Introduction to Research

Wilson-1982 “Research is still not accepted by

students as a respectable function for clinical practitioners.’To do’ not ‘to study’ sums up an attitude that clinical problems are far removed from research which has no value to student (clinical practitioners) immediate career goals and little clinical applicability.”

Purpose of Research Evidence-based practice

Validate clinical practice through scientific inquiry

Scientific rational must exist for clinical practice

Evidence Based Practice

Is the integration of best research evidence with clinical experience and patient values

Sackett et al 2000

Inter-relationship Between

Best Evidence Clinical Expertise Patient Preferences Clinical Context

Clinical Research Method of answering questions in

systematic and objective way Examines clinical conditions and

outcomes Establishes relationships among

clinical phenomena Provides impetus for improving

practice

Clinical Research Dynamic and creative

Using a variety of qualitative and quantitative measurement tools

Performed in a variety of settings

Justify treatment

Sources of Knowledge

WORSE

BETTER

Tradition - something is true because people have always known it to be true

Authority - if they say it is true, it must be

Trial and Error - haphazard and unsystematic

Logical Reasoning - Deductive Inductive

Scientific Method Most rigorous process for acquiring

new knowledge

Incorporates elements of deduction and induction

Systematic and controlled

Empirical

Scientific Method Critical examination of

hypothetical propositions (hypotheses) about the associations among natural phenomena

The Research Process

Phase I Formulate a specific research questionPhase II (Research Proposal) Describe the study Methods:

Subject selection Testing Measurement

The Research Process

Phase III Data collectionPhase IV Analyze Interpret Draw valid conclusions Phase V Research report

Research Process

Identify Problem

Review Literature

Identify Variables

State Hypotheses

Phase I – IdentifyResearch Question

Design ProtocolChoose Sample

Phase II – Design Study

Collect DataReduce Data

Phase III - Methods

Report FindingsSuggestions

Phase VCommunication

Analyze Data

Interpret Findings

Phase IV – DataAnalysis

Research Questions? Examination Evaluation Diagnosis Prognosis(plan of care) Intervention Outcomes

Basic vs. Applied

Experimental vs. Non-Experimental

Types of Research

True experimental

Quasi-experimental

Sequential clinical trials

Single-case experimental designs

Experimental Research

Descriptive Correlational Secondary Analysis Qualitative

Epidemiological

Non-experimental Research

Historical

Evaluation

Methodological

Non-experimental Research

Role of Theory

What is theory?

Set of inter-related concepts, definitions or propositions

Specifies relationships among variables

Represents a systematic view of specific phenomena

Role of Theory

Clinical research Systematic method for evaluating

effectiveness of treatment

Establishes basis for inductive generalizations about intervention

Research validates theory

Purpose of Theories Summarize existing knowledge

Explain observable events by showing how variables are related

Predict what should occur

Stimulate the development of new knowledge

Scientific ThoughtLaws

THEORYExplanation of relationships

Research HypothesesPredicted relationships

Conceptual FrameworkEmpirical generalizations

FACTS

Empirical Obseravations

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Characteristics of Theories

Rational explanation of observed

facts

Economical - efficient

Important

Consistent with observed facts

Theory Development Not discovered but created

Basic process is one of induction

Multiple observations collection of facts

Theory Testing In itself is not testable

Test hypotheses deduced from the theory

Validity of a theory is derived from: empirical testing of hypotheses observation of phenomena that theory

describes

Hypothesis Educated guess about outcome of study

Established after research questions are formulated and variables defined

Results of research will support or not support the hypothesis

Hypothesis Hypothesis supported theory

supported

Law theory reaches level of absolute

consistency in outcomes

Ethical Issues in Research

Relates to: conduct of clinical research in planning,

implementation and to the valuing of human dignity and the protection of human rights.

Ethical Issues in Research

Integrity of the Researcher Responsible for honesty and integrity Pursue questions in those areas of greater

importance to society Research must be meaningful Research must be reliable and valid Minimize bias Publish honest results Researchers should be aware of conflict of

interest True credit for authorship

Protection of Human Rights in Clinical Research

Clinical research - document the efficacy and efficiency of treatment interventions

Principles Respect for the individual Concern for each person’s well being Justice

Protection of Human Rights in Clinical Research

Establishment of Human Rights:

Syphilis Study

Nurenberg code of 1947

Declaration of Helsenki

1974 National Research Act

1974 National Research Act

Ensures the protection of human subjects in research:

Research proposal

Informed consent IRB approval of proposal and consent

Elements of Informed Consent

Subjects must be fully informed

Purpose

Procedures

Risks and discomforts

Benefits

Alternative to participation

Elements of Informed Consent

Confidentiality

Request for more information

Refusal or withdrawal

Injury statement

Consent statement

Signature

IRB Federal regulations (NIH) states: Must be 5 members Not all male or females , or member

of one professional group One member must be concerned with

non-scientific issues One member must not be affiliated

with the institution