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

Aesthet Surg J. 2021 Mar 12;41(4):NP162-NP176. doi: 10.1093/asj/sjaa341.

Abstract

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.

MeSH terms

  • Consensus
  • Delphi Technique
  • Disclosure
  • Humans
  • Informed Consent*
  • Mammaplasty* / adverse effects
  • Pilot Projects