Fragility of statistically significant outcomes in randomized trials comparing bariatric surgeries

Lee, Yung; Samarasinghe, Yasith; Chen, Lucy H.; Hapugall, Akithma; Javidan, Arshia; McKechnie, Tyler; Doumouras, Aristithes G.; Hong, Dennis

doi:10.1038/s41366-023-01298-1

Cited by 5 publications

(1 citation statement)

References 71 publications

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“…FMT was most commonly associated with nausea, and serious adverse events were rare [45][46][47][48]. A small number of children had fever, allergy, and other adverse events, but they were mild and transient [49][50][51]. Of concern, on 13 June 2019, the FDA issued an important warning that FMT may present a serious or life-threatening risk of infection, which may be associated with multidrug-resistant bacteria.…”

Section: Discussionmentioning

confidence: 99%

Fecal Microbiota Transplantation for Weight and Glycemic Control of Obesity as Well as the Associated Metabolic Diseases: Meta-Analysis and Comprehensive Assessment

Hu,

Zhao,

Zhang

et al. 2023

Life

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Objectives: An analysis of the weight and blood glucose management associated with fecal microbiota transplantation (FMT) as well as metabolic diseases associated with FMT was conducted by the authors in order to provide clinical recommendations regarding the treatment of nonalcoholic fatty liver disease (NAFLD) and type 2 diabetes mellitus (T2DM). Methods: We searched PubMed, Embase, and the Cochrane Library for papers that were published between the creation of the database and October 2022. We reviewed research that investigated how FMT affected weight and glycemic management in cases of obesity and metabolic conditions that are related to obesity. Studies that were published more than once, lacked the entire text, included insufficient information, or were impossible to extract data from were excluded. Additionally, case reports, reviews, and systematic reviews were excluded from the analysis. In order to analyze the data, STATA 15.1 was used. Outcomes: When we combined all of our findings, we discovered that pooled outcomes showed that weight levels (WMD equals −4.77, 95%CI: −7.40~−2.14), BMI levels (WMD equals −1.59, 95%CI: −2.21~−0.97), HOMA-IR (WMD equals −0.79, 95%CI: −1.57~−0.00), and HbA1c (WMD equals −0.65, 95%CI: −0.75~−0.55) after FMT treatment were significantly lower than before treatment. However, FMT treatment may have no effect on glucose and insulin levels in obese patients at fasting and related metabolic diseases. Additionally, subgroup analysis outcomes found that FMT significantly reduced fasting blood glucose in people with diabetes. Conclusions: As a weight loss and glycemic control therapy, FMT helps to prevent and treat metabolic problems linked to obesity, and is a viable alternative to bariatric surgery for patients who do not wish to undergo the procedure.

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Section: Discussionmentioning

confidence: 99%

Fecal Microbiota Transplantation for Weight and Glycemic Control of Obesity as Well as the Associated Metabolic Diseases: Meta-Analysis and Comprehensive Assessment

Hu,

Zhao,

Zhang

et al. 2023

Life

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Fragility of overactive bladder medication clinical trials: A systematic review

Li,

Venishetty,

Fernandez

et al. 2024

Neurourology and Urodynamics

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PurposeOveractive bladder (OAB) syndrome significantly impairs quality of life, often necessitating pharmacological interventions with associated risks. The fragility of OAB trial outcomes, as measured by the fragility index (FI: smallest number of event changes to reverse statistical significance) and quotient (FQ: FI divided by total sample size expressed as a percentage), is critical yet unstudied.Materials and MethodsWe conducted a systematic search for randomized controlled trials on OAB medications published between January 2000 and August 2023. Inclusion criteria were trials with two parallel arms reporting binary outcomes related to OAB medications. We extracted trial details, outcomes, and statistical tests employed. We calculated FI and FQ, analyzing associations with trial characteristics through linear regression.ResultsWe included 57 trials with a median sample size of 211 participants and a 12% median lost to follow‐up. Most studies investigated anticholinergics (37/57, 65%). The median FI/FQ was 5/3.5%. Larger trials were less fragile (median FI 8; FQ 1.0%) compared to medium (FI: 4; FQ 2.5%) and small trials (FI: 4; FQ 8.3%). Double‐blinded studies exhibited higher FQs (median 2.9%) than unblinded trials (6.7%). Primary and secondary outcomes had higher FIs (median 5 and 6, respectively) than adverse events (FI: 4). Each increase in 10 participants was associated with a +0.19 increase in FI (p < 0.001).ConclusionsA change in outcome for a median of five participants, or 3.5% of the total sample size, could reverse the direction of statistical significance in OAB trials. Studies with larger sample sizes and efficacy outcomes from blinded trials were less fragile.

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The fragility index and reverse fragility index of FDA investigational device exemption trials in spinal fusion surgery: a systematic review

Proal,

Moon,

Kwon

2024

Eur Spine J

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Fragility of statistically significant outcomes in randomized trials comparing bariatric surgeries

Cited by 5 publications

References 71 publications

Fecal Microbiota Transplantation for Weight and Glycemic Control of Obesity as Well as the Associated Metabolic Diseases: Meta-Analysis and Comprehensive Assessment

Fecal Microbiota Transplantation for Weight and Glycemic Control of Obesity as Well as the Associated Metabolic Diseases: Meta-Analysis and Comprehensive Assessment

Fragility of overactive bladder medication clinical trials: A systematic review

The fragility index and reverse fragility index of FDA investigational device exemption trials in spinal fusion surgery: a systematic review

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