{"title":"动脉瘤性蛛网膜下腔出血干预措施随机对照试验中的脆性指数：系统综述。","authors":"Aravind V Ramesh, Henry Np Munby, Matt Thomas","doi":"10.1177/17511437231218199","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Fragility analysis supplements the <i>p</i>-value and risk of bias assessment in the interpretation of results of randomised controlled trials. In this systematic review we determine the fragility index (FI) and fragility quotient (FQ) of randomised trials in aneurysmal subarachnoid haemorrhage.</p><p><strong>Methods: </strong>This is a systematic review registered with PROSPERO (ID: CRD42020173604). Randomised controlled trials in adults with aneurysmal subarachnoid haemorrhage were analysed if they reported a statistically significant primary outcome of mortality, function (e.g. modified Rankin Scale), vasospasm or delayed neurological deterioration.</p><p><strong>Results: </strong>We identified 4825 records with 18 randomised trials selected for analysis. The median fragility index was 2.5 (inter-quartile range 0.25-5) and the median fragility quotient was 0.015 (IQR 0.02-0.039). Five of 20 trial outcomes (25%) had a fragility index of 0. In seven trials (39.0%), the number of participants lost to follow-up was greater than or equal to the fragility index. Only 16.7% of trials are at low risk of bias.</p><p><strong>Conclusion: </strong>Randomised controlled trial evidence supporting management of aneurysmal subarachnoid haemorrhage is weaker than indicated by conventional analysis using <i>p</i>-values alone. Increased use of fragility analysis by clinicians and researchers could improve the translation of evidence to practice.</p>","PeriodicalId":39161,"journal":{"name":"Journal of the Intensive Care Society","volume":"25 2","pages":"164-170"},"PeriodicalIF":2.1000,"publicationDate":"2023-12-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11086711/pdf/","citationCount":"0","resultStr":"{\"title\":\"The fragility index in randomised controlled trials of interventions for aneurysmal subarachnoid haemorrhage: A systematic review.\",\"authors\":\"Aravind V Ramesh, Henry Np Munby, Matt Thomas\",\"doi\":\"10.1177/17511437231218199\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Fragility analysis supplements the <i>p</i>-value and risk of bias assessment in the interpretation of results of randomised controlled trials. In this systematic review we determine the fragility index (FI) and fragility quotient (FQ) of randomised trials in aneurysmal subarachnoid haemorrhage.</p><p><strong>Methods: </strong>This is a systematic review registered with PROSPERO (ID: CRD42020173604). Randomised controlled trials in adults with aneurysmal subarachnoid haemorrhage were analysed if they reported a statistically significant primary outcome of mortality, function (e.g. modified Rankin Scale), vasospasm or delayed neurological deterioration.</p><p><strong>Results: </strong>We identified 4825 records with 18 randomised trials selected for analysis. The median fragility index was 2.5 (inter-quartile range 0.25-5) and the median fragility quotient was 0.015 (IQR 0.02-0.039). Five of 20 trial outcomes (25%) had a fragility index of 0. In seven trials (39.0%), the number of participants lost to follow-up was greater than or equal to the fragility index. Only 16.7% of trials are at low risk of bias.</p><p><strong>Conclusion: </strong>Randomised controlled trial evidence supporting management of aneurysmal subarachnoid haemorrhage is weaker than indicated by conventional analysis using <i>p</i>-values alone. Increased use of fragility analysis by clinicians and researchers could improve the translation of evidence to practice.</p>\",\"PeriodicalId\":39161,\"journal\":{\"name\":\"Journal of the Intensive Care Society\",\"volume\":\"25 2\",\"pages\":\"164-170\"},\"PeriodicalIF\":2.1000,\"publicationDate\":\"2023-12-28\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11086711/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of the Intensive Care Society\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1177/17511437231218199\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/5/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q3\",\"JCRName\":\"CRITICAL CARE MEDICINE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of the Intensive Care Society","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1177/17511437231218199","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/5/1 0:00:00","PubModel":"eCollection","JCR":"Q3","JCRName":"CRITICAL CARE MEDICINE","Score":null,"Total":0}
The fragility index in randomised controlled trials of interventions for aneurysmal subarachnoid haemorrhage: A systematic review.
Background: Fragility analysis supplements the p-value and risk of bias assessment in the interpretation of results of randomised controlled trials. In this systematic review we determine the fragility index (FI) and fragility quotient (FQ) of randomised trials in aneurysmal subarachnoid haemorrhage.
Methods: This is a systematic review registered with PROSPERO (ID: CRD42020173604). Randomised controlled trials in adults with aneurysmal subarachnoid haemorrhage were analysed if they reported a statistically significant primary outcome of mortality, function (e.g. modified Rankin Scale), vasospasm or delayed neurological deterioration.
Results: We identified 4825 records with 18 randomised trials selected for analysis. The median fragility index was 2.5 (inter-quartile range 0.25-5) and the median fragility quotient was 0.015 (IQR 0.02-0.039). Five of 20 trial outcomes (25%) had a fragility index of 0. In seven trials (39.0%), the number of participants lost to follow-up was greater than or equal to the fragility index. Only 16.7% of trials are at low risk of bias.
Conclusion: Randomised controlled trial evidence supporting management of aneurysmal subarachnoid haemorrhage is weaker than indicated by conventional analysis using p-values alone. Increased use of fragility analysis by clinicians and researchers could improve the translation of evidence to practice.
期刊介绍：
The Journal of the Intensive Care Society (JICS) is an international, peer-reviewed journal that strives to disseminate clinically and scientifically relevant peer-reviewed research, evaluation, experience and opinion to all staff working in the field of intensive care medicine. Our aim is to inform clinicians on the provision of best practice and provide direction for innovative scientific research in what is one of the broadest and most multi-disciplinary healthcare specialties. While original articles and systematic reviews lie at the heart of the Journal, we also value and recognise the need for opinion articles, case reports and correspondence to guide clinically and scientifically important areas in which conclusive evidence is lacking. The style of the Journal is based on its founding mission statement to ‘instruct, inform and entertain by encompassing the best aspects of both tabloid and broadsheet''.
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