Informed Consent: Your First Line of Defense

Thorough education and rigorous documentation prepares patients and protects your practice.

BY LESLEY RANFT

Though ophthalmologists are very prudent about informed consent, legal professionals usually target deficiencies of informed consent at the time of most every form of litigation. In addition, it is all too common for patients to forget the details of their procedure, including the critical discussion of risks and alternatives, after the procedure has been performed. Rather, patients will build themselves up with visions of a positive outcome when faced with fears in surgery, suppressing awareness of a possible complication.

Trends indicate a continued need for ophthalmologists to focus on informed consent on a routine basis. Even the FDA recently weighed in, scolding ophthalmologists for not doing a better job of presenting refractive surgery in an evenhanded manner. Despite high levels of patient satisfaction among LASIK patients, especially when compared to procedures in other medical specialties, the April 2008 FDA hearing focused attention on unsatisfied patients.¹ As a result, the FDA had the following suggestions:

► Improve screening for LASIK patients.

► Improve communication and provide adequate information about LASIK prior to surgery.

► Improve marketing tactics to avoid a misleading vision of perfection from LASIK.

Informed Consent vs. Memory Downfall

Since allegations of lack of informed consent figure in virtually every malpractice lawsuit, the Ophthalmic Mutual Insurance Company (OMIC) devoted the Summer 2007 issue of its Digest to the topic. In the lead article, "My Doctor Never Told Me That Could Happen," OMIC Risk Manager Anne M. Menke, RN, PhD, points out a 2004 study of cataract patients that queried patients who had just signed an informed consent document on their understanding of the risks, and found that 76% believed there was no risk of a complication from surgery.² Other findings:

► 60% felt their surgery was not associated with any risks

► 78% indicated that the follow up discussion about informed consent had no bearing on their decision to proceed with the procedure

► 22% said that the informed consent reinforced their decision to proceed with the procedure.

Tools to Build Trust

As Richard L. Abbott, MD, Professor at UCSF and Secretary for Quality of Care at the American Academy of Ophthalmology explains, "The success of informed consent is founded upon the surgeon initiating the process well in advance of surgery to provide adequate time for all parties to participate in the process." Undoubtedly, the physician's training, education, board certification, associations and particular areas of surgical interest offer a patient the means to better identify the surgeon's qualifications. Yet, other methods are required to develop the crucial doctor-patient bond.

"There are two aspects of informed consent — the doctor-patient relationship and the medical-legal aspect — and the common denominator among patients with complaints is misunderstandings," explains Dr. Richard G. Shugarman, M.D., a private practitioner in West Palm Beach, Florida and Professor of Ophthalmology at Bascom Palmer Institute in Miami. "Strong doctor-patient relationships using methods to enhance communication and routine documentation reduce the risks associated with misunderstandings." Tools to reinforce patient trust can demonstrate an understanding of patient needs, improves patient satisfaction levels, and do not necessarily require a large amount of time, including:

► Visual props such as eye models reinforce communication about the procedure, risks associated with the procedure, coping skills required for complications and alternatives to the procedure.

► In-office video or audio tapes can deliver information about the procedure and informed consent priorities without requiring the involvement of the surgeon; a staff member can question the patient about the content and document their responses in the chart. This allows the surgeon to reconfirm the patient's understanding, focus time on other information and document the communication.

► DVDs that provide Q&As for the patient offer advanced interaction and can provide a record that the patient understands the DVD information.

► Practice Web sites that inform consumers about procedures, risks and recovery can leverage communication, particularly if they include video. In addition, patients often remember the pages they visited on the Web site — this can assist with informed consent if those particular page visits are documented in the chart.

Legal Consent Defined

Legally, consent is not only defined by proof of a consent form but a document demonstrating an oral discussion and an oral agreement. As James J. Salz, M.D., of Los Angeles explains, "The informed consent document does not protect the ophthalmologist unless they have a one-on-one conversation with the patient." The recollection of information that is communicated to patients helps to limit liability in litigation. However, it is virtually impossible for anyone to recall each conversation they have unless they document the conversations through practical methodology in the chart.

As Chicago attorney Linda Hay explains, "Routine documentation in every step of the informed consent forces the informed consent process. I have seen many well-educated patients that have experienced complications from numerous types of medical procedures proceed with litigation and have be awarded substantial compensation in cases that could have otherwise resulted in a more positive outcome for the doctor through adequate chart documentation."

According to a study of 16.3 million worldwide LASIK recipients released by the American Society of Cataract and Refractive Surgery in April 2008, retrospective review of over 3000 articles published over a 10-year period suggest that 95.4% of patients are satisfied.³ However, even a 1% complication rate produces thousands of patients that have struggled with complications.

As Monica L. Monica, M.D., Ph.D., spokesperson for the AAO, advises, "In the court of law, there is no perfect informed consent, so the doctor must show that he or she has done everything possible to provide accurate information about the procedure. This may be accomplished by having several Q&A encounters with the patient." To take it a step further, two or more practice visits with documentation contributes to a more solid informed consent agreement and can enhance the doctor patient relationship.

The Agreement

► Answering the "Top W"s: It's important for patients to understand and agree to the answers for the most crucial questions, including: What is wrong with the eyes? What is the goal of surgery? What will the surgery not correct? What are the high risk factors for the patient? What are the coping skills required to manage complications? Will the patient be resilient should the recovery be taxing or complications arise? What alternatives does the patient have? What type of support does the patient have?

