Mark P Cote, James H Lubowitz, Michael J Rossi, Elizabeth Matzkin
{"title":"The Fragility Index Is Typically Misinterpreted and of Low Value: Clinical Trials Are Designed to Be Fragile.","authors":"Mark P Cote, James H Lubowitz, Michael J Rossi, Elizabeth Matzkin","doi":"10.1016/j.arthro.2024.08.003","DOIUrl":null,"url":null,"abstract":"<p><p>The Fragility Index (FI) is defined as the number of patients whose outcome would need to change to reverse a statistically significant finding to a nonsignificant finding. The FI is nothing more than a repackaging of statistical significance based on the P value, perpetuating the (1) ignoring of results that are \"not\" statistically significant; (2) treating results that are statistically significant as certain; and (3) distracting from evaluation of clinical significance. A well-designed trial includes a sample size calculation to determine the minimum number of patients required to observe a difference between study groups (if a difference exists). By including this minimum number, clinical trials are designed to be fragile, yet subsequently criticized as such, leading readers to the incorrect conclusion that the studies are flawed. It's time to move past systematic reviews focused on the FI.</p>","PeriodicalId":55459,"journal":{"name":"Arthroscopy-The Journal of Arthroscopic and Related Surgery","volume":null,"pages":null},"PeriodicalIF":4.4000,"publicationDate":"2024-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Arthroscopy-The Journal of Arthroscopic and Related Surgery","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.arthro.2024.08.003","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ORTHOPEDICS","Score":null,"Total":0}
引用次数: 0
Abstract
The Fragility Index (FI) is defined as the number of patients whose outcome would need to change to reverse a statistically significant finding to a nonsignificant finding. The FI is nothing more than a repackaging of statistical significance based on the P value, perpetuating the (1) ignoring of results that are "not" statistically significant; (2) treating results that are statistically significant as certain; and (3) distracting from evaluation of clinical significance. A well-designed trial includes a sample size calculation to determine the minimum number of patients required to observe a difference between study groups (if a difference exists). By including this minimum number, clinical trials are designed to be fragile, yet subsequently criticized as such, leading readers to the incorrect conclusion that the studies are flawed. It's time to move past systematic reviews focused on the FI.
期刊介绍:
Nowhere is minimally invasive surgery explained better than in Arthroscopy, the leading peer-reviewed journal in the field. Every issue enables you to put into perspective the usefulness of the various emerging arthroscopic techniques. The advantages and disadvantages of these methods -- along with their applications in various situations -- are discussed in relation to their efficiency, efficacy and cost benefit. As a special incentive, paid subscribers also receive access to the journal expanded website.