Evidence map›Paper›PMID 37795709›Full record

Trial reportThe Journal of laryngology and otology2024

The fragility index: how robust are the outcomes of head and neck cancer randomised, controlled trials?

Neeraj V Suresh, Beatrice C Go, Christian G Fritz, Jacob Harris, Vinayak Ahluwalia, Katherine Xu, Joseph Lu, Karthik Rajasekaran

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of laryngology and otology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Beyond the Fragility Index.Pharmaceutical statistics
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Neeraj V SureshDepartment of Otorhinolaryngology - Head and Neck Surgery, University of Pennsylvania, Philadelphia, PA, USA.ORCID https://orcid.org/0000-0001-9404-3017
Beatrice C GoDepartment of Otorhinolaryngology - Head and Neck Surgery, University of Pennsylvania, Philadelphia, PA, USA.
Christian G FritzDepartment of Otorhinolaryngology - Head and Neck Surgery, University of Pennsylvania, Philadelphia, PA, USA.ORCID https://orcid.org/0000-0002-3821-3859
Jacob HarrisPerelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Vinayak AhluwaliaPerelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Katherine XuPerelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Joseph LuSidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA, USA.
Karthik RajasekaranDepartment of Otorhinolaryngology - Head and Neck Surgery, University of Pennsylvania, Philadelphia, PA, USA.ORCID https://orcid.org/0000-0003-2148-1643

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe fragility index represents the minimum number of patients required to convert an outcome from statistically significant to insignificant. This report assesses the fragility index of head and neck cancer randomised, controlled trials.

methodsStudies were extracted from PubMed/Medline, Scopus, Embase and Cochrane databases.

resultsOverall, 123 randomised, controlled trials were included. The sample size and fragility index medians (interquartile ranges) were 103 (56-213) and 2 (0-5), respectively. The fragility index exceeded the number of patients lost to follow up in 42.3 per cent (

conclusionHead and neck cancer randomised, controlled trials demonstrated low fragility index values, in which statistically significant results could be nullified by altering the outcomes of just two patients, on average. Future head and neck oncology randomised, controlled trials should report the fragility index in order to provide insight into statistical robustness.

Indexed as

Head and Neck NeoplasmsDatabases, FactualHumanscancer of the headcancer of the neckClinical trials, randomizedotolaryngologystatistics

Identifiers

PMID37795709
PMCPMC10950446

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.