This article is more than 5 years old. Information may no longer be current.
Symptoms and satisfaction of patients in the PROWL study: Pre- and postoperative legal implications
Click Here to Manage Email Alerts
From international law firm Arnold & Porter LLP comes a timely column that provides views on current regulatory and legislative topics that weigh on the minds of today’s physicians and health care executives.
In October 2009, the FDA, the National Eye Institute and the Department of Defense launched the LASIK Quality of Life Collaboration Project to help better understand the potential risk of severe problems that can result from LASIK surgery. On Nov. 23, the long-awaited Patient-Reported Outcomes with LASIK (PROWL) studies were published in JAMA Ophthalmology. The PROWL-1 study included 262 participants and assessed symptoms postoperatively at 1 month and 3 months. The PROWL-2 study included 312 participants and assessed symptoms at 6 months.
Bethan Jones
In particular, the symptoms and satisfaction of patients in the PROWL studies may have important preoperative and postoperative legal implications for physicians.
Preoperatively, the study’s conclusions may inform common law or statutory informed consent requirements. Formulations of the standard vary, but generally informed consent is approached from the viewpoint of reasonableness. For example, state statutes may impose a duty to disclose information a “reasonable patient would consider material to the decision whether or not to undergo treatment or diagnosis.” Other states may frame the inquiry from the perspective of a reasonable medical practitioner under similar circumstances.
Most importantly for informed consent purposes, the study concludes that “a large percentage of participants with no symptoms preoperatively reported new visual symptoms postoperatively.” Of those participants who reported no visual symptoms, such as halos, starburst, glare and double images, at baseline, 43% in the PROWL-1 study and 46% in the PROWL-2 study reported a new symptom at 3 months. This highlights the need to counsel patients about the possibility of developing new symptoms after LASIK surgery. “[P]atients should be adequately informed about the potential risks of developing dry eye symptoms, even if they are asymptomatic preoperatively,” the study further specifies.
Allison Shuren
On the postoperative end, the study may serve as a valuable medical malpractice risk management tool. The PROWL questionnaire is now a publicly available means of assessing patients’ visual and ocular systems and satisfaction. “A better understanding of the patients’ perceptions following this procedure will lead to better outcomes and will provide better information for informed consent to patients considering LASIK surgery,” the study concludes. A better understanding of patients’ perceptions will also, however, allow physicians to provide better follow-up care and importantly document the patient’s experience in their own words. This, in turn, may eschew unsubstantiated malpractice claims, clarify discrepancies in reported symptoms, and avoid unexpected malpractice claims, especially in light of the study’s finding that “patients were more likely to report visual and ocular symptoms on an online questionnaire than to their health care professional.”
For more information:
Bethan Jones can be reached at bethan.jones@aporter.com.
Allison W. Shuren, MSN, JD, a partner at Arnold & Porter LLP, can be reached at allison.shuren@aporter.com.