Fragility of Randomized Controlled Trials for Treatment of Proximal Humerus Fracture. (Record no. 699)

MARC details
000 -LEADER
fixed length control field 03997nam a22004217a 4500
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 220316s20222022 xxu||||| |||| 00| 0 eng d
022 ## - INTERNATIONAL STANDARD SERIAL NUMBER
International Standard Serial Number 1058-2746
024 ## - OTHER STANDARD IDENTIFIER
Standard number or code 10.1016/j.jse.2022.01.141 [doi]
024 ## - OTHER STANDARD IDENTIFIER
Standard number or code S1058-2746(22)00259-2 [pii]
040 ## - CATALOGING SOURCE
Original cataloging agency Ovid MEDLINE(R)
099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC)
PMID 35240302
245 ## - TITLE STATEMENT
Title Fragility of Randomized Controlled Trials for Treatment of Proximal Humerus Fracture.
251 ## - Source
Source Journal of Shoulder & Elbow Surgery. 2022 Feb 28
252 ## - Abbreviated Source
Abbreviated source J Shoulder Elbow Surg. 2022 Feb 28
253 ## - Journal Name
Journal name Journal of shoulder and elbow surgery
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Year 2022
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Manufacturer FY2022
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Publication date 2022 Feb 28
265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE]
Publication status aheadofprint
266 ## - Date added to catalog
Date added to catalog 2022-03-17
501 ## - WITH NOTE
Local holdings Available online from MWHC library: 1995 - present, Available in print through MWHC library:2004 - 2007
520 ## - SUMMARY, ETC.
Abstract BACKGROUND: Proximal humerus fracture represents an increasingly common pathology with evaluation and treatment often guided by evidence from randomized controlled trials (RCTs), but the strength of an RCT must be considered in this process. The purpose of this study was to evaluate the strength of outcomes in RCTs on the management of proximal humerus fractures using the fragility index (FI), a method used with statistically significant, dichotomous outcomes to assess the number of patients that would change an outcome measure from significant (P <= .05) to nonsignificant if the patient outcome changed. We also aimed to correlate the FI with other measures of study strength.
520 ## - SUMMARY, ETC.
Abstract CONCLUSION: In most studies of proximal humerus fractures, only 1 or 2 patients experiencing an alternative outcome or lost to follow-up would change the conclusions for the dichotomous outcome studied. Although the FI cannot be used to assess continuous variables, which are often the primary outcome variable of RCTs, it does offer an additional unique measure of study strength that surgeons should consider when evaluating RCTs.
520 ## - SUMMARY, ETC.
Abstract LEVEL OF EVIDENCE: Basic Science; Research Methodology, Systematic Review. Copyright © 2022. Published by Elsevier Inc.
520 ## - SUMMARY, ETC.
Abstract METHODS: A systematic review was performed using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines to evaluate RCTs on the management of proximal humerus fractures. PubMed, Ovid MEDLINE, Web of Science, and Embase were searched from database inception to May 2021. Randomized controlled trials with at least one statistically significant (P <= .05) dichotomous outcome were included. The FI was calculated for each included trial using Fisher's exact test. FI was correlated with study sample size and journal impact factor.
520 ## - SUMMARY, ETC.
Abstract RESULTS: Ten RCTs reporting on 656 patients and published between 2011 and 2020 were included. The median sample size was 67 patients (mean: 65.6; range: 40-86). Complications were the most commonly reported dichotomous statistically significant outcome. The median FI was 1 (mean: 2.6; range: 0-18), with four of the studies having a fragility index of zero. A median FI of 1 indicates that 1 patient experiencing an alternative outcome or having not been lost to follow-up could have changed the pertinent conclusions of the trial for that outcome. The median number of patients lost to follow-up was 3 (mean: 4.9; range: 0-16) and exceeded the FI in 50% of studies. There was no correlation between FI and sample size (Spearman coefficient, 0.0592; P = .865) or between FI or journal impact factor (Spearman coefficient,-0.0229; P = .522).
546 ## - LANGUAGE NOTE
Language note English
651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME
Institution MedStar Union Memorial Hospital
656 ## - INDEX TERM--OCCUPATION
Department General Surgery Residency
656 ## - INDEX TERM--OCCUPATION
Department Orthopaedic Surgery
657 ## - INDEX TERM--FUNCTION
Medline publication type Journal Article
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Murthi, Anand M
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Rigor, Paolo
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Wright, Melissa A
790 ## - Authors
All authors Carroll AH, Murthi AM, Rigor P, Wright MA
856 ## - ELECTRONIC LOCATION AND ACCESS
DOI <a href="https://dx.doi.org/10.1016/j.jse.2022.01.141">https://dx.doi.org/10.1016/j.jse.2022.01.141</a>
Public note https://dx.doi.org/10.1016/j.jse.2022.01.141
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Koha item type Journal Article
Item type description Article
Holdings
Withdrawn status Lost status Damaged status Not for loan Collection Home library Current library Date acquired Total Checkouts Full call number Barcode Date last seen Price effective from Koha item type
          MedStar Authors Catalog MedStar Authors Catalog 03/17/2022   35240302 35240302 03/17/2022 03/17/2022 Journal Article

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