Evaluating Randomised Trials of Minimally Invasive Surgery for Oesophageal Cancer
Author Information
Author(s): Katy Chalmers, Sian Cousins, Natalie Blencowe, Jane Blazeby
Primary Institution: Centre for Surgical Research, University of Bristol, Bristol, UK
Hypothesis
How applicable and valid are RCTs comparing minimally invasive and open surgery for oesophageal cancer?
Conclusion
Only one trial was considered pragmatic, indicating a need for clearer guidance on trial design to enhance applicability.
Supporting Evidence
- Only one of the nine RCTs reviewed was considered pragmatic.
- Most trials had narrow eligibility criteria and were conducted in single centers.
- Two studies were assessed as low risk of bias, while three were high risk.
Takeaway
This study looked at trials comparing two types of surgery for cancer and found that most trials were not designed in a way that makes their results useful for real-world situations.
Methodology
The study reviewed RCTs published from January 2012 to June 2023, assessing their applicability and validity using the PRECIS-2 and Risk of Bias 2 tools.
Potential Biases
Some studies had high risk of bias due to unblinded outcome assessment.
Limitations
The review was limited by the lack of standardized methods for defining trials as pragmatic or explanatory.
Participant Demographics
Most trials were conducted in China, with a few in Europe, and included a mix of single and multicenter studies.
Digital Object Identifier (DOI)
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