Patel Meenal, James Kirsty, Moss-Morris Rona, Husain Mujtaba, Ashworth Mark, Frank Philipp, Ferreira Nicola, Mosweu Iris, McCrone Paul, Hotopf Matthew, David Anthony, Landau Sabine, Chalder Trudie
Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
Biostatistics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
BMJ Open. 2019 Jul 23;9(7):e025513. doi: 10.1136/bmjopen-2018-025513.
Persistent physical symptoms (PPS), also known as medically unexplained symptoms are associated with profound physical disability, psychological distress and high healthcare costs. England's annual National Health Service costs of attempting to diagnose and treat PPS amounts to approximately £3 billion. Current treatment relies on a positive diagnosis, life-style advice and drug therapy. However, many patients continue to suffer from ongoing symptoms and general practitioners (GPs) are challenged to find effective treatments. Training GPs in basic cognitive behavioural skills and providing self-help materials to patients could be useful, but availability in primary care settings is limited.
A cluster randomised waiting list, controlled trial will be conducted to assess the feasibility of an integrated approach to care in general practice. Approximately 240 patients with PPS will be recruited from 8 to 12 GP practices in London. GP practices will be randomised to 'integrated GP care plus treatment as usual' or waiting list control. Integrated GP care plus treatment as usual will include GP training in cognitive behavioural skills, GP supervision and written and audio visual materials for both GPs and participants. The primary objectives will be assessment of trial and intervention feasibility. Secondary objectives will include estimating the intracluster correlation coefficient for potential outcome measures for cluster effects in a sample size calculation. Feasibility parameters and identification of suitable primary and secondary outcomes for future trial evaluations will be assessed prerandomisation and at 12 and 24 weeks' postrandomisation, using a mixed-methods approach.
Ethical approval was granted by the Camberwell St Giles Ethics Committee. Results will be disseminated via peer-reviewed publications and conference presentations. This trial will inform researchers, clinicians, patients and healthcare providers about the feasibility and potential cost-effectiveness of an integrated approach to managing PPS in primary care.
NCT02444520; Pre-results.
持续性身体症状（PPS），也被称为医学上无法解释的症状，与严重的身体残疾、心理困扰以及高昂的医疗费用相关。英国国家医疗服务体系每年用于诊断和治疗PPS的费用约为30亿英镑。目前的治疗依赖于明确的诊断、生活方式建议和药物治疗。然而，许多患者仍持续有症状，全科医生（GP）面临着寻找有效治疗方法的挑战。对全科医生进行基本认知行为技能培训并向患者提供自助材料可能会有所帮助，但在初级医疗环境中的可获得性有限。
将进行一项整群随机等待列表对照试验，以评估全科医疗中综合护理方法的可行性。将从伦敦的8至12家全科医生诊所招募约240名患有PPS的患者。全科医生诊所将被随机分为“综合全科医疗护理加常规治疗”组或等待列表对照组。综合全科医疗护理加常规治疗将包括对全科医生进行认知行为技能培训、全科医生监督以及为全科医生和参与者提供书面和视听材料。主要目标将是评估试验和干预的可行性。次要目标将包括在样本量计算中估计潜在结果测量的组内相关系数以评估组效应。将采用混合方法在随机分组前以及随机分组后12周和24周评估可行性参数，并确定适合未来试验评估的主要和次要结果。
获得了坎伯韦尔圣贾尔斯伦理委员会的伦理批准。结果将通过同行评审出版物和会议报告进行传播。该试验将告知研究人员、临床医生、患者和医疗服务提供者在初级医疗中管理PPS的综合方法的可行性和潜在成本效益。
NCT02444520；预结果。
