High continuous fragility index values for randomised controlled trials investigating medial patellofemoral ligament reconstruction for patellar instability: A systematic review
Bibliographic record
Abstract
PURPOSE: To evaluate the statistical fragility of randomised controlled trials (RCTs) investigating medial patellofemoral ligament reconstruction (MPFLR) of patients with patellar instability. METHODS: A search of PubMed, MEDLINE, and EMBASE databases for RCTs investigating surgical management of patients with patellar instability from inception to 25 April 2024. Studies that reported over one significant dichotomous outcome, significant continuous outcome, and/or nonsignificant dichotomous outcome were included for analysis. The fragility index (FI), continuous fragility index (CFI) and reverse fragility index (RFI) were calculated for significant dichotomous outcomes, significant continuous outcomes, and non-significant dichotomous outcomes, respectively. RESULTS: Thirteen RCTs were included which reported on a total of 929 patients (64.1% female, mean age of 24.4 years [range: 10-47 years] before any patients were lost to follow-up. The median FI was 1.0 (interquartile range [IQR], 1; 95% confidence interval [CI], 0.725-2.275; range, 0-4). The number of patients lost to follow-up at the final time point was greater than the study-specific FI in 7 out of 8 outcomes from four studies (87.5%). The overall median CFI for included RCTs amongst 31 outcomes from nine studies was 11.7 (IQR, 12.9-95% CI, 8.9-13.9; range 0-30.3). The number of patients lost to follow-up at the final time point was greater than the study-specific CFI in thirteen outcomes from six studies (41.9%). The median RFI was 7.0 (IQR, 1.0; 95% CI, 6.5-7.5). The number of participants lost to follow-up was greater than the study-specific RFI in a single outcome from one study (16.7%). CONCLUSION: This systematic review shows that while FI was low at a median of 1.0, consistent with RCTs in sports medicine, the other indicators of statistical fragility were relatively high, especially CFI (11.7). The level of fragility should be taken into account when assessing practical applicability of RCTs on patellar instability, in combination with other indicators of study rigour. LEVEL OF EVIDENCE: Level I.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.118 | 0.404 |
| Meta-epidemiology (narrow) | 0.002 | 0.002 |
| Meta-epidemiology (broad) | 0.020 | 0.021 |
| Bibliometrics | 0.017 | 0.015 |
| Science and technology studies | 0.001 | 0.004 |
| Scholarly communication | 0.007 | 0.006 |
| Open science | 0.004 | 0.003 |
| Research integrity | 0.005 | 0.004 |
| Insufficient payload (model declined to judge) | 0.007 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".