METHODS: Systematic review in PubMed, WOS and Scopus, Google and Google Scholar. An ad hoc list of 30 items was used to evaluate the ethical content of the protocols. The quality of guidelines was assessed with AGREE II.
RESULTS: The need for informed consent (IC) is reflected in 72% of the documents, the IC model sheet is included in only 41% of them, the rest of the analyzed characteristics on IC are fulfilled in percentages between 6% (the document includes the need to reevaluate the indication for IC) and 31% (the document contemplates to whom it should be requested). More than 20 ethical contents are reflected in 31% of them and less than 10 in 19% of the guidelines. The quality of the guides, according to AGREE II, ranged from 27 to 116 points (maximum possible 161), with a mean score of 68.7. Only 9% of the documents were classified as high quality. Finally, the correlation between ethical content and quality measured with AGREE II was 0.75.
CONCLUSIONS: The variability of ethical contents in guidelines on mechanical restraints is very high. The ethical requirements to be included in protocols, consensus or Clinical Practice Guidelines should be defined.
方法:PubMed,WOS和Scopus,谷歌和谷歌学者。使用30个项目的临时列表来评估协议的道德内容。使用AGREEII评估指南的质量。
结果:72%的文件反映了知情同意(IC)的需求,其中只有41%包括IC模型表,IC上的其余分析特征在6%(该文件包括需要重新评估IC的适应症)和31%(该文件考虑应该向谁请求)之间的百分比满足。31%的指南中反映了20多个道德内容,而19%的指南中反映了不到10个。导游的质量,根据AGREEII,范围从27到116点(最大可能161),平均得分为68.7分。只有9%的文件被归类为高质量。最后,使用AGREEII测量的伦理内容与质量之间的相关性为0.75.
结论:机械约束指南中伦理内容的变异性非常高。协议中要包含的道德要求,应制定共识或临床实践指南。