Kung Justin, Miller Ram R, Mackowiak Philip A
Department of Medicine, University of Maryland School of Medicine, Baltimore, USA.
Arch Intern Med. 2012 Nov 26;172(21):1628-33. doi: 10.1001/2013.jamainternmed.56.
In March 2011, the Institute of Medicine (IOM) issued a new set of standards for clinical practice guidelines intended to enhance the quality of guidelines being produced. To our knowledge, no systematic review of adherence to such standards has been undertaken since one published over a decade ago.
Two reviewers independently screened 130 guidelines selected at random from the National Guideline Clearinghouse (NGC) website for compliance with 18 of 25 IOM standards.
The overall median number (percentage) of IOM standards satisfied (out of 18) was 8 (44.4%), with an interquartile range of 6.5 (36.1%) to 9.5 (52.8%). Fewer than half of the guidelines surveyed met more than 50% of the IOM standards. Barely a third of the guidelines produced by subspecialty societies satisfied more than 50% of the IOM standards surveyed. Information on conflicts of interest (COIs) was given in fewer than half of the guidelines surveyed. Of those guidelines including such information, COIs were present in over two-thirds of committee chairpersons (71.4%) and 90.5% of co-chairpersons. Except for US government agency–produced guidelines, criteria used to select committee members and the selection process were rarely described. Committees developing guidelines rarely included an information scientist or a patient or patient representative. Non-English literature, unpublished data, and/or abstracts were rarely considered in developing guidelines; differences of opinion among committee members generally were not aired in guidelines; and benefits of recommendations were enumerated more often than potential harms. Guidelines published from 2006 through 2011 varied little with regard to average number of IOM standards satisfied.
Analysis of a random sample of clinical practice guidelines archived on the NGC website as of June 2011 demonstrated poor compliance with IOM standards, with little if any improvement over the past 2 decades.
2011年3月,美国医学研究所(IOM)发布了一套新的临床实践指南标准,旨在提高所制定指南的质量。据我们所知,自十多年前发表过一篇相关系统评价以来,尚未有对遵循此类标准情况的系统评价。
两名评审员独立筛选从国家指南库(NGC)网站随机选取的130篇指南,以确定其是否符合25项IOM标准中的18项。
所满足的IOM标准的总体中位数(百分比)(共18项)为8(44.4%),四分位间距为6.5(36.1%)至9.5(52.8%)。接受调查的指南中,不到一半的指南符合超过50%的IOM标准。专科协会制定的指南中,仅有三分之一多一点的指南符合超过50%的所调查IOM标准。不到一半的接受调查指南提供了利益冲突(COI)信息。在那些包含此类信息的指南中,超过三分之二的委员会主席(71.4%)和90.5%的联合主席存在利益冲突。除美国政府机构制定的指南外,用于选择委员会成员的标准和选择过程很少被描述。制定指南的委员会很少包括信息科学家或患者或患者代表。在制定指南时,很少考虑非英文文献、未发表数据和/或摘要;委员会成员之间的意见分歧通常不在指南中公布;推荐的益处比潜在危害列举得更频繁。2006年至2011年发布的指南在所满足的IOM标准平均数量方面变化不大。
对截至2011年6月存档于NGC网站的临床实践指南随机样本进行分析表明,对IOM标准的遵循情况较差,在过去20年中几乎没有改善。