Clinical guidelines: Beware, what are suggestions will become mandates

by Douglas W. Jackson, MD

Orthopedic surgeons are trying to incorporate “evidence-based medicine” at the same time they are trying to understand this concept. For the current practitioner, it is a blend of his or her interpretation of the existing applicable literature, clinical experience and what is presented at scientific meetings. A more rigid definition of it is clinical practice that “systematically finds, appraises, and uses the most current and valid research findings as the basis for clinical decisions.”

One problem with the current literature is the varying qualities of research evidence it contains. In an attempt to make sense of weak and conflicting data, scientific journals and organizations are trying to define “levels of evidence” to help us interpret the literature. Also, statistical meta-analyses are being used to draw information from weaker, smaller and less definitive studies and make it usable by consensus panels as a basis for evidence-based treatments, best practices and clinical-practice guidelines. Regardless of the name, these guidelines are being implemented and utilized by hospitals, insurance companies and government payers.

A frustrating example for orthopedic surgeons is the denial of requests for treatment and reimbursement based on the American College of Occupational and Environmental Medicine’s Practice Guidelines. This publication was prepared with little orthopedic input and is purported by some payers and the organization that prepared it to be the “gold standard” in effective treatment of occupational injuries.

The Centers for Medicare & Medicaid Services (CMS) currently has an obligation to pay for what is “reasonable and necessary.” Their interpretation of new technology is creating gray areas as to whether they are effective and appropriate at a time when an explicit definition for evidence-based, improved outcomes has not been worked out.

My experience with many existing guidelines is that they are the result of two strong factors driving their use — accrediting agencies and reimbursement issues — mostly by outsiders whose participation is driven by the concepts of controlling the cost of medical care or denying reimbursement.”

Conflict of interest

We should be concerned about the data that are being used by the consensus groups or expert panels as bases for establishing practice guidelines mainly due to the inadequacy of the existing orthopedic literature and the fact that conflict of interest issues are just starting to be dealt with by medicine and government agencies. We have seen how an investigator’s conflict of interest and industrial-funded research can influence results. An example of this is the recent Celebrex study for pain management that was shown to have falsified data reported.

Our scientific journals and meetings struggle with minimizing conflicts of interest and the use of falsified data. In addition our journals need to exclude faulty methodology and statistics, poorly conducted research and subject the papers to rigid analysis. One problem is some journals would not have enough articles if scrutiny was too vigorous.

Beware of evidence-based medicine studies founded on the work of investigators who are not caring for patients in the community and approach all problems as scientific models. There is the potential for published studies to be produced by academics who face “publish or perish” policies to keep their careers viable. Paradoxically, this is another reason clinicians must participate and critique the methodologies being used to determine what clinical care is appropriate. We should insist that isolated studies be duplicated by investigators in different settings to collaborate the published data and not just take it at face value.

Guides not mandates

Based on the current state of published medical science, I feel strongly that clinical practice guidelines should be guides rather than mandates. We need to protect individual judgment and insist on having the best possible evidence available for decision making in caring for our patients.

We need to go slow and be diligent in our march toward mandated care. We need to pay attention to all the changes that are being proposed, while keeping our patients’ concerns in the forefront.

Strong motivation

President Obama’s budget director, Peter Orszag, has quoted studies saying there is significant “waste” in our current medical care that doesn’t impact outcomes. He has also said that 30% of health care spending is “waste” and estimates $700 billion a year in U. S. medical care costs could be saved without harming quality.

It will be years for the necessary evidence-based medicine studies to be completed to clearly define this waste. During that time, we will see expert medical panels called upon to make decisions as to what is waste and what will be reimbursed — if we are not already.

While we can support expert medical panels, it will be difficult for them to remain free of political influence and reward. There is the possibility they will be used primarily for decisions related to the funding of health care. These expert panels will be powerful political tools as their recommendations become mandated guidelines used for deciding what is allowed and/or reimbursed.

Politicians have failed to demonstrate the stomach to develop meaningful health care reform to control costs. However, at the same time they are very reluctant to give up budgetary and fiscal power over medical expenditures and many see panels as a way to make these decisions.

Foolish faith

I recognize that there are existing expert clinical practice guidelines that are in place and working well. They are helpful in sorting through often conflicting clinical evidence. Oncologists have established helpful guidelines that are not seen as intrusions into their practice. However, orthopedists have experienced firsthand the confusion brought about by conflicts related to expert panels on deep vien thrombosis prophylaxis between the Chest Surgeons’ recommended guidelines and those of the academy (see cover story). Much of this was based on the interpretation of more generalized literature vs. literature addressing a specific population — joint replacement patients.

Albert Einstein once warned, “A foolish faith in authority is the worst enemy of truth.” Mandated treatment guidelines need to be removed from political influence and be evidence-based to be credible best practice guidelines. We must be wary of the idea and possibility of inserting government-controlled or influenced panels between patients and physicians as a method for cost control and whose guidelines could be adopted as a blueprint for health insurance reimbursement.

All of this mandated cost control will need to be balanced against the development of new, innovative medical practices that have increased costs with new associated technology and medications. Physicians must be cost conscious and amenable to change, but at the same time be the spokespersons for continued improvements to patient care.

• Douglas W. Jackson, MD, is Chief Medical Editor of Orthopedics Today. He can be reached at ortoday@slackinc.com.