Objectives To conduct a pilot trial of a primary care Symptoms Clinic for patients with medically unexplained symptoms and evaluate recruitment and retention, and acceptability of the intervention and to estimate potential treatment effects for a full trial.
Trial design Randomised parallel group pilot trial.
Setting Primary care in one locality.
Participants Primary care database and postal questionnaire were used to identify patients with multiple specialist referrals and multiple physical symptoms unlikely to be explained by disease.
Interventions General practitioner (GP) with special interest ‘Symptoms Clinic’ + usual care versus usual care alone. The Symptoms Clinic comprised one long (1 h) and three short (20 min) appointments.
Outcomes Number of patients identified and recruited; acceptability of the intervention (items from Client Satisfaction Questionnaire and interview); Medical Outcomes Survey Short Form 12 (SF-12) physical component summary.
Randomisation Automated blocked randomisation accessed by telephone.
Numbers randomized 16 to intervention and 16 to usual care alone.
Recruitment 72 patients, from seven GP practices, had repeated specialist referrals and a Patient Health Questionnaire (PHQ)-15 score of ≥10 indicating a high probability of medically unexplained symptoms. 15 were ineligible and 25 declined to participate.
Numbers analysed 26 patients; two patients randomised to the intervention group were incorrectly included, three patients in the intervention group and one control did not complete outcome measures.
Outcome Most patients randomised to the Symptoms Clinic found the intervention acceptable: eight out of 11 reported the intervention helped them to deal with their problems. The mean difference between groups in SF-12 physical component summary, adjusted for baseline, was 3.8 points (SD 6).
Harms No observed harms.
Conclusions Patients with multiple medically unexplained symptoms can be systematically identified in primary care; a randomised trial comparing the Symptoms Clinic with usual care is feasible and has the potential to show clinically meaningful benefit.
Trial registration ISRCTN63083469.
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To cite: Burton C, Weller D, Marsden W, et al. A primary care Symptoms Clinic for patients with medically unexplained symptoms: pilot randomised trial. BMJ Open 2012;2:e000513. doi:10.1136/bmjopen-2011-000513
Contributors CB conceived and designed the study in collaboration with MS, DW and AW; WM collected the data. CB drafted the paper with contributions from all authors. All authors approved the version submitted for publication.
Funding The study was funded by Chief Scientist Office (reference CZG/2/412).
Competing interests None.
Ethics approval Ethics approval was provided by South East Scotland REC.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement There is no additional data available.