Comprehension as the Gatekeeper of Valid Surgical Consent: A Cross-Sectional Medicolegal Analysis of 320 High-Risk Indonesian Surgical Patients

Abstract

Background. Documented consent without demonstrable comprehension is medicolegally insufficient, yet comprehension-based informed consent (IC) failure in collectivistic surgical populations is largely unquantified.

Objective. To estimate the prevalence of adequate IC efficacy among high-risk surgical patients and to test whether comprehension or cultural collectivism predicts adequacy.

Methods. This cross-sectional study, reported per STROBE, assessed 320 consecutive adults undergoing high-risk elective surgery (ASA physical status III–IV) at Private Hospital X, Palembang, Indonesia, in 2024. Six instruments standardised to 0–100 included the IC Comprehension Score (ICCS) and the five-domain composite IC Efficacy Score (ICE); adequacy was ICE ≥ 70. Analyses used exact intervals, permutation tests, effect sizes, E-values and fragility indices.

Results. Only 19 of 320 patients (5.9%, 95% CI 3.6–9.1) achieved adequate IC efficacy, below published comparators (exact binomial P < 0.001 versus 14.0% and 35.8%); standardisation to lower-education distributions reduced this to 2.74–3.79%, so 5.9% is an upper bound. Adequacy rose monotonically with education from 0.0% to 13.3% (exact Cochran–Armitage z = 3.66, P = 0.0003; tertiary versus lower education, odds ratio 8.27, 95% CI 2.36–29.00). ICCS was the only independent predictor in an exploratory multivariable model (odds ratio 13.75 per SD, 95% CI 3.32–56.92), partly constitutively because comprehension is an ICE domain. Family influence and collectivism did not predict adequacy.

Conclusion. Comprehension, not cultural collectivism, gates valid surgical consent. Adequate consent was rare in this high-risk population, so verified patient understanding, rather than a documented signature, should be the medicolegal standard, and larger multicentre studies should confirm these findings.