Study protocol for the Multiple Symptoms Study 3: a pragmatic, randomised controlled trial of a clinic for patients with persistent (medically unexplained) physical symptoms

ABSTRACT
Introduction Persistent physical symptoms (which cannot
be adequately attributed to physical disease) affect around
1million people (2% of adults) in the UK. They affect
patients’ quality of life and account for at least one third
of referrals from General Practitioners (GPs) to specialists.
These referrals give patients little benefit but have a real
cost to health services time and diagnostic resources.
The symptoms clinic has been designed to help people
make sense of persistent physical symptoms (especially
if medical tests have been negative) and to reduce the
impact of symptoms on daily life.
Methods and analysis This pragmatic, multicentre,
randomised controlled trial will assess the clinical and
cost-effectiveness of the symptoms clinic intervention
plus usual care compared with usual care alone. Patients
were identified through GP searches and mail-outs and
recruited by the central research team. 354 participants
were recruited and individually randomised (1:1). The
primary outcome is the self-reported Physical Health
Questionnaire-15 at 52 weeks postrandomisation.
Secondary outcome measures include the EuroQol 5
dimension 5 level and healthcare resource use. Outcome
measures will also be collected at 13 and 26 weeks
postrandomisation. A process evaluation will be conducted
including consultation content analysis and interviews with
participants and key stakeholders.
Ethics and dissemination Ethics approval has been
obtained via Greater Manchester Central Research
Ethics Committee (Reference 18/NW/0422). The results
of the trial will be submitted for publication in peerreviewed journals, presented at relevant conferences
and disseminated to trial participants and patient interest
groups.
Trial registration number ISRCTN57050216.