Max Planck Institute for Human Cognitive and Brain Sciences, Leipzig, Germany.
Health Qual Life Outcomes. 2013 Apr 23;11:68. doi: 10.1186/1477-7525-11-68.
Disease-specific patient-reported outcome measures (PROMs) have been developed as important research tools in the study of various diseases. For hypothyroidism there exist three validated disease-specific questionnaires in English: the Thyroid-Dependent Quality of Life Questionnaire (ThyDQoL), the Underactive Thyroid Symptom Rating Questionnaire (ThySRQ) and the Thyroid Treatment Satisfaction Questionnaire (ThyTSQ). We report psychometric properties of new German versions of the questionnaires including construct validity from two independent samples.
230 envelopes with ThyDQoL, ThySRQ and ThyTSQ were given out to patients receiving levothyroxine for diagnosed hypothyroidism. Reliability and factor analyses were performed, correlations and hypothesised subgroup differences calculated to assess psychometric properties. Independently, 18 patients with treated hypothyroidism for autoimmune thyroiditis (Hashimoto’s disease) and 18 healthy control subjects were enrolled in a clinical study. Participants filled in the above questionnaires alongside well-known generic PROMs, e.g. the Beck Depression Inventory, the 12-item Well-Being Questionnaire and the Short-Form-36. Two blood samples were taken. Groups were compared and correlations between disease-specific and generic instruments analysed. Relationships between PROMs and biochemically determined thyroid hormone status were investigated.
102 patients returned completed questionnaires (response rate 44%). The newly translated questionnaires had satisfactory psychometric properties. Cronbach’s alpha was 0.92 for ThyDQoL, 0.81 for ThySRQ and 0.86 for ThyTSQ. For each of the questionnaires, a single factor structure explained the data best. Adequately treated patients with thyroid stimulating hormone levels in the upper normal range reported more symptoms in the ThySRQ. Those with autoimmune hypothyroidism reported being more bothered by depressive symptoms. Within the clinical sample, correlation with well-known generic instruments revealed good construct validity. In the clinical sample patients reported more symptoms in the ThySRQ, being more bothered by tiredness, higher depression and reduced well-being despite biochemically adequate treatment. Correlations between PROMs and biochemical thyroid hormone status revealed moderate though consistent associations.
Psychometric properties including construct validity of German versions of the ThyDQoL, ThySRQ and ThyTSQ are satisfactory. Feasibility and sensitivity in a clinical sample could be shown. We encourage the use of disease-specific PROMs in future studies as important additions to generic instruments in clinical research on hypothyroidism.
特定于疾病的患者报告结局测量（PROMs）已作为研究各种疾病的重要研究工具得到发展。对于甲状腺功能减退症，有三种经过验证的特定于疾病的英语问卷：甲状腺依赖生活质量问卷（ThyDQoL）、甲状腺功能减退症状评分问卷（ThySRQ）和甲状腺治疗满意度问卷（ThyTSQ）。我们报告了新的德文版本问卷的心理测量特性，包括来自两个独立样本的构念效度。
向接受左甲状腺素治疗的诊断为甲状腺功能减退症的患者发放了 230 个包含 ThyDQoL、ThySRQ 和 ThyTSQ 的信封。进行了可靠性和因子分析，计算了相关性和假设的亚组差异，以评估心理测量特性。独立地，招募了 18 名患有自身免疫性甲状腺炎（桥本氏病）的甲状腺功能减退症患者和 18 名健康对照者参加临床研究。参与者填写了上述问卷以及众所周知的通用 PROMs，例如贝克抑郁量表、12 项幸福感问卷和简短形式 36 项。采集了两份血样。比较了组间差异，并分析了特定于疾病的问卷和通用问卷之间的相关性。研究了 PROMs 与生化确定的甲状腺激素状态之间的关系。
102 名患者返回了完整的问卷（应答率为 44%）。新翻译的问卷具有令人满意的心理测量特性。ThyDQoL 的 Cronbach's alpha 为 0.92，ThySRQ 为 0.81，ThyTSQ 为 0.86。对于每个问卷，单一的因子结构最好地解释了数据。促甲状腺激素水平在上限正常范围内的治疗充分的患者在 ThySRQ 中报告了更多的症状。自身免疫性甲状腺功能减退症患者报告说，抑郁症状更困扰他们。在临床样本中，与众所周知的通用工具的相关性显示出良好的构念效度。在临床样本中，患者在 ThySRQ 中报告了更多的症状，疲劳感更强，抑郁程度更高，幸福感降低，尽管生化治疗充分。PROMs 与生化甲状腺激素状态之间的相关性显示出中等但一致的关联。
德文版本的 ThyDQoL、ThySRQ 和 ThyTSQ 的心理测量特性，包括构念效度，均令人满意。在临床样本中证明了可行性和敏感性。我们鼓励在未来的研究中使用特定于疾病的 PROMs，作为临床研究甲状腺功能减退症中通用工具的重要补充。
