Cataract Surgery Informed Consent: Practice Patterns of Rhode Island Ophthalmologists

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Cataract Surgery Informed Consent Practice
Patterns of Rhode Island Ophthalmologists

• Xiaoqin Alexa Lu, M.D.
• King W. To, M.D.
• Kent L. Anderson, M.D., Ph.D.

• ASCRS Meeting
• San Francisco
• March 18 - 22, 2006

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Ophthalmic Mutual Insurance Company

• Over a 10-year period, 168 (33) out of 515
  claims involved cataract surgeries.
• Greater than 3 million were paid on 37 cataract
  cases (24 of the total indemnity)
• Better informed consents could decrease frequency
  and severity of claims

Brick, DC. Survey of Ophthalmology, 1999
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Informed Consent

• Goal a fully informed patient participating in
  choices about his/her health care
• Discussion of the following elements
• the nature of the procedure
• reasonable alternatives to the proposed
  intervention
• the relevant risks, benefits, and uncertainties
  related to each alternative
• assessment of patient understanding
• the acceptance of the intervention by the patient

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Purpose of our study

• To examine the cataract surgery informed consent
  process of Rhode Island ophthalmologists
• Make recommendations regarding practice
  guidelines

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Methods

• 81 volunteer paper surveys were distributed to
  all Rhode Island ophthalmologists.
• Surgeons were also asked to send in copies of
  their own informed consent forms.
• Answers to individual survey questions and the
  contents of consent forms were examined,
  compiled, and analyzed.

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81 ophthalmologists received surveys
53 returned surveys
19 specialists (no cataracts)
34 cataract surgeons
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Background information

• 82.4 (28) performed cataract surgeries for more
  than 10 years
• Number of cataract surgeries
• 5.6 per week
• 25.1 per month
• 230.8 per year
• 97 (33) saw patients post-operation day 1
• 68.8 (22) saw patients again 1 week after surgery

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3 Common Ways of Obtaining Consent

• Verbal discussion 97 (33)
• Standard written hospital form 76.5 (26)
• Private office forms 61.8 (21)

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Consent Process

• By surgeons 76.5 (26) technicians 35.3
  (12) secretaries 11.8 (4)
• 94.1 (32) were written
• Used both medical and laymans terms 41.2 (14)
• Used laymans terms 58.8 (20)
• 58.8 (20) were always witnessed

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Components of Informed Consent

• 88.2 (30) mentioned the diagnosis
• 70.6 (24) the purpose of the surgery
• 70.6 (24) possible benefits of surgery
• 64.7 (22) possibility of not having surgery
• 55.9 (19) alternative to surgery
• 47.1 (16) risks of not having surgery
• 38.2 (13) mentioned the actual risk percentages

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3 common poor outcomes sited verbally

• Loss of vision 94.1 (32)
• Bleeding 85.3 (29)
• Retinal detachment 76.5 (26)

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Common poor outcomes sited in writing

• Loss of vision 61.8 (21)
• Endophthalmitis 58.8 (20)
• Retinal detachment 52.9 (18)
• Bleeding 52.9 (18)

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5 common actual poor outcomes

• Posterior capsule opacity 97.1 (33)
• Macular edema 94.1 (32)
• Retained lens particle 91.2 (31)
• Posterior capsule rupture 91.2 (31)
• Vitreous loss 91.2 (31)

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3 common conditions that might affect the outcome
of the surgery

• Macular degeneration 88.2 (30)
• Diabetic retinopathy 85.3 (29)
• Fuchs corneal endothelial dystrophy 76.5 (26)

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Patient dissatisfaction

• 94.1 (32) had at least 1 dissatisfied patient
• Most common way to deal with an unhappy patient
  was to explain the complications 88.2 (30)
• Least common way was to ignore it 8.8 (3)
• 14.7 (5) had commented negatively on the surgery
  of another surgeon.
• 58.1 (18) would respond differently to a patient
  who complained but had good vision.

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Litigations

• 20.6 (7) had an official complaint.
• 26.5 (9) were explored for a medical lawsuit.
• 44.1 (15) were named in a medical lawsuit.
• 33.3 (5 out of 15) of those surgeons that had
  been named in a medical lawsuit settled a
  malpractice claim outside the courts.
• 38.2 (13) provided expert testimony in a trial
  or potential lawsuit.

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Conclusions

• Common complications need to be better explained
  as risks.
• Establishing guidelines or standardized forms may
  better inform patients and lower the likelihood a
  dissatisfied patient will pursue litigation.

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Risk Reduction Strategies

• Use informed consent specific to cataract
  surgery. Additional documentation of any
  findings increasing the risk of surgery is also
  very useful (e.g., diabetes).

Brick, DC. Survey of Ophthal, 1999
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Standardized Form

• Include key elements of the informed consent
• Description, risk, benefit, uncertainty,
  alternatives, understanding, acceptance
• Findings that might increase risk of surgery
• Visual improvement prognosis
• List of common and serious complications, include
  percentages whenever possible.

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Bibliography

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  Ophthalmology. 1999 43(4) 356-360.
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  Ophthalmology. 2004 88 331-332. 
• Kiss CG et al. Informed consent and decision
  making by cataract patients. Archives of
  Ophthalmology. 2004 122(1) 94-98. 
• Lanckton AV. The contours of informed consent.
  Survey of Ophthalmology. 1996 40(5) 391-394.
• Leydhecker W et al. Patient information before
  cataract surgery. Ophthalmologica. 1980 180(5)
  241-246. 
• Scanlan D et al. Informed consent for cataract
  surgery what patients do and do understand.
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