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<p>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. A cross-sectional study was conducted among 400 postoperative patients recruited consecutively from General Surgery, Orthopaedics, Obstetrics and Gynaecology, Otorhinolaryngology (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 &lt; 0.05 was considered statistically significant. The mean informed consent form (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 (<i>p</i> &lt; 0.05). Time spent on consent (β = 0.34, <i>p</i> &lt; 0.001), patient awareness (β = 0.28, <i>p</i> &lt; 0.001), and understanding (β = 0.22, <i>p</i> &lt; 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. 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.</p>

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Assessment of Informed Consent Practices in Surgical Procedures at a Tertiary Care Hospital of Northeast India

  • 期刊论文

  • 发表日期：

    2026年6月2日

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  • Nani Gopal Das,
  • Abhik Sil,
  • Nirmalendu Das,
  • Papiya Paul

摘要

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. A cross-sectional study was conducted among 400 postoperative patients recruited consecutively from General Surgery, Orthopaedics, Obstetrics and Gynaecology, Otorhinolaryngology (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. The mean informed consent form (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. 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.