Evidence map›Paper›PMID 36689016›Full record

ReviewEsophagus : official journal of the Japan Esophageal Society2023

The fragility of significant results from randomized controlled trials in esophageal surgeries.

Yung Lee, Yasith Samarasinghe, Arshia Javidan, Umair Tahir, Nadeesha Samarasinghe, Yaron Shargall, Christian Finley, Wael Hanna, John Agzarian

Abstract readReview
PubMed Publisher
In one paragraph

Review in Esophagus : official journal of the Japan Esophageal Society, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

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

  1. Pooled it
  2. 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

9 authors.

Yung LeeDivision of General Surgery, McMaster University, Hamilton, ON, Canada.
Yasith SamarasingheDivision of Thoracic Surgery, Department of Surgery, McMaster University, 50 Charlton Avenue East T-2105, Hamilton, ON, L8N 4A6, Canada.
Arshia JavidanDivision of Vascular Surgery, University of Toronto, Toronto, ON, Canada.
Umair TahirDivision of Thoracic Surgery, Department of Surgery, McMaster University, 50 Charlton Avenue East T-2105, Hamilton, ON, L8N 4A6, Canada.
Nadeesha SamarasingheSchulich School of Medicine and Dentistry, Western University, London, ON, Canada.
Yaron ShargallDivision of Thoracic Surgery, Department of Surgery, McMaster University, 50 Charlton Avenue East T-2105, Hamilton, ON, L8N 4A6, Canada.
Christian FinleyDivision of Thoracic Surgery, Department of Surgery, McMaster University, 50 Charlton Avenue East T-2105, Hamilton, ON, L8N 4A6, Canada.
Wael HannaDivision of Thoracic Surgery, Department of Surgery, McMaster University, 50 Charlton Avenue East T-2105, Hamilton, ON, L8N 4A6, Canada.
John AgzarianDivision of Thoracic Surgery, Department of Surgery, McMaster University, 50 Charlton Avenue East T-2105, Hamilton, ON, L8N 4A6, Canada. agzarij@mcmaster.ca.ORCID 0000-0002-6553-1262

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

While randomized controlled trials (RCTs) are regarded as one of the highest forms of clinical research, the robustness of their P values can be difficult to ascertain. Defined as the minimum number of patients in a study arm that would need to be changed from a non-event to event for the findings to lose significance, the Fragility Index is a method for evaluating results from these trials. This study aims to calculate the Fragility Index for trials evaluating perioperative esophagectomy-related interventions to determine the strength of RCTs in this field. MEDLINE and EMBASE were searched for RCTs related to esophagectomy that reported a significant dichotomous outcome. Two reviewers independently screened articles and performed the data extractions with risk of bias assessment. The Fragility Index was calculated using a two-tailed Fisher's exact test. Bivariate correlation was conducted to evaluate associations between the Fragility Index and study characteristics. 41 RCTs were included, and the median sample size was 80 patients [Interquartile range (IQR) 60-161]. Of the included outcomes, 29 (71%) were primary, and 12 (29%) were secondary. The median Fragility Index was 1 (IQR 1-3), meaning that by changing one patient from a non-event to event, the results would become non-significant. Fragility Index was correlated with P value, number of events, and journal impact factor. The RCTs related to esophagectomy did not prove to be robust, as the significance of their results could be changed by altering the outcome status of a handful of patients in one study arm.

Indexed as

EsophagectomyHumansRandomized Controlled Trials as TopicSample SizeEsophagectomyFragility indexP valueRCT

Identifiers

PMID36689016

What OpenQuestion holds

Textmetadata
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.