Autonomy with responsibility ¿Is informed consent just a signature on a paper? Evaluation in patients who underwent spine's surgery.
Autonomy
Informed consent
Responsibility
Risk
Surgery
Journal
European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society
ISSN: 1432-0932
Titre abrégé: Eur Spine J
Pays: Germany
ID NLM: 9301980
Informations de publication
Date de publication:
09 2023
09 2023
Historique:
received:
20
02
2023
accepted:
13
07
2023
revised:
11
06
2023
medline:
11
9
2023
pubmed:
23
7
2023
entrez:
23
7
2023
Statut:
ppublish
Résumé
To evaluate the information that patients undergoing spine surgery truly receive and assimilate when they sign their informed consent documents. 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. 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). 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.
Identifiants
pubmed: 37481758
doi: 10.1007/s00586-023-07867-2
pii: 10.1007/s00586-023-07867-2
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
2959-2966Informations de copyright
© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.
Références
Grady C (2015) Enduring and emerging challenges of informed consent. N Engl J Med 372(9):855–862. https://doi.org/10.1056/NEJMra1411250
doi: 10.1056/NEJMra1411250
pubmed: 25714163
Cocanour CS (2017) Informed consent–its’s more than a signature on a piece of paper. Am J Surg 214(6):993–997. https://doi.org/10.1016/j.amjsurg.2017.09.015
doi: 10.1016/j.amjsurg.2017.09.015
pubmed: 28974311
Garreau de Loubresse C (2014) Neurological risks in scheduled spinal surgery. Orthop Traumatol Surg Res 100(1 Suppl):S85–S90. https://doi.org/10.1016/j.otsr.2013.11.001
doi: 10.1016/j.otsr.2013.11.001
pubmed: 24412042
Schoenfeld AJ, Ochoa LM, Bader JO, Belmont PJ Jr (2011) Risk factors for immediate postoperative complications and mortality following spine surgery: a study of 3475 patients from the National Surgical Quality Improvement Program. J Bone Jt Surg Am 93(17):1577–1582. https://doi.org/10.2106/JBJS.J.01048
doi: 10.2106/JBJS.J.01048
Rougereau G, Marty-Diloy T, Bonaccorsi R, Vialle R, Boisrenoult P, Pascal-Moussellard H, Langlais T (2022) Malpractice litigation after spinal surgery: a review of allegations in France in 1990–2020. Orthop Traumatol Surg Res. https://doi.org/10.1016/j.otsr.2022.103510
doi: 10.1016/j.otsr.2022.103510
pubmed: 36509364
Selinger CP (2009) The right to consent: is it absolute? Br J Med Pract 2:50–54
Ricketts D, Roper T, Rogers B, Phadnis J, Elsayed S, Sokol D (2019) Informed consent: the view from the trenches. Ann R Coll Surg Engl 101(1):44–49. https://doi.org/10.1308/rcsann.2018.0140
doi: 10.1308/rcsann.2018.0140
pubmed: 30286630
Monib S (2022) Clinical importance of the informed consent process in breast surgery. Pan Afr Med J 41:188. https://doi.org/10.11604/pamj.2022.41.188.28872
Bazzano LA, Durant J, Brantley PR (2021) A modern history of informed consent and the role of key information. Ochsner J 21(1):81–85. https://doi.org/10.31486/toj.19.0105
Vollmann J, Winau R (1996) History of informed medical consent. Lancet (London, England) 347(8998):410
doi: 10.1016/S0140-6736(96)90597-8
pubmed: 8598747
Weindling P (2001) The origins of informed consent: the International Scientific Commission on medical war crimes, and the nuremburg code. Bull Hist Med 75:37–71. https://doi.org/10.1353/bhm.2001.0049
doi: 10.1353/bhm.2001.0049
