Novel Approach for Maximizing Follow-Up in Cosmetic Surgery Clinical Trials: The Ideal Implant Core Trial Experience.

BACKGROUND: High follow-up rates are critical for robust research with minimal bias, and are particularly important for breast implant Core Studies seeking U.S. Food and Drug Administration approval. The Core Study for IDEAL IMPLANT, the most recently U.S. Food and Drug Administration-approved breast implant, used a novel incentive payment model to achieve higher follow-up rates than in previous breast implant trials.

METHODS: At enrollment, $3500 was deposited into an independent, irrevocable trust for each of the 502 subjects and invested in a diversified portfolio. If a follow-up visit is missed, the subject is exited from the study and compensated for completed visits, but the remainder of her share of the funds stay in the trust. At the conclusion of the 10-year study, the trust will be divided among those subjects who completed all required follow-up visits. For primary and revision augmentation cohorts, the U.S. Food and Drug Administration published follow-up rates from Core Studies were compared for all currently available breast implants.

RESULTS: Five-year follow-up rates for the IDEAL IMPLANT Core Study are higher for both primary augmentation and revision augmentation cohorts (94.9 percent and 96.7 percent, respectively) when compared to all other trials that have used U.S. Food and Drug Administration standardized follow-up reporting (MemoryShape, Allergan 410, and Sientra Core Studies).

CONCLUSIONS: This trial demonstrates the utility of a novel incentive strategy to maximize follow-up in cosmetic surgery patients. This strategy may benefit future cosmetic surgery trials and perhaps any prospective research trial by providing more complete data.

CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.