Mayo proposes lung surgery indicators

Mayo Clinic (Rochester, Minnesota) surgeons have proposed a system of lung surgery quality indicators for surgeons and the public as a method to demonstrate best practices for obtaining positive patient outcomes.

Mayo surgeons believe the process is necessary because no other method currently exists to measure the quality of care received by patients undergoing lung surgery.

Death rates following surgery are reported. However, because they aren't adjusted for factors such as patient age and disease severity, they don't tell the whole story. To overcome this lack of risk adjustment in death rate data, the Mayo Clinic team proposed patient-centered processes that should occur prior to, during and after surgery to assure the likelihood of best surgical outcomes.

"There are certain processes that we can measure and report that clearly indicate whether a patient has received high-quality care around the time of their lung operation," said Stephen Cassivi, MD, Mayo Clinic thoracic surgeon.

Cassivi presented a list of proposed patient-centered quality indicators for lung surgery at the 43rd annual meeting of the Society of Thoracic Surgeons (STS; Chicago) last week in San Diego.

"Knowing this data can help the patient decide about the care they are about to receive and where to go to receive that care — and equally important, this knowledge can help chest surgery programs improve their quality of care by concentrating on identified weaknesses," Cassivi said. "Creating standards through measures of process will allow for directed quality improvement initiatives across all surgical centers."

To find the clearest and most meaningful measures to evaluate lung surgery quality, the Mayo Clinic team analyzed the care of 606 lung surgery patients who underwent 628 lung surgeries at Mayo Clinic during one year. The patients' average age was 65.8 years and ranged from 2 to 93 years.

From the analysis, the following list emerged for processes that should occur prior to surgery because of their potential contribution to positive patient outcomes.

• Pulmonary function testing
• Electrocardiogram
• Smoking history documented
• Smoking cessation therapy offered to those patients still smoking prior to surgery
• Appropriate preoperative staging of cancer

The Mayo Clinic will work to formalize its proposal with the STS. Adopting these quality process measures as standards and compiling data regarding adherence to these standards could be accomplished using the Society of Thoracic Surgeons national general thoracic surgery database.

Baush & Lomb files 2005 10-K

Baush & Lomb (Rochester, New York) filed its annual report on form 10-K for the year ended Dec. 31, 2005, with the Securities and Exchange Commission following the completion of its previously reported restatement of financial results. As detailed in the filing, the restatement reflects adjustments that correct for errors or departures from generally accepted accounting principles. The filing of the 2005 10-K brings the company into compliance with the annual reporting conditions for continued trading on the New York Stock Exchange, although the company will remain on the NYSE's late filer list until such time as it files its delayed Forms 10-Q for the third quarter of 2005 and the first three quarters of 2006.

"The restatement process took longer than we had expected, primarily due to having to analyze amounts associated with the highly technical and complex area of accounting for taxes in a number of jurisdictions around the world, and over a period of several years," said Bausch & Lomb's chairman and CEO Ronald Zarrella. "With the extensive and thorough restatement process complete, we can now move forward, fully focusing our energies on building new momentum in each of our businesses, starting with delivering against our operating objectives for 2007."

Bausch & Lomb is working to finalize and file its 2006 Form 10-K, which will be followed by the filing of its outstanding Quarterly Reports on Form 10-Q. While the company is working diligently to complete those filings, there can be no assurance as to when it will be current in its reporting obligations, it said. In any event, the company intends to provide investors with information about the results of 2006 operations around the end of February.

CytoCore readies for upgraded Pap device

CytoCore (Chicago), a late-stage bio-scientific research company advancing tools and testing for the early detection and diagnosis of deadly reproductive cancers, said it is ready to start making its cutting-edge e2 Collector sample retrieval device.

With a prototype model and engineering design refined through a thorough manufacturing development process, CytoCore is ready this month to start production on the e2 Collector for clinical testing, FDA review and subsequent distribution worldwide, the company said. According to CytoCore, the sample-collecting device's handle and balloon disposable component offer "excellent performance comparison and distinct patient comfort improvement over the brush-and-spatula method currently used by doctors in taking routine Pap samples for the early screening of cervical cancer."

The company's immediate focus will be on a clinical trial, which should be completed within 90 days, with FDA review to follow shortly afterward and sales and distribution agreements anticipated both within the U.S. and abroad, CytoCore said.

The first significant upgrade to the Pap test in 50 years, the e2 Collector is a small disposable balloon device designed to enhance the thoroughness and consistency of cell collections for the Pap smear and HPV test screenings performed annually on some 180 million women worldwide, the company said. The e2 Collector is designed to significantly improve both the patient's comfort and physician's confidence in the collection procedure.

CytoCore develops cost-effective cancer screening systems, which can be utilized in a laboratory or at the point-of-care, to assist in the early detection of cervical, endometrial, and other cancers.

Very briefly . . .

• Revolutions Medical (Mount Pleasant, South Carolina) reported an agreement with Strategic Product Development, which will provide FDA regulatory compliance, manufacturing management capabilities and ongoing product development. Revolutions Medical operates in the safety-engineered medical devices arena.

• JMAR Technologies (San Diego), a developer of advanced laser, high-resolution imaging and photonics technologies, said it has retained CEOcast as its investor relations firm. CEOcast will lead a program designed to increase awareness of the company among individual and institutional investors. JMAR Technologies develops laser-based technology and X-ray processes for nano-scale imaging, analysis and fabrication.