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Volume Issue

VIEWS: 4 PAGES: 17

									                                                      OP 49/04 — 1


                                                    Ophthalmology
                                              Volume 49, Issue 04
                                                February 21, 2011

                        ETHICAL CONCERNS

ETHICAL INFORMED CONSENT FOR REFRACTIVE SURGERY — Roberto

    Pineda, MD, Assistant Professor of Ophthalmology, Harvard

    Medical School, and Director of Refractive Surgery,

    Massachusetts Eye and Ear Infirmary, Boston, MA

Background: informed consent involves the professional

    responsibility to discuss risks, benefits, and alternatives

    of proposed treatment with patient

Requirements for informed consent: some states require

    “community standards” (ie, what the average prudent

    physician would disclose); most states require disclosure

    of all information that reasonable patients consider

    significant in decision to undergo treatment

Rules: include accurate disclosure of physician’s competence,

    obtaining appropriate informed consent before performing

    procedure, providing balanced, accurate information to

    public/patient

Surgery: studies showed that 44% of patients do not understand

    exact nature of operation even after they provide consent

    and undergo treatment; 45% of patients cannot recall the

    major risks associated with their procedure; 67% did not

    read consent form, and 60% of patients did not understand
                                                    OP 49/04 — 2


     information in consent form

Problem: omission of informed consent prevents patient from

     participating in own health care and violates professional

     and ethical obligations to patients; this opens physician

     and institution to liability; patients frequently cite

     communication as underlying cause of medical litigation

Professional definitions: Centers for Medicare and Medicaid

     Services (CMS) state that no informed consent obtained if

     patient does not understand procedure; Joint Commission on

     Accreditation of Healthcare Organizations (JACHO) requires

     mutual understanding between patient and physician

Refractive surgery: 1 to 1.5 million procedures performed

     annually in United States; third largest area of litigation

     after cataract surgery and problems after an examination;

     in 2007, 12% of litigations related to refractive surgery

Legal definitions: medical intervention without consent

     considered battery; intervention with inadequate or

     incomplete consent considered negligent, even if

     intervention competently performed

Practical issues: dialogue includes assessment of patient’s

     competence to decide about surgery, disclosure of relevant

     information, assessment of patient’s comprehension of

     procedure, and ability to obtain consent from patient or

     guardian
                                                     OP 49/04 — 3


Disclosure: comprises what a reasonable person would want to

    know about procedure (ie, nature of procedure, indications,

    expected benefits, advantages, disadvantages,

    uncertainties, and reasonable alternatives including

    observation or no intervention; physician responsible for

    performing process; avoid coercion  have discussion in

    advance of procedure; offer patient documentation of

    discussion; do not exert pressure because of potential for

    of financial or professional gain

Elements: informational  disclosure and comprehension; consent

     voluntary choice, patient competent to consent or has

    competent surrogate or guardian, acting in patient’s best

    interest

Documentation: should include rationale for and benefits of

    proposed treatment, potential adverse effects,

    alternatives, and special situations (eg, if patient

    participates in prospective or retrospective clinical

    research, receives off-label drugs or devices, or undergoes

    co-management); informed consent possibly invalidated by

    misleading advertising

Case example #1: physician examined patient for refractive

    surgery; discussed potential risks, poor outcomes, and

    significant complications of laser in situ keratomileusis
                                                      OP 49/04 — 4


    (LASIK); patient given no written material but told to

    consider information and call office with decision;

    informed consent process ethically and legally appropriate

    in this case although written consent advisable and

    physician did not discuss alternatives to LASIK

Case example #2: patient read advertising that described

    ophthalmologist as leading expert in refractive surgery who

    had treated thousands of patients, and these patients no

    longer required contact lenses or glasses; received and

    signed consent form listing some possible complications;

    patient first met with physician at time of surgery; after

    surgery, patient had unexpected residual astigmatism; in

    this case, physician’s brochures did not give balanced view

    of pros and cons of refractive surgery (eg, referred only

    to successful surgeries in brochure); also physician failed

    to discuss surgery in advance with patient

Physician report cards: not acceptable to quote published

    morbidity and mortality data; physician must disclose

    personal outcomes for particular surgery



CONFLICTS OF INTEREST — Nancy M. Holekamp, MD, Associate

    Professor of Clinical Ophthalmology, Washington University

    School of Medicine, St. Louis, MO

Background: conflicts of interest ubiquitous and unavoidable in
                                                    OP 49/04 — 5


