Health-care technology assessment of surgical procedures: the case of reduction pneumoplasty for emphysema.
End-stage chronic obstructive pulmonary disease (COPD) is frequent in the practice of pulmonology. The recent report that reduction pneumoplasty results in lung function improvement in a high proportion of patients with emphysema has raised the question of how effectively the medical profession assesses the efficacy of new surgical procedures. Unlike drugs and devices, the introduction of new surgical procedures is not regulated. Technique changes rapidly for a period of time after new procedures are introduced. Peer review is done mainly by quality-improvement activities in the surgeon's hospital and by publication in peer-reviewed journals. Randomized clinical trials (RCT) are procedurally and ethically difficult to do and few have been done for new surgical procedures. Some trials have been problematic. For example, a controlled cooperative trial of radial keratotomy resulted in unsuccessful antitrust suits brought by physicians and patients alleging that third-party payers would not reimburse them for surgery. RCTs that have been done have tended to be reported long after the procedure has been incorporated into surgical practice. A RCT of reduction pneumoplasty would be impossible at this time because of rapid flux in surgical techniques. There might also be ethical problems because of the substantial improvement in lung function of many patients in the existing case series, a level of improvement seen with no other treatment than lung transplantation. It is proposed that a prospective, cooperative, consecutive-case, observational study (registry) of reduction pneumoplasty for emphysema could greatly speed the acquisition of information about the efficacy of this new procedure.
Snider
G L
GL
Medical Service, Boston VA Medical Center, MA 02130, USA.
D006801:Humans; D008168:Lung / Q000601:surgery*; D011656:Pulmonary Emphysema / Q000503:physiopathology / Q000601:surgery*; D016032:Randomized Controlled Trials as Topic; D012042:Registries; D013673:Technology Assessment, Biomedical