Foster Juliet M, van Sonderen Eric, Lee Amanda J, Sanderman Robbert, Dijkstra Antoon, Postma Dirkje S, van der Molen Thys
Department of General Practice and Primary Care, University of Aberdeen, UK.
Respir Res. 2006 Oct 24;7(1):131. doi: 10.1186/1465-9921-7-131.
Patient-reported side effect questionnaires offer a simple method for the systematic measurement of drug-related side effects. In order to measure patients' inhaled corticosteroids (ICS) related side effect perceptions the 14-day retrospective Inhaled Corticosteroid Questionnaire (ICQ) was developed. In this research we aim to assess the construct validity and reliability of the ICQ and test its responsiveness to dose changes in adult asthma patients.
In a cross-sectional study, current inhaler users with asthma completed the ICQ (27 with non ICS inhaler; 61 BDP equivalent daily ICS low dose < or =400 microg; 62 mid dose 401-800 microg; and 105 with high dose >800 microg). We generated 3 construct validity hypotheses: 1) a hierarchical dose-response pattern for scoring of the individual items on the ICQ, and statistically significant differences in the scores of each of the 15 ICQ domains by ICS dose group 2) an association between ICS dose and ICQ scoring after adjusting for appropriate confounders in multiple regression; 3) greater convergence between local side effect domains than between systemic and local domains of the scale. Test-retest reliability was assessed on a randomly selected subgroup of patients (n = 73) who also completed the ICQ a second time after 7 days. In a separate longitudinal study, 61 patients with asthma completed the ICQ at baseline and after changing their daily ICS dose, at 2- and 6- months, in order to test the ICQ's responsiveness.
All three construct validity hypotheses were well supported: 1) a statistically significant difference existed in scores for 14 domains, the high ICS dose group scoring highest; 2) ICS dose independently predicted ICQ scoring after adjusting for confounders; 3) greater convergence existed between local ICQ domains than between local and systemic domains. The ICQ had good reproducibility: test-retest intraclass correlation coefficients were > or =0.69 for all but the 'Facial Oedema' domain. In the longitudinal study, ICQ scores for 'Voice Problems' changed significantly at 2- and 6-months from baseline and other ICQ domains displayed trends in scoring change accordant with dose modulation at 6-months.
The ICQ has good dose-related discriminative properties, is valid, reliable, and shows potential responsiveness to ICS dose change.
患者报告的副作用问卷为系统测量药物相关副作用提供了一种简单方法。为了测量患者对吸入性糖皮质激素（ICS）相关副作用的认知，开发了14天回顾性吸入性糖皮质激素问卷（ICQ）。在本研究中，我们旨在评估ICQ的结构效度和信度，并测试其对成年哮喘患者剂量变化的反应性。
在一项横断面研究中，当前使用吸入器的哮喘患者完成了ICQ（27例使用非ICS吸入器；61例每日ICS低剂量<或=400微克布地奈德等效剂量；62例中剂量401 - 800微克；105例高剂量>800微克）。我们提出了3个结构效度假设：1）ICQ各单项评分呈分层剂量反应模式，且ICS剂量组间15个ICQ领域的得分存在统计学显著差异；2）在多元回归中调整适当混杂因素后，ICS剂量与ICQ评分之间存在关联；3）量表的局部副作用领域之间的收敛性大于全身和局部领域之间的收敛性。在随机选择的患者亚组（n = 73）中评估重测信度，这些患者在7天后再次完成ICQ。在另一项纵向研究中，61例哮喘患者在基线时以及在2个月和6个月改变每日ICS剂量后完成ICQ，以测试ICQ的反应性。
所有三个结构效度假设均得到充分支持：1）14个领域的得分存在统计学显著差异，高ICS剂量组得分最高；2）调整混杂因素后，ICS剂量独立预测ICQ评分；3）ICQ局部领域之间的收敛性大于局部和全身领域之间的收敛性。ICQ具有良好的可重复性：除“面部水肿”领域外，所有领域的重测组内相关系数均≥0.69。在纵向研究中，“声音问题”的ICQ评分在2个月和6个月时与基线相比有显著变化，其他ICQ领域在6个月时显示出与剂量调整一致的评分变化趋势。
ICQ具有良好的剂量相关鉴别特性，有效、可靠，并且显示出对ICS剂量变化的潜在反应性。
