Finch William J G, Rochester Mark A, Mills Robert D
Department of Urology, Norfolk and Norwich University Hospital, UK.
Ann R Coll Surg Engl. 2009 Apr;91(3):232-8. doi: 10.1308/003588409X359277. Epub 2009 Feb 13.
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.
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.
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).
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.
传统的同意书往往包含与侵入性手术相关风险的不完整信息。英国泌尿外科学会（BAUS）引入了特定手术同意书（PSCF），记录与泌尿外科手术相关的风险。我们比较了患者在使用传统文件或PSCF进行同意过程后对经尿道前列腺切除术（TURP）风险和益处的理解。
100名患者被随机分配使用传统同意书或PSCF进行同意。3小时后，通过问卷调查评估他们的理解情况，问卷要求患者记录症状改善的指征和可能性、估计并发症的发生率以及未来再次手术的风险。数据通过曼-惠特尼检验进行比较。
每组随机分配50名患者。两组在平均年龄、获取同意的医生级别或从同意到问卷调查的时间间隔方面没有显著差异。两组都准确预测了症状改善的几率（中位数，80%）。患者对尿失禁、勃起功能障碍或逆行射精等并发症风险的中位数估计没有显著差异。使用PSCF进行同意的患者对再次手术风险的预测更准确（中位数答案，10%对30%；P = 0.007，曼-惠特尼检验）。
两组对数据的回忆都不太理想。对于大多数数据点，两组在风险估计方面没有显著差异。使用特定手术同意书进行同意的患者对10年后再次手术风险的预测更准确。在本研究中，特定手术同意书比传统同意书具有优势。我们认为提供书面结构化框架能使患者对TURP做出更明智的同意。
