TY - JOUR
T1 - Effectiveness of a symptom-clinic intervention delivered by general practitioners with an extended role for people with multiple and persistent physical symptoms in England
T2 - the Multiple Symptoms Study 3 pragmatic, multicentre, parallel-group, individually randomised controlled trial
AU - Burton, Christopher
AU - Mooney, Cara
AU - Sutton, Laura
AU - White, David
AU - Dawson, Jeremy
AU - Neilson, Aileen R.
AU - Rowlands, Gillian
AU - Thomas, Steve
AU - Horspool, Michelle
AU - Fryer, Kate
AU - Greco, Monica
AU - Sanders, Tom
AU - Thomas, Ruth E.
AU - Cooper, Cindy
AU - Turton, Emily
AU - Waheed, Waquas
AU - Woodward, Jonathan
AU - Mallender, Ellen
AU - Deary, Vincent
PY - 2024/6/15
Y1 - 2024/6/15
N2 - Background: 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 symptom-clinic intervention in people with multiple and persistent physical symptoms, hypothesising that this symptoms clinic plus usual care would be superior to usual care only. Methods: The Multiple Symptoms Study 3 was a pragmatic, multicentre, parallel-group, individually randomised controlled trial conducted in 108 general practices in the UK National Health Service in four regions of England between Dec 6, 2018, and June 30, 2023. Participants were individually randomised (1:1) to the symptom-clinic intervention plus usual care or to usual care only via a computer-generated, pseudo-random list stratified by trial centre. Allocation was done by the trial statistician and concealed with a centralised, web-based randomisation system; masking participants was not possible due to the nature of the intervention. The symptom-clinic intervention was a sequence of up to four medical consultations that aimed to elicit a detailed clinical history, fully hear and validate the participant, offer rational explanations for symptoms, and assist the participant to develop ways of managing their symptoms; it was delivered by general practitioners with an extended role. The primary outcome was Patient Health Questionnaire-15 (PHQ-15) score 52 weeks after randomisation, analysed by intention to treat. The trial is registered on the ISRCTN registry (ISRCTN57050216). Findings: 354 participants were randomly assigned; 178 (50%) were assigned to receive the community-based symptoms clinic plus usual care and 176 (50%) were assigned to receive usual care only. At the primary-outcome point of 52 weeks, PHQ-15 scores were 14·1 (SD 3·7) in the group receiving usual care and 12·2 (4·5) in the group receiving the intervention. The adjusted between-group difference of –1·82 (95% CI –2·67 to –0·97) was statistically significantly in favour of the intervention group (p<0·0001). There were 39 adverse events in the group receiving usual care and 36 adverse events in the group receiving the intervention. There were no statistically significant between-group differences in the proportion of participants who had non-serious adverse events (–0·03, 95% CI –0·11 to 0·05) or serious adverse events (0·02, –0·02 to 0·07). No serious adverse event was deemed to be related to the trial intervention. Interpretation: Our symptom-clinic intervention, which focused on explaining persistent symptoms to participants in order to support self-management, led to sustained improvement in multiple and persistent physical symptoms. Funding: UK National Institute for Health and Care Research.
AB - Background: 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 symptom-clinic intervention in people with multiple and persistent physical symptoms, hypothesising that this symptoms clinic plus usual care would be superior to usual care only. Methods: The Multiple Symptoms Study 3 was a pragmatic, multicentre, parallel-group, individually randomised controlled trial conducted in 108 general practices in the UK National Health Service in four regions of England between Dec 6, 2018, and June 30, 2023. Participants were individually randomised (1:1) to the symptom-clinic intervention plus usual care or to usual care only via a computer-generated, pseudo-random list stratified by trial centre. Allocation was done by the trial statistician and concealed with a centralised, web-based randomisation system; masking participants was not possible due to the nature of the intervention. The symptom-clinic intervention was a sequence of up to four medical consultations that aimed to elicit a detailed clinical history, fully hear and validate the participant, offer rational explanations for symptoms, and assist the participant to develop ways of managing their symptoms; it was delivered by general practitioners with an extended role. The primary outcome was Patient Health Questionnaire-15 (PHQ-15) score 52 weeks after randomisation, analysed by intention to treat. The trial is registered on the ISRCTN registry (ISRCTN57050216). Findings: 354 participants were randomly assigned; 178 (50%) were assigned to receive the community-based symptoms clinic plus usual care and 176 (50%) were assigned to receive usual care only. At the primary-outcome point of 52 weeks, PHQ-15 scores were 14·1 (SD 3·7) in the group receiving usual care and 12·2 (4·5) in the group receiving the intervention. The adjusted between-group difference of –1·82 (95% CI –2·67 to –0·97) was statistically significantly in favour of the intervention group (p<0·0001). There were 39 adverse events in the group receiving usual care and 36 adverse events in the group receiving the intervention. There were no statistically significant between-group differences in the proportion of participants who had non-serious adverse events (–0·03, 95% CI –0·11 to 0·05) or serious adverse events (0·02, –0·02 to 0·07). No serious adverse event was deemed to be related to the trial intervention. Interpretation: Our symptom-clinic intervention, which focused on explaining persistent symptoms to participants in order to support self-management, led to sustained improvement in multiple and persistent physical symptoms. Funding: UK National Institute for Health and Care Research.
UR - http://www.scopus.com/inward/record.url?scp=85195571375&partnerID=8YFLogxK
U2 - 10.1016/S0140-6736(24)00700-1
DO - 10.1016/S0140-6736(24)00700-1
M3 - Article
AN - SCOPUS:85195571375
SN - 0140-6736
VL - 403
SP - 2619
EP - 2629
JO - The Lancet
JF - The Lancet
IS - 10444
ER -