Table 2

Taxonomy of informed consent quality elements

Domain (n=3)	Dimension (n=20)	Element (n=53)
Content	Description of procedure	1. Rationale for the procedure.
		2. Level of invasiveness.
		3. Steps of the procedure.
	Postoperative expectations for procedure	4. Estimated recovery time.
		5. Estimated time before the patient can return to work or normal activity.
		6. Whether there is need for a family caregiver following the procedure.
		7. Description of how the procedure will influence future care (eg, follow-up visits).
	Goals (benefits) of procedure	8. What the patient hopes to get out of the procedure, tied to the patient’s care plan.
		9. What the procedure will not achieve.
		10. Procedure-specific benefits.
		11. General quantitative probabilities of benefits occurring.
	Disclosure of risks/side effects	12. Procedure-specific risks.
		13. General quantitative probabilities of risks occurring.
		14. Distinction between minor risks (side effects) and major risks.
	Alternatives to procedure	15. Potential alternative treatment options (eg, medication/physical therapy, alternative procedure, watch and wait, no treatment).
	Alternatives to procedure	16. Anticipated outcomes associated with potential alternative treatment options.
	Hospital-specific and/or physician-specific performance	17. Procedure volume (ie, the number of procedures performed) by physician/at hospital.
		18. Procedure success rate of physician/hospital.
		19. Procedure complication rate of physician/hospital, including postoperative complications (eg, infection).
		20. Cost of the procedure (eg, may refer to hospital’s base cost, noting that this is not the cost to the patient).
	Patient safety check	21. Review of medications taken by the patient, including over-the-counter medications.
		22. List of allergies.
		23. Note of prior reactions to anaesthesia (yes/no).
		24. Agreement between operative report and consent document, with caveat for unexpected findings/complications during procedure.
Content	Additional resources	25. Invitation for others, such as family caregivers, spouse and child, to be included in informed consent discussion.
		26. Invitation for additional medical consultation (eg, discussion with primary care provider or a second opinion).
		27. Reference to decision aids, patient education brochures, videos or links to relevant web pages.
		28. Phone numbers for support (eg, hospital’s patient relations, nurse/physician hotline or Department of Public Health).
		29. Referral to patient peer groups.
	Opt-out or strikeout instructions	30. Presence and role of students and trainees.
		31. Permission to take pictures or video for educational, advertising and/or other public purposes.
		32. For-profit use of tissue/specimen.
		33. Blood transfusion with description of risks if patient opts out.
	Type of anaesthesia	34. Description of anticipated type of anaesthesia: Conscious sedation. Local anaesthesia. Regional anaesthesia (eg, spinal, epidural). General anaesthesia. Local nerve block.
	Description of risks of anaesthesia	35. General risks of anticipated type of sedation/pain control.
	Description of risks of anaesthesia	36. Patient-specific risks of anticipated type of sedation/pain control.
	Postoperative expectations for anaesthesia	37. Recovery time from anaesthesia (eg, duration of unconsciousness, somnolence and cognitive effects).
		38. Disclaimer that recovery time may vary by patient.
		39. Instructions on immediate follow-up (eg, driving, operating machinery).
	Format	40. Identification of the method of distribution: patient portal, website link, electronic copy received via email, paper copy distributed at office, paper copy mailed to patient.
	Format	41. Alignment with the patient’s preferred method for reviewing the document (may be more than one format).
Content	Accessibility	42. Notation that the patient was offered: Braille or audio version of the document. Large-font document. Document in patient’s preferred language. Language interpretation/translation services.
Presentation	Legibility	43. All information is typed.
		44. Minimum font size.
		45. Minimum resolution (ie, visual clarity of language, avoiding blurred or overexposed printed/written language).
	Readability	46. Plain language and medical terms provided for the name of the procedure.
	Readability	47. Written at or below a 6th–8th grade reading level or written at a reading level that is compliant with the state’s recommended reading level for Medicaid patients.
	Organisation	48. Use of: Subheadings. Checkboxes. Bullet points.
	Organisation	49. Diagrams, figures, graphs or pictures.
	Length	50. Limit on the number of pages.
	Length	51. Limit on the average time required for a patient to read/review the document.
Timing	Time to review	52. Time stamp that indicates document received at least 72 hours (business days) prior to the procedure date, unless patient opts out of review time in order to have the procedure sooner.
Timing	Consistency over time	53. Checkbox on consent document indicates consistency between document received prior to the procedure and the document the patient signs.