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Autonomy with responsibility ¿Is informed consent just a signature on a paper? Evaluation in patients who underwent spine’s surgery

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Abstract

Purpose

To evaluate the information that patients undergoing spine surgery truly receive and assimilate when they sign their informed consent documents.

Methods

This was a retrospective study on patients who underwent spine arthrodesis or spine discectomy. Patients were given a full explanation of the surgical technique to be employed and its potential risks before they were included on the surgical waiting list. Before surgery, they were asked to sign an informed consent form. The studied variables included whether patients read the informed consent form, whether they recalled the surgical technique used or the spinal segment operated, whether they were aware of the surgical risks involved, and if they had looked for information about their procedure elsewhere. Answers were analyzed by age and educational level.

Results

Of a total of 458 total patients, only 51.9% answered all the questions. Sixty-three percent of patients said they had read the informed consent document before surgery. Although 91.6% of patients were aware of the spine segment operated, only 73.5% remembered the surgical technique employed. A total of 63.9% of patients could recall the vertebral levels operated. 39.1% were not aware of the surgical risks involved, and only 16.0% of patients admitted having looked for additional information. A statistically significant correlation was found between the search for additional information and young age (p < 0.001) on the one hand, and high educational level on the other (p = 0.023).

Conclusion

Even though obtaining informed consent is an important procedure before spinal surgery, almost 40% of the patients in this study underwent surgery without reading the informed consent document or being aware of the risks posed by the procedure.

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Funding

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

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Authors and Affiliations

Authors

Contributions

JHN contributed to conceptualization (lead), investigation (lead), methodology (lead), supervision (lead), validation (lead), writing—original draft (lead). MJJJ contributed to conceptualization (lead), investigation (equal), methodology (equal), supervision (equal), validation (equal), writing—review and editing (equal). AT contributed to conceptualization (equal), investigation (equal), methodology (equal), writing—original draft (equal). FAG contributed to conceptualization (equal), investigation (equal), methodology (equal), writing—original draft (equal). BEC contributed to conceptualization (equal), investigation (equal), methodology (equal), writing—original draft (equal). DBG contributed to conceptualization (equal), investigation (equal), methodology (equal), writing—original draft (equal).

Corresponding author

Correspondence to Jorge H. Núñez.

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Conflict of interest

Jorge H. Núñez, Maria Jose Jimenez-Jimenez, Anna Taberner, Francisco Alonzo-González, Berta Escudero Cisneros, David Bosch-García declared no potential conflicts of interest with respect to the research, authorship and/or publication of this article.

Ethical approval

This material is the authors' own original work, which has not been previously published elsewhere. The study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki.

Consent to participate

The patient’s consent was obtained from all participants.

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The patients were informed that data and images concerning their cases would be submitted for publication, and they provided written informed consent.

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Núñez, J.H., Jimenez-Jimenez, M.J., Taberner, A. et al. Autonomy with responsibility ¿Is informed consent just a signature on a paper? Evaluation in patients who underwent spine’s surgery. Eur Spine J 32, 2959–2966 (2023). https://doi.org/10.1007/s00586-023-07867-2

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