Duracinsky Martin, Lalanne Christophe, Goujard Cécile, Herrmann Susan, Cheung-Lung Christian, Brosseau Jean-Paul, Schwartz Yannick, Chassany Olivier
Université Paris-Diderot, Sorbonne Paris-Cité, Unité de Méthodologie des critères d'évaluation (Patient-Reported Outcomes), EA Recherche Clinique Coordonnée Ville-Hôpital, Méthodologies et Société (ED 393), Paris cedex 10, France.
J Med Internet Res. 2014 Apr 25;16(4):e115. doi: 10.2196/jmir.3330.
Electronic patient-reported outcomes (PRO) provide quick and usually reliable assessments of patients' health-related quality of life (HRQL).
An electronic version of the Patient-Reported Outcomes Quality of Life-human immunodeficiency virus (PROQOL-HIV) questionnaire was developed, and its face validity and reliability were assessed using standard psychometric methods.
A sample of 80 French outpatients (66% male, 52/79; mean age 46.7 years, SD 10.9) were recruited. Paper-based and electronic questionnaires were completed in a randomized crossover design (2-7 day interval). Biomedical data were collected. Questionnaire version and order effects were tested on full-scale scores in a 2-way ANOVA with patients as random effects. Test-retest reliability was evaluated using Pearson and intraclass correlation coefficients (ICC, with 95% confidence interval) for each dimension. Usability testing was carried out from patients' survey reports, specifically, general satisfaction, ease of completion, quality and clarity of user interface, and motivation to participate in follow-up PROQOL-HIV electronic assessments.
Questionnaire version and administration order effects (N=59 complete cases) were not significant at the 5% level, and no interaction was found between these 2 factors (P=.94). Reliability indexes were acceptable, with Pearson correlations greater than .7 and ICCs ranging from .708 to .939; scores were not statistically different between the two versions. A total of 63 (79%) complete patients' survey reports were available, and 55% of patients (30/55) reported being satisfied and interested in electronic assessment of their HRQL in clinical follow-up. Individual ratings of PROQOL-HIV user interface (85%-100% of positive responses) confirmed user interface clarity and usability.
The electronic PROQOL-HIV introduces minor modifications to the original paper-based version, following International Society for Pharmacoeconomics and Outcomes Research (ISPOR) ePRO Task Force guidelines, and shows good reliability and face validity. Patients can complete the computerized PROQOL-HIV questionnaire and the scores from the paper or electronic versions share comparable accuracy and interpretation.
电子患者报告结局（PRO）能快速且通常可靠地评估患者的健康相关生活质量（HRQL）。
开发了患者报告结局生活质量 - 人类免疫缺陷病毒（PROQOL - HIV）问卷的电子版，并使用标准心理测量方法评估其表面效度和信度。
招募了80名法国门诊患者样本（66%为男性，52/79；平均年龄46.7岁，标准差10.9）。纸质问卷和电子问卷采用随机交叉设计完成（间隔2 - 7天）。收集生物医学数据。在以患者为随机效应的双向方差分析中，对问卷版本和顺序效应进行全量表得分测试。使用Pearson相关系数和组内相关系数（ICC，95%置信区间）评估各维度的重测信度。根据患者调查报告进行可用性测试，具体包括总体满意度、完成的难易程度、用户界面的质量和清晰度以及参与后续PROQOL - HIV电子评估的积极性。
问卷版本和施测顺序效应（N = 59个完整病例）在5%水平上不显著，且未发现这两个因素之间存在交互作用（P = 0.94）。信度指标可接受，Pearson相关系数大于0.7，ICC范围为0.708至0.939；两个版本的得分在统计学上无差异。共有63份（79%）完整的患者调查报告可用，55%的患者（30/55）报告对临床随访中其HRQL的电子评估感到满意并感兴趣。PROQOL - HIV用户界面的个人评分（85% - 100%为积极回应）证实了用户界面的清晰度和可用性。
电子PROQOL - HIV遵循国际药物经济学和结局研究协会（ISPOR）ePRO工作组指南，对原始纸质版本进行了微小修改，显示出良好的信度和表面效度。患者可以完成计算机化的PROQOL - HIV问卷，纸质版或电子版的得分具有可比的准确性和解释性。