► Routine Discussions: In every consultation, use the same terms in easy to understand, scripted language to describe the procedure, risks and alternatives. Use the same props to reinforce the message. The ability to demonstrate a routine is valuable. Supporting the routine through documentation is a necessity in today's legal environment.

► Probing Questions: Ask the patient how they would cope with a suboptimal outcome or a complication, if one should arise. It might be wise to encourage the patient to discuss the procedure with a support person, bring that person to a consultation, seek out educational resources and research the Internet. In the end, it is important to know (and document) that the patient understands the impact that a complication can have on day-to-day life.

► The Q&A: Performing the Q&A three or more times over the course of at least two visits will help reinforce the message. In these discussions, support statements with example analogies or statistics. When asked a broad or "loaded" question, take a moment to formulate an answer, restate the objective of the message and support the objective with an example or statistic that relates to the question. It is also important to listen to patient questions and provide simple answers with the use of visual props. In the end, there may be multiple patient Q&A sessions with different members of the practice; when possible, one session including a family or support individual will augment communication.

The Documents

Template documents offer an efficient process to ensure informed consent documentation. As Adam Beck, M.D. of New England Eye Associates and a medical expert witness explains, "The difference between poor results, complications and medical malpractice is questioned in litigation and can be clarified through precise chart documentation. Always chart at the time that you are with the patient, never thereafter." In the charts, date, initial and refer to the specific numbered paragraph in the template document that covered the topic of discussion. Visual aids and signature requirements enhances communication, as follows:

► Sketches: Draw sketches for patients to point out specifics relating to the procedure, and query patients about the sketches. Then, documentation on the sketch can be made, dated, initialed and placed in the chart.

► Checklists: Checklists that cover preop, postop and recovery instructions with a space for surgical team member and patient signatures can be advantageous. These lists can be placed in the chart, with copies given to patients. If the patient has questions during checklist review, document the question (and the patient's understanding of the explanation) in the chart or on the copy.

► Take-Out Consent Forms: Allowing the patient to take the informed consent home can be beneficial. Encourage them to mark any unclear items and list additional questions on the form. Answer each question when they return, and initial and date each item. It's advantageous to document patient answers to your questions about knowledge of informed consent topics, save the form in the chart or indicate in the chart the specific paragraph you reviewed with the patient. If questions from the patient are lengthy, consider referring applicable questions to an appropriate surgical team member so they can address the patient's concerns and have the surgeon address the most important ones that he or she must address. Document every communiucation between your practice and the patient throughout this process.

The patient can be given a second informed consent form to sign and be sent home with a copy. Patients can even sit in the waiting room with a pen and the informed consent form to mark off questions and be called back to complete the informed consent process. Preserving the marked up informed consent may be invaluable in the eyes of the law.

Identifying High Risks

It's important to know the demographics of your patient base. If a candidate for a given procedure is illiterate or elderly, cater to them with visual props. If they don't speak English, use a translator and provide informed consent forms in their native language. Even with a technically savvy or well educated patient base, offering information in consistent easy-to-understand laymen language and the use visual props reinforces communication.

If you see many patients as a result of advertising and/or they have high expectations, consider an informed consent roundtable that patients can attend prior to the procedure or an educational seminar that is non-promotional in nature. As Dr. Abbott adds, "An evaluation of each patient and communication of high-risk circumstances is a necessity, including: job impact, cost, medical conditions, eye conditions, medications, stability of refraction, high or low refractive error, pupil size, corneal thickness and tear production. Patient personalities in relation to risks must be considered when identifying candidacy for a procedure." In the end, some patients may not be appropriate for surgery.

Battling the Media

As we know, media influence can be extremely powerful on consumer perceptions. Sifting through confusing information that patients have received through the media can be difficult at best. In fact, even positive coverage of LASIK can make a consultation problematic. As Menke explains, "Some LASIK ads promise not only perfect 20/20 results, but also present the surgery as a life-changing event instead of one that can reduce dependence on glasses or contact lenses. Patients whose surgeons did not help them develop more realistic expectations become surprised and angry when the outcome is not what they anticipated. The exchange of information will enhance the physician-patient relationship, the patient's understanding, and the patient's ability to cope with problems."

An advanced approach to the media challenge may be accomplished through an opinion editorial published in your local paper. Practices can respond to particular misleading media segments by writing an op-ed that reflects the surgeon's point of view on the topic. Copies of the article can be submitted to the press and given to patients. Then, patients can be encouraged to note any questions they have on the article and return to the office to receive answers to any outstanding inquires. Knowing that an ophthalmologist has taken the time to address topics of global concern helps patients to connect with the ophthalmologist.

You may hire a professional to develop the content for a nominal fee, or write the article yourself. Either way, keep the length at about 750-800 words. Op-eds should state the issue and how your point of view will or has solved the problem. It must be of general appeal to the audience, citing statistics or study results when possible.

The Final Verdict

There is of course no cookbook approach to the informed consent obligations of ophthalmology practice — the solutions that work for one practice may not work for another. With today's time management priorities, it may be difficult to embark on every potential strategy, but there are a few things we do know. Clearly, the relationship that the patient feels they have with the ophthalmologist can play a substantial role in the outcome of informed consent. Streamlined communication and message reinforcement is all part of the process. Yet, all may have little bearing without strong Q&A documentation should a legal situation develop over time. OM

References

1. http://www.lasiksurgerynews.com/news/FDA-panel-quality-of-life-after-lasik.shtml
2. http://www.omic.com/new/digest/Digestsummer_fin2.pdf
3. http://www.lasiksurgerynews.com/news/lasik-patient-satisfaction-2008.shtml