Abstract
Introduction:
Persistent physical symptoms (which cannot be adequately attributed to physical disease) affect around 1 million people (2% of adults) in the UK. They affect patients’ quality of life and account for at least one third of referrals from 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, multi-centre, 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 PHQ-15 at 52 weeks post-randomisation. Secondary outcome measures include the EQ-5D-5L and health care resource use. Outcome measures will also be collected at 13 and 26 weeks post-randomisation. 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 peer-reviewed journals, presented at relevant conferences and disseminated to trial participants and patient interest groups.
Trial Registration ISRCTN57050216
Persistent physical symptoms (which cannot be adequately attributed to physical disease) affect around 1 million people (2% of adults) in the UK. They affect patients’ quality of life and account for at least one third of referrals from 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, multi-centre, 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 PHQ-15 at 52 weeks post-randomisation. Secondary outcome measures include the EQ-5D-5L and health care resource use. Outcome measures will also be collected at 13 and 26 weeks post-randomisation. 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 peer-reviewed journals, presented at relevant conferences and disseminated to trial participants and patient interest groups.
Trial Registration ISRCTN57050216
| Original language | English |
|---|---|
| Journal | BMJ Open |
| Publication status | Submitted - 2022 |