Evidence map›Paper›PMID 32656478›Full record

ArticleJournal of the American Academy of Orthopaedic Surgeons. Global research & reviews2020

Statistical Fragility of Surgical and Procedural Clinical Trials in Orthopaedic Oncology.

Lynn Ann Forrester, Eugene Jang, Michelle M Lawson, Ana Capi, Wakenda K Tyler

Abstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of the American Academy of Orthopaedic Surgeons. Global research & reviews, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 10 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

19 citing papers in PubMed, 10 syntheses or guidelines pooled it.

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  5. The statistical fragility of intramedullary reaming in tibial nail fixation: a systematic review.European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2023
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  7. The fragility and reverse fragility indices of proximal humerus fracture randomized controlled trials: a systematic review.European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2022
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  10. The Fragility of Statistical Findings in Achilles Tendon Injury Research: A Systematic Review.Journal of the American Academy of Orthopaedic Surgeons. Global research & reviews · 2021
    Pooled it
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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.

Lynn Ann ForresterDepartment of Orthopedic Surgery, Columbia University Medical Center, New York, NY (Dr. Forrester, Dr. Jang, Ms. Capi, and Dr. Tyler) and the Department of Orthopaedics, University of Rochester, Rochester, NY (Ms. Lawson).
Eugene JangDepartment of Orthopedic Surgery, Columbia University Medical Center, New York, NY (Dr. Forrester, Dr. Jang, Ms. Capi, and Dr. Tyler) and the Department of Orthopaedics, University of Rochester, Rochester, NY (Ms. Lawson).
Michelle M LawsonDepartment of Orthopedic Surgery, Columbia University Medical Center, New York, NY (Dr. Forrester, Dr. Jang, Ms. Capi, and Dr. Tyler) and the Department of Orthopaedics, University of Rochester, Rochester, NY (Ms. Lawson).
Ana CapiDepartment of Orthopedic Surgery, Columbia University Medical Center, New York, NY (Dr. Forrester, Dr. Jang, Ms. Capi, and Dr. Tyler) and the Department of Orthopaedics, University of Rochester, Rochester, NY (Ms. Lawson).
Wakenda K TylerDepartment of Orthopedic Surgery, Columbia University Medical Center, New York, NY (Dr. Forrester, Dr. Jang, Ms. Capi, and Dr. Tyler) and the Department of Orthopaedics, University of Rochester, Rochester, NY (Ms. Lawson).

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The fragility index (FI) is a powerful tool that can be used to assess the statistical strength of a study outcome. This metric is defined as the number of patients who would need to have an alternative outcome to convert a clinical trial result from statistically significant to not statistically significant, or vice versa. No studies to date have used the FI to evaluate surgical and procedural clinical trials in the orthopaedic oncology literature. The primary purpose of this study was to use the FI to evaluate the statistical strength of widely cited surgical and procedural clinical trials in orthopaedic oncology. Methods: We performed a PubMed search for orthopaedic oncology clinical trials in high impact orthopaedics-focused, oncology-focused, and general medicine journals. For each study included in this analysis, we calculated the FI for all identified dichotomous, categorical outcomes. Results: We identified 23 studies with 48 outcomes. Twelve of these outcomes were statistically significant, with a median FI of two. Nine studies addressed the number of patients lost to follow up, and the FI was less than the number of patients lost to follow up for most outcomes (60%) in these studies. Conclusions: The orthopaedic oncology literature has substantial statistical fragility, likely explained by a high number of patients lost to follow up and small sample sizes. More multicenter, cooperative studies are necessary to increases the robustness of clinical research in orthopaedic oncology.

Indexed as

NeoplasmsOrthopedic ProceduresOrthopedicsHumansResearch DesignSample Size

Identifiers

PMID32656478
PMCPMC7322779

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.