Electronic-Based Patient-Reported Outcomes: Willingness, Needs, and Barriers in Adjuvant and Metastatic Breast Cancer Patients

Abstract

BackgroundPatient-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.ObjectiveThe 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.MethodsThe 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.ResultsA 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.ConclusionsSignificant 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 ...

An Electronic Patient-Reported Outcome Tool for the FACT-B (Functional Assessment of Cancer Therapy-Breast) Questionnaire for Measuring the Health-Related Quality of Life in Patients With Breast Cancer: Reliability Study (Preprint)

“…The first part focused on the patientsʼ While in the third part of the assessment, the patients were asked about preexisting technical skills, their willingness to use ePRO, and potential barriers in relation to their health status [37], the fourth part concerned with the patients´ evaluation of the ePRO tool (publication in preparation). The patients completed the second part of the assessment both on paper and using a tablet, while they answered the questions in the other parts only in paper-based form.…”

“…Although paperbased surveys of PRO still predominate because there are only a few reliable and validated ePRO questionnaires, numerous projects have evaluated feasibility and acceptance of HRQoL in ePRO measurement in the last few years [29][30][31][32][33][34]. Nevertheless, knowledge regarding patient acceptance, feasibility, and barriers remains limited [35], especially since hurdles might exist in relation to health status, technical skills, and socioeconomic aspects, which could influence both patients´ willingness to use ePRO and their response behavior [10,36,37]. Although studies have already demonstrated a potential equivalence between some paper-based PRO and ePRO, reliability of ePRO questionnaires should be verified so as not to endanger the validity of ePRO surveys [10,[36][37][38][39][40].…”

“…Nevertheless, knowledge regarding patient acceptance, feasibility, and barriers remains limited [35], especially since hurdles might exist in relation to health status, technical skills, and socioeconomic aspects, which could influence both patients´ willingness to use ePRO and their response behavior [10,36,37]. Although studies have already demonstrated a potential equivalence between some paper-based PRO and ePRO, reliability of ePRO questionnaires should be verified so as not to endanger the validity of ePRO surveys [10,[36][37][38][39][40]. Indeed, ePRO tools of the FACT-B questionnaire with proven reliability are missing so far.…”

“…The randomization procedure was based on permuted-block randomization, which strives to generate equally large treatment groups [41,42]. The post exposure acceptance for using the ePRO tool was high (92%) as the patients were asked whether they could potentially imagine using tablet-based tools before using ePRO [37].…”

“…Thus, a corresponding analysis in relation to differences and correlations between the paper-based vision of FACT-B and newly developed online tools are of great importance. It can be assumed that many aspects (i.e., sociodemographic aspects, technical skills, health condition, and perhaps design specifics of the ePRO tool) may influence both patients' willingness to use the tool and their response behavior, which underlines the need for reliability analyses [10,24,[35][36][37]. However, almost no scientific studies have dealt with the reliability of ePRO questionnaires.…”