The fragility of significant results from randomized controlled trials in esophageal surgeries

Lee, Yung; Samarasinghe, Yasith; Javidan, Arshia; Tahir, Umair; Samarasinghe, Nadeesha; Shargall, Yaron; Finley, Christian; Hanna, Waël C.; Agzarian, John

doi:10.1007/s10388-023-00985-2

Cited by 5 publications

(6 citation statements)

References 76 publications

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“…Reviewing the few surgical studies that analysed RFI, we found similar results to those in the present study; Khan et al [6] found a RFI of 8 (5)(6)(7)(8)(9)(10)(11)(12)(13) in the 167 RCTs analysed, and Dhingra et al [16] showed a RFI of 7 (5)(6)(7)(8)(9)(10)(11)(12) in their study of seven RCTs including 5383 patients.…”

Section: Comparative Literaturesupporting

confidence: 87%

“…In gastro-oesophageal surgery, Lee et al [8] evaluated 41 RCTs obtaining a FI value of 2 (1-3), similar to those found in our study on anal fistula. In colorectal surgery, Nelms et al [9] presented more than 90 RCTs with a FI of 3 (1-0), of which only eight were proctological studies; these had a FI of 4 (2-9.5).…”

Section: Comparative Literaturesupporting

confidence: 87%

“…However, in the nonsurgical literature the figures are significantly different, with median RFIs of 13 (5–26) and 12 (3–28) in two systematic reviews of RCTs in medical specialities [17, 18]. These studies show, as in surgical RCTs [7–9], a strong inverse correlation between the FI and both p value and the number of events. In addition, among the positive RCTs, a strong correlation was observed between RFI and p ‐value, sample size and NNT/NNH.…”

Section: Discussionmentioning

confidence: 99%

“…Of the 36 RCTs, 19 (53%) were Of the articles analysed, 66.7% were not registered, sample size calculation was not performed in 41.7% and 66.7% were single-centre studies. The median follow-up of these studies was 12 months [6][7][8][9][10][11][12].…”

Section: Re Sultsmentioning

confidence: 99%

“…Compared with other specialities, studies on the FI are rare in the field of general surgery. To date, only three studies have been published, analysing laparoscopic, oesophageal and colorectal surgery [7][8][9], and none have been performed with the RFI.…”

Section: Introductionmentioning

confidence: 99%

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An analysis of randomized controlled trials on anal fistula conducted between 2000 and 2020 based on the Fragility Index and Reverse Fragility Index

Placer‐Galán,

Enriquez‐Navascués,

Lopetegui

et al. 2023

Colorectal Disease

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AimThe aim of this work was to evaluate the robustness of randomized controlled trials (RCTs) on anal fistula management using the news tools of Fragility Index (FI), Reverse Fragility Index (RFI) and their corresponding fragility quotients.MethodA systematic search was conducted based on the Preferred Reporting Items for Systematic Reviews and Meta‐analysis (PRISMA) guidelines which utilized MEDLINE, EMBASE, Cochrane Library and Web of Science databases. Inclusion criteria included RCTs related to the management of anal fistula published from 2000 to 2022 with dichotomous outcomes measures and 1:1 allocation. Calculation of FI and RFI was performed by creating 2 × 2 contingency tables by successively changing one nonevent to an event for each outcome measure until the result was made nonsignificant or significant, respectively. The Fragility Quotients were calculated by dividing the FI or RFI by the total sample size. Fragile results were defined as those with a FI or RFI equal to or less than the number of patients lost to follow‐up. Additionally, those with a FI or RFI less than 3 were also considered fragile. Studies were considered extremely fragile if FI was ≤1 or FQ was ≤0.01.ResultsThere were 36 RCTs that met our criteria, with 3223 patients. Among these, 19 (53%) were positive RCTs (p < 0.005) and 17 (47%) were negative RCTs (p > 0.05). The median FI was 2 (0–5). The analysis by categorical subgroup showed a strong correlation between FI and the p‐value (p = 0.000) and the number of events (p = 0.011). The median RFI was 5 (3.5–9.5) and the subgroup analysis showed a strong correlation between RFI and the p‐value (p = 0.000), sample size (0.021) and number needed to treat/number needed to harm (0.000). We considered 63.2% of positive RCTs to be fragile and 35.3% of negative RCTs.ConclusionsIn the present study we demonstrated the lack of robustness of study findings in published RCTs in the field of anal fistula.

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