The Orthostatic Hypotension Questionnaire (OHQ): validation of a novel symptom assessment scale
The Orthostatic Hypotension Questionnaire (OHQ): validation of a novel symptom assessment scale
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DOI：
10.1007/s10286-011-0146-2
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发表时间：
2012-04-01
影响因子：
5.8
通讯作者：
Freeman, Roy
中科院分区：
文献类型：
--
作者：
Kaufmann, Horacio;Malamut, Richard;Freeman, Roy
目前还没有一个被广泛接受的有效量表来评估神经源性直立性低血压(NOH)的综合症状负担和严重程度。编制了直立性低血压问卷(OHQ)，由两部分组成：六项症状评估量表和四项日常活动量表，用于评估症状负担。然后对两个量表和OHQ的综合评分进行验证分析。OHQ的验证分析是使用参加α激动剂米多君IV期双盲、随机、交叉、安慰剂对照试验的NOH患者的数据进行的。通过将OHQ评分与临床医生对严重程度的总体印象评分以及一般健康问卷评分相关联来评估收敛效度。使用基线和交叉时的组内相关系数来评估测试-重测的可靠性，这些患者的子组报告在就诊期间症状没有变化，总体印象变化分数。通过确定患者潜在疾病状况的恶化或改善是否会导致OHQ评分的适当变化来检查响应性。收集了137名登记患者的基线数据，并收集了104名随机分配到治疗组的患者的随访数据。分析使用了所有可用的数据。地板和天花板的影响微乎其微。OHQ评分与患者报告的其他结果指标高度相关，表明具有极好的收敛效度。重测信度较好。OHQ评分可以区分症状严重和症状较轻的患者，并对治疗NOH的常用升压剂米多君有适当的反应。这些发现为OHQ可以准确评估NOH的症状严重程度和功能影响以及评估治疗效果提供了经验证据。
There is no widely accepted validated scale to assess the comprehensive symptom burden and severity of neurogenic orthostatic hypotension (NOH). The Orthostatic Hypotension Questionnaire (OHQ) was developed, with two components: the six-item symptoms assessment scale and a four-item daily activity scale to assess the burden of symptoms. Validation analyses were then performed on the two scales and a composite score of the OHQ.The validation analyses of the OHQ were performed using data from patients with NOH participating in a phase IV, double blind, randomized, cross over, placebo-controlled trial of the alpha agonist midodrine. Convergent validity was assessed by correlating OHQ scores with clinician global impression scores of severity as well as with generic health questionnaire scores. Test-retest reliability was evaluated using intraclass correlation coefficients at baseline and crossover in a subgroup of patients who reported no change in symptoms across visits on a patient global impression scores of change. Responsiveness was examined by determining whether worsening or improvement in the patients' underlying disease status produced an appropriate change in OHQ scores.Baseline data were collected in 137 enrolled patients, follow-up data were collected in 104 patients randomized to treatment arm. Analyses were conducted using all available data. The floor and ceiling effects were minimal. OHQ scores were highly correlated with other patient reported outcome measures, indicating excellent convergent validity. Test-retest reliability was good. OHQ scores could distinguish between patients with severe and patients with less severe symptoms and responded appropriately to midodrine, a pressor agent commonly used to treat NOH.These findings provide empirical evidence that the OHQ can accurately evaluate the severity of symptoms and the functional impact of NOH as well as assess the efficacy of treatment.