Sarah Sofie Bitsch Flyger, Sandra Sorenson, Lasse Pingel, Anders Peder Højer Karlsen, Anders Kehlet Nørskov, Ole Mathiesen, Mathias Maagaard
{"title":"评估周围神经阻滞辅助药物的随机临床试验的主要结果和预期效应大小：范围综述。","authors":"Sarah Sofie Bitsch Flyger, Sandra Sorenson, Lasse Pingel, Anders Peder Højer Karlsen, Anders Kehlet Nørskov, Ole Mathiesen, Mathias Maagaard","doi":"10.1111/aas.14489","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Prolonging effects of adjuncts to local anaesthetics in peripheral nerve blocks have been demonstrated in randomised clinical trials. The chosen primary outcome and anticipated effect size have major impact on the clinical relevance of results in these trials. This scoping review aims to provide an overview of frequently used outcomes and anticipated effect sizes in randomised trials on peripheral nerve block adjuncts.</p><p><strong>Methods: </strong>For our scoping review, we searched MEDLINE, Embase and CENTRAL for trials assessing effects of adjuncts for peripheral nerve blocks published in 10 major anaesthesia journals. We included randomised clinical trials assessing adjuncts for single-shot ultrasound-guided peripheral nerve blocks, regardless of the type of interventional adjunct and control group, local anaesthetic used and anatomical localization. Our primary outcome was the choice of primary outcomes and corresponding anticipated effect size used for sample size estimation. Secondary outcomes were assessor of primary outcomes, the reporting of sample size calculations and statistically significant and non-significant results related to the anticipated effect sizes.</p><p><strong>Results: </strong>Of 11,854 screened trials, we included 59. The most frequent primary outcome was duration of analgesia (35/59 trials, 59%) with absolute and relative median (interquartile range) anticipated effect sizes for adjunct versus placebo/no adjunct: 240 min (180-318) and 30% (25-40) and for adjunct versus active comparator: 210 min (180-308) and 17% (15-28). Adequate sample size calculations were reported in 78% of trials. Statistically significant results were reported for primary outcomes in 45/59 trials (76%), of which 22% did not reach the anticipated effect size.</p><p><strong>Conclusion: </strong>The reported outcomes and associated anticipated effect sizes can be used in future trials on adjuncts for peripheral nerve blocks to increase methodological homogeneity.</p>","PeriodicalId":6909,"journal":{"name":"Acta Anaesthesiologica Scandinavica","volume":" ","pages":"1293-1305"},"PeriodicalIF":1.9000,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Primary outcomes and anticipated effect sizes in randomised clinical trials assessing adjuncts to peripheral nerve blocks: A scoping review.\",\"authors\":\"Sarah Sofie Bitsch Flyger, Sandra Sorenson, Lasse Pingel, Anders Peder Højer Karlsen, Anders Kehlet Nørskov, Ole Mathiesen, Mathias Maagaard\",\"doi\":\"10.1111/aas.14489\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Prolonging effects of adjuncts to local anaesthetics in peripheral nerve blocks have been demonstrated in randomised clinical trials. The chosen primary outcome and anticipated effect size have major impact on the clinical relevance of results in these trials. This scoping review aims to provide an overview of frequently used outcomes and anticipated effect sizes in randomised trials on peripheral nerve block adjuncts.</p><p><strong>Methods: </strong>For our scoping review, we searched MEDLINE, Embase and CENTRAL for trials assessing effects of adjuncts for peripheral nerve blocks published in 10 major anaesthesia journals. We included randomised clinical trials assessing adjuncts for single-shot ultrasound-guided peripheral nerve blocks, regardless of the type of interventional adjunct and control group, local anaesthetic used and anatomical localization. Our primary outcome was the choice of primary outcomes and corresponding anticipated effect size used for sample size estimation. Secondary outcomes were assessor of primary outcomes, the reporting of sample size calculations and statistically significant and non-significant results related to the anticipated effect sizes.</p><p><strong>Results: </strong>Of 11,854 screened trials, we included 59. The most frequent primary outcome was duration of analgesia (35/59 trials, 59%) with absolute and relative median (interquartile range) anticipated effect sizes for adjunct versus placebo/no adjunct: 240 min (180-318) and 30% (25-40) and for adjunct versus active comparator: 210 min (180-308) and 17% (15-28). Adequate sample size calculations were reported in 78% of trials. Statistically significant results were reported for primary outcomes in 45/59 trials (76%), of which 22% did not reach the anticipated effect size.</p><p><strong>Conclusion: </strong>The reported outcomes and associated anticipated effect sizes can be used in future trials on adjuncts for peripheral nerve blocks to increase methodological homogeneity.</p>\",\"PeriodicalId\":6909,\"journal\":{\"name\":\"Acta Anaesthesiologica Scandinavica\",\"volume\":\" \",\"pages\":\"1293-1305\"},\"PeriodicalIF\":1.9000,\"publicationDate\":\"2024-11-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Acta Anaesthesiologica Scandinavica\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1111/aas.14489\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/7/8 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"ANESTHESIOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Acta Anaesthesiologica Scandinavica","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1111/aas.14489","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/7/8 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"ANESTHESIOLOGY","Score":null,"Total":0}
Primary outcomes and anticipated effect sizes in randomised clinical trials assessing adjuncts to peripheral nerve blocks: A scoping review.
Background: Prolonging effects of adjuncts to local anaesthetics in peripheral nerve blocks have been demonstrated in randomised clinical trials. The chosen primary outcome and anticipated effect size have major impact on the clinical relevance of results in these trials. This scoping review aims to provide an overview of frequently used outcomes and anticipated effect sizes in randomised trials on peripheral nerve block adjuncts.
Methods: For our scoping review, we searched MEDLINE, Embase and CENTRAL for trials assessing effects of adjuncts for peripheral nerve blocks published in 10 major anaesthesia journals. We included randomised clinical trials assessing adjuncts for single-shot ultrasound-guided peripheral nerve blocks, regardless of the type of interventional adjunct and control group, local anaesthetic used and anatomical localization. Our primary outcome was the choice of primary outcomes and corresponding anticipated effect size used for sample size estimation. Secondary outcomes were assessor of primary outcomes, the reporting of sample size calculations and statistically significant and non-significant results related to the anticipated effect sizes.
Results: Of 11,854 screened trials, we included 59. The most frequent primary outcome was duration of analgesia (35/59 trials, 59%) with absolute and relative median (interquartile range) anticipated effect sizes for adjunct versus placebo/no adjunct: 240 min (180-318) and 30% (25-40) and for adjunct versus active comparator: 210 min (180-308) and 17% (15-28). Adequate sample size calculations were reported in 78% of trials. Statistically significant results were reported for primary outcomes in 45/59 trials (76%), of which 22% did not reach the anticipated effect size.
Conclusion: The reported outcomes and associated anticipated effect sizes can be used in future trials on adjuncts for peripheral nerve blocks to increase methodological homogeneity.
期刊介绍：
Acta Anaesthesiologica Scandinavica publishes papers on original work in the fields of anaesthesiology, intensive care, pain, emergency medicine, and subjects related to their basic sciences, on condition that they are contributed exclusively to this Journal. Case reports and short communications may be considered for publication if of particular interest; also letters to the Editor, especially if related to already published material. The editorial board is free to discuss the publication of reviews on current topics, the choice of which, however, is the prerogative of the board. Every effort will be made by the Editors and selected experts to expedite a critical review of manuscripts in order to ensure rapid publication of papers of a high scientific standard.
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