Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Health Qual Life Outcomes. 2011 May 10;9:30. doi: 10.1186/1477-7525-9-30.
Patient-reported outcomes are measured in many epidemiologic studies using self- or interviewer-administered questionnaires. While in some studies differences between these administration formats were observed, other studies did not show statistically significant differences important to patients. Since the evidence about the effect of administration format is inconsistent and mainly available from cross-sectional studies our aim was to assess the effects of different administration formats on repeated measurements of patient-reported outcomes in participants with AIDS enrolled in the Longitudinal Study of Ocular Complications of AIDS.
We included participants enrolled in the Longitudinal Study of Ocular Complications in AIDS (LSOCA) who completed the Medical Outcome Study [MOS] -HIV questionnaire, the EuroQol, the Feeling Thermometer and the Visual Function Questionnaire (VFQ) 25 every six months thereafter using self- or interviewer-administration. A large print questionnaire was available for participants with visual impairment. Considering all measurements over time and adjusting for patient and study site characteristics we used linear models to compare HRQL scores (all scores from 0-100) between administration formats. We defined adjusted differences of ≥0.2 standard deviations [SD]) to be quantitatively meaningful.
We included 2,261 participants (80.6% males) with a median of 43.1 years of age at enrollment who provided data on 23,420 study visits. The self-administered MOS-HIV, Feeling Thermometer and EuroQol were used in 70% of all visits and the VFQ-25 in 80%. For eight domains of the MOS-HIV differences between the interviewer- and self- administered format were < 0.1 SD. Differences in scores were highest for the social and role function domains but the adjusted differences were still < 0.2 SD. There was no quantitatively meaningful difference between administration formats for EuroQol, Feeling Thermometer and VFQ-25 domain scores. For ocular pain (VFQ-25), we found a statistically significant difference of 3.5 (95% CI 0.2, 6.8), which did, however, not exceed 0.2 SD. For all instruments scores were similar for the large and standard print formats with all adjusted differences < 0.2 SD.
Our large study provides evidence that administration formats do not have a meaningful effect on repeated measurements of patient-reported outcomes. As a consequence, longitudinal studies may not need to consider the effect of different administration formats in their analyses.
在许多流行病学研究中，使用自我或访谈者管理的问卷来测量患者报告的结果。虽然在一些研究中观察到了这些管理格式之间的差异，但其他研究并没有显示出对患者有统计学意义的重要差异。由于关于管理格式效果的证据不一致，并且主要来自横断面研究，因此我们的目的是评估不同管理格式对 AIDS 纵向研究中的眼并发症患者报告结局的重复测量的影响。
我们纳入了参加 AIDS 纵向眼并发症研究（LSOCA）的参与者，他们在之后的每六个月使用自我或访谈者管理完成医疗结果研究[MOS]-HIV 问卷、EuroQol、感觉温度计和视觉功能问卷（VFQ）25。对于视力障碍的参与者，提供了大字体问卷。考虑到所有时间的测量值，并调整了患者和研究地点的特征，我们使用线性模型来比较管理格式之间的 HRQL 评分（所有评分范围为 0-100）。我们将调整差异≥0.2 标准差[SD]定义为具有定量意义。
我们纳入了 2261 名参与者（80.6%为男性），中位年龄为 43.1 岁，在入组时提供了 23420 次研究访问的数据。自我管理的 MOS-HIV、感觉温度计和 EuroQol 在所有访问中使用了 70%，VFQ-25 使用了 80%。在 MOS-HIV 的八个领域中，访谈者管理和自我管理格式之间的差异<0.1 SD。差异最大的是社会和角色功能领域，但调整后的差异仍<0.2 SD。在 EuroQol、感觉温度计和 VFQ-25 领域的评分方面，管理格式之间没有具有定量意义的差异。对于眼部疼痛（VFQ-25），我们发现有统计学意义的差异为 3.5（95%CI 0.2, 6.8），但未超过 0.2 SD。对于所有仪器，大字体和标准字体格式的评分相似，所有调整后的差异<0.2 SD。
我们的大型研究提供了证据表明，管理格式对患者报告结果的重复测量没有有意义的影响。因此，纵向研究在其分析中可能不需要考虑不同管理格式的影响。
