1. 2005;8;251-255Informed Consent in Interventional Spine Procedures: How Much Do Patients Understand?
   A Prospective Evaluation
   Clifford R. Everett, MD, Dmitry Novoseletsky, MD, Sarah Cole, SPT, Jason Frank, SPT, Christopher Remillard, SPT, and Rajeev K. Patel, MD.

Background: One of the most important issues that interventional physicians address during treatment is informing patients of their treatment options. Prior to beginning treatment, patients are given this information and allowed the opportunity to ask questions. Minimal qualitative information exists as to how much of this material patients retain and understand.

Objective: To determine the understanding and satisfaction patients have with the information provided through the informed consent process for interventional spine procedures.

Design: Prospective qualitative interview study.

Setting: University-based multidisciplinary spine practice.

Participants: Twenty-five consecutive patients undergoing spinal procedures who agreed to be interviewed about the informed consent process.

Interventions: Not applicable.

Main outcome measures: Domains of concern for patients undergoing spinal procedures were determined through a qualitative interview.

Results: Primary areas of concern for patients with the informed consent process centered on their desire for more information on the procedure and its risks, expectations of the procedure and benefits, and what treatments patients feel are effective.  Patients had difficulty recalling the potential risks and alternatives to the procedure. The majority of patients had tried physical therapy and medications, without benefit. The most common suggestion patients gave for improving the process was to produce a video of the procedure. Common themes encountered during the interview are reviewed, with common phrases presented for each theme.

Conclusions: Despite discussion in the office, handouts, and pre-procedure instructions, patients felt that additional sources of information would be useful to fully understand the procedure and its risks, benefits, and alternatives. Moreover, informing patients’ family members may enhance comprehension of all aspects of information provided within the informed consent process about interventional spine procedures.

Keywords: Chronic pain, spinal injections, informed consent, patient-physician relationship.