Despite international recommendations of including patient-reported outcomes (PROs) in randomised clinical trials (RCTs), a 2014 review concluded that few RCTs of bladder cancer (BC) report PRO as an outcome. We therefore aimed to update the 2014 review to synthesise current evidence-based knowledge of PROs from RCTs in BC. A secondary objective was to examine whether quality of PRO reporting has improved over time and to provide evidence-based recommendations for future studies in this area. We conducted a systematic literature search using PubMed/Medline, from April 2014 until June 2018. We included the RCTs identified in the previous review as well as newly published RCTs. Studies were evaluated using a predefined electronic-data extraction form that included information on basic trial demographics, clinical and PRO characteristics and standards of PRO reporting based on recommendation from the International Society of Quality of Life Research. Since April 2014 only eight new RCTs for BC included PROs as a secondary outcome. In terms of methodology, only the proportion of RCTs documenting the extent of missing PRO data (75% vs 11.1%, p = 0.03) and the identification of PROs in trial protocols (50% vs 0%, p = 0.015) improved. Statistical approaches for dealing with missing data were not reported in most new studies (75%). Little improvement into the uptake and assessment of PRO as an outcome in RCTs for BC has been made during recent years. Given the increase in (immunotherapy) drug trials with a potential for severe adverse events, there is urgent need to adopt the recommendations and standards available for PRO use in bladder cancer RCTs.

中文翻译：

---

膀胱癌随机临床试验中患者报告的结果：更新的系统评价

尽管国际上建议将患者报告的结果 (PRO) 纳入随机临床试验 (RCT)，但 2014 年的一项审查得出结论，很少有膀胱癌 (BC) 的 RCT 将 PRO 作为结果报告。因此，我们的目标是更新 2014 年的综述，以综合 BC 省随机对照试验中 PRO 的当前循证知识。第二个目标是检查 PRO 报告的质量是否随着时间的推移而提高，并为该领域的未来研究提供基于证据的建议。从 2014 年 4 月到 2018 年 6 月，我们使用 PubMed/Medline 进行了系统的文献检索。我们纳入了之前综述中确定的随机对照试验以及新发表的随机对照试验。研究使用预定义的电子数据提取表格进行评估，其中包括有关基本试验人口统计、临床和 PRO 特征以及基于国际生活质量研究学会建议的 PRO 报告标准的信息。自 2014 年 4 月以来，只有 8 个针对 BC 的新随机对照试验将 PRO 作为次要结果。就方法论而言，只有记录 PRO 数据缺失程度的 RCT 比例（75% vs 11.1%，p = 0.03）和试验方案中 PRO 的识别（50% vs 0%，p = 0.015）有所改善。大多数新研究（75%）没有报告处理缺失数据的统计方法。近年来，作为 BC 随机对照试验结果，PRO 的接受和评估几乎没有取得任何进展。鉴于可能发生严重不良事件的（免疫治疗）药物试验的增加，迫切需要采用可用于膀胱癌 RCT 中 PRO 使用的建议和标准。