Treatment Algorithms for Inflammatory Myopathies in Adults: from Guidelines to Clinical Practice

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Outcomes research examines the effects of healthcare interventions and policies on health outcomes for individual patients and populations in routine practice, as opposed to the idealized setting of clinical trials. A national survey from 1998 to 2000 that evaluated the extent to which patients received established processes of care for 30 medical conditions illustrated the importance of outcomes research.1 Among adults living in 12 metropolitan areas in the United States, only half of patients received proven elements of preventive care, treatments for acute illness, and chronic disease management for which they were eligible. For cardiovascular conditions, the use of proven therapies varied widely from 68% to 25% of patients who received recommended care for coronary artery disease and atrial fibrillation, respectively.1 Despite these gaps between ideal and actual care, patient outcomes have improved in many fields. For instance, the age-adjusted mortality from cardiovascular disease in the United States fell by >40% from 1980 to 2000 as a result of improvements in risk factor modification and uptake of evidence-based treatments for coronary artery disease, myocardial infarction, and heart failure.2,3 Nevertheless, many Americans do not receive the ideal recommended care (either at all or in a timely fashion), whereas others receive too much or the wrong care.4,5 In the field of cardiovascular diseases, substantial opportunities for improvement remain. Outcomes research has generated a foundation of knowledge about what constitutes ideal care and what gaps exist between ideal and actual care, but we have less understanding about how to deliver this ideal care to every patient every day. The potential for basic science breakthroughs to reach and improve the health of individual patients and populations may be substantially delayed or may not be realized if science is not efficiently translated to action. Moreover, in many cases, increased delivery of …

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Focus

British HIV Association (BHIVA) guidelines for the treatment of HIV-infected adults with antiretroviral therapy.

Well-designed and performed pivotal trials are critical in providing the efficacy and safety of a new drug for regulatory approval. The success of clinical drug development relies on the ability of clinical trial leaders to design and conduct international clinical studies. Physicians can do good clinical practice quality trials by following the protocols accurately but may not be able to design a complicated trial or lead an international clinical trial team. Clinical trial leaders are rarely born but have to be trained and learn through clinical research experience. Academic centers and drug industries have identified this need and proactively designed programs to nurture the clinical trial leaders of tomorrow via multidisciplinary programs. Using Taiwan as an example, the government has set up a Center of Excellence for Clinical Trials and Research (CECTR) in four medical centers. These national CECTRs complete a nationwide clinical trial network; strengthen clinical trial and clinical research infrastructure; set up national clinical trial and translational research centers; provide education and training for clinical researchers, doctors, nurses, and pharmacists; and improve quality, capacity, capability, and results of clinical trials. They are among the best in the world. Major pharmaceutical companies sponsored 200 international clinical trials for New Drug Applications in Taiwan in 2007. Our clinical investigators showed their clinical trial leadership by chairing many international clinical trials in Asia and worldwide. A Clinical Trial Academy for the training of clinical research leaders in Asia-Pacific is held regularly at the National CECTR at National Taiwan University Hospital. In collaboration with distinguished speakers from the industry, academia, and the local regulatory agency, promising young physicians from Asia-Pacific are trained in practical small-group workshops. Topics selected included how to perform international investigator meetings, how to write principal investigator (PI)-initiated clinical trial protocols, the concept of new drug development from the perspective of industry, experience in the institutional review board review of investigational new drug protocols, and so on. These investments in human resources have been well reflected in the number of clinical trials performed in Taiwan. Other than Australia, Taiwan has the highest number of PI-initiated clinical trials in Asia. We believe a good clinical research environment can attract young physicians to develop careers in clinical research and become clinical trial leaders of tomorrow.

The California Journal of Emergency Medicine VII:1, Jan-Mar, 2006 Page 17 Con: Should Evidence-Based Medicine Be Used More in Clinical Practice? Preston Maxim, MD Department of Emergency Medicine San Francisco General Hospital San Francisco, California A junior resident begins treatment of an elderly woman in the Emergency Department, who complains of severe epigastric abdominal pain for the last 6 hours with associated fever and vomiting. She has a rigid abdomen with diminished bowel tones, guarding and rebound. She is requesting pain medicine, but the resident refuses to give her any medications perhaps recalling the dogmatic teaching of his surgical attending, who claimed it would “mask” the etiology of her pain. When I came to see my mother-in-law 6 hours later, she remained in severe pain in spite of having a clear diagnosis of gallstone pancreatitis, based on physical, laboratory and ultrasonographic findings, and still had not received any pain medication. This in spite of a pantheon of articles finding that pain medication either improves or doesn’t change the sensitivity of physical exam findings in patients with abdominal pain. Clearly, evidence-based medicine needs to be used more in clinical practice, but there are limits within the Emergency Department. In medicine one must pay attention not to plausible theorizing, but to experience and reason together… Conclusions drawn from unaided reason can hardly be serviceable. —Hippocrates It is hard to believe that anything written now will have as much sustained relevance in medicine as the writings of Hippocrates nearly 2500 years ago. Prior to the advent of evidence-based medicine, medical practice was “plausible theorizing” based on a combination of knowledge of pathophysiology, clinical experience and common sense, a practice sometimes referred to as “authority-based medicine.” The practitioner arrived at a diagnosis based on history, physical exam and diagnostic reasoning, and when the diagnosis or treatment course remained unclear, the clinician reflected on the applicable pathophysiology of the disease, or sought the counsel of a teacher/expert in the field. Historically, the “authority-based” approach led to significant improvements in patient care and treatment regimens; however, it also produced significant clinician-based variations in patient care. Evidence-based medicine allows the comparison of different clinician-based treatment approaches and suggests which of them provide the best patient outcomes. Amongst the issues that have been examined is whether the use of analgesics in patients with abdominal pain masks the etiology of the pain. In fact, this issue has been addressed a number of times and the preponderance of evidence refutes the admonition against the use of analgesics in patients with significant abdominal pain. 1-4 The integration, albeit slowly, of this evidence and other evidence-based evaluations of clinical care has led to significant further improvements in patient outcomes. Ever since the phrase “evidence-based medicine” was defined in a 1992 JAMA article entitled “Evidence- based medicine: a new approach to teaching the practice of medicine,” there has been significant pressure to integrate “evidence” into clinical practice. 5 This has led to a relative explosion of clinical diagnostic and treatment guidelines and algorithms in the medical literature. Concomitantly, residency programs have begun to actively promote evidence-based training as a way to optimize patient care. Prior to completely abandoning the teachings of “authority-based” medicine, however, it is important to remember that there are significant issues with practicing medicine from a purely evidence-based standpoint. First of all, evidence-based medicine primarily focuses on the integration of randomized clinical trials and meta-analyses into clinical practice; however, not every clinical issue is significant enough to warrant a randomized clinical trial and other issues will never be examined in a randomized clinical trial for consent reasons. It is unlikely, for example, that a clinical trial comparing treatment modalities for chronic immersion foot in the homeless will ever be attempted, though

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