1) The document discusses the evolving standards for informed consent in medical procedures, moving from a professional standards approach to a reasonable patient standard that requires disclosure of all material risks. 2) Ensuring patient understanding of medical procedures and risks is challenging, as multiple factors like timing, education level, and context can influence comprehension. 3) Effective consent requires an ongoing process of discussion tailored to individual patient needs that incorporates written information, multimedia tools, and shared decision making to build trust and understanding.

1. Beyond Consent –
seeking understanding in surgical
patients
Sean Tierney
Surgical discussion group
November 2016

2. Vascular surgery @ Tallaght

3. Vascular surgery @ Tallaght
RCS England guidelines

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‘every human being of adult
years and sound mind
has a right to determine
what shall be done with
his body’
Benjamin Cardoza
Reich WT. Encyclopaedia of Bioethics. Simon & Schuster, 1995: Schloendorff v. Society of New York
Hospital (1914) 211 N.Y. 125
.
Modern Consent

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What should be disclosed?
• Professional standards approach
– the disclosures that a health professional,
practicing as a specialist in the field, would make
under the same or similar circumstances”
what a reasonable doctor would do
• “Reasonable patient” approach
– health provider is required to disclose all facts,
risks, and alternatives that a reasonable patient
would consider important, in deciding to have, or
not have, a recommended treatment.
what a reasonable patient should expect

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Canterbury v. Spence
• Laminectomy for arm pain
• Paraplegia (“minute risk”)
• “a doctor must disclose all risks which might
materially affect the patient’s decision”.
• “the patient had a right to know”
Canterbury v. Spence (1972) 464 f.2D 772 (

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Informed consent
‘duty to disclose to the patient all the facts
which mutually affect his rights and
interests and of the surgical risk, hazard
and danger, if any’
Salgo v. Leland Stanford Jr. University Bd. of Trustees (1957) 317 P.2d 170
Canterbury v. Spence (1972) 464 f.2D 772
• Procedure
• Alternatives
• Risks
• Benefits
Patient Centred approach

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Professional standards approach
• Bolam standards (1957)
• Sidaway: “An issue whether nondisclosure of
a particular risk or cluster of risks in a
particular case should be condemned as a
breach of the doctor’s duty of care is an issue
to be decided on the basis of expert medical
evidence.”1
11. Sidaway v Board of Governors of the Bethlem Royal Hospital [1985]

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Ireland - 1992
• Orchialgia after vasectomy
• The Chief Justice favoured the
application of the ‘professional standard
approach’, while other members
favoured the ‘reasonable patient test’
James Walsh Family Planning Services Ltd & ors [1992] IR 496

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Ireland - 2000
• Neuralgia after dental surgery
• Expert witnesses would not have
warned the patient
Peter Geoghegan v David Harris [2000] IR 536 Justice Kearns
• In such an elective procedure, the practitioner
must disclose all known risks, of grave
consequence or severe pain, no matter how
remote. This would ensure that the patient could
make a "real" choice.

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Ireland - precedent
• Elective operation
– Patient did not need the operation and the proposed
benefits did not, in his view, outweigh the detriment
which occurred.
• The complication was not minor or trivial
(however rare)
– obligation to disclose complications resulting in
grave consequence or severe pain is reasonable.
• Patient is the arbiter of whether a risk is
acceptable
Peter Geoghegan v David Harris [2000] IR 536 Justice Kearns

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Ireland - 2007
• Diplopia after squint surgery
• Whether patient was fully informed
• Consent on the morning of surgery
Fitzpatrick -v- White, [2007] IESC 51 (2007) Justice Kearns
• “in the context of elective surgery, a warning given only
shortly before an operation is undesirable. The patient
may be stressed, medicated or in pain, and may be less
likely for one or more of these reasons to make a calm
and reasoned decision.”

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Montgomery vs Lanarkshire Health 2015
• Shoulder dystocia
• Cerebral palsy after vaginal delivery
• “a woman had a right to information about
“any material risk” (however rare) in order to
make an autonomous decision about how to
give birth.
• The test for materiality is whether a
reasonable person in the position of a patient
would think the risk significant.

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What should be disclosed?
• Professional standards approach
• “Reasonable patient” approach
– US 1972
– Ireland 1992
– UK 2015
– health provider is required to disclose all facts,
risks, and alternatives that a reasonable patient
would consider important, in deciding to have, or
not have, a recommended treatment.
what a reasonable patient should expect

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GMC 2015
“…doctors should provide
person-centred care. They
must work in partnership
with their patients, listening
to their views and giving
them the information they
want and need to make
decisions.”
GMC chief executive Niall
Dickson

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Medical Council 2016
Doctors should
• support patients to make informed
decisions about their own health and
care4.2
• help patients make decisions that
are informed and right for them 9.1

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Medical Council 2016
Doctors must
• give patients enough information,
in a way that they can understand,
to enable them to exercise their
right to make informed decisions
about their care.
• Consent is not valid if the patient has not
been given enough information to make a
decision11.1

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Varicose veins
• To analyse whether the
outpatient process, together
with an educational leaflet,
affected patents
understanding about
varicose veins
• 83 patients
• Primary or some secondary
education: 41
• Leaving certificate or some
third level: 37
Dillon et al. Ir J Med Sci 2004

