In November last year, ADI held the first in a series of global webinars: Let’s Talk About Dementia Research: Demystifying Trials, Access and Understanding.
We created the series to provide a unique opportunity for the public and Alzheimer and dementia associations to engage directly with health and social care professionals, as well as companies involved in dementia research.
As far as we know, no other webinar has provided such ‘public to professional’ access before.
We heard from the pharmaceutical industry, researchers and clinicians conducting research and clinical trials, as well as primary care health professionals supporting patients and families. Most importantly, we heard stories of people living with dementia and their care partners about their lived experience.
During the webinar, we invited participants to ask our panel their most pressing questions. Whilst we were able to cover many of these topics live, in the lead up to our second webinar: Let’s Talk About Dementia Research: Global Barriers and Access to Trials, we wanted to respond to some of your unanswered questions.
Meet the panelists:
Professor Craig Ritchie, Chair, Psychiatry of Ageing, University of Edinburgh and Director of the Centre for Dementia Prevention
Piers Kotting, Programme Director, Office of the National Director for Dementia Research, National Institute for Health Research (NIHR)
Dr Gayle Madden, Professional and Practice Development Facilitator, Dementia UK
Alison Searle, Operations Program Leader, Roche
Eileen and Dubhglas Taylor, sharing their personal experience of dementia trials. They live in Australia and are retired Social Workers, who are actively involved in dementia advocacy both nationally and internationally.
Paola Barbarino, Chief Executive of Alzheimers’ Disease International (ADI
Q. The lack of psychological support at the end of a ‘failed’ trial struck me in the testimony of Eileen. There’s still an urgent need to build more bridges between the psychosocial field and the biomedical field. Wouldn’t that facilitate a more integrated approach of involvement in clinical trials?
Eileen and Dubhg:
During the trial, which lasted over five years, the support was amazing. There was a real sense of inclusion with the trial staff and the rest of the group. Along the way, we strongly identified with Tuckman’s model of group development – a universal model which includes five stages of group development: forming, storming, norming, and adjourning/ mourning. At the end of a trial – the adjourning/ mourning stage – there is often heightened emotionality. There is a real sense of loss, regret and grief, including feelings of denial, anger, sadness, bargaining and acceptance. Yet this stage often appears to be ignored by researchers. Without a debrief which acknowledges and validates the experience, the process of acceptance takes longer. We believe clinical trial researchers need to address this important issue of post-trial experiences and facilitate a smoother transition for participants back to ‘normal’ life.
In the event of negative trial, we do need to think carefully about how we communicate. Pharmaceutical companies provide information to the researchers at the hospitals, but we can’t provide information direct to patients very quickly because everything that we provide has to be reviewed by an Ethics Committee. What we could do is provide lay language information on why the trial failed and highlight what we’ve learnt from it to help future research.
Building bridges between fields is an ongoing challenge. In my experience, research nurses are the people who will support families when trials are unsuccessful or people have to withdraw, and we work closely with study doctors (who may be the ones to tell the participant the news).
I believe good communication is essential between all professionals at times like this and using person-centred, compassionate interventions is what will help families.
Q. Eileen and Dubhg talked about a language barrier between researchers and participants of research trials. In what way does this barrier contribute to the Alzheimer’s diagnosis? Has there been an evidence that a language barrier between a specialist and the patient/carer could delay a diagnosis?
Eileen and Dubhg:
Researchers need to be aware that people living with dementia can be sensitive to language. The Language Guidelines have been around for a few years now, yet we still see researchers referring to the person with dementia as the ‘patient’. The word patient should not be used outside a medical context, especially when the research is not a drug trial. Even then, the person would often prefer to be described as a ‘participant’.
Frequently, people living with dementia are described as ‘suffering’ with dementia or being a dementia ‘victim’. Although people may ‘suffer’ and at times feel like ‘victims’, the use of positive language is paramount in reducing stigma surrounding the diagnosis of dementia.
I think that the main barrier noted was between the clinicians and the researchers. Eileen and Dubhg mentioned that they were sent to Melbourne from Brisbane for a trial when the trial was open in their own city. I think that this type of communication needs to be fixed globally – i.e. bringing together clinicians and academics into the same mindset, or maybe even work space. I think the barrier they may also have noted is because research criteria and clinical criteria for Alzheimer’s disease and Alzheimer’s dementia are not 100% the same. This is a key issue we need to address and may be worth bringing up on the next webinar: Let’s Talk About Dementia Research: Global Barriers and Access to Trials.
