Embedding Patient Values in Randomized Control Trials: A Case Study

Project Summary

Clinical trials compare treatments or interventions to determine which treatment or intervention is best. However, the importance of various health outcomes and treatment requirements (for example, how a treatment is taken) varies between people, and this varying importance can influence ether or not a person chooses to take a given treatment. Traditional trial methods do not consider these variations, and often study outcomes that are important to researchers and clinicians, rather than patients.

Our project aimed to develop and test new methods to determine patient-oriented composite outcomes.

Project Findings

Our team identified which health outcomes and treatment requirements were most important for pregnant people choosing a treatment approach high blood pressure in pregnancy. We then developed new methods to allow clinical trials to reflect the varying importance different patients may assign to these outcomes and treatment requirements.

Using these new methods, we found that no single treatment approach was best for all individuals. Instead, which management approach was best depended on which health interventions and health outcomes were most important to the individual.

Publications

Metcalfe, Rebecca K. et al. Patient Preferences and Decisional Needs When Choosing a Treatment Approach for Pregnancy Hypertension: A Stated Preference Study. Canadian Journal of Cardiology, Volume 36, Issue 5, 775 – 779 2020. https://doi.org/10.1016/j.cjca.2020.02.090

Presentations

  • Metcalfe, R. K., Harrison, M., Singer, J., Lewisch, M., Magee, L. & Bansback, N. (Accepted). Integrating Patient Values into Clinical Trials Using Composite Endpoints: A Case Study Using the Control of Hypertension in Pregnancy Study. Oral Presentation at the Annual Meeting of the Society for Clinical Trialists, San Diego, USA.
  • Metcalfe, R. K., Harrison, M., Singer, J., Lewisch, M., Magee, L. & Bansback, N. (Accepted). What does this trial mean for me? Integrating patient values into clinical trials. Oral Presentation the 4th Annual Meeting of the B.C. SUPPORT Unit, Online.
  • Metcalfe, R. K., Harrison, M., Singer, J., Lewisch, M., Magee, L. & Bansback, N. (2022). From Trials to Treatment: New Methods to Integrate Patient Values and Clinical Evidence. Oral Presentation to Meeting of Clinical Trials BC, Canada.
  • Metcalfe, R. K., Harrison, M., Singer, J., Hutfield, A., Lewish, M., Muramatsu, M., Magee, L. & Bansback, N. (2019). The Importance of Emotion in Healthcare Decision-making in Pregnancy: Insights from a Qualitative Study. Poster presented at the 4th Annual Meeting of the B.C. SUPPORT Unit, Vancouver, Canada.

This project is part of the Real-World Clinical Trials Cluster.

Team

Joel Singer, PI
Nick Bansback, Co-I
Mark Harrison, Co-I
Mary Lewisch
Laura Magee
Peter von Dadelszen
Rebecca Metcalfe
Terry Lee – Statistician