The Clinical Outcomes (CO) team at Oxford University Innovation manages the licensing and support of high-quality clinical outcome assessments (COAs) developed at Oxford University and elsewhere, used to assess and support the treatment and recovery of patients suffering from a wide range of conditions.

The team manages a growing portfolio of health outcome measures and supports a broad customer base, such as the pharmaceutical industry, healthcare providers, academia and medical device manufacturers.

“This past year has been another very strong year of growth for the business,” explained David Churchman, Head of Clinical Outcomes. “From a financial point of view, we have recorded a growth of over 40% in income for the second year running. In particular, the new translation and linguistic validation activity has grown by over 75% from last year.”

With over 700 licences being granted, several high-impact events have also occurred this year for the CO team, including: –

-Nationwide licence for NHS Digital to deploy CO’s Musculoskeletal Health Questionnaire (MSK-HQ) and the widely used Recovering Quality of Life Questionnaire for Mental Health (ReQoL) via the National Clinical Content Repository – with both measures being used throughout the NHS in frontline care and data collected into datasets that inform national policies on the treatment of common conditions and mental health issues.

-Adoption by the International Consortium for Health Outcome Measures (ICHOM) of the ReQoL as part of their standard sets of measures for both psychotic and personality disorders. This is following rigorous evaluation by an international team of experts.

Growing Portfolio

Clinical Outcomes’ actively managed portfolio has grown this year by five newly launched measures (a health economics tool for use in assessing self-management of diabetes, Mathematics Attitudes and Anxiety Questionnaire, Oxford Arthroplasty Recovery Score and twin Oxford Arthroplasty Change Score, and Bluebelle Wound Healing Questionnaire). The team has also received ten new disclosures of new outcome measures or related projects from Oxford.

An extremely important and core part of the Clinical Outcomes business is the provision of translations (or cultural adaptions) of their managed Clinical Outcome Assessments for use in various countries.

“In the last couple of years, CO has seen a rapid growth in the translation business, and 2019/2020 was no different,” said Martina Zagaria, Project Manager. “With a current total of 482 translations of the 32 COAs we manage, we have added 28 new translations to the library this year and continue to strive to deliver the best possible quality of our translations for users in support of their clinical research – work which ultimately improves the quality of life of patients with different conditions around the world.”

To encourage the continued adoption of its managed COAs across the globe, a new member, Beatrice Tedeschi, joined the team in March 2020 as Translation Projects Coordinator (TPC). The aim of the TPC is to maintain CO’s growing library, improving processes and boosting the translation business by increasing the overall translation activity and further enhancing the reputation of the COA translation library at Oxford. Beatrice has already managed to bring the full weight of her existing translation expertise to the role by contributing to our very solid year end results.

Through the licensing of their managed Clinical Outcome Assessments, the CO team has this year seen a continued decision made by licensees to administer COA’s in an electronic format or mixed paper and electronic format, over conventional paper and pen completion. During 2019/2020, eCOA has represented the mode of administration for 12% of all licences granted.

Shift to Digital

With COVID-19 altering the way in which clinical trials, research and healthcare assessments are conducted, we saw an increased shift toward the remote delivery of COA’s in an electronic format over conventional modes. Understanding the challenges and setbacks faced by their userbase, the CO team have been instrumental in supporting licensees in migrating from paper-based completion of COA’s to electronic delivery formats. The CO team have been available to advise on best practices in faithfully migrating the COA instruments to ensure their measurement properties are retained and  they continue to deliver equivalent results to the pen and paper completion format – essential for the reliability of study results.

“To further support our userbase when they are developing eCOA versions of our COA instruments, the team has, over the past year, implemented a robust review and approval process,” said Justin Raymer, Marketing and eCOA Specialist.

Due to the rapid increase in demand from study managers adapting to COVID restrictions, Justin has trained colleagues to act as additional reviewers to satisfy the demand and need for a reliable migration testing and review service. A new reporting process has also been devised that presents findings in a clear and concise manner, making it easy for third party developers to accommodate suggested changes to content and features, all in a logical and timely manner. 2019/2020 saw 86 independent eCOA reviews being conducted by the CO team, a 59% increase on last year. This is not only a valued service to our Licensees but also a growing and healthy source of income to the business. So much so that Justin is already developing a new service offering for next year that will further contribute to the overall performance of the business.