Lohmann Anne Møller, Poder Petersen Anne, Schmid Johannes Martin, Hoffmann Hans Jürgen, Finderup Jeanette
Department of Public Health, Aarhus University, Aarhus, Denmark.
Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
PLoS One. 2025 Jun 16;20(6):e0326143. doi: 10.1371/journal.pone.0326143. eCollection 2025.
In a clinical trial of allergen-specific immunotherapy for allergic rhinoconjunctivitis, the Combined Symptom Medication Score (CSMS) was utilized as the primary endpoint. This was aligned with the European Academy of Allergy and Clinical Immunology recommendation. However, participants wanted to elaborate on how their behaviour affected their score, so voluntary free text boxes were added to the CSMS questionnaire. This study aimed to evaluate the patient-reported outcomes registered in the free text boxes to identify and understand contexts and mechanisms that may affect the CSMS.
The realist evaluation methodology was followed in four iterative steps: 1) development of the initial programme theory and context-mechanism-outcome (CMO) configurations, 2) collection of evidence, 3) data analysis, and 4) interpretation and assessment of results.
Seven CMO configurations were identified, highlighting contexts and mechanisms that may affect the CSMS. These included CMO1 - decision on preventive relief medication dosage, CMO2 - exhibiting symptom-relieving behaviour, CMO3 - being exposed to different levels of grass pollen, CMO4 - mistaking other symptoms for grass pollen-induced symptoms, CMO5 - different exposure to grass pollen when travelling abroad, CMO6 - reporting of relief medication for other allergies in CSMS, and CMO7 - failure to report symptoms not included in CSMS.
This realist evaluation contributes verified CMO configurations based on patient perspectives to understand how context and mechanisms may affect the CSMS. We recommend further investigation in quantitative studies, as awareness of these CMOs may increase the internal validity of future allergy trials using CSMS as an endpoint.
ILIT.NU: EudraCT 2020-001060-28.
在一项针对变应性鼻结膜炎的变应原特异性免疫治疗临床试验中，联合症状药物评分（CSMS）被用作主要终点。这与欧洲变态反应和临床免疫学会的建议一致。然而，参与者希望详细说明他们的行为如何影响其评分，因此在CSMS问卷中添加了自愿填写的自由文本框。本研究旨在评估自由文本框中记录的患者报告结局，以识别和理解可能影响CSMS的背景和机制。
遵循现实主义评价方法的四个迭代步骤：1）制定初始项目理论和背景-机制-结局（CMO）配置，2）收集证据，3）数据分析，4）结果解释和评估。
确定了七种CMO配置，突出了可能影响CSMS的背景和机制。这些包括CMO1 - 预防性缓解药物剂量的决定，CMO2 - 表现出症状缓解行为，CMO3 - 暴露于不同水平的草花粉，CMO4 - 将其他症状误认为草花粉引起的症状，CMO5 - 出国旅行时接触不同的草花粉，CMO6 - 在CSMS中报告其他过敏的缓解药物，以及CMO7 - 未报告CSMS中未包括的症状。
这项现实主义评价基于患者视角提供了经过验证的CMO配置，以了解背景和机制如何可能影响CSMS。我们建议在定量研究中进一步调查，因为了解这些CMO可能会提高未来以CSMS为终点的过敏试验的内部效度。
ILIT.NU：EudraCT 2020-001060-28。
