Today, the Institute of Medicine released a new report “Clinical Practice Guidelines We Can Trust”. I haven’t read the entire report (217 pages), but this emphasis on the word trust is important. Lyme patients have a number of complaints with the treatment guidelines developed by the Infectious Diseases Society of America. Mainly, we don’t trust them. Over 80% of the roughly 4,000 respondents to CALDA’s 2009 survey said that they would not choose to be treated under IDSA guidelines. That’s a boatload of dissatisfaction and distrust. Chief among the complaints about the IDSA guideline development process was that the panel was not balanced and excluded those who would be most affected by the guidelines—patients with chronic Lyme and the physicians who treat them. The IOM new report seeks to change this by recommending involvement in the guidelines process by “clinicians and populations expected to be affected by [the guidelines]” and by recommending that a patient or patient advocate be represented in the guideline development. That’s welcome news.

The main quote from the IOM summary report sets a tone that says NO to cookie cutter guidelines approaches and YES to patient preferences.

Rather than dictating a one-size-fits-all approach to patient care, clinical practice guidelines offer an evaluation of the quality of the relevant scientific literature and an assessment of the likely benefits and harms of a particular treatment. This information enables healthcare providers to proceed accordingly, selecting the best care for a unique patient based on his or her references.

The summary principles require balanced panels that include those who will be affected by the guidelines. Here are some snippets from the principles.

3.1  The [Guidelines Development Group] GDG should be multidisciplinary and balanced, comprising a variety of methodological experts and clinicians, and populations expected to be affected by the CPG. 

3.2  Patient and public involvement should be facilitated by including (at least at the time of clinical question formulation and draft CPG review) a current or former patient and a patient advocate or patient/consumer organization representative in the GDG.

3.3  Strategies to increase effective participation of patient and consumer representatives, including training in appraisal of evidence, should be adopted by GDGs.

5.1 A description and explanation of any differences of opinion regarding the recommendation.

7.1  External reviewers should comprise a full spectrum of relevant stakeholders, including scientific and clinical experts, organizations (e.g., health care, specialty societies), agencies (e.g., federal government), patients, and representatives of the public.

7.4 A draft of the CPG at the external review stage or immediately following it (i.e., prior to the final draft) should be made available to the general public for comment. Reasonable notice of impending publication should be provided to interested public stakeholders.

The IOM also intends to put some teeth into these concepts by recommending that the National Guidelines Clearinghouse, which distributes most guidelines through its website, follow its recommendations and “discontinue the inclusion of guidelines whose development is not sufficiently documented, and to prominently identify guidelines that reflect the committee’s proposed standards for trustworthiness.”  The full report is available on line for free.

The devil is in the details.  I like the broad patient participation principles, but have some concerns.  These revolve around the press toward standardization and whether smaller groups will be disadvantaged by the administrative burden the recommendations may impose. I’m also concerned about whether the patient’s role is meaningful or whether it can be used merely as window dressing on a panel heavily stacked to support a predetermined viewpoint.  Perhaps I’ll have a better sense of these issues with a deeper read. 

 You can contact Lorraine Johnson, JD, MBA at lbjohnson@lymedisease.org.