Abstract

Informed consent for surgery can address the legal aspects of care while also being simple, informative, and empathic. We developed interactive informed consents and compared them with standard printed informed consents asking: (1) are there any factors associated with lower decision conflict or greater patient-rated clinician empathy including consent format? (2) Are there any factors associated with rating the consent process as informative, comfortable, and satisfying including consent format? Ninety-four adult patients accepted an offer of surgery from one of three hand surgeons to address one of six common hand surgery diagnoses: carpal tunnel release, cubital tunnel release, trigger finger release, plate and screw fixation of a distal radius fracture, removal of a benign mass, including a ganglion cyst, and Dupuytren contracture release. Fifty-three patients were randomized to complete an interactive consent, and 41, a standard written consent. Symptoms of anxiety, depression, and unhelpful thoughts were measured. Patients completed the Decision Conflict Scale and the Jefferson Scale of Patient's Perceptions of Physician Empathy and rated the consent as informative, comfortable, and satisfactory on a scale of 0-10. Greater decisional conflict was slightly associated with greater patient unhelpful thoughts about symptoms and was not associated with consent format. A higher rating of comfort with the consent process was slightly associated with patient choice to proceed with surgical treatment, but not with consent format. Accounting for potential confounding in multivariable analysis, a higher rating of the consent process as informative was slightly associated with patient preference for surgical over nonsurgical treatment, CONCLUSIONS: The observation that an interactive consent form was not related to decision conflict or other aspects of patient experience suggests that such tools may not have much weight relative to the interaction between patient and clinician. Efforts to improve informed consent may need to focus on the dialog between patient and surgeon rather than how information is presented.

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