Patient priorities

Published on 12 April 2012
Source: Arthritis Today

Tim Fish 

Patient experiences are being used to develop new ways of assessing who gets anti-TNF and other biological therapies. Jane Tadman reports.

As a musician who depended on his ability to play the guitar to earn a living, developing rheumatoid arthritis in his hands and wrists in his early 40s was a potential disaster for Tim Fish. Tim, from Clifton in Bristol, went through a number of the standard disease-modifying drugs, including methotrexate and sulfasalazine, but none were successful in getting his disease under control.

“My wrists were getting worse and worse, and more worrying was that my hands and wrists were started to get deformed,” remembers Tim, now 58. “I was still earning a reasonable percentage of my living from playing in a couple of bands, and I was terribly worried about the implications of that. I was having to play my guitar higher and higher up my body because of the lack of wrist movement.”

Tim seemed like a perfect candidate for anti-TNF therapy except in one crucial area – his blood tests didn’t show a sufficiently high level of disease activity to meet the strict eligibility for the treatment.

The Disease Activity Score, or DAS, is a measurement tool used by rheumatologists to assess a patient’s level of disability, based on the level of inflammation in the joints, and taking into account the amount of tenderness and swelling. The tool was adopted by the British Society of Rheumatology and the National Institute for Health and Clinical Excellence (NICE) a decade ago when anti-TNF first started to be licensed, as a way of ensuring that only those patients with the most severe disease could gain access to expensive treatment.

“I qualified for anti-TNF in every other respect, and when I asked my rheumatologist, if an ideal world, he would prescribe anti-TNF for me? He said ‘yes, but I can’t’ ”, says Tim.

It was two years before blood tests showed a level of inflammation that confirmed the severity of Tim’s rheumatoid arthritis, during which time his hands grew more deformed and painful.

And once he was finally put on anti-TNF, the change in Tim’s condition was remarkable.

“A few days after my first injection of anti-TNF therapy I noticed that the swelling had gone down; I had my first gig five days after the first injection and I was aware that my hands were less puffy and I was able to play more easily and with less discomfort. My nurse said my response and reaction to the drug was untypically quick and I was flabbergasted by the change,” he says. “It was an emotional time because I was going back to doing something I thought might have gone forever.”

Tim’s rheumatoid arthritis is still effectively controlled by anti-TNF therapy to the extent that he sees his specialist nurse just once a year and hasn’t needed to see his consultant since his first treatment years ago. And he now manages to play in three local country bands: Wilderspin, The Shrinks and Sounds Country.

“Part of me thinks if only I had had anti-TNF when they wanted to give it to me I might have avoided that joint damage. I find that bloody annoying.”

“Apart from the odd hiccup it controls the disease amazingly well. Unless people know my history or look at my hands they wouldn’t have a clue that I have rheumatoid arthritis,” adds Tim. But he is frustrated by the knowledge that if he had started on anti-TNF earlier he could have had two more years of disease-free life.

“Part of me thinks if only I had had anti-TNF when they wanted to give it to me I might have avoided that joint damage. I find that bloody annoying.”

Tim’s experiences of anti-TNF and DAS scores have led to his involvement in a new Arthritis Research UK-funded pilot study being run by postdoctoral research fellow and sociologist Dr Tessa Sanderson at the University of the West of England in Bristol. Her study aims to help develop a new tool for measuring disease severity which takes into account the personal impact of the disease and factors that patients – not just medics – consider important.

The pilot tool will be used on patients starting on anti-TNF and other biologic drugs to see how it differs from the conventional DAS score, and could lead to an online patient-generated outcome score used by both clinicians and patients in future research. The hope is that it would be an additional tool used to assess people’s suitability for biologics, so giving patient impact a bigger role.

“Disease activity is measured using a standard set of outcomes that measure changes in the disease as a result of treatment,” explains Dr Sanderson. “However, these are based on factors that health professionals consider to be important. Whilst these measures have been useful for comparing trials of new drugs, outcomes that are important to patients, such as sleep or ability to cope, are not being assessed.

“What a doctor considers an improvement may not be the same for a patient,” she adds. “A drop in the DAS score may be a success for the doctor but does this match the magnitude of change in pain or the patient’s ability to carry out everyday activities?”

Earlier Bristol-based work has already established a patient-generated core set of priority treatment outcomes which focus on elements such as pain, joint damage, activities of daily living, mobility, life enjoyment, independence, fatigue and activities that patients value and make life worth living – playing the guitar, in Tim’s case.

As part of her pilot project, Dr Sanderson will now consult with patient research partners to see whether existing scales can be used, then hold focus groups with patients where new patient-centred questions are needed.

She will finally trial the tool on a small number of patients about to start anti-TNF therapy to compare it with the standard DAS scoring system.

“So far the feedback I’ve had from people has been very positive, and they’ve told me how pleased they are that I’m doing this piece of research: it really seems to have caught the imagination,” adds Dr Sanderson. “It’s a very practical piece of research and one that will make a difference to patients.”

Dr SandersonDr Sanderson’s pilot study was strongly influenced and led by patients. She is part of a team headed by Sarah Hewlett, Arthritis Research UK Professor of Nursing at UWE, who has been a strong advocate of the importance of patient-led research for a number of years and set up a patient research partner scheme with rheumatologist Professor John Kirwan at Bristol Royal Infirmary.

Professor Hewlett and the patient research partners were responsible for creating an international consensus that fatigue should be measured in all rheumatoid arthritis trials, and recently developed some new European guidelines that encourages the involvement of patient representatives in all scientific research projects.

Dr Emma Dures from the University of the West of England has an Arthritis Research UK pilot project investigating the level of support available for patients with inflammatory arthritis in terms of psychological and emotional support, the idea for which was also strongly influenced by patients. More details will follow in future editions of Arthritis Today.

“So far the feedback I’ve had from people has been very positive, and they’ve told me how pleased they are that I’m doing this piece of research: it really seems to have caught the imagination” – Dr Sanderson