The following blog post was submitted by Zarah Monfaredi (right), Strategy for Patient-Oriented Research (SPOR) Program Facilitator Ottawa Methods Centre, Ottawa Hospital Research Institute and Laurie Proulx (left), Board Member and 2nd Vice President, the Canadian Arthritis Patient Alliance.
Often times, a person enters into the healthcare system by surprise and is challenged with navigating this unfamiliar territory very quickly. Adding the option to participate in a clinical trial can be an added burden that many feel uncertain about. This is a highly personal decision and researchers have a responsibility to ensure information about clinical trials is communicated fairly, transparently, and at an appropriate time. Ideally, this communication would take the patient experience into consideration. So, how can we design our trials to be inherently more aligned with patient priorities?
Patient engagement in research offers a powerful solution to this problem. When patients become partners on a research team, they bring, among many things, their vast knowledge of living with an illness and experiencing the healthcare system. For trialists, this knowledge is invaluable. By listening to patient experiences, we gain a perspective that is often missed. By partnering with patients, we might just be able to successfully offer the option of participating in a clinical trial at the appropriate time and in an effective way.
From a patient perspective, research and clinical trials are often foreign ideas completed by people in universities and research institutions. The contributions of patients can bring significant improvements to clinical trials; simple things like the language used in a consent form can make the research process seem either complicated or simple for patients. Patient partners can also review or design recruitment materials to simplify messaging and increase the success of recruitment.
The implementation of the Operating Room Black Box® at The Ottawa Hospital is an excellent example of engaging patient partners in communication activities. Imagine being a patient, nervous about surgery, who hears that audiovisual data from your procedure may be captured. How do you explain this to a patient? That’s where patient partners came into the project and determined the best way to explain the new technology to surgical patients.
The outcome measures used in clinical trials can also make research more meaningful to patients. What do patients and their families care about? In rheumatology, the American College of Rheumatology (ACR) 20 was the primary outcome of nearly all clinical trials, until recently when its relevance was questioned. The ACR20 criteria is defined as an improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in disease activity and other disease symptoms like functional ability, pain, and blood markers like C-reactive protein. A study by Chiou showed that, ACR50 and ACR70 responses were more important to patients than an ACR20 response.
Patients (including the co-author of this paper) have benefited immensely from advances in medicine, and the contributions made by patients who have volunteered as research participants. Patients and their families have so many questions and many remain unanswered. Authentic patient-oriented research needs to focus on answering these questions and engaging patients in all aspects of the research process. It is the new imperative for successful research and clinical trial implementation. Through our work and engagement activities, we know of many partnership successes. We know there are more successes out there so tell us about them today using the hashtag #TalkClinicalTrials.