Abstract

Abstract:

BACKGROUND:

Heterogenous outcome reporting in non-muscle-invasive bladder cancer (NMIBC) effectiveness trials of adjuvant intervention after transurethral resection (TURBT) has been noted in systematic reviews (SRs). This hinders comparing results across trials, combining them in meta-analyses, and evidence-based decision-making for patients and clinicians.

OBJECTIVE:

We aimed to systematically review the extent of reporting and definition heterogeneity.

METHODS:

We included randomized controlled trials (RCTs) identified from SRs comparing adjuvant treatments after TURBT or TURBT alone in patients with NMIBC (with or without carcinoma in situ) published between 2000–2020. Abstracts and full texts were screened independently by two reviewers. Data were extracted by one reviewer and checked by another.

RESULTS:

We screened 807 abstracts; from 15 SRs, 57 RCTs were included. Verbatim outcome names were coded to standard outcome names and organised using the Williamson and Clarke taxonomy. Recurrence (98%), progression (74%), treatment response (in CIS studies) (40%), and adverse events (77%) were frequently reported across studies. However, overall (33%) and cancer-specific (33%) survival, treatment completion (17%) and treatment change (37%) were less often reported. Quality of Life (3%) and economic outcomes (2%) were rarely reported. Heterogeneity was evident throughout, particularly in the definitions of progression and recurrence, and how CIS patients were handled in the analysis of studies with predominantly papillary patients, highlighting further issues with the definition of recurrence and progression vs treatment response for CIS patients. Data reporting was also inconsistent, with some trials reporting event rates at various time-points and others reporting time-to-event with or without Hazard Ratios. Adverse events were inconsistently reported. QoL data was absent in most trials.

CONCLUSIONS:

Heterogenous outcome reporting is evident in NMIBC effectiveness trials. This has profound implications for meta-analyses, SRs and evidence-based treatment decisions. A core outcome set is required to reduce heterogeneity.

PATIENT SUMMARY:

This systematic review found inconsistencies in outcome definitions and reporting, pointing out the urgent need for a core outcome set to help improve evidence-based treatment decisions.

Keywords:

中文翻译：

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对非肌肉浸润性膀胱癌有效性试验的结果报告，定义和测量异质性的系统评价，经尿道切除后的预防性治疗

摘要

抽象的：

背景：

在系统评价（SR）中已注意到非肌肉浸润性膀胱癌（NMIBC）在经尿道切除术后辅助治疗（TURBT）的有效性试验中的异质结果报告。这妨碍了比较各个试验的结果，将其合并到荟萃分析中，以及为患者和临床医生提供基于证据的决策。

客观的：

我们旨在系统地审查报告和定义异质性的程度。

方法：

我们纳入了从SR中鉴定出的随机对照试验（RCT），比较了2000–2020年间发表的NMIBC患者（有或无原位癌）单独进行TURBT或TURBT后的辅助治疗。摘要和全文由两名审稿人独立筛选。数据由一名审阅者提取，然后由另一名审阅者检查。

结果：

我们筛选了807篇摘要；在15个SR中，包括了57个RCT。逐字记录的结果名称被编码为标准结果名称，并使用Williamson和Clarke分类法进行组织。在整个研究中，经常报告复发（98％），进展（74％），治疗反应（在CIS研究中）（40％）和不良事件（77％）。但是，较少报道总体生存率（33％）和癌症特异性生存率（33％），治疗完成率（17％）和治疗改变（37％）。生活质量（3％）和经济成果（2％）的报道很少。异质性在整个过程中都很明显，尤其是在进展和复发的定义中，以及在以乳头状为主的患者的研究分析中如何处理CIS患者，这突出了CIS患者复发和进展与治疗反应的定义有关的其他问题。数据报告也不一致，有些试验报告了不同时间点的事件发生率，而另一些试验报告了有或没有危险比的事件发生时间。不良事件的报道不一致。大多数试验中都没有QoL数据。

结论：

在NMIBC有效性试验中，异质结果报告很明显。这对荟萃分析，SR和循证治疗决策具有深远的影响。需要核心结果集以减少异质性。

病人总结：

这项系统的审查发现结果定义和报告不一致，指出迫切需要一套核心结果以帮助改善循证治疗决策。

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