An Expert Consensus Study for Informed Consent in Primary Breast Augmentation Surgery.

BACKGROUND

What constitutes adequate information for decision-making and informed consent is a practical question appropriately answered with deference to expertise.

OBJECTIVES

The aims of this study were: (1) to establish consensus on a procedure-specific core information set of essential informed consent information by relevant medical experts for primary breast augmentation surgery; and (2) to define from the clinical perspective the data source and imminence elements of evidence-based risk communication.

METHODS

The study followed a modified Delphi expert consensus model. Active members of The Aesthetic Society were identified as the relevant clinician experts and were recruited by email. Survey round 1 was informed by a scoping review of the relevant scientific and gray literature. Round 2 was informed by the initial survey round. Consensus was defined a priori as a 75% majority rating.

RESULTS

Expert consensus of essential information was achieved for 16 risk items, 1 risk factor, and 8 expectations-including benefits and burdens-along with clarification of clinically appropriate options to present to all patients considering primary implant-based breast augmentation surgery. A basic, procedure-specific, structure for evidence-based risk data is also described.

CONCLUSIONS

This paper reports results for the first phase of a larger pilot study aiming to develop a patient decision aid to replace traditional informed consent documents for the specified procedure. Implications for practice are encouraging in terms of reducing unwanted variation in disclosure practices and information overload.