Evidence map›Paper›PMID 39443379›Full record

SynthesisSurgical endoscopy2024

Evaluation of the robustness of randomized controlled trials for the treatment modalities of esophageal cancer using the fragility index - a systematic review.

Noam Kahana, Elad Boaz, Nir Horesh, Sameh Hany Emile, Justin Dourado, Pauline Aeschbacher, Pete Rogers, Rachel Gefen, Emanuele Lo Menzo, Raul J Rosenthal

Abstract readSystematic Review
PubMed Publisher
In one paragraph

Synthesis in Surgical endoscopy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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

1 citing paper in PubMed.

  1. 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

10 authors.

Noam Kahana *Department of General Surgery, Cleveland Clinic Florida, 2950 Cleveland Clinic Blvd., Weston, FL, 33331, USA.
Elad Boaz *Department of General Surgery, Cleveland Clinic Florida, 2950 Cleveland Clinic Blvd., Weston, FL, 33331, USA.
Nir HoreshDepartment of General Surgery, Cleveland Clinic Florida, 2950 Cleveland Clinic Blvd., Weston, FL, 33331, USA.
Sameh Hany EmileDepartment of General Surgery, Cleveland Clinic Florida, 2950 Cleveland Clinic Blvd., Weston, FL, 33331, USA.
Justin DouradoDepartment of General Surgery, Cleveland Clinic Florida, 2950 Cleveland Clinic Blvd., Weston, FL, 33331, USA.
Pauline AeschbacherDepartment of General Surgery, Cleveland Clinic Florida, 2950 Cleveland Clinic Blvd., Weston, FL, 33331, USA.
Pete RogersDepartment of General Surgery, Cleveland Clinic Florida, 2950 Cleveland Clinic Blvd., Weston, FL, 33331, USA.
Rachel GefenDepartment of General Surgery, Cleveland Clinic Florida, 2950 Cleveland Clinic Blvd., Weston, FL, 33331, USA.
Emanuele Lo MenzoDepartment of General Surgery, Cleveland Clinic Florida, 2950 Cleveland Clinic Blvd., Weston, FL, 33331, USA.
Raul J RosenthalDepartment of General Surgery, Cleveland Clinic Florida, 2950 Cleveland Clinic Blvd., Weston, FL, 33331, USA. rosentr@ccf.org.ORCID 0000-0002-7663-2464

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEsophageal cancer remains a significant global health challenge. Several treatment modalities were explored in randomized controlled trials (RCTs) in recent decades. This study evaluates the robustness of RCTs focusing on esophageal cancer treatment using the fragility index (FI) and reverse fragility index (RFI).

methodsA systematic review of RCTs studying different treatment modalities for esophageal cancer from 2000 to 2023 was conducted. The FI and RFI were utilized to gauge the robustness of statistically significant and non-significant outcomes, respectively. The FI represents the minimal number of patient outcomes that would need to alter to overturn a trial's statistical significance, while RFI indicates the minimal changes required to achieve significance in non-significant results.

resultsOut of 4028 studies retrieved, 21 RCTs were included for final analysis. The studies spanned 2001 to 2023 with a mean followup of 66 months (range, 29-108 months) and median number of patients of 194 (range, 45-802). The most common treatment modalities examined in these studies were neoadjuvant chemoradiotherapy (n = 7, 33.3%), neoadjuvant chemotherapy (n = 4, 19.0%), and neoadjuvant immunotherapy (n = 2, 9.5%). Only 5 studies (23.8%) had a statistically significant primary outcome result with a median FI of 6 (IQR, 2.5-8.5). Non-significant primary outcomes were seen in 16 studies (76.2%) with a median RFI of 4 (IQR 1-11) and lost to followup of 0 (IQR 0-4). In the study with the highest FI (10), the FI was lower than the number of patients lost to followup (13).

conclusionOur findings demonstrate that most RCTs on esophageal cancer treatments did not report significant primary outcomes. The few studies that reported significant results had a low fragility index, suggesting a vulnerability in their findings.

Indexed as

Esophageal NeoplasmsNeoadjuvant TherapyRandomized Controlled Trials as TopicChemoradiotherapyEsophagectomyHumansImmunotherapyChemotherapyEsophageal cancerFragility indexImmunotherapyRadiotherapySurgery

Identifiers

PMID39443379

What OpenQuestion holds

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Registered trials

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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.