pubmed: 11420451
Pace E (2021) PG Gebhard 69, developer of the term ‘informed consent’. Accessed on 26 Nov 2021. Available at: https://www.nytimes.com/1997/08/26/us/p-g-gebhard-69-developer-of-the-term-informed-consent.html
Salgo v Leland Stanford, Jr University Board of Trustees (1957) 154 Cal App 2d 560, 317 P2d 170. Accessed November 5, 2021. caselaw.findlaw.com/ca-court-of-appeal/1759823.html
Foy MA (2015) Informed consent: where are we in 2015? Bone Joint J 97-B(9):1159–61. https://doi.org/10.1302/0301-620X.97B9.36506
Falagas ME, Korbila IP, Giannopoulou KP, Kondilis BK, Peppas G (2009) Informed consent: how much and what do patients understand? Am J Surg 198(3):420–435. https://doi.org/10.1016/j.amjsurg.2009.02.010
doi: 10.1016/j.amjsurg.2009.02.010
pubmed: 19716887
Eigen ZJ (2012) Experimental evidence of the relationship between reading the fine print and performance of form-contract terms. J Instit Theor Econ 168(1):124–141. https://doi.org/10.1628/093245612799440050
doi: 10.1628/093245612799440050
RA Hillman (2006) Online Boilerplate: would mandatory website disclosure of e-standard terms backfire?, 104 Mich. L. Rev. 837. Available at: https://repository.law.umich.edu/mlr/vol104/iss5/2
Becher SI, Unger-Aviram E (2010) The law of standard form contracts: misguided intuitions and suggestions for reconstruction. DePaul Bus Commer Law J 8:199–223
Bakos Y, Marotta-Wurgler F, Trossen DR (2014) Does anyone read the fine print? Consumer attention to standard-form contracts. J Leg Stud 43(1):1–35
doi: 10.1086/674424
de Guzman GS, Amosco MDL (2022) Patient experience and decisional satisfaction with the informed consent process for elective gynecologic surgeries: a cross-sectional study. Ann Med Surg (Lond) 81:104551. https://doi.org/10.1016/j.amsu.2022.104551
doi: 10.1016/j.amsu.2022.104551
pubmed: 36147082
Slim K, Bazin JE (2019) From informed consent to shared decision-making in surgery. J Visc Surg 156(3):181–184. https://doi.org/10.1016/j.jviscsurg.2019.04.014
doi: 10.1016/j.jviscsurg.2019.04.014
pubmed: 31101549
Chan SW, Tulloch E, Cooper ES, Smith A, Wojcik W, Norman JE (2017) Montgomery and informed consent: where are we now? BMJ 357:2224. https://doi.org/10.1136/bmj.j2224
doi: 10.1136/bmj.j2224
Shanner L (1993) Informed consent and information inadequate medical. Lancet 346(8969):251. https://doi.org/10.1016/s0140-6736(95)91297-5
doi: 10.1016/s0140-6736(95)91297-5
Lloyd AJ, Hayes PD, London NJ, Bell PR, Naylor AR (1999) Patients’ ability to recall risk associated with treatment options. Lancet 353(9153):645. https://doi.org/10.1016/s0140-6736(98)05670-0
doi: 10.1016/s0140-6736(98)05670-0
pubmed: 10030337
Sarkar R, Sowmyanarayanan TV, Samuel P, Singh AS, Bose A, Muliyil J, Kang G (2010) Comparison of group counseling with individual counseling in the comprehension of informed consent: a randomized controlled trial. BMC Med Ethics 11:8. https://doi.org/10.1186/1472-6939-11-8
doi: 10.1186/1472-6939-11-8
pubmed: 20470423
pmcid: 2877053
Gattellari M, Butow PN, Tattersall MH (1999) Informed consent: what did the doctor say? Lancet 353(9165):1713. https://doi.org/10.1016/S0140-6736(05)77027-6
doi: 10.1016/S0140-6736(05)77027-6
pubmed: 10335821
Alfonsi P (1999) Informed consent: what did the doctor say? Lancet 354(9177):518. https://doi.org/10.1016/S0140-6736(05)75558-6
doi: 10.1016/S0140-6736(05)75558-6
pubmed: 10465211