Creating Bulletproof Informed Consent

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Neeraj Kohli, MD, MBA

Neeraj Kohli, MD, MBA, is Director, New England Center for Urogynecology, Affiliated with Newton-Wellesley Hospital/Brigham and Women’s Hospital, and Assistant Professor, Department of Ob/Gyn, Harvard Medical School, Boston, MA.


In the past 10 years, I have had the opportunity to review many medical malpractice cases for both a defense and plaintiff, and oftentimes, adequate, written informed consent becomes a significant basis for the case. In this day and age when patients are asking for more and more information and physicians have less and less time, it's important to make sure that you don't cut corners when it comes to informed consent.

An adequate informed consent form should be written in plain English terms at a fifth grade comprehension level and should be legible and complete, listing all major and minor complications associated with the specific procedure. Too often I have seen “chicken scratch” on the standard hospital consent form with only one or two—if any—complications specific to the procedure in question written down. It seems as if the physician was in a rush when the consent was quickly filled out and signed in the office. This is a significant document that can oftentimes protect both the patient and physician from unforeseen complications.

I would recommend a simple and easy solution utilizing readily available technology to all physicians. I currently operate at four hospitals and have taken the blank consent forms from each hospital and scanned them into my computer. Each scan is then used as a template in Microsoft Word as a background. Text boxes are then inserted in each area with prepopulated text for the surgeon’s name, condition, procedure, alternative treatment options, and detailed risks, as well as any other additional information that the consent form requires. You can even use Word to automatically insert the correct date and time when the document is printed. This form is then saved, and similar forms can be created for a different procedures and different combination of procedures. These different forms can then be saved on your office computer as files named for the specific procedure. During the preoperative visit, I simply open the correct consent form and quickly type in the patient's name and hit the "print" button. Voilà! A legible, comprehensive, and customized consent form is printed in a matter of minutes. After the patient signs the form, I give a copy of it to him or her for his or her review at home and for his or her records of the procedure.

We have received many comments from operating room nurses as well as risk management personal (these are the team that oversees medical-legal aspects of the hospital and help keep doctors out of trouble) in our hospitals that our consent forms should be used among all surgeons. In fact, many hospitals are now using Web-based programs that require all of this information to be filled in, but they require Internet access as well as repetitive typing for each individual form. Microsoft Word–based templates make work a lot easier and reduce your malpractice risk. Combine this with a short "informed consent" video (more on that on a future blog) and you will make your informed consent process bulletproof and patient friendly!