On antiretroviral guidelines and evidence based medicine.

individual patients, and that they are not the “Ten Commandments” written in stone. Decisions about the care of individual patients can not be purely based in a set of guidelines, even if they are based in the “sacrosanct” principles of evidence based medicine (EBM). EBM has its own limitations and optimal care of the individual patient still relies in other forms of knowledge that are not obtained through large randomized trials4. Is this knowledge wrong or inferior, as the A, B, C classification of the levels of evidence seems to suggest, or is it just different? I would favor the second interpretation. I will put two examples that apply to these specific guidelines in order to convey my viewpoint. The first example refers to prophylaxis of maternal-fetal transmission of HIV infection. We have good evidence that demonstrates that AZT monotherapy decreases the risk of transmission from the mother to the baby (evidence level A –from a randomized placebo controlled trial-). However nobody would recommend the administration of AZT monotherapy in this situation and most of us, including the authors of these guidelines, would recommend the administration of potent antiretroviral therapy, which has only been evaluated as part of large prospective cohort studies (evidence level B). Have we forgotten the principles of EBM? Are we comparing across trials with different designs? Should we wait for a large randomized trial to change the standard of care? The answer is no. The hierarchy that EBM applies to clinical evidence does not apply to this particular case (and many others). In this case, evidence based in cohort studies is “stronger” than the evidence obtained from a large randomized trial. The hierarchic classification of medical knowledge sometimes just does not work. The second example relates to the recommendations for the treatment of acute HIV infection. We lack the evidence of good clinical trials, and this and other guidelines do not support the use of antiretroviral therapy in this situation and instead recommend the politically correct “the patient should be enrolled in a clinical trial”. The problem is that sometimes there is no clinical trial around to enroll the patient and the patient and the doctor need to make a decision. Most HIV clinicians would evaluate that patient and if they felt there is a reasonable probability of success they would recommend treatment for a variable period of time. Again: are we all wrong? Where is EBM? Do we need a large randomized trial to recommend therapy in this situation? The answer is again probably no. There are Another year, another set of guidelines. What is the purpose of having multiple guidelines? Are they really different? Do we need a set of guidelines to treat HIV infection for each country of the world? All of us ask ourselves these kinds of questions every time we see this type of document. Obviously guidelines need to be updated as the science in the field progresses, and this document really fulfills that need. These guidelines1 are necessary, timely and reasonable, but I am supposed to editorialize about them. Kenneth Tynan, a caustic British theater critic once said that “A critic is a man who knows the way but can’t drive the car”. I feel a little like that, I know the problems of guidelines, but I do not know a very good alternative. I praise the authors for their courage writing them, and accept the criticism from people like me. The main objectives of therapeutic guidelines are to improve the quality, the appropriateness of care, and the cost-effectiveness of medical interventions, and to serve as educational tools for health care providers with less experience. There are many other, less altruistic objectives of guidelines that are almost never stated in public: recognition of the authors as experts in the particular field, setting up the “standard of care” for legal purposes in malpractice lawsuits, (especially in countries like the US where this is a frequent phenomenon), and last but not least, guiding insurance companies and governments with regards to which services should or should not be compensated. Hundreds of guidelines are published every year. There are web sites devoted to guidelines (http://www.guideline.gov); there are guidelines to make guidelines2, and articles have been published about how well guidelines follow guidelines3. Sometimes I feel we spend more time writing about how care should be done rather than providing care ourselves, and performing the studies necessary to improve it. If guidelines are used properly they are incredible tools that improve the quality of the care of our patients. If they are used like “cookbooks”, replacing clinical judgment, they become dangerous, because they remove the responsibility of care away from the physician and the individual patient. Physicians should be clearly aware that guidelines apply to populations and not necessarily to