Clinical ethics support services in paediatric practice: protocol for a mixed studies systematic review on structures, interventions and outcomes

INTRODUCTION: Clinical ethics support services (CESS) have been developing worldwide with growing interest in evaluating their quality. Paediatric-specific CESSs (p-CESS) have received little attention, and evidence from adult services might not be generalisable. Evidence on service models and practices is crucial to inform further research and debate on quality evaluation and minimum standards for p-CESSs. We aim to systematically identify, appraise and synthesise evidence for p-CESS structures, processes and outcomes. METHODS AND ANALYSIS: We will conduct a mixed-studies systematic review including peer-reviewed empirical studies published in English or Spanish language providing data on the evaluation and/or impact on any aspect of p-CESS. We will search seven electronic databases: MEDLINE, Philosopher’s Index, EMBASE, PsycINFO, LILACS, Web of Science and CINHAL, without filters applied. Search terms will be related to “clinical ethics support” AND “paediatrics” AND “structure/process/outcome”. Reference and citation list of included studies will be handsearched. A 10% random sample of retrieved titles/abstracts and all full texts will be independently dual-screened. We will conduct narrative and thematic synthesis for quantitative and qualitative data, respectively, following sequential explanatory synthesis guided by Donabedian’s framework of structure, process and outcomes. Quality will be assessed using the Mixed-Methods Appraisal Tool (2018). The review will be reported using the adapted Preferred Reporting Items for Systematic Reviews and Meta-Analyses for reporting systematic reviews of qualitative and quantitative evidence template. Stakeholders will be involved twice in the review process; prior to data extraction and synthesis and after preliminary results. ETHICS AND DISSEMINATION: As a systematic review of published data, no ethical approval is necessary. Results will be published in a relevant academic peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42021280978.