367 - Retention of Key Portions of Informed Consent in the Adult Deformity P...

#367 Retention of Key Portions of Informed Consent in the Adult Deformity Patient; Interim Report of a Prospective Study

General Session: Best Papers Session 2

Presented by: A. Clark

Author(s):

A.J. Clark (1)
J.K. Scheer (1)
C.I. Shaffrey (2)
J.S. Smith (2)
S. Bess (3)
P.V. Mummaneni (1)
I. McCarthy (4)
R. Hart (5)
M.F. O'Brien (6)
R.A. Hostin (6)
K.M. Kebaish (7)
E.O. Klineberg (8)
M. Gupta (8)
C.M. Li (1)
V. Lafage (9)
V. Deviren (1)0, F. Schwab (9)
C.P. Ames (1)
International Spine Study Group

(1) UCSF, Neurosurgery, San Francisco, CA, USA
(2) University of Virginia, Neurosurgery, Charlottesville, VA, USA
(3) Rocky Mountain Hospital for Children, Orthopaedic Surgery, Denver, CO, USA
(4) Baylor Health Care System, Institute for Health Care Research and Improvement, Houston, TX, USA
(5) Oregon Health and Science University, Orthopaedic Surgery, Portland, OR, USA
(6) Baylor Scoliosis Center, Orthopaedic Surgery, Houston, TX, USA
(7) Johns Hopkins University, Orthopaedic Surgery, Baltimore, MD, USA
(8) University of California, Davis, Orthopaedic Surgery, Sacramento, CA, USA
(9) NYU Hospital for Joint Diseases Spine Center, Orthopaedic Surgery, New York, NY, USA
(1) 0UCSF, Orthopaedic Surgery, San Francisco, CA, USA

Abstract

Objective: Studies show patients poorly retain information conveyed during standard informed consent processes. We designed a prospective study to assess retention of the informed consent components in adults undergoing spinal deformity surgery employing the standard informed consent process supplemented by a detailed video of risks and occurrence percentages.

Methods: Adult patients undergoing spinal deformity surgery at UCSF were eligible. In pre-operative clinic, patients underwent the standard informed consent discussion and also watched a 20 minute video detailing 11 complications; infection, new/worse pain, additional surgery required, medical complications, new weakness, positioning-related complications, instrumentation malposition, CSF leak, transfusion need, blindness, and death. Pre-operatively, at hospital discharge, and six weeks post-operatively, patients took a short quiz assessing recall of the 11 complications and underwent mini-mental status exam (MMSE-2). Patients then subjectively rated both the commonality and severity of each complication (scale 0-10). The association between continuous variables and complication recall were compared by linear regression, categorical variables by analysis of variance.

Results: 14 patients enrolled during the study period. Median age was 59 years (range 31-73). Eight (57%) were female. Two underwent cervical deformity procedures. Of the remainder, six were instrumented up to the thoracolumbar area and six up to the upper thoracic area. Overall, patients felt the informed consent process was important (median 8.5; scale 0-10) and the video was helpful (median 9.5). Patients felt that bleeding requiring transfusion was the most severe complication (median 7.5) while blindness was the least (median 2). New weakness (median 4) was considered more severe than blindness but less than death (median 5.5). Median pre-operative MMSE-2 was 15, 14 on discharge, and 15 at post-operative visit. Recall pre-operatively after video viewing was 47%. Recall on discharge was worse (28%, p=0.005). Recall six weeks after surgery was worse, but not significant (19%, p=0.15). There was no association between subjective severity score and recall pre-operatively or at discharge (p=0.81, 0.52, respectively). There was no correlation between age and pre-operative recall, on hospital discharge, or at six weeks (p=0.41, 0.29, 0.51, respectively). Prior spinal surgery was not associated with recall at the three time points (p=0.62, 0.74, 0.20, respectively). There was no correlation between matched MMSE-2 and recall at the three time points (p=0.15, 0.12, 0.31, respectively). There was no correlation between operating time (p=0.96, 0.82, respectively), ICU stay (p=0.74, 0.27, respectively), or total hospital stay (p=0.73, 0.24, respectively) and discharge or post-operative recall. Similarly, no association was noted between ASA class and recall at the time points (p=0.63, 0.75, 0.48, respectively). There was no association between post-operative complications and recall on hospital discharge or at six weeks (p=0.60, 0.24, respectively).

Conclusions: Although patients find informed consent important, recall of key components remains poor and deteriorates over time irrespective of other variables. Subjective severity ratings may differ from clinician expectations. Significant progress remains to improve informed consent retention.