    professional life; include any situations in which other

    interests of provider have reasonable chance of influencing

    professional judgment concerning well-being of patient

                          Case examples

Cataract surgery: although ophthalmology represents 3% of all

    medicine, cataract surgery performed more frequently than

    any other kind and amounts to $6 billion per yr

  Potential conflicts of interest; Medicare reimburses for

       cataract surgery, which represents financial incentive to

       surgeon; premium IOLs  only partially reimbursed;

       surgeon allowed to set fee for providing premium IOLs

       (because additional testing, consultation, and skill

       required); no rules limit fees (range from $600 to

       $3,000), so use of premium IOLs can substantially

       increase reimbursement for cataract surgery; physician-

       owned ambulatory surgery center (ASC)  physicians who

       own ASC reap financial benefits of facility fees for

       surgery

  Potential benefits: patient receives (and pays for) latest

       technology; physician appropriately paid for providing

       elite service; manufacturer rewarded for advancing

       progress in technology; owners of ASC receive dividends

       for investment risk; and patient receives excellent care
                                                    OP 49/04 — 6


  Potential problems: if ophthalmologist allows financial

       conflict of interest to influence decisions; eg,

       recommending premium IOL to patient with history of

       retinal detachment who has no ability for fine or near

       vision, charging exorbitant prices, or treating patients

       in ASC who would do better in hospital

  Gatekeeper: ophthalmologist forced to become ethical

       gatekeeper; surgeons encouraged to become owners of ASCs

       to increase efficiency of use of facility; ASCs exempted

       from anti-kickback laws because government defined ASCs

       (reimbursed at lower rate than hospitals) as extensions

       of physician’s office; surgeons given incentive to use

       premium IOLs because manufacturers create financial

       reward system to increase utilization

  Safeguards for patients: physician has duty to act in best

       interest of patients; interests of stakeholders (eg,

       patients, ophthalmologists, owners of ASC, federal

       government, and manufacturers) prioritized by physician;

       however, few ophthalmologists receive training in ethics

Unnecessary testing and poor compliance

  Ethical issue: medically necessary testing must influence

       treatment decision; extended ophthalmoscopy documents

       progression or disease changes in fundus appearance;

       fluorescein angiography constitutes invasive test and
                                                  OP 49/04 — 7


    requires expensive instrumentation and trained technician

    as do fundus photographs and OCT; physician had ordered

    frequent testing of both the patient’s better eye and the

    legally blind fellow eye with numerous techniques

    including those described above; bundled reimbursement

    from Medicare amounted to $410 in addition to office

    visit ($560 if unbundled); potential for conflict of

    interest in this scenario amounted to $20,000 per day

    for all of physician’s patients

Compliance issue: documentation showed no written orders for

    tests or interpretation of test results

Problem: physician decides whether test medically necessary

    but also stands to benefit by performing more tests

Advantages of in-office testing: provides rapid turnaround

    that benefits patients; physician receives reimbursement

    for service and capital investment

Potential problems: ethical burden falls on ophthalmologist;

    in this case, testing linked to diagnostic code for

    better eye; reimbursing agencies could not determine

    medical necessity and could not verify interpretation of

    reports without audit; audits potentially profitable for

    government

Multiple violations: physician violated ethical and compliance
                                                    OP 49/04 — 8


       rules; frequently physicians who violate standards

       violate more than one

  Bundling of reimbursement: recently vitrectomy codes bundled,

       possibly to reduce performance of unnecessary additional

       procedures

EXPERT WITNESS TESTIMONY — Dr. Holekamp

Problem: lack of accountability for content of expert testimony

    despite increasing financial incentives for expert

    witnesses

Regulations: Journal of American Medical Association stated that

    providing expert testimony constitutes practicing medicine

    and recommended monitoring by organized medicine; medical

    organizations have adopted rules and disciplined members,

    which allows for intervention in cases of inappropriate

    content in expert testimony

  American Academy of Ophthalmology (AAO) Code of Ethics Rule

       #16: requires that expert testimony be objective and use

       medical knowledge to form expert medical opinions

       unbiased by nonmedical factors; unethical to accept

       compensation contingent upon outcome of litigation or

       provide false, deceptive, or misleading testimony

  Types of testimony: witness of fact  treating physician who

       comments only on facts pertaining treatment of patient in

       question; expert witness  comments on standard of care
                                                      OP 49/04 — 9


