Digital consent in gynecology: an evaluation of patient experience.

Digital consent Electronic consent Patient experience e-Consent

Journal

Archives of gynecology and obstetrics
ISSN: 1432-0711
Titre abrégé: Arch Gynecol Obstet
Pays: Germany
ID NLM: 8710213

Informations de publication

Date de publication:
08 Dec 2023
Historique:
received: 25 08 2023
accepted: 08 11 2023
medline: 8 12 2023
pubmed: 8 12 2023
entrez: 8 12 2023
Statut: aheadofprint

Résumé

The surgical consent process is a crucial discussion between patient and surgeon, which is predominantly documented utilizing hand-written forms. The exchange of individualized information allows the patient to make a truly informed decision. Digital consent (also known as electronic consent or e-consent) has been shown to improve accuracy of information provided without increasing the time taken to consent patients. We aimed to evaluate patient experience and effectiveness of digital consent in a gynecology department in a tertiary London Teaching Hospital. A questionnaire was designed and completed by 100 patients undergoing gynecological surgery: 50 consented using paper and 50 consented digitally. The questionnaire included 8 statements, with five possible answers to select, ranging from strongly agree to strongly disagree, on a standard five-point Likert Scale. Patients were all female and categorized into age groups (deciles) and asked whether consent was taken digitally or on paper. Data were collected between January and July 2021. Most responses were positive with 87% (694/800) of responses to the questions being either strongly agree or agree. Patients who were consented using paper selected 'strongly agree' 43.5% (174/400) of the time in comparison to 64.8% (259/400) of the time when they were consented digitally. The majority, 86% (43/50), of digitally consented patients received a copy of the consent form in comparison to 18% (9/50) of those consented using paper. On average, the patients consented digitally were older than their paper-consented counterparts (49-58 and 59-68 respectively). The mean scores for the questions relating to the ease of reading the form, ease of understanding the form, understanding of the potential complications, and overall satisfaction were higher in those digitally consented (p < 0.05). Overall, patients were satisfied with both methods of consent. However, individuals who were consented digitally reported higher levels of satisfaction throughout the consent process, compared to paper consent. These data suggest that digital consent is an acceptable alternative to paper consent for patients and facilitates adherence to national consent guidance, which stipulates patients should be given the information they request.

Identifiants

pubmed: 38063894
doi: 10.1007/s00404-023-07304-1
pii: 10.1007/s00404-023-07304-1
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

© 2023. The Author(s).

