Hartkopf Andreas D, Graf Joachim, Simoes Elisabeth, Keilmann Lucia, Sickenberger Nina, Gass Paul, Wallwiener Diethelm, Matthies Lina, Taran Florin-Andrei, Lux Michael P, Wallwiener Stephanie, Belleville Eric, Sohn Christof, Fasching Peter A, Schneeweiss Andreas, Brucker Sara Y, Wallwiener Markus
Department of Women's Health, University Hospital Tuebingen, Tübingen, Germany.
Research Institute for Women's Health, Department of Women's Health, University Hospital Tuebingen, Tübingen, Germany.
JMIR Cancer. 2017 Aug 7;3(2):e11. doi: 10.2196/cancer.6996.
Patient-reported outcomes (PROs) play an increasingly important role as an adjunct to clinical outcome parameters in measuring health-related quality of life (HRQoL). In fact, PROs are already the accepted gold standard for collecting data about patients' subjective perception of their own state of health. Currently, paper-based surveys of PRO still predominate; however, knowledge regarding the feasibility of and barriers to electronic-based PRO (ePRO) acceptance remains limited.
The objective of this trial was to analyze the willingness, specific needs, and barriers of adjuvant breast cancer (aBC) and metastatic breast cancer (mBC) patients in nonexposed (no exposure to electronic assessment) and exposed (after exposure to electronic assessment decision, whether a tablet-based questionnaire is favored) settings before implementing digital ePRO assessment in relation to health status. We also investigated whether providing support can increase the patients' willingness to participate in such programs.
The nonexposed patients only answered a paper-based questionnaire, whereas the exposed patients filled out both paper- and tablet-based questionnaires. The assessment comprised socioeconomic variables, HRQoL, preexisting technical skills, general attitude toward electronic-based surveys, and potential barriers in relation to health status. Furthermore, nonexposed patients were asked about the existing need for technological support structures. In the course of data evaluation, we performed a frequency analysis as well as chi-square tests and Wilcoxon signed-rank tests. Subsequently, relative risks analysis, univariate categorical regression (CATREG), and mediation analyses (Hayes' bias-corrected bootstrap) were performed.
A total of 202 female breast cancer patients completed the PRO assessment (nonexposed group: n=96 patients; exposed group: n=106 patients). Self-reported technical skills were higher in exposed patients (2.79 vs 2.33, P ≤.001). Significant differences were found in relation to willingness to use ePRO (92.3% in the exposed group vs 59% in the nonexposed group; P=.001). Multiple barriers were identified, and most of them showed statistically significant differences in favor of the exposed patients (ie, data security [13% in the exposed patients vs 30% in the nonexposed patients; P=.003] and no prior technology usage [5% in the exposed group vs 15% in the nonexposed group; P=.02]), whereas the differences in disease burden (somatic dimension: 4% in the exposed group vs 9% in the nonexposed group; P=.13) showed no significance. In nonexposed patients, requests for support services were identified, which could increase their ePRO willingness.
Significant barriers in relation to HRQoL, cancer-related restrictions, and especially the setting of the survey were identified in this trial. Thus, it is necessary to address and eliminate these barriers to ensure data accuracy and reliability for future ePRO assessments. Exposure seems to be a potential option to increase willingness to use ePRO and to reduce barriers.
患者报告结局（PROs）作为衡量健康相关生活质量（HRQoL）的临床结局参数的辅助手段，发挥着越来越重要的作用。事实上，PROs已经是收集患者对自身健康状况主观认知数据的公认金标准。目前，基于纸质的PRO调查仍然占主导地位；然而，关于基于电子的PRO（ePRO）接受度的可行性和障碍的知识仍然有限。
本试验的目的是分析辅助性乳腺癌（aBC）和转移性乳腺癌（mBC）患者在未接触（未接触电子评估）和接触（在接触电子评估决策后，无论是否倾向于基于平板电脑的问卷）环境下，在实施数字ePRO评估前，与健康状况相关的参与意愿、具体需求和障碍。我们还调查了提供支持是否能提高患者参与此类项目的意愿。
未接触患者仅回答纸质问卷，而接触患者同时填写纸质和基于平板电脑的问卷。评估包括社会经济变量、HRQoL、先前存在的技术技能、对基于电子的调查的总体态度以及与健康状况相关的潜在障碍。此外，还询问了未接触患者对技术支持结构的现有需求。在数据评估过程中，我们进行了频率分析以及卡方检验和Wilcoxon符号秩检验。随后，进行了相对风险分析、单变量分类回归（CATREG）和中介分析（Hayes偏差校正自助法）。
共有202名女性乳腺癌患者完成了PRO评估（未接触组：n = 96例患者；接触组：n = 106例患者）。接触患者自我报告的技术技能更高（2.79对2.33，P≤.001）。在使用ePRO的意愿方面发现了显著差异（接触组为92.3%，未接触组为59%；P =.001）。确定了多个障碍，其中大多数在有利于接触患者方面显示出统计学显著差异（即数据安全[接触患者为13%，未接触患者为30%；P =.003]和无先前技术使用情况[接触组为5%，未接触组为15%；P =.02]），而疾病负担方面的差异（躯体维度：接触组为4%，未接触组为9%；P =.13）无显著性。在未接触患者中，确定了对支持服务的需求，这可能会提高他们使用ePRO的意愿。
本试验确定了与HRQoL、癌症相关限制，尤其是调查环境相关的重大障碍。因此，有必要解决和消除这些障碍，以确保未来ePRO评估的数据准确性和可靠性。接触似乎是提高使用ePRO意愿和减少障碍的一个潜在选择。
