Review methods

The PICUtrials database is part of an ongoing scoping review that uses comprehensive search strategies to identify published RCTs in pediatric critical care. This review was completed and published in 2013. Since then we have updated the searches quarterly — adding newly published RCTs.

Objective

The objective of this scoping review is to systematically identify and describe RCTs in pediatric critical care and make them readily accessible to clinicians and researchers.

Trial eligibility

We included studies published in any language that were:

  • RCTs or quasi-randomized trials
  • reporting the effect of any intervention in a pediatric intensive care unit on children or their families

We excluded studies that were:

  • enrolling exclusively preterm infants or infants in a neonatal intensive care unit
  • individual patient crossover trials
  • published only as abstracts.
  • substudies and secondary publications of included RCTs.

Definitions and assumptions:

  • We used the authors’ definitions of pediatric
  • We considered a unit to be an intensive or critical care unit if the authors described it as such AND it had the capacity to provide mechanical ventilation
  • We used the most recent publication for trials that were reported in multiple publication
  • We included trials in which critically ill children were a subgroup only if the demographic and outcome data for the critically ill children were reported separately

Searching

We search MEDLINE, EMBASE, LILACS and CENTRAL the first week of each January, April, July and October.

To identify RCTs we used previously tested search strategies for MEDLINE (the Cochrane Highly Sensitive Search Strategy, sensitivity- and precision-maximizing version), EMBASE and LILACS. To identify studies enrolling children in MEDLINE we used a previously tested strategy and adapted for the other databases. We then added search terms related to pediatric critical care; see below for the specific strategies we use.

To identify other potentially relevant trials, we also examined the reference lists of all included RCTs, systematic reviews identified by our searches, and the researchers’ personal files.

Study selection and data extraction

We developed an electronic data collection tool using DistillerSR™ (Evidence Partners Incorporated, Ottawa, ON, Canada) and an accompanying screening and data extraction manual. To increase consistency among reviewers, all reviewers screened the same 50 publications, discussed the results and amended the screening and data extraction manual before beginning screening for this review. Twelve reviewers working in pairs sequentially evaluated the titles, abstracts and then full text of all publications identified by our searches for potentially relevant publications. Reviewers then worked in pairs to independently and in duplicate extract data from the included trials using a pretested electronic data collection tool.

We recruited other individuals with a clinical or research methodology background to screen and extract data from non-English trials. We were not able to complete duplicate data extraction for two trials because of the language of publication. We resolved disagreements on study selection and data extraction by consensus and discussion with other reviewers if needed. We extracted data from the main trial publication and any supplemental materials.

Risk of bias assessment

We used the Cochrane Risk of Bias Tool to describe the risk of bias for the included trials. This tool rates each trial as low, unclear, or high risk of bias for each of the following factors: sequence generation; allocation concealment; blinding of participants and personnel; blinding of outcome assessment; incomplete outcome data; selective outcome reporting; and other sources of bias. We then classified the overall risk of bias for each trial as low (low risk of bias in all domains), high (high risk of bias in at least one domain), or unclear.

Impact

We use Web of Science to identify the number of times each publication has been cited per year since publication.

Search strategies

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