Study design: Presentation and analysis of a patient information sheet.
Objective: To produce an evidence-based information sheet that will serve as an aide-memoire to the process of taking informed consent prior to spinal surgery.
Summary of background data: Consent for a surgical intervention is the end of a process of discussion between the surgeon and the patient. It is essential that the patient has been provided with sufficient information to make an informed judgment as to whether the benefits of a proposed procedure will outweigh its risks.
Methods: We searched MEDLINE, the Cochrane database of systematic reviews and personal libraries for articles reporting complications of the surgical treatment of spinal diseases with particular reference to the most commonly treated conditions. A draft document was drawn up referencing the odds of specific complications. This was circulated to the National Health Service Scotland Central Legal Office for scrutiny and to an English language expert at the University of Edinburgh for translation to lay English. Finally, the document was issued to 50 patients in the outpatient clinic and scored on visual analog scales (VAS) for the ease of understanding, usefulness, and length.
Results: The product of this project was a two-page A4 sheet, with the front page outlining information applicable to spinal surgery "in general" and a back page detailing all common risks, relating to a headline procedure, that a Court of Law would expect a surgeon to discuss. The patients' VAS score (0-10) for "ease of understanding" was 8.8 ± 1.3 and for "usefulness" 8.9 ± 1.0 (means ± SD). Forty-three of 50 patients (86%) indicated that the length of the document was "just right" and seven (14%) of them that it was "too long."
Conclusion: The ISSiS is user friendly and can be employed as a tool in the process of obtaining consent.