Reporting guidelines: another perspective.

Abstract

The following data are required when reporting results of a procedure for occlusive disease of the lower limb: (1) PREOPERATIVE PATIENT ASSESSMENT: This should include age, sex, diabetes, smoking habit, whether the ischemic symptoms are at rest or after exercise, and the resting ankle or toe pressure. (2) INTENTION TO TREAT: This should be stated as a percentage of the number of procedures that actually were properly performed against the number of procedures scheduled. Only those procedures that were performed should be subsequently analyzed. (3) ACUTE RESULTS: This is assessed by an imaging technique, such as angiography or duplex ultrasound, and defined in terms of patency and degree of maximal stenosis in the area treated and 5 cm on either side. Change in symptoms, complications, and ankle pressures should be reported but are not criteria for procedural success or failure. The assessment should be done from 10 to 30 days following the procedure. (4) LONG-TERM RESULTS: As assessed by appropriate imaging techniques, outcome should be reported in terms of primary, assisted primary, and secondary patency. The degree of maximal stenosis in the treated segments and 5 cm on either side should be stated. The surveillance intervals would depend on the answers being sought in the follow-up period, but the minimum would be an annual review. Three-year results are required to give an adequate assessment of the durability of a procedure. (5) REPORTING: Life-table analysis should be used to present the data on patencies and the degree of stenosis.