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Vascular clinic
• Full history
• Physical examination
• SpR or Consultant
• Information leaflet
Dillon et al. Ir J Med Sci 2004

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Conclusions
• Despite a lengthy educational process varicose vein
patients are poorly informed as to the nature and
medical significance of their condition.
• In order to ensure valid consent and prevent
unrealistic expectations of surgery, extraordinary care
needs to be taken to educate patients preoperatively
Dillon et al. Ir J Med Sci 2004

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Patient perceptions of consent
• Bureaucratic hurdle
• Invokes fear and feeling of
pressure to sign
• Felt disempowered by the
process
• Do not read or understand
form
• Lacked the information to
resist decisions being made
on their behalf
Habiba M et al. Qual Saf Health Care 2004; 13: 422-7
Akkad A et al. BJOG 2004; 111: 1133-8

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Patients’ perceptions
• 20% removes right to change mind
• 16% removes right to compensation
• 10% did not know what they agreed to
• 46% to protect the hospital
• 68% hands control to Doctors
Akkad A et al. BMJ 2006; 333: 528

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On a positive note…
• 86% confirmed understanding
• 82% risks associated
Akkad A et al. BMJ 2006; 333: 528

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For the surgeon…

30. Recall & understanding

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200 patients
written and oral information
2 interviews pre-op
84% satisfied
85% knowledge of indication
51% knowledge of procedure
30% list one complication
Kriwanek S et al. Dig Surg 1998; 15: 669-73
Laparoscopic Cholecystectomy

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Carotid surgery or lower limb bypass
“Correct” response:
48% standard consent
59% + verbal
59% + written
55% + verbal & written
Stanley BM et al. Aust N Z J Surg 1998; 68: 788-91

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Current practice…
Berman L et al. J Vasc Surg 2008; 47: 287-295
Vohra et al. Cardiovasc Surg 2003; 11:64-9

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Current practice…AAA
Berman L et al. J Vasc Surg 2008; 47: 287-295
Vohra et al. Cardiovasc Surg 2003; 11:64-9

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Berman L et al J Vasc Surg 2008; 48: 296-302
Willaimson WK et. J Vasc Surg 2001; 33: 913-20
Elective AAA repair

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Berman L et al J Vasc Surg 2008; 48: 296-302
Willaimson WK et. J Vasc Surg 2001; 33: 913-20
Elective AAA repair
18% would not do it again

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How to improve patient understanding

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Improving understanding
• Information leaflets
• Structured discussion
• Multimedia

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Patient Information Leaflets
http://www.perfuse.net

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• 9 structured studies
– 4 RCT
– 2 demonstrated improvements in knowledge
• low overall scores in both groups
Non randomised
• Orthopaedic Unit 110 patients
• Hip arthroplasty 126 patients
• ENT 50 patients
Ashraff S et al. ANZ J Surg 2006. Langdon IJ et al. Ann R Coll Surg Engl 2002.
Brown TF et al. J Otolaryngol 2003. Fox R. J Public Health 2006; 28: 309-17.
Harwood A et al. J Orthod 2004
Information leaflets

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“… there is no evidence that information leaflets
enhance understanding in this [clinical trials]
patient group…”
Information leaflets
Ryan et al 2008

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Structured discussion
• “Repeat back”
– Improved understanding by 5% 1
• 15-30 minutes time 2
• Encouraged to raise concerns 3
• Opportunity for further discussion 4
– Clinical nurse specialist etc.?
1. Fink et al Ann Surg v2523. 3. Huddak JBJS 2008
2. Fink et al J Am Coll Surg v210 4. Flory JAMA 2004

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Multimedia
• a combination of interactive computer programmes,
videos and animation
• tailored to patient preference
• “mandatory” components
Flory J et al. JAMA 2004; 292: 1593-1601

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Multimedia (RCT)

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Multimedia
• Beneficial
• Modest scale
(14%)
• Procedure
specific
• ?internet based

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Decision Aids
• contain information on
conditions and their
treatment delivered in
an individualised
manner.
• help patients recognize
the relative importance
of treatment options and
the value they place on
these options

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Decision Aids
• Patients exposed to a
decision board had
– Higher knowledge scores
– Lower decisional conflict
– Higher satisfaction with
their decision
Breast cancer surgery options
Whelan JAMA 2004

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Online decision aids
IPADS guidelines
Ottawa health research institute - decisionaids.ohri.ca

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Decision aids

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Values

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Informed Consent
• process rather than an event
• shared decision making
• responsibilities on both sides
• distinct from documentation
• complex clinical circumstances
– life-saving vs quality of life
Best obtained in context of established
doctor-patient relationship provided in a
framework of accepted and assured
standards of practice

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Summary
• Informed consent requires that patients be fully informed of all
“material” risks (and benefits)
– a reasonable person in the position of a patient would think the risk
significant.
• Ensuring patients understand all the material facts is very
challenging
– time
– timing & context; more than once
– documentation important but not = consent
– involvement of family members/supporters may help
– process may assist in building trust - consistency
Mulsow JJ, Feeley TM, Tierney S. Am J Surg. 2012 PMID: 21641573

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Summary
• Written information leaflets do not replace the obligation to
explain
• Effective use of multimedia tools & decision aids may improve
matters
• Methodology should be tailored to patients individual needs and
values
Mulsow JJ, Feeley TM, Tierney S. Am J Surg. 2012 PMID: 21641573