Print This PostMy name is Victoria, and I’m an early career researcher at the Bristol Brain Centre in Southmead Hospital. You may recall from my first blog, on the 2nd October that I’m writing regular updates to document and share our work on a project that aims to influence which research outcomes clinical researchers include in their studies involving individuals with mild cognitive impairment (MCI). We’ll do that by spending the next year developing a ‘core outcome set’.
Last time I covered what a core outcome set was, and why we needed one specifically for people living with mild cognitive impairment (MCI). In today’s blog, I’ll explain how we’re going about developing the core outcome set, by involving those who understand MCI best: patients and the people who support them, both clinically and in their day-to-day lives.
We don’t want to miss any potentially important outcomes in the core outcome set. So, we’ve developed a multi-stage process so we can learn from research that has already taken place and from people with experience of MCI. The study involves:
- An umbrella review to see what outcomes have previously been used in MCI interventional research;
- Interviews with stakeholders to identify what outcomes matter most to them;
- Synthesising outcomes from the review and interviews into a long list of possible outcomes;
- Narrowing down the long list by conducting two rounds of Delphi surveys asking participants to rank the importance of outcomes;
- A consensus meeting of stakeholders to finalise the core outcome set which stakeholders agree should be the minimum dataset collected in trials for people living with MCI.
Standing on the shoulders of giants
Our first step was to look at what outcomes other researchers have reported in interventional trials for people with MCI. There are thousands of studies and hundreds of reviews which report the outcomes of interventions for people with MCI, so to make our review focused and feasible, we decided to do an umbrella review, where we reviewed studies published in systematic and scoping reviews of interventions.
For a study to be eligible to be included in the review, they needed to use standardised criteria for diagnosing MCI (such as the Petersen criteria) and report outcomes of people with MCI after completing an intervention of some kind. For each study, we go to the original paper and extract verbatim all of the outcomes they’ve used (e.g., global cognition) and how they were measured (e.g., ADAS-Cog). Through the review, we’re developing a list of “unique outcomes” – trial or study outcomes that have a distinct meaning. We’re now at the stage where we’re trying to decide on what constitutes a unique outcome, rather than multiple names for the same outcome. For example, is attention the same as concentration and focus? How about psychological wellbeing vs. satisfaction with life? Once this is done, we’ll publish our findings in a review paper, and the list of outcomes will be included for consideration in the core outcome set.
Learning from the best
A key concept in a core outcome set is that stakeholders should be involved in the decision-making process. By reviewing what’s been done before, we capture most likely what researchers, funders, and possibly peer reviewers think are the most important outcomes. But there are many other people who need to have an input here – most importantly, patients living with MCI and those who support them.
So, we’re recruiting 50 study participants to share their experiences of what matters most to people living with MCI and asking them what outcomes we should be measuring and aiming to improve in interventional trials. It’s very possible that what matters to patients, those who support them (e.g., relatives and partners), and those who provide key services (e.g., healthcare professionals) differ to what has historically been measured in research.
We’ll analyse the interviews and extract the outcomes – and add them to the list of unique outcomes that we’re developing from the review stage.
Putting it all together
Once we’ve finished with the review and the interviews, we’ll have a very long list of outcomes which could potentially be included in the COS. Many of these will be very important, but it’s unrealistic to expect researchers to collect them all, and unreasonable to ask participants to sit through incredibly long assessments during studies to measure every possible outcome that might be important. To get the core outcome set, we’ll need to narrow down the list. To do that, everyone we interviewed, plus about 75 more people with lived or professional experience of MCI, will be asked to rank the long list of outcomes in terms of how important they think each outcome is.
We’ll do this twice, with outcomes that most people want included being included, and outcomes that majority of people think are less important being dropped. By the end, we’re still anticipating that there might be too many outcomes, or some disagreement between participants – so, we’ll invite a selection of participants to share their views and reach consensus in what we’ll include in the final core outcome set.
The process is lengthy, but it will ensure that the patient and public voice, as well as the voices of researchers, clinicians, and other relevant professions who support people with MCI, are at the heart of the core outcome set.
Victoria Gabb
Author
Victoria Gabb is a Senior Research Associate in Sleep & Dementia Neuroscience at University of Bristol. Victoria is working on her PhD through publication and she is currently working on an important project to develop ‘Core Outcomes’ for Mild Cognitive Impairment. Her blogs on dementia researcher will be a way of sharing the progress of her work, to improve transparency, share the process and as a way to involve others – sharing the work, the process, and life in the pursuit of research.
