Saturday, January 26, 2013

Clinical Guidelines, Patient Complexity and Trust


“It is much more important to know what sort of patient has a disease than what sort of disease a patient has.” Sir William Osler. 

The use of guidelines in medical practice is necessary for good patient care.  Guidelines have always been with us in practice, although it is only in recent years that the “best practice” norms that all physicians and nurses are taught have been formalized into guidelines.  What is a guideline?  According to the Institute of Medicine (IOM) and as used by the federal government National Guideline Clearinghouse, “Clinical practice guidelines are systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.”
 
A recent article in the Journal of the American Medical Association points out that, to be effective, guidelines must be trusted and widely accepted.  The authors discuss that guidelines should be developed through a rigorous, standardized process so that they are consistent and reflect the best, most up to date thinking in order to build and to deserve trust.   However even the most rigorous approaches to guideline development will not guarantee trust if they are then used in ways that foster suspicion.    There is almost a “bait and switch” quality to developing a guideline to assist practitioners and patients and then using them to determine if a practitioner is high or low quality, to set insurance coverage and to determine reimbursement.The use of the guidelines in this way can be seen as threatening and as regulating rather than assisting.  

The National Heart, Lung and Blood Institute is careful topoint out in their definitions of guidelines that “The recommendations are not fixed protocols that must be followed.  Responsible clinician’s judgment on the management of patients remains paramount.  Clinicians and patients need to develop individual treatment plans that are tailored to the specific needs and circumstances of the patient.”

But that is not how they are applied.  The various ratings tools often used by the health plans and other third parties, can label a practitioner as a “bad doctor “if guidelines are not adhered to.  The insurance carriers and the government payers can withhold payment if you deviate from the guidelines.  Treatments that deviate due to a caring physician trying to “tailor to the specific needs and circumstances of the patient” can be labeled as “experimental” or not in keeping with the “medical policy” that governs the reimbursement and coverage.  While there are appeals mechanisms in place, they are often difficult, time consuming, and may be perceived by the treating doctor and patient as being biased towards the health plan or other entity.

The use of guidelines as de facto standards for payment and quality rating purposes has positive aspects.  For physicians as a profession, the adherence to guidelines within certain parameters may be a proxy for quality especially in view of the lack of other available metrics.    However the erosion of trust that occurs when they are used in that fashion is real and needs to be acknowledged and addressed. 

One of the reasons that guidelines are not standards is that they do not take into account the complexities of real patients.  The practice of medicine is, more often than not, driven as much by the complexity of the individual patients as it is by the complexity of the disease being treated as was noted so eloquently in the quote from William Osler above.  In an article in the Annals of Internal Medicine published in December 2011, the authors defined five domains of patient complexity as reflected in the attached chart from their study.  

  
Only one of the five domains, the “medical decision making”, is in the realm of clinical guidelines.  Even that domain is not fully addressed by disease specific guidelines as diseases usually do not occur in medical isolation but in the context of other chronic illnesses, other acute illnesses and other medical risk factors that may not be reflected in one specific medical guideline.  The patient personal characteristics, the mental health issues, both primary and secondary due to the stress of the medical illness, as well as the very real life socioeconomic circumstances may make the following of a guideline difficult to impossible. 

In this reality of patient complexity, clinical guidelines are extremely valuable when used to help the patient and the doctor as long as they engender trust.  When, instead they are seen as just interfering in good patient care by pushing a doctor into the untenable position of adjusting to the individual needs of the patient or being labeled as practicing poor quality care, we do all a disservice.
 
Guidelines are a very positive force to doctors, nurses, other health professionals and especially to patients if they are trusted however their use as a way to determine reimbursement and benefits coverage can seriously erode that trust.  We need to find ways to measure physician performance and drive payment parameters without compromising the trust needed for guidelines to be used.