Chase Meyer, Aaron Bowers, Daniel Tritz, Kaleb Fuller, C. Wayant, Courtney Cook, Trevor Torgerson, M. Som, M. Vassar
{"title":"消化不良和幽门螺杆菌感染管理的随机试验结果的脆弱性。","authors":"Chase Meyer, Aaron Bowers, Daniel Tritz, Kaleb Fuller, C. Wayant, Courtney Cook, Trevor Torgerson, M. Som, M. Vassar","doi":"10.1097/XEB.0000000000000203","DOIUrl":null,"url":null,"abstract":"AIM\nThe fragility index is calculated by changing one outcome event to a nonevent within a trial until the associated P value exceeds 0.05. In this study, we assessed the robustness, risk of bias (RoB), and power of randomized controlled trials that underlie recommendations set forth by the American College of Gastroenterology (ACG) on managing dyspepsia and Helicobacter pylori infections.\n\n\nMETHODS\nAll citations referenced in the guidelines were screened for inclusion criteria. The fragility indexes for eligible trials were then calculated. The likelihood and sources of bias in the included trials were evaluated by the Cochrane 'RoB' Tool 2.0.\n\n\nRESULTS\nThe median fragility index for the 52 trials was three events. Five studies (9.6%) resulted in a fragility index of 0 when statistical analysis was applied. For the 52 trials, 12 (23.1%) were at a low RoB, 15 (28.8%) had some concerns, and 25 (48.1%) were at a high RoB. High RoB was most commonly due to bias of selection in the reported result (15.5%).\n\n\nCONCLUSION\nA median of three events was needed to nullify statistical significance in 52 trials that underpin guideline recommendations on the management of dyspepsia and H. pylori infections. In addition, concerns for RoB were found for these trials.","PeriodicalId":55996,"journal":{"name":"International Journal of Evidence-Based Healthcare","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2020-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"4","resultStr":"{\"title\":\"The fragility of randomized trial outcomes underlying management of dyspepsia and Helicobacter pylori infections.\",\"authors\":\"Chase Meyer, Aaron Bowers, Daniel Tritz, Kaleb Fuller, C. Wayant, Courtney Cook, Trevor Torgerson, M. Som, M. Vassar\",\"doi\":\"10.1097/XEB.0000000000000203\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"AIM\\nThe fragility index is calculated by changing one outcome event to a nonevent within a trial until the associated P value exceeds 0.05. In this study, we assessed the robustness, risk of bias (RoB), and power of randomized controlled trials that underlie recommendations set forth by the American College of Gastroenterology (ACG) on managing dyspepsia and Helicobacter pylori infections.\\n\\n\\nMETHODS\\nAll citations referenced in the guidelines were screened for inclusion criteria. The fragility indexes for eligible trials were then calculated. The likelihood and sources of bias in the included trials were evaluated by the Cochrane 'RoB' Tool 2.0.\\n\\n\\nRESULTS\\nThe median fragility index for the 52 trials was three events. Five studies (9.6%) resulted in a fragility index of 0 when statistical analysis was applied. For the 52 trials, 12 (23.1%) were at a low RoB, 15 (28.8%) had some concerns, and 25 (48.1%) were at a high RoB. High RoB was most commonly due to bias of selection in the reported result (15.5%).\\n\\n\\nCONCLUSION\\nA median of three events was needed to nullify statistical significance in 52 trials that underpin guideline recommendations on the management of dyspepsia and H. pylori infections. In addition, concerns for RoB were found for these trials.\",\"PeriodicalId\":55996,\"journal\":{\"name\":\"International Journal of Evidence-Based Healthcare\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2020-03-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"4\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Evidence-Based Healthcare\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1097/XEB.0000000000000203\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Evidence-Based Healthcare","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1097/XEB.0000000000000203","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"Medicine","Score":null,"Total":0}
The fragility of randomized trial outcomes underlying management of dyspepsia and Helicobacter pylori infections.
AIM
The fragility index is calculated by changing one outcome event to a nonevent within a trial until the associated P value exceeds 0.05. In this study, we assessed the robustness, risk of bias (RoB), and power of randomized controlled trials that underlie recommendations set forth by the American College of Gastroenterology (ACG) on managing dyspepsia and Helicobacter pylori infections.
METHODS
All citations referenced in the guidelines were screened for inclusion criteria. The fragility indexes for eligible trials were then calculated. The likelihood and sources of bias in the included trials were evaluated by the Cochrane 'RoB' Tool 2.0.
RESULTS
The median fragility index for the 52 trials was three events. Five studies (9.6%) resulted in a fragility index of 0 when statistical analysis was applied. For the 52 trials, 12 (23.1%) were at a low RoB, 15 (28.8%) had some concerns, and 25 (48.1%) were at a high RoB. High RoB was most commonly due to bias of selection in the reported result (15.5%).
CONCLUSION
A median of three events was needed to nullify statistical significance in 52 trials that underpin guideline recommendations on the management of dyspepsia and H. pylori infections. In addition, concerns for RoB were found for these trials.
期刊介绍:
The International Journal of Evidence-Based Healthcare is the official journal of the Joanna Briggs Institute. It is a fully refereed journal that publishes manuscripts relating to evidence-based medicine and evidence-based practice. It publishes papers containing reliable evidence to assist health professionals in their evaluation and decision-making, and to inform health professionals, students and researchers of outcomes, debates and developments in evidence-based medicine and healthcare.
The journal provides a unique home for publication of systematic reviews (quantitative, qualitative, mixed methods, economic, scoping and prevalence) and implementation projects including the synthesis, transfer and utilisation of evidence in clinical practice. Original scholarly work relating to the synthesis (translation science), transfer (distribution) and utilization (implementation science and evaluation) of evidence to inform multidisciplinary healthcare practice is considered for publication. The journal also publishes original scholarly commentary pieces relating to the generation and synthesis of evidence for practice and quality improvement, the use and evaluation of evidence in practice, and the process of conducting systematic reviews (methodology) which covers quantitative, qualitative, mixed methods, economic, scoping and prevalence methods. In addition, the journal’s content includes implementation projects including the transfer and utilisation of evidence in clinical practice as well as providing a forum for the debate of issues surrounding evidence-based healthcare.