Research and Education Manager – Leading research study implementation in Australia

Monash University, Melbourne

Dr Liz Bishop, Michael Kirby Centre for Public Health and Human Rights – Overseeing ethical process; answering any ethics concerns or queries

Mark Skinner and Alfonso Iorio's PROBE Team at McMaster University in Canada are leading the international PROBE investigation with the Australian team.

PRIVACY

The PROBE study is voluntary and anonymous and surveys are treated confidentially. In Australia, people participating must return their print surveys in reply paid envelopes to HFA to ensure they are not identifiable. They are then uploaded securely for the international PROBE team data manager to analyze. Alternatively, if they complete their survey online, their survey results will go directly into to the secure PROBE survey database, auspiced by McMaster University, Canada. Only the PROBE teams at HFA and McMaster University will see the original print surveys and all original print surveys will be kept in locked and password protected secure storage at HFA and McMaster University. All survey data will be kept confidential and no data will be reported that could identify individuals.

The PROBE study has Human Research Ethics Approval from Monash University (MUHREC Project Number: CF15/4363 – 2015001518).

If you have any questions about the ethical process of this study, please contact:

Dr Liz Bishop. Monash University – liz.bishop@monash.edu 

If you have any concerns or complaints about the conduct of the project, please contact the Executive Officer, Monash University Human Research Ethics (MUHREC): muhrec@monash.edu

MORE INFORMATION

For more information about the PROBE international study, visit the PROBE study website – www.probestudy.org.

Or contact Suzanne O'Callaghan at HFA:

​E: socallaghan@haemophilia.org.au

T: 03 9885 780