  Use of medical knowledge: use of scientific principles, not

       anecdotal information or personal preference

  Nonmedical factors that should not bias testimony: include

       desire to please hiring attorney, competition with other

       physicians, and personal bias

Obligation to provide testimony: organized medicine asserts

    physicians have professional obligation to provide

    testimony for courts

Common problems

  Ignorance of torte process and expert’s role: expert must not

       confuse personal opinion with standard of care or allow

       counsel to lead or encourage remarks

  Misrepresentation of expert’s credentials: ophthalmologists

       have no subspecialty board certification to verify

       qualifications in subspecialty; witness must have

       appropriate expertise and must review all information

  Improper advocacy: disregarding or misrepresenting relevant

       facts that damage or cast doubt on case; confusing bad

       outcomes with negligence

Expert Witness Affirmation: adopted in 2004 by AAO’s board of

    trustees for voluntary use; witness pledges to provide

    truthful testimony, perform thorough fair and impartial

    review of all facts, only provide testimony within areas of

    expertise, perform evaluation in light of standard of care
                                               OP 49/04 — 10


(ie, reasonable care provided by physicians within region

for particular situation) at time of occurrence, provide

complete, objective, scientifically-based testimony,

provide clear distinction between departure from standard

of care and bad outcome, determine whether causal

relationship exists between alleged substandard practice

and outcome, allow peer review of testimony, and not accept

compensation contingent on outcome
                                                     OP 49/04 — 11


Educational Objectives


The goal of this program is to provide tools for

ophthalmologists to improve their management of ethical issues.

After hearing and assimilating this program, the participant

will be better able to:

   1. Properly obtain informed consent for all patients

     undergoing ophthalmological treatment.

   2. Define and describe the elements of informed consent.

   3. Disclose appropriate information about a proposed

     treatment to patients.

   4. Recognize situations that represent potential conflicts of

     interest in daily practice and continue to act in the

     patient’s best interest.

   5. Decide the appropriate course of action when invited to

     provide expert testimony in a court of law.



                          Suggested Reading
Abbott RL: Informed consent in cataract surgery. Curr Opin

Ophthalmol 20:52, 2009; Anderson OA, Wearne IM: Informed consent

for elective surgery—what is best practice? J R Soc Med 100:97,

2007; Augsburger JJ: Unnecessary clinical tests in

ophthalmology. Trans Am Ophthalmol Soc 103:143, 2005; Henderson

A, Henderson S: Provision of a surgeon’s performance data for

people considering elective surgery. Cochrane Database Syst Rev

11:CD006327, 2010; Jampol LM et al: A perspective on commercial
                                                    OP 49/04 — 12


relationships between ophthalmology and industry. Arch

Ophthalmol 127:1194, 2009; Leitch RF: Is medicolegal work a

duty? It is. Br J Ophthalmol 87:383, 2003; Mozaffarieg M,

Wedrich A: Malpractice in Ophthalmology: guidelines for

preventing pitfalls. Med Law 25:257, 2006; Raab EL: The

parameters of informed consent. Trans Am Ophthalmol Soc 102:225,

2004; Taylor D: Is medicolegal work a duty? It is not. Br J

Ophthalmol 87:383, 2003; Vincent AL, Kelly P: Retinal

haemorrhages in inflicted traumatic brain injury: the

ophthalmologist in court. Clin Experiment Ophthalmol 38:521,

2010.




                       Faculty Disclosure


In adherence to ACCME Standards for Commercial Support, Audio-

Digest requires all faculty and members of the planning
committee to disclose relevant financial relationships within

the past 12 months that might create any personal conflicts of

interest. Any identified conflicts were resolved to ensure that

this educational activity promotes quality in health care and

not a proprietary business or commercial interest. For this

program, Drs. Pineda and Holekamp and the planning committee

reported nothing to disclose.

