Taking medications as prescribed (i.e. medication adherence) is challenging for many people living with chronic health conditions such as rheumatic conditions. Many people living with inflammatory rheumatic conditions (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, lupus, gout and osteoporosis) need to take life-long medications to relieve symptoms, prevent long term joint and organ damage and improve daily activities. Despite an increasing number of strategies (or “interventions”) that have been tested to support medication adherence for patients with rheumatic conditions, many of these have not been shown to work. It is important that these studies are designed so that they evaluate results (also known as outcomes of a study) that are meaningful to patients and health professionals, and feasible to use by researchers.
Our research group has conducted multiple studies with a goal of improving future research testing different adherence interventions, including a review of existing studies aiming to improve medication adherence in rheumatology and an Australian focus group study that asked patients and caregivers with gout, osteoporosis and rheumatoid arthritis to discuss what they felt impacted their medication adherence. Building on this previous work, we were able to do international focus groups in Australia, Netherlands and Canada to understand what results or outcomes would be important to patients, if they were to be supported with medication adherence, this helps to identify a core set of outcomes of adherence interventions from a patient’s perspective.
In addition, to capture the perspectives of stakeholders that are experts in conducting and evaluating adherence interventions, interviews were conducted with international medication adherence researchers. Information gathered in these activities will be used to develop a multi-round online Delphi survey that will be sent to patients, caregivers, health professionals, researchers and others to get agreement on a core set of outcomes to be used in adherence intervention studies. Our overall goal is to improve the design of studies testing interventions aimed to improve medication adherence in rheumatology, so that they evaluate and ultimately improve outcomes that are consistent, and important particularly to patients and the health professionals who help manage them.
The questions we set out to answer with this grant were:
- To describe international patients’ perspectives on the design and evaluation of adherence intervention studies (Study 1).
- To describe adherence researchers’ perspectives and experiences on the design and evaluation of adherence intervention studies (Study 2).
We are also using the results of these two studies to design a further study:
- To generate a consensus-based prioritised list of core outcomes for trials testing adherence strategies in rheumatology (Study 3).
We conducted Study 1 as we wanted to gain insights into what patients value as outcomes of adherence interventions. To the best of our knowledge, patients have never been systematically asked to provide input into this aspect of adherence research design in any medical field. We conducted Study 2 as medication adherence research is an emerging field in Rheumatology, and we wanted to describe the perspectives of experienced adherence researchers. We believe Study 2 is also novel, and provides key insights to advance this field of research forward in Rheumatology. Overall both studies are important in order to design studies to support patients with their medication adherence, so that it addresses the outcomes that are of importance to patients, using the advice and knowledge of experts in the field.
Study 1 – Patient perspectives on outcome domains of medication adherence trials in inflammatory arthritis: an international OMERACT focus group study
Adult patients (≥18 years) with inflammatory arthritis using disease-modifying anti-rheumatic drugs (DMARDs) from centres across Australia, Canada, and the Netherlands participated in six focus groups (38 participants) to discuss outcome domains of medication adherence trials that they consider important. Improved outcome domains that patients would want from participating in an adherence trial were categorised into five types: medication adherence, adherence-related factors (e.g. medication knowledge), pathophysiology (e.g. physical functioning), life impact (e.g. ability to work), and economic impact (e.g. productivity loss). Three overarching themes reflecting why these outcome domains mattered to patients were identified. First, how taking medications could improve patient’s emotional and physical fitness to maintain their social function. Second, how improving knowledge and confidence in self-management increase patient’s trust in and motivation to take medications as agreed with minimal risk of harms. Finally, how respect and reassurance, reflecting healthcare that values patient’s opinions and is sensitive to patient’s individual goals could improve medication taking behaviour. Patients value various outcome domains to be evaluated in future adherence trials related to their overall well-being, confidence in medication use and patient-healthcare provider relationships.
Study 2 – Researchers’ perspectives on methodological challenges and outcomes selection in interventional studies targeting medication adherence in rheumatic diseases: An OMERACT-Adherence international qualitative study
Semi-structured interviews using audio conference were conducted with 13 researchers from seven countries, who had conducted an adherence study of any design in the past 10 years. We identified three themes: 1) improving measurement of adherence (considering all phases of adherence, using appropriate and relevant measures, and establishing clinically meaningful thresholds); 2) challenges in designing and appraising adherence intervention studies (considering the confusion over a plethora of outcomes, difficulties with powering studies to demonstrate meaningful changes, and suboptimal descriptions of adherence interventions in published studies); and 3) advancing outcome assessment in adherence intervention studies (capturing rationale for developing a core domain set as well as recommendations and anticipated challenges by participants). Gathering perspectives from international adherence researchers, our findings led to researcher-informed recommendations for improving adherence research including specifying the targeted adherence phase in designing interventions and studies and providing a glossary of terms to promote consistency in reporting. We also identified recommendations for developing a core domain set for interventional studies targeting medication adherence including involvement of patients, clinicians, and other stakeholders and methodological and practical considerations to establish rigor and support uptake.
Both study 1 and 2 are complete. Study 1 has had minor revisions and a resubmission for publication in a peer-reviewed journal, study 2 has been accepted for publication by the BMC Rheumatology journal. We are hoping that with further dissemination of these results, more research will continue in Rheumatology to support patients with medication adherence, and consider the values and perspectives of patients, and advice from medication adherence research experts.
We are using the results of all our previous research to design a Delphi survey. We have created a draft video (Click here to view) to introduce the survey to patients, and other participants. We have been accepted for the 2022 OMERACT conference to move to the final steps of this research.