The fragility of randomized trial outcomes underlying management of dyspepsia and Helicobacter pylori infections

Meyer, Chase; Bowers, Aaron; Tritz, Daniel; Fuller, Kaleb; Wayant, Cole; Cook, Courtney; Torgerson, Trevor; Som, Mousumi; Vassar, Matt

doi:10.1097/xeb.0000000000000203

Cited by 3 publications

(3 citation statements)

References 22 publications

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“…The inclusion criteria for the guidelines concerned: (1) adults; (2) with dyspepsia as defined by the Rome III or IV criteria; (3) the management and treatment strategy; (4) the presence of HP; (5) the guidelines available online, (6) in English or French languages; (7) developed at the national level by gastroenterological societies or health authorities (such as HAS and DGVS and others) and at the international level upon expert consensus.…”

Section: Selection Criteriamentioning

confidence: 99%

“…Many CPGs, that differ among themselves and are not necessarily of good quality, discuss the link between an HP infection and functional dyspepsia. In 2019 for example, Meyer et al questioned the quality of randomized trials on which the guidelines were based 5–7 . They showed that of the fourteen guidelines defined by the American College of Gastroenterology (ACG) on the management of dyspepsia, eight were based on data of low or very low level of evidence.…”

Section: Introductionmentioning

confidence: 99%

“…In 2019 for example, Meyer et al questioned the quality of randomized trials on which the guidelines were based. [5][6][7] They showed that of the fourteen guidelines defined by the American College of Gastroenterology (ACG) on the management of dyspepsia, eight were based on data of low or very low level of evidence.…”

Section: Introductionmentioning

confidence: 99%

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Critical appraisal of international guidelines for the management of Helicobacter pylori infection in case of dyspepsia

et al. 2023

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Background: Affecting between 20% and 90% of the world's population depending on the geo-socio-economic conditions, Helicobacter pylori (Hp) infection requires an adapted management because of the medico-economic stakes it generates. Also responsible for dyspepsia, the management of Hp infection differs in this context between international guidelines.Objectives: The primary outcome of the study was assessing the quality of current guidelines for HP eradication in dyspepsia. The secondary was defining the best therapeutic strategy for patients consulting with dyspepsia in the outpatient setting. Methods: Clinical practice guidelines (CPG) published between January 2000 andMay 2021 were retrieved from various databases (PubMed; Guidelines International Network; websites of scientific societies that issued the guidelines). Their quality was assessed using the AGREE II evaluation grid. To provide decision support for healthcare practitioners, particularly in primary care, a summary of the main points of interest for management was made for each guideline.Results: Fourteen guidelines were included. Only four (28.6%) could be validated according to AGREE II? Most of the non-validated guidelines had low ratings in the "Rigour of development" and "Applicability" domains with means of 40% [8%-71%] and 14% [0%-25%], respectively. Three out of four validated guidelines (75%) advocated a "test and treat" strategy for dyspepsia based on the national prevalence of Hp. Gastroscopy was the 1st line examination method in case of warning signs or high risk of gastric cancer. Triple therapy (Proton pomp inhibitor, amoxicillin, and clarithromycin) was favored for Hp eradication but required a study of the sensitivity to clarithromycin in the validated guidelines. Antibiotic resistance also had an impact on treatment duration.Conclusions: Many guidelines were of poor quality, providing few decision-making tools for practical use. Conversely, those of good quality had established a management strategy addressing the current problems associated with the emergence of antibiotic-resistant strains.

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Section: Selection Criteriamentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Critical appraisal of international guidelines for the management of Helicobacter pylori infection in case of dyspepsia

et al. 2023

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Evaluation of the fragility of pivotal trials used to support US Food and Drug Administration approval for plaque psoriasis

Shalhout

Bloom

Drake

et al. 2021

Journal of the American Academy of Dermatology

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Evaluation of Risks of Bias in Addiction Medicine Randomized Controlled Trials

Wayant

Tritz

Horn

et al. 2020

Alcohol and Alcoholism

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Aims Perhaps the most important step when designing and conducting randomized controlled trials (RCTs) in addiction is to put methodological safeguards in place to minimize the likelihood for bias to affect trial outcomes. In this study, we applied the revised Cochrane risk of bias tool (ROB 2) to RCTs of drug, alcohol or tobacco interventions. Methods We searched for trials published in 15 addiction medicine journals over a 7-year period. Our primary endpoint is the risk of bias of included studies. We conducted a sensitivity analysis of publicly funded trials. Results Overall, included RCTs were most often at high risk of bias per our judgments (244/487, 50.1%). However, significant proportions of included RCTs were at low risk of bias (123/487, 25.3%) or some concerns for bias (120/497, 24.6%). RCTs with behavioral modification interventions (19/44, 43.2%) and alcohol interventions (80/150, 53.3%) had the highest proportion of high-risk judgments. In a sensitivity analysis of publicly funded RCTs), 195/386 (50.5%) were at high risk of bias. Conclusions Approximately half of included drug, alcohol or tobacco RCTs in our sample were judged to be at high risk of bias with the most common reason being a lack of proper blinding or proper description of blinding. Key action items to reduce bias in future addiction RCTs include adequate randomization, blinding and inclusion of a trial registry number and protocol.

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The fragility of randomized trial outcomes underlying management of dyspepsia and Helicobacter pylori infections

Cited by 3 publications

References 22 publications

Critical appraisal of international guidelines for the management of Helicobacter pylori infection in case of dyspepsia

Critical appraisal of international guidelines for the management of Helicobacter pylori infection in case of dyspepsia

Evaluation of the fragility of pivotal trials used to support US Food and Drug Administration approval for plaque psoriasis

Evaluation of Risks of Bias in Addiction Medicine Randomized Controlled Trials

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