NHMRC Clinical Trials Centre, The University of Sydney, Camperdown, New South Wales, Australia
Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
BMJ Open. 2022 Dec 20;12(12):e066852. doi: 10.1136/bmjopen-2022-066852.
The benefits of patient-reported feedback, using questionnaires that allow patients to report how they feel and function without any interpretation from healthcare professionals, are well established. However, patient-reported outcomes measures (PROMs) are not routinely collected in patients with melanoma in Australia. The aim of this study is to evaluate the feasibility and acceptability of implementing electronic PROMs (ePROMs) into routine care from the perspectives of patients with stage III melanoma and their treating clinical team.
A minimum of 50 patients and 5 clinicians will be recruited to this prospective, longitudinal pilot study (ePROMs-MELanoma). The study uses a mixed-methods approach (quantitative PROMs questionnaires and end-of-study surveys with qualitative interviews) and commenced in May 2021 in surgical and medical melanoma clinics at two sites in metropolitan Sydney, Australia. The primary outcomes are measures of feasibility and acceptability, comprising descriptive questionnaire completion statistics, and proportion of patients who reported that these PROMs were easy to complete and measured items they considered important. Clinician and clinic staff views will be canvassed on the appropriateness of these PROMs for their patients, change in referral practice and uptake and incorporation into routine practice. Secondary aims include measurement of improvements in patients' emotional and physical health and well-being, and utility of real-time data capture and clinician feedback. All participants will complete the Distress Thermometer and EQ-5D-5L questionnaires in the clinic using a tablet computer at baseline and two to three subsequent follow-up appointments. Participants who report a score of 4 or higher on the Distress Thermometer will be triaged to complete an additional three questionnaires: the QLQ-C30, Depression, Anxiety and Stress Scale and Melanoma Concerns Questionnaire-28. Results will be generated in real time; patients with psychosocial distress or poor quality of life will discuss possible referral to appropriate allied health services with their clinician. Thematic analysis of interviews will be conducted.
Ethics approval obtained from St Vincent's Hospital Human Research Ethics Committee on 19 September 2019 (2019/ETH10558), with amendments approved on 8 June 2022. Patient consent is obtained electronically prior to questionnaire commencement. Dissemination strategies will include publication in peer-reviewed journals and presentation at international conferences, tailored presentations for clinical societies and government bodies, organisational reporting through multidisciplinary meetings and research symposia for local clinicians and clinic staff, and more informal, lay reports and presentations for consumer melanoma representative bodies and patient participants and their families.
ACTRN12620001149954.
患者报告反馈的益处已得到充分证实，使用允许患者报告自己感受和功能的问卷而无需医疗保健专业人员进行任何解释。然而，在澳大利亚，黑素瘤患者并未常规收集患者报告结局测量（PROMs）。本研究的目的是从 III 期黑素瘤患者及其治疗临床团队的角度评估电子 PROMs（ePROMs）纳入常规护理的可行性和可接受性。
本前瞻性纵向试点研究（ePROMs-MELanoma）将招募至少 50 名患者和 5 名临床医生。该研究采用混合方法（定量 PROMs 问卷和结束研究调查的定性访谈），于 2021 年 5 月在澳大利亚两个大都市悉尼的两个地点的外科和医学黑素瘤诊所开始。主要结局是可行性和可接受性的衡量标准，包括描述性问卷完成统计数据，以及报告这些 PROMs 易于完成和测量他们认为重要的项目的患者比例。将征求临床医生和诊所工作人员对这些 PROMs 适合他们的患者、转诊实践的变化以及纳入常规实践的看法。次要目标包括测量患者情绪和身心健康的改善，以及实时数据捕获和临床医生反馈的实用性。所有参与者将在基线时使用平板电脑在诊所完成焦虑自评量表、抑郁、焦虑和压力量表和黑素瘤担忧问卷-28 问卷调查，在两个至三个后续随访预约时完成 EQ-5D-5L 问卷。在 Distress Thermometer 上得分达到 4 或更高的参与者将被分诊完成另外三个问卷：QLQ-C30、抑郁、焦虑和压力量表和黑素瘤担忧问卷-28。结果将实时生成；有心理社会困扰或生活质量差的患者将与他们的临床医生讨论可能向适当的辅助健康服务转诊。将进行访谈的主题分析。
圣文森特医院人类研究伦理委员会于 2019 年 9 月 19 日获得伦理批准（2019/ETH10558），并于 2022 年 6 月 8 日批准了修正案。在开始问卷调查之前，患者通过电子方式获得同意。传播策略将包括在同行评议的期刊上发表和在国际会议上展示，为临床学会和政府机构量身定制的演示，为当地临床医生和诊所工作人员举办多学科会议和研究研讨会，以及为消费者黑素瘤代表机构和患者参与者及其家属提供更非正式的、外行的报告和演示。
ACTRN12620001149954。
