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Understand research design and methodology terminology
Describe classification of research designs in clinical research
Discuss common research methodologies in clinical research
Explain importance of reliability and validity in research
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Analytical studies
Biochemical methods
Biological assessments
Biophysical assessments
Case report
Case series
Case-control studies
Causality
Close-ended questions
Cohort studies
Construct validity
Constructivism
Content validity
Convenience sampling
Convergent design
Convergent validity
Criterion validity
Cross-sectional studies
Descriptive studies
Discriminant validity
Ethnography
Experimental designs
Explanatory sequential design
Exploratory sequential design
External validity
Face validity
Focus groups
Grounded theory
Internal consistency
Internal validity
Inter-rater reliability
Intervention studies
Interviews
Judgmental
Mail surveys
Microbiological methods
Mixed methods research
Observational designs
Observational technique
Obtrusive observation
Online or internet surveys
Open-ended questions
Phenomenology
Positivism
Primary methods
Prospective cohort study
Prospective studies
Purposive sampling
Qualitative research
Quantitative research
Quasi-experimental
Quota sampling
Randomized controlled trial
Reliability
Research design
Research methodology
Retrospective cohort study
Retrospective studies
Secondary methods
Selective
Self-reports
Semi-structured interviews
Snowball sampling
Structured (or standardized) interviews
Subjective sampling
Survey instrument
Surveys
Test-retest reliability
Theoretical sampling
Unobtrusive observation
Unstructured interviews
Validity
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Research design and methodology constitute the critical backbone for a sound scientific investigation. A good design increases the validity of research findings, whereas a flawed design could cast doubts on those findings. Well-designed clinical studies provide valuable evidence to assist practitioners in making decisions that best suit the needs of the patients. When practicing evidence-based medicine (EBM), clinicians integrate their own clinical expertise with the best available clinically relevant research.1 For a study to be considered as “best available clinically relevant research,” it should have a sound research design and methodology. Poorly designed studies have limited scientific value, and when incorporated into evidence-based practice, they could be wasteful or sometimes harmful to patients. Consequently, an understanding of research designs and methodology is essential to evaluate and apply research evidence.
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The purpose of this chapter is to introduce key issues related to clinical research design and methodology for research implementation and evaluation. This chapter describes the common terminology used for clinical research designs and methodologies. It provides a brief description of different clinical research designs, using various criteria such as purpose, time orientation, and investigator orientation for classification. It also discusses research methodologies with an overview of primary data collection and secondary research methods. Methodological issues related to measurement such as validity and reliability are also discussed. This chapter concludes by describing the different data collection methods that are commonly used in clinical research.
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Research design refers to the overall plan that allows researchers to seek answers to study questions and test study hypotheses.2 In other words, the research design is the means through which a researcher can answer the question under consideration. A researcher evaluates the available study designs and selects the most appropriate design to ...