Failure of Clinical Practice Guidelines to Meet Institute of Medicine Standards

BACKGROUND: 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. METHODS: Two reviewers independently screened 130 guidelines selected at random from the National Guideline Clearinghouse (NGC) website for compliance with 18 of 25 IOM standards. RESULTS: 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 Non-English literature, unpublished data, and/or abstracts were rarely considered in developing guidelines; differences of opinion among committee members generally were not aired in guidelines;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. CONCLUSION: 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.