Robustness and pragmatism of the evidence supporting the European Society for Medical Oncology guidelines for the diagnosis, treatment, and follow-up of follicular lymphoma

ABSTRACT

Background: Results of randomized clinical trials may not be entirely applicable to clinical practice. The present manuscript aims to explore the pragmatism and robustness of the evidence that supports the European Society for Medical Oncology (ESMO) follicular lymphoma (FL) guidelines.

Methods & design: Analysis of all trials used to support positive, therapeutic, oncological recommendations in the 2020 ESMO FL guidelines. Predefined data points were extracted from each trial. Pragmatism was assessed by means of the PRECIS-2 tool, the difference in overall survival in the interventions compared and the source of funding. Robustness was assessed by means of the fragility index and the p value.

Results: 28 trials were included. The full protocol or a protocol summary was provided for 12 (43%). Based on the PRECIS-2 domains, trials were considered pragmatic in organization, analysis and flexibility and explanatory in eligibility. Robustness was high, with 4/24 (17%) trials with p values between 0.05 and 0.005 and a median fragility index of 18.

Conclusions: Results of trials to support ESMO recommendations in FL were robust. Pragmatism was high in some domains but modest to low in others and the pattern was similar across trials. Transparency in the publication of trial protocols was suboptimal.

KEYWORDS:

• Follicular lymphoma
• pragmatic
• esmo
• fragility index
• precis-2
• eligibility

Acknowledgments

The authors thank the CERCA Programme/Generalitat de Catalunya and the Josep Carreras Foundation for institutional support

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosure

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

M Sorigue conceived the study, analyzed the data and drafted the manuscript. O Kuittinen analyzed the data and revised the manuscript. Both authors read and approved the final version of the manuscript.

Supplementary material

Supplemental data for this article can be accessed here

Additional information

Funding

This paper was not funded