Challenges in identifying and quantifying country-level participation in multi-country randomised controlled trials involving Ireland as a collaborating partner

Abstract

AbstractBackground and ObjectiveRandomised controlled trials (RCTs) provide vital information about healthcare interventions. Accurate reporting is vital for effective RCT dissemination. This study aimed to assess the reporting quality of multi-country RCTs, using Ireland as a case study, examining trial characteristics, adherence to reporting standards and the reporting of participation from Ireland.Study Design and SettingThis is a secondary analysis of RCTs identified in a previous observational study of RCTs where ≥80% of participants were recruited in Ireland. This current study focuses on multi-country RCTs with Ireland as a participating country. The current study involved an additional screening process according to these inclusion criteria: RCTs conducted on humans in a healthcare setting with centres based in Ireland, and <80% of participants recruited in Ireland. The primary outcome variables were trial characteristics and reporting rates for: trial registration, use of standardised reporting guidelines, number of Irish centres and number of participants recruited in Ireland. Descriptive statistics were used for analysis.ResultsOverall, 239 RCTs were included. The most common intervention was a drug (74.9% of RCTs). The most common setting was an ambulatory setting (74.1% of RCTs). The most common clinical domain was the cardiovascular system (18.0% of RCTs). Among RCTs published after the CONSORT reporting guideline was published (1996), 8.3% referred to a standardised reporting guideline. Among RCTs published after the International Committee of Medical Journal Editors mandated clinical trial registration (2005), 81.8% provided registration numbers. Number of Irish centres was reported in 75.3% (N=180) of RCTs. Number of participants recruited in Ireland was reported in 27.2% (N=65) of RCTs.ConclusionOur findings show deficits in reporting quality for multi-country RCTs, particularly in referring to reporting guidelines and reporting number of participants for the examined country. Institutions should create policies to ensure transparent RCT dissemination.