24 Jun 2020
ASCOT blog: A Consumer Representative’s experience working on a COVID-19 clinical trial
Sue Anderson is the Consumer Representative on the AustralaSian COVID-19 Clinical Trial (ASCOT) Steering Committee. She writes here of her experience. This article was first published by ASCOT.
What is a ‘consumer’?
The consumer in health sector terms is a person who has personal, ‘lived experience’ of a type relevant to an area of ongoing study or care provision. For example, a survivor of cancer would have lived experience of cancer treatments.
Involvement of consumers in all aspects of research from design to implementation and translation by health care professionals is a relatively new phenomenon. For centuries past, clinicians believed they alone ‘knew what was best’ for their patients.
In response, forerunners of the consumer movement have fought for ‘a place at the table,’ arguing, fundamentally, there can be ‘Nothing about us without us’. They advocated and agitated for the right of consumers to engage with, and provide input into, the health care they receive, on their own behalf and on the behalf of others. They fought to be rightfully acknowledged for the wealth of experience, that having lived the experience, imparts.
To these consumers past and present, I owe thanks. For it is through their work, their voice, their engagement and unyielding belief in their value, belief in the value of their experiences, their undeniable right for such to be heard, to have their experiences acknowledged and experiences incorporated into improving the standard of care for others, that created the circumstances whereby consumer experience is increasingly sought.
COVID-19 was declared a pandemic and the world around me immediately changed, altering in form and shape to a place without personal precedent.
Like many thousands of others, my employment suddenly ceased. I applied for JobSeeker support.
I watched news channels, read voraciously from reputable media, touched base with the fears and thoughts of others on the realm of social media, and learnt my brother had disembarked from the Ruby Princess.
Into this tumult came an email from the Health Issues Centre containing a call for a Consumer Representative to the Steering Committee of the AustralaSian COVID-19 Clinical Trial (ASCOT). I don’t normally respond to these. I can’t afford to.
In a capitalist world where work is ascribed financial value, much consumer input is still deemed a volunteer event without dollar worth.
Should a consultant provide findings on patient care that streamlines and improves clinical procedures, they would be very handsomely compensated.
I know of a hospital that provides tea and biscuits and reimburses public transport fares for the same work by consumers. They argue that ‘volunteers feeling good’ about such work is all that such work is worth. I argued that warm fuzzy feelings don’t help pay for groceries.
Here though, I felt that things were different. I had the choice, not of my making, to do nothing, or something, at a point where paralysis was an option, but action was essential.
A covering letter and CV were sent. In the briefest of time, I was accepted onto the Steering Committee.
I didn’t really understand what would be required of me, for I hadn’t sat on such a Steering Committee before. Although expectations of the consumer representative role had been outlined in the application document, it is only ever the reality of experience, rather than the theory of words, that imparts such knowledge.
I vowed to sit, listen, and learn.
A Clinical Trial Steering Committee
The ASCOT Steering Committee is comprised of clinicians, physicians, researchers, support staff and statisticians. All are highly intelligent and at the top of their game. I was surprised to discover this forum lacked ego.
Also unusual are well chaired meetings, meetings that run to schedule, at which people listen more often than speak and defer to others.
The agenda items were numerous and covered in depth, with a dizzying array of clinical trial and health sector acronyms pinging around the airspace, and often unpronounceable drug names flying by like projectiles.
But I have always been confident that that which needs to be known becomes clear with immersion, and indeed, this has been the case. I initially sank, but I knew that I knew how to swim.
At the outset of COVID-19 reaching Australia, death, disease, hospitals overflowing with people suffering from COVID-19 was a clear, constant, and present danger. As such, this clinical trial situation was far from normal. Timeframes for trial creation, action and implementation were vastly condensed from the norm. It resulted in a remarkable speed with which all trial stakeholders mobilised to combat the virus and surf the situation.
A muted, underlying urgency and tension in the Steering Committee members was apparent. They had huge and competing demands on their time.
They spoke of walkthroughs of hospital wards, engaging with other clinicians and patients, fulfilling the daily ‘what would be their normal’ as the extra-ordinary piled in on top.
Maintaining contact through phone calls and remote meetings with international colleagues to stay abreast of developments in a global pandemic. Reading reams of scientific and pharmaceutical literature, comprehending and condensing such data to inform the trial. Creating statistically rigorous databases. Raising funds. Compiling documents, policies and procedures to satisfy ethics committees…and so much more behind the scenes essential work to build a clinical trial from the beginning. I didn’t fully understand what needed to occur, and still don’t really know what took place.
I watched weekly as committee members dialled in exhausted, body and mental fatigue palpable across remote miles and through computer cams. The amount of work they were doing, the amount of work to be done – while not fully grasped – I nonetheless recognised to be immense.
I wondered when they slept.
Yet the critically important anchor and counterbalance of humour in times of dire situation was evident. Zoom backgrounds included a jungle-fringed white sandy beach, a broodingly atmospheric library groaning under the weight of floor-to-ceiling books, a scene from the movie Up.
A Consumer Representative role
Consideration of the health and safety of patients by the ASCOT Steering Committee is always apparent and paramount. The way this trial was established and sought to be run spoke volumes for what might be the experience of an inpatient. And I was afforded respect.
Yet, as a consumer representative on the Steering Committee, the position is ‘not about me.’ I am but one person and my personal view reflects that of one person only. I do not lay claim to be an ‘omnipotent voice’ or attempt to speak on behalf of all consumers.
As a health industry auditor, I interview many consumers and act as the conduit of their voice, their experiences, insights, positions, and beliefs. I take verbatim written record of consumer’s words from which commonalities are identified and report back on these themes.
Such commonalities are supported by supplying quotes from interviewees, employing their words exactly, to underpin and illuminate how the themes have been determined.
Consumer feedback becomes the foundation upon which quality health care providers adapt and deliver their service. To ensure ASCOT consulted widely, feedback on the wording of consent documents, trial design and process was sought from a COVID-19 consumer group.
Conversely, the failure to seek, heed and respond to care recipient feedback can have catastrophic results for all.
It’s not always an easy course to navigate.
Trial issues to consider
The delivery of quality health care requires clear and easily understood, accessible communication by all, to all, involved.
The information conveyed must necessarily be thorough. It incorporates and encompasses an intersection of legal considerations, ethics committee requirements and insurance entities.
The patient must know exactly what they are agreeing to if they are to provide informed consent to participate on any clinical trial.
They must know the likelihood of benefit to counterbalance risk or side-effects.
Dense pages of relevant information must be made comprehensible to the ill.
Not at all a simple task.
In all societies too, there are those who assume care for others. They are the parents, carers and guardians of those with disability – termed ‘surrogates’ in this forum. I learnt of differing state legislation in effect across Australia that afforded varying degrees of medical trial access to these people. In some states, tribunals determine the merit of trial participation. In one state, trial participation is just outright disallowed.
Still, today, systems exist to discriminate.
At this point, the imminent threat of COVID-19 in Australia has diminished. Initially it was not known how severely our society would be impacted by the virus, how many would become ill or die. Thankfully, measures to address the spread of infection have, so far, limited the spread of the disease.
As this outcome became apparent, and as it currently applies, I noticed the ASCOT Steering Committee members became less harried and exhausted. Unfortunately, this also meant fewer Zoom backgrounds employed at meetings.
ASCOT emphasis has shifted to an ongoing preparedness in Australia and New Zealand for any change of circumstance, and to helping others internationally.
And so ahead, for me, lay more to learn and experience for the first time.