Corrections

Huo CW, Malham GM, Biddau DT, Chung T, Wang YY. Lateral lumbar interbody fusion using expandable vs static titanium interbody cages: a prospective cohort study of clinical and radiographic outcomes. Int J Spine Surg. 2023;17(2):265-275. https://doi.org/10.14444/8422

The authors report that in discussion with the research governance teams of both St Vincent’s Hospital Melbourne and Epworth HealthCare, it has come to their attention that some errors occurred in this recently published article. The authors thus submit the following: The article states the following on page 266: “This was a multicenter prospective cohort study with institutional ethics committee approvals obtained (St Vincent’s Hospital Quality Assurance reference number: 21036; Epworth HealthCare Ethics approval: Professor Nikolas Zeps, Group Director of Research and Development). Ninety-eight consecutive patients underwent LLIF, with a total of 169 operative levels performed between December 2018 and February 2021 by 2 senior spinal fellowship trained neurosurgeons using the same surgical techniques. Informed consents were obtained from all patients.”First, while we individually obtained institutional approval to undertake a retrospective analysis of our own patient records (essentially, audits of our own respective practices), we are now aware that we did not obtain the necessary institutional approval to use our aggregated (non-identifiable) data in a published, combined comparison study. A single site quality assurance retrospective audit was registered with St Vincent’s Hospital Melbourne and institutional ethics approval from Epworth HealthCare was not received. Accordingly, stating that the “multicenter prospective cohort study” had “institutional ethics committee approvals” from the two institutions was a mistake.Second, we obtain patient consent for surgery at each institution, to allow analysis of patient treatment and outcome data for the purposes of quality assurance and quality improvement in our practices, as part of our routine consent to treatment. We believe that this is essential to maintaining high standards of safety and quality in our practices. However, we have now become aware that although we obtained patient consent prospectively to perform routine analysis of our own patient outcomes (including for research), specific patient consent for inclusion of their non-identifiable data in this published study was not obtained.A further consequence of this is that although consent was obtained prospectively, this does not mean that our study was prospective. That is, as we did not have the purpose of the study specifically in mind when we obtained the relevant patient consent, the study is in fact a retrospective analysis of routine clinical data collated prospectively.It is important to note that neither of these issues has had any adverse consequences for, or adverse effect on, either (a) patient safety or welfare, or (b) the integrity of the data that is the subject of the study. The amalgamation of our non-identifiable data was a decision that we made in good faith because we believed that it would create a larger and therefore more statistically robust data set. This decision did not involve any change to patient treatment, or the sharing of identifiable personal information with unauthorized persons (for example). At all times, the confidentiality of patient data has been maintained (as only non-identifiable data were used in the study). At all times, we acted in good faith in attempting to obtain the necessary approvals for this study.

Thus, the following corrections have been made to this article:

• The title of the article is changed from “Lateral Lumbar Interbody Fusion Using Expandable vs Static Titanium Interbody Cages: A Prospective Cohort Study of Clinical and Radiographic Outcomes” to “Lateral Lumbar Interbody Fusion Using Expandable vs Static Titanium Interbody Cages: A Retrospective Study of Clinical and Radiographic Outcomes”

• The approvals and consent statements previously listed are changed to “This was a multicenter retrospective cohort study. Institutional ethics committee approvals were obtained (St Vincent’s Hospital Quality Assurance reference number: 21036; Epworth HealthCare Ethics approval: Professor Nikolas Zeps, Group Director of Research and Development). Ninety-eight consecutive patients underwent LLIF, with a total of 169 operative levels performed between December 2018 and February 2021 by 2 senior spinal fellowship trained neurosurgeons using the same surgical techniques. Informed consent was obtained from patients at the time of data collection.”

(doi:10.14444/8422.cxx)

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