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Reporting infections in clinical trials of patients with haematological malignancies

N Tau1, L Shargian-Alon2, S Reich3

  • 1Department of Diagnostic Imaging, Chaim Sheba Medical Centre, Ramat Gan, Israel; Sackler School of Medicine, Tel Aviv University, Ramat Aviv, Israel.

Clinical Microbiology and Infection : the Official Publication of the European Society of Clinical Microbiology and Infectious Diseases
|May 18, 2019
PubMed
Abstract

Insights

Reporting of infectious complications in hematological malignancy trials is often incomplete. While most studies mention infections, detailed pathogen or source information is rare, hindering comprehensive understanding.

Area of Science:

  • Oncology
  • Infectious Diseases
  • Clinical Trials Methodology

Background:

  • Infections are a major cause of morbidity and mortality in patients undergoing treatment for hematological malignancies.
  • The extent to which infectious complications are completely reported in clinical trials for these malignancies is not well-established.

Purpose of the Study:

  • To systematically evaluate the completeness of reporting for infectious complications in randomized controlled trials (RCTs) for hematological malignancies.
  • To assess the quality of reporting using a modified CONSORT checklist for harms.

Main Methods:

  • A systematic literature search was conducted on the PubMed database.
  • Included were primary published phase II/III RCTs from September 2016 to September 2018, focusing on adult patients with hematological malignancies.
  • Data on study characteristics and infectious complication reporting were extracted and assessed using a 15-item modified CONSORT checklist.

Main Results:

  • 107 RCTs were analyzed, with 91% reporting some information on infections.
  • Pneumonia, sepsis, and neutropenic fever were reported in about half of the trials; fungal infections were reported in 11%.
  • Detailed reporting by pathogen type (8%) or source/type (45%) was infrequent, and infections were rarely discussed in trial titles, abstracts, or introductions.

Conclusions:

  • While most RCTs for hematological malignancies report on infectious complications, the reporting is predominantly incomplete.
  • Structured presentation of infection data, including pathogen type and source, is lacking in most published trials.
  • Improvements in reporting completeness are needed to better understand infection risks in this patient population.
Keywords:
CONSORTCONSORT harmsHaematological malignanciesRandomized controlled trials

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