Fulfilling a duty
Fulfilling a duty
Doctors have ethical obligation to inform patients
Emphysema patients who wish to participate in a study of the lung volume reduction procedure can be considered by obtaining a referral from their physician to one of the participating centers or by calling the patient coordinator at the nearest participating center.
However, before deciding to pursue this course, patients should be informed about the requirements of the study and the limitations of the procedure, says Robert Keenan, MD, vice chief of cardio-thoracic surgery at the University of Pittsburgh, and that center's principal investigator for the National Emphysema Treatment Trial (NETT). NETT is cosponsored by the Health Care Financing Administration and the National Institutes of Health.
First, says Keenan, patients must understand that the surgery, if they receive it, is not a cure. The procedure typically involves removal of between 20% to 30% of each lung, and there are no data indicating that it will extend the life of the patient, just that it may make him or her more comfortable.
"The surgical procedure itself is fundamentally a quality of life procedure," he says. "I used to tell patients it was our version of cosmetic surgery. I can't claim you'll live longer, nobody can."
In addition, "there are a whole set of inclusion and exclusion criteria," Keenan adds. Basically, to be considered for participation in both the NETT trial or the separate Overholt-Blue Cross Emphysema Surgery Trial (OBEST), patients must have a confirmed diagnosis of severe emphysema, but without any significant comorbidities, such as cancer or heart disease that would impair treatment.
Patients with other complications related to their emphysema, such as severe pulmonary hypertension or severe retention of carbon monoxide, will also be excluded from the NETT trial, says Keenan.
For the OBEST trial, patients must also be younger than age 75, with a need to be on maximum medical therapy according to specific guidelines, says Anthony Gray, MD, a pulmonologist with the Lahey Clinic in Brookline, MA, who is a co-investigator with the clinic's arm of the trial. These patients must also have no significant co-morbidities and must have appropriate insurance, either Blue Cross of Harvard-Pilgrim.
The decision to include patients in the study is left up to the individual center, adds Keenan. There may be patients who meet all the inclusion criteria, have none of the exclusion criteria, but the coordinator or surgeon may decide that the patient would not be a good study subject for other reasons. The centers have the right to not include these patients in the study.
Most importantly, patients must understand the study design and the process of randomization, say Gray and Keenan. At each center, the patient is given thorough preparation for participating in the study. Prior to inclusion, the principal investigators and patient coordinator talk to the patient to ensure they understand the process. They are then asked to sign a consent form, acknowledging they understand the study and agree to be randomized. There is always concern, however, that patients enter the study expecting to receive surgery.
"It is out of everybody's hands," Keenan explains. "Once you are in the trial, you are randomized to get the surgery or medical management."
Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.