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  • Adult Deformity Surgery (ASD) Patients Recall Fewer than 50% of the Risks Discussed in the Informed Consent Process Preoperatively and the Recall Rate Worsens Significantly in the Postoperative Period

    Final Number:

    Rajiv Saigal MD PhD; Aaron Clark MD PhD; Justin Scheer; Justin Smith MD PhD; Shay Bess MD; Praveen Mummaneni MD; Ian McCarthy PhD; Robert Hart MD; Khaled Kebaish MD; Eric Klineberg MD; Vedat Deviren MD; Frank Schwab MD PhD; Christopher Shaffrey MD FACS; Christopher Ames MD; ISSG

    Study Design:
    Clinical Trial

    Subject Category:

    Meeting: Congress of Neurological Surgeons 2013 Annual Meeting

    Introduction: Complication rates in ASD are high. Although informed consent is standard, there is a paucity of data to assess retention. Patients who experience complications may claim they were never informed of the risks simply because they cannot recall them. The goal of this study was to objectively quantitate retention of key portions of the consent process.

    Methods: Patients having ASD surgery underwent standard surgeon guided informed consent followed by watching a 20min video detailing 11 complications. At preop, hospital discharge, 6wks, and 3 and 6mos post-op, patients completed a quiz assessing recall of the 11 complications and rating of both the commonality and severity of each complication: 0(minor)–10(very severe). Patients were also scored on a 16 point mini-mental status exam (MMSE-BV).

    Results: 30 patients (median age=60.5yrs [range=26-83)]). Immediate preoperative recall after video viewing was 41%. Postoperative recall (vs preop) was worse on discharge (23%, p<0.001), 6wks (21%, p<0.001) and 6mos (20%, p=0.004). Preoperative MMSE-BV was 15, discharge (14), postop visit (15), and 6mos (15). Patients rated the process important (10, scale 0-10) and the video helpful (9). Patient severity scores were lower than surgeons for need for additional surgery, medical complications, new weakness, blindness, and death (all p<0.05). Patient severity scores were higher than surgeons for transfusion and CSF leak (all p<0.05). There was no association at any postoperative timepoint between recall and the following: subjective severity score, prior spinal surgery, ICU stay, total hospital stay, ASA class, MMSE-2 and postoperative complications (p>0.5).

    Conclusions: Patients feel the informed consent process is important, but their recall of key risks remains poor and declines over time, despite video augmentation. Significant progress remains to improve informed consent retention. Despite being well informed in an augmented informed consent process, patients cannot recall most surgical risks discussed.

    Patient Care: Improve our understanding of surgical treatment for adults with spinal deformity.

    Learning Objectives: By the conclusion of this session, participants should be able to: (1) Understand the importance of the informed consent process; (2) Appreciate that patients have limited recall of key risks associated with surgical treatment of adult spinal deformity and that this recall declines over the post-operative follow-up; (3) Appreciate the need for improvements in the informed consent process.


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