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

Area of Science:

• Medical Ethics
• Quality Improvement in Healthcare
• Surgical Patient Care

Background:

• Informed consent is a cornerstone of ethical medical practice, safeguarding patient autonomy and protecting healthcare providers.
• Deficiencies in the informed consent process can lead to suboptimal patient care and medicolegal issues.
• A quality improvement project was initiated to address these deficiencies in a surgical setting.

Purpose of the Study:

• To identify and rectify shortcomings in the surgical informed consent process.
• To enhance patient understanding and safety through improved consent procedures.
• To evaluate the effectiveness of targeted interventions in a tertiary care setting.

Main Methods:

• The Plan-Do-Study-Act methodology guided a two-cycle quality improvement project involving 80 surgical patients.
• Patient understanding of informed consent was assessed using structured interviews and questionnaires.
• Interventions included educational sessions for clinicians and the introduction of a new, detailed consent form.

Main Results:

• Incomplete consent forms decreased from 15% to 0%.
• Missing written procedure explanations dropped from 57.5% to 10%.
• Omissions in documenting potential complications and the right to withdraw were significantly reduced.

Conclusions:

• Targeted educational interventions and standardized consent forms substantially improve the quality of the informed consent process.
• Enhancements in informed consent contribute to safer, more patient-centered surgical care.
• The study highlights the successful implementation of quality improvement initiatives in a resource-limited setting.