Q. Are the drugs being trialled generally to cure or prevent?
It depends on each individual drug’s mode of action to some extent, but the field started off treating later stage disease and has been moving to earlier stages and most recently towards prevention. Prevention requires us to be able to successfully identify patients at risk of developing AD.
The drugs being trialed that attract most attention in the media are to alter the course of disease. At this stage we do not anticipate ‘cure’ i.e. the complete removal of pathology – but we do hope that we can slow the course of disease to such an extent that a dementia syndrome doesn’t occur.
When we use the term ‘prevent’ we have to be clear what it is we are trying to prevent – if it is the very earliest stages of brain disease – then that is primary prevention – the drugs we are trialling are for secondary prevention; that is you have some early brain disease but no or only mild symptoms – what we are trying to prevent in that scenario is onward decline to developing more severe symptoms.
Read more from Craig on the topic of prevention in ADI’s World Alzheimer Report 2018: The state of the art of dementia research: New frontiers
Q. What are the common assessment tools/ tests for persons with dementia?
There are many different assessment tools that can be used in studies and the type of study will influence which ones are chosen. The most common are separated into assessments for the person living with dementia and assessments for carers/family members to complete. Carers might be asked questions about how the person with dementia is managing on a day-to-day basis plus their own quality of life and that of the person with dementia. Tests for people living with dementia will involve testing cognition, memory, concentration, problem solving and asking them about their quality of life.
Q. Do you think there is a selection bias in recruitment and selection of people living with dementia into research?
There is evidence that people with dementia included in clinical research are younger than the general population, and that there is an under representation of people from certain ethnic groups. There are concerns that the way dementia is identified and categorised in clinical practice may present a section bias, particularly for treatment trials recruiting through memory clinics – often those in towns and cities linked to academic centres. Registers of people who have prospectively consented to being contacted for research are becoming increasingly popular. While they have some great benefits they also present risks of selection bias. For example people registering may be more likely to be those who are more pro-actively engaged in the management of their condition, or who have higher levels of education.
There is certainly a lack of diversity within clinical trial populations in terms of race, and socioeconomic status. There are multiple reasons including language barriers, cultural beliefs, ability to cope with the burden of trials and healthcare systems. There are a number of recent initiatives to look at this in more detail, but it’s definitely something we need to work on.
Q. It seems that the participants are requesting more of a relationship within the research process. Doesn’t that conflict with the concept of objective data collection? Treatment and research are not the same thing.
Not at all. Researchers and potential participants must work closely together to agree on the key priorities, feasibility and acceptability of the study, retention, dissemination of findings and feedback on participation. None of that will undermine data quality – there is only an upside to greater integration of researcher and participants.
While it is important to ensure that data is collected objectively and in accordance with protocols, it’s also understandable that people participating in research may want more out of the experience. On one hand it is often a benefit for people participating in research that they get more frequent contact with clinicians, or that they learn more about their disease. On the other hand, we need the involvement of research participants – and potential participants – throughout the process to support it, for example in the design of the study protocols and literature. It is completely reasonable for people to expect feedback about the research throughout their participation. We need to become more sophisticated in understanding the most appropriate level of engagement and make sure that people taking part understand what they can and can’t expect.
Q. Are there any resources you would recommend for finding out more about dementia research and clinical trials?
For dementia research, I’d recommend starting with ADI’s 2018 World Alzheimer Report: the state of dementia research: New frontiers. At the back of the report, we’ve included a full list of the interviewees, who work for a range of key institutions in dementia research. Most will have their own references, pages and social media to follow.
For clinical trials, start with our web page and related references and links, and follow the discussion in our upcoming second webinar.
Missed the live webinar? Watch for free on the ADI website.
next global webinar: Let’s Talk About Dementia Research: Global Barriers and
Access to Trials will be on 8 February 2019. Building upon themes of our first webinar, we’ll
discuss the barriers, enablers and opportunities in dementia research around
the world. Again, there will be an opportunity to ask your questions and engage
directly with health and social care professionals, as well as companies
involved in dementia research and clinical trials.
ADI would like to thank Roche for their generous contribution towards the running of our dementia research webinars, enabling us to open the debate on this important topic.