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Discerning quality: an analysis of informed consent documents for common cardiovascular procedures
  1. Andi Shahu1,
  2. Jennifer Schwartz2,
  3. Mallory Perez1,
  4. Susannah M Bernheim2,
  5. Harlan M Krumholz2,3,
  6. Erica S Spatz2,3
  1. 1Yale University School of Medicine, New Haven, Connecticut, USA
  2. 2Center for Outcomes & Evaluation (CORE), Yale New Haven Health, New Haven, Connecticut, USA
  3. 3Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, USA
  1. Correspondence to Andi Shahu, Yale University School of Medicine, New Haven, CT 06510, USA; andi.shahu{at}

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Informed consent provides a powerful opportunity to build trust between the patient and clinician while supporting patient autonomy, transparency and shared decision-making.1 ,2 However, it is often relegated to a perfunctory task, performed as an ethical-legal formality minutes prior to a procedure.3–5 As such, basic elements necessary for achieving the espoused goals of informed consent may be missing or suboptimally implemented, undermining patient-centred, high-quality decision-making. The types and extent of gaps in quality have not been systematically studied, limiting efforts to improve implementation. Our aim was to assess variation in quality of informed consent documents associated with three commonly performed cardiovascular procedures: left heart catheterisation, transesophageal echocardiography and implantation of a cardioverter defibrillator. We focused on basic elements of consent documents with the goal of illuminating opportunities to establish minimum standards for informed consent.


Between 1 April and 30 June 2014, we conducted a medical chart review of informed consent documents associated with three electively performed cardiovascular procedures performed at a large, urban hospital: left heart catheterisations (not associated with acute coronary syndrome or in the context of another acute illness; n=79), transesophageal echocardiography (n=39) and implantation of a cardioverter defibrillator (n=36). We developed an abstraction tool to rate basic components of consent documents that a reasonable patient would deem important for decision-making, derived from reliable sources that patients could access on the internet. The final tool assessed presentation (legibility of handwritten information, assessed subjectively as ‘legible’, ‘barely …

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  • Twitter Follow Erica Spatz at @SpatzErica and Andi Shahu at @andishahu

  • Contributors AS and ESS had full access to the data and take responsibility for the accuracy of the data analysis and interpretation of findings.

  • Funding ESS is supported by grant K12HS023000 from the Agency for Healthcare Research and Quality Patient Centered Outcomes Research Institutional Mentored Career Development Program. HMK is supported by grant U01 HL105270-05 (Center for Cardiovascular Outcomes Research at Yale University) from the National Heart, Lung, and Blood Institute.

  • Competing interests ESS, JS, SMB, HMK and MP report receiving support from the Centers for Medicare and Medicaid Services to develop and maintain performance measures that are used in public reporting programmes; they are currently developing a measure of informed consent document quality. HMK is a recipient of research agreements from Medtronic and from Johnson & Johnson (Janssen), through Yale University, to develop methods of clinical trial data sharing and chairs a cardiac scientific advisory board for UnitedHealth.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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