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Renal denervation for atrial fibrillation: the issue of bias due to nonblinding

Journal of Human Hypertension volume 37, page 88 (2023)Cite this article

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In a recent meta-analysis, Nawar et al. [1] investigated the safety and effectiveness of renal denervation (RDN) for hypertensive patients with atrial fibrillation (AF). The authors concluded that the addition of RDN to pulmonary vein isolation (PVI) in hypertensive patients with AF is more efficacious and superior to using PVI alone in treating AF.

In this otherwise excellently conducted study, we find it pertinent to highlight a couple of aspects that decrease the confidence in its rather strong conclusions. The authors chose to modify the six study domains of the Cochrane Risk of Bias Tool (RoB) 1.0 [2] in their quality assessment by excluding the domains of blinding of participants with no rationale given for this change. Presumably, this is due to the fact that sham-controlled trials are difficult to conduct, which makes blinding impossible. However, this is not a sound justification for not performing a formal assessment of the risk of bias in this domain. As none of the included trials were sham-controlled in the concerned meta-analysis, this would automatically put them at a high risk of bias as evident in a previous meta-analysis [3]. However, the limitations of RoB 1.0, which made Nawar et al. not use the blinding domain, have been addressed in the current version of the Cochrane Risk of Bias Tool, RoB 2.0 [4]. Specifically, RoB 2.0 prevents unblinded studies from being automatically at a high risk of bias and instead judges whether any potential bias could arise due to deviations from intended interventions that occurred due to trial context because blinding was either not feasible or was not implemented. Therefore, while RoB 2.0 is harder to use than its previous version, it provides a more accurate assessment of the risk of bias.

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Data availability

The data underlying this study are available from the corresponding author.

References

  1. Nawar K, Mohammad A, Johns EJ, Abdulla MH. Renal denervation for atrial fibrillation: a comprehensive updated systematic review and meta-analysis. J Hum Hypertens. 2022. https://doi.org/10.1038/s41371-022-00658-0.

  2. Higgins JPT, Altman DG, Gøtzsche PC, Jüni P, Moher D, Oxman AD, et al. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. BMJ. 2011;343:d5928.

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  3. Pranata R, Vania R, Raharjo SB. Efficacy and safety of renal denervation in addition to pulmonary vein isolation for atrial fibrillation and hypertension—systematic review and meta-analysis of randomized controlled trials. J Arrhythmia. 2020;36:386–94.

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  4. Sterne JAC, Savović J, Page MJ, Elbers RG, Blencowe NS, Boutron I, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ. 2019;366:l4898.

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  5. Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, et al. (eds.). Cochrane Handbook for Systematic Reviews of Interventions. 2nd edn. Hoboken: Wiley Blackwell; 2019.

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Acknowledgements

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Funding

No financial support was received for this study.

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Authors and Affiliations

  1. Department of Medicine, King Edward Medical University, Lahore, Pakistan

    Huzaifa Ahmad Cheema & Abia Shahid

Authors
  1. Huzaifa Ahmad Cheema
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  2. Abia Shahid
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Contributions

All authors contributed to the conception and design of this study, drafting and critical revision of the article, and gave final approval for it.

Corresponding author

Correspondence to Huzaifa Ahmad Cheema.

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Competing interests

The authors declare no competing interests.

Ethics approval

No ethical approval was required for this study as it is a letter to the editor and not based on any human data.

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Cheema, H.A., Shahid, A. Renal denervation for atrial fibrillation: the issue of bias due to nonblinding. J Hum Hypertens 37, 88 (2023). https://doi.org/10.1038/s41371-022-00699-5

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