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When every word counts

December 16, 2020

Communicating with vulnerable patients in the context of a clinical trial

The success of a clinical trial relies on the interplay between a number of complex factors.  The patient population in a trial needs to be representative of a real population and needs to be of sufficient size to demonstrate a genuine effect.  Recruiting the right patient population and keeping them engaged throughout the trial are significant challenges to success.1

How you communicate matters

According to Katz and colleagues, communication and trust are essential when it comes to recruitment and retention.2 You have to build trust with potential participants and ensure that they understand the commitment that they are making to the trial from day one. With this in mind an important question to ask is how to build trust with a patient who is made vulnerable by the very illness you are trying to treat?

Patients made vulnerable by their illness

Consider, for example, eating disorders.  According to the NHS, an eating disorder is characterised by an unhealthy relationship with food, or an obsession with body type and weight.3 Eating disorders can affect anyone at any stage of their life, though they are most commonly diagnosed in adolescent girls.4

Eating disorders pose a significant communications challenge as individuals living with an eating disorder view the world through a different lens to others.5 An innocuous comment about food or body weight to one person, could be devastating to someone suffering from an eating disorder.  Often eating disorders are accompanied by strong negative emotions, like guilt and shame that can prevent sufferers from seeking out help or failing to engage with help when it is made available.5

Communicating with vulnerable patients

With this context, it becomes easy to understand how recruiting individuals living with an eating disorder into a clinical trial may be challenging.  Factors in their environment can play a role in triggering the behaviours related to their eating disorder.

This makes it key that any public-facing clinical trial recruitment efforts, like social media adverts, are mindful of what could be considered triggering language or imagery.5 The wrong communication strategy not only risks pushing potential participants away, but it could in fact be very damaging to their mental health, exacerbating their eating disorder.

Include trusted physicians

The National Institute for Mental Health in the USA encourages people living with eating disorders to engage with research into their disorder through participation in clinical trials.4 Though it is important to note that they only encourage this after careful consultation with your trusted healthcare provider, such as a family physician or psychiatrist.

This shows how essential it can be to communicate effectively with the healthcare team of a vulnerable individual recruited into a clinical trial.  Katz and colleagues also make this point when discussing how to ensure your trial is a success – you need an individuals’ existing medical team to be on board and this can only be achieved by including them from the start.2

Get help with your clinical trial communications

At Enzyme Communications, we have experience communicating with different patient groups, including those who could be considered vulnerable, from a recruitment perspective,6 and during their time registered with clinical trials.  We also have the expertise and knowledge to communicate with the health care community.

Individuals with eating disorders are one example of vulnerable patient groups but there are many more and when you are communicating with them you need to remember that every word counts.  Contact us today to find out more about how our services can help to make your trials successful.

 

  1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7342339/
  2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3061013/
  3. https://www.nhs.uk/conditions/eating-disorders/
  4. https://www.nimh.nih.gov/health/publications/eating-disorders/index.shtml
  5. https://www.intechopen.com/books/eating-disorders-a-paradigm-of-the-biopsychosocial-model-of-illness/communication-challenges-within-eating-disorders-what-people-say-and-what-individuals-hear
  6. https://enzymecomms.com/2020/05/14/are-you-using-digital-marketing-to-locate-your-clinical-trial-participants/

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