Gamper Eva Maria, Nerich Virginie, Sztankay Monika, Martini Caroline, Giesinger Johannes M, Scarpa Lorenza, Buxbaum Sabine, Jeller Martin, Holzner Bernhard, Virgolini Irene
Department for Psychiatry and Psychotherapy, Medical University of Innsbruck, Innsbruck, Austria; Innsbruck Institute of Patient-Centered Outcome Research, Innsbruck, Austria.
INSERM, Unit 1098, University of Franche-Comté, Besançon, France; Department of Pharmacy, University Hospital of Besançon, Besançon, France.
Value Health. 2017 Apr;20(4):610-617. doi: 10.1016/j.jval.2017.01.009. Epub 2017 Mar 6.
Currently there is little knowledge on real-life sustainability of routine patient-reported outcome (PRO) measurement and the representativeness of collected data.
The investigation of routine PRO with regard to noncompletion bias and long-term adher- ence, considering the potential impact of mode of assessment (MOA) (paper-pencil vs. electronic PRO [ePRO]) and patient characteristics.
At our department, routine PRO measurement in oncological patients is being done since 2005 using different MOA (paper-pencil assessment until 2011 and ePRO assessment from 2011 onward). We analyzed two different patient groups: patients eligible in both periods (both-MOA group) and patients eligible in only one period (one-MOA group). The primary outcome was PRO noncompletion (100% missing questionnaires). The secondary outcome was poor PRO adherence (>20% missing questionnaires). Multivariate logistic regression models were developed, testing the impact of MOA and patient characteristics on the outcomes in the different patient groups.
Data from 1484 eligible patients were included in the analyses. Most of the patients could be included in PRO assessment at least once. PRO noncompletion rates were clearly higher during paper-pencil assessment (odds ratios between 2.72 and 4.31), as were poor PRO adherence rates (odd ratio 2.23). Analyses of potential bias by patient characteristics showed that male patients had a higher risk of poor adherence. Other factors with significant impact were age, country, and cancer diagnosis, but results were indecisive.
ePRO increased the feasibility of our clinical routine PRO data for retrospective analyses by increasing completion rates. In general, potential completion bias regarding certain patient characteristics requires attention before generalizing results to the respective populations.
目前对于常规患者报告结局（PRO）测量的实际可持续性以及所收集数据的代表性了解甚少。
研究常规PRO在未完成偏倚和长期依从性方面的情况，同时考虑评估方式（MOA）（纸笔评估与电子PRO [ePRO]）和患者特征的潜在影响。
自2005年起，我们科室使用不同的MOA对肿瘤患者进行常规PRO测量（2011年之前采用纸笔评估，2011年起采用ePRO评估）。我们分析了两个不同的患者组：两个时期均符合条件的患者（双MOA组）和仅在一个时期符合条件的患者（单MOA组）。主要结局是PRO未完成（问卷100%缺失）。次要结局是PRO依从性差（问卷缺失>20%）。建立多变量逻辑回归模型，测试MOA和患者特征对不同患者组结局的影响。
1484名符合条件的患者的数据纳入分析。大多数患者至少能被纳入一次PRO评估。纸笔评估期间PRO未完成率明显更高（优势比在2.72至4.31之间），PRO依从性差的比率也是如此（优势比2.23）。按患者特征分析潜在偏倚表明，男性患者依从性差的风险更高。其他有显著影响的因素包括年龄、国家和癌症诊断，但结果不明确。
ePRO通过提高完成率增加了我们临床常规PRO数据用于回顾性分析的可行性。一般而言，在将结果推广到相应人群之前，需要关注特定患者特征的潜在完成偏倚。
