Informed consent: is it more than a formality? a quality improvement project in surgical practice.

Abstract

Informed consent is a fundamental element of clinical practice. A well-structured and understandable consent form not only upholds patients' rights but also protects clinicians against medicolegal risks. This quality improvement project aimed to identify deficiencies in the consenting process for surgical procedures and implement changes to enhance patient care. The project was conducted in the Ear Nose Throat Department at Holy Family Hospital, Rawalpindi, a large tertiary care centre serving a predominantly low socioeconomic population in Pakistan. A total of 80 patients were included across two cycles (40 patients per cycle). Structured interviews and questionnaires were used to assess patient understanding of informed consent components. Key areas for improvement were identified. Educational sessions for doctors were organised and a new, detailed consent form was introduced. The project followed the Plan-Do-Study-Act methodology. Baseline measurements in cycle 1 showed that 15% (n=6) of consent forms were incomplete, reduced to 0% postintervention. A written explanation of the procedure was missing in 57.5% (n=23) of cases initially, improving to 10% (n=4) in cycle 2. Potential complications were not recorded in 37.5% (n=15) of cases at baseline, falling to 10% (n=4) after intervention. Verbal explanation of the procedure was omitted in 32.5% (n=13) of cases initially, reduced to 5% (n=2) postintervention. Documentation of the right to withdraw was absent in 12.5% (n=5) of cases in cycle 1, with full compliance achieved in cycle 2. This project demonstrates that targeted educational interventions and structured consent documentation can significantly improve the quality of the consenting process, promoting safer and more patient-centred care.