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INTRODUCTION

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The ultimate purpose of a profession is to develop a knowledge base that will maximize the effectiveness of practice. To that end, health professionals have recognized the necessity for documenting and testing elements of clinical practice through rigorous and objective analysis and scientific inquiry. The concept of evidence-based practice represents the fundamental principle that the provision of quality care will depend on our ability to make choices that have been confirmed by sound scientific data, and that our decisions are based on the best evidence currently available. If we look at the foundations of clinical practice, however, we are faced with the reality that often compels practitioners to make intelligent, logical, best-guess decisions when scientific evidence is either incomplete or unavailable.

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This situation is even more of an issue because of the economic challenges that continue to confront health care. Clinical research has, therefore, become an imperative, driving clinical judgments, the organization of practice, and reimbursement. The task of addressing the needs of the present and future is one that falls on the shoulders of all clinicians—whether we function as consumers of professional literature or scientific investigators—to collect meaningful data, to analyze outcomes, and to critically apply research findings to promote optimal clinical care. Through collaborative and interdisciplinary efforts, researchers and clinicians share a responsibility to explore the broadest implications of their work, to contribute to balanced scientific thought. The purpose of this text is to provide a frame of reference that will bring together the comprehensive skills needed to promote critical inquiry as part of the clinical decision making process.

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In this chapter we develop a concept of research that can be applied to clinical practice, as a method of generating new knowledge and providing evidence to justify treatment choices. We will explore an historic perspective of clinical research, the framework of evidence-based practice, the different types of research that can be applied to clinical questions, and the process of clinical research.

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DEFINING CLINICAL RESEARCH

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The concept of research in health professions has evolved along with the development of techniques of practice and changes in the health care system. Traditionally, research has connoted controlled laboratory experiments, run by scientists in white lab coats using complex instrumentation; however, the maturation of a clinical profession brings with it the realization that research has a broader meaning as it is applied to the patients and situations encountered in practice. Clinical research is a structured process of investigating facts and theories and exploring connections. It proceeds in a systematic way to examine clinical conditions and outcomes, to establish relationships among clinical phenomena, to generate evidence for decision making and to provide the impetus for improving methods of practice.

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Clinical research must be empirical and critical; that is, results must be observable, documented and examined for their validity.1 This objective process is, however, also a dynamic and creative activity, ...

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