A researcher, patient advisor and patient reviewer describe how they included patient input in a trial from the start right through to publication
Kate Jolly (research lead)
The idea for the PSM-COPD study came to the research team as a result of their work on another trial of case-finding in general practice for people with previously undiagnosed COPD. It seemed to us that we should identify effective ways of managing COPD in its early stages if we were to start identifying people earlier. There wasn’t much evidence of how best to support people with early or mild COPD as most research involves moderate or severe disease.
Rather than selecting patients for the study based on the severity of their disease, as measured by lung function tests, we selected them on their symptoms. These are what patients actually experience on a day-to-day basis and are what limit their activity and impact on their quality of life. We recruited participants based on how breathlessness affected their daily activities. Health related quality of life was the primary outcome, as this is what patients told us was important to them.
We embedded public and patient involvement in the PSM-COPD trial from the start. Our patient advisory group was already in place to support our five-year programme of research (BLISS) on COPD in primary care. All the patient advisors live with COPD. Michael Darby, a patient with COPD, chaired the patient advisory group for our five year National Institute for Health Research programme grant. The overall aim of the programme is to evaluate new ways of better identifying and managing patients with COPD in the community.
Patients contributed insights and ideas about what to measure and the development of the BLISS logo. They previewed, completed, and piloted the questionnaires, and they tried out all the planned tests. This testing informed our choice of outcome measures and helped us to plan recruitment sessions.
During the development of the research, the advisory group commented on patient intervention booklets and the daily activity diary. We shared research progress as a group. It helped to have several studies, all at different stages as there was something interesting to report at every meeting. When one study was in a data collection phase, another study required input, or there were research ideas and proposals to contribute to. Having one patient advisory group for the studies meant we could build a relationship and work together as a trained team, which also reduced costs.
Could we have done the research without patient input?—Yes, but we would have made more mistakes, the research may have been less patient-centred, and for the researchers who don’t work in clinical practice, meeting up with patients on a regular basis reminds us what it is all about. The PSM-COPD trial indicated some patients with mild disease improve their exercise levels, a crucial part of self-management behaviour, even though this did not translate into measurable quality of life benefits for all. Our next research steps are to tailor support for self-management for people with different levels of disease severity and to support primary care practitioners to manage COPD in low resource countries through our Breathe Well programme.
Michael Darby served as an excellent patient advisor for the PSM-COPD trial. With guidance from the lung clinic Michael self-manages his lung condition and he actively maintains good function and quality of life.
Michael Darby (patient advisor)
My lung condition started in early childhood with pneumonia followed by a lobectomy aged 14 to remove some diseased lung. My GP in the 1980s referred me to the bronchiectasis clinic, which was dedicated to long-term research. I received excellent care and have taken part in several research studies. I appreciate how quality of life for lung disease patients has improved over the years and know how important good care is for retaining quality of life. I keep as physically active as possible, largely because I have always enjoyed taking exercise, and also because it helps my lung condition. I also have a “rescue pack” of antibiotics to start when I get an exacerbation, although monitoring my sputum colour is a challenge as I am colour blind.
When I was invited to be a patient research advisor I agreed as I believe passionately in the importance of research. I hope that care will continue to improve in the next generation and that a cure may be found. Being part of the research team has shown me the variety of conditions covered by COPD and the severe difficulties that many patients face every day.
As a research advisor and a patient, I found it challenging to cut through the jargon and remember what the acronyms stood for. There are large numbers of researchers involved in each study. What I found helpful was to have a photo-sheet with all the meeting participants’ photos and a brief description of their role.
Amy Price (The BMJ patient reviewer)
It was exciting to serve as a BMJ patient reviewer for this trial as the emphasis was on early stage COPD where patients could use lifestyle change to improve their quality of life early on. This trial was challenging as it involves human behaviour and measuring quality of life. As a patient reviewer I was encouraged by the thoughtful way that the research team integrated patient involvement at each stage of the research. Their transparent and constructive outlook was inspiring as they outlined ways they would use the patient reviews to improve future studies.
The BMJ requires all those who submit research to include a public and patient involvement declaration. In early 2018, 86% of research papers sent out for review have included an invitation to a patient reviewer with close to 25% published with a completed patient review. Patient and peer reviews are published alongside the research to provide a full and balanced review. More about The BMJ Patient Partnership strategy is shared in the editorial Co-creating health: more than a dream. The BMJ welcomes new patient reviewers. Marilyn Mann and I shared our perspectives on being a patient reviewer in this article. Anyone who is interested can sign up here or contact Amy Price firstname.lastname@example.org
Kate Jolly is a professor of public health and primary care at the University of Birmingham, UK. She has a research interest in finding ways to support patients with a long term health condition to self-manage this to improve their quality of life.
Competing interests: KJ and AP: none declared. MD has shares in GlaxoSmithKline.