EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
Issue link: https://digital.eyeworld.org/i/111385
70 EW RESIDENTS February 2013 Cataract tips from the teachers Informed consent: Not just a signature on a document Roberto Pineda, M.D. Associate professor of ophthalmology Harvard Medical School Director of Refractive Surgery Massachusetts Eye and Ear In���rmary Sherleen Chen, M.D. Assistant professor of ophthalmology Harvard Medical School Director of Cataract and Comprehensive Ophthalmology Massachusetts Eye and Ear In���rmary Roberto Pineda, M.D. Assistant professor of ophthalmology Harvard Medical School Director of Refractive Surgery Massachusetts Eye and Ear In���rmary A lthough not formally taught like cataract surgery, there are few more important discussions we can have with our patients than the process of obtaining informed consent prior to cataract surgery. Many residents already feel quali���ed to obtain consent but may not fully realize the extent of professional responsibilities that govern the discussion of risks, bene���ts, and alternatives when medical or surgical treatments are proposed. Unfortunately, most residents only learn about the consent process through observation, with limited exposure to the ethics or medical legal implications. As such, the process may be reduced to simply obtaining the patient���s signature on the consent form. Sherleen Chen, M.D., and Roberto Pineda, M.D. A s a member of the American Academy of Ophthalmology (AAO) Ethics committee, I felt the consent process was a very important topic to include in this column. Many residents do not realize that even after patients agree to or receive care, recent studies1 have shown that ��� 44% do not understand the exact nature of their operation ��� 18-45% are unable to recall major risks of their surgery ��� 60-69% do not read the consent form ��� 60% do not understand information contained on the consent form When discussing informed consent with the residents, I emphasize that there are two principal components to the informed consent process���comprehension and competence. If the patient does not understand the procedure as well as the risks, benefits, and alternatives, informed consent has not occurred. Secondly, if the patient is not competent, consent has not occurred. Without proper informed consent, a surgeon may be legally liable and potentially charged with battery (no informed consent) or negligence (incomplete or inadequate informed consent). A legal guardian may be required in some adult cases if competence or comprehension is in question. I teach residents that lack of informed consent prevents patients from participating in their own healthcare. This violates a physician���s professional and ethical obligations to patients and exposes doctors and hospitals to liability. Additionally, I reinforce that communication is most frequently cited as the cause underlying medical malpractice litigation. I explain to our residents that although brochures and media (such as videos) about cataract surgery are helpful for increasing patient understanding and ancillary staff can assist with the informed consent process, it is ultimately the surgeon who is responsible for the final dis- cussion and documentation. I model this with them in the clinic. It is advisable to provide a copy of the consent form to patients after they sign the document. This is particularly important if the patient���s eyes have been dilated. Informed consent should include common risks of cataract surgery such as infection, cystoid macular edema, or posterior capsular opacification, as well as inform patients of anatomic issues or risk factors for their cataract surgery that will make the surgery more difficult or IOL determination less accurate (small pupil, pseudoexfoliation, synechiae, prior keratorefractive surgery, etc.). Legally, specific requirements of the informed consent process must be met. The AAO has Rules of Ethics that govern this process as well. Sometimes procedure-specific consent forms for cataract surgery are used, which provide more information about the surgery and related risks. The forms should be written in plain language the patient can understand. If there is a language barrier, be sure to discuss with a family member who can understand and translate or use an interpreter. Unrealistic expectations should be managed appropriately. If discussions are extensive, this should be documented as such in the medical record. In addition, for cataract surgery all IOL options should be discussed (monofocal, toric, and multifocal/accommodative) or at least mentioned even if patients are not candidates. In particular, the use of toric and multifocal or accommodative IOLs requiring an out-of-pocket expense to the patient will usually require a longer discussion regarding potential benefits but also the risks (halo, glare, blurry vision) and may include a separate consent form. The bottom line is residents need to understand that informed consent is both a discussion (between the patient and surgeon) and a document, with good communication between the physician and patient. This addresses both the legal and ethical issues surrounding this topic when things do not go as expected. The informed consent process should not be delegated, and it is one of the most important parts of the cataract surgical evaluation. Reference 1. Implementing a National Voluntary Consensus Standard for Informed Consent, A User���s Guide for Healthcare Professionals, National Quality Forum (NQF), 2005. Susan M. Ksiazek, M.D. Associate professor of surgery Section of Ophthalmology and Visual Sciences University of Chicago Medical Center The indication for cataract surgery needs to be considered, and this is an essential part of cataract surgical training. This discussion is tailored to the specific needs of the patient. Indications for surgery will be found in the answer to either of these questions: ���Why are you doing the surgery?��� or ���What is the patient complaining about?��� The decision to have the surgery is the patients,��� but they come to you for your opinion. I tell them that glasses won���t adequately help relieve their complaints. A 20/70 cataract is still legal to drive, and the patient may not have any complaints. However, I would tell patients I recommend the surgery because it will make them safer drivers. A truck driver with a 20/20 PSC will be a hazard on the road at night when his vision drops to 20/400 or worse. I use the mnemonic APRBE, which stands for Alternatives, Procedure, Risks, Benefits, and Expectations. Alternatives include not doing surgery. In all likelihood patients will get it done eventually, so I don���t push for surgery if they don���t want it just yet. I explain to them that the cataract will continue to grow. Alternatives also include multifocal, accommodating, or toric specialty lenses���what do you recommend and why. continued on page 72