Characteristics, reporting, risk of bias and pragmatism in prehospital emergency care randomised trials from 2010 to 2024 : a protocol for a meta-epidemiological study

Abstract

Introduction Prehospital emergency care (PEC) requires rapid evidence-based decisions to maximise the effectiveness of care and to improve clinical outcomes. There are multiple challenges related to clinical research performed in the PEC setting. The aim of our study is to systematically review and assess the characteristics, quality of reporting, risk of bias and pragmatism in recent PEC trials, thereby identifying potential gaps and strengths that can guide the design of future prehospital studies.

Methods and analysis We will systematically search databases MEDLINE, Embase and Cochrane CENTRAL to identify all randomised controlled trials conducted in the field of PEC and published in English language between 2010 and 2024. No restrictions will be made to the participants, interventions and outcomes. Risk of bias will be evaluated using the Cochrane Risk of Bias 2 tool. The level of pragmatism will be assessed using the Pragmatic-Explanatory Continuum Indicator Summary-2 score. Exploratory data analysis will be used to investigate and summarise main patterns. Differences in characteristics between PEC fields, study designs, publication year and associations between pragmatism levels, risk of bias and quality of reporting will be the primary focus.

Ethics and dissemination There are no ethical concerns directly relevant to this review. This study has been previously registered with the Open Science Framework (osf.io/rzn9j). The manuscript will be submitted for publication to a relevant, peer-reviewed journal.