Assessment of Informed Consent Practices in Surgical Procedures at a Tertiary Care Hospital of Northeast India: A Cross-Sectional Study.
Main Article Content
Keywords
Informed Consent, Patient Satisfaction, Autonomy, Documentation, Communication
Abstract
Background: Informed consent is an ethical and legal prerequisite for surgical care, yet its quality and comprehensibility vary widely across clinical settings. Factors such as communication barriers, limited patient understanding, and time constraints, especially in emergency surgeries, can compromise the consent process. This study assessed the quality of informed consent practices in major surgical departments of a tertiary care hospital in Northeast India and examined determinants of patient understanding and satisfaction.
Methodology: A cross-sectional study was conducted among 400 postoperative patients recruited consecutively from General Surgery, Orthopaedics, Obstetrics and Gynaecology, ENT, and Ophthalmology departments. Data were collected using a pre-validated Informed Consent Quality (ICF) checklist, a structured interview schedule, and a five-point satisfaction scale. Statistical analysis included chi-square tests, independent t-tests, ANOVA, Pearson’s correlation, multivariable logistic regression to identify predictors of satisfaction, and multiple linear regressions to determine predictors of ICF quality. A p-value <0.05 was considered statistically significant.
Results: The mean ICF Quality Score was 7.8 ± 1.9, and the mean Satisfaction Score was 4.1 ± 0.8. Elective surgeries showed significantly higher ICF quality and satisfaction than emergency procedures (p < 0.05). Time spent on consent (β = 0.34, p < 0.001), patient awareness (β = 0.28, p < 0.001), and understanding (β = 0.22, p < 0.001) emerged as independent predictors of ICF quality. Satisfaction was significantly associated with higher ICF scores, local language use, and adequate discussion of complications. Emergency status remained a negative predictor in regression analysis.
Conclusion: Effective communication, adequate time allocation, and use of local language substantially improve the ethical quality of surgical informed consent. Structured templates and AETCOM-based training may strengthen consent practices in Indian teaching hospitals.
References
2. Medical Council of India. Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002. Available from https://www.nmc.org.in/wp-content/uploads/2017/10/Ethics-Regulations-2002.pdf
3. Mukherjee JB, Karmakar RN. J.B. Mukherjee's Forensic Medicine & Toxicology. 5th ed. Kolkata: Academic Publishers; 2018.
4. Medical Council of India / National Medical Commission. AETCOM: Attitude, Ethics, and Communication Competencies for the Indian Medical Graduate. 2018–2020 modules.
5. National Medical Commission. Skill Training Module—Communication & consent skills (competency lists and learning objectives). 2019.
6. Fink AS, Prochazka AV, Henderson WG, Bartenfeld D, Nyirenda C, Webb A, Berger DH, Itani K, Whitehill T, Edwards J, Wilson M, Karsonovich C, Parmelee P. Predictors of comprehension during surgical informed consent. J Am Coll Surg. 2010 Jun; 210(6):919-26. doi: 10.1016/j.jamcollsurg.2010.02.049. PMID: 20510800.
7. Glaser J, Nouri S, Fernandez A, Sudore RL, Schillinger D, Klein-Fedyshin M, Schenker Y. Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: An Updated Systematic Review. Med Decis Making. 2020 Feb; 40(2):119-143. doi: 10.1177/0272989X19896348. Epub 2020 Jan 16. PMID: 31948345; PMCID: PMC7079202.
8. Biyazin, T., Taye, A. & Belay, Y. Patient satisfaction with surgical informed consent at Jimma Medical Center, Ethiopia. BMC Med Ethics 23, 103 (2022). https://doi.org/10.1186/s12910-022-00841-5
9. Kituuka, O., Mwaka, E., Munabi, I. et al. Experiences of patients and next of kin on informed consent process for emergency surgery in two urban university teaching hospitals in Uganda: a comparative cross sectional study. BMC Emerg Med 23, 82 (2023). https://doi.org/10.1186/s12873-023-00856-0
10. Kumru S, Albayrak H, Kaya S. Informed consent in surgical practice: Patients’ experiences and perspectives. Patient Experience Journal. 2023; 10(3):57–69.
11. Muskens IS, Gupta S, Robertson FC, Moojen WA, Kolias AG, Peul WC, Broekman MLD. When Time Is Critical, Is Informed Consent Less So? A Discussion of Patient Autonomy in Emergency Neurosurgery. World Neurosurg. 2019 May; 125:e336-e340. doi: 10.1016/j.wneu.2019.01.074. Epub 2019 Jan 26. PMID: 30690144.
12. Kituuka O, Munabi IG, Mwaka ES, Galukande M, Harris M, Sewankambo N. Informed consent process for emergency surgery: A scoping review of stakeholders’ perspectives, challenges, ethical concepts, and policies. Sage Open Medicine. 2023;11. doi:10.1177/20503121231176666
13. Drake BF, Brown KM, Gehlert S, Wolf LE, Seo J, Perkins H, Goodman MS, Kaphingst KA. Development of Plain Language Supplemental Materials for the Biobank Informed Consent Process. J Cancer Educ. 2017 Dec; 32(4):836-844. doi: 10.1007/s13187-016-1029-y. PMID: 27037699; PMCID: PMC5047847.
