Evidence map›Paper›PMID 39575398›Full record

ArticleFoot & ankle orthopaedics2024

The Fragility of Statistically Significant Binary Outcomes for Treating Achilles Tendinopathy: A Systematic Review of Randomized Trials.

Omkar S Anaspure, Shiv Patel, Anthony N Baumann, Andrew Newsom, Albert T Anastasio, Annunziato Amendola

Abstract read
In one paragraph

Article in Foot & ankle orthopaedics, 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. Review
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

6 authors.

Omkar S AnaspurePerelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.ORCID https://orcid.org/0000-0001-9135-0484
Shiv PatelPerelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Anthony N BaumannCollege of Medicine, Northeast Ohio Medical University, Rootstown, OH, USA.ORCID https://orcid.org/0000-0002-4175-3135
Andrew NewsomCollege of Medicine, Northeast Ohio Medical University, Rootstown, OH, USA.
Albert T AnastasioDepartment Orthopedic Surgery, Duke University, Durham, NC, USA.ORCID https://orcid.org/0000-0001-5817-3826
Annunziato AmendolaDepartment Orthopedic Surgery, Duke University, Durham, NC, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Randomized controlled trials (RCTs) are the gold standard for treatment efficacy, but foot and ankle RCTs are often small or inconsistent. The Fragility Index (FI) evaluates the stability of significant findings. This study assessed the fragility of RCT outcomes for Achilles tendon pathology (ATP) interventions. Methods: This systematic review queried PubMed up to May 14, 2024, for RCTs on ATP interventions. RCTs with significant binary outcomes were included. Two reviewers assessed eligibility, extracted data, calculated FIs, and evaluated risk of bias. Frequency-weighted means were used for narrative synthesis. Results: Eleven RCTs with 4506 patients (mean cohort size: 409.64 ± 160.54) and a mean age of 36.97 ± 13.51 years (n = 4356; 96.67%) were included, covering 24 binary outcomes. The median FI across all outcomes was 3 (interquartile range 1-4; mean 3.92), indicating that changing the outcome of just a few patients could shift a study's results from statistically significant to nonsignificant. Trials having an FI ≤3 comprised 58.33%. Three outcomes (12.5%) had an FI of zero after recalculating Conclusion: The FI assesses the fragility of statistically significant binary results, revealing that many ATP RCTs have fragile outcomes due to small sample sizes. A median FI of 3 means that changing the outcome of 3 patients could shift a study's results from statistically significant to nonsignificant.

Indexed as

AchillesFragility Indexoutcomesrandomized controlled trialsstatistical significance

Identifiers

PMID39575398
PMCPMC11580056

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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.