Reporting infections in clinical trials of patients with haematological malignancies

Abstract

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.

Keywords: CONSORT; CONSORT harms; Haematological malignancies; Randomized controlled trials.