Thursday 29 August 2019

Taking Part in Research - a relationship?

pint? Have you gone raving mad? [...] I mean, I came here in all good faith, to help my country. I don't mind giving a reasonable amount, but a pint? Why, that's very nearly an armful!  (Extract from The Blood Donor - Hancock's Half Hour)

In good faith?

Tony Hancock’s portrayal of a blood donor still resonates today. Donation, that selfless act of volunteering to help others. After almost 60 years, since the broadcast, is it time to redefine the relationship, particularly as it applies to health and care research? 

The concept of giving in itself implies receiving yet at times it may still feel, as Hancock observes, more like taking. This seems especially true in health and care research despite many robust efforts to make it more of a partnership. Too often, people take part in a study and never hear another word about it. Should this transaction become more of an on-going and transparent relationship?

Being clearer and more concise?

Over the past few months, I have been involved with the Health Research Authority helping to develop their Transparency Agenda. I am a member of the Strategy Group and have attended various meetings and a number of the #MakeItPublic workshops. The consultation is now finished.

In this context, Research Transparency has four key elements:

  1. Registering research
  2. Making the results of research public
  3. Letting research participants know about the results of the research
  4. Making data from studies available for further research.

I want to concentrate on the third element - letting research participants know about the results of the research. One of the commonest complaints from research participants is that they took part in a clinical trial and never heard anything further. In today’s world that looks like poor manners and may even seem unfair.

More than just the results

As the weeks have passed, my thinking has developed. I have begun to question whether it needs to be more than just informing those people who took part in a research study. 

There are a number of factors influencing my thoughts. Medical advances in recent years have meant that many people are now living longer as against a time when research was often seen as something that took place at end of life. Smartphones and other digital technologies gave us instant access to information and enable communications which were unimaginable a few years ago. Thirdly, the public frame of mind has become more exacting in our expectations and rights.

In the past few years patients have changed from being seen as the subjects to being partners, actively involved with researchers. We have moved from just raising funds to being active supporters engaged in many different aspects of medical research. Trust has become a major factor with those who give to medical research charities. We have also raised our expectations of how we wish to be dealt with in many other aspects of life.

Interestingly, one of the most pleasing comments from research participants is just how many are touched when a researcher does actually keep in contact with them and how that made them feel informed and included. It was seen as a lovely thing to do - of  good practice. These are matters of common courtesy, decency and in some respects as good ‘customer’ relations.

A Mutual Relationship

For health we are dependent on each other. Without our illnesses, conditions, diseases and ailments there would be little to actually research. Perhaps the whole consent process should be redefined as a two way procedure where, as participants we sign to join the study and the researchers sign as to the ways we can be kept informed? 

This, for me, comes down to mutual respect and a better understanding the research practice and experience. It may be worthwhile reflecting on Mahatma Gandhi’s saying - customer is the most important visitor on our premises. They are not dependent on us. We are dependent on them.

It is about knowing what we can expect, whether we will have the opportunity to receive updates on the progress of the study. This will be, I believe, be of importance with the development of Studies Within a Trial (SWAT) as people might be keen to hear about other research.

I am not suggesting that all the information about a study is revealed for all. 
It does not mean the actual evidence, the latest findings or any internal interim results. Transparency is about being distinct and clear. It is not being see-through.

Keeping in Touch

The first time I came across the good practice of keeping in touch with people who took part (healthy volunteers and patients) was the study on the Long term impact of screening on ovarian cancer mortality - the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS)

They produced a Thank You card which simply acknowledged their gratitude and set out the key facts from the study. It was informative, thoughtful and touching.

Some researchers are using digital technology like Cloudy with a Chance of Pain whilst others have set up either closed or public Facebook Groups.  For example the ALPHA Eczema Trial posts regular information about trial registration, public workshops and where the trial leads are speaking through their Twitter account @LICTR_Alpha and website

This is about being more open and keeping in touch. It is not about the trial results. I am talking here about information as to whether the trial has recruited the numbers of people it needs, how fast or slow this is taking, whether the team is looking into other similar areas of research and if they want/need patient insights.  

What might the relationship look like?

High quality peer reviewed research is necessary to improving wellbeing and healthcare. It requires rigour, time and to able to be reproduced. It does need to follow not however need to be entirely done in secret.

It seems to me that in a time of misinformation and distrust we need to focus more on being more open and transparent. We need to develop greater understanding of each other’s perspectives and come to some form of clarity as how we communicate with each other.

  1. TRUST is a key factor. The importance of doing research with people not to them. It is why the whole movement to actively involve patients and the public is so vital - it provides opportunities to ensure that research is relevant, appropriate and suitable.

Trust is gained by explaining why the research is important and acknowledging the contribution made by the participant - that recognition and thanks. It is also about a cultural attitude that conveys the value of learning. You can read more in this BMJ article about being Research Active.

  1. UNDERSTANDING is at the heart of the words informed consent. 
 is at the heart of the words informed consent. 

This is the importance of a good Lay Summary and Patient Information Leaflet - especially when these have been written by people affected by the condition and checked by members of the general public. It is the mutual gain from the exchange of knowledge and experience on both sides that helps us all understand.

  1. CLARITY around what, when, how and where information about the study will be made available. This should be the expectation of every study participant along with choices about how they wish to be kept in touch. 

I now believe that we have to consider that trial participation is as much about an agreement, a more equal relationship between research and the public - a commitment to each other.

Finally, a request

I also know that there are many researchers who keep in touch with those who have participated in their studies. There are many trial participants who have welcomed this contact and others who have helped prepare the lay summaries.  

Do you have any good examples to share? Please post examples using #MakeItPublic

Thank you Malcom Babb for drawing my attention to the lay summary of the results of thDe-ESCALaTE HPV Study which clearly states - Written by Patients for Patients. Thank you Dr Marianne Piano, who informs all her study participants at their final visit they'll hear from me again in the new year with a dementia-friendly postcard laying out the study results and what's happening next.

(which is now closed)

Please Note: Derek Stewart is an advocate for patient voice in health and care research. He is a member of the HRA Strategy Group and a Member of Cancer Research UK

No comments:

Post a Comment