Department of Oesophago-Gastric Surgery, Salford Royal NHS Foundation Trust, Salford, UK
Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK.
BMJ Open. 2020 Feb 12;10(2):e034782. doi: 10.1136/bmjopen-2019-034782.
The reporting of outcomes in surgical trials for gastric cancer is inconsistent. The GASTROS study (stric Cancer urgery ials eported utcome tandardisation) aims to address this by developing a core outcome set (COS) for use in all future trials within this field. A COS should reflect the views of all stakeholders, including patients. We undertook a series of interviews to identify outcomes important to patients which would be considered for inclusion in a COS.
All interviews took place within the UK. Interviews were carried out face-to-face at hospitals and cancer support centres or via the telephone.
Twenty participants at varying stages of recovery following surgery for gastric cancer with curative intent.
Qualitative design using semistructured interviews, supported by an interview guide which was iteratively modified; thematic analysis was used to explore patient priorities.
Six themes enveloping 38 outcomes were identified; surviving and controlling cancer, technical aspects of surgery, adverse events from surgery, recovering from surgery, long-term problems following surgery and long-term life impact of surgery. The 'most important' patient priority was to be 'cured of cancer'.
Surgical trials for gastric cancer should consider broader priorities of patients when choosing which outcomes to report. This study highlighted the importance of longer-term outcomes such as cancer survival. Outcomes identified in this study will be used to inform an international Delphi survey to develop a COS in this field.
胃癌手术试验的结果报告不一致。GASTROS 研究(胃癌手术临床试验报告结果标准化)旨在通过制定核心结果集(COS)来解决这个问题,以便在该领域的所有未来试验中使用。COS 应反映所有利益相关者的意见,包括患者。我们进行了一系列访谈,以确定对患者重要的结果,这些结果将被考虑纳入 COS。
所有访谈均在英国进行。访谈在医院和癌症支持中心进行面对面访谈,或通过电话进行。
20 名参与者,均为有治愈意图的胃癌手术后处于不同康复阶段的患者。
采用半结构化访谈的定性设计,并辅以迭代修改的访谈指南;采用主题分析来探讨患者的优先事项。
确定了 6 个主题,涵盖了 38 个结果;战胜和控制癌症、手术的技术方面、手术的不良事件、手术后的恢复、手术后的长期问题以及手术对长期生活的影响。患者的“最重要”的优先事项是“治愈癌症”。
胃癌手术试验在选择要报告的结果时,应考虑患者更广泛的优先事项。本研究强调了长期结果(如癌症生存)的重要性。本研究中确定的结果将用于告知该领域的国际 Delphi 调查,以制定 COS。