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Lookup NU author(s): Professor Gill Rowlands, Vincent Deary
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
Background People with multiple persistent physical symptoms have impaired quality of life and poor experiences of healthcare. They are commonly told their symptoms cannot be explained. We tested the effectiveness of a structured consultation intervention which aimed to validate the individual, explain symptoms using current science, and promote self-management. Methods Pragmatic multicentre individually randomised parallel group clinical trial comparing a community Symptoms Clinic plus usual care against usual care alone. Participants were recruited from GP practices in four regions of England between 06/12/2018 and 21/12/2021. Eligibility comprised coded symptom syndrome(s), specialist referrals in the preceding 3 years and multiple physical symptoms (PHQ-15 between 10 and 20). Individuals with diseases likely to cause multiple symptoms were ineligible. The symptoms clinic is an extended medical consultation intervention with four key components: recognition, explanation, action and learning. It involves 4 sessions (total 2 hours) over 8 weeks and is delivered by GPs with Extended Role. The primary outcome was physical symptoms (PHQ-15) at 52 weeks, analysed by intention to treat. Trial registration: ISRCTN 57050216 Findings 354 individuals were randomised (176 control, 178 intervention). 156 participants (87.6%) in the intervention arm completed at least 2 clinic sessions. Primary outcome was completed by 276 (78.0%) participants. Mean PHQ-15 fell from 14.9 (3.0) at baseline to 14.1 (3.7) at 52 weeks in the control group and from 15.0 (2.9) to 12.2 (4.5) in the intervention group. The between group difference, adjusted for age, gender, baseline PHQ-15, and clinician effect was -1.82 (95%CI -2.67 to -0.97, p <0.0001). There were 39 adverse events in the control group and 36 in the intervention group, with no instances of delayed diagnosis of serious disease due to focusing on symptom management. Conclusion: A Symptoms Clinic focused on explaining persistent symptoms to support self-management leads to sustained improvement in physical symptoms.
Author(s): Burton C, Mooney C, Sutton L, White D, Dawson J, Neilson AR, Rowlands G, Thomas S, Horspool M, Fryer K, Greco M, Sanders T, Thomas RE, Cooper C, Turton E, Waheed W, Woodward J, Mallender E, Deary V
Publication type: Article
Publication status: Published
Journal: The Lancet
Year: 2024
Volume: 403
Issue: 10444
Pages: 2619-2629
Print publication date: 15/06/2024
Online publication date: 15/06/2024
Acceptance date: 04/04/2024
Date deposited: 22/05/2024
ISSN (print): 0140-6736
ISSN (electronic): 1474-547X
Publisher: The Lancet Publishing Group
URL: https://doi.org/10.1016/S0140-6736(24)00700-1
DOI: 10.1016/S0140-6736(24)00700-1
Data Access Statement: De-identified datasets and statistical code will be available with publication from the Clinical Trials Research Unit at the University of Sheffield upon request to ctruqa@sheffield.ac.uk. Requests should state the fields required and purpose of the request—ideally with a protocol but, at a minimum, with a research plan. The statistical analysis plan is available in the appendix (pp 24–60). The data dictionary can be made available on request. Requests will be considered on a case-by-case basis and requestors will be asked to complete a data-sharing agreement with the University of Sheffield before data transfer. Data will be retained for 6 years after June 30, 2023, before being destroyed.
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