Department of Electrical, Computer and Biomedical Engineering, University of Pavia, Italy.
Department of Electrical, Computer and Biomedical Engineering, University of Pavia, Italy.
Int J Med Inform. 2019 Sep;129:404-412. doi: 10.1016/j.ijmedinf.2019.06.004. Epub 2019 Jul 24.
Multidisciplinary treatment for head and neck carcinoma offers the best curative results but generates acute toxicities, which negatively affect both patients' quality of life and treatment compliance. Usually, the patient's clinical condition is recorded during scheduled, time-limited office visits and patients might forget to discuss symptoms occurred weeks before. They could also have difficulties contacting their clinicians outside of these limited encounters. Technology-based interventions for oncological patients have already been proved to encourage accurate symptoms report through regular inquiries of their clinical conditions.
The aim of this work is to present the results of a pilot study about the assessment of a novel mobile application for reporting clinical parameters, quality of life, and symptoms of home patients affected by head and neck carcinoma, during chemo-radiotherapy and the subsequent follow-up period. Results will inform app designers about the necessary modifications to face a full-scale trial.
Ten patients used the app for the foreseen period (up to 65 days, median 50.5), at the end of which they answered a paper questionnaire addressing user satisfaction with the app. The questionnaire included 8 questions and a free text comment field. Patients were followed by three clinicians, who also answered a similar paper questionnaire at the end of the pilot study. Questionnaires total score ranged 0-25 and a threshold of 16 was set in the study protocol to represent an overall positive outcome. However, to consider the individual constructs, questions about usability, perceived usefulness and user acceptance were also analyzed separately, and association among them was investigated. Finally, the feasibility of the intervention was analyzed in terms of the actual use of the app, i.e. dropout rates and compliance with the required data input. Statistics were only performed on patients' data, due to the small number of doctors involved in the study.
The median of the total score per patient was 18.5 (interquartile range 11.2-20.5), and per doctor was 16 (range 11-20), thus showing a positive overall satisfaction with the app. Concerning patients, only 4 out of a total of 80 answers (10 patients × 8 questions) expressed a definite negative feeling. Perceived usefulness was a critical issue for some patients. It was positively correlated with usability, and both aspects were independent predictors of acceptance. Feasibility was demonstrated by the low percentage of dropouts (9%) and noncompliance with assignments (10%). A significant (p = 0.007) negative correlation between the severity of reported symptoms and the EuroQoL questionnaire scores was found, supporting the consistency of the entered data. Free comments were reported by 6 Patients.
This study was meant to explore the context of outpatients' remote monitoring through the collection of patient-reported outcomes. The intervention for a proactive approach to symptoms monitoring in curatively treated head and neck cancer patients resulted feasible and acceptable by both patients and oncologists. The study revealed a criticality on the perceived usefulness, but, at the same time, the patients' comments suggested how to improve this aspect. Further actions will need to focus on measuring the impact of HeNeA on the process of care and on the health outcomes.
头颈部癌的多学科治疗可带来最佳的治疗效果，但会产生急性毒性，这会对患者的生活质量和治疗依从性产生负面影响。通常，患者的临床状况在定期、限时的门诊就诊期间进行记录，患者可能会忘记讨论几周前发生的症状。他们在这些有限的接触之外也可能难以联系到他们的临床医生。针对肿瘤患者的基于技术的干预措施已经被证明可以通过定期询问他们的临床状况来鼓励准确报告症状。
本工作旨在介绍一项关于报告接受放化疗和随后随访期间头颈部癌家庭患者临床参数、生活质量和症状的新型移动应用评估的试点研究结果。研究结果将为应用设计师提供必要的修改信息，以进行全面的试验。
十名患者在预定期间（最长 65 天，中位数 50.5 天）使用该应用程序，在结束时，他们回答了一份纸质问卷，内容涉及对应用程序的满意度。问卷包括 8 个问题和一个自由文本评论字段。在试点研究结束时，三名临床医生也回答了一份类似的纸质问卷。问卷总分范围为 0-25 分，研究方案中设定了 16 分为代表总体积极结果的阈值。然而，为了考虑个别结构，还分别分析了可用性、感知有用性和用户接受度方面的问题，并对它们之间的关系进行了调查。最后，根据实际使用应用程序的情况，即退出率和遵守所需数据输入的情况，分析了干预措施的可行性。由于参与研究的医生人数较少，因此仅对患者的数据进行了统计分析。
每位患者的总分中位数为 18.5（四分位距 11.2-20.5），每位医生的中位数为 16（范围 11-20），表明对该应用程序的总体满意度为阳性。对于患者，在总共 80 个答案（10 名患者×8 个问题）中，只有 4 个表达了明确的负面感受。一些患者认为感知有用性是一个关键问题。它与可用性呈正相关，并且这两个方面都是接受的独立预测因素。低退出率（9%）和非遵守任务（10%）证明了可行性。还发现报告症状的严重程度与 EuroQoL 问卷评分之间存在显著（p=0.007）负相关，支持了输入数据的一致性。有 6 名患者提供了自由评论。
本研究旨在通过收集患者报告的结果来探索门诊患者远程监测的背景。针对接受根治性治疗的头颈部癌患者进行主动症状监测的干预措施对患者和肿瘤医生来说都是可行和可接受的。研究揭示了感知有用性的关键问题，但同时，患者的评论也提出了如何改进这一方面的问题。进一步的措施将需要集中于衡量 HeNeA 对护理过程和健康结果的影响。
