Effectiveness of pharmacological treatments for severe agitation in real-world emergency settings: protocol of individual-participant-data network meta-analysis.

Autor: Siafis S; Technical University of Munich, TUM School of Medicine and Health, Department of Psychiatry and Psychotherapy, Klinikum rechts der Isar, Munich, Germany. spyridon.siafis@tum.de.; German Center for Mental Health (DZPG), Partner site München/Augsburg, Munich, Germany. spyridon.siafis@tum.de., Wu H; Technical University of Munich, TUM School of Medicine and Health, Department of Psychiatry and Psychotherapy, Klinikum rechts der Isar, Munich, Germany., Nomura N; Technical University of Munich, TUM School of Medicine and Health, Department of Psychiatry and Psychotherapy, Klinikum rechts der Isar, Munich, Germany.; German Center for Mental Health (DZPG), Partner site München/Augsburg, Munich, Germany.; Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan., Schneider-Thoma J; Technical University of Munich, TUM School of Medicine and Health, Department of Psychiatry and Psychotherapy, Klinikum rechts der Isar, Munich, Germany.; German Center for Mental Health (DZPG), Partner site München/Augsburg, Munich, Germany., Bighelli I; Technical University of Munich, TUM School of Medicine and Health, Department of Psychiatry and Psychotherapy, Klinikum rechts der Isar, Munich, Germany.; German Center for Mental Health (DZPG), Partner site München/Augsburg, Munich, Germany., Lorenz C; Technical University of Munich, TUM School of Medicine and Health, Department of Psychiatry and Psychotherapy, Klinikum rechts der Isar, Munich, Germany., Dib JE; Division of Psychiatry & Applied Psychology, Institute of Mental Health, School of Medicine, University of Nottingham, Nottingham, Nottinghamshire, UK., Tharyan P; Clinical Epidemiology Unit, Christian Medical Centre, Vellore, India., Calver LA; School of Nursing and Midwifery, University of Newcastle, Callaghan, NSW, Australia., Isbister GK; Clinical Toxicology Research Group, University of Newcastle, Newcastle, NSW, Australia., Chan EWY; Department of Pharmacology and Pharmacy, University of Hong Kong, Pok Fu Lam, Hong Kong SAR, China.; Laboratory of Data Discovery for Health (D24H), Science Park, Hong Kong SAR, China.; Department of Pharmacy, HKU-Shenzhen Hospital, Shenzhen, China.; HKU-SZ Institute of Research and Innovation (SIRI), Shenzhen, China., Knott JC; Department of Critical Care, The University of Melbourne, Melbourne, VIC, Australia., Yap CYL; Department of Nursing, Faculty of Medicine, Dentistry and Health Sciences, Melbourne School of Health Sciences, The University of Melbourne, Melbourne, VIC, Australia., Mantovani C; Department of Neurosciences and Behavior, Ribeirao Preto School of Medicine, Universidade de Sao Paulo, São Paulo, Brazil., Martel ML; Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, MN, USA., Barbic D; Department of Emergency Medicine, University of British Columbia, Vancouver, BC, Canada.; Centre for Health Evaluation & Outcomes Sciences, St. Paul's Hospital, Vancouver, BC, Canada., Honer WG; Department of Psychiatry, Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada.; BC Mental Health and Substance Use Services Research Institute, Vancouver, BC, Canada., Hansen WP; BASTA-Das Bündnis für psychisch erkrankte Menschen, Munich, Germany., Huf G; National Institute of Quality Control in Health, Oswaldo Cruz Foundation, Av. Brasil 4365, Manguinhos, Rio de Janeiro, Brazil., Alexander J; SA Health, Adelaide, Australia., Raveendran NS; Department of Psychiatry, Christian Medical College, Vellore, Tamil Nadu, India., Coutinho ESF; Department of Epidemiology, Institute of Social Medicine, State University of Rio de Janeiro, Rio de Janeiro, Brazil., Priller J; Technical University of Munich, TUM School of Medicine and Health, Department of Psychiatry and Psychotherapy, Klinikum rechts der Isar, Munich, Germany.; German Center for Mental Health (DZPG), Partner site München/Augsburg, Munich, Germany.; Neuropsychiatry and Laboratory of Molecular Psychiatry, Charité - Universitätsmedizin Berlin and DZNE, Berlin, Germany.; University of Edinburgh and UK DRI, Edinburgh, UK., Adams CE; Institute of Mental Health, University of Nottingham, Nottingham, Nottinghamshire, UK., Salanti G; Institute of Social and Preventive Medicine (ISPM), University of Bern, Bern, Switzerland., Leucht S; Technical University of Munich, TUM School of Medicine and Health, Department of Psychiatry and Psychotherapy, Klinikum rechts der Isar, Munich, Germany.; German Center for Mental Health (DZPG), Partner site München/Augsburg, Munich, Germany.
Jazyk: angličtina
Zdroj: Systematic reviews [Syst Rev] 2024 Aug 02; Vol. 13 (1), pp. 205. Date of Electronic Publication: 2024 Aug 02.
DOI: 10.1186/s13643-024-02623-z
Abstrakt: Background: Severe psychomotor agitation and aggression often require immediate pharmacological intervention, but clear evidence-based recommendations for choosing among the multiple options are lacking. To address this gap, we plan a systematic review and individual-participant-data network meta-analysis to investigate their comparative effectiveness in real-world emergency settings with increased precision.
Methods: We will include randomized controlled trials investigating intramuscular or intravenous pharmacological interventions, as monotherapy or in combination, in adults with severe psychomotor agitation irrespective of the underlying diagnosis and requiring rapid tranquilization in general or psychiatric emergency settings. We will exclude studies before 2002, those focusing on specific reasons for agitation and placebo-controlled trials to avoid concerns related to the transitivity assumption and potential selection biases. We will search for eligible studies in BIOSIS, CENTRAL, CINAHL Plus, Embase, LILACS, MEDLINE via Ovid, PubMed, ProQuest, PsycINFO, ClinicalTrials.gov, and WHO-ICTRP. Individual-participant data will be requested from the study authors and harmonized into a uniform format, and aggregated data will also be extracted from the studies. At least two independent reviewers will conduct the study selection, data extraction, risk-of-bias assessment using RoB 2, and applicability evaluation using the RITES tool. The primary outcome will be the number of patients achieving adequate sedation within 30 min after treatment, with secondary outcomes including the need for additional interventions and adverse events, using odds ratios as the effect size. If enough individual-participant data will be collected, we will synthesize them in a network meta-regression model within a Bayesian framework, incorporating study- and participant-level characteristics to explore potential sources of heterogeneity. In cases where individual-participant data are unavailable, potential data availability bias will be explored, and models allowing for the inclusion of studies reporting only aggregated data will be considered. We will assess the confidence in the evidence using the Confidence in Network Meta-Analysis (CINeMA) approach.
Discussion: This individual-participant-data network meta-analysis aims to provide a fine-tuned synthesis of the evidence on the comparative effectiveness of pharmacological interventions for severe psychomotor agitation in real-world emergency settings. The findings from this study can greatly be provided clearer evidence-based guidance on the most effective treatments.
Systematic Review Registration: PROSPERO CRD42023402365.
(© 2024. The Author(s).)
Databáze: MEDLINE
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