Am. J. Respir. Crit. Care Med., Vol 153, No. 4, Apr 1996, 1208-1213.
Health-care technology assessment of surgical procedures: the case of reduction pneumoplasty for emphysema
GL Snider
Medical Service, Boston VA Medical Center, MA 02130, USA.
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.
