Neary Peter, Cahill Ronan A, Kirwan W O, Kiely E, Redmond H P
Department of Surgery, Cork University Hospital, Cork, Ireland.
Surg Endosc. 2008 Dec;22(12):2698-704. doi: 10.1007/s00464-008-9874-3. Epub 2008 Apr 10.
"Consent is a process by which a patient is informed and becomes a participant in decisions regarding their medical management." It is argued, however, that providing a signature to a form adds little to the quality of this process.
Views regarding the consent ritual of nonselected patients undergoing endoscopy (cystoscopy or sigmoidoscopy) were prospectively studied together with those of the attending staff. Patient volunteers were randomly assigned to one of two groups and given verbal explanation before the procedure, either alone (group A) or with a request to sign a form in addition (group B). A standardized questionnaire regarding preferences then was applied.
A total of 37 patients (22 men) were studied along with seven staff members. Most surveyed felt that signing a consent form helped to empower the patient (group A, 84%; group B, 83%; staff, 100%). Although the patients mainly believed that it functioned primarily to protect the hospital and doctor (group A, 89%; group B, 67%), only one patient (3% of total) felt that such a formality undermined the patient-doctor relationship. Most staff members favored signing a form (86%). The majority of patients either favored it (group A, 47%; group B, 78%) or expressed no strong preference (group A, 32%; group B, 11%). Interestingly, more women than men preferred signing (73 vs. 55%; p = 0.25), perhaps because more women believed that it functioned to preserve autonomy (93 vs. 77% of men). Age was no particular determinant of perspective.
Although it may be viewed as primarily serving to protect the doctor and hospital, the formal process of signing written consent forms appeals to patients and staff.
“知情同意是一个过程，在此过程中患者得到信息并成为其医疗管理决策的参与者。”然而，有人认为在表格上签字对这一过程的质量提升作用不大。
前瞻性地研究了接受内镜检查（膀胱镜检查或乙状结肠镜检查）的非特定患者及其医护人员对知情同意流程的看法。患者志愿者被随机分为两组，在检查前给予口头解释，一组仅接受口头解释（A组），另一组除口头解释外还被要求签署一份表格（B组）。然后应用一份关于偏好的标准化问卷。
共研究了37名患者（22名男性）和7名工作人员。大多数接受调查者认为签署同意书有助于增强患者的自主权（A组84%；B组83%；工作人员100%）。虽然患者主要认为同意书主要是为了保护医院和医生（A组89%；B组67%），但只有一名患者（占总数的3%）认为这种形式会破坏医患关系。大多数工作人员赞成签署表格（86%）。大多数患者要么赞成（A组47%；B组78%），要么没有强烈偏好（A组32%；B组11%）。有趣的是，女性比男性更喜欢签署同意书（73%对55%；p = 0.25），可能是因为更多女性认为这有助于维护自主权（93%对男性的77%）。年龄不是观点的特别决定因素。
虽然签署书面同意书的正式过程可能主要被视为是为了保护医生和医院，但它对患者和工作人员都有吸引力。