Références

England RCoSo. 3.5.1 Consent (2022). Available from https://www.rcseng.ac.uk/standards-and-research/gsp/domain-3/3-5-1-consent/2022 . Accessed 20 Aug 2022
Gynaecologists RCoOa (2015) Obtaining valid consent
Council GM (2020) Decision making and consent
Cheung E, Goodyear G, Yoong W (2016) Medicolegal update on consent: ‘the montgomery ruling.’ Obstet Gynaecol 18(3):171–172. https://doi.org/10.1111/tog.12303
doi: 10.1111/tog.12303
Government U (2009) Reference guide to consent for examination or treatment, 2nd edn. Available from https://www.gov.uk/government/publications/reference-guide-to-consent-for-examination-or-treatment-second-edition . Accessed 11 February 2023
St John E, Scott A, Collins E et al (2015) P127. Procedure-specific electronic consent forms (OpInform.com) reduces errors in consenting practice for breast surgery. Eur J Surg Oncol 41(6):S62. https://doi.org/10.1016/j.ejso.2015.03.165
doi: 10.1016/j.ejso.2015.03.165
Kenyon RM, Pomeroy E, Yeo R et al (2019) Consent documentation for elective orthopaedic surgery. Ir J Med Sci 188(3):861–866. https://doi.org/10.1007/s11845-018-1929-4[publishedOnlineFirst:20181119]
doi: 10.1007/s11845-018-1929-4[publishedOnlineFirst:20181119] pubmed: 30456515
Rollings L, Borghol K, Twohig E (2019) Skin surgery consent audit: introducing the electronic consent phenomenon. Br J Oral Maxillofac Surg 57(10):e15–e15. https://doi.org/10.1016/j.bjoms.2019.10.035
doi: 10.1016/j.bjoms.2019.10.035
Issa MM, Setzer E, Charaf C et al (2006) Informed versus uninformed consent for prostate surgery: the value of electronic consents. J Urol 176(2):694–699. https://doi.org/10.1016/j.juro.2006.03.037
doi: 10.1016/j.juro.2006.03.037 pubmed: 16813921
St John ER, Bakri AC, Johanson E et al (2021) Assessment of the introduction of semi-digital consent into surgical practice. Br J Surg 108(4):342–345. https://doi.org/10.1093/bjs/znaa119
doi: 10.1093/bjs/znaa119 pubmed: 33783479
Power FR, McClean A, Cashman J (2020) Influence of a preadmission procedure-specific consent document on patient recall of informed consent at 4 weeks after total hip replacement: a randomized controlled trial. J Patient Saf 18(1):e243–e248. https://doi.org/10.1097/PTS.0000000000000756
doi: 10.1097/PTS.0000000000000756
Garonzik-Wang JM, Brat G, Salazar JH et al (2013) Missing consent forms in the preoperative area. JAMA Surg 148(9):886. https://doi.org/10.1001/jamasurg.2013.354
doi: 10.1001/jamasurg.2013.354 pubmed: 23842781
Lunt H, Connor S, Skinner H et al (2019) Electronic informed consent: the need to redesign the consent process for the digital age. Intern Med J 49(7):923–929. https://doi.org/10.1111/imj.14339
doi: 10.1111/imj.14339 pubmed: 31295775
Shivabalendran T, Ahmed U, Eweiss A et al (2021) 1434° An audit of surgical consent standards in patients undergoing elective ENT surgery. Br J Surg. https://doi.org/10.1093/bjs/znab259.158
doi: 10.1093/bjs/znab259.158
Reeves JJ, Mekeel KL, Waterman RS et al (2020) Association of electronic surgical consent forms with entry error rates. JAMA Surg 155(8):777. https://doi.org/10.1001/jamasurg.2020.1014
doi: 10.1001/jamasurg.2020.1014 pubmed: 32432722 pmcid: 7240641
Loughran D (2015) Surgical consent: the world’s largest Chinese Whisper? A review of current surgical consent practices. J Med Ethics 41(2):206. https://doi.org/10.1136/medethics-2013-101931
doi: 10.1136/medethics-2013-101931 pubmed: 25205390
Concentric Health [program] (2022)
Bethune A, Davila-Foyo M, Valli M et al (2018) e-Consent: approaching surgical consent with mobile technology. Can J Surg 61(5):339–344. https://doi.org/10.1503/cjs.016017
doi: 10.1503/cjs.016017 pubmed: 30247010 pmcid: 6153099
Chen C, Lee PI, Pain KJ et al (2020) Replacing paper informed consent with electronic informed consent for research in academic medical centers: a scoping review. AMIA Jt Summits Transl Sci Proc 2020:80–88
pubmed: 32477626 pmcid: 7233043
Jiang L, Zhang G, Hao K et al (2022) Electronic transfusion consent and blood delivering pattern improve the management of blood bank in China. BMC Health Serv Res. https://doi.org/10.1186/s12913-022-07825-6
doi: 10.1186/s12913-022-07825-6 pubmed: 36527029 pmcid: 9652982
Abujarad F, Peduzzi P, Mun S et al (2021) Comparing a multimedia digital informed consent tool with traditional paper-based methods: randomized controlled trial. JMIR Form Res 5(10):e20458. https://doi.org/10.2196/20458[publishedOnlineFirst:20211019]
doi: 10.2196/20458[publishedOnlineFirst:20211019] pubmed: 34665142 pmcid: 8564662
De Sutter E, Zaçe D, Boccia S et al (2020) Implementation of electronic informed consent in biomedical research and stakeholders’ perspectives: systematic review. J Med Internet Res 22(10):e19129. https://doi.org/10.2196/19129
doi: 10.2196/19129 pubmed: 33030440 pmcid: 7582148
Gynaecologists ACoOa (2021) Informed consent and shared decision making in obstetrics and gynecology. February 2021. https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2021/02/informed-consent-and-shared-decision-making-in-obstetrics-and-gynecology
Likert R (1932) A technique for the measurement of attitudes. Archiv Psychol 22(140):55–55
Corporation M (2018) Microsoft Excel. Online
Team R (2020) RStudio: integrated development for R. PBC, Boston, MA
Wickham H, Averick M, Bryan J et al (2019) Welcome to the Tidyverse. J Open Source Softw 4(43):1686
doi: 10.21105/joss.01686
NHS (2019) The NHS Long Term Plan. Online
NHS (2021) Unified tech fund prospectus. Available from https://transform.england.nhs.uk/digitise-connect-transform/unified-tech-fund/unified-tech-fund-prospectus/#elective-recovery-technology-fund-applicant-information . Accessed 10 November 22
NHS (2022) The year of the digital profession. Available from https://transform.england.nhs.uk/digitise-connect-transform/the-year-of-the-digital-profession-2022/ . Accessed 10 November 22
Jaton E, Stang J, Biros M et al (2020) The use of electronic consent for COVID-19 clinical trials: lessons for emergency care research during a pandemic and beyond. Acad Emerg Med 27(11):1183–1186. https://doi.org/10.1111/acem.14141
doi: 10.1111/acem.14141 pubmed: 32970895 pmcid: 7536977
Curtis JR, Foster PJ, Saag KG (2019) Tools and methods for real-world evidence generation. Rheum Dis Clin North Am 45(2):275–289. https://doi.org/10.1016/j.rdc.2019.01.010
doi: 10.1016/j.rdc.2019.01.010 pubmed: 30952398 pmcid: 6499376
Ramos SR (2017) User-centered design, experience, and usability of an electronic consent user interface to facilitate informed decision-making in a HIV clinic. Comput Inf Nurs 35(11):556–564. https://doi.org/10.1097/CIN.0000000000000356
doi: 10.1097/CIN.0000000000000356
Lyons R, Payne C, Mccabe M et al (1998) Legibility of doctors’ handwriting: quantitative comparative study. BMJ 317(7162):863–864. https://doi.org/10.1136/bmj.317.7162.863
doi: 10.1136/bmj.317.7162.863 pubmed: 9748186 pmcid: 31098
Friedlander JA, Loeben GS, Finnegan PK et al (2011) A novel method to enhance informed consent: a prospective and randomised trial of form-based versus electronic assisted informed consent in paediatric endoscopy. J Med Ethics 37(4):194–200. https://doi.org/10.1136/jme.2010.037622
doi: 10.1136/jme.2010.037622 pubmed: 21245476
Dyke R, St-John E, Shah H et al (2022) Comparing shared decision making using a paper and digital consent process. A multi-site, single centre study in a trauma and orthopaedic department. Surgeon. https://doi.org/10.1016/j.surge.2022.05.004
doi: 10.1016/j.surge.2022.05.004 pubmed: 35697552
St John ER, Ezzat A, Holford N et al (2022) Digital consent to improve patient perception of shared decision-making: comparative study between paper and digital consent processes in patients undergoing breast surgery. Br J Surg 109(11):1172–1173. https://doi.org/10.1093/bjs/znac285
doi: 10.1093/bjs/znac285 pubmed: 35960998
Pace T, Martin JC, Waldschmidt BM et al (2020) Meaningful use: the electronic consent process. J Clin Anesth 65:109897. https://doi.org/10.1016/j.jclinane.2020.109897
doi: 10.1016/j.jclinane.2020.109897 pubmed: 32470839
Lawrence CE, Dunkel L, Mcever M et al (2020) A REDCap-based model for electronic consent (eConsent): moving toward a more personalized consent. J Clin Transl Sci 4(4):345–353. https://doi.org/10.1017/cts.2020.30
doi: 10.1017/cts.2020.30 pubmed: 33244416 pmcid: 7681162
Terp R, Kayser L, Lindhardt T (2021) Older patients’ competence, preferences, and attitudes toward digital technology use: explorative study. JMIR Hum Factors 8(2):e27005. https://doi.org/10.2196/27005
doi: 10.2196/27005 pubmed: 33988512 pmcid: 8164121
Hasnan S, Aggarwal S, Mohammadi L et al (2022) Barriers and enablers of uptake and adherence to digital health interventions in older patients with cancer: a systematic review. J Geriatr Oncol. https://doi.org/10.1016/j.jgo.2022.06.004
doi: 10.1016/j.jgo.2022.06.004 pubmed: 35752605
Wilbanks J (2018) Design issues in e-consent. J Law Med Ethics 46(1):110–118. https://doi.org/10.1177/1073110518766025
doi: 10.1177/1073110518766025 pubmed: 30057442 pmcid: 6062847
Weinreich H, Obendorf H, Herder E et al (2008) Not quite the average: an empirical study of web use. ACM Trans Web 2(1):1–31. https://doi.org/10.1145/1326561.1326566
doi: 10.1145/1326561.1326566
Safi S, Thiessen T, Schmailzl KJ (2018) Acceptance and resistance of new digital technologies in medicine: qualitative study. JMIR Res Protoc 7(12):e11072. https://doi.org/10.2196/11072
doi: 10.2196/11072 pubmed: 30514693 pmcid: 6299231
Health C (2022) Privacy notice. Available from https://concentric.health/resources/privacy-notice/ . Accessed 11 October 22
Chhin V, Roussos J, Michaelson T et al (2017) Leveraging mobile technology to improve efficiency of the consent-to-treatment process. JCO Clin Cancer Inf 1(1):1–8. https://doi.org/10.1200/CCI.17.00041
doi: 10.1200/CCI.17.00041

