San Norberto Enrique María, Gómez-Alonso Daniel, Trigueros José M, Quiroga Jorge, Gualis Javier, Vaquero Carlos
Servicio de Angiología y Cirugía Vascular, Hospital Clínico Universitario de Valladolid, Valladolid, España.
Servicio de Cirugía General y del Aparato Digestivo, Complejo Asistencial de Palencia, Palencia, España.
Cir Esp. 2014 Mar;92(3):201-7. doi: 10.1016/j.ciresp.2013.02.027. Epub 2013 Sep 20.
To assess the readability of informed consent documents (IC) of the different national surgical societies.
During January 2012 we collected 504 IC protocols of different specialties. To calculate readability parameters the following criteria were assessed: number of words, syllables and phrases, syllables/word and word/phrase averages, Word correlation index, Flesch-Szigriszt index, Huerta Fernández index, Inflesz scale degree and the Gunning-Fog index.
The mean Flesch-Szigriszt index was 50.65 ± 6,72, so readability is considered normal. There are significant differences between specialties such as Urology (43.00 ± 4.17) and Angiology and Vascular Surgery (63.00 ± 3.26, P<.001). No IC would be appropriate for adult readability according to the Fernández-Huerta index (total mean 55.77 ± 6.57); the IC of Angiology and Vascular Surgery were the closest ones (67.85 ± 3.20). Considering the Inflesz scale degree (total mean of 2.84 ± 3,23), IC can be described as «somewhat difficult». There are significant differences between the IC of Angiology and Vascular Surgery (3.23 ± 0.47) that could be qualified as normal, or Cardiovascular Surgery (2.79 ± 0.43) as «nearly normal readability»; and others such as Urology (1, 70 ± 0.46, P<.001) and Thoracic Surgery (1.90 ± 0.30, P<.001), with a readability between «very» and «somewhat» difficult. The Gunning-Fog indexes are far from the readability for a general audience (total mean of 26.29 ± 10,89).
IC developed by scientific societies of different surgical specialties do not have an adequate readability for patients. We recommend the use of readability indexes during the writing of these consent forms.
评估不同国家外科协会的知情同意书（IC）的可读性。
2012年1月期间，我们收集了504份不同专业的IC协议。为计算可读性参数，评估了以下标准：单词数量、音节和短语数量、平均音节/单词数和平均单词/短语数、单词相关指数、弗莱施-齐格里斯指数、韦尔塔·费尔南德斯指数、英弗莱斯量表程度和冈宁-福格指数。
平均弗莱施-齐格里斯指数为50.65±6.72，因此可读性被认为是正常的。不同专业之间存在显著差异，如泌尿外科（43.00±4.17）与血管病学和血管外科（63.00±3.26，P<0.001）。根据费尔南德斯-韦尔塔指数（总平均值55.77±6.57），没有IC适合成人阅读；血管病学和血管外科的IC最接近（67.85±3.20）。考虑到英弗莱斯量表程度（总平均值为2.84±3.23），IC可被描述为“有点难”。血管病学和血管外科的IC（3.23±0.47）可被判定为正常，或心血管外科的IC（2.79±0.43）为“接近正常可读性”，与其他科室存在显著差异，如泌尿外科（1.70±0.46，P<0.001）和胸外科（1.90±0.30，P<0.001），其可读性介于“非常”和“有点”难之间。冈宁-福格指数远未达到普通读者的可读性水平（总平均值为26.29±10.89）。
不同外科专业科学协会制定的IC对患者而言可读性不足。我们建议在撰写这些同意书时使用可读性指数。
