Article Date: 7/1/2004

standard of care
Examining The Standards of Care
This article discusses how standards develop and what optometrists can do to hit these unclear targets.
BY IAN BEN GADDIE, O.D., F.A.A.O., Louisville, Ky.

What's the "standard of care" for any given clinical management situation and who determines the thresholds of that standard? Interestingly, few of us are clear on those standards until an engagement on the witness stand reminds us. I'll discuss how standards of care come to be and what we can do to follow them.

The standards' purpose

Standards of care are the legal basis for malpractice suits and the courts use them to determine negligence. Managing a patient in a manner similar to other like practitioners in a community upholds the standard of care. According to John Classe, O.D., J.D., when negligence is at issue, the question the courts ask is, "What would a reasonable person have done under the same or similar circumstances?"

An even more pressing question is, "Can our neat little standards of care keep up with the huge strides technology is making in the eyecare world?"

Past and current standards

The technology of pachymetry has been in place since at least 1980. Although it was important for radial keratotomy and LASIK, it has taken on a whole new role in managing ocular hypertension and glaucoma since the release of the Ocular Hypertension Treatment Study (OHTS) results in 2002.

Many practitioners contend that pachymetry is the standard of care for determining the accuracy of the IOP measurement and that this measurement is flawed without adjusting for corneal thickness. However, the majority of private insurers don't yet reimburse for this technology. Ditto for the scanning laser devices used to manage glaucoma and retinal diseases.

While we're on the subject of the OHTS, how many of you were inundated with pharmaceutical sales reps who were eager to tell you that treating all ocular hypertensives was now the standard of care?

As it turns out, a closer look at the data revealed that only patients who have certain baseline characteristics (e.g., thin corneas, higher IOP, increased vertical cup-to-disc ratios and higher pattern standard deviations on visual field testing) were much more likely to develop glaucoma and therefore required treatment to reduce their pressure. Patients in the OHTS who didn't have those baseline tendencies didn't develop glaucoma. Therefore, it may become the standard of care not to treat ocular hypertensives who don't exhibit these baseline characteristics.

One new technology that has been getting much press regarding standards of care is Optos's Optomap Retinal Exam. Just when you thought everyone had reached a consensus about the need for routine dilated eye exams, a new device enters the arena that can image almost the entire retina without dilation. Is this technology an exception to the standard of care? What happens if a doctor misses a retinal tear or tumor and the only procedure he performed was using the Optomap?

We can all certainly miss pathology with our indirect ophthalmoscope. Which doctor is more culpable for missing retinal pathology: The doctor who misses it with the binocular indirect ophthalmoscope or the doctor who misses it with the Optomap? To my knowledge, a court has yet to make a judgment in a situation such as this. Unfortunately, negligence is often the catalyst for establishing the standard of care.

Pharmaceutical standards

Consider the rapid development of new pharmaceuticals to treat eye disease. Although they aren't FDA approved for corneal ulcers, the standard of care for treating infectious keratitis has evolved from fortified multi-agent antibiotics to the use of fourth-generation fluoroquinolones. In 2000, a significant number of eyecare practitioners still considered topical beta-blockers the standard of care when treating a newly diagnosed case of glaucoma, barring any contraindications. Now you'd have a difficult time arguing that the prostaglandin drugs aren't first-line preferred therapy.

Go to the guidelines

The American Optometric Association's (AOA's) Clinical Practice Guidelines, which you can view at, serve as an example of the minimum competencies required to manage any array of clinical situations. The development of the guidelines was a huge undertaking and we should commend the AOA for its efforts in determining common ground for the optometric profession.

Even though the AOA revised most of the guidelines over the past two years, there is still little direction given in the clinical recommendation for new technologies in routine practice. Look at the AOA guidelines on primary open-angle glaucoma, for example. Although mention is made of the newer scanning laser diagnostic devices, the guidelines preclude routine use and delegate it's use to experimental or research-based.

In its recent position paper, the American Academy of Ophthalmology also regards this technology as experimental. At this time, I think you'd find that most eyecare providers who treat glaucoma use one of these devices. The same AOA guidelines released in 2002 mention that corneal thickness does have some impact on the measurement of IOP, but not enough to justify adjusting or changing management decisions in clinical practice. It took just one study (OHTS) to change that notion.

Under the influence

We should all be concerned about the role that the ophthalmic industry plays in shaping our opinions of technology and the standard of care. It's obvious that the ophthalmic industry has an influence on the standard of care. Huge profits stand to be made if some governing body can establish a particular device, drug or procedure as the standard of care. The point is, who really defines the standard of care, and how do they disseminate this information to the rank-and-file clinician?

Leaving the past behind

Ten years ago, the definition of prudent or due care wasn't difficult to grasp. We'll remember the past decade as a time of rapid technological advancement and change in general. Standards of care aren't static, and time will dictate a more rigid set of expectations, which encompass the great strides in technology. We must continue to train optometrists to the highest scope so that we may best use our inherent skills and training. It's our responsibility to maintain these skills and to embrace potential technology so as to better serve our patients.

Dr. Gaddie completed a residency in ocular disease and a fellowship in glaucoma and laser therapy at the Northeastern State University College of Optometry, where he remains on the adjunct faculty. He's a frequent author and lecturer in the areas of ocular disease, glaucoma and new technologies.



Optometric Management, Issue: July 2004