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女性是否获得了有关乳腺 X 光筛查的相关信息以做出知情同意:对德国、意大利、西班牙和法国用于筛查邀请的信息手册进行批判性评估。

Are women getting relevant information about mammography screening for an informed consent: a critical appraisal of information brochures used for screening invitation in Germany, Italy, Spain and France.

机构信息

Department of General Practice, Universitätsklinikum, Heinrich-Heine-University, Düsseldorf, Germany.

出版信息

Eur J Public Health. 2010 Aug;20(4):409-14. doi: 10.1093/eurpub/ckp174. Epub 2009 Nov 5.

Abstract

BACKGROUND

The aim was to find out if information brochures on mammography screening in Germany, Italy, Spain and France contain more information to facilitate informed consent than in similar studies carried out over the last few years in Sweden, Canada, USA and the UK, countries with different medical cultures.

METHODS

We generated a list of essential information items on mammography screening for the purpose of informed consent. We mostly used the same items of information as had been used in previous studies and analysed the information brochures of major national initiatives in Germany and France, and three brochures each from regionalized programmes in Italy and Spain. We cross-checked which of our items were covered in the brochures and if correct numbers were given.

RESULTS

We found that the information brochures contained only about half of the information items we defined. Six of the eight brochures mentioned the reduction in breast-cancer fatalities. Four of the eight provided information on false positives, and four of the brochures highlighted the side-effects of radiation. The information on side-effects and risks provided by the brochures was generally of poor quality, and none of them referred to over diagnosis. When numbers were given, they were only indicated in terms of relative numbers.

CONCLUSION

The information brochures currently being used in Germany, Italy, Spain and France are no better than the brochures analysed some years ago. Our results suggest that the providers of mammography screening programmes continue to conceal information from women that is essential when making an informed decision.

摘要

背景

本研究旨在了解德国、意大利、西班牙和法国的乳腺 X 光筛查信息手册是否比过去几年在瑞典、加拿大、美国和英国开展的类似研究提供了更多便于知情选择的信息。这些国家具有不同的医疗文化。

方法

我们列出了乳腺 X 光筛查知情同意所需的基本信息项目清单。我们主要使用了与之前研究相同的信息项目,并分析了德国和法国主要国家倡议的信息手册,以及意大利和西班牙区域性计划的每个国家各三份手册。我们交叉核对了手册中涵盖的我们的项目以及是否给出了正确的数字。

结果

我们发现信息手册仅包含我们定义的信息项目的大约一半。八个手册中的六个提到了乳腺癌死亡率的降低。八个手册中的四个提供了关于假阳性的信息,四个手册强调了辐射的副作用。手册中提供的关于副作用和风险的信息质量普遍较差,并且它们都没有提到过度诊断。当给出数字时,仅以相对数字表示。

结论

目前在德国、意大利、西班牙和法国使用的信息手册并不比几年前分析的手册更好。我们的研究结果表明,乳腺 X 光筛查项目的提供者继续向女性隐瞒做出知情决定所必需的信息。

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