Shortcomings in reporting country-level participation in multicenter randomized controlled trials involving Ireland as a collaborating partner: a metaresearch study

A randomized controlled trial is a way of assessing the benefits of a medical intervention (like a treatment for a health issue). Randomized trials have at least two different treatment groups. The people taking part are put into one of the groups at random. This process is called "randomization" and is usually done by a computer. These trials are often conducted with people recruited from multiple countries, and Ireland is a country that sometimes plays a role. The key details about trials, such as the number of participants from each country, are often missing from publications related to trials. Information about the number of participants from each country is important, because it shows how applicable the results are to that country or similar countries. We want to find out if trials involving Ireland provide details of how many people from Ireland or how many healthcare centers in Ireland took part in the trial. We did this by looking through the researchers' main publication about the trials and seeing what information they reported. We found 239 trials published between 1968 and 2019, and among those, only 27% detailed the number of participants in Ireland. Three-quarters (75%) of the trials detailed the number of Irish healthcare centers involved. Some researchers are developing a checklist for how to report details of trials conducted across multiple countries; this may help address the shortcomings in the reporting discussed above. In general, those who fund research, publish research, regulate research, and employ researchers need to ensure there are adequate rules and incentives in place so that all relevant information about a trial is published.