Abrahamsen Cathrine, Reme Silje Endresen, Wangen Knut Reidar, Lindbæk Morten, Werner Erik Lønnmark
Faculty of Medicine, Department of General Practice, University of Oslo, Oslo, Norway.
Faculty of Social Sciences, Department of Psychology, University of Oslo, Norway.
EClinicalMedicine. 2023 Oct 6;65:102262. doi: 10.1016/j.eclinm.2023.102262. eCollection 2023 Nov.
Medically Unexplained Physical Symptoms (MUPS) are prevalent among primary care patients and frequently lead to diminished quality of life, increased healthcare costs, and decreased work participation. We aimed to examine the effects of a work-focused structured communication tool based on cognitive-behavioral therapy in patients with MUPS.
In a Norwegian two-arm cluster randomized trial, the effectiveness of the structured communication tool Individual Challenge Inventory Tool (ICIT) was compared to usual care for patients with MUPS using a two-arm cluster randomized design. Enrollment period was between March 7 and April 1, 2022. Ten groups (clusters) of 103 General Practitioners (GPs) were randomized to provide the ICIT or usual care for 11 weeks. Patients received two or more sessions with their GP, and outcomes were assessed individually. Primary outcome was patient-reported change in function, symptoms, and quality of life measured by the Patient Global Impression of Change (PGIC). Secondary outcomes included sick leave, work-related self-efficacy (RTW-SE), health-related quality of life (RAND-36), and patient experiences with consultants (PEQ). The trial was registered on ClinicalTrials.gov (NCT05128019).
A total of 541 patients with MUPS were enrolled in the study. In the intervention group 76% (n = 223) showed a significant overall improvement in function, symptoms, and quality of life as measured by the PGIC, compared to 38% (n = 236) in the usual care group (mean difference -0.8 ([95% CI -1.0 to -0.6]; p < 0.0001). At 11 weeks, the intervention group had a 27-percentage point decrease in sick leave (from 52.0 to 25.2), compared to 4-percentage point decrease (from 49.7 to 45.7) in the usual care group. Furthermore, compared to usual care, the intervention group reported significant improvements in work-related self-efficacy, health-related quality of life, and greater satisfaction with the communication during the consultations. No adverse events were reported.
The implementation of the structured communication tool ICIT in primary care significantly improved patient outcomes and reduced sick leave among patients with MUPS.
The study was funded by The Norwegian Research Fund for General Practice.
医学上无法解释的身体症状（MUPS）在初级保健患者中很常见，经常导致生活质量下降、医疗成本增加和工作参与度降低。我们旨在研究一种基于认知行为疗法的以工作为重点的结构化沟通工具对MUPS患者的影响。
在一项挪威双臂整群随机试验中，采用双臂整群随机设计，将结构化沟通工具个人挑战清单工具（ICIT）的有效性与MUPS患者的常规护理进行比较。入组期为2022年3月7日至4月1日。将10组（群）共103名全科医生（GP）随机分为两组，分别提供11周的ICIT或常规护理。患者接受与其GP的两次或更多次诊疗，结果进行个体评估。主要结局是患者报告的功能、症状和生活质量的变化，通过患者总体变化印象（PGIC）进行测量。次要结局包括病假、工作相关自我效能感（RTW-SE）、健康相关生活质量（RAND-36）以及患者对咨询的体验（PEQ）。该试验已在ClinicalTrials.gov注册（NCT05128019）。
共有541例MUPS患者纳入研究。干预组中，76%（n = 223）的患者在功能、症状和生活质量方面经PGIC测量显示出显著的总体改善，而常规护理组为38%（n = 236）（平均差异 -0.8 [95% CI -1.0至-0.6]；p < 0.0001）。在11周时，干预组的病假减少了27个百分点（从52.0降至25.2），而常规护理组减少了4个百分点（从49.7降至45.7）。此外，与常规护理相比，干预组在工作相关自我效能感、健康相关生活质量方面报告有显著改善，并且对咨询期间的沟通更满意。未报告不良事件。
在初级保健中实施结构化沟通工具ICIT可显著改善MUPS患者的结局并减少病假。
该研究由挪威全科医学研究基金资助。