Auteurs

Laura Burney Ellis (LB)

Imperial College London, Imperial College Healthcare NHS Trust, IRDB, Du Cane Road, London, W12 0NN, UK. lauraellis@doctors.org.uk.

Jennifer Barcroft (J)

Imperial College London, Imperial College Healthcare NHS Trust, IRDB, Du Cane Road, London, W12 0NN, UK.

Edward St John (E)

Portsmouth Hospitals University NHS Trust, Cosham, Portsmouth, PO6 3LY, UK.
University of Portsmouth, University House, Winston Churchill Ave, Portsmouth, PO1 2UP, UK.
Concentric Health, Tramshed Tech, Cardiff, CF11 6BH, UK.

Dafydd Loughran (D)

Concentric Health, Tramshed Tech, Cardiff, CF11 6BH, UK.

Maria Kyrgiou (M)

Imperial College London, Imperial College Healthcare NHS Trust, IRDB, Du Cane Road, London, W12 0NN, UK.

David Phelps (D)

Imperial College London, Imperial College Healthcare NHS Trust, IRDB, Du Cane Road, London, W12 0NN, UK.
University Hospitals Southampton NHS Foundation Trust, Princess Anne Hospital, Coxford Road, Southampton, SO16 5YA, UK.

Classifications MeSH