How Fragile Are Clinical Trial Outcomes That Support the CHEST Clinical Practice Guidelines for VTE?

Elizabeth Edwards, Cole Wayant, Jonathan Besas, Justin Chronister, Matt Vassar

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Background: VTE remains a health concern for global populations. Clinical practice guidelines are necessary to guide physicians in the prophylaxis and treatment of VTE. Methods: Our investigation assessed the robustness of the underlying evidence in 21 randomized controlled trials (RCTs) used to support treatment recommendations in the 2016 update of the CHEST Guideline and Expert Panel Report on Antithrombotic Therapy for VTE Disease. We calculated the fragility index and fragility quotient for qualifying outcomes within RCTs. Results: The median fragility index for all studies was 5 (interquartile range, 1-9), with a median fragility quotient of 0.012 (interquartile range, 0.002-0.032). Conclusions: Our conclusions parallel those of previous investigations of the fragility of RCT outcomes; we found that some outcomes used to support recommendations in AT10 are fragile. We recommend that the fragility index and fragility quotient be adopted as measures of robustness of clinical trial outcomes.

Original languageEnglish
Pages (from-to)512-520
Number of pages9
JournalChest
Volume154
Issue number3
DOIs
StatePublished - 1 Sep 2018

Fingerprint

Practice Guidelines
Randomized Controlled Trials
Clinical Trials
Therapeutics
Guidelines
Physicians
Population

Keywords

  • biostatistics
  • clinical practice guideline
  • clinical trial
  • fragility index
  • randomized controlled trial

Cite this

@article{68d6531a06694228b6e6f69f0cd06098,
title = "How Fragile Are Clinical Trial Outcomes That Support the CHEST Clinical Practice Guidelines for VTE?",
abstract = "Background: VTE remains a health concern for global populations. Clinical practice guidelines are necessary to guide physicians in the prophylaxis and treatment of VTE. Methods: Our investigation assessed the robustness of the underlying evidence in 21 randomized controlled trials (RCTs) used to support treatment recommendations in the 2016 update of the CHEST Guideline and Expert Panel Report on Antithrombotic Therapy for VTE Disease. We calculated the fragility index and fragility quotient for qualifying outcomes within RCTs. Results: The median fragility index for all studies was 5 (interquartile range, 1-9), with a median fragility quotient of 0.012 (interquartile range, 0.002-0.032). Conclusions: Our conclusions parallel those of previous investigations of the fragility of RCT outcomes; we found that some outcomes used to support recommendations in AT10 are fragile. We recommend that the fragility index and fragility quotient be adopted as measures of robustness of clinical trial outcomes.",
keywords = "biostatistics, clinical practice guideline, clinical trial, fragility index, randomized controlled trial",
author = "Elizabeth Edwards and Cole Wayant and Jonathan Besas and Justin Chronister and Matt Vassar",
year = "2018",
month = "9",
day = "1",
doi = "10.1016/j.chest.2018.01.031",
language = "English",
volume = "154",
pages = "512--520",
journal = "Chest",
issn = "0012-3692",
publisher = "American College of Chest Physicians",
number = "3",

}

How Fragile Are Clinical Trial Outcomes That Support the CHEST Clinical Practice Guidelines for VTE? / Edwards, Elizabeth; Wayant, Cole; Besas, Jonathan; Chronister, Justin; Vassar, Matt.

In: Chest, Vol. 154, No. 3, 01.09.2018, p. 512-520.

Research output: Contribution to journalArticle

TY - JOUR

T1 - How Fragile Are Clinical Trial Outcomes That Support the CHEST Clinical Practice Guidelines for VTE?

AU - Edwards, Elizabeth

AU - Wayant, Cole

AU - Besas, Jonathan

AU - Chronister, Justin

AU - Vassar, Matt

PY - 2018/9/1

Y1 - 2018/9/1

N2 - Background: VTE remains a health concern for global populations. Clinical practice guidelines are necessary to guide physicians in the prophylaxis and treatment of VTE. Methods: Our investigation assessed the robustness of the underlying evidence in 21 randomized controlled trials (RCTs) used to support treatment recommendations in the 2016 update of the CHEST Guideline and Expert Panel Report on Antithrombotic Therapy for VTE Disease. We calculated the fragility index and fragility quotient for qualifying outcomes within RCTs. Results: The median fragility index for all studies was 5 (interquartile range, 1-9), with a median fragility quotient of 0.012 (interquartile range, 0.002-0.032). Conclusions: Our conclusions parallel those of previous investigations of the fragility of RCT outcomes; we found that some outcomes used to support recommendations in AT10 are fragile. We recommend that the fragility index and fragility quotient be adopted as measures of robustness of clinical trial outcomes.

AB - Background: VTE remains a health concern for global populations. Clinical practice guidelines are necessary to guide physicians in the prophylaxis and treatment of VTE. Methods: Our investigation assessed the robustness of the underlying evidence in 21 randomized controlled trials (RCTs) used to support treatment recommendations in the 2016 update of the CHEST Guideline and Expert Panel Report on Antithrombotic Therapy for VTE Disease. We calculated the fragility index and fragility quotient for qualifying outcomes within RCTs. Results: The median fragility index for all studies was 5 (interquartile range, 1-9), with a median fragility quotient of 0.012 (interquartile range, 0.002-0.032). Conclusions: Our conclusions parallel those of previous investigations of the fragility of RCT outcomes; we found that some outcomes used to support recommendations in AT10 are fragile. We recommend that the fragility index and fragility quotient be adopted as measures of robustness of clinical trial outcomes.

KW - biostatistics

KW - clinical practice guideline

KW - clinical trial

KW - fragility index

KW - randomized controlled trial

UR - http://www.scopus.com/inward/record.url?scp=85044574268&partnerID=8YFLogxK

U2 - 10.1016/j.chest.2018.01.031

DO - 10.1016/j.chest.2018.01.031

M3 - Article

C2 - 29410171

AN - SCOPUS:85044574268

VL - 154

SP - 512

EP - 520

JO - Chest

JF - Chest

SN - 0012-3692

IS - 3

ER -