Evidence map›Paper›PMID 37093236›Full record

SynthesisKnee surgery, sports traumatology, arthroscopy : official journal of the ESSKA2023

The reverse fragility index: RCTs reporting non-significant differences in failure rates between hamstring and bone-patellar tendon-bone autografts have fragile results.

Verdinand C B Ruelos, Raisa Masood, Richard N Puzzitiello, Michael A Moverman, Nicholas R Pagani, Mariano E Menendez, Matthew J Salzler

Abstract readSystematic Review
PubMed Publisher
In one paragraph

Synthesis in Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. 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

7 authors.

Verdinand C B Ruelos *Tufts University School of Medicine, Boston, MA, USA.
Raisa Masood *Department of Orthopaedic Surgery, Tufts Medical Center, 270 Tremont St Biewend Building, Boston, MA, 02111, USA.
Richard N PuzzitielloDepartment of Orthopaedic Surgery, Tufts Medical Center, 270 Tremont St Biewend Building, Boston, MA, 02111, USA.
Michael A MovermanDepartment of Orthopaedic Surgery, Tufts Medical Center, 270 Tremont St Biewend Building, Boston, MA, 02111, USA.
Nicholas R PaganiDepartment of Orthopaedic Surgery, Tufts Medical Center, 270 Tremont St Biewend Building, Boston, MA, 02111, USA.
Mariano E MenendezMidwest Orthopaedics at Rush, Rush University Medical Center, Chicago, IL, USA.
Matthew J SalzlerDepartment of Orthopaedic Surgery, Tufts Medical Center, 270 Tremont St Biewend Building, Boston, MA, 02111, USA. MSalzler@tuftsmedicalcenter.org.ORCID http://orcid.org/0000-0002-9928-0879

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe reverse fragility index (RFI) is a novel metric to appraise the results of studies reporting statistically non-significant results. The purpose of this study was to determine the statistical robustness of randomized controlled trials (RCTs) reporting non-significant differences in anterior cruciate ligament reconstruction (ACLR) graft failure rates, defined as re-rupture/revision ACLR rate, between hamstring tendon (HT) and bone-patellar tendon-bone (BTB) autografts by calculating RFIs.

methodsA systematic review was performed to identify RCTs that compared HT to BTB grafts for ACLR through January 2022. Studies reporting non-significant differences in graft re-rupture and revision ACLR rate (n.s.) were included. The RFI, defined as the fewest number of event reversals needed to change the non-significant graft re-rupture/revision outcome to statistically significant (P < 0.05), was recorded for each study. In addition, the number of studies in which the loss to follow-up exceeded the RFI was recorded.

resultsAmong the 16 included RCTs, the median (interquartile range [IQR]) sample size was 71 (64-114), and the median (IQR) total number of graft re-rupture/revision ACLR events was 4 (4-6). The median (IQR) graft re-rupture/revision ACLR rate was 4.3% (3.0-6.4) overall, 4.1% (2.6-6.7) in the BTB group, and 5.4% (3.0-6.3) in the HT group. The median (IQR) RFI was 3 (3-4), signifying that a reversal of the outcome in 3 patients in one arm was needed to flip the studies' result from non-significant to statistically significant (P < 0.05). The median (IQR) number of participants lost to follow-up was 11 (3-13), and 13 (81.3%) of the included studies had a loss to follow-up greater than the studies' RFI.

conclusionThe results of RCTs reporting statistically non-significant re-rupture/revision ACLR rates between HT and BTB autografts would become significant if the outcome were reversed in a small number of patients-a number that was less than the loss to follow-up in the majority of studies. Thus, the neutrality of these studies is fragile, and a true statistically significant difference in re-rupture/revision rates may have been undetected. LEVEL OF EVIDENCE: Level I.

Indexed as

Anterior Cruciate Ligament InjuriesAnterior Cruciate Ligament ReconstructionHamstring TendonsPatellar LigamentAutograftsBone-Patellar Tendon-Bone GraftingHumansRandomized Controlled Trials as TopicTransplantation, AutologousACL reconstructionGraft selectionReverse fragility indexSports

Identifiers

PMID37093236

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.