TY - JOUR
T1 - Study protocol for the Multiple Symptoms Study 3
T2 - a pragmatic, randomised controlled trial of a clinic for patients with persistent (medically unexplained) physical symptoms
AU - Mooney, Cara
AU - White, David Alexander
AU - Dawson, Jeremy
AU - Deary, Vincent
AU - Fryer, Kate
AU - Greco, Monica
AU - Horspool, Michelle
AU - Neilson, Aileen
AU - Rowlands, Gillian
AU - Sanders, Tom
AU - Thomas, Ruth E
AU - Thomas, Steve
AU - Waheed, Waquas
AU - Burton, Christopher D
PY - 2022/11/15
Y1 - 2022/11/15
N2 - INTRODUCTION: Persistent physical symptoms (which cannot be adequately attributed to physical disease) affect around 1 million people (2% of adults) in the UK. They affect patients' quality of life and account for at least one third of referrals from General Practitioners (GPs) to specialists. These referrals give patients little benefit but have a real cost to health services time and diagnostic resources. The symptoms clinic has been designed to help people make sense of persistent physical symptoms (especially if medical tests have been negative) and to reduce the impact of symptoms on daily life.METHODS AND ANALYSIS: This pragmatic, multicentre, randomised controlled trial will assess the clinical and cost-effectiveness of the symptoms clinic intervention plus usual care compared with usual care alone. Patients were identified through GP searches and mail-outs and recruited by the central research team. 354 participants were recruited and individually randomised (1:1). The primary outcome is the self-reported Physical Health Questionnaire-15 at 52 weeks postrandomisation. Secondary outcome measures include the EuroQol 5 dimension 5 level and healthcare resource use. Outcome measures will also be collected at 13 and 26 weeks postrandomisation. A process evaluation will be conducted including consultation content analysis and interviews with participants and key stakeholders.ETHICS AND DISSEMINATION: Ethics approval has been obtained via Greater Manchester Central Research Ethics Committee (Reference 18/NW/0422). The results of the trial will be submitted for publication in peer-reviewed journals, presented at relevant conferences and disseminated to trial participants and patient interest groups.TRIAL REGISTRATION NUMBER: ISRCTN57050216.
AB - INTRODUCTION: Persistent physical symptoms (which cannot be adequately attributed to physical disease) affect around 1 million people (2% of adults) in the UK. They affect patients' quality of life and account for at least one third of referrals from General Practitioners (GPs) to specialists. These referrals give patients little benefit but have a real cost to health services time and diagnostic resources. The symptoms clinic has been designed to help people make sense of persistent physical symptoms (especially if medical tests have been negative) and to reduce the impact of symptoms on daily life.METHODS AND ANALYSIS: This pragmatic, multicentre, randomised controlled trial will assess the clinical and cost-effectiveness of the symptoms clinic intervention plus usual care compared with usual care alone. Patients were identified through GP searches and mail-outs and recruited by the central research team. 354 participants were recruited and individually randomised (1:1). The primary outcome is the self-reported Physical Health Questionnaire-15 at 52 weeks postrandomisation. Secondary outcome measures include the EuroQol 5 dimension 5 level and healthcare resource use. Outcome measures will also be collected at 13 and 26 weeks postrandomisation. A process evaluation will be conducted including consultation content analysis and interviews with participants and key stakeholders.ETHICS AND DISSEMINATION: Ethics approval has been obtained via Greater Manchester Central Research Ethics Committee (Reference 18/NW/0422). The results of the trial will be submitted for publication in peer-reviewed journals, presented at relevant conferences and disseminated to trial participants and patient interest groups.TRIAL REGISTRATION NUMBER: ISRCTN57050216.
KW - Adult
KW - Humans
KW - Cost-Benefit Analysis
KW - Medically Unexplained Symptoms
KW - Multicenter Studies as Topic
KW - Quality of Life
KW - Randomized Controlled Trials as Topic
KW - Referral and Consultation
KW - Surveys and Questionnaires
KW - Pragmatic Clinical Trials as Topic
U2 - 10.1136/bmjopen-2022-066511
DO - 10.1136/bmjopen-2022-066511
M3 - Article
C2 - 36379663
VL - 12
SP - e066511
JO - BMJ Open
JF - BMJ Open
SN - 2044-6055
IS - 11
ER -