Considering the fragility index in reporting trials on diverticular disease
The changing management paradigm of acute complicated diverticulitis and the elective indications for surgery have evolved in the last decade based on reported evidence-based data. Recently, it has been demonstrated that randomized controlled trials (RCTs), the highest trial format in the hierarchy...
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Open Exploration Publishing Inc.
2025-06-01
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| Series: | Exploration of Digestive Diseases |
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| Online Access: | https://www.explorationpub.com/uploads/Article/A100578/100578.pdf |
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| author | Andrew P. Zbar Nir Horesh |
| author_facet | Andrew P. Zbar Nir Horesh |
| author_sort | Andrew P. Zbar |
| collection | DOAJ |
| description | The changing management paradigm of acute complicated diverticulitis and the elective indications for surgery have evolved in the last decade based on reported evidence-based data. Recently, it has been demonstrated that randomized controlled trials (RCTs), the highest trial format in the hierarchy of evidence-based reporting, suffer from a ‘crisis of replicability’. The development of a fragility index (FI) quantitatively defines the robustness of an RCT by shifting the number of participants in a trial into a different binary group in an effort to influence reported statistical significance (the lower the FI the greater the study fragility). The only available report on FI in diverticular management showed that in an eclectic range of RCT’s comparing intervention and non-intervention, two-thirds of the studies had an FI ≤ 1 where statistical recalculation using Fisher’s Exact test rendered one-quarter of previously positive studies non-significant. Comparisons between studies and units are still dependent upon sample sizes and the numbers lost to follow-up even when some of the FI progeny (including a reverse FI, a fragility quotient dividing the FI by the sample size, or other incidence or generalized FI metrics) are utilized in assessment. Future analyses need to define all comparisons rather than cherry-picking examples where a p value approaches significance. Despite the fact that no FI value defines the strength of a RCT, its use attempts to link the reported p value with the sample size and the statistical power of the study. Positive findings in diverticular trials are then considered not so much definitive as rather provocateurs encouraging further similarly designed studies in different environments. Minimizing patient loss in treatment arms and reporting the reasons for drop-out, strictly adhering to randomization, consistent blinding, and group allocation concealment can all improve the logistical running of an RCT initially designed to evaluate some potentially important new treatment. |
| format | Article |
| id | doaj-art-bb23d817afb74c27bc6cece3c312f8bf |
| institution | Kabale University |
| issn | 2833-6321 |
| language | English |
| publishDate | 2025-06-01 |
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| series | Exploration of Digestive Diseases |
| spelling | doaj-art-bb23d817afb74c27bc6cece3c312f8bf2025-08-20T03:29:47ZengOpen Exploration Publishing Inc.Exploration of Digestive Diseases2833-63212025-06-01410057810.37349/edd.2025.100578Considering the fragility index in reporting trials on diverticular diseaseAndrew P. Zbar0https://orcid.org/0000-0002-0449-4648Nir Horesh1https://orcid.org/0000-0002-2459-8567Department of Neuroscience and Anatomy, Parkville Campus, University of Melbourne, Parkville 3010, AustraliaDepartment of Colorectal Surgery, Cleveland Clinic Florida, Weston, FL 33331, USA; Faculty of Medicine, Tel Aviv University, Tel Aviv 5224213, IsraelThe changing management paradigm of acute complicated diverticulitis and the elective indications for surgery have evolved in the last decade based on reported evidence-based data. Recently, it has been demonstrated that randomized controlled trials (RCTs), the highest trial format in the hierarchy of evidence-based reporting, suffer from a ‘crisis of replicability’. The development of a fragility index (FI) quantitatively defines the robustness of an RCT by shifting the number of participants in a trial into a different binary group in an effort to influence reported statistical significance (the lower the FI the greater the study fragility). The only available report on FI in diverticular management showed that in an eclectic range of RCT’s comparing intervention and non-intervention, two-thirds of the studies had an FI ≤ 1 where statistical recalculation using Fisher’s Exact test rendered one-quarter of previously positive studies non-significant. Comparisons between studies and units are still dependent upon sample sizes and the numbers lost to follow-up even when some of the FI progeny (including a reverse FI, a fragility quotient dividing the FI by the sample size, or other incidence or generalized FI metrics) are utilized in assessment. Future analyses need to define all comparisons rather than cherry-picking examples where a p value approaches significance. Despite the fact that no FI value defines the strength of a RCT, its use attempts to link the reported p value with the sample size and the statistical power of the study. Positive findings in diverticular trials are then considered not so much definitive as rather provocateurs encouraging further similarly designed studies in different environments. Minimizing patient loss in treatment arms and reporting the reasons for drop-out, strictly adhering to randomization, consistent blinding, and group allocation concealment can all improve the logistical running of an RCT initially designed to evaluate some potentially important new treatment.https://www.explorationpub.com/uploads/Article/A100578/100578.pdffragility indexp valuestatistical significancediverticular diseaserandomized controlled trials |
| spellingShingle | Andrew P. Zbar Nir Horesh Considering the fragility index in reporting trials on diverticular disease Exploration of Digestive Diseases fragility index p value statistical significance diverticular disease randomized controlled trials |
| title | Considering the fragility index in reporting trials on diverticular disease |
| title_full | Considering the fragility index in reporting trials on diverticular disease |
| title_fullStr | Considering the fragility index in reporting trials on diverticular disease |
| title_full_unstemmed | Considering the fragility index in reporting trials on diverticular disease |
| title_short | Considering the fragility index in reporting trials on diverticular disease |
| title_sort | considering the fragility index in reporting trials on diverticular disease |
| topic | fragility index p value statistical significance diverticular disease randomized controlled trials |
| url | https://www.explorationpub.com/uploads/Article/A100578/100578.pdf |
| work_keys_str_mv | AT andrewpzbar consideringthefragilityindexinreportingtrialsondiverticulardisease AT nirhoresh consideringthefragilityindexinreportingtrialsondiverticulardisease |