McGrath Clare, Chang Lynn, Dennis Kristopher
Division of Radiation Oncology, The Ottawa Hospital and the University of Ottawa, Ottawa, Canada.
Tech Innov Patient Support Radiat Oncol. 2020 Aug 17;15:22-28. doi: 10.1016/j.tipsro.2020.07.002. eCollection 2020 Sep.
Nausea is a difficult symptom to report and measure in clinical trials. We conducted a pilot interview study to improve our understanding of the nausea experience.
Female patients with breast cancer that had experienced nausea during radiation therapy and/or chemotherapy underwent semi-structured interviews that focused on patient-defined and standard definitions, preferences for nausea grading scales, and nausea sub-features: intensity, location, timing/duration, character, associated symptoms, precipitating/alleviating factors, impact on quality of life.
10 patients were interviewed. Patients defined nausea more variably than vomiting and retching/dry heaving. An ordinal grading scale with a 0-10 intensity range was preferred over visual-analogue and qualitative scales. Patients had experienced different intensities of nausea and deemed reporting their worst, average and least intensities feasible. High-intensity episodes were deemed more problematic than low-intensity episodes regardless of their duration. The duration and character of nausea were difficult to describe. A range of associated symptoms, precipitating and alleviating factors were documented. Nausea had a detrimental impact on quality of life.
Nausea has a range of subjective and objective features. Our pilot study provided valuable information that will inform the design of a planned larger survey study. Creating an operational clinical trial definition for nausea appears feasible.
在临床试验中,恶心是一种难以报告和测量的症状。我们开展了一项初步访谈研究,以增进对恶心体验的了解。
对在放疗和/或化疗期间经历过恶心的乳腺癌女性患者进行了半结构化访谈,重点关注患者定义和标准定义、恶心分级量表的偏好以及恶心的子特征:强度、位置、时间/持续时间、特征、相关症状、诱发/缓解因素、对生活质量的影响。
对10名患者进行了访谈。患者对恶心的定义比呕吐和干呕/恶心更为多样。与视觉模拟量表和定性量表相比,患者更倾向于采用强度范围为0至10的有序分级量表。患者经历过不同强度的恶心,并认为报告其最严重、平均和最轻强度是可行的。无论持续时间如何,高强度发作被认为比低强度发作问题更大。恶心的持续时间和特征难以描述。记录了一系列相关症状、诱发和缓解因素。恶心对生活质量有不利影响。
恶心具有一系列主观和客观特征。我们的初步研究提供了有价值的信息,将为计划中的更大规模调查研究的设计提供参考。为恶心制定一个可操作的临床试验定义似乎是可行的。