Recently, a group that writes guidelines asked for my input about the role of patients in the development of Evidence Based Medicine guidelines. With universal healthcare now ‘the law of the land’, treatment guidelines have become even more important. Preserving the integrity of the guideline development- process is what matters most. It is essential that patients play a role in the process that can so affect their lives. The question posed to me was why should those developing guidelines involve patients? My response follows.

First:   Evidence based medicine is “the integration of best research evidence with clinical expertise and patient values”.  Only the patient can provide patient values.  Researchers and physicians can provide research evidence and clinical expertise, but they cannot speak for patients. 

Second:   Patients are more affected by guidelines than any other stakeholder. 

Third:   Patients care more about preserving treatment choices and options than any other group.  Their health and quality of life may depend on access to different treatment options.

Fourth:   Patients care about access to flexible individualized care when treatment approaches that work for the majority fail.  This means that patient care about preserving “clinical judgment”.

Fifth:    Patients can make sure that legitimate treatment controversy is acknowledged.  As one author puts it: ‘the very nature of scientific debate is that no ‘right’ answer has emerged’. Treatment choices only arise when controversy is acknowledged.

Sixth:   Patients care about making autonomous choices.  When science is in controversy, the question is not “who is right”, but rather, “who decides.”  Autonomy—the patient’s right to make his own medical choices—is a right that arises from liberty.  As Thomas Jefferson said “Without health, there is no happiness.”  In democracy, the patient’s right to liberty trumps the doctor’s right to make the patient do what he thinks is best.  Patients are not always right, but they are most dogged in their pursuit of the right answer, more deeply affected by the wrong answer, and care more about their personal lot in life than any other stakeholder.

Seventh:  Patients promote transparency and get rid of the “clubby” closed room environment that currently dominates guideline development.

Eighth:  Patients are good at sniffing out industry conflicts of interest and bias.

And a caveat:  Patient choice is an individual matter.  Thus, patients serving on guidelines panels cannot speak for “all patients.”   Their role is to preserve choice for the individual patient.  This is the essence of autonomy—the freedom of the individual to make treatment choices.  For example, the treatment decision for a patient whose quality of life has not been impaired by illness may be very different from one whose quality of life has been substantially impaired–the latter is willing to risk more to attain health.  This choice belongs to the individual patient and even a panel of patients should not interfere with this right.

You can follow additional comments on Lyme policy at www.lymepolicywonk.org.  You can contact Lorraine Johnson, JD, MBA at lbjohnson@lymedisease.org.