Module 1 Introduction to Research and Biostats

Introduction to Research and Biostatistics

Course Name

HLS 4000: Research and Biostatistics

Course Outline

The course provides an overview of various aspects of research, including the theories and types of research, program evaluation, data sources, and ethics in research. Noteworthy quotes on research highlight its complexity and the continual dissatisfaction that fuels inquiry; for example, Laozi said, "The more you know the less you understand," while Charles Kettering remarked, "Research is an organized method for keeping you reasonably dissatisfied with what you have."

Defining Research

Research can be defined both as a noun and a verb. As a noun, it refers to studious inquiry or examination, involving the careful collection of information on a particular subject or diligence in search. As a verb, it signifies searching or investigating exhaustively.

Research Methods

Research methods necessitate a systematic design aimed at minimizing bias, with the goal of producing findings that authentically represent reality. Research is characterized as an evolving conversation over time.

Theories and Research

A theory can be understood as a unified explanation of observations that is generalizable beyond specific testing situations and is formed from evidence that confirms an original hypothesis. In research, individual pieces of evidence contribute to the formation of a theory. Researchers utilize two primary reasoning methods: deductive reasoning, which starts with a theory and tests predefined hypotheses, and inductive reasoning, which begins with observations and aggregates evidence to develop theories.

Ideal Research Characteristics

Ideal research studies require testing within the same individual to eliminate biases, as well as consistent testing conditions and timing, while exploring multiple exposures to determine effects. However, there are questions regarding the feasibility of adhering to these ideal standards.

Categorization of Research

Research can be categorized into various types, including primary research, which involves first-hand data collection, and secondary research, which aggregates existing studies. Other categorizations include quantitative research that analyzes easily quantifiable data statistically, qualitative research which collects subjective data to identify themes, experimental research where the researcher controls treatments or interventions, and non-experimental research where the researcher merely observes without control over treatments.

In-Depth Look at Research Types

Primary research encompasses randomized controlled trials (RCTs), observational studies, and qualitative research like surveys, offering more control over methodology but being costly and resource-intensive. Conversely, secondary research includes systematic reviews, meta-analyses, and clinical guidelines, providing broader evidence summaries though with less control over data. Quantitative research reports data as numbers—suitable for large sample sizes—while qualitative research presents data as words, identifying themes through an inductive approach, such as interviewing cancer patients about their quality of life. Mixed methods research combines elements of both qualitative and quantitative approaches.

Experimental and Non-Experimental Studies

Experimental studies provide high control over variables and help in establishing cause-effect relationships, typically involving random assignment. On the other hand, non-experimental studies offer observational data without control, resulting in associations and descriptive insights, which have real-world applicability but lower control over outcomes and cannot establish causation.

Program Evaluation

Program evaluation represents specific research focused on the practical application of research findings, necessitating a needs assessment and adaptive evaluation methods. For example, an evaluation of a nurse-led education program addressing diabetic ketoacidosis management illustrates practical application.

Ethical Considerations in Research

Historically, ethical considerations in research emerged from events like the Nuremberg Code, developed in response to unethical research practices during WWII, emphasizing voluntary informed consent and risk minimization. The Tuskegee Study serves as another example of unethical research practices, where treatment and information were withheld from participants for 40 years. Key principles from the Belmont Report include beneficence (protecting participants from harm), justice (ensuring equitable treatment), and autonomy (upholding informed decision-making rights). Informed consent considers the awareness of benefits and risks, including the ability to withdraw from participation, along with respect for participant confidentiality.

Institutional Oversight in Research

Oversight is maintained through the Institutional Review Board (IRB), responsible for ensuring ethical conduct in research, alongside Good Clinical Practices (GCP) which are guidelines for ethical pharmaceutical studies.

Structure of Research Manuscripts

Research manuscripts typically follow a structured format consisting of an abstract summarizing key components, a background/introduction providing context for the study purpose, methods detailing the research execution, and results presenting numerical data without interpretation, followed by a discussion linking findings to hypotheses and a conclusion reaffirming the primary endpoint. References include citations for all referenced research materials. Notable references might include the Merriam-Webster Dictionary for research definitions, the evidence pyramid in research methodology from the BMJ, and significant studies from the New England Journal of Medicine.