                        Acknowledgements
                                                     OP 49/04 — 13


Drs. Pineda and Holekamp spoke at the 731st Meeting of the New

England Ophthalmology Society: Ethics and Risk management, held

October 1, 2010, in Boston, MA, and presented by the New England

Ophthalmology Society (visit www.neos-eyes.org for a list of

upcoming meetings). The Audio-Digest Foundation thanks the

speakers and the New England Ophthalmology Society for their

cooperation in the production of this program.
                                                    OP 49/04 — 14


                                     Audio-Digest Ophthalmology
                                            Volume 49, Issue 04
                                              February 21, 2011

                      ETHICAL CONCERNS



1. Choose the correct statement about the activities that must

   be carried out as part of informed consent.

   (A) Disclosing the competence of the physician

   (B) Obtaining appropriate informed consent before

   performing procedure
   (C) Providing balanced, accurate information to the

   public/patient

   (D) A, B, and C*****

2. Studies have shown that _____ of patients do not understand

   the exact nature of their operation even after they have

   provided consent and undergone treatment.

   (A) 22%

   (B) 33%

   (C) 44%*****

   (D) 55%
3. Choose the correct statement(s) about informed consent.

 1. The Centers for Medicare and Medicaid Services (CMS)

 state that informed consent was not obtained if the patient

 does not understand the procedure

 2. Medical intervention without consent is legally

 considered battery
                                                  OP 49/04 — 15


 3. Medical intervention with inadequate or incomplete

 consent is legally considered negligent, even if competently

 performed

 4. Obtaining informed consent includes assessing the

 patient’s competence to make decisions about surgery

 5. The physician is required to disclose what a reasonable

 person would want to know about the procedure but is not

 required to discuss alternative treatments.

   (A) 1,2,3,4*****

   (B) 1,2,4,5

   (C) 1,3,4,5

   (D) 2,3,4,5

4. Which of the following practices is not recommended as part

   of the informed consent process?

   (A) Have the discussion about risks and benefits with the

   patient before the day of the procedure

   (B) Offer the patient documentation of the discussion

   about risks and benefits
   (C) Describe the indications and benefits for the proposed

   treatment

   (D) Quote the published morbidity and mortality data

   rather than personal record of outcomes for the

   procedure*****

5. Although ophthalmology represents 3% of all medicine,

   cataract surgery is the most frequently performed surgery

   of any kind.
   (A) True*****
                                                  OP 49/04 — 16


   (B) False

6. Which of the following aspects of ophthalmologic practice

   represent or create potential conflicts of interest?

   (A) The use of premium intraocular lenses (IOLs) can

   substantially increase reimbursement for cataract surgery

   (B) Physician-owners of ambulatory surgery centers reap the

   financial benefits of the facility fees for surgery

   (C) Manufacturers may create financial reward systems to

   increase utilization of products, such as, premium IOLs

   (D) A,B, and C*****

7. Ordering frequent testing with advanced instruments may be

   considered ethical as long as _____.

   (A) The testing can be done in the office to provide rapid

   turnaround

   (B) The physician receives appropriate reimbursement for

   their capital investment in instrumentation

   (C) Reimbursing agencies can verify the interpretation of

   reports without auditing the facility
   (D) The outcome of the tests will influence treatment

   decisions*****

8. Physicians should be held accountable for the content of

   expert testimony by making compensation for expert

   witnesses contingent on the outcome of the litigation.

   (A) True

   (B) False*****

9. Choose the correct statement(s) about testifying as a
   witness.
                                                    OP 49/04 — 17


   (A) A treating physician who comments only on the facts

   pertaining to the treatment of the patient in question is

   called a witness of fact*****

   (B) An expert witness should not offer a comment on the

   standard of care for a given situation

   (C) A clear distinction should be made between providing an

   expert medical opinion and practicing medicine

   (D) A, B, and C

10. A physician who signs the Expert Witness Affirmation

   adopted in 2004 pledges to do which of the following?

   (A) Provide truthful testimony

   (B) Determine whether a causal relationship exists between

   substandard practice and outcome

   (C) Allow peer review of testimony

   (D) A,B, and C*****

								
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