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'Doctor, I'm Sure You Didn't Tell Me About Those Risks!'

'Doctor, I'm Sure You Didn't Tell Me About Those Risks!'

Despite the significant legal and ethical implications surrounding informed consent conversations, having these far-reaching discussions can be a challenge. However, informed consent conversations are absolutely necessary: They ultimately result in a patient's agreement to undergo a treatment or procedure.

Physicians generally do an excellent job with explaining planned procedures to patients, but documentation of those conversations is often severely lacking. Patients typically receive either a generic "consent-to-treat" document or a "fill-in-the-blank" document. Neither captures what patients have discussed with their physicians.

Given the struggles with documenting informed consent, it is not surprising to find that in a recent survey of 402 physicians, 87% reported that "most" or "some" of their patients were under- or misinformed.

New technology could help solve this problem. Many doctors and healthcare organizations do not know that informed consent software exists.

Actually, many practices already use electronic consent software to prepare detailed patient information packets that educate patients about planned procedures. Patients receive these packets during an office visit before the scheduled procedure. Typically those packets include a copy of the procedure-specific consent form, which is comprehensive and easy to understand. Patients are always offered a copy of their consent form, which then serves as a transcript to help them remember the informed consent conversation and their choices.

Larger practices and hospitals that have invested heavily in automation have even more flexibility in documenting informed consent using software.

Easy to Use With Patients

Physicians typically obtain consent electronically in exactly in the manner as they do with conventional paper consent forms. The difference is that the workstations, tablet computers, and mobile point-of-care devices in the organization now have access to informed consent software that puts the procedure-specific information and forms at the doctors' fingertips.

Doctors can obtain signatures with a retail-style digitized signature capture pad or by using the stylus on a tablet computer. The innate flexibility of informed consent software means that physicians can acquire consents in the manner that is best suited to the physicians' style and preferences.

Software Helps Reduce Liability Exposure

Automatic informed consent software not only makes efficient use of time, but it also helps to minimize risk. Inadequate informed consent has been found to be a secondary cause in more than 90% of ophthalmologic malpractice cases, whereas other research has found that only 39% of closed claims against anesthesiologists were judged to have adequate informed consent.

A thorough informed consent process, supported by a software tool that generates detailed, procedure-specific and patient-specific consent forms, serves as a form of preemptive disclosure. Excellent patient communication ultimately helps minimize risk when patients and their families fully understand the complete range of complications that could result from a planned treatment or procedure, and that information is provided to them in easy-to-understand language.

Software that helps document the informed consent process can reduce liability exposure in other ways, as well. Obtaining consent in a physician's office, rather than the preoperative holding area, and documenting that consent discussion as a note in the medical record have both have been shown to reduce liability exposure. An automated informed consent application easily allows for documentation of the informed consent discussion in a physician's office. These Web-based tools can prepare consent documents with a hospital's template and the form preferred by a physician's practice. Both documents contain the same detailed description of the procedure, risks, benefits, and alternatives that are unique to the treatment planned for a particular patient.

Completing this process well before a patient arrives at the hospital or surgery center ensures that documentation of informed consent does not become the equivalent of a "medical Miranda warning."

Office-based informed consent systems typically cost less than $1 per day. Discounts on these tools are often available through professional liability insurers such as Medical Protective or professional organizations such as the American College of Surgeons or the American Urological Association.

Integrating the informed consent software into the electronic health record (EHR) or practice management system brings other benefits, too. Providers do not have to prepare a note describing completion of an informed consent discussion in the EHR. The informed consent software, in concert with the EHR, automatically generates that detailed note in the medical record – a note that, along with the signed consent form, better reduces liability risk.

Improving Patient Flow

A major problem with paper-based informed consent forms is that doctors and staff can easily lose or misplace them. The inability to locate these critical documents has been estimated to contribute $3.3 billion to the cost of healthcare in the United States due to resulting operating room delays. Those delays are particularly challenging for physicians who increasingly are pressed for time. Automated informed consent tools ensure that digitized images of signed consent forms instantly are available to the operating room staff for the preprocedure verification and for the time-out.

Other factors also play a major role in saving time and money. For instance, patients may arrive at hospitals ill-prepared for planned procedures, resulting in expensive cancellations. Meanwhile, patients who fail to follow postoperative instructions risk costly and often unreimbursed readmissions.

The most sophisticated informed consent software tools address these inefficiencies by providing detailed preprocedure instructions and comprehensive discharge instructions. Use of informed consent software to provide preprocedure instructions has been found to result in patients who take greater ownership in preparing for their procedures.[1] Similarly, the delivery of discharge instructions via an automated informed consent application was found to result in a 63% reduction in one medical center's 14-day readmission rate.[2]

Better Patient Understanding and Satisfaction

A recent randomized, multicenter study with informed consent software to assess patient comprehension of planned procedures uncovered 2 major findings.[3] First, and not surprisingly, patient understanding increased when physicians spent more time with their patients. The second finding was that the use of "teach-back" or "repeat-back" also significantly improved patient comprehension.

During this study, providers were prompted to ask patients a series of 6 questions to confirm patient understanding. This technique of National Quality Forum-Endorsed Safe Practices[4] was facilitated by the automated informed consent application. The software tool allowed providers to quickly verify and document patient understanding of the major aspects of contemplated procedures.

As the study demonstrates, patients can significantly benefit from informed consent software. The software employed in all Veterans Affairs (VA) hospitals, for instance, allows patients and physicians to review information together on a computer screen, or it allows patients to take a detailed document home to review at their own pace with family members.[5] In addition, any provider throughout the VA health system can easily check the consent form within a patient's EHR and answer questions as needed.

Patient satisfaction with an automated informed consent process was investigated: A study of VA urology patients found that 96% preferred the electronic process to a traditional paper-based informed consent process.[6] It is reasonable to conclude, therefore, that employing electronic tools to assist with informed consent is a valuable asset to efforts to improve efficiency, reduce risk, enhance safety, and ensure patient satisfaction.


  1. Isgett-Lynn B. Improving patient prep. Health Manage Technol. 2011;32:24-26.
  2. Boast P, Potts C. Enhancing patient safety by automating discharge instructions. Patient Safety Quality Healthcare. 2010;7:14-16.
  3. Fink AF, Prochazka AV, Henderson WG, et al. Predictors of comprehension during surgical informed consent. J Am Coll Surg. 2010;210:919-926.
  4. National Quality Forum. Safe Practices for Better Healthcare: A Consensus Report -- 2010 Update. Washington, DC: National Quality Forum; 2010.
  5. Franklin D. Uninformed consent: tech solutions for faulty permissions in health care. Sci Am. March 15, 2011. Available at: Accessed June 9, 2011.
  6. Issa MM, Setzer E, Charaf C, et al. Informed versus uninformed consent for prostate surgery: the value of electronic consents. J Urol. 2006;176:694-699.

Medscape Business of Medicine © 2011 WebMD, LLC

  Timothy J. Kelly, MBA

Op. Dr. Mustafa Kemal Calik
Cardio Vascular Surgeon