PRACTICE PEARLS
| MANAGING RISK— Linda J. Hay, JD, Alholm, Monahan, Klauke, Hay & Oldenburg, LLC, Chicago, IL
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| General: rendering good quality patient care best way to prevent medical malpractice claims; evaluation of case—
lawyers and insurance companies look at how often suits brought in particular area and severity of injury; “big dollar
(money)” cases translate in medical field as cases where patient may die, have brain injury, or blindness; big money lawsuits
or potential for big money lawsuits mean plaintiff’s attorneys more likely to take cases; attorneys willing to spend
more money to work up cases
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| Common law (standard of care): medical malpractice laws vary state to state; elements needed to pursue malpractice
case—duty (reasonable level of care in similar circumstances); breach (deviation from standard of care); proximate
cause; damage arising from breach; expert testimony needed on side of patient in order to pursue claim for medical malpractice
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| Theories of liability: lawsuit against individual (direct liability); agency named in lawsuit (vicarious liability)
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| Litigation process: long process (amount of time patient has to come back and sue [statute of limitations] 2 yr); time
from incident to trial potentially as long as 6 yr; documentation critical (physician recollection of details difficult over
this long period); discovery—process takes place after case filed; written documentation obtained (patient records); oral
phase includes depositions (plaintiff; defendant; other people involved [family members, other treating physicians]);
plaintiff’s expert witness disclosed; deposition of expert taken; defendant’s expert witness then disclosed; trial; alternatives
to trial—mediation and arbitration
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| Areas of litigation in informed consent: lack of signed consent form (not common in today’s practice); lack of
form that details risks and complications for particular procedure and for particular patient; battery—unauthorized
touching or procedure; battery claims not often covered under insurance policy (perceived as intentional actions); successful
claims difficult, except in extreme instances
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| Documentation: extremely important; plaintiff’s attorney’s first action involves getting copy of patient’s chart; red
flags—physical appearance of chart; legibility of entries; chronology (clear time sequence); information missing or
obliterated; cryptic notes (abbreviations that only physician or members of practice understand); professional disagreements;
adequate documentation (defendant’s memory decreases with time; plaintiff’s memory increases with time;
medical record only witness in case without memory problem [if not in record, did not happen])
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 | Elements of effective documentation: factual information (no opinions); timeliness; legibility; approved abbreviations;
physician’s signature or initials; corrections (document clearly as correction; do not “white out”; do not obliterate);
dictation of discharge instructions in timely manner; never alter record
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| Informed consent: issue whether doctor provided enough information to enable patient to make decision to have treatment;
written form helpful (potentially not enough by itself)
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| Top 10 mistakes in informed consent setting
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| Mistake #1: failure to develop written consent forms for risks, benefits, and alternatives attendant to common procedures;
important to have blank lines to tailor to specific procedure or patient, and place for patient to initial after each paragraph
and at end of form
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| Mistake #2: failure to have protocols in place to ensure that patients advised of risks, understand procedure, and have no
questions; protocols in place that every patient having particular procedure goes through; videos, brochures, and models
great
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| Mistake #3: failure to obtain written witnessed consent from patient; document if patient does not speak or read English well
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| Mistake #4: failure to have informed consent discussion with patient in neutral setting in advance of procedure
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| Mistake #5: failure to use audiovisual tools, brochures, pamphlets, and models in informed consent
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| Mistake #6: failure to advise staff and personnel of importance of recognizing lack of informed consent in patient
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| Mistake #7: failure to use laymen’s terms
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| Mistake #8: failure to document informed refusal of treatment; important to have patient sign off on something stating
they do not want procedure
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| Mistake #9: delegation of informed consent duties to other providers
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| Mistake #10: failure to document informed consent process
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| Other issues: translation issues; err on side of caution; prompt recognition of problems to defuse situations early (document
steps taken); use of resources and staff (make sure everyone aware of red flag issues); document even in limited-
contact situations (limited treatment does not mean limited liability); timing issues of care important; areas lacking
documentation—telephone calls, follow-up appointments; compliance with recommendations; prescriptions; referrals;
messages
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| Electronic medical records: how use of electronic medical records affects medical record (most important issue from legal
perspective); advantages for lawyer—contemporaneously dated, timed notes in sequential order; legible; neat physical
appearance; disadvantages for lawyer—lack of capability in program to include narrative and subjective information about
patient to trigger memories in physician; printed form potentially different from on-screen entry; typing (spelling); corrections
(late)
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| DRY EYE AND REFRACTIVE SURGERY —Jill F. Rodila, MD, Assistant Professor of Clinical Ophthalmology, Bascom
Palmer Eye Institute, Miami, FL
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| General: significant source of patient dissatisfaction after refractive surgery (study of why patients seek consultation with
another physician after refractive surgery showed 30% had dry eye); associated with regression after laser-assisted in situ
keratomileusis (LASIK; study showed that 27% of those with chronic dry eye found to have regression after LASIK vs
7% without)
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| Etiology of dry eye after LASIK: transection and ablation of corneal nerves—decrease in afferent stimulation
(decreased tearing and blinking); loss of neuroregulatory factors from corneal nerves that protect epithelium (study
showed punctate staining with relatively normal tear production until ≈6 mo after refractive surgery); alteration in corneal
shape (change in surface tension decreases tear stability); loss of conjunctival goblet cells caused by suction ring;
medication toxicity
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| Anatomy of corneal nerves: derived from long ciliary nerves from trigeminal nerve (cranial nerve [CN] V); enter limbus
radially through middle third of stroma; course anteriorly and centrally, penetrate Bowman’s layer, and form sub-
basal nerve plexus; branches given off and terminate at epithelial wing cell layer
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| Corneal nerve density after refractive surgery: decreased; slower recovery of corneal nerve density after LASIK
than with photorefractive keratectomy (PRK; study showed 51% reduction in density 1 yr after LASIK and 59% after PRK;
one-third reduction in density 2 and 3 yr after LASIK); 2-yr recovery time of sub-basal nerve densities after PRK vs 5 yr for
LASIK
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| PRK vs LASIK: corneal sensation and tear breakup time significantly reduced after LASIK, in comparison to PRK (observed
1 wk, 1 mo, and 3 mo after surgery); tear secretion—affected in both procedures up to 3 mo after surgery (no
significant difference); dry eye after LASIK—decreased Schirmer’s test and tear breakup time; decreased blink rate up
to 1 yr; corneal sensation after LASIK—dependent on type and amount of ablation (lower myopes [≤6 diopters] had
better corneal sensation than higher myopes and hyperopes); corneal sensation returned before full recovery of subbasal
corneal nerves
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| Risk factors: important to identify; maximize tear film preoperatively, adjust parameters intraoperatively, and follow
carefully after surgery; preexisting dry eye—history (symptoms; suspect with contact lens intolerance); physical examination
(Schirmer’s test; corneal or conjunctival staining; tear breakup time; underlying meibomian gland dysfunction);
patient factors—older age; female sex; treatment parameters—LASIK predisposes to dry eye more than surface ablation;
hyperopic and deeper ablation more challenging to tear film
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| Preoperative treatments: nonpreserved artificial tears; punctal occlusion (temporary collagen plugs at time of procedure);
ophthalmic cyclosporine [Restasis]; underlying meibomian gland dysfunction needs treatment (warm compresses;
topical steroids; oral doxycycline; oral omega-3 and flaxseed oils)
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| Operative considerations: larger hinge width; well-lubricated surface; minimal manipulation of epithelium; hinge
position—conflicting study results comparing corneal sensation; some studies show reduced sensation with superior
hinge compared to inferior hinge; opposite also shown; another study showed same frequency of dry eye, but better nasal
sensation 1 mo postoperatively with nasal hinge
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| Postoperative treatment: continue preoperative treatments—nonpreserved artificial tears; punctal occlusion; Restasis;
treatment of meibomian gland dysfunction or lipid tear deficiency; other considerations—eliminate aggravating
systemic medications (eg, antihistamines, decongestants); autologous serum tears if severe; therapeutic soft contact
lenses
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| Summary: refractive surgery challenges tear film by ablation and transsection of corneal nerves; typically longer recovery
after LASIK compared to surface ablation; important to identify patients at risk to optimize tear film preoperatively;
important to counsel appropriately as to timing of surgery and postoperative recovery (potentially several months for tear
film to stabilize); future treatments—nerve growth factor; secretagogues; retinoids; mucins; aquaporins
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| FUCHS’ HETEROCHROMIC IRIDOCYCLITIS: AN UNDERDIAGNOSED CONDITION —Allan R. Rutzen, MD,
FACS, Associate Professor of Ophthalmology and Visual Sciences, Department of Ophthalmology, University of Maryland
School of Medicine, Baltimore
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| General: represents 1 in 20 cases of uveitis; in some cases, condition obvious (irises different color; acquired case of heterochromia);
in other cases, person born with heterochromia (congenital heterochromia; in most cases condition benign);
differential diagnosis for acquired heterochromia—Fuchs’ heterochromic iridocyclitis (Fuchs’); siderosis bulbi; other
forms of inflammation
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| Example of person with Fuchs’: obvious difference in color of 2 eyes; pupil in affected eye opaque (cataract); affected
eye most commonly hypochromic (rare instances where affected eye hyperchromic)
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| Demographics: most commonly age 20 to 60 yr (youngest reported case 7-yr-old); no sex predisposition; no racial predilection;
no identifiable genetic basis
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| Presentation: decreased vision (cataract); floaters; mild discomfort (if discomfort severe, not likely Fuchs’); may be asymptomatic;
description of Fuchs’ largely unchanged since initial description in 1906
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| Synonyms: Fuchs’ heterochromic uveitis; Fuchs’ heterochromic cyclitis; Fuchs’ uveitis; Fuchs’ syndrome
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| Classic triad: iris heterochromia; cataract; keratitic precipitates (KP); do not need all 3 to make diagnosis; iris features
key; heterochromia not required (dark-pigmented people unlikely to develop heterochromia)
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| Anatomy of iris: anterior layer (anterior border layer), stroma, iris pigment epithelium; all 3 layers involved in condition
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| Points from examples: in some cases, can see infiltration of iris at anterior border layer; sometimes can see some of iris
pigment epithelium possibly missing at pupillary border (rough); gap in pupillary rough probably primary manifestation of
condition; smooth iris (decreased undulations); hyperchromia can occur if significant atrophy at anterior border layer and atrophy
of stroma (more common in people with blue eyes [low pigmentation])
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| Characteristic KP: small white KP; KP extend into superior cornea; close examination of endothelium shows small linear
features; small linear marks combined with small white round KP referred to as stellate KP
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| Cataracts: probably present in all patients, given long enough time; posterior subcapsular cataract (PSC)
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| Glaucoma: common (25%-60% of patients); most due to open-angle glaucoma; most respond well to medical treatment;
some require surgery
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| Histology: infiltration at anterior border layer (plasma cells); in some cases, see discontinuity in iris pigment epithelium;
some cases, atrophy of stroma; electron microscopy—melanocyte from patient with Fuchs’ abnormally round, with
fewer melanosomes
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| Treatment: Fuchs’ typically resistant to treatment with topical steroids, so prudent to avoid steroids; steroids potentially beneficial
with dense KP and newly presented glaucoma (pulse with steroids to see whether trabecular meshwork might clear);
prognosis—in general, better prognosis than other types of uveitis; do not tend to get posterior synechiae; glaucoma develops
if condition left untreated (never shown that steroid prevents); patients usually not symptomatic; mydriatics—not usually
needed because posterior synechiae do not usually develop
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| Cataracts: occur due to disease process or to long-term treatment with steroids; for most patients with uveitis, general
treatment strategy includes trying to keep uveitis under complete control for 3 to 6 mo, then performing cataract surgery
with good results; in patients with Fuchs’, safe to proceed with cataract surgery with good prognosis
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| Other considerations: cystoid macular edema (CME) rare in patients with Fuchs’; postoperative inflammation—severe
in some patients; intensive treatment with topical steroids or oral steroids with short taper ahead of time and periocular steroid
at time of surgery to try to prevent complications; glaucoma—most patients respond well to medical therapy; some patients
require trabeculectomy (consider mitomycin-C and 5-fluorouracil)
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| Summary: Fuchs’ different condition from most other causes of anterior uveitis; demographics similar to other patients
with uveitis; clinical characteristics—unique; KP reach superior part of cornea; iris atrophy at anterior border layer,
stroma, and iris pigment epithelium; absent pupillary rough; transillumination defects
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Educational Objectives
| The goal of this program is to provide the listener with information on avoiding legal problems as a patient caregiver,
dry eye after refractive surgery, and Fuchs’ heterochromic iridocyclitis. After hearing and assimilating this program,
the clinician will better able to:
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| 1. Describe the legal process involved in malpractice suits.
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| 2. Discuss the importance of informed consent and possible mistakes made during the consent process.
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| 3. Discuss advantages and disadvantages of electronic medical records.
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| 4. Explain the etiology of dry eye after refractive surgery and the importance of identifying patients at risk before
surgery.
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| 5. Diagnose Fuchs’ heterochromic iridocyclitis.
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Discussed on This Program
Cyclosporine, ophthalmic [Restasis]
Doxycycline [several trade names]
Fluorouracil (5-fluorouracil, 5-FU) [Adrucil, Carac, Efudex, Fluoroplex]
Mitomycin (mitomycin-C; MTC) [Mutamycin]
Suggested Reading
Albietz JM, et al: Dry eye after LASIK: comparison for Asian and Caucasian eyes. Clin Exp Optom 88:89, 2005;
Albietz JM, et al: Chronic dry eye and regression after laser in situ keratomileusis for myopia. J Cataract Refract
Surg 30:675, 2004; Albietz JM, Lenton LM: Management of the ocular surface and tear film before, during, and
after laser in situ keratomileusis. J Refract Surg 20:62, 2004; Bonfioli AA, et al: Fuchs’ heterochromic cyclitis.
Semin Ophthalmol 20:143, 2005; Huang B, et al: The effect of punctal occlusion on wavefront aberrations in dry
eye patients after laser in situ keratomileusis. Am J Ophthalmol 137:52, 2004; Jabbur NS, et al: Survey of complications
and recommendations for management in dissatisfied patients seeing a consultation after refractive surgery. J
Cataract Refract Surg 30:1867, 2004; Javadi MA, et al: Outcomes of phacoemulsification and in-the-bag intraocular
lens implantation in Fuchs’ heterochromic iridocyclitis. J Cataract Refract Surg 31:997, 2005; May K, Edwards
M: Surgery in patients with Fuchs’. Ophthalmology 113:503, 2006; Mohamed Q, Zamir E: Update on
Fuchs’ uveitis syndrome. Curr Opin Ophthalmol 16:356, 2005; Schallhorn SC, et al: Avoidance, recognition, and
management of LASIK complications. Am J Ophthalmol 141:733, 2006; Tejwani S, et al: Cataract extraction outcomes
in patients with Fuchs’ heterochromic cyclitis. J Cataract Refract Surg 32:1678, 2006; Ti SE, Chee SP: Cataract
surgery in patients with Fuchs’. Ophthalmology 113:1883, 2006; Wendin SR: The role of risk management in
reducing costs and increasing patient safety. World Hosp Health Serv 42:17, 2006.
Faculty Disclosure
In adherence to ACCME guidelines, the Audio-Digest Foundation requests all lecturers to disclose any significant financial
relationship with the manufacturer or provider of any commercial product or service discussed. For this issue,
the faculty reported nothing to disclose.
Ms. Hay was recorded at Women in Ophthalmology 2006 Summer Symposium held August 10-13, 2006, in Montreal,
QC, Canada. Dr. Rodila was recorded at Cataract and Refractive Surgery Congress, held February 24-25, 2006, in
Miami, FL, and sponsored by Bascom Palmer Eye Institute. Dr. Rutzen was recorded at The 5th Annual Downeast
Ophthalmology Symposium, held September 15-17, 2006, in Bar Harbor, ME, and sponsored by Alcon, Allergan, Genentech,
Merck, and Pfizer. The Audio-Digest Foundation thanks the speakers and the sponsors for their cooperation
in the production of this program.
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