Multiple Symptoms Study 3 – an extended-role general practitioner clinic for patients with persistent physical symptoms: a randomised controlled trial
Burton C, Mooney C, Sutton L, White D, Dawson J, Fryer K, Greco M, Horspool M, Neilson A, Rowlands G, Sanders T, Thomas R, Thomas S, Cooper C, Woodward J, Turton E, Waheed W, Kumar P, Ridsdale K, Mallender E, Deary V
Record ID 32018014011
English
Authors' objectives:
People with multiple and persistent physical symptoms have impaired quality of life and poor experiences of health care. We aimed to evaluate the effectiveness of a community-based Symptoms Clinic intervention in people with multiple and persistent physical symptoms.
Authors' results and conclusions:
Numbers randomised: 354 participants were randomised into the trial: 176 to the usual care group and 178 to the intervention group. Numbers analysed: 132 participants in the usual care group and 144 participants in the intervention group were included in the analysis representing 77.8% retention. Outcome: Mean (SD) PHQ-15 at baseline was 14.9 (3.0) in the control group and 15.0 (2.9) in the intervention group. At 52 weeks it was 14.1 (3.7) in the control group and 12.2 (4.5) in the intervention group. The between-group difference, adjusted for age, sex, baseline PHQ-15 and clinician effect was −1.82 (95% CI −2.67 to −0.97; p
Authors' methods:
Participants: Recruitment was between December 2018 and December 2021 in four areas of the UK. Eligibility was based on electronic health records, healthcare use and multiple physical symptoms (PHQ-15 between 10 and 20) which were not due to other medical conditions. Intervention delivery changed from face to face to online in 2020 in response to the pandemic. Interventions: Participants were randomised to receive the Symptoms Clinic plus usual care (intervention) or usual care alone (control). The Symptoms Clinic is a short-term extended medical consultation-based intervention delivered over approximately 8 weeks. Objective: To test the clinical and cost-effectiveness of an extended-role general practitioner ‘Symptoms Clinic’ for people with persistent physical symptoms. Outcome: The primary outcome measure was the PHQ-15 at 52 weeks post randomisation. Randomisation: Participants were randomised 1 : 1 using a centralised web-based system, stratified by study centre with random permuted blocks of varying sizes. Masking: It was not possible to mask participants to their allocation. Outcome assessors who handled patient-reported questionnaires were masked to allocation.
Details
Project Status:
Completed
URL for project:
https://www.journalslibrary.nihr.ac.uk/programmes/hsdr/NIHR135891
Year Published:
2025
URL for published report:
https://www.journalslibrary.nihr.ac.uk/hsdr/published-articles/KWGX2382
URL for additional information:
English
English language abstract:
An English language summary is available
Publication Type:
Full HTA
Country:
England, United Kingdom
DOI:
10.3310/KWGX2382
MeSH Terms
- Medically Unexplained Symptoms
- General Practitioners
- Physicians, Family
- Physicians, Primary Care
Contact
Organisation Name:
NIHR Health Services and Delivery Research programme
Contact Address:
NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK
Contact Name:
journals.library@nihr.ac.uk
Contact Email:
journals.library@nihr.ac.uk
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