A randomised trial of conventional versus BAUS procedure-specific consent forms for transurethral resection of prostate

Abstract

Introduction: Conventional consent forms often contain incomplete information regarding risks associated with invasive procedures. BAUS has introduced procedure-specific consent forms (PSCF) documenting the risks associated with urological procedures. We compared patients' understanding of the risks and benefits of TURP after the consenting process with either conventional documentation or PSCF.

Patients and methods: One hundred patients were randomised to be consented with either a conventional or PSCF. After 3 h, their understanding was assessed with a questionnaire asking patients to document the indication and likelihood of symptomatic improvement, estimate frequency of complications and the risk of future re-operation. Data were compared by Mann-Whitney test.

Results: Fifty patients were randomised to each group. There was no significant difference in mean age, grade of doctor obtaining consent or time interval from consent to questionnaire. Both groups accurately predicted the chance of improved symptoms (median, 80%). There was no significant difference in patients' median estimation of risk of complications such as incontinence, erectile dysfunction, or retrograde ejaculation. Patients consented with the PSCF predicted the risk of re-operation more accurately (median answer, 10% versus 30%; P = 0.007, Mann-Whitney test).

Conclusions: Recall of data was sub-optimal in both groups. For most data points there was no significant difference in estimation of risks between groups. Those consented with a procedure-specific consent form predicted risk of re-operation at 10 years more accurately. Procedure-specific consent forms offer an advantage over conventional consent in this study. We feel that the provision of a written structured framework allows better informed consent for TURP.

Figure 1

Patients' understanding of the indication for their procedure.

Figure 2

Patients' perception of the chance of improved symptoms after TURP (median ± interquartile range; P > 0.05).

Figure 3

Patients' estimated understanding of the risk of (A) erectile dysfunction and (B) incontinence following TURP.

Figure 3

Patients' estimated understanding of the risk of (A) erectile dysfunction and (B) incontinence following TURP.

Figure 4

Patients' median perception of risk for commonly described complications of TURP.

Figure 5

Patients' prediction of the risk of re-do at 10 years (median answer 10% versus 30%;P = 0.007, Mann–Whitney test). Error bars represent interquartile range.