Evidence map›Paper›PMID 36719446›Full record

SynthesisWorld journal of surgery2023

Predictors of Increased Fragility Index Scores in Surgical Randomized Controlled Trials: An Umbrella Review.

Prushoth Vivekanantha, Ajay Shah, Graeme Hoit, Olufemi Ayeni, Daniel Whelan

Abstract readSystematic Review
PubMed Publisher
In one paragraph

Synthesis in World journal of surgery, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 2 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, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. 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

5 authors.

Prushoth VivekananthaMichael DeGroote School of Medicine, McMaster University, Hamilton, ON, Canada.
Ajay ShahDivision of Orthopaedic Surgery, Postgraduate Medical Education, University of Toronto, Toronto, ON, Canada. drajay.shah@mail.utoronto.ca.
Graeme HoitDivision of Orthopaedic Surgery, Postgraduate Medical Education, University of Toronto, Toronto, ON, Canada.
Olufemi AyeniDivision of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada.
Daniel WhelanDivision of Orthopaedic Surgery, Department of Surgery, University of Toronto, 149 College St, Toronto, ON, M5T 1P5, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe fragility index (FI) is defined as the minimum number of patients or subjects needed to switch experimental groups for statistical significance to be lost in a randomized control trial (RCT). This index is used to determine the robustness of a study's findings and recently as a measure of evaluating RCT quality. The objective of this review was to identify and describe published systematic reviews utilizing FI to evaluate surgical RCTs and to determine if there were common factors associated with higher FI values.

methodsThree databases (PubMed, MEDLINE [Ovid], Embase) were searched, followed by a subsequent abstract/title and full-text screening to yield 50 reviews of surgical RCTs. Authors, year of publication, name of journal, study design, number of RCTs, subspecialty, sample size, median FI, patients lost to follow-up, and associations between variables and FI scores were collected.

resultsAmong 1007 of 2214 RCTs in 50 reviews reporting FI (median sample size 100), the pooled median FI was 3 (IQR: 1-7). Most reviews investigated orthopaedic surgery RCTs (n = 32). There was a moderate correlation between FI and p value (r = 0.-413), a mild correlation between FI and sample size (r = 0.188), and a mild correlation between FI and event number (r = 0.129).

conclusionBased on a limited sample of systematic reviews, surgical RCT FI values are still low (2-5). Future RCTs in surgery require improvement to study design in order to increase the robustness of statistically significant findings.

Indexed as

OrthopedicsResearch DesignHumansRandomized Controlled Trials as TopicSample SizeSystematic Reviews as Topic

Identifiers

PMID36719446

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.