Background

Infections are common among patients treated for haematological malignancies and are associated with significant morbidity and mortality. The completeness of reporting infectious complications in randomized controlled trials (RCTs) assessing treatments for haematological malignancies is unknown.

Objectives

We aimed to evaluate the completeness of reporting infectious complications in RCTs assessing treatments for haematological malignancies.

Data source

A systematic literature search was performed in PubMed database.

Study eligibility criteria and participants

All primary published phase II/III RCTs between September 2016 and September 2018 evaluating treatments for haematological malignancies in adult patients were included.

Intervention

Reporting infectious complications.

Methods

A systematic review was conducted to evaluate the completeness of reporting. Study characteristics and data concerning reporting of infectious complications were collected by two independent reviewers. Quality of reporting was assessed using a modification of the CONSORT extension checklist for harms, including 15 items.

Results

One-hundred and seven RCTs were included. Most trials (97; 91%) provided some report on infections. Approximately half reported on each of pneumonia, sepsis and neutropenic fever; 12 trials (11%) reported on fungal infections. Only nine trials (8%) listed infections by type of pathogen (i.e. bacterial, fungal or viral) and 48 (45%) by source/type of infection (i.e. pneumonia, urinary tract infection, etc.). Most trials did not address infections in their title, abstract, introduction or discussion. Median number of items of the CONSORT modification reported was 7 points, (interquartile range (IQR) 6–9) for all included trials, with lower median for 34 acute leukaemia trials (median 6, IQR 5–8).

Conclusions

Most trials evaluating treatment for haematological malignancies provide some data relating to infectious complications. The reports are mostly incomplete and rarely provided in a structured presentation.

中文翻译：

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在血液系统恶性肿瘤患者的临床试验中报告感染

背景

感染在接受血液系统恶性肿瘤治疗的患者中很常见，并且与显着的发病率和死亡率相关。在评估血液系统恶性肿瘤治疗的随机对照试验 (RCT) 中报告感染并发症的完整性尚不清楚。

目标

我们旨在评估在评估血液系统恶性肿瘤治疗的随机对照试验中报告感染并发症的完整性。

数据源

在 PubMed 数据库中进行了系统的文献检索。

研究资格标准和参与者

包括 2016 年 9 月至 2018 年 9 月期间发表的所有主要 II/III 期 RCT，评估成人患者血液系统恶性肿瘤的治疗。

干涉

报告感染并发症。

方法

进行了系统审查以评估报告的完整性。两名独立审查员收集了有关感染并发症报告的研究特征和数据。使用 CONSORT 扩展危害检查表的修改来评估报告的质量，包括 15 个项目。

结果

包括 107 项 RCT。大多数试验（97；91%）提供了一些关于感染的报告。大约一半报告了肺炎、败血症和中性粒细胞减少热；12 项试验（11%）报告了真菌感染。只有 9 项试验（8%）按病原体类型（即细菌、真菌或病毒）列出感染，48 项试验（45%）按感染源/类型（即肺炎、尿路感染等）列出。大多数试验的标题、摘要、介绍或讨论中都没有涉及感染问题。所有纳入试验报告的 CONSORT 修改项目的中位数为 7 分（四分位距 (IQR) 6-9），34 项急性白血病试验的中位数较低（中位数 6，IQR 5-8）。

结论

大多数评估血液系统恶性肿瘤治疗的试验都提供了一些与感染并发症有关的数据。这些报告大多不完整，很少以结构化的形式提供。