14. Sayfi S, Charide R, Elliott SA, Hartling L, Munan M, Stallwood L, Butcher NJ, Richards DP, Mathew JL, Suvada J, Akl EA, Kredo T, Mbuagbaw L, Motilall A, Baba A, Scott SD, Falavigna M, Klugar M, Friessová T, Lotfi T, Stevens A, Offringa M, Schünemann HJ, Pottie K. A multimethods randomized trial found that plain language versions improved adults understanding of health recommendations. J Clin Epidemiol. 2024 Jan; 165:111219. doi: 10.1016/j.jclinepi.2023.11.009. Epub 2023 Nov 25. PMID: 38008266.
15. Ayre J, Bonner C, Muscat DM, Cvejic E, Mac O, Mouwad D, Shepherd HL, Aslani P, Dunn AG, McCaffery KJ. Online Plain Language Tool and Health Information Quality: A Randomized Clinical Trial. JAMA Netw Open. 2024 Oct 1;7(10):e2437955. doi: 10.1001/jamanetworkopen.2024.37955. PMID: 39378036; PMCID: PMC11581667.
16. Feinberg IZ, Gajra A, Hetherington L, McCarthy KS. Simplifying informed consent as a universal precaution. Sci Rep. 2024 Jun 8;14(1):13195. doi: 10.1038/s41598-024-64139-9. PMID: 38851754; PMCID: PMC11162480.
17. Krieger JL, Neil JM, Strekalova YA, Sarge MA. Linguistic Strategies for Improving Informed Consent in Clinical Trials among Low Health Literacy Patients. J Natl Cancer Inst. 2016 Oct 28; 109(3):djw233. doi: 10.1093/jnci/djw233. PMID: 27794035; PMCID: PMC5441300.
18. Lal S, Sehgal P. Integration of attitude, ethics, and communication competencies into competency-based UG curriculum. Indian J Community Med. 2022; 47(1):4-7.
19. Patil A, Chawathey S, Malim A. Adequacy of Informed Consent in Elective Surgical Procedures: A Study in a Navi Mumbai Tertiary Care Centre. Cureus 15(7): e41777. doi 10.7759/cureus.41777.
20. Singh AD, Rochwani R, Oberoi S. Informed consent and responses of surgical patients: A study in North India. Natl J Physiol Pharm Pharmacol 2021;11(08):925-929.
21. García-Álvarez JM, Díaz-Agea JL, Suárez-Cortés M, Molina-Rodríguez A, Jiménez-Ruiz I, García-Sánchez A. Formal Quality and Compliance of Informed Consent Forms in Critical Care and Surgical Areas in Spain: An Observational Study. Nursing reports; 13(1): 43–50. https://doi.org/10.3390/nursrep13010004
22. Basukala S, Shrestha O, Thapa N, Karki S, Pandit A, Thapa BB, et al. How informed is informed consent? Evaluating the quality of informed consent among surgical patients in a tertiary care hospital in Nepal. PLOS ONE 18(7): e0288074. https://doi.org/10.1371/journal.pone.0288074.
23. Ochieng J, Buwembo W, Munabi I et al. Informed consent in clinical practice: patients’ experiences and perspectives following surgery. BMC Res Notes. 2015; 8, 765. https://doi.org/10.1186/s13104-015-1754-z.
24. Kebede BF, Tesfa TB, Hiwot AY et al. Knowledge of surgical informed consent and associated factors among patients undergone obstetric and gynaecologic surgery at Jimma Medical Center, Jimma, Ethiopia, 2020: an institutional based cross-sectional study. Perioper Med. 2023; 12, 6. https://doi.org/10.1186/s13741-023-00295-2.
25. Chane W, Birhanu B, Suga Y. Quality of Informed Consent Among Patients Who Underwent Major Surgical Procedure in a Tertiary Care Hospital, Addis Ababa, Ethiopia. Open Access Surgery. 2020; 13:27-33. https://doi.org/10.2147/OAS.S250532.
26. Vieira AL, Infante C, Santos S, Asseiro M, Ferreira C. A survey on current practice of informed consent process in surgical specialties of a Portuguese tertiary teaching hospital center: What is the state of play? Ethics Med Public Health. June 2023; 28:100910. http://doi:10.1016/j.jemep.2023.100910.
27. Agozzino E, Borrelli S, Cancellieri M, Carfora FM, Di Lorenzo T, Attena F. Does written informed consent adequately inform surgical patients? A cross-sectional study. BMC Med Ethics. 2019; 20(1):1. http://doi:10.1186/s12910-018-0340-z.
28. Amir M, Rabbani MZ, Parvez MB. Informed consent in elective surgical procedures: “What do the patients think?”. J Pak Med Assoc. 2009; 59(10):679-82.
29. Mbonera F, Chironda G. The relationship between knowledge and perception of patients regarding informed consent in surgical procedures in Rwanda. Int J Res Med Sci. 2018; 6(2):408-16.
30. Calle-Urra JE, Parra-Hidalgo P, Saturno-Hernández P, Fonseca-Miranda Y, Martínez-Martínez MJ. Evaluation and Improvement of the Informed Consent Documents in 9 Hospitals, Spain. Rev. Esp. Salud Publica 2015, 89, 307–319.
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