1. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins Chapter 4 EBM: A Historical Perspective

2. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins Overview of Chapter Drs. David Sacket, Gordon Guyatt, and colleagues coined the term clinical epidemiology: the vehicle through which evidence-based health care is practiced. Understand the role of clinical epidemiology in evidence- based medicine. Explain the differences between basic research, field research, and translational research. Clinical research asks questions about the usefulness of diagnostic tools and the effectiveness of prevention and treatment efforts. Understand the general goals of clinical research and evidence-based practice.

3. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins History and Direction of Clinical Fields The flaws in the assumption that the preparation and practice of physicians consistently results in optimal care are revealed: 1.When research fails to demonstrate the efficacy of interventions and the effectiveness of care. 2.When the management of patients with similar conditions varies widely among providers, care facilities, and regions. The paradigm of evidence-based practice has emerged so that the best clinical research is applied to the treatment decisions made on similar patients across disciplines, facilities. and regions. The best evidence is now more widely available to care providers everywhere because of the advances in information technology practice patterns.

4. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins Research in Medicine Biomedical research is the field in which questions related to the functions of the body, disease, responses to medications, injury mechanisms, disease and injury patterns, among others, are addressed. Biomedical research is much like a spider web, with strands representing areas of study that are often intricately connected to address complex problems.

5. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins Clinical Research Basic Science or Bench Research –Conducted in a laboratory environment under tightly controlled conditions Field Research –Conducted away from the laboratory, often in a natural setting Translational Research –Used to describe investigations that apply the results from basic science to the care of patients

6. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins Clinical Research Clinical Research: –Asks questions about the usefulness of diagnostic tools and the effectiveness of prevention and treatment efforts by enrolling patients and at-risk individuals. –Completes the translation from basic science to patient applications and lies at the heart of evidence- based medicine.

7. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins Clinical Research and Evidence-Based Practice Clinical research addresses issues of patient care: –Screening and diagnostic accuracy –Prognosis –Effectiveness of prevention and treatment strategies –Cost analyses Clinical epidemiology is the use of data collected from the study of samples to make decisions about the care of individual patients. The general goal of clinical research and EBM is to seek tests and procedures that will identify problems when they exist (specificity) but that rarely lead to false-positive findings (sensitivity). Clinicians also want to recommend prevention efforts that are generally effective and pose a low risk of adverse events.

8. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins Clinical Research and Evidence-Based Practice Prognosis studies can assist in identifying treatments that are most likely to lead to a favorable outcome. Once a level of proficiency is developed in consuming and critically appraising research related to screening, diagnosis, prevention, and treatment, the study of cost analysis will bring additional evidence to the decision-making process. This information is increasingly of interest to patients and consumers bearing an increased responsibility for paying for the services they receive.

9. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins Chapter Summary and Key Points The term “evidence-based medicine” first appeared in print in papers authored by Dr. Gordon Guyatt in 1991 and 1992. The efforts of Archie Cochrane to promote the use of randomized clinical trials to collect data to inform clinical practice were important in the development of the paradigm of evidence-based medicine. The paradigm of evidence-based health care is neither old nor fully established. Greater emphasis on translational research seeks to speed the use of new information and technology in patient care. Clinical research is essential to informing the practices of individual providers. Learning how to practice evidence-based health care is not about the provider but rather about the improved care delivered to the patient. We are all patients many times in our lives.