by Spronk, Pauline E. R.; Begum, Husna; Vishwanath, Swarna;
Crosbie, Andy; Earnest, Arul; Elder, Elisabeth; Lumenta, David B.;
Marinac-Dabic, Danica; Moore, Colin C. M.; Mureau, Marc A. M.; Perks, Graeme;
Pusic, Andrea L.; Stark, Birgit; von Fritschen, Uwe; Klein, Howard; Cooter,
Rodney D.; Rakhorst, Hinne A.; Hopper, Ingrid
Plastic and
Reconstructive Surgery: August 2020 -
Volume 146 - Issue 2 - p 255-267
Background:
The Poly Implant Prothèse incident and breast
implant-associated anaplastic large cell lymphoma have pointed to the need for
uniform registries for breast implants as key features to monitoring the
outcomes of breast implant surgeries internationally. The purpose of this study
was to identify and harmonize common data elements collected by breast implant
registries across the International Collaboration of Breast Registry Activities
(ICOBRA) global consortium.
Methods:
The authors convened an international group of surgeons,
consumers, nurses, registry experts, and regulators to review the data points.
A modified Delphi approach was applied, to rate the importance of each point on
a six-point Likert scale.
Results:
Data points from six national breast implant registries were
divided into categories: clinical, implant-related, patient-reported findings;
operation details and implanting technique details; patient characteristics;
unique device identifiers; unique patient identifiers; and clinical demographics.
A total of 52 data points collected by over 33 percent of national registries
were identified. After five rounds, 34 data points formed the final set with
agreed definitions. The group recognized the critical importance of additional
elements that are currently not uniformly collected (e.g., patient-reported
outcomes and long-term data) and set out the process for the dynamic global set
updates driven by evidence gaps.
Conclusions:
The authors defined internationally agreed on common data
elements and definitions used in breast implant registries. This collaboration
will allow data sets to be combined, enabling an effective global early warning
system of implant-related problems and further work on data sets.
