“How patients at different stages of the steroid weaning process helped to shape and design my research”

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In conversation with: Dr Katharine Lazarus, Diabetes and Endocrine Registrar and Clinical Research Fellow, working within the Section of Endocrinology and Investigative Medicine, Department of Metabolism, Digestion and Reproduction, Imperial College London

What is your research project about and what stage are you at?

Steroid tablets, such as prednisolone are widely used to treat conditions such as asthma and arthritis. One in six people take steroids at any one time and one in 50 adults (approximately 1 million in the UK) take steroids for a prolonged period.  Taking long term steroids is associated with adverse effects such as weight gain, bone thinning, diabetes, and heart disease. The cost of treating steroid-related adverse events is £165/patient/year, and  the potential cost to the NHS is £165 million per year.  Importantly, if people are treated with steroids for a long time, their adrenal glands switch off and do not produce the vital hormone, cortisol. Therefore, it is important that when individuals complete courses of steroids, they are taken off the medication carefully. If it is stopped too quickly, they may be at risk of a life-threatening crisis. If the medication is stopped too slowly, they may develop long-term side-effects.

My research aims to assess how best to reduce and eventually stop steroids when they are no longer required for the original reason they were started and to avoid unnecessary harm when doing so.

I have just submitted an NIHR fellowship proposal to study two different steroid weaning protocols to:

  • evaluate the safest way to stop the steroid tablet, prednisolone.
  • explore whether there is a blood test we can use to predict which patients are able to stop prednisolone safely.

What did you want patients/the public to help you with? 

I initially intended to hold a focus group for patients currently taking steroids to open up discussions around patients’ experiences of being on steroids and experiences of reducing doses of steroids – particularly around the support they might require if they were to participate in a trial.  However challenges in recruitment meant this became a virtual call with a patient, who unfortunately didn’t appear on zoom on the day! Nonetheless I had contact details for several patients who were at different stages of being weaned off steroids with several different types of medical conditions who were happy to be contacted.

I therefore undertook one-to-one conversations (in person and over the telephone) with eight patients at different stages of the steroid weaning process to inform my study protocol and review my plain English summary to ensure it was clear and easy to understand. I spoke to people who were currently being weaned, those who had been successfully weaned, and one patient who had not yet started the weaning process).

The nature of one-to-one conversations allowed patients to open up and gave me an insight into their lived experiences’ of being on steroids and experiences of weaning.   It also gave me an understanding of some of the challenges, such as fatigue and managing the symptoms of their underlying conditions and what they felt might have helped to overcome these.

 

Who did you involve and how did you find them?

I involved several patients who were referred (with consent) by colleagues, or who I had seen clinically and were happy to be contacted. In addition, with the help of the NIHR Imperial Patient Experience Research Centre, I advertised through Twitter.

Aside from being at different stages of the steroid weaning process, the patients I spoke with were living with different medical conditions e.g. asthma, polymyalgia and autoimmune conditions such as Immune thrombocytopenic purpura (ITP).  They were of varying ages and ethnicities and were fairly representative of the patients we see in we in our clinics at an inner London tertiary referral centre.  Their experiences reaffirmed the need to generate a study protocol that can be adopted by doctors in different fields to safely wean patients off steroids when they are no longer required.

Was any training provided to the people you involved?

The one-on-one conversations did not require any formal training as we were gathering lived experience.  Moving forwards however, we will offer patients who are involved in public involvement activities the opportunity to undertake the free online Public Involvement in Research . I am aware that the NIHR have created guidance documents for public contributors sitting on trial steering committees which we will also utilise in future as we intend to include a patient on the trial steering committee if the proposal is successful.

How did your research change as result of the public involvement insight? 

Public involvement provided a real opportunity to gain an insight into what it means for patients on a day-to-day basis, and to incorporate their experiences into the design of the trial and a funding application, which, if successful, will impact a significant number of patients. In particular, their insights informed a number of adjustments to the study design – particularly around providing support to trial participants during the weaning regimen and how we might do so on a practical level. Some of their ideas included having a symptom diary, and additional telephone calls or texts (as patients preferred between study visits) when they felt side effects of reducing their prednisolone dose were more noticeable.  Other suggestions included how we might manage disease flares and ensure accessibility/flexibility in arranging study visits – such as parking and overnight stays where travelling to early morning visits would be challenging.

I also obtained feedback on my proposal’s plain English summary to ensure it was clear and easy to understand. I identified several patients who have successfully been weaned off steroids who are happy to be involved in my study going forwards – including reviewing the participant support materials and sitting on the trial steering committee.

All the patients I spoke with were grateful to have stopped steroids or reduced their dose (if they were in the process of weaning) and were enthusiastic about the project.  They were all keen to be involved as much as possible and felt the study would benefit others like them.

What impact did the public involvement have on the people?

My conversations with patients had a positive impact on shaping my research and reaffirmed my aims of the project.  They agreed a trial would be an important way to generate evidence that could be used widely by other healthcare teams.   Patients welcomed the opportunity to talk about their experiences and their views as to how a trial could be designed which took their experiences into account.

It also gave me a chance to explain the project to people without a medical background which helped in the writing of a plain English summary.

What was the most challenging part of doing public involvement and how did you overcome it (or not)? 

The main challenge was recruiting for the focus group, and the disappointment when I was faced with an empty Zoom screen!

This meant I needed to be adaptable and flexible in my approach.  The one-on-one interviews with patients gave more time for patients to open up about their experiences and thoughts about the proposed project.  It also allowed me to develop a greater rapport with these patients and build relationships with those that the study will impact most.

What advice would you give other researchers interested in doing something like this?

Public involvement is essential – it’s not until you talk to patients about their experiences that you really get a sense of how and what your proposed research should look like.  It allows you to form aims and objectives that align with patients’ needs and experiences.

I would advise other researchers to start your public involvement early and be flexible in your approach.  Collaborate, seek advice and always have a Plan B for when Plan A doesn’t quite happen in the way you expected!  It’s important to have patients at the forefront of your research – from the initial concept and design stages, all the way through to reviewing and disseminating results.

Public involvement is very rewarding and a great reminder of the impact your research has the potential to make!

So, what’s next? 

I am in the process applying for PhD fellowships and waiting to hear about an interview for my NIHR application and have subsequently submitted an MRC fellowship application to evaluate treatments for steroid-induced diabetes.

I am also still in touch with some of the patients I interviewed, particularly around their weaning experiences, and plan to take these connections forward in future projects so patients can continue to support and discuss ways in which we can reduce steroid-related harms.

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