After a recent lecture by a cardiologist on the 30% reduction of coronary events with the use of HMG Co-A reductase inhibitors I asked what he thought of the Oxford study which showed a 77% reduction in coronary events with Vitamin E supplementation. His response was very revealing - "I take Vitamin E supplements myself but don't feel there is enough evidence to warrant my recommending it to patients." In other words as a patient he felt it would probably help but as a physician he felt that the benefit was not proven. What we see is a clear double standard as to the amount of proof required to distinguish between what we think will help and what we know to be helpful. 

LEGAL 
Double standards are not necessarily bad if they are used to provide a greater degree of protection to those that are more vulnerable. The legal system presumes innocence until proven otherwise and requires that a different "burden of proof" be used to determine liability in civil cases than it does for guilt in criminal cases. In civil cases liability is determined by the preponderance of evidence, or, "more likely than not." In other words, if it is 51% likely that the defendant is responsible for the damages sustained or suffered by the plaintiff then the jury is obliged to find the defendant liable. In criminal cases, where a much higher standard is required, the burden of proof is "beyond a reasonable doubt." The fact that O.J. Simpson was found liable in the civil trial but not guilty in the criminal trial is in part a reflection of the legal double standard regarding the burden of proof. The legal standard in criminal cases encourages dispassionate decisions with a higher degree of certainty because personal liberty, and sometimes a person's life depends on the verdict. In civil trials, where the penalties are monetary only, the burden of proof requires a lesser degree of certainty thus allowing opinion and passion to play a larger role. 

MEDICAL
In the research setting, where interventions are presumed worthless until proven otherwise (the null hypothesis), the dispassionate burden of proof to be published is p<.05 - beyond a reasonable doubt. In a typical Family Physician's office where we are passionate about helping our patients we frequently are inclined to offer them what will help more likely than not (p<0.49). 

INSURANCE
In the past health insurers have tended to reimburse for physician services without asking many questions. They presumed that what we were doing was helpful for patients. The medical profession, in turn presumed that the deep pockets of the insurance companies would continue to pay for whatever we deemed appropriate. As we all know this situation has changed dramatically with much of what we do as physicians being challenged by insurers with limited resources. With the government Office of Technology Assessment declaration that 70 to 80% of medical practices have not been proven to be effective the scrutiny of the medical profession has only increased further. The burden of proof required for reimbursement by insurance is changing before our eyes from "more likely than not" to "beyond a reasonable doubt." 

FAMILY PRACTICE
The evolution of managed care has placed Family Practice physicians in a pivotal role. Our training, which allows us to effectively manage over 90% of the patients presenting in our offices, makes us very cost effective primary care providers. What distinguishes our specialty from others and allows us to be so cost effective is its inclusiveness, integration and focus on what is "more likely than not" diagnostically and therapeutically. An inclusive, integrated approach can more effectively deal with uncertainty than specialties which define themselves by what they exclude and insist on ruling out, beyond a reasonable doubt, every possible diagnosis, no matter how improbable. A Family Practice physician tends to allocate diagnostic and therapeutic efforts/resources according to probability X severity. If the likelihood of litigation is factored into this formula then Family Practice physicians become less tolerant of uncertainty and their style and cost of practice becomes more like that of other specialties. 

The inclusive, integrative approach in Family Practice makes it easier for us to incorporate complementary/alternative medicine (CAM) in our practices than other specialties which tend to define themselves by exclusion and want proof beyond a reasonable doubt. The example of the cardiologist who was willing to take Vitamin E as a patient but was unwilling to recommend it to his patients illustrates how difficult it can be for some specialists to incorporate even the most benign of CAM approaches into their practices. Obviously, CAM needs to be tested and proven but the burden of proof should be the same as for conventional medical therapies and not higher. We desperately need to subject our conventional medical practices to the same rigorous standard being demanded of CAM. 

PROOF IN THE PUDDING
It's nice to pat ourselves on the back about how Family Practice physicians practice cost effectively and deserve a prominent role in the future of health care. Unfortunately, the insurance companies and some of our peers in other specialties are not taking our word for it. We have to prove our worth beyond a reasonable doubt with good research. We should not be fooled into thinking that the only recipe that can accomplish this is the double-blind, placebo controlled, randomized clinical trial. This is in fact the ideal recipe for evaluating exclusive, isolationist approaches seen in other specialties but this is a poor recipe for evaluating the inclusive, integrative approach in Family Practice. 

The proof is in the pudding, not the recipe. In other words, the proof of how valuable our services are is in the clinical outcomes and not in adhering to an inadequate research methodology. The research methodology needs to reflect what is being studied. For the inclusive, integrative approach used in Family Practice, outcome studies are a much better way of proving our worth. If multiple quality of life parameters are consistently higher and the total use of health care resources is consistently lower when patients with similar conditions are treated by Family Practice physicians as compared with other specialties, then we have proven our worth beyond a reasonable doubt. 

CONCLUSION
Family Practice by virtue of its inclusive, integrative approach and by focusing on what is more likely than not both diagnostically and therapeutically can often produce better outcomes at lower costs. We must continue to provide high quality care for our patients and at the same time take up the challenge to prove the value of what we do beyond a reasonable doubt. Outcome studies are ideally suited to this task. Double standards can be either destructive or constructive depending on how they are used. Our patients will be best served and our profession strengthened if we continue to practice passionately and research dispassionately.