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 Economic Challenges - Healthcare reform / Insurance Companies - Litigious Society

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 Ideal - “Scientist Practitioner” Reality - - usually not cost effective - clinicians lack the skills

Sources of Knowledge 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 WORSE BETTER Rehab is rich in tradition - offers a foundation Authority - experts (Galen - father of preventative medicine 138 -201 A.D.) Deductive - major premise - minor premise - conclusion Inductive - experience from observations - generalizations/ conclusions

Scientific Method Most rigorous process for acquiring new knowledge Incorporates elements of deduction and induction Systematic and controlled Empirical 1st Deductive - Hypothesis Later inductive - conclusions / generalizations Factor

Scientific Method Critical examination of hypothetical propositions (hypotheses) about the associations among natural phenomena

The Research Process Phase I Formulate a specific research question Phase II (Research Proposal) Describe the study Methods: Subject selection Testing Measurement

The Research Process Phase III Data collection Phase IV Analyze Interpret Draw valid conclusions Phase V Research report

Research Process Report Findings Suggestions Phase V Communication Identify Problem Review Literature Identify Variables State Hypotheses Phase I – Identify Research Question Analyze Data Interpret Findings Phase IV – Data Analysis Design Protocol Choose Sample Phase II – Design Study Collect Data Reduce Data Phase III - Methods

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

Types of Research Basic vs. Applied Experimental vs. Non-Experimental

Experimental Research True experimental Quasi-experimental Sequential clinical trials Single-case experimental designs

Non-experimental Research Descriptive Correlational Secondary Analysis Qualitative Epidemiological

Non-experimental Research Historical Evaluation Methodological

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 Thought Laws Theory testing Theory development DEDUCTION Explanation of relationships Theory testing Conceptual Framework Empirical generalizations Research Hypotheses Predicted relationships DEDUCTION Theory development INDUCTION FACTS Empirical Obseravations

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