A primary care Symptoms Clinic for patients with medically unexplained symptoms: pilot randomised trial.

ABSTRACT:

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.

Blinding

None. 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.

SUBMITTER: Burton C 

PROVIDER: S-EPMC3330253 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature