2014 V24 N4

http://www.omic.com/wp-content/uploads/2015/01/Digest-No4-for-web1.pdf

Message from the Chair

“Extra! Extra! Read all about it.”

This issue of the Digest may have some of the most practical information you’ll ever find on arguably the greatest global risk management issue in medicine: informed consent. When not managed properly, informed consent deficiencies can create trouble and misery for patients and physicians alike. A recent review of our own claims shows allegations of improper informed consent are over 50% more likely to result in a plaintiff award with damages that are substantially higher as well. Why is informed consent so critical? When we don’t take the time to properly educate patients about the pros, cons, and alternative options of the medical treatments we provide, we open ourselves to claims that they would have refused treatment had they been adequately apprised of the risks.

When things go wrong, there are two groups of patients who are more likely to allege improper consent: those who tend not to question the recommendations of their doctors and those who have strong—and potentially unrealistic—expectations for their clinical outcome. These are people who may have low health literacy (not to be confused with IQ) and need more explanation and education on the potential consequences of any medical intervention. In these situations, it is especially important that informed consent and patient instruction are not just thorough but meticulously documented. While it is neither possible nor practical to list every conceivable risk, the most common and the most catastrophic potential adverse events are a good place to start. Forms that use plain English and emphasize the active voice are most understandable, e.g., “Take your drops twice a day,” versus “Topical medications should be used twice daily.” Note in the record what patient education materials were given out. These resources serve as “extenders” of your informed consent discussion. Keep copies of these handouts as they will be powerful evidence in our defense of you should you be sued.

Feeling overwhelmed? We are here to help. OMIC has scores of procedure-specific consent forms—downloadable and customizable—that are now, through a partnership with the Academy’s Foundation, also translated into Spanish. Just a click away at www.omic.com, these forms combine frank discussions on risks/benefits/alternatives with disease-specific patient education to help arm patients with information they need to feel confident in their medical decision-making. Also on the website is an informed consent webinar, “My Doctor Never Told Me THAT Could Happen.” We feel so strongly that proper informed consent will strengthen our defense of any litigation that we will give ophthalmologists a 5% to 10% premium credit just for viewing it. Looking for more patient education materials to supplement your practice? Check out the new and innovative multimedia offerings on the aao.org website.

Informed consent is part of the conversation that we have with our patients. It acknowledges the vagaries inherent in medicine and fosters a climate of candor, rapport, and trust that may very well represent the best weapon we have against litigation: a meaningful personal connection with the patients we treat.

Happy reading.

Tamara R. Fountain, MD, Chair of the Board

What You Should Know about Rates and Dividends

The Board of Directors is pleased to announce a 25% dividend for all physician insureds in the form of a 2015 renewal premium credit and continuation of 2014 rates through your 2015 policy year. Issuance of the dividend requires that an active 2014 professional liability policy be renewed and maintained throughout the 2015 policy period. Mid-term cancellation would result in a pro-rata dividend.

Dividends appear on your policy invoice as a credit to either your annual or quarterly billing installment. OMIC issues dividends as a credit toward renewal premiums for two reasons. First, premium credits offer favorable tax implications for policyholders. Second, premium credits allow for easy and efficient distribution of dividends.

Each year OMIC’s Board receives a report from actuaries describing current claims trends and how they relate to rate levels for each state and territory. Using this information, we determine whether a rate increase or decrease for the current or upcoming year is warranted. Dividends, on the other hand, are generally determined on the basis of whether claims trends for past years are better (or worse) than expected. Because malpractice claims have a “long tail,” in which resolution often occurs several years after the incident is reported, trends are only evident after careful monitoring of claims over a significant period of time.

OMIC continues to reduce malpractice insurance costs through lower rates and paid dividends. In addition to average premium reductions of nearly 30% nationally since 2005, OMIC has announced dividend credits totaling more than $58 million since our company’s inception, outperforming our peer companies by a significant margin. Issuance of dividend credits is not guaranteed and is determined each year after careful analysis of our operating performance. OMIC’s philosophy is to return any premium above which is necessary to prudently operate the company and to do so at the earliest opportunity.

Plain Language Concepts in Consent Discussions 

Anne M. Menke, RN, PhD, OMIC Risk Manager

The analysis of informed consent claims presented in the lead article indicates that patients often don’t understand the planned surgery. How can busy eye surgeons and their staff better explain the risks of treatment while staying on schedule? How can they know which patients need additional guidance or have misinterpreted what they have been told? Health literacy experts suggest that the use of “plain language” can help. This article will introduce this idea and explore ways it may be used to communicate more effectively. It will also discuss why changes to the informed consent process need to be made with care.

Q What exactly is “plain language”?

A The term is often used to measure the understandability of written material but applies to speaking as well. A document written in plain language allows people to find what they need, understand what they find, and act appropriately on that understanding.¹

Q Are there guidelines for speaking and writing in plain language?

A Yes, there are a number of key principles, such as organizing material so the most important behavioral or action points come first and breaking complex information into understandable portions with one idea per sentence. One simple change you can make to enhance the clarity of messages is to use the active voice to make clear what action needs to be taken and by whom. Instead of “The drops should be used twice a day,” say “You need to put the drops into your eye twice a day.” Another tool is to use lists to make points: “You need to use three different eye drops after your surgery. The first one with the green label treats infection….” Employ “living room” words that patients already know to explain medical terms and include examples and analogies. For instance, “Eyes are usually round like a basketball. Yours is shaped like a football. This shape makes your vision blurry and is called astigmatism.”

Q I appreciate that anxious patients may have a hard time understanding the information I present. What else can I do to help?

A Start by stating the purpose of important parts of your discussion. “We know you have a cataract and that it needs to be removed. Now I need to decide what type of intraocular lens to put in your eye. To do that, I need to ask you some questions about how you use your eyes and what your goal is for the surgery.” Clarifying the key point is especially helpful for patients with complex conditions or those at higher risk. “You need this surgery to treat the hole in your retina. But your vision is already limited. I want to explain how the normal risks of this operation could cause extra problems for you.”

Q How can my staff and I tell if a patient needs additional guidance or has misinterpreted what we said?

A Communication experts suggest using a technique called “teach back” in which patients are asked to restate information in their own words. Suppose you have just finished recommending a combined cataract and glaucoma procedure. Say to your patient, “I want to make sure that I have explained why you need two different surgeries. Please tell me the two problems with your eyes that I am trying to help.” Use the same approach to clarify the goals of the surgery. “I want to make sure that I explained what vision you can expect with this type of lens. Please tell me when you might need to wear glasses.” Invite input from patients who do not seem to be actively engaged in the conversation. When doing so, avoid questions with yes and no answers (“Do you have any questions about your corneal transplant?”). Instead, you and your staff should encourage patients by asking open-ended questions: “We’ve presented a lot of information and may not have explained everything clearly. What questions do you have for me?”

Q How much information should we provide to minimize claims of lack of informed consent?

A Plain language experts feel patients are sometimes given too much information and recommend thinking of “need to know” instead of “good to know.” While this advice makes sense for clear communication, it may be problematic in the legal context of informed consent discussions. The informed consent process and forms serve a dual purpose: to inform the patient and to defend the physician against allegations of lack of informed consent. Physicians who shorten their forms and discussions too much may later be sued for failure to address certain issues. OMIC is actively exploring these issues with the help of plain language and legal consultants. We want to proceed carefully so both patients and physicians are well-served. For now, try incorporating some of these clear language principles into your conversations with patients.

1. “Plain Language: A Promising Strategy for Clearly Communicating Health Information and Improving Health Literacy.” http://www.health.gov/communication/literacy/plainlanguage/PlainLanguage.htm.

FFK Diagnosed on Day of Planned Bilateral LASIK 

Ryan Bucsi, OMIC Senior Litigation Analyst

Allegation

Failure to provide informed consent regarding risk of complications from PRK OS with forme fruste keratoconus.

Disposition

Case settled for $200,000.

Case summary

A 30-year-old female presented to an OMIC insured’s office for a LASIK evaluation. The initial consultation was handled by a technician, who discussed risks such as dry eyes, fluctuation in vision, light sensitivity, and glare with the patient. Upon examination, the insured noted SCVA of 20/800 OU and CCVA of 20/20 OD and 20/30 OS. The corneal examination revealed a pachymetry of 520 in each eye with a decreased tear film OU. The insured’s diagnosis was myopia and tear film insufficiency. The patient agreed to undergo bilateral simultaneous LASIK. Approximately two weeks later, when the patient presented for surgery, the insured diagnosed forme fruste keratoconus (FFK) OS based on the color topography. The patient signed consent forms for LASIK and PRK, and the insured performed LASIK OD and PRK OS. The postoperative course was unremarkable in the right eye; however, the patient complained of poor visual acuity, blurry vision, halos, light sensitivity, and headache in the left eye. Visual acuity fluctuated between SCVA 20/200-20/800 OS with CCVA 20/70 OS. The insured treated the patient’s complaints with Pred Forte and oral Prednisolone. After several months with no improvement, the patient requested and the insured provided a referral for a second opinion. The second opinion was central haze and inferior steepening on topography post PRK. Visual acuity was SCVA 20/200 pinholed to 20/30 OS. The patient was advised by the second ophthalmologist to continue Pred Forte and was fitted with a rigid gas permeable contact lens (RGPCL). The patient returned to the insured, who documented CCVA of 20/30 OS with the RGPCL; however, the patient could not tolerate the lens and a soft contact lens did not improve her vision. The insured noted SCVA of 20/400 OS. The patient self-referred to a third ophthalmologist, who diagnosed inferior steepening and mild corneal haze OS following PRK with FFK. CCVA was 20/80 OS. The third ophthalmologist recommended that the patient continue with the RGPCL. During the insured’s final exam, the SCVA was 20/20+1 OD and 20/400 OS, with CCVA of 20/60 OS. The insured’s diagnostic impressions were corneal haze and FFK OS.

Analysis

A dispute existed between the insured and the patient regarding the informed consent process. The insured informed our defense counsel that he fully discussed the risks of PRK with the patient due to the diagnosis of FFK on the day of surgery. The insured handwrote in the chart that he discussed this with the patient. The patient testified at her deposition that she did not recall the insured having any discussion with her about the risks, benefits, and alternatives to PRK with the diagnosis of FFK. Defense experts retained by OMIC felt that, even though the more conservative PRK procedure was performed on the left eye, the patient deserved more information regarding the specific higher risks she faced postoperatively due to the FFK. Defense counsel estimated a defense verdict chance of 50% with a plaintiff verdict as high as $500,000. With the insured’s consent, the case was settled for $200,000.

Risk management principles

It is important to review key studies like topography before the day of surgery. Even though the ophthalmologist correctly revised the surgical plan from bilateral simultaneous LASIK to LASIK OD and PRK OS, there was no urgency to perform either procedure the same day the FFK OS diagnosis was made. Due to the increased risk of complications following PRK on an eye with FFK, surgery could have been postponed to give the patient more time to reconsider whether to proceed with what are both elective procedures in light of this new information. Since the decision was made not to postpone surgery, the insured should have expanded his handwritten note to include a more thorough description of exactly which risks, benefits, and alternatives were discussed with the patient. Furthermore, a notation should have been made that the patient understood the new diagnosis along with the associated increased risks and still wished to proceed with surgery.