Clinical diversity in trials from a Cochrane systematic review of targeted oxygen therapy in the intensive care unit – protocol for a systematic evaluation
Autor: | Thomas Lass Klitgaard, Bodil Steen Rasmussen, Olav Lilleholt Schjørring, Frederik Mølgaard Nielsen, Elena Crescioli, Jørn Wetterslev, Marija Barbateskovic |
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Jazyk: | angličtina |
Rok vydání: | 2022 |
Předmět: | |
ISSN: | 0000-0000 |
DOI: | 10.5281/zenodo.6683688 |
Popis: | Introduction Oxygen therapy is used extensively in the intensive care unit (ICU) to prevent or treat hypoxaemia. However, the current evidence is insufficient to determine the optimum dosage of supplementary oxygen, and conducted meta-analyses of randomised clinical trials assume comparability across clinical aspects of included trials without accounting for potential clinical diversity. Objectives We aim to assess the potential clinical diversity of trials identified in a recent Cochrane review evaluating higher versus lower oxygenation strategies in the ICU and ascertain the implications for the interpretation of the current evidence on this topic. Methods We will update the search from the Cochrane review to ensure all recently published trial results have been included. We will systematically search the Cochrane Trial database (CENTRAL), MEDLINE, Embase, Science Citation Index, BIOSIS Previews, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Latin American and Caribbean Health Sciences Literature (LILACS), clinicaltrials.gov, International Clinical Trials Registry Platform (ICTRP), EU Clinical Trials Register, and the Australian New Zealand Clinical Trials Registry (ANZCTR) for relevant trials. Reference lists of included trial reports, reviews, relevant papers, randomised and non-randomised trials, and editorials will be screened for potential additional relevant trials. Meta-analyses will be performed on the outcomes all-cause mortality, serious adverse events, and quality of life. We will use a novel tool to map and assess the clinical diversity of trials in meta-analyses that scores diversity in four domains: setting, population, intervention, and outcome. A total of 11 items are covered by the tool: years reported, performed in developed vs developing country, and unit type; age; sex; inclusion criteria and baseline severity of illness; comorbidities; diversity of intervention; timing; control intervention; cointerventions; definitions of outcomes; and timing of outcome measurement. We will explore the possible impact of clinical diversity using subgroup meta-analyses and meta-regression analyses where appropriate. Dissemination The results of this study will be published regardless of the findings, preferably in a relevant, high-quality, peer-reviewed journal. Clinical Diversity In Meta-analyses of interventions {"references":["Helmerhorst HJF, Arts DL, Schultz MJ, et al. Metrics of arterial hyperoxia and associated outcomes in critical care. Critical Care Medicine. 2017;45(2):187–95. doi:10.1097/CCM.0000000000002084","Palmer E, Post B, Klapaukh R, et al. 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