REVISITING AN SMDM CALL FOR SHARED DECISION-MAKING IN ADVANCED HEART FAILURE

Purpose: In 2012, SMDM endorsed a call to develop shared decision-making and patient-centered care in advanced heart failure. This statement rightly designates informed consent as the “embodiment” of autonomy, however this publication moves past the consent process of potential treatment options without a critical appraisal of current consent standards, which serve as the foundation for any attempt at shared/patient-centered decision-making. The study evaluates a sample of Left Ventricular Assist Device (LVAD) consent forms (CFs) to assess for compliance standards and other usability considerations.  

Method: LVAD CFs were collected from US LVAD programs paired with transplant centers. A rubric was developed to analyze CFs based on universally accepted standards published by the American College of Surgeons (ACS) to assess CF content, including purpose of LVAD, benefits, risks (surgical, short, & long-term), and considerations for alternative therapies. Content standards were rated as missing, incomplete, or complete by the consensus of three researchers. Standards suggested by AHRQ were also used to assess syntax and layout. Syntax was objectively evaluated for readability using the Flesch-Kincaid Formula.

Result: 19 CFs representing all UNOS regions were analyzed. Considering universally accepted ACS standards: 13 (68%) completely discussed LVAD purpose; 13 completely described expected benefits; 17 (90%) completely described surgical risks, 10 (53%) completely described short-term risks, and 7 (37%) completely described long-term risks; 6 (32%) completely listed reasonable alternatives, with 1 (5%) completely discussing the benefits of those alternatives and 3 (16%) completely discussing the risks of those alternatives. Considering AHRQ suggested standards: 1 met the criteria of 8th grade reading level or lower. 

Conclusion: No consent form (0%) out of 19 met all CF standards circulated by the ACS. Almost a third of CFs did not discuss the purpose of LVAD implant strategy, which may confuse patients on whether or not they are considering lifelong LVAD therapy. Discussion regarding LVAD benefits focuses on increasing life expectancy and greater "quality of life" without defining said term. Discussion of alternatives skirted around the topic of death, removing exploration of palliative and supportive care. Most CFs are written far beyond the 8th grade level, creating an unusable document for patients with varying degrees of vascular dementia. Clinicians in advanced heart failure must resolve these systemic issues to ensure a foundation exists for shared and patient-centered decision-making going forward.