General Approach to Medical Procedures
Before any medical procedure, the performing physician must ensure valid informed consent through a documented process that includes written information provided in advance, verbal discussion of risks and benefits, assessment of patient capacity, and confirmation that the patient still consents immediately before the procedure begins. 1
Pre-Procedure Informed Consent Process
Written Information Requirements
- Provide procedure-specific written information sufficiently in advance to allow the patient time to read, evaluate, and seek additional information 1
- Written materials must be available in languages common to the local population and reviewed by lay people for comprehension 1
- Information leaflets should be written at or below sixth-grade reading level 1
- For infrequent or specialist procedures without standard leaflets, arrange a documented face-to-face or telephone discussion with the endoscopist before the appointment 1
Essential Information to Communicate
- The aims of the proposed investigation or treatment 1
- Expected level of pain or discomfort and steps to minimize it 1
- Material risks specific to the procedure 1
- Alternative treatment options and the option of no treatment 1
- Individual risk factors based on patient frailty or comorbidity, discussed verbally with additional written documentation 1
Capacity Assessment
- The physician performing the procedure is ultimately responsible for ensuring the patient has capacity to consent 1
- If capacity appears to have changed since initial consent, reassessment is required before proceeding 1
- Where doubt exists about capacity, delay the procedure unless unsafe to do so and seek consultation from colleagues or psychiatric team 1
Timing and Documentation
- Consent should be a process, not a one-off event, obtained well in advance when there is time to respond to questions 1
- Immediately before the procedure, confirm the patient still consents even if no new information needs to be provided 1
- Seeking consent just before the procedure when the patient feels vulnerable creates real doubt about validity 1
- All discussions, concerns expressed by patients, and decisions must be clearly documented in medical records 1
Postoperative Education and Expectations
Pain Management Planning
- Discuss specific pain control strategies before surgery, including both opioid and non-opioid options 1
- Pain typically peaks over the first 3 days following procedures 1
- Patients with history of antidepressant use may require more analgesics 1
Activity Restrictions and Recovery
- Specify limitations on weightlifting and vigorous activity for the early postoperative period 1
- Clarify plans for returning to normal activity, exercise, work, or school so patients can coordinate with employers and teachers 1
- These restrictions have important socioeconomic implications and must be clearly communicated 1
Medical Management Expectations
- Inform patients about perioperative medications they may receive: oral corticosteroids, topical nasal steroid spray, steroid-eluting stents, oral antibiotics, or high-volume saline irrigations 1
- Clarify timing for resuming medications that were held perioperatively 1
- Explain the duration and frequency of follow-up visits 1
Debridement and Wound Care
- Discuss anticipated postoperative debridement procedures 1
- Explain the potential for recurrent disease or revision surgery 1
Emergency Procedures
Modified Consent Requirements
- When full written consent is not possible in emergencies, use verbal consent but fully document it in medical notes 1
- Where neither written nor verbal consent can be obtained, take the least restrictive action of the patient's future options 1
Scope of Consent and Unexpected Findings
- Define the extent of consent before the procedure 1
- Consent should cover treatments that can reasonably be expected to occur during the procedure 1
- Do not exceed the scope of consent unless failure to intervene would cause immediate harm 1
Special Populations
Inpatients
- Provide written information in appropriate format before the patient leaves the ward for the procedure, allowing sufficient time to read and ask questions 1
- Ward staff must ensure patients have access to someone who can answer their questions 1
Patients Who Decline Information
- Provide minimum information including aims of the procedure, expected pain/discomfort levels, and steps to minimize it 1
- Ascertain and record the level of risk information the patient wishes to know or not know 1
Pediatric Patients
- Apply similar principles for young people over 16 years 1
- For competent children under 16 years, confirm competence through practitioners trained and experienced in pediatric capacity assessment 1
Common Pitfalls to Avoid
- Never obtain consent only in the procedure room when the patient is vulnerable - this practice is difficult to defend legally 1
- Do not provide information only verbally - written materials are essential even though they represent only part of the consent process 1
- Do not delegate consent discussions without ensuring the delegate is competent to perform the procedure - the performing physician retains ultimate responsibility 1
- Do not assume capacity remains unchanged - reassess if there are concerns, particularly for procedures scheduled long after initial consent 1