Oxford’s Electronic Endometriosis Survey brings Women’s Health into Focus
4th April 2013
Oxford University Innovation, the University of Oxford’s technology transfer company, in partnership with ERT and PharmaQuest have developed an electronic questionnaire to better understand a condition that affects 10% of women. Endometriosis is a chronic, painful gynaecological condition that typically affects women of reproductive age and can lead to infertility. The questionnaire gauges the success of current endometriosis treatments as well as the impact on patient quality-of-life.
Isis Outcomes, the branch of Isis dealing with Patient Reported Outcomes (PROs), made available an electronic version of their Endometriosis Health Profile (EHP) instrument. EHP is a PRO questionnaire developed by researchers at the University of Oxford and the Nuffield Department of Obstetrics and Gynaecology to measure the health related quality-of-life of women with endometriosis. The questionnaire is now available in electronic form (e-EHP).
Isis has already licensed the use of the paper version of the measure (EHP) to companies including pharmaceutical leader Novartis and PregLem, a specialist biopharmaceutical company focused on drug development for women’s reproductive medicine. The e-EHP is completed by endometriosis patients via ERT’s DIARYpro® Mobile, as part of an electronic patient diary. The eDiary easily and conveniently captures responses to questions assessing quality-of-life relating to disease progression and treatment interventions.
In order to meet regulatory requirements, the e-EHP was extensively tested among endometriosis sufferers and shown to be equivalent to the validated paper version. Interviews with the target patient population ensured patients’ understanding of each question and confirmed scale validity and ease-of-use on ERT’s proven mobile platform.
It is anticipated that the e-EHP instrument will improve patient self-reporting response rates. A more frequent and reliable information stream will ultimately give a better measure of success for the various endometriosis treatments. The impact of treatments on patient quality-of-life is an important factor used by regulatory bodies in reviewing the suitability for approval of novel treatments or deciding on the adoption of one treatment over another.
The release of the e-EHP marks the first of a series of such migrations of PRO measures from paper to electronic media by Isis Outcomes and their partners. PROs are questionnaires that are fast becoming the most widely accepted way of quantifying patient benefit. Explaining the importance of PROs, Dr David Churchman, Head of Isis Outcomes said: “Accurately measuring patient related outcomes is a complex process that involves using questionnaires that have gone through a proper validation process that is recognised by the likes of the FDA. To effectively measure health outcomes requires the use of correctly validated PROs and their careful application.”
About Isis Outcomes
Isis Outcomes (IO) provides access to and supports the use of high quality condition-specific Patient Reported Outcomes (PRO) and is part of Oxford University Innovation Ltd., the Technology Transfer Company of the University of Oxford. IO provides copyright licenses and PRO support services including new instrument development and validation, translation and linguistic validation, and e-platform migration, to our customers including the pharmaceutical industry, healthcare providers, medical device companies and the academic sector. For further information, or for enquiries relating to migration of existing paper-based PRO questionnaires to electronic platforms, new e-PRO development and validation, or other PRO measures from Isis Outcomes, please contact Isis Outcomes at healthoutcomes@innovation.ox.ac.uk.
About ERT
ERT is a leading provider of high-quality patient safety and efficacy endpoint data collection solutions for use in clinical drug development. ERT delivers a combination of technology, services, and consulting that increase the accuracy and reliability of patient data and improve the efficiency of the clinical development process throughout the product lifecycle. ERT delivers the most widely deployed solutions in centralized cardiac safety, respiratory services, suicide risk monitoring, and Clinical Outcome Assessments (COA) – which includes patient, clinician, and observer reported outcomes. By efficiently integrating these solutions through a system built upon a scientific and regulatory foundation, ERT collects, analyzes, and delivers safety and efficacy data critical to the approval, labeling and reimbursement of pharmaceutical products. ERT is a global organization with headquarters in Philadelphia, PA and offices throughout the U.S., U.K., Japan, and Germany.
About PharmaQuest
PharmaQuest Ltd is a medical translation company specialising in the translation and linguistic validation of PRO measures. In addition to this core service, PharmaQuest supports the pharmaceutical and medical sector by providing translatability assessments, ePRO migration and testing, medical translations and clinician reviews.
