Ramsey Imogen, Corsini Nadia, Hutchinson Amanda D, Marker Julie, Eckert Marion
Rosemary Bryant AO Research Centre, School of Nursing and Midwifery and UniSA Cancer Research Institute, University of South Australia, Adelaide, Australia.
School of Psychology, Social Work and Social Policy, University of South Australia, Adelaide, Australia.
JMIR Res Protoc. 2020 Jan 28;9(1):e14544. doi: 10.2196/14544.
Core outcome sets seek to improve the consistency and quality of research by providing agreed-upon recommendations regarding what outcomes should be measured as a minimum for a population and setting. The problems arising from a lack of outcome standardization in population-based cancer survivorship research indicate the need for agreement on a core set of patient-reported outcomes (PROs) to enhance data quality, consistency, and comparability.
This study aims to identify a core set of PROs, representing the most important issues impacting on cancer survivors' long-term health, functioning and quality of life, to inform population-based research on cancer survivorship.
In Phase I, a list of all potentially important outcomes will be generated through focus group discussions with cancer survivors and a review of measures for assessing quality of life in cancer survivorship. The consolidated list will be advanced to Phase II, where a stakeholder consensus process will be conducted with national experts in cancer survivorship to refine and prioritize the outcomes into a core outcome set. The process will consist of a two-round Delphi survey and a consensus meeting. Cancer survivors, oncology health care professionals, and potential end users of the core outcome set with expertise in cancer survivorship research or policy will be invited to participate. In Phase III, recommended measures for assessment of the core outcome set will be selected with advice from experts on the assessment, analysis, and interpretation of PROs.
As of April 2019, data collection for Phase I is complete and data analysis is underway. These data will inform the list of outcomes to be advanced into Phase II. Recruitment for Phase II will commence in June 2019, and it is anticipated that it will take 6 months to complete the three-step consensus process and identify a provisional core outcome set. The study results are expected to be published in early 2020.
Expert consensus-driven recommendations on outcome measurement will facilitate the inclusion of survivorship outcomes considered important by cancer survivors and health professionals in future research. Adoption of the core outcome set will enable comparison and synthesis of evidence across studies and enhance the quality of PRO data collected in cancer survivorship research, particularly when applied to address macro-level questions.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/14544.
核心结局集旨在通过就针对特定人群和研究背景应至少测量哪些结局提供商定的建议，来提高研究的一致性和质量。基于人群的癌症幸存者研究中因缺乏结局标准化而产生的问题表明，需要就一套核心患者报告结局（PROs）达成共识，以提高数据质量、一致性和可比性。
本研究旨在确定一套核心PROs，代表影响癌症幸存者长期健康、功能和生活质量的最重要问题，为基于人群的癌症幸存者研究提供参考。
在第一阶段，通过与癌症幸存者进行焦点小组讨论以及回顾评估癌症幸存者生活质量的测量方法，生成所有潜在重要结局的列表。合并后的列表将进入第二阶段，在该阶段将与癌症幸存者领域的国家专家进行利益相关者共识过程，以完善结局并将其优先排序为核心结局集。该过程将包括两轮德尔菲调查和一次共识会议。将邀请癌症幸存者、肿瘤医疗保健专业人员以及在癌症幸存者研究或政策方面具有专业知识的核心结局集潜在最终用户参与。在第三阶段，将在PROs评估、分析和解释方面的专家建议下，选择评估核心结局集的推荐测量方法。
截至2019年4月，第一阶段的数据收集已完成，数据分析正在进行中。这些数据将为进入第二阶段的结局列表提供参考。第二阶段的招募将于2019年6月开始，预计将需要6个月完成三步共识过程并确定一个临时核心结局集。研究结果预计将于2020年初发表。
由专家共识驱动的结局测量建议将有助于在未来研究中纳入癌症幸存者和卫生专业人员认为重要的幸存者结局。采用核心结局集将能够对各项研究的证据进行比较和综合，并提高癌症幸存者研究中收集的PRO数据的质量，特别是在应用于解决宏观层面问题时。
国际注册报告识别号（IRRID）：DERR1-10.2196/14544
