October 07, 2003
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Surgeon points to limitations of knowledge from glaucoma studies

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PHILADELPHIA — More rigorous science is needed to improve the results of ophthalmic research, according to a surgeon here who addressed the limitations of clinical studies.

William Steinmann, MD, MSc, said that only 20.3% of evidence used to manage glaucoma has been derived from randomized, controlled trials (RCTs). The rest of the information is garnered from case reports, case series, cross-sectional studies, case-control studies, cohort studies and controlled non-randomized trials; “expert opinion” is also widely used, Dr. Steinmann said.

Even RCTs are fraught with limitation, he cautioned attendees of a meeting celebrating the 40th anniversary of the Wills Eye Hospital glaucoma fellowship program.

"I wouldn’t discount the evidence [of RCTs] but I would emphasize that they need to be well-done," he said. "The validity of the results can be compromised by the methodology."

He noted that large RCTs can cost tens of millions of dollars to conduct, and that funding sources, often in industry, may set limits on the endpoints of the studies.

Dr. Steinmann also questioned whether clinical trials, with their strict and narrow entrance criteria, can produce information that can be generalized to the population at large. He added that statistics cannot answer important questions about quality of life and how to deliver health care to people who need it.

Dr. Steinmann also noted that few published studies include all of the information necessary to objectively evaluate them. For example, he said, only 35% of studies revealed whether investigators had been masked, 53% included subject eligibility and 21% included a confidence interval.

"Let’s raise our level of criteria for accepting papers for publication," he said. "I think we need to practice evidence-based ophthalmology. You as practitioners have to practice it."