Methodological and ethical quality of surgical trials from 2016 to 2020

Papet, Eloïse; Moutel, Grégoire; Pinson, Jean; Monge, Matthieu; Roussel, Edouard; Teniere, Tom; Tuech, Jean‐Jacques; Bridoux, Valérie

doi:10.1007/s00423-022-02649-8

Cited by 2 publications

(3 citation statements)

References 21 publications

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“…This means that fewer RCTs have evaluated surgical interventions. In addition, the methodological and reporting quality of existing trials is poor, which means there is limited high‐quality evidence on which to base surgical decisions 9 . A comprehensive summary of RCTs in the field of hepatobiliary surgery could facilitate the translation of research evidence into clinical practice, leading to improved patient outcomes, enhanced quality of care, and optimized resource utilization in healthcare systems 10 .…”

Section: Introductionmentioning

confidence: 99%

Evaluation of quality and quantity of randomized controlled trials in hepatobiliary surgery: A scoping/mapping review

Majlesara,

Aminizadeh,

Ramouz

et al. 2024

Eur J Clin Investigation

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AimTo evaluate the quantity and quality of randomized controlled trials (RCTs) in hepatobiliary surgery and for identifying gaps in current evidences.MethodsA systematic search was conducted in MEDLINE (via PubMed), Web of Science, and Cochrane Controlled Register of Trials (CENTRAL) for RCTs of hepatobiliary surgery published from inception until the end of 2023. The quality of each study was assessed using the Cochrane risk‐of‐bias (RoB) tool. The associations between risk of bias and the region and publication date were also assessed. Evidence mapping was performed to identify research gaps in the field.ResultsThe study included 1187 records. The number and proportion of published randomized controlled trials (RCTs) in hepatobiliary surgery increased over time, from 13 RCTs (.0005% of publications) in 1970–1979 to 201 RCTs (.003% of publications) in 2020–2023. There was a significant increase in the number of studies with a low risk of bias in RoB domains (p < .01). The proportion of RCTs with low risk of bias improved significantly after the introduction of CONSORT guidelines (p < .001). The evidence mapping revealed a significant research focus on major and minor hepatectomy and cholecystectomy. However, gaps were identified in liver cyst surgery and hepatobiliary vascular surgery. Additionally, there are gaps in the field of perioperative management and nutrition intervention.ConclusionThe quantity and quality of RCTs in hepatobiliary surgery have increased over time, but there is still room for improvement. We have identified gaps in current research that can be addressed in future studies.

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Section: Introductionmentioning

confidence: 99%

Evaluation of quality and quantity of randomized controlled trials in hepatobiliary surgery: A scoping/mapping review

Majlesara,

Aminizadeh,

Ramouz

et al. 2024

Eur J Clin Investigation

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“…The evidence pyramid describes levels of evidence based on the robustness and reliability of data generated by each type of evidence, with randomized controlled trials (RCTs) and meta‐analyses considered to provide evidence of the highest level 3 . However, despite the robust quality of data that stands to be generated, poor patient accrual, difficulties in standardizing surgical interventions, relative lack of accrual to the control arm, underrepresentation of ethnic minorities, escalating costs, industry influence, prolonged study duration, rapidly changing treatment paradigms, diminishing relevance of results over time, and multiple sources of bias are only few of the challenges one encounters while conducting RCTs, especially in the context of surgical oncology, which limits the number of RCTs reaching a successful conclusion or publication 4–8 . Consequently, the number of new surgical RCTs conducted has been slowly dwindling over the last few decades 9,10 …”

Section: Introductionmentioning

confidence: 99%

“…relevance of results over time, and multiple sources of bias are only few of the challenges one encounters while conducting RCTs, especially in the context of surgical oncology, which limits the number of RCTs reaching a successful conclusion or publication. [4][5][6][7][8] Consequently, the number of new surgical RCTs conducted has been slowly dwindling over the last few decades. 9,10 To overcome the pitfalls of surgical RCTs, there has been a growing interest in alternative research methodologies, such as the use of large database studies, or big data analytics.…”

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confidence: 99%

Big data and RCT's in surgical oncology: Impact on improving hepatopancreatobiliary cancer surgical care on the global stage

Shrikhande,

Kunte,

Chopde

et al. 2023

Journal of Surgical Oncology

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Randomized controlled clinical trials (RCTs) are at the heart of “evidence‐based” medicine. Conducting well‐designed RCTs for surgical procedures is often challenged by inadequate recruitment accrual, blinding, or standardization of the surgical procedure, as well as lack of funding and evolution of the treatment strategy during the many years over which such trials are conducted. In addition, most clinical trials are performed in academic high‐volume centers with highly selected patients, which may not necessarily reflect a “real‐world” practice setting. Large databases provide easy and inexpensive access to data on a large and diverse patient population at a variety of treatment centers. Furthermore, large database studies provide the opportunity to answer questions that would be impossible or very arduous to answer using RCTs, including questions regarding health policy efficacy, trends in surgical practice, access to health care, the impact of hospital volume, and adherence to practice guidelines, as well as research questions regarding rare disease, infrequent surgical outcomes, and specific subpopulations. Prospective data registries may also allow for quality benchmarking and auditing. There are several high‐quality RCTs providing evidence to support current practices in hepatopancreatobiliary (HPB) oncology. Evidence from big data bridges the gap in several instances where RCTs are lacking. In this article, we review the evidence from RCTs and big data in HPB oncology identify the existing lacunae, and discuss the future directions of research in HPB oncology.

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Methodological and ethical quality of surgical trials from 2016 to 2020

Cited by 2 publications

References 21 publications

Evaluation of quality and quantity of randomized controlled trials in hepatobiliary surgery: A scoping/mapping review

Evaluation of quality and quantity of randomized controlled trials in hepatobiliary surgery: A scoping/mapping review

Big data and RCT's in surgical oncology: Impact on improving hepatopancreatobiliary cancer surgical care on the global stage

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