Division of Population Health, University of Sheffield, Sheffield, UK.
Clinical Trials Research Unit, University of Sheffield, Sheffield, UK.
Lancet. 2024 Jun 15;403(10444):2619-2629. doi: 10.1016/S0140-6736(24)00700-1.
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.
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).
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.
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.
UK National Institute for Health and Care Research.
患有多种持续性躯体症状的人群生活质量受损，对医疗保健的体验较差。我们旨在评估基于社区的症状诊所干预对患有多种持续性躯体症状的人群的有效性，假设该症状诊所加常规护理比仅常规护理更有效。
多症状研究 3 是一项实用的、多中心、平行组、个体随机对照试验，于 2018 年 12 月 6 日至 2023 年 6 月 30 日在英国国民保健制度的四个英格兰地区的 108 家普通实践中进行。参与者通过计算机生成的、基于试验中心分层的伪随机列表，以 1:1 的比例随机分配到症状诊所干预加常规护理或仅常规护理。所有分配均由试验统计学家进行，并通过中央、基于网络的随机化系统进行隐藏；由于干预的性质，对参与者进行盲法是不可能的。症状诊所干预是一系列最多四次的医疗咨询，旨在详细了解病史，充分倾听并验证参与者，为症状提供合理的解释，并帮助参与者找到管理症状的方法；由具有扩展角色的全科医生提供。主要结局指标是随机分组后 52 周的患者健康问卷-15（PHQ-15）评分，分析采用意向治疗。该试验在 ISRCTN 注册处（ISRCTN57050216）注册。
354 名参与者被随机分配；178 名（50%）被分配到接受基于社区的症状诊所加常规护理，176 名（50%）被分配到仅接受常规护理。在主要结局点 52 周时，接受常规护理的组的 PHQ-15 评分为 14.1（标准差 3.7），接受干预的组为 12.2（4.5）。干预组与对照组之间的调整后差异为-1.82（95%置信区间-2.67 至-0.97），具有统计学意义（p<0.0001）。接受常规护理的组中有 39 例不良事件，接受干预的组中有 36 例不良事件。两组间非严重不良事件（-0.03，95%置信区间-0.11 至 0.05）或严重不良事件（0.02，-0.07）的比例无统计学显著差异。没有严重不良事件被认为与试验干预有关。
我们的症状诊所干预侧重于向参与者解释持续性症状，以支持自我管理，从而持续改善多种持续性躯体症状。
英国国家卫生与保健研究所。
