Title: Multiple Symptoms Study 3: pragmatic trial of a community based clinic for patients with persistent (medically unexplained) physical symptoms
Funder: Department of Health and Social Care

Abstract: BACKGROUND Persistent physical symptoms, which are disproportionate to biomedical disease affect around 1 million people (2% of adults) in the UK. These “medically unexplained” symptoms (MUS) cause distress to patients and account for over one third of referrals to specialists. Although most persistent symptoms can be explained, many patients do not receive adequate explanations for their symptoms. We have rigorously developed the Symptoms Clinic treatment model, to focus on explaining symptoms and guide self-management. In preliminary studies it was acceptable to patients and showed promising results. AIMS AND RESEARCH QUESTIONS We aim to examine the effectiveness of a Symptoms Clinic by conducting a pragmatic RCT to test the primary hypothesis that compared to usual care alone, the Symptoms Clinic plus usual care leads to a clinically meaningful improvement in patients’ symptoms. The secondary hypothesis is that healthcare use will be reduced in a cost-effective way. Within the trial we will conduct a detailed process evaluation of the Symptoms Clinic. METHODS The trial will take place in three UK centres, delivered in newly configured Symptoms Clinics by specially trained GPs. Adults aged 18 or over will be recruited from GP practice lists using a three stage procedure: clinical record search, GP record screening and postal questionnaire. Inclusion criteria will be multiple persistent physical symptoms of moderate severity (PHQ-15 between 10 and 20) and repeated referral for diagnostic tests or specialist opinion. Patients will be excluded if their symptoms are primarily attributable to biomedical illness, or if they have severe disability. Patients will be randomised to receive either the Symptoms Clinic plus usual care or usual care alone. INTERVENTION The Symptoms Clinic Intervention (SCI) comprises extended psychologically -informed medical consultations. Patients receive an initial 50 minute consultation and 2-3 follow ups of 20 minutes. Clinic doctors explain symptoms as understandable bodily processes, and aim that patients feel understood and more able to self-manage. OUTCOMES The primary outcome will be symptoms (PHQ15) at 52 weeks after randomisation. Secondary outcomes will include healthcare use over 52 weeks (GP consults, referrals & tests), symptoms at 13 weeks and quality of life (conventional and capabilities based measures) at 13 and 52 weeks. ANALYSIS Outcomes will be analysed on an intention to treat basis using a general linear model correcting for baseline values. A sample size of 188 in each arm provides 90% power to detect a meaningful 2 point difference in PHQ15 allowing for 25% loss to follow up. PROCESS EVALUATIONS Pre-specified content analysis of consultations and interviews with selected patients and stakeholders will inform detailed process evaluations. HEALTH ECONOMIC EVALUATION Within-trial cost-effectiveness analysis will estimate cost per QALY. BENEFITS AND IMPACTS FOR NHS. The intervention is designed to improve patients' symptoms and reduce their healthcare use, particularly referral for specialist opinion and tests. We have seen improvement in symptoms in both our preliminary studies. In the longer run it is plausible that Symptom Clinics will act as a focus for the development and testing of further treatments, allow for the diffusion of skills into wider practice and contribute to the wider public discourse about persistent physical symptoms

Lay abstract: OUR AIM We will test the benefit of attending a Symptoms Clinic for people with persistent physical symptoms. The Symptoms Clinic is a new service which aims to help people understand their symptoms and find ways to manage them better. The Symptoms Clinic has been rigorously developed by a team of expert clinicians and researchers. WHO IS IT FOR? Approximately 1 million adults in the UK have persistent physical symptoms which are not due to serious disease but which continue to limit activity and cause worry. Doctors are often poor at explaining how or why these symptoms happen. In the Symptoms Clinic we explain symptoms as the result of understandable body and brain processes. We call these “rational explanations”. Rational explanations are acceptable to patients and lead to action which the patient can take to manage the symptoms. WHAT DOES IT INVOLVE? The Symptoms Clinic involves one long (50 minute) appointment with the doctor and two or three shorter (20 minute) appointments. We involved patients in its design and have tested it in two earlier studies. In a pilot trial we showed it is feasible and likely to produce meaningful changes in patients’ symptoms. In a second study we showed that we can teach GPs to deliver the Symptoms Clinic effectively. In both studies patients valued the time spent discussing symptoms and their symptoms improved. We now need to know if there are long-term benefits for patients and health services which would make the Symptoms Clinic worthwhile. HOW WILL WE TEST THE SYMPTOMS CLINIC? We will conduct a randomised controlled trial, with clinics in three cities. We will train clinic doctors to deliver the Symptoms Clinic at the start and monitor and supervise them to ensure they provide suitable explanations. We will invite patients to take part in the study who have multiple persistent physical symptoms. They will be identified from GP records and sent postal information and a symptoms checklist. In our earlier studies we found this was acceptable, that we contacted around 10 people per thousand in each GP practice and 1 or 2 of each 10 took part. To ensure that any benefits we observe are due to the Symptoms Clinic, we will randomly allocate half the patients who join the study to attend the clinic while continuing with usual medical care and the other half to usual care alone. This study will need a total of 376 participants, from around 51 practices in three cities, for us to be confident in the result. We will assess the benefit of the Symptoms Clinic by asking study participants to complete surveys about symptoms and quality of life at entry into the study, then 3 months and 12 months later. We will also record their use of healthcare over the 12 months from entering the study from GP records. We expect that the number and intensity of symptoms will be reduced and that people will need fewer specialist tests and referrals because they understand their symptoms and feel able to manage them better. MAKING A DIFFERENCE We will ensure our results are reported in medical journals and at professional and public meetings. We are active in teaching professionals and students about explaining symptoms and will continue this. If Symptoms Clinics improve patient well-being and reduce the need for tests they will be popular with health services and patients. We believe it is important to test the Symptom Clinic to see whether it should be made widely available

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL;8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: GENERIC HEALTH RELEVANCE