Outcome studies yield better care

January 1, 2011

The lack of randomized, controlled clinical trials of blepharoplasty and ptosis repair leaves oculoplastics open to challenge for reliance on anecdotal evidence of the efficacy of common surgical procedures.

Chicago-The lack of randomized, controlled clinical trials of blepharoplasty and ptosis repair leaves oculoplastics open to challenge for reliance on anecdotal evidence of the efficacy of common surgical procedures.

Rigorous outcomes studies are needed to show that these procedures help patients and also will strengthen the position of oculoplastic surgeons in a cost-conscious, competitive market, according to Elizabeth A. Bradley, MD.

"Completing these studies will allow us to provide the highest-quality patient care and demonstrate that our services provide good health-care value," said Dr. Bradley during a review of the state of the evidence for blepharoplasty and ptosis repair. She presented a keynote lecture at the inaugural oculofacial plastic surgery subspecialty day during the annual meeting of the American Academy of Ophthalmology.

Some oculoplastic surgeons question the need for outcomes research studies, since they perform blepharoplasty and ptosis surgery nearly every day and can verify that patients look better and have improved vision. Dr. Bradley responds that outcomes studies address two primary needs. One is to fulfill the physician's responsibility to provide the best possible care to patients by performing surgeries that are efficacious and safe. The second is to enable physicians to continue earning a living.

"In a time of cost containment and evidence-based medicine, payers, policy makers, and even patients are demanding better data," said Dr. Bradley, assistant professor of ophthalmology, Mayo Clinic, Rochester, MN. "Simply put, no outcomes means no income."

Steps are being taken to develop the necessary data on clinical outcomes and quality of life. For example, an evidence-based review of blepharoplasty and ptosis surgery in adults recently was completed and will be published in 2011. The literature retrieval for this review yielded more than 1,000 references, but most were excluded for irrelevancy or methodological flaws. Most of the remainder reported margin reflex distance, rather than a more clinically relevant outcome, as their primary outcome measure. Only 13 references were relevant to some functional outcome, while a few showed a correlation between the severity of ptosis and loss of peripheral visual field. A single study showed improved quality of life after ptosis surgery. There were no randomized, controlled clinical trials.

Other studies have relied on retrospective case series data to assess the safety of blepharoplasty-ptosis surgery. These data showed that the reoperation rate was typically 5% to 10%, postoperative dry eye occurred in 10% to 20% of cases, and hemorrhage and infection were more rare. There were no prospective studies, nor were there any data on cost effectiveness.

Addressing the financial implications of the lack of outcomes data, Dr. Bradley noted that the cost of blepharoplasty and ptosis surgery is estimated to approach $600 million in 2011. However, oculoplastic surgeons already are seeing some incursions in health-care dollars directed toward their specialty due to recent cuts in Medicare reimbursement through bundling of codes. Also, of 175 total quality measures approved in Medicare's Physician Quality Reporting Initiative, there is not a single oculoplastic-specific measure. Without a database, Dr. Bradley said, oculoplastics has been unable to move its quality measures toward acceptance.

The way forward

She suggested that the way forward is to undertake randomized control trials to show efficacy, establish national surgical registries to show patient safety, and conduct cost effectiveness studies to show value. Although there are obstacles to completing these studies, specialties such as cardiology, obstetrics and gynecology, and orthopedic surgery have shown that randomized trials of elective procedures can be successfully performed.

Based on what has been learned from other disciplines, leaders in oculoplastics have devised a plan for moving toward improved patient outcomes. Besides the evidence-based review, one development is the formation of an ophthalmic plastic and orbital surgery investigator network, established with the support of the American Society of Ophthalmic Plastic and Reconstructive Surgery (ASOPRS) executive committee. The network has four goals:

Four additional areas of focus are eyelid malposition, eyelid and orbital oncology, lacrimal disorders, and nonthyroid orbital inflammation.

The next steps for this research network are to establish disease registries-a goal supported by the ASOPRS Foundation, to define the questions to be answered in each of their core fields of interest, to define the data elements that would be included in a registry, to design and test a case report form, and to begin enrolling patients.

fyiElizabeth A. Bradley, MD
E-mail: bradley.elizabeth@mayo.edu

Dr. Bradley does not have any financial disclosures.