• Jennifer L Hallock, Rebeca Rios, and Victoria L Handa.
• Department of Gynecology and Obstetrics, Female Pelvic Medicine and Reconstructive Surgery, Johns Hopkins University School of Medicine, Baltimore, MD. Electronic address: jlh2131@columbia.edu.
• Am. J. Obstet. Gynecol. 2017 Aug 1; 217 (2): 181.e1-181.e7.

BackgroundInformed consent is a process that necessitates time and effort. Underlying this investment is the belief that informing patients about the surgery promotes patient satisfaction with the decision for surgery and potentially satisfaction more broadly.ObjectiveThe objective of the study was to investigate the extent to which preoperative satisfaction with a decision to pursue surgery is associated with understanding after an informed consent discussion.Study DesignWe performed an observational study of adult women seeking surgical treatment for pelvic floor disorders. Study participants were recruited after routine preoperative counseling by board-certified or board-eligible urogynecologists. In our practice, the preoperative informed consent process typically includes a discussion of the indications, risks, benefits, alternatives, and chance of success of the procedures. Participants completed a 35 question survey preoperatively at one setting. The primary outcome, satisfaction with decision, was measured with a validated 6 item Satisfaction with Decision Scale-Pelvic Floor Disorder. Participants were classified as highly satisfied if they indicated the highest level of satisfaction for all items. The primary exposure was patient knowledge of the planned surgery, measured using a newly adapted 20 item Informed Consent Questionnaire including 15 yes/no questions and 5 free-text questions. Additionally, the survey included a validated 3 item tool for health literacy, a single-item anxiety measure, and demographic data. Analyses were performed with a χ2 test, a Student t test, and a multivariable logistic regression using the binary outcome variable, highly satisfied or not highly satisfied.ResultsA total of 150 participants were enrolled, with a mean age of 57.5 years. The majority were non-Hispanic (97.3%) or white (87.3%), with at least some college education (51.0%). The median number of days between the informed consent discussion and the survey was 35. The mean total Satisfaction with Decision score was 27.9 (SD, 2.6; range, 19-30), indicating overall high satisfaction with the decision. A patient's preoperative satisfaction with her decision was strongly associated with increased knowledge of the planned surgery, as measured on the Informed Consent Questionnaire (P = .003). The mean score for the highly satisfied group was 17.8 (n = 70; SD, 3.6; range, 6-20) and for the not highly satisfied group was 16.1 (n = 77; SD, 2.8; range, 9-20). There were no significant differences between the highly satisfied and not highly satisfied groups with respect to age, race, education level, anxiety score, or health literacy. The odds of being highly satisfied increased for every 1 point increase in the Informed Consent Questionnaire score (odds ratio, 1.28; 95% confidence interval, 1.06-1.32; P = .003). The association between decisional satisfaction and knowledge persisted after controlling for demographic and clinical variables including education level, health literacy, race/ethnicity, age, surgeon years since completing fellowship, diagnosis, surgery category, number of visits in the past 6 months, and number of days between informed consent discussion and survey.ConclusionThis study found that patient knowledge and understanding of surgery are important components of a patient's satisfaction with her decision to proceed with pelvic floor surgery. By measuring patient understanding after informed consent discussions, clinicians may be able to better manage preoperative expectations, increase patient satisfaction, and improve the informed consent process.Copyright © 2017 Elsevier Inc. All rights reserved.

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