Hospital informed consent for procedure forms - Facilitating quality patient-physician interaction
Hospital informed consent for procedure forms - Facilitating quality patient-physician interaction
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DOI：
10.1001/archsurg.135.1.26
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发表时间：
2000-01-01
影响因子：
--
通讯作者：
Emanuel, LL
中科院分区：
文献类型：
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作者：
Bottrell, MM;Alpert, H;Emanuel, LL
背景：知情同意书应记录并反映知情同意和共同决策的目标。我们进行这项研究的目的是检验手术表格的知情同意书在多大程度上符合公认的知情同意标准、州知情同意法规与这些标准的相关性如何，以及现有表格是否可以增强患者与医生或其他医疗保健提供者之间的互动。假设：知情同意书不符合公认的标准。不同的格式可能对患者与医生的互动更有用。设计：对 1994 年美国医院协会会员名录中随机选择的医院中的医院手术表格知情同意书进行内容分析。检查表格中是否有知情同意书基本要素（手术的性质、风险、益处和替代方案）以及可能增强医患互动和鼓励共同决策的项目的证据。分析单位：检查了全国 157 家医院的 540 份医院的手术知情同意书。测量和主要结果：96% 的表格表明了手术的性质，但发现风险、益处和替代方案的情况较少。只有 26% 的表格包含所有 4 个基本要素，35% 包含 4 个要素中的 3 个，23% 包含 4 个要素中的 2 个，14% 仅包含 1 个要素，2% 没有任何要素。表格似乎是授权治疗（75%）或保护医院和护理人员免于承担责任（59%），而不是澄清有关手术的信息（40%）或帮助患者做出决策（14%）。来自有法规要求提供所有 4 个要素的州的表格并不比其他州更可能包含这些要素（Fisher 精确检验 = 1.000）。不到 40% 的表格支持共同决策模型。结论：大多数表格的内容不符合知情同意或医患互动的公认标准。我们提出了一种更全面支持理想知情同意和共同决策模型的形式，以增强知情同意在临床环境中的适用性。
Background: Informed consent forms should document and reflect the goals of informed consent and shared decision making. We conducted this study to examine the extent to which informed consent for procedure forms meet accepted informed consent standards, how well state informed consent statutes correlate with these standards, and whether existing forms can enhance the interactions between patients and physicians or other health care providers.Hypothesis: Informed consent forms do not meet accepted standards. A different format may be more useful for patient-physician interactions.Design: A content analysis was conducted of hospital informed consent for procedure forms from a random selection of hospitals in the 1994 American Hospital Association membership directory. Forms were examined for evidence of the basic elements of informed consent (nature of the procedure, risks, benefits, and alternatives) and items that might enhance patient-physician interactions and encourage shared decision making.Unit of Analysis: From 157 hospitals nationwide, 540 hospital informed consent for procedure forms were examined.Measurements and Main Results: Ninety-six percent of forms indicated the nature of the procedure, but risks, benefits, and alternatives were found less often. Only 26% of forms included all 4 basic elements, 35% included 3 of 4 elements, 23% had 2 of 4 elements, 14% had only 1 element, and 2% had none of the elements. Forms appear to authorize treatment (75%) or protect hospitals and caregivers from liability (59%) rather than clarify information about procedures (40%) or aid patients in decision making (14%). Forms from states with statutes that require that all 4 elements be provided were no more likely than other states to include them (Fisher exact test = 1.000). Fewer than 40% of forms supported models of shared decision making.Conclusions: The content of most forms did not meet accepted standards of informed consent or patient-physician interactions. We propose a form that more fully supports the models of ideal informed consent and shared decision making to enhance the applicability of informed consent in the clinical setting.