In the following guest post, Carlos Luna, Director of Government Affairs for Reed Group’s MDGuidelines, explores the National Guideline Clearinghouse and whether or not it performs its function – assessing the quality of medical guidelines and improving transparency in the guideline industry.
As the Legislature is soon to begin its Regular Session on April 10th and workers’ comp officials anticipate a bill to incorporate the ODG formulary in Louisiana’s system, read on to get Luna’s take on how the National Guideline Clearinghouse could benefit stakeholders across the board.
Medical practitioners face considerable uncertainty practicing the art of medicine. They rely on their knowledge, skills, experience, and patient preferences. They also rely on the scientific literature to inform their decisions on treatment planning and measuring patient restoration of function. Marketing-savvy device and drug manufacturers often cloud the picture and make identifying effective treatment protocols more difficult. The quality of life for many injured workers weighs in the balance, which is why it is necessary to have organizations such as the National Guidelines Clearinghouse separate trustworthy content from marketing speak.
Institute of Medicine Standards for Trustworthy Guidelines
As of 2011, there were over 3,700 published clinical practice guidelines from 39 countries available for use. Hundreds of these guidelines meet the definition of nationally recognized guidelines; a definition used in most legislative bills introduced and enacted by state legislatures to govern the standard of care for injured workers throughout the country. Being nationally recognized does not mean a guideline is safe and trustworthy to use as a standard of care for injured workers.
Because the term “evidence-based” has been thrown around quite readily, the U.S. Congress tasked the Institute of Medicine (IOM), now known as the National Academy of Medicine, through the Medicare Improvements for Patients and Providers Act of 2008 to initiate a study defining best practices used in developing rigorous, trustworthy clinical practice guidelines. The outcome of the request became the formation of an expert committee. The committee developed eight standards focused on developing guidelines using approaches that are objective, scientifically valid, consistent, transparent, and free of bias.
Evaluation of Guidelines’ Trustworthiness
The Agency for Healthcare Research and Quality (AHRQ) directs a portion of its research funding, through its National Guideline Clearinghouse (NGC), to evaluate guideline provider submissions against the Institute of Medicine’s eight standards. Assessments are made to determine the reliability, validity, and effects of these guidelines on health care quality and patient outcomes. As a result, the NGC is required to discontinue the inclusion of guidelines whose development does not meet the eight standards and whose development is insufficiently documented.
The standards used by National Guideline Clearinghouse to assess rigor and trustworthiness include:
Establishing transparency, management of conflict of interest, guideline development group composition, clinical practice guideline–systematic review intersection, establishing evidence foundations for and rating strength of recommendations, articulation of recommendations, external review, and updating.
NGC’s Applicability to Commercially Available Guidelines
NGC made national headlines in June of 2016 after announcing the removal of the Official Disability Guidelines (ODG), published by Work Loss Data Institute from its database of trustworthy clinical practice guidelines. According to NGC, the removal of ODG took place due to the following deficiencies:
- Failure to explain how they selected studies for their evidence-based review;
- Document did not include the number of studies identified or the number of studies evaluated;
- No summary of inclusion and exclusion criteria; and
- ODG did not provide synthesized detailed descriptions or evidence tables.
Phil Denniston, ODG’s former-President, went on the record commenting that the Clearinghouse “has moved in the direction of hosting academic guidelines, primarily guidelines produced by medical specialty societies who give the guidelines away to support the interests of their members.”
Mr. Denniston continued: “All of the leading commercial medical treatment guidelines, including Hearst, Milliman, MCG, Zynx, McKesson, Interqual, Dynamed, UpToDate, and others, now also decline to participate in NGC.”
Could it be that the pursuit of healthier margins are the reason commercial treatment guidelines publishers have declined to participate?
Meeting strict standards is not easy and it is not cheap, but the health of injured workers is too important and because of this importance, ReedGroup, owners of the ACOEM Practice Guidelines, have made the requisite commitment to meet the eight essential standards described earlier. As a result, NGC notified ReedGroup on March 2nd, 2017, that guidelines it submitted for evaluation were accepted for inclusion in the NGC. For the record, Reed Group’s ACOEM Practice Guidelines is the only other nationally recognized commercially available guideline for workers’ compensation.
The Importance of University-based Research
Reed Group’s approach to development using a university-based research team anchors the effort to produce trustworthy clinical practice guidelines. The team consults various databases for primary sources of original research. Also searched, are other databases likely to contain references to high quality literature:
- National Library of Medicine’s National Institute of Health (PubMed)
- CINAHL (nursing, biomedicine, health sciences librarianship, alternative/complementary medicine, consumer health and 17 allied health disciplines)
- Cochrane Central Register of Controlled Trials
- Google Scholar
ODG’s methodology document, posted on its website, lists literature sources that include textbooks, conference proceedings/presentation slides, and case reports and descriptions. None of these sources meet the selection criteria for creating quality guidelines and rating literature set forth by the Institute of Medicine.
What does this mean to Louisiana and the rest of the country?
If the evidence underpinning the guidelines is in question, then every recommendation (conservative or invasive care, pharmacological, etc.) stemming from the guidelines must also be in question.
Discussions to adopt evidence-based drug formularies continue across the country. Will legislatures continue to perpetuate actions focused on fiscal benefits? Or, will a leader emerge in the south to recognize the relevance of the National Guideline Clearinghouse’s rigorous assessment of quality and trustworthiness among a sea of guidelines promoting physical benefits?
Meeting NGC criteria is not only relevant, it’s vital.