beyond consent

Beyond Consent –seeking understanding in surgical

patients

Sean Tierney

Surgical discussion group November 2016

Vascular surgery @ Tallaght


RCS England guidelines


‘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


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


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 (


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


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]


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


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.


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


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.”


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.


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


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


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


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


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: 37Dillon et al. Ir J Med Sci 2004


Vascular clinic

• Full history• Physical examination• SpR or Consultant• Information leaflet

Dillon et al. Ir J Med Sci 2004


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


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


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


On a positive note…

• 86% confirmed understanding• 82% risks associated

Akkad A et al. BMJ 2006; 333: 528


For the surgeon…

http://upload.wikimedia.org/wikipedia/commons/e/e7/Longleat_Hedge_Maze_%28detail%29.JPG

Recall & understanding

http://upload.wikimedia.org/wikipedia/commons/a/a2/Circle_reflect_wikipedia_sky.jpg


200 patientswritten and oral information2 interviews pre-op

84% satisfied85% knowledge of indication51% knowledge of procedure30% list one complication

Kriwanek S et al. Dig Surg 1998; 15: 669-73

Laparoscopic Cholecystectomy


Carotid surgery or lower limb bypass

“Correct” response:

48% standard consent59% + verbal59% + written55% + verbal & written

Stanley BM et al. Aust N Z J Surg 1998; 68: 788-91


Current practice…

Berman L et al. J Vasc Surg 2008; 47: 287-295

Vohra et al. Cardiovasc Surg 2003; 11:64-9


Current practice…AAA

Berman L et al. J Vasc Surg 2008; 47: 287-295

Vohra et al. Cardiovasc Surg 2003; 11:64-9


Berman L et al J Vasc Surg 2008; 48: 296-302

Willaimson WK et. J Vasc Surg 2001; 33: 913-20

Elective AAA repair


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


How to improve patient understanding


Improving understanding

• Information leaflets• Structured discussion• Multimedia


Patient Information Leaflets

http://www.perfuse.net


• 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


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

Information leaflets

Ryan et al 2008


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 v252 3. 3. Huddak JBJS 2008

2. Fink et al J Am Coll Surg v210 4. Flory JAMA 2004


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


Multimedia (RCT)


Multimedia

• Beneficial• Modest scale

(14%)• Procedure

specific• ?internet based


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


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


Online decision aids

IPADS guidelinesOttawa health research institute - decisionaids.ohri.ca


Decision aids


Values


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


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


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

beyond consent

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