ArticleBMC medical research methodology2021
On clinical trial fragility due to patients lost to follow up.
Article in BMC medical research methodology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
Who cites it
9 citing papers in PubMed, 1 synthesis or guideline pooled it.
- The Statistical Fragility of Marrow Stimulation for Cartilage Defects of the Knee: A Systematic Review of Randomized Controlled Trials.Cartilage · 2024Pooled it
- Recurring low statistical robustness in orthopaedic surgery: A systematic review of 84 fragility index studies.Journal of experimental orthopaedics · 2025Review
- Pediatric lower extremity fracture treatments: a statistical review of randomized controlled trials.Journal of orthopaedics · 2025Review
- Fragility in cardiovascular randomized controlled trials with primary continuous outcomes (2018-2022) from multi-perspectives assessment: a cross-sectional survey.Annals of medicine · 2024Article
- Robustness Assessment of Oncology Dose-Finding Trials Using the Modified Fragility Index.Cancers · 2024Article
- Assessing robustness of results of randomised clinical trials using Fragility Index.European archives of paediatric dentistry : official journal of the European Academy of Paediatric Dentistry · 2024Article
- Assessing the robustness of results from clinical trials and meta-analyses with the fragility index.American journal of obstetrics and gynecology · 2023Review
- Empirical assessment of fragility index based on a large database of clinical studies in the Cochrane Library.Journal of evaluation in clinical practice · 2023Article
- Beyond the Fragility Index.Pharmaceutical statisticsArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
backgroundClinical trials routinely have patients lost to follow up. We propose a methodology to understand their possible effect on the results of statistical tests by altering the concept of the fragility index to treat the outcomes of observed patients as fixed but incorporate the potential outcomes of patients lost to follow up as random and subject to modification.
methodsWe reanalyse the statistical results of three clinical trials on coronary artery bypass grafting (CABG) to study the possible effect of patients lost to follow up on the treatment effect statistical significance. To do so, we introduce the LTFU-aware fragility indices as a measure of the robustness of a clinical trial's statistical results with respect to patients lost to follow up.
resultsThe analyses illustrate that clinical trials can either be completely robust to the outcomes of patients lost to follow up, extremely sensitive to the outcomes of patients lost to follow up, or in an intermediate state. When a clinical trial is in an intermediate state, the LTFU-aware fragility indices provide an interpretable measure to quantify the degree of fragility or robustness.
conclusionsThe LTFU-aware fragility indices allow researchers to rigorously explore the outcomes of patients who are lost to follow up, when their data is the appropriate kind. The LTFU-aware fragility indices are sensitivity measures in a way that the original fragility index is not.
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Registered trials
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.