How could we reduce the attrition rate in clinical trials?

 

“We have thousands of clinical experts and they’ve been working for years on this problem.” 

 

Well perhaps this is symptomatic of the fact that we are looking in the wrong place.

 

Sometimes the answers are staring us right in the face; sometimes the solution is even too obvious to receive much attention. 

 

There are well-worn and tried and tested ways of doing things, and it’s difficult to question these or even to simply conceive of things differently.

 

The way that the patient is treated is so important for the way the patient feels, improves, and recovers.

 

But a patient who fails to fully comprehend what is written in the instruction leaflet, or loses interest, or forgets, or misunderstands is a patient who may be lost to the trial, and also be lost to good health.

 

Whilst the science of medicine works through consent and ethics, it also includs communication and empathy. In fact, for practitioners of alternative medicines this can often be their only channel, and yet it can have such a potent effect.  

Legitimate channels of communication includ the doctor – patient relationship, which can take many forms between considerate and direct, structured and animated.  Ethical channels includ press articles and frameworks for advertising and sales.

 

The leaflet and the labelling are two of the primary channels of communication.  The guidelines that exist for packaging are a good example of how to communicate information effectively.  Yet many of these guidelines are rarely applied in the spirit of good communication, even if the letter of the regulations is applied.

 

Regulations underline the importance of making information difficult to misinterpret, difficult to ignore, whilst easy to read, easy to understand, and as intuitive and natural for human comprehension as possible.  This is about design: design of the packaging, the labelling and the leaflet that serve to provide the best results.

 

Amongst the recommendations in the European Commission “Guideline on the Readability of the Labelling and Package Leaflet of Medicinal Products for Human Use” are found information on the type size and font, design and layout if the information, headings, prints colour, syntax, style, use of symbols and pictograms and special considerations for sight impairment.  Some of the highlights:

 

-          “Symbols and pictograms are useful providing the meaning is clear and the size of the graphic makes it clearly legible. They should only be used to aid navigation, clarify or highlight certain aspects of the text and should not replace the actual text.”

-          “Characters may be printed in one or several colours allowing them to be clearly distinguished from the background.  A different type size or colour is one way of making headings or other important information clearly recognizable.”

-          “The package leaflet is intended for the patient/user.  If the package leaflet is well designed and clearly worded, this maximises the number of people who can use the information, including older children and adolescents, those with poor literary skills and those with some degree of sight loss.  Companies are encouraged to seek advice from specialists in information design when devising their house style for the packaging leaflet to ensure that the design facilitates navigation and access to information.”

 

These guidelines become even more important in an era of electronic communication to a wider and larger sample of the patient population.

 

It is obvious from reading the text that it is not just a question of the letter of the guidelines, the clauses of the regulations or the chapters of the law.  It’s more about the spirit of the regulations than the letters on the page. 

 

Quite simply it is just good design practice to make text, and especially critical medical advice, easy to understand.  It is not enough for the leaflet to be understood only by medics with a PHD; it has to be understood by the patient and those who should not be patients.  

 

And this principle can be carried forward into so many other areas of the patient experience that is also governed by regulation.  A little more empathic design and a little less bureaucracy good go a long way towards better health care and better return in efforts.