Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK.
Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neurosciences, Psychology and Neuroscience King's College, London, UK.
BMC Fam Pract. 2020 Oct 7;21(1):207. doi: 10.1186/s12875-020-01269-9.
Patients continue to suffer from medically unexplained symptoms otherwise referred to as persistent physical symptoms (PPS). General practitioners (GPs) play a key role in the management of PPS and require further training. Patients are often frustrated with the care they receive. This study aims to assess the acceptability of an 'integrated GP care' approach which consists of offering self-help materials to patients with PPS and offering their GPs training on how to utilise cognitive behavioural skills within their consultations, as well as assessing the feasibility of conducting a future trial in primary care to evaluate its benefit.
A feasibility cluster randomised controlled trial was conducted in primary care, South London, UK. GP practices (clusters) were randomly allocated to 'integrated GP care plus treatment as usual' or 'treatment as usual'. Patients with PPS were recruited from participating GP practices before randomisation. Feasibility parameters, process variables and potential outcome measures were collected at pre-randomisation and at 12- and 24-weeks post-randomisation at cluster and individual participant level.
Two thousand nine hundred seventy-eight patients were identified from 18 GP practices. Out of the 424 patients who responded with interest in the study, 164 fully met the eligibility criteria. One hundred sixty-one patients provided baseline data before cluster randomisation and therefore were able to participate in the study. Most feasibility parameters indicated that the intervention was acceptable and a future trial feasible. 50 GPs from 8 GP practices (randomised to intervention) attended the offer of training and provided positive feedback. Scores in GP knowledge and confidence increased post-training. Follow-up rate of patients at 24 weeks was 87%. However estimated effect sizes on potential clinical outcomes were small.
It was feasible to identify and recruit patients with PPS. Retention rates of participants up to 24 weeks were high. A wide range of health services were used. The intervention was relatively low cost and low risk. This complex intervention should be further developed to improve patients'/GPs' utilisation of audio/visual and training resources before proceeding to a full trial evaluation.
NCT02444520 (ClinicalTrials.gov).
患者仍在遭受医学无法解释的症状困扰，也被称为持续性躯体症状（PPS）。全科医生（GP）在 PPS 的管理中发挥着关键作用，需要进一步培训。患者通常对他们所接受的护理感到不满。本研究旨在评估一种“综合 GP 护理”方法的可接受性，该方法包括向 PPS 患者提供自助材料，并为他们的 GP 提供如何在咨询中使用认知行为技能的培训，同时评估在初级保健中进行未来试验的可行性，以评估其益处。
在英国伦敦南部的初级保健中进行了一项可行性集群随机对照试验。GP 实践（集群）被随机分配到“综合 GP 护理加常规治疗”或“常规治疗”。在随机分组前，从参与的 GP 实践中招募 PPS 患者。在预随机分组和随机分组后 12 周和 24 周，在集群和个体参与者水平上收集可行性参数、过程变量和潜在结局测量。
从 18 个 GP 实践中确定了 2978 名患者。在对研究感兴趣并做出回应的 424 名患者中，有 164 名完全符合纳入标准。161 名患者在集群随机分组前提供了基线数据，因此能够参与研究。大多数可行性参数表明该干预措施是可接受的，并且未来的试验是可行的。8 个 GP 实践中有 50 名 GP 参加了培训的邀请，并提供了积极的反馈。培训后 GP 的知识和信心评分有所提高。24 周时患者的随访率为 87%。然而，潜在临床结局的估计效应大小较小。
本研究可以确定并招募 PPS 患者。参与者的 24 周保留率较高。广泛利用了各种卫生服务。该干预措施相对低成本和低风险。在进行全面试验评估之前，应进一步开发这种复杂的干预措施，以提高患者/ GP 对音频/视频和培训资源的利用。
NCT02444520（ClinicalTrials.gov）。
